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Background: Since the development of the OMERACT Systemic Lupus Erythematosus (SLE) Core Outcome Set (COS) in 1998, many new SLE domains have been identified and measures developed, creating a need to update the SLE COS. To revisit the 1998 SLE COS and research agenda domains, and generate new candidate domains, we conducted this study of patients with SLE and collaborators., Objective: (1) To evaluate existing candidate SLE domains for inclusion in the SLE COS. (2) To generate additional candidate SLE domains for COS consideration. (3) To engage SLE collaborators, including patients, in developing the updated SLE COS., Methods: The OMERACT SLE Working Group's steering committee developed a survey to assess the importance of candidate SLE domains and generate additional domains for consideration towards the SLE COS. Patients with SLE followed at the University of Toronto Lupus Clinic (patient group) and members of the OMERACT SLE Working Group (collaborator group) were invited to complete the survey between August 2022 and February 2023., Results: A total of 175 patients were invited and 100 completed the survey. Of 178 collaborators invited, 145 completed the survey. Patients tended to prioritize life-impact domains while collaborators prioritized clinical domains. Both patients and collaborators recommended additional domains to those included in the 1998 SLE COS and research agenda., Conclusion: The domain inclusion and importance results demonstrate that patients and collaborators prioritize different domains, so capturing the perspectives of both groups is essential to ensure a holistic assessment of SLE. The results of the study identify domains that already have a high level of agreement for potential inclusion in the SLE COS, domains that require further explanation, and novel domains that warrant consideration., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Inc.)

Objective: This manuscript highlights the importance of enhancing the uptake of Core Outcome Sets (COS) by building partnerships with Collaborators and addressing their needs in COS development., Methods and Setting: This session was structured as a simulation, resembling a format akin to a classic television game show. The moderator posed a series of questions to eight different Collaborator groups who briefly described the importance of COS within their areas of interest. Previous studies examining the uptake of individual core outcomes revealed disparities in uptake rates. The Identified barriers to the uptake of COS include the lack of recommendations for validated instruments for each domain, insufficient involvement of patients and key Collaborator groups in COS development, and a lack of awareness regarding the existence of COS., Conclusions: This analysis underscores the need for COS development approaches that prioritize the inclusion of patients and diverse Collaborator groups at every stage. While current studies on COS uptake are limited, future research should explore the broader implementation of COS across diverse disease categories and delve into the factors that hinder or facilitate their uptake such as, the importance of COS developers extending their work to recommending domains with well validated instruments. Embracing patient leadership and multifaceted engagement is essential for advancing the relevance and impact of COS in clinical research., Competing Interests: Declaration of competing interest Beverley Shea: Senior methodologist support Jordi Pardo Pardo: Travel costs for the meeting were covered by OMERACT. Shawna Grosskleg: None Dorcas E Beaton: Member of the management committee. Leads the Methods initiative and Co-Chair-of the Technical Advisory Group. Philip Conaghan: Member of the management committee. Wim Goettsch: None Catherine Hofstetter: OMERACT bi-annual meeting Lara Maxwell: OMERACT Staff Joachim Musaus: None Daniel Ollendorf: Health Technology Assessment International Honorarium paid to Tufts Medical Center to chair a forum that has discussed core outcome sets, among other topics. OMERACT Reimbursement for travel to attend conference and participate in session highlighted in manuscript Grayson Schultz: None Randall Stevens Centrexion Therapeutics Corporation Part of supporting role as the Chief Medical CMO of Centrexion Therapeutics Corporation Officer (CMO) of the company Centrexion Therapeutics Corporation Private biotechnology company – salaried employee Vibeke Strand: vibekestrand@me.com Peter Tugwell: None Paula Williamson: COMET Initiative chair the COMET Management Group Sean Tunis: OMERACT Covered travel and hotel for the bi-annual mtg in Colorado Springs. Lee Simon: Member of the management committee., (Copyright © 2024. Published by Elsevier Inc.)

Background: The Outcome Measures in Rheumatology (OMERACT) Systemic Lupus Erythematosus (SLE) Working Group held a Special Interest Group (SIG) at the OMERACT 2023 conference in Colorado Springs where SLE collaborators reviewed domain sub-themes generated through qualitative research and literature review., Objective: The objective of the SIG and the subsequent meetings of the SLE Working Group was to begin the winnowing and binning of candidate domain sub-themes into a preliminary list of candidate domains that will proceed to the consensus Delphi exercise for the SLE COS., Methods: Four breakout groups at the SLE SIG in Colorado Springs winnowed and binned 132 domain sub-themes into candidate domains, which was continued with a series of virtual meetings by an advisory group of SLE patient research partners (PRPs), members of the OMERACT SLE Working Group Steering Committee, and other collaborators., Results: The 132 domain sub-themes were reduced to a preliminary list of 20 candidate domains based on their clinical and research relevance for clinical trials and research studies., Conclusion: A meaningful and substantial winnowing and binning of candidate domains for the SLE COS was achieved resulting in a preliminary list of 20 candidate domains., Competing Interests: Declaration of competing interest Wils Nielsen, Lee Simon, Maya Desai, Yvonne Enman, Daniel Wallace, Cynthia Aranow, Meggan Mackay, Kimberly Trotter, Ali Duarte Garcia, John A Reynolds, Danaë Papachristos, Sandra Navarra, Amita Aggarwal, Chi Chiu Mok, Keishi Fujio, Rosalind Ramsey-Goldman, Aaron Howe, Behdin Nouwrouzi-Kia, Dennisse Bonilla, Julian Thumboo, Martin Aringer, Sindhu R. Johnson, Zahi Touma: None. 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. Ioannis Parodis:All support for the present manuscript (e.g., funding, provision of study materials, medical writing, article processing charges, etc.): I have received research funding from Amgen, I have received research funding from GlaxoSmithKline, I have received research funding from Astra-Zeneca, I have received research funding from Janssen Pharmaceuticals, I have received research funding from Aurinia Pharmaceuticals, I have received research funding from Novartis, I have received research funding from Elly Lilly and Company, I have received research funding from Otsuka Pharmaceutical, I have received research funding from Gilead Sciences, I have received research funding from F. Hoffmann-La Roche AG Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: I have received research funding from Amgen, I have received research funding from GlaxoSmithKline, I have received research funding from Astra-Zeneca, I have received research funding from Janssen Pharmaceuticals, I have received research funding from Aurinia Pharmaceuticals, I have received research funding from Novartis, I have received research funding from Elly Lilly and Company, I have received research funding from Otsuka Pharmaceutical, I have received research funding from Gilead Sciences, I have received research funding from F. Hoffmann-La Roche AG Alfred Kim:Grants or Contracts from any entity: Rheumatology Research Foundation – Institution, National Multiple Sclerosis Society – Institution, GlaxoSmithKline – Institution, Novartis – Institution, NIH/NIAMS P30AR073752 – Institution, BMS – Institution Consulting Fees: Alexion Pharmaceuticals – Self, ANI Pharmaceuticals – Self, AstraZeneca – Self, Aurinia Pharmaceuticals – Self, Kypha Inc – Self, Pfizer Inc – Self Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: GlaxoSmithKline – Self, Exagen Diagnostics – Self, UpToDate – Self Patents planned, issued, or pending: Kypha US Patent 1102931882 Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Lupus Foundation of America-Heartland Chapter – Unpaid, St Louis Rheumatology Association – Unpaid, Rheumatology Research Foundation – Unpaid, Lupus Research Alliance – Unpaid Daniel Wallace:Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: Speakers bureau GSK, Merck-Serono, Astra Zeneca Yashaar Chaichian:Grants or Contracts from any entity: Lupus Therapeutics, LLC - Payments made to institution, Eli Lilly & Company - Payments made to institution, Amgen Inc. - Payments made to institution, Stanford University, Discovery Innovation Fund in Basic Biomedical Sciences - Payments made to institution Support for attending meetings and/or travel: Lupus Therapeutics, LLC (provided support to attend the 2022 and 2023 LuCIN Community Meeting) -Payments made to institution Oshrat Tayer-Shifman:Consulting Fees: Astra-Zeneca – Payed to me, Abbvie – Payed to me Support for attending meetings and/or travel: Astra-Zeneca – Payment made to institution Lai Shan Tam:Consulting Fees: Janssen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Pfizer, and Sanofi – me Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: Pfizer, Abbvie, Janssen – me Support for Attending Meetings and/or travel: abbvie – other institutions Participation on a Data Safety Monitoring Board or Advisory Board: Pfizer, Abbvie, Janssen, AstraZeneca – me Leasdership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Convenor of the APLAR Academy – unpaid Other financial and non-financial interests: Unrestricted grant from Amgen, Boehringer Ingelheim, GSK, Janssen, Novartis, and Pfizer - To the Chinese University of Hong Kong Manuel F. Ugarte-Gil:Grants or Contracts: Janssen, GSK – Payments were made to my institution Consulting Fees: Astra-Zeneca Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: Astra-Zeneca, GSK Guillermo Pons-Estel:Grants of Contracts from any entity: I received grant from Janssen – Payment was made to GLADEL (Latin American Group for the Study of Lupus) Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: I received honoraria from GSK for lectures - Payment was made to myself, I received honoraria from Werfen for lectures - Payment was made to myself, I received honoraria from Novartis for lectures - Payment was made to myself, I received honoraria from Pfizer for lectures - Payment was made to myself, I received honoraria from Janssen for lectures - Payment was made to myself. Support for Attending Meetings and/or travel: I received support from ABBVIE to attend to the ACR 2021, I received support from Pfizer to attend to the EULAR 2023 Participation on a Data Safety Monitoring Board or Advisory Board: I received honoraria from Janssen for Advisory Board - Payment was made to myself, I received honoraria from Astra Zeneca for Advisory Board - Payment was made to myself, I received honoraria from GSK for Advisory Board - Payment was made to myself, I received honoraria from Novartis for Advisory Board - Payment was made to myself Mandana Nikpour:Grants of Contracts from any entity: Research grants from Janssen to support the ongoing research of the Australian Scleroderma Cohort Study - Payments made to my institution Consulting Fees: I have consulted for Janssen, Boehringer Ingelheim and Astra Zeneca - Payments made to me Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: I have presented for Janssen, Boehringer Ingelheim, Astra Zeneca and GSK - Payments made to me Support for Attending Meetings and/or travel: Support from Boehringer Ingelheim to attend the EULAR Conference in 2023 - No payment made to me or my institution Alberta Hoi:Grants or Contracts from any entity: Arthritis Australia - I was grant recipient, AstraZeneca - Sponsorship of the Australian Lupus Registry and Biobank and Asia Pacific Lupus Collaboration, and also contract research on unmet needs in Australian lupus patients, Perpetual IMPACT - fund I was grant recipient, BMS, Merck Serono, GSK, Eli Lilly, UCB - Sponsored Asia Pacific Lupus Collaboration, for which I contribute data towards, Janssen - Contracted the Asia Pacific Lupus Collaboration to conduct a research study on medication use Consulting Fees: UCB Advisory Board Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: Novartis Speaker Fee, Janssen honoraria for chairing Juanita Romero-Diaz:Consulting Fees: Novartis, Biogen Support for Attending Meetings and/or travel: Boehringer Participation on a Data Safety Monitoring Board or Advisory Board: Biogen Marta Mosca:Consulting Fees: Astra Zeneca, GSK, Lilly, UCB, BMS, Idorsia, Otsuka, Abbvie Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: Atra Zeneca, GSK, Otsuka, Janssen, UCB, Abbvie Support for Attending Meetings and/or travel: Janssen to attend the European Lupus Meeting in 2022 Participation on a Data Safety Monitoring Board or Advisory Board: Idorsia Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: EMA liaison for EULAR Receipt of equipment, materials, drugs, medical writing, gifts or other services: I have received Anifrolumab as for compassionate use from Astra Zeneca Aaron Drucker:Grants of Contracts from any entity: National Eczema Association, Eczema Society of Canada, Canadian Dermatology Foundation, CIHR, NIH, PSI Foundation Consulting Fees: Canadian Agency for Drugs and Technologies in Health Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: British Journal of Dermatology, American Academy of Dermatology, National Eczema Association, Canadian Dermatology Today Eric Morand:Grants of Contracts from any entity: grant/research support from: AbbVie, Amgen, AstraZeneca, Biogen, Bristol Myers Squibb, Eli Lilly and Company, EMD Serono, Genentech, GlaxoSmithKline, Janssen, and UCB Pharma – Research grants to institution Consulting Fees: Consulting fees from AbbVie, AstraZeneca, Biogen, Bristol Myers Squibb, Eli Lilly and Company, EMD Serono, Genentech, GlaxoSmithKline, Janssen, Novartis, Servier, Wolf, Zenas Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: Honoraria from AstraZeneca, Biogen, Bristol Myers Squibb, EMD Serono, Gilead Support for Attending Meetings and/or travel: Travel support from AstraZeneca Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Board Director, Rare Voices Australia – Not for Profit, Board Directory, Exosome Biosciences Ian Bruce:Grants of Contracts from any entity: Janssen Research - Grant to institution, Astra Zeneca - Research Grant to institution, GSK - Research Grant to institution Consulting Fees: GSK - Speaker fees to institution, Astra Zeneca - Speaker fees to institution, Janssen - Speaker fees to institution Participation on a Data Safety Monitoring Board or Advisory Board: AstraZeneca and Merck Serono - INB has served on boards for AstraZeneca and Merck Serono, (Copyright © 2024. Published by Elsevier Inc.)

Sjögren's disease (SjD) is a systemic autoimmune exocrinopathy with key features of dryness, pain, and fatigue. SjD can affect any organ system with a variety of presentations across individuals. This heterogeneity is one of the major barriers for developing effective disease modifying treatments. Defining core disease domains comprising both specific clinical features and incorporating the patient experience is a critical first step to define this complex disease. The OMERACT SjD Working Group held its first international collaborative hybrid meeting in 2023, applying the OMERACT 2.2 filter toward identification of core domains. We accomplished our first goal, a scoping literature review that was presented at the Special Interest Group held in May 2023. Building on the domains identified in the scoping review, we uniquely deployed multidisciplinary experts as part of our collaborative team to generate a provisional domain list that captures SjD heterogeneity., Competing Interests: Declaration of competing interest Valerie Devauchelle reports receinving funds for consulting to Novartis, Abbvie, Fresenius Kabi. Divi Cornec declares no personal financial competing interests and received research funding from Novartis and GSK. Benjamin A. Fisher has undertaken consultancy for Novartis, BMS, Servier, Galapagos, Roche, UCB, Sanofi and Janssen, and received grant/research support from Janssen, Celgene, Galapagos, Servier. Alberta Hoi reports receiving research funding from AstraZeneca, Bristol-Myers Squibb, Novartis, Janssen. Chiara Baldini reports receiving funds for consulting to GSK, Novartis and Horizon, honoraria for educational events from GSK and Sanofi, support for attending meetings from Abbvie and Bristol-Myers Squibb. WF Ng has consulted for Novartis, GlaxoSmithKline, Abbvie, BMS, Sanofi, MedImmune, Resolves Therapeutics, Janssen and UCB. Simon Bowman receiving funds for consulting from Bristol-Myers Squibb, Iqvia, Janssen, Kiniksa, Novartis, Otsuka-Visterra. His-salary is part funded by the Birmingham Biomedical Research Centre, Birmingham, UK. Karina Torralba reports receiving funds for consulting to Horizon, AstraZeneca, Janssen; for contracted research work with Bioclinica; for clinical trial funding from Novartis, AstraZeneca, GlaxoSmithKline, Amgen. Athena Papas declares grant funding from Novartis and Horizon; advisory board for Novartis. Ionut Pintilie reports receiving funds for consulting to Abbvie, Novartis, Pfizer, Sandoz, Ewopharma, KRKA, Stada, Boehringer Ingelheim, MagnaPharm, MSD. Xavier Mariette declares consulting fee from Astra Zeneca, BMS, Galapagos, GSK, Novartis, and Pfizer. Maria Antonietta D'Agostino, MD, PhD Speakers, or consultant fees from Amgen, Abbvie, BMS, Novartis, Galapagos, UCB, Pfizer, Lily, Janssen. Alan Baer reports receiving funds for consulting to Bristol-Myers Squibb and iCell Gene Therapeutics. Blake M. Warner declares research funding and material transfer agreements with Pfizer, Inc., and Mitobridge, Inc. Soumya D. Chakravarty is an employee of Janssen Scientific Affairs, LLC, and owns stock or stock options in Johnson & Johnson, of which Janssen Scientific Affairs, LLC is a wholly owned subsidiary. Nevsun Inanc reports claims to have received speakers fee from Novartis, Abbvie, Pfizer, UCB, Eli-Lilly and consultancy fee from Abbvie, UCB, Eli-Lilly. Vibeke Strand reports being 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. Md Yuzaiful Md Yusof has received speaker fees from Roche and Novartis and consultancy fees from Aurinia Pharmaceuticals and UCB. Suzanne Arends declares consultancy fees from Argenx and Novartis. Anas Alexis Benyoussef is a consultant for Horus Pharma and Quantel Medical. Sharmila Masli is a consultant for Stellular Bio Inc. and Proteris Biotech. Maureen Rischmueller has undertaken consultancy/speaker engagements for AbbVie, Boehringer Ingelheim, Janssen Global Services, Novartis, Pfizer and Sandoz, and received grant/research support from AbbVie, Amgen, AstraZeneca, BMS, GSK, Janssen, Lilly, Novartis, Pfizer, Servier and UCB. Sara McCoy reports receiving funds for consulting to Bristol-Myers Squibb, Horizon, Novartis, Kiniksa, Targe RWE, Otsuka, Visterra, and iCell. Her time is supported by the Clinical and Translational Science Award (CTSA) program, through the NIH National Center for Advancing Translational Sciences (NCATS), grant 1KL2TR002374 and NIH/NIDCR R03DE031340. Raphaele Seror reports receiving funds for consulting to Bristol-Myers Squibb, Novartis, GSK, Janssen, Amgen. Hendrika Bootsma declares consultancy fees from Argenx, Novartis, BMS, AztraZeneca, Galapagos.Independent grants from AstraZeneca, Novartis, BMS., (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.)

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: To define and select rheumatoid arthritis (RA)-specific core domain set for Longitudinal Observational Studies (LOS) within the Outcome Measures in Rheumatology (OMERACT) framework., Methods: A three-round online Delphi exercise, including patient research partners (PRPs) and other community partners in healthcare, was conducted. Domains scored 7-9 (i.e., critically important to include) by ≥ 70 % of participants in both groups were included. Items were consolidated in a subsequent dedicated meeting., Results: Nineteen domains scored ≥ 70 % consensus in both groups. The focus group refined these into a list of twelve domains., Conclusion: The achieved consensus will inform the next steps of developing the core domain set for LOS in RA., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: DB: Speakers bureau: Janssen, UCB, MSD, Abbvie, Galapagos, Lilly. Research Grant: Novartis; LC: Participation on a Data Safety Monitoring Board or Advisory Board: Lilly, Hospital Clínico San Carlos. EULAR Chair of Advocacy; MALO: Grants: National Cancer Institute, Rheumatology Research Foundation, Duncan Family Institute for Cancer Prevention and Risk Assessment. Consulting fees: American Cancer Society; MdW: Speakers bureau: UCB. Convenor EULAR study group for collaborative research; VS: Founding member of the executive committee of OMERACT [1992 – present]; DBB: Support for attending meetings: Erna Hamilton Foundation. Grants: PhD Scholarships from Odense University Hospital and from the Faculty of Health Sciences; Peter Böhm: Support for attending meetings and/or travel: EULAR, FOREUM. MSA: Consulting fees: Pfizer, Eli Lilly, Syneos Health and Celgene. The rest of the authors declare no conflicts of interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objectives: To develop an understanding of the concept of safety/harms experienced by patients involved in clinical trials for their rheumatic and musculoskeletal diseases (RMDs) and to seek input from the OMERACT community before moving forward to developing or selecting an outcome measurement instrument., Methods: OMERACT 2023 presented and discussed interview results from 34 patients indicating that up to 171 items might be important for patients' harm-reporting., Results: Domain was defined in detail and supported by qualitative work. Participants in the Special-Interest-Group endorsed (96 %) that enough qualitative data are available to start Delphi survey(s)., Conclusion: We present a definition of safety/harms that represents the patient voice (i.e., patients' perception of safety) evaluating the symptomatic treatment-related adverse events for people with RMDs enrolled in clinical trials., Competing Interests: Declaration of Competing Interest Dorthe B. Berthelsen: None; fellow of the OMERACT Safety Working Group. Lee S. Simon: None; co-chair of the OMERACT Safety Working Group. John P. A. Ioannidis: Part of the CONSORT Harms Group. Marieke Voshaar: None. Pam Richards: None. Niti Goel: No relevant disclosures. Vibeke Strand: Reports being 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. Sabrina M. Nielsen(:) None. Beverly J. Shea: None. Peter Tugwell: None. Susan J. Bartlett: None. Glen S. Hazlewood: None. Lyn March: Has received institutional support from Janssen Australia and the Australian Government. Jasvinder A. Singh: JAS has received consultant fees from Schipher, 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; the National Institutes of Health; and the American College of Rheumatology. JAS has received institutional research support from Biomet Holdings. JAS received food and beverage payments from Intuitive Surgical Inc./Philips Electronics North America. 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. JAS previously owned stock options in Amarin, Viking and Moderna pharmaceuticals. JAS is on the speaker's bureau of Simply Speaking. JAS was 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. Maria E. Suarez-Almazor: Has received consultant fees from Eli Lilly, Pfizer, Celgene and Syneos Health Maarten Boers: None. Randall M Stevens: None. Daniel E. Furst: None. Thasia Woodworth: None. Amye Leong: None. Peter M Brooks: None; co-chair of the OMERACT Safety Working Group. Caroline Flurey: None; co-chair of the OMERACT Safety Working Group. Robin Christensen: None; co-chair of the OMERACT Safety Working Group., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objectives: To identify patient-centered domains with long-term relevance to people with rheumatoid arthritis (RA)., Methods: We conducted semi-structured individual cognitive interviews of patients with RA with at least five years of disease duration, sampled from five different countries (United States, Italy, Spain, Mexico, and Argentina). Participants were encouraged to discuss their long-term concerns regarding RA. Interviews were transcribed and analyzed using qualitative content analysis within a constructivist/interpretivist theoretical framework., Results: Twenty-eight participants were interviewed, 24 were women. Six main themes, representing important aspects of the daily life of people with RA were generated: (i) Living with symptoms and functional limitations, (ii) Lack of participation, (iii) Partner and family issues, (iv) Risk of damage to vital organs, (v) Coping strategies, and (vi) Healthcare concerns, primarily expressed by participants from non-European countries lacking universal healthcare coverage. In addition, participants discussed the importance of contextual factors and how they impact long-term outcomes. These included attitudes towards disease, social support, or financial burdens., Conclusions: We identified six domains of importance to people with RA that are seldom measured in longitudinal registries and should be considered in patient-centered longitudinal studies., (Copyright © 2022. Published by Elsevier Inc.)

Background: In most rheumatic and musculoskeletal diseases (RMDs), global assessments of disease activity by physicians and patients are 'anchor outcomes' in therapeutic trials evaluating whether a treatment is effective., Objectives: To compare physicians' vs patients' global assessments of disease activity in RMD trials and explore reasons for discrepancies between them., Methods: Eligible trials were sampled from systematic reviews of treatments for RMDs by using the Cochrane database of systematic reviews (i.e., reviews from the Cochrane Musculoskeletal Group, [CMSG]). Randomized controlled trials (RCTs) of interventions for RMDs were eligible if they reported quantitative analyses of both physicians´ and patients´ global assessments at the same time point for the comparison of the same experimental intervention against the same comparator (i.e., placebo, no treatment, or other treatment). We accepted data from trial comparisons for each type of outcome, regardless of the type of intervention and type of RMD within the CMSG. Using mixed-effects meta-regression models, we assigned the dependent variable as the ratio of odds ratios (ROR) of global change with the experimental intervention, versus the control comparator. An ROR>1 would indicate that physicians rated the experimental intervention more favorable than their patients did., Results: We were able to estimate the ROR (data from both physicians' and patients' global assessments) across 70 trials (116 randomized comparisons) in 7 diseases (ankylosing spondylitis, fibromyalgia, psoriatic arthritis, osteoarthritis, rheumatoid arthritis, systemic lupus erythematosus, and gout). The combined ROR across all effectiveness comparisons were rated significantly in favor of the intervention by physicians: ROR=1.15 CI 95% (1.07 to 1.23). This combined ROR was based on a substantial heterogeneity across comparisons (I 2 =89.1%). Across all the stratified analyses, the type of the RMD was an informative reason for discrepancies, with a statistically significant ROR in rheumatoid arthritis ROR=1.33, CI 95% (1.13 to 1.56), unlike the ROR in all other conditions (ROR=1.04, CI 95% (0.95-1.14)., Conclusion: In comparative effectiveness research on rheumatology, physicians' global assessments of disease activity, surprisingly, are more in favor of the experimental interventions than are those of the patients., Competing Interests: Competing interests This study reports no financial competing interests. The Parker Institute is grateful for the financial support received from public and private foundations, companies, and private individuals., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Biologics have provided improved clinical benefits to patients, but they come at a huge expense due to the high costs associated with their development and manufacturing. Biosimilars, which have been clinically studied and have demonstrated to be efficacious and safe, are more cost-effective versions of biologics, however, their uptake has been slow in the United States (US) compared to in the European Union (EU)., Objectives: In this analysis, we review the challenges to increased biosimilar use in the US and the successful strategies employed to increase biosimilar uptake in the EU., Conclusions: Greater utilization of biosimilars in the US is an achievable goal but the federal government, pharmaceutical companies, and medical associations/institutions will need to work together to address patient and physician concerns and to remove incentives for using more expensive treatment options., Competing Interests: Declarations of interest None., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: The Outcome Measures in Rheumatology (OMERACT) is a research organization focused on improving health care outcomes for patients with autoimmune and musculoskeletal diseases. The Connective Tissue Disease-Interstitial Lung Disease (CTD-ILD) Working Group on Lung Physiology is a group within OMERACT charged with identifying outcome measures that should be implemented in studies of patients with CTD-ILD. The OMERACT Filter 2.1 is an evidence-based algorithm used to identify outcome measures that are truthful, feasible, and able to discriminate between groups of interest. Our objective was to summate evidence (published literature, key opinion leader input, patient perspectives) that would influence the CTD-ILD Working Group's vote to accept or reject the use of two measures of lung physiology, the forced vital capacity (FVC) and the diffusion capacity of carbon monoxide (DLco) for use in randomized controlled trials (RTCs) and longitudinal observational studies (LOSs) involving patients with systemic sclerosis associated ILD (SSc-ILD)., Methods: Patient Research Partners (those afflicted with SSc-ILD) and the CTD-ILD Working Group on Lung Physiology were polled to assess their opinion on the FVC and DLco in terms of feasibility; the CTD-ILD Working Group was also queried on these instruments' face and content validity. We then conducted a systematic literature review to identify articles in the SSc-ILD population that assessed the following measurement properties of FVC and DLco: (1) construct validity, (2) test-retest reliability, (3) longitudinal construct validity, (4) clinical trial discrimination/sensitivity to detect change in clinical trials, and (5) thresholds of meaning. Results were summarized in a Summary of Measurement Properties (SOMP) table for each instrument. OMERACT CTD-ILD Working Group members discussed and voted on the strength of evidence supporting these two instruments and voted to endorse, provisionally endorse, or not endorse either instrument., Results: Forty Patient Research Partners reported these two measures are feasible (are not an unnecessary burden or represent an infeasible longitudinal assessment of their disease). A majority of the 18 CTD-ILD Working Group members voted that both the FVC and DLco are feasible and have face and content validity. The systematic literature review returned 1,447 non-duplicated articles, of which 177 met eligibility for full text review. Forty-eight studies (13 RCTs, 35 LOSs) were included in the qualitative analysis. The FVC SOMP table revealed high quality, consistent data with evidence of good performance for all five measurement properties, suggesting requisite published evidence to proceed with endorsement. The DLco SOMP table showed a lack of data to support test-retest reliability and inadequate evidence to support clinical trial discrimination. There was unanimous agreement (15 [100%]) among voting CTD-ILD Working Group members to endorse the FVC as an instrument for lung physiology in RCTs and LOSs in SSc-ILD. Based on currently available evidence, DLco did not meet the OMERACT criteria and is not recommended for use in RCTs to represent lung physiology of SSc-ILD. The OMERACT Technical Advisory Group agreed with these decisions., Conclusion: The OMERACT Filter 2.1 was successfully applied to the domain of lung physiology in patients with SSc-ILD. The FVC was endorsed for use in RCTs and LOSs based on the Working Group's vote; DLco was not endorsed., Competing Interests: Declaration of Competing Interest Please see each author's ICJME form., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: To identify patient-centered core domains for prospective longitudinal observational studies (LOS) in rheumatoid arthritis., Methods: Our working group held a virtual meeting in November 2020 to review data from a literature review and patient qualitative interviews, and to discuss strategies to move forward on domain identification and selection using the OMERACT 2.1 domain selection process., Results: Important candidate domains and subdomains were identified including in the areas of life impact. Consensus was reached on moving forward with a Delphi process., Conclusions: The meeting provided future directions to identify and select a core set of domains for use in LOS., Competing Interests: Declaration of Competing Interest LC has not received fees or personal grants from any pharmaceutical companies, but her Institute performs contract work for pharmaceutical companies including Abbvie Spain, Eisai, Gebro Pharma, Merck Sharp & Dohme España, S.A., Novartis Farmaceutica, Pfizer, Roche Farma, Sanofi Aventis, Astellas Pharma, Actelion Pharmaceuticals España, Grünenthal GmbH, and UCB Pharma LM – Honorarium for speaker fees in past 3 years from Pfizer, Abbvie, Eli Lilly, Novartis; grants from Janssen, Roche. All unrelated to this work. Member of OMERACT Exec which receives current educational grants from 9 companies. RC acknowledges that the Parker Institute,Bispebjerg and Frederiksberg Hospital is supported by a core grant from the Oak Foundation (OCAY-13–309). MSA – Past consultant for Pfizer, AbbVie, Eli Lilly, Agile Therapeutics, AMAG Pharmaceuticals, Gilead, Avenue Therapeutics, and ChemoCentryx, all unrelated to the topic of this paper. Member of Celgene advisory board. All activities unrelated to this work., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: Physical function is one of the core domains to be measured in all trials in psoriatic arthritis (PsA). We aimed to evaluate two instruments for physical function in PsA: The Health Assessment Questionnaire-disability index (HAQ-DI) and the physical functioning subscale of the Medical Outcome Survey Short-Form 36 items (SF-36 PF)., Methods: We followed guidelines set out by the OMERACT Filter 2.1. A working group was formed to evaluate each instrument for domain match and feasibility to reach consensus. Two systematic literature reviews (SLRs) were conducted to identify the relevant articles supporting measurement properties of both instruments. Five additional measurement properties were appraised: construct validity, test-retest reliability, longitudinal construct validity, clinical trial discrimination, and threshold of meaning. New evidence was synthesized to fill the gap. Data were presented to the OMERACT technical advisory group (TAG) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) community for endorsement., Results: The results for seven measurement properties for HAQ-DI and SF-36 PF were presented in Summary of Measurement Property (SOMP) tables. The working group proposed "Provisional Endorsement" for both instruments. The body of evidence was approved by the OMERACT TAG. In two Delphi exercises among GRAPPA members, HAQ-DI received 93.9% and 97.5% endorsement votes, while that for SF-36 PF were 86.7% and 77.3%., Conclusion: Both HAQ-DI and SF-36 PF were provisionally endorsed for the measurement of physical function in PsA trials, using the OMERACT Filter 2.1., Competing Interests: Declaration of Competing Interest This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. YYL is funded by the Clinician Scientist award of the National Medical Research Council, Singapore (NMRC/CSA-INV/0022/2017). AMO is funded by the Jerome L. Greene Foundation Scholar Award, the Staurulakis Family Discovery Award, the Rheumatology Research Foundation, and the National Institutes of Health (NIH) through the Rheumatic Diseases Resource-based Core Center (P30-AR053503 Cores A and D, and P30-AR070254, Cores A and B). PH and RC (The Parker Institute, Bispebjerg and Frederiksberg Hospital) is supported by a core grant from the Oak Foundation (OCAY-18-774-OFIL). LCC is funded by a National Institute for Health Research Clinician Scientist award, and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC). AO is funded by NIH/NIAMS R01 AR072363. All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the funding agencies., (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.)

Competing Interests: Declaration of Competing Interest All authors are members of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies.

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: Underreporting of harms in randomized controlled trials (RCTs) may lead to incomplete or erroneous assessments of the perceived benefit-to-harm profile of an intervention. To compare benefit with harm in clinical practice and future clinical studies, adverse event (AE) profiles including severity need to be understood. Even though patients report harm symptoms earlier and more frequently than clinicians, rheumatology RCTs currently do not provide a reporting framework from the patient's perspective regarding harms. Our objective for this meta-research project was to identify AEs in order to determine harm clusters and whether these could be self-reported by patients. Our other objective was to examine reported severity grading of the reported harms., Methods: We considered primary publications of RCTs eligible if they were published between 2008 and 2018 evaluating pharmacological interventions in patients with a rheumatic or musculoskeletal condition and if they were included in Cochrane reviews. We extracted data on harms such as reported AE terms together with severity (if described), and categorized AE- and severity-terms into overall groups. We deemed all AEs with felt components appropriate for patient self-reporting., Results: The literature search identified 187 possible Cochrane reviews, of which 94 were eligible for evaluation, comprising 1,297 articles on individual RCTs. Of these RCTs, 93 pharmacological trials met our inclusion criteria (including 31,023 patients; representing 20,844 accumulated patient years), which reported a total of 21,498 AEs, corresponding to 693 unique reported terms for AEs. We further sub-categorized these terms into 280 harm clusters (i.e., themes). AEs appropriate for patient self-reporting accounted for 58% of the AEs reported. Among the reported AEs, we identified medical terms for all of the 117 harm clusters appropriate for patient reporting and lay language terms for 86%. We intended to include severity grades of the reported AEs, but there was no evidence for systematic reporting of clinician- or patient-reported severity in the primary articles of the 93 trials. However, we identified 33 terms suggesting severity, but severity grading was discernible in only 9%, precluding a breakdown by severity in this systematic review., Conclusions: Our results support the need for a standardized framework for patients' reporting of harms in rheumatology trials. Reporting of AEs with severity should be included in future reporting of harms, both from the patients' and investigators' perspectives., Registration: PROSPERO: CRD42018108393., Competing Interests: Declaration of Competing Interest Berthelsen: none Woodworth: none Ioannidis: none Tugwell: none relevant Devoe: none relevant Williamson: none Terwee: none Suarez-Almazor: none Strand: none relevant Leong: none Goel: none relevant Conaghan: none relevant Boers: none relevant Shea: none relevant Brooks: none relevant Simon: none relevant Furst: none relevant Christensen: none relevant, (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Structural damage is as an important outcome in the Psoriatic Arthritis (PsA) Core Domain Set and its assessment is recommended at least once in the development of a new drug., Objectives: To conduct a systematic review (SR) to identify studies addressing the measurement properties of radiographic outcome instruments for structural damage in PsA and appraise the evidence through the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 Framework Instrument Selection Algorithm (OFISA)., Methods: A SR was conducted using search strategies in EMBASE and MEDLINE to identify full-text English studies which aimed to develop or assess the measurement properties of radiographic outcome instruments in PsA. Determination of eligibility and data extraction was performed independently by two reviewers with input from a third to achieve consensus. Two reviewers assessed the methodology and results of eligible studies and synthesized the evidence using OMERACT methodology., Results: Twelve articles evaluating radiographic instruments were included. The articles assessed nine peripheral (hands, wrists and/or feet) and six axial (spinal and/or sacroiliac joints) radiographic instruments. The peripheral radiographic instruments with some evidence for reliability, cross-sectional construct validity and longitudinal construct validity were the Ratingen and modified Sharp van der Heijde scores. No instruments had evidence for clinical trial discrimination or thresholds of meaning. There was limited evidence for the measurement properties of all identified axial instruments., Conclusion: There are significant knowledge gaps in the responsiveness of peripheral radiographic instruments. Axial radiographic instruments require further validation, and the need to generate novel instruments and utilise other imaging modalities should be considered., Competing Interests: Declaration of Competing Interest Antony A, Holland R, D'Agostino MA, Maksymomwych W.P., Bertheussen H, Schick L, Goel N, Orbai AM, Højgaard P, Coates L, Strand V, Christensen R, Leung YY and Tillett W have no conflicts to declare. Dr. Ogdie reports personal fees from Abbvie, grants and personal fees from Amgen, personal fees from BMS, personal fees from Celgene, personal fees from Corrona, personal fees from Janssen, personal fees from Lilly, grants, personal fees and other from Novartis, grants and personal fees from Pfizer, outside the submitted work; Husband receives royalties from Novartis. Dr. Gladman reports grants and personal fees from Abbvie, grants and personal fees from Amgen, personal fees from BMS, grants and personal fees from Celgene, grants and personal fees from Eli Lilly, personal fees from Gilead, personal fees from Galapagos, grants and personal fees from Janssen, grants and personal fees from Novartis, grants and personal fees from Pfizer, grants and personal fees from UCB, outside the submitted work; Dr. Mease reports grants and personal fees from AbbVie, grants and personal fees from Amgen, grants and personal fees from Bristol Myers Squibb, personal fees from Boehringer Ingelheim, grants and personal fees from Celgene, personal fees from Galapagos, personal fees from Genentech, personal fees from Gilead, personal fees from GlaxoSmithKline, grants and personal fees from Janssen, grants and personal fees from Lilly, grants and personal fees from Novartis, grants and personal fees from Pfizer, grants and personal fees from Sun, grants and personal fees from UCB,  outside the submitted work. Dr. Leung reports personal fees from AbbVie, Novartis, Elli Lilly and Janssen outside if the submitted work. Dr Tillett reports grants from Abbvie, Celgene, Janssen, Lilly, and personal fees from Abbvie, Amgen, Celgene, Lilly, Janssen, MSD, Novartis, Pfizer and UCB, outside the submitted work. All authors are members of OMERACT, an organization that develops and validates outcome measures in rheumatology randomized controlled trials and longitudinal observational studies and receives arms-length funding from 36 sponsors. Professor R. Christensen acknowledges that the Parker Institute, Bispebjerg and Frederiksberg Hospital is supported by a core grant from the Oak Foundation (OCAY-18-774-OFIL). None of the funding sources had any influence on the study design, on data collection, data synthesis, data interpretation, writing the report, or the decision to submit the manuscript for publication., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: Physical function (PF) is a core domain to be measured in randomized controlled trials (RCTs) of psoriatic arthritis (PsA), yet the discriminative performance of patient reported outcome measures (PROMs) for PF in RCTs has not been evaluated systematically. In this systematic review, we aimed to evaluate the clinical trial discrimination of PF-PROMs in PsA RCTs., Methods: We searched PubMed and Scopus databases in English to identify all original RCTs on biological and targeted synthetic disease modifying anti-rheumatic drugs (DMARDs) conducted in PsA. We assessed quality in each article using the OMERACT good method checklist. Effect sizes (ES) for the PF-PROMs were calculated and appraised using a priori hypotheses. Evidence supporting clinical trial discrimination for each PF-PROM was summarized to derive recommendations., Results: 35 articles from 31 RCTs were included. Four PF-PROMs had data for evaluation: HAQ-Disability Index (DI), HAQ-Spondyloarthritis (S), and Short Form 36-item Health Survey Physical Component Summary (SF-36 PCS) and Physical Functioning domain (SF-36 PF). As anticipated, higher ES values were observed for intervention groups than the control groups. Across all studies, for HAQ-DI, the median ES were -0.73 and -0.24 for intervention and control groups, respectively. Whereas for SF-36 PCS, the median ES were 0.77 and 0.23. For intervention and control groups, respectively., Conclusion: Clinical trial discrimination was supported for HAQ-DI and SF-36 PCS in PsA with low risk of bias; and for SF-36 PF and HAQ-S with some caution. More studies are required for HAQ-S., Competing Interests: Declaration of Competing Interest This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. YYL is funded by the Clinician Scientist award of the National Medical Research Council, Singapore (NMRC/CSA-INV/0022/2017). AMO is funded by the Jerome L. Greene Foundation Scholar Award, the Staurulakis Family Discovery Award, the Rheumatology Research Foundation, and the National Institutes of Health (NIH) through the Rheumatic Diseases Resource-based Core Center (P30-AR053503 Cores A and D, and P30-AR070254, Cores A and B). PH and RC (The Parker Institute, Bispebjerg and Frederiksberg Hospital) is supported by a core grant from the Oak Foundation (OCAY-18–774-OFIL). LCC is funded by a National Institute for Health Research Clinician Scientist award, and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC). AO is funded by the Rheumatology Research Foundation and NIH/NIAMS R01 AR072363. All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the funding agencies., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: Patients with psoriatic arthritis (PsA) experience substantial physical impairment. This is commonly assessed using the patient-reported Health Assessment Questionnaire-Disability Index (HAQ-DI), which was originally developed in rheumatoid arthritis. The purpose of this review is to examine the value and challenges of using the HAQ-DI in patients with PsA, and to discuss alternative measures of functional impairment in this condition., Methods: A literature search was performed in the MEDLINE, BIOSIS Previews, Embase, Derwent Drug File, and SciSearch databases using relevant terms and key words. Additional references from personal libraries were identified by the authors., Results: Although validated in PsA, the HAQ-DI has limitations, including marked floor effects, lack of responsiveness to treatment effects in later disease stages, and underestimation of physical impairment in patients whose symptoms are predominantly skin related. Nonetheless, it has been widely used in clinical trials of PsA treatment and is generally responsive to change with effective therapy, discriminating between active and placebo treatments. Other generic or arthritis-specific patient-reported questionnaires with a focus on physical impairment include the Medical Outcomes Study Short Form-36 Health Survey, the EuroQol-5D, the Arthritis Impact Measurement Scales, and the Routine Assessment of Patient Index Data 3. There are currently no PsA-specific instruments to assess physical function, but health-related quality-of-life questionnaires with elements related to functional impairment include the PsA Quality of Life questionnaire, the PsA Impact of Disease questionnaire, and VITACORA-19. As the available measures of physical impairment may not reflect the impact of all aspects of PsA on a patient, additional health-related quality-of-life instruments, such as the Dermatology Life Quality Index, may be used in parallel to obtain a more complete picture of the disease burden., Conclusions: The HAQ-DI is a valuable assessment tool that clinicians should continue to use in clinical trials and practice. Because instruments to specifically assess physical function in patients with PsA are currently lacking, clinicians should consider using a combination of instruments to conduct the most thorough evaluation possible., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: An updated psoriatic arthritis (PsA) core outcome set (COS) for randomized controlled trials (RCTs) was endorsed at the Outcome Measures in Rheumatology (OMERACT) meeting in 2016., Objectives: To synthesize the evidence on measurement properties of patient reported outcome measures (PROMs) for PsA and thereby contribute to development of a PsA core outcome measurement set (COMS) as described by the OMERACT Filter 2.0., Methods: A systematic literature search was performed in EMBASE, MEDLINE and PsycINFO on Jan 1, 2017 to identify full-text articles with an aim of assessing the measurement properties of PROMs in PsA. Two independent reviewers rated the quality of studies using the COnsensus based standards for the Selection of health Measurement INstruments (COSMIN) checklist, and performed a qualitative evidence synthesis., Results: Fifty-five studies were included in the systematic review. Forty-four instruments and a total of 89 scales were analyzed. PROMs measuring COS domains with at least fair quality evidence for good validity and reliability (and no evidence for poor properties) included the Stockerau Activity Score for PsA (German), Psoriasis Symptom Inventory, visual analogue scale for Patient Global, 36 Item Short Form Health Survey Physical Function subscale, Health Assessment Questionnaire Disability Index, Bath Ankylosing Spondylitis Functional Index, PsA Impact of Disease questionnaire, PsA Quality of Life questionnaire, VITACORA-19, Functional Assessment of Chronic Illness Therapy Fatigue scale and Social Role Participation Questionnaire., Conclusions: At least one PROM with some evidence for aspects of validity and reliability was available for six of the eight mandatory domains of the PsA COS., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Advances in rheumatology occur at a rapid pace and staying abreast of important changes is a challenge for all. Both novel drug development and enhanced understanding of conventional or historic therapies have molded current day rheumatologic practice. Rheumatology has led the way in the use of outcome measures and imaging modalities in common disorders like rheumatoid arthritis, osteoarthritis, and gout. The expertise of the rheumatologist has widened such that knowledge of economics, legal issues, related disorders and extraarticular disease is essential. In February 2013, the 6th annual Rheumatology Winter Clinical Symposium was held. At this meeting, faculty and participants held discussions and exchanged knowledge about new scientific data and how it may impact the care of rheumatology patients. Excerpts from some of the lectures from the Rheumatology Winter Clinical Symposium 2013 are included in this review. These and other presentations can be viewed in their entirety at http://www.r-w-c-s.com., (Copyright © 2013 Elsevier Inc. All rights reserved.)