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Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension

Reporting guideline provided for?
(i.e. exactly what the authors state in the paper)
Reporting in clinical trial protocols in which patient-reported outcomes (PROs) are a primary or key secondary outcome.
Full bibliographic reference Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan A-W, King MT; and the SPIRIT-PRO Group. Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension. JAMA. 2018;319(5):483-494.
Language English
PubMed ID 29411037
Relevant URLs
(full-text if available)
The the full-text of this reporting guideline is available at: https://jamanetwork.com/journals/jama/article-abstract/2671472
Relevant more generic / specialised reporting guidelines
(i.e. main generic guideline or extension to a generic guideline)
Generic
SPIRIT 2013: Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin J, Doré C, Parulekar W, Summerskill W, Groves T, Schulz K, Sox H, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: Defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200-207. PMID: 23295957

 
Reporting guideline acronym SPIRIT-PRO
Study design Study protocols
Applies to the whole report or to individual sections of the report? Outcomes (variables)
Record last updated on October 30, 2018

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