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Biomedical subjects

Atul A Gawande

Publications and source records attributed to Atul A Gawande.

9 recordsLinked to original sources

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↗

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↗

Reassessment of parathyroid hormone monitoring during parathyroidectomy for primary hyperparathyroidism after 2 preoperative localization studies.

HYPOTHESIS: For patients with primary hyperparathyroidism and patients with 2 localization studies showing the same single location of parathyroid disease, use of intraoperative parathyroid hormone (IOPTH) measurement does not significantly increase the success of minimally invasive parathyroidectomy. DESIGN: Retrospective cohort study. SETTING: Experience of 2 academic centers over 5 years (at Brigham and Women's Hospital, Boston, Mass) and almost 4 years (at Rhode Island Hospital, Providence). PATIENTS: A total of 569 patients with primary hyperparathyroidism who underwent technetium Tc 99m sestamibi (MIBI) parathyroid imaging and neck ultrasonography (US). MAIN OUTCOME MEASURES: Incidence of correct prediction of location and extent of disease. RESULTS: In 322 patients (57%), MIBI and US imaging identified the same single site of disease. In 319 (99%) of these 322 patients, surgical exploration confirmed a parathyroid adenoma at that site, and the IOPTH levels normalized on removal. In 3 (1%) of the 322 patients, IOPTH measurement identified unsuspected additional disease. In 3 (1%) of the remaining 319 patients, IOPTH-guided removal of a single adenoma failed to correct hypercalcemia. Therefore, the failure rate of surgery in patients with positive MIBI and positive US imaging was 1% with IOPTH measurement and 2% without IOPTH measurement (P = .50). In 201 (35%) of the 569 patients, only 1 of the 2 studies recognized an abnormality or the studies disagreed on location. In these cases, either MIBI imaging or US imaging (if MIBI imaging was negative) failed to predict the correct site or extent of disease in 76 (38%) of the 201 patients (P<.001 vs concordant studies). CONCLUSIONS: In primary hyperparathyroidism, concordant preoperative localization with MIBI and US imaging is highly accurate. Use of IOPTH measurement in these cases adds only marginal benefit. When only 1 of the 2 studies identifies disease or the studies conflict, however, IOPTH measurement remains essential during minimally invasive parathyroidectomy.

Chi-Square Distribution↗

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↗

Proficiency of surgeons in inguinal hernia repair: effect of experience and age.

OBJECTIVES: We examined the influence of surgeon age and other factors on proficiency in laparoscopic or open hernia repair. SUMMARY BACKGROUND DATA: In a multicenter, randomized trial comparing open and laparoscopic herniorrhaphies, conducted in Veterans Administration hospitals (CSP 456), we reported significant differences in recurrence rates (RR) for the laparoscopic procedure as a result of surgeons' experience. We have also reported significant differences in RR for the open procedure related to resident postgraduate year (PGY) level. METHODS: We analyzed data from unilateral laparoscopic and open herniorrhaphies from CSP 456 (n = 1629). Surgeon's experience (experienced > or =250 procedures; inexperienced <250), surgeon's age, median PGY level of the participating resident, operation time, and hospital observed-to-expected (O/E) ratios for mortality were potential independent predictors of RR. RESULTS: Age was dichotomized into older (> or =45 years) and younger (<45 years). Surgeon's inexperience and older age were significant predictors of recurrence in laparoscopic herniorrhaphy. The odds of recurrence for an inexperienced surgeon aged 45 years or older was 1.72 times that of a younger inexperienced surgeon. For open repairs, although surgeon's age and operation time appeared to be related to recurrence, only median PGY level of <3 was a significant independent predictor. CONCLUSION: This analysis demonstrates that surgeon's age of 45 years and older, when combined with inexperience in laparoscopic inguinal herniorrhaphies, increases risk of recurrence. For open repairs, only a median PGY level of <3 was a significant risk factor.

Adult↗

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↗

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↗

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↗