SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials

Melanie Calvert; Madeleine King; Rebecca Mercieca-Bebber; Olalekan Aiyegbusi; Derek Kyte; Anita Slade; An Wen Chan; E. Basch; Jill Bell; Antonia Bennett; Vishal Bhatnagar; Jane Blazeby; Andrew Bottomley; Julia Brown; Michael Brundage; Lisa Campbell; Joseph C. Cappelleri; Heather Draper; Amylou C. Dueck; Carolyn Ells; Lori Frank; Robert M. Golub; Ingolf Griebsch; Kirstie Haywood; Amanda Hunn; Bellinda King-Kallimanis; Laura Martin; Sandra Mitchell; Thomas Morel; Linda Nelson; Josephine Norquist; Daniel O'connor; Michael Palmer; Donald Patrick; Gary Price; Antoine Regnault; Ameeta Retzer; Dennis Revicki; Jane Scott; Richard Stephens; Grace Turner; Antonia Valakas; Galina Velikova; Maria Von Hildebrand; Anita Walker; Lari Wenzel

doi:10.1136/bmjopen-2020-045105

SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials

Melanie Calvert, Madeleine King, Rebecca Mercieca-Bebber, Olalekan Aiyegbusi, Derek Kyte, Anita Slade, An Wen Chan, E. Basch, Jill Bell, Antonia Bennett, Vishal Bhatnagar, Jane Blazeby, Andrew Bottomley, Julia Brown, Michael Brundage, Lisa Campbell, Joseph C. Cappelleri, Heather Draper, Amylou C. Dueck, Carolyn EllsLori Frank, Robert M. Golub, Ingolf Griebsch, Kirstie Haywood, Amanda Hunn, Bellinda King-Kallimanis, Laura Martin, Sandra Mitchell, Thomas Morel, Linda Nelson, Josephine Norquist, Daniel O'connor, Michael Palmer, Donald Patrick, Gary Price, Antoine Regnault, Ameeta Retzer, Dennis Revicki, Jane Scott, Richard Stephens, Grace Turner, Antonia Valakas, Galina Velikova, Maria Von Hildebrand, Anita Walker, Lari Wenzel

Research output: Contribution to journal › Article › peer-review

Abstract

Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients' symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item's importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs.

Original language	English (US)
Article number	045105
Journal	BMJ open
Volume	11
Issue number	6
DOIs	https://doi.org/10.1136/bmjopen-2020-045105
State	Published - Jun 30 2021

Keywords

clinical trials
education & training (see medical education & training)
protocols & guidelines
statistics & research methods

ASJC Scopus subject areas

General Medicine

Access to Document

10.1136/bmjopen-2020-045105

Cite this

Calvert, M., King, M., Mercieca-Bebber, R., Aiyegbusi, O., Kyte, D., Slade, A., Chan, A. W., Basch, E., Bell, J., Bennett, A., Bhatnagar, V., Blazeby, J., Bottomley, A., Brown, J., Brundage, M., Campbell, L., Cappelleri, J. C., Draper, H., Dueck, A. C., ... Wenzel, L. (2021). SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials. BMJ open, 11(6), Article 045105. https://doi.org/10.1136/bmjopen-2020-045105

Calvert, M, King, M, Mercieca-Bebber, R, Aiyegbusi, O, Kyte, D, Slade, A, Chan, AW, Basch, E, Bell, J, Bennett, A, Bhatnagar, V, Blazeby, J, Bottomley, A, Brown, J, Brundage, M, Campbell, L, Cappelleri, JC, Draper, H, Dueck, AC, Ells, C, Frank, L, Golub, RM, Griebsch, I, Haywood, K, Hunn, A, King-Kallimanis, B, Martin, L, Mitchell, S, Morel, T, Nelson, L, Norquist, J, O'connor, D, Palmer, M, Patrick, D, Price, G, Regnault, A, Retzer, A, Revicki, D, Scott, J, Stephens, R, Turner, G, Valakas, A, Velikova, G, Von Hildebrand, M, Walker, A & Wenzel, L 2021, 'SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials', BMJ open, vol. 11, no. 6, 045105. https://doi.org/10.1136/bmjopen-2020-045105

@article{dd1a291ab28946e496c8064cd59fdc7e,

title = "SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials",

abstract = "Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients' symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item's importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs.",

keywords = "clinical trials, education & training (see medical education & training), protocols & guidelines, statistics & research methods",

author = "Melanie Calvert and Madeleine King and Rebecca Mercieca-Bebber and Olalekan Aiyegbusi and Derek Kyte and Anita Slade and Chan, {An Wen} and E. Basch and Jill Bell and Antonia Bennett and Vishal Bhatnagar and Jane Blazeby and Andrew Bottomley and Julia Brown and Michael Brundage and Lisa Campbell and Cappelleri, {Joseph C.} and Heather Draper and Dueck, {Amylou C.} and Carolyn Ells and Lori Frank and Golub, {Robert M.} and Ingolf Griebsch and Kirstie Haywood and Amanda Hunn and Bellinda King-Kallimanis and Laura Martin and Sandra Mitchell and Thomas Morel and Linda Nelson and Josephine Norquist and Daniel O'connor and Michael Palmer and Donald Patrick and Gary Price and Antoine Regnault and Ameeta Retzer and Dennis Revicki and Jane Scott and Richard Stephens and Grace Turner and Antonia Valakas and Galina Velikova and {Von Hildebrand}, Maria and Anita Walker and Lari Wenzel",

note = "Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",

year = "2021",

month = jun,

day = "30",

doi = "10.1136/bmjopen-2020-045105",

language = "English (US)",

volume = "11",

journal = "BMJ open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "6",

}

TY - JOUR

T1 - SPIRIT-PRO Extension explanation and elaboration

T2 - guidelines for inclusion of patient-reported outcomes in protocols of clinical trials

AU - Calvert, Melanie

AU - King, Madeleine

AU - Mercieca-Bebber, Rebecca

AU - Aiyegbusi, Olalekan

AU - Kyte, Derek

AU - Slade, Anita

AU - Chan, An Wen

AU - Basch, E.

AU - Bell, Jill

AU - Bennett, Antonia

AU - Bhatnagar, Vishal

AU - Blazeby, Jane

AU - Bottomley, Andrew

AU - Brown, Julia

AU - Brundage, Michael

AU - Campbell, Lisa

AU - Cappelleri, Joseph C.

AU - Draper, Heather

AU - Dueck, Amylou C.

AU - Ells, Carolyn

AU - Frank, Lori

AU - Golub, Robert M.

AU - Griebsch, Ingolf

AU - Haywood, Kirstie

AU - Hunn, Amanda

AU - King-Kallimanis, Bellinda

AU - Martin, Laura

AU - Mitchell, Sandra

AU - Morel, Thomas

AU - Nelson, Linda

AU - Norquist, Josephine

AU - O'connor, Daniel

AU - Palmer, Michael

AU - Patrick, Donald

AU - Price, Gary

AU - Regnault, Antoine

AU - Retzer, Ameeta

AU - Revicki, Dennis

AU - Scott, Jane

AU - Stephens, Richard

AU - Turner, Grace

AU - Valakas, Antonia

AU - Velikova, Galina

AU - Von Hildebrand, Maria

AU - Walker, Anita

AU - Wenzel, Lari

PY - 2021/6/30

Y1 - 2021/6/30

N2 - Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients' symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item's importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs.

AB - Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients' symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item's importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs.

KW - clinical trials

KW - education & training (see medical education & training)

KW - protocols & guidelines

KW - statistics & research methods

UR - http://www.scopus.com/inward/record.url?scp=85108994322&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85108994322&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2020-045105

DO - 10.1136/bmjopen-2020-045105

M3 - Article

C2 - 34193486

AN - SCOPUS:85108994322

SN - 2044-6055

VL - 11

JO - BMJ open

JF - BMJ open

IS - 6

M1 - 045105

ER -

SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this