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September 1, 2021

Replication Studies for Database Research

Author Affiliations
  • 1Department of Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California
JAMA Surg. 2021;156(12):1081-1082. doi:10.1001/jamasurg.2021.4132

Many clinical questions cannot be answered with a randomized trial because of issues surrounding ethics, cost, and practicality. Observational studies can help fill this void; however, the ability to translate findings into clinical practice depends on the quality and rigor of study design and statistical analysis. Over the past several years, JAMA Surgery has focused on this concept by publishing guidelines to improve the quality of research performed using large databases.1 Recently, we proposed the concept of “replication studies.”2 The idea is simple—external researchers reproduce a study’s results and perform novel sensitivity analyses to ascertain how consistent the findings are, the purpose of which is to confirm that the sign and magnitude of the primary coefficient are accurate. Signals that persist are more “robust” and are therefore more likely to have the desired outcome in clinical practice. Journals would these replication studies as a more structured version of a Letter to the Editor or Invited Commentary. In this Viewpoint we provide a template and example of a replication analysis for an article published in JAMA Surgery in 2018 (Table).3 In this study, National Surgical Quality Improvement Project (NSQIP) data were used to assess the association between perioperative blood transfusion and risk of venous thromboembolic events (VTE).

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