BMJ Open (Jun 2021)
SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials
- Kirstie Haywood,
- Joseph C Cappelleri,
- Ameeta Retzer,
- Anita Slade,
- Derek Kyte,
- Melanie Calvert,
- Jane Blazeby,
- An-Wen Chan,
- Rebecca Mercieca-Bebber,
- Antonia Bennett,
- Carolyn Ells,
- Gary Price,
- Galina Velikova,
- Heather Draper,
- Dennis Revicki,
- Julia Brown,
- laura Martin,
- Lori Frank,
- Madeleine King,
- Jane Scott,
- Sandra Mitchell,
- Grace Turner,
- Michael Brundage,
- Andrew Bottomley,
- Michael Palmer,
- Richard Stephens,
- Ingolf Griebsch,
- Donald Patrick,
- Lari Wenzel,
- Daniel O'Connor,
- Robert M Golub,
- Olalekan Aiyegbusi,
- E Basch,
- Jill Bell,
- Vishal Bhatnagar,
- Lisa Campbell,
- Amylou C Dueck,
- Amanda Hunn,
- Bellinda King-Kallimanis,
- Thomas Morel,
- Linda Nelson,
- Josephine Norquist,
- Antoine Regnault,
- Antonia Valakas,
- Maria von Hildebrand,
- Anita Walker
Affiliations
- Kirstie Haywood
- Warwick Research in Nursing, University of Warwick, Coventry, UK
- Joseph C Cappelleri
- Global Research and Development, Pfizer Inc, Groton, Connecticut, USA
- Ameeta Retzer
- Centre for Patient Reported Outcomes Research, Institute for Applied Health Research, University of Birmingham, Birmingham, UK
- Anita Slade
- Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK
- Derek Kyte
- 3 School of Allied Health and Community, University of Worcester, Worcester, UK
- Melanie Calvert
- director and centre director and academic lead
- Jane Blazeby
- professor
- An-Wen Chan
- professor
- Rebecca Mercieca-Bebber
- NHMRC Clinical Trials Centre, Camperdown, New South Wales, Australia
- Antonia Bennett
- Cancer Outcomes Research Program, University of North Carolina, Chapel Hill, North Carolina, USA
- Carolyn Ells
- School of Population and Global Health, McGill University, Montreal, Quebec, Canada
- Gary Price
- Patient Advisory Group, Centre for Patient-Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK
- Galina Velikova
- 1 Patient Centred Outcomes Research Group, Leeds Institute of Medical Research at St James`s, University of Leeds, Leeds, UK
- Heather Draper
- University of Warwick, Coventry, UK
- Dennis Revicki
- Outcomes Research Consulting, Sarasota, Florida, USA
- Julia Brown
- School of Medicine, University of Leeds, Leeds, UK
- laura Martin
- 1 Department of Respiratory Medicine, St Mary`s Hospital, Imperial College Healthcare NHS Trust, London, UK
- Lori Frank
- Patient-Centered Outcomes Research Institute, Washington, DC, USA
- Madeleine King
- Faculty of Science, School of Psychology, University of Sydney, Sydney, New South Wales, Australia
- Jane Scott
- 6Somerset-wide Integrated Sexual Health Service, Taunton, UK
- Sandra Mitchell
- National Cancer Institute, Rockville, Maryland, USA
- Grace Turner
- Institute of Applied Health Research, University of Birmingham, Birmingham, UK
- Michael Brundage
- Department of Oncology, Queen’s University Cancer Research Institute, Kingston, Ontario, Canada
- Andrew Bottomley
- Department of Quality of Life, European Organisation for Research and Treatment of Cancer, Brussels, Belgium
- Michael Palmer
- Cancer Research Institute, Queen`s University, Kingston, Ontario, Canada
- Richard Stephens
- National Cancer Research Institute Consumer Forum, London, UK
- Ingolf Griebsch
- Boehringer Ingelheim International GmbH, Ingelheim, Germany
- Donald Patrick
- Department of Health Services, University of Washington, Seattle, Washington, USA
- Lari Wenzel
- University of California, Irvine, California, USA
- Daniel O'Connor
- Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK
- Robert M Golub
- professor
- Olalekan Aiyegbusi
- Institute of Applied Health Research, University of Birmingham, Birmingham, UK
- E Basch
- University of North Carolina, Chapel Hill, North Carolina, USA
- Jill Bell
- Oncology Digital Health, AstraZeneca, Gaithersburg, Maryland, USA
- Vishal Bhatnagar
- US Food and Drug Administration, Silver Spring, Maryland, USA
- Lisa Campbell
- Medicines and Healthcare Products Regulatory Agency, London, UK
- Amylou C Dueck
- Department of Quantitative Health Sciences, Mayo Clinic, Phoenix, Arizona, USA
- Amanda Hunn
- Independent Advisor, Manchester, UK
- Bellinda King-Kallimanis
- US Food and Drug Administration, Silver Spring, Maryland, USA
- Thomas Morel
- Patient-Centered Outcomes Research, UCB Pharma, Brussels, Belgium
- Linda Nelson
- Value Evidence and Outcomes—Patient Centered Outcomes, GSK, Collegeville, Pennsylvania, USA
- Josephine Norquist
- Center for Observational Real-world Evidence (CORE), Patient-Centered Endpoints & Strategy, Merck & Co Inc, Kenilworth, New Jersey, USA
- Antoine Regnault
- Modus Outcomes, Lyon, France
- Antonia Valakas
- EMD Serono Inc, Healthcare Business of Merck KGaA, Darmstadt, Germany
- Maria von Hildebrand
- Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK
- Anita Walker
- Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK
- DOI
- https://doi.org/10.1136/bmjopen-2020-045105
- Journal volume & issue
-
Vol. 11,
no. 6
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.
