Abstract
Introduction Patient-reported outcomes (PROs) are increasingly used in clinical trials to assess the impact of disease and treatment on patient symptoms and quality of life. Involving patients in the co-design of trials can help ensure the trial captures PROs that matter to patients and reduce missing data during trial conduct. The SPIRIT-PRO Extension provides international guidelines on what PRO information should be included in clinical trial protocols. However, there is lack of training materials and tools to support patient partners involved in the co-design of PRO clinical trials. Therefore, the aim of this research was to: a) to adapt the SPIRIT-PRO Extension guidance to a user-friendly format for patient partners; and b) co-design a web-based tool to support the dissemination and uptake of the SPIRIT-PRO Extension by patient partners.
Methods A patient partner produced an initial lay summary of the SPIRIT-PRO guideline and drafted a glossary. We held a one-day patient and public involvement session in November 2019 at the University of Birmingham. Five patient partners discussed the draft lay summary, agreed on the final wording, and co-designed vocabulary and agreed the final content for both tools. Two additional patient partners were involved in writing the manuscript. The study was compileddeveloped withusing INVOLVE guidelines and was reported according to the GRIPP 2 checklist.
Results Two user-friendly tools were developed to help patients and members of the public be involved in the co-design 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.
Strengths and limitations
• Two user-friendly tools were co-developed with PPI partners for the use of patient partners involved in the co-design of clinical trials collecting PROs.
• The research was reported according to GRIPP 2 checklist and adhered to INVOLVE recommendations.
• The user-friendly tools were not tested among a wider patient partner group.
• In addition, the PPI partners included in the co-development of the tools were mainly oncology patients.
Methods A patient partner produced an initial lay summary of the SPIRIT-PRO guideline and drafted a glossary. We held a one-day patient and public involvement session in November 2019 at the University of Birmingham. Five patient partners discussed the draft lay summary, agreed on the final wording, and co-designed vocabulary and agreed the final content for both tools. Two additional patient partners were involved in writing the manuscript. The study was compileddeveloped withusing INVOLVE guidelines and was reported according to the GRIPP 2 checklist.
Results Two user-friendly tools were developed to help patients and members of the public be involved in the co-design 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.
Strengths and limitations
• Two user-friendly tools were co-developed with PPI partners for the use of patient partners involved in the co-design of clinical trials collecting PROs.
• The research was reported according to GRIPP 2 checklist and adhered to INVOLVE recommendations.
• The user-friendly tools were not tested among a wider patient partner group.
• In addition, the PPI partners included in the co-development of the tools were mainly oncology patients.
Original language | English |
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Article number | e046450 |
Journal | BMJ open |
Volume | 11 |
Issue number | 6 |
DOIs | |
Publication status | Published - 30 Jun 2021 |
Keywords
- protocols & guidelines
- qualitative research
- quality in health care
ASJC Scopus subject areas
- Medicine(all)