Balancing Ethical Goals in Challenging Individual Participant Scenarios Occurring in a Trial Conducted with Exception from Informed Consent

In 1996, federal regulations were put into effect that allowed enrollment of critically ill or injured patients into Food and Drug Administration (FDA)‐regulated clinical trials using an exception from informed consent (EFIC) under narrowly prescribed research circumstances. Despite the low likelihood that a legally authorized representative (LAR) would be present within the interventional time frame, the EFIC regulations require the availability of an informed consent process, to be applied if an LAR is present and able to provide prospective consent for patient enrollment into the trial. The purpose of this article is to describe a series of unanticipated consent‐related questions arising when a potential surrogate decision‐maker appeared to be available at the time of patient enrollment into a trial proceeding under EFIC.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/110828/1/acem12602.pd

Emergency Medicine Research Directors and Research Programs: Characteristics and Factors Associated with Productivity

: Background: Periodic surveys of research directors (RDs) in emergency medicine (EM) are useful to assess the specialty's development and evolution of the RD role. Objectives: To assess associations between characteristics and research productivity of RDs and EM programs. Methods: A survey of EM RDs was developed using the nominal group technique and pilot tested. RDs or surrogate respondents at programs certified by the Accreditation Council for Graduate Medical Education were contacted by e-mail in early 2005. The survey assessed programs' research infrastructure and productivity, as well as RD characteristics, responsibilities, and career satisfaction. Three measures of research productivity were empirically defined: research publications, grant awards, and grant revenue. Results: Responses were received from 86% of 123 EM programs. Productivity was associated with the presence of nonclinical faculty, dedicated research coordinators, and reduced clinical hours for research faculty. Programs with an RD did not have greater research productivity, using any measure, than those without an RD. The majority of RDs cited pursuing their own studies, obtaining funding, research mentoring, and research administration to be major responsibilities. The majority characterized internal research funding, grant development support, and support from other faculty as inadequate. Most RDs are satisfied with their careers and expect to remain in the position for three or more years. Conclusions: Research productivity of EM residency programs is associated with the presence of dedicated research faculty and staff and with reduced clinical demands for research faculty. Despite perceiving deficiencies in important resources, most RDs are professionally satisfied.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/72908/1/j.aem.2006.01.027.pd

Efficacy of Losartan in Hospitalized Patients With COVID-19-Induced Lung Injury: A Randomized Clinical Trial

Importance: SARS-CoV-2 viral entry may disrupt angiotensin II (AII) homeostasis, contributing to COVID-19 induced lung injury. AII type 1 receptor blockade mitigates lung injury in preclinical models, although data in humans with COVID-19 remain mixed. Objective: To test the efficacy of losartan to reduce lung injury in hospitalized patients with COVID-19. Design, Setting, and Participants: This blinded, placebo-controlled randomized clinical trial was conducted in 13 hospitals in the United States from April 2020 to February 2021. Hospitalized patients with COVID-19 and a respiratory sequential organ failure assessment score of at least 1 and not already using a renin-angiotensin-aldosterone system (RAAS) inhibitor were eligible for participation. Data were analyzed from April 19 to August 24, 2021. Interventions: Losartan 50 mg orally twice daily vs equivalent placebo for 10 days or until hospital discharge. Main Outcomes and Measures: The primary outcome was the imputed arterial partial pressure of oxygen to fraction of inspired oxygen (Pao2:Fio2) ratio at 7 days. Secondary outcomes included ordinal COVID-19 severity; days without supplemental o2, ventilation, or vasopressors; and mortality. Losartan pharmacokinetics and RAAS components (AII, angiotensin-[1-7] and angiotensin-converting enzymes 1 and 2)] were measured in a subgroup of participants. Results: A total of 205 participants (mean [SD] age, 55.2 [15.7] years; 123 [60.0%] men) were randomized, with 101 participants assigned to losartan and 104 participants assigned to placebo. Compared with placebo, losartan did not significantly affect Pao2:Fio2 ratio at 7 days (difference, -24.8 [95%, -55.6 to 6.1]; P = .12). Compared with placebo, losartan did not improve any secondary clinical outcomes and led to fewer vasopressor-free days than placebo (median [IQR], 9.4 [9.1-9.8] vasopressor-free days vs 8.7 [8.2-9.3] vasopressor-free days). Conclusions and Relevance: This randomized clinical trial found that initiation of orally administered losartan to hospitalized patients with COVID-19 and acute lung injury did not improve Pao2:Fio2 ratio at 7 days. These data may have implications for ongoing clinical trials. Trial Registration: ClinicalTrials.gov Identifier: NCT04312009

A primer of inter-rater reliability in clinical measurement studies: Pros and pitfalls

[Extract] Quality and sound measurement are fundamental to creating professional knowledge to provide a foundation for clinical decision-making in health services. Therefore, measurement scales are commonly used in health, particularly mental health research. Although there are different types of rating scales, they are often used by a rater to make a judgement about variable/s of interest, for example participants' psychological traits such as empathy, by assigning scores to the scale designed to measure that trait (Tinsley & Weiss, 1975). Measurement instruments are not only required to be valid and reliable but also to measure what they claim to measure in a reproducible manner. Where the validity of a measurement instrument indicates its ability to measure what it intends to, the reliability estimates show the precision of the measurement in producing similar results; both of which provide evidence about the usefulness of assessments, often in terms of scores assigned to evaluate behaviours, abilities or symptoms, relevant to psychology, education and health sciences

Factors Affecting Candidate Placement on an Emergency Medicine Residency Program's Rank Order List

INTRODUCTION: Several factors influence the final placement of a medical student candidate on an emergency medicine (EM) residency program’s rank order list, including EM grade, standardized letter of recommendation, medical school class rank, and US Medical License Examination (USMLE) scores. We sought to determine the correlation of these parameters with a candidate’s final rank on a residency program’s rank order list. METHODS: We used a retrospective cohort design to examine 129 candidate packets from an EM residency program. Class ranks were assessed according to the instructions provided by the students’ medical schools. EM grades were scored from 1 (honors) to 5 (fail). Global assessments noted on the standardized letter of recommendation (SLOR) were scored from 1 (outstanding) to 4 (good). USMLE scores were reported as the candidate’s 3-digit scores. Spearman’s rank correlation coefficient was used to analyze data. RESULTS: Electronic Residency Application Service packets for 127/129 (98.4%) candidates were examined. The following parameters correlated positively with a candidate’s final placement on the rank order list: EM grade, ρ = 0.379, P < 0.001; global assessment, ρ = 0.332, P < 0.001; and class rank, ρ = 0.234, P = 0.035. We found a negative correlation between final placement on the rank order list with both USMLE step 1 scores, ρ = −0.253, P=0.006; and USMLE step 2 scores, ρ = −0.348, P = 0.004. CONCLUSION: Higher scores on EM rotations, medical school class ranks, and SLOR global assessments correlated with higher placements on a rank order list, whereas candidates with higher USMLE scores had lower placements on a rank order list. However, none of the parameters examined correlated strongly with ultimate position of a candidate on the rank list, which underscores that other factors may influence a candidate’s final ranking

Factors Affecting Candidate Placement on an Emergency Medicine Residency Program’s Rank Order List

Introduction: Several factors influence the final placement of a medical student candidate on anemergency medicine (EM) residency program’s rank order list, including EM grade, standardized letterof recommendation, medical school class rank, and US Medical License Examination (USMLE) scores.We sought to determine the correlation of these parameters with a candidate’s final rank on a residencyprogram’s rank order list.Methods: We used a retrospective cohort design to examine 129 candidate packets from an EMresidency program. Class ranks were assessed according to the instructions provided by the students’medical schools. EM grades were scored from 1 (honors) to 5 (fail). Global assessments noted on the standardized letter of recommendation (SLOR) were scored from 1 (outstanding) to 4 (good). USMLEscores were reported as the candidate’s 3-digit scores. Spearman’s rank correlation coefficient wasused to analyze data.Results: Electronic Residency Application Service packets for 127/129 (98.4%) candidates wereexamined. The following parameters correlated positively with a candidate’s final placement on therank order list: EM grade, q¼0.379, P , 0.001; global assessment, q¼0.332, P , 0.001; and classrank, q¼0.234, P¼0.035. We found a negative correlation between final placement on the rank orderlist with both USMLE step 1 scores, q¼0.253, P¼0.006; and USMLE step 2 scores, q¼0.348, P¼0.004.Conclusion: Higher scores on EM rotations, medical school class ranks, and SLOR globalassessments correlated with higher placements on a rank order list, whereas candidates with higherUSMLE scores had lower placements on a rank order list. However, none of the parameters examined correlated strongly with ultimate position of a candidate on the rank list, which underscores that otherfactors may influence a candidate’s final ranking. [West J Emerg Med. 2012;13(6):458–462.

Notes to factor analysis techniques for construct validity

This paper introduces and discusses factor analysis techniques for construct validity, including some suggestions for reporting using the evidence to support the construct validity from exploratory and confirmatory factor analysis techniques. Construct validity is a vital part of psychological testing and a prerequisite to every measurement instrument, including aptitude, achievement, and interests. Research, particularly in nursing and the health sciences, depends on reliable valid measurements. Therefore, a growing emphasis is on assessing validity regarding the structure of test variables commonly estimated by factor analysis techniques. However, it is not always clear how to report the analysis and use it to support the construct validity. Both exploratory and confirmatory factor analysis techniques provide vital evidence to support the construct validity. However, these are not the only available evidence for construct validity, and the researcher should always consider other sources of evidence to develop and support the construct validity of their intended measures. In addition, the collection and presentation of this evidence are not limited to a time, but the validity of constructs is a continuous process that leads to validating the underlying theories from which constructs have emerged

A primer of inter‐rater reliability in clinical measurement studies: Pros and pitfalls

Quality and sound measurement are fundamental to creating professional knowledge to provide a foundation for clinical decision-making in health services. Therefore, measurement scales are commonly used in health, particularly mental health research. Although there are different types of rating scales, they are often used by a rater to make a judgement about variable/s of interest, for example participants' psychological traits such as empathy, by assigning scores to the scale designed to measure that trait (Tinsley & Weiss, 1975)