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

Chloë Jacklin | Zendy; Jeremy Rodrigues | Zendy; Joanna Collins | Zendy; Jonathan Cook | Zendy; Conrad Harrison | Zendy

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

Author(s) -

Chloë Jacklin,

Jeremy Rodrigues,

Joanna Collins,

Jonathan Cook,

Conrad Harrison

Publication year - 2021

Publication title -

british journal of surgery

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 2.202

H-Index - 201

eISSN - 1365-2168

pISSN - 0007-1323

DOI - 10.1093/bjs/znab421

Subject(s) - medicine , sample size determination , outcome (game theory) , sample (material) , clinical trial , medline , large sample , statistics , chemistry , mathematics , mathematical economics , chromatography , political science , law

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.

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