Biomedical subjects

David M Studdert

Publications and source records attributed to David M Studdert.

48 records · Page 3Linked to original sources

PubMedDate not supplied

Researchers' views of the acceptability of restrictive provisions in clinical trial agreements with industry sponsors.

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

Administrative Personnel↗

PubMedDate not supplied

Patients in conflict with managed care: a profile of appeals in two HMOs.

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

Conflict, Psychological↗

PubMedDate not supplied

The rise of nursing home litigation: findings from a national survey of attorneys.

Lawsuits against nursing homes are a relatively recent phenomenon. Despite a growing sense of alarm among policymakers, little is known about these lawsuits' scale, dynamics, or outcomes. To describe these characteristics, we conducted a Web-based survey of attorneys nationwide who bring and defend this litigation. Our respondents and their firms were involved in 4,677 and 8,256 claims, respectively, in 2001; more than half of these claims were in Florida and Texas. The costs of nursing home litigation are substantial, both in the aggregate and per claim, especially in states where the litigation is most prevalent. These findings elevate concerns about quality of nursing home care and indicate that litigation diverts resources from resident care, which may fuel quality problems.

Aged↗

PubMedDate not supplied

The Leapfrog standards: ready to jump from marketplace to courtroom?

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

Guidelines as Topic↗

PubMedDate not supplied

Hospital disclosure practices: results of a national survey.

New patient safety standards from JCAHO that require hospitals to disclose to patients all unexpected outcomes of care took effect 1 July 2001. In an early 2002 survey of risk managers at a nationally representative sample of hospitals, the vast majority reported that their hospital's practice was to disclose harm at least some of the time, although only one-third of hospitals actually had board-approved policies in place. More than half of respondents reported that they would always disclose a death or serious injury, but when presented with actual clinical scenarios, respondents were much less likely to disclose preventable harms than to disclose nonpreventable harms of comparable severity. Reluctance to disclose preventable harms was twice as likely to occur at hospitals having major concerns about the malpractice implications of disclosure.

Health Care Surveys↗

PubMedDate not supplied

The McLawsuit: the fast-food industry and legal accountability for obesity.

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

Causality↗

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Hospitals' behavior in a tort crisis: observations from Pennsylvania.

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

Economics, Medical↗

PubMedDate not supplied

A quiet revolution: law as an agent of health system change.

This paper considers law's impact on health system change. Federal courts and state regulators have remade the rules of the medical marketplace, restricting the methods available to managed care organizations to control costs. Legal conflict, however, has had a larger effect through its influence on market actors' perceptions and expectations. In anticipation of adverse legal outcomes and in response to consumers' and investors' anxiety, health plans changed business strategies, backing away from aggressive cost management. We conclude with four lessons about law's role in the health sphere-lessons that stress the power of legal conflict to shape perceptions and to thereby change behavior before legal change occurs.

Delivery of Health Care↗

PubMedDate not supplied

Caring for patients in a malpractice crisis: physician satisfaction and quality of care.

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

Attitude of Health Personnel↗

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Are damages caps regressive? A study of malpractice jury verdicts in California.

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

Adolescent↗

PubMedDate not supplied

Disclosure of medical injury to patients: an improbable risk management strategy.

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

Compensation and Redress↗

PubMedDate not supplied

Managing care: utilization review in action at two capitated medical groups.

Despite widespread concern about denials of coverage by managed care organizations, little empirical information exists on the profile and outcomes of utilization review decisions. This study examines the outcomes of nearly a half-million coverage requests in two large medical groups that contract with health plans to deliver care and conduct utilization review. We found much higher denial rates than those previously reported. Denials were particularly common for emergency care and durable medical equipment. Retrospective requests were nearly four times more likely than prospective requests were to be denied, and when prospective requests were denied, it was more likely because the service fell outside the scope of covered benefits than because it was not medically necessary.

California↗