‘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
Ameeta Retzer,
Anita Slade,
Melanie Calvert,
Rebecca Mercieca-Bebber,
Gary Price,
Lesley Roberts,
Claudia Rutherford,
Olalekan Lee Aiyegbusi,
Samantha Cruz Rivera,
Richard Stephens,
Rav Verdi,
Roger Wilson,
Philip Edge,
Lesley Gosden
Affiliations
Ameeta Retzer
National Institute for Health and Care Research (NIHR) Applied Research Centre, West Midlands, Birmingham, UK
Anita Slade
Institute of Applied Health Research, Centre for Patient Reported Outcomes Research, University of Birmingham, Birmingham, UK
Melanie Calvert
Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
Rebecca Mercieca-Bebber
NHMRC Clinical Trials Centre, Camperdown, New South Wales, Australia
Gary Price
Patient Advisory Group, Centre for Patient-Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK
Lesley Roberts
Centre for Patient Reported Outcomes, University of Birmingham, Birmingham, UK
Claudia Rutherford
Sydney Quality of Life Office (SQOLO), The University of Sydney Susan Wakil School of Nursing and Midwifery, Sydney, New South Wales, Australia
Olalekan Lee Aiyegbusi
Institute of Applied Health Research, University of Birmingham, Birmingham, UK
Samantha Cruz Rivera
Centre for Patient Reported Outcomes Research (CPROR), University of Birmingham, Birmingham, UK
Richard Stephens
National Cancer Research Institute Consumer Forum, London, UK
Rav Verdi
Patient Partner, Institute of Applied Health Research,Centre for Patient-Reported Outcomes Research (CPROR), University of Birmingham, Birmingham, UK
Roger Wilson
NCRI Consumer Forum, London, UK
Philip Edge
Centre for Patient Reported Outcomes, University of Birmingham, Birmingham, UK
Lesley Gosden
Centre for Patient Reported Outcomes, University of Birmingham, Birmingham, UK
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.
