Sex as a Biological Variable in Emergency Medicine Research and Clinical Practice: A Brief Narrative Review.
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ABSTRACT:
SUBMITTER: McGregor AJ
PROVIDER: S-EPMC5654878 | biostudies-other | 2017 Oct
REPOSITORIES: biostudies-other
Publications
Sex as a Biological Variable in Emergency Medicine Research and Clinical Practice: A Brief Narrative Review.
McGregor Alyson J AJ Beauchamp Gillian A GA Wira Charles R CR Perman Sarah M SM Safdar Basmah B
The western journal of emergency medicine 20171006 6
The National Institutes of Health recently highlighted the significant role of sex as a biological variable (SABV) in research design, outcome and reproducibility, mandating that this variable be accounted for in all its funded research studies. This move has resulted in a rapidly increasing body of literature on SABV with important implications for changing the clinical practice of emergency medicine (EM). Translation of this new knowledge to the bedside requires an understanding of how sex-bas ...[more]
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Project description:IntroductionOver 25 years, emergency medicine in the United States has amassed a large evidence base that has been systematically assessed and interpreted through ACEP Clinical Policies. While not previously studied in emergency medicine, prior work has shown that nearly half of all recommendations in medical specialty practice guidelines may be based on limited or inconclusive evidence. We sought to describe the proportion of clinical practice guideline recommendations in Emergency Medicine that are based upon expert opinion and low level evidence.MethodsSystematic review of clinical practice guidelines (Clinical Policies) published by the American College of Emergency Physicians from January 1990 to January 2016. Standardized data were abstracted from each Clinical Policy including the number and level of recommendations as well as the reported class of evidence. Primary outcomes were the proportion of Level C equivalent recommendations and Class III equivalent evidence. The primary analysis was limited to current Clinical Policies, while secondary analysis included all Clinical Policies.ResultsA total of 54 Clinical Policies including 421 recommendations and 2801 cited references, with an average of 7.8 recommendations and 52 references per guideline were included. Of 19 current Clinical Policies, 13 of 141 (9.2%) recommendations were Level A, 57 (40.4%) Level B, and 71 (50.4%) Level C. Of 845 references in current Clinical Policies, 67 (7.9%) were Class I, 272 (32.3%) Class II, and 506 (59.9%) Class III equivalent. Among all Clinical Policies, 200 (47.5%) recommendations were Level C equivalent, and 1371 (48.9%) of references were Class III equivalent.ConclusionsEmergency medicine clinical practice guidelines are largely based on lower classes of evidence and a majority of recommendations are expert opinion based. Emergency medicine appears to suffer from an evidence gap that should be prioritized in the national research agenda and considered by policymakers prior to developing future quality standards.
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Project description:In June 2015, the National Institutes of Health (NIH) released a Guide notice (NOT-OD-15-102) that highlighted the expectation of the NIH that the possible role of sex as a biologic variable be factored into research design, analyses, and reporting of vertebrate animal and human studies. Anticipating these guidelines, the NIH Office of Research on Women's Health, in October 2014, convened key stakeholders to discuss methods and techniques for integrating sex as a biologic variable in preclinical research. The workshop focused on practical methods, experimental design, and approaches to statistical analyses in the use of both male and female animals, cells, and tissues in preclinical research. Workshop participants also considered gender as a modifier of biology. This article builds on the workshop and is meant as a guide to preclinical investigators as they consider methods and techniques for inclusion of both sexes in preclinical research and is not intended to prescribe exhaustive/specific approaches for compliance with the new NIH policy.-Miller, L. R., Marks, C., Becker, J. B., Hurn, P. D., Chen, W.-J., Woodruff, T., McCarthy, M. M., Sohrabji, F., Schiebinger, L., Wetherington, C. L., Makris, S., Arnold, A. P., Einstein, G., Miller, V. M., Sandberg, K., Maier, S., Cornelison, T. L., Clayton, J. A. Considering sex as a biological variable in preclinical research.
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Project description:BACKGROUND:Clinical practice guidelines (CPGs) have been published by the American College of Emergency Physicians (ACEP) since 1990 to advance evidence-based emergency care. ACEP clinical policies have drawn anecdotal criticism for bias, yet the overall quality of these guidelines has not previously been quantified. We sought to examine ACEP clinical policies using a recognised, validated appraisal instrument: Appraisal of Guidelines for Research & Evaluation (AGREE II). METHODS:Systematic assessment of current ACEP clinical policies was conducted using the AGREE II instrument, which contains 23 appraisal items (scored on a 1-7 scale) in six domains and two overall assessments. Each policy was independently appraised by five trained appraisers. Primary outcomes were AGREE II ratings for each item, domain and "Overall Assessment," and scores were reported as standardised percentages from all five appraisers. Secondary analyses examined associations between AGREE II ratings and policy publication date, strength of underlying evidence and strength of recommendations. Additional analysis examined relationships between domain and "Overall Assessment" ratings. RESULTS:Twenty guidelines published from April 2007 to November 2017 were included. Of the six domains, "Scope and Purpose" scored highest (mean 90%) and "Applicability" scored lowest (mean 35%). The four remaining domains ("Stakeholder Involvement," "Rigor of Development," "Clarity of Presentation" and "Editorial Independence") had mean scores of 53%-78%. The mean "Overall Assessment" rating was 69% and was not associated with policy publication date, strength of underlying evidence or strength of recommendations. We found positive associations between "Overall Assessment" ratings and two domains: "Rigor of Development" (r = 0.70) and "Clarity of Presentation" (r = 0.70). CONCLUSIONS:Based on validated AGREE II criteria, ACEP clinical policies can be most improved by addressing their application in practice. ACEP clinical policies' overall quality did not improve over the assessed time period and is not explained by the quality of underlying evidence.
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Project description:Despite rapid technical progress and demonstrable effectiveness for some types of diagnosis and therapy, much remains to be learned about clinical genome and exome sequencing (CGES) and its role within the practice of medicine. The Clinical Sequencing Exploratory Research (CSER) consortium includes 18 extramural research projects, one National Human Genome Research Institute (NHGRI) intramural project, and a coordinating center funded by the NHGRI and National Cancer Institute. The consortium is exploring analytic and clinical validity and utility, as well as the ethical, legal, and social implications of sequencing via multidisciplinary approaches; it has thus far recruited 5,577 participants across a spectrum of symptomatic and healthy children and adults by utilizing both germline and cancer sequencing. The CSER consortium is analyzing data and creating publically available procedures and tools related to participant preferences and consent, variant classification, disclosure and management of primary and secondary findings, health outcomes, and integration with electronic health records. Future research directions will refine measures of clinical utility of CGES in both germline and somatic testing, evaluate the use of CGES for screening in healthy individuals, explore the penetrance of pathogenic variants through extensive phenotyping, reduce discordances in public databases of genes and variants, examine social and ethnic disparities in the provision of genomics services, explore regulatory issues, and estimate the value and downstream costs of sequencing. The CSER consortium has established a shared community of research sites by using diverse approaches to pursue the evidence-based development of best practices in genomic medicine.
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Project description:INTRODUCTION:Evaluators use assessment data to make judgments on resident performance within the Accreditation Council for Graduate Medical Education (ACGME) milestones framework. While workplace-based narrative assessments (WBNA) offer advantages to rating scales, validity evidence for their use in assessing the milestone sub-competencies is lacking. This study aimed to determine the frequency of sub-competencies assessed through WBNAs in an emergency medicine (EM) residency program. METHODS:We performed a retrospective analysis of WBNAs of postgraduate year (PGY) 2-4 residents. A shared mental model was established by reading and discussing the milestones framework, and we created a guide for coding WBNAs to the milestone sub-competencies in an iterative process. Once inter-rater reliability was satisfactory, raters coded each WBNA to the 23 EM milestone sub-competencies. RESULTS:We analyzed 2517 WBNAs. An average of 2.04 sub-competencies were assessed per WBNA. The sub-competencies most frequently identified were multitasking, medical knowledge, practice-based performance improvement, patient-centered communication, and team management. The sub-competencies least frequently identified were pharmacotherapy, airway management, anesthesia and acute pain management, goal-directed focused ultrasound, wound management, and vascular access. Overall, the frequency with which WBNAs assessed individual sub-competencies was low, with 14 of the 23 sub-competencies being assessed in less than 5% of WBNAs. CONCLUSION:WBNAs identify few milestone sub-competencies. Faculty assessed similar sub-competencies related to interpersonal and communication skills, practice-based learning and improvement, and medical knowledge, while neglecting sub-competencies related to patient care and procedural skills. These findings can help shape faculty development programs designed to improve assessments of specific workplace behaviors and provide more robust data for the summative assessment of residents.
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Project description:AimTo explore health professionals' intentional behaviour and what determines their intention to use products of research in clinical practice.BackgroundTrying to get research and products of research into clinical practice is an enduring problem. A clearer picture is emerging as to how individual practitioners respond toward practical problems of changing clinical practice, but this does not include health professionals' intentions to use products of research and what influences their intentions.DesignSystematic Review and Narrative Synthesis.Data sourcesFive databases were searched systematically. This included BNI, HMIC, Psych INFO, CINHAL and MEDLINE; articles published in the English language only were included.Review methodsPRISMA guidelines were used as a framework for structuring the review and methods of narrative synthesis to analyse study outcomes.ResultsEighteen studies matched the final inclusion criteria. All studies used questionnaires to measure intention. Most studies involved Nurses or Physicians. Nurses' intentions were mostly influenced by their perceived ability to use guidelines in their practice. Physicians' intentions were often influenced by their perceptions of the usefulness and relevance of the guideline and peer pressure amongst the professional group. Practice habits, when added to intentional models were also predictive of intentional behaviour. In studies that compared intentions with behaviour, the level of intention often did not match self-report or actual behaviour.
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