Cognitive errors and logistical breakdowns contributing to missed and delayed diagnoses of breast and colorectal cancers: a process analysis of closed malpractice claims.

PURPOSE: To erform a process analysis of missed and delayed diagnoses of breast and colorectal cancers to identify: (1) the cognitive and logistical factors that lead to these diagnostic errors, and (2) prevention strategies. METHODS: Using 56 cases (43 breast, 13 colon) of missed and delayed diagnosis, we performed structured analyses to identify specific points in the diagnostic process in which errors occurred. Each error was classified as either a cognitive error or logistical breakdown. Finally, two physician-investigators identified strategies to prevent the errors in each case. RESULTS: Virtually all cases involved one or more cognitive errors (53/56, 95 %) and approximately half (31/56, 55 %) involved logistical breakdowns. The clinical activity most prone to cognitive error was the selection of the diagnostic strategy, both during the office visit (25/56, 45 %) and during interpretation of test results (22/50, 44 %). Arrangement of follow-up visits with a primary care physician (8/29, 28 %) or specialist physician (7/29, 26 %) were especially prone to logistical breakdowns. Adherence to current clinical guidelines could have prevented at least one error in 66 % of cases and assistance from a patient advocate could have prevented at least one error in 48 % of cases. CONCLUSIONS: Cognitive errors and logistical breakdowns are common among missed and delayed diagnoses of breast and colorectal cancers. Prevention strategies should focus on ensuring improving the effectiveness and use of clinical guidelines in the selection of diagnostic strategy, both during office visits and when interpreting test results. Tools to facilitate communication and to ensure that follow-up visits occur should also be considered.

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.

Process of care failures in breast cancer diagnosis.

BACKGROUND: Process of care failures may contribute to diagnostic errors in breast cancer care. OBJECTIVE: To identify patient- and provider-related process of care failures in breast cancer screening and follow-up in a non-claims-based cohort. DESIGN: Retrospective chart review of a cohort of patients referred to two Boston cancer centers with new breast cancer diagnoses between January 1, 1999 and December 31, 2004. PARTICIPANTS: We identified 2,275 women who reported > or =90 days between symptom onset and breast cancer diagnosis or presentation with at least stage II disease. We then selected the 340 (14.9%) whose physicians shared an electronic medical record. We excluded 238 subjects whose records were insufficient for review, yielding a final cohort of 102 patients. INTERVENTIONS: None MEASUREMENTS: We tabulated the number and types of process of care failures and examined risk factors using bivariate analyses and multivariable Poisson regression. MAIN RESULTS: Twenty-six of 102 patients experienced > or =1 process of care failure. The most common failures occurred when physicians failed to perform an adequate physical examination, when patients failed to seek care, and when diagnostic or laboratory tests were ordered but patients failed to complete them. Failures were attributed in similar numbers to provider- and patient-related factors (n = 30 vs. n = 25, respectively). Process of care failures were more likely when the patient's primary care physician was male (IRR 2.8, 95% CI 1.2 to 6.5) and when the patient was non-white (IRR 2.8, 95% CI 1.4 to 5.7). CONCLUSIONS: Process failures were common in this patient cohort, with both clinicians and patients contributing to breakdowns in the diagnostic process.

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.

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.

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.

Iatrogenic events resulting in intensive care admission: frequency, cause, and disclosure to patients and institutions.

PURPOSE: To identify the frequency and type of iatrogenic medical events requiring admission to an intensive care unit. To assess the consequences of iatrogenic medical events for patients and institutions. To assess the prevalence of disclosure of iatrogenic medical events to patients, surrogates, and institutions. METHODS: The project on Care Improvement for the Critically Ill enrolled 5727 patients to 8 intensive care units at 4 Boston teaching hospitals. To determine the nature, consequences, and disclosure of iatrogenic medical events, we did a retrospective chart review on all patients whose admission to an intensive care unit was precipitated by an iatrogenic event. RESULTS: Sixty-six patients (1.2 %) were identified by an intensive care unit's clinical team as having an iatrogenic medical event as the primary reason for admission to the unit. The majority (29, or 45%) of iatrogenic medical events were secondary to technical error, but a high percentage (21, or 33%) was due to iatrogenic drug events. Twenty-two (34%) cases were assessed by the investigators to have been preventable. In 60 (94%) cases there was no documentation in the patient's chart of communication to the patient regarding the reason for admission to the intensive care unit. In 11 (17%) cases there was documentation of a discussion with the surrogate about the reason for admission to the unit. In only 3 (5%) cases was there documentation that the patient or surrogate was informed that an iatrogenic medical event was the reason for admission to the intensive care unit. Incident reports or malpractice claims were filed in only 4 (6 %) cases. CONCLUSION: The frequency of iatrogenic medical events resulting in admission to intensive care units is lower than previous studies have reported. Iatrogenic drug events continue to be an important source of error. A considerable percentage of iatrogenic events may be preventable. Health care professionals rarely document disclosure of iatrogenic events to patients and surrogates.

Race and family history assessment for breast cancer.

OBJECTIVE: Studies have demonstrated disparities in breast cancer screening between racial and ethnic groups. Knowledge of a woman's family history of breast cancer is important for initiating early screening interventions. The purpose of this study was to determine whether differences exist in the collection of family history information based on patient race. DESIGN: Cross-sectional patient telephone interview and medical record review. SETTING: Eleven primary care practices in the Greater Boston area, all associated with Harvard Medical School teaching hospitals. PARTICIPANTS: One thousand seven hundred fifty-nine women without a prior history of breast cancer who had been seen at least once by their primary care provider during the prior year. MEASUREMENTS AND MAIN RESULTS: Data were collected on patients regarding self-reported race, family breast cancer history information, and breast cancer screening interventions. Twenty-six percent (462/1,759) of the sample had documentation within their medical record of a family history for breast cancer. On multivariate analysis, after adjusting for patient age, education, number of continuous years in the provider's practice, language, and presentation with a breast complaint, white women were more likely to be asked about a breast cancer family history when compared to nonwhite women (odds ratio, 1.68; 95% confidence interval, 1.21 to 2.35). CONCLUSIONS: The majority of women seen by primary care providers do not have documentation of a family breast cancer history assessment within their medical record. White women were more likely to have family breast cancer information documented than nonwhites.

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.

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.

Liability impact of the hospitalist model of care.

BACKGROUND: An increasingly large proportion of inpatient care is provided by hospitalists. The care discontinuities inherent to hospital medicine raise concerns about malpractice risk. However, little published data exist on the medical liability risks associated with care by hospitalists. OBJECTIVE: We sought to determine the risks and outcomes of malpractice claims against hospitalists in internal medicine. DESIGN: Retrospective observational analysis. MEASUREMENTS: Using claims data from a liability insurer-maintained database of over 52,000 malpractice claims, we measured the rates of malpractice claims against hospitalists compared to other physician specialties, types of allegations against hospitalists, contributing factors, and the severity of injury in and outcomes of these claims. RESULTS: Hospitalists had a malpractice claims rate of 0.52 claims per 100 physician coverage years (PCYs), which was significantly lower than that of nonhospitalist internal medicine physicians (1.91 claims per 100 PCYs), emergency medicine physicians (3.50 claims per 100 PCYs), general surgeons (4.70 claims per 100 PCYs), and obstetricians-gynecologists (5.56 claims per 100 PCYs) (P < 0.001 for all comparisons). The most common allegation types made against hospitalists were for errors in medical treatment (41.5%) and diagnosis (36.0%). The most common contributing factors underlying claims were deficiencies in clinical judgment (54.4%) and communication (36.4%). Of the claims made against hospitalists, 50.4% involved the death of the patient. CONCLUSIONS: Despite fears of increased liability from the hospitalist model of care, hospitalists in internal medicine are subject to medical malpractice claims less frequently when compared to other internal medicine physicians and specialties.

Primary care closed claims experience of Massachusetts malpractice insurers.

IMPORTANCE: Despite prior focus on high-impact inpatient cases, there are increasing data and awareness that malpractice in the outpatient setting, particularly in primary care, is a leading contributor to malpractice risk and claims. OBJECTIVE: To study patterns of primary care malpractice types, causes, and outcomes as part of a Massachusetts ambulatory malpractice risk and safety improvement project. DESIGN, SETTING, AND PARTICIPANTS: Retrospective review of pooled closed claims data of 2 malpractice carriers covering most Massachusetts physicians during a 5-year period (January 1, 2005, through December 31, 2009). Data were harmonized between the 2 insurers using a standardized taxonomy. Primary care practices in Massachusetts. All malpractice claims that involved primary care practices insured by the 2 largest insurers in the state were screened. A total of 551 claims from primary care practices were identified for the analysis. MAIN OUTCOMES AND MEASURES: Numbers and types of claims, including whether claims involved primary care physicians or practices; classification of alleged malpractice (eg, misdiagnosis or medication error); patient diagnosis; breakdown in care process; and claim outcome (dismissed, settled, verdict for plaintiff, or verdict for defendant). RESULTS: During a 5-year period there were 7224 malpractice claims of which 551 (7.7%) were from primary care practices. Allegations were related to diagnosis in 397 (72.1%), medications in 68 (12.3%), other medical treatment in 41 (7.4%), communication in 15 (2.7%), patient rights in 11 (2.0%), and patient safety or security in 8 (1.5%). Leading diagnoses were cancer (n = 190), heart diseases (n = 43), blood vessel diseases (n = 27), infections (n = 22), and stroke (n = 16). Primary care cases were significantly more likely to be settled (35.2% vs 20.5%) or result in a verdict for the plaintiff (1.6% vs 0.9%) compared with non-general medical malpractice claims (P < .001). CONCLUSIONS AND RELEVANCE: In Massachusetts, most primary care claims filed are related to alleged misdiagnosis. Compared with malpractice allegations in other settings, primary care ambulatory claims appear to be more difficult to defend, with more cases settled or resulting in a verdict for the plaintiff.

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.

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.

Inconsistent report cards: assessing the comparability of various measures of the quality of ambulatory care.

BACKGROUND: Report cards based on various performance measures have become increasingly common for rating hospitals and health care plans. However, little has been done to create report cards at the ambulatory clinic level, nor has there been much comparison of the potential components of report cards. OBJECTIVES: To create a report card for ambulatory clinics based on different data collection methods and to assess the correlations of clinic scores across various domains of quality. RESEARCH DESIGN: Cross-sectional chart review (n = 3614), patient (n = 2180), and physician surveys (n = 169). SUBJECTS: Sample of outpatients ages 20 to 75 and their primary care providers in 11 ambulatory clinic sites in the Boston-area from May 1996 to June 1997. MEASURES: Performance on various quality indicators for each site. RESULTS: Report card scores for five quality domains (performance on HEDIS-like measures, clinic function, patient satisfaction, diabetes guideline compliance, asthma guideline compliance) were created for each site. None of the five domain scores were significantly correlated with any of the other domains. In addition, there was substantial intraclinic variation in domain scores when compared with the corresponding mean domain score across all clinics. Additional clinic domain scores were created by limiting measures to those found on chart review or survey alone. The chart review and survey domain scores for each clinic were also not significantly correlated. CONCLUSIONS: Report cards that emphasize only one domain of quality or use limited data collection methods may provide incomplete or inconsistent information to health care consumers about the overall quality of an outpatient clinic.

Influence of body weight on patients' satisfaction with ambulatory care.

Patients with obesity experience psychosocial consequences because of their weight and report physician bias. We examined whether obesity is associated with lower patient satisfaction with ambulatory care among 2,858 patients seen at 11 academically affiliated primary care practices in Boston. Compared with normal weight patients (body mass index [BMI], 19.0 to 24.9 kg/M 2), overweight (BMI, 25.0 to 29.9 kg/M 2) and obese patients (BMI > or =30 kg/M 2) reported lower overall satisfaction scores at their most recent visit; the scores were 85.5, 85.0, and 82.6 out a possible 100, respectively (P =.05). After adjustment for potential confounders including illness burden, obese patients reported lower scores but the difference was not statistically significant (mean difference, 1.23 [95% confidence interval -0.67 to 3.12]). Patient satisfaction with their usual provider and their practice did not vary by BMI group. Obesity is associated with only modest decreases in satisfaction scores with the most recent visit, which were explained largely by higher illness burden among obese patients.