Pharmacologic therapies for neuropathic pain: an assessment of reporting biases in randomized controlled trials.

ABSTRACT: Several different reporting biases cited in scientific literature have raised concerns about the overestimation of effects and the subsequent potential impact on the practice of evidence-based medicine and human health. Up to 7% to 8% of the population experiences neuropathic pain (NP), and established treatment guidelines are based predominantly on published clinical trial results. Therefore, we examined published randomized controlled trials (RCTs) of first-line drugs for NP and assessed the relative proportions with statistically significant (ie, positive) and nonsignificant (ie, negative) results and their rates of citation. We determined the relationships between reported study outcome and the frequency of their citations with journal impact factor, sample size, time to publication after study completion, and study quality metrics. We also examined the association of study outcome with maximum study drug dosage and conflict of interest. We found that of 107 published RCTs, 68.2% reported a statistically significant outcome regarding drug efficacy for chronic peripheral and central NP. Positive studies were cited nearly twice as often as negative studies in the literature (P = 0.01), despite similar study sample size, quality metrics, and publication in journals with similar impact factors. The time to publication, journal impact factor, and conflict of interest did not differ statistically between positive and negative studies. Our observations that negative and positive RCTs were published in journals with similar impact at comparable time-lags after study completion are encouraging. However, the citation bias for positive studies could affect the validity and generalization of conclusions in literature and potentially influence clinical practice.

Resident Preparation for the American Board of Anesthesiology Objective Standardized Clinical Examination: A Comparison of Virtual Telesimulation With In-person Simulation.

BACKGROUND: The Objective Structured Clinical Examination (OSCE) is part of the American Board of Anesthesiology (ABA) certification process. A simulated OSCE can aid examination preparation, but the COVID-19 pandemic prevented in-person simulation training. Therefore, we adapted our in-person simulated OSCE (SOSCE) as a Zoom-based telesimulation OSCE (ZOSCE), permitting examinees to participate remotely. Comparing this process with historical in-person SOSCE cohorts, we hypothesized that this telesimulation-based format would still be well received by the trainees as a substitute when it was not possible to provide in-person practice and formative assessment. Subsequently, the ABA proposed a virtual-format OSCE. METHODS: We conducted our 7-station ZOSCE according to the ABA content outline for all graduating third-year clinical anesthesia residents (CA-3) in 2020. From a main meeting room, the facilitator paired each CA-3 with a faculty proctor, assigned them to their own breakout room for each station, and rotated standardized patients in. The faculty proctor observed the CA-3's performance in real time using an assessment tool with objectives graded on a 0-2 scale. At the conclusion of the ZOSCE, proctors reviewed the assessment tool with the CA-3 and provided personalized global feedback. Assessment tool scores were used to calculate performance data for the study group that were compared with a SOSCE historical cohort from 2017 and 2018. All parties completed a Likert-style evaluation specific to the ZOSCE. RESULTS: A total of 22 CA-3 residents participated. Mean performance scores ranged from 82.2%-94.9% (minimum = 38%, maximum = 100%). Compared with the historical SOSCE cohort, ZOSCE scores for 5 of 7 stations were not different, but scores in communication with professionals (P = .007) and ultrasound (P < .001) stations were lower. Overall, CA-3 participants rated the learning experience positively and felt it was a reasonable substitution for in-person simulation, with responses similar to those of a historical in-person SOSCE cohort. CONCLUSIONS: A telesimulation-based practice ZOSCE for formative examination preparation for the ABA OSCE resulted in similar institutional scoring for most stations compared with in-person SOSCE, but some stations may be better practiced in person or require modifications. The virtual format may permit flexible scheduling during nonclinical times or for learners in remote locations. These findings have implications for future formative exercises and the formal summative examination process.

Coronary artery spasm following dobutamine stress echocardiogram.

A 53-year-old woman with atypical chest pain underwent a dobutamine stress echocardiogram (DSE) and developed a coronary spasm (CS) with severe pain and dramatic ST-segment elevation 9 min after dobutamine infusion was discontinued. The spasm resolved after sublingual nitroglycerin administration. The same-day coronary angiogram showed non-significant stenosis in the three coronary territories. Retrospectively, we found that the patient had vasospastic angina (VSA), a condition that has been strongly associated with the development of dobutamine-induced CS. Mechanisms of dobutamine-induced CS are not fully understood and include endothelial dysfunction leading to deficient nitric oxide-mediated coronary vasodilation in response to increased myocardial oxygen demand as well as imbalance between ß1 and ß2 adrenergic effects of dobutamine. Dobutamine-induced CS has also been much more frequently reported in patients from Asian descent with VSA. VSA should be systemically recognised in patients considered for DSE and, if present, other modalities of stress imaging should be discussed.

A Case of Tracheobronchomalacia Mimicking Acute Pulmonary Embolism.

BACKGROUND Pulmonary embolism is a common acute postoperative complication and is associated with 100,000 deaths per year in the USA. Tracheobronchomalacia is an uncommon condition, which presents with similar symptoms to pulmonary embolism, including hypoxemia, tachycardia, and shortness of breath. We describe a case of a patient who presented with postoperative pulmonary symptoms that were initially thought to be due to pulmonary embolism. However, following imaging investigations these symptoms were found to be due to tracheobronchomalacia. CASE REPORT A 73-year-old woman underwent elective ventral hernia repair and takedown of a Hartmann's pouch. On the ninth postoperative day, she developed symptoms of acute respiratory distress and was admitted to the surgical intensive care unit. Respiratory function tests and blood gas evaluation showed that her alveolar-arterial oxygen gradient (A-a gradient) and modified Wells' score were suggestive of a diagnosis of pulmonary embolism. A contrast-enhanced computed tomography (CT) scan of the lungs was negative for pulmonary embolism but demonstrated findings suggestive of tracheobronchomalacia. CONCLUSIONS Tracheobronchomalacia should be considered in the differential diagnosis of hypoxia when evaluating a patient in the ICU.

Daily mood monitoring of symptoms using smartphones in bipolar disorder: A pilot study assessing the feasibility of ecological momentary assessment.

BACKGROUND: Personal device technology has facilitated gathering data in real-time using Ecological momentary assessment (EMA). We hypothesized that using smartphones to measure symptoms in auto-generated surveys twice a day would be feasible in a group with bipolar disorder (BD). A second exploratory objective of this study was to compare potential differences in core symptoms between BD and healthy control (HC) groups. METHODS: A two-arm, parallel group, observational study was designed to measure completion rates of surveys of symptoms of mood, energy, speed of thought, impulsivity, and social stress in BD (N=10) and HC (N=10) participants. The surveys were auto-generated twice a day for fourteen days, and subjects could also perform self-generated surveys. Completion rates were compared between BD and HC groups. Scores were averaged for each participant over the 14 day period, and group medians were compared. RESULTS: Median completion rates did not differ between groups: 95% in BD, 88% in HC (p=0.68); the median completion rate of auto-generated surveys in the BD group was 79% and in the HC group was 71% (p=0.22). The BD group had significantly lower median mood score (p=0.043) and energy score (p=0.007) than the HC group. Median scores of speed of thoughts (p=0.739), impulsivity (p=0.123) and social stress (p=0.056) did not significantly differ between BD and HC. The BD group had significantly higher range of variability of group median mood (p=0.043), speed of thoughts (p=0.002) and impulsivity (p=0.005) scores over the course of 14 days than HC, while range of variability of energy (p=0.218) and social stress (p=0.123) scores did not differ. Results were not significantly different between auto-generated and self-generated surveys for BD or HC. LIMITATIONS: This pilot study was conducted for a short time and with a small sample. CONCLUSIONS: This study demonstrates feasibility of using EMA with a smartphone to gather data on BD symptoms.