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Age, sex, race and ethnicity representativeness of randomised controlled trials in peri?operative medicine

Lindsay, W. A.; Murphy, M. M.; Almghairbi, D. S.; Moppett, I. K.

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Authors

W. A. Lindsay

M. M. Murphy

D. S. Almghairbi

IAIN MOPPETT iain.moppett@nottingham.ac.uk
Professor of Anaesthesia and Perioperative Medicine



Abstract

The applicability of the results of any clinical trial will depend to a large extent on whether the study population is representative of the population seen in clinical practice. The growing older surgical population presents challenges for peri-operative researchers to ensure there is adequate representation of patients in terms of their age, sex, race and ethnicity in clinical trials. A review of purposively sampled published randomised controlled trials was performed to establish the age, sex, race and ethnicity of study participants. These data were compared to national registry data for the relevant surgical populations. We included 224 peri-operative trials that had been cited in 469 retrieved meta-analyses. Of these, 50 (22.3%) had an upper age limit to recruitment. The median (range [IQR]) difference in study population age from the registry population age was -2.4 (-6.2 to 1.0 [-34.7 to 14.5]) years for all the randomised controlled trials identified, -6.2 (-9.4 to -2.8 [-18.6 to 4.6]) years for randomised controlled trials investigating patients undergoing hip arthroplasty and - 3.4 (-9.6 to -1.1 [-34.7 to 2.9]) years for trials involving patients undergoing surgery for fractured neck of femur. In 92 (41.1%) randomised controlled trials, the proportion of each sex in the study population was more than 25% different from the proportion in the registry population. Only 5 (2.2%) published data on the race or ethnicity of participants. We conclude that peri-operative randomised controlled trials are unlikely to be representative of the age and sex of clinically treated surgical populations. Researchers must endeavour to ensure representative study populations are recruited to future clinical trials.

Citation

Lindsay, W. A., Murphy, M. M., Almghairbi, D. S., & Moppett, I. K. (2020). Age, sex, race and ethnicity representativeness of randomised controlled trials in peri?operative medicine. Anaesthesia, 75(6), 809-815. https://doi.org/10.1111/anae.14967

Journal Article Type Article
Acceptance Date Dec 2, 2019
Online Publication Date Feb 5, 2020
Publication Date 2020-06
Deposit Date Jan 21, 2020
Publicly Available Date Mar 28, 2024
Journal Anaesthesia
Print ISSN 0003-2409
Electronic ISSN 1365-2044
Publisher Wiley
Peer Reviewed Peer Reviewed
Volume 75
Issue 6
Pages 809-815
DOI https://doi.org/10.1111/anae.14967
Keywords Anesthesiology and Pain Medicine
Public URL https://nottingham-repository.worktribe.com/output/3777449
Publisher URL https://onlinelibrary.wiley.com/doi/full/10.1111/anae.14967
Additional Information Accepted: 2019-12-02; Published: 2020-02-05

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