Practical guidance for engaging patients in health research, treatment guidelines and regulatory processes: results of an expert group meeting organized by the World Health Organization (WHO) and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).

Maarten de Wit, Cyrus Cooper, Peter Tugwell, Nathalie Bere, John Kirwan, Philip G Conaghan, Charlotte Roberts, Isabelle Aujoulat, Nasser Al-Daghri, Islene Araujo de Carvalho, Mary Barker, Nicola Bedlington, Maria Luisa Brandi, Olivier Bruyère, Nansa Burlet, Philippe Halbout, Mickaël Hiligsmann, Famida Jiwa, John A Kanis, Andrea Laslop, Wendy Lawrence, Daniel Pinto, Concepción Prieto Yerro, Véronique Rabenda, René Rizzoli, Marieke Scholte-Voshaar, Mila Vlaskovska, Jean-Yves Reginster

Journal: Aging clinical and experimental research 2019;31(7):905-915

PMID: 30993659

Abstract

There is increasing emphasis on patient-centred research to support the development, approval and reimbursement of health interventions that best meet patients' needs. However, there is currently little guidance on how meaningful patient engagement may be achieved. An expert working group, representing a wide range of stakeholders and disciplines, was convened by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the World Health Organization (WHO). Through a structured, collaborative process the group generated practical guidance to facilitate optimal patient engagement in clinical development and regulatory decisions. Patient engagement is a relational process. The principles outlined in this report were based on lessons learned through applied experience and on an extensive dialogue among the expert participants. This practice guidance forms a starting point from which tailoring of the approach to suit different chronic diseases may be undertaken.

Address: Department of Medical Humanities, Amsterdam University Medical Centre, Amsterdam, The Netherlands.; MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton, UK.; NIHR Musculoskeletal Biomedical Research Unit, University of Oxford, Oxford, UK.; WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Aging, Liège, Belgium.; Department of Medicine, University of Ottawa, Ottawa, Canada.; Public Engagement Department, European Medicines Agency, 30 Churchill Place, Canary Wharf, London, E14 5EU, UK.; Emeritus Professor of Rheumatic Diseases, University of Bristol, Bristol, UK.; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.; NIHR Leeds Biomedical Research Centre, Leeds, UK.; International Consortium for Health Outcomes Measurement, Hamilton House, 4 Mabledon Place, Bloomsbury, London, WC1H 9BB, UK.; Université Catholique de Louvain, Institute of Health & Society, Brussels, Belgium.; Chair for Biomarkers of Chronic Diseases, Biochemistry Department, College of Science, King Saud University, Riyadh, Kingdom of Saudi Arabia.; Department of Ageing and Life Course, World Health Organization, 20 Avenue Appia, 1211, Geneva 27, Switzerland.; MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton, UK.; European Patients' Forum, Chaussée d'Etterbeek 180, Etterbeek, 1040, Brussels, Belgium.; Department of Surgery and Translational Medicine, University of Florence, Florence, Italy.; Fondazione F.I.R.M.O., Florence, Italy.; WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Aging, Liège, Belgium.; Department of Public Health, Epidemiology and Health Economics, University of Liège, CHU Sart Tilman B23, 4000, Liège, Belgium.; WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Aging, Liège, Belgium.; International Osteoporosis Foundation, 9 Rue Juste-Olivier, 1260, Nyon, Switzerland.; Department of Health Services Research, CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.; Osteoporosis Canada, Toronto, ON, Canada.; Mary McKillop Health Institute, Australian Catholic University, Melbourne, Australia.; Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Sheffield, UK.; Scientific Office, Federal Office for Safety in Health Care, Austrian Agency for Health and Food Safety, Vienna, Austria.; MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton, UK.; NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.; Department of Physical Therapy, College of Health Sciences, Marquette University, Milwaukee, USA.; Center for Healthcare Studies, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.; Spanish Agency for Drugs and Medical Devices, Calle Campezo 1, Building 8, 28022, Madrid, Spain.; Department of Public Health, Epidemiology and Health Economics, University of Liège, CHU Sart Tilman B23, 4000, Liège, Belgium.; WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Aging, Liège, Belgium.; Division of Bone Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.; Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands.; Medical Faculty, Department of Pharmacology, Medical University Sofia, 2, Zdrave Str, 1431, Sofia, Bulgaria.; WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Aging, Liège, Belgium. [email protected].; Chair for Biomarkers of Chronic Diseases, Biochemistry Department, College of Science, King Saud University, Riyadh, Kingdom of Saudi Arabia. [email protected].; Department of Public Health, Epidemiology and Health Economics, University of Liège, CHU Sart Tilman B23, 4000, Liège, Belgium. [email protected].
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