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 Lee Aiyegbusi; Derek Kyte; Anita Slade; A. W. Chan; Ethan Basch; JA Bell; AV Bennett; V Bhatnagar; J Blazeby; A Bottomley; J. Brown; L Campbell; JC Cappelleri; H Draper; A Dueck; C Ells; L Frank; Robert M. Golub; I Griebsch; Kirstie Haywood; A Hunn; BL King-Kallimanis; L Martin; S Mitchell; T Morel; L Nelsen; Josephine M. Norquist; D O'Connor; Michael J Palmer; D Patrick; Gary Price; A Regnault; Ameeta Retzer; D Revicki; R Stephens; Grace Turner; A Valakas; Galina Velikova; Maria Von Hildebrand; Anita Walker; Linda Wenzel; Jane A  Scott

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 Lee Aiyegbusi, Derek Kyte, Anita Slade, A. W. Chan, Ethan Basch, JA Bell , AV Bennett , V Bhatnagar , J Blazeby, A Bottomley , J. Brown, L Campbell, JC Cappelleri , H Draper, A Dueck , C Ells , L Frank Robert M. Golub, I Griebsch, Kirstie Haywood, A Hunn, BL King-Kallimanis , L Martin, S Mitchell , T Morel , L Nelsen , Josephine M. Norquist, D O'Connor, Michael J Palmer, D Patrick, Gary Price, A Regnault , Ameeta Retzer, D Revicki, R Stephens, Grace Turner, A Valakas , Galina Velikova, Maria Von Hildebrand, Anita Walker, Linda Wenzel, Jane A Scott

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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 SPIRIT-PRO Extension. The SPIRIT-PRO Extension is a sixteen-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. Article Summary Strengths and limitations of this study • The SPIRIT-PRO Extension aims to improve the completeness and transparency of trial protocols where patient-reported outcomes (PROs) are a primary or key secondary outcomes and was developed following EQUATOR Network Guidance. • This Explanation and Elaboration paper provides information to promote understanding and facilitate uptake of the recommended PRO protocol SPIRIT-PRO checklist items for clinical trials. • A comprehensive protocol template and selected examples from existing trial protocols are provided to facilitate implementation. • The protocol template and explanation and elaboration paper were developed with multi-stakeholder international input including: trialists, PRO methodologists, psychometricians, patient partners, industry representatives, journal editors, regulators and ethicists. • Although the guidance is limited in focus to clinical trials, many of the SPIRIT-PRO items may also provide useful prompts about PRO content for cohort studies and other non-randomised designs.

Original language	English
Article number	e045105
Number of pages	35
Journal	BMJ
Volume	11
Issue number	6
DOIs	https://doi.org/10.1136/bmjopen-2020-045105
Publication status	Published - 30 Jun 2021

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This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1136/bmjopen-2020-045105Licence: Creative Commons: Attribution-NonCommercial (CC BY-NC)

calvertm2021spiritFinal published version, 2.11 MBLicence: Creative Commons: Attribution-NonCommercial (CC BY-NC)

Evaluation of Patient-Reported Outcome (PRO) Protocol Content and Reporting in UK Cancer Clinical Trials - EPiC
Kyte, D. & Calvert, M.
Macmillan Cancer Support
7/03/16 → 31/12/19
Project: Research

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Calvert, M., King, M., Mercieca-bebber, R., Aiyegbusi, O. L., Kyte, D., Slade, A., Chan, A. W., Basch, E., Bell , JA., Bennett , AV., Bhatnagar , V., Blazeby, J., Bottomley , A., Brown, J., Campbell, L., Cappelleri , JC., Draper, H., Dueck , A., Ells , C., ... Scott, J. A. (2021). SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials. BMJ, 11(6), Article e045105. https://doi.org/10.1136/bmjopen-2020-045105

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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{\textquoteright} 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 SPIRIT-PRO Extension. The SPIRIT-PRO Extension is a sixteen-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{\textquoteright}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. Article Summary Strengths and limitations of this study • The SPIRIT-PRO Extension aims to improve the completeness and transparency of trial protocols where patient-reported outcomes (PROs) are a primary or key secondary outcomes and was developed following EQUATOR Network Guidance. • This Explanation and Elaboration paper provides information to promote understanding and facilitate uptake of the recommended PRO protocol SPIRIT-PRO checklist items for clinical trials. • A comprehensive protocol template and selected examples from existing trial protocols are provided to facilitate implementation. • The protocol template and explanation and elaboration paper were developed with multi-stakeholder international input including: trialists, PRO methodologists, psychometricians, patient partners, industry representatives, journal editors, regulators and ethicists. • Although the guidance is limited in focus to clinical trials, many of the SPIRIT-PRO items may also provide useful prompts about PRO content for cohort studies and other non-randomised designs. ",

author = "Melanie Calvert and Madeleine King and Rebecca Mercieca-bebber and Aiyegbusi, {Olalekan Lee} and Derek Kyte and Anita Slade and Chan, {A. W.} and Ethan Basch and JA Bell and AV Bennett and V Bhatnagar and J Blazeby and A Bottomley and J. Brown and L Campbell and JC Cappelleri and H Draper and A Dueck and C Ells and L Frank and Golub, {Robert M.} and I Griebsch and Kirstie Haywood and A Hunn and BL King-Kallimanis and L Martin and S Mitchell and T Morel and L Nelsen and Norquist, {Josephine M.} and D O'Connor and Palmer, {Michael J} and D Patrick and Gary Price and A Regnault and Ameeta Retzer and D Revicki and R Stephens and Grace Turner and A Valakas and Galina Velikova and {Von Hildebrand}, Maria and Anita Walker and Linda Wenzel and Scott, {Jane A}",

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

language = "English",

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issn = "0959-8138",

publisher = "BMJ Publishing Group",

number = "6",

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Calvert, M, King, M, Mercieca-bebber, R, Aiyegbusi, OL, Kyte, D, Slade, A, Chan, AW, Basch, E, Bell , JA, Bennett , AV, Bhatnagar , V, Blazeby, J, Bottomley , A, Brown, J, Campbell, L, Cappelleri , JC, Draper, H, Dueck , A, Ells , C, Frank , L, Golub, RM, Griebsch, I, Haywood, K, Hunn, A, King-Kallimanis , BL, Martin, L, Mitchell , S, Morel , T, Nelsen , L, Norquist, JM, O'Connor, D, Palmer, MJ, Patrick, D, Price, G, Regnault , A, Retzer, A, Revicki, D, Stephens, R, Turner, G, Valakas , A, Velikova, G, Von Hildebrand, M, Walker, A, Wenzel, L & Scott, JA 2021, 'SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials', BMJ, vol. 11, no. 6, e045105. https://doi.org/10.1136/bmjopen-2020-045105

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 Lee

AU - Kyte, Derek

AU - Slade, Anita

AU - Chan, A. W.

AU - Basch, Ethan

AU - Bell , JA

AU - Bennett , AV

AU - Bhatnagar , V

AU - Blazeby, J

AU - Bottomley , A

AU - Brown, J.

AU - Campbell, L

AU - Cappelleri , JC

AU - Draper, H

AU - Dueck , A

AU - Ells , C

AU - Frank , L

AU - Golub, Robert M.

AU - Griebsch, I

AU - Haywood, Kirstie

AU - Hunn, A

AU - King-Kallimanis , BL

AU - Martin, L

AU - Mitchell , S

AU - Morel , T

AU - Nelsen , L

AU - Norquist, Josephine M.

AU - O'Connor, D

AU - Palmer, Michael J

AU - Patrick, D

AU - Price, Gary

AU - Regnault , A

AU - Retzer, Ameeta

AU - Revicki, D

AU - Stephens, R

AU - Turner, Grace

AU - Valakas , A

AU - Velikova, Galina

AU - Von Hildebrand, Maria

AU - Walker, Anita

AU - Wenzel, Linda

AU - Scott, Jane A

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 SPIRIT-PRO Extension. The SPIRIT-PRO Extension is a sixteen-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. Article Summary Strengths and limitations of this study • The SPIRIT-PRO Extension aims to improve the completeness and transparency of trial protocols where patient-reported outcomes (PROs) are a primary or key secondary outcomes and was developed following EQUATOR Network Guidance. • This Explanation and Elaboration paper provides information to promote understanding and facilitate uptake of the recommended PRO protocol SPIRIT-PRO checklist items for clinical trials. • A comprehensive protocol template and selected examples from existing trial protocols are provided to facilitate implementation. • The protocol template and explanation and elaboration paper were developed with multi-stakeholder international input including: trialists, PRO methodologists, psychometricians, patient partners, industry representatives, journal editors, regulators and ethicists. • Although the guidance is limited in focus to clinical trials, many of the SPIRIT-PRO items may also provide useful prompts about PRO content for cohort studies and other non-randomised designs.

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 SPIRIT-PRO Extension. The SPIRIT-PRO Extension is a sixteen-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. Article Summary Strengths and limitations of this study • The SPIRIT-PRO Extension aims to improve the completeness and transparency of trial protocols where patient-reported outcomes (PROs) are a primary or key secondary outcomes and was developed following EQUATOR Network Guidance. • This Explanation and Elaboration paper provides information to promote understanding and facilitate uptake of the recommended PRO protocol SPIRIT-PRO checklist items for clinical trials. • A comprehensive protocol template and selected examples from existing trial protocols are provided to facilitate implementation. • The protocol template and explanation and elaboration paper were developed with multi-stakeholder international input including: trialists, PRO methodologists, psychometricians, patient partners, industry representatives, journal editors, regulators and ethicists. • Although the guidance is limited in focus to clinical trials, many of the SPIRIT-PRO items may also provide useful prompts about PRO content for cohort studies and other non-randomised designs.

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DO - 10.1136/bmjopen-2020-045105

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

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Evaluation of Patient-Reported Outcome (PRO) Protocol Content and Reporting in UK Cancer Clinical Trials - EPiC

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