Improving benefit-harm assessment of glucocorticoid therapy incorporating the patient perspective: The OMERACT glucocorticoid core domain set.

Autor:	Tieu J; Rheumatology Research Group, Basil Hetzel Institute, Adelaide, Australia, Adelaide Medical School, University of Adelaide, Rheumatology Unit, The Queen Elizabeth Hospital, Adelaide, Australia, Rheumatology Unit, Lyell McEwin Hospital, Adelaide, Australia, Adelaide, Australia., Cheah JT; Division of Rheumatology, University of Massachusetts Medical School, Worcester, Massachusetts, USA, Division of Rheumatology, UMass Memorial Health Care, Worcester, MA, USA., Black RJ; Rheumatology Research Group, Basil Hetzel Institute, Adelaide, Australia, Adelaide Medical School, University of Adelaide, Adelaide, Australia, Rheumatology Unit, The Queen Elizabeth Hospital, Adelaide, Australia, Rheumatology Unit, Royal Adelaide Hospital, Adelaide, Australia., Christensen R; Musculoskeletal Statistics Unit at The Parker Institute, Bispebjerg, Denmark, Frederiksberg Hospital, Copenhagen & Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark., Ghosh N; Division of Rheumatology, Hospital for Special Surgery, New York, USA., Richards P; Patient research partner., Robson J; Rheumatology Research, Centre for Health and Clinical Research, University of the West of England, Bristol, UK, Rheumatology Department, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK., Shea B; Bruyère Research Institute, Senior Methodologist, Ottawa Hospital Research Institute, Ottawa, Canada, Adjunct Professor, Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada., Simon LS; SDG, LLC, Cambridge, MA, USA., Singhi JA; Medicine Service, VA Medical Center, 700 19th St S, Birmingham, AL 35233 USA, Department of Medicine at the School of Medicine, University of Alabama at Birmingham (UAB), 1720 Second Ave. South, Birmingham, AL 35294-0022, USA, Department of Epidemiology at the UAB School of Public Health, 1665 University Blvd., Ryals Public Health Building, Room 220, Birmingham, AL, 35294-0022, USA., Tugwell P; Division of Rheumatology, Department of Medicine, University of Ottawa, School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Abbreviation., Boers M; Department of Epidemiology & Data Science, Amsterdam Rheumatology and Immunology Center, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands, Marco A Alba Garibay, Vasculitis Research Unit, Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, IRB-CELLEX, Institut d'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Barcelona, Spain., Garibay MAA; Vasculitis Research Unit, Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, IRB-CELLEX, Institut d'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Barcelona, Spain., Campochiaro C; Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele, Vita-Salute San Raffaele University, Milan, Italy., Decary S; Patient-Oriented Rehabilitation Lab (SPOR-REHAB), University of Sherbrooke, Faculty of Medicine and Health Sciences, School of Rehabilitation, Research Centre of the CHUS, CIUSSS de l'Estrie-CHUS, Canada., de Witt M; Patient research partner., Fernandez AP; Department of Dermatology & Department of Pathology Cleveland Clinic, Cleveland, OH, USA., Keen HI; School of Medicine, University of Western Australia, Perth, Australia, Rheumatology Department, Fiona Stanley Hospital, Perth, Australia., King L; Department of Medicine, University of Toronto, Canada., Hinojosa-Azaola A; Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico., Hofstetter C; Patient research partner., Gaydukova I; North-Western State medical University named after II Mechnikov, Saint-Petersburg, Russia., George MD; University of Pennsylvania, Division of Rheumatology, Philadelphia, PA, USA., Gupta L; Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow India., Lyne S; Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, College of Medicine and Public Health, Flinders University, Adelaide, South Australia., Makol A; Division of Rheumatology, Mayo Clinic, Rochester, MN, USA., Mukhtyar C; Rheumatologist, Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, UK., Oo WM; Rheumatology department, Royal North Shore Hospital, Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, Australia, University of Medicine, Mandalay, Mandalay, Myanmar., Petri M; Division of Rheumatology, Johns Hopkins University School of Medicine, USA., Pisaniello HL; Discipline of Medicine, Faculty of Health and Medical Sciences, The University of Adelaide, South Australia, Australia, Rheumatology Research Group, Basil Hetzel Institute for Translational Health Research, The Queen Elizabeth Hospital, Woodville South, South Australia, Australia., Sattui SE; Division of Rheumatology, Hospital for Special Surgery, New York, USA., Russell O; Adelaide Medical School, The University of Adelaide, Adelaide, South Australia., Teixeira V; Serviço de Reumatologia, Hospital de Faro, Centro Hospitalar Universitário do Algarve, Portugal., Toupin-April K; School of Rehabilitation Sciences, Faculty of Health Sciences, University of Ottawa, Department of Pediatrics, Faculty of Medicine, University of Ottawa, Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada., Uhunmwangho C; Department of Medicine, University of Jos, Nigeria., Whitstock M; Patient research partner., Yip K; Division of Rheumatology, Hospital for Special Surgery, New York, USA., Mackie SL; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK., Goodman SM; Division of Rheumatology, Hospital for Special Surgery, New York, USA, Weill Cornell Medical College, New York, USA., Hill CL; Rheumatology Unit, The Queen Elizabeth Hospital, Adelaide, Australia, Rheumatology Research Group, Basil Hetzel Institute, Adelaide, Australia, Adelaide Medical School, University of Adelaide, Adelaide, Australia. Electronic address: catherine.hill@sa.gov.au.
Jazyk:	angličtina
Zdroj:	Seminars in arthritis and rheumatism [Semin Arthritis Rheum] 2021 Oct; Vol. 51 (5), pp. 1139-1145. Date of Electronic Publication: 2021 Jun 25.
DOI:	10.1016/j.semarthrit.2021.06.010
Abstrakt:	Objective: Our primary objective was to develop an Outcome Measures in Rheumatology (OMERACT) core domain set to capture the impact of glucocorticoids (GC), both positive and negative, on patients with Rheumatic conditions. Methods: The OMERACT Filter 2.1 was used to guide core domain selection. Systematic literature reviews, qualitative studies and quantitative surveys were conducted by the OMERACT GC Impact working group to identify candidate domains for a core domain set. A summary of prior work and Delphi exercise were presented at the OMERACT 2020 virtual GC workshop. A proposed GC Impact core domain set derived from this work was presented for discussion in facilitated breakout groups. Participants voted on the proposed GC Impact core domain set. Results: 113 people, including 23 patient research partners, participated in two virtual workshops conducted at different times on the same day. The proposed mandatory domains to be evaluated in clinical trials involving GCs were: infection, bone fragility, hypertension, diabetes, weight, fatigue, mood disturbance and death. In addition, collection of disease specific outcomes was included in the core domain set as "mandatory in specific circumstances". The proposed core domain set was endorsed by 100% (23/23) of the patient research partners and 92% (83/90) of the remaining participants, including clinicians, researchers and industry stakeholders. Conclusion: A GC Impact core domain set was endorsed at the OMERACT 2020 virtual workshop. The OMERACT GC Impact working group will now progress to identify, develop and validate measurement tools to best address these domains in clinical trials. Competing Interests: Declaration of Competing Interest MD George reports grants from Bristol-Myers Squibb and personal fees from Dysimmune Diseases Foundation outside the submitted work. M de Witt reports being a collaborating partner in the EU/IMI funded trial to investigate the efficacy and safety of low-dose GC in the elderly. M Boers is principal investigator of the GLORIA trial on low-dose prednisolone or placebo in elderly RA patients, funded by the European Union's Horizon 2020 research and innovation program under the topic ‘’Personalizing Health and Care’’, grant agreement No 634886. M Petri reports grants and personal fees from AstraZeneca, grants and personal fees from Eli Lilly, grants and personal fees from Exagen, grants and personal fees from GSK, grants and personal fees from Thermofisher, personal fees from Aurinia, personal fees from Abbvie, personal fees from Amgen, personal fees from Blackrock, personal fees from BMS, personal fees from Glenmark, personal fees from IQVIA, grants and personal fees from Janssen, personal fees from Merck EMD Serono, personal fees from Novartis, personal fees from Sanofi Japan, personal fees from UCB, outside the submitted work. JA Singh has received consultant fees from Crealta/Horizon, Medisys, Fidia, Two labs Inc, Adept Field Solutions, Clinical Care options, Clearview healthcare partners, Putnam associates, Focus forward, Navigant consulting, Spherix, MedIQ, UBM LLC, Trio Health, Medscape, WebMD, and Practice Point communications; and the National Institutes of Health and the American College of Rheumatology. JA Singh owns stock options in TPT Global Tech, Vaxart pharmaceuticals and Charlotte's Web Holdings, Inc. JAS previously owned stock options in Amarin, Viking and Moderna pharmaceuticals. JA Singh is on the speaker's bureau of Simply Speaking. JA Singh is a member of the executive of Outcomes Measures in Rheumatology (OMERACT), an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. JA Singh serves on the FDA Arthritis Advisory Committee. JAS is the chair of the Veterans Affairs Rheumatology Field Advisory Committee. JAS is the editor and the Director of the University of Alabama at Birmingham (UAB) Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis. R Christensen reports honoraria paid to the Parker institute from: Lecture- Research Methods (Pfizer, DK; 2017), GRADE Lecture (Celgene, DK; 2017), Ad Board Lecture: CAM (Orkla Health, DK; 2017), Project Grant: "GreenWhistle" (Mundipharma, 2019), Lecture: Diet in RMD (Novartis, DK; 2019), Consultancy Report: Network MA's (Biogen, DK; 2017), Ad Board Lecture: GRADE (Lilly, DK; 2017), Consultancy Report: GRADE (Celgene, 2018), Lecture: Network MA's (LEO; 2020), outside the submitted work; and Musculoskeletal Statistics Unit, The Parker Institute is grateful for the financial support received from public and private foundations, companies and private individuals over the years. The Parker Institute is supported by a core grant from the Oak Foundation. R Christensen is a founding member of the Technical Advisory Group of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. I Gaydukova reports personal fees from Abbvie, grants and personal fees from Pfizer, grants and personal fees from MSD, grants and personal fees from Novartis, personal fees from Sandoz, personal fees from Celgen, grants and personal fees from Biocad, personal fees from Teva, outside the submitted work. A Fernandez reports personal fees and other from AbbVie, grants and personal fees from Novartis, grants and personal fees from Mallinckrodt, personal fees from BMS, personal fees from Alexion, other from Corbus, other from Pfizer, outside the submitted work. S Goodman reports research grant support from Novartis and Horizon, and consulting fees from UCB. J Tieu reports research grant support from Vifor Pharmaceuticals, outside the submitted work. C Hill reports research grant support from Vifor Pharmaceuticals, outside the submitted work. H Keen reports personal fees from Roche and Pfizer, outside the submitted work. P Tugwell is a member of the executive of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. S Mackie reports consultancy on behalf of her institution for Roche/Chugai, Sanofi, AbbVie and AstraZeneca, and received support from Roche to attend EULAR2019. SLM is supported by the Leeds Biomedical Research center. J Robson reports speaker fees from Roche and Vifor Pharma, research support from Vifor Pharma and acted as a clinical trials investigator for Chemocentryx and Novartis, outside the submitted work. No disclosures: A Makol, L King, A Hinojosa-Azaola, O Russell, S Lyne, K Toupin-April, S Decary, M Whitstock, L Gupta, M Alba Garibay, K Yip, C Mukhtyar, C Uhunmwangho, WM Oo, C Ruediger, L Yue, LS Simon, RJ Black, JTL Cheah, N Ghosh, C Campochiaro, B Shea, P Richards. MD George reports grants from Bristol-Myers Squibb and personal fees from Dysimmune Diseases Foundation outside the submitted work. M de Witt reports being a collaborating partner in the EU/IMI funded trial to investigate the efficacy and safety of low-dose GC in the elderly. M Boers is principal investigator of the GLORIA trial on low-dose prednisolone or placebo in elderly RA patients, funded by the European Union's Horizon 2020 research and innovation program under the topic ‘’Personalizing Health and Care’’, grant agreement No 634886. M Petri reports grants and personal fees from AstraZeneca, grants and personal fees from Eli Lilly, grants and personal fees from Exagen, grants and personal fees from GSK, grants and personal fees from Thermofisher, personal fees from Aurinia, personal fees from Abbvie, personal fees from Amgen, personal fees from Blackrock, personal fees from BMS, personal fees from Glenmark, personal fees from IQVIA, grants and personal fees from Janssen, personal fees from Merck EMD Serono, personal fees from Novartis, personal fees from Sanofi Japan, personal fees from UCB, outside the submitted work. JA Singh has received consultant fees from Crealta/Horizon, Medisys, Fidia, Two labs Inc, Adept Field Solutions, Clinical Care options, Clearview healthcare partners, Putnam associates, Focus forward, Navigant consulting, Spherix, MedIQ, UBM LLC, Trio Health, Medscape, WebMD, and Practice Point communications; and the National Institutes of Health and the American College of Rheumatology. JA Singh owns stock options in TPT Global Tech, Vaxart pharmaceuticals and Charlotte's Web Holdings, Inc. JAS previously owned stock options in Amarin, Viking and Moderna pharmaceuticals. JA Singh is on the speaker's bureau of Simply Speaking. JA Singh is a member of the executive of Outcomes Measures in Rheumatology (OMERACT), an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. JA Singh serves on the FDA Arthritis Advisory Committee. JAS is the chair of the Veterans Affairs Rheumatology Field Advisory Committee. JAS is the editor and the Director of the University of Alabama at Birmingham (UAB) Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis. R Christensen reports honoraria paid to the Parker institute from: Lecture- Research Methods (Pfizer, DK; 2017), GRADE Lecture (Celgene, DK; 2017), Ad Board Lecture: CAM (Orkla Health, DK; 2017), Project Grant: "GreenWhistle" (Mundipharma, 2019), Lecture: Diet in RMD (Novartis, DK; 2019), Consultancy Report: Network MA's (Biogen, DK; 2017), Ad Board Lecture: GRADE (Lilly, DK; 2017), Consultancy Report: GRADE (Celgene, 2018), Lecture: Network MA's (LEO; 2020), outside the submitted work; and Musculoskeletal Statistics Unit, The Parker Institute is grateful for the financial support received from public and private foundations, companies and private individuals over the years. The Parker Institute is supported by a core grant from the Oak Foundation. R Christensen is a founding member of the Technical Advisory Group of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. I Gaydukova reports personal fees from Abbvie, grants and personal fees from Pfizer, grants and personal fees from MSD, grants and personal fees from Novartis, personal fees from Sandoz, personal fees from Celgen, grants and personal fees from Biocad, personal fees from Teva, outside the submitted work. A Fernandez reports personal fees and other from AbbVie, grants and personal fees from Novartis, grants and personal fees from Mallinckrodt, personal fees from BMS, personal fees from Alexion, other from Corbus, other from Pfizer, outside the submitted work. S Goodman reports research grant support from Novartis and Horizon, and consulting fees from UCB. J Tieu reports research grant support from Vifor Pharmaceuticals, outside the submitted work. C Hill reports research grant support from Vifor Pharmaceuticals, outside the submitted work. H Keen reports personal fees from Roche and Pfizer, outside the submitted work. P Tugwell is a member of the executive of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. S Mackie reports consultancy on behalf of her institution for Roche/Chugai, Sanofi, AbbVie and AstraZeneca, and received support from Roche to attend EULAR2019. SLM is supported by the Leeds Biomedical Research center. J Robson reports speaker fees from Roche and Vifor Pharma, research support from Vifor Pharma and acted as a clinical trials investigator for Chemocentryx and Novartis, outside the submitted work. No disclosures: A Makol, L King, A Hinojosa-Azaola, O Russell, S Lyne, K Toupin-April, S Decary, M Whitstock, L Gupta, M Alba Garibay, K Yip, C Mukhtyar, C Uhunmwangho, WM Oo, C Ruediger, L Yue, LS Simon, RJ Black, JTL Cheah, N Ghosh, C Campochiaro, B Shea, P Richards. (Copyright © 2021. Published by Elsevier Inc.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu Full Text from ScienceDirect