Availability and Use of Shared Data From Cardiometabolic Clinical Trials.

BACKGROUND: Sharing of patient-level clinical trial data has been widely endorsed. Little is known about how extensively these data have been used for cardiometabolic diseases. We sought to evaluate the availability and use of shared data from cardiometabolic clinical trials. METHODS: We extracted data from ClinicalStudyDataRequest.com, a large, multisponsor data-sharing platform hosting individual patient-level data from completed studies sponsored by 13 pharmaceutical companies. RESULTS: From January 2013 to May 2017, the platform had data from 3374 clinical trials, of which 537 (16%) evaluated cardiometabolic therapeutics (phase 1, 36%; phase 2, 17%; phase 2/3, 1%; phase 3, 42%; phase 4, 4%). They covered 74 therapies and 398 925 patients. Diabetes mellitus (60%) and hypertension (15%) were the most common study topics. Median time from study completion to data availability was 79 months. As of May 2017, ClinicalStudyDataRequest.com had received 318 submitted proposals, of which 163 had signed data-sharing agreements. Thirty of these proposals were related to cardiometabolic therapies and requested data from 79 unique studies (15% of all trials, 29% of phase 3/4 trials). Most (96%) data requesters of cardiometabolic clinical trial data were from academic centers in North America and Western Europe, and half the proposals were unfunded. Most proposals were for secondary hypothesis-generating questions, with only 1 proposed reanalysis of the original study primary hypothesis. To date, 3 peer-reviewed articles have been published after a median of 19 months (9-32 months) from the data-sharing agreement. CONCLUSIONS: Despite availability of data from >500 cardiometabolic trials in a multisponsor data-sharing platform, only 15% of these trials and 29% of phase 3/4 trials have been accessed by investigators thus far, and a negligible minority of analyses have reached publication.

Reviewing Internal Medicine Clerkship Grading Through a Proequity Lens: Results of a National Survey.

PURPOSE: Equity in assessment and grading has become imperative across medical education. Although strategies to promote equity exist, there may be variable penetrance across institutions. The objectives of this study were to identify strategies internal medicine (IM) clerkship directors (CDs) use to reduce inequities in assessment and grading and explore IM CDs' perceptions of factors that impede or facilitate the implementation of these strategies. METHOD: From October to December 2021, the Clerkship Directors in Internal Medicine of the Alliance for Academic Internal Medicine conducted its annual survey of IM core CDs at 137 U.S. and U.S. territory-based medical schools. This study is based on 23 questions from the survey about equity in IM clerkship assessment and grading. RESULTS: The survey response rate was 73.0% (100 of 137 medical school CDs). Use of recommended evidence-based strategies to promote equity in clerkship assessment and grading varied among IM clerkships. Only 30 respondents (30.0%) reported that their clerkships had incorporated faculty development on implicit bias for clinical supervisors of students; 31 (31.0%) provided education to faculty on how to write narrative assessments that minimize bias. Forty respondents (40.0%) provided guidance to clerkship graders on how to minimize bias when writing final IM clerkship summaries, and 41 (41.0%) used grading committees to determine IM clerkship grades. Twenty-three CDs (23.0%) received formal education by their institution on how to generate clerkship grades and summaries in a way that minimized bias. CONCLUSIONS: This national survey found variability among medical schools in the application of evidence-based strategies to promote equity in assessment and grading within their IM clerkships. Opportunities exist to adopt and optimize proequity grading strategies, including development of programs that address bias in clerkship assessment and grading, reevaluation of the weight of standardized knowledge exam scores on grades, and implementation of grading committees.

Examining Risk: A Systematic Review of Perioperative Cardiac Risk Prediction Indices.

OBJECTIVE: To conduct a systematic review of published cardiac risk indices relevant to patients undergoing noncardiac surgery and to provide clinically meaningful recommendations to physicians regarding the use of these indices. METHODS: A literature search of articles published from January 1, 1999, through December 28, 2018, was conducted in Ovid (MEDLINE), PubMed, Embase, CINAHL, and Web of Science. Publications describing models predicting risk of cardiac complications after noncardiac surgery were included and citation chaining was used to identify additional studies for inclusion. RESULTS: Eleven risk indices involving 2,910,297 adult patients were included in this analysis. Studies varied in size, population, quality, risk of bias, outcome event definitions, risk factors identified, index outputs, accuracy, and clinical usefulness. Studies considered 6 to 83 variables to develop their models. Among the identified models, the factors with the highest predictiveness for adverse cardiac outcomes included congestive heart failure, type of surgery, creatinine, diabetes, history of stroke or transient ischemic attack, and emergency surgery. Substantial data from the large studies also supports advancing age, American Society of Anesthesiology physical status classification, functional status, and hypertension as additional risks. CONCLUSION: The risk indices identified generally fell into two groups - those with higher accuracy for predicting a narrow range of cardiac outcomes and those with lower accuracy for predicting a broader range of cardiac outcomes. Using one index from each group may be the most clinically useful approach. Risk factors identified varied widely among studies. In addition to judicious use of predictive indices, reasoned clinical judgment remains indispensable in assessing perioperative cardiac risk.

Supporting Faculty Development in Hospital Medicine: Design and Implementation of a Personalized Structured Mentoring Program.

The guidance of a mentor can have a tremendous influence on the careers of academic physicians. The lack of mentorship in the relatively young field of hospital medicine has been documented, but the efficacy of formalized mentorship programs has not been well studied. We implemented and evaluated a structured mentorship program for junior faculty at a large academic medical center. Of the 16 mentees who participated in the mentorship program, 14 (88%) completed preintervention surveys and 10 (63%) completed postintervention surveys. After completing the program, there was a statistically significant improvement in overall satisfaction within 5 specific domains: career planning, professional connectedness, self-reflection, research skills, and mentoring skills. All mentees reported that they would recommend that all hospital medicine faculty participate in similar mentorship programs. In this small, single-center pilot study, we found that the addition of a structured mentorship program based on training sessions that focus on best practices in mentoring was feasible and led to increased satisfaction in certain career domains among early-career hospitalists. Larger prospective studies with a longer follow-up are needed to assess the generalizability and durability of our findings.

Effect of Increased Inpatient Attending Physician Supervision on Medical Errors, Patient Safety, and Resident Education: A Randomized Clinical Trial.

Importance: While the relationship between resident work hours and patient safety has been extensively studied, little research has evaluated the role of attending physician supervision on patient safety. Objective: To determine the effect of increased attending physician supervision on an inpatient resident general medical service on patient safety and educational outcomes. Design, Setting, and Participants: This 9-month randomized clinical trial performed on an inpatient general medical service of a large academic medical center used a crossover design. Participants were clinical teaching attending physicians and residents in an internal medicine residency program. Interventions: Twenty-two faculty provided either (1) increased direct supervision in which attending physicians joined work rounds on previously admitted patients or (2) standard supervision in which attending physicians were available but did not join work rounds. Each faculty member participated in both arms in random order. Main Outcomes and Measures: The primary safety outcome was rate of medical errors. Resident education was evaluated via a time-motion study to assess resident participation on rounds and via surveys to measure resident and attending physician educational ratings. Results: Of the 22 attending physicians, 8 (36%) were women, with 15 (68%) having more than 5 years of experience. A total of 1259 patients (5772 patient-days) were included in the analysis. The medical error rate was not significantly different between standard vs increased supervision (107.6; 95% CI, 85.8-133.7 vs 91.1; 95% CI, 76.9-104.0 per 1000 patient-days; P = .21). Time-motion analysis of 161 work rounds found no difference in mean length of time spent discussing established patients in the 2 models (202; 95% CI, 192-212 vs 202; 95% CI, 189-215 minutes; P = .99). Interns spoke less when an attending physician joined rounds (64; 95% CI, 60-68 vs 55; 95% CI, 49-60 minutes; P = .008). In surveys, interns reported feeling less efficient (41 [55%] vs 68 [73%]; P = .02) and less autonomous (53 [72%] vs 86 [91%]; P = .001) with an attending physician present and residents felt less autonomous (11 [58%] vs 30 [97%]; P < .001). Conversely, attending physicians rated the quality of care higher when they participated on work rounds (20 [100%] vs 16 [80%]; P = .04). Conclusions and Relevance: Increased direct attending physician supervision did not significantly reduce the medical error rate. In designing morning work rounds, residency programs should reconsider their balance of patient safety, learning needs, and resident autonomy. Trial Registration: ClinicalTrials.gov Identifier: NCT03318198.

Late presentation of fatal hyperammonemic encephalopathy after Roux-en-Y gastric bypass.

Worldwide, there have been <25 reported cases of hyperammonemic encephalopathy associated with Roux-en-Y gastric bypass surgery in the absence of cirrhosis. We describe a 42-year-old woman who presented with subacute but progressive neurological decline late in her postoperative course, which deteriorated despite multiple conservative and aggressive measures, including hemodialysis, in an attempt to reduce measured plasma ammonia levels. This syndrome of hyperammonemic encephalopathy represents a serious, underrecognized, and potentially treatable complication after Roux-en-Y gastric bypass.

Pulmonary involvement of peripheral T-cell lymphoma manifesting as crazy paving pattern.

Crazy paving pattern is a finding on computed tomography of the chest that is characterized by interlobular septal thickening and ground-glass opacities. Though classically associated with pulmonary alveolar proteinosis, the differential diagnosis for this pattern is broad, and initial workup includes bronchoscopy with bronchoalveolar lavage to evaluate for malignancy, diffuse alveolar hemorrhage, pulmonary alveolar proteinosis, infection, and eosinophilic pneumonia. Herein we present an unusual case of peripheral T-cell lymphoma not otherwise specified (PTCL NOS) with pulmonary involvement that demonstrated crazy paving pattern. The diagnosis was confirmed after cytology from bronchoalveolar lavage revealed atypical lymphocytes with an immunologic profile consistent with the patient's known PTCL NOS.

Metastatic pancreatic neuroendocrine tumor with ectopic adrenocorticotropic hormone production.

We describe a 71-year-old man who presented with abdominal pain, lower-extremity edema, recent unintentional weight loss, hypertension, hyperglycemia, hypokalemia, and metabolic alkalosis. Serum cortisol levels remained elevated after overnight high-dose dexamethasone suppression. Magnetic resonance imaging revealed a small mass in the head of the pancreas with scattered liver metastases. Both endoscopic ultrasound-guided pancreatic biopsy and liver biopsy revealed a well-differentiated neuroendocrine tumor. These lesions did not show significant uptake on octreotide scan. Medical management and hepatic artery chemoembolization were attempted. Ultimately, the patient underwent bilateral adrenalectomy, but died within 4 months of symptom onset secondary to postoperative complications.