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)

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作者
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
机构
[1] Amsterdam University Medical Centre,Department of Medical Humanities
[2] University of Southampton,MRC Lifecourse Epidemiology Unit
[3] Southampton General Hospital,NIHR Musculoskeletal Biomedical Research Unit
[4] University of Oxford,Department of Medicine
[5] WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Aging,Public Engagement Department
[6] University of Ottawa,Emeritus Professor of Rheumatic Diseases
[7] European Medicines Agency,Leeds Institute of Rheumatic and Musculoskeletal Medicine
[8] University of Bristol,Chair for Biomarkers of Chronic Diseases, Biochemistry Department, College of Science
[9] University of Leeds,Department of Ageing and Life Course
[10] NIHR Leeds Biomedical Research Centre,Department of Surgery and Translational Medicine
[11] International Consortium for Health Outcomes Measurement,Department of Public Health, Epidemiology and Health Economics
[12] Université Catholique de Louvain,Department of Health Services Research, CAPHRI Care and Public Health Research Institute
[13] Institute of Health & Society,Mary McKillop Health Institute
[14] King Saud University,Department of Physical Therapy, College of Health Sciences
[15] World Health Organization,Center for Healthcare Studies, Feinberg School of Medicine
[16] European Patients’ Forum,Division of Bone Diseases
[17] University of Florence,Department of Psychology, Health and Technology
[18] Fondazione F.I.R.M.O.,Medical Faculty, Department of Pharmacology
[19] University of Liège,undefined
[20] International Osteoporosis Foundation,undefined
[21] Maastricht University,undefined
[22] Osteoporosis Canada,undefined
[23] Australian Catholic University,undefined
[24] Centre for Metabolic Bone Diseases,undefined
[25] University of Sheffield Medical School,undefined
[26] Scientific Office,undefined
[27] Federal Office for Safety in Health Care,undefined
[28] Austrian Agency for Health and Food Safety,undefined
[29] NIHR Southampton Biomedical Research Centre,undefined
[30] University Hospital Southampton NHS Foundation Trust,undefined
[31] Marquette University,undefined
[32] Northwestern University,undefined
[33] Spanish Agency for Drugs and Medical Devices,undefined
[34] Geneva University Hospitals and Faculty of Medicine,undefined
[35] University of Twente,undefined
[36] Medical University Sofia,undefined
关键词
Outcomes research; Patient engagement; Patient preference; Regulatory process; Treatment guidelines;
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学科分类号
摘要
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.
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页码:905 / 915
页数:10
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