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Sample size calculations in high-profile surgical trials that use patient-reported outcome measures : systematic review
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Jacklin, Chloe, Rodrigues, Jeremy N., Collins, Joanna, Cook, Jonathan and Harrison, Conrad J. (2022) Sample size calculations in high-profile surgical trials that use patient-reported outcome measures : systematic review. British Journal of Surgery, 109 (2). pp. 178-181. doi:10.1093/bjs/znab421
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WRAP-sample-size-calculations-high-profile-surgical-trials-systematic-review-Rodrigues-2022.pdf - Accepted Version - Requires a PDF viewer. Download (1258Kb) | Preview |
Official URL: http://dx.doi.org/10.1093/bjs/znab421
Abstract
Patient-reported outcome measures (PROMs) are questionnaires that assess aspects of patients’ perceived health. They may be generic, or specific to a condition, disease, or treatment. The use of PROMs has gained credibility and popularity, and this trajectory is set to continue with increasing recognition from governing and advisory bodies.
Determining a meaningful difference between PROM scores is not intuitive because, without context, PROM scores are challenging to interpret. This is relevant to setting target differences for sample size calculations in RCTs. Flawed target differences can lead to type I and type II errors, and/or excessive recruitment which incurs unnecessary cost and risk to participants.
For trials using PROMs as primary outcome measures, the target difference should be the PROM’s minimal important difference (MID). A popular definition of MID is ‘the smallest difference in score in the domain of interest which patients perceived as beneficial and which would mandate, in the absence of troublesome side-effects and excessive cost, a change in the patient’s management’. The MID should not be confused with the minimal detectable change (MDC), which is the smallest change in score that cannot be completely attributed to the instrument’s inherent test–retest error.
Item Type: | Journal Item | |||||||||
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Subjects: | R Medicine > RD Surgery | |||||||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Library of Congress Subject Headings (LCSH): | Surgery, Surgery, Operative, Medical statistics, Clinical trials, Outcome assessment (Medical care) | |||||||||
Journal or Publication Title: | British Journal of Surgery | |||||||||
Publisher: | Oxford University Press | |||||||||
ISSN: | 1365-2168 | |||||||||
Official Date: | February 2022 | |||||||||
Dates: |
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Volume: | 109 | |||||||||
Number: | 2 | |||||||||
Page Range: | pp. 178-181 | |||||||||
DOI: | 10.1093/bjs/znab421 | |||||||||
Status: | Peer Reviewed | |||||||||
Publication Status: | Published | |||||||||
Reuse Statement (publisher, data, author rights): | This is a pre-copyedited, author-produced version of an article accepted for publication in British Journal of Surgery following peer review. The version of record: Jacklin, Chloe, Rodrigues, Jeremy N., Collins, Joanna, Cook, Jonathan and Harrison, Conrad J. (2022) Sample size calculations in high-profile surgical trials that use patient-reported outcome measures : systematic review. British Journal of Surgery, 109 (2). pp. 178-181 is available online at https://academic.oup.com/bjs/article/109/2/178/6463583 | |||||||||
Access rights to Published version: | Restricted or Subscription Access | |||||||||
Copyright Holders: | The Authors | |||||||||
Date of first compliant deposit: | 9 May 2022 | |||||||||
Date of first compliant Open Access: | 16 December 2022 | |||||||||
RIOXX Funder/Project Grant: |
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