SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials
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 polic...
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| Published in: | BMJ open Vol. 11; no. 6; p. e045105 |
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| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
England
British Medical Journal Publishing Group
30.06.2021
BMJ Publishing Group LTD BMJ Publishing Group |
| Series: | Communication |
| Subjects: | |
| ISSN: | 2044-6055, 2044-6055 |
| Online Access: | Get full text |
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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 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. |
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| AbstractList | 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. 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.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. |
| Author | Ells, Carolyn Bhatnagar, Vishal Bennett, Antonia Velikova, Galina Chan, An-Wen Scott, Jane Hunn, Amanda Retzer, Ameeta Calvert, Melanie Palmer, Michael Wenzel, Lari Blazeby, Jane Patrick, Donald O'Connor, Daniel Golub, Robert M von Hildebrand, Maria Mitchell, Sandra Campbell, Lisa Walker, Anita Slade, Anita Regnault, Antoine Frank, Lori Valakas, Antonia Stephens, Richard Aiyegbusi, Olalekan Brundage, Michael King-Kallimanis, Bellinda Griebsch, Ingolf Brown, Julia Cappelleri, Joseph C Nelson, Linda Bottomley, Andrew Kyte, Derek Draper, Heather Morel, Thomas Basch, E King, Madeleine Martin, Laura Dueck, Amylou C Haywood, Kirstie Bell, Jill Revicki, Dennis Norquist, Josephine Mercieca-Bebber, Rebecca Price, Gary Turner, Grace |
| AuthorAffiliation | 4 NIHR Surgical Reconstruction and Microbiology Research Centre , Birmingham , UK 13 NIHR Bristol Biomedical Research Centre , University of Bristol , Bristol , UK 37 Johnson and Johnson , Janssen Global Services LLC , High Wycombe , UK 41 University of California , Irvine , California , USA 8 Women’s College Research Institute, Department of Medicine , University of Toronto , Toronto , Ontario , Canada 17 Department of Oncology , Queen’s University Cancer Research Institute , Kingston , Ontario , Canada 27 Independent Advisor , Manchester , UK 32 Center for Observational Real-world Evidence (CORE), Patient-Centered Endpoints & Strategy , Merck & Co Inc , Kenilworth , New Jersey , USA 36 Outcomes Research Consulting , Sarasota , Florida , USA 3 NIHR Biomedical Research Centre , Institute of Translational Medicine , Birmingham , UK 23 Patient-Centered Outcomes Research Institute , Washington , DC , USA 7 Faculty of Medicine and Health, NHMRC Clinical Trials Centre , University of Sydney , Sydney , |
| AuthorAffiliation_xml | – name: 16 Clinical Trials Research Unit , University of Leeds , Leeds , UK – name: 21 Department of Health Sciences Research , Mayo Clinic , Scottsdale , Arizona , USA – name: 20 University of Warwick , Coventry , UK – name: 11 Cancer Outcomes Research Program , University of North Carolina , Chapel Hill , North Carolina , USA – name: 30 Patient-Centered Outcomes Research , UCB Pharma , Brussels , Belgium – name: 7 Faculty of Medicine and Health, NHMRC Clinical Trials Centre , University of Sydney , Sydney , New South Wales , Australia – name: 18 Medicines and Healthcare Products Regulatory Agency , London , UK – name: 34 Department of Health Services , University of Washington , Seattle , Washington , USA – name: 28 Daiichi Sankyo Europe GmbH , Munchen , Germany – name: 4 NIHR Surgical Reconstruction and Microbiology Research Centre , Birmingham , UK – name: 36 Outcomes Research Consulting , Sarasota , Florida , USA – name: 5 NIHR Applied Research Collaboration West Midlands , University of Birmingham , Birmingham , UK – name: 39 EMD Serono Inc , Healthcare Business of Merck KGaA , Darmstadt , Germany – name: 6 Faculty of Science, School of Psychology , University of Sydney , Sydney , New South Wales , Australia – name: 22 School of Population and Global Health , McGill University , Montreal , Quebec , Canada – name: 26 Warwick Research in Nursing , University of Warwick, Warwick Medical School , Coventry , UK – name: 41 University of California , Irvine , California , USA – name: 8 Women’s College Research Institute, Department of Medicine , University of Toronto , Toronto , Ontario , Canada – name: 27 Independent Advisor , Manchester , UK – name: 24 JAMA , Chicago , Illinois , USA – name: 9 University of North Carolina , Chapel Hill , North Carolina , USA – name: 10 Oncology Digital Health , AstraZeneca , Gaithersburg , Maryland , USA – name: 29 National Cancer Institute , Rockville , Maryland , USA – name: 25 Boehringer Ingelheim International GmbH , Ingelheim , Germany – name: 1 Centre for Patient Reported Outcome Research, Institute of Applied Health Research , University of Birmingham , Birmingham , UK – name: 15 Department of Quality of Life , European Organisation for Research and Treatment of Cancer , Brussels , Belgium – name: 14 Division of Surgery, Head and Neck , University Hospitals Bristol NHS Foundation Trust , Bristol , UK – name: 40 Leeds Institute of Medical Research at St James’s , University of Leeds , Leeds , UK – name: 33 Cancer Research Institute , Queen's University , Kingston , Ontario , Canada – name: 12 US Food and Drug Administration , Silver Spring , Maryland , USA – name: 37 Johnson and Johnson , Janssen Global Services LLC , High Wycombe , UK – name: 32 Center for Observational Real-world Evidence (CORE), Patient-Centered Endpoints & Strategy , Merck & Co Inc , Kenilworth , New Jersey , USA – name: 3 NIHR Biomedical Research Centre , Institute of Translational Medicine , Birmingham , UK – name: 17 Department of Oncology , Queen’s University Cancer Research Institute , Kingston , Ontario , Canada – name: 23 Patient-Centered Outcomes Research Institute , Washington , DC , USA – name: 38 National Cancer Research Institute Consumer Forum , London , UK – name: 19 Global Biometrics & Data Management—Statistics , Pfizer Inc , New York City , New York , USA – name: 31 Value Evidence and Outcomes—Patient Centered Outcomes , GSK , Collegeville , Pennsylvania , USA – name: 13 NIHR Bristol Biomedical Research Centre , University of Bristol , Bristol , UK – name: 35 Modus Outcomes , Lyon , France – name: 2 Birmingham Health Partners Centre for Regulatory Science and Innovation , University of Birmingham , Birmingham , UK |
| Author_xml | – sequence: 1 givenname: Melanie orcidid: 0000-0002-1856-837X surname: Calvert fullname: Calvert, Melanie email: M.Calvert@bham.ac.uk organization: NIHR Applied Research Collaboration West Midlands, University of Birmingham, Birmingham, UK – sequence: 2 givenname: Madeleine surname: King fullname: King, Madeleine organization: Faculty of Science, School of Psychology, University of Sydney, Sydney, New South Wales, Australia – sequence: 3 givenname: Rebecca orcidid: 0000-0003-3708-9099 surname: Mercieca-Bebber fullname: Mercieca-Bebber, Rebecca organization: Faculty of Medicine and Health, NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia – sequence: 4 givenname: Olalekan surname: Aiyegbusi fullname: Aiyegbusi, Olalekan organization: NIHR Biomedical Research Centre, Institute of Translational Medicine, Birmingham, UK – sequence: 5 givenname: Derek surname: Kyte fullname: Kyte, Derek organization: Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK – sequence: 6 givenname: Anita surname: Slade fullname: Slade, Anita organization: NIHR Surgical Reconstruction and Microbiology Research Centre, Birmingham, UK – sequence: 7 givenname: An-Wen surname: Chan fullname: Chan, An-Wen organization: Women’s College Research Institute, Department of Medicine, University of Toronto, Toronto, Ontario, Canada – sequence: 8 givenname: E surname: Basch fullname: Basch, E organization: University of North Carolina, Chapel Hill, North Carolina, USA – sequence: 9 givenname: Jill surname: Bell fullname: Bell, Jill organization: Oncology Digital Health, AstraZeneca, Gaithersburg, Maryland, USA – sequence: 10 givenname: Antonia surname: Bennett fullname: Bennett, Antonia organization: Cancer Outcomes Research Program, University of North Carolina, Chapel Hill, North Carolina, USA – sequence: 11 givenname: Vishal surname: Bhatnagar fullname: Bhatnagar, Vishal organization: US Food and Drug Administration, Silver Spring, Maryland, USA – sequence: 12 givenname: Jane orcidid: 0000-0002-3354-3330 surname: Blazeby fullname: Blazeby, Jane organization: Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK – sequence: 13 givenname: Andrew surname: Bottomley fullname: Bottomley, Andrew organization: Department of Quality of Life, European Organisation for Research and Treatment of Cancer, Brussels, Belgium – sequence: 14 givenname: Julia surname: Brown fullname: Brown, Julia organization: Clinical Trials Research Unit, University of Leeds, Leeds, UK – sequence: 15 givenname: Michael surname: Brundage fullname: Brundage, Michael organization: Department of Oncology, Queen’s University Cancer Research Institute, Kingston, Ontario, Canada – sequence: 16 givenname: Lisa surname: Campbell fullname: Campbell, Lisa organization: Medicines and Healthcare Products Regulatory Agency, London, UK – sequence: 17 givenname: Joseph C surname: Cappelleri fullname: Cappelleri, Joseph C organization: Global Biometrics & Data Management—Statistics, Pfizer Inc, New York City, New York, USA – sequence: 18 givenname: Heather surname: Draper fullname: Draper, Heather organization: University of Warwick, Coventry, UK – sequence: 19 givenname: Amylou C surname: Dueck fullname: Dueck, Amylou C organization: Department of Health Sciences Research, Mayo Clinic, Scottsdale, Arizona, USA – sequence: 20 givenname: Carolyn surname: Ells fullname: Ells, Carolyn organization: School of Population and Global Health, McGill University, Montreal, Quebec, Canada – sequence: 21 givenname: Lori surname: Frank fullname: Frank, Lori organization: Patient-Centered Outcomes Research Institute, Washington, DC, USA – sequence: 22 givenname: Robert M surname: Golub fullname: Golub, Robert M organization: JAMA, Chicago, Illinois, USA – sequence: 23 givenname: Ingolf surname: Griebsch fullname: Griebsch, Ingolf organization: Boehringer Ingelheim International GmbH, Ingelheim, Germany – sequence: 24 givenname: Kirstie surname: Haywood fullname: Haywood, Kirstie organization: Warwick Research in Nursing, University of Warwick, Warwick Medical School, Coventry, UK – sequence: 25 givenname: Amanda orcidid: 0000-0003-2156-7279 surname: Hunn fullname: Hunn, Amanda organization: Independent Advisor, Manchester, UK – sequence: 26 givenname: Bellinda surname: King-Kallimanis fullname: King-Kallimanis, Bellinda organization: US Food and Drug Administration, Silver Spring, Maryland, USA – sequence: 27 givenname: Laura surname: Martin fullname: Martin, Laura organization: Daiichi Sankyo Europe GmbH, Munchen, Germany – sequence: 28 givenname: Sandra surname: Mitchell fullname: Mitchell, Sandra organization: National Cancer Institute, Rockville, Maryland, USA – sequence: 29 givenname: Thomas surname: Morel fullname: Morel, Thomas organization: Patient-Centered Outcomes Research, UCB Pharma, Brussels, Belgium – sequence: 30 givenname: Linda surname: Nelson fullname: Nelson, Linda organization: Value Evidence and Outcomes—Patient Centered Outcomes, GSK, Collegeville, Pennsylvania, USA – sequence: 31 givenname: Josephine surname: Norquist fullname: Norquist, Josephine organization: Center for Observational Real-world Evidence (CORE), Patient-Centered Endpoints & Strategy, Merck & Co Inc, Kenilworth, New Jersey, USA – sequence: 32 givenname: Daniel surname: O'Connor fullname: O'Connor, Daniel organization: Medicines and Healthcare Products Regulatory Agency, London, UK – sequence: 33 givenname: Michael surname: Palmer fullname: Palmer, Michael organization: Cancer Research Institute, Queen's University, Kingston, Ontario, Canada – sequence: 34 givenname: Donald surname: Patrick fullname: Patrick, Donald organization: Department of Health Services, University of Washington, Seattle, Washington, USA – sequence: 35 givenname: Gary surname: Price fullname: Price, Gary organization: Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK – sequence: 36 givenname: Antoine surname: Regnault fullname: Regnault, Antoine organization: Modus Outcomes, Lyon, France – sequence: 37 givenname: Ameeta surname: Retzer fullname: Retzer, Ameeta organization: Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK – sequence: 38 givenname: Dennis surname: Revicki fullname: Revicki, Dennis organization: Outcomes Research Consulting, Sarasota, Florida, USA – sequence: 39 givenname: Jane surname: Scott fullname: Scott, Jane organization: Johnson and Johnson, Janssen Global Services LLC, High Wycombe, UK – sequence: 40 givenname: Richard surname: Stephens fullname: Stephens, Richard organization: National Cancer Research Institute Consumer Forum, London, UK – sequence: 41 givenname: Grace orcidid: 0000-0002-9783-9413 surname: Turner fullname: Turner, Grace organization: NIHR Surgical Reconstruction and Microbiology Research Centre, Birmingham, UK – sequence: 42 givenname: Antonia surname: Valakas fullname: Valakas, Antonia organization: EMD Serono Inc, Healthcare Business of Merck KGaA, Darmstadt, Germany – sequence: 43 givenname: Galina surname: Velikova fullname: Velikova, Galina organization: Leeds Institute of Medical Research at St James’s, University of Leeds, Leeds, UK – sequence: 44 givenname: Maria surname: von Hildebrand fullname: von Hildebrand, Maria organization: Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK – sequence: 45 givenname: Anita surname: Walker fullname: Walker, Anita organization: Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK – sequence: 46 givenname: Lari surname: Wenzel fullname: Wenzel, Lari organization: University of California, Irvine, California, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/34193486$$D View this record in MEDLINE/PubMed |
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342 Gladman, Rigby, Azevedo (R103) 2017; 377 Rochette, Korner-Bitensky, Bishop (R53) 2010; 10 King, Link, Whelan (R49) 2020; 21 Winther, Watt, Bjørner (R47) 2014; 15 Collinson, Gregory, McCabe (R67) 2012; 12 Reale, De Luca, Lombardi (R127) 2020; 139 King (R51) 2011; 11 Schandelmaier, Conen, von Elm (R120) 2015; 26 Tam, Hotte (R128) 2008; 26 Turner, Aiyegbusi, Price (R134) 2020; 113 Chan, Tetzlaff, Altman (R1) 2013; 158 Mercieca-Bebber, Rouette, Calvert (R122) 2017; 26 Furman, Sharman, Coutre (R29) 2014; 370 Kyte, Ives, Draper (R116) 2016; 11 Mercieca-Bebber, King, Calvert (R65) 2018; 9 Regnault, Herdman (R83) 2015; 24 Mercieca-Bebber, Palmer, Brundage (R30) 2016; 6 Wilson, Cleary (R44) 1995; 273 Bell, Fiero, Horton (R98) 2014; 14 Howland, Allan, Carlton (R90) 2017; 8 Staniszewska, Brett, Simera (R28) 2017; 358 Hardouin, Conroy, Sébille (R109) 2011; 11 Patrick, Burke, Gwaltney (R60) 2011; 14 Hurt, Nixon, Griffiths (R54) 2011; 11 Breugelmans (R81) 2009; 136 Patrick, Burke, Powers (R58) 2007; 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| Snippet | Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients’ symptoms,... Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients' symptoms,... |
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| SubjectTerms | Checklist Clinical trials Data collection education & training (see medical education & training) Humans Hypotheses Intervention Patient Reported Outcome Measures Patient-centered care protocols & guidelines Quality of Life Research Design Research Methods Research Report Shared decision making statistics & research methods |
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| Title | SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials |
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