101. Quality and Publication of Emergency Medicine Trials Registered in ClinicalTrials.gov
- Author
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Lisa Calvocoressi, James Dziura, Benjamin Johnson, Meghan M Warzoha, Federico E. Vaca, Lori A. Post, Jesse Reynolds, and Megan K. Carroll
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medicine.medical_specialty ,Blinding ,Randomization ,Industry funding ,MEDLINE ,lcsh:Medicine ,Subspecialty ,medicine ,Humans ,Original Research ,Clinical Trials as Topic ,Descriptive statistics ,business.industry ,Publications ,lcsh:R ,lcsh:Medical emergencies. Critical care. Intensive care. First aid ,General Medicine ,lcsh:RC86-88.9 ,United States ,Clinical trial ,National Institutes of Health (U.S.) ,Sample size determination ,Research Design ,Emergency medicine ,Emergency Medicine ,business - Abstract
Introduction Promoting emergency medicine (EM) clinical trials research remains a priority. To characterize the status of clinical EM research, this study assessed trial quality, funding source, and publication of EM clinical trials and compared EM and non-EM trials on these key metrics. We also examined the volume of EM trials and their subspecialty areas. Methods We abstracted data from ClinicalTrials.gov (February 2000 - September 2013) and used individual study National Clinical Trial numbers to identify published trials (January 2007 - September 2016). We used descriptive statistics and chi-square tests to examine study characteristics by EM and non-EM status, and Kaplan-Meier curves and log-rank tests to compare time to publication of completed EM and non-EM studies. Results We found 638 interventional EM trials and 59,512 non-EM interventional trials conducted in the United States between February 2000 and September 2013, registered on ClinicalTrials.gov. EM studies were significantly less likely than non-EM studies to be National Institutes of Health-funded or to evaluate a drug or biologic. However, EM studies had significantly larger sample sizes, and were significantly more likely to use randomization and blinding. Overall, 34.3% of EM and 26.0% of non-EM studies were published in peer-reviewed journals. By subspecialty, more EM trials concerned medical/surgical and psychiatric/neurological conditions than trauma. Conclusion Although EM studies were less likely to have received federal or industry funding, and the EM portfolio consisted of only 638 trials over the 14-year study period, the quality of EM trials surpassed that of non-EM trials, based on indices such as randomization and blinding. This novel finding bodes well for the future of clinical EM research, as does the higher proportion of published EM than non-EM trials. Our study also revealed that trauma studies were under-represented among EM studies. Periodic assessment of EM trials with the metrics used here could provide an informative and valuable longitudinal view of progress in clinical EM research.
- Published
- 2020