Article Abstract

Barriers to conducting a multi-center randomized controlled trial of surgical stabilization of rib fractures (and how to overcome them)

Authors: Fredric M. Pieracci, Kiara Leasia, SarahAnn Whitbeck

Abstract

Surgical stabilization of rib fractures (SSRF) has become a standardized procedure, routinely performed at trauma centers over the last 40 years, however, it remains a controversial practice. Multicenter, randomized controlled trials (RCT) would provide compelling evidence in the efficacy of SSRF but there are theoretical obstacles involved with execution and design of this type of investigation. Through the systematic review of current literature on the topics of SSRF for flail and non-fail patterns, medical device industry conflicts of interests, working with international review boards (IRB), the surveyed opinions of surgeons, and through the experience gained from conducting a multicenter RCT on SSRF, it was possible to identify the major barriers that come with successful implementation of this type of study. In identifying these obstacles, it was then possible to propose their solutions, specifically to the issues that make the effort underpowered, underfunded, understaffed, with not enough time for completion. These barriers can be overcome with understanding, up front, that a mutlicenter RCT of SSRF will involve a multi-year and multi-hundred thousand dollar commitment, with support from parent organizations, and a dedicated, full-time research staff (and the solutions of how to overcome them). These barriers stem from poor planning which result specifically in an effort that is underpowered, under funded, under staffed, with not enough time for completion.

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