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Objectives: To identify barriers, facilitators, and strategies for future implementation of the OMERACT-Adherence Core Outcome Set (COS) in medication adherence trials for rheumatic conditions., Methods: Preliminary Delphi survey findings were discussed at OMERACT 2023, utilising the Consolidated Framework for Implementation Research 2 to identify implementation barriers, facilitators, and solutions., Results: Implementation strategies included simplifying the COS definitions, making it adaptabile for clinical practice and drug trials, adherence trial training workshops, and collaborating with key stakeholders such as payers and other COS developers., Conclusion: Ongoing collaboration with individuals and organisations within and beyond rheumatology ensures broader applicability of OMERACT-Adherence COS., Competing Interests: Declaration of competing interest All authors named on this manuscript declare that they have no conflicts of interest., (Copyright © 2024. Published by Elsevier Inc.)

Objectives: Shared decision making (SDM) is a central tenet in rheumatic and musculoskeletal care. The lack of standardization regarding SDM instruments and outcomes in clinical trials threatens the comparative effectiveness of interventions. The Outcome Measures in Rheumatology (OMERACT) SDM Working Group is developing a Core Outcome Set for trials of SDM interventions in rheumatology and musculoskeletal health. The working group reached consensus on a Core Outcome Domain Set in 2020. The next step is to develop a Core Outcome Measurement Set through the OMERACT Filter 2.2., Methods: We conducted a scoping review (PRISMA-ScR) to identify candidate instruments for the OMERACT Filter 2.2 We systematically reviewed five databases (Ovid MEDLINE®, Embase, Cochrane Library, CINAHL and Web of Science). An information specialist designed search strategies to identify all measurement instruments used in SDM studies in adults or children living with rheumatic or musculoskeletal diseases or their important others. Paired reviewers independently screened titles, abstracts, and full text articles. We extracted characteristics of all candidate instruments (e.g., measured construct, measurement properties). We classified candidate instruments and summarized evidence gaps with an adapted version of the Summary of Measurement Properties (SOMP) table., Results: We found 14,464 citations, read 239 full text articles, and included 99 eligible studies. We identified 220 potential candidate instruments. The five most used measurement instruments were the Decisional Conflict Scale (traditional and low literacy versions) (n=38), the Hip/Knee-Decision Quality Instrument (n=20), the Decision Regret Scale (n=9), the Preparation for Decision Making Scale (n=8), and the CollaboRATE (n=8). Only 44 candidate instruments (20%) had any measurement properties reported by the included studies. Of these instruments, only 57% matched with at least one of the 7-criteria adapted SOMP table., Conclusion: We identified 220 candidate instruments used in the SDM literature amongst people with rheumatic and musculoskeletal diseases. Our classification of instruments showed evidence gaps and inconsistent reporting of measurement properties. The next steps for the OMERACT SDM Working Group are to match candidate instruments with Core Domains, assess feasibility and review validation studies of measurement instruments in rheumatic diseases or other conditions. Development and validation of new instruments may be required for some Core Domains., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Anthony P. Fernandez, MD, PhD: Past 36 months: Grants or contracts from any entity: Mallinckrodt, Novartis, Pfizer. Payments to institution and (partial) to me. Consulting fees: AbbVie, Biogen, UCB, BMS, Alexion: Payments to me. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: AbbVie, BMS, Kyowa Kirin, Mallinckrodt: Payments to me. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Board of Directors, American Society of Dermatopathology; Associate Editor, Journal of the American Academy of Dermatology. Arundathi Jayatilleke: Pas 36 months: Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Pennsylvania Rheumatology Society, board member: unpaid. Claire Barber: Pas 36 months: Grants or contracts from any entity: CIHR – 3: Peer reviewed national funding unrelated to current project. CIORA (Canadian Rheumatology Association): Peer reviewed national funding unrelated to current project. Cumming school of medicine Seed Grant: Local university funding, peer reviewed, unrelated to current project. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Past chair Human Resource Committee, Canadian Rheumatology Association: Unrelated to current project. Dorcas Beaton: Past 36 months: Support for attending meetings and/or travel: OMERACT Management Team: OMERACT covers travel costs for members of management team to attend conferences on behalf of OMERACT. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Member of Management team of OMERACT, chair of methodology at OMERACT: I help make decisions on the methods that will be used to come to a decision about core outcome sets at OMERACT. This would have informed methods used in this paper. Dorthe B Berthelsen: Past 36 months: Grants or contracts from any entity: Have received PhD Scholarships from Odense University Hospital and from the Faculty of Health Sciences, University of Southern Denmark. Support for attending meetings and/or travel: Have received a grant from the Erna Hamilton Foundation to cover meeting registration fee and travel costs for OMERACT 2023. Dawn Stacey: Past 36 months: Grants or contracts from any entity: Canadian Institutes of Health Research. Support for attending meetings and/or travel: Beijing University of Chinese Medicine – August 2023. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Co-Chair International Patient Decision Aid Standards Collaboration (unpaid). Karine Toupin-April: Past 36 months: Support for attending meetings and/or travel: OMERACT travel award given to the Shared decision making group to help attend the OMERACT 2023 meeting. Lyn MARCH: Past 36 months: Grants or contracts from any entity: Commonwealth Government of Australia Medical Research Future Fund: RCT for biological tapering in RA and PsA (Utilising shared decision making): Payment to institution. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Chair, Australian Rheumatology Association Research Fund Committee: unpaid. Executive, Global Alliance for MSK Health: unpaid. Maria Suarez-Almazor: Past 36 months: Consulting fees: Pfizer: Consultant. Eli Lilly: Consultant. Syneos Health: Consultant. Participation on a Data Safety Monitoring Board or Advisory Board: Celgene: DSMB member. Maarten de Wit: Past 36 months: Consulting fees: UCB: Payment to Stichting Tools, Netherlands. Peter Tugwell: Past 36 months: Consulting fees: Reformulary Group: Providing independent medical consultation professional services to the firms listed in this section. Participation on a Data Safety Monitoring Board or Advisory Board: UCB Biopharma GmbH & SPRL, Parexel International, Prahealth Sciences: An independent Committee Member for clinical trial Data Safety Monitoring Boards for FDA approved trials being conducted by:  - UCB Biopharma GmbH & SPRL, - Parexel International, - Prahealth Sciences. Other financial or non-financial interests: Abbvie, Astra Zeneca, Aurinia, BMS, Centrexion, GSK, Horizon Pharma Inc, Janssen, Novartis, Pfizer & Sparrow: I am [unpaid] Chair of the Management Group of a registered non-profit independent medical research organization, OMERACT, whose goal is to improve and advance the health outcomes for patients suffering from musculoskeletal conditions. OMERACT receives arms-length funding from 11 companies. Rieke Alten: Past 36 months: Consulting fees: Abbvie, BMS, CELLTRION; Eli Lilly; Galapagos, Janssen, Lilly, Novartis, Pfizer, Roche, UCB, Viatris. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: Abbvie, BMS, CELLTRION; Eli Lilly; Galapagos, Janssen, Lilly, Novartis, Pfizer, Roche, UCB, Viatris. Support for attending meetings and/or travel: Abbvie, BMS, CELLTRION; Eli Lilly; Galapagos, Janssen, Lilly, Novartis, Pfizer, Roche, UCB, Viatris. Participation on a Data Safety Monitoring Board or Advisory Board: Abbvie, BMS, CELLTRION; Eli Lilly; Galapagos, Janssen, Lilly, Novartis, Pfizer, Roche, UCB, Viatris. Susan J. Bartlett: Past 36 months: Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: American Thoracic Society Board of Directors: 2020–2022; unpaid. PROMIS Health Organization – President Elect, Board of Directors: unpaid. American College of Rheumatology Association of Rheumatology Professionals Executive Committee: 2021–2023; unpaid. Simon Stones: Past 36 months: Consulting fees: Future Science Group: Payment for document review. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: RAiISE: Director. Stock or stock options: Envision Pharma Group: Related to employment. Other financial or non-financial interests: Envision Pharma Group: Employment. Esi Morgan: Past 36 months: Grants or contracts from any entity: Pfizer, Inc: Educational Program to Optimize Delivery of Care to Families with Juvenile Idiopathic Arthritis Over Telemedicine; Investigator Initiated Grant to Seattle Children's Research Institute, role – co-Investigator. Agency for Healthcare Research and Quality: Informing personalized treatment decision with advanced Bayesian causal inference - A patient-centred evidence-based shared decision making (SDM) digital health technology; Investigator Initiated Grant to Seattle Children's Research Institute, role – PI (multi-PI grant). Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: American College of Rheumatology: Honorarium, Education Conference April 2023. Support for attending meetings and/or travel: American College of Rheumatology: Travel Support Education Exchange Conference April 2023. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: pediatric Rheumatology Care and Outcomes Improvement Network: Principal Investigator. Francis GUILLEMIN: Past 36 months: Grants or contracts from any entity: Novartis: Payment to my institution. Hemalatha Srinivasalu: Past 36 months: Grants or contracts from any entity: CARRA Registry Associate and NIAMS Intramural program. Janet Jull: Past 36 months: Grants or contracts from any entity: Canadian Institutes of Health Research. Jennifer L. Barton: Past 36 months: Grants or contracts from any entity: US Department of Veterans Affairs. Jasvinder A. Singh: Past 36 months: Consulting fees: Crealta/Horizon, Medisys, Fidia, PK Med, Two labs Inc., Adept Field Solutions, Clinical Care options, Clearview healthcare partners, Putnam associates, Focus forward, Navigant consulting, Spherix, MedIQ, Jupiter Life Science, UBM LLC, Trio Health, Medscape, WebMD, and Practice Point communications; and the National Institutes of Health and the American College of Rheumatology: Consultant fees paid to me for each entity. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: JAS is on the speaker's bureau of Simply Speaking: Consultant fees paid to me. Support for attending meetings and/or travel: Past steering committee member of OMERACT: I previously received support from the organization to attend their meeting every 2 years. Participation on a Data Safety Monitoring Board or Advisory Board: FDA Arthritis Advisory Committee: JAS serves as a member. No financial support. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Past steering committee member of the OMERACT, an international organization that develops measures for clinical trials and receives arms length funding from 12 pharmaceutical companies: I previously received support from the organization to attend their meeting every 2 years. Co-Chair of the Veterans Affairs Rheumatology Field Advisory Committee: No financial support. Editor and the Director of the UAB Cochrane Musculoskeletal Group Satellite center on Network Meta-analysis: No financial support. Stock or stock options: JAS owns stock options in Atai life sciences, Kintara therapeutics, Intelligent Biosolutions, Acumen pharmaceutical, TPT Global Tech, Vaxart pharmaceuticals, Atyu biopharma, Adaptimmune Therapeutics, GeoVax Labs, Pieris Pharmaceuticals, Enzolytics Inc., Seres Therapeutics, Tonix Pharmaceuticals Holding Corp., and Charlotte's Web Holdings, Inc.: I own stock options. JAS previously owned stock options in Amarin, Viking and Moderna pharmaceuticals: I owned stock options in these companies previously. Saurab Sharma: Past 36 months: Grants or contracts from any entity: I am supported by the International Association for the Study of Pain John J. Bonica Postdoctoral Fellowship. The funder does not have any influence on my research. Support for attending meetings and/or travel: My travel was supported to present a talk (unrelated to the manuscript) at the International Association for the Study of Pain (IASP) Congress in Toronto in 2022. Victor Sloan: Past 36 months: Consulting fees: Boehringer-Ingelheim: Payment to me. Stock or stock options: Stock in UCB Pharma. Willemina Campbell: Past 36 months: Payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events: ABBVIE and Einstein Medical School. Support for attending meetings and/or travel: OMERACT and GRAPPA. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: GRAPPA PRP CHAIR-past., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: To educate and discuss pain mechanisms (nociceptive, neuropathic, nociplastic) illuminating its possible impact when measuring different outcomes, which may modify, confound and potentially bias the outcome measures applied across various aspects of Rheumatic Musculoskeletal Diseases (RMDs) clinical trials., Methods: In the plenary presentations, PM lectured on different pain mechanisms and impact on disease activity assessment. Data from two data sets of RMDs patients, which assessed the prevalence and impact of nociplastic pain were presented and reviewed. Audience breakout group sessions and polling were conducted., Results: Mixed pain etiologies may differentially influence disease activity assessment and therapeutic decision-making. Polling demonstrated a consensus on the need to assess different types of pain as a phenotype, as it constitutes an important contextual factor (a variable that is not an outcome of the trial, but needs to be recognized [and measured] to understand the study results), and to standardize across RMDs., Conclusion: There is need for a standardized pain measure that can differentiate underlying pain mechanisms., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Mary Cowern Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid - Leadership role - Head of Nations at Versus Arthritis - Paid role Lee S Simon Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid - Chair of OMERACT Finance Committee Caitlin M P Jones Grants or contracts from any entity - Awarded seed funding grants for unrelated projects from Arthritis Australia, ANZBACK and Wiser healthcare Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events - Contractor to OMERACT for casual research work (not related to this project) Support for attending meetings and/or travel - OMERACT supported me to attend OMERACT 2023 in Colorado USA (economy class flights, accommodation and conference registration) Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid - Member of the ANZMUSC ECR committee, Member of the Sydney University School of Public Health EMCR committee Lara J Maxwell Other financial or non-financial interests - LJM is a paid staff member of OMERACT Beverley Shea Other financial or non-financial interests - OMERACT Senior Methodologist Vibeke Strand All support for the present manuscript (e.g., funding, provision of study materials, medical writing, article processing charges, etc.) - I am a founding member of the executive committee of Outcome Measures in Rheumatology (OMERACT) [1992 – present], an international consensus organization that develops and validates outcome measures in rheumatology randomized controlled trials and longitudinal observational studies and has received arms-length funding from as many as 36 sponsors. Grants or contracts from any entity - I am a founding member of the executive committee of Outcome Measures in Rheumatology (OMERACT) [1992 – present], an international consensus organization that develops and validates outcome measures in rheumatology randomized controlled trials and longitudinal observational studies and has received arms-length funding from as many as 36 sponsors. Karine Toupin-April Support for attending meetings and/or travel - OMERACT travel award given to the Shared decision making group to help attend the OMERACT 2023 meeting Philip Mease Grants or contracts from any entity - Acelyrin, Amgen, Bristol Myers Squib, Eli Lilly, Janssen, Novartis, Pfizer, UCB Consulting fees - Acelyrin, Aclaris, Amgen, Bristol Myers Squib, CorEvitas, Eli Lilly, Inmagene, Janssen, Moonlake Pharma, Novartis, Pfizer, UCB, Ventyx Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events - Amgen, Eli Lilly, Janssen, Novartis, Pfizer, UCB Participation on a Data Safety Monitoring Board or Advisory Board - Genascence – DSMB Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid - Group for Research and Assessment of Psoriasis and Psoriatic Arthritis – Executive board, Spondyloarthritis Research and Therapy Network Ernest Choy Grants or contracts from any entity - Bio-Cancer, Biogen, Novartis, Pfizer, Sanofi Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events - Abbvie, Amgen, Asofarma, Biogen, Bristol Myer Squibbs, Chugai Pharma, Eli Lilly, Fresenius Kabi, Galapagos, Janssen, Novartis, Pfizer, Sanofi, UCB Support for attending meetings and/or travel - Galapagos, Janssen, UCB Stock or stock options – Inmedix Receipt of equipment, materials, drugs, medical writing, gifts or other services - Inmedix, (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

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.)

Objective: Nonadherence to medications is common in rheumatic conditions and associated with increased morbidity. Heterogeneous outcome reporting by researchers compromises the synthesis of evidence of interventions targeting adherence. We aimed to assess the scope of outcomes in interventional studies of medication adherence., Methods: We searched electronic databases to February 2019 for published randomized controlled trials and observational studies of interventions with the primary outcome of medication adherence including adults with any rheumatic condition, written in English. We extracted and analyzed all outcome domains and adherence measures with prespecified extraction and analysis protocols., Results: Overall, 53 studies reported 71 outcome domains classified into adherence (1 domain), health outcomes (38 domains), and adherence-related factors (e.g., medication knowledge; 32 domains). We subdivided adherence into 3 phases: initiation (n = 13 studies, 25%), implementation (n = 32, 60%), persistence (n = 27, 51%), and phase unclear (n = 20, 38%). Thirty-seven different instruments reported adherence in 115 unique ways (this includes different adherence definitions and calculations, metric, and method of aggregation). Forty-one studies (77%) reported health outcomes. The most frequently reported were medication adverse events (n = 24, 45%), disease activity (n = 11, 21%), bone turnover markers/physical function/quality of life (each n = 10, 19%). Thirty-three studies (62%) reported adherence-related factors. The most frequently reported were medication beliefs (n = 8, 15%), illness perception/medication satisfaction/satisfaction with medication information (each n = 5, 9%), condition knowledge/medication knowledge/trust in doctor (each n = 3, 6%)., Conclusion: The outcome domains and adherence measures in interventional studies targeting adherence are heterogeneous. Consensus on relevant outcomes will improve the comparison of different strategies to support medication adherence in rheumatology.

Objective: The Outcome Measures in Rheumatology (OMERACT) Shared Decision Making (SDM) Working Group aims to determine the core outcome domain set for measuring the effectiveness of SDM interventions in rheumatology trials., Methods: A white paper was developed to clarify the draft core domain set. It was then used to prepare for interviews to investigate reasons for lack of consensus on it and to suggest further improvements., Results: OMERACT scientists/clinicians (n = 13) and patients (n = 10) suggested limiting the core domain set to outcome domains, removing process domains, and clarifying remaining domains., Conclusion: A revised core domain set will undergo further consensus-building.

Objective: The Contextual Factors Working Group aims to provide guidance on addressing contextual factors in rheumatology trials within OMERACT., Methods: During the Special Interest Group session at OMERACT 2018, preliminary results were presented from a case scenario survey and semistructured interviews, including contextual factors mentioned in these. A group-based exercise sought to identify and rank important generic contextual factors., Results: A total of 79 candidate factors were listed. Across the 3 groups, gender/sex, comorbidities, and the healthcare system were ranked as most important., Conclusion: The identified important contextual factor domains may be considered a provisional list pending further research.

Background: Over the last 20 years, there have been marked improvements in the availability of effective medications for rheumatic conditions such as gout, osteoporosis and rheumatoid arthritis (RA), which have led to a reduction in disease flares and the risk of re-fracture in osteoporosis, and the slowing of disease progression in RA. However, medication adherence remains suboptimal, as treatment regimens can be complex and difficult to continue long term. Many trials have been conducted to improve adherence to medication. Core domains, which are the outcomes of most relevance to patients and clinicians, are a pivotal component of any trial. These core domains should be measured consistently, so that all relevant trials can be combined in systematic reviews and meta-analyses to reach conclusions that are more valid. Failure to do this severely limits the potential for trial-based evidence to inform decisions on how to support medication adherence. The Outcome Measures in Rheumatology (OMERACT) - Interventions for Medication Adherence study by the OMERACT-Adherence Group aims to develop a core domain set for interventions that aim to support medication adherence in rheumatology., Methods/design: This OMERACT-Adherence study has five phases: (1) a systematic review to identify outcome domains that have been reported in interventions focused on supporting medication adherence in rheumatology; (2) semi-structured stakeholder interviews with patients and caregivers to determine their views on the core domains; (3) focus groups using the nominal group technique with patients and caregivers to identify and rank domains that are relevant to them, including the reasons for their choices; (4) an international three-round modified Delphi survey involving patients with diverse rheumatic conditions, caregivers, health professionals, researchers and other stakeholders to develop a preliminary core domain set; and (5) a stakeholder workshop with OMERACT members to review, vote on and reach a consensus on the core domain set for interventions to support medication adherence in rheumatology., Discussion: Establishing a core domain set to be reported in all intervention studies undertaken to support patients with medication adherence will enhance the relevance and the impact of these results and improve the lives of people with rheumatic conditions.

Objective: The aim of this Outcome Measures in Rheumatology (OMERACT) Working Group was to determine the core set of outcome domains and subdomains for measuring the effectiveness of shared decision-making (SDM) interventions in rheumatology clinical trials., Methods: Following the OMERACT Filter 2.0, and based on a previous literature review of SDM outcome domains and a nominal group process at OMERACT 2014, (1) an online Delphi survey was conducted to gather feedback on the draft core set and refine its domains and subdomains, and (2) a workshop was held at the OMERACT 2016 meeting to gain consensus on the draft core set., Results: A total of 170 participants completed Round 1 of the Delphi survey, and 116 completed Round 2. Respondents came from 29 countries, with 49% being patients/caregivers. Results showed that 14 out of the 17 subdomains within the 7 domains exceeded the 70% criterion (endorsement ranged from 83% to 100% of respondents). At OMERACT 2016, only 8% of the 96 attendees were patients/caregivers. Despite initial votes of support in breakout groups, there was insufficient comfort about the conceptualization of these 7 domains and 17 subdomains for these to be endorsed at OMERACT 2016 (endorsement ranged from 17% to 68% of participants)., Conclusion: Differences between the Delphi survey and consensus meeting may be explained by the manner in which the outcomes were presented, variations in participant characteristics, and the context of voting. Further efforts are needed to address the limited understanding of SDM and its outcomes among OMERACT participants.

Objective: The goal of the Outcome Measures in Rheumatology (OMERACT) 12 (2014) equity working group was to determine whether and how comprehensibility of patient-reported outcome measures (PROM) should be assessed, to ensure suitability for people with low literacy and differing cultures., Methods: The English, Dutch, French, and Turkish Health Assessment Questionnaires and English and French Osteoarthritis Knee and Hip Quality of Life questionnaires were evaluated by applying 3 readability formulas: Flesch Reading Ease, Flesch-Kincaid grade level, and Simple Measure of Gobbledygook; and a new tool, the Evaluative Linguistic Framework for Questionnaires, developed to assess text quality of questionnaires. We also considered a study assessing cross-cultural adaptation with/without back-translation and/or expert committee. The results of this preconference work were presented to the equity working group participants to gain their perspectives on the importance of comprehensibility and cross-cultural adaptation for PROM., Results: Thirty-one OMERACT delegates attended the equity session. Twenty-six participants agreed that PROM should be assessed for comprehensibility and for use of suitable methods (4 abstained, 1 no). Twenty-two participants agreed that cultural equivalency of PROM should be assessed and suitable methods used (7 abstained, 2 no). Special interest group participants identified challenges with cross-cultural adaptation including resources required, and suggested patient involvement for improving translation and adaptation., Conclusion: Future work will include consensus exercises on what methods are required to ensure PROM are appropriate for people with low literacy and different cultures.