Medical malpractice.
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Defensive Medicine↗
Biomedical subjects
David M Studdert
Publications and source records attributed to David M Studdert.
Disputes over coverage of emergency department services: a study of two health maintenance organizations.
STUDY OBJECTIVE: We describe the characteristics and outcomes of enrollee-health plan disputes over insurance coverage for emergency department (ED) services at 2 large health maintenance organizations (HMOs) that apply the prudent layperson standard. METHODS: We abstracted information from a stratified random sample of approximately 3,500 appeals of coverage denials lodged by privately insured enrollees between 1998 and 2000 at 2 of the nation's largest HMOs (hereafter referred to as Plan 1 and Plan 2). We describe appeals involving ED services in terms of the timing of visits, patient age, costs of services, primary reason the patient sought care, and appeal outcome. RESULTS: Disputes over ED services accounted for approximately one half (52%) of postservice appeals at Plan 1 and one third (34%) at Plan 2. Nearly one half (46%) of ED appeals involved weekend, nighttime, or holiday visits to the ED; 22% were children's visits. The average cost of services in dispute was US$1,107. The most common general reasons for the ED visits in dispute were symptoms of illness (64%), injuries (22%), and services related to disease (8%). The most common presenting symptoms were abdominal pain, cramps, or spasms (7.6%); earaches or ear infections (3.4%); and lacerations/cuts (2.9%). Enrollees won more than 90% of appeals. CONCLUSION: The prevalence of ED cases among all appeals reflects disagreement between lay and expert judgments about what constitutes emergency care under the prudent layperson standard. The high rate at which enrollees win these appeals highlights significant disagreement in interpretation of the standard among different adjudicators within managed care organizations (medical groups and health plans). When enrollees fail to challenge denials that would be reversed on appeal, they bear the financial brunt of ambiguities in interpretation of the prudent layperson standard.
Adult↗
Nursing home litigation and tort reform: a case for exceptionalism.
The medical malpractice crisis that is currently spreading across the United States bears many similarities to earlier crises. One novel aspect of the current crisis is the explicit inclusion of litigation against nursing homes as a target of reform. Encouraged by the nursing home industry, policymakers are considering the extension of conventional medical malpractice tort reforms to the nursing home sector. In this article, we caution against such an approach. Nursing home litigation has a number of distinctive features that raise serious questions about the wisdom of implementing reforms generically across the care continuum. Drawing on findings from our previous study of nursing home litigation, we outline these features and argue for careful attention to them as policymakers evaluate options for reform.
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↗
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.
Explore the source record for details and available documents.
Health Policy↗
Enrollee appeals of preservice coverage denials at 2 Health Maintenance Organizations.
CONTEXT: Congress and state legislatures are considering patient bills of rights that seek to strengthen opportunities for patients to have denials of coverage reconsidered by their health plans. Little is publicly known about such appeals systems. OBJECTIVE: To improve understanding of the sources, types, and outcomes of conflicts between patients and managed care organizations over coverage of services. DESIGN AND SETTING: Descriptive study of information abstracted from 1774 preservice appeals out of a larger stratified random sample of 3519 appeals lodged between January 1998 and June 2000 at 2 large US health maintenance organizations. MAIN OUTCOME MEASURES: Classification of preservice appeals according to whether they contested access to out-of-network care, the contractual limits of coverage, or the medical necessity of services; analysis of contractual coverage and medical necessity appeals by the services in dispute and out-of-network appeals by enrollees' reasons for seeking care; and comparison of the proportions of appeals won by enrollees across types of appeals and services. RESULTS: Approximately one third (36.9%) of preservice appeals involved medical necessity determinations, another third (36.6%) centered on the scope of contractually covered benefits, and most of the remainder (19.7%) involved out-of-network care. Enrollee wins were significantly more frequent among medical necessity appeals than out-of-network or contractual coverage appeals (52.2% vs 35.4% and 33.2%, respectively; P<.001). Appeals were concentrated among relatively few services and among therapies that are generally regarded as nonessential. CONCLUSIONS: A majority of preservice appeals disputed choice of provider or contractual coverage issues, rather than medical necessity. Medical necessity disputes proliferate not around life-saving treatments but in areas of societal uncertainty about the legitimate boundaries of insurance coverage. Greater transparency about the coverage status of specific services, through more precise contractual language and consumer education about benefits limitations, may help to avoid a large proportion of disputes in managed care.
California↗
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↗
Risk factors for retained instruments and sponges after surgery.
BACKGROUND: Risk factors for medical errors remain poorly understood. We performed a case-control study of retained foreign bodies in surgical patients in order to identify risk factors for this type of error. METHODS: We reviewed the medical records associated with all claims or incident reports of a retained surgical sponge or instrument filed between 1985 and 2001 with a large malpractice insurer representing one third of the physicians in Massachusetts. For each case, we identified an average of four randomly selected controls who underwent the same type of operation during the same six-month period. RESULTS: Our study included 54 patients with a total of 61 retained foreign bodies (of which 69 percent were sponges and 31 percent instruments) and 235 control patients. Thirty-seven of the patients with retained foreign bodies (69 percent) required reoperation, and one died. Patients with retained foreign bodies were more likely than controls to have had emergency surgery (33 percent vs. 7 percent, P<0.001) or an unexpected change in surgical procedure (34 percent vs. 9 percent, P<0.001). Patients with retained foreign bodies also had a higher mean body-mass index and were less likely to have had counts of sponges and instruments performed. In multivariate analysis, factors associated with a significantly increased risk of retention of a foreign body were emergency surgery (risk ratio, 8.8 [95 percent confidence interval, 2.4 to 31.9]), unplanned change in the operation (risk ratio, 4.1 [95 percent confidence interval, 1.4 to 12.4]), and body-mass index (risk ratio for each one-unit increment, 1.1 [95 percent confidence interval, 1.0 to 1.2]). CONCLUSIONS: The risk of retention of a foreign body after surgery significantly increases in emergencies, with unplanned changes in procedure, and with higher body-mass index. Case--control analysis of medical-malpractice claims may identify and quantify risk factors for specific types of errors.
Analysis of Variance↗
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↗
Analysis of errors reported by surgeons at three teaching hospitals.
BACKGROUND: Little is known of the factors that underlie surgical errors. Incident reporting has been proposed as a method of obtaining information about medical errors to help identify such factors. METHODS: Between November 1, 2000, and March 15, 2001, we conducted confidential interviews with randomly selected surgeons from three Massachusetts teaching hospitals to elicit detailed reports on surgical adverse events resulting from errors in management ("incidents"). Data on the characteristics of the incidents and the factors that surgeons reported to have contributed to the errors were recorded and analyzed. RESULTS: Among 45 surgeons approached for interviews, 38 (84%) agreed to participate and provided reports on 146 incidents. Thirty-three percent of incidents resulted in permanent disability and 13% in patient death. Seventy-seven percent involved injuries related to an operation or other invasive intervention (visceral injuries, bleeding, and wound infection/dehiscence were the most common subtypes), 13% involved unnecessary or inappropriate procedures, and 10% involved unnecessary advancement of disease. Two thirds of the incidents involved errors during the intraoperative phase of surgical care, 27% during preoperative management, and 22% during postoperative management. Two or more clinicians were cited as substantially contributing to errors in 70% of the incidents. The most commonly cited systems factors contributing to errors were inexperience/lack of competence in a surgical task (53% of incidents), communication breakdowns among personnel (43%), and fatigue or excessive workload (33%). Surgeons reported significantly more systems failures in incidents involving emergency surgical care than those involving nonemergency care (P <.001). CONCLUSIONS: Subjective incident reports gathered through interviews allow identification of characteristics of surgical errors and their leading contributing factors, which may help target research and interventions to reduce such errors.
Clinical Competence↗
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↗
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↗
Impact of the National Practitioner Data Bank on resolution of malpractice claims.
Policymakers and commentators are concerned that the National Practitioner Data Bank (NPDB) has influenced malpractice litigation dynamics. This study examines whether the introduction of the NPDB changed the outcomes, process, and equity of malpractice litigation. Using pre- and post-NPDB analyses, we examine rates of unpaid claims, trials, resolution time, physician defense costs, and payments on claims with a low/high probability of negligence. We find that physicians and their insurers have been less likely to settle claims since introduction of the NPDB, especially for payments less than dollars 50,000. Because this disruption appears to have decreased the proportion of questionable claims receiving compensation, the NPDB actually may have increased overall tort system specificity.
Attitude of Health Personnel↗
Charges of human immunodeficiency virus discrimination in the workplace: the Americans with Disabilities Act in action.
Congress enacted the Americans with Disabilities Act (ADA) to provide persons living with the human immunodeficiency virus (HIV) and other vulnerable populations with legal means of redress against discrimination, yet virtually nothing is known about how the intended beneficiaries have used these protections. This study aimed to describe the epidemiology of ADA charges alleging employment-related discrimination due to HIV and to investigate the charge-filing behavior of workers with HIV. Using a national database of all HIV discrimination charges filed since the inception of the ADA in 1991, the author described respondent employers, issues in dispute, and outcomes of charges. Next, he used multivariate regression analyses to compare the sociodemographic characteristics of charge filers with those of a nationally representative baseline sample of workers with HIV. Of the 3,520 HIV discrimination charges filed through 1999, 18.0% had merit and 14.1% received monetary compensation. Workers who were female (odds ratio (OR) = 0.79, p < 0.01), aged less than 25 years (OR = 0.36, p < 0.01), and aged 25-34 years (OR = 0.77, p < 0.01) filed disproportionately fewer charges. Controlling for underlying rates of discrimination in the baseline population magnified this "underclaiming" among young workers. The findings should help to target dissemination and support activities, designed to help workers take advantage of antidiscrimination protections, at the subgroups of workers who need them most.
Adult↗
The reliability of medical record review for estimating adverse event rates.
BACKGROUND: The data used by the U.S. Institute of Medicine to estimate deaths from medical errors come from a study that relied on nurse and physician reviews of medical records to detect the errors. OBJECTIVE: To measure the reliability of medical record review for detecting adverse events and negligent adverse events. DESIGN: Medical record review. SETTING: Hospitalizations in Utah and Colorado in 1992. MEASUREMENTS: After three independent reviews of 500 medical records, the following were measured: reliability and the effect of varying criteria for reviewer confidence in and reviewer agreement about the presence of adverse events. RESULTS: For agreements in judgments of adverse events among the three sets of reviews, the kappa statistics ranged from 0.40 to 0.41 (95% CIs ranged from 0.30 to 0.51) for adverse events and from 0.19 to 0.23 (CIs, 0.05 to 0.37) for negligent adverse events. Rates for adverse events and for negligent adverse events varied substantially depending on the degree of agreement and the level of confidence that was required among reviewers. CONCLUSION: Estimates of adverse event rates from medical record review, including those reported by the Institute of Medicine in its 2000 report on medical errors, are highly sensitive to the degree of consensus and confidence among reviewers.
Colorado↗
Personal choices of health plans by managed care experts.
BACKGROUND: Expert opinion has not been used as a basis for comparing different forms of health insurance, in part because this perspective may not be appropriately sensitive to aspects of care that consumers value. RESEARCH DESIGN: Using a case-control design, managed care experts were surveyed at 17 academic institutions in the United States to determine the type of health plan they chose (fee-for-service, HMO, POS, PPO, or catastrophic). Controls consisted of academicians from other disciplines at these institutions who ostensibly faced the same insurance options. We then compared the choices of physician experts, nonphysician experts and controls using a multinomial logit model that was sensitive to the choice set available at each institution. We also examined the choice behavior of respondents within moderate (< $150,000) and high (> or =$150,000) income levels. RESULTS: Four hundred thirty-seven experts and 465 controls were surveyed and responses were received from 73.7% and 52.7%, respectively. Physician experts were approximately half as likely (14.9%) as controls (26.6%) or nonphysician experts (27.6%) to enroll in HMO plans. In moderate-income households, both physicians (Relative Risk [RR] = 0.42; P <0.01) and nonphysician experts (RR = 0.71; P <0.1) were less likely than controls to opt for an HMO. Experts' propensity to choose HMO coverage varied little with income, whereas controls' propensity changed dramatically between moderate (39.1% in HMOs) and high (14.0% in HMOs) income categories. CONCLUSIONS: The aversion of physician experts, and nonphysician experts with moderate income, to HMO plans may be caused by their stronger distaste for the constraints on choice and access that typically accompany HMO coverage. Alternatively, it may be explained by their superior ability to absorb, understand, and use information about available insurance options. Insights into quality in managed care may also play a role.
Adult↗