Sample size calculations in high-profile surgical trials that use patient-reported outcome measures: systematic review

Chloe Jacklin; Jeremy N Rodrigues; Joanna Collins; Jonathan Cook; Conrad J Harrison

doi:10.1093/bjs/znab421

Sample size calculations in high-profile surgical trials that use patient-reported outcome measures: systematic review

Br J Surg. 2022 Feb 1;109(2):178-181. doi: 10.1093/bjs/znab421.

Authors

Chloe Jacklin¹, Jeremy N Rodrigues^{2

3}, Joanna Collins¹, Jonathan Cook¹, Conrad J Harrison¹

Affiliations

¹ Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
² Department of Plastic Surgery, Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust, Aylesbury, UK.
³ Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.

PMID: 34915565
DOI: 10.1093/bjs/znab421

Abstract

Sample size calculations from high-profile surgical RCTs that used a patient-reported outcome measure as primary outcome were reviewed systematically against Difference ELicitation in TriAls (DELTA2) standards, with a focus on target differences. In this sample of trials, there was frequent use of suboptimal methods to determine the target difference, and sample size calculations were generally not reported to DELTA2 standards. This risks over-recruitment and/or erroneous trial conclusions, which clinicians should be aware of when interpreting published trials.

Publication types

Research Support, Non-U.S. Gov't
Systematic Review

MeSH terms

Equivalence Trials as Topic
Humans
Patient Reported Outcome Measures*
Randomized Controlled Trials as Topic / economics
Randomized Controlled Trials as Topic / methods*
Randomized Controlled Trials as Topic / standards*
Randomized Controlled Trials as Topic / statistics & numerical data
Research Support as Topic
Sample Size*
Surgical Procedures, Operative*