SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials

Volume: 11, Issue: 6, Pages: e045105 - e045105
Published: Jun 1, 2021
Abstract
Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients' symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this...
Paper Details
Title
SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials
DOI
Published Date
Jun 1, 2021
Journal
Volume
11
Issue
6
Pages
e045105 - e045105
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