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Bio

Bio

RANDALL S. STAFFORD, MD, PhD, is a Professor of Medicine at the Stanford School of Medicine and the Director of the Program on Prevention Outcomes and Practices (PPOP). After undergraduate studies in medical sociology at Reed College, Dr. Stafford received a Master's degree in Health Administration from Johns Hopkins University, a PhD in Epidemiology from UC Berkeley, and his Medical degree from UC San Francisco. He completed a residency in primary care internal medicine at Massachusetts General Hospital and a post-doctoral fellowship in epidemiology at the U.S. Centers for Disease Control and Prevention. In addition to his research focus, Dr. Stafford is a primary care physician in the Stanford Internal Medicine Clinic where he focuses on chronic disease prevention and treatment. He serves on expert committees advising a diverse range of organizations, including the California Medicaid program, the National Committee on Quality Assurance, the American Heart Association, and the American Journal of Preventive Medicine.
Professor Stafford and his research team focus on investigating physician and patient practices in order to create effective healthcare models that emphasize prevention and wellness, rather than treatment of disease symptoms. His mission is to improve population health outcomes through research that facilitates the development and broad dissemination of effective, efficient, innovative, and evidence-based prevention strategies. Examples of these innovations include team-based care, patient self-management, health policy strategies, the use of mobile health technology, and online physician retraining. In addition, Dr. Stafford seeks to develop future leaders in prevention research and to broadly communicate the critical value of a population health perspective.
Dr. Stafford has been principal investigator on many research investigations that test strategies to diminish the burden of obesity, diabetes, and heart disease while reducing health disparities and decreasing health care costs. Dr. Stafford?s rigorous, high-quality research has led to more than 160 peer-reviewed articles, including many in such high impact journals as JAMA and NEJM. His accomplishments have been recognized by advancement to fellowship in the American College of Preventive Medicine and the American Heart Association.
Professor Stafford was the founding leader of the WELL-China initiative, part of Stanford?s Wellness Living Laboratory (WELL) that has additional sites in Taiwan, Singapore, and California. Taking place in the famous city of Hangzhou, WELL-China is a multidisciplinary, collaborative initiative between Dr. Stafford, the Health Bureau of Hangzhou, and leading researchers from Zhejiang University, one of China's oldest and most prestigious universities.
The WELL-China project focuses on measuring well-being, human function, chronic disease risk factors, environmental indicators, and biomarkers in a sample of 10,000 citizen scientists recruited from the Xihu (Westlake) District of Hangzhou. By investigating the interplay among health behaviors, well-being, and the development of chronic disease, the project will make new discoveries about well-being at the community level. At the same time, the project will help local health centers reduce the burden of chronic disease in the population. The WELL-China population will also serve as a platform for clinical trials that test multiple strategies to improve and maintain well-being. Whether focused on specific conditions or aimed at well-being in the whole population, these approaches will include physical activity, sleep and stress management, dietary changes, and other modalities growing out of both Western medicine and Traditional Chinese Medicine (TCM). These comparative effectiveness clinical trials will identify the most cost-effective and sustainable approaches to improving well-being in communities.

Clinical Focus

  • Hyperlipidemia (high cholesterol)
  • Hypertension (high blood pressure)
  • Diabetes Mellitus
  • Cardiology (Heart), Preventive
  • Obesity
  • Primary Prevention
  • Internal Medicine

Academic Appointments

Administrative Appointments

  • Program Director, Program on Prevention Outcomes and Practices (2001 - Present)

Honors & Awards

  • Outstanding Teaching Award, Stanford Prevention Research Center (2009)

Boards, Advisory Committees, Professional Organizations

  • Hypertension Guidelines Working Group, American Heart Association/American College of Cardiology (2014 - 2018)
  • Board of Governors, American Journal of Preventive Medicine (2011 - 2017)
  • Drug Utilization Review Board, State of California, Department of Health Care Services (Medicaid) (2014 - Present)
  • Cardiovascular Disease Measurement Advisory Panel, National Commission for Quality Assurance (2011 - Present)

Professional Education

  • PhD Training:UC Berkeley School of Public Health (1990) CA
  • Medical Education:University of California at San Francisco School of Medicine (1992) CA
  • Residency:Massachusetts General Hospital (1994) MA
  • Fellowship:Centers for Disease Control and Prevention (1991) GA
  • Internship:Massachusetts General Hospital (1993) MA
  • MD, UC Berkeley / UC San Francisco, Medicine (1992)
  • PhD, UC Berkeley, Epidemiology (1990)
  • MS, UC Berkeley, Public Health (1988)
  • MHS, Johns Hopkins, Health Administration (1982)

Community and International Work

  • Osteoporosis Decision-Making

    Partnering Organization(s)

    University of Auckland, New Zealand

    Populations Served

    New Zealand

    Location

    International

    Ongoing Project

    Yes

    Opportunities for Student Involvement

    No

Contact

    Fax: (650) 725-6247
  • Stanford Internal Medicine 211 Quarry Rd Ste 305 MC 5987 Palo Alto, CA 94304
    • Tel: (650) 723-6028
    Fax: (650) 725-7078

Links

Research & Scholarship

Current Research and Scholarly Interests

My research aims to advance scientific understanding of the forces that influence physician and patient behavior, with a focus on evaluating and modifying physician and patient practices to improve health outcomes through prevention. The process by which new medical practices and knowledge are disseminated often fails to serve the best interests of patients. Frequently, new practices are readily adopted without adequate assessment. Paradoxically, other practices with strong evidence-based support are adopted only slowly and then inconsistently. By understanding the determinants of health behaviors, specific factors that facilitate or impede the adoption of appropriate new practices can be identified. These issues are critical to the future of medicine. Rising health care costs and the changing organization of health care have increased societal demands for high quality, yet cost-effective, clinical care. A preventive model that focuses on reducing the risk of future adverse outcomes, rather than symptom management, has become a dominant goal of health care delivery. By evaluating current practices and designing interventions to improve health care, my work responds to these demands. In addition, this nation’s investment in biomedical science is jeopardized if we fail to recognize that the adoption of new medical practices and health behaviors is a complex, yet potentially modifiable, process. My objective is to further develop the science of health care innovation as a mean for understanding current patterns of health care and as a vehicle for designing interventions to facilitate the adoption of evidence-based practices by patients, their care providers, and health care systems. This research agenda is reinforced and stimulated by an array of clinical and teaching activities. My clinical work in general internal medicine and preventive cardiology provide a rich observational experience that guides my research, as well as a context for applying clinical insights derived from my research. My educational activities involving undergraduates through post-doctoral fellows provide numerous opportunities to excite future clinicians and researchers about a population-based perspective.

My focus on the adoption of innovation encompasses four several closely related themes. First, a focal point of my research is the investigation of health care disparities by gender, race, socioeconomic status, and advanced age. Second, my work emphasizes epidemiological methods for the analysis of large, administrative data sources. Third, the measurement and improvement of health care quality is an increasingly important component of my work. Finally, my work involves use of clinical trial methods to investigate whether strategies for improvement in prevention are both effective and cost-effective. In pursuit of these four themes, my research spans a broad clinical range including cesarean section use, recommended cardiac medications, prevention practices, antibiotic use, screening tests, and patterns of disease management. While much of my research has focused on physician practices, newly initiated and planned future work emphasizes interventions that engage patients, physicians and health care systems to improve health outcomes through adherence to evidence-based recommendations. A main focus of this new line of research is optimizing the use of cardiovascular disease prevention guidelines within specific health care systems. The overarching aim of my research agenda is add to knowledge about the process of behavior change in individuals and institutional change in health care systems with the ultimate goal of improving health outcomes. A diverse portfolio of grant funding by the NIH, AHRQ, and private foundations currently supports this research agenda. The pursuit of this research agenda has been facilitated by a growing number of collaborators, trainees and staff members affiliated with my Program on Prevention Outcomes and Practices.

Clinical Trials

  • A Patient-Centered Strategy for Improving Diabetes Prevention in Urban American Indians Not Recruiting

    The goal of the proposed research is to identify effective patient-centered strategies to prevent diabetes in high-risk populations in real world settings. The investigators will accomplish this by conducting a randomized controlled trial comparing an enhanced Diabetes Prevention Program addressing psychosocial stressors to a standard version in a high-risk population of urban American Indian and Alaskan Native peoples within a primary care setting.

    Stanford is currently not accepting patients for this trial. For more information, please contact Randall S Stafford, MD, PhD, 650-724-2400.

    View full details

  • Improving Coronary Prevention in a County Health System Not Recruiting

    To examine whether the Stanford Health Education and Risk Reduction Training (HEAR2T) program , a case management approach, can be effectively used to manage the risk of coronary artery disease.

    Stanford is currently not accepting patients for this trial.

    View full details

  • Understanding Pine Bark Extract as an Alternative Treatment (UPBEAT) Study Not Recruiting

    The purpose of this study is to investigate the efficacy of Flavangenol® (Toyo Shinyaku, Japan), a pine bark extract, in lowering blood pressure and improving glycemic control and plasma lipoprotein profile.

    Stanford is currently not accepting patients for this trial. For more information, please contact Rebbeca Drieling, (650) 723 - 6528.

    View full details

  • Vivamos Activos Fair Oaks Program for Weight Loss in Low Income Latinos Not Recruiting

    Physician-based primary care has thus far failed to address the obesity epidemic. In this randomized clinical trial of 200 obese patients with heart disease risk factors, the investigators will evaluate the impact of nurse and dietitian case management on weight loss and weight maintenance, as an adjunct to physician care. In addition, the investigators will test the incremental benefit of an environmental support strategy using community health workers to help patients navigate their home and neighborhood environments to achieve weight loss. The innovative intervention model developed and evaluated in this project has the potential to provide a blueprint for successful primary care-based obesity services

    Stanford is currently not accepting patients for this trial. For more information, please contact Randall Stafford, (650) 724 - 2400.

    View full details

Projects

  • WELL-China Initiative, Stanford Prevention Research Center (2014 - 2018)

    Professor Stafford now leads the WELL-China initiative, part of Stanford?s Wellness Living Laboratory (WELL) that has additional sites in Taiwan and California. Taking place in the famous city of Hangzhou, WELL-China is a multidisciplinary, collaborative initiative between Dr. Stafford, the Health Bureau of Hangzhou, and leading researchers from Zhejiang University, one of China's oldest and most prestigious universities.
    The WELL-China project focuses on measuring well-being, human function, chronic disease risk factors, environmental indicators, and biomarkers in a sample of 10,000 citizen scientists recruited from the Xihu (Westlake) District of Hangzhou. By investigating the interplay among health behaviors, well-being, and the development of chronic disease, the project will make new discoveries about well-being at the community level. At the same time, the project will help local health centers reduce the burden of chronic disease in the population. The WELL-China population will also serve as a platform for clinical trials that test multiple strategies to improve and maintain well-being. Whether focused on specific conditions or aimed at well-being in the whole population, these approaches will include physical activity, sleep and stress management, dietary changes, and other modalities growing out of both Western medicine and Traditional Chinese Medicine (TCM). These comparative effectiveness clinical trials will identify the most cost-effective and sustainable approaches to improving well-being in communities.

    Location

    Hangzhou China

Teaching

2018-19 Courses

Graduate and Fellowship Programs

Publications

All Publications

  • Association of Visual Impairment With Economic Development Among Chinese Schoolchildren. JAMA pediatrics Jan, C., Xu, R., Luo, D., Xiong, X., Song, Y., Ma, J., Stafford, R. S. 2019: e190914

    Abstract

    Importance: Few studies have reported the association of economic growth with trends of visual impairment in schoolchildren in China or elsewhere.Objectives: To describe 30-year trends and patterns in visual impairment in China and to explore the association between visual impairment and economic development.Design, Setting, and Participants: In this time series analysis of 7 successive cross-sectional surveys from 1985 to 2014, a total of 1?951?084 schoolchildren aged 7 to 18 years from all provinces and autonomous regions of mainland China, excluding Tibet, were studied. In 1985, the survey was conducted between March to June; In 1991-2014, the surveys were conducted between September and November. Data analysis was performed from April 1, 2018, to January 31, 2019.Exposures: The province-level gross domestic product (GDP) per capita was extracted from the China Statistical Yearbook.Main Outcomes and Measures: Visual impairment, defined as unaided distance visual acuity of worse than 6/7.5 (20/25 Snellen equivalent), and moderate to severe visual impairment, defined as unaided distance visual acuity of worse than 6/18 (20/63 Snellen equivalent), in the worse eye.Results: A total of 1?951?084 participants (mean [SD] age, 12.6 [3.4] years; 50.5% male) were included in the analysis. Among students aged 7 to 18 years, the prevalence of visual impairment increased from 23.7% (95% CI, 23.6%-23.8%) in 1985 to 35.1% (95% CI, 34.9%-35.3%) in 1995 to 55.0% (95% CI, 54.8%-55.3%) in 2014. In 2014, the prevalence was higher among girls (58.3%; 95% CI, 54.8%-55.3%) vs boys (51.8%; 95% CI, 51.5%-52.1%) (prevalence ratio [PR] girls vs boys, 1.12; 95% CI, 1.11-1.13) and among students living in urban (59.9%; 95% CI, 59.6%-60.2%) vs rural (50.2%; 95% CI, 49.9%-50.5%) areas (PR urban vs rural, 1.17; 95% CI, 1.16-1.18), although a more rapid relative increase in prevalence occurred in rural areas (15.3% in 1985 to 50.2% in 2014) than in urban areas (31.5% in 1985 to 59.9% in 2014). From 1995 to 2014, the GDP in China increased from $1263 to $7594 (in 2014 US$ constant price). After demographic characteristics (cluster effect of school, age, sex, urban vs rural location, and relative socioeconomic status within province) were adjusted for, the regression model revealed that every 100% increase in GDP was associated with a 20% (PR, 1.20; 95% CI, 1.20-1.21) increase in the relative risk of visual impairment and a 27% (PR, 1.27; 95% CI, 1.26-1.27) increase in the relative risk of moderate to severe visual impairment. The association was stronger in male (PR, 1.22; 95% CI, 1.21-1.23 for male [as reference] vs 1.19; 95% CI, 1.18-1.19 for female; P<.001), rural (PR, 1.32; 95% CI, 1.31-1.33 for rural [as reference] vs 1.12; 95% CI, 1.12,-1.33 for urban; P<.001), and younger age groups (PR, 1.27; 95% CI, 1.24-1.29 for 7-9 years of age [as reference] vs 1.34; 95% CI, 1.32-1.36 for 10-12 years of age; P<.001; 1.21; 95% CI, 1.20-1.22 for 13-15 years of age; P<.001; and 1.12; 95% CI, 1.11,-1.13 for 16-18 years of age; P<.001).Conclusions and Relevance: The rapid increase of visual impairment prevalence and the association between GDP and visual impairment over time suggest that further exacerbation of childhood visual impairment may occur as economic development continues in China.

    View details for PubMedID 31058915

  • New High Blood Pressure Guidelines: Back on Track With Lower Treatment Goals, but Implementation Challenges Abound. American journal of preventive medicine Stafford, R. S. 2018

    Abstract

    The recently released 2017 High Blood Pressure Guidelines depart from past guidelines in both their approach and recommendations. Developed by multiple health organizations, including the American College of Preventive Medicine, the guidelines continue to define normal blood pressure as <120/80 mmHg, but now define hypertension as ?130/80 mmHg (previously ?140/90 mmHg). This change categorizes 101 million Americans (46% of adults) as hypertensive (compared to 32% previously). The guidelines rely heavily on findings from the Systolic Blood Pressure Intervention Trial (SPRINT). This clinical trial demonstrated substantial reductions in key adverse outcomes from intensive blood pressure management (goal systolic blood pressure <120 mmHg) compared to standard treatment (<140 mmHg). The guidelines emphasize non-drug strategies for blood pressure management, particularly healthy diet, several forms of physical activity, reduction in sodium intake, enhancement of potassium intake, reduction in alcohol use, and weight loss. A risk-based approach is recommended for drug therapy. Individuals with an elevated 10-year risk of future cardiovascular disease events should receive drug therapies for blood pressures ?130/80 mmHg, whereas those at lower risk should receive antihypertensive medications for blood pressures ?140/90 mmHg. Given that high blood pressure is poorly managed even with easier-to-reach goals, effective implementation of the guidelines will present significant challenges. The guidelines suggest that successful implementation requires the adoption of new models of chronic disease care, including team-based care, telehealth, a shift towards self-management, better approaches to patient adherence, and use of home blood pressure monitoring. Attention to systems level issues is much needed, including population-based management, aligned financial incentives, improved health literacy, community interventions, and improved access to primary care and medications.

    View details for PubMedID 30093159

  • 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines HYPERTENSION Whelton, P. K., Carey, R. M., Aronow, W. S., Casey, D. E., Collins, K. J., Himmelfarb, C., DePalma, S. M., Gidding, S., Goff, D. C., Jamerson, K. A., Jones, D. W., MacLaughlin, E. J., Muntner, P., Ovbiagele, B., Smith, S. C., Spencer, C. C., Stafford, R. S., Taler, S. J., Thomas, R. J., Williams, K. A., Williamson, J. D., Wright, J. T., Writing Committee Members 2018; 71 (6): 1269?1324

    Abstract

    Recent publications have stated that the blood pressure (BP) measurement technique used in SPRINT (Systolic Blood Pressure Intervention Trial) was unattended. However, the SPRINT protocol does not address the issue of attendance. A survey was conducted immediately after SPRINT closeout visits were completed to inquire whether BP measurements were usually attended or unattended by staff. There were 4082 participants at 38 sites that measured BP after leaving the participant alone the entire time (always alone), 2247 at 25 sites that had personnel in the room the entire time (never alone), 1746 at 19 sites that left the participant alone only during the rest period (alone for rest), and 570 at 6 sites that left the participant alone only during the BP readings (alone for BP measurement). Similar systolic and diastolic BPs within randomized groups were noted during follow-up at the majority of visits in all 4 measurement categories. In the always alone and never alone categories, the intensive group had a similarly reduced risk for the primary outcome compared with the standard group (hazard ratio, 0.62; 95% confidence interval, 0.51-0.76 and hazard ratio, 0.64; 95% confidence interval, 0.46-0.91, respectively; pairwise interaction P value, 0.88); risk was not significantly reduced for the intensive group in the smaller alone-for-rest and the alone-for-BP-measurement categories. Similar BP levels and cardiovascular disease risk reduction were observed in the intensive group in SPRINT participants whether the measurement technique used was primarily attended or unattended.URL: http://www.clinicaltrials.gov. Unique identifier: NCT01206062.

    View details for DOI 10.1161/HYP.0000000000000066

    View details for Web of Science ID 000441020300050

    View details for PubMedID 29531173

    View details for PubMedCentralID PMC5967644

  • Quality of Prescribing by Physicians, Nurse Practitioners, and Physician Assistants in the United States PHARMACOTHERAPY Jiao, S., Murimi, I. B., Stafford, R. S., Mojtabai, R., Alexander, G. 2018; 38 (4): 417?27

    Abstract

    Nurse practitioners (NPs) and physician assistants (PAs) have increasingly broad prescribing authority in the United States, yet little is known regarding how the quality of their prescribing practices compares with that of physicians. The objective of this study was to compare the quality of prescribing practices of physicians and nonphysician providers.A serial cross-sectional analysis of the 2006-2012 National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey was performed. Ambulatory care services in physician offices, hospital emergency departments, and outpatient departments were evaluated using a nationally representative sample of patient visits to physicians, NPs, and PAs. Main outcome measures were 13 validated outpatient quality indicators focused on pharmacologic management of chronic diseases and appropriate medication use.A total of 701,499 sampled patient visits were included during the study period, representing ~8.33 billion visits nationwide. Physicians were the primary provider for 96.8% of all outpatient visits examined; NPs and PAs each accounted for 1.6% of these visits. The proportion of eligible visits where quality standards were met ranged from 34.1% (angiotensin-converting enzyme inhibitor use for congestive heart failure) to 89.5% (avoidance of inappropriate medications among elderly). The median overall performance across all indicators was 58.7%. On unadjusted analyses, differences in quality of care between nonphysicians and physicians for each indicator did not consistently favor one practitioner type over others. After adjustment for potentially confounding patient and provider characteristics, the quality of prescribing by NPs and PAs was similar to the care delivered by physicians for 10 of the 13 indicators evaluated, and no consistent directional association was found between provider type and indicator fulfillment for the remaining measures.Although significant shortfalls exist in the quality of ambulatory prescribing across all practitioner types, the quality of care delivered by nonphysicians and physicians was generally comparable.

    View details for PubMedID 29457258

  • Patterns of Systolic Blood Pressure Control in the United States, 2016. Journal of general internal medicine Shah, S. J., Stafford, R. S. 2018

    View details for PubMedID 29679225

  • Overdose Risk Associated with Opioid Use upon Hospital Discharge in Veterans Health Administration Surgical Patients. Pain medicine (Malden, Mass.) Mudumbai, S. C., Lewis, E. T., Oliva, E. M., Chung, P. D., Harris, B., Trafton, J., Mariano, E. R., Wagner, T., Clark, J. D., Stafford, R. S. 2018

    Abstract

    To determine an association between opioid use upon hospital discharge (ongoing and newly started) in surgical patients and risks of opioid overdose and delirium for the first year.Retrospective, cohort study.Population-level study of Veterans Health Administration patients.All Veterans Health Administration patients (N?=?64,391) who underwent surgery in 2011, discharged after one or more days, and without a diagnosis of opioid overdose or delirium from 90?days before admission through 30 days postdischarge (to account for additional opioid dosing in the context of chronic use).Patients' opioid use was categorized as 1) no opioids, 2) tramadol only, 3) short-acting only, 4) long-acting only, 5) short- and long-acting. We calculated unadjusted incidence rates and the incidence rate ratio (IRR) for opioid overdose and drug delirium for two time intervals: postdischarge days 0-30 and days 31-365. We then modeled outcomes of opioid overdose and delirium for postdischarge days 31-365 using a multivariable extended Cox regression model. Sensitivity analysis examined risk factors for overdose for postdischarge days 0-30.Incidence of overdose was 11-fold greater from postdischarge days 0-30 than days 31-365: 26.3 events/person-year (N?=?68) vs 2.4 events/person-year (N?=?476; IRR = 10.80, 95% confidence interval [CI] = 8.37-13.92). Higher-intensity opioid use was associated with increasing risk of overdose for the year after surgery, with the highest risk for the short- and long-acting group (hazard ratio = 4.84, 95% CI = 3.28-7.14). Delirium (IRR?=?10.66, 95% CI?=?7.96-14.29) was also associated with higher opioid intensity.Surgical patients should be treated with the lowest effective intensity of opioids and be monitored to prevent opioid-related adverse events.

    View details for PubMedID 30137452

  • Improving the health and well-being of children of migrant workers BULLETIN OF THE WORLD HEALTH ORGANIZATION Jan, C., Zhou, X., Stafford, R. S. 2017; 95 (12): 850?52

    View details for DOI 10.2471/BLT.17.196329

    View details for Web of Science ID 000417649000016

  • Current Trends of Hypertension Treatment in the United States. American journal of hypertension Shah, S. J., Stafford, R. S. 2017

    Abstract

    To examine current patterns of hypertension (HTN) treatment in the United States, including blood pressure (BP) control, prevalence of different antihypertensive agents, and variations in treatment associated with patient and physician characteristics.We used data from the National Disease and Therapeutic Index (NDTI), a nationally representative physician survey produced by QuintilesIMS. We selected patients with a diagnosis of HTN and identified those prescribed antihypertensive therapies. We analyzed the type of antihypertensive agents prescribed. Extent of BP control, and associated patient and physician characteristics. We calculated 95% confidence intervals that accounted for the multistage NDTI sampling design.Among those treated for HTN in 2014, BP control varied: systolic BP (SBP) ?160 (15%) vs. SBP 150-159 (9%) vs. SBP 140-149 (19%) vs. SBP 130-139 (26%) vs. SBP <130 (32%). Of those treated for HTN, 29% used of angiotensin-converting enzyme inhibitors (ACEIs); 24%, thiazide-like diuretics; 22%, angiotensin receptor blockers (ARBs), 21%, calcium-channel blockers (CCBs); and 19% beta-blockers. Newer drugs had very limited uptake; no drugs approved after 2002 were used in more than 5% of patients. Selection of agents varied only modestly by patient and physician characteristics.The treatment of HTN in 2014 predominantly involved older medications in 5 major classes of drugs: ACEIs, thiazide diuretics, ARBs, CCBs, and beta-blockers. Selection of antihypertensive agents showed limited variation by age, gender, race, and insurance type. Although 58% of treated patients had SBP <140, 24% had poorly controlled HTN with SBP ?150, indicating the need for improved treatment.

    View details for DOI 10.1093/ajh/hpx085

    View details for PubMedID 28531239

  • Improving the health and well-being of children of migrant workers. Bulletin of the World Health Organization Jan, C., Zhou, X., Stafford, R. S. 2017; 95 (12): 850?52

    View details for PubMedID 29200527

  • Time-to-Cessation of Postoperative Opioids: A Population-Level Analysis of the Veterans Affairs Health Care System. Pain medicine Mudumbai, S. C., Oliva, E. M., Lewis, E. T., Trafton, J., Posner, D., Mariano, E. R., Stafford, R. S., Wagner, T., Clark, J. D. 2016; 17 (9): 1732-1743

    Abstract

    This study aims to determine 1) the epidemiology of perioperative opioid use; and 2) the association between patterns of preoperative opioid use and time-to-cessation of postoperative opioids.Retrospective, cohort study.National, population-level study of Veterans Healthcare Administration (VHA) electronic clinical data.All VHA patients (n?=?64,391) who underwent surgery in 2011, discharged after stays of ?1?day, and receiving ?1 opioid prescription within 90 days of discharge.Patients' preoperative opioid use were categorized as 1) no opioids, 2) tramadol only, 3) short-acting (SA) acute/intermittent (? 90 days fill), 4) SA chronic (> 90 days fill), or 5) any long-acting (LA). After defining cessation as 90 consecutive, opioid-free days, the authors calculated time-to-opioid-cessation (in days), from day 1 to day 365, after hospital discharge. The authors developed extended Cox regression models witha prioriidentified predictors. Sensitivity analyses used alternative cessation definitions (30 or 180 consecutive days).Almost 60% of the patients received preoperative opioids: tramadol (7.5%), SA acute/intermittent (24.1%), SA chronic (17.5%), and LA (5.2%). For patients opioid-free preoperatively, median time-to-cessation of opioids postoperatively was 15 days. The SA acute/intermittent cohort (HR?=1.96; 95% CI?=1.92-2.00) had greater risk for prolonged time-to-cessation than those opioid-free (reference), but lower risk than those taking tramadol only, SA chronic (HR?= 9.09; 95% CI?= 8.33-9.09), or LA opioids (HR?=?9.09; 95% CI?=?8.33-10.00). Diagnoses of chronic pain, substance-use, or affective disorders were weaker positive predictors. Sensitivity analyses maintained findings.Greater preoperative levels of opioid use were associated with progressively longer time-to-cessation postoperatively.

    View details for DOI 10.1093/pm/pnw015

    View details for PubMedID 27084410

  • Development and evaluation of an enhanced diabetes prevention program with psychosocial support for urban American Indians and Alaska natives: A randomized controlled trial CONTEMPORARY CLINICAL TRIALS Rosas, L. G., Vasquez, J. J., Naderi, R., Jeffery, N., Hedlin, H., Qin, F., LaFromboise, T., Megginson, N., Pasqua, C., Flores, O., McClinton-Brown, R., Evans, J., Stafford, R. S. 2016; 50: 28-36

    Abstract

    Diabetes is highly prevalent, affecting over 25 million adults in the US, yet it can be effectively prevented through lifestyle interventions, including the well-tested Diabetes Prevention Program (DPP). American Indian/Alaska Native (AIAN) adults, the majority of whom live in urban settings, are more than twice as likely to develop diabetes as non-Hispanic whites. Additionally, prevalent mental health issues and psychosocial stressors may facilitate progression to diabetes and hinder successful implementation of lifestyle interventions for AIAN adults. This 2-phased study first engaged community stakeholders to develop culturally-tailored strategies to address mental health concerns and psychosocial stressors. Pilot testing (completed) refined those strategies that increase engagement in an enhanced DPP for urban AIAN adults. Second, the enhanced DPP will be compared to a standard DPP in a randomized controlled trial (ongoing) with a primary outcome of body mass index (BMI) and a secondary outcome of quality of life (QoL) over 12months. Obese self-identified AIAN adults residing in an urban setting with one or more components of the metabolic syndrome (excluding waist circumference) will be randomized to the enhanced or standard DPP (n=204). We hypothesize that addressing psychosocial barriers within a culturally-tailored DPP will result in clinical (BMI) and superior patient-centered (QoL) outcomes as compared to a standard DPP. Exploratory outcomes will include cardiometabolic risk factors (e.g., waist circumference, blood pressure, fasting glucose) and health behaviors (e.g., diet, physical activity). Results of this trial may be applicable to other urban AIAN or minority communities or even diabetes prevention in general.

    View details for DOI 10.1016/j.cct.2016.06.015

    View details for PubMedID 27381232

  • Patterns and Correlates of Baseline Thiazide-Type Diuretic Prescription in the Systolic Blood Pressure Intervention Trial HYPERTENSION Chang, T. I., Evans, G., Cheung, A. K., Cushman, W. C., Diamond, M. J., Dwyer, J. P., Huan, Y., Kitzman, D., Kostis, J. B., Oparil, S., Rastogi, A., Roumie, C. L., Sahay, R., Stafford, R. S., Taylor, A. A., Wright, J. T., Chertow, G. M. 2016; 67 (3): 550-555

    Abstract

    Thiazides and thiazide-type diuretics are recommended as first-line agents for the treatment of hypertension, but contemporary information on their use in clinical practice is lacking. We examined patterns and correlates of thiazide prescription in a cross-sectional analysis of baseline data from participants enrolled in the Systolic Blood Pressure Intervention Trial (SPRINT). We examined baseline prescription of thiazides in 7582 participants receiving at least 1 antihypertensive medication by subgroup, and used log-binomial regression to calculate adjusted prevalence ratios for thiazide prescription (versus no thiazide). Forty-three percent of all participants were prescribed a thiazide at baseline, but among participants prescribed a single agent, the proportion was only 16%. The prevalence of thiazide prescription differed significantly by demographic factors, with younger participants, women, and blacks all having higher adjusted prevalence of thiazide prescription than other corresponding subgroups. Participants in the lowest category of kidney function (estimated glomerular filtration rate <30 mL/min per 1.73 m2) were half as likely to be prescribed a thiazide as participants with preserved kidney function. In conclusion, among persons with hypertension and heightened cardiovascular risk, we found that thiazide prescription varied significantly by demographics and kidney disease status, despite limited evidence about relative differences in effectiveness.

    View details for DOI 10.1161/HYPERTENSIONAHA.115.06851

    View details for PubMedID 26865200

  • The effectiveness of two community-based weight loss strategies among obese, low-income US Latinos. Journal of the Academy of Nutrition and Dietetics Rosas, L. G., Thiyagarajan, S., Goldstein, B. A., Drieling, R. L., Romero, P. P., Ma, J., Yank, V., Stafford, R. S. 2015; 115 (4): 537-50 e2

    Abstract

    Latino immigrants have high rates of obesity and face barriers to weight loss.To evaluate the effectiveness of a case-management (CM) intervention with and without community health workers (CHWs) for weight loss.This was a 2-year, randomized controlled trial comparing two interventions with each other and with usual care (UC).Eligible participants included Latinos with a body mass index of 30 to 60 and one or more heart disease risk factors. The 207 participants recruited during 2009-2010 had a mean age of 47 years and were mostly women (77%). At 24 months, 86% of the sample was assessed.The CM+CHW (n=82) and CM (n=84) interventions were compared with each other and with UC (n=41). Both included an intensive 12-month phase followed by 12 months of maintenance. The CM+CHW group received home visits.Weight change at 24 months.Generalized estimating equations using intent-to-treat.At 6 months, mean weight loss in the CM+CHW arm was -2.1 kg (95% CI -2.8 to -1.3) or -2% of baseline weight (95% CI -1% to -2%) compared with -1.6 kg (95% CI -2.4 to -0.7; % weight change, -2%, -1%, and -3%) in CM and -0.9 kg (95% CI -1.8 to 0.1; % weight change, -1%, 0%, and -2%) in UC. By 12 and 24 months, differences narrowed and CM+CHW was no longer statistically distinct. Men achieved greater weight loss than women in all groups at each time point (P<0.05). At 6 months, men in the CM+CHW arm lost more weight (-4.4 kg; 95% CI -6.0 to -2.7) compared with UC (-0.4 kg; 95% CI -2.4 to 1.5), but by 12 and 24 months differences were not significant.This study demonstrated that incorporation of CHWs may help promote initial weight loss, especially among men, but not weight maintenance. Additional strategies to address social and environmental influences may be needed for Latino immigrant populations.

    View details for DOI 10.1016/j.jand.2014.10.020

    View details for PubMedID 25578925

  • The Effectiveness of Two Community-Based Weight Loss Strategies among Obese, Low-Income US Latinos JOURNAL OF THE ACADEMY OF NUTRITION AND DIETETICS Rosas, L. G., Thiyagarajan, S., Goldstein, B. A., Drieling, R. L., Romero, P. P., Ma, J., Yank, V., Stafford, R. S. 2015; 115 (4): 537-U300

    Abstract

    Latino immigrants have high rates of obesity and face barriers to weight loss.To evaluate the effectiveness of a case-management (CM) intervention with and without community health workers (CHWs) for weight loss.This was a 2-year, randomized controlled trial comparing two interventions with each other and with usual care (UC).Eligible participants included Latinos with a body mass index of 30 to 60 and one or more heart disease risk factors. The 207 participants recruited during 2009-2010 had a mean age of 47 years and were mostly women (77%). At 24 months, 86% of the sample was assessed.The CM+CHW (n=82) and CM (n=84) interventions were compared with each other and with UC (n=41). Both included an intensive 12-month phase followed by 12 months of maintenance. The CM+CHW group received home visits.Weight change at 24 months.Generalized estimating equations using intent-to-treat.At 6 months, mean weight loss in the CM+CHW arm was -2.1 kg (95% CI -2.8 to -1.3) or -2% of baseline weight (95% CI -1% to -2%) compared with -1.6 kg (95% CI -2.4 to -0.7; % weight change, -2%, -1%, and -3%) in CM and -0.9 kg (95% CI -1.8 to 0.1; % weight change, -1%, 0%, and -2%) in UC. By 12 and 24 months, differences narrowed and CM+CHW was no longer statistically distinct. Men achieved greater weight loss than women in all groups at each time point (P<0.05). At 6 months, men in the CM+CHW arm lost more weight (-4.4 kg; 95% CI -6.0 to -2.7) compared with UC (-0.4 kg; 95% CI -2.4 to 1.5), but by 12 and 24 months differences were not significant.This study demonstrated that incorporation of CHWs may help promote initial weight loss, especially among men, but not weight maintenance. Additional strategies to address social and environmental influences may be needed for Latino immigrant populations.

    View details for DOI 10.1016/j.jand.2014.10.020

    View details for Web of Science ID 000351779000008

    View details for PubMedID 25578925

    View details for PubMedCentralID PMC4380577

  • Tackling China's noncommunicable diseases: shared origins, costly consequences and the need for action. Chinese medical journal Min, Y., Jiang, L., Yan, L. L., Wang, L., Basu, S., Wu, Y., Stafford, R. S. 2015; 128 (6): 839-843

    View details for DOI 10.4103/0366-6999.152690

    View details for PubMedID 25758283

  • National Trends in the Ambulatory Treatment of Hypertension in the United States, 1997-2012 PLOS ONE Zhou, M., Daubresse, M., Stafford, R. S., Alexander, G. C. 2015; 10 (3)

    Abstract

    Hypertension is common and costly. Over the past decade, new antihypertensive therapies have been developed, several have lost patent protection and additional evidence regarding the safety and effectiveness of these agents has accrued.To examine trends in the use of antihypertensive therapies in the United States between 1997 and 2012.We used nationally representative audit data from the IMS Health National Disease and Therapeutic Index to examine the ambulatory pharmacologic treatment of hypertension.Our primary unit of analysis was a visit where hypertension was a reported diagnosis and treated with a pharmacotherapy (treatment visit). We restricted analyses to the use of six therapeutic classes of antihypertensive medications among individuals 18 years or older.Annual hypertension treatment visits increased from 56.9 million treatment visits (95% confidence intervals [CI], 53.9-59.8) in 1997 to 83.3 million visits (CI 79.2-87.3) in 2008, then declined steadily to 70.9 million visits (CI 66.7-75.0) by 2012. Angiotensin receptor blocker utilization increased substantially from 3% of treatment visits in 1997 to 18% by 2012, whereas calcium channel blocker use decreased from 27% to 18% of visits. Rates of diuretic and beta-blocker use remained stable and represented 24%-30% and 14-16% of visits, respectively. Use of direct renin inhibitor accounted for fewer than 2% of annual visits. The proportion of visits treated using fixed-dose combination therapies increased from 28% to 37% of visits.Several important changes have occurred in the landscape of antihypertensive treatment in the United States during the past decade. Despite their novel mechanism of action, the adoption rate of direct renin inhibitors remains low.

    View details for DOI 10.1371/journal.pone.0119292

    View details for PubMedID 25738503

  • Ambulatory Diagnosis and Treatment of Nonmalignant Pain in the United States, 2000-2010 MEDICAL CARE Daubresse, M., Chang, H., Yu, Y., Viswanathan, S., Shah, N. D., Stafford, R. S., Kruszewski, S. P., Alexander, G. C. 2013; 51 (10): 870-878

    Abstract

    Escalating rates of prescription opioid use and abuse have occurred in the context of efforts to improve the treatment of nonmalignant pain.The aim of the study was to characterize the diagnosis and management of nonmalignant pain in ambulatory, office-based settings in the United States between 2000 and 2010.Serial cross-sectional and multivariate regression analyses of the National Ambulatory Medical Care Survey (NAMCS), a nationally representative audit of office-based physician visits, were conducted.(1) Annual visit volume among adults with primary pain symptom or diagnosis; (2) receipt of any pain treatment; and (3) receipt of prescription opioid or nonopioid pharmacologic therapy in visits for new musculoskeletal pain.Primary symptoms or diagnoses of pain consistently represented one-fifth of visits, varying little from 2000 to 2010. Among all pain visits, opioid prescribing nearly doubled from 11.3% to 19.6%, whereas nonopioid analgesic prescribing remained unchanged (26%-29% of visits). One-half of new musculoskeletal pain visits resulted in pharmacologic treatment, although the prescribing of nonopioid pharmacotherapies decreased from 38% of visits (2000) to 29% of visits (2010). After adjusting for potentially confounding covariates, few patient, physician, or practice characteristics were associated with a prescription opioid rather than a nonopioid analgesic for new musculoskeletal pain, and increases in opioid prescribing generally occurred nonselectively over time.Increased opioid prescribing has not been accompanied by similar increases in nonopioid analgesics or the proportion of ambulatory pain patients receiving pharmacologic treatment. Clinical alternatives to prescription opioids may be underutilized as a means of treating ambulatory nonmalignant pain.

    View details for PubMedID 24025657

  • From Sick Care to Health Care - Reengineering Prevention into the U.S. System NEW ENGLAND JOURNAL OF MEDICINE Marvasti, F. F., Stafford, R. S. 2012; 367 (10): 889-891

    View details for DOI 10.1056/NEJMp1206230

    View details for PubMedID 22931257

  • Practical Research Strategies for Reducing Social and Racial/Ethnic Disparities in Obesity. International journal of obesity Rosas, L. G., Stafford, R. S. 2012; 2012 (2): s16-s22

    Abstract

    Adult and childhood obesity and related adverse outcomes are most common among racial/ethnic minorities and socio-economically disadvantaged populations in the United States . Research approaches to obesity developed in mainstream populations and deploying new information technologies may exacerbate existing disparities in obesity. Current obesity management and prevention research priorities will not maximally impact this critical problem unless investigators explicitly focus on discovering innovative strategies for preventing and managing obesity in the disadvantaged populations that are most affected. On the basis of our research experience, four key research approaches are needed: (1) elucidating the underlying social forces that lead to disparities; (2) directly involving community members in the development of research questions and research methods; (3) developing flexible strategies that allow tailoring to multiple disadvantaged populations; and (4) building culturally and socio-economically tailored strategies specifically for populations most affected by obesity. Our experience with a community-based longitudinal cohort study and two health center-based clinical trials illustrate these principles as a contrast to traditional research priorities that can inadvertently worsen existing social inequities. If obesity research does not directly address healthcare and health-outcome disparities, it will contribute to their perpetuation.

    View details for PubMedID 23667289

  • Off-Label Use of Drugs and Medical Devices: A Review of Policy Implications CLINICAL PHARMACOLOGY & THERAPEUTICS Stafford, R. S. 2012; 91 (5): 920-925

    View details for DOI 10.1038/clpt.2012.22

    View details for Web of Science ID 000303047400027

    View details for PubMedID 22472990

  • Enhancing Prescription Drug Innovation and Adoption ANNALS OF INTERNAL MEDICINE Alexander, G. C., O'Connor, A. B., Stafford, R. S. 2011; 154 (12): 833-U89

    Abstract

    The adoption and use of a new drug would ideally be guided by its innovation and cost-effectiveness. However, information about the relative efficacy and safety of a drug is typically incomplete even well after market entry, and various other forces create a marketplace in which most new drugs are little better than their older counterparts. Five proposed mechanisms are considered for promoting innovation and reducing the use of therapies ultimately found to offer poor value or have unacceptable risks. These changes range from increasing the evidence required for U.S. Food and Drug Administration approval to modifying the structure of drug reimbursement. Despite the challenges of policy implementation, the United States has a long history of successfully improving the societal value and safe use of prescription medicines.

    View details for Web of Science ID 000291800500020

    View details for PubMedID 21690598

  • Systematic Review: Benefits and Harms of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications ANNALS OF INTERNAL MEDICINE Yank, V., Tuohy, C. V., Logan, A. C., Bravata, D. M., Staudenmayer, K., Eisenhut, R., Sundaram, V., McMahon, D., Olkin, I., McDonald, K. M., Owens, D. K., Stafford, R. S. 2011; 154 (8): 529-W190

    Abstract

    Recombinant factor VIIa (rFVIIa), a hemostatic agent approved for hemophilia, is increasingly used for off-label indications.To evaluate the benefits and harms of rFVIIa use for 5 off-label, in-hospital indications: intracranial hemorrhage, cardiac surgery, trauma, liver transplantation, and prostatectomy.Ten databases (including PubMed, EMBASE, and the Cochrane Library) queried from inception through December 2010. Articles published in English were analyzed.Two reviewers independently screened titles and abstracts to identify clinical use of rFVIIa for the selected indications and identified all randomized, controlled trials (RCTs) and observational studies for full-text review.Two reviewers independently assessed study characteristics and rated study quality and indication-wide strength of evidence.16 RCTs, 26 comparative observational studies, and 22 noncomparative observational studies met inclusion criteria. Identified comparators were limited to placebo (RCTs) or usual care (observational studies). For intracranial hemorrhage, mortality was not improved with rFVIIa use across a range of doses. Arterial thromboembolism was increased with medium-dose rFVIIa use (risk difference [RD], 0.03 [95% CI, 0.01 to 0.06]) and high-dose rFVIIa use (RD, 0.06 [CI, 0.01 to 0.11]). For adult cardiac surgery, there was no mortality difference, but there was an increased risk for thromboembolism (RD, 0.05 [CI, 0.01 to 0.10]) with rFVIIa. For body trauma, there were no differences in mortality or thromboembolism, but there was a reduced risk for the acute respiratory distress syndrome (RD, -0.05 [CI, -0.02 to -0.08]). Mortality was higher in observational studies than in RCTs.The amount and strength of evidence were low for most outcomes and indications. Publication bias could not be excluded.Limited available evidence for 5 off-label indications suggests no mortality reduction with rFVIIa use. For some indications, it increases thromboembolism.

    View details for PubMedID 21502651

  • National trends in stunting, thinness and overweight among Chinese school-aged children, 1985-2014 INTERNATIONAL JOURNAL OF OBESITY Song, Y., Agardh, A., Ma, J., Li, L., Lei, Y., Stafford, R. S., Prochaska, J. J. 2019; 43 (2): 402?11

    Abstract

    We sought to examine changes in regional and sex disparities in stunting, thinness, and overweight among Chinese school-aged children from 1985 to 2014.We analyzed data on 1,489,953 children aged 7-18 years in the Chinese National Survey on Students' Constitution and Health. Stunting, thinness, and overweight were defined according to WHO anthropomorphic definitions. After adjustment for age, socioeconomic status, and school, logistic regression was used to estimate the prevalence of stunting, thinness, and overweight by region and sex over 30 years' time.From 1985 to 2014, the prevalence of stunting progressively decreased from 16.4% in 1985 to 2.3% in 2014, thinness prevalence also declined overtime, from 8.4 to 4.0% and overweight prevalence continually increased from 1.1% in 1985 to 20.4% in 2014 in Chinese school-aged children. Stunting and thinness were more common in rural areas, although urban/rural differences declined over time. Overweight was a greater problem in urban than rural areas, and this difference increased over time. Some provinces showed high levels of stunting, thinness, and overweight. The stunting prevalence of boys was higher than girls from 1985 and 1995, but lower than girls for the past 15 years. Thinness was consistently more common in boys than girls across regions and time. Overweight continuously increased for boys and girls; however, the increase was more rapid in boys.Over the past 30 years, Chinese children have shifted in anthropomorphic measures indicating a shift from problems of under-nutrition to measures consistent with over-nutrition, particularly in urban areas and among boys. Some regions are burdened by problems of both under- and over-nutrition. Regional and sex-specific guidelines and public health policies for childhood nutrition are needed in China.

    View details for PubMedID 29915362

  • Neural correlates of perceived physical and mental fatigability in older adults: A pilot study EXPERIMENTAL GERONTOLOGY Wasson, E., Rosso, A. L., Santanasto, A. J., Rosano, C., Butters, M. A., Rejeski, W., Boudreau, R. M., Aizenstein, H., Gmelin, T., Glynn, N. W., Pahor, M., Guralnik, J. M., Anton, S. D., Buford, T. W., Leeuwenburgh, C., Nayfield, S. G., Manini, T. M., Caudle, C., Crump, L., Holmes, L., Lee, J., Lu, C., Miller, M. E., Espeland, M. A., Ambrosius, W. T., Applegate, W., Beavers, D. P., Byington, R. P., Cook, D., Furberg, C. D., Harvin, L. N., Henkin, L., Hepler, J., Hsu, F., Joyce, K., Lovato, L., Pierce, J., Roberson, W., Robertson, J., Rushing, J., Rushing, S., Stowe, C. L., Walkup, M. P., Hire, D., Katula, J. A., Brubaker, P. H., Mihalko, S. L., Jennings, J. M., Hadley, E. C., Romashkan, S., Patel, K., Bonds, D., Mcdermott, M. M., Spring, B., Hauser, J., Kerwin, D., Domanchuk, K., Graff, R., Rego, A., Church, T. S., Blair, S. N., Myers, V. H., Monce, R., Britt, N. E., Harris, M., McGucken, A., Rodarte, R., Millet, H. K., Tudor-Locke, C., Butitta, B. P., Donatto, S. G., Cocreham, S. H., King, A. C., Castro, C. M., Haskell, W. L., Stafford, R. S., Pruitt, L. A., Yank, V., Berra, K., Bell, C., Thiessen, R. M., Youngman, K. P., Virgen, S. B., Maldonado, E., Tarin, K. N., Klaftenegger, H., Prosak, C. A., Campero, I., Garcia, D. M., Soto, J., Chio, L., Hoskins, D., Fielding, R. A., Nelson, M. E., Folta, S. C., Phillips, E. M., Liu, C. K., McDavitt, E. C., Reid, K. F., Kim, D. R., Pasha, E. P., Kim, W. S., Krol, J. M., Beard, V. E., Tsiroyannis, E. X., Hau, C., Marsiske, M., Sandesara, B. D., Black, M. L., Burk, W. L., Hoover, B. M., Knaggs, J. D., Marena, W. C., Korytov, I., Curtis, S. D., Lorow, M. S., Goswami, C. S., Lewis, M. A., Kamen, M., Bitz, J. N., Stanton, B. K., Hicks, T. T., Gay, C. W., Xie, C., Morris, H. L., Singletary, F. F., Causer, J., Yonce, S., Radcliff, K. A., Smith, M., Scott, J. S., Rodriguez, M. M., Fitch, M. S., Dunn, M. C., Schllesinger, J. Q., Newman, A. B., Studenski, S. A., Goodpaster, B. H., Lopez, O., Nadkarni, N. K., Ives, D. G., Newman, M. A., Grove, G., Williams, K., Bonk, J. T., Rush, J., Kost, P., Vincent, P., Gerger, A., Romeo, J. R., Monheim, L. C., Kritchevsky, S. B., Marsh, A. P., Brinkley, T. E., Demons, J. S., Sink, K. M., Kennedy, K., Shertzer-Skinner, R., Wrights, A., Fries, R., Barr, D., Gill, T. M., Axtell, R. S., Kashaf, S. S., de Rekeneire, N., McGloin, J. M., Mautner, R., Huie-White, S. M., Bianco, L., Zocher, J., Wu, K. C., Shepard, D. M., Fennelly, B., Castro, R., Halpin, S., Brennan, M., Barnett, T., Iannone, L. P., Zenoni, M. A., Bugaj, J. A., Bailey, C., Charpentier, P., Hawthorne-Jones, G., Mignosa, B., Lewis, L., Williamson, J., Hendrie, H. C., Rapp, S. R., Verghese, J., Woolard, N., Espeland, M., Jennings, J., Wilson, V. K., Pepine, C. J., Ariet, M., Handberg, E., Deluca, D., Hill, J., Szady, A., Chupp, G. L., Flynn, G. M., Hankinson, J. L., Fragoso, C., Groessl, E. J., Kaplan, R. M., LIFE Study Grp 2019; 115: 139?47

    Abstract

    This pilot work examined associations of brain grey matter volumes (GMV) with perceived fatigability in older adults to elucidate disablement mechanisms. A subsample (n?=?29; age?=?77.2?±?5.5; 86% female) of participants from the Lifestyle Interventions and Independence for Elders (LIFE) Study was utilized to quantify GMV for regions of interest in the basal ganglia and limbic system normalized to intracranial volume. The Pittsburgh Fatigability Scale measured physical and mental fatigability (score 0-50; higher physical fatigability???15; higher mental fatigability???13). We used an exploratory alpha level of p?

    View details for DOI 10.1016/j.exger.2018.12.003

    View details for Web of Science ID 000455223100016

    View details for PubMedID 30528639

    View details for PubMedCentralID PMC6331252

  • Effect of Hospitalizations on Physical Activity Patterns in Mobility-Limited Older Adults. Journal of the American Geriatrics Society Wanigatunga, A. A., Gill, T. M., Marsh, A. P., Hsu, F., Yaghjyan, L., Woods, A. J., Glynn, N. W., King, A. C., Newton, R. L., Fielding, R. A., Pahor, M., Manini, T. M., Lifestyles Intervention and Independence for Elders Study Investigators 2018

    Abstract

    OBJECTIVES: To evaluate the effect of hospitalizations on patterns of sedentary and physical activity time in mobility-limited older adults randomized to structured physical activity or health education.DESIGN: Secondary analysis of investigator-blinded, parallel-group, randomized trial conducted at 8 U.S. centers between February 2010 and December 2013.PARTICIPANTS: Sedentary men and women aged 70 to 89 at baseline who wore a hip-fitted accelerometer 7 consecutive days at baseline and 6, 12, and 24 months after randomization (N=1,341).MEASUREMENTS: Participants were randomized to a physical activity (PA; n = 669) intervention that included aerobic, resistance, and flexibility training or to a health education (HE; n = 672) intervention that consisted of workshops on older adult health and light upper-extremity stretching. Accelerometer patterns were characterized as bouts of sedentary (<100 counts/min; ?1, ?10, ?30, ?60 minute lengths) and activity (?100 counts/min; ?1, ?2, ?5, ?10 minute lengths) time. Each participant was categorized as having 0, 1 to 3, or 4 or more cumulative hospital days before each accelerometer assessment.RESULTS: Hospitalization increased sedentary time similarly in both intervention groups (8 min/d for 1-3 cumulative hospital days and 16 min/d for ?4 cumulative hospital days). Hospitalization was also associated with less physical activity time across all bouts of less than 10 minutes (?1: -7 min/d for 1-3 cumulative hospital days, -16 min/d for ?4 cumulative hospital days; ?2: -5 min/d for 1-3 cumulative hospital days, -11 min/d for ?4 cumulative hospital days; ?5: -3 min/d for 1-3 cumulative hospital days, -4 min/d for ?4 cumulative hospital days). There was no evidence of recovery to prehospitalization levels (time effect p >.41). PA participants had less sedentary time in bouts of less than 30 minutes than HE participants (-8 to -10 min/d) and more total activity (+3 to +6 min/d), although hospital-related changes were similar between the intervention groups (interaction effect p >.26).CONCLUSION: Participating in a PA intervention before hospitalization had expected benefits, but participants remained susceptible to hospitalization's detrimental effects on their daily activity levels. There was no evidence of better activity recovery after hospitalization.

    View details for PubMedID 30452084

  • The Effect of a Behavioral Weight-Loss Intervention on Depressive Symptoms Among Latino Immigrants in a Randomized Controlled Trial JOURNAL OF IMMIGRANT AND MINORITY HEALTH Figueroa, S., Stafford, R. S., Heaney, C. A., Rosas, L. G. 2018; 20 (5): 1182?89

    Abstract

    Evidence of whether behavioral weight-loss interventions reduce depressive symptoms among Latino immigrants is limited. The effect of a behavioral weight-loss intervention on depressive symptoms was assessed using data from a clinical trial among Latino immigrants. Participants were randomized to a usual care (UC) control (n?=?41), case management (CM) alone (n?=?84), or CM with community health worker support (CM+CHW) (n?=?82). Generalized estimating equation models were used to compare the impact of each intervention with UC. Effect modification by poverty level was further investigated. Overall, treatment groups were not significantly associated with 24-month changes in CES-D scores. Among participants below the 100% federal poverty level (FPL), those randomized to CM+CHW had 24-month CES-D scores significantly lower (? coefficient?=?0.72; 95% CI 0.55-0.93) than those in UC (p?=?0.01). A behavioral weight-loss intervention providing case management and support from a CHW reduced depressive symptoms among Latino immigrants below the 100% FPL.

    View details for PubMedID 29038966

  • Off-label prescription: experience is a gloomy lantern that does not even illuminate its bearer. Author response JOURNAL OF CLINICAL EPIDEMIOLOGY Ladanie, A., Ioannidis, J. A., Stafford, R. S., Ewald, H., Bucher, H. C., Hemkens, L. G., Hemkens, L. G. 2018; 101: 127?28

    View details for PubMedID 29800688

  • Biomarkers, menopausal hormone therapy and risk of venous thrombosis: The Women's Health Initiative RESEARCH AND PRACTICE IN THROMBOSIS AND HAEMOSTASIS Cushman, M., Larson, J. C., Rosenthal, F. R., Heckbert, S. R., Curb, J., Phillips, L. S., Baird, A. E., Eaton, C. B., Stafford, R. S. 2018; 2 (2): 310?19

    Abstract

    Oral menopausal hormone therapy causes venous thrombosis but whether biomarkers of thrombosis risk can identify women at risk is unknown.We completed a nested case control study in the two Women's Health Initiative hormone trials; 27 347 women aged 50-79 were randomized to hormone therapy (conjugated equine estrogen with or without medroxyprogesterone acetate) or placebo. With 4 years follow-up, biomarkers were measured using stored baseline samples prior to starting treatment, and one-year later, in 215 women who developed thrombosis and 867 controls.Overall, lower protein C and free protein S, and higher D-dimer, prothrombin fragment 1.2 and plasmin-antiplasmin complex were associated with risk of future thrombosis with odds ratios ranging from 1.9 to 3.2. Compared to women with normal biomarkers assigned to placebo, the risk of thrombosis with hormone therapy was increased among women with abnormal biomarkers, especially elevated D-dimer, elevated plasmin-antiplasmin, and low free protein S; the largest association was for D-dimer: odds ratio 6.0 (95% CI 3.6-9.8). Differences in associations by hormone use were not significant on the multiplicative scale. Considering a multi-marker score of eight biomarkers, women with three or more abnormal biomarkers had 15.5-fold increased odds of VT (95% CI 6.8-35.1). One-year changes in biomarkers were not robustly associated with subsequent thrombosis risk.Abnormal levels of biomarkers of thrombosis risk identified women at increased risk of future venous thrombosis with oral menopausal hormone therapy. Findings support the potential for clinical use of D-dimer testing in advance of hormone therapy prescription.

    View details for PubMedID 30046733

  • UNDERSTANDING HISTORICAL TRAUMA AMONG INDIGENOUS ADULTS AT RISK FOR DIABETES TO INFORM BEHAVIORAL INTERVENTIONS Garcia, L. C., Vasquez, J. J., Stafford, R. S., Sallas, I., Kendrick, A. E., Rosas, L. OXFORD UNIV PRESS INC. 2018: S219

    View details for Web of Science ID 000431185200516

  • Off-label treatments were not consistently better or worse than approved drug treatments in randomized trials JOURNAL OF CLINICAL EPIDEMIOLOGY Ladanie, A., Ioannidis, J. A., Stafford, R. S., Ewald, H., Bucher, H. C., Hemkens, L. G. 2018; 94: 35?45

    Abstract

    Off-label drug use is highly prevalent but controversial and often discouraged assuming generally inferior medical effects associated with off-label use.We searched PubMed, MEDLINE, PubMed Health, and the Cochrane Library up to May 2015 for systematic reviews including meta-analyses of randomized clinical trials (RCTs) comparing off-label and approved drugs head-to-head in any population and on any medical outcome. We combined the comparative effects in meta-analyses providing summary odds ratios (sOR) for each treatment comparison and outcome, and then calculated an overall summary of the sOR across all comparisons (ssOR).We included 25 treatment comparisons with 153 RCTs and 24,592 patients. In six of 25 comparisons (24%), off-label drugs were significantly superior (five of 25) or inferior (one of 25) to approved treatments. There was substantial statistical heterogeneity across comparisons (I2 = 43%). Overall, off-label drugs were more favorable than approved treatments (ssOR 0.72; 95% CI = 0.54-0.95). Analyses of patient-relevant outcomes were similar (statistical significant differences in 24% (six of 25); ssOR 0.74; 95% CI = 0.56-0.98; I2 = 60%). Analyses of primary outcomes of the systematic reviews (n = 22 comparisons) indicated less heterogeneity and no statistically significant difference overall (ssOR 0.85; 95% CI = 0.67-1.06; I2 = 0%).Approval status does not reliably indicate which drugs are more favorable in situations with clinical trial evidence comparing off-label with approved use. Drug effectiveness assessments without considering off-label use may provide incomplete information. To ensure that patients receive the best available care, funding, policy, reimbursement, and treatment decisions should be evidence based considering the entire spectrum of available therapeutic choices.

    View details for PubMedID 29146289

  • The association between insulin resistance and atrial fibrillation: A cross-sectional analysis from SPRINT (Systolic Blood Pressure Intervention Trial) JOURNAL OF CLINICAL HYPERTENSION Cho, M. E., Craven, T. E., Cheung, A. K., Glasser, S. P., Rahman, M., Soliman, E. Z., Stafford, R. S., Johnson, K. C., Bates, J. T., Burgner, A., Taylor, A. A., Tamariz, L., Tang, R., Beddhu, S., SPRINT Study Res Grp 2017; 19 (11): 1152?61

    Abstract

    It is unclear whether metabolic syndrome (MetS) is associated with atrial fibrillation (AF) in an older population with greater cardiovascular risk, including those with chronic kidney disease. The authors investigated the association between MetS and AF in participants in SPRINT (Systolic Blood Pressure Intervention Trial). MetS was defined based on the Modified Third National Cholesterol Education Program. The baseline prevalence rate for MetS was 55%, while 8.2% of the participants had AF. In multivariate regression analyses, AF was not associated with presence of MetS in either chronic kidney disease or non-chronic kidney disease subgroups. Age, race, history of cardiovascular diseases, decreased triglycerides, decreased pulse pressure, and albuminuria remained significantly associated with AF risk. In contrast to the general population, MetS was not associated with AF in the older population with increased cardiovascular risk studied in SPRINT.

    View details for PubMedID 28866864

  • Impact of moderate physical activity on the longitudinal trajectory of a cardiac specific biomarker of injury: Results from a randomized pilot study of exercise intervention. American heart journal Defilippi, C. R., de Lemos, J. A., Newman, A. B., Guralnik, J. M., Christenson, R. H., Pahor, M., Church, T., Espeland, M., Krithevsky, S. B., Stafford, R., Seliger, S. L. 2016; 179: 151-156

    Abstract

    In animal models, physical activity (PA) prevents cardiac myocyte cell death. Data for PA mitigating myocyte injury in humans are limited to observational studies. Using a randomized controlled trial design, we sought to determine if introducing moderate PA to previously sedentary older adults could reduce the trajectory of myocardial injury as measured by the high-sensitive cardiac troponin T (hs-cTnT) assay.Participants (age ?70 years) were assigned to a 1-year intervention of moderate PA or health education control. High-sensitive cTnT was measured at baseline and 1 year in the 307 of 424 subjects who had available stored serum. Changes in hs-cTnT within 1 year were compared between PA and control groups, as were differences in the proportion of subjects with a significant rise in hs-cTnT (prospectively defined as a>50% increase at follow-up from baseline). Moderate to vigorous PA in kcal/wk was estimated with the CHAMPS questionnaire.Baseline hs-cTnT levels and PA kcal/wk were similar for both groups. Activity kcal/wk increased in the PA, but not in the control group at 1 year. The median increase in hs-cTnT level from baseline was >3 times larger in the control (0.73 ng/L, interquartile range -0.64 to 2.59) vs the PA group (0.19ng/L, interquartile range -1.10 to 1.93) (P=.02). The proportion with a>50% increase in hs-cTnT was larger in the control group than in the PA group (9.3% vs 5.1%), but this difference was not statistically significant (P=.16).Initiation of moderate PA in sedentary older adults may favorably modify subclinical myocardial injury.

    View details for DOI 10.1016/j.ahj.2016.07.001

    View details for PubMedID 27595690

  • Cardiovascular Events in a Physical Activity Intervention Compared With a Successful Aging Intervention: The LIFE Study Randomized Trial. JAMA cardiology Newman, A. B., Dodson, J. A., Church, T. S., Buford, T. W., Fielding, R. A., Kritchevsky, S., Beavers, D., Pahor, M., Stafford, R. S., Szady, A. D., Ambrosius, W. T., McDermott, M. M. 2016; 1 (5): 568-574

    Abstract

    Whether sustained physical activity prevents cardiovascular disease (CVD) events in older adults is uncertain.To test the hypothesis that cardiovascular morbidity and mortality would be reduced in participants in a long-term physical activity program.The Lifestyle Interventions and Independence for Elders (LIFE) study was a multicenter, randomized trial. Participants were recruited at 8 centers in the United States. We randomized 1635 sedentary men and women aged 70 to 89 years with a Short Physical Performance Battery (SPPB) score of 9 or less but able to walk 400 m.The physcial activity (PA) intervention was a structured moderate-intensity program, predominantly walking 2 times per week on site for 2.6 years on average. The successful aging intervention consisted of weekly health education sessions for 6 months, then monthly.Total CVD events, including fatal and nonfatal myocardial infarction, angina, stroke, transient ischemic attack, and peripheral artery disease, were adjudicated by committee, and silent myocardial infarction was assessed by serial electrocardiograms. A limited outcome of myocardial infarction, stroke, and CVD death was also studied. Outcome assessors and adjudicators were blinded to intervention assignment.The 1635 LIFE study participants were predominantly women (67%), with a mean (SD) age of 78.7 (5.2) years; 20% were African-American, 6% were Hispanic or other race or ethnic group, and 74% were non-Latino white. New CVD events occurred in 121 of 818 PA participants (14.8%) and 113 of 817 successful aging participants (13.8%) (HR, 1.10; 95% CI, 0.85-1.42). For the more focused combined outcome of myocardial infarction, stroke, or cardiovascular death, rates were 4.6% in PA and 4.5% in the successful aging group (HR,?1.05; 95% CI, 0.67-1.66). Among frailer participants with an SPPB score less than 8, total CVD rates were 14.2% in PA vs 17.7% in successful aging (HR,?0.76; 95% CI, 0.52-1.10), compared with 15.3% vs 10.5% among those with an SPPB score of 8 or 9 (HR, 1.59; 95% CI, 1.09-2.30) (P for interaction?=?.006). With the limited end point, the interaction was not significant (P?=?.59), with an HR of?0.94 (95% CI, 0.50-1.75) for an SPPB score less than 8 and an HR of?1.20 (95% CI, 0.62-2.34) for an SBBP score of 8 or 9.Among participants in the LIFE Study, an aerobically based, moderately intensive PA program was not associated with reduced cardiovascular events in spite of the intervention's previously documented ability to prevent mobility disability.clinicaltrials.gov Identifier: NCT00116194.

    View details for DOI 10.1001/jamacardio.2016.1324

    View details for PubMedID 27439082

  • Antihypertensive Use and the Effect of a Physical Activity Intervention in the Prevention of Major Mobility Disability Among Older Adults: The LIFE Study. journals of gerontology. Series A, Biological sciences and medical sciences Buford, T. W., Miller, M. E., Church, T. S., Gill, T. M., Henderson, R., Hsu, F., McDermott, M. M., Nadkarni, N., Pahor, M., Stafford, R. S., Carter, C. S. 2016; 71 (7): 974-981

    Abstract

    This subgroup analysis of the Lifestyle Intervention and Independence for Elders trial evaluates the impact of a long-term physical activity (PA) intervention on rates of major mobility disability (MMD) among older adults according to their antihypertensive medication use.Lifestyle Intervention and Independence for Elders study participants were randomized to center-based PA or health education for a median of 2.7 years. Participants were sedentary men and women aged 70-89 years with objectively measured physical limitations. This analysis evaluated rates of MMD and persistent MMD among 1,633 participants, according to antihypertensive medication use. Participants were designated as either (i) an angiotensin-converting enzyme (ACE) inhibitor user (ACEi+), (ii) a user of other antihypertensives not including ACEi (ACEi-), or (iii) nonusers of antihypertensive medications (AHT-). Interactions were explored between antihypertensive use and randomized arm.Interaction terms for MMD (p = .214) and persistent MMD (p = .180) did not reach statistical significance. For MMD, PA displayed marginal effects among ACEi+ (hazard ratio [HR] = 0.76; 95% confidence interval [CI] = 0.57, 1.02) and ACEi- (HR = 0.76; 95% CI = 0.60, 0.97) but not AHT- (HR = 1.19; 95% CI = 0.75, 1.87). For persistent MMD, the effect of PA was greatest among ACEi+ (HR = 0.57; 95% CI = 0.39, 0.84) when compared to ACEi- (HR = 0.76; 95% CI = 0.55, 1.06) or AHT- (HR = 1.18; 95% CI = 0.59, 2.36).The effects of long-term PA on the incidence of MMD and persistent MMD were similar among three subgroups of older adults stratified by their antihypertensive medication use. However, though statistical interactions did not reach significance, several findings may warrant future study in other cohorts given the post hoc nature of this study.

    View details for DOI 10.1093/gerona/glv222

    View details for PubMedID 26865496

  • Effect of Statin Use on Mobility Disability and its Prevention in At-risk Older Adults: The LIFE Study. journals of gerontology. Series A, Biological sciences and medical sciences Henderson, R. M., Lovato, L., Miller, M. E., Fielding, R. A., Church, T. S., Newman, A. B., Buford, T. W., Pahor, M., McDermott, M. M., Stafford, R. S., Lee, D. S., Kritchevsky, S. B. 2016: -?

    Abstract

    HMG-CoA reductase inhibitors (statins) are among the most commonly prescribed classes of medications. Although their cardiovascular benefits and myalgia risks are well documented, their effects on older adults initiating an exercise training program are less understood.1,635 sedentary men and women aged 70-89 years with Short Physical Performance Battery (SPPB) score of 9 or below and were able to walk 400 m were randomized to a structured, moderate-intensity physical activity (PA) program consisting of both center-based (twice/wk) and home-based (3-4 times/wk) aerobic, resistance, and flexibility training or to a health education (HE) program combined with upper extremity stretching.Overall, the PA intervention was associated with lower risk of major mobility disability (hazard ratio [HR] = 0.82; 95% confidence interval [CI] = 0.69-0.98). The effect was similar (p value for interaction = .62) in both statin users (PA n = 415, HE n = 412; HR = 0.86, 95% CI = 0.67-1.1) and nonusers (PA n = 402, HE n = 404; HR = 0.78, 95% CI = 0.61-1.01). Attendance was similar for statin users (65%) and nonusers (63%). SPPB at 12 months was slightly greater for PA (8.35±0.10) than for HE (7.94±0.10) in statin users but not in nonusers (PA 8.25±0.10, HE 8.16±0.10), though the interaction effect was not statistically significant. Self-reported PA levels were not different between statin users and nonusers.Although statins have been associated with adverse effects on muscle, data from the LIFE Study show that statin users and nonusers both benefit from PA interventions. Older adults who require statin medications to manage chronic medical conditions and are sedentary will be able to benefit from interventions to increase PA.

    View details for PubMedID 26988662

  • Effect of Structured Physical Activity on Respiratory Outcomes in Sedentary Elderly Adults with Mobility Limitations JOURNAL OF THE AMERICAN GERIATRICS SOCIETY Fragoso, C. A., Beavers, D. P., Anton, S. D., Liu, C. K., McDermott, M. M., Newman, A. B., Pahor, M., Stafford, R. S., Gill, T. M. 2016; 64 (3): 501-509

    View details for DOI 10.1111/jgs.14013

    View details for Web of Science ID 000373066800004

  • Effect of Structured Physical Activity on Respiratory Outcomes in Sedentary Elderly Adults with Mobility Limitations. Journal of the American Geriatrics Society Vaz Fragoso, C. A., Beavers, D. P., Anton, S. D., Liu, C. K., McDermott, M. M., Newman, A. B., Pahor, M., Stafford, R. S., Gill, T. M. 2016; 64 (3): 501-509

    Abstract

    To evaluate the effect of structured physical activity on respiratory outcomes in community-dwelling elderly adults with mobility limitations.Multicenter, randomized trial of physical activity vs health education, with respiratory variables prespecified as tertiary outcomes over an intervention period of 24-42 months. Physical activity included walking (goal of 150 min/week) and strength, flexibility, and balance training. Health education included workshops on topics relevant to older adults and upper extremity stretching exercises.Lifestyle Interventions and Independence in Elders (LIFE) Study.Community-dwelling persons aged 70-89 with Short Physical Performance Battery scores less than 10 (N = 1,635).Dyspnea severity (defined as moderate to severe according to a Borg index >2 immediately after a 400-m walk), forced expiratory volume in 1 second (FEV1) (

    View details for DOI 10.1111/jgs.14013

    View details for PubMedID 27000324

  • Effects of a one-year physical activity program on serum C-terminal Agrin Fragment (CAF) concentrations among mobility-limited older adults JOURNAL OF NUTRITION HEALTH & AGING Bondoc, I., Cochrane, S. K., Church, T. S., Dahinden, P., Hettwer, S., Hsu, F., Stafford, R. S., Pahor, M., Buford, T. W. 2015; 19 (9): 922-927

    Abstract

    C-terminal Agrin Fragment (CAF) has been proposed as a potential circulating biomarker for predicting changes in physical function among older adults. To determine the effect of a one-year PA intervention on changes in CAF concentrations and to evaluate baseline and longitudinal associations between CAF concentrations and indices of physical function.Ancillary study to the Lifestyle Interventions and Independence for Elders Pilot (LIFE-P), a multi-site randomized clinical trial designed to evaluate the effects of chronic exercise on the physical function of older adults at risk for mobility disability.Four academic research centers within the U.S.Three hundred thirty three older adults aged 70 to 89 with mild to moderate impairments in physical function.A 12-month intervention of either structured physical activity (PA) or health education promoting successful aging (SA).Serum CAF concentrations and objectives measures of physical function - i.e. gait speed and performance on the Short Physical Performance Battery (SPPB).The group*time interaction was not significant for serum CAF concentrations (p=0.265), indicating that the PA intervention did not significantly reduce serum CAF levels compared to SA. Baseline gait speed was significantly correlated with baseline CAF level (r = -0.151, p= 0.006), however the association between CAF and SPPB was not significant. Additionally, neither baseline nor the change in CAF concentrations strongly predicted the change in either performance measure following the PA intervention.In summary, the present study shows that a one-year structured PA program did not reduce serum CAF levels among mobility-limited older adults. However, further study is needed to definitively determine the utility of CAF as a biomarker of physical function.

    View details for DOI 10.1007/s12603-015-0474-3

    View details for Web of Science ID 000364577300008

    View details for PubMedID 26482694

    View details for PubMedCentralID PMC4682669

  • Aspirin Use Among Adults in the US Results of a National Survey AMERICAN JOURNAL OF PREVENTIVE MEDICINE Williams, C. D., Chan, A. T., Elman, M. R., Kristensen, A. H., Miser, W. F., Pignone, M. P., Stafford, R. S., McGregor, J. C. 2015; 48 (5): 501-508

    Abstract

    The use of aspirin in patients without cardiovascular disease remains controversial. Patients' understanding of the risks and benefits of aspirin likely contribute to the decision of whether or not to use aspirin regularly. The purpose of this study is to assess patients' knowledge of aspirin and identify factors contributing to regular use.A survey of U.S. adults aged 45-75 years was performed to ascertain aspirin use and factors that may be associated with use. Multivariate logistic regression was used to identify predictors of current use of aspirin among those with a primary prevention indication. The survey was completed in 2012 with data analysis performed in 2013.Among 2,509 respondents, 52% reported current aspirin use. Among 2,039 respondents without a history of cardiovascular disease, current use of aspirin was 47%. Regular use of aspirin for primary prevention was associated with the presence of major cardiovascular disease risk factors (OR=3.0, 95% CI=2.4, 3.7), high self-assessed knowledge of aspirin (OR=9.1, 95% CI=5.2, 15.7), and having discussed aspirin therapy with a provider (OR=25.9, 95% CI=19.7, 34.1). Several markers of healthy lifestyle choices were also associated with regular use. After multivariate analysis, the strongest independent predictor of regular aspirin use was having discussed aspirin therapy with a provider (OR=23.79, 95% CI=17.8, 31.5).Approximately half of the nationwide survey of U.S. adults reported regular aspirin use. Among those with a primary prevention indication, having discussed aspirin with a provider was the strongest predictor of regular use.

    View details for DOI 10.1016/j.amepre.2014.11.005

    View details for PubMedID 25891049

  • Tackling China's Noncommunicable Diseases: Shared Origins, Costly Consequences and the Need for Action CHINESE MEDICAL JOURNAL Min, Y., Jiang, L., Yan, L. L., Wang, L., Basu, S., Wu, Y., Stafford, R. S. 2015; 128 (6): 839-843

    View details for DOI 10.4103/0366-6999.152690

    View details for Web of Science ID 000351219700024

  • Initiation of treatment for incident diabetes: evidence from the electronic health records in an ambulatory care setting. Primary care diabetes Chung, S., Zhao, B., Lauderdale, D., Linde, R., Stafford, R., Palaniappan, L. 2015; 9 (1): 23-30

    Abstract

    We examined patterns and predictors of initiation of treatment for incident diabetes in an ambulatory care setting in the US.Data were extracted from electronic health records (EHR) for active patients ?35 years in a multispecialty, multiclinic ambulatory care organization with 1000 providers. New onset type 2 diabetes and subsequent treatment were identified using lab, diagnosis, medication prescription, and service use data. Time from the first evidence of diabetes until initial treatment, either medication or education/counseling, was examined using a Kaplan-Meier hazards curve. Potential predictors of initial treatment were examined using multinomial logistic models accounting for physician random effects.Of 2258 patients with incident diabetes, 55% received either medication or education/counseling (20% received both) during the first year. Of the treated patients, 68% received a treatment within the first four weeks, and 13% after initial 16 weeks. Strong positive predictors (P<0.01) of combined treatment were younger age, higher fasting glucose at diagnosis, obesity, and visits with an endocrinologist.Among insured patients who have a primary care provider in a multispecialty health care system, incident diabetes is treated only half the time. Improved algorithms for identifying incident diabetes from the EHR and team approach for monitoring may help treatment initiation.

    View details for DOI 10.1016/j.pcd.2014.04.005

    View details for PubMedID 24810147

  • Initiation of treatment for incident diabetes: Evidence from the electronic health records in an ambulatory care setting. Primary care diabetes Chung, S., Zhao, B., Lauderdale, D., Linde, R., Stafford, R., Palaniappan, L. 2015; 9 (1): 23-30

    View details for DOI 10.1016/j.pcd.2014.04.005

    View details for PubMedID 24810147

  • Quality of medical management in coronary artery disease ANNALS OF SAUDI MEDICINE Al Shammeri, O., Stafford, R. S., Alzenaidi, A., Al-Hutaly, B., Abdulmonem, A. 2014; 34 (6): 488-493

    Abstract

    Patients with coronary artery disease (CAD) are at high risk of recurrent adverse cardiac events. Such risk can be diminished through a guideline-recommend optimal medical therapy (OMT), defined as adherence to appropriate antiplatelet therapy, lipid-lowering agents, beta-blockers and angio.tensin-converting enzyme inhibitors, blood pressure < 140/90 mm Hg ( < 130/80 mm Hg in diabetics and renal disease patients), low-density lipoprotein (LDL) < 2 mmol/L, smoking cessation and aerobic physical activity, and hemoglobin (Hb) A1c < 7%. Unfortunately, preliminary data suggest a wide gap between recommended and actual practices. The study aims to estimate the rate of achieving of OMT in CAD patients in Qassim Province.This observational study enrolled 207 consecutive CAD patients seen in cardiology clinic in Prince Sultan Cardiac Center in Qassim between January 2012 and May 2012.Eligible participants were over the age of 18, with CAD documented by either noninvasive testing or by coronary angiogram. We collected the demographic, medications, laboratory, and clinical data through in-person interviews, medical records, and an electronic patient database.OMT was achieved in only 10.4% of CAD patients. The rate of achievement of target systolic blood pressure was 76.5%, target diastolic blood pressure 88%, target LDL 68%, adherence to medications 91%. Diabetes was common (64% of all patients), and only 24% of these patients achieved the target HbA1c.The poor achievement of optimal medical therapy in CAD patients contributes to prevent.able mortality, morbidity, and health care costs. The observed shortcomings warrant investment in strategies to achieve OMT in these high-risk patients.

    View details for DOI 10.5144/0256-4947.2014.488

    View details for Web of Science ID 000356419600005

    View details for PubMedID 25971821

  • Combined Reduced Forced Expiratory Volume in 1 Second (FEV1) and Peripheral Artery Disease in Sedentary Elders With Functional Limitations JOURNAL OF THE AMERICAN MEDICAL DIRECTORS ASSOCIATION Fragoso, C. A., Hsu, F., Brinkley, T., Church, T., Liu, C. K., Manini, T., Newman, A. B., Stafford, R. S., McDermott, M. M., Gill, T. M. 2014; 15 (9): 665-670

    Abstract

    Because they are potentially modifiable and may coexist, we evaluated the combined occurrence of a reduced forced expiratory volume in 1 second (FEV1) and peripheral artery disease (PAD), including its association with exertional symptoms, physical inactivity, and impaired mobility, in sedentary elders with functional limitations.Cross sectional.Lifestyle Interventions and Independence in Elder (LIFE) Study.A total of 1307 sedentary community-dwelling persons, mean age 78.9, with functional limitations (Short Physical Performance Battery [SPPB] <10).A reduced FEV1 was defined by a z-score less than -1.64 (

    View details for DOI 10.1016/j.jamda.2014.05.008

    View details for Web of Science ID 000341167700011

    View details for PubMedID 24973990

    View details for PubMedCentralID PMC4145029

  • Characterizing the relationship between free drug samples and prescription patterns for acne vulgaris and rosacea. JAMA dermatology Hurley, M. P., Stafford, R. S., Lane, A. T. 2014; 150 (5): 487-493

    Abstract

    IMPORTANCE Describing the relationship between the availability of free prescription drug samples and dermatologists' prescribing patterns on a national scale can help inform policy guidelines on the use of free samples in a physician's office. OBJECTIVES To investigate the relationships between free drug samples and dermatologists' local and national prescribing patterns and between the availability of free drug samples and prescription costs. DESIGN, SETTING, AND PARTICIPANTS Cross-sectional study investigating prescribing practices for acne, a common dermatologic condition for which free samples are often available. The settings were, first, the offices of nationally representative dermatologists from the National Disease and Therapeutic Index (an IMS Health Incorporated database) and, second, an academic medical center clinic without samples. Participants were ambulatory patients who received a prescription from a dermatologist for a primary initial diagnosis of acne vulgaris or rosacea in 2010. MAIN OUTCOMES AND MEASURES National trends in dermatologist prescribing patterns, the degree of correlation between the availability of free samples and the prescribing of brand-name medications, and the mean cost of acne medications prescribed per office visit nationally and at an academic medical center without samples. RESULTS On a national level, the provision of samples with a prescription by dermatologists has been increasing over time, and this increase is correlated (r?=?0.92) with the use of the branded generic drugs promoted by these samples. Branded and branded generic drugs comprised most of the prescriptions written nationally (79%), while they represented only 17% at an academic medical center clinic without samples. Because of the increased use of branded and branded generic drugs, the national mean total retail cost of prescriptions at an office visit for acne was conservatively estimated to be 2 times higher (approximately $465 nationally vs $200 at an academic medical center without samples). CONCLUSIONS AND RELEVANCE Free drug samples can alter the prescribing habits of physicians away from the use of less expensive generic medications. The benefits of free samples in dermatology must be weighed against potential negative effects on prescribing behavior and prescription costs.

    View details for DOI 10.1001/jamadermatol.2013.9715

    View details for PubMedID 24740450

  • Characterizing the relationship between free drug samples and prescription patterns for acne vulgaris and rosacea. JAMA dermatology Hurley, M. P., Stafford, R. S., Lane, A. T. 2014; 150 (5): 487-493

    Abstract

    IMPORTANCE Describing the relationship between the availability of free prescription drug samples and dermatologists' prescribing patterns on a national scale can help inform policy guidelines on the use of free samples in a physician's office. OBJECTIVES To investigate the relationships between free drug samples and dermatologists' local and national prescribing patterns and between the availability of free drug samples and prescription costs. DESIGN, SETTING, AND PARTICIPANTS Cross-sectional study investigating prescribing practices for acne, a common dermatologic condition for which free samples are often available. The settings were, first, the offices of nationally representative dermatologists from the National Disease and Therapeutic Index (an IMS Health Incorporated database) and, second, an academic medical center clinic without samples. Participants were ambulatory patients who received a prescription from a dermatologist for a primary initial diagnosis of acne vulgaris or rosacea in 2010. MAIN OUTCOMES AND MEASURES National trends in dermatologist prescribing patterns, the degree of correlation between the availability of free samples and the prescribing of brand-name medications, and the mean cost of acne medications prescribed per office visit nationally and at an academic medical center without samples. RESULTS On a national level, the provision of samples with a prescription by dermatologists has been increasing over time, and this increase is correlated (r?=?0.92) with the use of the branded generic drugs promoted by these samples. Branded and branded generic drugs comprised most of the prescriptions written nationally (79%), while they represented only 17% at an academic medical center clinic without samples. Because of the increased use of branded and branded generic drugs, the national mean total retail cost of prescriptions at an office visit for acne was conservatively estimated to be 2 times higher (approximately $465 nationally vs $200 at an academic medical center without samples). CONCLUSIONS AND RELEVANCE Free drug samples can alter the prescribing habits of physicians away from the use of less expensive generic medications. The benefits of free samples in dermatology must be weighed against potential negative effects on prescribing behavior and prescription costs.

    View details for DOI 10.1001/jamadermatol.2013.9715

    View details for PubMedID 24740450

  • Ambulatory Treatment of Type 2 Diabetes in the U.S., 1997-2012 DIABETES CARE Turner, L. W., Nartey, D., Stafford, R. S., Singh, S., Alexander, G. C. 2014; 37 (4): 985-992

    Abstract

    OBJECTIVE Type 2 diabetes is increasingly common and associated with substantial morbidity and mortality. This study examines trends in the patterns and costs of drug treatment of type 2 diabetes from 1997 to 2012. RESEARCH DESIGN AND METHODS We conducted descriptive analyses of cross-sectional data using the IMS Health National Disease and Therapeutic Index, a nationally representative audit of ambulatory physician practices in the U.S. We focused on visits for diabetes among patients 35 years of age or older. We used the IMS Health National Prescription Audit of pharmacy dispensing to derive information about drug expenditures. RESULTS Ambulatory diabetes visits increased from 23 million treatment visits in 1997 (95% CI 21-25) to 35 million (32-37) in 2007 and declined to 31 million visits by 2012 (27-31). Between 1997 and 2012 biguanide use increased, from 23% (20-26) to 53% (50-56) of treatment visits. Glitazone use grew from 6% (4-8) in 1997 (41% [39-43] of all visits in 2005), but declined to 16% (14-18) by 2012. Since 2005, dipeptidyl peptidase-4 (DPP-4) inhibitor use increased steadily, representing 21% (18-23) of treatment visits by 2012. Glucagon-like peptide 1 (GLP-1) agonists accounted for 4% of treatment visits in 2012. Visits where two or more drug compounds were used increased nearly 40% from 1997 to 2012. Between 2008 and 2012, drug expenditures increased 61%, driven primarily by use of insulin glargine and DPP-4 inhibitors. CONCLUSIONS Declining sulfonylurea and glitazone use has been offset by increases in DPP-4 inhibitor use and, to a lesser degree, use of GLP-1 agonists. Treatment of diabetes has grown in complexity while older treatments continue to be replaced or supplemented by newer therapies.

    View details for DOI 10.2337/dc13-2097

    View details for Web of Science ID 000333414700028

    View details for PubMedID 24198301

  • Respiratory Impairment and Dyspnea and Their Associations with Physical Inactivity and Mobility in Sedentary Community-Dwelling Older Persons JOURNAL OF THE AMERICAN GERIATRICS SOCIETY Fragoso, C. A., Beavers, D. P., Hankinson, J. L., Flynn, G., Berra, K., Kritchevsky, S. B., Liu, C. K., McDermott, M., Manini, T. M., Rejeski, W. J., Gill, T. M. 2014; 62 (4): 622-628

    Abstract

    To evaluate the prevalence of respiratory impairment and dyspnea and their associations with objectively measured physical inactivity and performance-based mobility in sedentary older persons.Cross-sectional.Lifestyle Interventions and Independence for Elders Study.Community-dwelling older persons (n = 1,635, mean age 78.9) who reported being sedentary (<20 min/wk of regular physical activity and <125 min/wk of moderate physical activity in past month).Respiratory impairment was defined as low ventilatory capacity (forced expiratory volume in 1 second less than lower limit of normal (LLN)) and respiratory muscle weakness (maximal inspiratory pressure

    View details for DOI 10.1111/jgs.12738

    View details for Web of Science ID 000334289900004

    View details for PubMedCentralID PMC3989438

  • Community Resource Utilization, Psychosocial Health, and Sociodemographic Factors Associated with Diet and Physical Activity among Low-Income Obese Latino Immigrants JOURNAL OF THE ACADEMY OF NUTRITION AND DIETETICS Drieling, R. L., Rosas, L. G., Ma, J., Stafford, R. S. 2014; 114 (2): 257-265

    Abstract

    Low-socioeconomic-status (SES) Latinos are disproportionately represented among the 78 million obese Americans. Tailored behavioral weight-loss interventions show promise, but there is limited adaptation to lower-SES Latino immigrants. This study provides guidance for tailoring obesity-reduction strategies for this population by evaluating food security, educational community resource utilization, education level, depression, sex, and length of US residence as predictors of diet and physical activity. The cross-sectional study used baseline data collected in July 2009 through September 2010 for a weight-loss trial among lower-SES obese (body mass index 30 to 55) Latino immigrants who were enrolled at a community health clinic (n=207). Physical activity was measured using 7-day pedometer recording. Dietary intake was measured using an interviewer-administered food frequency questionnaire. Factors assessed by questionnaire included education community resource use (nutrition and physical activity classes), education level, US residence (years), food security, and depressive symptoms. Data were analyzed using multivariate-adjusted linear regression models. More than one third of participants were sedentary (<5,000 steps/day), and 41% had low fruit and vegetable intake (<5 servings/day). In multivariate-adjusted models, educational community resource use, male sex, less education, fewer depressive symptoms, and shorter US residence time were associated with more physical activity (all, P ? 0.05). Educational community resource use was positively associated with fruit and vegetable intake (P=0.05). Male sex was associated with more sweet-beverage intake (P=0.02) and fast-food intake (P=0.04). Fewer depressive symptoms were associated with lower sweet-beverage intake (P=0.05). In conclusion, obesity-reduction strategies among low-SES Latino immigrants might effectively emphasize educational community resource use and interventions tailored for psychosocial and sociodemographic characteristics.

    View details for DOI 10.1016/j.jand.2013.07.025

    View details for Web of Science ID 000331853100012

    View details for PubMedID 24119533

    View details for PubMedCentralID PMC3947013

  • Short-term weight loss patterns, baseline predictors, and longer-term follow-up within a randomized controlled trial OBESITY Yank, V., Xiao, L., Wilson, S. R., Stafford, R. S., Rosas, L. G., Ma, J. 2014; 22 (1): 45-51

    Abstract

    OBJECTIVE: To examine weight loss patterns and predictors among participants in a primary care-based translation study of the Diabetes Prevention Program lifestyle intervention. DESIGN AND METHODS: Cluster analysis identified short-term (12-week) weight loss patterns among 72 intervention participants. Analysis of variance assessed cluster differences in weight loss maintenance at 15-month follow-up. Discriminant analysis identified baseline characteristics that best differentiated between clusters. RESULTS: Participants had baseline mean (SD) age of 55.0 (10.8) years and BMI of 31.9 (5.2) kg/m(2) . Cluster analysis identified three short-term weight loss patterns: modest (n=15; 21%), moderate-and-steady (n=43; 60%), and substantial-and-early (n=14; 19%). Only participants with the latter two patterns achieved clinically significant (? 5%) short-term weight loss and maintained it at 15 months. On discriminant analysis, the modest cluster was most differentiated from other clusters by high friend encouragement for dietary change, high obesity-related problems, and low physical well-being. The moderate-and-steady cluster was differentiated by lower physical activity, family encouragement, and depression symptoms. CONCLUSION: Results provide insight into the heterogeneity of response to an effective lifestyle intervention by identifying short-term weight loss patterns and their baseline predictors and relationship to 15-month success. If replicated, results may help tailor strategies for participant subgroups in weight loss programs.

    View details for DOI 10.1002/oby.20510

    View details for PubMedID 23740619

  • Association of age and packed red blood cell transfusion to 1-year survival - an observational study of ICU patients TRANSFUSION MEDICINE Mudumbai, S. C., Cronkite, R., Hu, K. U., Heidenreich, P. A., Gonzalez, C., Bertaccini, E., Stafford, R. S., Cason, B. A., Mariano, E. R., Wagner, T. 2013; 23 (4): 231-237

    Abstract

    OBJECTIVES: To compare the 1-year survival for different age strata of intensive care unit (ICU) patients after receipt of packed red blood cell (PRBC) transfusions. BACKGROUND: Despite guidelines documenting risks of PRBC transfusion and data showing that increasing age is associated with ICU mortality, little data exist on whether age alters the transfusion-related risk of decreased survival. METHODS: We retrospectively examined data on 2393 consecutive male ICU patients admitted to a tertiary-care hospital from 2003 to 2009 in age strata: 21-50, 51-60, 61-70, 71-80 and >80?years. We calculated Cox regression models to determine the modifying effect of age on the impact of PRBC transfusion on 1-year survival by using interaction terms between receipt of transfusion and age strata, controlling for type of admission and Charlson co-morbidity indices. We also examined the distribution of admission haematocrit and whether transfusion rates differed by age strata. RESULTS: All age strata experienced statistically similar risks of decreased 1-year survival after receipt of PRBC transfusions. However, patients age >80 were more likely than younger cohorts to have haematocrits of 25-30% at admission and were transfused at approximately twice the rate of each of the younger age strata. DISCUSSION: We found no significant interaction between receipt of red cell transfusion and age, as variables, and survival at 1?year as an outcome.

    View details for DOI 10.1111/tme.12010

    View details for Web of Science ID 000321975300005

    View details for PubMedID 23480030

  • Translating an evidence-based lifestyle intervention program into primary care: lessons learned. Health promotion practice Blonstein, A. C., Yank, V., Stafford, R. S., Wilson, S. R., Rosas, L. G., Ma, J. 2013; 14 (4): 491-497

    Abstract

    The E-LITE (Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care) trial evaluated the feasibility and potential effectiveness of translating an evidence-based lifestyle intervention for the management of obesity and related risk factors in a primary care setting. Delivered by allied health care providers, the intervention promoted at least 7% weight loss and at least 150 minutes per week of moderate-intensity physical activity through gradual, sustainable lifestyle changes. Activities included interactive group lessons, food tasting, guided physical activity, and technology-mediated self-monitoring and behavioral counseling. This article discusses insights and potential areas for improvement to strengthen program implementation for dissemination of the E-LITE program to other primary care settings. We focus on (a) the role of allied health professionals in program delivery, (b) strengthening program integration within a primary care clinic, and (c) the use of information technology to extend the reach and impact of the program. Our experience shows the feasibility of implementing an evidence-based lifestyle intervention program combining group-delivered nutrition and behavioral counseling, physical activity training, and technology-mediated follow-up in a primary care setting. Challenges remain, and we offer possible solutions to overcome them.

    View details for DOI 10.1177/1524839913481604

    View details for PubMedID 23539264

  • TRENDS IN BUPRENORPHINE AND METHADONE SALES AND UTILIZATION IN THE UNITED STATES, 1997-2012 Turner, L. W., Kruszewski, S., Mojtabai, R., Webster, D., Nesbit, S., Stafford, R. S., Alexander, G. C. ELSEVIER SCIENCE INC. 2013: A56?A56

    View details for Web of Science ID 000318916400290

  • AMBULATORY DIAGNOSIS AND TREATMENT OF NON-MALIGNANT PAIN IN THE UNITED STATES, 2000-2010 DAUBRESSE, M., Chang, H. Y., Viswanathan, S., Yu, Y., Shah, N., Stafford, R. S., Kruszewski, S., Alexander, G. C. ELSEVIER SCIENCE INC. 2013: A127?A127

    View details for Web of Science ID 000318916401157

  • Translating the Diabetes Prevention Program Lifestyle Intervention for Weight Loss Into Primary Care A Randomized Trial JAMA INTERNAL MEDICINE Ma, J., Yank, V., Xiao, L., Lavori, P. W., Wilson, S. R., Rosas, L. G., Stafford, R. S. 2013; 173 (2): 113-121

    Abstract

    The Diabetes Prevention Program (DPP) lifestyle intervention reduced the incidence of type 2 diabetes mellitus (DM) among high-risk adults by 58%, with weight loss as the dominant predictor. However, it has not been adequately translated into primary care.We evaluated 2 adapted DPP lifestyle interventions among overweight or obese adults who were recruited from 1 primary care clinic and had pre-DM and/or metabolic syndrome. Participants were randomized to (1) a coach-led group intervention (n = 79), (2) a self-directed DVD intervention (n = 81), or (3) usual care (n = 81). During a 3-month intensive intervention phase, the DPP-based behavioral weight-loss curriculum was delivered by lifestyle coach-led small groups or home-based DVD. During the maintenance phase, participants in both interventions received lifestyle change coaching and support remotely-through secure email within an electronic health record system and the American Heart Association Heart360 website for weight and physical activity goal setting and self-monitoring. The primary outcome was change in body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) from baseline to 15 months.At baseline, participants had a mean (SD) age of 52.9 (10.6) years and a mean BMI of 32.0 (5.4); 47% were female; 78%, non-Hispanic white; and 17%, Asian/Pacific Islander. At month 15, the mean ± SE change in BMI from baseline was -2.2 ± 0.3 in the coach-led group vs -0.9 ± 0.3 in the usual care group (P < .001) and -1.6 ± 0.3 in the self-directed group vs usual care (P = .02). The percentages of participants who achieved the 7% DPP-based weight-loss goal were 37.0% (P = .003) and 35.9% (P = .004) in the coach-led and self-directed groups, respectively, vs 14.4% in the usual care group. Both interventions also achieved greater net improvements in waist circumference and fasting plasma glucose level.Proven effective in a primary care setting, the 2 DPP-based lifestyle interventions are readily scalable and exportable with potential for substantial clinical and public health impact.clinicaltrials.gov Identifier: NCT00842426.

    View details for DOI 10.1001/2013.jamainternmed.987

    View details for Web of Science ID 000317239700008

    View details for PubMedID 23229846

  • Baseline reach and adoption characteristics in a randomized controlled trial of two weight loss interventions translated into primary care: A structured report of real-world applicability CONTEMPORARY CLINICAL TRIALS Yank, V., Stafford, R. S., Rosas, L. G., Ma, J. 2013; 34 (1): 126-135

    Abstract

    Although the Diabetes Prevention Program (DPP) lifestyle intervention reduced type 2 diabetes incidence by 58% among high-risk adults at academic centers, it requires translation into typical primary care settings. Using baseline data from the Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care (E-LITE) randomized controlled trial, we evaluated the potential of its two DPP-based interventions to reach their target populations and be adopted into routine use.Overweight/obese adults with increased cardiometabolic risk enrolled from one primary care clinic. Using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) model, we assessed reach with data on patient identification, participation, and representativeness, and adoption with data on intervention feasibility and potential for organizational diffusion.The target population was identified by searching electronic health records. Contact was attempted for 2391 patients who completed initial screening by phone (56% uptake) or online (44%). Most (88%) of those screened ineligible were not within the target population; 12% were excluded because of research requirements. Conservatively estimated participation rate was 44%. Participants (n=241) included 54% men and had a mean (SD) age of 52.9 years (10.6) and body mass index of 32 kg/m(2) (5.4). Regarding adoption, all clinic physicians agreed to participate. The feasibility of intervention implementation and dissemination was enhanced by leveraging existing intervention, training, and primary care resources.E-LITE's lifestyle interventions had fair-to-good potential for primary care reach and adoption. Our trial evidence and structured reporting may inform real-world implementation of translational trials by health networks, physicians, and payers.

    View details for DOI 10.1016/j.cct.2012.10.007

    View details for PubMedID 23124047

  • Total and Abdominal Adiposity Are Associated With Inflammation in Older Adults Using a Factor Analysis Approach JOURNALS OF GERONTOLOGY SERIES A-BIOLOGICAL SCIENCES AND MEDICAL SCIENCES Brinkley, T. E., Hsu, F., Beavers, K. M., Church, T. S., Goodpaster, B. H., Stafford, R. S., Pahor, M., Kritchevsky, S. B., Nicklas, B. J. 2012; 67 (10): 1099-1106

    Abstract

    Obesity-related increases in multiple inflammatory markers may contribute to the persistent subclinical inflammation common with advancing age. However, it is unclear if a specific combination of markers reflects the underlying inflammatory state. We used factor analysis to identify inflammatory factor(s) and examine their associations with adiposity in older adults at risk for disability.Adiponectin, CRP, IL-1ra, IL-1sRII, IL-2sR?, IL-6, IL-6sR, IL-8, IL-15, sTNFRI, sTNFRII, and TNF-? were measured in 179 participants from the Lifestyle Interventions and Independence for Elders Pilot (Mean ± SD age 77 ± 4 years, 76% white, 70% women). Body mass index, waist circumference, and total fat mass were assessed by anthropometry and dual-energy x-ray absorptiometry.IL-2sR?, sTNFRI, and sTNFRII loaded highest on the first factor (factor 1). CRP, IL-1ra, and IL-6 loaded highest on the second factor (factor 2). Factor 2, but not factor 1, was positively associated with 1-SD increments in waist circumference (? = 0.160 ± 0.057, p = .005), body mass index (? = 0.132 ± 0.053, p = .01), and total fat mass (? = 0.126 ± 0.053, p = .02) after adjusting for age, gender, race/ethnicity, site, smoking, anti-inflammatory medications, comorbidity index, health-related quality of life, and physical function. These associations remained significant after further adjustment for grip strength, but only waist circumference remained associated with inflammation after adjusting for total lean mass. There were no significant interactions between adiposity and muscle mass or strength for either factor.Greater total and abdominal adiposity are associated with higher levels of an inflammatory factor related to CRP, IL-1ra, and IL-6 in older adults, which may provide a clinically useful measure of inflammation in this population.

    View details for DOI 10.1093/gerona/gls077

    View details for Web of Science ID 000308530400013

    View details for PubMedID 22451470

    View details for PubMedCentralID PMC3437966

  • National Trends in Oral Anticoagulant Use in the United States, 2007 to 2011 CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Kirley, K., Qato, D. M., Kornfield, R., Stafford, R. S., Alexander, G. C. 2012; 5 (5): 615-621

    Abstract

    Little is known regarding the adoption of direct thrombin inhibitors in clinical practice. We examine trends in oral anticoagulation for the prevention of thromboembolism in the United States.We used the IMS Health National Disease and Therapeutic Index, a nationally representative audit of office-based providers, to quantify patterns of oral anticoagulant use among all subjects and stratified by clinical indication. We quantified oral anticoagulant expenditures using the IMS Health National Prescription Audit. Between 2007 and 2011, warfarin treatment visits declined from ?2.1 million (M) quarterly visits to ?1.6M visits. Dabigatran use increased from 0.062M quarterly visits (2010Q4) to 0.363M visits (2011Q4), reflecting its increasing share of oral anticoagulant visits from 3.1% to 18.9%. In contrast to warfarin, the majority of dabigatran visits have been for atrial fibrillation, though this proportion decreased from 92% (2010Q4) to 63% (2011Q4), with concomitant increases in dabigatran's off-label use. Among atrial fibrillation visits, warfarin use decreased from 55.8% visits (2010Q4) to 44.4% (2011Q4), whereas dabigatran use increased from 4.0% to 16.9%. Of atrial fibrillation visits, the fraction not treated with any oral anticoagulants has remained unchanged at ?40%. Expenditures related to dabigatran increased rapidly from $16M in 2010Q4 to $166M in 2011Q4, exceeding expenditures on warfarin ($144M) in 2011Q4.Dabigatran has been rapidly adopted into ambulatory practice in the United States, primarily for treatment of atrial fibrillation, but increasingly for off-label indications. We did not find evidence that it has increased overall atrial fibrillation treatment rates.

    View details for DOI 10.1161/CIRCOUTCOMES.112.967299

    View details for Web of Science ID 000309109000007

    View details for PubMedID 22949490

  • Federally Qualified Health Centers and Private Practice Performance on Ambulatory Care Measures AMERICAN JOURNAL OF PREVENTIVE MEDICINE Goldman, L. E., Chu, P. W., Tran, H., Romano, M. J., Stafford, R. S. 2012; 43 (2): 142-149

    Abstract

    The 2010 Affordable Care Act relies on Federally Qualified Health Centers (FQHCs) and FQHC look-alikes (look-alikes) to provide care for newly insured patients, but ties increased funding to demonstrated quality and efficiency.To compare FQHC and look-alike physician performance with private practice primary care physicians (PCPs) on ambulatory care quality measures.The study was a cross-sectional analysis of visits in the 2006-2008 National Ambulatory Medical Care Survey. Performance of FQHCs and look-alikes on 18 quality measures was compared with private practice PCPs. Data analysis was completed in 2011.Compared to private practice PCPs, FQHCs and look-alikes performed better on six measures (p<0.05); worse on diet counseling in at-risk adolescents (26% vs 36%, p=0.05); and no differently on 11 measures. Higher performance occurred in ACE inhibitors use for congestive heart failure (51% vs 37%, p=0.004); aspirin use in coronary artery disease (CAD; 57% vs 44%, p=0.004); ?-blocker use for CAD (59% vs 47%, p=0.01); no use of benzodiazepines in depression (91% vs 84%, p=0.008); blood pressure screening (90% vs 86%, p<0.001); and screening electrocardiogram (EKG) avoidance in low-risk patients (99% vs 93%, p<0.001). Adjusting for patient characteristics yielded similar results, except that private practice PCPs no longer performed better on any measures.FQHCs and look-alikes demonstrated equal or better performance than private practice PCPs on select quality measures despite serving patients who have more chronic disease and socioeconomic complexity. These findings can provide policymakers with some reassurance as to the quality of chronic disease and preventive care at Federally Qualified Health Centers and look-alikes, as they plan to use these health centers to serve 20 million newly insured individuals.

    View details for DOI 10.1016/j.amepre.2012.02.033

    View details for Web of Science ID 000306476200006

    View details for PubMedID 22813678

    View details for PubMedCentralID PMC3595189

  • Angiotensin-Converting Enzyme Inhibitor Use by Older Adults Is Associated with Greater Functional Responses to Exercise JOURNAL OF THE AMERICAN GERIATRICS SOCIETY Buford, T. W., Manini, T. M., Hsu, F., Cesari, M., Anton, S. D., Nayfield, S., Stafford, R. S., Church, T. S., Pahor, M., Carter, C. S. 2012; 60 (7): 1244-1252

    Abstract

    To assess the association between angiotensin converting enzyme inhibitors (ACEis) and improvements in the physical function of older adults in response to chronic exercise training.Secondary analysis of the Lifestyle Interventions and Independence for Elders Pilot (LIFE-P) study, a multisite randomized clinical trial to evaluate the effects of chronic exercise on the physical function of older adults at risk for mobility disability.Four academic research centers within the United States.Four hundred twenty-four individuals aged 70 to 89 with mild to moderate functional impairments categorized for this analysis as ACEi users, users of other antihypertensive drugs, or antihypertensive nonusers.A 12-month intervention of structured physical activity (PA) or health education promoting successful aging (SA).Change in walking speed during a 400-m test and performance on a battery of short-duration mobility tasks (Short Physical Performance Battery (SPPB)).Physical activity significantly improved the adjusted walking speed of ACEi users (P < .001) but did not of nonusers. PA improved the adjusted SPPB score of ACEi users (P < .001) and of persons who used other antihypertensive drugs (P = .005) but not of antihypertensive nonusers (P = .91).The percentage of ACEi users deriving clinically significant benefit from exercise training for walking speed (30%) and SPPB score (48%) was dramatically higher than for nonusers (14% and 12%, respectively).For older adults at risk for disability, exercise-derived improvements in physical function were greater for ACEi users than users of other antihypertensive drugs and antihypertensive nonusers.

    View details for DOI 10.1111/j.1532-5415.2012.04045.x

    View details for Web of Science ID 000306311600007

    View details for PubMedID 22726232

  • The availability of free samples of acne medications increases the prescription of more expensive, branded drugs in lieu of generic alternatives 75th Annual Meeting of the Society-for-Investigative-Dermatology Hurley, M., Stafford, R., Lane, A. NATURE PUBLISHING GROUP. 2012: S45?S45

    View details for Web of Science ID 000302866900264

  • Effects of a 12-Month Physical Activity Intervention on Prevalence of Metabolic Syndrome in Elderly Men and Women JOURNALS OF GERONTOLOGY SERIES A-BIOLOGICAL SCIENCES AND MEDICAL SCIENCES Wang, X., Hsu, F., Isom, S., Walkup, M. P., Kritchevsky, S. B., Goodpaster, B. H., Church, T. S., Pahor, M., Stafford, R. S., Nicklas, B. J. 2012; 67 (4): 417-424

    Abstract

    There is a lack of information on whether exercise training alone can reduce the prevalence of metabolic syndrome (MetS) in elderly men and women.This study was an ancillary to the Lifestyle Interventions and Independence for Elders Pilot Study, a four-site, single-blind, randomized controlled clinical trial comparing a 12-month physical activity (PA) intervention (N = 180) with a successful aging intervention (N = 181) in elderly (70-89 years) community-dwelling men and women at risk for physical disability. The PA intervention included aerobic, strength, and flexibility exercises, with walking as the primary mode. MetS was defined using the National Cholesterol Education Program criteria.There was no significant change in body weight or fat mass after either intervention. The trend of MetS prevalence over the intervention period was similar between PA and successful aging groups (p = .77). Overall, the prevalence of MetS decreased significantly from baseline to 6 months (p = .003) but did not change further from 6- to 12-month visits (p = .11). There were no group differences in any individual MetS components (p > .05 for all group by visit interactions). However, in individuals not using medications at any visit to treat MetS components, those in the PA intervention had lower odds of having MetS than those in the successful aging group during follow-up (odds ratio = 0.28, 95% confidence interval = 0.08-0.96).In this sample, a 12-month PA intervention did not reduce the prevalence of MetS more than a successful aging intervention, perhaps due to the large proportion of individuals taking medications for treating MetS components.

    View details for DOI 10.1093/gerona/glr187

    View details for Web of Science ID 000301974500012

    View details for PubMedID 22024949

    View details for PubMedCentralID PMC3309873

  • Underdiagnosis of Hypertension Using Electronic Health Records AMERICAN JOURNAL OF HYPERTENSION Banerjee, D., Chung, S., Wong, E. C., Wang, E. J., Stafford, R. S., Palaniappan, L. P. 2012; 25 (1): 97-102

    Abstract

    Hypertension is highly prevalent and contributes to cardiovascular morbidity and mortality. Appropriate identification of hypertension is fundamental for its management. The rates of appropriate hypertension diagnosis in outpatient settings using an electronic health record (EHR) have not been well studied. We sought to identify prevalent and incident hypertension cases in a large outpatient healthcare system, examine the diagnosis rates of prevalent and incident hypertension, and identify clinical and demographic factors associated with appropriate hypertension diagnosis.We analyzed a 3-year, cross-sectional sample of 251,590 patients aged ?18 years using patient EHRs. Underlying hypertension was defined as two or more abnormal blood pressure (ABP) readings ?140/90 mm Hg and/or pharmaceutical treatment. Appropriate hypertension diagnosis was defined by the reporting of ICD-9 codes (401.0-401.9). Factors associated with hypertension diagnosis were assessed through multivariate analyses of patient clinical and demographic characteristics.The prevalence of hypertension was 28.7%, and the diagnosis rate was 62.9%. The incidence of hypertension was 13.3%, with a diagnosis rate of 19.9%. Predictors of diagnosis for prevalent hypertension included older age, Asian, African American, higher body mass index (BMI), and increased number of ABP readings. Predictors for incident hypertension diagnosis were similar. In patients with two or more ABP readings, hypertension diagnosis was associated with significantly higher medication treatment rates (92.6% vs. 15.8%, P < 0.0001).Outpatient EHR diagnosis rates are suboptimal, yet EHR diagnosis of hypertension is strongly associated with treatment. Targeted efforts to improve diagnosis should be a priority.

    View details for DOI 10.1038/ajh.2011.179

    View details for PubMedID 22031453

  • An Internet-Based Osteoporotic Fracture Risk Program: Effect on Knowledge, Attitudes, and Behaviors JOURNAL OF WOMENS HEALTH Drieling, R. L., Ma, J., Thiyagarajan, S., Stafford, R. S. 2011; 20 (12): 1895-1907

    Abstract

    The 2004 Surgeon General's Bone Health Report calls for innovative interventions to reduce osteoporotic fracture. We developed an Internet-based risk- and stage-tailored intervention to promote self-management of fracture risk.We randomized 121 women to receive 18 personalized Internet-based tutorials with behavior modification strategies for nutrition, exercise, and other behaviors (n=61) or to receive standard information (n=60). Tutorials were tailored for 10-year hip fracture risk, osteoporosis knowledge, attitudes about osteoporosis, nutritional intake, and exercise levels. Participants in both groups completed questionnaires at baseline, 3 months, and 6 months. Qualitative data included tutorial evaluation forms and focus groups. Main outcomes were perceived impact of the intervention, and changes in osteoporosis knowledge and beliefs, calcium and vitamin D intake, and exercise levels.At 6 months, 80% of intervention and 92% of control group participants completed the study. The intervention group significantly increased general osteoporosis knowledge (p=0.03) and calcium knowledge (p=0.02) compared with the control group. At 6 months, intervention participants were not significantly more likely to meet recommendations for calcium (OR: 1.39; 95% CI: 0.64-3.0; p=0.40), vitamin D (OR: 1.27; CI: 0.61-2.66; p=0.53), or aerobic (OR: 1.49; 95% CI: 0.63-3.48; p=0.36) or resistance exercise (OR: 1.36; 95% CI: 0.66-2.79; p=0.40) compared with control group participants. Thematic analyses of two focus groups and 794 tutorial evaluation forms, however, indicated that the intervention improved participant ability to implement and maintain healthy behaviors. Participants suggested program refinements including virtual support groups, applications for portable devices, and tailoring of tutorial length.The risk- and stage-tailored intervention was associated with improved knowledge but was not associated with significant behavioral improvements. Qualitative results suggest the intervention improved behavior implementation and maintenance. A refined intervention with additional tailoring capabilities could be used with Internet-based fracture risk assessment tools to confront the growing societal burden of osteoporotic fractures.

    View details for DOI 10.1089/jwh.2010.2515

    View details for Web of Science ID 000298155700020

    View details for PubMedID 21970565

  • National Trends in Ambulatory Asthma Treatment, 1997-2009 JOURNAL OF GENERAL INTERNAL MEDICINE Higashi, A., Zhu, S., Stafford, R. S., Alexander, G. C. 2011; 26 (12): 1465-1470

    Abstract

    Despite reductions in morbidity and mortality and changes in guidelines, little is known regarding changes in asthma treatment patterns.To examine national trends in the office-based treatment of asthma between 1997 and 2009.We used the National Ambulatory Care Survey (NAMCS) and the National Disease and Therapeutic Index? (NDTI), nationally representative audits of office-based physicians, to examine patients diagnosed with asthma less than 50 years of age.Visits where asthma was diagnosed and use of six therapeutic classes (short-acting ?(2) agonists [SABA], long-acting ?(2) -agonists [LABA], inhaled steroids, antileukotrienes, anticholinergics, and xanthines).Estimates from NAMCS indicated modest increases in the number of annual asthma visits from 9.9 million [M] in 1997 to 10.3M during 2008; estimates from the NDTI suggested more gradual continuous increases from 8.7M in 1997 to 12.6M during 2009. NAMCS estimates indicated declines in use of SABAs (from 80% of treatment visits in 1997 to 71% in 2008), increased inhaled steroid use (24% in 1997 to 33% in 2008), increased use of fixed dose LABA/steroid combinations (0% in 1997 to 19% in 2008), and increased leukotriene use (9% in 1997 to 24% in 2008). The ratio of controller to total asthma medication use increased from 0.5 (1997) to a peak of 0.7 (2004). In 2008, anticholinergics, xanthines, and LABA use without concomitant steroids accounted for fewer than 4% of all treatment visits. Estimates from NDTI corroborated these trends.Changes in office-based treatment, including increased inhaled steroid use and increased combined steroid/long-acting ?(2)-agonist use coincide with reductions in asthma morbidity and mortality that have been demonstrated over the same period. Xanthines, anticholinergics, and increasingly, LABA without concomitant steroid use, account for a very small fraction of all asthma treatments.

    View details for DOI 10.1007/s11606-011-1796-4

    View details for Web of Science ID 000297146100013

    View details for PubMedID 21769507

  • Is Clinical Decision Support the Missing Link in Prevention? ARCHIVES OF INTERNAL MEDICINE Stafford, R. S., Romano, M. J. 2011; 171 (19): 1745-1746

    View details for Web of Science ID 000296198200010

    View details for PubMedID 22025431

  • Promoting culturally targeted chronic disease prevention research through an adapted participatory research approach: The Qassim-Stanford Universities project. Translational behavioral medicine Winter, S. J., King, A. C., Stafford, R. S., Winkleby, M. A., Haskell, W. L., Farquhar, J. W. 2011; 1 (2): 289-298

    Abstract

    The Kingdom of Saudi Arabia (KSA), similar to other countries in the Eastern Mediterranean, has been experiencing a recent rapid increase in the prevalence of chronic diseases and associated risk factors. To begin to take advantage of the chronic disease prevention and health promotion (CDPHP) knowledge available from other nations, researchers at a newly established University in the Qassim Province of the KSA have partnered with Stanford University in the United States of America. To ensure that CDPHP research and interventions are culturally relevant and appropriate, a participatory research approach has been adopted where local researchers are the target "community." Contextual challenges of conducting CDPHP research in the KSA, at the individual, social/cultural, organizational and environmental/policy levels, are identified, as well as examples of CDPHP intervention strategies that may be culturally appropriate at each level.

    View details for DOI 10.1007/s13142-011-0033-3

    View details for PubMedID 24073051

  • Promoting culturally targeted chronic disease prevention research through an adapted participatory research approach: The Qassim-Stanford Universities project TRANSLATIONAL BEHAVIORAL MEDICINE Winter, S. J., King, A. C., Stafford, R. S., Winkleby, M. A., Haskell, W. L., Farquhar, J. W. 2011; 1 (2): 289-298

    Abstract

    The Kingdom of Saudi Arabia (KSA), similar to other countries in the Eastern Mediterranean, has been experiencing a recent rapid increase in the prevalence of chronic diseases and associated risk factors. To begin to take advantage of the chronic disease prevention and health promotion (CDPHP) knowledge available from other nations, researchers at a newly established University in the Qassim Province of the KSA have partnered with Stanford University in the United States of America. To ensure that CDPHP research and interventions are culturally relevant and appropriate, a participatory research approach has been adopted where local researchers are the target "community." Contextual challenges of conducting CDPHP research in the KSA, at the individual, social/cultural, organizational and environmental/policy levels, are identified, as well as examples of CDPHP intervention strategies that may be culturally appropriate at each level.

    View details for DOI 10.1007/s13142-011-0033-3

    View details for Web of Science ID 000209412000013

    View details for PubMedCentralID PMC3717657

  • Electronic Health Records and Clinical Decision Support Systems Impact on National Ambulatory Care Quality ARCHIVES OF INTERNAL MEDICINE Romano, M. J., Stafford, R. S. 2011; 171 (10): 897-903

    Abstract

    Electronic health records (EHRs) are increasingly used by US outpatient physicians. They could improve clinical care via clinical decision support (CDS) and electronic guideline-based reminders and alerts. Using nationally representative data, we tested the hypothesis that a higher quality of care would be associated with EHRs and CDS.We analyzed physician survey data on 255,402 ambulatory patient visits in nonfederal offices and hospitals from the 2005-2007 National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey. Based on 20 previously developed quality indicators, we assessed the relationship of EHRs and CDS to the provision of guideline-concordant care using multivariable logistic regression.Electronic health records were used in 30% of an estimated 1.1 billion annual US patient visits. Clinical decision support was present in 57% of these EHR visits (17% of all visits). The use of EHRs and CDS was more likely in the West and in multiphysician settings than in solo practices. In only 1 of 20 indicators was quality greater in EHR visits than in non-EHR visits (diet counseling in high-risk adults, adjusted odds ratio, 1.65; 95% confidence interval, 1.21-2.26). Among the EHR visits, only 1 of 20 quality indicators showed significantly better performance in visits with CDS compared with EHR visits without CDS (lack of routine electrocardiographic ordering in low-risk patients, adjusted odds ratio, 2.88; 95% confidence interval, 1.69-4.90). There were no other significant quality differences.Our findings indicate no consistent association between EHRs and CDS and better quality. These results raise concerns about the ability of health information technology to fundamentally alter outpatient care quality.

    View details for DOI 10.1001/archinternmed.2010.527

    View details for PubMedID 21263077

  • Off-Label Use of Recombinant Factor VIIa in US Hospitals: Analysis of Hospital Records ANNALS OF INTERNAL MEDICINE Logan, A. C., Yank, V., Stafford, R. S. 2011; 154 (8): 516-W175

    Abstract

    Recombinant factor VIIa (rFVIIa) is approved for treatment of bleeding in patients who have hemophilia with inhibitors but has been applied to a wide range of off-label indications.To estimate patterns of off-label rFVIIa use in U.S. hospitals.Retrospective database analysis.Data were extracted from the Premier Perspectives database (Premier, Charlotte, North Carolina), which contains discharge records from a sample of academic and nonacademic U.S. hospitals. Patients: 12 644 hospitalizations for patients who received rFVIIa during a hospital stay.Hospital diagnoses and patient dispositions from 1 January 2000 to 31 December 2008. Statistical weights for each hospital were used to provide national estimates of rFVIIa use.From 2000 to 2008, off-label use of rFVIIa in hospitals increased more than 140-fold, such that in 2008, 97% (95% CI, 96% to 98%) of 18 311 in-hospital uses were off-label. In contrast, in-hospital use for hemophilia increased less than 4-fold and accounted for 2.7% (CI, 1.9% to 3.5%) of use in 2008. Adult and pediatric cardiovascular surgery (29% [CI, 21% to 33%]), body and brain trauma (29% [CI, 19% to 38%]), and intracranial hemorrhage (11% [CI, 7.7% to 14%]) were the most common indications for rFVIIa use. Across all indications, in-hospital mortality was 27% (CI, 19% to 34%) and 43% (CI, 26% to 59%) of patients were discharged to home.Accuracy and completeness of the discharge diagnoses and patient medication records in the database sample cannot be verified.Off-label use of rFVIIa in the hospital setting far exceeds use for approved indications. These patterns raise concern about the application of rFVIIa to conditions for which strong supporting evidence is lacking.

    View details for PubMedID 21502649

  • Health Outcomes After Stopping Conjugated Equine Estrogens Among Postmenopausal Women With Prior Hysterectomy A Randomized Controlled Trial JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION LaCroix, A. Z., Chlebowski, R. T., Manson, J. E., Aragaki, A. K., Johnson, K. C., Martin, L., Margolis, K. L., Stefanick, M. L., Brzyski, R., Curb, J. D., Howard, B. V., Lewis, C. E., Wactawski-Wende, J. 2011; 305 (13): 1305-1314

    Abstract

    The Women's Health Initiative Estrogen-Alone Trial was stopped early after a mean of 7.1 years of follow-up because of an increased risk of stroke and little likelihood of altering the balance of risk to benefit by the planned trial termination date. Postintervention health outcomes have not been reported.To examine health outcomes associated with randomization to treatment with conjugated equine estrogens (CEE) among women with prior hysterectomy after a mean of 10.7 years of follow-up through August 2009.The intervention phase was a double-blind, placebo-controlled, randomized clinical trial of 0.625 mg/d of CEE compared with placebo in 10,739 US postmenopausal women aged 50 to 79 years with prior hysterectomy. Follow-up continued after the planned trial completion date among 7645 surviving participants (78%) who provided written consent.The primary outcomes were coronary heart disease (CHD) and invasive breast cancer. A global index of risks and benefits included these primary outcomes plus stroke, pulmonary embolism, colorectal cancer, hip fracture, and death.The postintervention risk (annualized rate) for CHD among women assigned to CEE was 0.64% compared with 0.67% in the placebo group (hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.75-1.25), 0.26% vs 0.34%, respectively, for breast cancer (HR, 0.75; 95% CI, 0.51-1.09), and 1.47% vs 1.48%, respectively, for total mortality (HR, 1.00; 95% CI, 0.84-1.18). The risk of stroke was no longer elevated during the postintervention follow-up period and was 0.36% among women receiving CEE compared with 0.41% in the placebo group (HR, 0.89; 95% CI, 0.64-1.24), the risk of deep vein thrombosis was lower at 0.17% vs 0.27%, respectively (HR, 0.63; 95% CI, 0.41-0.98), and the risk of hip fracture did not differ significantly and was 0.36% vs 0.28%, respectively (HR, 1.27; 95% CI, 0.88-1.82). Over the entire follow-up, lower breast cancer incidence in the CEE group persisted and was 0.27% compared with 0.35% in the placebo group (HR, 0.77; 95% CI, 0.62-0.95). Health outcomes were more favorable for younger compared with older women for CHD (P = .05 for interaction), total myocardial infarction (P = .007 for interaction), colorectal cancer (P = .04 for interaction), total mortality (P = .04 for interaction), and global index of chronic diseases (P = .009 for interaction).Among postmenopausal women with prior hysterectomy followed up for 10.7 years, CEE use for a median of 5.9 years was not associated with an increased or decreased risk of CHD, deep vein thrombosis, stroke, hip fracture, colorectal cancer, or total mortality. A decreased risk of breast cancer persisted.clinicaltrials.gov Identifier: NCT00000611.

    View details for Web of Science ID 000289162400019

    View details for PubMedID 21467283

  • Trends in menopausal hormone therapy use of US office-based physicians, 2000-2009 MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY Tsai, S. A., Stefanick, M. L., Stafford, R. S. 2011; 18 (4): 385-392

    Abstract

    The aim of this study was to evaluate recent trends and the adoption of practice recommendations for menopausal hormone therapy (MHT) use from 2001 to 2009 by formulation, dose, woman's age, and characteristics of physicians reporting MHT visits.The IMS Health (Plymouth Meeting PA) National Disease and Therapeutic Index physician survey data from 2001 to 2009 were analyzed for visits in which MHT use was reported by US office-based physicians. Estimated national volume of visits for which MHT use was reported.MHT use declined each year since 2002. Systemic MHT use fell from 16.3 million (M) visits in 2001 to 6.1 M visits in 2009. Declines were greatest for women 60 years or older (64%) but were also substantial for women younger than 50 years (59%) and women 50 to 59 years old (60%). Women 60 years or older accounted for 37% of MHT use. Lower dose product use increased modestly, from 0.7 M (2001) to 1.3 M (2009), as did vaginal MHT use, from 1.8 M (2001) to 2.4 M (2009). Declines in continuing systemic MHT use (65%) were greater than for newly initiated MHT use (51%). Compared with other physicians, obstetrician/gynecologists changed their practices less, thereby increasing their overall share of total MHT visits from 72% (2001) to 82% (2009).Total MHT use has steadily declined. Increased use of lower dose and vaginal products reflects clinical recommendations. Uptake of these products, however, has been modest, and substantial use of MHT continues in older women.

    View details for DOI 10.1097/gme.0b013e3181f43404

    View details for Web of Science ID 000288781800009

    View details for PubMedID 21127439

    View details for PubMedCentralID PMC3123410

  • Evaluating clinic and community-based lifestyle interventions for obesity reduction in a low-income Latino neighborhood: Vivamos Activos Fair Oaks Program BMC PUBLIC HEALTH Drieling, R. L., Ma, J., Stafford, R. S. 2011; 11

    Abstract

    Obesity exerts an enormous health impact through its effect on coronary heart disease and its risk factors. Primary care-based and community-based intensive lifestyle counseling may effectively promote weight loss. There has been limited implementation and evaluation of these strategies, particularly the added benefit of community-based intervention, in low-income Latino populations.The Vivamos Activos Fair Oaks project is a randomized clinical trial designed to evaluate the clinical and cost-effectiveness of two obesity reduction lifestyle interventions: clinic-based intensive lifestyle counseling, either alone (n = 80) or combined with community health worker support (n = 80), in comparison to usual primary care (n = 40). Clinic-based counseling consists of 15 group and four individual lifestyle counseling sessions provided by health educators targeting behavior change in physical activity and dietary practices. Community health worker support includes seven home visits aimed at practical implementation of weight loss strategies within the person's home and neighborhood. The interventions use a framework based on Social Cognitive Theory, the Transtheoretical Model of behavior change, and techniques from previously tested lifestyle interventions. Application of the framework was culturally tailored based on past interventions in the same community and elsewhere, as well as a community needs and assets assessment. The interventions include a 12-month intensive phase followed by a 12-month maintenance phase. Participants are obese Spanish-speaking adults with at least one cardiovascular risk factor recruited from a community health center in a low-income neighborhood of San Mateo County, California. Follow-up assessments occur at 6, 12, and 24 months for the primary outcome of percent change in body mass index at 24 months. Secondary outcomes include specific cardiovascular risk factors, particularly blood pressure and fasting glucose levels.If successful, this study will provide evidence for broad implementation of obesity interventions in minority populations and guidance about the selection of strategies involving clinic-based case management and community-based community health worker support.ClinicalTrials.gov: NCT01242683.

    View details for DOI 10.1186/1471-2458-11-98

    View details for Web of Science ID 000287587100001

    View details for PubMedID 21320331

  • Safety of Recombinant Activated Factor VII in Randomized Clinical Trials NEW ENGLAND JOURNAL OF MEDICINE Yank, V., Stafford, R. S. 2011; 364 (6): 575-575

    View details for Web of Science ID 000287139900018

    View details for PubMedID 21306248

  • Increasing off-label use of antipsychotic medications in the United States, 1995-2008 PHARMACOEPIDEMIOLOGY AND DRUG SAFETY Alexander, G. C., Gallagher, S. A., Mascola, A., Moloney, R. M., Stafford, R. S. 2011; 20 (2): 177-184

    Abstract

    To evaluate patterns of antipsychotic use. DESIGN, SETTING, AND MEASUREMENTS: We used nationally representative data from the IMS Health National Disease and Therapeutic Index to describe outpatient antipsychotic use. The primary outcome was the volume of visits where antipsychotics were used for specific indications (treatment visits). We also quantified use without U.S. Food and Drug Administration approval (off-label use) and off-label use with compendium data suggesting an uncertain evidence base.Antipsychotic use increased from 6.2 million (M) treatment visits (95% CI, 5.4-7.0) in 1995 to 16.7 M visits (15.5-18.2) in 2006, then declined to 14.3 M visits (13.0-15.6) by 2008. A shift occurred from typical agents in 1995 (84% of all antipsychotic visits) to atypical agents by 2008 (93%). As they declined, typical medications shifted toward use in schizophrenia (30% in 1995 to 48% 2008). In contrast, use of atypical agents expanded for bipolar affective disorder (10 to 34%), remained stable for depression (12 to 14%), and declined for schizophrenia (56 to 23%). Overall, antipsychotic use for indications without FDA approval increased from 4.4 M visits in 1995 to 9.0 M in 2008. The estimated cost associated with off-label use in 2008 was US$6.0 billion.Atypical use has grown far beyond substitution for the now infrequently used typical agents. Antipsychotics are increasingly used for conditions where FDA approval and associated clinical evidence is less certain. Despite the value of innovation, the benefits of widening atypical antipsychotic use should be weighed against their cost, regulatory status, and incomplete nature of available evidence.

    View details for DOI 10.1002/pds.2082

    View details for Web of Science ID 000287716100009

    View details for PubMedID 21254289

  • Antiviral Prescribing by Office-Based Physicians During the 2009 H1N1 Pandemic ANNALS OF INTERNAL MEDICINE Hersh, A. L., Stafford, R. S. 2011; 154 (1): 74-76

    View details for Web of Science ID 000285830900017

    View details for PubMedID 21200049

  • A trial of inpatient indication based prescribing during computerized order entry with medications commonly used off-label APPLIED CLINICAL INFORMATICS Walton, S. M., Galanter, W. L., Rosencranz, H., Meltzer, D., Stafford, R. S., Tiryaki, F., Sarne, D. 2011; 2 (1): 94-103

    View details for DOI 10.4338/ACI-2010-11-RA-0072

    View details for Web of Science ID 000208686500008

  • A trial of inpatient indication based prescribing during computerized order entry with medications commonly used off-label. Applied clinical informatics Walton, S. M., Galanter, W. L., Rosencranz, H., Meltzer, D., Stafford, R. S., Tiryaki, F., Sarne, D. 2011; 2 (1): 94-103

    Abstract

    Requiring indications for inpatient medication orders may improve the quality of prescribing and allow for easier placement of diagnoses on the problem list. Indications for inpatient medication orders are also required by some regulators.This study assessed a clinical decision support (CDS) system designed to obtain indications and document problems during inpatient computerized physician order entry (CPOE) of medications frequently used off-label.A convenience sample of three medications frequently used off-label were selected: the PPI lansoprazole; intravenous immune globulin, and recombinant Factor VIIa. Alerts triggered when a medication was ordered without an FDA approved indication in the problem list. The alerts prompted clinicians to enter either a labeled or off-label indication for the order. Chart review was used as the gold standard to assess the accuracy of clinician entered information.The PPI intervention generated 873 alerts during 60 days of operation; IVIG 55 alerts during alerts during 93 days; Factor VIIa 25 alerts during 175 days. Agreement between indications entered and chart review was 63% for PPI, 49% for IVIG, and 29% for Factor VIIa. The alerts for PPI, IVIG and Factor VIIa alerts produced accurate diagnoses for the problem list 9%, 16% and 24% respectively. Rates of off-label use measured by chart review were 87% for PPI, and 100% for IVIG and factor VIIa, which were higher than if measured using the ordering clinicians' indications.This trial of indication-based prescribing using CDS and CPOE produced less than optimal accuracy of the indication data as well as a low yield of accurate problems placed on the problem list. These results demonstrate the challenge inherent in obtaining accurate indication information during prescribing and should raise concerns over potential mandates for indication based prescribing and motivate further study of appropriate mechanisms to obtain indications during CPOE.

    View details for DOI 10.4338/ACI-2010-11-RA-0072

    View details for PubMedID 23616862

  • Underdiagnosis of Pediatric Obesity during Outpatient Preventive Care Visits ACADEMIC PEDIATRICS Patel, A. I., Madsen, K. A., Maselli, J. H., Cabana, M. D., Stafford, R. S., Hersh, A. L. 2010; 10 (6): 405-409

    Abstract

    To examine obesity diagnosis, obesity-related counseling, and laboratory testing rates among obese pediatric patients seen in US preventive outpatient visits and to determine patient, provider, and practice-level factors that are associated with obesity diagnosis.By using 2005-2007 National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey data, outpatient preventive visits made by obese (body mass index ?95%) 2- to 18-year-old patients were examined for frequencies of obesity diagnosis, diet, exercise, or weight reduction counseling, and glucose or cholesterol testing. Multivariable logistic regression was used to examine whether patient-level (gender, age, race/ethnicity, insurance type) and provider/practice-level (geographic region, provider specialty, and practice setting) factors were associated with physician obesity diagnosis.Physicians documented an obesity diagnosis in 18% (95% confidence interval, 13-23) of visits made by 2- to 18-year-old patients with a body mass index ?95%. Documentation of an obesity diagnosis was more likely for non-white patients (odds ratio 2.87; 95% confidence interval, 1.3-6.3). Physicians were more likely to provide obesity-related counseling (51% of visits) than to conduct laboratory testing (10% of visits) for obese pediatric patients.Rates of documented obesity diagnosis, obesity-related counseling, and laboratory testing for comorbid conditions among obese pediatric patients seen in US outpatient preventive visits are suboptimal. Efforts should target enhanced obesity diagnosis as a first step toward improving pediatric obesity management.

    View details for Web of Science ID 000284253800009

    View details for PubMedID 21075322

  • Estrogen Plus Progestin and Breast Cancer Incidence and Mortality in Postmenopausal Women JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Chlebowski, R. T., Anderson, G. L., Gass, M., Lane, D. S., Aragaki, A. K., Kuller, L. H., Manson, J. E., Stefanick, M. L., Ockene, J., Sarto, G. E., Johnson, K. C., Wactawski-Wende, J., Ravdin, P. M., Schenken, R., Hendrix, S. L., Rajkovic, A., Rohan, T. E., Yasmeen, S., Prentice, R. L. 2010; 304 (15): 1684-1692

    Abstract

    In the Women's Health Initiative randomized, placebo-controlled trial of estrogen plus progestin, after a mean intervention time of 5.6 (SD, 1.3) years (range, 3.7-8.6 years) and a mean follow-up of 7.9 (SD, 1.4) years, breast cancer incidence was increased among women who received combined hormone therapy. Breast cancer mortality among participants in the trial has not been previously reported.To determine the effects of therapy with estrogen plus progestin on cumulative breast cancer incidence and mortality after a total mean follow-up of 11.0 (SD, 2.7) years, through August 14, 2009.A total of 16,608 postmenopausal women aged 50 to 79 years with no prior hysterectomy from 40 US clinical centers were randomly assigned to receive combined conjugated equine estrogens, 0.625 mg/d, plus medroxyprogesterone acetate, 2.5 mg/d, or placebo pill. After the original trial completion date (March 31, 2005), reconsent was required for continued follow-up for breast cancer incidence and was obtained from 12,788 (83%) of the surviving participants.Invasive breast cancer incidence and breast cancer mortality.In intention-to-treat analyses including all randomized participants and censoring those not consenting to additional follow-up on March 31, 2005, estrogen plus progestin was associated with more invasive breast cancers compared with placebo (385 cases [0.42% per year] vs 293 cases [0.34% per year]; hazard ratio [HR], 1.25; 95% confidence interval [CI], 1.07-1.46; P = .004). Breast cancers in the estrogen-plus-progestin group were similar in histology and grade to breast cancers in the placebo group but were more likely to be node-positive (81 [23.7%] vs 43 [16.2%], respectively; HR, 1.78; 95% CI, 1.23-2.58; P = .03). There were more deaths directly attributed to breast cancer (25 deaths [0.03% per year] vs 12 deaths [0.01% per year]; HR, 1.96; 95% CI, 1.00-4.04; P = .049) as well as more deaths from all causes occurring after a breast cancer diagnosis (51 deaths [0.05% per year] vs 31 deaths [0.03% per year]; HR, 1.57; 95% CI, 1.01-2.48; P = .045) among women who received estrogen plus progestin compared with women in the placebo group.Estrogen plus progestin was associated with greater breast cancer incidence, and the cancers are more commonly node-positive. Breast cancer mortality also appears to be increased with combined use of estrogen plus progestin.clinicaltrials.gov Identifier: NCT00000611.

    View details for Web of Science ID 000283129700022

    View details for PubMedID 20959578

  • No Beneficial Effects of Pine Bark Extract on Cardiovascular Disease Risk Factors ARCHIVES OF INTERNAL MEDICINE Drieling, R. L., Gardner, C. D., Ma, J., Ahn, D. K., Stafford, R. S. 2010; 170 (17): 1541-1547

    Abstract

    Although modifiable cardiovascular disease risk factors are common, some patients eschew conventional drug treatments in favor of natural alternatives. Pine bark extract, a dietary supplement source of antioxidant oligomeric proanthocyanidin complexes, has multiple putative cardiovascular benefits. Studies published to date about the supplement have notable methodological limitations.We randomized 130 individuals with increased cardiovascular disease risk to take 200 mg of a water-based extract of pine bark (n = 64; Toyo-FVG, Toyo Bio-Pharma, Torrance, California; Shinyaku Co, Ltd, Saga, Japan; also marketed as Flavagenol in Japan) or placebo (n = 66) once per day. Blood pressure, our primary outcome, and other cardiovascular disease risk factors were measured at baseline and at 6 and 12 weeks. Statistical analyses were conducted using regression models.Baseline characteristics did not differ between the study groups. Over the 12-week intervention, the sum of systolic and diastolic blood pressures decreased by 1.0 mm Hg (95% confidence interval, -4.2 to 2.1 mm Hg) in the pine bark extract-treated group and by 1.9 mm Hg (-5.5 to 1.7 mm Hg) in the placebo group (P = .87). Other outcomes were likewise not significantly different, including body mass index, lipid panel measures, liver transaminase test results, lipoprotein cholesterol particle size, and levels of insulin, lipoprotein(a), fasting glucose, and high-sensitivity C-reactive protein. There were no subgroups for whom intake of pine bark extract affected cardiovascular disease risk factors.This pine bark extract (at a dosage of 200 mg/d) was safe but was not associated with improvement in cardiovascular disease risk factors. Although variations among participants, dosages, and chemical preparations could contribute to different findings compared with past studies, our results are consistent with a general failure of antioxidants to demonstrate cardiovascular benefits.clinicaltrials.gov Identifier: NCT00425945.

    View details for PubMedID 20876405

  • Lack of Improvement in Outpatient Management of Congestive Heart Failure in the United States ARCHIVES OF INTERNAL MEDICINE Banerjee, D., Stafford, R. S. 2010; 170 (15): 1399-1400

    View details for Web of Science ID 000280651500020

    View details for PubMedID 20696970

  • Impact of the ALLHAT/JNC7 Dissemination Project on Thiazide-Type Diuretic Use ARCHIVES OF INTERNAL MEDICINE Stafford, R. S., Bartholomew, L. K., Cushman, W. C., Cutler, J. A., Davis, B. R., Dawson, G., Einhorn, P. T., Furberg, C. D., Piller, L. B., Pressel, S. L., Whelton, P. K. 2010; 170 (10): 851-858

    Abstract

    Strategies are needed to improve the translation of clinical trial results into practice. We assessed the impact of the ALLHAT/JNC7 Dissemination Project's academic detailing component on thiazide-type diuretic prescribing (ALLHAT indicates Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial; JNC7 indicates the Seventh Report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure).We used 2 national databases available from IMS Health: a physician survey of medications reported for hypertension and a pharmacy dispensing database on antihypertensive medications. At a county level, we correlated medication data with Dissemination Project intensity. Practices before the Dissemination Project in 2004 were compared with those after its completion in 2007. We also examined 2000-2008 national trends.Academic detailing reached 18 524 physicians in 1698 venues via 147 investigator-educators. We noted an association between ALLHAT/JNC7 academic detailing activities and increased prescribing of thiazide-type diuretics. Physician survey data showed that the percentage of hypertension visits where the physician recorded a thiazide-type diuretic increased the most in counties where academic detailing activity was the highest (an increase of 8.6%, from 37.9% to 46.5%) compared with counties where activity was moderate (an increase of 2%) or low (a decrease of 2%), or where there was none (an increase of 2%; P value for trend, <.05). Pharmacy dispensing data showed that thiazide-type diuretic prescribing increased by 8.7% in counties with Dissemination Project activities compared with 3.9% in those without activities (P < .001). Nationally, thiazide-type diuretic use did not increase between 2004 and 2008.The ALLHAT/JNC7 Dissemination Project was associated with a small effect on thiazide-type diuretic use consistent with its small dose and the potential of external factors to diminish its impact. Academic detailing may increase physicians' implementation of clinical trial results, thereby making prescribing more consistent with evidence.

    View details for PubMedID 20498411

  • Bar charts enhance Bland-Altman plots when value ranges are limited JOURNAL OF CLINICAL EPIDEMIOLOGY Smith, M. W., Ma, J., Stafford, R. S. 2010; 63 (2): 180-184

    Abstract

    A common form of validation study compares alternative methods for collecting data. The Bland-Altman plot pairs observations across methods and plots their mean values vs. their difference. This method provides only limited information, however, when the range of observed values is small relative to the number of observations. This brief report shows how adding a simple bar chart to a Bland-Altman plot adds essential additional information.The methodological approach is illustrated using data from a randomized controlled clinical trial of patients in a U.S. county health system.When the number of unique values is small, a Bland-Altman plot alone may provide inadequate information. Adding a bar chart yields new and essential information about agreement, bias, and heteroscedasticity.Studies validating one data-collection method against another can be performed successfully even when the number of unique values is small.

    View details for DOI 10.1016/j.jclinepi.2009.06.001

    View details for Web of Science ID 000274062400013

    View details for PubMedID 19716265

  • Case Management to Reduce Risk of Cardiovascular Disease in a County Health Care System ARCHIVES OF INTERNAL MEDICINE Ma, J., Berra, K., Haskell, W. L., Klieman, L., Hyde, S., Smith, M. W., Xiao, L., Stafford, R. S. 2009; 169 (21): 1988-1995

    Abstract

    Case management (CM) is a systematic approach to supplement physician-centered efforts to prevent cardiovascular disease (CVD). Research is limited on its implementation and efficacy in low-income, ethnic minority populations.We conducted a randomized clinical trial to evaluate a nurse- and dietitian-led CM program for reducing major CVD risk factors in low-income, primarily ethnic minority patients in a county health care system, 63.0% of whom had type 2 diabetes mellitus. The primary outcome was the Framingham risk score (FRS).A total of 419 patients at elevated risk of CVD events were randomized and followed up for a mean of 16 months (81.4% retention). The mean FRS was significantly lower for the CM vs usual care group at follow-up (7.80 [95% confidence interval, 7.21-8.38] vs 8.93 [8.36-9.49]; P = .001) after adjusting for baseline FRS. This is equivalent to 5 fewer heart disease events per 1000 individuals per year attributable to the intervention or to 200 individuals receiving the intervention to prevent 1 event per year. The pattern of group differences in the FRS was similar in subgroups defined a priori by sex and ethnicity. The main driver of these differences was lowering the mean (SD) systolic (-4.2 [18.5] vs 2.6 [22.7] mm Hg; P = .003) and diastolic (-6.0 [11.6] vs -3.0 [11.7] mm Hg; P = .02) blood pressures for the CM vs usual care group.Nurse and dietitian CM targeting multifactor risk reduction can lead to modest improvements in CVD risk factors among high-risk patients in low-income, ethnic minority populations receiving care in county health clinics.clinicaltrials.gov Identifier: NCT00128687.

    View details for Web of Science ID 000272036900010

    View details for PubMedID 19933961

  • Comparison of Thromboembolic Event Rates in Randomized Controlled Trials and Observational Studies of Recombinant Factor VIIa for Off-Label Indications. 51st Annual Meeting and Exposition of the American-Society-of-Hematology Yank, V., Logan, A. C., Tuohy, C. V., Bravata, D. M., Staudenmayer, K., Eisenhut, R., Sundaram, V., McMahon, D., McDonald, K. M., Owens, D., Stafford, R. S. AMER SOC HEMATOLOGY. 2009: 571?72

    View details for Web of Science ID 000272725801583

  • Evaluation of lifestyle interventions to treat elevated cardiometabolic risk in primary care (E-LITE): a randomized controlled trial BMC FAMILY PRACTICE Ma, J., King, A. C., Wilson, S. R., Xiao, L., Stafford, R. S. 2009; 10

    Abstract

    Efficacy research has shown that intensive individual lifestyle intervention lowers the risk for developing type 2 diabetes mellitus and the metabolic syndrome. Translational research is needed to test real-world models of lifestyle interventions in primary care settings.E-LITE is a three-arm randomized controlled clinical trial aimed at testing the feasibility and potential effectiveness of two lifestyle interventions: information technology-assisted self-management, either alone or in combination with care management by a dietitian and exercise counselor, in comparison to usual care. Overweight or obese adults with pre-diabetes and/or metabolic syndrome (n = 240) recruited from a community-based primary care clinic are randomly assigned to one of three treatment conditions. Treatment will last 15 months and involves a three-month intensive treatment phase followed by a 12-month maintenance phase. Follow-up assessment occurs at three, six, and 15 months. The primary outcome is change in body mass index. The target sample size will provide 80% power for detecting a net difference of half a standard deviation in body mass index at 15 months between either of the self-management or care management interventions and usual care at a two-sided alpha level of 0.05, assuming up to a 20% rate of loss to 15-month follow-up. Secondary outcomes include glycemic control, additional cardiovascular risk factors, and health-related quality of life. Potential mediators (e.g., treatment adherence, caloric intake, physical activity level) and moderators (e.g., age, gender, race/ethnicity, baseline mental status) of the intervention's effect on weight change also will be examined.This study will provide objective evidence on the extent of reductions in body mass index and related cardiometabolic risk factors from two lifestyle intervention programs of varying intensity that could be implemented as part of routine health care.

    View details for DOI 10.1186/1471-2296-10-71

    View details for Web of Science ID 000272354600001

    View details for PubMedID 19909549

  • Predictors of Hypertension Awareness, Treatment, and Control Among Mexican American Women and Men JOURNAL OF GENERAL INTERNAL MEDICINE Bersamin, A., Stafford, R. S., Winkleby, M. A. 2009; 24: 521-527

    Abstract

    The burden of hypertension and related health care needs among Mexican Americans will likely increase substantially in the near future.In a nationally representative sample of U.S. Mexican American adults we examined: 1) the full range of blood pressure categories, from normal to severe; 2) predictors of hypertension awareness, treatment and control and; 3) prevalence of comorbidities among those with hypertension.Cross-sectional analysis of pooled data from the National Health and Nutrition Examination Surveys (NHANES), 1999-2004.The group of participants encompassed 1,359 Mexican American women and 1,421 Mexican American men, aged 25-84 years, who underwent a standardized physical examination.Physiologic measures of blood pressure, body mass index, and diabetes. Questionnaire assessment of blood pressure awareness and treatment.Prevalence of Stage 1 hypertension was low and similar between women and men ( approximately 10%). Among hypertensives, awareness and treatment were suboptimal, particularly among younger adults (65% unaware, 71% untreated) and those without health insurance (51% unaware, 62% untreated). Among treated hypertensives, control was suboptimal for 56%; of these, 23% had stage >/=2 hypertension. Clustering of CVD risk factors was common; among hypertensive adults, 51% of women and 55% of men were also overweight or obese; 24% of women and 23% of men had all three chronic conditions-hypertension, overweight/obesity and diabetes.Management of hypertension in Mexican American adults fails at multiple critical points along an optimal treatment pathway. Tailored strategies to improve hypertension awareness, treatment and control rates must be a public health priority.

    View details for DOI 10.1007/s11606-009-1094-6

    View details for PubMedID 19842001

  • Oestrogen plus progestin and lung cancer in postmenopausal women (Women's Health Initiative trial): a post-hoc analysis of a randomised controlled trial LANCET Chlebowski, R. T., Schwartz, A. G., Wakelee, H., Anderson, G. L., Stefanick, M. L., Manson, J. E., Rodabough, R. J., Chien, J. W., Wactawski-Wende, J., Gass, M., Kotchen, J. M., Johnson, K. C., O'Sullivan, M. J., Ockene, J. K., Chen, C., Hubbell, F. A. 2009; 374 (9697): 1243-1251

    Abstract

    In the post-intervention period of the Women's Health Initiative (WHI) trial, women assigned to treatment with oestrogen plus progestin had a higher risk of cancer than did those assigned to placebo. Results also suggested that the combined hormone therapy might increase mortality from lung cancer. To assess whether such an association exists, we undertook a post-hoc analysis of lung cancers diagnosed in the trial over the entire follow-up period.The WHI study was a randomised, double-blind, placebo-controlled trial undertaken in 40 centres in the USA. 16 608 postmenopausal women aged 50-79 years with an intact uterus were randomly assigned by a computerised, stratified, permuted block algorithm to receive a once-daily tablet of 0.625 mg conjugated equine oestrogen plus 2.5 mg medroxyprogesterone acetate (n=8506) or matching placebo (n=8102). We assessed incidence and mortality rates for all lung cancer, small-cell lung cancer, and non-small-cell lung cancer by use of data from treatment and post-intervention follow-up periods. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00000611.After a mean of 5.6 years (SD 1.3) of treatment and 2.4 years (0.4) of additional follow-up, 109 women in the combined hormone therapy group had been diagnosed with lung cancer compared with 85 in the placebo group (incidence per year 0.16%vs 0.13%; hazard ratio [HR] 1.23, 95% CI 0.92-1.63, p=0.16). 96 women assigned to combined therapy had non-small-cell lung cancer compared with 72 assigned to placebo (0.14%vs 0.11%; HR 1.28, 0.94-1.73, p=0.12). More women died from lung cancer in the combined hormone therapy group than in the placebo group (73 vs 40 deaths; 0.11%vs 0.06%; HR 1.71, 1.16-2.52, p=0.01), mainly as a result of a higher number of deaths from non-small-cell lung cancer in the combined therapy group (62 vs 31 deaths; 0.09%vs 0.05%; HR 1.87, 1.22-2.88, p=0.004). Incidence and mortality rates of small-cell lung cancer were similar between groups.Although treatment with oestrogen plus progestin in postmenopausal women did not increase incidence of lung cancer, it increased the number of deaths from lung cancer, in particular deaths from non-small-cell lung cancer. These findings should be incorporated into risk-benefit discussions with women considering combined hormone therapy, especially those with a high risk of lung cancer.National Heart, Lung and Blood Institute, National Institutes of Health.

    View details for DOI 10.1016/S0140-6736(09)61526-9

    View details for Web of Science ID 000270852500030

    View details for PubMedID 19767090

  • New, but Not Improved? Incorporating Comparative-Effectiveness Information into FDA Labeling NEW ENGLAND JOURNAL OF MEDICINE Stafford, R. S., Wagner, T. H., Lavori, P. W. 2009; 361 (13): 1230-1233

    View details for DOI 10.1056/NEJMp0906490

    View details for PubMedID 19675326

  • Does Comparative Effectiveness Have a Comparative Edge? JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Alexander, G. C., Stafford, R. S. 2009; 301 (23): 2488-2490

    View details for Web of Science ID 000267028100027

    View details for PubMedID 19531789

  • Adult Obesity and Office-based Quality of Care in the United States OBESITY Ma, J., Xiao, L., Stafford, R. S. 2009; 17 (5): 1077-1085

    Abstract

    Nationally representative data on the quality of care for obese patients in US-ambulatory care settings are limited. We conducted a cross-sectional analysis of the 2005 and 2006 National Ambulatory Medical Care Survey (NAMCS). We examined obesity screening, diagnosis, and counseling during adult visits and associations with patient and provider characteristics. We also assessed performance on 15 previously published ambulatory quality indicators for obese vs. normal/overweight patients. Nearly 50% (95% confidence interval (CI): 46-54%) of visits lacked complete height and weight data needed to screen for obesity using BMI. Of visits by patients with clinical obesity (BMI >or=30.0 kg/m(2)), 70% (66-74%) were not diagnosed and 63% (59-68%) received no counseling for diet, exercise, or weight reduction. The percentage of visits not being screened (48%), diagnosed (66%), or counseled (54%) for obesity was also notably higher than expected even for patients with known obesity comorbidities. Performance (defined as the percentage of applicable visits receiving appropriate care) on the quality indicators was suboptimal overall. In particular, performance was no better than 50% for eight quality indicators, which are all related to the prevention and treatment of obesity comorbidities, e.g., coronary artery disease, hypertension, hyperlipidemia, asthma, and depression. Performance did not differ by weight status for any of the 15 quality indicators; however, poorer performance was consistently associated with lack of height and weight measurements. In conclusion, many opportunities are missed for obesity screening and diagnosis, as well as for the prevention and treatment of obesity comorbidities, in office-based practices across the United States, regardless of patient and provider characteristics.

    View details for DOI 10.1038/oby.2008.653

    View details for Web of Science ID 000265709800041

    View details for PubMedID 19197264

  • Underdiagnosis of Obesity in Adults in US Outpatient Settings ARCHIVES OF INTERNAL MEDICINE Ma, J., Xiao, L., Stafford, R. S. 2009; 169 (3): 313-314

    View details for Web of Science ID 000263202600016

    View details for PubMedID 19204224

  • Prioritizing Future Research on Off-Label Prescribing: Results of a Quantitative Evaluation PHARMACOTHERAPY Walton, S. N., Schumock, G. T., Lee, K., Alexander, G. C., Meltzer, D., Stafford, R. S. 2008; 28 (12): 1443-1452

    Abstract

    To develop a prioritized list of individual drugs for which future research regarding off-label uses is warranted.Retrospective, cross-sectional study.Commercial database that provides ongoing estimates of drug prescribing practices of office-based physicians in the United States and an Internet database of comprehensive evidence-based drug information.The base analyses incorporated three key factors based on the theory of value of information: volume of off-label use with inadequate evidence, drug safety, and cost and market considerations. Nationally representative prescribing data were used to estimate the number of off-label drug uses by indication from January 1, 2005-June 30, 2007, in the United States, and these indications were then categorized according to the adequacy of scientific support. Black-box warnings and safety alerts, drug cost, date of market entry, and marketing expenditures were also incorporated into the final model to produce a priority score. Sensitivity analyses were conducted by varying key model parameters. Our findings identified a high volume of off-label prescribing in the absence of good evidence for a substantial number of drugs, particularly antidepressants, antipsychotics, and anxiolytic-sedatives. Drugs that consistently ranked high in both our base model and sensitivity analyses were quetiapine, warfarin, escitalopram, risperidone, montelukast, bupropion, sertraline, venlafaxine, celecoxib, lisinopril, duloxetine, trazodone, olanzapine, and epoetin alfa.Future research into off-label drug use should focus on drugs used frequently with inadequate supporting evidence, particularly if further concerns are raised by known safety issues, high drug cost, recent market entry, and extensive marketing. Our quantitative analysis identified particular concerns with the off-label use of antipsychotic and antidepressant drugs. Targeted research and policy activities on our list of prioritized drugs have high potential value.

    View details for Web of Science ID 000261482200005

    View details for PubMedID 19025425

  • National Trends in Treatment of Type 2 Diabetes Mellitus, 1994-2007 ARCHIVES OF INTERNAL MEDICINE Alexander, G. C., Sehgal, N. L., Moloney, R. M., Stafford, R. S. 2008; 168 (19): 2088-2094

    Abstract

    Diabetes mellitus is common, costly, and increasingly prevalent. Despite innovations in therapy, little is known about patterns and costs of drug treatment.We used the National Disease and Therapeutic Index to analyze medications prescribed between 1994 and 2007 for all US office visits among patients 35 years and older with type 2 diabetes. We used the National Prescription Audit to assess medication costs between 2001 and 2007.The estimated number of patient visits for treated diabetes increased from 25 million (95% confidence interval [CI], 23 million to 27 million) in 1994 to 36 million (95% CI, 34 million to 38 million) by 2007. The mean number of diabetes medications per treated patient increased from 1.14 (95% CI, 1.06-1.22) in 1994 to 1.63 (1.54-1.72) in 2007. Monotherapy declined from 82% (95% CI, 75%-89%) of visits during which a treatment was used in 1994 to 47% (43%-51%) in 2007. Insulin use decreased from 38% of treatment visits in 1994 to a nadir of 25% in 2000 and then increased to 28% in 2007. Sulfonylurea use decreased from 67% of treatment visits in 1994 to 34% in 2007. By 2007, biguanides (54% of treatment visits) and glitazones (thiazolidinediones) (28%) were leading therapeutic classes. Increasing use of glitazones, newer insulins, sitagliptin phosphate, and exenatide largely accounted for recent increases in the mean cost per prescription ($56 in 2001 to $76 in 2007) and aggregate drug expenditures ($6.7 billion in 2001 to $12.5 billion in 2007).Increasingly complex and costly diabetes treatments are being applied to an increasing population. The magnitude of these rapid changes raises concerns about whether these more costly therapies will result in proportionately improved outcomes.

    View details for Web of Science ID 000260332400005

    View details for PubMedID 18955637

  • Conjugated equine estrogens and colorectal cancer incidence and survival: The women's health initiative randomized clinical trial CANCER EPIDEMIOLOGY BIOMARKERS & PREVENTION Ritenbaugh, C., Stanford, J. L., Wu, L., Shikany, J. M., Schoen, R. E., Stefanick, M. L., Taylor, V., Garland, C., Frank, G., Lane, D., Mason, E., Mcneeley, S. G., Ascensao, J., Chlebowski, R. T. 2008; 17 (10): 2609-2618

    Abstract

    In separate Women's Health Initiative randomized trials, combined hormone therapy with estrogen plus progestin reduced colorectal cancer incidence but estrogen alone in women with hysterectomy did not. We now analyze features of the colorectal cancers that developed and examine the survival of women following colorectal cancer diagnosis in the latter trial.10,739 postmenopausal women who were 50 to 79 years of age and had undergone hysterectomy were randomized to conjugated equine estrogens (0.625 mg/d) or matching placebo. Colorectal cancer incidence was a component of the monitoring global index of the study but was not a primary study endpoint. Colorectal cancers were verified by central medical record and pathology report review. Bowel exam frequency was not protocol defined, but information on their use was collected.After a median 7.1 years, there were 58 invasive colorectal cancers in the hormone group and 53 in the placebo group [hazard ratio, 1.12; 95% confidence interval (95% CI), 0.77-1.63]. Tumor size, stage, and grade were comparable in the two randomization groups. Bowel exam frequency was also comparable in the two groups. The cumulative mortality following colorectal cancer diagnosis among women in the conjugated equine estrogen group was 34% compared with 30% in the placebo group (hazard ratio, 1.34; 95% CI, 0.58-3.19).In contrast to the preponderance of observational studies, conjugated equine estrogens in a randomized clinical trial did not reduce colorectal cancer incidence nor improve survival after diagnosis.

    View details for DOI 10.1158/1055-9965.EPI-08-0385

    View details for Web of Science ID 000260051000013

    View details for PubMedID 18829444

    View details for PubMedCentralID PMC2937217

  • An international pilot study of oncology physicians' opinions and practices on Complementary and Alternative Medicine (CAM) INTEGRATIVE CANCER THERAPIES Lee, R. T., Hlubocky, F. J., Hu, J., Stafford, R. S., Daugherty, C. K. 2008; 7 (2): 70-75

    Abstract

    In China and Taiwan, Complementary and Alternative Medicine (CAM) therapies such as traditional Chinese medicine have been an option to cancer patients for centuries, whereas in the United States, CAM has been growing in popularity only in the past few decades. Prior research has indicated that the prevalence of CAM use among cancer patients may exceed 80%. Because of a long cultural history of CAM, we hypothesized that oncologists in China and Taiwan (C/T) would communicate and combine CAM with conventional treatments more often than US oncologists.In 2004-2005, a convenience sample of oncologists from the United States, mainland China, and Taiwan were surveyed regarding their opinions and self-reported practice patterns regarding CAM.A total 95 oncologists returned surveys, providing a 38% response rate. Four out of 5 respondents (78%) felt their medical training was inadequate to use CAM. However, 70% reported they would allow CAM use during active cancer treatment, even in the setting of curable disease. Responding C/T oncologists tended to ask patients more frequently (they ask > 25% of patients) about CAM use and recommended CAM more commonly (recommend to > 10%) to patients than surveyed US oncologists, 55% versus 37% (P = .09) and 81% versus 53% (P < .05). Respondents from the United States felt no more prepared for CAM use than C/T respondents, but 70% reported willingness to combine CAM with conventional treatments for curable disease as compared with only 48% (P < .05) of C/T oncologists.As expected, responding C/T oncologists communicate more often about CAM with patients by asking and recommending CAM. However, contrary to our original hypothesis, C/T oncologists reported a much lower rate of combining CAM with conventional treatment among curable patients than responding US oncologists. Further research is needed to explore, in depth, the reasons for differences in CAM practice patterns among oncologists.

    View details for DOI 10.1177/1534735408319059

    View details for Web of Science ID 000256934000003

    View details for PubMedID 18505899

  • Screening, treatment, and control of hypertension in US private physician offices, 2003-2004 HYPERTENSION Ma, J., Stafford, R. S. 2008; 51 (5): 1275-1281

    Abstract

    Essential hypertension is the most common diagnosis in US primary care settings for middle-aged persons and seniors. Yet, data on hypertension screening, treatment, and control in such settings are limited. We analyzed National Ambulatory Medical Care Survey data to examine the rates of and factors associated with hypertension screening, treatment, and control during US office visits in 2003 and 2004. Blood pressure was measured in 56% (95% confidence limits: 52% to 59%) of all visits by patients > or =18 years of age and in 93% (95% confidence limits: 89% to 96%) of hypertensive patient visits. Among the latter, 62% (95% confidence limits: 55% to 69%) were treated. Diuretics were the most commonly prescribed antihypertensive agents (46%; 95% confidence limits: 41% to 50%), and combination therapy was reported in 58% (95% confidence limits: 54% to 63%) of treated visits. Only 39% (95% confidence limits: 34% to 43%) of treated visits were at recommended blood pressure goals. The odds of not being screened for hypertension were notably greater for visits with a provider other than a primary care physician or cardiologist (10.0; 95% confidence limits: 5.5 to 16.7) and for nonwell care visits (5.6; 95% confidence limits: 3.6 to 8.3). Greater odds of not being treated for hypertension were noted by geographic region (South versus Northeast: 2.6; 95% confidence limits: 1.2 to 5.6) and visit type (first time versus return visits; 1.6; 95% confidence limits: 1.1 to 2.4). The odds of not having blood pressure controlled were greater for patients with comorbidities (1.6; 95% confidence limits: 1.1 to 2.4). In conclusion, more intervention efforts are needed to further reduce the gaps and variations in routine practice in relation to evidence-based practice guidelines for hypertension screening, treatment, and control.

    View details for DOI 10.1161/HYPERTENSIONAHA.107.107086

    View details for Web of Science ID 000255016500007

    View details for PubMedID 18347229

  • Regulating off-label drug use - Rethinking the role of the FDA NEW ENGLAND JOURNAL OF MEDICINE Stafford, R. S. 2008; 358 (14): 1427-1429

    View details for PubMedID 18385495

  • The feasibility and value of new measures showing patterns of quality for patients with 3 chronic conditions. The Journal of ambulatory care management Davidson, S. M., Shwartz, M., Stafford, R. S. 2008; 31 (1): 37-51

    Abstract

    The aim of this study was to create new measures of quality that combine individual service measures. Using an all-or-none approach, we identify 5 levels of care reflecting the extent to which optimal patterns of service were obtained by patients with asthma, diabetes, and heart failure. We also assess the feasibility of these levels-of-care measures and their potential value in quality improvement efforts. The study was designed to analyze claims data to reflect patterns of services used in a single metropolitan market of about 1 million residents in the northeastern United States. More than 80,000 patients insured over 4 years (1994-1997) had claims with 1 or more of 3 chronic conditions. The analysis showed that the measures discriminated effectively among groups of patients with the 3 chronic conditions and highlighted areas to target quality improvement efforts. Although the numbers vary by year, for two of the diagnoses, most patients were in the lowest categories (59%-75%), and for the third, 40% were in these categories. Few were in the highest category. Most patients were in the same category from one year to the next. The levels-of-care approach to quality measurement can help caregivers and policy makers find methods for avoiding unnecessary utilization and expenditures while raising--not lowering--the probability that utilization patterns will conform to condition-specific recommended care.

    View details for PubMedID 18162795

  • Implementing cardiac risk-factor case management: lessons learned in a county health system. Critical pathways in cardiology Berra, K., Ma, J., Klieman, L., Hyde, S., Monti, V., Guardado, A., Rivera, S., Stafford, R. S. 2007; 6 (4): 173-179

    Abstract

    Case-management (CM) can positively influence chronic disease care by facilitating guideline-concordant interventions that improve outcomes through intensive, individualized, longitudinal care. Implementation of CM, however, is difficult. We have identified lessons learned from a cardiovascular risk reduction CM program that may aid future CM implementation.Heart to Heart is both a clinical trial and program dissemination project implementing CM for persons at elevated risk of coronary heart disease (CHD) events in a multiethnic, low-income population in a county health system. Patients were randomized to CM plus usual primary care (N = 212) or primary care alone (N = 207). CM patients received face-to-face nurse and dietitian visits (mean of 14 hours) over 17 months. Visits emphasized behavior change, risk-factor monitoring, and guideline-based pharmacotherapy. A total of 341 patients (81%) were available for follow-up. This CM model is currently transitioning to a County-run program.Findings demonstrated statistically significant reductions in mean Framingham Risk for CM versus usual primary care (1.56% absolute decrease in 10-year CHD risk, P = 0.007). Favorable changes were noted across most major CHD risk factors. Lessons learned are the need for the following: (1) Strategies for implementing CM in low-income, ethnically-diverse populations, (2) Methods for developing clinically more effective CM, and (3) Approaches to increase the efficiency of cardiovascular CM.CM for cardiac risk factors faces notable implementation barriers, particularly in County health systems. Specific implementation solutions recommended may help confront these barriers and improve diffusion of this evidence-based and patient centered model of care.

    View details for PubMedID 18091408

  • Coagulation factors, postmenopausal hormone replacement therapy and the risk of venous thrombosis: The WHI clinical trials of postmenopausal hormone therapy Cushman, M., Larson, J., Rosendaal, F. R., Phillips, L. S., Howard, B. V., Curb, J., Hays-Grudo, J., Baird, A., Eaton, C. B., Heckbert, S. R., Stafford, R. S. AMER SOC HEMATOLOGY. 2007: 46A

    View details for Web of Science ID 000251100800128

  • Women's awareness and knowledge of hormone therapy post-Women's Health Initiative MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY Rigby, A. J., Ma, J., Stafford, R. S. 2007; 14 (5): 853-858

    Abstract

    Findings from the Women's Health Initiative (WHI) failed to confirm previous expectations about the net benefits of menopausal hormone therapy and have resulted in reduced use of these medications. The aim of this study was to evaluate women's awareness and knowledge concerning the risks and benefits of hormone therapy.A nationally representative survey was completed for a sample of 781 women (ages 40-60 y, mean 49 y) drawn from the Knowledge Networks Internet panel 24 months after publication of the first WHI findings, in June 2004. Responses were weighted to reflect the demographics of the US population. The main outcome measures were awareness of WHI and knowledge of its findings. An aggregate score was constructed to assess women's knowledge of the impact of hormone therapy on seven key disease outcomes. Logistic regression determined the independent predictors of (1) WHI awareness and (2) a positive aggregate knowledge score, reflecting appropriate responses about risks and benefits.Only 29% of women were aware of the WHI results. Only 40% of women had a positive aggregate knowledge score. Aside from awareness of WHI and independent of other factors, knowledge scores were lower for African American women (odds ratio, 0.4; 95% CI: 0.2-0.6) and among women with less education (odds ratio, 0.5; 95% CI: 0.3-0.9). Knowledge was greatest for breast cancer and osteoporosis outcomes and most limited for colorectal cancer and memory loss.Surveyed women had limited awareness and knowledge of the WHI results, suggesting limited diffusion. Targeting younger, less educated, and African American women is warranted.

    View details for DOI 10.1097/gme.0b013e3180333a33

    View details for PubMedID 17429334

  • Critical factors in case management: Practical lessons from a cardiac case management program DISEASE MANAGEMENT Stafford, R. S., Berra, K. 2007; 10 (4): 197-207

    Abstract

    Case management (CM) is an important strategy for chronic disease care. By utilizing non-physician providers for conditions requiring ongoing care and follow-up, CM can facilitate guideline-concordant care, patient empowerment, and improvement in quality of life. We identify a series of critical factors required for successful CM implementation. Heart to Heart is a clinical trial evaluating CM for coronary heart disease (CHD) risk reduction in a multiethnic, low-income population. Patients at elevated cardiac risk were randomized to CM plus primary care (212 patients) or to primary care alone (207). Over a mean follow-up of 17 months, patients received face-to-face nurse and dietitian visits. Mean contact time was 14 hours provided at an estimated cost of $1250 per patient for the 341 (81%) patients completing follow-up. Visits emphasized behavior change, risk-factor monitoring, self-management skills, and guideline-based pharmacotherapy. A statistically significant reduction in mean Framingham risk probability occurred in CM plus primary care relative to primary care alone (1.6% decrease in 10-year CHD risk, p = 0.007). Favorable changes were noted across individual risk factors. Our findings suggest that successful CM implementation relies on choosing appropriate case managers and investing in training, integrating CM into existing care systems, delineating the scope and appropriate levels of clinical decision making, using information systems, and monitoring outcomes and costs. While our population, setting, and intervention model are unique, these insights are broadly relevant. If implemented with attention to critical factors, CM has great potential to improve the process and outcomes of chronic disease care.

    View details for DOI 10.1089/dis.2007.103624

    View details for PubMedID 17718658

  • Comparison of weight-loss diets - Reply JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Gardner, C. D., Stafford, R. S., King, A. C. 2007; 298 (2): 174?75

    View details for DOI 10.1001/jama.298.2.174-b

    View details for Web of Science ID 000247910600015

  • Electronic health record use and the quality of ambulatory care in the United States 29th Annual Meeting of the Society-of-General-Internal-Medicine Linder, J. A., Ma, J., Bates, D. W., Middleton, B., Stafford, R. S. AMER MEDICAL ASSOC. 2007: 1400?1405

    Abstract

    Electronic health records (EHRs) have been proposed as a sustainable solution for improving the quality of medical care. We assessed the association between EHR use, as implemented, and the quality of ambulatory care in a nationally representative survey.We performed a retrospective, cross-sectional analysis of visits in the 2003 and 2004 National Ambulatory Medical Care Survey. We examined EHR use throughout the United States and the association of EHR use with 17 ambulatory quality indicators. Performance on quality indicators was defined as the percentage of applicable visits in which patients received recommended care.Electronic health records were used in 18% (95% confidence interval [CI], 15%-22%) of the estimated 1.8 billion ambulatory visits (95% CI, 1.7-2.0 billion) in the United States in 2003 and 2004. For 14 of the 17 quality indicators, there was no significant difference in performance between visits with vs without EHR use. Categories of these indicators included medical management of common diseases, recommended antibiotic prescribing, preventive counseling, screening tests, and avoiding potentially inappropriate medication prescribing in elderly patients. For 2 quality indicators, visits to medical practices using EHRs had significantly better performance: avoiding benzodiazepine use for patients with depression (91% vs 84%; P = .01) and avoiding routine urinalysis during general medical examinations (94% vs 91%; P = .003). For 1 quality indicator, visits to practices using EHRs had significantly worse quality: statin prescribing to patients with hypercholesterolemia (33% vs 47%; P = .01).As implemented, EHRs were not associated with better quality ambulatory care.

    View details for Web of Science ID 000247891500010

    View details for PubMedID 17620534

  • Americans are not meeting current calcium recommendations AMERICAN JOURNAL OF CLINICAL NUTRITION Ma, J., Johns, R. A., Stafford, R. S. 2007; 85 (5): 1361-1366

    Abstract

    Recent research has raised doubts about the efficacy of calcium supplementation in preventing fractures; however, adequate calcium intake remains important.Using data from the 1999-2002 National Health and Nutrition Examination Survey, we assessed dietary and supplemental calcium consumption among US men and women according to risk of osteoporosis and stratified by sex, race/ethnicity, and socioeconomic status.We categorized risk of osteoporosis as high (having an osteoporosis diagnosis or treatment), moderate (aged >50 y), or low (aged 19-50 y). Main study outcomes included milligrams of dietary and supplemental calcium intake, likelihood of meeting national calcium adequate intake (AI) levels, and likelihood of taking supplemental calcium.Mean (95% CI) total calcium consumption was 944 (846, 1043) mg in the high-risk group, 821 (788, 854) mg in the moderate-risk group, and 846 (812, 871) mg in the low-risk group. Overall, 40% of the sample met the calcium AI amount and 48% reported taking supplemental calcium. After adjustment for daily caloric intake, the greater likelihood of meeting calcium AI levels was associated with [odds ratio (95% CI)] low [versus moderate, 1.5 (1.2, 1.7)] and high [versus moderate, 1.9 (1.3, 2.6)] osteoporosis risk, female sex [1.6 (1.3, 1.8)], non-Hispanic white ethnicity [versus nonwhite, 1.9 (1.7, 2.3)], and education beyond high school [versus less than high school, 1.5 (1.2, 1.9)]. These same factors were also associated with an increased likelihood of taking supplemental calcium, except for a consistent increase with higher osteoporosis risk.Many Americans--particularly men, ethnic minorities, and the socially disadvantaged--are not meeting the current recommendations for adequate calcium intake through diet alone or with supplements.

    View details for PubMedID 17490974

  • Elective and isolated carotid endarterectomy: Health disparities in utilization and outcomes, but not readmission JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION Kennedy, B. S., Fortmann, S. P., Winkleby, M. A., Stafford, R. S. 2007; 99 (5): 480-488

    Abstract

    Carotid endarterectomy (CEA) has been shown to decrease future ischemic stroke risk in selected patients. However, clinical trials did not examine the risk-benefit ratio for nonwhites, who have a greater ischemic stroke risk than whites. In general, few studies have examined the effects of race on CEA use and complications, and data on race and CEA readmission are lacking.This study used administrative data for patients discharged from California hospitals between January 1 and December 31, 2000. Selection criteria of cases included: ICD-9 principal procedure code 38.12, principal diagnostic code 433 and diagnosis-related group 5. There were 8,080 white and 1196 nonwhite patients (228 blacks, 643 Hispanics, 325 Asians/Pacific Islanders) identified that underwent an elective and isolated CEA. For both groups, CEA rates were compared. Logistic regression was used to examine the independent effects of race on in-hospital death and stroke, as well as CEA readmission.Rates of CEA use were more than three times greater for whites than nonwhites, although nonwhites were more likely to have symptomatic disease. For all patients, the complication rate was 1.9%. However, the odds of in-hospital death and stroke were greater for nonwhites than whites, but after adjustment for patient and hospital factors, these differences were only significant for stroke (OR = 1.7, P = 0.013). For both outcomes, the final models had good predictive accuracy. Overall, CEA readmission risk was 7%, and no significant racial differences were observed (P = 0.110).The data suggest that CEA is performed safely in California. However, nonwhites had lower rates of initial CEA use but higher rates of in-hospital death and stroke than whites. Racial differences in stroke risk persisted after adjustment for patient and hospital factors. Finally, this study found that despite significant racial disparities in initial CEA use, whites and nonwhites were similar in their CEA readmission rates. These findings may suggest that screening initiatives are lacking for nonwhites, which may increase their risk for poorer outcomes.

    View details for Web of Science ID 000246468500001

    View details for PubMedID 17534005

    View details for PubMedCentralID PMC2576064

  • Development of a web-based intervention to reduce women's risk for osteoporotic fractures through risk assessment, education, and behavior change Drieling, R. L., Ma, J., Stafford, R. S. SPRINGER LONDON LTD. 2007: S242?S243

    View details for Web of Science ID 000245981100092

  • Comparison of the Atkins, Zone, Ornish, and LEARN diets for change in weight and related risk factors among overweight premenopausal women JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Gardner, C. D., Kiazand, A., Alhassan, S., Kim, S., Stafford, R. S., Balise, R. R., Kraemer, H. C., King, A. C. 2007; 297 (9): 969-977

    Abstract

    Popular diets, particularly those low in carbohydrates, have challenged current recommendations advising a low-fat, high-carbohydrate diet for weight loss. Potential benefits and risks have not been tested adequately.To compare 4 weight-loss diets representing a spectrum of low to high carbohydrate intake for effects on weight loss and related metabolic variables.Twelve-month randomized trial conducted in the United States from February 2003 to October 2005 among 311 free-living, overweight/obese (body mass index, 27-40) nondiabetic, premenopausal women.Participants were randomly assigned to follow the Atkins (n = 77), Zone (n = 79), LEARN (n = 79), or Ornish (n = 76) diets and received weekly instruction for 2 months, then an additional 10-month follow-up.Weight loss at 12 months was the primary outcome. Secondary outcomes included lipid profile (low-density lipoprotein, high-density lipoprotein, and non-high-density lipoprotein cholesterol, and triglyceride levels), percentage of body fat, waist-hip ratio, fasting insulin and glucose levels, and blood pressure. Outcomes were assessed at months 0, 2, 6, and 12. The Tukey studentized range test was used to adjust for multiple testing.Weight loss was greater for women in the Atkins diet group compared with the other diet groups at 12 months, and mean 12-month weight loss was significantly different between the Atkins and Zone diets (P<.05). Mean 12-month weight loss was as follows: Atkins, -4.7 kg (95% confidence interval [CI], -6.3 to -3.1 kg), Zone, -1.6 kg (95% CI, -2.8 to -0.4 kg), LEARN, -2.6 kg (-3.8 to -1.3 kg), and Ornish, -2.2 kg (-3.6 to -0.8 kg). Weight loss was not statistically different among the Zone, LEARN, and Ornish groups. At 12 months, secondary outcomes for the Atkins group were comparable with or more favorable than the other diet groups.In this study, premenopausal overweight and obese women assigned to follow the Atkins diet, which had the lowest carbohydrate intake, lost more weight at 12 months than women assigned to follow the Zone diet, and had experienced comparable or more favorable metabolic effects than those assigned to the Zone, Ornish, or LEARN diets [corrected] While questions remain about long-term effects and mechanisms, a low-carbohydrate, high-protein, high-fat diet may be considered a feasible alternative recommendation for weight loss.clinicaltrials.gov Identifier: NCT00079573.

    View details for PubMedID 17341711

  • Response to target blood pressure level before antihypertensive class to improve outcomes more quickly in uncomplicated hypertension HYPERTENSION Ma, J., Lee, K., Stafford, R. S. 2007; 49 (3): E17

    View details for DOI 10.1161/01.HYP.0000257804.20496.4f

    View details for Web of Science ID 000244245200047

  • Outpatient hypertension treatment, treatment intensification, and control in western Europe and the United States ARCHIVES OF INTERNAL MEDICINE Wang, Y. R., Alexander, G. C., Stafford, R. S. 2007; 167 (2): 141-147

    Abstract

    Hypertension guidelines in the United States tend to have more aggressive treatment recommendations than those in European countries.To explore international differences in hypertension treatment, treatment intensification, and hypertension control in western Europe and the United States, we conducted cross-sectional analyses of the nationally representative CardioMonitor 2004 survey, which included 21 053 hypertensive patients visiting 291 cardiologists and 1284 primary care physicians in 5 western European countries and the United States. The main outcome measures were latest systolic and diastolic blood pressure (BP) levels, hypertension control (latest BP level, <140/90 mm Hg), and medication increase (dose escalation or an addition to or switch of drug therapy) for inadequately controlled hypertension.At least 92% of patients in each country received antihypertensive drug treatment. The initial pretreatment BP levels were lowest and the use of combination drug therapy (>or=2 antihypertensive drug classes) was highest in the United States. Multivariate analyses controlling for age, sex, current smoking, and physician specialty indicated that, compared with US patients, European patients had higher latest systolic BP levels (by 5.3-10.2 mm Hg across countries examined) and diastolic BP levels (by 1.9-5.3 mm Hg), a smaller likelihood of hypertension control (odds ratios, 0.27-0.50), and a smaller likelihood of medication increase for inadequately controlled hypertension (odds ratios, 0.29-0.65) (all P<.001). In addition, controlling for initial pretreatment BP level attenuated the differences in latest systolic and diastolic BP levels and the likelihood of hypertension control.Lower treatment thresholds and more intensive treatment contribute to better hypertension control in the United States compared with the western European countries studied.

    View details for Web of Science ID 000243685100005

    View details for PubMedID 17242314

  • Positive outcomes through the appropriate use of off-label prescribing - In reply ARCHIVES OF INTERNAL MEDICINE Stafford, R. S., Radley, D. C., Finkelstein, S. N. 2006; 166 (22): 2555

    View details for DOI 10.1001/archinte.166.22.2555

    View details for Web of Science ID 000242732500023

  • Changes in antihypertensive prescribing during US outpatient visits for uncomplicated hypertension between 1993 and 2004 HYPERTENSION Ma, J., Lee, K., Stafford, R. S. 2006; 48 (5): 846-852

    Abstract

    Monitoring national patterns of antihypertensive drug therapy is essential to assessing adherence to treatment guidelines and the impact of major scientific publications on physician prescribing. We analyzed data from 2 US National Ambulatory Care Surveys to examine trends between 1993 and 2004 in the prescription of antihypertensive drug classes for uncomplicated hypertension and the association between thiazide and beta-blocker prescribing and physician and patient characteristics. Diuretic prescriptions remained level through 2001 (39%; 95% CI: 34% to 44%) but increased to 53% (48% to 58%) in 2003, largely because of a 72% increase in thiazide prescriptions in the first quarter of 2003 (50%; 95% CI: 40% to 59%). However, these increases did not sustain in 2004. Beta-blocker prescriptions increased modestly from 1993 (24%; 95% CI: 19% to 29%) to 2004 (33%; 95% CI: 28% to 39%). Prescription of calcium channel blockers and angiotensin-converting enzyme inhibitors declined significantly following the sixth Joint National Committee report, but both subsequently rebounded to prereport levels. Prescription of angiotensin II receptor blockers increased continuously from 1% in 1995 to 23% by 2004. Polytherapy prescriptions, particularly those involving > or = 3 drug classes, became increasingly prevalent, accounting for 60% of antihypertensive drug visits by 2004. Prescriptions of thiazides and beta-blockers were both more likely in 1998-2004 (versus 1993-1997). Blacks, women, and hospital outpatients were more likely to receive thiazides. Also, cardiologists were more likely to prescribe beta-blockers. Evidence-based guidelines for antihypertensive drug therapy do impact physician prescribing, but the impact seems to be short lived. Future interventions are imperative for promoting long-term adherence to published guidelines.

    View details for DOI 10.1161/01.HYP.0000240931.90917.0c

    View details for Web of Science ID 000243598000017

    View details for PubMedID 16982967

  • Case-management for multiple CHD risk factors is effective in a low-income, ethnically diverse population Stafford, R. S., Ma, J., Lee, K., Berra, K. LIPPINCOTT WILLIAMS & WILKINS. 2006: 429

    View details for Web of Science ID 000241792802599

  • Metabolic syndrome: Does definition determine prevalence? Alhassan, S., Kiazand, A., Balise, R. R., Stafford, R. S., King, A. C., Gardner, C. D. LIPPINCOTT WILLIAMS & WILKINS. 2006: 873

    View details for Web of Science ID 000241792805522

  • Long-term and short-term changes in antihypertensive prescribing by office-based physicians in the United States HYPERTENSION Stafford, R. S., Monti, V., Furberg, C. D., Ma, J. 2006; 48 (2): 213-218

    Abstract

    Medication choices for the treatment of elevated blood pressure have a large potential impact on both patient outcomes and health care costs. Historic trends of prescribing for hypertension will advance the understanding of physician practice of evidence-based medicine. This study describes both long- and short-term trends in US antihypertensive prescribing from 1990 through 2004. Data were extracted from the National Disease and Therapeutic Index, a continuing survey of a national sample of US office-based physicians. Cox and Stuart and z tests were performed. Diuretics ranked among the top 3 antihypertensive drug classes throughout the entire study time span. Angiotensin-converting enzyme (ACE) inhibitors and calcium channel blockers (CCBs) were preferred over diuretics beginning in 1993, with diuretics surpassing CCBs in 2000. Beta-blockers were consistently the fourth most common class until 2002, when exceeded by angiotensin II receptor antagonists (ARBs). Most recent trends indicated an immediate but short-lived increase in the prescription of thiazide diuretics after the new clinical evidence released in December 2002 demonstrating clinical equivalence of thiazides to ACE inhibitors and CCBs. In contrast, prescription of ACE inhibitors declined, accompanied by continuation of a pre-existing increase in the prescription of ARBs, whereas prescription of CCBs remained essentially stable after the new evidence was released. The recorded long- and short-term trends indicate that evidence-based clinical recommendations had an impact on antihypertensive prescribing practices, but the magnitude of impact may be smaller and of more limited duration than desired.

    View details for DOI 10.1161/01.HYP.0000229653.73128.b6

    View details for PubMedID 16785334

  • Off-label prescribing among office-based physicians ARCHIVES OF INTERNAL MEDICINE Radley, D. C., Finkelstein, S. N., Stafford, R. S. 2006; 166 (9): 1021-1026

    Abstract

    Unlike medicines prescribed for Food and Drug Administration-approved indications, off-label uses may lack rigorous scientific scrutiny. Despite concerns about patient safety and costs to the health care system, little is known about the frequency of off-label drug use or the degree of scientific evidence supporting this practice.We used nationally representative data from the 2001 IMS Health National Disease and Therapeutic Index (NDTI) to define prescribing patterns by diagnosis for 160 commonly prescribed drugs. Each reported drug-diagnosis combination was identified as Food and Drug Administration-approved, off-label with strong scientific support, or off-label with limited or no scientific support. Outcome measures included (1) the proportion of uses that were off-label and (2) the proportion of off-label uses supported by strong scientific evidence. Multivariate analyses were used to identify drug-specific characteristics predictive of increased off-label use.In 2001, there were an estimated 150 million (95% confidence interval, 127-173 million) off-label mentions (21% of overall use) among the sampled medications. Off-label use was most common among cardiac medications (46%, excluding antihyperlipidemic and antihypertensive agents) and anticonvulsants (46%), whereas gabapentin (83%) and amitriptyline hydrochloride (81%) had the greatest proportion of off-label use among specific medications. Most off-label drug mentions (73%; 95% confidence interval, 61%-84%) had little or no scientific support. Although several functional classes were associated with increased off-label use (P<.05), few other drug characteristics predicted off-label prescription.Off-label medication use is common in outpatient care, and most occurs without scientific support. Efforts should be made to scrutinize underevaluated off-label prescribing that compromises patient safety or represents wasteful medication use.

    View details for Web of Science ID 000237334900012

    View details for PubMedID 16682577

  • US women desire greater professional guidance on hormone and alternative therapies for menopause symptom management MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY Ma, J., Drieling, R., Stafford, R. S. 2006; 13 (3): 506-516

    Abstract

    Women increasingly use alternative therapies for menopause symptom relief. We examined 1) current use and perceptions of hormone and alternative therapies for symptom relief among US women, and 2) healthcare provider involvement in women's decision making.An online survey was completed by a national sample of 781 US women aged 40 to 60 years (72% survey completion rate) drawn from the Knowledge Networks panel in June 2004. Nationally representative estimates of women's use and perceptions of hormone and alternative therapies were made by accounting for sampling weights and survey design.Hormone therapy was reported among 263 or 37% of this largely symptomatic sample, of whom 59% had stopped primarily due to concern about its potential risks. Herbal products and soy supplements separately were used among 31% and 13% of symptomatic women, of whom 41% and 67% were current users. Forty-four percent of herb users considered these products helpful with symptom relief. Sampled women generally felt ill informed about proper doses and usage of herbal products. Also, 58% of the sampled women expressed at least some concerns about these products, whereas proven safety was the most important factor when women consider such products. Despite considering healthcare providers the most reliable source of information, sampled women expressed low confidence in their ability to give sufficient information about treatment options for menopause symptoms.Alternative therapies have become increasing popular and are quickly approaching hormone therapy in frequency as therapies for symptom relief among menopause-age women in the United States. However, large gaps exist between patient expectations and provider preparedness to guide patient decision making.

    View details for DOI 10.1097/01.gme.0000179047.00748.53

    View details for PubMedID 16735949

  • What are the public health effects of direct-to-consumer drug advertising? PLOS MEDICINE Almasi, E. A., Stafford, R. S., Kravitz, R. L., Mansfield, P. R. 2006; 3 (3): 284-288

    Abstract

    Only two industrialized countries, the United States and New Zealand, allow direct-to-consumer advertising (DTCA) of prescription medicines, although New Zealand is planning a ban. The challenge for these governments is ensuring that DTCA is more beneficial than harmful. Proponents of DTCA argue that it helps to inform the public about available treatments and stimulates appropriate use of drugs for high-priority illnesses (such as statin use in people with ischemic heart disease). Critics argue that the information in the adverts is often biased and misleading, and that DTCA raises prescribing costs without net evidence of health benefits.

    View details for DOI 10.1371/journal.pmed.0030145

    View details for PubMedID 16563041

  • Implementation of case management to reduce cardiovascular disease risk in the Stanford and San Mateo Heart to Heart randomized controlled trial: study protocol and baseline characteristics IMPLEMENTATION SCIENCE Ma, J., Lee, K., Berra, K., Stafford, R. S. 2006; 1

    Abstract

    Case management has emerged as a promising alternative approach to supplement traditional one-on-one sessions between patients and doctors for improving the quality of care in chronic diseases such as coronary heart disease (CHD). However, data are lacking in terms of its efficacy and cost-effectiveness when implemented in ethnic and low-income populations.The Stanford and San Mateo Heart to Heart (HTH) project is a randomized controlled clinical trial designed to rigorously evaluate the efficacy and cost-effectiveness of a multi-risk cardiovascular case management program in low-income, primarily ethnic minority patients served by a local county health care system in California. Randomization occurred at the patient level. The primary outcome measure is the absolute CHD risk over 10 years. Secondary outcome measures include adherence to guidelines on CHD prevention practice. We documented the study design, methodology, and baseline sociodemographic, clinical and lifestyle characteristics of 419 participants.We achieved equal distributions of the sociodemographic, biophysical and lifestyle characteristics between the two randomization groups. HTH participants had a mean age of 56 years, 63% were Latinos/Hispanics, 65% female, 61% less educated, and 62% were not employed. Twenty percent of participants reported having a prior cardiovascular event. 10-year CHD risk averaged 18% in men and 13% in women despite a modest low-density lipoprotein cholesterol level and a high on-treatment percentage at baseline. Sixty-three percent of participants were diagnosed with diabetes and an additional 22% had metabolic syndrome. In addition, many participants had depressed high-density lipoprotein (HDL) cholesterol levels and elevated values of total cholesterol-to-HDL ratio, triglycerides, triglyceride-to-HDL ratio, and blood pressure. Furthermore, nearly 70% of participants were obese, 45% had a family history of CHD or stroke, and 16% were current smokers.We have recruited an ethnically diverse, low-income cohort in which to implement a case management approach and test its efficacy and cost-effectiveness. HTH will advance the scientific understanding of better strategies for CHD prevention among these priority subpopulations and aid in guiding future practice that will reduce health disparities.

    View details for DOI 10.1186/1748-5908-1-21

    View details for PubMedID 17005050

  • Underutilization of aspirin persists in US ambulatory care for the secondary and primary prevention of cardiovascular disease PLOS MEDICINE Stafford, R. S., Monti, V., Ma, J. 2005; 2 (12): 1292-1298

    Abstract

    Despite the proven benefits of aspirin therapy in the primary and secondary prevention of cardiovascular disease (CVD), utilization rates of aspirin remain suboptimal in relation to recommendations. We studied national trends of aspirin use among intermediate- to high-risk patients in the US ambulatory care settings and compared the priority given to aspirin versus statins for CVD risk reduction. We also examined patient and health care provider contributors to the underuse of aspirin.We used the 1993-2003 US National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey to estimate aspirin use by cardiovascular risk. Physician-noted cardiovascular diseases defined high risk. Intermediate risk was defined as having diabetes mellitus or multiple major risk factors. The proportion of patient visits in which aspirin was reported increased from 21.7% (95% confidence interval: 18.8%-24.6%) in 1993-1994 to 32.8% (25.2%-40.4%) in 2003 for the high-risk category, 3.5% (2.0%-5.0%) to 11.7% (7.8%-15.7%) for visits by patients diagnosed with diabetes, and 3.6% (2.6%-4.6%) to 16.3% (11.4%-21.2%) for those with multiple CVD risk factors. Beginning in 1997-1998, statins were prioritized over aspirin as prophylactic therapy for reducing CVD risk, and the gaps remained wide through 2003. In addition to elevated CVD risk, greater aspirin use was independently associated with advanced age, male gender, cardiologist care, and care in hospital outpatient departments.Improvements in use of aspirin in US ambulatory care for reducing risks of CVD were at best modest during the period under study, particularly for secondary prevention, where the strongest evidence and most explicit guidelines exist. Aspirin is more underused than statins despite its more favorable cost-effectiveness. Aggressive and targeted interventions are needed to enhance provider and patient adherence to consensus guidelines for CVD risk reduction.

    View details for DOI 10.1371/journal.pmed.0020353

    View details for PubMedID 16277554

  • Depression treatment during outpatient visits by US children and adolescents JOURNAL OF ADOLESCENT HEALTH Ma, J., Lee, K. V., Stafford, R. S. 2005; 37 (6): 434-442

    Abstract

    Depression affects approximately 2-8% of all children and adolescents, and treatment of depression in children and adolescents has been the center of recent serious debates. We examined national trends in depression visits and treatment among outpatients aged 7 to 17 years.We analyzed visit-based data between 1995 and 2002 in two national ambulatory care surveys.The number of visits by children and adolescents during which depression was reported more than doubled from 1995-1996 (1.44 million) to 2001-2002 (3.22 million). The proportion of these visits during which antidepressants were prescribed rose slightly from 47% in 1995-1996 to 52% in 2001-2002, whereas the proportion during which psychotherapy or mental health counseling was provided declined from 83% to 68%. Selective serotonin reuptake inhibitors (SSRI) represented 76% of all antidepressants prescribed in 1995-1996 and 81% in 2001-2002. In absolute terms, SSRIs were reported in 1.35 million visits in 2001-2002, reflecting a 2.6-fold increase from 1995-1996. Fluoxetine was prescribed in 207,914 visits in 1995-1996 and increased 100% to 415,580 visits in 2001-2002. The use of sertraline increased by 62% to 345,576 visits and paroxetine by 269% to 279,275 visits.We observed a declining trend in the provision of psychotherapy/mental health counseling during outpatient visits by children and adolescents diagnosed with depression. Although the likelihood of receiving antidepressants remained essentially unchanged, the number of children and adolescents whose visits involved prescription of antidepressants, particularly SSRIs, has increased markedly through 2002. Although fluoxetine remained the most commonly prescribed, other SSRIs were increasingly prescribed through 2002. These trends raise concerns regarding the widespread off-label use of antidepressants lacking reliable evidence of safety and efficacy for use in children and adolescents.

    View details for DOI 10.1016/j.jadohealth.2005.07.012

    View details for PubMedID 16310120

  • National patterns of calcium use in osteoporosis in the United States JOURNAL OF REPRODUCTIVE MEDICINE Stafford, R. S., Drieling, R. L., Johns, R., Ma, J. 2005; 50 (11): 885-890

    Abstract

    Although calcium intake is considered integral to appropriate management of osteoporosis, we hypothesized that the recent therapeutic dominance of bisphosphonates in osteoporosis treatment may have led calcium to be neglected as a component of effective management.Two national databases were used to assess the adequacy of calcium intake in patients with osteoporosis. Trends in reported supplemental calcium use among physician visits by patients with osteoporosis were assessed using nationally representative 1994-2004 IMS HEALTH National Disease and Therapeutic Index data. Quantity of calcium intake, from both supplements and food, among individuals with osteoporosis (n = 38 men and 376 women) was estimated using the 1999-2002 National Health and Nutrition Examination Survey (NHANES).Physician visits for osteoporosis in the United States increased 4.5-fold between 1994 (1.3 million visits) and 2004 (5.8 million visits). During this time the proportion of osteoporosis visits in which bisphosphonates were prescribed increased from 14% to 81%, while reported calcium use fell from 43% to 23% of visits. Among osteoporosis patients in NHANES, 64% reported using calcium-containing supplements. Reported median calcium intake was 433 (interquartile range: 295, 705) mg/d for calcium supplement nonusers and 1,319 (845, 1,874) mg for calcium supplement users. Overall, only 40% of osteoporosis patients had calcium intake exceeding 1,200 mg/d.While osteoporosis is increasingly identified and treated with effective medications, calcium is being neglected as a component of osteoporosis management. Despite the fact that the efficacy of new osteoporosis medications depends on adequate calcium intake, reported calcium intake in osteoporosis patients is far below recommended levels.

    View details for PubMedID 16422278

  • Quality of US outpatient care - Temporal changes and racial/ethnic disparities ARCHIVES OF INTERNAL MEDICINE Ma, J., Stafford, R. S. 2005; 165 (12): 1354-1361

    Abstract

    The current national measure set for the quality of health care underrepresents the spectrum of outpatient care and makes limited use of readily available national ambulatory care survey data.We examined 23 outpatient quality indicators in 1992 and again in 2002 to measure overall performance and racial/ethnic disparities in outpatient care in the United States. The National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey yielded information about ambulatory services provided in private physician offices and hospital outpatient departments, respectively. Quality indicator performance was defined as the percentage of applicable visits receiving appropriate care.In 2002, mean performance was 50% or more of applicable visits for 12 quality indicators, 7 of which were in the areas of appropriate antibiotic use and avoiding unnecessary routine screening. The performance of the remaining 11 indicators ranged from 15% to 42%. Overall, changes between 1992 and 2002 were modest, with significant improvements in 6 indicators: treatment of depression (47% vs 83%), statin use for hyperlipidemia (10% vs 37%), inhaled corticosteroid use for asthma in adults (25% vs 42%) and children (11% vs 36%), avoiding routine urinalysis during general medical examinations (63% vs 73%), and avoiding inappropriate medications in the elderly (92% vs 95%). After adjusting for potential confounders, race/ethnicity did not seem to affect quality indicator performance, except for greater angiotensin-converting enzyme inhibitor use for congestive health failure among blacks and less unnecessary antibiotic use for uncomplicated upper respiratory tract infections among whites.Measurable quality deficits and modest improvements across time call for greater adherence to evidence-based medicine in US ambulatory settings. Although significant racial disparities have been described in a variety of settings, we observed that similar, although less than optimal, care is being provided on a per-visit basis regardless of patient racial/ethnic background.

    View details for PubMedID 15983283

  • The who, what, and why of risk adjustment: A technology on the cusp of adoption JOURNAL OF HEALTH POLITICS POLICY AND LAW Blumenthal, D., Weissman, J. S., Wachterman, M., Weil, E., Stafford, R. S., Perrin, J. M., Ferris, T. G., Kuhlthau, K., Kaushal, R., Lezzoni, L. I. 2005; 30 (3): 453-473

    Abstract

    Risk adjustment (RA) consists of a series of techniques that account for the health status of patients when predicting or explaining costs of health care for defined populations or for evaluating retrospectively the performance of providers who care for them. Although the federal government seems to have settled on an approach to RA for Medicare Advantage programs, adoption and implementation of RA techniques elsewhere have proceeded much more slowly than was anticipated. This article examines factors affecting the adoption and use of RA outside the Medicare program using case studies in six U.S. health care markets (Baltimore, Seattle, Denver, Cleveland, Phoenix, and Atlanta) as of 2001. We found that for purchasing decisions, RA was used exclusively by public agencies. In the private sector, use of risk adjustment was uncommon and scattered and assumed informal and unexpected forms. The most common private sector use of RA was by health plans, which occasionally employed RA in negotiations with purchasers or to allocate resources internally among providers. The article uses classic technology diffusion theory to explain the adoption and use of RA in these six markets and derives lessons for health policy generally and for the future of RA in particular. For health policy generally, the differing experiences of public and private actors with RA serve as markers of the divergent paths that public and private health care sectors are pursuing with respect to managed care and risk sharing. For the future of RA in particular, its history suggests the need for health service researchers to consider barriers to use adoption and new analytic technologies as they develop them.

    View details for Web of Science ID 000237158400006

    View details for PubMedID 16089112

  • U.S. adolescents receive suboptimal preventive counseling during ambulatory care. journal of adolescent health Ma, J., Wang, Y., Stafford, R. S. 2005; 36 (5): 441-?

    Abstract

    To examine U.S. adolescents' (age 13-18) utilization of ambulatory care and the likelihood of receiving preventive counseling from 1993 through 2000.The National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey provided visit-based data on counseling services that occurred in private physician offices and hospital outpatient departments. Main outcome measures included adolescents' use of outpatient care and their likelihood of being counseled on 3 health promotion topics (i.e., diet, exercise, and growth/development) and 5 risk reduction topics (i.e., tobacco use/exposure, skin cancer prevention, injury prevention, family planning/contraception, and HIV/STD transmission).Adolescents had the lowest rates of outpatient visits among all age groups, with particularly low rates among boys and ethnic minorities. Most frequently, adolescent visits were for upper respiratory tract conditions, acne, routine medical or physical examinations, and, for girls, prenatal care. In 1997-2000, counseling services were documented for 39% (99% CI: 32-46%) of all adolescent general medical/physical examination (GME) visits. Diet [26% of GME visits (20-32%)] and exercise [22% (17-28%)] were the most frequent counseling topics. The counseling rates of the other six topics ranged from as low as 3 to 20%, with skin cancer prevention, HIV/STD transmission, and family planning/contraception ranking the lowest. These rates represented minimal improvements from 1993-1996 both in absolute term and in relation to the gaps between practices and recommendations.Adolescents underutilize primary care, and even those who do receive care are underserved for their health counseling needs. The noted lack of change over time suggests that satisfactory improvement is unlikely unless substantial interventions are undertaken.

    View details for PubMedID 15841517

  • National trends in statin use by coronary heart disease risk category PLOS MEDICINE Ma, J., Sehgal, N. L., Ayanian, J. Z., Stafford, R. S. 2005; 2 (5): 434-440

    Abstract

    Only limited research tracks United States trends in the use of statins recorded during outpatient visits, particularly use by patients at moderate to high cardiovascular risk.Data collected between 1992 and 2002 in two federally administered surveys provided national estimates of statin use among ambulatory patients, stratified by coronary heart disease risk based on risk factor counting and clinical diagnoses. Statin use grew from 47% of all lipid-lowering medications in 1992 to 87% in 2002, with atorvastatin being the leading medication in 2002. Statin use by patients with hyperlipidemia, as recorded by the number of patient visits, increased significantly from 9% of patient visits in 1992 to 49% in 2000 but then declined to 36% in 2002. Absolute increases in the rate of statin use were greatest for high-risk patients, from 4% of patient visits in 1992 to 19% in 2002. Use among moderate-risk patients increased from 2% of patient visits in 1992 to 14% in 1999 but showed no continued growth subsequently. In 2002, 1 y after the release of the Adult Treatment Panel III recommendations, treatment gaps in statin use were detected for more than 50% of outpatient visits by moderate- and high-risk patients with reported hyperlipidemia. Lower statin use was independently associated with younger patient age, female gender, African American race (versus non-Hispanic white), and non-cardiologist care.Despite notable improvements in the past decade, clinical practice fails to institute recommended statin therapy during many ambulatory visits of patients at moderate-to-high cardiovascular risk. Innovative approaches are needed to promote appropriate, more aggressive statin use for eligible patients.

    View details for DOI 10.1371/journal.pmed.0020123

    View details for PubMedID 15916463

  • Fluoroquinolone prescribing in the United States: 1995 to 2002 AMERICAN JOURNAL OF MEDICINE Linder, J. A., Huang, E. S., Steinman, M. A., Gonzales, R., Stafford, R. S. 2005; 118 (3): 259-268

    Abstract

    To measure changes in the rate and type of fluoroquinolones prescribed in the United States from 1995 to 2002.We performed a longitudinal analysis of the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey of adult visits to physicians in ambulatory clinics and emergency departments throughout the United States from 1995 to 2002. The main outcomes were fluoroquinolone prescribing rates and prescribing in accordance with Food and Drug Administration approval as of December 2002.Between 1995 and 2002, fluoroquinolones became the most commonly prescribed class of antibiotics to adults in the United States. Fluoroquinolone prescribing rose threefold, from 7 million visits in 1995 to 22 million visits in 2002 (P < 0.0001). Fluoroquinolone prescribing increased as a proportion of overall antibiotic prescribing (from 10% to 24%; P < 0.0001) and as a proportion of the U.S. population (from 39 to 106 prescriptions per 1000 adults; P < 0.001). These increases were due to the use of newer fluoroquinolones with activity against Streptococcus pneumoniae. Forty-two percent of fluoroquinolone prescriptions were for nonapproved diagnoses. Among patients receiving antibiotics, nonapproved fluoroquinolone prescribing increased over time (odds ratio = 1.18 per year; 95% confidence interval: 1.13 to 1.24).Fluoroquinolone prescribing increased threefold in outpatient clinics and emergency departments in the United States from 1995 to 2002. Fluoroquinolones became the most commonly prescribed class of antibiotics to adults in 2002. Nonapproved fluoroquinolone prescribing was common and increased over time. Such prescribing patterns are likely to be followed by an increasing prevalence of fluoroquinolone-resistant bacteria.

    View details for DOI 10.1016/j.amjmed.2004.09.015

    View details for Web of Science ID 000227653900012

    View details for PubMedID 15745724

  • National trends in cyclooxygenase-2 inhibitor use since market release - Nonselective diffusion of a selectively cost-effective innovation ARCHIVES OF INTERNAL MEDICINE Dai, C. L., Stafford, R. S., Alexander, C. 2005; 165 (2): 171-177

    Abstract

    The withdrawal of rofecoxib has highlighted concerns regarding the safety of cyclooxygenase-2 (COX-2) inhibitors. In some patients COX-2 inhibitors may be safer than nonselective nonsteroidal anti-inflammatory drugs (NSAIDs); however, the public health benefit of COX-2 inhibitors depends on their use in patients at higher than normal risk from NSAIDs. We examined trends in COX-2 inhibitor use based on risk for adverse events from NSAIDs.We analyzed data from the National Ambulatory Medical Care Survey (1999-2002) and National Hospital Ambulatory Medical Care Survey (1999-2001), nationally representative surveys of community and hospital-based outpatient practices. The main outcome measure was the proportion of patient visits in which COX-2 inhibitors were prescribed, stratified by risk of adverse gastrointestinal (GI) events from NSAIDs.Of the visits in which either a COX-2 inhibitor or NSAID was prescribed, the frequency of COX-2 inhibitor use increased from 35% (1999) to 55% (2000) to 61% (2001 and 2002). Among patients with the lowest risk for adverse events from NSAIDs, the proportion receiving a COX-2 inhibitor increased from 12% in 1999 to 35% in 2002. Overall, increases in COX-2 inhibitor use among patients in whom NSAIDs could be used accounted for more than 63% of the growth in COX-2 inhibitor use during the period examined.Marked increases in COX-2 inhibitor use have occurred since their release, primarily among patients at low risk for adverse events from NSAIDs. These findings demonstrate the challenge of limiting innovative therapies to the settings in which they are initially targeted and maximally beneficial.

    View details for Web of Science ID 000226455500006

    View details for PubMedID 15668363

  • New cardiovascular drugs: Patterns of use and association with non-drug health expenditures INQUIRY-THE JOURNAL OF HEALTH CARE ORGANIZATION PROVISION AND FINANCING Miller, G. E., Moeller, J. F., Stafford, R. S. 2005; 42 (4): 397-412

    Abstract

    The potential role of new drugs in reducing expenditures for non-drug health services has received considerable attention in recent policy debates. We estimate expenditure models to determine whether the use of newer drugs to treat cardiovascular conditions is associated with lower (or higher) non-drug expenditures for these conditions. We fail to substantiate the findings of previous research that newer drugs are associated with reductions in non-drug expenditures. We find, however, that increases in the number of drugs used, or the mix of drugs of different ages, are associated with increased non-drug expenditures and find that the number or mix of drugs used are important confounders in the estimated association between drug age and non-drug expenditures.

    View details for Web of Science ID 000236123500007

    View details for PubMedID 16568931

  • Promotion and prescribing of hormone therapy after report of harm by the women's health initiative JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Majumdar, S. R., Almasi, E. A., Stafford, R. S. 2004; 292 (16): 1983-1988

    Abstract

    Little is known about how the pharmaceutical industry responds to evidence of harm associated with its products, such as the publication in July 2002 of the Women's Health Initiative Estrogen Plus Progestin Trial (WHI E+P) report demonstrating that standard-dose Prempro produced significant harm and lacked net benefits.To examine pharmaceutical industry response to the WHI E+P results by analyzing promotional expenditures for hormone therapy before and after July 2002.Nationally representative and prospectively collected longitudinal data (January 2001 through December 2003) on prescribing and promotion of hormone therapies were obtained from IMS Health and Consumer Media Reports.Trends in quarterly prescriptions for hormone therapy and expenditures on 5 modes of drug promotion: samples, office-based detailing, hospital-based promotion, journal advertisements, and direct-to-consumer advertising.Prior to the WHI E+P report, prescribing rates and promotional spending for hormone therapy were stable. In the quarter before the WHI E+P report (April-June 2002), 22.4 million prescriptions for hormone therapy were dispensed and 71 million dollars was spent on promotion (in annual terms, 350 dollars per year per US physician). Within 9 months of the report's publication (quarter 1 of 2003), there was a 32% decrease in hormone therapy prescriptions, and a nadir had been reached for promotional spending (37% decrease compared with pre-WHI E+P levels). Spending decreased for all promotional activities and most hormone therapies. Overall, the greatest declines were for samples (36% decrease as of quarter 1 of 2003) and direct-to-consumer advertising (100% decrease). The greatest declines in promotion occurred for standard-dose Prempro (61% decrease as of quarter 1 of 2003), the agent implicated by the WHI E+P report. More recently, promotional efforts have increased, particularly for lower-dose Prempro, a resurgence associated with modestly increased prescriptions for this newer agent.Concordant with its widespread use, hormone therapy was among the most heavily promoted medications prior to the WHI E+P report. Following reporting of the evidence of harm from this trial, there was a substantial decline in promotional spending for hormone therapy, particularly for the agents most directly implicated in the trial. Interrelated with the impact of the trial results themselves and the ensuing media coverage, reduced promotion may have contributed to a substantial decline in hormone therapy prescriptions.

    View details for Web of Science ID 000224682900023

    View details for PubMedID 15507584

  • Estrogen plus progestin and risk of venous thrombosis JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Cushman, M., Kuller, L. H., Prentice, R., Rodabough, R. J., Psaty, B. M., Stafford, R. S., Sidney, S., Rosendaal, F. R. 2004; 292 (13): 1573-1580

    Abstract

    Postmenopausal hormone therapy increases the risk of venous thrombosis. It is not known whether other factors influencing thrombosis add to this risk.To report final data on incidence of venous thrombosis in the Women's Health Initiative Estrogen Plus Progestin clinical trial and the association of hormone therapy with venous thrombosis in the setting of other thrombosis risk factors.Double-blind randomized controlled trial of 16,608 postmenopausal women between the ages of 50 and 79 years, who were enrolled in 1993 through 1998 at 40 US clinical centers with 5.6 years of follow up; and a nested case-control study. Baseline gene variants related to thrombosis risk were measured in the first 147 women who developed thrombosis and in 513 controls.Random assignment to 0.625 mg/d of conjugated equine estrogen plus 2.5 mg/d of medroxyprogesterone acetate, or placebo.Centrally validated deep vein thrombosis and pulmonary embolus.Venous thrombosis occurred in 167 women taking estrogen plus progestin (3.5 per 1000 person-years) and in 76 taking placebo (1.7 per 1000 person-years); hazard ratio (HR), 2.06 (95% confidence interval [CI], 1.57-2.70). Compared with women between the ages of 50 and 59 years who were taking placebo, the risk associated with hormone therapy was higher with age: HR of 4.28 (95% CI, 2.38-7.72) for women aged 60 to 69 years and 7.46 (95% CI, 4.32-14.38) for women aged 70 to 79 years. Compared with women who were of normal weight and taking placebo, the risk associated with taking estrogen plus progestin was increased among overweight and obese women: HR of 3.80 (95% CI, 2.08-6.94) and 5.61 (95% CI, 3.12-10.11), respectively. Factor V Leiden enhanced the hormone-associated risk of thrombosis with a 6.69-fold increased risk compared with women in the placebo group without the mutation (95% CI, 3.09-14.49). Other genetic variants (prothrombin 20210A, methylenetetrahydrofolate reductase C677T, factor XIII Val34Leu, PAI-1 4G/5G, and factor V HR2) did not modify the association of hormone therapy with venous thrombosis.Estrogen plus progestin was associated with doubling the risk of venous thrombosis. Estrogen plus progestin therapy increased the risks associated with age, overweight or obesity, and factor V Leiden.

    View details for Web of Science ID 000224254600024

    View details for PubMedID 15467059

  • Diet and physical activity counseling during ambulatory care visits in the United States PREVENTIVE MEDICINE Ma, J., Urizar, G. G., Alehegn, T., Stafford, R. S. 2004; 39 (4): 815-822

    Abstract

    Research is limited regarding national patterns of behavioral counseling during ambulatory care. We examined time trends and independent correlates of diet and physical activity counseling for American adults with an elevated cardiovascular risk during their outpatient visits.The National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) provided 1992-2000 national estimates of counseling practices in private physician offices and hospital outpatient departments.Rates of diet and physical activity counseling among visits by at-risk adults exhibited a modest ascending trend from 1992 to 2000, with the biggest growth found between 1996 and 1997. Throughout the 1990s, however, diet counseling was provided in <45% and physical activity counseling in < or = 30% of visits by adults with hyperlipidemia, hypertension, obesity, or diabetes mellitus. Lower likelihood of either counseling was significantly associated with patients who were > or = 75 years of age, seen by generalists, and those with fewer risk factors. Also, diet counseling was less frequently provided during visits by whites vs. ethnic minorities and by men vs. women.Despite available national guidelines, diet and physical activity counseling remain below expectations during outpatient visits by adults with an elevated cardiovascular risk. Given recent trends, immediate, satisfactory improvement is unlikely without future innovative interventions.

    View details for DOI 10.1016/j.ypmed.2004.03.006

    View details for PubMedID 15351551

  • National trends in osteoporosis visits and osteoporosis treatment, 1988-2003 ARCHIVES OF INTERNAL MEDICINE Stafford, R. S., Drieling, R. L., Hersh, A. L. 2004; 164 (14): 1525-1530

    Abstract

    Research is limited on physicians' prescribing practices for osteoporosis treatment. We investigated patterns of pharmacotherapy from 1988 to 2003 and the impact of new medications on identification and treatment of patients with osteoporosis.We tracked trends from 1988 through 2003 in the frequency of osteoporosis visits and patterns of pharmacotherapy associated with these visits using nationally representative data on prescribing patterns by office-based US physicians from the IMS HEALTH National Disease and Therapeutic Index.The number of physician visits for osteoporosis increased 4-fold between 1994 (1.3 million visits) and 2003 (6.3 million visits), whereas it had remained stable in prior years. This increase coincided with the availability of oral daily bisphosphonates and the selective estrogen receptor modulator raloxifene. The annualized percentage of osteoporosis visits where medications were prescribed increased from 82% in 1988 to 97% by 2003. Prior to 1994, the leading choices for osteoporosis therapy were calcium and estrogens, with lesser roles played by calcitonins and bisphosphonates. Between 1994 and 2003, the percentage of visits where bisphosphonates and raloxifene were prescribed increased from 14% to 73% and from 0% to 12%, respectively, while prescriptions for other medications declined.New medications for osteoporosis offering improved efficacy and convenient dosing were associated with increased frequency of patient visits and treatment. This finding suggests that new drug therapy contributed to increased disease recognition and treatment.

    View details for PubMedID 15277283

  • Costs of antidepressant medications associated with inadequate treatment AMERICAN JOURNAL OF MANAGED CARE Weilburg, J. B., Stafford, R. S., O'Leary, K. M., Meigs, J. B., Finkelstein, S. N. 2004; 10 (6): 357-365

    Abstract

    To determine the costs of antidepressant medications used during inadequate treatment.Retrospective database analysis of pharmacy claims made by patients who were treated under routine clinical conditions from July 1, 1999, through September 30, 2002.Our participants included 21,632 patients enrolled in a commercial HMO who had a primary care physician associated with our healthcare system. Patients never receiving at least a minimum likely effective antidepressant dose for at least 90 days were defined as having inadequate treatment. This study calculated the costs of antidepressants involved with inadequate treatment at the level of the patient and the medication trial.A majority of patients (51%) received inadequate treatment. Of overall antidepressant costs, 16% were incurred during trials for patients never adequately treated. The majority of inadequate trials were short and unlikely to have been effective. Most patients (64%) had only a single trial of antidepressants. Venlafaxine, fluoxetine, and sertraline had significantly lower first-trial inadequacy rates compared with the most commonly prescribed agent, citalopram.Improved patient care quality and lower antidepressant costs could result if clinicians and healthcare systems focus on reducing short trial rates. Initiating treatment with agents least likely to be discontinued prematurely may be helpful.

    View details for Web of Science ID 000221941200002

    View details for PubMedID 15209479

  • Estrogen plus progestin and colorectal cancer in postmenopausal women NEW ENGLAND JOURNAL OF MEDICINE Chlebowski, R. T., Wactawski-Wende, J., Ritenbaugh, C., Hubbell, F. A., Ascensao, J., Rodabough, R. J., Rosenberg, C. A., Taylor, V. M., Harris, R., Chen, C., Adams-Campbell, L. L., White, E., Alving, B., Rossouw, J., Pottern, L., Ludlam, S., McGowan, J., Prentice, R., Anderson, G., Lacroix, A., Patterson, R., McTiernan, A., Cochrane, B., Hunt, J., Tinker, L., Kooperberg, C., McIntosh, M., Wang, C. Y., Chen, C., Bowen, D., Kristal, A., Stanford, J., Urban, N., Weiss, N., White, E., Shumaker, S., Rautaharju, P., Prineas, R., Naughton, M., Stein, E., Laskarzewski, P., Cummings, S., Nevitt, M., Dockrell, M., Harnack, L., Cammarata, F., Lindenfelser, S., Psaty, B., Heckbert, S., Wassertheil-Smoller, S., Frishman, W., Wylie-Rosett, J., Barad, D., Freeman, R., Hays, J., Young, R., Anderson, J., Lithgow, S., Bray, P., Manson, J., Buring, J., Gaziano, J. M., Rexrode, K., Chae, C., Assaf, A. R., WHEELER, C., Eaton, C., Cyr, M., Phillips, L., PEDERSEN, M., Strickland, O., Huber, M., Porter, V., Beresford, S. A., Taylor, V. M., Woods, N. F., Henderson, M., Kestin, M., Hsia, J., Gaba, N., Ascensao, J., Chlebowski, R., Detrano, R., Nelson, A., Heiner, J., Marshall, J., Ritenbaugh, C., Valanis, B., Elmer, P., Stevens, V., Karanja, N., Caan, B., Sidney, S., Bailey, G., HIRATA, J., Kotchen, J. M., Barnabei, V., Kotchen, T. A., Gilligan, M. A., Neuner, J., Howard, B. V., Adams-Campbell, L., Passaro, M., Rainford, M., Agurs-Collins, T., Van Horn, L., Greenland, P., Khandekar, J., Liu, K., Rosenberg, C., BLACK, H., Powell, L., Mason, E., Stefanick, M. L., Hlatky, M. A., Chen, B., Stafford, R. S., Giudice, L. C., Lane, D., Granek, I., Lawson, W., San Roman, G., Messina, C., Jackson, R., Harris, R., Paskett, E., Mysiw, W. J., Blumenfeld, M., Lewis, C. E., Oberman, A., Shikany, J. M., Safford, M., Britt, B. K., Bassford, T., Mattox, J., Ko, M., Lohman, T., Wactawski-Wende, J., Trevisan, M., Smit, E., Graham, S., Chang, J., Robbins, J., Yasmeen, S., Lindfors, K., Stern, J., Hubbell, A., Frank, G., Wong, N., Greep, N., Monk, B., Judd, H., Heber, D., Elashoff, R., Langer, R. D., Criqui, M. H., Talavera, G. T., Garland, C. F., Hanson, R. E., Gass, M., Wernke, S., Watts, N., Limacher, M., Perri, M., Kaunitz, A., Williams, R. S., Brinson, Y., Curb, D., Petrovitch, H., Rodriguez, B., Masaki, K., Sharma, S., Wallace, R., Torner, J., JOHNSON, S., Snetselaar, L., VanVoorhis, B., Ockene, J., Rosal, M., Ockene, I., Yood, R., Aronson, P., Lasser, N., Singh, B., Lasser, V., Kostis, J., O'Sullivan, M. J., PARKER, L., Estape, R., Fernandez, D., Margolis, K. L., Grimm, R. H., Hunninghake, D. B., LaValleur, J., Kempainen, S., Brunner, R., Graettinger, W., Oujevolk, V., Heiss, G., Haines, P., Ontjes, D., Sueta, C., Wells, E., Kuller, L., Cauley, J., Milas, N. C., Johnson, K. C., Satterfield, S., Ke, R. W., Vile, J., Tylavsky, F., Brzyski, R., Schenken, R., Trabal, J., Rodriguez-Sifuentes, M., Mouton, C., Sarto, G., Laube, D., McBride, P., Mares-Perlman, J., Loevinger, B., Bonds, D., BURKE, G., Crouse, R., Parsons, L., Vitolins, M., Hendrix, S., Simon, M., McNeely, G., Gordon, P., MAKELA, P., Allen, C., Dougherty, S., Carleton, R. 2004; 350 (10): 991-1004

    Abstract

    Although the Women's Health Initiative (WHI) trial of estrogen plus progestin in postmenopausal women identified more overall health risks than benefits among women in the hormone group, the use of estrogen plus progestin was associated with a significant decrease in the risk of colorectal cancer. We analyzed features of the colorectal cancers that developed and their relation to the characteristics of the participants.In the WHI trial, 16,608 postmenopausal women who were 50 to 79 years of age and had an intact uterus were randomly assigned to a combination of conjugated equine estrogens (0.625 mg per day) plus medroxyprogesterone acetate (2.5 mg per day) or placebo. The main outcome measures were the incidence, stages, and types of colorectal cancer, as determined by blinded central adjudication.There were 43 invasive colorectal cancers in the hormone group and 72 in the placebo group (hazard ratio, 0.56; 95 percent confidence interval, 0.38 to 0.81; P=0.003). The invasive colorectal cancers in the hormone group were similar in histologic features and grade to those in the placebo group but with a greater number of positive lymph nodes (mean +/-SD, 3.2+/-4.1 vs. 0.8+/-1.7; P=0.002) and were more advanced (regional or metastatic disease, 76.2 percent vs. 48.5 percent; P=0.004). In exploratory analyses, women in the hormone group with antecedent vaginal bleeding had colorectal cancers with a greater number of positive nodes than women in the hormone group who did not have vaginal bleeding (3.8+/-4.3 vs. 0.7+/-1.5 nodes, P=0.006).Relatively short-term use of estrogen plus progestin was associated with a decreased risk of colorectal cancer. However, colorectal cancers in women who took estrogen plus progestin were diagnosed at a more advanced stage than those in women who took placebo.

    View details for Web of Science ID 000189363600007

    View details for PubMedID 14999111

  • National trends in antiarrhythmic and antithrombotic medication use in atrial fibrillation 25th Annual Meeting of the Society-of-General-Internal-Medicine Fang, M. C., Stafford, R. S., Ruskin, J. N., Singer, D. E. AMER MEDICAL ASSOC. 2004: 55?60

    Abstract

    Atrial fibrillation is the most common cardiac arrhythmia associated with significant medical complications. We examined trends in the medical therapy of atrial fibrillation in the United States from 1991 through 2000.Data from 1355 visits among patients with atrial fibrillation were obtained from the National Ambulatory Medical Care Survey, a nationally representative assessment of office-based practice. We assessed trends in medication use for ventricular rate control (digoxin, beta-blockers, and calcium channel blockers), sinus rhythm maintenance (class IA, IC, and III antiarrhythmics), and thromboembolism prevention (oral anticoagulants and aspirin).Overall rate control medication use decreased from 72% of visits in 1991-1992 to 56% in 1999-2000 (P =.01 for trend) due to declining digoxin use (64% to 37%, P<.001 for trend). beta-Blocker and calcium channel blocker use remained unchanged. Although there was no change in overall sinus rhythm medication use over time, amiodarone hydrochloride use increased from 0.2% to 6.4% (P<.001 for trend), while quinidine use decreased from 5.0% to 0.0% (P =.01 for trend). Oral anticoagulant use increased (28% to 41%, P =.01 for trend), with the greatest increase in patients aged 80 years and older (14% to 48%, P<.001 for trend). Despite this, only 46.5% of patients at high risk for stroke were taking anticoagulants in 1999-2000.Digoxin use in atrial fibrillation decreased over time, without concomitant increases in beta-blocker or calcium channel blocker use. Amiodarone replaced quinidine as the dominant sinus rhythm medication. Although oral anticoagulant use increased over time, particularly in the oldest patients, fewer than half of the patients at high risk for stroke were anticoagulated.

    View details for Web of Science ID 000188045200006

    View details for PubMedID 14718322

  • National use of postmenopausal hormone therapy - Annual trends and response to recent evidence JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Hersh, A. L., Stefanick, M. L., Stafford, R. S. 2004; 291 (1): 47-53

    Abstract

    Postmenopausal hormone therapy use increased dramatically during the past 2 decades because of a prevailing belief in its health benefits. Recent evidence from randomized trials published in July 2002 demonstrated adverse cardiovascular disease events and other risks with hormone therapy in the form of oral estrogen combined with progestin.To describe patterns of hormone therapy use from 1995 until July 2003, including the impact of recent evidence.Two databases were used to describe national trends in hormone therapy use from January 1995 to July 2003. The National Prescription Audit database provided data on the number of hormone therapy prescriptions filled by retail pharmacies and the National Disease and Therapeutic Index database provided data on patient visits to office-based physicians during which hormone therapy was prescribed.Annual number of hormone therapy prescriptions and characteristics of visits to physicians during which hormone therapy was prescribed.Annual hormone therapy prescriptions increased from 58 million in 1995 to 90 million in 1999, representing approximately 15 million women per year, then remained stable through June 2002. Adoption of new oral estrogen/progestin combinations, primarily Prempro, accounted for most of this growth. Obstetrician/gynecologists provided more than 70% of hormone therapy prescriptions, and more than one third of patients were older than 60 years. Following the publication of trial results in July 2002, hormone therapy prescriptions declined in successive months. Relative to January-June 2002, prescriptions from January-June 2003 declined by 66% for Prempro and 33% for Premarin. Small increases were observed in vaginal formulations and in new prescriptions for low-dose Premarin. If prescription rates observed through July 2003 remain stable, a decline to 57 million prescriptions for 2003, similar to the rate in 1995, is projected.Clinical practice responded rapidly to recent evidence of harms associated with hormone therapy. Since July 2002, many patients have discontinued hormone therapy or are tapering to lower doses.

    View details for PubMedID 14709575

  • Impact of clinical trial results on national trends in alpha-blocker prescribing, 1996-2002 JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Stafford, R. S., Furberg, C. D., Finkelstein, S. N., Cockburn, I. M., Alehegn, T., Ma, J. 2004; 291 (1): 54-62

    Abstract

    Research on factors that influence prescribing patterns and the extent of change produced by clinical trial findings is limited.To examine the changes in prescribing of alpha-blockers for hypertension treatment before and after the April 2000 publication of the unfavorable Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) early termination involving the study's doxazosin mesylate arm. Changes in prescribing were considered in the context of other potential concurrent influences on medication use between 1996 and 2002, including changes in alpha-blocker drug prices, generic conversion, drug promotion, and competition.Using 2 national pharmaceutical market research reports published by IMS HEALTH, alpha-blocker prescription orders reported in the National Prescription Audit-a random computerized sample of about 20 000 of 29 000 retail, independent, and mail order pharmacies and mass merchandise and discount houses--and office-based physician alpha-blocker prescribing patterns reported in the National Disease and Therapeutic Index--a random stratified sample of about 3500 physician offices--were tracked.Trends in physician-reported use of alpha-blockers and alpha-blocker prescribing and dispensing by US pharmacies.There were steady increases in alpha-blocker new prescriptions, dispensed prescriptions, and physician drug use from 1996 through 1999. There was a moderate reversal in these trends following ALLHAT early termination and subsequent publications in early 2000. Between 1999 and 2002, new annual alpha-blocker prescription orders declined by 26% (from 5.15 million to 3.79 million), dispensed prescriptions by 22% (from 17.2 million to 13.4 million), and physician-reported drug use by 54% (from 2.26 million to 1.03 million). Other potential influences did not appear to have contributed significantly to this decline although cessation of alpha-blocker marketing may have hastened the decline.Modest yet statistically significant declines in the use of doxazosin and other alpha-blockers coincided with the early termination of the ALLHAT doxazosin arm. Although physicians responded to this new evidence, strategies to augment the impact of clinical trials on clinical practice are warranted.

    View details for PubMedID 14709576

  • Modelling the ability of risk adjusters to reduce adverse selection in managed care. Applied health economics and health policy Stafford, R. S., Li, D., Davis, R. B., Iezzoni, L. I. 2004; 3 (2): 107-114

    Abstract

    Population-based risk adjustment, as applied to reimbursement in managed care settings, may reduce pressures for adverse selection by managed care organisations. Using insurance claims data from 184 340 plan members, we compared the performance of three risk-adjustment methods. We present a model for measuring the impact of risk adjustment on the likelihood that individual members will be at risk for adverse selection. These results are compared with resource allocation based on age/sex. The predictive ability of alternative allocation schemes increased from an R(2) of 1.2% for age-sex allocation to 11.4% based on risk adjustment using diagnostic cost groups. However, the impact of risk adjustment on the proportion of members at risk for adverse selection was small. At an absolute threshold loss of $US2400 per year, 8.3% to 8.6% of members were at risk for adverse selection compared with 9.3% based on age-sex allocation. The limited impact of risk adjustment on the likelihood of adverse selection suggests that other strategies for reducing adverse selection may be required.

    View details for PubMedID 15702948

  • Hormone therapy and venous thrombosis: Final results of the Women's Health Initiative trial of estrogen plus progestin. Cushman, M., Kuller, L. H., Prentice, R., Psaty, B. M., Sidney, S., Stafford, R., Rodabough, R., Rosendaal, F. R. AMER SOC HEMATOLOGY. 2003: 208A

    View details for Web of Science ID 000186536700729

  • Symptoms of depression as a risk factor for incident diabetes: Findings from the National Health and Nutrition Examination Epidemiologic Follow-up study, 1971-1992 AMERICAN JOURNAL OF EPIDEMIOLOGY Carnethon, M. R., Kinder, L. S., Fair, J. M., Stafford, R. S., Fortmann, S. P. 2003; 158 (5): 416-423

    Abstract

    Symptoms of depression may predict incident diabetes independently or through established risk factors for diabetes. US men and women aged 25-74 years who were free of diabetes at baseline (n = 6,190) were followed from 1971 to 1992 (mean, 15.6 years; standard deviation, 6) for incident diabetes. Depressive symptoms were measured by using the General Well-Being Depression subscale and were categorized to compare persons with high (9%), intermediate (32%), and low (59%) numbers of symptoms. The incidence of diabetes was highest among participants reporting high numbers of depressive symptoms (7.3 per 1,000 person-years) and did not differ between persons reporting intermediate and low numbers of symptoms (3.4 and 3.6 per 1,000 person-years, respectively) (p < 0.01 for high vs. low). In the subset of participants with less than a high school education (a marker of low socioeconomic status), the risk of developing diabetes was three times higher (95% confidence interval: 2.0, 4.7) for persons reporting high versus low numbers of depressive symptoms. These results persisted following adjustment for established diabetes risk factors. Depressive symptoms had no impact on diabetes incidence among persons with at least a high school education. Results suggest an independent role for depressive symptoms in the development of diabetes in populations with low educational attainment.

    View details for DOI 10.1093/aje/kwg172

    View details for PubMedID 12936896

  • US physician adherence to standards in asthma pharmacotherapy varies by patient and physician characteristics JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY Ma, J., Stafford, R. S. 2003; 112 (3): 633-635

    View details for DOI 10.1067/MAI.2003.1712

    View details for Web of Science ID 000185231200030

    View details for PubMedID 13679830

  • Association between antibiotic prescribing and visit duration in adults with upper respiratory tract infections 25th Annual Meeting of the Society-of-General-Internal-Medicine Linder, J. A., Singer, D. E., Stafford, R. S. ELSEVIER. 2003: 2419?30

    Abstract

    Upper respiratory tract infections (URTIs) are the most common reason for individuals to seek health care in the United States. Inappropriate antibiotic use exposes patients unnecessarily to potential adverse events and increases the prevalence of antibiotic-resistant bacteria. One of the reasons physicians may prescribe an antibiotic inappropriately is to save time.The aim of this study was to determine whether there is an association between antibiotic use and a shorter visit duration in adults with URTIs.Visits to office-based primary care physicians made by adults aged 18 to 60 years from 1995 through 2000 were extracted from the National Ambulatory Medical Care Survey. Visits that resulted in a primary diagnosis of acute URTI; acute nasopharyngitis; acute bronchitis; sinusitis; streptococcal sore throat, acute pharyngitis, or acute tonsillitis; or otitis media were included in the study. Visits associated with >1 diagnosis were included in a separate category Visit duration was defined as the face-to-face time between the patient and physician.There were 3764 visits that met the criteria for inclusion in this study, representing an estimated 27 million annual visits to office-based primary care physicians by adults with URTIs. Antibiotics were prescribed in 67% of visits. The mean visit duration associated with prescription of an antibiotic was 14.2 minutes, compared with 15.2 minutes without prescription of an antibiotic (P = 0.007). In multivariable modeling, independent predictors of visit duration were calendar year (additional 0.3 minute per year; 95% CI, 0.1 to 0.6), internal medicine specialty (additional 2.2 minutes vs family practice; 95% CI, 1.3 to 3.1), covisit with a nurse-practitioner or physician assistant (6.6 minutes shorter; 95% CI, -2.7 to -10.6), and Midwestern location of practice (1.1 minutes shorter vs Northeast; 95% CI, -0.1 to -2.2). Antibiotic use was marginally associated with a shorter visit duration (0.7 minute shorter; 95% CI, 0.0 to -1.3; P = NS).In the present study, antibiotic use was marginally associated with a shorter visit duration for adults with URTIs. Any potential efficiencies gained by physicians through prescribing antibiotics for adults with URTIs are likely to be outweighed by increases in antimicrobial resistance and exposure of patients to unneeded medication.

    View details for Web of Science ID 000185869700005

    View details for PubMedID 14604741

  • Evaluation of the adequacy of outpatient antidepressant treatment 155th Annual Meeting of the American-Psychiatric-Association Weilburg, J. B., O'Leary, K. M., Meigs, J. B., Hennen, J., Stafford, R. S. AMER PSYCHIATRIC PUBLISHING, INC. 2003: 1233?39

    Abstract

    Most studies evaluating the adequacy of antidepressant treatment have focused on the relatively small segment of the medicated population with a diagnosis of depression. This study assessed the rates and determinants of the adequacy of antidepressant treatment among all outpatients who receive antidepressants.A retrospective analysis was conducted using pharmacy claims made by patients with a primary care physician in a managed care plan at an academic medical center from 1996 through 1999. Adequate antidepressant treatment was defined as prescription of the lowest likely effective dosage of an antidepressant for at least 90 consecutive days. Data for a total of 15,476 records and 1,550 patients were available.Overall, 46 percent of the patients receiving antidepressants received minimally adequate treatment. The rates of adequate treatment were significantly higher among patients whose antidepressant prescriptions were written by both primary care physicians and psychiatrists than among patients whose antidepressants were prescribed solely by primary care physicians (61 percent versus 31 percent). Patients who had trials of SSRIs had significantly higher rates of treatment adequacy than those who had trials of tricyclic antidepressants but not SSRIs (51 percent compared with 27 percent) or trials with other antidepressants only (24 percent).Pharmacy claims from all patients receiving antidepressants indicate that these drugs are prescribed in ways that are unlikely to be fully effective across the broad spectrum of patients. Adequate antidepressant treatment trials were most likely when psychiatrists collaborated with primary care physicians or other specialists and when SSRIs were used.

    View details for Web of Science ID 000222758700009

    View details for PubMedID 12954939

  • Estrogen plus progestin and the risk of coronary heart disease NEW ENGLAND JOURNAL OF MEDICINE Manson, J. E., Hsia, J., Johnson, K. C., Rossouw, J. E., Assaf, A. R., Lasser, N. L., Trevisan, M., Black, H. R., Heckbert, S. R., Detrano, R., Strickland, O. L., Wong, N. D., Crouse, J. R., Stein, E., Cushman, M., Alving, B., Rossouw, J. E., Pottern, L., Ludlam, S., McGowan, J. A., Prentice, R., Anderson, G., Lacroix, A., Patterson, R., McTiernan, A., Cochrane, B., Hunt, J., Tinker, L., Kooperberg, C., McIntosh, M., Wang, C. Y., Chen, C., Bowen, D., Kristal, A., Stanford, J., Urban, N., Weiss, N., White, E., Shumaker, S., Rautaharju, P., Prineas, R., Naughton, M., Stein, E., Laskarzewski, P., Cummings, S., Nevitt, M., Dockrell, M., Harnack, L., Cammarata, F., Lindenfelser, S., Psaty, B., Heckbert, S., Wassertheil-Smoller, S., Frishman, W., Wylie-Rosett, J., Barad, D., Freeman, R., Hays, J., Young, R., Anderson, J., Lithgow, S., Bray, P., Manson, J., Buring, J., Gaziano, J. M., Rexrode, K., Chae, C., Assaf, A. R., Carleton, R., WHEELER, C., Eaton, C., Cyr, M., Phillips, L., PEDERSEN, M., Strickland, O., Huber, M., Porter, V., Beresford, S. A., Taylor, V. M., Woods, N. F., Henderson, M., Kestin, M., Hsia, J., Gaba, N., Ascensao, J., Laowattana, S., Chlebowski, R., Detrano, R., Nelson, A., Heiner, J., Marshall, J., Ritenbaugh, C., Valanis, B., Elmer, P., Stevens, V., Karanja, N., Caan, B., Sidney, S., Bailey, G., HIRATA, J., Kotchen, J. M., Barnabei, V., Kotchen, T. A., Gilligan, M. A., Neuner, J., Howard, B. V., Adams-Campbell, L., Passaro, M., Rainford, M., Agurs-Collins, T., Van Horn, L., Greenland, P., Khandekar, J., Liu, K., Rosenberg, C., BLACK, H., Powell, L., Mason, E., Stefanick, M. L., Hlatky, M. A., Chen, B., Stafford, R. S., Giudice, L. C., Lane, D., Granek, I., Lawson, W., San Roman, G., Messina, C., Jackson, R., Harris, R., Frid, D., Mysiw, W. J., Blumenfeld, M., Lewis, C. E., Oberman, A., Fouad, M. N., Shikany, J. M., West, D. S., Bassford, T., Mattox, J., Ko, M., Lohman, T., Trevisan, M., Wactawski-Wende, J., Graham, S., Chang, J., Smit, E., Robbins, J., Yasmeen, S., Lindfors, K., Stern, J., Hubbell, A., Frank, G., Wong, N., Greep, N., MoOnk, B., Judd, H., Heber, D., Elashoff, R., Langer, R. D., Criqui, M. H., Talavera, G. T., Garland, C. F., Hanson, R. E., Gass, M., Wernke, S., Watts, N., Limacher, M., Perri, M., Kaunitz, A., Williams, R. S., Brinson, Y., Curb, D., Petrovitch, H., Rodriguez, B., Masaki, K., Sharma, S., Wallace, R., Torner, J., JOHNSON, S., Snetselaar, L., VanVoorhis, B., Ockene, I., Yood, R., Aronson, P., Lasser, N., Hymowitz, N., Lasser, V., Safford, M., Kostis, J., O'Sullivan, M. J., PARKER, L., Estape, R., Fernandez, D., Margolis, K. L., Grimm, R. H., Hunninghake, D. B., LaValleur, J., Hall, K. M., Brunner, R., St Jeor, S., Graettinger, W., Oujevolk, V., Heiss, G., Haines, P., Ontjes, D., Sueta, C., Wells, E., Kuller, L., Caggiula, A., Cauley, J., Berga, S., Milas, N. C., Johnson, K. C., Satterfield, S., Ke, T. W., Vile, J., Tylavsky, F., Brzyski, R., Schenken, R., Trabal, J., Rodriguez-Sifuentes, M., Mouton, C., Allen, C., Laube, D., McBride, P., Mares-Perlman, J., Loevinger, B., BURKE, G., Crouse, R., Parsons, L., Vitolins, M., Hendrix, S., Simon, M., McNeeley, G., Gordon, P., MAKELA, P. 2003; 349 (6): 523-534

    Abstract

    Recent randomized clinical trials have suggested that estrogen plus progestin does not confer cardiac protection and may increase the risk of coronary heart disease (CHD). In this report, we provide the final results with regard to estrogen plus progestin and CHD from the Women's Health Initiative (WHI).The WHI included a randomized primary-prevention trial of estrogen plus progestin in 16,608 postmenopausal women who were 50 to 79 years of age at base line. Participants were randomly assigned to receive conjugated equine estrogens (0.625 mg per day) plus medroxyprogesterone acetate (2.5 mg per day) or placebo. The primary efficacy outcome of the trial was CHD (nonfatal myocardial infarction or death due to CHD).After a mean follow-up of 5.2 years (planned duration, 8.5 years), the data and safety monitoring board recommended terminating the estrogen-plus-progestin trial because the overall risks exceeded the benefits. Combined hormone therapy was associated with a hazard ratio for CHD of 1.24 (nominal 95 percent confidence interval, 1.00 to 1.54; 95 percent confidence interval after adjustment for sequential monitoring, 0.97 to 1.60). The elevation in risk was most apparent at one year (hazard ratio, 1.81 [95 percent confidence interval, 1.09 to 3.01]). Although higher base-line levels of low-density lipoprotein cholesterol were associated with an excess risk of CHD among women who received hormone therapy, higher base-line levels of C-reactive protein, other biomarkers, and other clinical characteristics did not significantly modify the treatment-related risk of CHD.Estrogen plus progestin does not confer cardiac protection and may increase the risk of CHD among generally healthy postmenopausal women, especially during the first year after the initiation of hormone use. This treatment should not be prescribed for the prevention of cardiovascular disease.

    View details for Web of Science ID 000184563500003

    View details for PubMedID 12904517

  • Trends in Prescribing of Selective Serotonin Reuptake Inhibitors and Other Newer Antidepressant Agents in Adult Primary Care. Primary care companion to the Journal of clinical psychiatry Pirraglia, P. A., Stafford, R. S., Singer, D. E. 2003; 5 (4): 153-157

    Abstract

    BACKGROUND: The introduction of selective serotonin reuptake inhibitors (SSRIs) represented a breakthrough in depression treatment due to their safety and ease of use. The purpose of this study was to extend previous work on trends in antidepressant use to include recent data and to provide more detailed analysis of prescribing trends for SSRIs and newer non-SSRI antidepressants, specifically in adult primary care practice. METHOD: Adult primary care visits from the National Ambulatory Medical Care Survey (NAMCS) between 1989 and 2000 were analyzed. Chi-square tests for trend and multivariable logistic regression models were utilized to examine patterns of antidepressant use over time. SSRIs (citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) and newer non-SSRI antidepressants (bupropion, mirtazapine, nefazodone, venlafaxine) were classified as newer agents. RESULTS: 89,424 adult primary care visits were recorded in the NAMCS during the period studied. Antidepressant use increased in primary care from 2.6% ( approximately 6 million visits) in 1989 to 7.1% ( approximately 20.5 million) in 2000 (p <.001). SSRI and newer non-SSRI use increased linearly from 1989 to 2000 (p <.001), with an adjusted odds ratio for use of 1.27 per year (95% confidence interval = 1.25 to 1.29). The increase in antidepressant use was due to these newer agents (13.5% of all antidepressant use in 1989 to 82.3% in 2000) with each new agent adding to a stable base of previously introduced newer antidepressant agents. CONCLUSIONS: The prevalence of antidepressant use in adult primary care has risen dramatically since 1989, largely reflecting use of newer agents. The detailed pattern of increased use of these medications is striking, with each new agent adding to aggregate use without concomitant decrease in previously introduced newer agents. Such trends reflect more widespread pharmacologic treatment of depressed primary care patients.

    View details for PubMedID 15213776

  • Feedback intervention to reduce routine electrocardiogram use in primary care AMERICAN HEART JOURNAL Stafford, R. S. 2003; 145 (6): 979-985

    Abstract

    Although physicians frequently order non-essential diagnostic tests, including screening tests such as electrocardiograms (ECGs), effective strategies for achieving evidence-based test-ordering are not proven. Our objective was to evaluate the impact of a feedback intervention designed to reduce the rate of screening ECG use and its variation.A non-randomized pre-post intervention trial assessed the ordering of ECGs among primary care providers affiliated with Massachusetts General Hospital. Among outpatients visiting providers, those with cardiac diagnoses or symptoms were excluded, as were providers with <120 annual visits. Data were available on 117 providers, 105,682 patients, and 511,328 patient visits. During a 9-month intervention, providers received periodic case-mix-adjusted peer-comparisons of their screening ECG use. Two computerized billing systems tracked baseline (December 1996 to March 1998), intervention (April 1998 to December 1998), and post-intervention (January 1999 to September 1999) ECG use. Our outcome measures were: 1) the likelihood of ECG ordering at office visits and 2) provider practice variation, indicated by coefficient of variation and interquartile range.ECGs were ordered in 4.6% of visits before the intervention. Provider variation in case-mix adjusted ECG ordering was substantial (coefficient of variation, 101.6%; interquartile range, 3.2% [1.5%-4.7%]). ECG ordering averaged 3.5% during the intervention and 2.8% post-intervention (P <.001). Variation in ECG ordering narrowed considerably (coefficient of variation, 92.5%; interquartile range, 2.0% [1.0%-3.0%]) after the intervention. Multivariate analysis confirmed a persistent impact of the intervention.Feedback to primary care providers successfully reduced ECG use and its variation. This approach may be applicable to other physician behaviors that remain contrary to evidence, but are not questioned because peer comparisons are unavailable.

    View details for DOI 10.1016/S0002-8703(03)00107-8

    View details for Web of Science ID 000183556100009

    View details for PubMedID 12796752

  • National trends in antiobesity medication use ARCHIVES OF INTERNAL MEDICINE Stafford, R. S., Radley, D. C. 2003; 163 (9): 1046-1050

    Abstract

    The use of medications to treat obesity remains controversial. Our goal was to assess national trends in antiobesity medication use with a focus on patterns surrounding the 1997 removal of antiobesity drugs from the market.Using a serial cross-sectional study design, we analyzed a nationally representative sample of US office-based physician visits from 1991 to 2002. Data come from the IMS HEALTH National Disease and Therapeutic Index. These data include a sample of 13 452 patient visits for which a diagnosis of clinical obesity was made, with annual visits ranging from 666 in 1994 to 1854 in 1996. The unit of analysis is the patient visit, while the primary outcome measures are the annual and quarterly number of antiobesity drug mentions for clinically obese patients.At its peak in the second quarter of 1997, 2.5 million Americans were taking antiobesity medications, a 4-fold increase over the prior 2 years. Although antiobesity medication use diminished following the market exit of fenfluramine hydrochloride and dexfenfluramine hydrochloride, current levels of use remain above those in the early 1990s. Phentermine has consistently been the most common antiobesity medication. In 2002, an annualized 1.2 million mentions of phentermine use were noted (31% of drug-treated obese patients). Newly released medications, orlistat (0.6 million) and sibutramine hydrochloride (0.4 million), were used less often. Most antiobesity medication use occurs in patients without other reported medical conditions.Use of antiobesity medications increased rapidly with public and professional interest in fenfluramine-phentermine (fen-phen) combination therapy. Despite reports of adverse outcomes associated with fenfluramine agents (fen-phen and dexfenfluramine), the use of these medication therapies did not diminish until soon before their removal from the market in 1997.

    View details for Web of Science ID 000182781300006

    View details for PubMedID 12742801

  • A statistical analysis of the magnitude and composition of drug promotion in the United States in 1998 CLINICAL THERAPEUTICS Ma, J., Stafford, R. S., Cockburn, I. M., Finkelstein, S. N. 2003; 25 (5): 1503-1517

    Abstract

    Although pharmaceutical industry marketing and other factors may influence physician decisions regarding medication prescribing in the United States, little information is available about the composition of promotional efforts by promotional mode and medication class.The aims of this study were to determine the magnitude of expenditures for common modes of promotion and to delineate patterns of promotional strategies for particular classes of medications.Nationally representative data on expenditures (in US $) for the 250 most promoted medications in the United States in 1998 were available from an independent pharmaceutical market research company for the 5 most commonly used modes of promotion. Key patterns of drug promotion were identified by descriptive statistics, a cluster analysis of expenditures by class, and an analysis of expenditure concentration.In 1998, the pharmaceutical industry spent $12,724 million promoting its products in the United States, of which 85.9% was accounted for by the top 250 drugs and 51.6% by the top 50 drugs. Direct-to-consumer (DTC) advertising was more concentrated on a small subset of medications than was promotion to professionals. Overall, 1998 expenditures were dominated by free drug samples provided to physicians (equivalent retail cost of $6602 million) and office promotion ($3537 million), followed by DTC advertising ($1337 million), hospital promotion ($705 million), and advertising in medical journals ($540 million). Four distinct patterns of expenditures were observed: promotion to office physicians with little consumer promotion (14 drug classes); dual focus on office physicians and consumer advertising (4 drug classes); predominant DTC advertising (1 class: smoking-cessation products); and promotion to office- and hospital-based professionals without consumer advertising (1 class: narcotic analgesics).The present findings reinforce the perception that the pharmaceutical industry invests heavily in promoting its products and demonstrates that promotional expenditures are concentrated on a small number of medications. Although promotion to professionals remains dominant, DTC advertising has become key for a subset of common medications

    View details for PubMedID 12867225

  • Chronic disease medication use in managed care and indemnity insurance plans HEALTH SERVICES RESEARCH Stafford, R. S., Davidson, S. M., Davidson, H., Miracle-McMahill, H., Crawford, S. L., Blumenthal, D. 2003; 38 (2): 595-612

    Abstract

    To evaluate the impact of managed care on the use of chronic disease medications.Claims data from 1997 from two indemnity and three independent practice association (IPA) model managed care insurance plans.Cross-sectional analysis of claims data.Adult patients with diabetes mellitus (DM, n = 26,444), congestive heart failure (CHF, n = 7,978), and asthma (n = 9,850) were identified by ICD-9 codes. Chronic disease medication use was defined through pharmacy claims for patients receiving one or more prescriptions for drugs used in treating these conditions. Using multiple logistic regression we adjusted for patient case mix and the number of primary care visits.With few exceptions, managed care patients were more likely to use chronic disease medications than indemnity patients. In DM, managed care patients were more likely to use sulfonylureas (43 percent versus 39 percent for indemnity), metformin (26 percent versus 18 percent), and troglitazone (8.8 percent versus 6.4 percent), but not insulin. For CHF patients, managed care patients were more likely to use loop diuretics (45 percent versus 41 percent), ACE inhibitors or angiotensin receptor blockers (50 percent versus 41 percent), and beta-blockers (23 percent versus 16 percent), but we found no differences in digoxin use. In asthma, managed care patients were more likely to use inhaled corticosteroids (34 percent versus 30 percent), systemic corticosteroids (18 percent versus 16 percent), short-acting beta-agonists (42 percent versus 33 percent), long-acting beta-agonists (9.9 percent versus 8.6 percent), and leukotriene modifiers (5.4 percent versus 4.1 percent), but not cromolyn or methylxanthines. Statistically significant differences remained after multivariate analysis that controlled for age, gender, and severity.Chronic disease patients in these managed care plans are more likely to receive both inexpensive and expensive medications. Exceptions included older medications partly supplanted by newer therapies. Differences may be explained by the fact that patients in indemnity plans face higher out-of-pocket costs and managed care plans promote more aggressive medication use. The relatively low likelihood of condition-specific medications in both plan types is a matter of concern, however.

    View details for PubMedID 12785563

  • Fluoroquinolone prescribing in the United States, 1995 to 2000. 26th Annual Meeting of the Society-of-General-Internal-Medicine Linder, J. A., Huang, E. S., Steinman, M. A., Gonzales, R., Stafford, R. S. SPRINGER. 2003: 209?210

    View details for Web of Science ID 000182564300827

  • National trends in asthma visits and asthma pharmacotherapy, 1978-2002 JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY Stafford, R. S., Ma, J., Finkelstein, S. N., Haver, K., Cockburn, I. 2003; 111 (4): 729-735

    Abstract

    Research is limited on physicians' compliance with recent clinical guidelines for asthma treatment.Our purpose was to investigate the relationships among clinical guidelines, asthma pharmacotherapy, and office-based visits through use of nationally representative data.Nationally representative data on prescribing patterns by office-based US physicians were extracted from the National Disease and Therapeutic Index. We tracked 1978-2002 trends in the frequency of asthma visits and patterns of asthma pharmacotherapy, focusing on the use of controller and reliever medications.The estimated annual number of asthma visits in the United States increased continuously from 1978 through 1990 (18 million visits); since 1990, it has remained relatively stable. Controller medication use increased 8-fold between 1978 and 2002, inhaled corticosteroids manifesting the biggest increases. The use of reliever medications, particularly short-acting oral beta(2)-agonists, decreased modestly over this period. The aggregate use of controllers (83% of visits) superseded that of relievers (80%) for the first time in 2001. Improved appropriateness of asthma pharmacotherapy was also suggested by an increase in the controller-to-reliever ratio, which reached 92% in 2002. Xanthines, which once dominated asthma therapy (63% of visits in 1978), were used in only 2% of visits in 2002. More recent drug entrants have been adopted rapidly, single-entity long-acting inhaled beta(2)-agonists being used in 9% of visits and leukotriene modifiers in 24% of visits in 2002.Asthma pharmacotherapy has changed extensively in the past 25 years. Practices over the last decade are increasingly consistent with evidence-based guidelines. These changes in medication use might have contributed to the lack of a recent increase in asthma visits.

    View details for DOI 10.1067/mai.2003.177

    View details for PubMedID 12704350

  • The underutilization of cardiac medications of proven benefit, 1990 to 2002 JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Stafford, R. S., Radley, D. C. 2003; 41 (1): 56-61

    Abstract

    To evaluate recent trends, we examined longitudinal national data on the outpatient use of warfarin in atrial fibrillation (AF), beta-blockers and aspirin in coronary artery disease (CAD), and angiotensin-converting enzyme inhibitors (ACEIs) in congestive heart failure (CHF).Previous studies indicate that specific cardiac medications are underutilized.We used the National Disease and Therapeutic Index (NDTI) (produced by IMS HEALTH, Plymouth Meeting, Pennsylvania) for 1990 to 2002, and the National Ambulatory Medical Care Surveys (NAMCS) for 1990 to 2000 to follow nationally representative samples of outpatient visits. For visits by patients with AF (total n = 14,634 visits), CAD (n = 35,295), and CHF (n = 33,008), we examined trends in the proportion of visits with the selected medications reported.Warfarin use in AF increased from 12% in 1990, to 41% in 1995, to 58% in 2001 in NDTI; a similar moderation of recent increase was seen in NAMCS. For CAD in NDTI, beta-blocker use increased slowly from 19% in 1990, to 20% in 1995, then to 40% in 2001; NAMCS showed this same pattern. Aspirin use in CAD in NDTI increased from 18% in 1990, to 19% in 1995, to 38% in 2001; NAMCS, however, showed lower use rates. For NDTI, ACEI use in CHF increased from 24% in 1990 to 36% in 1996, but increased to only 39% by 2001, a general pattern also seen in NAMCS.Both national datasets demonstrate continuing underutilization of these cardiac medications of proven benefit. Although use is increasing, it remains lower than expected, and some increases noted in earlier years have slowed. Substantial public health benefits would result from further adoption of these effective therapies.

    View details for PubMedID 12570945

  • The potential of pill splitting to achieve cost savings AMERICAN JOURNAL OF MANAGED CARE Stafford, R. S., Radley, D. C. 2002; 8 (8): 706-712

    Abstract

    To present a methodology for identifying specific medications for which pill splitting is clinically appropriate and cost saving, to present data from a commercial managed care population on current pill-splitting practices, and to estimate additional cost savings from extended use of this strategy.Retrospective pharmacy claims analysis.Pharmacy claims data from a commercial managed care health plan covering 19,000 lives and national drug data were used to compile a list of frequently prescribed medications. Excluding medications in which packaging, formulation, and potential adverse pharmacologic outcomes prohibited splitting, we performed a cost analysis of medications amenable to splitting.Eleven medications amenable to pill splitting were identified based on potential cost savings and clinical appropriateness: clonazepam, doxazosin, atorvastatin, pravastatin, citalopram, sertraline, paroxetine, lisinopril, nefazadone, olanzapine, and sildenafil. For these medications, pill splitting is currently infrequent, accounting for annual savings of $6200 (or $0.03 per member per month), just 2% of the potential $259,500 (or $1.14 per member per month) that more comprehensive pill-splitting practices could save annually.Pill splitting can be a cost-saving practice when implemented judiciously using drug- and patient-specific criteria aimed at clinical safety, although this strategy is used infrequently.

    View details for Web of Science ID 000177637000004

    View details for PubMedID 12212758

  • Trends in medication use for osteoarthritis treatment JOURNAL OF RHEUMATOLOGY Ausiello, J. C., Stafford, R. S. 2002; 29 (5): 999-1005

    Abstract

    To investigate recent national trends in nonsteroidal antiinflammatory drug (NSAID) and acetaminophen use for osteoarthritis (OA).Using data from the 1989-98 National Ambulatory Medical Care Survey, a representative sample of US office based physician visits, we assessed 4471 visits by patients 45 years or older with a diagnosis of OA. We examined cross sectional and longitudinal patterns of OA pharmacotherapy. The independent effects of patient and physician characteristics on NSAID and acetaminophen use were examined using multiple logistic regression analysis.Pharmacological treatment for OA (either NSAID, acetaminophen, or both) has steadily decreased from 49% of visits (1989-91) to 46% (1992-94) to 40% (1995-98) (p = 0.001). Reduced NSAID use over this time period (46% to 33%; p = 0.001) was partially offset by a modest increase in acetaminophen use (5% to 10%; p = 0.001). Among individual NSAID, ibuprofen (5.7% of OA visits), nabumetone (4.9%), naproxen (4.6%), and aspirin (4.4%) were the most frequently reported in 1995-98. For patient visits in 1995-98, 45 to 59-year-olds (38%) received NSAID more often than 60 to 74-year-olds (34%) or patients older than 75 (28%; p = 0.029). Other possible predictors of OA therapy included patient race and physician specialty.The decline in the use of NSAID from 1989 to 1998, especially among elderly patients, and the frequent selection of safer medications may reflect awareness of the literature citing the risks of nonsteroidals for OA. However, variations in prescribing patterns among different patient populations and the modest use of acetaminophen, despite evidence supporting its efficacy, suggest that better assimilation of the literature into medical practice is needed to optimize OA therapy.

    View details for Web of Science ID 000175430100024

    View details for PubMedID 12022364

  • National patterns in the treatment of urinary tract infections in women by ambulatory care physicians ARCHIVES OF INTERNAL MEDICINE Huang, E. S., Stafford, R. S. 2002; 162 (1): 41-47

    Abstract

    Trimethoprim-sulfamethoxazole has consistently been the recommended drug for uncomplicated urinary tract infections in women. Which antibiotics physicians use has implications for patient outcomes, antimicrobial resistance, and costs.This study was based on a sample survey of practicing physicians participating in the National Ambulatory Medical Care Survey from 1989 through 1998. Eligible visits were limited to those by women aged 18 to 75 years diagnosed with uncomplicated acute cystitis or urinary tract infection (N = 1478). We evaluated trends in the proportions of visits at which physicians prescribed (1) trimethoprim-sulfamethoxazole, (2) recommended fluoroquinolones, (3) nitrofurantoin, and (4) nonrecommended antibiotics (neither trimethoprim-sulfamethoxazole nor recommended fluoroquinolones). We also identified predictors of specific antibiotic prescribing among visits to primary care physicians.The most frequently prescribed antibiotics were trimethoprim-sulfamethoxazole, recommended fluoroquinolones, and nitrofurantoin. We found that the proportion of trimethoprim-sulfamethoxazole prescriptions declined from 48% in 1989-1990 to 24% in 1997-1998 (adjusted odds ratio [OR], 0.33; 95% confidence interval [CI], 0.21-0.52 per decade). Conversely, fluoroquinolone use increased (19% to 29%) (OR, 2.28; 95% CI, 1.35-3.83) as did nitrofurantoin prescribing (14% to 30%) (OR, 2.44; 95% CI, 1.44-4.13). Among primary care physicians, internists were the most likely to prescribe fluoroquinolones while obstetricians were the most likely to use nitrofurantoin.Ambulatory care physicians are increasing their use of fluoroquinolones and nitrofurantoin, even though they are not highly recommended and not the most cost-effective. Antibiotic prescribing in urinary tract infections may be influenced by clinical factors such as pregnancy and drug allergies but may also be shaped by nonclinical factors such as subspecialty culture.

    View details for Web of Science ID 000173214400004

    View details for PubMedID 11784218

  • National Patterns of Medication Treatment for Depression, 1987 to 2001. Primary care companion to the Journal of clinical psychiatry Stafford, R. S., MacDonald, E. A., Finkelstein, S. N. 2001; 3 (6): 232-235

    Abstract

    BACKGROUND: We investigated trends in antidepressant use, as well as broader changes in depression treatment, following the availability of selective serotonin reuptake inhibitors (SSRIs). METHOD: Using data from the National Disease and Therapeutic Index, a nationally representative survey of U.S. office-based physicians conducted by IMS HEALTH, we analyzed trends in antidepressant prescribing patterns from 1987 through the third quarter of 2001. Annual sample sizes of physician visits by patients reported to have depression ranged from 3901 visits in 1987 to 6639 in 1998. Outcomes examined included the frequency of depression visits, the likelihood of antidepressant therapy, and the use of specific medications. RESULTS: The estimated national number of physician visits by patients with depression increased from 14.4 million visits in 1987 to 24.5 million in 2001 (annualized). The rate of antidepressant medication treatment in these patients also increased from 70% in 1987 to 89% in 2001. In 1987, tricyclic antidepressants were prescribed to 47% of patients with depression. The most common individual antidepressants were amitriptyline (14%), trazodone (12%), doxepin (8%), and desipramine (6%). In 1989, a year after its introduction, fluoxetine was prescribed to 21% of patients with depression. The introduction of other SSRIs led aggregate SSRI use to grow to 38% in 1992, 60% in 1996, and 69% in 2000. In 2001, sertraline (18%), paroxetine (16%), fluoxetine (14%), citalopram (13%), and bupropion (9%) were the leading antidepressants, while tricyclics were used in only 2% of patients. The use of benzodiazepines in depression declined from 21% of patients in 1987 to 8% in 2001. CONCLUSION: The increasing therapeutic dominance of SSRIs may have contributed to other changes in depression treatment, including declining benzodiazepine use, increased aggregate antidepressant treatment rates, and increased reporting of depression.

    View details for PubMedID 15014590

  • Variation in routine electrocardiogram use in academic primary care practice ARCHIVES OF INTERNAL MEDICINE Stafford, R. S., MISRA, B. 2001; 161 (19): 2351-2355

    Abstract

    Lack of practical consensus regarding routine electrocardiogram (ECG) ordering in primary care led us to hypothesize that nonclinical variations in ordering would exist among primary care providers.We used 2 computerized billing systems to measure ECG ordering at visits to providers in 10 internal medicine group practices affiliated with a large, urban teaching hospital from October 1, 1996, to September 30, 1997. To focus on screening or routine ECGs, patients with known cardiac disease or suggestive symptoms were excluded, as were providers with fewer than 200 annual patient visits. Included were 69 921 patients making 190 238 visits to 125 primary care providers. Adjusted rates of ECG ordering accounted for patient age, sex, and 5 key diagnoses. Logistic regression evaluated additional predictors of ECG ordering.Electrocardiograms were ordered in 4.4% of visits to patients without reported cardiac disease. Among the 10 group practices, ECG ordering varied from 0.5% to 9.6% of visits (adjusted rates, 0.8%-8.6%). Variations between individual providers were even more dramatic: adjusted rates ranged from 0.0% to 24% of visits, with an interquartile range of 1.4% to 4.7% and a coefficient of variation of 88%. Significant predictors of ECG use were older patient age, male sex, and the presence of clinical comorbidities. Additional nonclinical predictors included Medicare as a payment source, older male providers, and providers who billed for ECG interpretation.Variations in ECG ordering are not explained by patient characteristics. The tremendous nonclinical variations in ECG test ordering suggest a need for greater consensus about use of screening ECGs in primary care.

    View details for Web of Science ID 000171649600009

    View details for PubMedID 11606151

  • Antibiotic treatment of adults with sore throat by community primary care physicians - A national survey, 1989-1999 24th Annual Meeting of the Society-of-General-Internal-Medicine Linder, J. A., Stafford, R. S. AMER MEDICAL ASSOC. 2001: 1181?86

    Abstract

    Most sore throats are due to viral upper respiratory tract infections. Group A beta-hemolytic streptococci (GABHS), the only common cause of sore throat warranting antibiotics, is cultured in 5% to 17% of adults with sore throat. The frequency of antibiotic use for pharyngitis has greatly exceeded the prevalence of GABHS, but less is known about specific classes of antibiotics used. Only penicillin and erythromycin are recommended as first-line antibiotics against GABHS.To measure trends in antibiotic use for adults with sore throat and to determine predictors of antibiotic use and nonrecommended antibiotic use.Retrospective analysis of 2244 visits to primary care physicians in office-based practices in the National Ambulatory Medical Care Survey, 1989-1999, by adults with a chief complaint of sore throat.Treatment with antibiotics and treatment with nonrecommended antibiotics, extrapolated to US annual national rates.There were an estimated 6.7 million annual visits in the United States by adults with sore throat between 1989 and 1999. Antibiotics were used in 73% (95% confidence interval [CI], 70%-76%) of visits. Patients treated with antibiotics were given nonrecommended antibiotics in 68% (95% CI, 64%-72%) of visits. From 1989 to 1999, there was a significant decrease in use of penicillin and erythromycin and an increase in use of nonrecommended antibiotics, especially extended-spectrum macrolides and extended-spectrum fluoroquinolones (P<.001 for all trends). In multivariable modeling, increasing patient age (odds ratio [OR], 0.86 per decade; 95% CI, 0.79-0.94) and general practice specialty (OR, 1.54 compared with family practice specialty; 95% CI, 1.10-2.14) were independent predictors of antibiotic use. Among patients receiving antibiotics, nonrecommended antibiotic use became more frequent over time (OR, 1.17 per year; 95% CI, 1.11-1.24).More than half of adults are treated with antibiotics for sore throat by community primary care physicians. Use of nonrecommended, more expensive, broader-spectrum antibiotics is frequent.

    View details for Web of Science ID 000170910400027

    View details for PubMedID 11559262

  • Randomized clinical trials and recent patterns in the use of statins AMERICAN HEART JOURNAL Wang, T. J., Stafford, R. S., Ausiello, J. C., Chaisson, C. E. 2001; 141 (6): 957-963

    Abstract

    Three landmark trials involving 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins) were published between 1994 and 1996 (the Scandinavian Simvastatin Survival Study [4S], the West of Scotland Coronary Prevention Study, and the Cholesterol and Recurrent Events trial). These trials provided evidence that lipid-lowering therapy decreases cardiovascular events, including mortality. Whether these recent data caused a shift toward statin use has not been evaluated.Data from the National Ambulatory Medical Care Survey in 1980, 1981, 1985, and 1989 through 1998 were used. We analyzed 5053 visits by patients taking lipid-lowering medications to office-based physicians selected by stratified random sampling. The main outcome measure was use of specific lipid-lowering medications, including statins.In 1980 resins and niacin were the most commonly used lipid-lowering medications. By 1985 rising use of fibrates caused reductions in niacin use and resin use. By 1989 statins replaced fibrates as the most heavily used medications. Statin use climbed continuously thereafter, accounting for 90% of visits by patients treated for hypercholesterolemia in 1998. In time series analyses, increases in overall statin use were temporally unrelated to the publication of clinical trials, although the 4S trial may have contributed to a shift from older statins to simvastatin. For patients receiving lipid-lowering therapy in 1993 to 1998, statin use was significantly more likely for female patients, white patients, and patients visiting cardiologists.Although the market for lipid-lowering medications is dominated by statins, the rise in statins predated the recent clinical trials supporting their use.

    View details for DOI 10.1067/mhj.2001.115587

    View details for Web of Science ID 000169033500013

    View details for PubMedID 11376310

  • The diagnosis and treatment of cough. NEW ENGLAND JOURNAL OF MEDICINE Linder, J. A., Stafford, R. S. 2001; 344 (14): 1097-1097

    View details for Web of Science ID 000167860400018

    View details for PubMedID 11291671

  • US physicians' treatment of smoking in outpatients with psychiatric diagnoses. Nicotine & tobacco research Thorndike, A. N., Stafford, R. S., Rigotti, N. A. 2001; 3 (1): 85-91

    Abstract

    A 1996 American Psychiatric Association (APA) guideline recommends the routine treatment of smoking for patients with psychiatric diagnoses. This study evaluates how often US physicians identified and treated smoking among these patients in the ambulatory setting just prior to publication of this guideline, by analysis of 1991-1996 data from the National Ambulatory Medical Care Survey, an annual survey of a random sample of US office-based physicians. Physicians were more likely to identify the smoking status of patients with psychiatric diagnoses compared to patients without these diagnoses (76% vs. 64% of visits, p<0.0001). Smokers with psychiatric diagnoses were more likely to be counseled about smoking than were smokers with non-psychiatric diagnoses (23% vs. 18% of visits, p<0.0001), although the absolute difference was small. Primary care physicians counseled smokers with psychiatric diagnoses more often than did psychiatrists, but both groups of physicians counseled at less than half of smokers' visits. All physicians were more likely to counsel smokers with the diagnosis of anxiety but less likely to counsel smokers with the diagnosis of an affective disorder compared to smokers without these diagnoses. Physicians usually identified the smoking status of patients with psychiatric diagnoses but infrequently acted on this information by counseling smokers to quit. Physicians are missing an important opportunity to prevent tobacco-related morbidity and mortality among this group of patients.

    View details for PubMedID 11260815

  • National Patterns of Depression Treatment in Primary Care. Primary care companion to the Journal of clinical psychiatry Stafford, R. S., Ausiello, J. C., Misra, B., Saglam, D. 2000; 2 (6): 211-216

    Abstract

    BACKGROUND: While past studies suggest that primary care physicians underdiagnose and undertreat depression, little is known about recent national patterns of depression treatment. METHOD: Using the 1995 and 1996 National Ambulatory Medical Care Surveys, we analyzed 1322 primary care office visits by patients reported to have depression. Rates of psychotherapy/mental health counseling, antidepressant use, and benzodiazepine use were assessed. Independent predictors of depression therapy were examined using multiple logistic regression. Where instructive, we compared the practices of primary care physicians with those of psychiatrists (2418 depression visits). RESULTS: Primary care physicians reported depression in 7.8% of their office visits. For these depression visits, antidepressants (42%) were the most common form of treatment, followed by psychotherapy/mental health counseling (28%) and benzodiazepines (21%). Among specific antidepressants, selective serotonin reuptake inhibitors were most often prescribed by primary care physicians (26% of depression visits). Rates of antidepressant and benzodiazepine use varied significantly by primary care specialty. In addition, geographic region and health insurance status influenced the likelihood of receiving benzodiazepines. In their depression visits, psychiatrists reported psychotherapy/mental health counseling (88%) most frequently, followed by antidepressants (64%) and benzodiazepines (25%). CONCLUSION: The predominant use of selective serotonin reuptake inhibitors suggests that primary care physicians have begun to adopt new therapeutic strategies for depression. The modest rate of antidepressant therapy for a clinical population specifically identified by primary care physicians as having depression may indicate undertreatment of depression in primary care settings. Furthermore, high rates of benzodiazepine use are inconsistent with treatment guidelines, and variations in treatment patterns suggest that nonclinical factors influence depression management.

    View details for PubMedID 15014631

  • Certain cardiac risk factors predict risk factor interventions and influence communication between physicians and patients AMERICAN JOURNAL OF CARDIOLOGY Mora, S., Stafford, R. S., Pasternak, R. C. 2000; 86 (7): 783-?

    Abstract

    We assessed predictors of cardiac risk factor testing and services and the degree of concordance among patients, physicians, and the medical records for these services, and found considerable variability among different risk factors. The data suggest that baseline risk factors influence communication and performance of interventions and that physicians appear to be underestimating the importance of treating multiple risk factors simultaneously.

    View details for Web of Science ID 000089526500015

    View details for PubMedID 11018202

  • Patterns and costs for hypertension treatment in the United States - Clinical, lifestyle and socioeconomic predictors from the 1987 National Medical Expenditures Survey CLINICAL DRUG INVESTIGATION Huttin, C., Moeller, J. F., Stafford, R. S. 2000; 20 (3): 181-195

    View details for Web of Science ID 000089549000006

  • National patterns of physician activities related to obesity management ARCHIVES OF FAMILY MEDICINE Stafford, R. S., Farhat, J. H., MISRA, B., Schoenfeld, D. A. 2000; 9 (7): 631-?

    Abstract

    National physician practices related to the clinical recognition and management of obesity are unknown.To estimate national patterns of office-based, obesity-related practices and to determine the independent predictors of these practices.Serial cross-sectional surveys of physician office visits.Ambulatory medical care in the United States.We analyzed 55,858 adult physician office visits sampled in the 1995-1996 National Ambulatory Medical Care Surveys. Data from the Third National Health and Nutrition Examination Surveys, 1988-1994 were used to assess and, then, adjust for the underreporting of obesity.Reporting of obesity at office visits and physician counseling for weight loss, exercise, and diet among patients identified as obese.Physicians reported obesity in only 8.6% of 1995-1996 National Ambulatory Medical Care Surveys visits. The 22.7% prevalence rate of the Third National Health and Nutrition Examination Surveys, 1988-1994 suggests that physicians reported obesity in only 38% of their obese patients. Among visits by patients identified as obese, physicians frequently provided counseling for weight loss (35.5%), exercise (32.8%), and diet (41.5%). Adjusted for population prevalence; however, each service was provided to no more than one quarter of all obese patients. While patients with obesity-related comorbidities were treated more aggressively, in these patients, weight loss counseling occurred at only 52% of the visits.Specific interventions to address obesity are infrequent in visits to US physicians. Obesity is underreported and interventions are only moderately likely among patients identified as obese, even for those with serious obesity-related comorbidities.

    View details for Web of Science ID 000088169300013

    View details for PubMedID 10910311

  • Cardiovascular disease prevention practices by US physicians for patients with diabetes JOURNAL OF GENERAL INTERNAL MEDICINE Meigs, J. B., Stafford, R. S. 2000; 15 (4): 220-228

    Abstract

    Cardiovascular diseases account for the majority of morbidity and mortality in patients with type 2 diabetes mellitus. We describe patterns of cardiovascular disease primary prevention practices used for patients with diabetes by U.S. office-based physicians.We analyzed a representative sample of 14,038 visits from the 1995 and 1996 National Ambulatory Medical Care Surveys (NAMCS), including 1,489 visits by patients with diabetes. Physicians completed visit forms describing diagnoses, demographics, services provided, and current medications. Diabetes was defined by diagnostic codes; patients with ischemic heart disease or younger than 30 years were excluded. We estimated national visit volumes by extrapolation using NAMCS sampling weights. Independent determinants of prevention practices were evaluated using multiple logistic regression. Actual visits sampled translated into an estimated 407 million office visits in 1995 and 1996, of which 44.8 million (11%) were by patients with diabetes. Overall, patients with diabetes received more cardiovascular disease prevention services than patients without diabetes, including cholesterol reduction (8% vs 5%, P <.001) and exercise counseling (22% vs 13%, P <.001), blood pressure measurement (82% vs 72%, P <.001), and aspirin prescription (5% vs 2%, P <.001). Patients with diabetes and hyperlipidemia were more likely to receive lipid-lowering medications than patients without these diagnoses (67% vs 51%, P =.007), but those who had diabetes and hypertension or who smoked were no more likely than those without to receive antihypertensive medications or smoking cessation counseling, respectively. These effects persisted in multiple logistic regression analyses controlling for potential confounders.Patients with diabetes visiting U.S. physicians in 1995 and 1996 received somewhat more cardiovascular disease prevention services than patients without diabetes. Absolute rates of services, however, remained lower than desired based on national recommendations. Current evidence suggests that wider implementation of these recommendations can be expected to reduce the burden of cardiovascular disease in patients with diabetes.

    View details for Web of Science ID 000086631300002

    View details for PubMedID 10759996

  • Aspirin use is low among United States outpatients with coronary artery disease CIRCULATION Stafford, R. S. 2000; 101 (10): 1097-1101

    Abstract

    The goal of the present study was to assess national trends and patterns of aspirin use among outpatients with coronary artery disease. Although there is strong evidence that the use of aspirin reduces the risk of death and recurrent events in patients with coronary artery disease, current national patterns of aspirin use are unknown.We used data from the 1980 to 1996 National Ambulatory Medical Care Surveys. These surveys provide a nationally representative sample of physician activities during patient visits to physician offices. We evaluated the report of aspirin as a new or continuing medication in 10 942 visits to cardiologists and primary care physicians by patients with coronary artery disease. We evaluated trends in the use of aspirin for 1980 to 1996 and used logistic regression to identify independent predictors of aspirin use for 1993 to 1996. Aspirin use in outpatient visits by persons with coronary artery disease without reported contraindications increased from 5.0% in 1980 to 26.2% in 1996. Large increases occurred in the early 1990s. Independent predictors of aspirin use in 1993 to 1996 were male patient gender (29% versus 21% for females), patient age of <80 years (28% versus 17% for age of >/=80 years), and presence of hyperlipidemia (45% versus 24% for patients without hyperlipidemia; all comparisons P<0. 001). Cardiologists (37%) were more likely to report aspirin use than were internists (20%), family physicians (18%), or general practitioners (11%; P<0.001). These effects persisted after we controlled for potential confounders with the use of logistic regression.Although aspirin use in patients with coronary artery disease has increased dramatically, it remains suboptimum. Low rates of aspirin use and variations in use suggest a need to better translate clinical recommendations into practice.

    View details for Web of Science ID 000085857400014

    View details for PubMedID 10715254

  • Age-specific patterns of prostate-specific antigen testing among primary care physician visits. journal of family practice McNaughton Collins, M., Stafford, R. S., Barry, M. J. 2000; 49 (2): 169-172

    Abstract

    Early detection of prostate cancer is thought to be effective, and indirect evidence suggests that men aged 50 to 69 years will benefit most while those aged 70 and older will benefit least from it. The goal of our study was to describe usual care patterns for prostate-specific antigen (PSA) testing by primary care physicians in the United States.We analyzed office visits made by adult men to family physicians, general internists, general practitioners, and geriatricians recorded by the 1995 and 1996 National Ambulatory Medical Care Surveys. Our outcome measure was the probability of a primary care physician ordering a PSA test during a visit.Seventeen percent of the tests reported were among men aged younger than 50 years, 50% were for men aged 50 to 69 years, and 33% were for men aged 70 years and older. The frequency of PSA testing was highest during visits by men aged 60 to 64 years (7.1%), 65 to 69 years (7.0%), 70 to 74 years (7.0%), and 75 to 79 years (6.3%) but lower for men aged older than 80 years (3.1%).Our findings suggest that during the mid-1990s prostate cancer screening decisions by primary care physicians were not sensitive to patients' ages.

    View details for PubMedID 10718695

  • Age-specific patterns of prostate-specific antigen testing among primary care physician visits Meeting of the National-Society-of-General-Internal-Medicine Collins, M. M., Stafford, R. S., Barry, M. J. DOWDEN HEALTH MEDIA. 2000: 169?72

    View details for Web of Science ID 000087077900009

  • Stress testing: National patterns and predictors of test ordering 70th Scientific Session of the American-Heart-Association Cohen, M. C., Stafford, R. S., MISRA, B. MOSBY-ELSEVIER. 1999: 1019?24

    Abstract

    To determine predictors of ordering of exercise stress tests.Because exercise stress testing is routinely used and widely available and may have an effect on subsequent evaluation of and therapy for heart disease, understanding current patterns of ordering exercise stress tests may have important implications for national health care costs. We hypothesized that factors other than clinical condition exert an influence on ordering of exercise stress tests.Data from the 1991 and 1992 National Ambulatory Medical Care Surveys conducted by the National Center for Health Statistics were analyzed by means of multivariate logistic regression.In an estimated 1.12 billion adult visits to office-based physicians in the United States (95% confidence interval [CI], 1.07-1.16 billion), 6.2 million (95% CI, 4.8-7.6 million) exercise stress tests were ordered. After adjustment for clinical and nonclinical variables associated with the office visit, cardiologists were 3.7 (95% CI, 2.7-5.1) times more likely to order exercise stress tests than were internists, who were more likely to order an exercise stress test than were family and general practitioners (0.5, 95% CI, 0.3-0.7). Nonclinical factors associated with increased ordering of exercise stress tests included male sex (odds ratio 2.5; 95% CI, 2.0-3.2), white race (odds ratio 1.6; 95% CI, 1.1-2.3), new referral status (odds ratio 3.8; 95% CI, 2.5-5.8), and private insurance (odds ratio 1.4; 95% CI, 1.1-1.8). Medicare recipients were about half (95% CI, 0.4-0.9) as likely as other patients to have an exercise stress test ordered.Factors other than clinical condition exert an influence on ordering of exercise stress tests and may represent modifiable elements associated with appropriate practice.

    View details for Web of Science ID 000084053300009

    View details for PubMedID 10577430

  • Rates of US physicians counseling adolescents about smoking JOURNAL OF THE NATIONAL CANCER INSTITUTE Thorndike, A. N., Ferris, T. G., Stafford, R. S., Rigotti, N. A. 1999; 91 (21): 1857-1862

    Abstract

    The health care system provides an important opportunity for addressing tobacco use among youths, but there is little information about how frequently physicians discuss smoking with their adolescent patients. We analyzed data from the National Ambulatory Medical Care Surveys to assess the prevalence and the predictors of physicians' identification of smoking status and counseling about smoking at office visits by adolescents.From 1991 through 1996, 5087 physicians recorded data on 16 648 visits by adolescents aged 11-21 years. We determined the proportion of office visits at which physicians identified an adolescent's smoking status and counseled about smoking and then identified predictors of these outcomes with logistic regression. Statistical tests were two-sided.In 1991, physicians identified an adolescent's smoking status at 72.4% of visits but provided smoking counseling at only 1.6% of all adolescent visits and 16.9% of visits by adolescents identified as smokers. These proportions did not increase from 1991 through 1996. Compared with specialists, primary care physicians were more likely to identify smoking status (odds ratio [OR] = 1.70; 95% confidence interval [CI] = 1.53-1.89) and to counsel about smoking (OR = 3.43; 95% CI = 2.18-5.38). Patients with diagnoses of conditions potentially complicated by smoking were more likely to have their smoking status identified and to be counseled about smoking. Younger and nonwhite adolescents were less likely to be counseled about smoking than older and white teens.We found that physicians frequently identified adolescents' smoking status but rarely counseled them about smoking. Physicians' practices did not improve in the first half of the 1990s, despite a clear consensus about the importance of this activity and the publication of physician guidelines targeting this population. Physicians treating adolescents are missing opportunities to discourage tobacco use among teens.

    View details for Web of Science ID 000083491300016

    View details for PubMedID 10547392

  • Distinguishing chronic prostatitis and benign prostatic hyperplasia symptoms: Results of national survey of physician visits 93rd Annual Meeting of the American-Urological-Association Collins, M. M., Stafford, R. S., O'Leary, M. P., Barry, M. J. ELSEVIER SCIENCE INC. 1999: 921?25

    Abstract

    The morbidity of chronic prostatitis results from a constellation of genitourinary symptoms. A recent study classified 21 of these symptoms into three categories: pain, voiding complaints, and sexual dysfunction. Pain symptoms predominated among patients with prostatitis. Using data from a nationwide survey of physician visits, we examined the most common symptoms reported by men at chronic prostatitis visits and contrasted the results with visits for benign prostatic hyperplasia (BPH).We analyzed 81,034 visits by men (18 years and older) to office-based physicians of all specialties in the National Ambulatory Medical Care Surveys of 1990 to 1996, using sampling weights to make national estimates. U.S. physicians selected by random stratified sampling completed visit forms that included patients' reasons for visits and physicians' diagnoses.In 1990 to 1996, there were 765 visits (national estimate 1.5 million visits/yr; 95% confidence interval = 0.9 to 2.1) with a diagnosis of chronic prostatitis. Among chronic prostatitis visits, 20% were for pain, 19% for urinary symptoms, and 1% for sexual dysfunction. Among 2271 BPH visits, 2% were for pain, 33% for voiding complaints, and 1% for sexual dysfunction. The most common reason coded for chronic prostatitis visits was painful urination (14% of chronic prostatitis visits, but only 1.7% of BPH visits).Pain was slightly more common than voiding complaints, but much more common than sexual dysfunction among chronic prostatitis visits. The most common reason for chronic prostatitis visits was painful urination, which was uncommon among patients with BPH. Pain distinguished chronic prostatitis from BPH better than any other urinary symptom.

    View details for Web of Science ID 000079898200012

    View details for PubMedID 10223484

  • Trends in antihypertensive drug advertising, 1985-1996 CIRCULATION Wang, T. J., Ausiello, J. C., Stafford, R. S. 1999; 99 (15): 2055-2057

    Abstract

    Over the past decade, calcium channel blockers (CCBs) and ACE inhibitors have been used increasingly in the treatment of hypertension. In contrast, beta-blocker and diuretic use has decreased. It has been suggested that pharmaceutical marketing has influenced these prescribing patterns. No objective analysis of advertising for antihypertensive therapies exists, however.We reviewed the January, April, July, and October issues of the New England Journal of Medicine from 1985 to 1996 (210 issues). The intensity of drug promotion was measured as the proportion of advertising pages used to promote a given medication. Statistical analyses used the chi2 test for trend. Advertising for CCBs increased from 4.6% of advertising pages in 1985 to 26.9% in 1996, while advertising for beta-blockers (12.4% in 1985 to 0% in 1996) and diuretics (4.2% to 0%) decreased (all P<0.0001). A nonsignificant increase was observed in advertising for ACE inhibitors (3.5% to 4.3%, P=0.17). Although the total number of drug advertising pages per issue decreased from 60 pages in 1985 to 42 pages in 1996 (P<0.001), the number of pages devoted to calcium channel blocker advertisements nearly quadrupled.Increasing promotion of CCBs has mirrored trends in physician prescribing. An association between advertising and prescribing patterns could explain why CCBs have supplanted better-substantiated therapies for hypertension.

    View details for Web of Science ID 000079731500018

    View details for PubMedID 10209012

  • The duration of ambulatory visits to physicians JOURNAL OF FAMILY PRACTICE Blumenthal, D., Causino, N., Chang, Y. C., Culpepper, L., Marder, W., Saglam, D., Stafford, R., Starfield, B. 1999; 48 (4): 264-271

    Abstract

    The objective of our study was to determine the typical length of ambulatory visits to a nationally representative sample of primary care physicians, and the patient, physician, practice, and visit characteristics affecting duration of visit.We used an analysis of cross-sectional survey data to determine duration of visit and the characteristics associated with it. The data sources were a random sample of the 19,192 visits by adults to 686 primary care physicians contained in the 1991-1992 National Ambulatory Medical Care Survey, and the results of the Physician Induction Interview conducted by the National Center for Health Statistics. Duration of visit was defined as the total time spent in face-to-face contact with the physician.Mean duration of visit was 16.3 minutes (standard deviation = 9.7). Multivariate analysis allowed the calculation of the independent effect on visit length of a variety of characteristics of patients, physicians, organizational/practice setting, geographic location, and visit content. Certain patient characteristics (increasing age and the presence of psychosocial problems) were associated with increased duration of visit. Visit content was also associated with increased duration, including ordering or performing 4 or more diagnostic tests (71% increase), Papanicolaou smears (34%), ambulatory surgical procedures (34%), patient admission to the hospital (32%), and 3 preventive screening tests (25%). Reduced duration of visit was associated with availability of non-physician support personnel and health maintenance organization and Medicaid insurance.Multiple factors affect duration of visit. Clinicians, policymakers, and health system managers should take these considerations into account in managing physician resources during daily ambulatory practice.

    View details for Web of Science ID 000087076400003

    View details for PubMedID 10229250

  • Trends in adult visits to primary care physicians in the United States ARCHIVES OF FAMILY MEDICINE Stafford, R. S., Saglam, D., Causino, N., Starfield, B., Culpepper, L., Marder, W. D., Blumenthal, D. 1999; 8 (1): 26-32

    Abstract

    Although numerous changes are apparent in the US health care system, little is known about how these changes have altered the work of primary care physicians.We analyzed a nationally representative sample of 136,233 adult office visits to general internists, general practitioners, and family physicians contained in the 1978 through 1981, 1985, and 1989 through 1994 National Ambulatory Medical Care Surveys. Annual sample sizes varied between 5662 and 19,977 visits. Measures included the characteristics of patients presenting to primary care physicians, physician activities during these visits, and the disposition of the visits to primary care physicians.Visits to primary care physicians have diminished as a proportion of all adult visits from 52% in 1978 to 41% in 1994. Dramatic trends in adult primary care included the growing racial or ethnic diversity of patients, the doubling (since 1985) of health maintenance organization coverage, increased provision of prevention services, changes in the most common medications, and an 18% increase in the duration of adult visits to primary care physicians.Trends in primary care practice reflect changes in society and in the US health care system, including demographic changes, an emphasis on prevention, and the growth of managed care. The increasing role of managed care, with its emphasis on increased productivity, appears at odds with primary care physicians' increasing responsibility for prevention and the associated increase in the duration of primary care visits.

    View details for Web of Science ID 000079405100007

    View details for PubMedID 9932068

  • Specialty differences in cardiovascular disease prevention practices JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Stafford, R. S., Blumenthal, D. 1998; 32 (5): 1238-1243

    Abstract

    The aim of this study was to examine physician specialty differences in cardiovascular disease prevention practices.Despite the importance of cardiovascular disease prevention, little is known about current national practices, particularly physician specialty differences.Using a national survey of office visits, we evaluated differences in the propensity of physicians of different specialties to provide prevention services. We analyzed 30,929 adult visits to 1,521 physicians selected by stratified random sampling in the 1995 National Ambulatory Medical Care Survey. Standard and ordinal multiple logistic regression models were employed to estimate the independent effects of physician and patient characteristics.A variety of cardiovascular disease prevention services were provided during an estimated 547 million adult office visits to US physicians in 1995, including blood pressure measurement (50% of visits), cholesterol testing (5%) and counseling for exercise (12%), weight (6%), cholesterol (4%) and smoking (3%). In addition, medication management was reflected by the report of antihypertensives in 12% of visits and lipid-lowering medications in 2%. Across these eight services, propensity to provide services varied consistently with specialty. Controlling for patient and visit characteristics and compared to general internists, the likelihood of providing services was higher for cardiologists (adjusted odds ratio 1.65, 95% confidence interval 1.44 to 1.89) but lower for obstetrician/gynecologists (0.75, 0.68 to 0.82), family physicians (0.69, 0.64 to 0.74), general practitioners (0.58, 0.53 to 0.63), other medical specialists (0.65, 0.59 to 0.72) and surgeons (0.06, 0.05 to 0.06).Cardiologists have the greatest propensity to provide cardiovascular disease prevention services, while primary care physicians vary substantially in their practices. These findings suggest a need to address variations in cardiovascular disease prevention.

    View details for Web of Science ID 000076759600011

    View details for PubMedID 9809931

  • Rate control and sinus rhythm maintenance in atrial fibrillation - National trends in medication use, 1980-1990 ARCHIVES OF INTERNAL MEDICINE Stafford, R. S., Robson, D. C., MISRA, B., Ruskin, J., Singer, D. E. 1998; 158 (19): 2144-2148

    Abstract

    Little is known about national patterns of pharmacological treatment of atrial fibrillation, in particular, use of medications for ventricular rate control and for restoration and maintenance of sinus rhythm.We analyzed 1555 visits by patients with atrial fibrillation to randomly selected office-based US physicians included in National Ambulatory Medical Care surveys conducted in 1980, 1981, 1985, and 1989 through 1996. To determine national trends, we evaluated the proportion of atrial fibrillation visits with reported use of rate control medications (digoxin and antiarrhythmics in classes II and IV) and sinus rhythm medications (classes IA, IC, and III).The use of rate control agents decreased from 79% of atrial fibrillation visits in 1980-1981 to 62% in 1994-1996. Declining use was noted for both digoxin (76% in 1980-1981 to 53% in 1994-1996) and beta-blockers (19%-13%). After their introduction, the use of verapamil hydrochloride and diltiazem hydrochloride increased to 15% of atrial fibrillation visits in 1994-1996. Sinus rhythm agent use decreased from 18% of visits in 1980-1981 to 4% in 1992-1993 and then rose to 13% in 1994-1996. The use of class IA agents declined from 18% in 1980-1981 to 3.5% in 1992-1993 and then increased to 8% in 1994-1996. Quinidine remained the most widely used sinus rhythm medication, despite its declining share of this category. Newly available sotalol hydrochloride and amiodarone hydrochloride were used in 3.6% of visits in 1994-1996.Despite changes in the treatment of atrial fibrillation, digoxin remains the dominant rate control medication. Medications for sinus rhythm maintenance are not widely used. Quinidine use declined prominently in the 1980s, possibly because of concerns about proarrhythmic effects. The use of sinus rhythm agents, however, is now rising.

    View details for Web of Science ID 000076577500009

    View details for PubMedID 9801182

  • The declining impact of race and insurance status on hormone replacement therapy MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY Stafford, R. S., Saglam, D., Causino, N., Blumenthal, D. 1998; 5 (3): 140-144

    Abstract

    Socioeconomic barriers may limit the adoption of hormone replacement therapy, but little is known about recent trends in their influence. We evaluated trends in the impact of race and insurance status on national rates of hormone replacement therapy.We analyzed 32,608 physician office visits by nonpregnant women 40 years of age and older available from the 1989 through 1996 National Ambulatory Medical Care Surveys. The proportion of visits with new or continuing use of noncontraceptive estrogens reported was the main outcome measured. Multiple logistic regression was used to evaluate the independent effects of year, race, and expected payment source on hormone replacement therapy.Overall, the report of hormone replacement therapy increased from 5.7% of visits in 1989-1990 to 10.9% in 1995-1996. In 1989-1990, hormone replacement therapy was less likely in nonwhite women (3.6% vs. 6.3% for whites) and in women with Medicaid coverage (1.3% vs. 8.4% for privately insured women). These differences diminished over time, particularly for women without menopausal symptoms. In 1989-1990, the adjusted odds ratio of hormone replacement in women without menopausal symptoms was 0.31 (95% confidence interval 0.2-0.5) in nonwhites compared with whites, but increased to 0.57 (0.4-0.8) by 1995-1996. In 1989-1990, the adjusted odds ratio for hormone replacement among women with Medicaid was 0.31 (0.09-1.0) compared with those with private insurance. This ratio increased to 0.86 (0.5-1.4) by 1995-1996.Racial and payment source influences on hormone replacement therapy appeared to have lessened over time. Despite these changes substantial socioeconomic differences in treatment patterns remain to be addressed.

    View details for Web of Science ID 000075966600002

    View details for PubMedID 9774758

  • National patterns and predictors of beta-blocker use in patients with coronary artery disease ARCHIVES OF INTERNAL MEDICINE Wang, T. J., Stafford, R. S. 1998; 158 (17): 1901-1906

    Abstract

    Prior studies suggest underuse of beta-blockers in patients with coronary artery disease, but these studies have been based on selected populations of recently hospitalized patients.To describe national patterns and determinants of beta-blocker use in the ambulatory setting.We analyzed 11745 visits by patients with coronary artery disease to randomly selected, office-based physicians in the National Ambulatory Medical Care Surveys for 1980, 1981, 1985, and 1989 through 1996. We used multiple logistic regression to determine the independent effect of sociodemographic and clinical factors on beta-blocker use.Beta-blocker use at patient visits.Beta-blocker use was reported in only 20.9% of office visits by patients with coronary artery disease and no strong contraindications between 1993 and 1996. In multivariate analyses, age younger than 75 years, residence in the Northeast, and visits to cardiologists and internists compared with family and general practitioners predicted greater use of beta-blocker therapy. White race and private insurance also were significant predictors of beta-blocker use between 1980 and 1996. Longitudinal analyses revealed a significant decline in beta-blocker use from 1980 to 1990, followed by a gradual increase in recent years.Beta-blockers appear to be underused in ambulatory patients with coronary artery disease. Our data suggest that nonclinical factors may influence rates of use, indicating the need for closer scrutiny of variations in physician prescribing practices.

    View details for Web of Science ID 000076166800006

    View details for PubMedID 9759686

  • National trends in the use of antibiotics by primary care physicians for adult patients with cough 20th Annual Meeting of the Society-of-General-Internal-Medicine Metlay, J. P., Stafford, R. S., Singer, D. E. AMER MEDICAL ASSOC. 1998: 1813?18

    Abstract

    Increased antibiotic use for outpatient illnesses has been identified as an important determinant of the recent rise in antibiotic resistance among common respiratory pathogens. Efforts to reduce the inappropriate use will need to be evaluated against current trends in the outpatient use of antibiotics.To examine national trends in the use of antibiotics by primary care physicians in the care of adult patients with cough and identify patient factors that may influence antibiotic use for these patients.This study was based on a serial analysis of results from all National Ambulatory Medical Care Surveys beginning in 1980 (when therapeutic drug use was first recorded) to 1994 (the most recent survey year available). These surveys are a random sampling of visits to US office-based physicians in 1980, 1981, 1985, and annually from 1989-1994. Eligible visits included those by adults presenting to general internists, family practitioners, or general practitioners with a chief complaint of cough. A total of 3416 visits for cough were identified over the survey years. Survey results were extrapolated, based on sampling weights in each year, to project national rates of antibiotic use for patients with cough. Additional analyses examined the rates of antibiotic use stratified by patient age, race, and clinical diagnosis.Overall, an antibiotic was prescribed 66% of the time during office visits for patients with cough: 59% of patient visits in 1980 rising to 70% of visits in 1994 (P = .002 for trend). In every study year, white, non-Hispanic patients and patients younger than 65 years were more likely to receive antibiotics compared with nonwhite patients and patients 65 years or older, respectively.The rate of antibiotic use by primary care physicians for patients with cough remained high from 1980 to 1994, and was influenced by nonclinical characteristics of patients.

    View details for Web of Science ID 000075829200011

    View details for PubMedID 9738612

  • Recent national patterns of warfarin use in atrial fibrillation CIRCULATION Stafford, R. S., Singer, D. E. 1998; 97 (13): 1231-1233

    Abstract

    Studies of selected populations suggest that anticoagulation in atrial fibrillation is underused and that nonclinical factors influence the use of this stroke-preventing therapy. We wished to examine recent national trends and predictors of warfarin sodium use in atrial fibrillation.A nationally representative sample of office visits from the 1989 to 1996 National Ambulatory Medical Care Surveys was used. We selected 1125 visits by patients with atrial fibrillation, including 877 visits to cardiologists and primary care physicians in which apparent contraindications for anticoagulation were absent. The principal outcome measure was the proportion of visits with warfarin reported. We analyzed trends in warfarin use and statistically evaluated the predictors of warfarin use. Warfarin use increased from 13% of atrial fibrillation visits in 1989 to 40% in 1993 (P for trend <.001) in patients without contraindications. Between 1993 and 1996, however, there was no change in warfarin use. Independent of other factors, warfarin was significantly more likely to be reported in patients with a history of stroke and in patients residing outside of the South.Warfarin use in atrial fibrillation has not increased recently, indicating inadequate implementation of this highly effective therapy. Barriers to anticoagulation in real-world clinical practice need to be identified and addressed.

    View details for Web of Science ID 000072936900005

    View details for PubMedID 9570191

  • How common is prostatitis? A national survey of physician visits 92nd Annual Meeting of the American-Urological-Association Collins, M. M., Stafford, R. S., O'Leary, M. P., Barry, M. J. ELSEVIER SCIENCE INC. 1998: 1224?28

    Abstract

    We used a national data base to explore the epidemiology of physician visits for genitourinary symptoms or a diagnosis of prostatitis.We analyzed 58,955 visits by men 18 years old or older to office based physicians of all specialties, as included in the National Ambulatory Medical Care Surveys from 1990 to 1994. Physicians selected by random sampling completed visit forms that included information on patient reasons for visits and physician diagnoses.From 1990 to 1994, 5% of all ambulatory visits by men 18 years old or older included genitourinary symptoms as a reason for the visit. In almost 2 million visits annually prostatitis was listed as a diagnosis, including 0.7 million by men 18 to 50 years old and 0.9 million by those older than 50 years. Of the prostatitis visits 46 and 47% were to urologists and primary care physicians, respectively. A prostatitis diagnosis was assigned at 8 and 1% of all urologist and primary care physician visits, respectively. The odds of a prostatitis diagnosis were 13-fold greater at visits to urologists compared with visits to primary care physicians, and approximately 2-fold greater in the south than in the northeast. Surprisingly, compared with men 66 years old or older, prostatitis was more commonly diagnosed in men 36 to 65 than men 18 to 35 years old. When a prostatitis diagnosis was given, antimicrobial use was likely to be reported 45% of the time for men with and 27% for those without genitourinary symptoms. Visits to primary care physicians were more often associated with antimicrobial use than visits to urologists.Genitourinary symptoms are a frequent reason for office visits by younger and older men, and prostatitis is a common diagnosis. Despite a report that less than 10% of prostatitis cases are bacterial, a much higher proportion of men in whom prostatitis is diagnosed receive antimicrobials.

    View details for Web of Science ID 000072442700036

    View details for PubMedID 9507840

  • Changes in the daily practice of primary care for children ARCHIVES OF PEDIATRICS & ADOLESCENT MEDICINE Ferris, T. G., Saglam, D., Stafford, R. S., Causino, N., Starfield, B., Culpepper, L., Blumenthal, D. 1998; 152 (3): 227-233

    Abstract

    The environment in which medicine is practiced has changed in the past 2 decades, but little information has been available on how the day-to-day practice of primary care for children has changed during this period.To identify aspects of primary care practices for children that are undergoing substantial changes.Analysis of National Ambulatory Medical Care Surveys from 1979 to 1981, 1985, and 1989 to 1994.Primary care practitioners recorded data on 58,488 child visits. MAIN OUT COME MEASURES: Characteristics and insurance status of children, physician activities during visits, and disposition after visit.Child visits to primary care physicians increased by 22% between 1979 and 1994. The mean age of children visiting primary care physicians decreased from 6.7 years in 1979 to 5.7 years in 1994 (P for trend, < .001). The ethnic diversity of child visits increased primarily as a result of an increasing proportion of visits by Hispanic (6.0% in 1979 to 12.6% in 1994, P for trend, < .001) and Asian patients (1.6% in 1979 to 4.1% in 1994, P for trend, < .001). Medicaid and managed care increased dramatically as sources of payment. Changes in physician activities included an increase in some preventive services, changes in the most commonly encountered medications, and an increased mean duration of patient visits (11.8 minutes in 1979 to 14.2 minutes in 1994, P for trend, < .001).These data may assist in the development of educational and research initiatives for physicians caring for children. The declining proportion of adolescent visits may present physicians with challenges in the care of adolescents. Physician prescribing practices showed changes without evidence of a benefit to child health. The increased ethnic diversity and provision of preventive services were associated with an increased mean duration of primary care visits. The increased duration of child visits may conflict with the managed care emphasis on physician productivity.

    View details for Web of Science ID 000072519500003

    View details for PubMedID 9529458

  • National patterns in the treatment of smokers by physicians JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Thorndike, A. N., Rigotti, N. A., Stafford, R. S., Singer, D. E. 1998; 279 (8): 604-608

    Abstract

    Routine treatment of smokers by physicians is a national health objective for the year 2000, a quality measure for health care plans, and the subject of evidence-based clinical guidelines. There are few national data on how physicians' practices compare with these standards.To assess recent trends in the treatment of smokers by US physicians in ambulatory care and to determine whether physicians' practices meet current standards.Analysis of 1991-1995 data from the National Ambulatory Medical Care Survey, an annual survey of a random sample of US office-based physicians.Physicians' offices.A total of 3254 physicians recorded data on 145716 adult patient visits.The proportion of visits at which physicians (1) identified a patient's smoking status, (2) counseled a smoker to quit, and (3) used nicotine replacement therapy.Smoking counseling by physicians increased from 16% of smokers' visits in 1991 to 29% in 1993 (P<.001) and then decreased to 21% of smokers' visits in 1995 (P<.001). Nicotine replacement therapy use followed a similar pattern, increasing from 0.4% of smokers' visits in 1991 to 2.2% in 1993 (P<.001) and decreasing to 1.3% of smokers' visits in 1995 (P=.007). Physicians identified patients' smoking status at 67% of all visits in 1991; this proportion did not increase over time. Primary care physicians were more likely to provide treatment to smokers than were specialists. All physicians were more likely to treat patients with smoking-related diagnoses.US physicians' treatment of smokers improved little in the first half of the 1990s, although a transient peak in counseling and nicotine replacement use occurred in 1993 after the introduction of the nicotine patch. Physicians' practices fell far short of national health objectives and practice guidelines. In particular, patient visits for diagnoses not related to smoking represent important missed opportunities for intervention.

    View details for Web of Science ID 000072041900036

    View details for PubMedID 9486755

  • National patterns of angiotensin-converting enzyme inhibitor use in congestive heart failure 69th Annual Scientific Session of the American-Heart-Association Stafford, R. S., Saglam, D., Blumenthal, D. AMER MEDICAL ASSOC. 1997: 2460?64

    Abstract

    While the use of angiotensin-converting enzyme (ACE) inhibitors for patients with congestive heart failure (CHF) is supported by the results of clinical trials and expert guidelines, national physician practices are unknown.We analyzed 1529 physician office visits by patients with CHF available from the 1989 through 1994 National Ambulatory Medical Care Surveys. We examined changes over time in the use of ACE inhibitors and use of other medications for CHF. Potential clinical and nonclinical predictors of use of ACE inhibitors were evaluated using multiple logistic regression.The prevalence of CHF increased from 0.9% of all office visits in 1989 to 1.1% in 1994. Use of ACE inhibitors increased from 24% in visits by patients with CHF in 1989 to 31% in 1994 (P = .02). From 1989 through 1994, use of ACE inhibitors was more likely in visits to cardiologists (46% vs 22% for all other physicians), in the Midwest (31% vs 24% in all other regions), in whites (27% vs 21% in nonwhites), in privately insured patients (31% vs 24% in all others), and in men (29% vs 23% in women). Multiple logistic regression analysis showed independent effects of specialty, region, and sex. Other medications commonly used for patients with CHF included diuretics (62% of visits for 1989-1994), digoxin (38%), and calcium channel antagonists (15%). Use of diuretics showed no significant trend between 1989 and 1994, whereas use of digoxin decreased significantly.The low rates of use of ACE inhibitors in patients with CHF and the wide variations in their use suggest a need to move beyond clinical trials and focus attention on modifying physician practices.

    View details for Web of Science ID A1997YH22200007

    View details for PubMedID 9385297

  • The impact of cancer on the physical function of the elderly and their utilization of health care CANCER Stafford, R. S., Cyr, P. L. 1997; 80 (10): 1973-1980

    Abstract

    Controversy about whether cancer has an independent impact on patient quality of life led the authors to evaluate the effects of cancer on a range of quality-of-life and health care utilization measures within an elderly population.The authors analyzed a nationally representative sample of 9745 elderly community-based Medicare beneficiaries sampled in the 1991 Medicare Current Beneficiary Survey. Of these, 1647 reported being diagnosed by a physician as having a malignancy that was not of the skin. Multiple logistic regression was used to identify the independent predictors of functional limitation, poor health status, health care utilization, and patient satisfaction with medical care.Cancer was reported by 17% of the elderly. Individuals with cancer reported poorer health, more limitations of the activities of daily living (ADLs) and the instrumental activities of daily living (IADLs), and greater health care utilization than individuals without cancer. For individuals with cancer, difficulty walking (38%) and getting out of a chair (21%) were the most commonly reported ADL limitations, whereas difficulty completing heavy housework (34%) and shopping (17%) were the most common IADL limitations. Carcinomas of the lung, prostate, and colon independently predicted poorer health status. Lung carcinoma was independently associated with more ADL limitations. Lung, bladder, and prostate carcinomas predicted increased health care utilization. Overall, cancer patients were at least as satisfied with their medical care as those without cancer.Cancer increased the use of health care resources and modestly reduced physical function. By identifying specific connections between cancer and physical function, these findings have implications for improving cancer care.

    View details for Web of Science ID A1997YE28600015

    View details for PubMedID 9366301

  • Low rates of hormone replacement in visits to United States primary care physicians 59th Annual Meeting of the South-Atlantic-Association-of-Obstetricians-and-Gynecologists Stafford, R. S., Saglam, D., Causino, N., Blumenthal, D. MOSBY-ELSEVIER. 1997: 381?87

    Abstract

    Our objective was to determine national rates and predictors of hormone replacement therapy. We analyzed a nationally representative sample of 6341 office visits by women aged > or = 40 years to primary care physicians in the 1993 and 1994 National Ambulatory Medical Care Surveys. Independent predictors of estrogen use were determined by logistic regression. Time trends from 1989 through 1994 also were evaluated. Hormone replacement therapy was documented in 4.7% of visits in 1989 to 1990 and 8.0% in 1993 to 1994. In 1993 to 1994 women with menopausal symptoms were six times more likely to have hormone replacement reported. In the absence of symptoms, obstetrician-gynecologists were nearly four times as likely to report hormone replacement therapy. Age 50 to 59 years, white race, osteoporosis, hyperlipidemia, and residence in the West and in nonmetropolitan areas also independently-predicted hormone replacement. Low rates of estrogen therapy by non-obstetrician-gynecologists and substantial practice variations suggest missed opportunities for hormone replacement therapy.

    View details for Web of Science ID A1997XU86500036

    View details for PubMedID 9290455

  • Variations in cholesterol management practices of US physicians JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Stafford, R. S., Blumenthal, D., Pasternak, R. C. 1997; 29 (1): 139-146

    Abstract

    This study sought to evaluate national cholesterol management practices of U.S. physicians.Past studies show that nonclinical factors affect physician practices. We tested the hypothesis that physician and patient characteristics influence cholesterol management.We used a stratified, random sample of 2,332 office-based physicians providing 56,215 visits to adults in the 1991-1992 National Ambulatory Medical Care Surveys. We investigated physicians' reporting of cholesterol-related screening, counseling or medications during office visits and used multiple logistic regression to assess independent predictors.An estimated 1.12 billion adult office visits occurred in 1991 and 1992 (95% confidence interval 1.06 to 1.18 billion). For the 1.03 billion visits by patients without reported hyperlipidemia, cholesterol screening (2.8% of visits) and counseling (1.2%) were not frequent. The likelihood of screening increased with older age, cardiovascular disease risk factors, white race and private insurance. We estimate that only 1 in 12 adults received cholesterol screening annually. In the 85 million visits by patients with hyperlipidemia, cholesterol testing was reported in 22.9%, cholesterol counseling in 34.4% and lipid-lowering medications in 23.1%. Testing was more likely in diabetic and nonobese patients. Counseling was more likely with younger age, cardiovascular disease and private insurance. Medications use was associated with cardiovascular disease, Northeast region of the United States, nonobese patients and visits to internists. Physician practices did not differ by patient gender.Although clinical conditions strongly influence cholesterol management, the appropriateness of variations noted by payment source, geographic region and physician specialty deserve further evaluation. These variations and the low estimated volume of services suggest that physicians have not fully adopted recommended cholesterol management practices.

    View details for Web of Science ID A1997WB90200020

    View details for PubMedID 8996306

  • National patterns of warfarin use in atrial fibrillation ARCHIVES OF INTERNAL MEDICINE Stafford, R. S., Singer, D. E. 1996; 156 (22): 2537-2541

    Abstract

    Despite consensus that patients with atrial fibrillation benefit from warfarin sodium anticoagulation, little is known about national trends and predictors of anticoagulant use.We analyzed 1062 visits by patients with atrial fibrillation to randomly selected office-based physicians included in the National Ambulatory Medical Care Surveys in 1980, 1981, 1985, and 1989 through 1993. Warfarin and aspirin use in these patients was extrapolated to national patterns and logistic regression was used to determine independent predictors.Patients with atrial fibrillation made an estimated 1.3 (1980) to 3.1 (1992) million annual visits to physicians. Warfarin use in atrial fibrillation increased from 7% in 1980 and 1981 to 32% in 1992 and 1993 (P < .001 for trend). In 1992 and 1993, patients 80 years or older were significantly less likely to be taking warfarin (19%) compared with younger patients (36%), but showed similar rates of increase from 1980 and 1981 to 1992 and 1993. In 1992 and 1993, anticoagulation therapy was significantly more likely to be reported in visits to cardiologists (32%) and general internists (40%) compared with general and family practitioners (15%), but was similar in women (34%) and men (30%). Residents of the South (16%) had significantly lower rates of warfarin use than those in other regions of the United States (36%). Aspirin use increased from 3% to 10% (P = .001 for trend) and showed little overlap with warfarin use. Multiple logistic regression indicated that more recent year, residence outside the South, patient aged 65 to 74 years, and visits to cardiologists and internists increased the likelihood of warfarin use.Anticoagulant use for atrial fibrillation has increased dramatically. The substantial increase from 1989 and 1990 to 1992 and 1993 coincided with the publication of several randomized clinical trials reporting the benefits of warfarin. Although it is unrealistic to expect universal warfarin use, the 1992 and 1993 rate of 32% is probably suboptimal given the benefit of anticoagulation in preventing embolic strokes. The oldest patients, in whom warfarin may have its greatest benefit, appear to have the lowest rates of anticoagulant use.

    View details for Web of Science ID A1996VX01300003

    View details for PubMedID 8951296

  • TRENDS IN CESAREAN-SECTION USE IN CALIFORNIA, 1983 TO 1990 AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY Stafford, R. S., Sullivan, S. D., Gardner, L. B. 1993; 168 (4): 1297-1302

    Abstract

    Our aim was to assess recent trends in cesarean section use in California.California discharge abstract data on hospital deliveries in 1983 through 1990 (379,759 to 587,508 annual deliveries) were used to analyze time trends by indication, age, race, and payment source.California cesarean section rates increased annually from 21.8% in 1983 to 25.0% in 1987 and then decreased to 22.7% by 1990. Similar patterns were noted for all age and race or ethnicity groups. Primary cesarean section rates increased from 15.2% in 1983 to 17.9% in 1987, then decreased to 16.2% by 1990. Declines in repeat cesarean section rates continued throughout 1983 through 1990, accelerating after 1987. For both primary and repeat cesarean section rates, time trends after mid-1987 were significantly different than those for 1983 to 1987.After increasing from 1983 to 1987, California cesarean section rates declined from 1988 to 1990. Existing payment source differences in cesarean section use increased in magnitude from 1983 to 1990, with privately insured women consistently having the highest cesarean section rates.

    View details for Web of Science ID A1993KY81300031

    View details for PubMedID 8475978

  • HIV infection among patients in U.S. acute care hospitals. Strategies for the counseling and testing of the hospital patients. The Hospital HIV Surveillance Group. New England journal of medicine Janssen, R. S., St Louis, M. E., Satten, G. A., Critchley, S. E., Petersen, L. R., Stafford, R. S., Ward, J. W., Hanson, D. L., Olivo, N., Schable, C. A. 1992; 327 (7): 445-452

    Abstract

    Routine, voluntary testing of hospital patients for the human immunodeficiency virus (HIV) has been proposed in order to identify those with early HIV infection in a setting where there is ready access to counseling, appropriate clinical referral, evaluation, and therapy. We studied the pattern of HIV infection among patients in 20 U.S. hospitals, in order to evaluate possible national strategies for the routine, voluntary HIV counseling and testing of hospital patients.Blood specimens remaining after clinical use from a systematically selected sample of patients at 20 hospitals in 15 U.S. cities were tested anonymously for antibody to HIV type 1 (HIV-1). Multivariate regression was used to determine which variables best predicted HIV seroprevalence in individual hospitals. Using these data, we estimated the number of HIV-positive patients in all U.S. hospitals and considered the efficiency of routine counseling and testing in different subgroups of patients and hospitals.From September 1989 through October 1991, 9286 of 195,829 specimens (4.7 percent) were positive for HIV-1 in the 20 hospitals. The seroprevalence of HIV at these institutions ranged from 0.2 percent to 14.2 percent. Among HIV-positive patients, 32 percent had symptomatic HIV infection or the acquired immunodeficiency syndrome (AIDS) at the time of admission or evaluation. In the 20 hospitals, HIV seroprevalence was 10.4 times (95 percent confidence interval, 8.8 to 12.0) the AIDS-diagnosis rate (the annual number of patients with new diagnoses of AIDS per 1000 discharges in 1990). In a multivariate model that included 13 hospital-specific variables, only the AIDS-diagnosis rate was associated with the hospital-specific HIV-seroprevalence rate (P less than 0.001). Using these data and the AIDS-diagnosis rates for all U.S. acute care hospitals, we estimated that 225,000 HIV-positive persons were hospitalized (95 percent confidence interval, 190,000 to 260,000) in all 5558 such hospitals in 1990, including 163,000 persons presenting with conditions other than HIV or AIDS (95 percent confidence interval, 130,000 to 196,000). In 1990, in 593 U.S. hospitals with AIDS-diagnosis rates of 1.0 or more per 1000 discharges, HIV testing of patients 15 to 54 years old (3 million patients, or 12.0 percent of all patients in U.S. acute care hospitals) would have identified an estimated 68 percent of all HIV-positive patients (110,000 patients) who were admitted with conditions other than symptomatic HIV infection or AIDS.We estimate that about 225,000 HIV-positive persons were hospitalized in 1990, of whom only one third were admitted for symptomatic HIV infection or AIDS. Routine, voluntary HIV testing of patients 15 to 54 years old in hospitals with 1 or more patients with newly diagnosed AIDS per 1000 discharges per year could potentially have identified as many as 110,000 patients with HIV infection that was previously unrecognized.

    View details for PubMedID 1625734

  • HIV-INFECTION AMONG PATIENTS IN UNITED-STATES ACUTE CARE HOSPITALS - STRATEGIES FOR THE COUNSELING AND TESTING OF HOSPITAL PATIENTS NEW ENGLAND JOURNAL OF MEDICINE Janssen, R. S., STLOUIS, M. E., Satten, G. A., Critchley, S. E., Petersen, L. R., Stafford, R. S., Ward, J. W., Hanson, D. L., Olivo, N., Schable, C. A., Dondero, T. J. 1992; 327 (7): 445-452

    View details for Web of Science ID A1992JH34000001

  • THE IMPACT OF NONCLINICAL FACTORS ON REPEAT CESAREAN-SECTION JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Stafford, R. S. 1991; 265 (1): 59-63

    Abstract

    Nonclinical factors, including the setting in which health care takes place, influence clinical decisions. This research measures the independent effects of organizational and socioeconomic factors on repeat cesarean section use in California. Of 45,425 births to women with previous cesarean sections in 1986, vaginal birth after cesarean section occurred in 10.9%. Sizable nonclinical variations were noted. By hospital ownership, rates ranged from 4.9% (for-profit hospitals) to 29.2% (University of California). Variations also existed by hospital teaching level (nonteaching hospitals, 7.0%, vs formalized teaching hospitals, 23.3%); payment source (private insurance, 8.1%, vs indigent services, 25.2%); and obstetric volume (low-volume hospitals, 5.4%, vs high-volume hospitals, 16.6%). Multiple logistic regression demonstrated that these variables had independent effects after accounting for their overlapping influences and the effects of patient characteristics. The observed variations demonstrate the prominence of nonclinical factors in decision making and question the clinical appropriateness of current practice patterns.

    View details for Web of Science ID A1991EP55500028

    View details for PubMedID 1984126

  • RECENT TRENDS IN CESAREAN-SECTION USE IN CALIFORNIA WESTERN JOURNAL OF MEDICINE Stafford, R. S. 1990; 153 (5): 511-514

    Abstract

    Cesarean section use in the United States has increased to 24.7% of deliveries in 1988 and is the most common hospital surgical procedure. California cesarean section rates were examined to measure recent trends in obstetric practices and to project future patterns of cesarean section use. Using discharge abstracts from 1983 to 1987 California hospital deliveries, total cesarean section rates were found to increase from nearly 22% in 1983 to 25% in 1987, an increase of 15%. Using a series of least-squares regression models, time trends in the distribution of indications associated with cesarean section among all deliveries and indication-specific cesarean section rates were evaluated. Increases in the number of women with previous cesarean section and fetal distress contributed to rising cesarean section rates. In addition, indication-specific cesarean section rates increased for breech presentation and dystocia. These trends were counterbalanced, in part, by declining rates of repeat cesarean sections. Trends noted for July 1985 through 1987 did not differ substantially from those observed for January 1983 to June 1985, suggesting that recent policy attempts to alter cesarean section use have not had a measurable effect on existing trends. Projections suggest that California cesarean section rates will rise to a level of 34% by the year 2000.

    View details for Web of Science ID A1990EH94600004

    View details for PubMedID 2260286

  • CESAREAN-SECTION USE AND SOURCE OF PAYMENT - AN ANALYSIS OF CALIFORNIA HOSPITAL DISCHARGE ABSTRACTS AMERICAN JOURNAL OF PUBLIC HEALTH Stafford, R. S. 1990; 80 (3): 313-315

    Abstract

    This study assessed the relation between payment source and cesarean section use by analyzing California data on hospital deliveries. Of 461,066 deliveries in 1986, cesarean sections were performed in 24.4 percent. Women with private insurance had the highest cesarean section rates (29.1 percent). Successively lower rates were observed for women covered by non-Kaiser health maintenance organizations (26.8 percent), Medi-Cal (22.9 percent), Kaiser (19.7 percent), self-pay (19.3 percent), and Indigent Services (15.6 percent). Vaginal birth after cesarean (VBAC) occurred more than twice as frequently in women covered by Kaiser (19.9 percent) and Indigent Services (24.8 percent), compared to those with private insurance (8.1 percent). Sizable, although less pronounced, associations between payment source and cesarean section use were noted for the indications of breech presentation, dystocia, and fetal distress. Accounting for maternal age and race/ethnicity did not alter these findings. Variations in the use of cesarean section have a substantial financial impact on health care payors.

    View details for Web of Science ID A1990CU30000014

    View details for PubMedID 2305912

  • ALTERNATIVE STRATEGIES FOR CONTROLLING RISING CESAREAN-SECTION RATES JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Stafford, R. S. 1990; 263 (5): 683-687

    Abstract

    Cesarean section rates in the United States have increased from 5.5% in 1970 to 24.4% in 1987. This dramatic increase has generated considerable concern, leading to a variety of proposals to control rising use of cesarean section. Six strategies have been adopted or proposed to reduce cesarean section use: (1) education and peer evaluation, (2) external review, (3) public dissemination of cesarean section rates, (4) changes in physician payment, (5) changes in hospital payment, and (6) medical malpractice reform. These strategies differ in their specific assumptions regarding the process of clinical decision making, implications for physician autonomy, and methods of implementation. Educational efforts have been the most widely promoted. Of these, formal programs aimed at modifying practices within individual hospitals appear to be the most successful. However, insufficient research has been conducted to compare conclusively the impact and feasibility of these six strategies, pointing to the need for further study.

    View details for Web of Science ID A1990CK53300033

    View details for PubMedID 2296123

  • SOCIOECONOMIC DIFFERENCES IN RATES OF CESAREAN-SECTION NEW ENGLAND JOURNAL OF MEDICINE Gould, J. B., Davey, B., Stafford, R. S. 1989; 321 (4): 233-239

    Abstract

    Increasing cesarean-section rates have focused attention on variations in the use of this procedure that appear to be independent of medical indication. We investigated the relation between the rate of primary cesarean section and socioeconomic status in a cohort of 245,854 singleton infants born to non-Hispanic white, black, Asian-American, and Mexican-American residents of Los Angeles County, California. On the basis of birth-certificate data for 1982 and 1983, a significant relation, independent of maternal age, parity, or birth weight, was found between the rates of primary cesarean section and socioeconomic status. Women who lived in census tracts with a median family income of more than $30,000 had a primary cesarean-section rate of 22.9 percent, as compared with 13.2 percent among women residing in areas with a median family income under $11,000. In women between the ages of 18 and 34, the incidence of reported complications of pregnancy or childbirth in the lowest-income group was 10.9 percent, as compared with 17.4 percent in the highest-income group (accounting for 42 percent of the difference in the rate of primary cesarean section between groups); the rate of primary cesarean section in the presence of complications in these two groups was 65.4 percent and 79.3 percent (accounting for 17 percent of the difference); and the primary rate in the absence of reported complications in these two groups was 6.4 percent and 10.5 percent (accounting for 41 percent of the difference). The rates of primary cesarean section were highest among non-Hispanic whites (20.6 percent), intermediate among Asian Americans (19.2 percent) and blacks (18.9 percent), and lowest among Mexican Americans (13.9 percent). Significant socioeconomic differences in these rates were observed in all four groups (P less than 0.01). We conclude that the rates of primary cesarean section vary directly with socioeconomic status and that this association cannot be accounted for by differences in maternal age, parity, birth weight, race, ethnic group, or complications of pregnancy or childbirth.

    View details for Web of Science ID A1989AG41100006

    View details for PubMedID 2747759

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