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result(s) for
"Studdert, David M"
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“Vaccine Passport” Certification — Policy and Ethical Considerations
2021
Rejecting both a sweeping public Covid-vaccination-passport scheme and a ban on private certification is an easy call. In navigating the large, complex space in between, policymakers should consider the nature of privileged activities and the identity of the regulator.
Journal Article
Accuracy of Valuations of Surgical Procedures in the Medicare Fee Schedule
by
Huynh, Johnny
,
Studdert, David M
,
Chan, David C
in
Accuracy
,
Advisory Committees
,
American Medical Association
2019
A 2005–2015 analysis of the accuracy of valuations of 293 common surgical procedures showed substantial absolute discrepancies in operative times estimated by the Relative Value Scale Update Committee (RUC) and times recorded in a surgical registry, but the RUC did not systematically over- or underestimate times.
Journal Article
Protection against Omicron from Vaccination and Previous Infection in a Prison System
by
Leidner, David
,
Goldhaber-Fiebert, Jeremy D.
,
Studdert, David M.
in
California - epidemiology
,
Coronavirus
,
Coronaviruses
2022
Unvaccinated persons without previous Covid-19 had the highest risk of omicron infection; those who had been infected after emergence of the delta variant and had received three mRNA vaccine doses were the most protected.
Journal Article
Searching for Public Health Law’s Sweet Spot: The Regulation of Sugar-Sweetened Beverages
by
Studdert, David M.
,
Mello, Michelle M.
,
Flanders, Jordan
in
Advertising as Topic
,
Beverage industry
,
Beverages - economics
2015
David Studdert and colleagues explore how to balance public health, individual freedom, and good government when it comes to sugar-sweetened drinks.David Studdert and colleagues explore how to balance public health, individual freedom, and good government when it comes to sugar-sweetened drinks.
Journal Article
Disease Control, Civil Liberties, and Mass Testing — Calibrating Restrictions during the Covid-19 Pandemic
2020
There is emerging consensus that a graduated approach to Covid-19–related restrictive measures will be needed. Decisions to continue, modify, or lift restrictions — particularly bans on movement and gathering — could be tailored using individualized risk assessment.
Journal Article
Identification of practitioners at high risk of complaints to health profession regulators
by
Studdert, David M.
,
Bismark, Marie M.
,
Spittal, Matthew J.
in
Age groups
,
Algorithms
,
Analysis
2019
Background
Some health practitioners pose substantial threats to patient safety, yet early identification of them is notoriously difficult. We aimed to develop an algorithm for use by regulators in prospectively identifying practitioners at high risk of attracting formal complaints about health, conduct or performance issues.
Methods
Using 2011—2016 data from the national regulator of health practitioners in Australia, we conducted a retrospective cohort study of 14 registered health professions. We used recurrent-event survival analysis to estimate the risk of a complaint and used the results of this analysis to develop an algorithm for identifying practitioners at high risk of complaints. We evaluated the algorithm’s discrimination, calibration and predictive properties.
Results
Participants were 715,415 registered health practitioners (55% nurses, 15% doctors, 6% midwives, 5% psychologists, 4% pharmacists, 15% other). The algorithm, PRONE-HP (Predicted Risk of New Event for Health Practitioners), incorporated predictors for sex, age, profession and specialty, number of prior complaints and complaint issue. Discrimination was good (
C
-index = 0·77, 95% CI 0·76–0·77). PRONE-HP’s score values were closely calibrated with risk of a future complaint: practitioners with a score ≤ 4 had a 1% chance of a complaint within 24 months and those with a score ≥ 35 had a higher than 85% chance. Using the 90th percentile of scores within each profession to define “high risk”, the predictive accuracy of PRONE-HP was good for doctors and dentists (PPV = 93·1% and 91·6%, respectively); moderate for chiropractors (PPV = 71·1%), psychologists (PPV = 54·9%), pharmacists (PPV = 39·9%) and podiatrists (PPV = 34·0%); and poor for other professions.
Conclusions
The performance of PRONE-HP in predicting complaint risks varied substantially across professions. It showed particular promise for flagging doctors and dentists at high risk of accruing further complaints. Close review of available information on flagged practitioners may help to identify troubling patterns and imminent risks to patients.
Journal Article
Claims, Errors, and Compensation Payments in Medical Malpractice Litigation
2006
Frivolous lawsuits have been cited as a major contributor to the high costs of the malpractice system in the United States. In this national study of 1452 closed claims, physician reviewers found no evidence of medical errors in 37 percent. Most claims, however, did not result in payment to the plaintiffs. Claims not associated with errors accounted for only 13 to 16 percent of the total costs.
In this national study of 1452 closed claims, physician reviewers found no evidence of medical errors in 37 percent. Most claims, however, did not result in payment to the plaintiffs. Claims not associated with errors accounted for only 13 to 16 percent of the total costs.
The debate over medical malpractice litigation continues unabated in the United States
1
and other countries.
2
–
4
Advocates of tort reform, including members of the Bush administration, lament the burden of “frivolous” malpractice lawsuits and cite them as a driving force behind rising health care costs.
5
,
6
(A frivolous claim is one that “present[s] no rational argument based upon the evidence or law in support of the claim.”
7
) Plaintiffs' attorneys refute this charge, countering that contingency fees and the prevalence of medical errors make the pursuit of meritless lawsuits bad business and unnecessary.
8
,
9
Previous research has established that the . . .
Journal Article
Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints
by
Studdert, David M.
,
Kesselheim, Aaron S.
,
Mello, Michelle M.
in
Complaints
,
Drug Administration Schedule
,
Drug dosages
2011
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.
Journal Article
Relationship between Malpractice Litigation Pressure and Rates of Cesarean Section and Vaginal Birth after Cesarean Section
by
Mello, Michelle M.
,
Subramanian, S. V.
,
Studdert, David M.
in
Adult
,
Cesarean section
,
Cesarean Section - legislation & jurisprudence
2009
Background: 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. Objective: To estimate the effects of malpractice pressure on rates of VBAC and cesarean section. Research Design, Subjects, Measures: 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. Results: Malpractice premiums were positively associated with rates of cesarean section (β = 0.15, P = 0.02) and primary cesarean section (β = 0.16, P = 0.009), and negatively associated with VBAC rates (β = -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. Conclusions: 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.
Journal Article
Declines in the Lethality of Suicide Attempts Explain the Decline in Suicide Deaths in Australia
by
Studdert, David M.
,
Miller, Matthew
,
Pirkis, Jane
in
Age Distribution
,
Asphyxia - mortality
,
Australia
2012
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.
Journal Article