What Have We Learned From Malpractice Claims Involving the Surgical Management of Benign Biliary Disease?: A 128 Million Dollar Question.

OBJECTIVE: We aimed to study the contributing factors and costs of malpractice claims involving the surgical management of benign biliary disease given the emotional, physical, and financial toll of these claims on patients, providers, and the healthcare system. SUMMARY BACKGROUND DATA: Cholecystectomy complications carry significant morbidity and rank among the leading sources of surgical malpractice claims. METHODS: Using the CRICO Strategies' Comparative Benchmarking System database, representing approximately 30% of all paid and unpaid malpractice claims in the United States, 4081 closed claims filed against general surgeons from 1995 to 2015 were reviewed to isolate 745 cholecystectomy-related claims. A multivariable model was used to determine factors associated with claim outcome. RESULTS: The most common associated complications included bile duct injury (n = 397), bowel perforation (n = 96), and hemorrhage (n = 78). Bile duct injuries were recognized intraoperatively only 19% of the time and required biliary reconstruction surgery 77% of the time. The total cost for all claims over the study period was over $128 M and the median time from event to case close was over 3 years. 40% of claims resulted in patient payout; of these, most claims were settled out of court and the median cost per claim was $264,650. For the 60% of claims not resulting in patient payout, most cases were denied, dropped, or dismissed, yet still averaged over $15,000 per claim in legal and administrative fees. On multivariable analysis, bile duct injury, bowel perforation, and high clinical severity were associated with patient payout, while a resident or fellow being named in a claim was negatively associated with patient payout (P < 0.05). CONCLUSION: Cholecystectomy-related claims are costly and time-consuming. Strategies that reduce the risk and aid in recognition of cholecystectomy complications, as well as advance support of patients and families after poor outcomes, may improve clinical care and reduce claim burden.

On-call transthoracic echocardiographic interpretation by first year cardiology fellows: comparison with attending cardiologists.

BACKGROUND: Transthoracic echocardiograms (TTE) performed and interpreted by cardiology fellows during off-duty hours are critical to patient care, however limited data exist on their interpretive accuracy. Our aims were to determine the discordance rate between TTEs performed and interpreted by cardiology fellows and National Board of Echocardiography certified attending cardiologists and to identify factors associated with discordance. METHODS: Consecutive on-call TTEs acquired and interpreted by 1st year cardiology fellows over 4.6 years at an academic center were prospectively evaluated by attending cardiologists. Fellow interpretations were classified as concordant or discordant with the attending interpretation. We assessed the association of patient, imaging and fellow characteristics with discordance. RESULTS: A total of 777 TTE interpretations (730 patients) were performed/interpreted by 40 first year fellows and overread by 13 attendings. The most common indications were assessment of left ventricular function (40.9%) and pericardial effusion (37.3%). There was a major or minor discordance in 4.1 and 17.4% of studies, respectively with 42.1% of disagreements occurring in assessment of left ventricular size and function. The indication to assess left ventricular function [OR 2.19, 95% CI (1.32, 3.62), P = 0.002 vs. pericardial effusion] and greater duration of echocardiographic image acquisition (OR 1.02, 95% CI 1.01, 1.03, P = 0.004) were independently associated with overall discordance. CONCLUSIONS: In this large prospective study we found that attending cardiologists disagreed with 1 in 5 fellow TTE interpretations. Standardized tools for evaluation of echocardiograms performed by fellows are needed to ensure quality of training and patient safety.

Wide Variation in Reported Rates of Stroke Across Cohorts of Patients With Atrial Fibrillation.

BACKGROUND: Oral anticoagulants decrease ischemic stroke rates in patients with atrial fibrillation (AF) but increase the risk of bleeding. For the average patient with AF, the threshold of annual ischemic stroke rate where the benefit of anticoagulation outweighs the bleeding risk (net clinical benefit) has been shown to be ≈1% to 2%. Guideline recommendations for oral anticoagulants in AF are based on the CHA2DS2-VASc stroke risk point scores, assuming that those scores translate to fixed stroke rates. However, the relationship between stroke point scores and annual stroke rates may vary substantially across populations. We sought to comprehensively assess the reported rates of stroke in patients with AF and the relationship of stroke rates to stroke risk point scores. METHODS: A systematic review of cohort studies and randomized controlled trials enrolled patients with nonvalvular AF not treated with oral anticoagulants. RESULTS: Of the 3552 studies screened, we identified 34 studies eligible for analysis. Overall stroke rates in cohort studies were highly heterogeneous (Q=5706.54, P<0.001; I2 = 99.6%) and ranged from 0.45% to 9.28% per year, despite being of similar objective study quality. The mean North American stroke rate was less than one-third that of the mean European stroke rate (P<0.0001). However, a random effects regression indicated that between-study variability was not significantly accounted for by cohort region, prospective versus retrospective design, calendar year of study, or outcome event cluster. At a CHA2DS2-VASc score of 1, 76% of cohorts reported ischemic stroke rates <1% per year and only 18% of cohorts reported a stroke rate >2% per year. At a CHA2DS2-VASc score of 2, 27% of cohorts reported stroke rates below 1% per year, 40% reported stroke rates between 1 and 2% per year, and 33% reported stroke rates >2% per year. CONCLUSIONS: Substantial variation exists across cohorts in overall stroke rates and rates corresponding to CHA2DS2-VASc point scores. These variations can affect the point score threshold for recommending oral anticoagulants in AF. The majority of cohorts did not observe stroke rates that would indicate a clear expected net clinical benefit for anticoagulating AF patients with CHA2DS2-VASc scores of 1 or 2.

Missed Diagnosis of Cardiovascular Disease in Outpatient General Medicine: Insights from Malpractice Claims Data.

BACKGROUND: Diagnostic errors are an underrecognized source of patient harm, and cardiovascular disease can be challenging to diagnose in the ambulatory setting. Although malpractice data can inform diagnostic error reduction efforts, no studies have examined outpatient cardiovascular malpractice cases in depth. A study was conducted to examine the characteristics of outpatient cardiovascular malpractice cases brought against general medicine practitioners. METHODS: Some 3,407 closed malpractice claims were analyzed in outpatient general medicine from CRICO Strategies' Comparative Benchmarking System database-the largest detailed database of paid and unpaid malpractice in the world-and multivariate models were created to determine the factors that predicted case outcomes. RESULTS: Among the 153 patients in cardiovascular malpractice cases for whom patient comorbidities were coded, the majority (63%) had at least one traditional cardiac risk factor, such as diabetes, tobacco use, or previous cardiovascular disease. Cardiovascular malpractice cases were more likely to involve an allegation of error in diagnosis (75% vs. 47%, p <0.0001), have high clinical severity (86% vs. 49%, p <0.0001) and result in death (75% vs. 27%, p <0.0001), as compared to noncardiovascular cases. Initial diagnoses of nonspecific chest pain and mimics of cardiovascular pain (for example, esophageal disease) were common and independently increased the likelihood of a claim resulting in a payment (p <0.01). CONCLUSION: Cardiovascular malpractice cases against outpatient general medicine physicians mostly occur in patients with conventional risk factors for coronary artery disease and are often diagnosed with common mimics of cardiovascular pain. These findings suggest that these patients may be high-yield targets for preventing diagnostic errors in the ambulatory setting.

"Not so fast!" the complexity of attempting to decrease door-to-floor time for emergency department admissions.

BACKGROUND: Successful quality improvement is fundamental to high-performing health care systems, but becomes increasingly difficult as systems become more complex. Previous attempts at the University of California, San Francisco (UCSF) Medical Center to reduce door-to-floor (D2F) time -the time required to move an ill patient through the emergency department (ED) to an appropriate inpatient bed-had not resulted in meaningful improvement. An analysis of why attempts at decreasing D2F times in the ED had failed, with attention to contextual factors, yields recommendations on how to decrease D2F time. METHODS: A team of 11 internal medicine residents, in partnership with the Patient Flow Executive Steering Committee, performed a literature review, process mapping, and analysis of the admissions process. The team conducted interviews with medical center staff across disciplines, members of high-performing patient care units, and leaders of peer institutions who had undertaken similar efforts. FINDINGS AND RECOMMENDATIONS: Each of the following three domains-(1) Improving Work Flow, (2) Changing Culture, and (3) Understanding Incentives-is independently an important source of resistance and opportunity. However, the improvement work and understanding of complexity science suggest that all three domains must be addressed simultaneously to effect meaningful change. Recommendations include eliminating redundant and frustrating processes; encouraging multidisciplinary collaboration; fostering trust between departments; providing feedback on individual performance; enhancing provider buy-in; and, ultimately, uniting staff behind a common goal. CONCLUSION: By conceptualizing the hospital as a complex adaptive system, multiple interrelated groups can be encouraged to work together and accomplish a common goal.

Defining Best Practices for Interhospital Transfers.

INTRODUCTION: Interhospital transfers (IHT) are important yet high-risk transitions in care. Variable IHT processes and a lack of clarity around best practice may contribute to risk. To define the best practice principles for IHTs and identify improvement opportunities in the transfer process to our hospital's Cardiology services. METHODS: Through literature review, interviews with experts and key stakeholders, a survey of health care professionals at our institution, and a failure modes effect analysis, we identified themes in IHT best practices and improvement opportunities. RESULTS: We identified six critical elements of IHT: (1) initiation of transfer request; (2) the management of transfer request and information exchange; (3) updates between transfer acceptance and patient transport; (4) transport; (5) patient admission and information availability; and (6) measurement, evaluation, and feedback. Improvement opportunities were found in all elements. CONCLUSIONS: The standardization of these six critical elements may improve the safety of IHTs.

Missed diagnosis of cancer in primary care: Insights from malpractice claims data.

BACKGROUND: In the ambulatory setting, missed cancer diagnoses are leading contributors to patient harm and malpractice risk; however, there are limited data on the malpractice case characteristics for these cases. OBJECTIVE: The aim of this study was to examine key features and factors identified in missed cancer diagnosis malpractice claims filed related to primary care and evaluate predictors of clinical and claim outcomes. METHODS: We analyzed 2155 diagnostic error closed malpractice claims in outpatient general medicine. We created multivariate models to determine factors that predicted case outcomes. RESULTS: Missed cancer diagnoses represented 980 (46%) cases of primary care diagnostic errors, most commonly from lung, colorectal, prostate, or breast cancer. The majority (76%) involved errors in clinical judgment, such as a failure or delay in ordering a diagnostic test (51%) or failure or delay in obtaining a consult or referral (37%). These factors were independently associated with higher-severity patient harm. The majority of these errors were of high severity (85%). CONCLUSIONS: Malpractice claims involving missed diagnoses of cancer in primary care most often involve routine screening examinations or delays in testing or referral. Our findings suggest that more reliable closed-loop systems for diagnostic testing and referrals are crucial for preventing diagnostic errors in the ambulatory setting.

Functional impairment in body dysmorphic disorder: a prospective, follow-up study.

Cross-sectional/retrospective studies indicate that individuals with body dysmorphic disorder (BDD) have markedly impaired psychosocial functioning. However, no study has prospectively examined functioning in BDD. In this study, which is to our knowledge the first prospective study of the course of BDD, psychosocial functioning was assessed at baseline and over 1-3 years (mean=2.7+/-0.9 years) of follow-up with the Global Assessment of Functioning scale (GAF), Social and Occupational Functioning Scale (SOFAS), and LIFE-RIFT (Range of Impaired Functioning Tool). Psychosocial functioning was poor during the follow-up period. Functioning remained stably poor over time on the SOFAS and LIFE-RIFT, although there was a trend for a gradual and slight improvement on the GAF over time. The cumulative probability of attaining functional remission on the GAF (score>70 for at least 2 consecutive months) during the follow-up period was only 5.7%. On the SOFAS, the cumulative probability of attaining functional remission (score>70 for at least 2 consecutive months) was 10.6%. BDD severity significantly predicted functioning on the GAF (p=0.0012), SOFAS (p=0.0017), and LIFE-RIFT (p=0.0015). A trend for a time-by-BDD severity interaction was found on the GAF (p=0.033) but not the SOFAS or LIFE-RIFT. More delusional BDD symptoms also predicted poorer functioning on all measures, although this finding was no longer significant when controlling for BDD severity. Functioning was not predicted, however, by age, gender, BDD duration, or a personality disorder. In conclusion, psychosocial functioning was poor over time, and few subjects attained functional remission. Greater BDD severity predicted poorer functioning.

Methodologic Differences Across Studies of Patients With Atrial Fibrillation Lead to Varying Estimates of Stroke Risk.

BACKGROUND: Guidelines for anticoagulation in atrial fibrillation (AF) assume that stroke risk scheme point scores correspond to fixed stroke rates. However, reported stroke rates vary widely across AF cohort studies, including studies from the same country. Reasons for this variation are unclear. This study compares methodologies used to assemble and analyze large AF cohorts worldwide and assesses potential bias in estimating stroke rates. METHODS AND RESULTS: From a previous systematic review of AF cohorts, we analyzed studies including at least 5000 patients. We assessed methods used to generate rates of ischemic stroke off anticoagulants, according to a structured inventory of database interrogation methods. Nine studies (497 578 total patients) met our criteria. Overall cohort stroke rates ranged from 0.45% to 7.03% per year. In bivariate study-level analysis, multiple features were associated with higher stroke rates, including AF identified as inpatients versus outpatients (rate ratio 2.60, 95% confidence interval, 1.19, 5.68), and lack of clinical validation of outcome events (rate ratio 4.09, 95% confidence interval, 1.06, 15.70). European studies reported rates more than 4-fold higher than North American studies. International Classification of Diseases (ICD) coding schemes for outcomes varied widely. Multiple high rate features coexisted in the same studies. CONCLUSIONS: Among AF cohort studies, differences in the composition, method of assembly, determination of clinical features and outcomes, and analytic approach were strongly associated with reported stroke rates. Our study highlights the need for standardized and validated methodologies for AF cohort assembly and analysis to generate accurate stroke rates to better support anticoagulation guidelines for patients with AF.

Selective Serotonin Reuptake Inhibitors and Bleeding Risk in Anticoagulated Patients With Atrial Fibrillation: An Analysis From the ROCKET AF Trial.

Background There is concern that selective serotonin reuptake inhibitors ( SSRI s) substantially increase bleeding risk in patients taking anticoagulants. Methods and Results We studied 737 patients taking SSRI s in the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Embolism and Stroke Trial in Atrial Fibrillation) trial of rivaroxaban compared with warfarin for the prevention of stroke/systemic embolism in patients with atrial fibrillation. These patients were propensity score matched 1:1 to 737 patients not taking SSRI s. The primary outcome measure was major and nonmajor clinically relevant bleeding events, the principal safety outcome in ROCKET AF . Over a mean 1.6 years of follow-up, the rate of major/ nonmajor clinically relevant bleeding was 18.57 events/100 patient-years for SSRI users versus 16.84 events/100 patient-years for matched comparators, adjusted hazard ratio ( aHR ) of 1.16 (95% confidence interval [CI], 0.95-1.43). The aHR s were similar in patients taking rivaroxaban ( aHR 1.11 [95% CI, 0.82-1.51]) and those taking warfarin ( aHR 1.21 [95% CI, 0.91-1.60]). For the rarer outcome of major bleeding, the aHR for SSRI users versus those not taking SSRI s was 1.13 (95% CI, 0.62-2.06) for rivaroxaban; for warfarin, the aHR was higher, at 1.58 (95% CI , 0.96-2.60) but not statistically significantly elevated. Conclusions We found no significant increase in bleeding risk when SSRI s were combined with anticoagulant therapy, although there was a suggestion of increased bleeding risk with SSRI s added to warfarin. While physicians should be vigilant regarding bleeding risk, our results provide reassurance that SSRI s can be safely added to anticoagulants in patients with atrial fibrillation . Clinical Trial Registration URL : https://www.clinicaltrials.gov . Unique identifier: NCT 00403767.

How Well Do Stroke Risk Scores Predict Hemorrhage in Patients With Atrial Fibrillation?

The decision to use anticoagulants for atrial fibrillation depends on comparing a patient's estimated risk of stroke to their bleeding risk. Several of the risk factors in the stroke risk schemes overlap with hemorrhage risk. We compared how well 2 stroke risk scores (CHADS2 and CHA2DS2-VASc) and 2 hemorrhage risk scores (the ATRIA bleeding score and the HAS-BLED score) predicted major hemorrhage on and off warfarin in a cohort of 13,559 community-dwelling adults with AF. Over a cumulative 64,741 person-years of follow-up, we identified a total of 777 incident major hemorrhage events. The ATRIA bleeding score had the highest predictive ability of all the scores in patients on warfarin (c-index of 0.74 [0.72 to 0.76] compared with 0.65 [0.62 to 0.67] for CHADS2, 0.65 [0.62 to 0.67] for CHA2DS2-VASc, and 0.64 [0.61 to 0.66] for HAS-BLED) and in those off warfarin (0.77 [0.74 to 0.79] compared with 0.67 [0.64 to 0.71] for CHADS2, 0.67 [0.64 to 0.70] for CHA2DS2-VASc, and 0.68 [0.65 to 0.71] for HAS-BLED). In conclusion, although CHADS2 and CHA2DS2-VASc stroke scores were better at predicting hemorrhage than chance alone, they were inferior to the ATRIA bleeding score. Our study supports the use of dedicated hemorrhage risk stratification tools to predict major hemorrhage in atrial fibrillation.

A prospective evaluation of interrupted nitinol surgical clips in arteriovenous fistula for hemodialysis.

BACKGROUND: The use of a self-closing nitinol surgical clip (Coalescent Surgical U-Clip) is a novel technique of creating an interrupted vascular anastomosis, which also eliminates the knot tying associated with a conventional vascular anastomosis. The purpose of this study was to compare the clinical outcome of arteriovenous fistulae (AVF) for hemodialysis as constructed using interrupted U-Clip devices and conventional continuous polypropylene sutures. METHODS: We prospectively studied the clinical course of 132 patients (149 access) undergoing either forearm autologous arteriovenous fistula (FAVF, n = 69) or upper arm autologous arteriovenous fistula (UAVF, n = 80) or creations during a 39-month period. Among the FAVF, U-Clips and polypropylene sutures were used in 37 and 32 anastomoses, respectively. Among the UAVF, U-Clips and polypropylene sutures were used in 41 and 30 anastomoses, respectively. Primary patency, complication, and maturation rates were analyzed. RESULTS: Clipped FAVF had an improved maturation rate at 6 weeks (32 of 37, 86%) when compared with sutured FAVF (22 of 32, 69%, P <0.05). There was no difference in the maturation rate among UAVF constructed with either U-Clips or sutures (88% versus 87%, not significant). The primary patency rates at 12, 24, and 36 months were 91%, 84%, and 75% for the clipped FAVF; and 83%, 74%, and 61% for the sutured FAVF (P <0.05) There was no difference in the patency rate of UAVF constructed with either U-Clips or polypropylene sutures at either 12, 24 or 36 moths (91%, 80%, and 75% versus 83%, 77%, and 69%, respectively). CONCLUSIONS: The U-Clips are a viable alternative to sutures for creating vascular anastomosis. It provides a improved maturation and patency rates when compared with the conventional sutured AVF in the forearm. The clinical benefit of the U-Clips may be due in part to the improved compliance created by the interrupted anastomotic technique.

Effect of selective serotonin reuptake inhibitors on bleeding risk in patients with atrial fibrillation taking warfarin.

Selective serotonin reuptake inhibitor (SSRI) medications have been linked to increased bleeding risk; however, the actual association among warfarin, SSRI exposure, and bleeding risk has not been well-established. We studied the AnTicoagulation and Risk factors In Atrial fibrillation cohort of 13,559 adults with atrial fibrillation, restricted to the 9,186 patients contributing follow-up time while taking warfarin. Exposure to SSRIs and tricyclic antidepressants (TCAs) was assessed from pharmacy database dispensing data. The main outcome was hospitalization for major hemorrhage. Results were adjusted for bleeding risk and time in international normalized ratio range >3. We identified 461 major hemorrhages during 32,888 person-years of follow-up, 45 events during SSRI use, 12 during TCA-only use, and 404 without either medication. Hemorrhage rates were higher during periods of SSRI exposure compared with periods on no antidepressants (2.32 per 100 person-years vs 1.35 per 100 person-years, p <0.001) and did not differ between TCA exposure and no antidepressants (1.30 per 100 person-years on TCAs, p = 0.94). After adjustment for underlying bleeding risk and time in international normalized ratio range >3, SSRI exposure was associated with an increased rate of hemorrhage compared with no antidepressants (adjusted relative risk 1.41, 95% confidence interval 1.04 to 1.92, p = 0.03), whereas TCA exposure was not (adjusted relative risk 0.82, 95% confidence interval 0.46 to 1.46, p = 0.50). In conclusion, SSRI exposure was associated with higher major hemorrhage risk in patients taking warfarin, and this risk should be considered when selecting antidepressant treatments in those patients.

Atrial fibrillation: stroke prevention in older adults.

Atrial fibrillation (AF) is an increasingly prevalent disease in the elderly. Patients with AF are at increased risk of ischemic stroke, resulting in significant morbidity and mortality. Warfarin is highly effective at reducing stroke risk, with a net clinical benefit favoring treatment in older individuals. The advent of newer oral anticoagulants provides promising alternatives to warfarin. Appropriate risk stratification for stroke should be performed for all patients with AF to guide antithrombotic therapy. For patients at lower stroke risk, bleeding risk stratification tools can also be used when the benefit of anticoagulant therapy is unclear.