ArticleBMJ open2021
'Give Us The Tools!': development of knowledge transfer tools to support the involvement of patient partners in the development of clinical trial protocols with patient-reported outcomes (PROs), in accordance with SPIRIT-PRO Extension.
Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed.
- A qualitative study of cancer clinical trial network consumers' acceptability of the modular approach to patient-reported outcome measurement: how much of it is "common sense"?Journal of patient-reported outcomes · 2026Article
- The PRO-CAR-T™ study: achieving excellence in patient and public involvement and engagement.Journal of patient-reported outcomes · 2026Article
- Improving Collaborative Engagement in Health State Valuation: A Scoping Review of Current Practices and Emerging Recommendations.PharmacoEconomics · 2026Review
- The Importance of Patient Reported Outcomes in Oncology Clinical Trials and Clinical Practice to Inform Regulatory and Healthcare Decision-Making.Drugs in R&D · 2024Article
- Recommendations to address respondent burden associated with patient-reported outcome assessment.Nature medicine · 2024Review
- Engagement of patients and the public in personalised prevention in Europe using genomic information: a scoping review.Frontiers in public health · 2024Article
- Article
- Patient-centred clinical trial design.Nature reviews. Nephrology · 2022Review
- Patient-reported outcomes and target effect sizes in pragmatic randomized trials in ClinicalTrials.gov: A cross-sectional analysis.PLoS medicine · 2022Review
- Review
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Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectives(a) To adapt the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-patient-reported outcome (PRO) Extension guidance to a user-friendly format for patient partners and (b) to codesign a web-based tool to support the dissemination and uptake of the SPIRIT-PRO Extension by patient partners.
designA 1-day patient and public involvement session.
participantsSeven patient partners.
methodsA patient partner produced an initial lay summary of the SPIRIT-PRO guideline and a glossary. We held a 1-day PPI session in November 2019 at the University of Birmingham. Five patient partners discussed the draft lay summary, agreed on the final wording, codesigned and agreed the final content for both tools. Two additional patient partners were involved in writing the manuscript. The study compiled with INVOLVE guidelines and was reported according to the Guidance for Reporting Involvement of Patients and the Public 2 checklist.
resultsTwo user-friendly tools were developed to help patients and members of the public be involved in the codesign of clinical trials collecting PROs. The first tool presents a lay version of the SPIRIT-PRO Extension guidance. The second depicts the most relevant points, identified by the patient partners, of the guidance through an interactive flow diagram.
conclusionsThese tools have the potential to support the involvement of patient partners in making informed contributions to the development of PRO aspects of clinical trial protocols, in accordance with the SPIRIT-PRO Extension guidelines. The involvement of patient partners ensured the tools focused on issues most relevant to them.
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