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  • 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 DOI 10.1001/jama.2018.9942

    View details for Web of Science ID 000442958800020

    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
  • 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 DOI 10.1136/bmjopen-2017-020803

    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 DOI 10.1111/ans.14225

    View details for Web of Science ID 000428994400041

    View details for PubMedID 28889480

  • 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 DOI 10.1186/s12916-018-1030-x

    View details for Web of Science ID 000427133900001

    View details for PubMedID 29514646

    View details for PubMedCentralID PMC5842619

  • 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

    View details for PubMedCentralID PMC5099192

  • The modern coroner as injury preventer INJURY PREVENTION Studdert, D. M. 2016; 22 (5): 311–13
  • 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
  • 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
  • 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 DOI 10.1111/1475-6773.12623

    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

  • 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
  • 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

  • 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 DOI 10.1016/j.jad.2014.02.032

    View details for Web of Science ID 000334741200007

    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

  • 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 DOI 10.1002/hast.246

    View details for Web of Science ID 000334608300006

    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 DOI 10.1136/bmjqs-2012-001691

    View details for Web of Science ID 000320508400004

    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
  • 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 DOI 10.1371/journal.pone.0060812

    View details for Web of Science ID 000319109800103

    View details for PubMedID 23577165

    View details for PubMedCentralID PMC3618270

  • 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 DOI 10.1093/ije/dyt021

    View details for Web of Science ID 000317627800029

    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 DOI 10.1071/AH13125

    View details for Web of Science ID 000332573500021

    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
  • 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 DOI 10.1136/bmj.e8308

    View details for Web of Science ID 000312495700007

    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 DOI 10.1136/bmjqs-2012-000941

    View details for Web of Science ID 000311348000008

    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 DOI 10.1186/1471-2334-12-311

    View details for Web of Science ID 000312982800001

    View details for PubMedID 23164090

    View details for PubMedCentralID PMC3533824

  • 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 DOI 10.1016/j.bjps.2012.05.004

    View details for Web of Science ID 000311682700017

    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 DOI 10.1016/j.healthplace.2012.08.002

    View details for Web of Science ID 000311140800028

    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 DOI 10.5694/mja12.10632

    View details for Web of Science ID 000310660100016

    View details for PubMedID 23072241

  • Contrasting coroners Respond CANADIAN MEDICAL ASSOCIATION JOURNAL Walter, S. J., Studdert, D. M. 2012; 184 (14): 1604
  • 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 DOI 10.1371/journal.pone.0044565

    View details for Web of Science ID 000308463800077

    View details for PubMedID 22957084

    View details for PubMedCentralID PMC3434145

  • 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 DOI 10.1371/journal.pmed.1001283

    View details for Web of Science ID 000308494600004

    View details for PubMedID 22879818

    View details for PubMedCentralID PMC3413715

  • 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
  • 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 DOI 10.1503/cmaj.110865

    View details for Web of Science ID 000303149700029

    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 DOI 10.1001/jama.2011.2009

    View details for Web of Science ID 000299161200020

    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 DOI 10.1016/j.puhe.2011.10.002

    View details for Web of Science ID 000298138900002

    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 DOI 10.1186/1471-2334-11-257

    View details for Web of Science ID 000295776900001

    View details for PubMedID 21958428

    View details for PubMedCentralID PMC3190378

  • 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 DOI 10.1136/bmjqs-2011-000109

    View details for Web of Science ID 000294115500011

    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
  • 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 Web of Science ID 000292802500009

    View details for PubMedID 21728937

  • 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 Web of Science ID 000290550100007

    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
  • 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
  • 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 DOI 10.1186/1471-2334-11-2

    View details for Web of Science ID 000286613000001

    View details for PubMedID 21199583

    View details for PubMedCentralID PMC3025855

  • 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 Web of Science ID 000281833900009

    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 Web of Science ID 000280421800021

    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
  • 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 Web of Science ID 000277753200015

    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 Web of Science ID 000277597800006

    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 Web of Science ID 000275526000010

    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 DOI 10.1371/journal.pmed.1000210

    View details for Web of Science ID 000274162800010

    View details for PubMedID 20052278

    View details for PubMedCentralID PMC2796388

  • 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 Web of Science ID 000272529600005

    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 Web of Science ID 000270195200005

    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
  • 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 DOI 10.1056/NEJMhle0807695

    View details for Web of Science ID 000264976800016

    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 DOI 10.1521/suli.2009.39.2.190

    View details for Web of Science ID 000266941100008

    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
  • 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 DOI 10.1093/ije/dyn090

    View details for Web of Science ID 000261461700021

    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
  • 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
  • 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

  • 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
  • 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
  • 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