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.
Original language | English |
---|---|
Pages (from-to) | 905-915 |
Number of pages | 11 |
Journal | Aging Clinical and Experimental Research |
Volume | 31 |
Issue number | 7 |
DOIs | |
Publication status | Published - Jul 2019 |
Keywords
- Outcomes research
- Patient engagement
- Patient preference
- Regulatory process
- Treatment guidelines
- DISCRETE-CHOICE EXPERIMENT
- PUBLIC INVOLVEMENT
- DRUG DEVELOPMENT
- CORE SET
- PREFERENCES
- ENGAGEMENT
- PARTNERS
Access to Document
- 10.1007/s40520-019-01193-8Licence: CC BY
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In: Aging Clinical and Experimental Research, Vol. 31, No. 7, 07.2019, p. 905-915.
Research output: Contribution to journal › (Systematic) Review article › peer-review
TY - JOUR
T1 - Practical guidance for engaging patients in health research, treatment guidelines and regulatory processes
T2 - 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)
AU - de Wit, Maarten
AU - Cooper, Cyrus
AU - Tugwell, Peter
AU - Bere, Nathalie
AU - Kirwan, John
AU - Conaghan, Philip G.
AU - Roberts, Charlotte
AU - Aujoulat, Isabelle
AU - Al-Daghri, Nasser
AU - de Carvalho, Islene Araujo
AU - Barker, Mary
AU - Bedlington, Nicola
AU - Brandi, Maria Luisa
AU - Bruyere, Olivier
AU - Burlet, Nansa
AU - Halbout, Philippe
AU - Hiligsmann, Mickael
AU - Jiwa, Famida
AU - Kanis, John A.
AU - Laslop, Andrea
AU - Lawrence, Wendy
AU - Pinto, Daniel
AU - Prieto Yerro, Concepcin
AU - Rabenda, Veronique
AU - Rizzoli, Ren
AU - Scholte-Voshaar, Marieke
AU - Vlaskovska, Mila
AU - Reginster, Jean-Yves
N1 - Funding Information: funded by the ESCEO asbl, a Belgian not-for-profit organisation. The authors thank the Chair for Biomarkers of Chronic Diseases and the International Scientific Partnership Program (ISPP#0111) at King Saud University, Riyadh, Saudi Arabia for their support. Role of medical writer/editor Editorial assistance in the preparation of this manuscript was provided by Lisa Buttle, PhD, of Medscript Ltd., which was funded by the ESCEO asbl, Belgium. Funding Information: Conflict of interest 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, EU-PATI 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. Publisher Copyright: © 2019, The Author(s).
PY - 2019/7
Y1 - 2019/7
N2 - 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.
AB - 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.
KW - Outcomes research
KW - Patient engagement
KW - Patient preference
KW - Regulatory process
KW - Treatment guidelines
KW - DISCRETE-CHOICE EXPERIMENT
KW - PUBLIC INVOLVEMENT
KW - DRUG DEVELOPMENT
KW - CORE SET
KW - PREFERENCES
KW - ENGAGEMENT
KW - PARTNERS
U2 - 10.1007/s40520-019-01193-8
DO - 10.1007/s40520-019-01193-8
M3 - (Systematic) Review article
C2 - 30993659
SN - 1594-0667
VL - 31
SP - 905
EP - 915
JO - Aging Clinical and Experimental Research
JF - Aging Clinical and Experimental Research
IS - 7
ER -