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Biomedical subjects

Michelle M Mello

Publications and source records attributed to Michelle M Mello.

At least 19 recordsLinked to original sources
PubMed2006

Claims, errors, and compensation payments in medical malpractice litigation.

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

Adolescent↗
PubMed2006

"Health courts" and accountability for patient safety.

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

Compensation and Redress↗
PubMed2005

Defensive medicine among high-risk specialist physicians in a volatile malpractice environment.

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

Defensive Medicine↗
PubMed2005

Academic medical centers' standards for clinical-trial agreements with industry.

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

Academic Medical Centers↗
PubMed2005

Surgical residents' perceptions of the effects of the ACGME duty hour requirements 1 year after implementation.

BACKGROUND: In July 2003, the Accreditation Council for Graduate Medical Education implemented nationwide requirements on resident duty hours with the aim of improving quality of care. Our objectives were (1) to determine the extent and means of compliance with the ACGME requirements within general surgery residency programs and (2) to examine general surgery residents' perceptions of the effects of the ACGME requirements on patient care and residents' training experience. METHODS: A survey was mailed to residents in 19 New England general surgery programs in spring 2004 (n=238). RESULTS: The overall response rate was 36%. More than 89% of respondents reported that the requirements generally were being enforced, and respondents' mean work hours (80.8 +/- 11.7 per week) supported this claim. Forty-three percent felt that quality of care had deteriorated. Although 70% perceived decrements in continuity of care, only 32% believed that the risk of patient management errors had increased. Sixty percent reported doing fewer operations, and half felt that residents missed out on too many learning opportunities. Yet, only 39% reported that the requirements had worsened the quality of training. Residents consistently reported an improved quality of life. Seventy-five percent felt that, overall, the requirements were a good thing. CONCLUSIONS: Most surgical residents do not believe that the ACGME duty hour requirements have had their intended effect of improving quality of care and are ambivalent about effects on the quality of their training. However, they report an improved quality of life, and most residents do support the requirements overall.

Adult↗
PubMed2005

Advising patients about patient safety: current initiatives risk shifting responsibility.

BACKGROUND: Many health care providers now disseminate advisories telling patients what they can do to avoid errors and harms in their care. METHODS: The content of five leading safety advisories for patients was analyzed and a critique of their development, content, and impact was developed, drawing on published literature and 40 interviews with a diverse sample of 50 key informants. FINDINGS: Very little is known about the effects of the distribution of safety advisories to patients, but several grounds for concern were identified. There was a lack of attention to patients' perspectives during the development of advisory messages, and the advisories say little about what health care providers should do to ensure patient safety. Patients are given little practical support to carry out the recommended actions, and health professionals' responses may render their attempts to act to secure their own safety ineffective. Some messages suggest an inappropriate shifting of responsibility onto patients. Advice that involves checking on or challenging health professionals' actions appears to be particularly problematic for patients. Such behaviors conflict with the expectations many people have--and think health professionals have--of patients' roles. DISCUSSION: A serious commitment to optimizing patients' contributions to safe care requires a research-based understanding of patients' perspectives and more practical facilitation of patient involvement.

Counseling↗
PubMed2005

Effects of a professional liability crisis on residents' practice decisions.

OBJECTIVE: Pennsylvania, like many states, is in a professional liability crisis characterized by escalating cost and decreasing availability of liability insurance. Medical and surgical specialists have experienced especially large increases in insurance premiums. The objective of this study was to estimate the impact of liability concerns during a professional liability crisis on Pennsylvania residents' decisions regarding their future practice. It was hypothesized that liability concerns would negatively affect Pennsylvania residents' propensity to practice in the state following residency. METHODS: Statewide mail surveys were completed in 2003 by 68 Pennsylvania residency program directors and 360 residents nearing the end of their training in anesthesiology, general surgery, emergency medicine, obstetrics and gynecology, orthopedics, and radiology residencies. RESULTS: One third of residents in their final or next-to-last year of residency planned to leave Pennsylvania because of the lack of availability of affordable malpractice coverage. Although, in general, residents' geographic decisions are influenced by a range of factors, those who are about to leave Pennsylvania named malpractice costs as the primary reason 3 times more often than any other factor. Seventy-one percent of residency program directors reported a decrease in retention of residents in the state since the onset of the professional liability crisis. For some programs the decreases were very large. CONCLUSION: An environment of mounting liability costs in Pennsylvania appears to have dissuaded substantial numbers of residents in high-risk specialties from locating their clinical practices in the state. The impact of decreased resident retention on the future availability of specialist services in high-cost states merits close monitoring.

Adult↗
PubMed2005

Effects of a malpractice crisis on specialist supply and patient access to care.

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

Career Choice↗
PubMed2005

Fostering rational regulation of patient safety.

After decades of inattention to the problem of medical injuries, patient safety is now occupying a prominent place on the health policy agenda and garnering renewed regulatory interest. Health care providers' behavior, with respect to patient safety and health care quality improvement, is now being shaped by top-down regulation through statutes and administrative agency oversight, as well as bottom-up drivers such as tort litigation and the forces of the consumer-driven health care market. Patient safety today exemplifies that eclectic mix of regulation that can occur when a new problem is exposed to the general public; it also demonstrates the difficulties of coordinating regulatory signals from multiple sources and regulating incomplete information. This article reviews the evolution of the regulatory environment for patient safety, examines some of the tensions and challenges that currently define patient safety oversight, and suggests strategies for more rational and responsive regulation.

Government Regulation↗
PubMed2004

Medical malpractice as an epidemiological problem.

The notion that the tort liability system deters negligence in health care has been invoked to make the "business case for patient safety." However, existing data on the relationship between hospital adverse events and malpractice claims typically are interpreted as evidence that the tort system does not deter negligence because of the poor fit between those who are negligently injured and those who sue. Using a familiar analogy from epidemiology--the problem of false positives in screening tests for rare diseases--and data from two large studies of medical injuries and malpractice claims in the United States, this paper presents an argument that the standard interpretation overlooks a complexity in the data. Although most malpractice claims do not actually involve a negligent injury, a patient who suffers a negligent injury is more than 20 times more likely, on average, to file a claim than a patient who does not. However, because malpractice claiming is a rare event with many false positives, for the average hospital or group practice, even substantial improvements in rates of negligent injury will not lead to a large reduction in claims rates. These findings suggest that the strength of the business case for patient safety depends on the perspective from which one views the data.

Humans↗