Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension
Open accessAbstract
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 (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017). Prior to voting, consensus meeting participants were informed of the results of the Delphi exercise and given data from structured reviews evaluating the PRO protocol content of 3 defined samples of trial protocols. Results: The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce (n = 21) reduced this to 56 items, which were considered by 138 international stakeholder survey participants and 99 Delphi panelists. The final wording of the SPIRIT-PRO Extension was agreed on at a consensus meeting (n = 29 participants) and reviewed by external group of experts during a consultation period. Eleven extensions and 5 elaborations to the SPIRIT 2013 checklist were recommended for inclusion in clinical trial protocols in which PROs are a primary or key secondary outcome. Extension items focused on PRO-specific issues relating to the trial rationale, objectives, eligibility criteria, concepts used to evaluate the intervention, time points for assessment, PRO instrument selection and measurement properties, data collection plan, translation to other languages, proxy completion, strategies to minimize missing data, and whether PRO data will be monitored during the study to inform clinical care. Conclusions and Relevance: 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.
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The investigation will be conducted in accordance with SPIRIT 2013 and CONSORT 2010 statements.
“The investigation will be conducted at La Paz University Hospital (Madrid, Spain) in accordance with SPIRIT 2013 [25, 26] and CONSORT 2010 [27] statements.”
From Mindfulness-based social cognition training (SocialMIND) versus psychoeducational multicomponent intervention for people with a first episode of psychosis: A study protocol for a randomised controlled trial (2019) · cites this paper as [26]
The paper’s Discussion describes SPIRIT-PRO as guidance to be used alongside SPIRIT 2013, so it is relevant to the cited protocol-guidance claim. But it is an extension concerning patient-reported outcomes, not the SPIRIT 2013 statement itself; the paper lists that statement as a separate work in its References. CONSORT 2010 is attributed to a different citation in the citing sentence. (LLM, conf=0.86)
Experimental — accuracy not yet measuredThe SPIRIT 2013 statement provides minimum reporting guidance for clinical trial protocols and has been widely endorsed as an international standard.
“The SPIRIT statement was published in 2013 to provide guidance for the minimum reporting content of a clinical-trial protocol and has been widely endorsed as an international standard3–5.”
From Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension (2020) · cites this paper as [4]
The Abstract says SPIRIT was published in 2013 and provides an evidence-based list of items recommended for inclusion in clinical trial protocols, supporting the date and guidance portion of the claim. Our copy does not say that SPIRIT 2013 has been widely endorsed as an international standard. The Discussion’s reference to “minimum requirements” concerns the SPIRIT-PRO extension, not an endorsement of SPIRIT 2013. (LLM, conf=0.84)
Experimental — accuracy not yet measuredThe study protocol was designed following the SPIRIT guidelines and the SPIRIT-PRO Extension.
“The study protocol was designed following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines (S1 Appendix) [55], and The SPIRIT-PRO Extension [56].”
The study will adhere to the SPIRIT guidelines extension to PROM.
“considering this, our study will adhere to the SPIRIT guidelines extension to PROM [26].”
The SPIRIT-AI extension provides international consensus-based guidance on AI-specific information that should be reported in clinical trial protocols, alongside SPIRIT 2013 and other relevant SPIRIT extensions.
“The SPIRIT-AI extension provides international consensus-based guidance on AI-specific information that should be reported in clinical trial protocols, alongside SPIRIT 2013 and other relevant SPIRIT extensions4,46.”
From Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension (2020) · cites this paper as [4]
Striking the best balance between respect for autonomy and beneficence or non-maleficence has been recognised as one of the greatest challenges of emergency research conduct.
“Striking the best balance between respect for autonomy (i.e. the right to selfdetermination) and beneficence (i.e. improving patient outcomes) or even non-maleficence (i.e. avoiding patient exposure to unproven treatments) has been recognised as one of the greatest challenges of emergency research conduct. 63,195,317,319”
From European Resuscitation Council Guidelines 2021: Ethics of resuscitation and end of life decisions (2021) · cites this paper as [319]
The Ethical Review of Study section describes consent for this paper’s surveys and consensus meeting, while the Additional information section lists general trial-protocol consent requirements; neither discusses the ethical balance in emergency research. Searches for autonomy, beneficence, non-maleficence, and emergency research found no passage addressing the claim. Page numbers were not provided. (LLM, conf=0.75)
Experimental — accuracy not yet measuredThe SPIRIT 2025 update identified relevant SPIRIT or CONSORT extensions and related guidelines.
“identified relevant SPIRIT or CONSORT extensions and related guidelines (eg,21 22 23 24)”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [23]
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- Authors
- Calvert, M., Kyte, D., Mercieca-Bebber, R., Slade, A., Chan, A.-W., King, M. T., and the SPIRIT-PRO Group, Hunn, A., Bottomley, A., Regnault, A., Chan, A.-W., Ells, C., O’Connor, D., Revicki, D., Patrick, D., Altman, D., Basch, E., Velikova, G., Price, G., Draper, H., Blazeby, J., Scott, J., Coast, J., Norquist, J., Brown, J., Haywood, K., Johnson, L. L., Campbell, L., Frank, L., von Hildebrand, M., Brundage, M., Palmer, M., Kluetz, P., Stephens, R., Golub, R. M., Mitchell, S., & Groves, T.
- Affiliations
- University of Birmingham (GB)
- Sydney Medical School, Faculty of Medicine and School of Psychology, Faculty of Science, University of Sydney, Sydney, Australia
- The University of Sydney (AU)
- Health Research Authority (GB)
- European Organisation for Research and Treatment of Cancer (BE)
- University of Toronto (CA)
- Medicines and Healthcare products Regulatory Agency (GB)
- University of Washington (US)
- University of North Carolina at Chapel Hill (US)
- University of Leeds (GB)
- University of Warwick (GB)
- University of Bristol (GB)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- United States Food and Drug Administration (US)
- Patient-Centered Outcomes Research Institute (US)
- Patient Partner, Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, England
- Queen's University (CA)
- National Cancer Research Institute (GB)
- National Institutes of Health (US)
- British Medical Journal, London, England
- Corresponding author
- Calvert, Melanie
- ORCID
- Calvert, Melanie
- Kyte, Derek
- Slade, Anita
- King, Madeleine T.
- Hunn, Amanda
- Bottomley, Andrew
- Regnault, Antoine
- Ells, Carolyn
- O’Connor, Daniel
- Revicki, Dennis
- Patrick, Donald
- Basch, Ethan
- Velikova, Galina
- Draper, Heather
- Blazeby, Jane
- Scott, Jane
- Coast, Joanna
- Norquist, Josephine
- Brown, Julia
- Haywood, Kirstie
- Johnson, Laura Lee
- Campbell, Lisa
- Frank, Lori
- Brundage, Michael
- Palmer, Michael
- Kluetz, Paul
- Mitchell, Sandra
- Groves, Trish
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2018-02-06
- Volume
- 319
- Issue
- 5
- Pages
- 483
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2782908833
- Cited by
- 814
- References
- 37
- Citations by year
- 2026: 80 · 2025: 99 · 2024: 107 · 2023: 104 · 2022: 112 · 2021: 105 · 2020: 97 · 2019: 75 · 2018: 34
- FWCI
- 176.89
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion, cc-by-nc-nd)
- Warwick Research Archive Portal (University of Warwick) (acceptedVersion)
- Bristol Research (University of Bristol) (acceptedVersion, other-oa)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion, other-oa)
- University of Warwick (cc-by)
- Funders
- Cancer Research Institute
- Patient-Centered Outcomes Research Institute
- University of Washington
- National Cancer Research Institute
- Macmillan Cancer Support
- Cancer Research UK (16895)
- National Institute for Health and Care Research (NF-SI-0514-10114, PDF-2016-09-009, SPCR-017)
- University of Warwick
- University of Oxford
- University of Leeds
- University of Bristol
- Queen's University
- University of Toronto
- Surgical Reconstruction and Microbiology Research Centre
- Canadian Institutes of Health Research
- Natural Sciences and Engineering Research Council of Canada
- Social Sciences and Humanities Research Council of Canada
- Birmingham Biomedical Research Centre
- National Cancer Institute
- Topics
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- patient-reported outcomes, patient involvement, shared decision-making, quality of life, reporting guidelines, EQUATOR Network, Delphi consensus, stakeholder survey, health policy evidence, patient advocacy
- MeSH terms
- Patient Reported Outcome Measures, Clinical Protocols, Clinical Trials as Topic, Decision Making, Humans, Guidelines as Topic
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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