Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols

作者：Melanie Calvert, Derek Kyte, Rebecca Mercieca‐Bebber, Anita Slade, An‐Wen Chan, Madeleine King, and the SPIRIT-PRO Group, Amanda Hunn, Andrew Bottomley, Antoine Regnault, An‐Wen Chan, Carolyn Ells, Daniel O’Connor, Dennis A. Revicki, Donald L. Patrick, Doug Altman, Ethan Basch, Galina Velikova, Gary Price, Heather Draper, Jane Blazeby, Jane Scott, Joanna Coast, Josephine M. Norquist, Julia Brown, Kirstie Haywood, Laura Lee Johnson, Lisa Campbell, Lori Frank, Maria Hildebrand, Michael Brundage, Michael Palmer, Paul G. Kluetz, Richard Stephens, Robert Golub, Sandra A. Mitchell, Trish Groves · 发表于：JAMA · 年份：2018 · DOI：10.1001/jama.2017.21903 · 被引用次数：822 · 研究领域：Cancer survivorship and care、Delphi Technique in Research、Health Systems, Economic Evaluations, Quality of Life

Importance: Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance. Objective: To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension). Design, Setting, and Participants: The SPIRIT-PRO Extension was developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network's methodological framework for guideline development. This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (di...