David Studdert

All Publications

• Waiting for data: Barriers to executing data use agreements. Science (New York, N.Y.) Mello, M. M., Triantis, G., Stanton, R., Blumenkranz, E., Studdert, D. M. 2020; 367 (6474): 150–52

  View details for DOI 10.1126/science.aaz7028

  View details for PubMedID 31919212

• Complaint risk among mental health practitioners compared with physical health practitioners: a retrospective cohort study of complaints to health regulators in Australia. BMJ open Veness, B. G., Tibble, H., Grenyer, B. F., Morris, J. M., Spittal, M. J., Nash, L., Studdert, D. M., Bismark, M. M. 2019; 9 (12): e030525

  Abstract

  OBJECTIVES: To understand complaint risk among mental health practitioners compared with physical health practitioners.DESIGN: Retrospective cohort study, using incidence rate ratios (IRRs) to analyse complaint risk and a multivariate regression model to identify predictors of complaints.SETTING: National study using complaints data from health regulators in Australia.PARTICIPANTS: All psychiatrists and psychologists ('mental health practitioners') and all physicians, optometrists, physiotherapists, osteopaths and chiropractors ('physical health practitioners') registered to practice in Australia between 2011 and 2016.OUTCOME MEASURES: Incidence rates, source and nature of complaints to regulators.RESULTS: In total, 7903 complaints were lodged with regulators over the 6-year period. Most complaints were lodged by patients and their families. Mental health practitioners had a complaint rate that was more than twice that of physical health practitioners (complaints per 1000 practice years: psychiatrists 119.1 vs physicians 48.0, p<0.001; psychologists 21.9 vs other allied health 7.5, p<0.001). Their risk of complaints was especially high in relation to reports, records, confidentiality, interpersonal behaviour, sexual boundary breaches and the mental health of the practitioner. Among mental health practitioners, male practitioners (psychiatrists IRR: 1.61, 95%CI 1.39 to 1.85; psychologists IRR: 1.85, 95% CI 1.65 to 2.07) and older practitioners (≥65 years compared with 36-45 years: psychiatrists IRR 2.37, 95%CI 1.95 to 2.89; psychologists IRR 1.78, 95%CI 1.47 to 2.14) were at increased risk of complaints.CONCLUSIONS: Mental health practitioners were more likely to be the subject of complaints than physical health practitioners. Areas of increased risk are related to professional ethics, communication skills and the health of mental health practitioners themselves. Further research could usefully explore whether addressing these risk factors through training, professional development and practitioner health initiatives may reduce the risk of complaints about mental health practitioners.

  View details for DOI 10.1136/bmjopen-2019-030525

  View details for PubMedID 31874871

• Assembly of the LongSHOT cohort: public record linkage on a grand scale. Injury prevention : journal of the International Society for Child and Adolescent Injury Prevention Zhang, Y., Holsinger, E. E., Prince, L., Rodden, J. A., Swanson, S. A., Miller, M. M., Wintemute, G. J., Studdert, D. M. 2019

  Abstract

  BACKGROUND: Virtually all existing evidence linking access to firearms to elevated risks of mortality and morbidity comes from ecological and case-control studies. To improve understanding of the health risks and benefits of firearm ownership, we launched a cohort study: the Longitudinal Study of Handgun Ownership and Transfer (LongSHOT).METHODS: Using probabilistic matching techniques we linked three sources of individual-level, state-wide data in California: official voter registration records, an archive of lawful handgun transactions and all-cause mortality data. There were nearly 28.8 million unique voter registrants, 5.5 million handgun transfers and 3.1 million deaths during the study period (18 October 2004 to 31 December 2016). The linkage relied on several identifying variables (first, middle and last names; date of birth; sex; residential address) that were available in all three data sets, deploying them in a series of bespoke algorithms.RESULTS: Assembly of the LongSHOT cohort commenced in January 2016 and was completed in March 2019. Approximately three-quarters of matches identified were exact matches on all link variables. The cohort consists of 28.8million adult residents of California followed for up to 12.2 years. A total of 1.2million cohort members purchased at least one handgun during the study period, and 1.6million died.CONCLUSIONS: Three steps taken early may be particularly useful in enhancing the efficiency of large-scale data linkage: thorough data cleaning; assessment of the suitability of off-the-shelf data linkage packages relative to bespoke coding; and careful consideration of the minimum sample size and matching precision needed to support rigorous investigation of the study questions.

  View details for DOI 10.1136/injuryprev-2019-043385

  View details for PubMedID 31662345

• Valuations of Surgical Procedures in the Medicare Fee Schedule Reply NEW ENGLAND JOURNAL OF MEDICINE Chan, D. C., Huynh, J., Studdert, D. M. 2019; 381 (4): 391

  View details for Web of Science ID 000477993600026

• Characteristics of Lawyers Who Are Subject to Complaints and Misconduct Findings JOURNAL OF EMPIRICAL LEGAL STUDIES Sklar, T., Taouk, Y., Studdert, D., Spittal, M., Paterson, R., Bismark, M. 2019; 16 (2): 318–42

  View details for DOI 10.1111/jels.12216

  View details for Web of Science ID 000467977700004

• Accuracy of Valuations of Surgical Procedures in the Medicare Fee Schedule NEW ENGLAND JOURNAL OF MEDICINE Chan, D. C., Huynh, J., Studdert, D. M. 2019; 380 (16): 1546–54

  View details for DOI 10.1056/NEJMsa1807379

  View details for Web of Science ID 000465144100015

• Changes in Practice among Physicians with Malpractice Claims NEW ENGLAND JOURNAL OF MEDICINE Studdert, D. M., Spittal, M. J., Zhang, Y., Wilkinson, D. S., Singh, H., Mello, M. M. 2019; 380 (13): 1247–55

  View details for DOI 10.1056/NEJMsa1809981

  View details for Web of Science ID 000463251600009

• Changes in Practice among Physicians with Malpractice Claims. The New England journal of medicine Studdert, D. M., Spittal, M. J., Zhang, Y., Wilkinson, D. S., Singh, H., Mello, M. M. 2019; 380 (13): 1247–55

  Abstract

  BACKGROUND: Physicians with poor malpractice liability records may pose a risk to patient safety. There are long-standing concerns that such physicians tend to relocate for a fresh start, but little is known about whether, how, and where they continue to practice.METHODS: We linked an extract of the National Practitioner Data Bank to the Medicare Data on Provider Practice and Specialty data set to create a national cohort of physicians 35 to 65 years of age who practiced during the period from 2008 through 2015. We analyzed associations between the number of paid malpractice claims that physicians accrued and exits from medical practice, changes in clinical volume, geographic relocation, and change in practice-group size.RESULTS: The cohort consisted of 480,894 physicians who had 68,956 paid claims from 2003 through 2015. A total of 89.0% of the physicians had no claims, 8.8% had 1 claim, and the remaining 2.3% had 2 or more claims and accounted for 38.9% of all claims. The number of claims was positively associated with the odds of leaving the practice of medicine (odds ratio for 1 claim vs. no claims, 1.09; 95% confidence interval [CI], 1.06 to 1.11; odds ratio for ≥5 claims, 1.45; 95% CI, 1.20 to 1.74). The number of claims was not associated with geographic relocation but was positively associated with shifts into smaller practice settings. For example, physicians with 5 or more claims had more than twice the odds of moving into solo practice than physicians with no claims (odds ratio, 2.39; 95% CI, 1.79 to 3.20).CONCLUSIONS: Physicians with multiple malpractice claims were no more likely to relocate geographically than those with no claims, but they were more likely to stop practicing medicine or switch to smaller practice settings. (Funded by SUMIT Insurance and the Australian Research Council.).

  View details for PubMedID 30917259

• Valuations of Surgical Procedures in the Medicare Fee Schedule. Reply. The New England journal of medicine Chan, D. C., Huynh, J., Studdert, D. M. 2019; 381 (4): 391

  View details for DOI 10.1056/NEJMc1906724

  View details for PubMedID 31340110

• Association of Prior Convictions for Driving Under the Influence With Risk of Subsequent Arrest for Violent Crimes Among Handgun Purchasers. JAMA internal medicine Kagawa, R. M., Stewart, S., Wright, M. A., Shev, A. B., Pear, V. A., McCort, C. D., Pallin, R., Asif-Sattar, R., Sohl, S., Kass, P. H., Cerdá, M., Gruenewald, P., Studdert, D. M., Wintemute, G. J. 2019

  Abstract

  Alcohol use is a risk factor for firearm-related violence, and firearm owners are more likely than others to report risky drinking behaviors.To study the association between prior convictions for driving under the influence (DUI) and risk of subsequent arrest for violent crimes among handgun purchasers.In this retrospective, longitudinal cohort study, 79 678 individuals were followed up from their first handgun purchase in 2001 through 2013. The study cohort included all legally authorized handgun purchasers in California aged 21 to 49 years at the time of purchase in 2001. Individuals were identified using the California Department of Justice (CA DOJ) Dealer's Record of Sale (DROS) database, which retains information on all legal handgun transfers in the state.The primary exposure was DUI conviction prior to the first handgun purchase in 2001, as recorded in the CA DOJ Criminal History Information System.Prespecified outcomes included arrests for violent crimes listed in the Crime Index published by the Federal Bureau of Investigation (murder, rape, robbery, and aggravated assault), firearm-related violent crimes, and any violent crimes.Of the study population (N=79 678), 91.0% were males and 68.9% were white individuals; the median age was 34 (range, 21-49) years. The analytic sample for multivariable models included 78 878 purchasers after exclusions. Compared with purchasers who had no prior criminal history, those with prior DUI convictions and no other criminal history were at increased risk of arrest for a Crime Index-listed violent crime (adjusted hazard ratio [AHR], 2.6; 95% CI, 1.7-4.1), a firearm-related violent crime (AHR, 2.8; 95% CI, 1.3-6.4), and any violent crime (AHR, 3.3; 95% CI, 2.4-4.5). Among purchasers with a history of arrests or convictions for crimes other than DUI, associations specifically with DUI conviction remained.This study's findings suggest that prior DUI convictions may be associated with the risk of subsequent violence, including firearm-related violence, among legal purchasers of handguns. Although the magnitude was diminished, the risk associated with DUI conviction remained elevated even among those with a history of arrests or convictions for crimes of other types.

  View details for DOI 10.1001/jamainternmed.2019.4491

  View details for PubMedID 31566654

• Identification of practitioners at high risk of complaints to health profession regulators. BMC health services research Spittal, M. J., Bismark, M. M., Studdert, D. M. 2019; 19 (1): 380

  Abstract

  Some health practitioners pose substantial threats to patient safety, yet early identification of them is notoriously difficult. We aimed to develop an algorithm for use by regulators in prospectively identifying practitioners at high risk of attracting formal complaints about health, conduct or performance issues.Using 2011-2016 data from the national regulator of health practitioners in Australia, we conducted a retrospective cohort study of 14 registered health professions. We used recurrent-event survival analysis to estimate the risk of a complaint and used the results of this analysis to develop an algorithm for identifying practitioners at high risk of complaints. We evaluated the algorithm's discrimination, calibration and predictive properties.Participants were 715,415 registered health practitioners (55% nurses, 15% doctors, 6% midwives, 5% psychologists, 4% pharmacists, 15% other). The algorithm, PRONE-HP (Predicted Risk of New Event for Health Practitioners), incorporated predictors for sex, age, profession and specialty, number of prior complaints and complaint issue. Discrimination was good (C-index = 0·77, 95% CI 0·76-0·77). PRONE-HP's score values were closely calibrated with risk of a future complaint: practitioners with a score ≤ 4 had a 1% chance of a complaint within 24 months and those with a score ≥ 35 had a higher than 85% chance. Using the 90th percentile of scores within each profession to define "high risk", the predictive accuracy of PRONE-HP was good for doctors and dentists (PPV = 93·1% and 91·6%, respectively); moderate for chiropractors (PPV = 71·1%), psychologists (PPV = 54·9%), pharmacists (PPV = 39·9%) and podiatrists (PPV = 34·0%); and poor for other professions.The performance of PRONE-HP in predicting complaint risks varied substantially across professions. It showed particular promise for flagging doctors and dentists at high risk of accruing further complaints. Close review of available information on flagged practitioners may help to identify troubling patterns and imminent risks to patients.

  View details for DOI 10.1186/s12913-019-4214-y

  View details for PubMedID 31196074

• Accuracy of Valuations of Surgical Procedures in the Medicare Fee Schedule. The New England journal of medicine Chan, D. C., Huynh, J., Studdert, D. M. 2019; 380 (16): 1546–54

  Abstract

  BACKGROUND: The Relative Value Scale Update Committee (RUC) of the American Medical Association plays a central role in determining physician reimbursement. The RUC's role and performance have been criticized but subjected to little empirical evaluation.METHODS: We analyzed the accuracy of valuations of 293 common surgical procedures from 2005 through 2015. We compared the RUC's estimates of procedure time with "benchmark" times for the same procedures derived from the clinical registry maintained by the American College of Surgeons National Surgical Quality Improvement Program (NSQIP). We characterized inaccuracies, quantified their effect on physician revenue, and examined whether re-review corrected them.RESULTS: At the time of 108 RUC reviews, the mean absolute discrepancy between RUC time estimates and benchmark times was 18.5 minutes, or 19.8% of the RUC time. However, RUC time estimates were neither systematically shorter nor longer than benchmark times overall (beta, 0.97; 95% confidence interval, 0.94 to 1.01; P=0.10). Our analyses suggest that whereas orthopedic surgeons and urologists received higher payments than they would have if benchmark times had been used ($160 million and $40 million more, respectively, in Medicare reimbursement in 2011 through 2015), cardiothoracic surgeons, neurosurgeons, and vascular surgeons received lower payments ($130 million, $60 million, and $30 million less, respectively). The accuracy of RUC time estimates improved in 47% of RUC revaluations, worsened in 27%, and was unchanged in 25%. (Percentages do not sum to 100 because of rounding.).CONCLUSIONS: In this analysis of frequently conducted operations, we found substantial absolute discrepancies between intraoperative times as estimated by the RUC and the times recorded for the same procedures in a surgical registry, but the RUC did not systematically overestimate or underestimate times. (Funded by the National Institutes of Health.).

  View details for PubMedID 30995374

• Getting the "Informed" into "Informed Consent," and Proving It JOURNAL OF LAW MEDICINE & ETHICS Studdert, D. M. 2018; 46 (4): 975–77

  View details for DOI 10.1177/1073110518821998

  View details for Web of Science ID 000456694800027

• Eyes and Ears on Patient Safety: Sources of Notifications About the Health, Performance, and Conduct of Health Practitioners. Journal of patient safety Bismark, M., Tibble, H., Moore, J. S., Morris, J. M., Paterson, R., Fletcher, M., Studdert, D. 2018

  Abstract

  OBJECTIVE: The aim of the study was to describe the sources of notifications of concern ("notifications") regarding the health, performance, and conduct of health practitioners from 14 registered professions in Australia.METHODS: This retrospective cohort study analyzed 43,256 notifications lodged with the Australian Health Practitioner Regulation Agency and the Health Professional Councils Authority between 2011 and 2016. We used descriptive statistical analysis to describe the characteristics of these notifications, including their source, issue and domain, and subject.RESULTS: Patients and their relatives lodged more than three-quarters (78%) of notifications regarding clinical performance, including diagnosis, treatment, and communication. Fellow practitioners were a common source of notifications about advertising and titles. Self-reports commonly related to health impairments, such as mental illness or substance use. Other agencies played a role in reporting concerns about prescribing or supply of medicines.CONCLUSIONS: Various actors in the healthcare system play different roles in sketching the picture of healthcare quality and safety that notifications present to regulators. Improved understanding of which sources are most likely to raise which concerns may enhance regulators' ability to identify and respond to patient safety risks.

  View details for PubMedID 30480651

• Firearm-Related Mortality A Global Public Health Problem JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Rivara, F. P., Studdert, D. M., Wintemute, G. J. 2018; 320 (8): 764–65

  View details for PubMedID 30167677

• Feasibility of a Health-Utility Approach to Quantifying Noneconomic Losses from Personal Injury JOURNAL OF EMPIRICAL LEGAL STUDIES Carvalho, N., Fish, D., Grant, G. M., Salomon, J. A., Studdert, D. M. 2018; 15 (2): 278–319

  View details for Web of Science ID 000431655600002

• Development of prediction models of stress and long-term disability among claimants to injury compensation systems: a cohort study. BMJ open Spittal, M. J., Grant, G., O'Donnell, M., McFarlane, A. C., Studdert, D. M. 2018; 8 (4): e020803

  Abstract

  OBJECTIVES: We sought to develop prognostic risk scores for compensation-related stress and long-term disability using markers collected within 3 months of a serious injury.DESIGN: Cohort study. Predictors were collected at baseline and at 3 months postinjury. Outcome data were collected at 72 months postinjury.SETTING: Hospitalised patients with serious injuries recruited from four major trauma hospitals in Australia.PARTICIPANTS: 332 participants who made claims for compensation for their injuries to a transport accident scheme or a workers' compensation scheme.PRIMARY OUTCOME MEASURES: 12-item WHO Disability Assessment Schedule and 6 items from the Claims Experience Survey.RESULTS: Our model for long-term disability had four predictors (unemployed at the time of injury, history of a psychiatric disorder at time of injury, post-traumatic stress disorder symptom severity at 3 months and disability at 3 months). This model had good discrimination (R2=0.37) and calibration. The disability risk score had a score range of 0-180, and at a threshold of 80 had sensitivity of 56% and specificity of 86%. Our model for compensation-related stress had five predictors (intensive care unit admission, discharged to home, number of traumatic events prior to injury, depression at 3 months and not working at 3 months). This model also had good discrimination (area under the curve=0.83) and calibration. The compensation-related stress risk score had score range of 0-220 and at a threshold of 100 had sensitivity of 74% and specificity of 75%. By combining these two scoring systems, we were able to identify the subgroup of claimants at highest risk of experiencing both outcomes.CONCLUSIONS: The ability to identify at an early stage claimants at high risk of compensation-related stress and poor recovery is potentially valuable for claimants and the compensation agencies that serve them. The scoring systems we developed could be incorporated into the claims-handling processes to guide prevention-oriented interventions.

  View details for PubMedID 29705763

• Why do surgeons receive more complaints than their physician peers? ANZ JOURNAL OF SURGERY Tibble, H. M., Broughton, N. S., Studdert, D. M., Spittal, M. J., Hill, N., Morris, J. M., Bismark, M. M. 2018; 88 (4): 269–73

  Abstract

  Compared with other doctors, surgeons are at an increased risk of medicolegal events, including patient complaints and negligence claims. This retrospective study aimed to describe the frequency and nature of complaints involving surgeons compared with physicians.We assembled a national data set of complaints about surgeons and physicians lodged with medical regulators in Australia from 2011 to 2016. We classified the complaints into 19 issues across four domains: treatment and procedures, other performance, professional conduct and health. We assessed differences in complaint risk using incidence rate ratios (IRRs). Finally, we used a multivariate model to identify predictors of complaints among surgeons.The rate of complaints was 2.3 times higher for surgeons than physicians (112 compared with 48 complaints per 1000 practice years, P < 0.001). Two-fifths (41%) of the higher rate of complaints among surgeons was attributable to issues other than treatments and procedures, including fees (IRR = 2.68), substance use (IRR = 2.10), communication (IRR = 1.98) and interpersonal behaviour (IRR = 1.92). Male surgeons were at a higher risk of complaints, as were specialists in orthopaedics, plastic surgery and neurosurgery.Surgeons are more than twice as likely to attract complaints as their physician peers. This elevated risk arises partly from involvement in surgical procedures and treatments, but also reflects wider concerns about interpersonal skills, professional ethics and substance use. Improved understanding of these patterns may assist efforts to reduce harm and support safe practise.

  View details for PubMedID 28889480

• Development of prediction models of stress and long-term disability among claimants to injury compensation systems: a cohort study BMJ OPEN Spittal, M. J., Grant, G., O'Donnell, M., McFarlane, A. C., Studdert, D. M. 2018; 8 (4)

  View details for DOI 10.1136/bmjopen-2017-020803

  View details for Web of Science ID 000435176700197

• Outcomes of notifications to health practitioner boards: a retrospective cohort study (vol 14, 198, 2016) BMC MEDICINE Spittal, M. J., Studdert, D. M., Paterson, R., Bismark, M. M. 2018; 16: 38

  Abstract

  The original article [1] contains a major error whereby all rates in Table 2 are mistakenly presented as 50% of their true values; this error was caused by a miscalculation in annualising the original values that represented the rates.

  View details for PubMedID 29514646

• Handgun Acquisitions in California After Two Mass Shootings ANNALS OF INTERNAL MEDICINE Studdert, D. M., Zhang, Y., Rodden, J. A., Hyndman, R. J., Wintemute, G. J. 2017; 166 (10): 698-?

  Abstract

  Mass shootings are common in the United States. They are the most visible form of firearm violence. Their effect on personal decisions to purchase firearms is not well-understood.To determine changes in handgun acquisition patterns after the mass shootings in Newtown, Connecticut, in 2012 and San Bernardino, California, in 2015.Time-series analysis using seasonal autoregressive integrated moving-average (SARIMA) models.California.Adults who acquired handguns between 2007 and 2016.Excess handgun acquisitions (defined as the difference between actual and expected acquisitions) in the 6-week and 12-week periods after each shooting, overall and within subgroups of acquirers.In the 6 weeks after the Newtown and San Bernardino shootings, there were 25 705 (95% prediction interval, 17 411 to 32 788) and 27 413 (prediction interval, 15 188 to 37 734) excess acquisitions, respectively, representing increases of 53% (95% CI, 30% to 80%) and 41% (CI, 19% to 68%) over expected volume. Large increases in acquisitions occurred among white and Hispanic persons, but not among black persons, and among persons with no record of having previously acquired a handgun. After the San Bernardino shootings, acquisition rates increased by 85% among residents of that city and adjacent neighborhoods, compared with 35% elsewhere in California.The data relate to handguns in 1 state. The statistical analysis cannot establish causality.Large increases in handgun acquisitions occurred after these 2 mass shootings. The spikes were short-lived and accounted for less than 10% of annual handgun acquisitions statewide. Further research should examine whether repeated shocks of this kind lead to substantial increases in the prevalence of firearm ownership.None.

  View details for DOI 10.7326/M16-1574

  View details for Web of Science ID 000401240200013

  View details for PubMedID 28462425

• Medical Liability - Prospects for Federal Reform NEW ENGLAND JOURNAL OF MEDICINE Mello, M. M., Kachalia, A., Studdert, D. M. 2017; 376 (19): 1806-1808

  View details for DOI 10.1056/NEJMp1701174

  View details for Web of Science ID 000400891100003

  View details for PubMedID 28402244

• The effect of federal and state off-label marketing investigations on drug prescribing: The case of olanzapine PLOS ONE Wang, B., Studdert, D. M., Sarpatwari, A., Franklin, J. M., Landon, J., Kesselheim, A. S. 2017; 12 (4)

  Abstract

  In the past decade, the federal government has frequently investigated and prosecuted pharmaceutical manufacturers for illegal promotion of drugs for indications not approved by the Food and Drug Administration (FDA) ("off-label" uses). State governments can choose to coordinate with the federal investigation, or pursue their own independent state investigations. One of the largest-ever off-label prosecutions relates to the atypical antipsychotic drug olanzapine (Zyprexa). In a series of settlements between 2008 and 2010, Eli Lilly paid $1.4 billion to the federal government and over $290 million to state governments. We examined the effect of these settlements on off-label prescribing of this medication, taking advantage of geographical differences in states' involvement in the investigations and the timing of the settlements. However, we did not find a reduction in off-label prescribing; rather, there were no prescribing changes among states that joined the federal investigation, those that pursued independent state investigations, and states that pursued no investigations at all. Since the settlements of state investigations of off-label prescribing do not appear to significantly impact prescribing rates, policymakers should consider alternate ways of reducing the prevalence of non-evidence-based off-label use to complement their ongoing investigations.

  View details for DOI 10.1371/journal.pone.0175313

  View details for Web of Science ID 000399375800039

  View details for PubMedID 28388667

• Linking Immunization Status and Eligibility for Welfare and Benefits Payments: The Australian "No Jab, No Pay" Legislation. JAMA Yang, Y. T., Studdert, D. M. 2017; 317 (8): 803-804

  View details for DOI 10.1001/jama.2017.0123

  View details for PubMedID 28245331

• Association of Unsolicited Patient Observations With the Quality of a Surgeon's Care. JAMA surgery Kachalia, A., Mello, M. M., Studdert, D. M. 2017

  View details for DOI 10.1001/jamasurg.2016.5705

  View details for PubMedID 28199449

• Testing the Immunity of the Firearm Industry to Tort Litigation JAMA INTERNAL MEDICINE Studdert, D. M., Donohue, J. J., Mello, M. M. 2017; 177 (1): 102-105

  Abstract

  In the absence of congressional action to reinstate the federal ban on assault weapons, tort litigation offers an alternative strategy for regulating what have become the weapons of choice in mass shootings. However, opportunities to bring successful claims are limited. To prevail, plaintiffs must show that their suit fits within exceptions to the broad immunity from tort actions that Congress gave the firearm industry in the 2005 Protection of Lawful Commerce in Arms Act. In one particularly high-profile lawsuit, families of victims of the school shooting in Newtown, Connecticut, in 2012 sued the makers and sellers of the military-style rifle used in the attack, alleging negligence and deceptive marketing. The trial court dismissed the case on October 14, 2016, but the plaintiffs plan to appeal. We review the history of tort litigation against the firearm industry, outline the Newtown families' claims, and describe the decision.

  View details for DOI 10.1001/jamainternmed.2016.7043

  View details for Web of Science ID 000392196200023

  View details for PubMedID 27842188

• Outcomes of notifications to health practitioner boards: a retrospective cohort study BMC MEDICINE Spittal, M. J., Studdert, D. M., Paterson, R., Bismark, M. M. 2016; 14

  Abstract

  Medical boards and other practitioner boards aim to protect the public from unsafe practice. Previous research has examined disciplinary actions against doctors, but other professions (e.g., nurses and midwives, dentists, psychologists, pharmacists) remain understudied. We sought to describe the outcomes of notifications of concern regarding the health, performance, and conduct of health practitioners from ten professions in Australia and to identify factors associated with the imposition of restrictive actions.We conducted a retrospective cohort study of all notifications lodged with the Australian Health Practitioner Regulation Agency over 24 months. Notifications were followed for 30-54 months. Our main outcome was restrictive actions, defined as decisions that imposed undertakings, conditions, or suspension or cancellation of registration.There were 8307 notifications. The notification rate was highest among doctors (IR = 14.5 per 1000 practitioners per year) and dentists (IR = 20.7) and lowest among nurses and midwives (IR = 2.0). One in ten notifications resulted in restrictive action; fewer than one in 300 notifications resulted in suspension or cancellation of registration. Compared with notifications about clinical care, the odds of restrictive action were higher for notifications relating to health impairments (drug misuse, OR = 7.0; alcohol misuse, OR = 4.6; mental illness, OR = 4.1, physical or cognitive illness, OR = 3.7), unlawful prescribing or use of medications (OR = 2.1) and violation of sexual boundaries (OR = 1.7). The odds were higher where the report was made by another health practitioner (OR = 2.9) or employer (OR = 6.9) rather than a patient or relative. Nurses and midwives (OR = 1.8), psychologists (OR = 4.5), dentists (OR = 4.7), and other health practitioners (OR = 5.3) all had greater odds of being subject to restrictive actions than doctors.Restrictive actions are the strongest measures health practitioner boards can take to protect the public from harm and these actions can have profound effects on the livelihood, reputations and well-being of practitioners. In Australia, restrictive actions are rarely imposed and there is variation in their use depending on the source of the notification, the type of issue involved, and the profession of the practitioner.

  View details for DOI 10.1186/s12916-016-0748-6

  View details for Web of Science ID 000391068500001

  View details for PubMedID 27908294

• The Australian longitudinal study on male health-methods BMC PUBLIC HEALTH Currier, D., Pirkis, J., Carlin, J., Degenhardt, L., Dharmage, S. C., Giles-Corti, B., Gordon, I., Gurrin, L., Hocking, J., Kavanagh, A., Keogh, L. A., Koelmeyer, R., LaMontagne, A. D., Schlichthorst, M., Patton, G., Sanci, L., Spittal, M. J., Studdert, D. M., Williams, J., English, D. R. 2016; 16

  Abstract

  The Australian Longitudinal Study on Male Health (Ten to Men) was established in 2011 to build the evidence base on male health to inform policy and program development.Ten to Men is a national longitudinal study with a stratified multi-stage cluster random sample design and oversampling in rural and regional areas. Household recruitment was conducted from October 2013 to July 2014. Males who were aged 10 to 55 years residing in private dwellings were eligible to participate. Data were collected via self-completion paper questionnaires (participants aged 15 to 55) and by computer-assisted personal interview (boys aged 10 to 14). Household and proxy health data for boys were collected from a parent via a self-completion paper-based questionnaire. Questions covered socio-demographics, health status, mental health and wellbeing, health behaviours, social determinants, and health knowledge and service use.A cohort of 15,988 males aged between 10 and 55 years was recruited representing a response fraction of 35 %.Ten to Men is a unique resource for investigating male health and wellbeing. Wave 1 data are available for approved research projects.

  View details for DOI 10.1186/s12889-016-3698-1

  View details for Web of Science ID 000392422000003

  View details for PubMedID 28185550

• Inequalities in socio-economic characteristics and health and wellbeing of men with and without disabilities: a cross-sectional analysis of the baseline wave of the Australian Longitudinal Study on Male Health BMC PUBLIC HEALTH Kavanagh, A. M., Aitken, Z., Emerson, E., Sahabandu, S., Milner, A., Bentley, R., LaMontagne, A. D., Pirkis, J., Studdert, D. 2016; 16

  Abstract

  Internationally, men with disabilities have higher rates of social and economic disadvantage and poorer health and wellbeing than men without disabilities. No single study has provided comprehensive, population-level information about the magnitude of such differences among adult men using a well-validated instrument to measure disability.We analysed baseline data from Ten to Men - an Australian longitudinal study of male health. Ten to Men used a stratified multi-stage cluster random sample design to recruit a national sample of males aged 10 to 55 years residing in private dwellings. Data were collected between October 2013 and July 2014 from 15,988 males. This analysis was restricted to 18-55 year old participants with data available on age and disability (n = 13,569). We compared the demographic, socio-economic characteristics and health and wellbeing of men with and without disabilities using chi squared tests for proportions and t tests for continuous variables. Linear regression adjusted for age was used to assess the association between disability status and health and wellbeing, which were measured using the SF-12 mental and physical health component scores and the Personal Wellbeing Index.Men with disabilities were older and more likely to be born in Australia, speak English at home, be Aboriginal and Torres Strait Islander and were less likely to be married or de facto, or to live in urban areas. They were less likely to have completed secondary school, be employed and live in affordable housing, and were more likely to live on low incomes, in more socio-economically disadvantaged areas, and in rental accommodation and to experience shortages of money. Among employed men, those with disabilities were less likely to be in high skilled jobs, worked less hours on average, and were more likely to report that they would prefer to work more. Men with disabilities had lower levels of social support and community participation and poorer mental and physical health and overall wellbeing.Adult men with disabilities experience marked social and economic disadvantage and poorer health and wellbeing. Improving the health and wellbeing of disabled men should be a priority for public health researchers and policy-makers.

  View details for DOI 10.1186/s12889-016-3700-y

  View details for Web of Science ID 000392422000005

  View details for PubMedID 28185560

• Evaluation of California's Armed and Prohibited Persons System: study protocol for a cluster-randomised trial. Injury prevention Wintemute, G. J., Beckett, L., Kass, P. H., Tancredi, D., Studdert, D., Pierce, G., Braga, A. A., Wright, M. A., Cerdá, M. 2016

  Abstract

  Too little is known about the effectiveness of efforts to prevent firearm violence. Our objective is to evaluate California's Armed and Prohibited Persons System (APPS), a law enforcement intervention that seeks to recover firearms from individuals who purchased them legally but subsequently became prohibited from having access to firearms. Prohibitions usually arise from events suggesting an increased risk for future violence.This group-randomised trial involves approximately 20 000 APPS-eligible individuals in 1041 communities. Randomisation was performed at the community level, to early or later intervention (Group 1 and Group 2, respectively) with stratification by region, population and violent crime rate.APPS is being implemented by the California Department of Justice. The principal outcome measure is the incidence of arrest for a firearm-related or violent crime. Primary analysis will be on an intention-to-treat basis, comparing individuals in Group 1 and Group 2 communities. Analyses will focus on time to event, using proportional hazards regression with adjustment for the clustered nature of the data and incorporating individual- and community-level characteristics. Secondary analyses will examine the effect of the intervention on an as treated basis, effects on subgroups, and effects on community-wide measures such as crime rates.APPS may have a significant impact on risk for future violence among members of its target population. The findings of this study will likely be generalisable and have clear implications for violence prevention policy and practice.NCT02318732.

  View details for DOI 10.1136/injuryprev-2016-042194

  View details for PubMedID 27729440

• Duration of death investigations that proceed to inquest in Australia INJURY PREVENTION Studdert, D. M., Walter, S. J., Kemp, C., Sutherland, G. 2016; 22 (5): 314-320

  Abstract

  Recent government inquiries in several countries have identified the length of time it takes coroners to investigate deaths due to injury and other unnatural causes as a major problem. Delays undermine the integrity of vital statistics and adversely affect the deceased's family and others with interests in coroners' findings. Little is publicly known about the extent, nature and causes of these delays.We used Kaplan-Meier estimates and multivariable regression analysis to decompose the timelines of nearly all inquest cases (n=5096) closed in coroners' courts in Australia between 1 January 2007 and 31 December 2013.The cases had a median closure period of 19.0 months (95% CI 18.4 to 19.6). Overall, 70% of cases were open at 1 year, 40% at 2 years and 22% at 3 years, but there was substantial variation by jurisdiction. Adjusted analyses showed a difference of 22 months in the average closure time between the fastest and slowest jurisdictions. Cases involving deaths due to assault (+12.2 months, 95% CI 7.8 to 17.0) and complications of medical care (+9.0 months, 95% CI 5.5 to 12.3) had significantly longer closure periods than other types of death. Cases that produced public health recommendations also had relatively long closure periods (+8.9 months, 95% CI 7.6 to 10.3).Nearly a quarter of inquests in Australia run for more than 3 years. The size of this caseload tail varies dramatically by jurisdiction and case characteristics. Interventions to reduce timelines should be tried and carefully evaluated.

  View details for Web of Science ID 000385948400002

  View details for PubMedID 27435099

• The modern coroner as injury preventer INJURY PREVENTION Studdert, D. M. 2016; 22 (5): 311–13

  View details for DOI 10.1136/injuryprev-2016-042076

  View details for Web of Science ID 000385948400001

  View details for PubMedID 27435101

• Mandatory responses to public health and safety recommendations issued by coroners: a content analysis. Australian and New Zealand journal of public health Sutherland, G., Kemp, C., Studdert, D. M. 2016; 40 (5): 451-456

  Abstract

  This study investigated the extent to which mandatory responses to coronial recommendations in one state of Australia (Victoria) provided a clear picture of action taken by organisations to protect public health and safety.Analysis of organisations' responses to recommendations issued by coroners over the first three years of Victoria's newly introduced mandatory response regime was carried out.Most responses were provided to the court within the legislated three-month timeframe and were signed by persons in senior or executive management. Analysis of 282 recommendation-response pairs, found that less than half (44%) provided explicit statements about whether action had or would be taken. In the remaining 56% of responses there was no explicit statement of action or intent. Ambiguity in the response was strongly associated with lack of implementation.Our findings suggest that the founding objectives of Victoria's innovative mandatory response regime are being compromised by the opacity of many response letters. Implications for public health: Recommendations from the coroner can profoundly affect whether the community is exposed to unsafe practices, policies and products, but without such compliance, the potential for the coroner to make a meaningful contribution to protecting public and safety is substantially compromised.

  View details for DOI 10.1111/1753-6405.12580

  View details for PubMedID 27623713

• Cohort Profile: Ten to Men (the Australian Longitudinal Study on Male Health). International journal of epidemiology Pirkis, J., Currier, D., Carlin, J., Degenhardt, L., Dharmage, S. C., Giles-Corti, B., Gordon, I. R., Gurrin, L. C., Hocking, J. S., Kavanagh, A., Keogh, L., Koelmeyer, R., LaMontagne, A. D., Patton, G., Sanci, L., Spittal, M. J., Schlichthorst, M., Studdert, D., Williams, J., English, D. R. 2016

  View details for PubMedID 27686951

• Prevalence and Characteristics of Physicians Prone to Malpractice Claims EDITORIAL COMMENT OBSTETRICAL & GYNECOLOGICAL SURVEY Studdert, D. M., Bismark, M. M., Mello, M. M., Singh, H., Spittal, M. J. 2016; 71 (5): 289–90

  View details for Web of Science ID 000376274700014

• Legal and Policy Interventions to Improve Patient Safety CIRCULATION Kachalia, A., Mello, M. M., Nallamothu, B. K., Studdert, D. M. 2016; 133 (7): 661-671

  View details for DOI 10.1161/CIRCULATIONAHA.115.015880

  View details for Web of Science ID 000371010100006

  View details for PubMedID 26884621

• Prevalence and Characteristics of Physicians Prone to Malpractice Claims. New England journal of medicine Studdert, D. M., Bismark, M. M., Mello, M. M., Singh, H., Spittal, M. J. 2016; 374 (4): 354-362

  Abstract

  The distribution of malpractice claims among physicians is not well understood. If claim-prone physicians account for a substantial share of all claims, the ability to reliably identify them at an early stage could guide efforts to improve care.Using data from the National Practitioner Data Bank, we analyzed 66,426 claims paid against 54,099 physicians from 2005 through 2014. We calculated concentrations of claims among physicians. We used multivariable recurrent-event survival analysis to identify characteristics of physicians at high risk for recurrent claims and to quantify risk levels over time.Approximately 1% of all physicians accounted for 32% of paid claims. Among physicians with paid claims, 84% incurred only one during the study period (accounting for 68% of all paid claims), 16% had at least two paid claims (accounting for 32% of the claims), and 4% had at least three paid claims (accounting for 12% of the claims). In adjusted analyses, the risk of recurrence increased with the number of previous paid claims. For example, as compared with physicians who had one previous paid claim, the 2160 physicians who had three paid claims had three times the risk of incurring another (hazard ratio, 3.11; 95% confidence interval [CI], 2.84 to 3.41); this corresponded in absolute terms to a 24% chance (95% CI, 22 to 26) of another paid claim within 2 years. Risks of recurrence also varied widely according to specialty--for example, the risk among neurosurgeons was four times as great as the risk among psychiatrists.Over a recent 10-year period, a small number of physicians with distinctive characteristics accounted for a disproportionately large number of paid malpractice claims.

  View details for DOI 10.1056/NEJMsa1506137

  View details for PubMedID 26816012

• Reporting of health practitioners by their treating practitioner under Australia's national mandatory reporting law. Medical journal of Australia Bismark, M. M., Spittal, M. J., Morris, J. M., Studdert, D. M. 2016; 204 (1): 24-?

  Abstract

  To describe the frequency, nature and outcomes of reports about health practitioners made by their treating practitioners under Australia's new mandatory reporting system.Retrospective case file review and analysis of treating practitioner reports received by the Australian Health Practitioner Regulation Agency between 1 November 2011 and 31 January 2013, and of the outcomes of the completed investigations of these reports to November 2014.Characteristics of treating practitioners and reported practitioners; nature of the care relationship; grounds for report; regulatory action taken in response to report.Of 846 mandatory reports about medical practitioners, 64 (8%) were by treating practitioners. A minority of reports (14 of 64) were made by a practitioner-patient's regular care provider; most (50 of 64) arose from an encounter during an acute admission, first assessment or informal corridor consultation. The reported practitioner-patients were typically being treated for mental illness (28 of 64) or substance misuse (25 of 64). In 80% of reports (50 of 64), reporters described practitioner-patients who exhibited diminished insight, dishonesty, disregard for patient safety, or an intention to self-harm.The nature and circumstances of the typical treating practitioner report challenge assumptions expressed in policy debates about the merits of the new mandatory reporting law. Mandatory reports by treating practitioners are rare. The typical report is about substance misuse or mental illness, is made by a doctor who is not the patient's regular care provider, and identifies an impediment to safely managing the risk posed by the practitioner-patient within the confines of the treating relationship.

  View details for PubMedID 26763812

• The Choice Between Total Hip Arthroplasty and Arthrodesis in Adolescent Patients: A Survey of Orthopedic Surgeons JOURNAL OF ARTHROPLASTY Kelman, M. G., Studdert, D. M., Callaghan, J. J., Farid, M. S., Titan, A. L., Dietz, F. R. 2016; 31 (1): 70-75

  Abstract

  For adolescent patients with end-stage hip disease, the choice between total hip arthroplasty (THA) and arthrodesis is complex; the clinical evidence is not definitive, and there are difficult trade-offs between clear short-term benefits from THA and uncertain long-term risks. We surveyed nearly 700 members of the Pediatric Orthopedic Society of North America and the American Association of Hip and Knee Surgeons. Respondents chose between a recommendation of THA or arthrodesis in four clinical vignettes. A clear majority of surgeons recommended THA in two of the vignettes, however opinion was somewhat divided in one vignette (overweight adolescent) and deeply divided in another (adolescent destined for manual labor job). Across all vignettes, recommendations varied systematically according to surgeons' age and their attitudes regarding tradeoffs between life stages.

  View details for DOI 10.1016/j.arth.2015.07.020

  View details for Web of Science ID 000366677000014

  View details for PubMedID 26298281

• Building a National Surveillance System for Malpractice Claims. Health services research Mello, M. M., Studdert, D. M. 2016; 51 Suppl 3: 2642–48

  View details for PubMedID 27892620

  View details for PubMedCentralID PMC5134343

• Views on mandatory reporting of impaired health practitioners by their treating practitioners: a qualitative study from Australia BMJ OPEN Bismark, M. M., Mathews, B., Morris, J. M., Thomas, L. A., Studdert, D. M. 2016; 6 (12)

  Abstract

  To explore the views and experiences of health sector professionals in Australia regarding a new national law requiring treating practitioners to report impaired health practitioners whose impairments came to their attention in the course of providing treatment.We conducted a thematic analysis of in-depth, semistructured interviews with 18 health practitioners and 4 medicolegal advisors from Australia's 6 states, each of whom had experience with applying the new mandatory reporting law in practice.Interviewees perceived the introduction of a mandatory reporting law as a response to failures of the profession to adequately protect the public from impaired practitioners. Mandatory reporting of impaired practitioners was reported to have several benefits: it provides treating practitioners with a 'lever' to influence behaviour, offers protections to those who make reports and underscores the duty to protect the public from harm. However, many viewed it as a blunt instrument that did not sufficiently take account of the realities of clinical practice. In deciding whether or not to make a report, interviewees reported exercising clinical discretion, and being influenced by three competing considerations: protection of the public, confidentiality of patient information and loyalty to their profession.Competing ethical considerations limit the willingness of Australian health practitioners to report impaired practitioner-patients under a mandatory reporting law. Improved understanding and implementation of the law may bolster the public protection offered by mandatory reports, reduce the need to breach practitioner-patient confidentiality and help align the law with the loyalty that practitioners feel to support, rather than punish, their impaired colleagues.

  View details for DOI 10.1136/bmjopen-2016-011988

  View details for Web of Science ID 000391303600011

  View details for PubMedID 27993902

  View details for PubMedCentralID PMC5168668

• Relationship between penalties for road traffic infringements and crash risk in Queensland, Australia: a case-crossover study INTERNATIONAL JOURNAL OF EPIDEMIOLOGY Walter, S. J., Studdert, D. M. 2015; 44 (5): 1722-1730

  Abstract

  Most countries have detailed lists of traffic rules and elaborate legal regimes for penalizing drivers who break them. Previous research has suggested that drivers tend to drive more safely after receiving penalties for traffic infringements.We linked driver-level data on infringements and crashes in Queensland, Australia (1995-2010) with information on the licence histories of all drivers in the state. We used a case-crossover design to examine drivers' risk of crashing in the month following an infringement penalty. We also examined whether changes in crash risk following infringement penalties varied according to driver age and gender, type of infringement and whether the offender was at fault in a subsequent crash.Drivers had higher risks of crashes following infringement penalties [odds ratio (OR) 1.32; 95% confidence interval (CI) 1.29-1.36], especially crashes in which the offender was at fault (1.41; 1.36-1.46). Crash risk relative to a comparable period was particularly high for teenage drivers (1.55; 1.34-1.78) and among drivers penalized for dangerous driving (3.19; 2.52-4.03) or driving under the influence of alcohol (1.99; 1.67-2.37). The risk remained relatively high for more than 6 months after the penalty, but declined steadily over this period.Crash risk among drivers in Queensland was higher, not lower, following receipt of penalties for traffic infringements. Penalties themselves are unlikely to increase crash risk. A more likely explanation is that penalties (or the corresponding infringements) mark episodes of risky driving. Our findings suggest that such episodes trounce any deterrent effect penalties may produce.

  View details for DOI 10.1093/ije/dyv148

  View details for Web of Science ID 000367178000039

• Will Divestment from Employment-Based Health Insurance Save Employers Money? The Case of State and Local Governments JOURNAL OF EMPIRICAL LEGAL STUDIES Goldhaber-Fiebert, J. D., Studdert, D. M., Farid, M. S., Bhattacharya, J. 2015; 12 (3): 343-394

  View details for DOI 10.1111/jels.12076

  View details for Web of Science ID 000360209700001

• Shifting Vaccination Politics - The End of Personal-Belief Exemptions in California NEW ENGLAND JOURNAL OF MEDICINE Mello, M. M., Studdert, D. M., Parmet, W. E. 2015; 373 (9): 785-787

  View details for DOI 10.1056/NEJMp1508701

  View details for Web of Science ID 000360171700002

  View details for PubMedID 26200843

• Compensation Seeking and Disability After Injury: The Role of Compensation-Related Stress and Mental Health JOURNAL OF CLINICAL PSYCHIATRY O'Donnell, M. L., Grant, G., Alkemade, N., Spittal, M., Creamer, M., Silove, D., McFarlane, A., Bryant, R. A., Forbes, D., Studdert, D. M. 2015; 76 (8): E1000-?

  Abstract

  Claiming for compensation after injury is associated with poor health outcomes. This study examined the degree to which compensation-related stress predicts long-term disability and the mental health factors that contribute to this relationship.In a longitudinal, multisite cohort study, 332 injury patients (who claimed for compensation) recruited from April 2004 to February 2006 were assessed during hospitalization and at 3 and 72 months after injury. Posttraumatic stress, depression, and anxiety symptoms (using the Mini-International Neuropsychiatric Interview) were assessed at 3 months; compensation-related stress and disability levels (using the World Health Organization Disability Assessment Schedule II) were assessed at 72 months.A significant direct relationship was found between levels of compensation-related stress and levels of long-term disability (β = 0.35, P < .001). Three-month posttraumatic stress symptoms had a significant relationship with compensation-related stress (β = 0.29, P < .001) as did 3-month depression symptoms (β = 0.39, P < .001), but 3-month anxiety symptoms did not. A significant indirect relationship was found for posttraumatic stress symptoms and disability via compensation stress (β = 0.099, P = .001) and for depression and disability via compensation stress (β = 0.136, P < .001).Stress associated with seeking compensation is significantly related to long-term disability. Posttraumatic stress and depression symptoms increase the perception of stress associated with the claims process, which in turn is related to higher levels of long-term disability. Early interventions targeting those at risk for compensation-related stress may decrease long-term costs for compensation schemes.

  View details for DOI 10.4088/JCP.14m09211

  View details for Web of Science ID 000361593800002

  View details for PubMedID 26335085

• Searching for Public Health Law's Sweet Spot: The Regulation of Sugar-Sweetened Beverages. PLoS medicine Studdert, D. M., Flanders, J., Mello, M. M. 2015; 12 (7)

  Abstract

  David Studdert and colleagues explore how to balance public health, individual freedom, and good government when it comes to sugar-sweetened drinks.

  View details for DOI 10.1371/journal.pmed.1001848

  View details for PubMedID 26151360

  View details for PubMedCentralID PMC4494810

• Searching for Public Health Law's Sweet Spot: The Regulation of Sugar-Sweetened Beverages. PLoS medicine Studdert, D. M., Flanders, J., Mello, M. M. 2015; 12 (7): e1001848

  Abstract

  David Studdert and colleagues explore how to balance public health, individual freedom, and good government when it comes to sugar-sweetened drinks.

  View details for DOI 10.1371/journal.pmed.1001848

  View details for PubMedID 26151360

  View details for PubMedCentralID PMC4494810

• Survival of the fittest: retrospective cohort study of the longevity of Olympic medallists in the modern era BRITISH JOURNAL OF SPORTS MEDICINE Clarke, P. M., Walter, S. J., Hayen, A., Mallon, W. J., Heijmans, J., Studdert, D. M. 2015; 49 (13): 898-902

  Abstract

  To determine whether Olympic medallists live longer than the general population.Retrospective cohort study, with passive follow-up and conditional survival analysis to account for unidentified loss to follow-up.15 174 Olympic athletes from nine country groups (United States, Germany, Nordic countries, Russia, United Kingdom, France, Italy, Canada, and Australia and New Zealand) who won medals in the Olympic Games held in 1896-2010. Medallists were compared with matched cohorts in the general population (by country, age, sex, and year of birth).Relative conditional survival.More medallists than matched controls in the general population were alive 30 years after winning (relative conditional survival 1.08,95% confidence interval 1.07 to1.10). Medallists lived an average of2.8 years longer than controls. Medallists in eight of the nine country groups had a significant survival advantage compared with controls. Gold, silver, and bronze medallists each enjoyed similar sized survival advantages. Medallists in endurance sports and mixed sports had a larger survival advantage over controls at 30 years (1.13, 1.09 to 1.17; 1.11,1.09 to 1.13) than that of medallists in power sports (1.05,1.01 to 1.08).Olympic medallists live longer than the general population, irrespective of country, medal, or sport. This study was not designed to explain this effect, but possible explanations include genetic factors, physical activity, healthy lifestyle, and the wealth and status that come with international sporting glory.

  View details for DOI 10.1136/bjsports-2015-e8308rep

  View details for Web of Science ID 000356361400013

  View details for PubMedID 26084528

• Emergency Medical Treatment and Labor Act What Every Physician Should Know About the Federal Antidumping Law CHEST Hyman, D. A., Studdert, D. M. 2015; 147 (6): 1691-1696

  Abstract

  Since 1986, the Emergency Medical Treatment and Labor Act (EMTALA) has imposed an obligation on hospitals and physicians to evaluate and stabilize patients who present to a hospital ED seeking care. Available sanctions for noncompliance include fines, damages awarded in civil litigation, and exclusion from Medicare. EMTALA uses several terms that are familiar to physicians (eg, "emergency medical condition," "stabilize," and "transfer"), but the statutory definitions do not map neatly onto the way in which these terms are used and understood in clinical settings. Thus, there is potential for a mismatch between a physician's on-the-spot professional judgment and what the statute demands. We review what every physician should know about EMTALA and answer six common questions about the law.

  View details for DOI 10.1378/chest.14-2046

  View details for Web of Science ID 000355837900051

  View details for PubMedID 26033130

• The PRONE score: an algorithm for predicting doctors' risks of formal patient complaints using routinely collected administrative data BMJ QUALITY & SAFETY Spittal, M. J., Bismark, M. M., Studdert, D. M. 2015; 24 (6): 360-368

  Abstract

  Medicolegal agencies-such as malpractice insurers, medical boards and complaints bodies-are mostly passive regulators; they react to episodes of substandard care, rather than intervening to prevent them. At least part of the explanation for this reactive role lies in the widely recognised difficulty of making robust predictions about medicolegal risk at the individual clinician level. We aimed to develop a simple, reliable scoring system for predicting Australian doctors' risks of becoming the subject of repeated patient complaints.Using routinely collected administrative data, we constructed a national sample of 13,849 formal complaints against 8424 doctors. The complaints were lodged by patients with state health service commissions in Australia over a 12-year period. We used multivariate logistic regression analysis to identify predictors of subsequent complaints, defined as another complaint occurring within 2 years of an index complaint. Model estimates were then used to derive a simple predictive algorithm, designed for application at the doctor level.The PRONE (Predicted Risk Of New Event) score is a 22-point scoring system that indicates a doctor's future complaint risk based on four variables: a doctor's specialty and sex, the number of previous complaints and the time since the last complaint. The PRONE score performed well in predicting subsequent complaints, exhibiting strong validity and reliability and reasonable goodness of fit (c-statistic=0.70).The PRONE score appears to be a valid method for assessing individual doctors' risks of attracting recurrent complaints. Regulators could harness such information to target quality improvement interventions, and prevent substandard care and patient dissatisfaction. The approach we describe should be replicable in other agencies that handle large numbers of patient complaints or malpractice claims.

  View details for DOI 10.1136/bmjqs-2014-003834

  View details for Web of Science ID 000355207300004

  View details for PubMedID 25855664

  View details for PubMedCentralID PMC4453507

• Medical liability and reporting malpractice payments--reply. JAMA Mello, M. M., Studdert, D. M., Kachalia, A. 2015; 313 (10): 1058-1059

  View details for DOI 10.1001/jama.2015.0688

  View details for PubMedID 25756448

• Global Health Law (Book Review) MILBANK QUARTERLY Book Review Authored by: Studdert, D. M. 2015; 93 (1): 211-214

  View details for DOI 10.1111/1468-0009.12110

  View details for Web of Science ID 000350752800015

• A step towards evidence-based regulation of health practitioners AUSTRALIAN HEALTH REVIEW Bismark, M. M., Fletcher, M., Spittal, M. J., Studdert, D. M. 2015; 39 (4): 483-485

  Abstract

  In 2010 Australia established a national registration and accreditation scheme, covering more than 620 000 health practitioners. The data held by the Australian Health Practitioner Regulation Agency is a remarkable platform for research aimed at improving health practitioner regulation, health care quality and workforce planning.

  View details for DOI 10.1071/AH14222

  View details for Web of Science ID 000360660800023

• A step towards evidence-based regulation of health practitioners. Australian health review : a publication of the Australian Hospital Association Bismark, M. M., Fletcher, M., Spittal, M. J., Studdert, D. M. 2015; 39 (4): 483–85

  Abstract

  In 2010 Australia established a national registration and accreditation scheme, covering more than 620 000 health practitioners. The data held by the Australian Health Practitioner Regulation Agency is a remarkable platform for research aimed at improving health practitioner regulation, health care quality and workforce planning.

  View details for PubMedID 25796534

• The Medical Liability Climate and Prospects for Reform JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Mello, M. M., Studdert, D. M., Kachalia, A. 2014; 312 (20): 2146-2155

  Abstract

  For many physicians, the prospect of being sued for medical malpractice is a singularly disturbing aspect of modern clinical practice. State legislatures have enacted tort reforms, such as caps on damages, in an effort to reduce the volume and costs of malpractice litigation. Attempts to introduce similar traditional reform measures at the federal level have so far failed. Much less prominent, but potentially more important, are proposed alternative approaches for resolving medical injuries; a number of these efforts are currently being tested in federally sponsored demonstration projects. These nontraditional reforms have considerable promise for addressing some of the system's most challenging issues, including high costs and barriers to accessing compensation. In this Special Communication, we review recent national trends in medical liability claims and costs, which indicate a sharp reduction in the rate of paid claims and flat or declining levels in compensation payments and liability insurance costs over the last 7 to 10 years. We discuss a number of nontraditional reform approaches--communication-and-resolution programs, presuit notification and apology laws, safe harbor legislation, judge-directed negotiation, and administrative compensation systems--and we conclude by describing several forces likely to shape change in the medical liability environment over the next decade.

  View details for DOI 10.1001/jama.2014.10705

  View details for Web of Science ID 000345626800018

• Mandatory reports of concerns about the health, performance and conduct of health practitioners MEDICAL JOURNAL OF AUSTRALIA Bismark, M. M., Spittal, M. J., Plueckhahn, T. M., Studdert, D. M. 2014; 201 (7): 399-403

  Abstract

  To describe the frequency and characteristics of mandatory reports about the health, competence and conduct of registered health practitioners in Australia.Retrospective review and multivariate analysis of allegations of "notifiable conduct" involving health practitioners received by the Australian Health Practitioner Regulation Agency (AHPRA) between 1 November 2011 and 31 December 2012.Statutory grounds for reports, types of behaviour reported, and incidence of notifications by profession, sex, age, jurisdiction and geographic area.Of 819 mandatory notifications made during the study period, 501 (62%) related to perceived departures from accepted professional standards, mostly standards of clinical care. Nurses and doctors dominated notifications: 89% (727/819) involved a doctor or nurse in the role of notifier and/or respondent. Health professionals other than the respondents' treating practitioners made 46% of notifications (335/731), and the profession of the notifier and respondent was the same in 80% of cases (557/697). Employers made 46% of notifications (333/731). Psychologists had the highest rate of notifications, followed by medical practitioners, and then nurses and midwives (47, 41 and 40 reports per 10 000 practitioners per year, respectively). Incidence of notifications against men was more than two-and-a-half times that for women (46 v 17 reports per 10 000 practitioners per year; P < 0.001) and there was fivefold variation in incidence across states and territories.Although Australia's mandatory reporting regime is in its infancy, our data suggest that some of the adverse effects and manifest benefits forecast by critics and supporters, respectively, have not materialised. Further research should explore the variation in notification rates observed, evaluate the outcomes of reports, and test the effects of the mandatory reporting law on whistleblowing and help-seeking behaviour.

  View details for DOI 10.5594/mja14.00210

  View details for Web of Science ID 000344137400017

• Governance of quality of care: a qualitative study of health service boards in Victoria, Australia BMJ QUALITY & SAFETY Bismark, M. M., Studdert, D. M. 2014; 23 (6): 474–82

  Abstract

  To describe the engagement of health service boards with quality-of-care issues and to identify factors that influence boards' activities in this area.We conducted semistructured interviews with 35 board members and executives from 13 public health services in Victoria, Australia. Interviews focused on the role currently played by boards in overseeing quality of care. We also elicited interviewees' perceptions of factors that have influenced their current approach to governance in this area. Thematic analysis was used to identify key themes from interview transcripts.Virtually all interviewees believed boards had substantial opportunities to influence the quality of care delivered within the service, chiefly through setting priorities, monitoring progress, holding staff to account and shaping culture. Perceived barriers to leveraging this influence included insufficient resources, gaps in skills and experience among board members, inadequate information on performance and regulatory requirements that miss the mark. Interviewees converged on four enablers of more effective quality governance: stronger regional collaborations; more tailored board training on quality issues; smarter use of reporting and accreditation requirements; and better access to data that was reliable, longitudinal and allowed for benchmarking against peer organisations.Although health service boards are eager to establish quality of care as a governance priority, several obstacles are blocking progress. The result is a gap between the rhetoric of quality governance and the reality of month-to-month activities at the board level. The imperative for effective board-level engagement in this area cannot be met until these barriers are addressed.

  View details for DOI 10.1136/bmjqs-2013-002193

  View details for Web of Science ID 000336914900006

  View details for PubMedID 24327735

  View details for PubMedCentralID PMC4033274

• The Repeated Episodes of Self-Harm (RESH) score: A tool for predicting risk of future episodes of self-harm by hospital patients JOURNAL OF AFFECTIVE DISORDERS Spittal, M. J., Pirkis, J., Miller, M., Carter, G., Studdert, D. M. 2014; 161: 36–42

  Abstract

  Repetition of hospital-treated deliberate self-harm is common. Several recent studies have used emergency department data to develop clinical tools to assess risk of self-harm or suicide. Longitudinal, linked inpatient data is an alternative source of information.We identified all individuals admitted to hospital for deliberate self-harm in two Australian states (~350 hospitals). The outcome of interest was a repeated episode of self-harm (non-fatal or fatal) within 6 months. Logistic regression was used to identify a set of predictors of repetition. A risk calculator (RESH: Repeated Episodes of Self-Harm) was derived directly from model coefficients.There were 84,659 episodes of self-harm during the study period. Four variables - number of prior episodes, time between episodes, prior psychiatric diagnoses and recent psychiatric hospital stay - strongly predicted repetition. The RESH score showed good discrimination (AUC=0.75) and had high specificity. Patients with scores of 0-3 had 14% risk of repeat episodes, whereas patients with scores of 20-25 had over 80% risk. We identified five thresholds where the RESH score could be used for prioritising interventions.The trade-off of a highly specific test is that the instrument has poor sensitivity. As a consequence, the RESH score cannot be used reliably for "ruling out" those who score below the thresholds.The RESH score could be useful for prioritising patients to interventions to reduce readmission for deliberate self-harm. The five thresholds, representing the continuum from low to high risk, enable a stepped care model of overlapping or sequential interventions to be deployed to patients at risk of self-harm.

  View details for PubMedID 24751305

• Relationship Between Stressfulness of Claiming for Injury Compensation and Long-term Recovery: A Prospective Cohort Study. JAMA psychiatry Grant, G. M., O'Donnell, M. L., Spittal, M. J., Creamer, M., Studdert, D. M. 2014; 71 (4): 446-453

  Abstract

  IMPORTANCE Each year, millions of persons worldwide seek compensation for transport accident and workplace injuries. Previous research suggests that these claimants have worse long-term health outcomes than persons whose injuries fall outside compensation schemes. However, existing studies have substantial methodological weaknesses and have not identified which aspects of the claiming experience may drive these effects. OBJECTIVE To determine aspects of claims processes that claimants to transport accident and workers' compensation schemes find stressful and whether such stressful experiences are associated with poorer long-term recovery. DESIGN, SETTING, AND PARTICIPANTS Prospective cohort study of a random sample of 1010 patients hospitalized in 3 Australian states for injuries from 2004 through 2006. At 6-year follow-up, we interviewed 332 participants who had claimed compensation from transport accident and workers' compensation schemes ("claimants") to determine which aspects of the claiming experience they found stressful. We used multivariable regression analysis to test for associations between compensation-related stress and health status at 6 years, adjusting for baseline determinants of long-term health status and predisposition to stressful experiences (via propensity scores). MAIN OUTCOMES AND MEASURES Disability, quality of life, anxiety, and depression. RESULTS Among claimants, 33.9% reported high levels of stress associated with understanding what they needed to do for their claim; 30.4%, with claim delays; 26.9%, with the number of medical assessments; and 26.1%, with the amount of compensation they received. Six years after their injury, claimants who reported high levels of stress had significantly higher levels of disability (+6.94 points, World Health Organization Disability Assessment Schedule sum score), anxiety and depression (+1.89 points and +2.61 points, respectively, Hospital Anxiety and Depression Scale), and lower quality of life (-0.73 points, World Health Organization Quality of Life instrument, overall item), compared with other claimants. Adjusting for claimants' vulnerability to stress attenuated the strength of these associations, but most remained strong and statistically significant. CONCLUSIONS AND RELEVANCE Many claimants experience high levels of stress from engaging with injury compensation schemes, and this experience is positively correlated with poor long-term recovery. Intervening early to boost resilience among those at risk of stressful claims experiences and redesigning compensation processes to reduce their stressfulness may improve recovery and save money.

  View details for DOI 10.1001/jamapsychiatry.2013.4023

  View details for PubMedID 24522841

• Relationship Between Stressfulness of Claiming for Injury Compensation and Long-term Recovery JAMA PSYCHIATRY Grant, G. M., O'Donnell, M. L., Spittal, M. J., Creamer, M., Studdert, D. M. 2014; 71 (4): 446-453

  Abstract

  IMPORTANCE Each year, millions of persons worldwide seek compensation for transport accident and workplace injuries. Previous research suggests that these claimants have worse long-term health outcomes than persons whose injuries fall outside compensation schemes. However, existing studies have substantial methodological weaknesses and have not identified which aspects of the claiming experience may drive these effects. OBJECTIVE To determine aspects of claims processes that claimants to transport accident and workers' compensation schemes find stressful and whether such stressful experiences are associated with poorer long-term recovery. DESIGN, SETTING, AND PARTICIPANTS Prospective cohort study of a random sample of 1010 patients hospitalized in 3 Australian states for injuries from 2004 through 2006. At 6-year follow-up, we interviewed 332 participants who had claimed compensation from transport accident and workers' compensation schemes ("claimants") to determine which aspects of the claiming experience they found stressful. We used multivariable regression analysis to test for associations between compensation-related stress and health status at 6 years, adjusting for baseline determinants of long-term health status and predisposition to stressful experiences (via propensity scores). MAIN OUTCOMES AND MEASURES Disability, quality of life, anxiety, and depression. RESULTS Among claimants, 33.9% reported high levels of stress associated with understanding what they needed to do for their claim; 30.4%, with claim delays; 26.9%, with the number of medical assessments; and 26.1%, with the amount of compensation they received. Six years after their injury, claimants who reported high levels of stress had significantly higher levels of disability (+6.94 points, World Health Organization Disability Assessment Schedule sum score), anxiety and depression (+1.89 points and +2.61 points, respectively, Hospital Anxiety and Depression Scale), and lower quality of life (-0.73 points, World Health Organization Quality of Life instrument, overall item), compared with other claimants. Adjusting for claimants' vulnerability to stress attenuated the strength of these associations, but most remained strong and statistically significant. CONCLUSIONS AND RELEVANCE Many claimants experience high levels of stress from engaging with injury compensation schemes, and this experience is positively correlated with poor long-term recovery. Intervening early to boost resilience among those at risk of stressful claims experiences and redesigning compensation processes to reduce their stressfulness may improve recovery and save money.

  View details for DOI 10.1001/jamapsychiatry.2013.4023

  View details for Web of Science ID 000335926500016

• What happens to coroners' recommendations for improving public health and safety? Organisational responses under a mandatory response regime in Victoria, Australia. BMC public health Sutherland, G., Kemp, C., Bugeja, L., Sewell, G., Pirkis, J., Studdert, D. M. 2014; 14: 732-?

  Abstract

  Several countries of the British Commonwealth, including Australia and the United Kingdom, vest in coroners the power to issue recommendations for protecting public health and safety. Little is known about whether and how organisations that receive recommendations act on them. Concerns that recommendations are frequently ignored prompted the government of Victoria, Australia, to introduce a requirement in 2008 compelling organisations that receive recommendations to provide a written statement of action.We conducted a prospective study of organisations that received recommendations from Victorian coroners over a 33-month period. Using an online survey, we asked representatives of "recipient organisations" what action (if any) their organisations took, and what factors influenced their decision. We also probed views of the quality of the recommendations and the mandatory response regime in general. Responses were analysed at the recommendation- and recipient organisation-level by calculating counts and proportions and using chi-square analyses to test for sub-group differences.Ninety of 153 recipient organisations surveyed responded (59% response rate); they received 164 recommendations (mean = 1.9; range, 1-7) from 74 cases. A total of 37% (60/164) of the recommendations were accepted and implemented, 27% (45/164) were rejected, and for 36% (59/164) the recommended action was "supplanted" (i.e., action had already been taken). In nearly half of rejected recommendations (18/45), recipient organisations indicated implementation was not logistically viable. In half of supplanted recommendations, an internal investigation had prompted the action. Three quarters (67/90) of recipient organisations believed the introduction of a mandatory response regime was a good idea, but fewer regarded the recommendations they received as appropriate (52/90) or likely to be effective in preventing death and injury (45/90).Only a third of coroners' recommendations were implemented by the organisations to which they were directed. In drawing policy lessons, it is important to separate recommendations that were rejected from those in which action had already been taken. Rejected recommendations raise questions about the quality of the recommendations, the reasonableness of the organisation's response, or both. Supplanted recommendations focus attention on the adequacy of consultation between coroners and affected organisations and the length of time it takes for recommendations to be issued.

  View details for DOI 10.1186/1471-2458-14-732

  View details for PubMedID 25037095

• Mandatory reports of concerns about the health, performance and conduct of health practitioners. The Medical journal of Australia Bismark, M. M., Spittal, M. J., Plueckhahn, T. M., Studdert, D. M. 2014; 201 (7): 399–403

  Abstract

  To describe the frequency and characteristics of mandatory reports about the health, competence and conduct of registered health practitioners in Australia.Retrospective review and multivariate analysis of allegations of "notifiable conduct" involving health practitioners received by the Australian Health Practitioner Regulation Agency (AHPRA) between 1 November 2011 and 31 December 2012.Statutory grounds for reports, types of behaviour reported, and incidence of notifications by profession, sex, age, jurisdiction and geographic area.Of 819 mandatory notifications made during the study period, 501 (62%) related to perceived departures from accepted professional standards, mostly standards of clinical care. Nurses and doctors dominated notifications: 89% (727/819) involved a doctor or nurse in the role of notifier and/or respondent. Health professionals other than the respondents' treating practitioners made 46% of notifications (335/731), and the profession of the notifier and respondent was the same in 80% of cases (557/697). Employers made 46% of notifications (333/731). Psychologists had the highest rate of notifications, followed by medical practitioners, and then nurses and midwives (47, 41 and 40 reports per 10 000 practitioners per year, respectively). Incidence of notifications against men was more than two-and-a-half times that for women (46 v 17 reports per 10 000 practitioners per year; P < 0.001) and there was fivefold variation in incidence across states and territories.Although Australia's mandatory reporting regime is in its infancy, our data suggest that some of the adverse effects and manifest benefits forecast by critics and supporters, respectively, have not materialised. Further research should explore the variation in notification rates observed, evaluate the outcomes of reports, and test the effects of the mandatory reporting law on whistleblowing and help-seeking behaviour.

  View details for PubMedID 25296061

• Making the Case for Health-Enhancing Laws after Bloomberg HASTINGS CENTER REPORT Mello, M. M., Studdert, D. M. 2014; 44 (1): 8

  View details for PubMedID 24408591

• In response to 'Correspondence: Identification of doctors at risk of recurrent complaints: a national study of healthcare complaints in Australia' BMJ QUALITY & SAFETY Bismark, M. M., Spittal, M. J., Studdert, D. M. 2013; 22 (10): 879–80

  View details for DOI 10.1136/bmjqs-2013-002340

  View details for Web of Science ID 000326659100014

  View details for PubMedID 24048617

• Identification of doctors at risk of recurrent complaints: a national study of healthcare complaints in Australia BMJ QUALITY & SAFETY Bismark, M. M., Spittal, M. J., Gurrin, L. C., Ward, M., Studdert, D. M. 2013; 22 (7): 532–40

  Abstract

  (1) To determine the distribution of formal patient complaints across Australia's medical workforce and (2) to identify characteristics of doctors at high risk of incurring recurrent complaints.We assembled a national sample of all 18 907 formal patient complaints filed against doctors with health service ombudsmen ('Commissions') in Australia over an 11-year period. We analysed the distribution of complaints among practicing doctors. We then used recurrent-event survival analysis to identify characteristics of doctors at high risk of recurrent complaints, and to estimate each individual doctor's risk of incurring future complaints.The distribution of complaints among doctors was highly skewed: 3% of Australia's medical workforce accounted for 49% of complaints and 1% accounted for a quarter of complaints. Short-term risks of recurrence varied significantly among doctors: there was a strong dose-response relationship with number of previous complaints and significant differences by doctor specialty and sex. At the practitioner level, risks varied widely, from doctors with <10% risk of further complaints within 2 years to doctors with >80% risk.A small group of doctors accounts for half of all patient complaints lodged with Australian Commissions. It is feasible to predict which doctors are at high risk of incurring more complaints in the near future. Widespread use of this approach to identify high-risk doctors and target quality improvement efforts coupled with effective interventions, could help reduce adverse events and patient dissatisfaction in health systems.

  View details for PubMedID 23576774

  View details for PubMedCentralID PMC3711360

• Does Litigation Increase or Decrease Health Care Quality? A National Study of Negligence Claims Against Nursing Homes MEDICAL CARE Stevenson, D. G., Spittal, M. J., Studdert, D. M. 2013; 51 (5): 430-436

  Abstract

  The tort system is supposed to help improve the quality and safety of health care, but whether it actually does so is controversial. Most previous studies modeling the effect of negligence litigation on quality of care are ecologic.To assess whether the experience of being sued and incurring litigation costs affects the quality of care subsequently delivered in nursing homes.We linked information on 6471 negligence claims brought against 1514 nursing homes between 1998 and 2010 to indicators of nursing home quality drawn from 2 US national datasets (Online Survey, Certification, and Reporting system; Minimum Data Set Quality Measure/Indicator Reports). At the facility level, we tested for associations between 9 quality measures and 3 variables indicating the nursing homes' litigation experience in the preceding 12-18 months (total indemnity payments; total indemnity payments plus administrative costs; ≥ 1 paid claims vs. none). The analyses adjusted for quality at baseline, case-mix, ownership, occupancy, year, and facility and state random effects.Nearly all combinations of the 3 litigation exposure measures and 9 quality measures--27 models in all--showed an inverse relationship between litigation costs and quality. However, only a few of these associations were statistically significant, and the effect sizes were very small. For example, a doubling of indemnity payments was associated with a 1.1% increase in the number of deficiencies and a 2.2% increase in pressure ulcer rates.Tort litigation does not increase the quality performance of nursing homes, and may decrease it slightly.

  View details for DOI 10.1097/MLR.0b013e3182881ccc

  View details for Web of Science ID 000317653900010

  View details for PubMedID 23552438

• IDENTIFICATION OF DOCTORS AT RISK OF RECURRENT COMPLAINTS: A NATIONAL STUDY OF HEALTH CARE COMPLAINTS IN AUSTRALIA Bismark, M., Spittal, M., Ward, M., Studdert, D. WILEY-BLACKWELL. 2013: 3

  View details for Web of Science ID 000318911400007

• Patents Associated with High-Cost Drugs in Australia PLOS ONE Christie, A. F., Dent, C., McIntyre, P., Wilson, L., Studdert, D. M. 2013; 8 (4): e60812

  Abstract

  Australia, like most countries, faces high and rapidly-rising drug costs. There are longstanding concerns about pharmaceutical companies inappropriately extending their monopoly position by "evergreening" blockbuster drugs, through misuse of the patent system. There is, however, very little empirical information about this behaviour. We fill the gap by analysing all of the patents associated with 15 of the costliest drugs in Australia over the last 20 years. Specifically, we search the patent register to identify all the granted patents that cover the active pharmaceutical ingredient of the high-cost drugs. Then, we classify the patents by type, and identify their owners. We find a mean of 49 patents associated with each drug. Three-quarters of these patents are owned by companies other than the drug's originator. Surprisingly, the majority of all patents are owned by companies that do not have a record of developing top-selling drugs. Our findings show that a multitude of players seek monopoly control over innovations to blockbuster drugs. Consequently, attempts to control drug costs by mitigating misuse of the patent system are likely to miss the mark if they focus only on the patenting activities of originators.

  View details for PubMedID 23577165

• The effectiveness of structural interventions at suicide hotspots: a meta-analysis INTERNATIONAL JOURNAL OF EPIDEMIOLOGY Pirkis, J., Spittal, M. J., Cox, G., Robinson, J., Cheung, Y., Studdert, D. 2013; 42 (2): 541–48

  Abstract

  Certain sites have gained notoriety as 'hotspots' for suicide by jumping. Structural interventions (e.g. barriers and safety nets) have been installed at some of these sites. Individual studies examining the effectiveness of these interventions have been underpowered.We conducted a meta-analysis, pooling data from nine studies.Following the interventions, there was an 86% reduction in jumping suicides per year at the sites in question (95% CI 79% to 91%). There was a 44% increase in jumping suicides per year at nearby sites (95% CI 15% to 81%), but the net gain was a 28% reduction in all jumping suicides per year in the study cities (95% CI 13% to 40%).Structural interventions at 'hotspots' avert suicide at these sites. Some increases in suicide are evident at neighbouring sites, but there is an overall gain in terms of a reduction in all suicides by jumping.

  View details for PubMedID 23505253

• Risks of complaints and adverse disciplinary findings against international medical graduates in Victoria and Western Australia REPLY MEDICAL JOURNAL OF AUSTRALIA Studdert, D. M., Spittal, M. J., Elkin, K. 2013; 198 (5): 258

  View details for DOI 10.5694/mja12.11624

  View details for Web of Science ID 000316846300013

  View details for PubMedID 23496396

• The role of boards in clinical governance: activities and attitudes among members of public health service boards in Victoria AUSTRALIAN HEALTH REVIEW Bismark, M. M., Walter, S. J., Studdert, D. M. 2013; 37 (5): 682–87

  Abstract

  To determine the nature and extent of governance activities by health service boards in relation to quality and safety of care and to gauge the expertise and perspectives of board members in this area.This study used an online and postal survey of the Board Chair, Quality Committee Chair and two randomly selected members from the boards of all 85 health services in Victoria. Seventy percent (233/332) of members surveyed responded and 96% (82/85) of boards had at least one member respond.Most boards had quality performance as a standing item on meeting agendas (79%) and reviewed data on medication errors and hospital-acquired infections at least quarterly (77%). Fewer boards benchmarked their service's quality performance against external comparators (50%) or offered board members formal training on quality (53%). Eighty-two percent of board members identified quality as a top priority for board oversight, yet members generally considered their boards to be a relatively minor force in shaping the quality of care. There was a positive correlation between the size of health services (total budget, inpatient separations) and their board's level of engagement in quality-related activities. Ninety percent of board members indicated that additional training in quality and safety would be 'moderately useful' or 'very useful'. Almost every respondent believed the overall quality of care their service delivered was as good as, or better than, the typical Victorian health service.Collectively, health service boards are engaged in an impressive range of clinical governance activities. However, the extent of engagement is uneven across boards, certain knowledge deficits are evident and there was wide agreement among board members that further training in quality-related issues would be useful.

  View details for PubMedID 24183262

• THE INJURY BROKERS: AN EMPIRICAL PROFILE OF MEDICAL EXPERT WITNESSES IN PERSONAL INJURY LITIGATION MELBOURNE UNIVERSITY LAW REVIEW Grant, G., Studdert, D. M. 2013; 36 (3): 831–70

  View details for Web of Science ID 000322535200002

• Survival of the fittest: retrospective cohort study of the longevity of Olympic medallists in the modern era BRITISH MEDICAL JOURNAL Clarke, P. M., Walter, S. J., Hayen, A., Mallon, W. J., Heijmans, J., Studdert, D. M. 2012; 345: e8308

  Abstract

  To determine whether Olympic medallists live longer than the general population.Retrospective cohort study, with passive follow-up and conditional survival analysis to account for unidentified loss to follow-up.15,174 Olympic athletes from nine country groups (United States, Germany, Nordic countries, Russia, United Kingdom, France, Italy, Canada, and Australia and New Zealand) who won medals in the Olympic Games held in 1896-2010. Medallists were compared with matched cohorts in the general population (by country, age, sex, and year of birth).Relative conditional survival.More medallists than matched controls in the general population were alive 30 years after winning (relative conditional survival 1.08, 95% confidence interval 1.07 to 1.10). Medallists lived an average of 2.8 years longer than controls. Medallists in eight of the nine country groups had a significant survival advantage compared with controls. Gold, silver, and bronze medallists each enjoyed similar sized survival advantages. Medallists in endurance sports and mixed sports had a larger survival advantage over controls at 30 years (1.13, 1.09 to 1.17; 1.11, 1.09 to 1.13) than that of medallists in power sports (1.05, 1.01 to 1.08).Olympic medallists live longer than the general population, irrespective of country, medal, or sport. This study was not designed to explain this effect, but possible explanations include genetic factors, physical activity, healthy lifestyle, and the wealth and status that come with international sporting glory.

  View details for PubMedID 23241272

• Removal of doctors from practice for professional misconduct in Australia and New Zealand BMJ QUALITY & SAFETY Elkin, K., Spittal, M. J., Elkin, D., Studdert, D. M. 2012; 21 (12): 1027–33

  Abstract

  To examine how disciplinary tribunals assess different forms of misconduct in deciding whether to remove doctors from practice for professional misconduct.Multivariable regression analysis of 485 cases in which tribunals found doctors guilty of professional misconduct. The cases came from four Australian states (New South Wales, Victoria, Queensland and Western Australia) and New Zealand and were decided over a 10-year period (1 January 2000 - 30 September 2009).Type of misconduct, the tribunal's explanation for why the misconduct occurred, and the disciplinary measure imposed.43% of the cases resulted in removal of the offending doctor from practice, 37% in restrictions on practice and 19% in non-restrictive sanctions. The odds of removal were very high in cases involving sexual relationships with patients (OR 22.59; 95% CI 10.18 to 50.14) and moderately high in cases involving inappropriate sexual conduct (not in the context of a relationship), commission of criminal offences, and forms of inappropriate conduct unrelated to patients. Cases in which the misconduct was judged to be due to willful wrongdoing (OR 17.14; 95% CI 8.62 to 34.09), incompetence (OR 6.02; 95% CI 2.87 to 12.63) and issues in the doctor's personal life (OR 4.17; 95% CI 2.07 to 8.41) also had higher odds removal from practice.Tribunals in Australia and New Zealand tend to remove doctors from practice for behaviours indicative of character flaws and lack of insight, rather than behaviours exhibiting errors in care delivery, poor clinical judgement or lack of knowledge. The generalisability of these findings to regulatory regimes for health practitioners in other countries should be tested.

  View details for PubMedID 22822240

• Leave entitlements, time off work and the household financial impacts of quarantine compliance during an H1N1 outbreak BMC INFECTIOUS DISEASES Kavanagh, A. M., Mason, K. E., Bentley, R. J., Studdert, D. M., McVernon, J., Fielding, J. E., Petrony, S., Gurrin, L., LaMontagne, A. D. 2012; 12: 311

  Abstract

  The Australian state of Victoria, with 5.2 million residents, enforced home quarantine during a H1N1 pandemic in 2009. The strategy was targeted at school children. The objective of this study was to investigate the extent to which parents' access to paid sick leave or paid carer's leave was associated with (a) time taken off work to care for quarantined children, (b) household finances, and (c) compliance with quarantine recommendations.We conducted an online and telephone survey of households recruited through 33 schools (85% of eligible schools), received 314 responses (27%), and analysed the subsample of 133 households in which all resident parents were employed.In 52% of households, parents took time off work to care for quarantined children. Households in which no resident parent had access to leave appeared to be less likely to take time off work (42% vs 58%, p=0.08) although this difference had only borderline significance. Among parents who did take time off work, those in households without access to leave were more likely to lose pay (73% vs 21%, p<0.001). Of the 26 households in which a parent lost pay due to taking time off work, 42% experienced further financial consequences such as being unable to pay a bill. Access to leave did not predict compliance with quarantine recommendations.Future pandemic plans should consider the economic costs borne by households and options for compensating quarantined families for income losses.

  View details for PubMedID 23164090

• Legal disputes over informed consent for cosmetic procedures: A descriptive study of negligence claims and complaints in Australia JOURNAL OF PLASTIC RECONSTRUCTIVE AND AESTHETIC SURGERY Bismark, M. M., Gogos, A. J., McCombe, D., Clark, R. B., Gruen, R. L., Studdert, D. M. 2012; 65 (11): 1506–12

  Abstract

  Plastic surgeons and other doctors who perform cosmetic procedures face relatively high risks of malpractice claims and complaints. In particular, alleged problems with the consent process abound in this area, but little is known about the clinical circumstances of these cases.We reviewed 481 malpractice claims and serious health care complaints resolved in Australia between 2002 and 2008 that alleged failures in the informed consent process for cosmetic and other procedures. We identified all "cases" involving cosmetic procedures and reviewed them in-depth. We calculated their frequency, and described the treatments, allegations, and outcomes involved.A total of 16% (77/481) of the legal disputes over informed consent involved cosmetic procedures. In 70% (54/77) of these cases, patients alleged that the doctor failed to disclose risks of a particular complication, in 39% patients claimed that potential lack of benefit was not explained, and in 26% patients allegations centred on the process by which consent was sought. Five treatment types-liposuction, breast augmentation, face/neck lifts, eye/brow lifts, and rhinoplasty/septoplasty-featured in 70% (54/77) of the cases. Scarring (30/77) and the need for reoperation (18/77) were among the most prevalent adverse health outcomes at issue.A mix of factors "supercharges" the informed consent process for cosmetic procedures. Doctors who deliver these procedures should take special care to canvas the risks and possible outcomes that matter most to patients.

  View details for PubMedID 22652290

• Cognitive Errors and Logistical Breakdowns Contributing to Missed and Delayed Diagnoses of Breast and Colorectal Cancers: A Process Analysis of Closed Malpractice Claims JOURNAL OF GENERAL INTERNAL MEDICINE Poon, E. G., Kachalia, A., Puopolo, A., Gandhi, T. K., Studdert, D. M. 2012; 27 (11): 1416–23

  Abstract

  To erform a process analysis of missed and delayed diagnoses of breast and colorectal cancers to identify: (1) the cognitive and logistical factors that lead to these diagnostic errors, and (2) prevention strategies.Using 56 cases (43 breast, 13 colon) of missed and delayed diagnosis, we performed structured analyses to identify specific points in the diagnostic process in which errors occurred. Each error was classified as either a cognitive error or logistical breakdown. Finally, two physician-investigators identified strategies to prevent the errors in each case.Virtually all cases involved one or more cognitive errors (53/56, 95 %) and approximately half (31/56, 55 %) involved logistical breakdowns. The clinical activity most prone to cognitive error was the selection of the diagnostic strategy, both during the office visit (25/56, 45 %) and during interpretation of test results (22/50, 44 %). Arrangement of follow-up visits with a primary care physician (8/29, 28 %) or specialist physician (7/29, 26 %) were especially prone to logistical breakdowns. Adherence to current clinical guidelines could have prevented at least one error in 66 % of cases and assistance from a patient advocate could have prevented at least one error in 48 % of cases.Cognitive errors and logistical breakdowns are common among missed and delayed diagnoses of breast and colorectal cancers. Prevention strategies should focus on ensuring improving the effectiveness and use of clinical guidelines in the selection of diagnostic strategy, both during office visits and when interpreting test results. Tools to facilitate communication and to ensure that follow-up visits occur should also be considered.

  View details for DOI 10.1007/s11606-012-2107-4

  View details for Web of Science ID 000310161500008

  View details for PubMedID 22610909

  View details for PubMedCentralID PMC3475819

• Geographic variation in inquest rates in Australia HEALTH & PLACE Walter, S. J., Bugeja, L., Spittal, M. J., Studdert, D. M. 2012; 18 (6): 1430–35

  Abstract

  This paper examines the relationship between the remoteness of locations in which deaths occur and coroners' decisions to hold inquests. We analysed 16,242 deaths investigated by coroners in three Australian states over 7.5 yrs. We used a choropleth map to show inquest rates in each remoteness locality (excluding deaths for which inquests were mandated by statute). We then used adjusted logistic regression to assess the association between the remoteness of a death's location and the odds coroners would select it for investigation by inquest. We found the remoteness of a death's location strongly and positively predicts the chance that an inquest will be held. Like analogous findings in the delivery of health services, this small-area variation in legal decision making raises questions of appropriateness.

  View details for PubMedID 22959660

• Risks of complaints and adverse disciplinary findings against international medical graduates in Victoria and Western Australia MEDICAL JOURNAL OF AUSTRALIA Elkin, K., Spittal, M. J., Studdert, D. M. 2012; 197 (8): 448–52

  Abstract

  To determine whether international medical graduates (IMGs) have more complaints made against them to medical boards and experience more adverse disciplinary findings than Australian-trained doctors.Data on all complaints made against doctors to medical boards in VICtoria and Western Australia over 7.5 years and 5.25 years, respectively, were extracted and linked with information on all doctors registered in those states over the same time periods. The data pertained to complaints resolved before February 2010 in Western Australia and June 2010 in VICtoria, the dates of the respective extractions. We tested for associations between IMG status and the incidence of complaints using multivariable logistic regression.Incidences of complaints and adverse disciplinary findings.Among 39 155 doctors registered in VICtoria and Western Australia in the study period, 5323 complaints were made against 3191 doctors. Thirty-seven per cent of registered doctors were IMGs. The odds of complaints were higher against IMGs than non-IMGs (odds ratio [OR], 1.24; 95% CI, 1.13-1.36; P < 0.001), as were the odds of adverse disciplinary findings (OR, 1.41; 95% CI, 1.07-1.85; P = 0.01). However, disaggregation of IMGs into their countries of qualification showed wide variation: doctors who qualified in Nigeria (OR, 4.02; 95% CI, 2.38-6.77), Egypt (OR, 2.32; 95% CI, 1.77-3.03), Poland (OR, 2.28; 95% CI, 1.43-3.61), Russia (OR, 2.21; 95% CI, 1.14-4.26), Pakistan (OR, 1.80; 95% CI, 1.09-2.98), the Philippines (OR, 1.80; 95% CI, 1.08-3.00) and India (OR, 1.61; 95% CI, 1.33-1.95) had higher odds of attracting complaints, but IMGs from the 13 other countries examined had odds that were not significantly different from Australian-trained doctors.Overall, IMGs are more likely than Australian-trained doctors to attract complaints to medical boards and adverse disciplinary findings, but the risks differ markedly by country of training. Better understanding of such heterogeneity could inform a more evidence-based approach to registration and oversight rules.

  View details for PubMedID 23072241

• Contrasting coroners Respond CANADIAN MEDICAL ASSOCIATION JOURNAL Walter, S. J., Studdert, D. M. 2012; 184 (14): 1604

  View details for DOI 10.1503/cmaj.112-2053

  View details for Web of Science ID 000311316600034

• Declines in the Lethality of Suicide Attempts Explain the Decline in Suicide Deaths in Australia PLOS ONE Spittal, M. J., Pirkis, J., Miller, M., Studdert, D. M. 2012; 7 (9): e44565

  Abstract

  To investigate the epidemiology of a steep decrease in the incidence of suicide deaths in Australia.National data on suicide deaths and deliberate self-harm for the period 1994-2007 were obtained from the Australian Institute of Health and Welfare. We calculated attempt and death rates for five major methods and the lethality of these methods. Negative binomial regression was used to estimate the size and significance of method-specific time-trends in attempts and lethality.Hanging, motor vehicle exhaust and firearms were the most lethal methods, and together accounted for 72% of all deaths. The lethality of motor vehicle exhaust attempts decreased sharply (RR = 0.94 per year, 95% CI 0.93-0.95) while the motor vehicle exhaust attempt rate changed little; this combination of motor vehicle exhaust trends explained nearly half of the overall decline in suicide deaths. Hanging lethality also decreased sharply (RR = 0.96 per year, 95% CI 0.956-0.965) but large increases in hanging attempts negated the effect on death rates. Firearm lethality changed little while attempts decreased.Declines in the lethality of suicide attempts-especially attempts by motor vehicle exhaust and hanging-explain the remarkable decline in deaths by suicide in Australia since 1997.

  View details for PubMedID 22957084

• Legal Disputes over Duties to Disclose Treatment Risks to Patients: A Review of Negligence Claims and Complaints in Australia PLOS MEDICINE Bismark, M. M., Gogos, A. J., Clark, R. B., Gruen, R. L., Gawande, A. A., Studdert, D. M. 2012; 9 (8): e1001283

  View details for PubMedID 22879818

• Conflict of Interest Reporting by Authors Involved in Promotion of Off-Label Drug Use: An Analysis of Journal Disclosures PLOS MEDICINE Kesselheim, A. S., Wang, B., Studdert, D. M., Avorn, J. 2012; 9 (8)

  Abstract

  Litigation documents reveal that pharmaceutical companies have paid physicians to promote off-label uses of their products through a number of different avenues. It is unknown whether physicians and scientists who have such conflicts of interest adequately disclose such relationships in the scientific publications they author.We collected whistleblower complaints alleging illegal off-label marketing from the US Department of Justice and other publicly available sources (date range: 1996-2010). We identified physicians and scientists described in the complaints as having financial relationships with defendant manufacturers, then searched Medline for articles they authored in the subsequent three years. We assessed disclosures made in articles related to the off-label use in question, determined the frequency of adequate disclosure statements, and analyzed characteristics of the authors (specialty, author position) and articles (type, connection to off-label use, journal impact factor, citation count/year). We identified 39 conflicted individuals in whistleblower complaints. They published 404 articles related to the drugs at issue in the whistleblower complaints, only 62 (15%) of which contained an adequate disclosure statement. Most articles had no disclosure (43%) or did not mention the pharmaceutical company (40%). Adequate disclosure rates varied significantly by article type, with commentaries less likely to have adequate disclosure compared to articles reporting original studies or trials (adjusted odds ratio [OR] = 0.10, 95%CI = 0.02-0.67, p = 0.02). Over half of the authors (22/39, 56%) made no adequate disclosures in their articles. However, four of six authors with ≥ 25 articles disclosed in about one-third of articles (range: 10/36-8/25 [28%-32%]).One in seven authors identified in whistleblower complaints as involved in off-label marketing activities adequately disclosed their conflict of interest in subsequent journal publications. This is a much lower rate of adequate disclosure than has been identified in previous studies. The non-disclosure patterns suggest shortcomings with authors and the rigor of journal practices. Please see later in the article for the Editors' Summary.

  View details for DOI 10.1371/journal.pmed.1001280

  View details for Web of Science ID 000308494600001

  View details for PubMedID 22899894

  View details for PubMedCentralID PMC3413710

• Does Tort Law Improve the Health of Newborns, or Miscarry? A Longitudinal Analysis of the Effect of Liability Pressure on Birth Outcomes JOURNAL OF EMPIRICAL LEGAL STUDIES Yang, Y. T., Studdert, D. M., Subramanian, S. V., Mello, M. M. 2012; 9 (2): 217-245

  View details for DOI 10.1111/j.1740-1461.2012.01252.x

  View details for Web of Science ID 000303807100002

• Infant deaths due to heparin overdose: Time for a concerted action on prevention JOURNAL OF PAEDIATRICS AND CHILD HEALTH Monagle, P., Studdert, D. M., Newall, F. 2012; 48 (5): 380–81

  Abstract

  Heparin is one of the most commonly used drugs in tertiary paediatric centres. Across the last decade, targeted research has been directed towards improving the level of evidence supporting paediatric-specific recommendations for the use and management of heparin in infants and children. In contrast, little effort has been directed towards improving the safe use of heparin despite a plethora of fatal and non-fatal heparin-related errors being reported in the lay press. This short report highlights the need for united and concerted action to develop strategies aimed at minimising avoidable infant deaths related to heparin errors.

  View details for DOI 10.1111/j.1440-1754.2011.02127.x

  View details for Web of Science ID 000303733700004

  View details for PubMedID 21679338

• Factors predicting coroners' decisions to hold discretionary inquests CANADIAN MEDICAL ASSOCIATION JOURNAL Walter, S. J., Bugeja, L., Spittal, M. J., Studdert, D. M. 2012; 184 (5): 521–28

  Abstract

  Coroners in Australia, Canada, New Zealand and other countries in the Commonwealth hold inquests into deaths in two situations. Mandatory inquests are held when statutory rules dictate they must be; discretionary inquests are held based on the decisions of individual coroners. Little is known as to how and why coroners select particular deaths for discretionary inquests.We analyzed the deaths investigated by Australian coroners for a period of seven and one-half years in five jurisdictions. We classified inquests as mandatory or discretionary. After excluding mandatory inquests, we used logistic regression analysis to identify the factors associated with coroners' decisions to hold discretionary inquests.Of 20 379 reported deaths due to external causes, 1252 (6.1%) proceeded to inquest. Of these inquests, 490 (39.1%) were mandatory and 696 (55.6%) were discretionary. In unadjusted analyses, the rates of discretionary inquests varied widely in terms of age of the decedent and cause of death. In adjusted analyses, the odds of discretionary inquests declined with the age of the decedent; the odds were highest for children (odds ratio [OR] 2.17, 95% confidence interval [CI] 1.54-3.06) and lowest for people aged 65 years and older (OR 0.38, 95% CI 0.28-0.51). Using poisoning as a reference cause of death, the odds of discretionary inquests were highest for fatal complications of medical care (OR 12.83, 95% CI 8.65-19.04) and lowest for suicides (OR 0.44, 95% CI 0.30-0.65).Deaths that coroners choose to take to inquest differ systematically from those they do not. Although this vetting process is invisible, it may influence the public's understanding of safety risks, fatal injury and death.

  View details for PubMedID 22291169

  View details for PubMedCentralID PMC3307557

• Plain Packaging of Tobacco Products in Australia A Novel Regulation Faces Legal Challenge JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Mitchell, A. D., Studdert, D. M. 2012; 307 (3): 261–62

  View details for PubMedID 22253391

• False Claims Act Prosecution Did Not Deter Off-Label Drug Use In The Case Of Neurontin HEALTH AFFAIRS Kesselheim, A. S., Darby, D., Studdert, D. M., Glynn, R., Levin, R., Avorn, J. 2011; 30 (12): 2318–27

  Abstract

  Since 2004 the United States has collected approximately $8 billion from fraud enforcement actions against pharmaceutical manufacturers accused under the federal False Claims Act of illegally promoting drugs for off-label uses. Using the case of gabapentin (Neurontin), a drug approved for epilepsy but prescribed for a variety of conditions, we sought to determine whether the enforcement action also influenced off-label prescribing rates. We conducted a segmented time-series analysis using key legal milestones: the initiation of a sealed investigation, public announcement of the investigation, and settlement of the case. Off-label use grew steadily until settlement, when gabapentin prescriptions declined for both off-label and on-label indications. Because enforcement actions targeting illegal off-label promotion might not have a substantial deterrent effect on prescription rates until after settlement, they should be combined with other efforts to combat off-label promotion. These could include additional resources for enforcement and a steep increase in penalties because settlements to this point have been dwarfed by the financial gains to pharmaceutical companies from engaging in improper off-label marketing.

  View details for DOI 10.1377/hlthaff.2011.0370

  View details for Web of Science ID 000298233600013

  View details for PubMedID 22147859

• Can law improve prevention and treatment of cancer? PUBLIC HEALTH Magnusson, R. S., Gostin, L. O., Studdert, D. M. 2011; 125 (12): 813–20

  View details for PubMedID 22088769

• Recommendations for and compliance with social restrictions during implementation of school closures in the early phase of the influenza A (H1N1) 2009 outbreak in Melbourne, Australia BMC INFECTIOUS DISEASES McVernon, J., Mason, K., Petrony, S., Nathan, P., LaMontagne, A. D., Bentley, R., Fielding, J., Studdert, D. M., Kavanagh, A. 2011; 11: 257

  Abstract

  Localized reactive school and classroom closures were implemented as part of a suite of pandemic containment measures during the initial response to influenza A (H1N1) 2009 in Melbourne, Australia. Infected individuals, and those who had been in close contact with a case, were asked to stay in voluntary home quarantine and refrain from contact with visitors for seven days from the date of symptom onset or exposure to an infected person. Oseltamivir (Tamiflu) was available for treatment or prophylaxis.We surveyed affected families through schools involved in the closures. Analyses of responses were descriptive. We characterized recommendations made to case and contact households and quantified adherence to guidelines and antiviral therapy.Of the 314 respondent households, 51 contained a confirmed case. The prescribed quarantine period ranged from 1-14 days, reflecting logistic difficulties in reactive implementation relative to the stated guidelines. Household-level compliance with the requirement to stay at home was high (84.5%, 95% CI 79.3,88.5) and contact with children outside the immediate family infrequent.Levels of compliance with recommendations in our sample were high compared with other studies, likely due to heightened public awareness of a newly introduced virus of uncertain severity. The variability of reported recommendations highlighted the difficulties inherent in implementing a targeted reactive strategy, such as that employed in Melbourne, on a large scale during a public health emergency. This study emphasizes the need to understand how public health measures are implemented when seeking to evaluate their effectiveness.

  View details for PubMedID 21958428

• When informed consent goes poorly: a descriptive study of medical negligence claims and patient complaints MEDICAL JOURNAL OF AUSTRALIA Gogos, A. J., Clark, R. B., Bismark, M. M., Gruen, R. L., Studdert, D. M. 2011; 195 (6): 340–44

  Abstract

  To describe the frequency, characteristics, and outcomes of medicolegal disputes over informed consent.Retrospective review and analysis of negligence claims against doctors insured by Avant Mutual Group Limited and complaints lodged with the Office of the Health Services Commissioner of Victoria that alleged failures in the informed consent process and were adjudicated between 1 January 2002 and 31 December 2008.Case frequency (by medical specialty), type of allegation, type of treatment.A total of 481 cases alleged deficiencies in the informed consent process (218 of 1898 conciliated complaints [11.5%]; 263 of 7846 negligence claims [3.4%]). 57% of these cases were against surgeons. Plastic surgeons experienced dispute rates that were more than twice those of any other specialty or subspecialty group. 92% of cases (442/481) involved surgical procedures and 16% (77/481) involved cosmetic procedures. The primary allegation in 71% of cases was that the clinician failed to mention or properly explain risks of complications. Five treatment types - procedures on reproductive organs (12% of cases), procedures on facial features excluding eyes (12%), prescription medications (8%), eye surgery (7%) and breast surgery (7%) - accounted for 46% of all cases.The typical dispute over informed consent involves an operation, often cosmetic, and allegations that a particular complication was not properly disclosed. With Australian courts now looking to patient preferences in setting legal standards of care for risk disclosure, medicolegal disputes provide valuable insights for targeting both quality improvement efforts and risk management activities.

  View details for DOI 10.5694/mja11.10379

  View details for Web of Science ID 000295543000022

  View details for PubMedID 21929499

• Remedies sought and obtained in healthcare complaints BMJ QUALITY & SAFETY Bismark, M. M., Spittal, M. J., Gogos, A. J., Gruen, R. L., Studdert, D. M. 2011; 20 (9): 806–10

  Abstract

  In the wake of adverse events, injured patients and their families have a complex range of needs and wants. The tort system, even when operating at its best, will inevitably fall far short of addressing them. In Australia and New Zealand, government-run health complaints commissions take a more flexible and expansive approach to providing remedies for patients injured by or disgruntled with care. Unfortunately, survey research has shown that many patients in these systems are dissatisfied with their experience. We hypothesised that an important explanation for this dissatisfaction is an 'expectations gap'; discordance between what complainants want and what they eventually get out of the process. Analysing a sample of complaints relating to informed consent from the Commission in Victoria (Australia's second largest state, with 5.2 million residents), we found evidence of such a gap. One-third (59/189) of complainants who sought restoration received it; 1 in 5 complainants (17/101) who sought correction received assurances that changes had been or would be made to reduce the risk of others suffering a similar harm; and fewer than 1 in 10 (3/37) who sought sanctions saw steps taken to achieve this outcome initiated. We argue that bridging the expectations gap would go far toward improving patient satisfaction with complaints systems, and suggest several ways this might be done.

  View details for PubMedID 21859814

• Quality of Care and Negligence Litigation in Nursing Homes REPLY NEW ENGLAND JOURNAL OF MEDICINE Studdert, D. M., Stevenson, D. G., Spittal, M. J. 2011; 365 (1): 93

  View details for Web of Science ID 000292459400024

• Prevalence and characteristics of complaint-prone doctors in private practice in Victoria MEDICAL JOURNAL OF AUSTRALIA Bismark, M. M., Spittal, M. J., Studdert, D. M. 2011; 195 (1): 25–28

  Abstract

  To identify characteristics of doctors who are repeated subjects of complaints by patients.Case-control study of doctors about whom patients had complained to the Victorian Health Services Commissioner between 1 January 2000 and 31 December 2009.384 doctors in private practice; cases comprised 96 doctors who were the subject of four or more separate complaints; and the control group comprised 288 doctors who were the subject of a single complaint over the study period.Among doctors in private practice in Victoria, 20.5% (95% CI, 19.7%-21.3%) experienced at least one complaint over the decade. Among doctors who were the subject of a complaint, 4.5% (95% CI, 3.6%-5.4%) had four or more complaints, and this group accounted for 17.6% (95% CI, 16.3%-19.0%) of all complaints to the Victorian Health Services Commissioner. Multivariate analyses showed that surgeons (odds ratio [OR], 8.90; 95% CI, 3.69-21.50) and psychiatrists (OR, 4.59; 95% CI, 1.46-14.43) had higher odds of being in the complaint-prone group than general practitioners. Doctors trained overseas had lower odds of being complaint-prone than those trained in Australia (OR, 0.31; 95% CI, 0.13-0.72).A small group of doctors in private practice in Victoria account for nearly 18% of complaints. Interventions to improve patient satisfaction and public confidence in health services should target complaint-prone subgroups of practitioners.

  View details for PubMedID 21728937

• Administrative compensation for medical injuries: lessons from three foreign systems. Issue brief (Commonwealth Fund) Mello, M. M., Kachalia, A., Studdert, D. M. 2011; 14: 1-18

  Abstract

  The United States requires patients injured by medical negligence to seek compensation through lawsuits, an approach that has drawbacks related to fairness, cost, and impact on medical care. Several countries, including New Zealand, Sweden, and Denmark, have replaced litigation with administrative compensation systems for patients who experience an avoidable medical injury. Sometimes called "no-fault" systems, such schemes enable patients to file claims for compensation without using an attorney. A governmental or private adjudicating organization uses neutral medical experts to evaluate claims of injury and does not require patients to prove that health care providers were negligent in order to receive compensation. Information from claims is used to analyze opportunities for patient safety improvement. The systems have successfully limited liability costs while improving injured patients' access to compensation. American policymakers may find many of the elements of these countries' systems to be transferable to demonstration projects in the U.S.

  View details for PubMedID 21770079

• Doctors disciplined for professional misconduct in Australia and New Zealand, 2000-2009 MEDICAL JOURNAL OF AUSTRALIA Elkin, K. J., Spittal, M. J., Elkin, D. J., Studdert, D. M. 2011; 194 (9): 452–56

  Abstract

  To describe professional discipline cases in Australia and New Zealand in which doctors were found guilty of professional misconduct, and to develop a typology for describing the misconduct.A retrospective analysis of disciplinary cases adjudicated in five jurisdictions (New South Wales, Victoria, Queensland, Western Australia and New Zealand) in 2000-2009.Characteristics of the cases (setting, misconduct type, patient outcomes, disciplinary measure imposed), characteristics of the doctors involved (sex, specialty, years since qualification) and population-level case rates (by doctor characteristics).The tribunals studied disciplined 485 doctors. Male doctors were disciplined for misconduct at four times the rate of their female colleagues (91 versus 22 cases per 100 000 doctor-years). Obstetrics and gynaecology and psychiatry were the specialties with the highest rates (224 and 178 cases per 100 000 doctor-years). The mean age of disciplined doctors did not differ from that of the general doctor population. The most common types of offences considered as the primary issue were sexual misconduct (24% of cases), illegal or unethical prescribing (21%) and inappropriate medical care (20%). In 78% of cases, the tribunal made no mention of any patient having experienced physical or mental harm as a result of the misconduct. Penalties were severe, with 43% of cases resulting in removal from practice and 37% in restrictions on practice.Disciplinary cases in Australia and New Zealand have features distinct from those studied internationally. The recent nationalisation of Australia's medical boards offers new possibilities for tracking and analysing disciplinary cases to improve the safety and quality of health care.

  View details for PubMedID 21534900

• PREVALENCE AND CHARACTERISTICS OF COMPLAINT-PRONE DOCTORS IN VICTORIA, AUSTRALIA Bismark, M., Spittal, M., Studdert, D. WILEY-BLACKWELL. 2011: 33–34

  View details for Web of Science ID 000290272200102

• THE DISCLOSURE GAP: PATIENT AND PROVIDER PERSPECTIVE ON THE QUALITY OF ACTUAL DISCLOSURES Gallagher, T. H., Brock, D., Eichler, M., Lembitz, A., Studdert, D. M., Varnell, J., Boyle, D. J. SPRINGER. 2011: S150

  View details for Web of Science ID 000208812701039

• Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints PLOS MEDICINE Kesselheim, A. S., Mello, M. M., Studdert, D. M. 2011; 8 (4)

  Abstract

  Despite regulatory restrictions, off-label marketing of pharmaceutical products has been common in the US. However, the scope of off-label marketing remains poorly characterized. We developed a typology for the strategies and practices that constitute off-label marketing.We obtained unsealed whistleblower complaints against pharmaceutical companies filed in US federal fraud cases that contained allegations of off-label marketing (January 1996-October 2010) and conducted structured reviews of them. We coded and analyzed the strategic goals of each off-label marketing scheme and the practices used to achieve those goals, as reported by the whistleblowers. We identified 41 complaints arising from 18 unique cases for our analytic sample (leading to US$7.9 billion in recoveries). The off-label marketing schemes described in the complaints had three non-mutually exclusive goals: expansions to unapproved diseases (35/41, 85%), unapproved disease subtypes (22/41, 54%), and unapproved drug doses (14/41, 34%). Manufacturers were alleged to have pursued these goals using four non-mutually exclusive types of marketing practices: prescriber-related (41/41, 100%), business-related (37/41, 90%), payer-related (23/41, 56%), and consumer-related (18/41, 44%). Prescriber-related practices, the centerpiece of company strategies, included self-serving presentations of the literature (31/41, 76%), free samples (8/41, 20%), direct financial incentives to physicians (35/41, 85%), and teaching (22/41, 54%) and research activities (8/41, 20%).Off-label marketing practices appear to extend to many areas of the health care system. Unfortunately, the most common alleged off-label marketing practices also appear to be the most difficult to control through external regulatory approaches.

  View details for DOI 10.1371/journal.pmed.1000431

  View details for Web of Science ID 000289937700004

  View details for PubMedID 21483716

  View details for PubMedCentralID PMC3071370

• Relationship between Quality of Care and Negligence Litigation in Nursing Homes NEW ENGLAND JOURNAL OF MEDICINE Studdert, D. M., Spittal, M. J., Mello, M. M., O'Malley, A. J., Stevenson, D. G. 2011; 364 (13): 1243-1250

  Abstract

  It is unclear whether high-quality health care institutions are less likely to be sued for negligence than their low-performing counterparts.We linked information on tort claims brought against 1465 nursing homes between 1998 and 2006 to 10 indicators of nursing home quality drawn from two U.S. national data sets: the Online Survey, Certification, and Reporting system and the Minimum Data Set Quality Measure/Indicator Report. We tested for associations between the incidence of claims and the quality measures at the facility calendar-quarter level, correcting for facility clustering and adjusting for case mix, ownership, occupancy, year, and state. Odds ratios were calculated for the effect of a change of 1 SD in each quality measure on the odds of one or more claims in each facility calendar-quarter.Nursing homes with more deficiencies (odds ratio, 1.09; 95% confidence interval [CI], 1.05 to 1.13) and those with more serious deficiencies (odds ratio, 1.04; 95% CI, 1.00 to 1.08) had higher odds of being sued; this was also true for nursing homes that had more residents with weight loss (odds ratio, 1.05; 95% CI, 1.01 to 1.10) and with pressure ulcers (odds ratio, 1.09; 95% CI, 1.05 to 1.14). The odds of being sued were lower in nursing homes with more nurse's aide-hours per resident-day (odds ratio, 0.95; 95% CI, 0.91 to 0.99). However, all these effects were relatively small. For example, nursing homes with the best deficiency records (10th percentile) had a 40% annual risk of being sued, as compared with a 47% risk among nursing homes with the worst deficiency records (90th percentile).The best-performing nursing homes are sued only marginally less than the worst-performing ones. Such weak discrimination may subvert the capacity of litigation to provide incentives to deliver safer care.

  View details for Web of Science ID 000288951300008

  View details for PubMedID 21449787

• Newborn screening cards: a legal quagmire MEDICAL JOURNAL OF AUSTRALIA Bowman, D. M., Studdert, D. M. 2011; 194 (6): 319-322

  Abstract

  Newborn screening (NBS) programs are a well established and cost-effective method for early identification of genetic disorders. However, a raft of legal questions surrounds the collection, storage, ownership and secondary use of NBS cards. The absence of clear legal rules governing NBS programs in Australia means that there are few straightforward answers to these questions. A series of controversial incidents have exposed this uncertainty in Australia, and remarkably similar controversies have occurred in the United States and European Union. We review the situation, using Victoria as a case study. We also make the case for a dedicated regulatory regime for NBS programs, arguing that the lack of such a regime threatens public trust and the robust operation of NBS programs in Australia. New rules would likely introduce stricter requirements for informed consent at the point of blood collection than has been the norm to date. However, the scope for use of cards in research could expand rather than contract, and it may be possible to reduce the risk that vast card archives will need to be destroyed in response to future public outcries.

  View details for Web of Science ID 000288839000016

  View details for PubMedID 21426290

• Sources, perceived usefulness and understanding of information disseminated to families who entered home quarantine during the H1N1 pandemic in Victoria, Australia: a cross-sectional study BMC INFECTIOUS DISEASES Kavanagh, A. M., Bentley, R. J., Mason, K. E., McVernon, J., Petrony, S., Fielding, J., LaMontagne, A. D., Studdert, D. M. 2011; 11: 2

  Abstract

  Voluntary home quarantine of cases and close contacts was the main non-pharmaceutical intervention used to limit transmission of pandemic (H1N1) 2009 influenza (pH1N1) in the initial response to the outbreak of the disease in Australia. The effectiveness of voluntary quarantine logically depends on affected families having a clear understanding of what they are being asked to do. Information may come from many sources, including the media, health officials, family and friends, schools, and health professionals. We report the extent to which families who entered home quarantine received and used information on what they were supposed to do. Specifically, we outline their sources of information; the perceived usefulness of each source; and associations between understanding of recommendations and compliance.Cross-sectional survey administered via the internet and computer assisted telephone interview to families whose school children were recommended to go into home quarantine because they were diagnosed with H1N1 or were a close contact of a case. The sample included 314 of 1157 potentially eligible households (27% response rate) from 33 schools in metropolitan Melbourne. Adjusting for clustering within schools, we describe self-reported 'understanding of what they were meant to do during the quarantine period'; source of information (e.g. health department) and usefulness of information. Using logistic regression we examine whether compliance with quarantine recommendations was associated with understanding and the type of information source used.Ninety per cent understood what they were meant to do during the quarantine period with levels of understanding higher in households with cases (98%, 95% CI 93%-99% vs 88%, 95% CI 84%-91%, P = 0.006). Over 87% of parents received information about quarantine from the school, 63% from the health department and 44% from the media. 53% of households were fully compliant and there was increased compliance in households that reported that they understood what they were meant to do (Odds Ratio 2.27, 95% CI 1.35-3.80).It is critical that public health officials work closely with other government departments and media to provide clear, consistent and simple information about what to do during quarantine as high levels of understanding will maximise compliance in the quarantined population.

  View details for PubMedID 21199583

• Legal aspects of open disclosure II: attitudes of health professionals - findings from a national survey MEDICAL JOURNAL OF AUSTRALIA Studdert, D. M., Piper, D., Iedema, R. 2010; 193 (6): 351-355

  Abstract

  To assess the attitudes of health care professionals engaged in open disclosure (OD) to the legal risks and protections that surround this activity.National cross-sectional survey of 51 experienced OD practitioners conducted in mid 2009.Perceived barriers to OD; awareness of and attitudes towards medicolegal protections; recommendations for reform.The vast majority of participants rated fears about the medicolegal risks (45/51) and inadequate education and training in OD skills (43/51) as major or moderate barriers to OD. A majority (30/51) of participants viewed qualified privilege laws as having limited or no effect on health professionals' willingness to conduct OD, whereas opinion was divided about the effect of apology laws (state laws protecting expressions of regret from subsequent use in legal proceedings). In four states and territories (Western Australia, South Australia, Tasmania and the Northern Territory), a majority of participants were unaware that their own jurisdiction had apology laws that applied to OD. The most frequent recommendations for legal reform to improve OD were strengthening existing protections (23), improving education and awareness of applicable laws (11), fundamental reform of the medical negligence system (8), and better alignment of the activities of certain legal actors (eg, coroners) with OD practice (6).Concerns about both the medicolegal implications of OD and the skills needed to conduct it effectively are prevalent among health professionals at the leading edge of the OD movement in Australia. The ability of current laws to protect against use of this information in legal proceedings is perceived as inadequate.

  View details for Web of Science ID 000282565400010

  View details for PubMedID 20854241

• Legal aspects of open disclosure: a review of Australian law MEDICAL JOURNAL OF AUSTRALIA Studdert, D. M., Richardson, M. W. 2010; 193 (5): 273–76

  Abstract

  Health professionals worry that information about adverse events conveyed to patients in open disclosure (OD) may be used against them in medicolegal proceedings. Whether and how strongly state and federal laws in Australia protect against such uses is unclear. Our analysis concludes that existing laws do not prohibit the sharing of most types of information on adverse events with patients. However, none of these laws was enacted with OD in mind and, in general, the protections they provide are quite weak. If policymakers want OD to become a routine part of medical practice, law reform may be needed in the form of stronger protections directed specifically at the contents of OD communications.

  View details for PubMedID 20819045

• National Costs Of The Medical Liability System HEALTH AFFAIRS Mello, M. M., Chandra, A., Gawande, A. A., Studdert, D. M. 2010; 29 (9): 1569-1577

  Abstract

  Concerns about reducing the rate of growth of health expenditures have reignited interest in medical liability reforms and their potential to save money by reducing the practice of defensive medicine. It is not easy to estimate the costs of the medical liability system, however. This article identifies the various components of liability system costs, generates national estimates for each component, and discusses the level of evidence available to support the estimates. Overall annual medical liability system costs, including defensive medicine, are estimated to be $55.6 billion in 2008 dollars, or 2.4 percent of total health care spending.

  View details for DOI 10.1377/hlthaff.2009.0807

  View details for Web of Science ID 000281601300003

  View details for PubMedID 20820010

  View details for PubMedCentralID PMC3048809

• Does access to compensation have an impact on recovery outcomes after injury? MEDICAL JOURNAL OF AUSTRALIA Studdert, D. M., Luntz, H., Grant, G. 2010; 193 (3): 189

  View details for Web of Science ID 000280753000025

  View details for PubMedID 20830857

• Are rates of pathology test ordering higher in general practices co-located with pathology collection centres? MEDICAL JOURNAL OF AUSTRALIA Studdert, D. M., Britt, H. C., Pan, Y., Fahridin, S., Bayram, C. F., Gurrin, L. C. 2010; 193 (2): 114–19

  Abstract

  To determine whether rates of pathology test ordering by general practitioners in general practices co-located with pathology collection centres (PCCs) are higher than those of GPs in practices located apart from PCCs.We identified all practices in the Melbourne and Sydney metropolitan areas that were co-located with PCCs (same or immediately adjacent suite) and the date co-location was established. This information was merged with the Bettering the Evaluation and Care of Health database to identify samples of GP-patient encounters in co-located practices (n = 31,700) and practices located apart from the nearest PCC (n = 289,700) over the period 2000-2009. Using Poisson regression analysis and logistic regression analysis, we compared GP test-ordering rates across the two types of practices, controlling for a range of potential confounders.Numbers of tests ordered per encounter; likelihood of ordering one or more tests per encounter.In unadjusted analyses, GPs in co-located practices ordered more pathology tests than GPs in practices located apart from PCCs (40.3 v 37.0 tests per 100 encounters, P = 0.01) and had a higher likelihood of ordering one or more tests (16.8% v 15.5% of encounters, P < 0.01). After adjusting for other predictors of test ordering, however, neither test-ordering rate (rate ratio, 0.98; 95% CI, 0.93-1.05; P = 0.56) nor likelihood of ordering one or more tests per encounter (odds ratio, 1.01; 95% CI, 0.95-1.07; P = 0.79) differed significantly by co-location status. Sub-analyses within specific test groups and types showed few systematic differences.Pathology test-ordering rates are not higher in practices co-located with PCCs. To the extent inappropriate commercial influences and relationships exist in the pathology sector, GPs' test-ordering behaviour may be unaffected.

  View details for PubMedID 20642420

• How Will Health Insurers Respond To New Rules Under Health Reform? HEALTH AFFAIRS Brennan, T. A., Studdert, D. M. 2010; 29 (6): 1147–51

  Abstract

  The Patient Protection and Affordable Care Act creates a host of new rules for all entities in health care, but especially for health insurers. The statute itself, and the regulations to which it gives rise, will change the nature of the insurance business, particularly in the small-group and individual markets. Regulatory proceedings and some litigation are likely to determine the final shape of the new rules. At the same time, collaborative efforts among insurers, providers, and regulators could lead to innovations that increase access to coverage while also reducing costs.

  View details for DOI 10.1377/hlthaff.2010.0421

  View details for Web of Science ID 000278467000012

  View details for PubMedID 20530345

• Using malpractice claims to identify risk factors for neurological impairment among infants following non-reassuring fetal heart rate patterns during labour JOURNAL OF EVALUATION IN CLINICAL PRACTICE Kesselheim, A. S., November, M. T., Lifford, K. L., McElrath, T. F., Puopolo, A. L., Orav, E., Studdert, D. M. 2010; 16 (3): 476–83

  Abstract

  We sought to use a novel case-selection methodology to identify antenatal or intrapartum risk factors associated with neonatal neurological impairment following non-reassuring fetal heart rate patterns during labour.We used a retrospective case-control design with bivariate and multivariate conditional logistic regression. Cases were births in which electronic fetal monitoring (EFM) showed non-reassuring patterns and the infant had neurological disability. Controls were births in which EFM was non-reassuring but the infant was born healthy. We identified 36 cases from among malpractice claims filed with a liability insurer in Massachusetts between 1985 and 2001 and randomly selected 70 controls, matching them to cases by hospital, birth date and gestational age.More cases had maternal antenatal vaginal bleeding (P = 0.004), a prolonged latent phase or protracted dilation during the first stage of labour (P = 0.03), and protracted descent or prolonged second stage (P = 0.01). More cases also had minimal variability on EFM on admission (P = 0.02) and during the second stage (P = 0.02). Multivariate analysis highlighted three significant predictors of neurological injury following complicated labour: antenatal vaginal bleeding (OR = 27.1), prolonged latent phase or protracted dilation in the first stage (OR = 4.0) and EFM showing minimal variability in the first stage (OR = 4.3).These promising initial findings suggest that future research into outcomes from complicated labour with non-reassuring heart rate patterns should focus on maternal history of vaginal bleeding, slow labour and minimal variability on EFM.

  View details for DOI 10.1111/j.1365-2753.2009.01148.x

  View details for Web of Science ID 000278077900014

  View details for PubMedID 20482746

• EXPERIENCES OF WHISTLEBLOWERS IN MAJOR FRAUD LITIGATION AGAINST PHARMACEUTICAL MANUFACTURERS Kesselheim, A., Mello, M., Studdert, D. SPRINGER. 2010: 273

  View details for Web of Science ID 000277282300154

• Realising the research power of complaints data NEW ZEALAND MEDICAL JOURNAL Bismark, M. M., Studdert, D. M. 2010; 123 (1314): 12–17

  View details for Web of Science ID 000422402100006

  View details for PubMedID 20581908

• Whistle-Blowers' Experiences in Fraud Litigation against Pharmaceutical Companies NEW ENGLAND JOURNAL OF MEDICINE Kesselheim, A. S., Studdert, D. M., Mello, M. M. 2010; 362 (19): 1832-1839

  View details for Web of Science ID 000277555500014

  View details for PubMedID 20463344

• Restricted career paths for overseas students graduating from Australian medical schools: legal and policy considerations MEDICAL JOURNAL OF AUSTRALIA Elkin, K. J., Studdert, D. M. 2010; 192 (9): 517–19

  Abstract

  A sharp increase in the number of students graduating from Australian medical schools over the next few years looks set to outpace available intern positions. Graduating overseas students will be the first to miss out. While this treatment of overseas students is unlikely to be found unlawful, questions of fairness remain. From a policy standpoint, the bottleneck in intern places could be quite damaging as: it encourages Australian-trained medical graduates with high-quality training and culturally-relevant skills to leave; and it extinguishes a valuable opportunity to steer some of these graduates into geographical areas with the greatest medical workforce needs.

  View details for PubMedID 20438428

• Defensive Medicine and Tort Reform: A Wide View JOURNAL OF GENERAL INTERNAL MEDICINE Studdert, D. M., Mello, M. M., Brennan, T. A. 2010; 25 (5): 380–81

  View details for DOI 10.1007/s11606-010-1319-8

  View details for Web of Science ID 000276721900003

  View details for PubMedID 20349156

  View details for PubMedCentralID PMC2854998

• Impact of coronial investigations on manner and cause of death determinations in Australia, 2000-2007 MEDICAL JOURNAL OF AUSTRALIA Studdert, D. M., Cordner, S. M. 2010; 192 (8): 444–47

  Abstract

  To evaluate the changes in the understanding of the manner and cause of death occurring during the course of coronial investigations.Retrospective analysis of deaths reported to coroners in Australia between 1 July 2000 and 31 December 2007, using the National Coroners Information System.(i) Manner of death (natural, external, unknown); (ii) intent classification (eg, unintentional injury, suicide, assault) among deaths with external causes; and, (iii) changes in the manner of death and intent classification between the presumption made at case notification and the coroner's final determination.The coronial investigation changed the presumption about manner of death or intent classification in 5.2% (6222/120 452) of cases in which a presumption was made. Among deaths with a change in attribution from natural causes to external causes, unintentional falls (442/1891) and pharmaceutical poisoning (427/1891) each accounted for 23%. Among deaths with attribution changing from external causes to natural causes, the leading medical causes of death were cardiovascular compromise (551/842; 65%) and infection (124/842; 15%). Of deaths understood correctly at notification to be due to external causes, but the wrong external cause, 34% (206/600) were ultimately judged to be unintentional injuries, and 22% (133/600) were judged to be suicides.Coronial investigations transform basic understanding of cause of death in only a small minority of cases. However, the benefits to families and society of accurate cause-of-death determinations in these difficult cases may be considerable.

  View details for PubMedID 20402607

• Ethics review of multisite studies: the difficult case of community-based Indigenous health research MEDICAL JOURNAL OF AUSTRALIA Studdert, D. M., Vu, T. M., Fox, S. S., Anderson, I. P., Keeffe, J. E., Taylor, H. R. 2010; 192 (5): 275–80

  Abstract

  Researchers have longstanding concerns about the logistical and administrative burdens posed by ethics review of multisite studies involving human participants. Centralised ethics review, in which approval by one committee has authority across multiple sites, is widely touted as a strategy for streamlining the process. The Harmonisation of Multi-centre Ethical Review (HoMER) project is currently developing such a system for Australia. It is unclear how centralised review will work for multisite Indigenous health research, where the views of local stakeholders are important and community consultation is mandatory. Our recent experience in conducting the National Indigenous Eye Health Survey (NIEHS) shows how elaborate the current ethics approval and community consultation processes can be, and points to several lessons and ideas to guide pending reforms.

  View details for PubMedID 20201762

• Relationship between Vehicle Emissions Laws and Incidence of Suicide by Motor Vehicle Exhaust Gas in Australia, 2001-06: An Ecological Analysis PLOS MEDICINE Studdert, D. M., Gurrin, L. C., Jatkar, U., Pirkis, J. 2010; 7 (1): e1000210

  Abstract

  Globally, suicide accounts for 5.2% of deaths among persons aged 15 to 44 years and its incidence is rising. In Australia, suicide rates peaked in 1997 and have been declining since. A substantial part of that decline stems from a plunge in suicides by one particular method: asphyxiation by motor vehicle exhaust gas (MVEG). Although MVEG remains the second most common method of suicide in Australia, its incidence decreased by nearly 70% in the decade to 2006. The extent to which this phenomenon has been driven by national laws in 1986 and 1999 that lowered permissible levels of carbon monoxide (CO) emissions is unknown. The objective of this ecological study was to test the relationship by investigating whether areas of Australia with fewer noxious vehicles per capita experienced lower rates of MVEG suicide.We merged data on MVEG suicides in Australia (2001-06) with data on the number and age of vehicles in the national fleet, as well as socio-demographic data from the national census. Poisson regression was used to analyse the relationship between the incidence of suicide within two levels of geographical area--postcodes and statistical subdivisions (SSDs)--and the population density of pre-1986 and pre-1999 passenger vehicles in those areas. (There was a mean population of 8,302 persons per postcode in the study dataset and 87,413 persons per SSD.) The annual incidence of MVEG suicides nationwide decreased by 57% (from 2.6 per 100,000 in 2001 to 1.1 in 2006) during the study period; the population density of pre-1986 and pre-1999 vehicles decreased by 55% (from 14.2 per 100 persons in 2001 to 6.4 in 2006) and 26% (from 44.5 per 100 persons in 2001 to 32.9 in 2006), respectively. Area-level regression analysis showed that the suicide rates were significantly and positively correlated with the presence of older vehicles. A percentage point decrease in the population density of pre-1986 vehicles was associated with a 6% decrease (rate ratio [RR] = 1.06; 95% confidence interval [CI] 1.05-1.08) in the incidence of MVEG suicide within postcode areas; a percentage point decrease in the population density of pre-1999 vehicles was associated with a 3% decrease (RR = 1.03; 95% CI 1.02-1.04) in the incidence of MVEG suicide.Areas of Australia with fewer vehicles predating stringent CO emission laws experience lower rates of MVEG suicide. Although those emission laws were introduced primarily for environmental reasons, countries that lack them may miss the benefits of a serendipitous suicide prevention strategy. Please see later in the article for the Editors' Summary.

  View details for PubMedID 20052278

• Victims of violence among Indigenous mothers living with dependent children MEDICAL JOURNAL OF AUSTRALIA Cripps, K., Bennett, C. M., Gurrin, L. C., Studdert, D. M. 2009; 191 (9): 481–85

  Abstract

  To identify individual and household factors associated with violence among Australian Indigenous women with dependent children.Univariate and multivariable analysis of data from the 2002 National Aboriginal and Torres Strait Islander Social Survey, stratified by area.Self-reported experience of being a victim of violence in the previous year.One in four Indigenous women living with dependent children younger than 15 years reported being victims of violence in the previous year; this corresponds to an estimated 24 221 Indigenous mothers (95% CI, 21 507-26 935) nationwide. Violence was more prevalent in regional areas and cities than remote areas. In remote areas, mothers who had been removed from their natural families during childhood had nearly threefold greater odds of being victims of violence (odds ratio [OR], 2.90; 95% CI, 1.82-4.61); in non-remote areas, the odds were 72% greater (OR, 1.72; 95% CI, 1.23-2.39). Older maternal age (> or = 45 years) was associated with lower odds of experiencing violence in both non-remote areas (OR, 0.39; 95% CI, 0.25-0.60) and remote areas (OR, 0.46; 95% CI, 0.30-0.70). Women with partners residing in the household faced lower odds of violence in both non-remote areas (OR, 0.54; 95% CI, 0.41-0.72) and remote areas (OR, 0.46; 95% CI, 0.32-0.67).The prevalence of violence against Indigenous mothers with young children is alarmingly high across remote and non-remote areas. This study identified distinctive characteristics of victims, but further research is needed to assess potential risk factors, such as history of removal from natural family.

  View details for PubMedID 19883341

• Is uptake of genetic testing for colorectal cancer influenced by knowledge of insurance implications? MEDICAL JOURNAL OF AUSTRALIA Keogh, L. A., van Vliet, C. M., Studdert, D. M., Maskiell, J. A., Macrae, F. A., St John, D., Gaff, C. L., Young, M., Southey, M. C., Giles, G. G., Rosenthal, D. A., Hopper, J. L., Jenkins, M. A. 2009; 191 (5): 255–58

  Abstract

  To assess whether knowledge of insurance implications influenced uptake of genetic testing by participants in a research study of the causes of colorectal cancer.Analysis of uptake of genetic testing by participants in the population-based Victorian Colorectal Cancer Family Study during two periods: from 1999 to 2003, when participants were not informed of any potential effect of genetic testing conducted during the study on their eligibility for new insurance policies; and from 2003 to 2006, when the protocol was changed to provide participants with information on the potential effect of genetic testing on insurance eligibility.Uptake of genetic testing for germline mutations in DNA mismatch repair (MMR) genes at a family cancer clinic.The proportion of participants who declined genetic testing among those informed of insurance implications was more than double the proportion among those without this knowledge (29/59 [49%] v 9/47 [19%]; P = 0.002). This difference could not be explained statistically by adjusting for measured putative predictors.Identification of people with a mutation in an MMR gene has clinical importance, and such screening may be a cost-effective way to reduce the burden of colorectal cancer in the community. If people are choosing not to obtain genetic information because of how it will affect their eligibility for insurance, reforms to existing insurance practices are indicated.

  View details for PubMedID 19740045

• Process of Care Failures in Breast Cancer Diagnosis Weingart, S. N., Saadeh, M. G., Simchowitz, B., Gandhi, T. K., Nekhlyudov, L., Studdert, D. M., Puopolo, A., Shulman, L. N. SPRINGER. 2009: 702–9

  Abstract

  Process of care failures may contribute to diagnostic errors in breast cancer care.To identify patient- and provider-related process of care failures in breast cancer screening and follow-up in a non-claims-based cohort.Retrospective chart review of a cohort of patients referred to two Boston cancer centers with new breast cancer diagnoses between January 1, 1999 and December 31, 2004.We identified 2,275 women who reported > or =90 days between symptom onset and breast cancer diagnosis or presentation with at least stage II disease. We then selected the 340 (14.9%) whose physicians shared an electronic medical record. We excluded 238 subjects whose records were insufficient for review, yielding a final cohort of 102 patients.NoneWe tabulated the number and types of process of care failures and examined risk factors using bivariate analyses and multivariable Poisson regression.Twenty-six of 102 patients experienced > or =1 process of care failure. The most common failures occurred when physicians failed to perform an adequate physical examination, when patients failed to seek care, and when diagnostic or laboratory tests were ordered but patients failed to complete them. Failures were attributed in similar numbers to provider- and patient-related factors (n = 30 vs. n = 25, respectively). Process of care failures were more likely when the patient's primary care physician was male (IRR 2.8, 95% CI 1.2 to 6.5) and when the patient was non-white (IRR 2.8, 95% CI 1.4 to 5.7).Process failures were common in this patient cohort, with both clinicians and patients contributing to breakdowns in the diagnostic process.

  View details for DOI 10.1007/s11606-009-0982-0

  View details for Web of Science ID 000266241300002

  View details for PubMedID 19387748

  View details for PubMedCentralID PMC2686776

• Preemption and Malpractice Liability Reply NEW ENGLAND JOURNAL OF MEDICINE Kesselheim, A. S., Studdert, D. M. 2009; 360 (21): 2258

  View details for Web of Science ID 000266206000033

• Shifting Terrain in the Regulation of Off-Label Promotion of Pharmaceuticals. NEW ENGLAND JOURNAL OF MEDICINE Mello, M. M., Studdert, D. M., Brennan, T. A. 2009; 360 (15): 1557–66

  View details for PubMedID 19357413

• Legal Bans on Pro-Suicide Web Sites: An Early Retrospective from Australia SUICIDE AND LIFE-THREATENING BEHAVIOR Pirkis, J., Neal, L., Dare, A., Blood, R., Studdert, D. 2009; 39 (2): 190–93

  Abstract

  There are worldwide concerns that pro-suicide web sites may trigger suicidal behaviors among vulnerable individuals. In 2006, Australia became the first country to criminalize such sites, sparking heated debate. Concerns were expressed that the law casts the criminal net too widely; inappropriately interferes with the autonomy of those who wish to die; and has jurisdictional limitations, with off-shore web sites remaining largely immune. Conversely, proponents point out that the law may limit access to domestic pro-suicide web sites, raise awareness of Internet-related suicide, mobilize community efforts to combat it, and serve as a powerful expression of societal norms about the promotion of suicidal behavior.

  View details for PubMedID 19527159

• Relationship Between Malpractice Litigation Pressure and Rates of Cesarean Section and Vaginal Birth After Cesarean Section MEDICAL CARE Yang, Y. T., Mello, M. M., Subramanian, S. V., Studdert, D. M. 2009; 47 (2): 234-242

  Abstract

  Since the 1990s, nationwide rates of vaginal birth after cesarean section (VBAC) have decreased sharply and rates of cesarean section have increased sharply. Both trends are consistent with clinical behavior aimed at reducing obstetricians' exposure to malpractice litigation.To estimate the effects of malpractice pressure on rates of VBAC and cesarean section.We used state-level longitudinal mixed-effects regression models to examine data from the Natality Detail File on births in the United States (1991-2003). Malpractice pressure was measured by liability insurance premiums and tort reforms. Outcome measures were rates of VBAC, cesarean section, and primary cesarean section.Malpractice premiums were positively associated with rates of cesarean section (beta = 0.15, P = 0.02) and primary cesarean section (beta = 0.16, P = 0.009), and negatively associated with VBAC rates (beta = -0.35, P = 0.01). These estimates imply that a $10,000 decrease in premiums for obstetrician-gynecologists would be associated with an increase of 0.35 percentage points (1.45%) in the VBAC rate and decreases of 0.15 and 0.16 percentage points (0.7% and 1.18%) in the rates of cesarean section and primary cesarean section, respectively; this would correspond to approximately 1600 more VBACs, 6000 fewer cesarean sections, and 3600 fewer primary cesarean sections nationwide in 2003. Two types of tort reform-caps on noneconomic damages and pretrial screening panels-were associated with lower rates of cesarean section and higher rates of VBAC.The liability environment influences choice of delivery method in obstetrics. The effects are not large, but reduced litigation pressure would likely lead to decreases in the total number cesarean sections and total delivery costs.

  View details for Web of Science ID 000262913200014

  View details for PubMedID 19169125

  View details for PubMedCentralID PMC3096673

• POISONED CHALICE? A CRITICAL ANALYSIS OF THE EVIDENCE LINKING PERSONAL INJURY COMPENSATION PROCESSES WITH ADVERSE HEALTH OUTCOMES MELBOURNE UNIVERSITY LAW REVIEW Grant, G., Studdert, D. M. 2009; 33 (3): 865–85

  View details for Web of Science ID 000282073700007

• Professional Oversight of Physician Expert Witnesses An Analysis of Complaints to the Professional Conduct Committee of the American Association of Neurological Surgeons, 1992-2006 ANNALS OF SURGERY Kesselheim, A. S., Studdert, D. M. 2009; 249 (1): 168–72

  Abstract

  To investigate the role of the professional conduct review program that is operated by the American Association of Neurological Surgeons (AANS). The program adjudicates complaints against AANS members for their work as expert witnesses in medical malpractice litigation.Policymakers worry that physician expert witnesses who espouse unfounded views in malpractice cases may fuel inappropriate litigation. A growing number of professional societies have sought to oversee their members' work as expert witnesses by instituting standards to regulate this conduct and enforcing those standards through formal disciplinary procedures. The AANS runs the longest-established and busiest program of this kind in the country. Plaintiffs' lawyers and consumer advocates have questioned the even-handedness of this form of self-regulation.We reviewed the confidential case summaries of all 59 complaints involving charges of inappropriate expert witness testimony adjudicated by the AANS Professional Conduct Committee from 1992 to 2006. We developed descriptive categories for the characteristics of the complainant and respondent, the types of misconduct alleged, and the outcomes of the review, including penalties imposed.The most common type of allegation was presentation of testimony that misrepresented the standard of care. Nineteen complaints (32%) were dismissed, but 40 (68%) resulted in sanctions ranging from censure to expulsion from membership. Both the frequency of complaints and length of sanctions have increased in the last 4 years. Although the AANS is highly attentive to procedural fairness, the overwhelming majority (57/59, 97%) of complaints related to testimony from witnesses acting for plaintiffs.Professional organizations may play a useful role in oversight of expert witness conduct, provided they maintain procedural fairness and strive for impartiality, as the AANS program seems to have done. However, from a policy perspective, this form of oversight is incomplete and should be complemented by other mechanisms aimed at ensuring the quality of physician testimony.

  View details for DOI 10.1097/SLA.0b013e31818a14ef

  View details for Web of Science ID 000262219300028

  View details for PubMedID 19106694

• Use of breast cancer screening and treatment services by Australian women aged 2544 years following Kylie Minogues breast cancer diagnosis INTERNATIONAL JOURNAL OF EPIDEMIOLOGY Kelaher, M., Cawson, J., Miller, J., Kavanagh, A., Dunt, D., Studdert, D. M. 2008; 37 (6): 1326–32

  Abstract

  To examine the effects of the publicity surrounding Kylie Minogue's diagnosis with breast cancer on doctor-referred breast imaging, image-guided biopsy, and cancer excisions among a low-risk population of women in Australia. Method We examine changes in unilateral and bilateral breast imaging, image-guided breast biopsies, and surgical excisions of breast cancer before and after the announcement of Kylie Minogue's diagnosis with breast cancer in May 2005. The study included procedures provided through the Australian public health system to women aged 25-44 years from October 2004 and June 2006.The odds of women aged 25-44 years undergoing imaging procedures increased by 20% in the first and second quarters after the Minogue publicity, compared to the preceding two quarters. The volume of biopsies als increased but the biopsy rate, measured as a proportion of imaging procedures, did not change among women aged 25-34 years and decreased among women aged 35-44 years. The volume of operations to excise breast cancers did not change for either age group. Compared to the 6 month period before the publicity, there was a large and significant decrease in the odds that an excision would follow biopsy (25-34 years: OR 95% CI=0.69, 0.48-0.98; 35-44 years: OR 95% CI=0.83, 0.72-0.95).High-publicised illnesses may affect both consumer and provider behaviour. Although they present opportunities to improve public health, they also have the potential to adversely impact the appropriateness and cost-effectiveness of service delivery.

  View details for PubMedID 18515324

• Management or Avoidance of Medical Malpractice Crises? Time to Choose CHEST Studdert, D. M. 2008; 134 (5): 901–2

  View details for DOI 10.1378/chest.08-1857

  View details for Web of Science ID 000260918500004

  View details for PubMedID 18988774

• Whistleblower-initiated enforcement actions against health care fraud and abuse in the United States, 1996 to 2005 ANNALS OF INTERNAL MEDICINE Kesselheim, A. S., Studdert, D. M. 2008; 149 (5): 342–W71

  Abstract

  Federal regulators have aggressively prosecuted health care fraud since the early 1990s, leading to billions of dollars in financial recoveries. Nearly all major cases today are qui tam actions, involving whistleblowers with inside knowledge of the allegedly illegal schemes. This article documents the outcomes of major enforcement actions and describe the schemes, defendants, and whistleblowers involved. The authors obtained an inventory of unsealed federal qui tam litigation targeting health care fraud that was resolved between 1996 and 2005 from the U.S. Department of Justice and gathered further information from publicly available sources. Among 379 cases, $9.3 billion was recovered, with more than $1.0 billion paid to whistleblowers. Case frequency peaked in 2001, but annual recoveries increased sharply from 2002 to 2005. Whistleblowers were frequently executives or physicians, and 75% were employees of defendant organizations. The 13 (4%) cases against pharmaceutical companies accounted for $3.6 billion (39%) of total recoveries. This study illuminates the scope and characteristics of qui tam fraud litigation and the whistleblowers who animate this important tool for addressing waste in the health care sector.

  View details for DOI 10.7326/0003-4819-149-5-200809020-00009

  View details for Web of Science ID 000259229300007

  View details for PubMedID 18765704

• Regulating physician expert witness testimony - Reply JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Kesselheim, A. S., Studdert, D. M. 2008; 299 (14): 1668

  View details for DOI 10.1001/jama.299.14.1668

  View details for Web of Science ID 000254749600022

• Can liability rules keep pace with best practice? The case of multidisciplinary cancer care MEDICAL JOURNAL OF AUSTRALIA Studdert, D. M. 2008; 188 (7): 380–81

  View details for Web of Science ID 000255802800002

  View details for PubMedID 18393736

• A Longitudinal Analysis of the Impact of Liability Pressure on the Supply of Obstetrician-Gynecologists JOURNAL OF EMPIRICAL LEGAL STUDIES Yang, Y. T., Studdert, D. M., Subramanian, S. V., Mello, M. M. 2008; 5 (1): 21-53

  View details for DOI 10.1111/j.1740-1461.2007.00117.x

  View details for Web of Science ID 000207805400002

• Deconstructing negligence: The role of individual and system factors in causing medical injuries GEORGETOWN LAW JOURNAL Mello, M. M., Studdert, D. M. 2008; 96 (2): 599-623

  View details for Web of Science ID 000253035300013

• Adjudicating Severe Birth Injury Claims in Florida and Virginia: The Experience of a Landmark Experiment in Personal Injury Compensation AMERICAN JOURNAL OF LAW & MEDICINE Siegal, G., Mello, M. M., Studdert, D. M. 2008; 34 (4): 493-537

  View details for Web of Science ID 000262868600003

  View details for PubMedID 19216246

• Beyond negligence: Avoidability and medical injury compensation SOCIAL SCIENCE & MEDICINE Kachalia, A. B., Mello, M. M., Brennan, T. A., Studdert, D. M. 2008; 66 (2): 387-402

  Abstract

  Disenchantment with the tort system and negligence standard in the United States is fueling interest in alternate compensation systems for medical injury. One possibility is experimentation with administrative "health courts," through which specialized adjudicators would utilize neutral experts to render compensability determinations. Compensation would be based not on negligence, but rather on a broader avoidable medical injury (avoidability) standard. Although considerable interest in health courts exists, stakeholders frequently express uncertainty about the meaning and operation of an avoidability standard. Three nations-Sweden, Denmark, and New Zealand-have long operated administrative schemes. We conducted interviews with administrators and stakeholders in these systems. Our goal was to garner lessons on how to operate a health court, and specifically, how to develop and apply alternate compensation criteria such as avoidability. This article reports our findings on the origins and operations of the systems, the evolution of their compensation criteria, and how these criteria are actually applied. We found that all three systems had their primary genesis in ensuring compensation for the injured, as opposed to sanctioning providers. All have abandoned the negligence standard. The Nordic systems use an avoidability standard, principally defined as injury that would not occur in the hands of the best practitioner. Their experience demonstrates that this definition is feasible to apply. New Zealand's recent move to a no-fault system sheds light on the benefits and drawbacks of a variety of compensation standards. Key lessons for successfully applying an alternate standard, such as avoidability, include a strict adherence to national precedent, the use of neutral and experienced experts, and a block on routine transfer of information from compensation investigations to disciplinary authorities. Importantly, all three nations are harnessing their systems' power to improve patient safety, and the avoidability standard appears to be well suited for this task.

  View details for DOI 10.1016/j.socscimed.2007.08.020

  View details for Web of Science ID 000252822000016

  View details for PubMedID 17931762

• Role of professional organizations in regulating physician expert witness testimony JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Kesselheim, A. S., Studdert, D. M. 2007; 298 (24): 2907–9

  View details for DOI 10.1001/jama.298.24.2907

  View details for Web of Science ID 000251816000024

  View details for PubMedID 18159060

• Medical errors involving trainees - A study of closed malpractice claims from 5 insurers Singh, H., Thomas, E. J., Petersen, L. A., Studdert, D. M. AMER MEDICAL ASSOC. 2007: 2030–36

  Abstract

  Despite wide recognition that the delivery of medical care by trainees involves special risks, information about the types and causes of medical errors involving trainees is limited. To describe the characteristics of and factors contributing to trainee errors, we analyzed malpractice claims in which trainees were judged to have played an important role in harmful errors.The claims were closed between 1984 and 2004, and the errors occurred between 1979 and 2001. Specialist physicians reviewed random samples of closed malpractice claim files at 5 liability insurers from 2002 to 2004 and determined whether injuries had occurred, and if so, whether they were due to error. We described the clinical circumstances and contributing factors associated with harmful errors involving trainees ("cases"). We also compared the characteristics of cases with their nontrainee counterparts and probed trainee errors attributed to teamwork problems and lack of technical competence or knowledge.Among 240 cases, errors in judgment (173 of 240 [72%]), teamwork breakdowns (167 of 240 [70%]), and lack of technical competence (139 of 240 [58%]) were the most prevalent contributing factors. Lack of supervision and handoff problems were most prevalent types of teamwork problems, and both were disproportionately more common among errors that involved trainees than those that did not (respectively, 54% vs 7% [P < .001] and 20% vs 12% [P = .009]). The most common task during which failures of technical competence occurred were diagnostic decision making and monitoring of the patient or situation. Trainee errors appeared more complex than nontrainee errors (mean of 3.8 contributing factors vs 2.5 [P < .001]).In addition to problems with handoffs, house staff are particularly vulnerable to medical errors owing to teamwork failures, especially lack of supervision. Graduate medical education reform should focus on strengthening these aspects of training.

  View details for DOI 10.1001/archinte.167.19.2030

  View details for Web of Science ID 000250326900003

  View details for PubMedID 17954795

• Disclosing harmful medical errors to patients NEW ENGLAND JOURNAL OF MEDICINE Gallagher, T. H., Studdert, D., Levinson, W. 2007; 356 (26): 2713–19

  View details for DOI 10.1056/NEJMra070568

  View details for Web of Science ID 000247564500009

  View details for PubMedID 17596606

• When tort resolutions are "wrong": Predictors of discordant outcomes in medical malpractice litigation Conference on Current Research on Medical Malpractice Liability Studdert, D. M., Mello, M. M. UNIV CHICAGO PRESS. 2007: S47–S78

  View details for Web of Science ID 000254223400003

• Open disclosure: Details matter - Response HEALTH AFFAIRS Studdert, D., Mello, M., Gawande, A., Brennan, T. 2007; 26 (3): 904–5

  View details for DOI 10.1377/hlthaff.26.3.904

  View details for Web of Science ID 000246458300052

• Changes in physician supply and scope of practice during a malpractice crisis: Evidence from Pennsylvania HEALTH AFFAIRS Mello, M. M., Studdert, D. M., Schumi, J., Brennan, T. A., Sage, W. M. 2007; 26 (3): W425-W435

  Abstract

  The extent to which liability costs cause physicians to restrict their scope of practice or cease practicing is controversial in policy debates over malpractice "crises." We used insurance department administrative data to analyze specialist physician scope-of-practice changes and exits in Pennsylvania in 1993-2002. In most specialties the proportions of high-risk specialists restricting their scope of practice did not increase during the crisis; however, the supply of obstetrician-gynecologists decreased by 8 percent in the three years following premium increases in 1999. We discuss methodological issues that could explain the disparate findings regarding physician supply effects in studies using administrative data sets and survey data.

  View details for DOI 10.1377/hlthaff.26.3.w425

  View details for Web of Science ID 000246458300066

  View details for PubMedID 17456502

• Disclosure of medical injury to patients: An improbable risk management strategy HEALTH AFFAIRS Studdert, D. M., Mello, M. M., Gawande, A. A., Brennan, T. A., Wang, Y. C. 2007; 26 (1): 215-226

  Abstract

  Pressure mounts on physicians and hospitals to disclose adverse outcomes of care to patients. Although such transparency diverges from traditional risk management strategy, recent commentary has suggested that disclosure will actually reduce providers' liability exposure. We tested this theory by modeling the litigation consequences of disclosure. We found that forecasts of reduced litigation volume or cost do not withstand close scrutiny. A policy question more pressing than whether moving toward routine disclosure will expand litigation is the question of how large such an expansion might be.

  View details for DOI 10.1377/hlthaff.26.1.215

  View details for Web of Science ID 000244223200024

  View details for PubMedID 17211031

• Patterns of technical error among surgical malpractice claims: an analysis of strategies to prevent injury to surgical patients. Annals of surgery Regenbogen, S. E., Greenberg, C. C., Studdert, D. M., Lipsitz, S. R., Zinner, M. J., Gawande, A. A. 2007; 246 (5): 705–11

  Abstract

  To identify the most prevalent patterns of technical errors in surgery, and evaluate commonly recommended interventions in light of these patterns.The majority of surgical adverse events involve technical errors, but little is known about the nature and causes of these events. We examined characteristics of technical errors and common contributing factors among closed surgical malpractice claims.Surgeon reviewers analyzed 444 randomly sampled surgical malpractice claims from four liability insurers. Among 258 claims in which injuries due to error were detected, 52% (n = 133) involved technical errors. These technical errors were further analyzed with a structured review instrument designed by qualitative content analysis.Forty-nine percent of the technical errors caused permanent disability; an additional 16% resulted in death. Two-thirds (65%) of the technical errors were linked to manual error, 9% to errors in judgment, and 26% to both manual and judgment error. A minority of technical errors involved advanced procedures requiring special training ("index operations"; 16%), surgeons inexperienced with the task (14%), or poorly supervised residents (9%). The majority involved experienced surgeons (73%), and occurred in routine, rather than index, operations (84%). Patient-related complexities-including emergencies, difficult or unexpected anatomy, and previous surgery-contributed to 61% of technical errors, and technology or systems failures contributed to 21%.Most technical errors occur in routine operations with experienced surgeons, under conditions of increased patient complexity or systems failure. Commonly recommended interventions, including restricting high-complexity operations to experienced surgeons, additional training for inexperienced surgeons, and stricter supervision of trainees, are likely to address only a minority of technical errors. Surgical safety research should instead focus on improving decision-making and performance in routine operations for complex patients and circumstances.

  View details for PubMedID 17968158

• Claims, errors, and compensation payments in medical malpractice litigation NEW ENGLAND JOURNAL OF MEDICINE Studdert, D. M., Mello, M. M., Gawande, A. A., Gandhi, T. K., Kachalia, A., Yoon, C., Puopolo, A. L., Brennan, T. A. 2006; 354 (19): 2024-2033

  Abstract

  In the current debate over tort reform, critics of the medical malpractice system charge that frivolous litigation--claims that lack evidence of injury, substandard care, or both--is common and costly.Trained physicians reviewed a random sample of 1452 closed malpractice claims from five liability insurers to determine whether a medical injury had occurred and, if so, whether it was due to medical error. We analyzed the prevalence, characteristics, litigation outcomes, and costs of claims that lacked evidence of error.For 3 percent of the claims, there were no verifiable medical injuries, and 37 percent did not involve errors. Most of the claims that were not associated with errors (370 of 515 [72 percent]) or injuries (31 of 37 [84 percent]) did not result in compensation; most that involved injuries due to error did (653 of 889 [73 percent]). Payment of claims not involving errors occurred less frequently than did the converse form of inaccuracy--nonpayment of claims associated with errors. When claims not involving errors were compensated, payments were significantly lower on average than were payments for claims involving errors (313,205 dollars vs. 521,560 dollars, P=0.004). Overall, claims not involving errors accounted for 13 to 16 percent of the system's total monetary costs. For every dollar spent on compensation, 54 cents went to administrative expenses (including those involving lawyers, experts, and courts). Claims involving errors accounted for 78 percent of total administrative costs.Claims that lack evidence of error are not uncommon, but most are denied compensation. The vast majority of expenditures go toward litigation over errors and payment of them. The overhead costs of malpractice litigation are exorbitant.

  View details for Web of Science ID 000237413100007

  View details for PubMedID 16687715

• The Medical Malpractice System Structure and Performance MEDICAL MALPRACTICE AND THE U.S. HEALTH CARE SYSTEM Mello, M. M., Studdert, D. M., Sage, W. M., Kersh, R. 2006: 11–29

  View details for DOI 10.1017/CBO9780511617836.002

  View details for Web of Science ID 000297343200002

• Relationship between complaints and quality of care in New Zealand: a descriptive analysis of complainants and non-complainants following adverse events. Quality & safety in health care Bismark, M. M., Brennan, T. A., Paterson, R. J., Davis, P. B., Studdert, D. M. 2006; 15 (1): 17–22

  Abstract

  To estimate the proportion and characteristics of patients injured by medical care in New Zealand public hospitals who complain to an independent health ombudsman, the Health and Disability Commissioner ("the Commissioner").The percentage of injured patients who lodge complaints was estimated by linking the Commissioner's complaints database to records reviewed in the New Zealand Quality of Healthcare Study (NZQHS). Bivariate and multivariate analyses investigated sociodemographic and socioeconomic differences between complainants and non-complainants.New Zealand public hospitals and the Office of the Commissioner in 1998.Patients who lodged claims with the Commissioner (n = 398) and patients identified by the NZQHS as having suffered an adverse event who did not lodge a complaint with the Commissioner (n = 847).Adverse events, preventable adverse events, and complaints lodged with the Commissioner.Among adverse events identified by the NZQHS, 0.4% (3/850) resulted in complaints; among serious, preventable adverse events 4% (2/48) resulted in complaints. The propensity of injured patients to complain increased steeply with the severity of the injury: odds of complaint were 11 times greater after serious permanent injuries than after temporary injuries, and 18 times greater after deaths. Odds of complaining were significantly lower for patients who were elderly (odds ratio (OR) 0.2, 95% confidence interval (CI) 0.1 to 0.4), of Pacific ethnicity (OR 0.3, 95% CI 0.1 to 0.9), or lived in the most deprived areas (OR 0.3, 95% CI 0.2 to 0.6).Most medical injuries never trigger a complaint to the Commissioner. Among complaints that are brought, severe and preventable injuries are common, offering a potentially valuable "window" on serious threats to patient safety. The relatively low propensity to complain among patients who are elderly, socioeconomically deprived, or of Pacific ethnicity suggests troubling disparities in access to and utilisation of complaints processes.

  View details for PubMedID 16456205

  View details for PubMedCentralID PMC2563994

• Will physician-level measures of clinical performance be used in medical malpractice litigation? JAMA Kesselheim, A. S., Ferris, T. G., Studdert, D. M. 2006; 295 (15): 1831–34

  View details for PubMedID 16622145

• Obesity--the new frontier of public health law. The New England journal of medicine Mello, M. M., Studdert, D. M., Brennan, T. A. 2006; 354 (24): 2601–10

  View details for PubMedID 16775242

• Characteristics of physicians who frequently act as expert witnesses in neurologic birth injury litigation. Obstetrics and gynecology Kesselheim, A. S., Studdert, D. M. 2006; 108 (2): 273–79

  Abstract

  Much debate surrounds physicians who testify in controversial types of medical malpractice litigation, but little is known about them. We sought to describe characteristics of physicians who frequently act as expert witnesses in neurologic birth injury litigation.Using jury verdict reports, we identified 827 cases between 1990 and 2005 involving birth-related neurologic injury to a child. Frequent expert witnesses were defined as those associated with more than 10 cases. From the verdict reports and other public data sources, we compiled case descriptions (injury type and severity, legal outcomes) and characteristics of the frequent witnesses (age, gender, board certification, academic publication record). We analyzed these characteristics by comparing witnesses with each other (plaintiff compared with defendant) and with nationally representative data.Seventy-one frequent witnesses participated in 738 cases (89% of the sample), which paid 2.9 billion US dollars in compensation. Most (56 of 71) testified for one side in at least three fourths of cases, and 40% of cases were located outside the witnesses' home states. Frequent plaintiff witnesses had a higher median annual case rate than their defendant counterparts (2.9 compared with 1.9 cases, P=.002). They were also older (57.2 compared with 50.8 years, P=.007), less likely to have subspecialty board certification (38% compared with 95%, P<.001), and had fewer academic publications (5.0 compared with 53.5, P=.002).A small cadre of physicians testifies in most neurologic birth injury litigation, and witnesses tend to act consistently for one side. Plaintiff witnesses have fewer markers of expertise than defendant witnesses. These descriptive and analytical findings may reflect suboptimal expertise or bias in physician expert testimony.

  View details for PubMedID 16880295

• Claiming behaviour in a no-fault system of medical injury: a descriptive analysis of claimants and non-claimants. The Medical journal of Australia Bismark, M. M., Brennan, T. A., Davis, P. B., Studdert, D. M. 2006; 185 (4): 203–7

  Abstract

  (i) To determine the proportion of patients in New Zealand who claim compensation from the national no-fault compensation program after experiencing a compensable injury; and (ii) to identify characteristics of injured patients who are least likely to claim despite having sustained a compensable injury.We estimated the percentage of eligible patients who claim no-fault compensation by linking a national claims database (Accident Compensation Corporation) to records reviewed in the New Zealand Quality of Healthcare Study (NZQHS). Bivariate and multivariate analyses were used to investigate socioeconomic and sociodemographic differences between claimants and injured non-claimants.Patients who experienced an adverse event associated with care in NZ public hospitals in 1998 and claimed compensation with the ACC, the national no-fault insurer (n = 741). Patients identified by the NZQHS as having sustained an adverse event associated with hospital care in the same year who did not file a compensation claim (n = 839).Adverse events, compensable adverse events, and compensation claims.Among patients judged by NZQHS reviewers to be eligible for compensation, 2.9% (6/210) claimed. Odds of claiming after an adverse event were significantly lower for patients who were elderly (odds ratio [OR], 0.20; 95% CI, 0.14-0.28), from the most deprived areas (OR, 0.36; 95% CI, 0.23-0.57), or of Ma ori or Pacific ethnicity (OR, 0.47; 95% CI, 0.32-0.69 and OR, 0.26, 95% CI, 0.11-0.58).Despite few apparent institutional or economic barriers, the proportion of injured patients in NZ who seek compensation after sustaining a compensable injury is very low. Hence, substantial underclaiming occurs in both negligence and no-fault systems. The disproportionately low propensity of elderly, poor and minority patients to seek compensation also appears to be pervasive.

  View details for PubMedID 16922665

• Missed and delayed diagnoses in the ambulatory setting: a study of closed malpractice claims. Annals of internal medicine Gandhi, T. K., Kachalia, A., Thomas, E. J., Puopolo, A. L., Yoon, C., Brennan, T. A., Studdert, D. M. 2006; 145 (7): 488–96

  Abstract

  Although missed and delayed diagnoses have become an important patient safety concern, they remain largely unstudied, especially in the outpatient setting.To develop a framework for investigating missed and delayed diagnoses, advance understanding of their causes, and identify opportunities for prevention.Retrospective review of 307 closed malpractice claims in which patients alleged a missed or delayed diagnosis in the ambulatory setting.4 malpractice insurance companies.Diagnostic errors associated with adverse outcomes for patients, process breakdowns, and contributing factors.A total of 181 claims (59%) involved diagnostic errors that harmed patients. Fifty-nine percent (106 of 181) of these errors were associated with serious harm, and 30% (55 of 181) resulted in death. For 59% (106 of 181) of the errors, cancer was the diagnosis involved, chiefly breast (44 claims [24%]) and colorectal (13 claims [7%]) cancer. The most common breakdowns in the diagnostic process were failure to order an appropriate diagnostic test (100 of 181 [55%]), failure to create a proper follow-up plan (81 of 181 [45%]), failure to obtain an adequate history or perform an adequate physical examination (76 of 181 [42%]), and incorrect interpretation of diagnostic tests (67 of 181 [37%]). The leading factors that contributed to the errors were failures in judgment (143 of 181 [79%]), vigilance or memory (106 of 181 [59%]), knowledge (86 of 181 [48%]), patient-related factors (84 of 181 [46%]), and handoffs (36 of 181 [20%]). The median number of process breakdowns and contributing factors per error was 3 for both (interquartile range, 2 to 4).Reviewers were not blinded to the litigation outcomes, and the reliability of the error determination was moderate.Diagnostic errors that harm patients are typically the result of multiple breakdowns and individual and system factors. Awareness of the most common types of breakdowns and factors could help efforts to identify and prioritize strategies to prevent diagnostic errors.

  View details for PubMedID 17015866

• "Health courts" and accountability for patient safety MILBANK QUARTERLY Mello, M. M., Studdert, D. M., Kachalia, A. B., Brennan, T. A. 2006; 84 (3): 459-492

  Abstract

  Proposals that medical malpractice claims be removed from the tort system and processed in an alternative system, known as administrative compensation or "health courts," attract considerable policy interest during malpractice "crises," including the current one. This article describes current proposals for the design of a health court system and the system's advantages for improving patient safety. Among these advantages are the cultivation of a culture of transparency regarding medical errors and the creation of mechanisms to gather and analyze data on medical injuries. The article discusses the experiences of foreign countries with administrative compensation systems for medical injury, including their use of claims data for research on patient safety; choices regarding the compensation system's relationship to physician disciplinary processes; and the proposed system's possible limitations.

  View details for Web of Science ID 000240027400002

  View details for PubMedID 16953807

• Liability, Patient Safety, and Defensive Medicine What Does the Future Hold? MEDICAL MALPRACTICE AND THE U.S. HEALTH CARE SYSTEM Brennan, T. A., Mello, M. M., Studdert, D. M., Sage, W. M., Kersh, R. 2006: 93–114

  View details for DOI 10.1017/CBO9780511617836.007

  View details for Web of Science ID 000297343200007

• Effects of a malpractice crisis on specialist supply and patient access to care ANNALS OF SURGERY Mello, M. M., Studdert, D. M., DesRoches, C. M., Peugh, J., Zapert, K., Brennan, T. A., Sage, W. M. 2005; 242 (5): 621-628

  Abstract

  To investigate specialist physicians' practice decisions in response to liability concerns and their perceptions of the impact of the malpractice environment on patient access to care.A perennial concern during "malpractice crises" is that liability costs will drive physicians in high-risk specialties out of practice, creating specialist shortages and access-to-care problems.Mail survey of 824 Pennsylvania physicians in general surgery, neurosurgery, orthopedic surgery, obstetrics/gynecology, emergency medicine, and radiology eliciting information on practice decisions made in response to rising liability costs.Strong majorities of specialists reported increases over the last 3 years in patients' driving distances (58%) and waiting times (83%) for specialist care or surgery, waiting times for emergency department care (82%), and the number of patients forced to switch physicians (89%). Professional liability costs and managed care were both considered important contributing factors. Small proportions of specialists reported that they would definitely retire (7%) or relocate their practice out of state (4%) within the next 2 years; another third (32% and 29%, respectively) said they would likely do so. Forty-two percent of specialists have reduced or eliminated high-risk aspects of their practice, and 50% are likely to do so over the next 2 years.Our data suggest that claims of a "physician exodus" from Pennsylvania due to rising liability costs are overstated, but the malpractice situation is having demonstrable effects on the supply of specialist physicians in affected areas and their scope of practice, which likely impinges upon patients' access to care.

  View details for DOI 10.1097/01.sla.0000182957.54783.9a

  View details for Web of Science ID 000233215500001

  View details for PubMedID 16244532

  View details for PubMedCentralID PMC1409847

• Researchers' views of the acceptability of restrictive provisions in clinical trial agreements with industry sponsors. Accountability in research Mello, M. M., Clarridge, B. R., Studdert, D. M. 2005; 12 (3): 163-191

  Abstract

  We conducted a mail survey of 884 U.S. medical school faculty active in clinical research to elicit their views about the acceptability of provisions in contracts for industry-sponsored clinical trials that would restrict investigators' academic freedom and control over trials. We compared their responses to results from a similar survey of research administrators at 107 medical schools. There was substantial variation among clinical researchers in their acceptability judgments, with a relatively large proportion of clinical trial investigators willing to accept provisions that give industry sponsors considerable control over the dissemination of research results. There were significant differences in the perceptions of clinical trial investigators versus other recently published clinical researchers; investigators with a high versus low percentage of research support from industry; junior versus senior faculty; and investigators at institutions with high versus low National Institute of Health (NIH) funding ranks. There was also a significant divergence of views in a number of areas between clinical trialists and research administrators who negotiate clinical trial contracts on their behalf. Medical school faculty could benefit from additional guidance about what their institution views as acceptable parameters for industry-sponsored clinical trial agreements.

  View details for PubMedID 16634168

• Defensive medicine among high-risk specialist physicians in a volatile malpractice environment JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Studdert, D. M., Mello, M. M., Sage, W. M., DesRoches, C. M., Peugh, J., Zapert, K., Brennan, T. A. 2005; 293 (21): 2609-2617

  Abstract

  How often physicians alter their clinical behavior because of the threat of malpractice liability, termed defensive medicine, and the consequences of those changes, are central questions in the ongoing medical malpractice reform debate.To study the prevalence and characteristics of defensive medicine among physicians practicing in high-liability specialties during a period of substantial instability in the malpractice environment.Mail survey of physicians in 6 specialties at high risk of litigation (emergency medicine, general surgery, orthopedic surgery, neurosurgery, obstetrics/gynecology, and radiology) in Pennsylvania in May 2003.Number of physicians in each specialty reporting defensive medicine or changes in scope of practice and characteristics of defensive medicine (assurance and avoidance behavior).A total of 824 physicians (65%) completed the survey. Nearly all (93%) reported practicing defensive medicine. "Assurance behavior" such as ordering tests, performing diagnostic procedures, and referring patients for consultation, was very common (92%). Among practitioners of defensive medicine who detailed their most recent defensive act, 43% reported using imaging technology in clinically unnecessary circumstances. Avoidance of procedures and patients that were perceived to elevate the probability of litigation was also widespread. Forty-two percent of respondents reported that they had taken steps to restrict their practice in the previous 3 years, including eliminating procedures prone to complications, such as trauma surgery, and avoiding patients who had complex medical problems or were perceived as litigious. Defensive practice correlated strongly with respondents' lack of confidence in their liability insurance and perceived burden of insurance premiums.Defensive medicine is highly prevalent among physicians in Pennsylvania who pay the most for liability insurance, with potentially serious implications for cost, access, and both technical and interpersonal quality of care.

  View details for Web of Science ID 000229443400019

  View details for PubMedID 15928282

• Academic medical centers' standards for clinical-trial agreements with industry NEW ENGLAND JOURNAL OF MEDICINE Mello, M. M., Clarridge, B. R., Studdert, D. M. 2005; 352 (21): 2202-2210

  Abstract

  Although industry sponsors provide approximately 70 percent of the funding for clinical drug trials in the United States, little is known about the legal agreements that exist between industry sponsors and academic investigators. We studied institutional standards regarding contractual provisions that restrict investigators' control over trials.We used a structured, cross-sectional mail survey of medical-school research administrators responsible for negotiating clinical-trial agreements with industry sponsors.Of 122 institutions approached, 107 participated. There was a high degree of consensus among administrators about the acceptability of several contractual provisions relating to publications. For example, more than 85 percent reported that their office would not approve provisions giving industry sponsors the authority to revise manuscripts or decide whether results should be published. There was considerable disagreement about the acceptability of provisions allowing the sponsor to insert its own statistical analyses in manuscripts (24 percent allowed them, 47 percent disallowed them, and 29 percent were not sure whether they should allow them), draft the manuscript (50 percent allowed it, 40 percent disallowed it, and 11 percent were not sure whether they should allow it), and prohibit investigators from sharing data with third parties after the trial is over (41 percent allowed it, 34 percent disallowed it, and 24 percent were not sure whether they should allow it). Disputes were common after the agreements had been signed and most frequently centered on payment (75 percent of administrators reported at least one such dispute in the previous year), intellectual property (30 percent), and control of or access to data (17 percent).Standards for certain restrictive provisions in clinical-trial agreements with industry sponsors vary considerably among academic medical centers. Greater sharing of information about legal relationships with industry sponsors is desirable in order to build consensus about appropriate standards.

  View details for Web of Science ID 000229333300008

  View details for PubMedID 15917385

• Caring for patients in a malpractice crisis: Physician satisfaction and quality of care HEALTH AFFAIRS Mello, M. M., Studdert, D. M., DesRoches, C. M., Peugh, J., Zapert, K., Brennan, T. A., Sage, W. M. 2004; 23 (4): 42-53

  Abstract

  The rhetoric of malpractice reform is at fever pitch, but political advocacy does not necessarily reflect grassroots opinion. To determine whether the ongoing liability crisis has greatly reduced physicians' professional satisfaction, we surveyed specialist physicians in Pennsylvania. We found widespread discontent among physicians practicing in high-liability environments, which seems to be compounded by other financial and administrative pressures. Opinion alone should not determine public policy, but physicians' perceptions matter for two reasons. First, perceptions influence behavior with respect to practice environment and clinical decision making. Second, perceptions influence the physician-patient relationship and the interpersonal quality of care.

  View details for DOI 10.1377/hlthaff.23.4.42

  View details for Web of Science ID 000222499600006

  View details for PubMedID 15318566

• Are damages caps regressive? A study of malpractice jury verdicts in California HEALTH AFFAIRS Studdert, D. M., Yang, Y. T., Mello, M. M. 2004; 23 (4): 54-67

  Abstract

  Caps on damages have emerged as the most controversial legislative response to the new malpractice crisis. We analyzed a sample of high-end jury verdicts in California that were subjected to the state's dollars 250,000 cap on noneconomic damages. We found strong evidence that the cap's fiscal impact was distributed inequitably across different types of injuries. In absolute dollar terms, the reductions imposed on grave injury were seven times larger than those for minor injury; the largest proportional reductions were for injuries that centered on pain and disfigurement. Use of sliding scales of damages instead of or in conjunction with caps would mitigate their adverse impacts on fairness.

  View details for DOI 10.1377/hlthaff.23.4.54

  View details for Web of Science ID 000222499600007

  View details for PubMedID 15318567

• Decision making and satisfaction with care in the pediatric intensive care unit: findings from a controlled clinical trial. Pediatric critical care medicine Mello, M. M., Burns, J. P., Truog, R. D., Studdert, D. M., Puopolo, A. L., Brennan, T. A. 2004; 5 (1): 40-47

  Abstract

  To facilitate critical decision making and improve satisfaction with care among families of patients in a pediatric intensive care unit.Prospective observational study followed by a nonrandomized controlled trial of a clinical intervention to identify conflicts and facilitate communication between families and the clinical team.The pediatric intensive care unit of a Boston teaching hospital.A total of 127 patients receiving care in the pediatric intensive care unit in 1998-1999 and their families.Interviews were conducted with surrogates and decisionally capable older children concerning the adequacy of information provided, understanding, communication, and perceived decisional conflicts. Findings were relayed to the clinical team, who then developed tailored follow-up recommendations.A survey administered to surrogates at baseline and day 7 or intensive care unit discharge measured satisfaction with care. Information on patient acuity and hospital stay were extracted from medical records and hospital databases. Wilcoxon rank-sum tests and incidence rate comparisons were used to assess the impact of the intervention on satisfaction and sentinel decision making, respectively. Incidence rates of care plan decision making, including decisions to adopt a comfort-care-only plan and decisions to forego resuscitation, were lower among families who received the intervention. The intervention did not significantly affect satisfaction with care.Prospectively screening for and intervening to mitigate potential conflict did not increase decision making or parental satisfaction with the care provided in this pediatric intensive care unit.

  View details for PubMedID 14697107

• Medical malpractice. The New England journal of medicine Studdert, D. M., Mello, M. M., Brennan, T. A. 2004; 350 (3): 283–92

  View details for PubMedID 14724310

• The pharmaceutical industry versus Medicaid--limits on state initiatives to control prescription-drug costs. The New England journal of medicine Mello, M. M., Studdert, D. M., Brennan, T. A. 2004; 350 (6): 608–13

  View details for PubMedID 14762190

• Nursing home litigation and tort reform: a case for exceptionalism. The Gerontologist Studdert, D. M., Stevenson, D. G. 2004; 44 (5): 588–95

  Abstract

  The medical malpractice crisis that is currently spreading across the United States bears many similarities to earlier crises. One novel aspect of the current crisis is the explicit inclusion of litigation against nursing homes as a target of reform. Encouraged by the nursing home industry, policymakers are considering the extension of conventional medical malpractice tort reforms to the nursing home sector. In this article, we caution against such an approach. Nursing home litigation has a number of distinctive features that raise serious questions about the wisdom of implementing reforms generically across the care continuum. Drawing on findings from our previous study of nursing home litigation, we outline these features and argue for careful attention to them as policymakers evaluate options for reform.

  View details for PubMedID 15498834

• Financial conflicts of interest in physicians' relationships with the pharmaceutical industry--self-regulation in the shadow of federal prosecution. The New England journal of medicine Studdert, D. M., Mello, M. M., Brennan, T. A. 2004; 351 (18): 1891–1900

  View details for PubMedID 15509824

• Hospitals' behavior in a tort crisis: observations from Pennsylvania. Health affairs Mello, M. M., Kelly, C. N., Studdert, D. M., Brennan, T. A., Sage, W. M. 2003; 22 (6): 225-233

  Abstract

  Pennsylvania, like many states around the country, is in the throes of a "tort crisis." The cost of professional liability insurance for physicians and hospitals is escalating rapidly, as its availability shrinks. Many hospitals are poorly situated to bear these rising costs, especially in an environment of flat reimbursement rates and poor investment returns. This paper examines the impact of the liability crisis on Pennsylvania hospitals and the strategies being used to weather the storm, including alternative risk financing and closer ties between hospitals and affiliated physicians. It concludes by connecting these trends to larger medical malpractice policy issues.

  View details for PubMedID 14649450

• Trends - The McLawsult: The fast-food industry and legal accountability for obesity HEALTH AFFAIRS Mello, M. M., Rimm, E. B., Studdert, D. M. 2003; 22 (6): 207-216

  Abstract

  Recent litigation brought by a group of overweight children against the McDonald's Corporation that seeks compensation for obesity-related health problems has provoked an intense public response. Many have derided this lawsuit as representing the worst excesses of the tort liability system, while others have drawn parallels to tobacco litigation. Fast-food litigation raises the question of where accountability for the economic and public health consequences of obesity properly rests. In this paper we consider the reasonableness of the claims against fast-food companies and discuss several social effects that the litigation may have irrespective of its outcome in court.

  View details for Web of Science ID 000186632200027

  View details for PubMedID 14649448

• Nature of conflict in the care of pediatric intensive care patients with prolonged stay PEDIATRICS Studdert, D. M., Burns, J. P., Mello, M. M., Puopolo, A. L., Truog, R. D., Brennan, T. A. 2003; 112 (3): 553-558

  Abstract

  To determine the frequency, types, sources, and predictors of conflict surrounding the care of pediatric intensive care unit (PICU) patients with prolonged stay.A tertiary care, university-affiliated PICU in Boston.All patients admitted over an 11-month period whose stay exceeded 8 days (the 85th percentile length of stay for the PICU under study), and intensive care physicians and nurses who were responsible for their care.We prospectively identified conflicts by interviewing the treating physicians and nurses at 2 stages during the patients' PICU stay. All conflicts detected were classified by type (team-family, intrateam, or intrafamily) and source. Using a case-control design, we then identified predictors of conflict through bivariate and multivariate analyses.We enrolled 110 patients based on the length-of-stay criterion. Clinicians identified 55 conflicts involving 51 patients in this group. Hence, nearly one half of all patients followed had a conflict associated with their care. Thirty-three of the conflicts (60%) were team-family, 21 (38%) were intrateam, and the remaining 1 was intrafamily. The most commonly cited sources of team-family conflict were poor communication (48%), unavailability of parents (39%), and disagreements over the care plan (39%). Medicaid insurance status was independently associated with the occurrence of conflict generally (odds ratio = 4.97) and team-family conflict specifically (odds ratio = 7.83).Efforts to reduce and manage conflicts that arise in the care of critically ill children should be sensitive to the distinctive features of these conflicts. Knowledge of risk factors for conflict may also help to target such interventions at the patients and families who need them most.

  View details for Web of Science ID 000185035100027

  View details for PubMedID 12949283

• Conflict in the care of patients with prolonged stay in the ICU: types, sources, and predictors INTENSIVE CARE MEDICINE Studdert, D. M., Mello, M. M., Burns, J. P., Puopolo, A. L., Galper, B. Z., Truog, R. D., Brennan, T. A. 2003; 29 (9): 1489-1497

  Abstract

  To determine types, sources, and predictors of conflicts among patients with prolonged stay in the ICU.We prospectively identified conflicts by interviewing treating physicians and nurses at two stages during the patients' stays. We then classified conflicts by type and source and used a case-control design to identify predictors of team-family conflicts.Seven medical and surgical ICUs at four teaching hospitals in Boston, USA.All patients admitted to the participating ICUs over an 11-month period whose stay exceeded the 85th percentile length of stay for their respective unit ( n=656).Clinicians identified 248 conflicts involving 209 patients; hence, nearly one-third of patients had conflict associated with their care: 142 conflicts (57%) were team-family disputes, 76 (31%) were intrateam disputes, and 30 (12%) occurred among family members. Disagreements over life-sustaining treatment led to 63 team-family conflicts (44%). Other leading sources were poor communication (44%), the unavailability of family decision makers (15%), and the surrogates' (perceived) inability to make decisions (16%). Nurses detected all types of conflict more frequently than physicians, especially intrateam conflicts. The presence of a spouse reduced the probability of team-family conflict generally (odds ratio 0.64) and team-family disputes over life-sustaining treatment specifically (odds ratio 0.49).Conflict is common in the care of patients with prolonged stays in the ICU. However, efforts to improve the quality of care for critically ill patients that focus on team-family disagreements over life-sustaining treatment miss significant discord in a variety of other areas.

  View details for DOI 10.1007/s00134-003-1853-5

  View details for Web of Science ID 000185665800015

  View details for PubMedID 12879243

• The rise of litigation in human subjects research ANNALS OF INTERNAL MEDICINE Mello, M. M., Studdert, D. M., Brennan, T. A. 2003; 139 (1): 40-45

  Abstract

  Owing to widespread public concern about the adequacy of protections for human research subjects and recent instances of serious injury to subjects at several major research institutions, lawsuits against investigators, institutional review boards, and academic institutions are becoming increasingly common. Several claim-promoting conditions are ripe to promote the further growth of this litigation and raise the stakes for research institutions. While this litigation may serve a valuable compensation function for injured subjects, it will also have profound effects on institutional review boards, leading to a more legalistic, mechanistic approach to ethical review that does not further the interests of human subjects or scientific progress.

  View details for Web of Science ID 000183823200006

  View details for PubMedID 12834317

• The leapfrog standards: Ready to jump from marketplace to courtroom? HEALTH AFFAIRS Mello, M. M., Studdert, D. M., Brennan, T. A. 2003; 22 (2): 46-59

  Abstract

  The Leapfrog Group, a consortium of large employers, aims to use its collective purchasing power to motivate hospitals to implement particular measures designed to improve patient safety and the quality of care. While these criteria are meant to be purely aspirational, and while Leapfrog's effort is praiseworthy, we caution that the articulation of these standards of care may have unintended legal consequences. Efforts by aggressive medical malpractice attorneys could rapidly transform Leapfrog's standards from marketplace advantages for compliant hospitals to performance expectations required by law. This undesirable potential outcome compounds the importance of selecting these standards with the utmost care.

  View details for Web of Science ID 000181450400011

  View details for PubMedID 12674407

• Medical monitoring for pharmaceutical injuries - Tort law for the public's health? JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Studdert, D. M., Mello, M. M., Brennan, T. A. 2003; 289 (7): 889-894

  Abstract

  A remarkable development in personal injury litigation in recent years involves attempts to expand legal claims beyond existing injuries to anticipated future harms. Attorneys have begun to sue on behalf of individuals exposed to defective pharmaceutical products who have no current injury, but who may be at risk for developing one after a latency period. This strategy seeks to make drug manufacturers pay for medical monitoring, a court-ordered program that provides diagnostic tests to exposed individuals to facilitate early detection of adverse health effects. Because medical monitoring does not depend on the existence of an actual injury and large populations may be exposed, some commentators have warned that it has the potential to spiral out of control. We examine medical monitoring in the context of 2 major cases involving diet drugs and an oral hypoglycemic drug. We conclude that this expansion of tort law should be applied sparingly, but that the performance of courts to date in these cases gives cause for optimism. Judges appear to be paying close attention to sophisticated epidemiological, clinical, and cost-effectiveness considerations. Medical monitoring arms the courts with a new mechanism for addressing harms proactively rather than reactively, which could yield new victories for public health.

  View details for Web of Science ID 000181072200034

  View details for PubMedID 12588274

• Analysis of errors reported by surgeons at three teaching hospitals. Surgery Gawande, A. A., Zinner, M. J., Studdert, D. M., Brennan, T. A. 2003; 133 (6): 614–21

  Abstract

  Little is known of the factors that underlie surgical errors. Incident reporting has been proposed as a method of obtaining information about medical errors to help identify such factors.Between November 1, 2000, and March 15, 2001, we conducted confidential interviews with randomly selected surgeons from three Massachusetts teaching hospitals to elicit detailed reports on surgical adverse events resulting from errors in management ("incidents"). Data on the characteristics of the incidents and the factors that surgeons reported to have contributed to the errors were recorded and analyzed.Among 45 surgeons approached for interviews, 38 (84%) agreed to participate and provided reports on 146 incidents. Thirty-three percent of incidents resulted in permanent disability and 13% in patient death. Seventy-seven percent involved injuries related to an operation or other invasive intervention (visceral injuries, bleeding, and wound infection/dehiscence were the most common subtypes), 13% involved unnecessary or inappropriate procedures, and 10% involved unnecessary advancement of disease. Two thirds of the incidents involved errors during the intraoperative phase of surgical care, 27% during preoperative management, and 22% during postoperative management. Two or more clinicians were cited as substantially contributing to errors in 70% of the incidents. The most commonly cited systems factors contributing to errors were inexperience/lack of competence in a surgical task (53% of incidents), communication breakdowns among personnel (43%), and fatigue or excessive workload (33%). Surgeons reported significantly more systems failures in incidents involving emergency surgical care than those involving nonemergency care (P <.001).Subjective incident reports gathered through interviews allow identification of characteristics of surgical errors and their leading contributing factors, which may help target research and interventions to reduce such errors.

  View details for PubMedID 12796727

• Enrollee appeals of preservice coverage denials at 2 Health Maintenance Organizations. JAMA Studdert, D. M., Gresenz, C. R. 2003; 289 (7): 864–70

  Abstract

  Congress and state legislatures are considering patient bills of rights that seek to strengthen opportunities for patients to have denials of coverage reconsidered by their health plans. Little is publicly known about such appeals systems.To improve understanding of the sources, types, and outcomes of conflicts between patients and managed care organizations over coverage of services.Descriptive study of information abstracted from 1774 preservice appeals out of a larger stratified random sample of 3519 appeals lodged between January 1998 and June 2000 at 2 large US health maintenance organizations.Classification of preservice appeals according to whether they contested access to out-of-network care, the contractual limits of coverage, or the medical necessity of services; analysis of contractual coverage and medical necessity appeals by the services in dispute and out-of-network appeals by enrollees' reasons for seeking care; and comparison of the proportions of appeals won by enrollees across types of appeals and services.Approximately one third (36.9%) of preservice appeals involved medical necessity determinations, another third (36.6%) centered on the scope of contractually covered benefits, and most of the remainder (19.7%) involved out-of-network care. Enrollee wins were significantly more frequent among medical necessity appeals than out-of-network or contractual coverage appeals (52.2% vs 35.4% and 33.2%, respectively; P<.001). Appeals were concentrated among relatively few services and among therapies that are generally regarded as nonessential.A majority of preservice appeals disputed choice of provider or contractual coverage issues, rather than medical necessity. Medical necessity disputes proliferate not around life-saving treatments but in areas of societal uncertainty about the legitimate boundaries of insurance coverage. Greater transparency about the coverage status of specific services, through more precise contractual language and consumer education about benefits limitations, may help to avoid a large proportion of disputes in managed care.

  View details for PubMedID 12588270

• The new medical malpractice crisis. The New England journal of medicine Mello, M. M., Studdert, D. M., Brennan, T. A. 2003; 348 (23): 2281–84

  View details for PubMedID 12788991

• MarketWatch - Patients in conflict with managed care: A profile of appeals in two HMOs HEALTH AFFAIRS Gresenz, C. R., Studdert, D. M., Campbell, N., Hensler, D. R. 2002; 21 (4): 189-196

  Abstract

  Despite speculation about the nature of disputes between managed care enrollees and their health plans over benefit denials, little empirical information exists about the details of such disputes and how they are actually handled. In this study we profile more than 11,000 appeals lodged between 1998 and 2000 by enrollees at two of the nation's largest health maintenance organizations (HMOs), to shed some preliminary light on the vast terrain of enrollee appeals. As many as half of appeals involved requests for reimbursement for costs of services already obtained ("retrospective" appeals), as opposed to services sought ("prospective appeals"). Enrollees won 36 percent of prospective appeals at Plan 1 and 70 percent at Plan 2, compared with 89 percent and 78 percent, respectively, of retrospective appeals. The success rate among retrospective appeals involving emergency room services--95 percent at both plans--was particularly striking.

  View details for Web of Science ID 000176978400024

• Personal choices of health plans by managed care experts MEDICAL CARE Studdert, D. M., Bhattacharya, J., Schoenbaum, M., Warren, B., Escarce, J. J. 2002; 40 (5): 375-386

  Abstract

  Expert opinion has not been used as a basis for comparing different forms of health insurance, in part because this perspective may not be appropriately sensitive to aspects of care that consumers value.Using a case-control design, managed care experts were surveyed at 17 academic institutions in the United States to determine the type of health plan they chose (fee-for-service, HMO, POS, PPO, or catastrophic). Controls consisted of academicians from other disciplines at these institutions who ostensibly faced the same insurance options. We then compared the choices of physician experts, nonphysician experts and controls using a multinomial logit model that was sensitive to the choice set available at each institution. We also examined the choice behavior of respondents within moderate (< $150,000) and high (> or =$150,000) income levels.Four hundred thirty-seven experts and 465 controls were surveyed and responses were received from 73.7% and 52.7%, respectively. Physician experts were approximately half as likely (14.9%) as controls (26.6%) or nonphysician experts (27.6%) to enroll in HMO plans. In moderate-income households, both physicians (Relative Risk [RR] = 0.42; P <0.01) and nonphysician experts (RR = 0.71; P <0.1) were less likely than controls to opt for an HMO. Experts' propensity to choose HMO coverage varied little with income, whereas controls' propensity changed dramatically between moderate (39.1% in HMOs) and high (14.0% in HMOs) income categories.The aversion of physician experts, and nonphysician experts with moderate income, to HMO plans may be caused by their stronger distaste for the constraints on choice and access that typically accompany HMO coverage. Alternatively, it may be explained by their superior ability to absorb, understand, and use information about available insurance options. Insights into quality in managed care may also play a role.

  View details for Web of Science ID 000175375400003

  View details for PubMedID 11961472

• The reliability of medical record review for estimating adverse event rates. Annals of internal medicine Thomas, E. J., Lipsitz, S. R., Studdert, D. M., Brennan, T. A. 2002; 136 (11): 812–16

  Abstract

  The data used by the U.S. Institute of Medicine to estimate deaths from medical errors come from a study that relied on nurse and physician reviews of medical records to detect the errors.To measure the reliability of medical record review for detecting adverse events and negligent adverse events.Medical record review.Hospitalizations in Utah and Colorado in 1992.After three independent reviews of 500 medical records, the following were measured: reliability and the effect of varying criteria for reviewer confidence in and reviewer agreement about the presence of adverse events.For agreements in judgments of adverse events among the three sets of reviews, the kappa statistics ranged from 0.40 to 0.41 (95% CIs ranged from 0.30 to 0.51) for adverse events and from 0.19 to 0.23 (CIs, 0.05 to 0.37) for negligent adverse events. Rates for adverse events and for negligent adverse events varied substantially depending on the degree of agreement and the level of confidence that was required among reviewers.Estimates of adverse event rates from medical record review, including those reported by the Institute of Medicine in its 2000 report on medical errors, are highly sensitive to the degree of consensus and confidence among reviewers.

  View details for PubMedID 12044129

• Toward a workable model of "no-fault" compensation for medical injury in the United States. American journal of law & medicine Studdert, D. M., Brennan, T. A. 2001; 27 (2-3): 225–52

  View details for PubMedID 11467111

• Alternative treatments for weight-loss: caveat emptor. Critical reviews in food science and nutrition Studdert, D. M. 2001; 41 (1): 29–31

  View details for PubMedID 11152042

• Negligent care and malpractice claiming behavior in Utah and Colorado. Medical care Studdert, D. M., Thomas, E. J., Burstin, H. R., Zbar, B. I., Orav, E. J., Brennan, T. A. 2000; 38 (3): 250–60

  Abstract

  Previous studies relating the incidence of negligent medical care to malpractice lawsuits in the United States may not be generalizable. These studies are based on data from 2 of the most populous states (California and New York), collected more than a decade ago, during volatile periods in the history of malpractice litigation.The study objectives were (1) to calculate how frequently negligent and nonnegligent management of patients in Utah and Colorado in 1992 led to malpractice claims and (2) to understand the characteristics of victims of negligent care who do not or cannot obtain compensation for their injuries from the medical malpractice system.We linked medical malpractice claims data from Utah and Colorado with clinical data from a review of 14,700 medical records. We then analyzed characteristics of claimants and nonclaimants using evidence from their medical records about whether they had experienced a negligent adverse event.The study measures were negligent adverse events and medical malpractice claims.Eighteen patients from our study sample filed claims: 14 were made in the absence of discernible negligence and 10 were made in the absence of any adverse event. Of the patients who suffered negligent injury in our study sample, 97% did not sue. Compared with patients who did sue for negligence occurring in 1992, these nonclaimants were more likely to be Medicare recipients (odds ratio [OR], 3.5; 95% CI [CI], 1.3 to 9.6), Medicaid recipients (OR, 3.6; 95% CI, 1.4 to 9.0), > or =75 years of age (OR, 7.0; 95% CI, 1.7 to 29.6), and low income earners (OR, 1.9; 95% CI, 0.9 to 4.2) and to have suffered minor disability as a result of their injury (OR, 6.3; 95% CI, 2.7 to 14.9).The poor correlation between medical negligence and malpractice claims that was present in New York in 1984 is also present in Utah and Colorado in 1992. Paradoxically, the incidence of negligent adverse events exceeds the incidence of malpractice claims but when a physician is sued, there is a high probability that it will be for rendering nonnegligent care. The elderly and the poor are particularly likely to be among those who suffer negligence and do not sue, perhaps because their socioeconomic status inhibits opportunities to secure legal representation.

  View details for PubMedID 10718350

• Expanded managed care liability: What impact on employer coverage? HEALTH AFFAIRS Studdert, D. M., Sage, W. M., Gresenz, C. R., Hensler, D. R. 1999; 18 (6): 7-27

  Abstract

  Policymakers are considering legislative changes that would increase managed care organizations' exposure to civil liability for withholding coverage or failing to deliver needed care. Using a combination of empirical information and theoretical analysis, we assess the likely responses of health plans and Employee Retirement Income Security Act (ERISA) plan sponsors to an expansion of liability, and we evaluate the policy impact of those moves. We conclude that the direct costs of liability are uncertain but that the prospect of litigation may have other important effects on coverage decision making, information exchange, risk contracting, and the extent of employers' involvement in health coverage.

  View details for Web of Science ID 000083687800002

  View details for PubMedID 10650685

• Clinical trials in developing countries: scientific and ethical issues. The Medical journal of Australia Studdert, D. M., Brennan, T. A. 1998; 169 (10): 545–48

  Abstract

  Since the 1994 finding that intensive zidovudine treatment of mothers and infants can dramatically reduce perinatal transmission of human immunodeficiency virus, this treatment has been widely adopted in developed countries. In developing countries, trials of less-intensive (and cheaper) regimens have gone ahead, many funded by foreign governments and the United Nations. Controversy has erupted over these trials, particularly over their use of placebo controls. Do differences in healthcare needs and budgets justify different ethical standards in the developed and the developing world?

  View details for PubMedID 9861913

• Medical malpractice implications of alternative medicine. JAMA Studdert, D. M., Eisenberg, D. M., Miller, F. H., Curto, D. A., Kaptchuk, T. J., Brennan, T. A. 1998; 280 (18): 1610–15

  Abstract

  Although use of alternative therapies in the United States is widespread and growing, little is known about the malpractice experience of practitioners who deliver these therapies or about the legal principles that govern the relationship between conventional and alternative medicine. Using data from malpractice insurers, we analyzed the claims experience of chiropractors, massage therapists, and acupuncturists for 1990 through 1996. We found that claims against these practitioners occurred less frequently and typically involved injury that was less severe than claims against physicians during the same period. Physicians who may be concerned about their own exposure to liability for referral of patients for alternative treatments can draw some comfort from these findings. However, liability for referral is possible in certain situations and should be taken seriously. Therefore, we review relevant legal principles and case law to understand how malpractice law is likely to develop in this area. We conclude by suggesting some questions for physicians to ask themselves before referring their patients to alternative medicine practitioners.

  View details for PubMedID 9820265

• A Selected Bibliography of Women's Health and Human Rights. Health and human rights Gruskin, S., Studdert, D. 1995; 1 (4): 477–97

  View details for PubMedID 10393801