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

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Funders improved the management of learning and clustering effects through design and analysis of randomized trials involving surgery. / Conroy, Elizabeth Jane; Rosala-Hallas, Anna; Blazeby, Jane; Burnside, Girvan ; Cook, Jonathan; Gamble, Carrol.

In: Journal of Clinical Epidemiology, Vol. 113, 01.09.2019, p. 28-35.

Research output: Contribution to journalArticle

Harvard

Conroy, EJ, Rosala-Hallas, A, Blazeby, J, Burnside, G, Cook, J & Gamble, C 2019, 'Funders improved the management of learning and clustering effects through design and analysis of randomized trials involving surgery', Journal of Clinical Epidemiology, vol. 113, pp. 28-35. https://doi.org/10.1016/j.jclinepi.2019.05.007

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Conroy, Elizabeth Jane ; Rosala-Hallas, Anna ; Blazeby, Jane ; Burnside, Girvan ; Cook, Jonathan ; Gamble, Carrol. / Funders improved the management of learning and clustering effects through design and analysis of randomized trials involving surgery. In: Journal of Clinical Epidemiology. 2019 ; Vol. 113. pp. 28-35.

Bibtex

@article{d7bb10bd54514197abc891637b68cdd5,
title = "Funders improved the management of learning and clustering effects through design and analysis of randomized trials involving surgery",
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.",
keywords = "Clustering, Learning curve, Randomized controlled trials, Statistics, Surgery, Surgical intervention",
author = "Conroy, {Elizabeth Jane} and Anna Rosala-Hallas and Jane Blazeby and Girvan Burnside and Jonathan Cook and Carrol Gamble",
year = "2019",
month = "9",
day = "1",
doi = "10.1016/j.jclinepi.2019.05.007",
language = "English",
volume = "113",
pages = "28--35",
journal = "Journal of Clinical Epidemiology",
issn = "0895-4356",
publisher = "Elsevier Inc.",

}

RIS - suitable for import to EndNote

TY - JOUR

T1 - Funders improved the management of learning and clustering effects through design and analysis of randomized trials involving surgery

AU - Conroy, Elizabeth Jane

AU - Rosala-Hallas, Anna

AU - Blazeby, Jane

AU - Burnside, Girvan

AU - Cook, Jonathan

AU - Gamble, Carrol

PY - 2019/9/1

Y1 - 2019/9/1

N2 - 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.

AB - 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.

KW - Clustering

KW - Learning curve

KW - Randomized controlled trials

KW - Statistics

KW - Surgery

KW - Surgical intervention

UR - http://www.scopus.com/inward/record.url?scp=85067263461&partnerID=8YFLogxK

U2 - 10.1016/j.jclinepi.2019.05.007

DO - 10.1016/j.jclinepi.2019.05.007

M3 - Article

VL - 113

SP - 28

EP - 35

JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

SN - 0895-4356

ER -