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Review
. 2019 Jul;31(7):905-915.
doi: 10.1007/s40520-019-01193-8. Epub 2019 Apr 16.

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  1 , Cyrus Cooper  2   3   4 , Peter Tugwell  5 , Nathalie Bere  6 , John Kirwan  7 , Philip G Conaghan  8   9 , Charlotte Roberts  10 , Isabelle Aujoulat  11 , Nasser Al-Daghri  12 , Islene Araujo de Carvalho  13 , Mary Barker  2 , Nicola Bedlington  14 , Maria Luisa Brandi  15   16 , Olivier Bruyère  4   17 , Nansa Burlet  4 , Philippe Halbout  18 , Mickaël Hiligsmann  19 , Famida Jiwa  20 , John A Kanis  21   22 , Andrea Laslop  23 , Wendy Lawrence  2   24 , Daniel Pinto  25   26 , Concepción Prieto Yerro  27 , Véronique Rabenda  17 , René Rizzoli  4   28 , Marieke Scholte-Voshaar  29 , Mila Vlaskovska  30 , Jean-Yves Reginster  31   32   33
Affiliations
Review

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 et al. Aging Clin Exp Res. 2019 Jul.

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.

Keywords: Outcomes research; Patient engagement; Patient preference; Regulatory process; Treatment guidelines.

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Conflict of interest statement

O Bruyère reports grants from Biophytis, IBSA, MEDA, Servier, SMB, and Theramex, outside of the submitted work. N. Bedlington’s organisation has received grants from GSK, Abbvie, Pfizer, Janssen, CSL Behring, Almirall, Baxter, Sanofi-Pasteur, EUPATI project (IMI-JU) industry consortium (UCB, Amgen, Genzyme, VFA, AZ, Novo Nordisk, Bayer, Merck, Janssen, GSK, Chiesi, Hoffmann, Lilly, Novartis, Esteve), Gilead, Eli-Lilly, Johnson & Johnson, MSD, Alexion, Mylan, Servier, Teva, Celgene, Novartis, Vertex, AIPP, Bosch Foundation, Sanofi Aventis, Hoffman La Roche, Grunenthal, European Commission. She has an advisory role with Janssen, Teva and GSK, outside of the submitted work. M.L. Brandi reports personal fees from Amgen, Bruno Farmaceutici, Kyowa Kirin, grants and personal fees from Abiogen, Alexion, Amgen, Bruno Farmaceutici, Eli Lilly, Kyowa Kirin, MSD, NPS, Servier, Shire, SPA, personal fees from Alexion, Bruno Farmaceutici, Kyowa Kirin, Servier, Shire, outside the submitted work. N. Burlet is a full-time employee at Sanofi Pasteur headquarters, Lyon, France. P.G. Conaghan is supported in part by the National Institute for Health Research (NIHR) Leeds Biomedical Research Centre, outside of the submitted work. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. C. Cooper reports personal fees from Alliance for Better Bone Health, Amgen, Eli Lilly, GSK, Medtronic, Merck, Novartis, Pfizer, Roche, Servier, Takeda and UCB, outside of the submitted work. M. de Wit has received fees for lectures or consultancy through Stichting Tools from Abbvie, BMS, Celgene, Eli Lilly, Janssen-Cilag, Novartis, Pfizer and Roche, outside of the submitted work. J.A. Kanis reports grants from Amgen, grants from Lilly, grants from Radius Health, grants from UCB, other from Meda, outside the submitted work; and is a member of the National Osteoporosis Guideline Group (NOGG) and the principal architect of FRAX but derives no financial benefit. W. Lawrence reports personal fees from Danone Nutricia, outside the submitted work. J.Y. Reginster reports personal fees and other from Servier, IBSA, Genevrier, UCB, Asahi, Radius Health, Meda, Pierre Fabre, grants from Merck Sharp & Dohme (MSD), Amgen, Lilly, Servier, Pfizer, Danone, Meda, Cniel, IBSA, Genevrier, personal fees from MSD, IBSA, Genevrier, Servier, Danone, Pharmevo, Cniel, Meda, and the Dairy Research Council (DRC), outside of the submitted work. R. Rizzoli reports personal fees from Radius Health, Effryx and Danone, outside of the submitted work. M. Scholte-Voshaar has received a grant for her PhD research from Roche and fees for lectures from Pfizer, outside of the submitted work. All other authors report nothing to disclose relating to the submitted work: N. Al-Daghri, I. Araujo de Carvalho, I. Aujoulat, N. Bere, M. Barker, P. Halbout, M. Hiligsmann, F. Jiwa, J. Kirwan, A. Laslop, D. Pinto, C. Prieto Yerro, V. Rabenda, C. Roberts, P. Tugwell, M. Vlaskovska.

Figures

Fig. 1
Fig. 1
Patient involvement in all steps of the update to the core outcome set for psoriatic arthritis
Fig. 2
Fig. 2
Patient involvement can occur at all steps along the medicine development and regulatory lifecycle
See this image and copyright information in PMC

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