Selective serotonin reuptake inhibitor (SSRI) medications have been linked to increased bleeding risk, however, the actual association between warfarin, SSRI exposure, and bleeding risk has not been well-established. We studied the AnTicoagulation and Risk factors In Atrial fibrillation (ATRIA) cohort of 13,559 adults with atrial fibrillation (AF), restricted to the 9186 patients contributing follow-up time while taking warfarin. Exposure to SSRIs and tricyclic antideprssants (TCAs) were assessed from pharmacy database dispensing data. The main outcome was hospitalization for major hemorrhage. Results were adjusted for bleeding risk and time in an INR 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 = 0.93). After adjusting for bleeding risk and time in INR range > 3, SSRI exposure was associated with an increased rate of hemorrhage compared with no antidepressants (adjusted relative risk 1.41, 95% CI: 1.04-1.92, p=0.03), whereas TCA exposure was not (adjusted relative risk 0.82, 95% CI: 0.46-1.46, p=0.50). In conclusion, SSRI exposure was associated with higher major hemorrhage risk in patients on warfarin and this risk should be considered when selecting antidepressant treatments in those patients.

Substantial variation exists across cohorts in overall stroke rates and rates corresponding to CHADS-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 CHADS-VASc scores of 1 or 2.

BackgroundThere is concern that selective serotonin reuptake inhibitors (SSRIs) substantially increase bleeding risk in patients taking anticoagulants.Methods and ResultsWe studied 737 patients taking SSRIs 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 SSRIs. 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 aHRs 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 SSRIs 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.ConclusionsWe found no significant increase in bleeding risk when SSRIs were combined with anticoagulant therapy, although there was a suggestion of increased bleeding risk with SSRIs added to warfarin. While physicians should be vigilant regarding bleeding risk, our results provide reassurance that SSRIs can be safely added to anticoagulants in patients with atrial fibrillation.Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT00403767.

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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 to 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=.0012), SOFAS (p=.0017), and LIFE-RIFT (p=.0015). A trend for a time-by-BDD severity interaction was found on the GAF (p=.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.

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.

This article is ASHRM CE eligible. Earn 1.0 credit hours of Continuing Education by passing an online quiz based on your reading at ASHRM.org/JournalCE. 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.

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.