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Biomedical subjects

David M Studdert

Publications and source records attributed to David M Studdert.

At least 19 recordsLinked to original sources
PubMed2006

Missed and delayed diagnoses in the ambulatory setting: a study of closed malpractice claims.

BACKGROUND: Although missed and delayed diagnoses have become an important patient safety concern, they remain largely unstudied, especially in the outpatient setting. OBJECTIVE: To develop a framework for investigating missed and delayed diagnoses, advance understanding of their causes, and identify opportunities for prevention. DESIGN: Retrospective review of 307 closed malpractice claims in which patients alleged a missed or delayed diagnosis in the ambulatory setting. SETTING: 4 malpractice insurance companies. MEASUREMENTS: Diagnostic errors associated with adverse outcomes for patients, process breakdowns, and contributing factors. RESULTS: A total of 181 claims (59%) involved diagnostic errors that harmed patients. Fifty-nine percent (106 of 181) of these errors were associated with serious harm, and 30% (55 of 181) resulted in death. For 59% (106 of 181) of the errors, cancer was the diagnosis involved, chiefly breast (44 claims [24%]) and colorectal (13 claims [7%]) cancer. The most common breakdowns in the diagnostic process were failure to order an appropriate diagnostic test (100 of 181 [55%]), failure to create a proper follow-up plan (81 of 181 [45%]), failure to obtain an adequate history or perform an adequate physical examination (76 of 181 [42%]), and incorrect interpretation of diagnostic tests (67 of 181 [37%]). The leading factors that contributed to the errors were failures in judgment (143 of 181 [79%]), vigilance or memory (106 of 181 [59%]), knowledge (86 of 181 [48%]), patient-related factors (84 of 181 [46%]), and handoffs (36 of 181 [20%]). The median number of process breakdowns and contributing factors per error was 3 for both (interquartile range, 2 to 4). LIMITATIONS: Reviewers were not blinded to the litigation outcomes, and the reliability of the error determination was moderate. CONCLUSIONS: Diagnostic errors that harm patients are typically the result of multiple breakdowns and individual and system factors. Awareness of the most common types of breakdowns and factors could help efforts to identify and prioritize strategies to prevent diagnostic errors.

Adolescent↗
PubMed2006

Missed and delayed diagnoses in the emergency department: a study of closed malpractice claims from 4 liability insurers.

STUDY OBJECTIVES: Diagnostic errors in the emergency department (ED) are an important patient safety concern, but little is known about their cause. We identify types and causes of missed or delayed diagnoses in the ED. METHODS: This is a review of 122 closed malpractice claims from 4 liability insurers in which patients had alleged a missed or delayed diagnosis in the ED. Trained physician reviewers examined the litigation files and the associated medical records to determine whether an adverse outcome because of a missed diagnosis had occurred, what breakdowns were involved in the missed diagnosis, and what factors contributed to it. Main outcome measures were missed diagnoses, process breakdowns, and contributing factors. RESULTS: A total of 79 claims (65%) involved missed ED diagnoses that harmed patients. Forty-eight percent of these missed diagnoses were associated with serious harm, and 39% resulted in death. The leading breakdowns in the diagnostic process were failure to order an appropriate diagnostic test (58% of errors), failure to perform an adequate medical history or physical examination (42%), incorrect interpretation of a diagnostic test (37%), and failure to order an appropriate consultation (33%). The leading contributing factors to the missed diagnoses were cognitive factors (96%), patient-related factors (34%), lack of appropriate supervision (30%), inadequate handoffs (24%), and excessive workload (23%). The median numbers of process breakdowns and contributing factors per missed diagnosis were 2 and 3, respectively. CONCLUSION: Missed diagnoses in the ED have a complex cause. They are typically the result of multiple breakdowns in the diagnostic process and several contributing factors.

Adolescent↗
PubMed2006

Claiming behaviour in a no-fault system of medical injury: a descriptive analysis of claimants and non-claimants.

OBJECTIVES: (i) To determine the proportion of patients in New Zealand who claim compensation from the national no-fault compensation program after experiencing a compensable injury; and (ii) to identify characteristics of injured patients who are least likely to claim despite having sustained a compensable injury. DESIGN: We estimated the percentage of eligible patients who claim no-fault compensation by linking a national claims database (Accident Compensation Corporation) to records reviewed in the New Zealand Quality of Healthcare Study (NZQHS). Bivariate and multivariate analyses were used to investigate socioeconomic and sociodemographic differences between claimants and injured non-claimants. PARTICIPANTS AND SETTING: Patients who experienced an adverse event associated with care in NZ public hospitals in 1998 and claimed compensation with the ACC, the national no-fault insurer (n = 741). Patients identified by the NZQHS as having sustained an adverse event associated with hospital care in the same year who did not file a compensation claim (n = 839). MAIN OUTCOME MEASURES: Adverse events, compensable adverse events, and compensation claims. RESULTS: Among patients judged by NZQHS reviewers to be eligible for compensation, 2.9% (6/210) claimed. Odds of claiming after an adverse event were significantly lower for patients who were elderly (odds ratio [OR], 0.20; 95% CI, 0.14-0.28), from the most deprived areas (OR, 0.36; 95% CI, 0.23-0.57), or of Ma ori or Pacific ethnicity (OR, 0.47; 95% CI, 0.32-0.69 and OR, 0.26, 95% CI, 0.11-0.58). CONCLUSIONS: Despite few apparent institutional or economic barriers, the proportion of injured patients in NZ who seek compensation after sustaining a compensable injury is very low. Hence, substantial underclaiming occurs in both negligence and no-fault systems. The disproportionately low propensity of elderly, poor and minority patients to seek compensation also appears to be pervasive.

Adult↗
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

Incidence, patterns, and prevention of wrong-site surgery.

HYPOTHESIS: We hypothesized that wrong-site surgery is infrequent and that a substantial proportion of such incidents are not preventable by current site-verification protocols. DESIGN: Case series and survey of site-verification protocols. SETTING: Hospitals and a malpractice liability insurer. PATIENTS AND OTHER PARTICIPANTS: All wrong-site surgery cases reported to a large malpractice insurer between 1985 and 2004. MAIN OUTCOME MEASURES: Incidence, characteristics, and causes of wrong-site surgery and characteristics of site-verification protocols. RESULTS: Among 2,826,367 operations at insured institutions during the study period, 25 nonspine wrong-site operations were identified, producing an incidence of 1 in 112,994 operations (95% confidence interval, 1 in 76,336 to 1 in 174,825). Medical records were available for review in 13 cases. Among reviewed claims, patient injury was permanent-significant in 1, temporary-major in 2, and temporary-minor or temporary-insignificant in 10. Under optimal conditions, the Joint Commission on Accreditation of Healthcare Organizations Universal Protocol might have prevented 8 (62%) of 13 cases. Hospital protocol design varied significantly. The protocols mandated 2 to 4 personnel to perform 12 separate operative-site checks on average (range, 5-20). Five protocols required site marking in cases that involved nonmidline organs or structures; 6 required it in all cases. CONCLUSIONS: Wrong-site surgery is unacceptable but exceedingly rare, and major injury from wrong-site surgery is even rarer. Current site-verification protocols could have prevented only two thirds of the examined cases. Many protocols involve considerable complexity without clear added benefit.

Humans↗
PubMed2006

Analysis of surgical errors in closed malpractice claims at 4 liability insurers.

BACKGROUND: The relative importance of the different factors that cause surgical error is unknown. Malpractice claim file analysis may help to identify leading causes of surgical error and identify opportunities for prevention. METHODS: We retrospectively reviewed 444 closed malpractice claims, from 4 malpractice liability insurers, in which patients alleged a surgical error. Surgeon-reviewers examined the litigation file and medical record to determine whether an injury attributable to surgical error had occurred and, if so, what factors contributed. Detailed descriptive information concerning etiology and outcome was recorded. RESULTS: Reviewers identified surgical errors that resulted in patient injury in 258 of the 444 (58%) claims. Sixty-five percent of these cases involved significant or major injury; 23% involved death. In most cases (75%), errors occurred in intraoperative care; 25% in preoperative care; 35% in postoperative care. Thirty-one percent of the cases had errors occurring during multiple phases of care; in 62%, more than 1 clinician played a contributory role. Systems factors contributed to error in 82% of cases. The leading system factors were inexperience/lack of technical competence (41%) and communication breakdown (24%). Cases with technical errors (54%) were more likely than those without technical errors to involve errors in multiple phases of care (36% vs 24%, P = .03), multiple personnel (83% vs 63%, P < .001), lack of technical competence/knowledge (51% vs 29%, P < .001) and patient-related factors (54% vs 33%, P = .001). CONCLUSIONS: Systems factors play a critical role in most surgical errors, including technical errors. Closed claims analysis can help to identify priority areas for intervening to reduce errors.

Adolescent↗
PubMed2006

Characteristics of physicians who frequently act as expert witnesses in neurologic birth injury litigation.

OBJECTIVE: Much debate surrounds physicians who testify in controversial types of medical malpractice litigation, but little is known about them. We sought to describe characteristics of physicians who frequently act as expert witnesses in neurologic birth injury litigation. METHODS: Using jury verdict reports, we identified 827 cases between 1990 and 2005 involving birth-related neurologic injury to a child. Frequent expert witnesses were defined as those associated with more than 10 cases. From the verdict reports and other public data sources, we compiled case descriptions (injury type and severity, legal outcomes) and characteristics of the frequent witnesses (age, gender, board certification, academic publication record). We analyzed these characteristics by comparing witnesses with each other (plaintiff compared with defendant) and with nationally representative data. RESULTS: Seventy-one frequent witnesses participated in 738 cases (89% of the sample), which paid 2.9 billion US dollars in compensation. Most (56 of 71) testified for one side in at least three fourths of cases, and 40% of cases were located outside the witnesses' home states. Frequent plaintiff witnesses had a higher median annual case rate than their defendant counterparts (2.9 compared with 1.9 cases, P=.002). They were also older (57.2 compared with 50.8 years, P=.007), less likely to have subspecialty board certification (38% compared with 95%, P<.001), and had fewer academic publications (5.0 compared with 53.5, P=.002). CONCLUSION: A small cadre of physicians testifies in most neurologic birth injury litigation, and witnesses tend to act consistently for one side. Plaintiff witnesses have fewer markers of expertise than defendant witnesses. These descriptive and analytical findings may reflect suboptimal expertise or bias in physician expert testimony.

Birth Injuries↗
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

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↗
PubMed2004

Professional liability issues in graduate medical education.

Resident physicians, attending physicians, and graduate medical education (GME) institutions share a collective responsibility to deliver safe and appropriate care to patients. The law does not offer concessions in quality of care to accommodate GME. Resident physicians are generally held to the same standard of care as attending physicians in their respective specialties. This principle encourages resident physicians to seek supervision and attending physicians to provide the same. Attending physicians face malpractice exposure not only for the care they provide but also for the care they direct. In addition, they may be held vicariously liable for the negligence of resident physicians working with them, or directly liable for inadequate supervision. What constitutes adequate supervision is unsettled in the law. As the standards in this area evolve, it is reasonable to expect that the profession's and the public's heightened attention to patient safety will continue to move the courts toward higher standards of supervision. GME institutions and programs bear legal responsibility for both the care they deliver and the negligence of their employees. They also face liability for failing to administer safe systems of care. Work hour restrictions and a growing understanding of the role of organizational factors in contributing to and preventing medical injury may increase the legal expectations imposed on GME programs.

Education, Medical, Graduate↗