“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

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“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. / Cruz Rivera, Samantha; Stephens, Richard; Mercieca-Bebber, Rebecca; Retzer, Ameeta; Rutherford, Claudia ; Price, Gary; Slade, Anita; Aiyegbusi, Olalekan Lee; Edge, Philip ; Gosden, Lesley ; Roberts, Lesley; Verdi, Rav ; Wilson, Roger ; Calvert, Melanie.

In: BMJ open, 08.01.2021.

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@article{486b2c5924964d16b5126fb83ca879ae,
title = "“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",
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. ",
author = "{Cruz Rivera}, Samantha and Richard Stephens and Rebecca Mercieca-Bebber and Ameeta Retzer and Claudia Rutherford and Gary Price and Anita Slade and Aiyegbusi, {Olalekan Lee} and Philip Edge and Lesley Gosden and Lesley Roberts and Rav Verdi and Roger Wilson and Melanie Calvert",
note = "Not yet published as of 08/08/2021.",
year = "2021",
month = jan,
day = "8",
language = "English",
journal = "BMJ open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",

}

RIS

TY - JOUR

T1 - “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

AU - Cruz Rivera, Samantha

AU - Stephens, Richard

AU - Mercieca-Bebber, Rebecca

AU - Retzer, Ameeta

AU - Rutherford, Claudia

AU - Price, Gary

AU - Slade, Anita

AU - Aiyegbusi, Olalekan Lee

AU - Edge, Philip

AU - Gosden, Lesley

AU - Roberts, Lesley

AU - Verdi, Rav

AU - Wilson, Roger

AU - Calvert, Melanie

N1 - Not yet published as of 08/08/2021.

PY - 2021/1/8

Y1 - 2021/1/8

N2 - 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.

AB - 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.

M3 - Article

JO - BMJ open

JF - BMJ open

SN - 2044-6055

ER -