Quality and Publication of Emergency Medicine Trials Registered in ClinicalTrials.gov

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..

Medienart:	E-Artikel

Erscheinungsjahr:	2020
Erschienen:	2020

Enthalten in:	Zur Gesamtaufnahme - volume:21
Enthalten in:	Western Journal of Emergency Medicine - 21(2020), 2

Sprache:	Englisch

Beteiligte Personen:	Lisa Calvocoressi [VerfasserIn] Jesse Reynolds [VerfasserIn] Benjamin Johnson [VerfasserIn] Meghan M. Warzoha [VerfasserIn] Megan Carroll [VerfasserIn] Federico E. Vaca [VerfasserIn] Lori Post [VerfasserIn] James Dziura [VerfasserIn]

Links:	doi.org [kostenfrei] doaj.org [kostenfrei] escholarship.org [kostenfrei] Journal toc [kostenfrei]

Themen:	Medical emergencies. Critical care. Intensive care. First aid Medicine R

doi:	10.5811/westjem.2019.12.44096

funding:
Förderinstitution / Projekttitel:

PPN (Katalog-ID):	DOAJ036235350