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. 2017 Aug;60(4):280-287.
doi: 10.1503/cjs.002217.

Users' guide to the surgical literature: how to assess an article using surrogate end points

Lucas Gallo  1 , Cagla Eskicioglu  1 , Luis H Braga  1 , Forough Farrokhyar  1 , Achilleas Thoma  1
Affiliations

Users' guide to the surgical literature: how to assess an article using surrogate end points

Lucas Gallo et al. Can J Surg. 2017 Aug.

Abstract

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.

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Conflict of interest statement

Competing interests: None declared.

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References

    1. Fleming TR, DeMets D. Surrogate end points in clinical trials: Are we being misled? Ann Intern Med. 1996;125:605. - PubMed
    1. Guyatt G, Rennie D, Meade M, et al. Users’ guides to the medical literature: a manual for evidence-based clinical practice. 3rd ed. McGraw-Hill; 2015.
    1. Yudkin JS, Lipska K, Montori V. The idolatry of the surrogate. BMJ. 2011;343:d7995. - PubMed
    1. Prentice RL. Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med. 1989;8:431–40. - PubMed
    1. Boissel JP, Collet J, Moleur P, et al. Surrogate endpoints: a basis for a rational approach. Eur J Clin Pharmacol. 1992;43:235–44. - PubMed

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