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

2018779 citationsJournal Articlebronze Open Access

Authors

Melanie Calvert · University of Birmingham

Derek Kyte · University of Birmingham

Rebecca Mercieca‐Bebber · The University of Sydney

Anita Slade · University of Birmingham

An‐Wen Chan · University of Toronto

Madeleine King · The University of Sydney

and the SPIRIT-PRO Group ·

Abstract

The SPIRIT-PRO guidelines provide recommendations for items that should be addressed and included in clinical trial protocols in which PROs are a primary or key secondary outcome. Improved design of clinical trials including PROs could help ensure high-quality data that may inform patient-centered care.

Topics & Keywords

Health Systems, Economic Evaluations, Quality of Life Clinical practice guidelines implementation Meta-analysis and systematic reviews

UN Sustainable Development Goals

Partnerships for the goals

Publication Details

Published in: JAMA

Volume 319, Issue 5, pp. 483-483

DOI: 10.1001/jama.2017.21903

Field-Weighted Citation Impact: 193.38