Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Jun 30;11(6):e046450.
doi: 10.1136/bmjopen-2020-046450.

'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

Samantha Cruz Rivera  1 , Richard Stephens  2 , Rebecca Mercieca-Bebber  3 , Ameeta Retzer  1 , Claudia Rutherford  4 , Gary Price  1 , Anita Slade  1 , Olalekan Lee Aiyegbusi  1 , Philip Edge  5 , Lesley Roberts  1   5 , Lesley Gosden  5 , Rav Verdi  5 , Roger Wilson  6 , Melanie Calvert  7
Affiliations

'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

Samantha Cruz Rivera et al. BMJ Open. .

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.

Design: A 1-day patient and public involvement session.

Participants: Seven patient partners.

Methods: A 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.

Results: Two 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.

Conclusions: These 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.

Keywords: protocols & guidelines; qualitative research; quality in health care.

PubMed Disclaimer

Conflict of interest statement

Competing interests: MC and AS receive funding from the National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, the NIHR Surgical Reconstruction and Microbiology Research Centre and NIHR ARC West Midlands at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Health Data Research UK, Innovate UK (part of UK Research and Innovation), Macmillan Cancer Support, UCB Pharma. The views expressed in this article are those of the author(s) and not necessarily those of the NIHR, or the Department of Health and Social Care. MC has received personal fees from Astellas, Takeda, Merck, Daiichi Sankyo, Glaukos, GlaxoSmithKline and the Patient-Centered Outcomes Research Institute (PCORI) outside the submitted work. RM-B is supported by the Australian Government by a National Health and Medical Research. OLA declares personal fees from Gilead Sciences Ltd and GlaxoSmithKline outside the submitted work.

Figures

Figure 1
Figure 1
User-friendly SPIRIT-PRO Extension and glossary methods. PPI, patient and public involvement; PRO, patient-reported outcome; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials.
Figure 2
Figure 2
Web-tool for patient advocates involved in coproduction of PRO research or review. PRO, patient-reported outcome.
See this image and copyright information in PMC

References

    1. FDA . Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims., 2009. Available: http://wwwfdagov/downloads/Drugs/GuidanceComplianceRegulatoryInformation... - PMC - PubMed
    1. Wilson IB, Cleary P. Linking clinical variables with health-related quality of life. JAMA 1995;273:59. 10.1001/jama.1995.03520250075037 - DOI - PubMed
    1. UK Clinical Research Collaboration . Understanding clinical trials 2006. Available: https://www.ukcrc.org/wp-content/uploads/2014/03/iCT_Booklet.pdf
    1. Ahmed K, Kyte D, Keeley T, et al. . Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPIC study protocol. BMJ Open 2016;6:e012863. 10.1136/bmjopen-2016-012863 - DOI - PMC - PubMed
    1. Retzer A, Keeley T, Ahmed K, et al. . Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPIC study qualitative protocol. BMJ Open 2018;8:e017282. 10.1136/bmjopen-2017-017282 - DOI - PMC - PubMed

Publication types

LinkOut - more resources