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Objective: The OMERACT Composite Working Group hosted a workshop at OMERACT 2023 to explore the complexities of weighting components in the development of composite outcomes. This study presents the methodology and findings of this workshop, exploring the complexities of weighting the individual components of composite outcome measures., Methods: The workshop featured a multifaceted program, beginning with a plenary session that introduced the concept of composite outcomes, shared a patient's journey with rheumatic disease through a narrative, illustrated a composite outcome for Osteoarthritis Flares, and outlined the five domains selected for this composite outcome. A breakout exercise engaged participants in ranking and assigning weights to these domains, followed by group discussions to reach a consensus on weights. The workshop concluded with another plenary session that discussed various weighting approaches, including discrete choice and conjoint analysis from the ANCA-Associated Vasculitis working group, and outlined future directions for research on composite outcome methods., Results: The breakout exercise revealed the challenges in assigning relative importance to different domains, highlighting the variability in participant perspectives. Consensus discussions highlighted the diversity in approaches to weighting, the need for appropriate methods to determine domain weights and the impact of such weights on the interpretation of composite scores., Conclusion: The OMERACT 2023 workshop underscored the significance of a systematic approach to weighting components in composite outcome development. It highlighted the complexity of achieving consensus on the importance of domains and the role of incorporating the perspectives of patient research partners in this process. Future research directions include refining weighting methodologies, moving composites through the OMERACT Filter and enhancing understanding of their implications for clinical trials. The findings contribute to the ongoing discourse on optimizing composite outcome measures in rheumatology and beyond, advocating for a balanced integration of scientific rigour and patient-centeredness in their development., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Peter Tugwell receives consulting fees from Reformulary Group for providing independent medical consultation professional services to the firms listed in this section. Participation on a Data Safety Monitoring Board or Advisory Board for UCB Biopharma GmbH & SPRL Parexel International Prahealth Sciences. Is 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 with Abbvie, Astra Zenaca, Aurinia, BMS, Centrexion, GSK, Horizon Pharma Inc, Janssen, Novartis, Pfizer & Sparrow. He is [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 8 companies. Dorcas Beaton has an unpaid leadership role as a member of the Management team at OMERACT, co-chair of the methods group, and technical advisory group of OMERACT. Maarten de Wit receives consulting fees from Evidera (Patient Partner Advisory Council), honoraria from UCB 2022, 2023 for facilitating a workshop. Sara Monti received consulting fees from CLS-Vi for AstraZeneca All other authors have no conflicts to declare., (Copyright © 2024. Published by Elsevier Inc.)

Objective: To increase awareness and understanding of the principles of Equity, Diversity, and Inclusivity (EDI) within Outcome Measures in Rheumatology's (OMERACT) members. For this, we aimed to obtain ideas on how to promote and foster these principles within the organization and determine the diversity of the current membership in order to focus future efforts., Methods: We held a plenary workshop session at OMERACT 2023 with roundtable discussions on barriers and solutions to increased diversity within OMERACT. We conducted an anonymous, web-based survey of members to record characteristics including population group, gender identity, education level, age, and ability., Results: The workshop generated ideas to increase diversity of participants across the themes of building relationships [12 topics], materials and methods [5 topics], and conference-specific [6 topics]. Four hundred and seven people responded to the survey (25 % response rate). The majority of respondents were White (75 %), female (61 %), university-educated (94 %), Christian (42 %), spoke English at home (60 %), aged 35 to 55 years (50 %), and did not report a disability (64 %)., Conclusion: OMERACT is committed to improving its diversity. Next steps include strategic recruitment of members to the EDI working group, drafting an EDI mission statement centering equity and inclusivity in the organization, and developing guidance for the OMERACT Handbook to help all working groups create actionable plans for promoting EDI principles., Competing Interests: Declaration of competing interest GS, AA, JLB, SG, CH, CB, EN, PH, JP, BJS have no relevant conflicts of interest to disclose. LJM is a paid staff member of OMERACT. GCW has received fees, research grants from AbbVie, AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Company, Gilead Sciences, GSK, Janssen Biotech, Novartis, Pfizer, Sanofi Genzyme, UCB FG received a grant from NOVARTIS paid to his institution. WC reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Abbvie and Einstein Medical College; support for attending meetings and/or travel for previous OMERACT and GRAPPA meetings; and was past GRAPPA PRP Chair. NG reports support by OMERACT to attend the 2023 OMERACT in person meeting. Owner of stock in Abcuro and UCB and stock option grant at TrialSpark. TrialSpark grant expires 11 Oct 2023. Minority holder in all companies. Former employee of TrialSpark, Inc. (position terminated 11 Jul 2023). LSS is on the Management Committee of OMERACT and is Chair, Finance Committee of OMERACT. PT: Consulting Fees from Reformulary Group. 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. 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: Abbvie, Astra Zenaca, Aurinia, BMS, Centrexion, GSK, Horizon Pharma Inc, Janssen, Novartis, Pfizer & Sparrow., (Copyright © 2024. Published by Elsevier Inc.)

Objective: To gain consensus on the definitions and descriptions of the domains of the Outcome Measures in Rheumatology (OMERACT) core domain set for rheumatology trials evaluating shared decision making (SDM) interventions., Methods: Following the OMERACT Handbook methods, our Working Group (WG), comprised of 90 members, including 17 patient research partners (PRPs) and 73 clinicians and researchers, had six virtual meetings in addition to email exchanges to develop draft definitions and descriptions. The WG then conducted an international survey of its members to gain consensus on the definitions and descriptions. Finally, the WG members had virtual meetings and e-mail exchanges to review survey results and finalize names, definitions and descriptions of the domains., Results: WG members contributed to developing the definitions. Fifty-two members representing four continents and 13 countries completed the survey, including 15 PRPs, 33 clinicians and 37 researchers. PRPs and clinicians/researchers agreed with all definitions and descriptions with agreements ranging from 87% to 100%. Respondents suggested wording changes to the names, definitions and descriptions to better reflect the domains. Discussions led to further simplification and clarification to address common questions/concerns about the domains., Conclusion: Our WG reached consensus on the definitions and descriptions of the domains of the core domain set for rheumatology trials of SDM interventions. This step is crucial to understand each domain and provides the foundation to identify instruments to measure each domain for inclusion in the Core Outcome Measurement Set., Clinical Significance: The current study provides consensus-based definitions and descriptions for the domains of the OMERACT core domain set for shared decision making interventions from patients/caregivers, clinicians and researchers. This is a crucial step to understand each domain and provides the foundation to identify instruments to measure each domain for inclusion in the Core Outcome Measurement Set for trials of SDM interventions., Competing Interests: Declaration of competing interest Karine Toupin-April, Simon Décary, Maarten de Wit, Florian Naye, Alexa Meara, Jennifer L. Barton, Liana Fraenkel, Linda C. Li, Peter Brooks, Beverley Shea, Dawn Stacey, Cathie Hofstetter, Marieke Voshaar, Maria E. Suarez-Almazor, Tanya Meade, Janet Elizabeth Jull, Willemina Campbell, Rieke Alten, Esi M. Morgan, Ayano Kelly, Lara J. Maxwell, Francis Guillemin, Dorcas Beaton, Yasser El-Miedany, Shikha Mittoo, Tiffany Westrich Robertson, Susan J. Bartlett, Melissa Mannion, Samah Ismail Nasef, Adewale Adebajo, Laurent Arnaud, Tiffany K. Gill, Ellen Moholt, Jennifer Burt, Aruni Jayatilleke, Ihsane Hmamouchi, David Carrott, Kate Mather, Ajesh Maharaj, Saurab Sharma, Francesco Caso, Christopher Fong, Allyson Jones, Regina Greer-Smith, Akpabio Akpabio, Valerie Umaefulam, Sara Monti, Grayson Schultz, Rebecca R. Lee, Glen Stewart Hazlewood, Claire E.H. Barber, Dorthe B. Berthelsen, Laure Gossec, Sabrina May Nielsen, Sabrina Cavallo, Sonam Kiwalkar, Hemalatha Srinivasalu, Deb Constien, Vicki Evans and Peter Tugwell have nothing to disclose. Anne Boel is employed by UCB Pharma, B.V. Netherlands. Simon Stones is employed by Envision Pharma Group, Wilmslow, UK. Robin Christensen reports other potential COI from Lecture: Research Methods (Pfizer, DK; 2017), other from Lecture: GRADE Lecture (Celgene, DK; 2017), other from Ad Board Lecture: CAM (Orkla Health, DK; 2017), other from Project Grant: "GreenWhistle" (Mundipharma, 2019), other from Lecture: Diet in RMD (Novartis, DK; 2019), other from Consultancy Report: Network MA's (Biogen, DK; 2017), other from Ad Board Lecture: GRADE (Lilly, DK; 2017), other from Consultancy Report: GRADE (Celgene, 2018), other from 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; The Oak Foundation is a group of philanthropic organizations that, since its establishment in 1983, has given grants to not-for-profit organizations around the world. Annelies Boonen reports grants from Abbvie, grants from Celgene, other from UCB, other from Galapagos, other from Eli Lilly, outside the submitted work. Lyn March reports personal fees from Pfizer Australia, personal fees from Abbvie Australia, grants from Janssen Australia, outside the submitted work; Dr March is a member of OMERACT executive that receives arms-length funding from 9 companies. Willemina Campbell received OMERACT funded travel to a conference to attend meetings in regard to this paper. Jasvinder Singh reports personal fees from Crealta/Horizon, Medisys, Fidia, UBM LLC, Trio health, Medscape, WebMD, Adept Field Solutions, Clinical Care options, Clearview healthcare partners, Putnam associates, Focus forward, Navigant consulting, Spherix, Practice Point communications, the National Institutes of Health and the American College of Rheumatology, personal fees from Simply Speaking, other from Vaxart pharmaceuticals and Charlotte's Web Holdings (current); Amarin, Viking, and Moderna (previously owned), non-financial support from FDA Arthritis Advisory Committee, non-financial support from Steering committee of OMERACT, an international organization that develops measures for clinical trials and receives arms’ length funding from 12 pharmaceutical companies, non-financial support from Veterans Affairs Rheumatology Field Advisory Committee, non-financial support from Editor and the Director of the UAB Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis, outside the submitted work. Francisco J. Blanco reports grants from Gedeon Richter Plc., Bristol-Myers Squibb International Corporation (BMSIC), Sun Pharma Global FZE, Celgene Corporation, Janssen Cilag International N.V, Janssen Research & Development, Viela Bio, Inc., Astrazeneca AB, UCB BIOSCIENCES GMBH, UCB BIOPHARMA SPRL, AbbVie Deutschland GmbH & Co.KG, Merck KGaA, Amgen, Inc., Novartis Farmacéutica, S.A., Boehringer Ingelheim España, S.A, CSL Behring, LLC, Glaxosmithkline Research & Development Limited, Pfizer Inc, Lilly S.A., Corbus Pharmaceuticals Inc., Biohope Scientific Solutions for Human Health S.L., Centrexion Therapeutics Corp., Sanofi, MEIJI FARMA S.A., Kiniksa Pharmaceuticals, Ltd. Grunenthal, Asofarma Mexico, Gebro Pharma, Roche, Galapagos, Regeneron; outside the submitted work. Anthony P. Fernandez reports personal fees and other from AbbVie, grants, personal fees and other from Novartis, grants, personal fees and other from Mallinkrodt, other from Corbus, other from Pfizer, outside the submitted work. Sarah Mackie reports: Consultancy on behalf of her institution for Roche/Chugai, Sanofi, AbbVie, AstraZeneca, Pfizer; Investigator on clinical trials for Sanofi, GSK, Sparrow; speaking/lecturing on behalf of her institution for Roche/Chugai, Vifor, Pfizer, UCB, Novartis and AbbVie; chief investigator on STERLING-PMR trial, funded by NIHR; patron of the charity PMRGCAuk. No personal remuneration was received for any of the above activities. Support from Roche/Chugai to attend EULAR2019 in person and from Pfizer to attend ACR Convergence 2021 virtually. She is supported in part by the NIHR Leeds Biomedical Research Centre. The views expressed in this article are those of the authors and not necessarily those of the NIHR, the NIHR Leeds Biomedical Research Centre, the National Health Service or the UK Department of Health and Social Care. Elena Nikiphorou reports personal fees and other from AbbVie, personal fees and other from Eli-Lilly, personal fees and other from Gilead, personal fees and other from Celltrion, personal fees and other from Pfizer, other from Sanofi, outside the submitted work. Victor S. Sloan reports and paid consultant to various pharmaceutical companies and healthcare consultancies providing advice on clinical research and advisory committee preparation outside the scope of the submitted work. He is a shareholder in UCB Pharma. He is in the Peace Corps. This is his personal work, and does not reflect the opinion of the Peace Corps or the United States Government. Vibeke Strand reports consulting fees from AbbVie, Amgen, Arena, AstraZeneca, BMS, Boehringer Ingelheim, Celltrion, CORRONA, Crescendo/Myriad, Equillium, Genentech/Roche, GSK, Horizon, Inmedix, Janssen, Eli Lilly, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Samsung, Sandoz, Sanofi, TwoXAR and UCB, outside the submitted work. Esi M. Morgan reports grant support from Agency for Healthcare Research and Quality and Pfizer., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: To describe the evolution of the OMERACT Fellows Program (OM FP) and to evaluate the innovative changes implemented in the 2023 program., Methods: The OM FP, the first of its kind in global rheumatology, was developed in 2000 to mentor early career researchers in methods and processes for reaching evidence-driven consensus for outcome measures in clinical studies. The OM FP has evolved through continuing iterations of face to face and online feedback. Key new features delivered in 2023 included e-learning modules, virtual introductory pre-meetings, increased networking with Patient Research Partners (PRPs), learning opportunities to give and receive personal feedback, ongoing performance feedback during the meeting from Fellow peers, PRPs, senior OMERACTers (members of the OMERACT community) and Emerging Leader mentors, involvement in pitching promotions, two-minute Lightning Talks in a plenary session and an embedded poster tour. An online survey was distributed after the meeting to evaluate the program., Results: OM FP has included 208 fellows from 16 countries across 4 continents covering 47 different aspects of rheumatology outcomes since its inception. Over 50 % have remained engaged with OMERACT work. In 2023, 18 Fellows attended and 15 (83 %) completed the post-meeting survey. A dedicated OM FP was deemed important by all respondents, and 93 % would attend the meeting in future. The PRP/Fellow Connection Carousel and Lightning Talks were rated exceptional by 93 %. Key components to improve included clarification of expectations, overall workload, the Emerging Leaders Mentoring Program, and the content and duration of daily summary sessions., Conclusion: The innovations in the 2023 OM FP were well received by the majority of participants and supports early career rheumatology researchers to develop collaborations, skills and expertise in outcome measurement. Implementation of feedback from Fellows will enhance the program for future meetings, continuing to facilitate learning and succession planning within OMERACT., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Lara Chapman Grants or contracts from any entity: HEE/NIHR Clinical Doctoral Research Fellowship (ID NIHR30217) Nilasha Ghosh Consulting fees: Musculo Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: GoodRx Clinical Review Board Francis Guillemin Grants or contracts from any entity: NOVARTIS Max Weinbrecht-Mischkewitz OMERACT, Minister Erna Hamiltons Legat, and The Parker Institute, Bispebjerg and Frederiksberg Hospital and the Department of Internal Medicine, Rheumatology, Clinical Immunology and Osteology, Schlosspark-Klinik, University Medicine Berlin - Funding for OMERACT 2023 registration fee and travel costs Romi Haas Support for attending meetings and/or travel: 2023 Advancing Women's Success Grant, Monash University - Support to attend OMERACT meeting 2023 Colorado Springs Rachael A. Gordon Grants or contracts from any entity: Sjogrens Foundation Pilot Grant - NIH 5T32AI089443–13 - support for attending meetings and/or travel, (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objectives: To generate candidates for contextual factors (CFs) for each CF type (i.e., Effect Modifying Contextual Factors (EM-CFs), Outcome Influencing Contextual Factors (OI-CFs), and Measurement Affecting Contextual Factors (MA-CFs)) considered important within rheumatology., Methods: We surveyed OMERACT working groups and conducted a Special Interest Group (SIG) session at the OMERACT 2023 meeting, where the results were reviewed, and additional CFs suggested., Results: The working groups suggested 44, 49, and 21 generic EM-CFs, OI-CFs, and MA-CFs, respectively. SIG participants added 49, 44, and 55 factors, respectively., Conclusion: Candidate CFs were identified, next step is a consensus-based set of endorsed (important) CFs., Competing Interests: Declaration of competing interest Amye Leong reports unpaid leadership or fiduciary roles at the Arthritis Foundation, the United States Bones and Joint Initiative and the FDA Patient Engagement Advisory Committee. Annelies Boonen reports a research grant from Abbvie and honoraria from Abbvie, Pfizer, UCB, Novartis and Galapagos for lectures or advisory boards, all to her department. Dorthe Bang Berthelsen reports PhD Scholarships from Odense University Hospital and from the Faculty of Health Sciences, University of Southern Denmark. Francis Guillemin reports grant by Novartis, paid to his institution. Irene van der Horst-Bruinsma reports travel support for EULAR 2023 by Pfizer and unpaid membership in the ASAS advisory board. Maria A. Lopez-Olivo reports grants or contracts from the National Cancer Institute, the Rheumatology Research Foundation and the Duncan Family Institute for Cancer Prevention and Risk Assessment, and consulting fees from the American Cancer Society. Niti Goel reports that she is an owner of stock in Abcuro and UCB and that she is a former employee of TrialSpark, Inc. Peter Tugwell reports consulting fees from the Reformulary Group, being independent Committee Member for clinical trial Data Safety Monitoring Boards for UCB Biopharma GmbH & SPRL, Parexel International and PRA Health Sciences and being chair of the Management Group of OMERACT, a registered non-profit independent medical research organization. OMERACT receives arms-length funding from eleven companies (Abbvie, Astra Zenaca, Aurinia, BMS, Centrexion, GSK, Horizon Pharma Inc, Janssen, Novartis, Pfizer, Sparrow). Rieke Alten reports personal and institutional payments from BMS, Galapagos, Janssen, Lilly, Novartis, Pfizer and UCB as wells as institutional payments from Abbvie and Amgen, support for attending meetings from Celltrion, Lilly and UCB, and membership of an advisory board for Pfizer. Saurab Sharma was supported by the International Association for the Study of Pain John J. Bonica Postdoctoral Fellowship (2021-2023) and travel support to the International Association for the Study of Pain (IASP) Congress in Toronto (2022) both unrelated to the current work. Victor S. Sloan reports consulting fees from Boehringer-Ingelheim, stock in UCB Pharma and as an employee of the Peace Corps states: “This is my personal work, and does not reflect the opinion of the Peace Corps or the United States Government.”. The other authors have no conflict of interest relevant to the content of this study., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

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.)

Purpose: We aimed to analyze the content validity/domain match and feasibility of self-report instruments that could measure flare in osteoarthritis (OA), by extending our 2017 literature review on the definition of flare in knee and hip OA., Method: We searched PubMed (Medline), Web of Science and PsycInfo (Ebsco Host) databases for original articles reporting research about flare (or synonyms) in humans with knee and hip OA, between 2017 and 2023. Four experts worked independently, checking the records, and assessing content validity and feasibility, writing justification for exclusion., Results: At literature review phase, 575 papers were filtered. After experts' analysis, 59 studies were included, and 44 instruments associated with flare in OA were identified. Most were studies about pain in knee or hip OA (35 %), cultural adaptation of a measure (33 %) or studies investigating psychometric properties of full (16 %) or short form (4 %) instruments. The assessment of domain match and feasibility revealed that 15 instruments were assigned a label of 'yes' or 'uncertain' as to whether or not there was a good match with the domain concept or whether the instrument was considered feasible to use., Discussion: Most identified instruments considered different aspects of pain and the associated discomfort in performing daily activities but did not include the central aspects of flare in OA, i.e. the change of state, nor the additional Outcome Measures in Rheumatology (OMERACT) endorsed domains for OA flare namely stiffness, swelling, psychological aspects, impact of symptoms including fatigue and sleep disturbance. Although it is possible that the period specified to conduct this literature review may have led to some recognized instruments being excluded, this review demonstrates the need for the research community to reach consensus on the best way to measure self-reported flares in future clinical trials and observational studies., Competing Interests: Declaration of Competing Interest The authors declare that they have no conflict of interest., (Copyright © 2023. Published by Elsevier Inc.)

Objective: A EULAR taskforce was convened to develop recommendations for lifestyle behaviours amongst people with rheumatic and musculoskeletal diseases (RMDs). This paper reviews the literature on work-related factors and disease-specific outcomes for people with osteoarthritis, rheumatoid arthritis (RA), systemic lupus erythematosus, axial spondyloarthritis (axSpA), psoriatic arthritis, systemic sclerosis (SSc) and gout., Methods: Two separate systematic literature reviews (SLRs) were conducted. The first identified SLRs, published between 01/2013 and 09/2018. The second identified original observational and intervention studies published before 05/2019. Manuscripts were included if they assessed the effects of vocational interventions on disease-specific outcomes (i.e. clinical outcomes, patient-reported outcomes, and work outcomes) or if they assessed the association between work-related factors and these outcomes. Medline, Embase, Cochrane Library of systematic reviews and CENTRAL databases were searched., Results: Two SLRs were identified including individuals with SSc and inflammatory arthritis. Subsequently, 23 original manuscripts were identified, with most of them (43.5%) including people with RA and no manuscripts on gout. Most observational studies evaluated the association between work-related factors and work outcomes while limited information was available on the impact of work on clinical outcomes. A few studies suggested that physically demanding jobs have a small detrimental effect on radiographic progression in axSpA and PsA. Intervention studies showed beneficial effects of vocational interventions for disease-specific outcomes, but with small effect sizes., Conclusion: Many studies indicated that work participation is not likely to be detrimental and, in some cases, may be beneficial for RMD-specific outcomes and should therefore receive attention within healthcare consultations., Competing Interests: Conflicts of interest The authors declare no conflicts of interest., (Copyright © 2022. Published by Elsevier Inc.)

Background: Clinical trial design requires value judgements and understanding patient preferences may help inform these judgements, for example when prioritizing treatment candidates, designing complex interventions, selecting appropriate outcomes, determining clinically important thresholds, or weighting composite outcomes. Preference elicitation methods are quantitative approaches that can estimate patients' preferences to quantify the absolute or relative importance of outcomes or other attributes relevant to the decision context. We aimed to explore stakeholder perceptions of using preference elicitation methods to inform judgements when designing clinical trials in rheumatology., Methods: We conducted 1-on-1 semi-structured interviews with patients with rheumatic diseases and rheumatology clinicians/researchers, recruited using purposive and snowball sampling. Participants were provided pre-interview materials, including a video and a document, to introduce the topic of preference elicitation methods and case examples of potential applications to clinical trials. Interviews were conducted via Zoom and were audio-recorded and transcribed. We used thematic analysis to analyze our data., Results: We interviewed 17 patients and 9 clinicians/researchers, until data and inductive thematic saturation were achieved within each group. Themes were grouped into overall perceptions, barriers, and facilitators. Patients and clinicians/researchers generally agreed that preference elicitation studies can improve clinical trial design, but that many considerations are required around preference heterogeneity and feasibility. A key barrier identified was the additional resources and expertise required to measure and incorporate preferences effectively in trial design. Key facilitators included developing guidance on how to use preference elicitation to inform trial design, as well as the role of external decision-makers in developing such guidance, and the need to leverage the movement towards patient engagement in research to encourage including patient preferences when designing trials., Conclusion: Our findings allowed us to consider the potential applications of patient preferences in trial design according to stakeholders within rheumatology who are involved in the trial process. Future research should be conducted to develop comprehensive guidance on how to meaningfully include patient preferences when designing clinical trials in rheumatology. Doing so may have important downstream effects for shared decision-making, especially given the chronic nature of rheumatic diseases., Competing Interests: Declaration of Competing Interest None., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)

The OMERACT Technical Advisory Group recognises that working groups during the process of creating a core outcome set may identify an outcome domain that would be best represented as a composite that encapsulates these component outcome domains by bringing them together into a single outcome. A multi-outcome domain (MOD) is a within-patient combination of component outcomes, and an individual patient's evaluation depends on the observation of all of the components in that patient with a single overall rating determined according to a specified rule; which is often applicable when we consider a disease activity score. A composite outcome domain (COD) consists of a number of component outcomes and is defined as the occurrence in a patient of one, some or all of these specified components; which is often applicable when we consider the risk of adverse events or remission criteria. We review the general benefits, challenges, reporting and interpretation of using MODs and CODs. The development of the MOD or COD instrument for an OMERACT core outcome measurement set is considered through four distinct steps: choosing relevant outcome domains; finding high quality instruments for each of these outcome domains; weighting the outcome domain instruments in the MOD/COD instrument; and putting MOD/COD instrument through the OMERACT Filter. Guidance and training are in preparation for working groups who will be completing the OMERACT Instrument Selection Algorithm (OFISA). As for other initiatives in OMERACT, we will seek feedback from OMERACT working groups who complete the development of their MOD/COD, which will then be incorporated into the refinement of the guidance and training., Competing Interests: Declaration of Competing Interest GAW, DB, PT are members of the executive of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. The other authors have no conflict of interest relevant to the content of this study., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Introduction: Transient episodes of increased pain, stiffness or swelling are common in people with osteoarthritis (OA). Yet, evidence-based management strategies for lessening the impact of OA flares are rarely covered in clinical guidelines and have been identified as a gap by clinicians delivering OA care. We aimed to identify evidence on behavioral, lifestyle or other adjunctive flare management strategies that could be used by clinicians or consumers., Materials and Methods: A literature search between 1990-2020 was performed in three databases using a scoping methodology. We included qualitative or quantitative studies, and reviews that examined OA flare management, or that reported OA flare outcomes at timepoints ≤2 weeks post-intervention. Outcomes included any physical or psychological OA outcome treatable with a therapeutic intervention., Results: We included 9 studies, all of which examined the relationship between therapeutic exercise/ physical activity and OA flares. All studies reported pain outcomes at the knee. Two also included the hip. Only two studies examined specific management strategies for OA flares. Both favorably reported the benefits of undertaking an exercise program modified accordingly during an episode, but the quality of the evidence was low., Discussion: This scoping review highlights the paucity of evidence available on non-pharmacological treatments of OA flare management that could influence clinical practice. At present, there is no robust evidence to support or reject any specific therapies for OA flare management in clinical practice. Future work is needed, particularly around outcomes beyond pain, trajectories of symptom improvement, and for joints other than the knee., Competing Interests: Declaration of Competing Interest DJH provides consulting advice to Pfizer, Lilly, Merck Serono, and TLC bio. The other authors declare no competing interests., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: To inform a research plan for future studies by obtaining stakeholder input on the application of preference-based methods to clinical trial design., Methods: We conducted a virtual OMERACT session to encourage stakeholder engagement. We developed materials for the session to facilitate discussion based on identified case examples and feedback sessions., Results: Participants prioritized incorporating patient preferences in all aspects of trial design with an emphasis on outcome selection. Participants highlighted the need for careful consideration around preference heterogeneity and equity factors., Conclusion: Including patient preferences in trial design was considered a priority requiring further exploration to develop comprehensive guidance., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: Towards developing an instrument to measure knee and hip osteoarthritis (KHOA) flare, the Outcome Measures in Rheumatology (OMERACT) Flares in OA Working Group first sought to identify and define relevant domains of flare in KHOA., Methods: Guided by OMERACT Filter 2.1, candidate domains were identified from data generated in interviews, in English or French, with persons with KHOA and health professionals (HPs) who treat OA. The first and second rounds of an online Delphi process with patients and HPs, including researchers, selected relevant domains. The third round provided agreement on the selected domains and their definitions. At the virtual OMERACT 2020 workshop, the proposed domains and their definitions were discussed in facilitated breakout groups with patients and HPs. Participants then voted, with consensus set at ≥70%., Results: Qualitative interviews characterizing OA flare were completed with 29 persons with KHOA and 16 HPs. Content was analyzed and grouped into nine clusters. These candidate domains were included in two Delphi rounds, completed by 91 patients and 165 HPs then 50 patients and 116 HPs, per round, respectively. This resulted in selecting five relevant domains. A final Delphi round, completed by 38 patients and 89 HPs, provided agreement on these domains and their definitions. The OMERACT virtual vote included 27 patients and 106 HPs. The domains and their definitions were endorsed with ≥98% agreement. Domains include: Pain, Swelling, Stiffness, Psychological aspects, and Impact of symptoms, all defined "during flare"., Conclusion: Using OMERACT methodology, we have developed five domains of KHOA flare that were highly endorsed by patients and HPs., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: To develop an operational definition of contextual factors (CF) [1]., Methods: Based on previously conducted interviews, we presented three CF types in a Delphi survey; Effect Modifying -, Outcome Influencing - and Measurement Affecting CFs. Subsequently, a virtual Special Interest Group (SIG) session was held for in depth discussion of Effect Modifying CFs., Results: Of 161 Delphi participants, 129 (80%) completed both rounds. After two rounds, we reached consensus (≥70% agreeing) for all but two statements. The 45 SIG participants were broadly supportive., Conclusion: Through consensus we developed an operational definition of CFs, which was well received by OMERACT members., Competing Interests: Declaration of Competing Interest Dr. Alten reports personal fees from Abbvie, personal fees from BMS, personal fees from Celltrion, grants from Galapagos, personal fees from Gilead, personal fees from Lilly, grants and personal fees from Pfizer, outside the submitted work. Annelies Boonen received research grants form Celgene and Abbvie and fees for advisory boards from Abbvie, Eli Lilly and Galapagos, all paid to her department. Dr. Furst reports NO stocks, royalties, direct financial holding, expert testimony, board of director. Grant/Research Support Actelion, Amgen, BMS Corbus, Galapagos GSK, NIH, Novartis, Pfizer, Sanofi, Roche/Genentech. Consultant Actelion, Amgen, BMS, Corbus, Galapagos Novartis, Pfizer, Speakers Bureau CME only. Dr. March reports personal fees from Pfizer Australia Ltd, personal fees from Bristol Myer Squibb Australia, personal fees from Elsevier Ltd, personal fees from Up To Date, grants from Janssen Australia, outside the submitted work; and LM is a member of the executive of OMERACT. Dr. Shea reports being the senior methodologist on this project. Dr. Singh reports personal fees from Crealta/Horizon, Medisys, Fidia, UBM LLC, Trio health, Adept Field solutions, Medscape, WebMD, Clinical Care options, Clearview healthcare partners, Putnam associates, Focus forward, Navigant consulting, Spherix, Practice Point communications, the National Institutes of Health and the American College of Rheumatology, personal fees from Simply Speaking, other from Amarin, Viking, Moderna and Vaxart pharmaceuticals; and Charlotte's Web Holdings, non-financial support from FDA Arthritis Advisory Committee, non-financial support from Steering committee of OMERACT, non-financial support from Veterans Affairs Rheumatology Field Advisory Committee, non-financial support from Editor and the Director of the UAB Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis, outside the submitted work. Dr. Smolen received grants to his institution from Abbvie, AstraZeneca, Janssen, Lilly, Merck Sharpe & Dohme, Pfizer, and Roche and provided expert advice for, or had symposia speaking engagements with, AbbVie, Amgen, AstraZeneca, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Gilead, ILTOO Pharma, Janssen, Lilly, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi, and UCB. V. Strand is a member of the executive of OMERACT. OMERACT, an organization that develops outcome measures in rheumatology, receives arms-length funding from 8 companies. The other authors have no conflict of interest relevant to the content of this study., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: To gain consensus on the Outcome Measures in Rheumatology (OMERACT) core domain set for rheumatology trials of shared decision making (SDM) interventions., Methods: The process followed the OMERACT Filter 2.1 methodology, and used consensus-building methods, with patients involved since the inception. After developing the draft core domain set in previous research, we conducted five steps: (i) improving the draft core domain set; (ii) developing and disseminating white-board videos to promote its understanding; (iii) conducting an electronic survey to gather feedback on the draft core domain set; (iv) finalizing the core domain set and developing summaries, a plenary session video and discussion boards to promote its understanding; and (v) conducting virtual workshops with voting to endorse the core domain set., Results: A total of 167 participants from 28 countries answered the survey (62% were patients/caregivers). Most participants rated domains as relevant (81%-95%) and clear (82%-93%). A total of 149 participants (n = 48 patients/caregivers, 101 clinicians/researchers) participated in virtual workshops and voted on the proposed core domain set which received endorsement by 95%. Endorsed domains are: 1- Knowledge of options, their potential benefits and harms; 2- Chosen option aligned with each patient's values and preferences; 3- Confidence in the chosen option; 4- Satisfaction with the decision-making process; 5- Adherence to the chosen option and 6- Potential negative consequences of the SDM intervention., Conclusion: We achieved consensus among an international group of stakeholders on the OMERACT core domain set for rheumatology trials of SDM interventions. Future research will develop the Core Outcome Measurement Set., Clinical Significance: Prior to this study, there had been no consensus on the OMERACT core domain set for SDM interventions. The current study shows that the OMERACT core domain set achieved a high level of endorsement by key stakeholders, including patients/caregivers, clinicians and researchers., Competing Interests: Declaration of Competing Interest Karine Toupin-April, Simon Décary, Maarten de Wit, Alexa Meara, Jennifer L. Barton, Liana Fraenkel, Linda C. Li, Peter Brooks, Beverley Shea, Dawn Stacey, France Légaré, Anne Lyddiatt, Cathie Hofstetter, Laurie Proulx, Marieke Voshaar, Maria E. Suarez-Almazor, Tanya Meade, Janet Elizabeth Jull, Willemina Campbell, Rieke Alten, Esi M. Morgan, Ayano Kelly, Jessica Kaufman, Lara J. Maxwell, Francis Guillemin, Dorcas Beaton, Yasser El-Miedany, Shikha Mittoo, Tiffany Westrich Robertson, Susan J. Bartlett, Melissa Mannion, Samah Ismail Nasef, Savia de Souza, Anne Boel, Adewale Adebajo, Laurent Arnaud, Tiffany Gill, Ellen Moholt, Jennifer Burt, Aruni Jayatilleke, Ihsane Hmamouchi, David Carrott, Kate Mather, Ajesh Maharaj, Saurab Sharma, Francesco Caso, Christopher Fong, Allyson Jones, Regina Greer-Smith, Akpabio Akpabio, Valerie Umaefulam, Sara Monti, Charmaine Melburn, Kirsten Schultz, Simon Stones, Sonam Kiwalkar, Hemalatha Srinivasalu, Deb Constien, Lauren K. King and Peter Tugwell have nothing to disclose. Robin Christensen reports other from Lecture: Research Methods (Pfizer, DK; 2017), other from Lecture: GRADE Lecture (Celgene, DK; 2017), other from Ad Board Lecture: CAM (Orkla Health, DK; 2017), other from Project Grant: "GreenWhistle" (Mundipharma, 2019), other from Lecture: Diet in RMD (Novartis, DK; 2019), other from Consultancy Report: Network MA's (Biogen, DK; 2017), other from Ad Board Lecture: GRADE (Lilly, DK; 2017), other from Consultancy Report: GRADE (Celgene, 2018), other from 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; The Oak Foundation is a group of philanthropic organizations that, since its establishment in 1983, has given grants to not-for-profit organizations around the world. Annelies Boonen reports grants from Abbvie, grants from Celgene, other from UCB, other from Galapagos, other from Eli Lilly, outside the submitted work. Lyn March reports personal fees from Pfizer Australia, personal fees from Abbvie Australia, grants from Janssen Australia, outside the submitted work; Dr March is a member of OMERACT executive that receives arms-length funding from 9 companies. Willemina Campbell received OMERACT funded travel to a conference to attend meetings in regard to this paper. Sophie Hill is the Coordinating Editor of the Cochrane Consumers and Communication Group which publishes reviews of the evidence on shared decision making. Jasvinder Singh reports personal fees from Crealta/Horizon, Medisys, Fidia, UBM LLC, Trio health, Medscape, WebMD, Adept Field Solutions, Clinical Care options, Clearview healthcare partners, Putnam associates, Focus forward, Navigant consulting, Spherix, Practice Point communications, the National Institutes of Health and the American College of Rheumatology, personal fees from Simply Speaking, other from Vaxart pharmaceuticals and Charlotte's Web Holdings (current); Amarin, Viking, and Moderna (previously owned), non-financial support from FDA Arthritis Advisory Committee, non-financial support from Steering committee of OMERACT, an international organization that develops measures for clinical trials and receives arms’ length funding from 12 pharmaceutical companies, non-financial support from Veterans Affairs Rheumatology Field Advisory Committee, non-financial support from Editor and the Director of the UAB Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis, outside the submitted work. Francisco J. Blanco reports grants from Abbvie, grants and personal fees from Pfizer, grants from UCB, grants from Bristol-Mayers Squibb, grants from Roche, grants from Servier, grants from Bioiberica, grants from Sanofie, grants from Grunenthal, grants from GlaxoSmithKline, grants from Lilly, grants from Janssen, grants from Regeneron, grants from Amgen, grants from TRB Chemedica, outside the submitted work. Anthony P. Fernandez reports personal fees and other from AbbVie, grants, personal fees and other from Novartis, grants, personal fees and other from Mallinkrodt, other from Corbus, other from Pfizer, outside the submitted work. Sarah Mackie reports other from Roche Chugai, non-financial support from Roche, other from Sanofi, outside the submitted work; and Patron of the patient charity PMRGCAuk. Elena Nikiphorou reports personal fees and other from AbbVie, personal fees and other from Eli-Lilly, personal fees and other from Gilead, personal fees and other from Celltrion, personal fees and other from Pfizer, other from Sanofi, outside the submitted work. Victor S. Sloan reports having served as paid consultant to various pharmaceuticalcompanies and healthcare consultancies providing advice on clinicalresearch and advisory committee preparation outside the scope of thesubmitted work. Shareholder in UCB Pharma. Vibeke Strand reports consulting fees from AbbVie, Amgen, Arena, AstraZeneca, BMS, Boehringer Ingelheim, Celltrion, CORRONA, Crescendo/Myriad, Equillium, Genentech/Roche, GSK, Horizon, Inmedix, Janssen, Eli Lilly, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Samsung, Sandoz, Sanofi, TwoXAR and UCB, outside the submitted work., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Considering the role of metabolic diseases in osteoarthritis (OA), we investigated whether biomarkers of adipose tissue dysfunction could be associated with OA-related pain., Design: We cross-sectionally analyzed patients with knee and/or hip OA at inclusion in the KHOALA cohort. We used visual analogic scale (VAS) for pain, the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Osteoarthritis Knee and Hip Quality of Life (OAKHQOL) pain subscores. At inclusion, we measured ultra-sensitive CRP (usCRP), leptin and adiponectin for calculation of leptin:adiponectin ratio (LAR), a marker of adipose tissue dysfunction associated with central adiposity, high-molecular-weight adiponectin, visfatin and apolipoproteins. Univariate and multivariable analyses using stepwise linear regression models were performed to search for correlation between pain assessments and these biomarkers, with systematic adjustment on age., Results: In 596 women with hip and/or knee OA, multivariable analyses indicated that higher pain intensity was associated with higher LAR (VAS pain: β=0.49; p = 0.0001, OAKHQOL pain: β=-0.46; p = 0.0002, WOMAC pain: β=0.30; p = 0.001) in the whole group as well as in hip or knee OA patients considered separately. Pain intensity correlated also with usCRP level (VAS pain: β= 0.27; p = 0.02, OAKHQOL pain: β =-0.30; p = 0.01) and Kellgren-Lawrence score. In 267 men, no correlation between biomarkers and pain was found., Conclusion: Serum LAR and usCRP level are associated with pain level, independently of radiographic structural severity in women with hip and/or knee OA, emphasizing the role of adipose tissue dysfunction and of meta-inflammation in pain experience in the female population., Competing Interests: Declaration of Competing Interest JS reports personal fees from MSD, Pfizer, Abbvie, Fresenius Kabi, BMS, Roche Chugai, Sandoz, Lilly, Gilead, Novartis, Janssen, outside the submitted work and unrelated to osteoarthritis research or treatment. A-CR reports personal fees from Sanofi genzyme, Lilly, Pfizer, outside the submitted work. SF, JP-B, NS, HKE, JC, PR, FG have nothing to disclose. XC reports personal fees from Ibsa, Flexion, Pfizer, Labbrha, Dielen, Sanofi, outside the submitted work. FB reports personal fees from Boehringer, Bone Therapeutics, Expanscience, Galapagos, Gilead, GSK, Lilly, Merck Sereno, MSD, Nordic, Novartis, Pfizer, Regulaxis, Roche, Sandoz, Sanofi, Servier, UCB, Peptinov, TRB Chemedica, 4P Pharma, during the conduct of the study. In addition, FB has a patent WO2014023923-A2 issued, and a patent PCT/IB2019/059,889 issued., (Copyright © 2020. Published by Elsevier Inc.)

Objective: The Flare Assessment in Rheumatoid Arthritis (FLARE-RA) questionnaire was devised for the detection of flares in patients with RA. We aimed to define construct validity and cut-off(s) for the FLARE-RA questionnaire., Methods: This cross-sectional study included adult patients with prevalent RA (2010 ACR/EULAR criteria) attending outpatient rheumatology clinics in France (n = 138), Denmark (n = 253), USA (n = 75), and Argentina (n = 105). Flare occurrence over the past 3 months was assessed with the FLARE-RA questionnaire scoring from 0 (no flare) to 10 (maximum flare). The cut-offs for the FLARE-RA score were defined using the following anchor items obtained at the same encounter: (1) Patient report of flare; (2) DAS28-CRP > 3.2; (3) Change of anti-rheumatic treatment, based on the area under the receiver operating characteristic curve (AUC) and distance to (0,1)., Results: Four hundred seventy four patients with RA duration ≥2 years (mean age 58.6 years, 74.9% female) were included in the main analysis. The discrimination for the FLARE-RA cut-offs was acceptable-to-excellent: AUC for the global FLARE-RA score ranged from 0.71 to 0.92. The cut-offs for the FLARE-RA score were lower using "patient report of flare" than DAS28-CRP and "change of anti-rheumatic treatment". Proposed FLARE-RA cut-offs for clinical detection and change of anti-rheumatic treatment are 2 and 5, respectively, for patients with RA duration 2-5 years, and 2 and 3.5, respectively, for patients with RA duration >5 years., Conclusions: Proposed FLARE-RA cut-offs have acceptable discriminative capacity across the tested anchor items and are expected to aid in early recognition and timely management of RA flares., Competing Interests: Declaration of competing interest Dr. Myasoedova reports a grant from Pfizer Grant ID 15322005, during the conduct of the study. Dr. De Thurah reports grants from Central Region Denmark Health Research Foundation, the Danish Rheumatism Foundation (grant A2920), grants from the Novo Nordisk Research Foundation (grant NNF14OC0013029), grants from the Hede Nielsen Family Foundation, during the conduct of the study. Dr. Erpelding reports a grant from AbbVie (ACA-FRAN-11-02), during the conduct of the study. Dr. Schneeberger has nothing to disclose. Dr. Maribo reports grants from Central Region Denmark Health Research Foundation, the Danish Rheumatism Foundation (grant A2920), grants from the Novo Nordisk Research Foundation (grant NNF14OC0013029), grants from the Hede Nielsen Family Foundation, during the conduct of the study. Dr. Citera has nothing to disclose. Dr. Davis, III reports a grant from Pfizer Grant ID 15322005, during the conduct of the study. Dr. Matteson reports a grant from Pfizer Grant ID 15322005, during the conduct of the study. Dr. Crowson reports a grant from Pfizer Grant ID 15322005, during the conduct of the study. D. Fautrel reports a grant from AbbVie (ACA-FRAN-11-02), during the conduct of the study. Dr. Guillemin reports a grant from AbbVie (ACA-FRAN-11-02), during the conduct of the study., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: To analyze the associations between body composition, notably low lean mass, and clinical symptoms [pain, physical function, quality of life (QoL)] in patients with symptomatic hip and/or knee OA., Methods: Cross-sectional study using data from the 3-year follow-up visit of the Knee and Hip OsteoArthritis Long-term assessment (KHOALA) cohort. Skeletal muscle and fat mass were measured by dual X-ray absorptiometry (DXA). Fat mass index (FMI) was defined as total fat mass/height 2 . Appendicular lean mass was adjusted on body mass index (ALM/BMI), and low lean mass was defined according to the definition of FNIH Sarcopenia Project recommendations. Pain and function were measured by the WOMAC index and QoL by the SF-36., Results: In total, 358 patients underwent DXA (67% women, mean [SD] age 63.4 [8.4] years, mean BMI 29.5 [5.6]kg/m 2 ). The visual analog scale (0-100) pain score was 38.0 [24.7] and 25.4% had hip and 74.6% knee OA. Low lean mass and ALM/BMI were associated with impaired QoL and WOMAC scores on bivariate analysis (all p ≤ 0.001) but not on multivariate analysis after adjustment for FMI. For patients with normal BMI, mean [SD] WOMAC scores were higher (greater impairment) with low lean mass than normal body composition (WOMAC function 33.4 [23.3] and 24.0 [17.4], p = 0.02), and mean SF-36 physical component score was lower (greater impairment) 40.3 [10.2] and (44.3 [8.4], p = 0.04). Among patients with obesity, low lean mass had no additional effect., Conclusion: For patients with OA and normal BMI, QoL and function were more impaired for those with than without low lean mass. Conserving muscle mass in people with OA could have functional and antalgic benefits especially for those with normal BMI., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: General recommendations for a reference case for economic studies in rheumatic diseases were published in 2002 in an initiative to improve the comparability of cost-effectiveness studies in the field. Since then, economic evaluations in osteoarthritis (OA) continue to show considerable heterogeneity in methodological approach., Objectives: To develop a reference case specific for economic studies in OA, including the standard optimal care, with which to judge new pharmacologic and non-pharmacologic interventions., Methods: Four subgroups of an ESCEO expert working group on economic assessments (13 experts representing diverse aspects of clinical research and/or economic evaluations) were charged with producing lists of recommendations that would potentially improve the comparability of economic analyses in OA: outcome measures, comparators, costs and methodology. These proposals were discussed and refined during a face-to-face meeting in 2013. They are presented here in the format of the recommendations of the recently published Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, so that an initiative on economic analysis methodology might be consolidated with an initiative on reporting standards., Results: Overall, three distinct reference cases are proposed, one for each hand, knee and hip OA; with diagnostic variations in the first two, giving rise to different treatment options: interphalangeal or thumb-based disease for hand OA and the presence or absence of joint malalignment for knee OA. A set of management strategies is proposed, which should be further evaluated to help establish a consensus on the "standard optimal care" in each proposed reference case. The recommendations on outcome measures, cost itemisation and methodological approaches are also provided., Conclusions: The ESCEO group proposes a set of disease-specific recommendations on the conduct and reporting of economic evaluations in OA that could help the standardisation and comparability of studies that evaluate therapeutic strategies of OA in terms of costs and effectiveness., (Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: Existing practice guidelines for osteoarthritis (OA) analyze the evidence behind each proposed treatment but do not prioritize the interventions in a given sequence. The objective was to develop a treatment algorithm recommendation that is easier to interpret for the prescribing physician based on the available evidence and that is applicable in Europe and internationally. The knee was used as the model OA joint., Methods: ESCEO assembled a task force of 13 international experts (rheumatologists, clinical epidemiologists, and clinical scientists). Existing guidelines were reviewed; all interventions listed and recent evidence were retrieved using established databases. A first schematic flow chart with treatment prioritization was discussed in a 1-day meeting and shaped to the treatment algorithm. Fine-tuning occurred by electronic communication and three consultation rounds until consensus., Results: Basic principles consist of the need for a combined pharmacological and non-pharmacological treatment with a core set of initial measures, including information access/education, weight loss if overweight, and an appropriate exercise program. Four multimodal steps are then established. Step 1 consists of background therapy, either non-pharmacological (referral to a physical therapist for re-alignment treatment if needed and sequential introduction of further physical interventions initially and at any time thereafter) or pharmacological. The latter consists of chronic Symptomatic Slow-Acting Drugs for OA (e.g., prescription glucosamine sulfate and/or chondroitin sulfate) with paracetamol at-need; topical NSAIDs are added in the still symptomatic patient. Step 2 consists of the advanced pharmacological management in the persistent symptomatic patient and is centered on the use of oral COX-2 selective or non-selective NSAIDs, chosen based on concomitant risk factors, with intra-articular corticosteroids or hyaluronate for further symptom relief if insufficient. In Step 3, the last pharmacological attempts before surgery are represented by weak opioids and other central analgesics. Finally, Step 4 consists of end-stage disease management and surgery, with classical opioids as a difficult-to-manage alternative when surgery is contraindicated., Conclusions: The proposed treatment algorithm may represent a new framework for the development of future guidelines for the management of OA, more easily accessible to physicians., (Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: There is an important need to evaluate therapeutic approaches for osteoarthritis (OA) in terms of cost-effectiveness as well as efficacy., Methods: The ESCEO expert working group met to discuss the epidemiological and economic evidence that justifies the increasing concern of the impact of this disease and reviewed the current state-of-the-art in health economic studies in this field., Results: OA is a debilitating disease; it is increasing in frequency and is associated with a substantial and growing burden on society, in terms of both burden of illness and cost of illness. Economic evaluations in this field are relatively rare, and those that do exist, show considerable heterogeneity of methodological approach (such as indicated population, comparator, decision context and perspective, time horizon, modeling and outcome measures used). This heterogeneity makes comparisons between studies problematic., Conclusions: Better adherence to guidelines for economic evaluations is needed. There was strong support for the definition of a reference case and for what might constitute "standard optimal care" in terms of best clinical practice, for the control arms of interventional studies., (Copyright © 2013 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: To assess the prevalence of systemic sclerosis (SSc) in the Lorraine region, France., Methods: Data from three sources - general practitioners and community and hospital specialists, medical records departments, and regional and national laboratories-and a capture-recapture method with log-linear models were used to estimate SSc prevalence in the region. Double recording was checked, and reported cases were validated after a review of medical records., Results: We identified 560 records of suspected SSc cases corresponding to 327 unique suspected SSc cases existing on June 30, 2006, in Lorraine. On the basis of the 193 validated cases (22 [11.4%] with diffuse disease, 136 [70.5%] with limited disease, 31 [16.1%] with limited involvement and 4 unknown), the observed overall crude prevalence of SSc was 105.4 cases per million adult inhabitants (95% confidence interval [CI]: 91.0; 121.4). With the capture-recapture method, the estimated number of SSc cases was 233 (95% CI: 217.3; 260.0), so an estimated 40 cases were not identified by the three sources. The estimated overall prevalence was 132.2 cases per million adult inhabitants (95% CI: 115.8; 154.0)., Conclusions: Our study provides the first estimate of SSc prevalence in the Lorraine region. The capture-recapture method allowed us to estimate an additional 21% of unobserved cases and is a good alternative to the community-based study design for estimating the prevalence of rare diseases., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Gastrointestinal (GI) manifestations of systemic sclerosis (SSc) were found in 82% of 262 patients followed up prospectively. Esophageal dysmotility, lower esophageal sphincter laxity, bacterial overgrowth, and wide mouth diverticuli were the most common findings. The disease is usually diffuse with multiple levels of involvement. Gastrointestinal involvement was not significantly correlated with gender, age at SSc diagnosis or disease type (limited or diffuse scleroderma). Upper GI symptoms develop early in the course of SSc and may not correlate with objective findings. Various investigations, treatment regimens, and less frequent disease manifestations are reviewed and discussed.