Medical malpractice.
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Defensive Medicine↗
Biomedical subjects
Michelle M Mello
Publications and source records attributed to Michelle M Mello.
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↗
Decision making and satisfaction with care in the pediatric intensive care unit: findings from a controlled clinical trial.
OBJECTIVE: To facilitate critical decision making and improve satisfaction with care among families of patients in a pediatric intensive care unit. DESIGN: Prospective observational study followed by a nonrandomized controlled trial of a clinical intervention to identify conflicts and facilitate communication between families and the clinical team. SETTING: The pediatric intensive care unit of a Boston teaching hospital. PATIENTS: A total of 127 patients receiving care in the pediatric intensive care unit in 1998-1999 and their families. INTERVENTIONS: Interviews were conducted with surrogates and decisionally capable older children concerning the adequacy of information provided, understanding, communication, and perceived decisional conflicts. Findings were relayed to the clinical team, who then developed tailored follow-up recommendations. MEASUREMENTS AND MAIN RESULTS: A survey administered to surrogates at baseline and day 7 or intensive care unit discharge measured satisfaction with care. Information on patient acuity and hospital stay were extracted from medical records and hospital databases. Wilcoxon rank-sum tests and incidence rate comparisons were used to assess the impact of the intervention on satisfaction and sentinel decision making, respectively. Incidence rates of care plan decision making, including decisions to adopt a comfort-care-only plan and decisions to forego resuscitation, were lower among families who received the intervention. The intervention did not significantly affect satisfaction with care. CONCLUSIONS: Prospectively screening for and intervening to mitigate potential conflict did not increase decision making or parental satisfaction with the care provided in this pediatric intensive care unit.
Boston↗
Due process in investigations of research misconduct.
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Academies and Institutes↗
Patient safety and medical malpractice: a case study.
The system of tort liability for medical malpractice is frequently criticized for poorly performing its theoretical functions of compensating injured patients, deterring negligence, and dispensing corrective justice. Working from an actual malpractice case involving serious injury but no apparent negligence, the authors explore these criticisms from the perspectives of both the plaintiff-patient and the defendant-physician. They then examine the tort system through the lens of patient safety and conclude that the tensions between the system and patient safety initiatives suggest a need to reexamine our attachment to adversarial dispute resolution in health care. They propose targeted reforms that could improve the functioning of the system and create incentives to improve safety and quality.
Female↗
Conflict in the care of patients with prolonged stay in the ICU: types, sources, and predictors.
OBJECTIVE: To determine types, sources, and predictors of conflicts among patients with prolonged stay in the ICU. DESIGN AND SETTING: We prospectively identified conflicts by interviewing treating physicians and nurses at two stages during the patients' stays. We then classified conflicts by type and source and used a case-control design to identify predictors of team-family conflicts. DESIGN AND SETTING: Seven medical and surgical ICUs at four teaching hospitals in Boston, USA. PATIENTS: All patients admitted to the participating ICUs over an 11-month period whose stay exceeded the 85th percentile length of stay for their respective unit ( n=656). MEASUREMENTS AND RESULTS: Clinicians identified 248 conflicts involving 209 patients; hence, nearly one-third of patients had conflict associated with their care: 142 conflicts (57%) were team-family disputes, 76 (31%) were intrateam disputes, and 30 (12%) occurred among family members. Disagreements over life-sustaining treatment led to 63 team-family conflicts (44%). Other leading sources were poor communication (44%), the unavailability of family decision makers (15%), and the surrogates' (perceived) inability to make decisions (16%). Nurses detected all types of conflict more frequently than physicians, especially intrateam conflicts. The presence of a spouse reduced the probability of team-family conflict generally (odds ratio 0.64) and team-family disputes over life-sustaining treatment specifically (odds ratio 0.49). CONCLUSIONS: Conflict is common in the care of patients with prolonged stays in the ICU. However, efforts to improve the quality of care for critically ill patients that focus on team-family disagreements over life-sustaining treatment miss significant discord in a variety of other areas.
Adult↗
The rise of litigation in human subjects research.
Owing to widespread public concern about the adequacy of protections for human research subjects and recent instances of serious injury to subjects at several major research institutions, lawsuits against investigators, institutional review boards, and academic institutions are becoming increasingly common. Several claim-promoting conditions are ripe to promote the further growth of this litigation and raise the stakes for research institutions. While this litigation may serve a valuable compensation function for injured subjects, it will also have profound effects on institutional review boards, leading to a more legalistic, mechanistic approach to ethical review that does not further the interests of human subjects or scientific progress.
Biomedical Research↗
The new medical malpractice crisis.
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Health Policy↗
Medical monitoring for pharmaceutical injuries: tort law for the public's health?
A remarkable development in personal injury litigation in recent years involves attempts to expand legal claims beyond existing injuries to anticipated future harms. Attorneys have begun to sue on behalf of individuals exposed to defective pharmaceutical products who have no current injury, but who may be at risk for developing one after a latency period. This strategy seeks to make drug manufacturers pay for medical monitoring, a court-ordered program that provides diagnostic tests to exposed individuals to facilitate early detection of adverse health effects. Because medical monitoring does not depend on the existence of an actual injury and large populations may be exposed, some commentators have warned that it has the potential to spiral out of control. We examine medical monitoring in the context of 2 major cases involving diet drugs and an oral hypoglycemic drug. We conclude that this expansion of tort law should be applied sparingly, but that the performance of courts to date in these cases gives cause for optimism. Judges appear to be paying close attention to sophisticated epidemiological, clinical, and cost-effectiveness considerations. Medical monitoring arms the courts with a new mechanism for addressing harms proactively rather than reactively, which could yield new victories for public health.
Appetite Depressants↗
Reduced medicolegal risk by compliance with obstetric clinical pathways: a case--control study.
OBJECTIVE: To estimate whether guideline compliance affected medicolegal risk in obstetrics and whether malpractice claims data can provide useful information on guideline noncompliance by focusing on the claims experience of a large health system delivering approximately 12000 infants annually. METHODS: We retrospectively identified 290 delivery-related (diagnosis-related groups 370-374) malpractice claims and 262 control deliveries at the health system during the period from 1988 to 1998. Clinical pathways for vaginal and cesarean delivery implemented in 1998 were used as a "standard of care." We compared rates of noncompliance with the pathways in the claims and control groups, calculated an odds ratio for increased risk of being sued given departure from the guideline standards, and calculated the elevated risk of litigation introduced by noncompliance. We also compared the frequencies of different types of departures across claims and control groups. RESULTS: Claims closely resembled controls on several descriptive measures (mother's age, location of delivery, type of delivery, and complication rates), but noncompliance with the clinical pathway was significantly more common among claims than controls (43.2% versus 11.7%, P <.001; odds ratio = 5.76, 95% confidence interval 3.59, 9.2). In 81 (79.4%) of the claims involving noncompliance with the pathway, the main allegation in the claim related directly to the departure from the pathway. The excess malpractice risk attributable to noncompliance explained approximately one third (104 of 290) of the claims filed (attributable risk = 82.6%). There were no significant differences in the types of deviation from the guidelines across claims and control groups. CONCLUSION: In addition to reducing clinical variation and improving clinical quality of care, adherence to clinical pathways might protect clinicians and institutions against malpractice litigation. Malpractice data might also be a useful resource in understanding breakdowns in processes of care.
Adult↗
Work hours reform: perceptions and desires of contemporary surgical residents.
BACKGROUND: New Accreditation Council for Graduate Medical Education (ACGME) requirements on resident duty hours are scheduled to undergo nationwide implementation in July 2003. General surgery residents, because of their long duty hours, are likely to be among those most affected by changes imposed to comply with the ACGME requirements. There are few contemporary data on their attitudes toward work hours reform. STUDY DESIGN: The study entailed a region-wide survey of residents enrolled in general surgery residencies in New England to characterize the perceptions and desires of surgical residents on the issue of work hours reform. RESULTS: Respondents reported working a mean of 105 +/- 0.7 hours per week, considerably more than the 80-hour limit stipulated by the ACGME. Of the respondents, 81% reported that sleep deprivation had negatively affected their work. A strong majority of respondents believe that work hours reform would improve their quality of life but less than one half expect it to have a positive impact on patient care. A greater percentage of senior residents than junior residents (p < 0.05) have negative perceptions of work hour limitations, particularly with respect to consequences for patient care. Other findings suggest that residents who have actually experienced work hour restrictions are less positive about such restrictions than these residents who had not yet experienced them. CONCLUSIONS: Changes imposed by residency programs to comply with work hour requirements might have detrimental effects on senior residents and patient care. The impact of such changes should be carefully monitored as the ACGME requirements are implemented.
Accreditation↗
Results of a clinical trial on care improvement for the critically ill.
OBJECTIVE: To develop, deploy, and evaluate an intervention designed to identify and mitigate conflict in decision making in the intensive care unit. DESIGN: Nonrandomized, controlled trial. SETTING: Seven intensive care units at four Boston teaching hospitals. PATIENTS: A total of 1,752 critically ill patients, including 873 study cases analyzed here. INTERVENTION: Social workers interviewed families of patients deemed at high risk for decisional conflict and provided feedback to the clinical team, who then implemented measures to address the problems identified. MEASUREMENTS AND MAIN RESULTS: Patient or surrogate satisfaction with intensive care unit care and the probability of choosing a specific plan for treatment in the intensive care unit was studied. Inclusion criteria identified 873 patients at risk for decisional conflict. Thirty-nine percent of the patients in the intervention phase of the study (172 patients) received the intervention. In multivariate analyses, receiving the intervention significantly increased the likelihood of deciding to forgo resuscitation (odds ratio [OR] = 1.81, p =.017), the likelihood of choosing a treatment plan for comfort-care only (OR = 1.94, p =.018), and the likelihood of choosing an aggressive-care treatment plan (OR = 2.30, p =.002). Receiving the intervention did not significantly affect overall satisfaction with the care provided (OR = 0.68, p =.14), satisfaction with the amount of information provided (OR = 0.86, p =.44), or satisfaction with the degree of involvement in decision making (OR = 0.84, p =.54). CONCLUSIONS: Although there was no impact on patient or surrogate satisfaction with care provided in the intensive care unit, the intervention did facilitate deliberative decision making in cases deemed at high risk for conflict. The lessons learned from the experience with this intervention should be helpful in ongoing efforts to improve care and to achieve outcomes desired by critically ill patients, their families, and critical care clinicians.
Adult↗
Implementing resident work hour limitations: lessons from the New York State experience.
OBJECTIVE: To determine the impact of work hour limitations imposed by the 405 (Bell) Regulations as perceived by general surgery residents in New York State. SUMMARY BACKGROUND DATA: New Accreditation Council for Graduate Medical Education (ACGME) requirements on resident duty hours are scheduled to undergo nationwide implementation in July 2003. State regulations stipulating similar resident work hour limitations have already been enacted in New York. METHODS: A statewide survey of residents enrolled in general surgery residencies in New York was administered. RESULTS: Most respondents reported general compliance with 405 Regulations in their residency programs, a finding corroborated by reported work hours and call schedules. Whereas a majority of residents reported improved quality of life as a result of the work hour limitations, a substantial portion reported negative impacts on surgical training and quality and continuity of patient care. Negative perceptions of the impact of duty hour restrictions were more prevalent among senior residents and residents at academic medical centers than among junior residents and residents at community hospitals. CONCLUSIONS: Implementation of resident work hour limitations in general surgery residencies may have negative consequences for patient care and resident education. As surgical residency programs develop strategies for complying with ACGME requirements, these negative consequences must be addressed.
Adult↗
Understanding biased selection in Medicare HMOs.
OBJECTIVE: To investigate the extent of favorable health maintenance organization (HMO) selection for a longitudinal cohort of Medicare beneficiaries, examine whether the extent of favorable selection varies with the degree of Medicare HMO market penetration in a county, and explain conflicting findings in the literature on favorable HMO selection. DATA SOURCES: A panel of 1992-1996 data from the Medicare Current Beneficiary Survey (MCBS), supplemented with linked data from the Area Resource File and Medicare administrative datasets. STUDY DESIGN: Using random effects probit estimation, we model a beneficiary's HMO enrollment status as a function of self-reported health status and Medicare HMO market penetration. DATA EXTRACTION METHODS: The MCBS data for beneficiaries residing in states served by Medicare HMOs in 1992-1996 were linked by county to the supplementary datasets. PRINCIPAL FINDINGS: We find that favorable selection persists in the cohort over time on some, but not all, measures. We find no substantial association between favorable HMO selection and HMO market penetration. We find that conflicting findings in the literature on favorable HMO selection may be explained by several methodological choices, including the choice of health status measure and the structure of the sample. CONCLUSIONS: Our results support further risk adjustment of the adjusted average per capita cost (AAPCC) payment formula.
Aged↗
Nature of conflict in the care of pediatric intensive care patients with prolonged stay.
OBJECTIVE: To determine the frequency, types, sources, and predictors of conflict surrounding the care of pediatric intensive care unit (PICU) patients with prolonged stay. SETTING: A tertiary care, university-affiliated PICU in Boston. PARTICIPANTS: All patients admitted over an 11-month period whose stay exceeded 8 days (the 85th percentile length of stay for the PICU under study), and intensive care physicians and nurses who were responsible for their care. METHODS: We prospectively identified conflicts by interviewing the treating physicians and nurses at 2 stages during the patients' PICU stay. All conflicts detected were classified by type (team-family, intrateam, or intrafamily) and source. Using a case-control design, we then identified predictors of conflict through bivariate and multivariate analyses. RESULTS: We enrolled 110 patients based on the length-of-stay criterion. Clinicians identified 55 conflicts involving 51 patients in this group. Hence, nearly one half of all patients followed had a conflict associated with their care. Thirty-three of the conflicts (60%) were team-family, 21 (38%) were intrateam, and the remaining 1 was intrafamily. The most commonly cited sources of team-family conflict were poor communication (48%), unavailability of parents (39%), and disagreements over the care plan (39%). Medicaid insurance status was independently associated with the occurrence of conflict generally (odds ratio = 4.97) and team-family conflict specifically (odds ratio = 7.83). CONCLUSIONS: Efforts to reduce and manage conflicts that arise in the care of critically ill children should be sensitive to the distinctive features of these conflicts. Knowledge of risk factors for conflict may also help to target such interventions at the patients and families who need them most.
Case-Control Studies↗
Do Medicare HMOs still reduce health services use after controlling for selection bias?
This study models the relationship between Medicare beneficiary decisions to join Medicare HMOs and subsequent health services utilization. The relationship between health plan choice and utilization is thought to be endogenous because of favorable selection into HMOs. Previous studies found significantly lower inpatient utilization among Medicare HMO enrollees than among nonenrollees, but lacked strong controls for selection bias. Thus, a firm conclusion could not be drawn as to whether the observed differences were attributable to the HMO practice setting or to baseline differences in the illness profiles of the two groups studied. The present study uses simultaneous equations methods, including discrete factor estimation, to test the effect of Medicare HMOs on utilization when strong controls for selection bias are imposed. The model was run on a panel of 1993-1996 data from the Medicare Current Beneficiary Survey, supplemented with linked data on Medicare HMO characteristics and area supply characteristics. The study found that even when favorable selection is controlled for, Medicare HMOs significantly reduce both the probability of hospitalization and the number of inpatient days used by those who are hospitalized. Medicare HMOs do not, however, appear to reduce the use of physician services.
Aged↗
Policing Medicaid and Medicare managed care: the role of courts and administrative agencies.
The much-publicized 2000 case of Frew v. Gilbert, in which a federal judge castigated the State of Texas for deficiencies in its Medicaid program, brought renewed attention to the issue of regulating the quality of care in Medicaid and Medicare HMOs. Frew and other recent cases highlight both the promise and the pitfalls of relying on courts to correct deficiencies in public managed care programs. This article argues that while litigation over inadequacies in Medicare and Medicaid managed care can serve an important signaling function in alerting agencies and legislatures about the need for reform, the role of the courts in policing public managed care is circumscribed by several constraints. Barriers to class action litigation and differences in the institutional capacities of courts and administrative agencies mean that litigation is best viewed as a supplement, not an alternative, to a renewed commitment to strong quality monitoring on the part of Centers for Medicare and Medicaid Services and state Medicaid agencies.
Centers for Medicare and Medicaid Services, U.S.↗
Direct-to-consumer advertising and shared liability for pharmaceutical manufacturers.
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Advertising↗