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OBJECTIVES:To determine the relationship between manufacturer-related financial ties among investigators of published drug trials and rates of discrepant registered and published primary trial outcomes. DESIGN:Cross-sectional study. SETTING:Human subjects drug trials published in 'core clinical' MEDLINE journals in 2013. PRIMARY AND SECONDARY OUTCOME MEASURES:The primary study endpoint was the presence of a prospectively registered, clearly defined primary outcome that matched the published primary outcome for each included trial. Secondary outcomes included assessments of registration timing and quality, and the impact of outcome discrepancies between registration and publication on the statistical significance of the included trials. RESULTS:Of 192 included trials, 134 (70%) were positive and 58 (30%) were negative. Financial ties were present between first or last authors and drug manufacturers for 130 trials (68%), of which 78% were positive, versus 53% of trials with no financial ties that were positive. Clearly defined, prospectively registered outcomes that matched the published outcomes were present in just 76 of the 192 trials (40%). After adjusting for study start date and sample size, the observed relationship between investigator financial ties and the presence of a match between prospectively registered and published primary outcomes was of borderline statistical significance (OR 2.12, 95% CI 0.998 to 4.50). Studies with financial ties present were more likely than studies without ties to have been prospectively registered (78%vs48%, P

Introduction: Social disconnection is a public health problem in older adults, as it can lead to decreased quality of life for this population. This study describes the prevalence of social disconnection and patient interest in social resources to address social disconnection among older adults receiving emergency department (ED) care.Methods: We conducted a cross-sectional survey of community-dwelling older adults (≥65 years) receiving care at two U.S. EDs. We described participant characteristics (demographic, social, and health variables), social disconnection prevalence, and desire for social resources using percentages and 95% confidence intervals. Then, we performed Chi Square tests and logistic regression to determine factors associated with positive screens for social disconnection.Results: Of 289 participants, 51% were female and the median age was 72 (interquartile range: 69-78). Most (76%) engaged with the community regularly, and 68% reported driving. Regarding social disconnection, a substantial minority of participants reported feeling as if they were burdensome to others (37%); as if they didn’t belong (27%); or that people would be better off if they were gone (15%); 52% reported at least one of these. In separate regression analyses, the perceptions of being a burden or better off if gone were each significantly associated with needing help with routine tasks (odds ratio [OR] [5.87, 5.90]); perceived burden was associated with hospitalization in theprior month (OR [2.09]); and low belonging was associated with not engaging in the community regularly (OR [2.50]), not seeing family regularly (OR [3.82]), and difficulty affording food (OR [2.50]). Regarding potential ED referrals, most participants were interested in transportation options (68%), food assistance (58%), and mental health resources (55%). Participants experiencing difficulties affording food were interested in food and housing assistance (p=.03; p=.01).Conclusion: Over half of this sample of older ED patients reported feeling socially disconnected. Social and functional health problems are often related and both must be addressed to optimize older ED patient quality of life. Future research should consider the impact of social disconnection on older adults discharged from the ED and work to develop ED services that could refer this population to programs that may decrease social disconnection.

Introduction: Triage of patients is critical to patient safety, yet no clear information exists as to the utility of initial vital signs in identifying critically ill older emergency department (ED) patients. The objective of this study is to evaluate a set of initial vital sign thresholds as predictors of severe illness and injury among older adults presenting to the ED.Methods: We reviewed all visits by patients aged 75 and older seen during 2007 at an academic ED serving a large community of older adults. Patients’ charts were abstracted for demographic and clinical information including vital signs, via automated electronic methods. We used bivariate analysis to investigate the relationship between vital sign abnormalities and severe illness or injury, defined as intensive care unit (ICU) admission or ED death. In addition, we calculated likelihood ratios for normal and abnormal vital signs in predicting severe illness or injury.Results: 4,873 visits by patients aged 75 and above were made to the ED during 2007, and of these 3,848 had a complete set of triage vital signs. For these elderly patients, the sensitivity and specificity of an abnormal vital sign taken at triage for predicting death or admission to an ICU were 73% (66,81) and 50% (48,52) respectively (positive likelihood ratio 1.47 (1.30,1.60); negative likelihood ratio 0.54 (0.30,0.60).Conclusion: Emergency provider assessment and triage scores that rely primarily on initial vital signs are likely to miss a substantial portion of critically ill older adults. [West J Emerg Med. 2013;14(5):453–460.]

Introduction: We examined the accuracy of research participant characterizations of motor vehicle collisions (MVC).Methods: We conducted an emergency department-based prospective study of adults presenting for care after experiencing an MVC. Study participants completed a structured clinical interview that assessed the number of lanes of the road where the collision took place, vehicle type, road condition, speed limit, seat belt use, airbag deployment, vehicle damage, time of collision, and use of ambulance transportation. Study participant data were then compared with information recorded by Michigan State Police at the scene of the MVC. Agreement between research participant reports and police-reported data were assessed by using percentage agreement and j coefficients for categorical variables and correlation coefficients for continuous variables.Results: There were 97 study participants for whom emergency department interviews and Michigan State Police Report information were available. Percentage agreement was 51% for number of lanes,76% for car drivability, 88% for road condition, 91% for vehicle type, 92% for seat belt use, 94% for airbag deployment, 96% for speed limit, 97% for transportation by ambulance, and 99% for vehicle seat position. j values were 0.32 for seat belt use, 0.34 for number of lanes, 0.73 for vehicle type, 0.76 for speed limit, 0.77 for road condition, 0.87 for airbag deployment, 0.90 for vehicle seat position, and 0.94for transport by ambulance. Correlation coefficients were 0.95 for the time of the collision, and 0.58 for extent of damage to the vehicle. Most discrepancies between patients and police about extent of vehicle damage occurred for cases in which the patient reported moderate or severe damage but the police reported only slight damage.Conclusion: For most MVC characteristics, information reported by research participants was consistent with police-reported data. Agreement was moderate or high for characteristics of greatestrelevance to injury biomechanics. These results suggest that research participant report is an acceptable source of collision information. [West J Emerg Med. 2012;13(4):329–334.]

BackgroundDeploying accurate computable phenotypes in pragmatic trials requires a trade-off between precise and clinically sensical variable selection. In particular, evaluating the medical encounter to assess a pattern leading to clinically significant impairment or distress indicative of disease is a difficult modeling challenge for the emergency department. ObjectiveThis study aimed to derive and validate an electronic health record–based computable phenotype to identify emergency department patients with opioid use disorder using physician chart review as a reference standard. MethodsA two-algorithm computable phenotype was developed and evaluated using structured clinical data across 13 emergency departments in two large health care systems. Algorithm 1 combined clinician and billing codes. Algorithm 2 used chief complaint structured data suggestive of opioid use disorder. To evaluate the algorithms in both internal and external validation phases, two emergency medicine physicians, with a third acting as adjudicator, reviewed a pragmatic sample of 231 charts: 125 internal validation (75 positive and 50 negative), 106 external validation (56 positive and 50 negative). ResultsCohen kappa, measuring agreement between reviewers, for the internal and external validation cohorts was 0.95 and 0.93, respectively. In the internal validation phase, Algorithm 1 had a positive predictive value (PPV) of 0.96 (95% CI 0.863-0.995) and a negative predictive value (NPV) of 0.98 (95% CI 0.893-0.999), and Algorithm 2 had a PPV of 0.8 (95% CI 0.593-0.932) and an NPV of 1.0 (one-sided 97.5% CI 0.863-1). In the external validation phase, the phenotype had a PPV of 0.95 (95% CI 0.851-0.989) and an NPV of 0.92 (95% CI 0.807-0.978). ConclusionsThis phenotype detected emergency department patients with opioid use disorder with high predictive values and reliability. Its algorithms were transportable across health care systems and have potential value for both clinical and research purposes.

Introduction: Snakebite is an urgent, unmet global medical need causing significant morbidity and mortality worldwide. Varespladib is a potent inhibitor of venom secretory phospholipase A2 (sPLA2) that can be administered orally via its prodrug, varespladib-methyl. Extensive preclinical data support clinical evaluation of varespladib as a treatment for snakebite envenoming (SBE). The protocol reported here was designed to evaluate varespladib-methyl for SBE from any snake species in multiple geographies. Methods and Analysis: BRAVO (Broad-spectrum Rapid Antidote: Varespladib Oral for snakebite) is a multicenter, randomized, double-blind, placebo-controlled, phase 2 study to evaluate the safety, tolerability, and efficacy of oral varespladib-methyl plus standard of care (SoC) vs. SoC plus placebo in patients presenting with acute SBE by any venomous snake species. Male and female patients 5 years of age and older who meet eligibility criteria will be randomly assigned 1:1 to varespladib-methyl or placebo. The primary outcome is the Snakebite Severity Score (SSS) that has been modified for international use. This composite outcome is based on the sum of the pulmonary, cardiovascular, nervous, hematologic, and renal systems components of the updated SSS. Ethics and Dissemination: This protocol was submitted to regulatory authorities in India and the US. A Clinical Trial No Objection Certificate from the India Central Drugs Standard Control Organisation, Drug Controller General-India, and a Notice to Proceed from the US Food and Drug Administration have been obtained. The study protocol was approved by properly constituted, valid institutional review boards or ethics committees at each study site. This study is being conducted in compliance with the April 1996 ICH Guidance for Industry GCP E6, the Integrated Addendum to ICH E6 (R2) of November 2016, and the applicable regulations of the country in which the study is conducted. The trial is registered on Clinical trials.gov, NCT#04996264 and Clinical Trials Registry-India, 2021/07/045079 000062. [ABSTRACT FROM AUTHOR]