Skip to content Skip to navigation
University of Warwick
  • Study
  • |
  • Research
  • |
  • Business
  • |
  • Alumni
  • |
  • News
  • |
  • About

University of Warwick
Publications service & WRAP

Highlight your research

  • WRAP
    • Home
    • Search WRAP
    • Browse by Warwick Author
    • Browse WRAP by Year
    • Browse WRAP by Subject
    • Browse WRAP by Department
    • Browse WRAP by Funder
    • Browse Theses by Department
  • Publications Service
    • Home
    • Search Publications Service
    • Browse by Warwick Author
    • Browse Publications service by Year
    • Browse Publications service by Subject
    • Browse Publications service by Department
    • Browse Publications service by Funder
  • Help & Advice
University of Warwick

The Library

  • Login
  • Admin

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

Tools
- Tools
+ Tools

Calvert, Melanie, King, Madeleine, Mercieca-Bebber, Rebecca, Aiyegbusi, Olalekan, Kyte, Derek, Slade, Anita, Chan, An-Wen, Basch, E, Bell, Jill, Bennett, Antonia et al.
(2021) SPIRIT-PRO Extension explanation and elaboration : guidelines for inclusion of patient-reported outcomes in protocols of clinical trials. BMJ Open, 11 (6). e045105. doi:10.1136/bmjopen-2020-045105 ISSN 2044-6055.

[img]
Preview
PDF
WRAP-SPIRIT-PRO-extension-explanation-elaboration-Haywood-2021.pdf - Published Version - Requires a PDF viewer.
Available under License Creative Commons: Attribution-Noncommercial 4.0.

Download (2157Kb) | Preview
Official URL: http://dx.doi.org/10.1136/bmjopen-2020-045105

Request Changes to record.

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 issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item’s importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs.

Item Type: Journal Article
Subjects: R Medicine > R Medicine (General)
Divisions: Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences
Faculty of Science, Engineering and Medicine > Science > Physics
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Clinical trials, Outcome assessment (Medical care) -- Methodology, Patient satisfaction, Medicine -- Research -- Evaluation
Journal or Publication Title: BMJ Open
Publisher: BMJ
ISSN: 2044-6055
Official Date: 30 June 2021
Dates:
DateEvent
30 June 2021Published
30 June 2021Available
8 January 2021Accepted
Volume: 11
Number: 6
Article Number: e045105
DOI: 10.1136/bmjopen-2020-045105
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access (Creative Commons)
Date of first compliant deposit: 5 July 2021
Date of first compliant Open Access: 7 July 2021
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
5592105Macmillan Cancer Supporthttp://dx.doi.org/10.13039/100011715
UNSPECIFIEDUCB Pharmahttp://viaf.org/viaf/155958740
UNSPECIFIEDUniversity Of Birminghamhttp://dx.doi.org/10.13039/501100000855
UNSPECIFIEDNational Institute for Health Research (NIHR) Birmingham Biomedical Research CentreUNSPECIFIED
UNSPECIFIEDNational Institute for Health Research Surgical Reconstruction and MicrobiologyUNSPECIFIED
UNSPECIFIEDNational Institute for Health Research. Applied Research Collaboration (ARC) West MidlandsUNSPECIFIED
UNSPECIFIEDInnovate UKhttp://dx.doi.org/10.13039/501100006041
UNSPECIFIEDHealth Data Research UKUNSPECIFIED
UNSPECIFIEDCancer Australiahttp://dx.doi.org/10.13039/501100001111
UNSPECIFIEDNational Health and Medical Research Councilhttp://dx.doi.org/10.13039/501100000925
Is Part Of: 1

Request changes or add full text files to a record

Repository staff actions (login required)

View Item View Item

Downloads

Downloads per month over past year

View more statistics

twitter

Email us: wrap@warwick.ac.uk
Contact Details
About Us