Can J Surg 2017;60(4):280-287 | PDF
Lucas Gallo, BHSc, MD (candidate); Cagla Eskicioglu, MD; Luis H. Braga, MD,PhD; Forough Farrokhyar, PhD; Achilleas Thoma, MD, MSc
Phase 3 randomized controlled trials are the widely accepted gold standard through which treatment decisions are made, as they assess the efficacy of a novel treatment against the control on the relevant patient population. The effectiveness of the novel treatment should be derived by measuring patient-important outcomes; however, to accurately assess these outcomes, clinical trials often require extensive patient follow-up and large sample sizes that can incur substantial expense. For this reason, investigators substitute surrogate end points to reduce the sample size and duration of a trial, ultimately reducing cost. The purpose of this article is to help surgeons appraise the surgical literature that use surrogate end points for patient-important outcomes.
Accepted Mar. 14, 2017
Affiliations: From the Division of General Surgery, McMaster University, Hamilton, Ont. (Eskicioglu); the Division of Urology, McMaster University, Hamilton, Ont. (Braga); the Division of Plastic Surgery, McMaster University, Hamilton, Ont. (Thoma); the Department of Surgery, McMaster University, Hamilton, Ont. (Eskicioglu, Braga, Farrokhyar, Thoma); the Faculty of Health Sciences, McMaster University, Hamilton, Ont. (Gallo); and the Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ont. (Farrokhyar, Thoma).
Competing interests: None declared.
Contributors: All authors designed the study. L. Gallo acquired and analyzed the data, which L. Braga and A. Thoma also analyzed. L. Gallo and A. Thoma wrote the article, which all authors reviewed and approved for publication.
Correspondence to: A. Thoma, Department of Surgery, McMaster University, 206 James St. South, Suite 101, Hamilton ON L8P 3A9; email@example.com