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The importance of patient-reported outcomes in clinical trials and strategies for future optimization.

作者信息

Mercieca-Bebber Rebecca, King Madeleine T, Calvert Melanie J, Stockler Martin R, Friedlander Michael

机构信息

NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia,

Central Clinical School, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia.

出版信息

Patient Relat Outcome Meas. 2018 Nov 1;9:353-367. doi: 10.2147/PROM.S156279. eCollection 2018.


DOI:10.2147/PROM.S156279
PMID:30464666
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6219423/
Abstract

Patient-reported outcomes (PROs) can be included in clinical trials as primary or secondary endpoints and are increasingly recognized by regulators, clinicians, and patients as valuable tools to collect patient-centered data. PROs provide unique information on the impact of a medical condition and its treatment from the patient's perspective; therefore, PROs can be included in clinical trials to ensure the impact of a trial intervention is comprehensively assessed. This review first discusses examples of how PRO endpoints have added value to clinical trial interpretation. Second, it describes the problems with current practices in designing, implementing, and reporting PRO studies, and how these problems may be addressed by complying with guidance for protocol development, selecting appropriate PRO measures to match clinically motivated PRO hypotheses, minimizing the rates of avoidable missing PRO data, analyzing and interpreting PRO data, and transparently reporting PRO findings.

摘要

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本文引用的文献

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