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Funders improved the management of learning and clustering effects through design and analysis of randomized trials involving surgery

Research output: Contribution to journalArticle

Original languageEnglish
Pages (from-to)28-35
Number of pages8
JournalJournal of Clinical Epidemiology
Volume113
Early online date20 May 2019
DOIs
DateAccepted/In press - 15 May 2019
DateE-pub ahead of print - 20 May 2019
DatePublished (current) - 1 Sep 2019

Abstract

Objective: The objective of this study was to provide insight into current practice in planning for, and acknowledging, the presence of learning and clustering effects, by treating center and surgeon, when developing randomized surgical trials. Study Design and Setting: Complexities associated with delivering surgical interventions, such as clustering effects, by center or surgeon, and surgical learning should be considered at trial design. Main trial publications, within the wider literature, under-report these considerations. Funded applications, within a 4-year period, from a leading UK funding body were searched. Data were extracted on considerations for learning and clustering effects and the driver, funder, or applicant, behind these. Results: Fifty trials were eligible. Managing learning through establishing predefined center and surgeon credentials was common. One planned exploratory analysis of learning within center, and two within surgeon. Clustering, by site and surgeon, was often managed through stratifying randomization, with 81% and 60%, respectively, also planning to subsequently adjust analysis. One-third of responses to referees contained funder led changes accounting for learning and/or clustering. Conclusion: This review indicates that researchers do consider impact of learning and clustering, by center and surgeon, during trial development. Furthermore, the funder is identified as a potential driver of considerations.

    Research areas

  • Clustering, Learning curve, Randomized controlled trials, Statistics, Surgery, Surgical intervention

    Structured keywords

  • Centre for Surgical Research

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    Rights statement: This is the final published version of the article (version of record). It first appeared online via Elsevier at https://www.sciencedirect.com/science/article/pii/S0895435619300630 . Please refer to any applicable terms of use of the publisher.

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    Licence: CC BY-NC-ND

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