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Review
Alternative clinical trial designs
  1. John A Harvin1,
  2. Ben L Zarzaur2,
  3. Raminder Nirula3,
  4. Benjamin T King4,
  5. Ajai K Malhotra5
  6. the Coalition for National Trauma Research Scientific Advisory Committee
  1. 1Surgery, University of Texas McGovern Medical School, Houston, Texas, USA
  2. 2Surgery, University of Wisconsin Madison School of Medicine and Public Health, Madison, Wisconsin, USA
  3. 3Surgery, University of Utah School of Medicine, Salt Lake City, Utah, USA
  4. 4Neurology, University of Texas at Austin Dell Medical School, Austin, Texas, USA
  5. 5Surgery, University of Vermont Medical Center, Burlington, Vermont, USA
  1. Correspondence to Dr Ajai K Malhotra, Surgery, University of Vermont Medical Center, Burlington, VT 05401, USA; ajai.malhotra{at}uvmhealth.org

Abstract

High-quality clinical trials are needed to advance the care of injured patients. Traditional randomized clinical trials in trauma have challenges in generating new knowledge due to many issues, including logistical difficulties performing individual randomization, unclear pretrial estimates of treatment effect leading to often unpowered studies, and difficulty assessing the generalizability of an intervention given the heterogeneity of both patients and trauma centers. In this review, we discuss alternative clinical trial designs that can address some of these difficulties. These include pragmatic trials, cluster randomization, cluster randomized stepped wedge designs, factorial trials, and adaptive designs. Additionally, we discuss how Bayesian methods of inference may provide more knowledge to trauma and acute care surgeons compared with traditional, frequentist methods.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/tsaco-2019-000420

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    Footnotes

    • Collaborators Members of the Coalition for National Trauma Research Scientific Advisory Committee: Saman Arbabi, MD FACS, Eileen M. Bulger, MD FACS (Department of Surgery, University of Washington); Mitchell J. Cohen, MD FACS (Department of Surgery, University of Colorado); Todd W. Costantini, MD FACS (Department of Surgery, UC San Diego School of Medicine); Marie M. Crandall, MD, MPH FACS (Department of Surgery, University of Florida College of Medicine Jacksonville); Rochelle A. Dicker, MD FACS (Departments of Surgery and Anesthesia, UCLA Geffen School of Medicine); Elliott R. Haut, MD, PhD FACS (Departments of Surgery, Anesthesiology and Critical Care Medicine and Emergency Medicine, The Johns Hopkins University School of Medicine; The Armstrong Institute for Patient Safety and Quality, Johns Hopkins Medicine; Department of Health Policy and Management, The Johns Hopkins Bloomberg School of Public Health); Bellal Joseph, MD FACS (Department of Surgery, University of Arizona); Rosemary A. Kozar, MD, PhD FACS (Department of Surgery, University of Maryland); Ajai K. Malhotra, MD FACS (Department of Surgery, University of Vermont); Avery B. Nathens, MD, PhD, FRCS, FACS (Department of Surgery, University of Toronto); Raminder Nirula, MD, MPH FACS (Department of Surgery, University of Utah); Michelle A. Price, PhD, MEd (National Trauma Institute, UT Health - San Antonio); Jason W. Smith, MD FACS (Department of Surgery, University of Louisville); Deborah M. Stein, MD, MPH FACS FCCM (Department of Surgery, University of California - San Francisco); Ben L. Zarzaur, MD, MPH FACS (Department of Surgery, University of Wisconsin School of Medicine and Public Health).

    • Contributors All authors (JAH, BLZ, RN, BTK, AKM) made substantial contributions to the design, drafting, and critical revisions of the work. All authors also gave final approval of the version submitted.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; internally peer reviewed.