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Objective: Our objectives were to quantify the relationships among fatigue, pain interference, and physical disability in children with juvenile idiopathic arthritis (JIA) and to test whether fatigue mediates the relationship between pain interference and physical disability in JIA., Methods: Patients enrolled within three months of JIA diagnosis in the Canadian Alliance of Pediatric Rheumatology Investigators (CAPRI) Registry between February 2017 and May 2023 were included. Their parents completed the Patient-Reported Outcomes Measurement Information System fatigue and pain interference short proxy questionnaires and the Childhood Health Assessment Questionnaire disability index at registry enrollment. Associations were assessed using Pearson correlations and multiple linear regression. Structural equation modeling (SEM) was used to test if fatigue mediates the relationship between pain interference and physical disability., Results: Among 855 patients (61.4% female, 44.1% with oligoarthritis), most reported fatigue and pain interference scores similar to those in the reference population, but 15.6% reported severe fatigue and 7.3% reported severe pain interference, with wide variation across JIA categories. Fatigue was strongly correlated with pain interference (r = 0.72, P < 0.001) and with physical disability (r = 0.60, P < 0.001). Pain interference (β = 0.027, P < 0.001) and fatigue (β = 0.013, P < 0.001) were both associated with physical disability after controlling for each other and potential confounders. SEM supported our hypothesis that fatigue partially mediates the relationship between pain interference and physical disability., Conclusion: Our findings suggest both fatigue and pain interference are independently associated with physical disability in children newly diagnosed with JIA, and the effect of pain interference may be partly mediated by fatigue., (© 2024 The Author(s). Arthritis Care & Research published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)

Background: Individuals with advanced cancer can benefit from physical activity (PA), but face barriers to PA participation. Physiotherapists can be well-positioned to support this patient population., Objective: Our objective was to describe the perspectives, practices, knowledge, and skills of oncology physiotherapists related to PA in people with advanced cancer., Methods: In this mixed-methods study, we recruited Canadian physiotherapists with current or recent clinical experience with advanced cancer. Phase I consisted of an online survey about views toward PA in advanced cancer and activity-related recommendations and concerns for two case scenarios. Phase II involved individual, semi-structured interviews about perspectives related to working with advanced cancer., Results: Sixty-two physiotherapists participated in the survey, of which 13 participated in interviews. Most respondents (> 85%) agreed or strongly agreed PA is important and safe for individuals with advanced cancer. Case responses highlighted cancer-related considerations (e.g. bone metastases) tailored activity recommendations, and patient-centered, interprofessional care. Interview themes included: 1) situating PA within individually meaningful goals; 2) tailored strategies to promote PA; 3) overarching roles in functional optimization and symptom management; and 4) generalized lack of awareness regarding physiotherapy., Conclusion: Our findings indicate Canadian oncology physiotherapists describe knowledge of the safety and importance of PA, as well as key considerations in advanced cancer. Moreover, they highlight the importance of a patient-centered approach to support this population, particularly in facilitating safe and meaningful PA, as well as optimizing function and alleviating symptom burden. Further efforts are needed to investigate the development and integration of physiotherapy within cancer care.

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

Purpose: Leisure-time physical activity (LTPA) can be beneficial for individuals with advanced cancer, but little is known on how to tailor rehabilitation strategies targeting LTPA in cancer care. Our objective was to explore perspectives and experiences of LTPA in people with stage 4 cancer., Materials and Methods: Guided by interpretive-description methodology, our qualitative study consisted of individual, semi-structured interviews with 20 Canadian adults diagnosed with stage 4 cancer. Interviews were transcribed verbatim and analyzed inductively., Results: The participants' median age was 51.5 (range, 35-73) years. Cancer types included breast ( n  = 12), lung ( n  = 4), and other ( n  = 4). Participants highlighted their experiences of LTPA as diverse and complex, impacted by individual and cancer-related factors. They emphasized being intentional with LTPA through activity planning and modification. LTPA participation was linked to physical well-being, social connections, and meanings of accomplishment and loss. Many participants desired personalized support related to LTPA, that is integrated, interprofessional, and accessible in cancer care., Conclusion: The experiences of LTPA for people with stage 4 cancer are personal and connected to health and psychosocial meanings. Further efforts in rehabilitation are needed to address the challenges faced by people with advanced cancer and optimize safe, meaningful participation in LTPA.IMPLICATIONS FOR REHABILITATIONExperiences of leisure-time physical activity in individuals with stage 4 cancer are personal and linked to health benefits and psychosocial meanings.Activity participation frequently involves consideration of cancer-related symptoms, management of risks, and intentional planning and modification of activities.Trained rehabilitation professionals integrated in cancer care may be well suited to support people with stage 4 cancer through personalized activity recommendations.This research can help inform future clinical, research, and educational efforts in rehabilitation aimed at targeting physical activity in individuals with advanced cancer.

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

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

Objective: Complementary Health Approaches (CHA) are commonly used by children with cancer; however, a few health care providers (HCPs) inquire about the use of CHA. A standardized questionnaire could facilitate such clinical discussions. We aimed to adapt and determine the face and content validity of the "Which Health Approaches and Treatments are you using?" (WHAT) child and parent-report questionnaires in pediatric oncology., Methods: An electronic Delphi survey that included children with cancer (8-18 years), parents, and HCPs and CHA researchers was conducted to reach consensus on the content of the WHAT questionnaires in pediatric oncology. Children and parents from the Hospital for Sick Children (SickKids), and HCPs and researchers from the International Society of Pediatric Oncology and Pediatric Complementary and Alternative Medicine Research and Education Network completed the survey. To determine the face and content validity of the questionnaires, two iterative cycles of individual interviews were conducted with purposive samples of children (8-18 years), parents, and HCPs from SickKids., Results: Consensus was reached on all domains and items of the original WHAT questionnaires after one Delphi cycle (n = 61). For face and content validity testing, the first cycle of interviews (n = 19) revealed that the questionnaires were mostly comprehensive and relevant. However, the paper-based format of the original WHAT was not user-friendly, and generic items were vague and not aimed at facilitating clinical dialogues about CHA use. The WHAT questionnaires were then modified into electronic cancer-specific self- and proxy-report questionnaires including 13 and 15 items, respectively. The second cycle (n = 21) showed no need for further changes., Conclusions: The modified electronic cancer-specific WHAT questionnaires showed adequate face and content validity. The next step is to determine inter-rater reliability, construct validity, and feasibility of administration of the modified WHAT questionnaires in pediatric oncology., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Alqudimat et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objective: The OMERACT Juvenile Idiopathic Arthritis (JIA) Working Group (WG) aimed to reach agreement on a consensus-based definition and description of the core domain related to patient perception of overall well-being and disease activity., Methods: A committee of patient research partners, clinicians, methodologists, and researchers drafted working definitions and descriptions. The WG conducted two iterative electronic stakeholder surveys to obtain consensus on domain description, definition, and the distinction between patient perception of overall well-being and disease activity. These definitions were then presented at the OMERACT 2023 Special Interest Group (SIG) session for agreement., Results: Forty-five participants, from 7 countries and 4 continents, were comprised of six patients, 18 caregivers, and 21 healthcare providers. The consensus threshold (70%) was exceeded on all survey questions from both stakeholder groups (patients/caregivers, all others). Agreement was obtained on the new definition, description, and domain title, along with agreement on separate assessments of two target domains, patient perception of overall well-being as it relates to disease and patient perception of disease activity., Conclusion: Through an iterative consensus process and achieving agreement from the OMERACT SIG session attendees, the JIA WG has created a detailed definition and description for the two target domains in the patient perception of overall well-being related to disease core domain of the JIA mandatory core domain set. The next phase of this work will be instrument selection using the OMERACT filter 2.2., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Erin Balay-Dustrude reports travel was provided by Omeract - Outcome Measures in Rheumatology. Ben Horgan reports travel was provided by Omeract - Outcome Measures in Rheumatology. Grayson Shultz reports travel was provided by Omeract - Outcome Measures in Rheumatology. Alessandro Consolaro reports a relationship with Pfizer that includes: funding grants and speaking and lecture fees. Joost F. Swart reports a relationship with Amgen Inc that includes: consulting or advisory. Esi M Morgan reports a relationship with Pfizer that includes: funding grants. Esi M Morgan reports a relationship with Agency for Healthcare Research and Quality that includes: funding grants. Esi M Morgan reports a relationship with American College of Rheumatology that includes: speaking and lecture fees and travel reimbursement. Esi M Morgan reports a relationship with Pediatric Rheumatology Care and Outcomes Improvement Network that includes: board membership., (Copyright © 2023. Published by Elsevier Inc.)

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: This study aimed to synthesise information concerning the potential benefits and risks related to cochlear implants (CIs) versus hearing aids (HAs) in children with residual hearing., Design: A systematic review of articles published from January 2003 to January 2019 was conducted., Study Sample: Our review included studies that compared the benefits and risks of CIs versus HAs in children (≤18 years old) with residual hearing. A total of 3265 citations were identified; 8 studies met inclusion criteria., Results: Children with CIs showed significantly better speech perception scores post-CI than pre-CI. There was limited evidence related to improvement in everyday auditory performance, and the results showed non-significant improvement in speech intelligibility. One study on social-emotional functioning suggested benefits from CIs. In four studies, 37.2% (16/43) of children showed loss of residual hearing and 14.0% (8/57) had discontinued or limited use of their device., Conclusions: Children with CIs showed improvement in speech perception outcomes compared to those with HAs. However, due to the limited number of studies and information to guide decision-making related to other areas of development, it will be important to conduct further research of both benefits and risks of CIs in this specific population to facilitate decision-making.

Interprofessional communication about inflammatory and non-inflammatory musculoskeletal conditions is an important component of assessment and management in paediatric rheumatology. Chronic pain is a feature of some of these conditions which likely influences the extent and type of communication about pain. Research investigating interprofessional communication about paediatric pain is limited but has found that communication is inclusive of the biopsychosocial context of children/adolescents as well as their families. The aim of this ethnographic study was to explore interprofessional communication about children and adolescents with chronic musculoskeletal pain in paediatric rheumatology. We observed forty-five healthcare professionals recruited from 3 UK paediatric rheumatology teams during thirty multi-disciplinary team meetings. Contemporaneous field notes created during observations were analysed using grounded theory procedures. Core processes identified in interprofessional communication involved describing, making sense of, and managing children/adolescents with pain and their families. Topic areas discussed within these core processes included healthcare professional perceptions about children's and parents' personality characteristics, as well as healthcare professionals' familiarity with families. Underlying diagnoses and possible attributions of pain aetiology were also discussed. Interprofessional narratives included consideration of the potential anxieties and uncertainties about pain within families. Healthcare professionals communicated about strategies for managing expectations about pain. These findings characterise the nuances in interprofessional communication about pain and can be used to inform future work aimed at understanding and optimising the impact of interprofessional communication on clinical decisions and pain outcomes. PERSPECTIVE: This study characterises the processes (series of actions), the function (purpose) and the content (topic areas) of interprofessional communication about paediatric pain in rheumatology settings. These findings should be used to inform interventions targeting both the appropriateness and effectiveness of this communication., (Copyright © 2023 United States Association for the Study of Pain, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Cochlear implant (CI) decision-making is particularly challenging for families of children who have residual hearing. Parents of these children may be uncertain about whether the potential benefits of CIs outweigh the risks. This study aimed to understand parents' decisional needs during the decision-making process for children with residual hearing., Method: Semi-structured interviews were conducted with parents of 11 children who had received CIs. Open-ended questions were asked to encourage parents to share their experiences about the decision-making process, their values/preferences, and their needs. The interviews were transcribed verbatim and analyzed using thematic analysis., Results: Data were organized according to three key themes: (1) Parents' decisional conflict, (2) values and preferences, (3) decision support and parents' needs. We found that overall parents were satisfied with their decision-making process and the decision support from practitioners. However, parents stressed the importance of receiving more personalized information that considers their specific concerns, values and preferences related to family's circumstances., Conclusions: Our research provides additional evidence to guide the CI decision-making process for children with residual hearing. Additional collaborative research with audiology and decision-making experts specifically on facilitating shared decision-making is needed to provide better decision coaching for these families.

Background: This study aimed to test the inter-rater reliability, construct validity, and feasibility of the modified "Which Health Approaches and Treatments Are You Using?" (WHAT) questionnaires in pediatric oncology; Methods: Parent-child dyads were invited to complete self- and proxy-report-modified WHAT, Pediatric Quality of Life Inventory, demographics, a diary of the child's recent use of CHA, and a questionnaire assessing the aspects of feasibility. Parents were asked to complete a satisfaction of their children's use of the CHA survey; Results: Twenty-four dyads completed the study. The mean weighted kappa showed strong inter-rater reliability (k = 0.77, SE = 0.056), and strong agreements between the modified WHAT and the diary (self-report [k = 0.806, SE = 0.046] and proxy-report [k = 0.894, SE = 0.057]). Significant relationships were found only between recent and non-recent CHA users in relation to the easy access to CHA (self-report [ p = 0.02], proxy-report [ p < 0.001]). The mean scores of the feasibility scale (out of 7.0) for the self- and proxy-report were 5.64 (SD = 0.23) and 5.81 (SD = 0.22), respectively, indicating the feasibility of the modified WHAT; Conclusions: The findings provide initial evidence of the reliability and validity of the modified WHAT and their feasibility. Further research is needed to test the theoretical relationships and further explore the validity and reliability of the modified WHAT.

Background: Involving collaborators and partners in research may increase relevance and uptake, while reducing health and social inequities. Collaborators and partners include people and groups interested in health research: health care providers, patients and caregivers, payers of health research, payers of health services, publishers, policymakers, researchers, product makers, program managers, and the public. Evidence syntheses inform decisions about health care services, treatments, and practice, which ultimately affect health outcomes. Our objectives are to: A. Identify, map, and synthesize qualitative and quantitative findings related to engagement in evidence syntheses B. Explore how engagement in evidence synthesis promotes health equity C. Develop equity-oriented guidance on methods for conducting, evaluating, and reporting engagement in evidence syntheses METHODS: Our diverse, international team will develop guidance for engagement with collaborators and partners throughout multiple sequential steps using an integrated knowledge translation approach: 1. Reviews. We will co-produce 1 scoping review, 3 systematic reviews and 1 evidence map focusing on (a) methods, (b) barriers and facilitators, (c) conflict of interest considerations, (d) impacts, and (e) equity considerations of engagement in evidence synthesis. 2. Methods study, interviews, and survey. We will contextualise the findings of step 1 by assessing a sample of evidence syntheses reporting on engagement with collaborators and partners and through conducting interviews with collaborators and partners who have been involved in producing evidence syntheses. We will use these findings to develop draft guidance checklists and will assess agreement with each item through an international survey. 3., Consensus: The guidance checklists will be co-produced and finalised at a consensus meeting with collaborators and partners. 4., Dissemination: We will develop a dissemination plan with our collaborators and partners and work collaboratively to improve adoption of our guidance by key organizations., Conclusion: Our international team will develop guidance for collaborator and partner engagement in health care evidence syntheses. Incorporating partnership values and expectations may result in better uptake, potentially reducing health inequities., (© 2023. The Author(s).)

Background: Juvenile idiopathic arthritis (JIA) is a common pediatric rheumatic condition and is associated with symptoms such as joint pain that can negatively impact health-related quality of life. To effectively manage pain in JIA, young people, their families, and health care providers (HCPs) should be supported to discuss pain management options and make a shared decision. However, pain is often under-recognized, and pain management discussions are not optimal. No studies have explored decision-making needs for pain management in JIA using a shared decision making (SDM) model. We sought to explore families' decision-making needs with respect to pain management among young people with JIA, parents/caregivers, and HCPs., Methods: We conducted semi-structured virtual or face-to-face individual interviews with young people with JIA 8-18 years of age, parents/caregivers and HCPs using a qualitative descriptive study design. We recruited participants online across Canada and the United States, from a hospital and from a quality improvement network. We used interview guides based on the Ottawa Decision Support Framework to assess decision-making needs. We audiotaped, transcribed verbatim and analyzed interviews using thematic analysis., Results: A total of 12 young people (n = 6 children and n = 6 adolescents), 13 parents/caregivers and 11 HCPs participated in interviews. Pediatric HCPs were comprised of rheumatologists (n = 4), physical therapists (n = 3), rheumatology nurses (n = 2) and occupational therapists (n = 2). The following themes were identified: (1) need to assess pain in an accurate manner; (2) need to address pain in pediatric rheumatology consultations; (3) need for information on pain management options, especially nonpharmacological approaches; (4) importance of effectiveness, safety and ease of use of treatments; (5) need to discuss young people/families' values and preferences for pain management options; and the (6) need for decision support. Themes were similar for young people, parents/caregivers and HCPs, although their respective importance varied., Conclusions: Findings suggest a need for evidence-based information and communication about pain management options, which would be addressed by decision support interventions and HCP training in pain and SDM. Work is underway to develop such interventions and implement them into practice to improve pain management in JIA and in turn lead to better health outcomes., (© 2023. The Author(s).)

Introduction: The 2021 Action Plan for Pain from the Canadian Pain Task Force advocates for patient-centred pain care at all levels of healthcare across provinces. Shared decision-making is the crux of patient-centred care. Implementing the action plan will require innovative shared decision-making interventions, specifically following the disruption of chronic pain care during the COVID-19 pandemic. The first step in this endeavour is to assess current decisional needs (ie, decisions most important to them) of Canadians with chronic pain across their care pathways., Methods and Analysis: Design Grounded in patient-oriented research approaches, we will perform an online population-based survey across the ten Canadian provinces. We will report methods and data following the CROSS reporting guidelines. Sampling The Léger Marketing company will administer the online population-based survey to its representative panel of 500 000 Canadians to recruit 1646 adults (age ≥18 years old) with chronic pain according to the definition by the International Association for the Study of Pain (eg, pain ≥12 weeks). Content Based on the Ottawa Decision Support Framework, the self-administered survey has been codesigned with patients and contain six core domains: (1) healthcare services, consultation and postpandemic needs, (2) difficult decisions experienced, (3) decisional conflict, (4) decisional regret, (5) decisional needs and (6) sociodemographic characteristics. We will use several strategies such as random sampling to improve survey quality. Analysis We will perform descriptive statistical analysis. We will identify factors associated with clinically significant decisional conflict and decision regret using multivariate analyses., Ethics and Dissemination: Ethics was approved by the Research Ethics Board at the Research Centre of the Centre Hospitalier Universitaire de Sherbrooke (project #2022-4645). We will codesign knowledge mobilisation products with research patient partners (eg, graphical summaries and videos). Results will be disseminated via peer-reviewed journals and national and international conferences to inform the development of innovative shared decision-making interventions for Canadians with chronic pain., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To (i) validate the JIA parent global assessment (parent global) as a health-related quality of life (HRQoL) instrument; (ii) evaluate measurement properties of accepted HRQoL measures relative to those of the parent global; and (iii) assess causal pathways determining parent global scores., Methods: Data from the Research in Arthritis in Canadian Children emphasizing outcomes (ReACCh-Out) cohort were used. Measurement properties were assessed in 344 patients at enrolment and 6 months later. Causal pathways were tested by structural equation modelling to understand root causes and mediators leading to parent global scores., Results: Construct validity was supported by Spearman correlations of 0.53-0.70 for the parent global with the Juvenile Arthritis Quality of Life Questionnaire, Quality of My Life health scale (HRQoML), Pediatric Quality of Life Inventory (PedsQL)-Parent, and Child Health Questionnaire (CHQ)-Physical. Exceptions were PedsQL-Child (0.44) and CHQ-Psychosocial (0.31). Correlations were lower (0.14-0.49) with disease activity measures (physician global assessment of disease activity, active joint count, ESR). Responsiveness of the parent global to improvement according to parent ratings (0.51) was acceptable and within the range (0.32-0.71) of that of other measures. Reliability estimates and measurement errors for all measures were unsatisfactory, likely due to the prolonged time between assessments. Causal pathways for the parent global matched those previously reported for HRQoML., Conclusions: Our results offer support for the parent global as a valid measure of HRQoL for JIA. If confirmed, existing studies using the parent global may be re-interpreted, enhancing our knowledge of HRQoL in children with JIA., (© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Despite recommendations for regular lung volume recruitment (LVR) use in clinical practice guidelines for children with neuromuscular disease, adherence to LVR is poor. We aimed to describe the experience of LVR by boys with Duchenne muscular dystrophy (DMD), their families, and healthcare providers (HCPs), as well as to identify the barriers and facilitators to LVR use., Methods: This multicenter, qualitative study evaluated boys with DMD (n = 11) who used twice-daily LVR as part of a randomized controlled trial, as well as their parents (n = 11), and HCPs involved in the clinical use of LVR (n = 9). Semistructured interviews were conducted to identify participants' understanding of LVR therapy and their beliefs, barriers and facilitators to its use. Thematic analysis was conducted using an inductive approach. A subanalysis compared adherent and nonadherent children., Results: Seven themes were identified related to participants' beliefs and experiences with LVR: emotional impact, adaptation to LVR, perceived benefits of LVR, routine, family engagement, clinical resources, and equipment-related factors. Strategies to improve adherence were also identified, including education, reinforcement and demonstration of LVR benefit, as well as clinician support. There were no thematic differences between adherent and nonadherent children., Discussion: Despite the benefits of LVR and positive experiences with it by many families, there remain barriers to adherence to treatment. HCPs need to balance the need for early introduction to give families time to adapt to LVR while ensuring that the benefit of LVR outweighs the burden. Clinician support is important for family engagement., (© 2022 Wiley Periodicals LLC.)

Purpose: The main objective was to assess the feasibility of conducting a full randomized controlled trial (RCT) to test the effectiveness of the OA Go Away (OGA) behavioural intervention on adherence to prescribed exercise, level of physical activity, goal attainment, and health outcomes, and to determine the acceptability of the OGA. The OGA is an internal reinforcement tool designed to promote exercise adherence for people with hip or knee OA. Method: This 3-month pragmatic pilot RCT included 40 participants with hip or knee OA who were randomized into the treatment group who used the OGA for three months, or standard care. Results: This pilot RCT which included 37 participants (17 in the treatment group and 20 in the control group) showed that it would be feasible to complete a full RCT of the OGA behavioural intervention with adjustments to the format of the OGA (electronic), inclusion criteria, outcome measures and duration. The OGA was felt to be useful (75%) and motivational (82%) by participants. Conclusions: This pilot RCT justifies a formal RCT of the OGA and shows promising results concerning its acceptability, especially if available in an electronic format., (© Canadian Physiotherapy Association.)

Aims: To compare the efficacy and safety of antihyperglycemic agents, taken in combination with metformin, for the treatment of type 2 diabetes mellitus (T2DM)., Methods: A previous 2016 comprehensive search of Ovid MEDLINE, PubMed, and Cochrane CENTRAL was updated to October 2018, and a systematic review and network meta-analysis (NMA) was conducted. Randomized controlled trials (RCTs) of patients with T2DM taking an antihyperglycemic agent in combination with metformin were included. Bayesian NMA was performed to assess the relative efficacy and safety of the antihyperglycemic classes., Results: In total, 204 RCTs were included, which assessed the efficacy and safety of eight antihyperglycemic drug classes (i.e., sulfonylureas, meglitinides, alpha-glucosidase inhibitors, thiazolidinediones, basal and biphasic insulin, dipeptidyl peptidase 4 inhibitors, glucagon-like-peptide-1 receptor agonists and sodium-glucose cotransport-2 inhibitors). All drug classes significantly reduced haemoglobin A1c (HbA1c) compared to metformin monotherapy (mean reduction from 0.50 to 0.92). The drug classes varied in their relative effects on hypoglycemia, body weight, body mass index, systolic and diastolic blood pressure, total cholesterol, high and low density lipoprotein cholesterol, and the classes had differing safety profiles on total adverse events, urogenital adverse events, heart failure, serious adverse events, and withdraw due to adverse events., Conclusions: All eight antihyperglycemic drug classes, taken in combination with metformin, reduced HbA1c levels; however, the effects of the agents on other outcomes varied among the classes., (© 2021 John Wiley & Sons Ltd.)

Introduction: Building capacity to improve sex/gender knowledge and strengthen patient engagement in clinical trials requires training and support. The overall goal of this 2-year project is to refine, translate and evaluate two web-based open-access patient and investigator decision aids aimed to improve patient engagement partnerships in clinical trials., Methods and Analysis: Two decision aids were designed in Phase 1 of this programme of research and this protocol describes a subsequent sequential phased approach to refine/translate (Phase 2A) and conduct alpha/usability (Phase 2B) and beta/field (Phase 3) testing. Decision aid development is guided by the International Patient Decision Aid Standards, User-Centred Design, Ottawa Decision-Support Framework and the Ottawa Model of Research Use. We have integrated patient-oriented research methods by engaging patient partners across all phases of our programme of research. Decision aids will first be refined and then translated to French (Phase 2A). Eight iterative cycles of semistructured interviews with 40 participants (20 patient partners and 20 investigators) will be conducted to determine usability (Phase 2B). A pragmatic pre/post pilot study design will then be implemented for field/beta testing using another purposive sample of 80 English-speaking and French-speaking participants (40 patients and 40 investigators). The samples are purposive to ensure an equal representation of English-speaking and French-speaking participants and an equal representation of men and women. Since sex and/or gender differences in utilisation and effectiveness of decision aids have not been previously reported, Phase 3 outcomes will be reported for the total sample and separately for men and women., Ethics and Dissemination: Ethics approval has been granted from the University of Toronto (41109, 28 September 2021). Informed consent will be obtained from participants. Dissemination will include co-authored publications, conference presentations, educational national public forums, fact sheets/newsletters, social media sharing and videos/webinars., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Appendicitis is one of the most commonly encountered pediatric surgical diagnoses, with non-operative management of perforated appendicitis leading to two treatment options: an interval appendectomy (IA) or expectant management. The primary objective of this study was to assess parents' need for a patient decision aid (PDA) among parents considering IA or expectant management. A secondary objective was to determine parent preferences for the format and distribution plan of a drafted patient decision aid., Methods: Coulter's systematic development process for PDA was used to guide the assessment interviews for parents. Participants included caregivers of a patient who experienced perforated appendicitis, and admission between 2019 and 2020. Semi-structured individual interviews were conducted to collect information about decision-making needs of parents of children who experienced perforated appendicitis., Results: A total of 12 different parents participated in the interviews. Results indicate decisional conflict associated with the lack of evidence for optimal treatment, supporting the need for the development of a patient decision aid to assist in clarifying information and parent values with practitioners. Parents clearly identified a need for evidence to support decision-making in various formats (eg, pamphlet or electronic). Timing of when to deliver the PDA varied (ie, during hospital admission, at discharge, or at follow-up appointment)., Conclusion: Results indicated various factors contributing to parental decisional conflict, including the lack of evidence showing the optimal treatment, the need for more information, and guidance from practitioners. Overall, findings indicate a strong need for a patient decision aid., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Cochlear implants (CI) candidacy criteria have expanded to include children with more residual hearing. This study explored the clinical profiles and outcomes of children with CIs who had preoperative residual hearing in at least one ear., Design: A retrospective chart review was conducted to collect clinical characteristics and speech perception data. Pre- and post-CI auditory and speech perception data were analysed using a modified version of the Pediatric Ranked Order Speech Perception (PROSPER) score., Study Sample: This study included all children with residual hearing who received CIs in one Canadian paediatric centre from 1992 to 2018., Results: A total of 100 of 389 (25.7%) children with CIs had residual hearing (median 77.6 dB HL, better ear). The proportion of children with residual hearing increased from 1992 to 2018. Children who had auditory behaviour and speech perception tests (n = 83) showed higher modified PROSPER scores post-CI compared to pre-CI. Phonologically Balanced Kindergarten (PBK) test scores were available for 71 children post-CI; 81.7% (58/71) of children achieved > 80% on the PBK., Conclusions: One in four children who received CIs had residual hearing, and most of them had severe hearing loss at pre-CI. These children showed a high level of speech perception with CIs.

Objective: Produce a French-Canadian translation of AMSTAR 2, affirm its content validity, and examine interrater reliability. Methods: Based on Vallerand's methodological approach, we conducted forward and parallel inverse-translations. Subsequently, an expert panel evaluated the translations to create a preliminary experimental French-Canadian version. A second expert panel examined this version and proposed additional modifications. Twenty future health professionals then rated the second experimental version for ambiguity on a scale (from 1 to 7). The principal co-investigators then reviewed the problematic elements and proposed a pre-official version. To ascertain content validity, a final back-translation was conducted resulting in the official version. Four judges evaluated 13 systematic reviews using the official French-Canadian version of AMSTAR 2. The Kappa coefficient was used to evaluate interrater reliability. Results: This rigorous adaptation enabled the development of a Franco-Canadian version of AMSTAR 2. Its application demonstrated low ambiguity (mean 1.15; SD 0.26) as well as good overall interrater reliability (total κ > 0.64) across all items. Conclusion: The French-Canadian version of AMSTAR 2 can now support francophone clinicians, educators, and managers in Canada as they undertake evidence-based practice., (© Canadian Physiotherapy Association.)

Objective: Our primary objective was to develop an Outcome Measures in Rheumatology (OMERACT) core domain set to capture the impact of glucocorticoids (GC), both positive and negative, on patients with Rheumatic conditions., Methods: The OMERACT Filter 2.1 was used to guide core domain selection. Systematic literature reviews, qualitative studies and quantitative surveys were conducted by the OMERACT GC Impact working group to identify candidate domains for a core domain set. A summary of prior work and Delphi exercise were presented at the OMERACT 2020 virtual GC workshop. A proposed GC Impact core domain set derived from this work was presented for discussion in facilitated breakout groups. Participants voted on the proposed GC Impact core domain set., Results: 113 people, including 23 patient research partners, participated in two virtual workshops conducted at different times on the same day. The proposed mandatory domains to be evaluated in clinical trials involving GCs were: infection, bone fragility, hypertension, diabetes, weight, fatigue, mood disturbance and death. In addition, collection of disease specific outcomes was included in the core domain set as "mandatory in specific circumstances". The proposed core domain set was endorsed by 100% (23/23) of the patient research partners and 92% (83/90) of the remaining participants, including clinicians, researchers and industry stakeholders., Conclusion: A GC Impact core domain set was endorsed at the OMERACT 2020 virtual workshop. The OMERACT GC Impact working group will now progress to identify, develop and validate measurement tools to best address these domains in clinical trials., Competing Interests: Declaration of Competing Interest MD George reports grants from Bristol-Myers Squibb and personal fees from Dysimmune Diseases Foundation outside the submitted work. M de Witt reports being a collaborating partner in the EU/IMI funded trial to investigate the efficacy and safety of low-dose GC in the elderly. M Boers is principal investigator of the GLORIA trial on low-dose prednisolone or placebo in elderly RA patients, funded by the European Union's Horizon 2020 research and innovation program under the topic ‘’Personalizing Health and Care’’, grant agreement No 634886. M Petri reports grants and personal fees from AstraZeneca, grants and personal fees from Eli Lilly, grants and personal fees from Exagen, grants and personal fees from GSK, grants and personal fees from Thermofisher, personal fees from Aurinia, personal fees from Abbvie, personal fees from Amgen, personal fees from Blackrock, personal fees from BMS, personal fees from Glenmark, personal fees from IQVIA, grants and personal fees from Janssen, personal fees from Merck EMD Serono, personal fees from Novartis, personal fees from Sanofi Japan, personal fees from UCB, outside the submitted work. JA Singh has received consultant fees from Crealta/Horizon, Medisys, Fidia, Two labs Inc, Adept Field Solutions, Clinical Care options, Clearview healthcare partners, Putnam associates, Focus forward, Navigant consulting, Spherix, MedIQ, UBM LLC, Trio Health, Medscape, WebMD, and Practice Point communications; and the National Institutes of Health and the American College of Rheumatology. JA Singh owns stock options in TPT Global Tech, Vaxart pharmaceuticals and Charlotte's Web Holdings, Inc. JAS previously owned stock options in Amarin, Viking and Moderna pharmaceuticals. JA Singh is on the speaker's bureau of Simply Speaking. JA Singh is a member of the executive of Outcomes Measures in Rheumatology (OMERACT), an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. JA Singh serves on the FDA Arthritis Advisory Committee. JAS is the chair of the Veterans Affairs Rheumatology Field Advisory Committee. JAS is the editor and the Director of the University of Alabama at Birmingham (UAB) Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis. R Christensen reports honoraria paid to the Parker institute from: Lecture- Research Methods (Pfizer, DK; 2017), GRADE Lecture (Celgene, DK; 2017), Ad Board Lecture: CAM (Orkla Health, DK; 2017), Project Grant: "GreenWhistle" (Mundipharma, 2019), Lecture: Diet in RMD (Novartis, DK; 2019), Consultancy Report: Network MA's (Biogen, DK; 2017), Ad Board Lecture: GRADE (Lilly, DK; 2017), Consultancy Report: GRADE (Celgene, 2018), Lecture: Network MA's (LEO; 2020), outside the submitted work; and Musculoskeletal Statistics Unit, The Parker Institute is grateful for the financial support received from public and private foundations, companies and private individuals over the years. The Parker Institute is supported by a core grant from the Oak Foundation. R Christensen is a founding member of the Technical Advisory Group of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. I Gaydukova reports personal fees from Abbvie, grants and personal fees from Pfizer, grants and personal fees from MSD, grants and personal fees from Novartis, personal fees from Sandoz, personal fees from Celgen, grants and personal fees from Biocad, personal fees from Teva, outside the submitted work. A Fernandez reports personal fees and other from AbbVie, grants and personal fees from Novartis, grants and personal fees from Mallinckrodt, personal fees from BMS, personal fees from Alexion, other from Corbus, other from Pfizer, outside the submitted work. S Goodman reports research grant support from Novartis and Horizon, and consulting fees from UCB. J Tieu reports research grant support from Vifor Pharmaceuticals, outside the submitted work. C Hill reports research grant support from Vifor Pharmaceuticals, outside the submitted work. H Keen reports personal fees from Roche and Pfizer, outside the submitted work. P Tugwell is a member of the executive of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. S Mackie reports consultancy on behalf of her institution for Roche/Chugai, Sanofi, AbbVie and AstraZeneca, and received support from Roche to attend EULAR2019. SLM is supported by the Leeds Biomedical Research center. J Robson reports speaker fees from Roche and Vifor Pharma, research support from Vifor Pharma and acted as a clinical trials investigator for Chemocentryx and Novartis, outside the submitted work. No disclosures: A Makol, L King, A Hinojosa-Azaola, O Russell, S Lyne, K Toupin-April, S Decary, M Whitstock, L Gupta, M Alba Garibay, K Yip, C Mukhtyar, C Uhunmwangho, WM Oo, C Ruediger, L Yue, LS Simon, RJ Black, JTL Cheah, N Ghosh, C Campochiaro, B Shea, P Richards. MD George reports grants from Bristol-Myers Squibb and personal fees from Dysimmune Diseases Foundation outside the submitted work. M de Witt reports being a collaborating partner in the EU/IMI funded trial to investigate the efficacy and safety of low-dose GC in the elderly. M Boers is principal investigator of the GLORIA trial on low-dose prednisolone or placebo in elderly RA patients, funded by the European Union's Horizon 2020 research and innovation program under the topic ‘’Personalizing Health and Care’’, grant agreement No 634886. M Petri reports grants and personal fees from AstraZeneca, grants and personal fees from Eli Lilly, grants and personal fees from Exagen, grants and personal fees from GSK, grants and personal fees from Thermofisher, personal fees from Aurinia, personal fees from Abbvie, personal fees from Amgen, personal fees from Blackrock, personal fees from BMS, personal fees from Glenmark, personal fees from IQVIA, grants and personal fees from Janssen, personal fees from Merck EMD Serono, personal fees from Novartis, personal fees from Sanofi Japan, personal fees from UCB, outside the submitted work. JA Singh has received consultant fees from Crealta/Horizon, Medisys, Fidia, Two labs Inc, Adept Field Solutions, Clinical Care options, Clearview healthcare partners, Putnam associates, Focus forward, Navigant consulting, Spherix, MedIQ, UBM LLC, Trio Health, Medscape, WebMD, and Practice Point communications; and the National Institutes of Health and the American College of Rheumatology. JA Singh owns stock options in TPT Global Tech, Vaxart pharmaceuticals and Charlotte's Web Holdings, Inc. JAS previously owned stock options in Amarin, Viking and Moderna pharmaceuticals. JA Singh is on the speaker's bureau of Simply Speaking. JA Singh is a member of the executive of Outcomes Measures in Rheumatology (OMERACT), an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. JA Singh serves on the FDA Arthritis Advisory Committee. JAS is the chair of the Veterans Affairs Rheumatology Field Advisory Committee. JAS is the editor and the Director of the University of Alabama at Birmingham (UAB) Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis. R Christensen reports honoraria paid to the Parker institute from: Lecture- Research Methods (Pfizer, DK; 2017), GRADE Lecture (Celgene, DK; 2017), Ad Board Lecture: CAM (Orkla Health, DK; 2017), Project Grant: "GreenWhistle" (Mundipharma, 2019), Lecture: Diet in RMD (Novartis, DK; 2019), Consultancy Report: Network MA's (Biogen, DK; 2017), Ad Board Lecture: GRADE (Lilly, DK; 2017), Consultancy Report: GRADE (Celgene, 2018), Lecture: Network MA's (LEO; 2020), outside the submitted work; and Musculoskeletal Statistics Unit, The Parker Institute is grateful for the financial support received from public and private foundations, companies and private individuals over the years. The Parker Institute is supported by a core grant from the Oak Foundation. R Christensen is a founding member of the Technical Advisory Group of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. I Gaydukova reports personal fees from Abbvie, grants and personal fees from Pfizer, grants and personal fees from MSD, grants and personal fees from Novartis, personal fees from Sandoz, personal fees from Celgen, grants and personal fees from Biocad, personal fees from Teva, outside the submitted work. A Fernandez reports personal fees and other from AbbVie, grants and personal fees from Novartis, grants and personal fees from Mallinckrodt, personal fees from BMS, personal fees from Alexion, other from Corbus, other from Pfizer, outside the submitted work. S Goodman reports research grant support from Novartis and Horizon, and consulting fees from UCB. J Tieu reports research grant support from Vifor Pharmaceuticals, outside the submitted work. C Hill reports research grant support from Vifor Pharmaceuticals, outside the submitted work. H Keen reports personal fees from Roche and Pfizer, outside the submitted work. P Tugwell is a member of the executive of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. S Mackie reports consultancy on behalf of her institution for Roche/Chugai, Sanofi, AbbVie and AstraZeneca, and received support from Roche to attend EULAR2019. SLM is supported by the Leeds Biomedical Research center. J Robson reports speaker fees from Roche and Vifor Pharma, research support from Vifor Pharma and acted as a clinical trials investigator for Chemocentryx and Novartis, outside the submitted work. No disclosures: A Makol, L King, A Hinojosa-Azaola, O Russell, S Lyne, K Toupin-April, S Decary, M Whitstock, L Gupta, M Alba Garibay, K Yip, C Mukhtyar, C Uhunmwangho, WM Oo, C Ruediger, L Yue, LS Simon, RJ Black, JTL Cheah, N Ghosh, C Campochiaro, B Shea, P Richards., (Copyright © 2021. Published by Elsevier Inc.)

Background: Exercise therapy is effective in reducing symptoms and disability associated with hand osteoarthritis (HOA) but often has low adherence. An intervention consisting in a meaningful occupation, such as knitting, may improve adherence to treatment. This pilot randomized controlled trial (RCT) studied the adherence and clinical effectiveness of a knitting program in older females suffering from HOA to evaluate the acceptability of this intervention and assess the feasibility of a larger-scale RCT., Methods: Single-blind, two-arm pilot RCT with a parallel group design with 37 participants (18 control, 19 intervention). Control participants were given an educational pamphlet and assigned to a waiting list. The knitting program (8-week duration) had two components: bi-weekly 20-min group knitting sessions and daily 20-min home knitting session on the 5 remaining weekdays. Measures included knitting adherence (implementation outcomes) as well as stiffness, pain, functional status, hand physical activity level, patient's global impression of change, health-related quality of life, self-efficacy, and grip strength (clinical outcomes measured throughout the 8-week program and 4 weeks after the intervention)., Results: Our protocol is feasible and the intervention was acceptable and enjoyable for participants, who showed high adherence. No difference was observed between the two groups for any of the clinical outcome measures (all p > .05)., Conclusion: Knitting is a safe and accessible activity for older women with HOA. However, our 8-week knitting program did not result in improvements in any of our outcome measures. Knitting for a longer period and/or with higher frequency may yield better outcomes., Competing Interests: Declaration of competing interest The authors declare that they have no competing interests., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

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

Objective: To gain consensus on the Outcome Measures in Rheumatology (OMERACT) core domain set for rheumatology trials of shared decision making (SDM) interventions., Methods: The process followed the OMERACT Filter 2.1 methodology, and used consensus-building methods, with patients involved since the inception. After developing the draft core domain set in previous research, we conducted five steps: (i) improving the draft core domain set; (ii) developing and disseminating white-board videos to promote its understanding; (iii) conducting an electronic survey to gather feedback on the draft core domain set; (iv) finalizing the core domain set and developing summaries, a plenary session video and discussion boards to promote its understanding; and (v) conducting virtual workshops with voting to endorse the core domain set., Results: A total of 167 participants from 28 countries answered the survey (62% were patients/caregivers). Most participants rated domains as relevant (81%-95%) and clear (82%-93%). A total of 149 participants (n = 48 patients/caregivers, 101 clinicians/researchers) participated in virtual workshops and voted on the proposed core domain set which received endorsement by 95%. Endorsed domains are: 1- Knowledge of options, their potential benefits and harms; 2- Chosen option aligned with each patient's values and preferences; 3- Confidence in the chosen option; 4- Satisfaction with the decision-making process; 5- Adherence to the chosen option and 6- Potential negative consequences of the SDM intervention., Conclusion: We achieved consensus among an international group of stakeholders on the OMERACT core domain set for rheumatology trials of SDM interventions. Future research will develop the Core Outcome Measurement Set., Clinical Significance: Prior to this study, there had been no consensus on the OMERACT core domain set for SDM interventions. The current study shows that the OMERACT core domain set achieved a high level of endorsement by key stakeholders, including patients/caregivers, clinicians and researchers., Competing Interests: Declaration of Competing Interest Karine Toupin-April, Simon Décary, Maarten de Wit, Alexa Meara, Jennifer L. Barton, Liana Fraenkel, Linda C. Li, Peter Brooks, Beverley Shea, Dawn Stacey, France Légaré, Anne Lyddiatt, Cathie Hofstetter, Laurie Proulx, Marieke Voshaar, Maria E. Suarez-Almazor, Tanya Meade, Janet Elizabeth Jull, Willemina Campbell, Rieke Alten, Esi M. Morgan, Ayano Kelly, Jessica Kaufman, Lara J. Maxwell, Francis Guillemin, Dorcas Beaton, Yasser El-Miedany, Shikha Mittoo, Tiffany Westrich Robertson, Susan J. Bartlett, Melissa Mannion, Samah Ismail Nasef, Savia de Souza, Anne Boel, Adewale Adebajo, Laurent Arnaud, Tiffany Gill, Ellen Moholt, Jennifer Burt, Aruni Jayatilleke, Ihsane Hmamouchi, David Carrott, Kate Mather, Ajesh Maharaj, Saurab Sharma, Francesco Caso, Christopher Fong, Allyson Jones, Regina Greer-Smith, Akpabio Akpabio, Valerie Umaefulam, Sara Monti, Charmaine Melburn, Kirsten Schultz, Simon Stones, Sonam Kiwalkar, Hemalatha Srinivasalu, Deb Constien, Lauren K. King and Peter Tugwell have nothing to disclose. Robin Christensen reports other from Lecture: Research Methods (Pfizer, DK; 2017), other from Lecture: GRADE Lecture (Celgene, DK; 2017), other from Ad Board Lecture: CAM (Orkla Health, DK; 2017), other from Project Grant: "GreenWhistle" (Mundipharma, 2019), other from Lecture: Diet in RMD (Novartis, DK; 2019), other from Consultancy Report: Network MA's (Biogen, DK; 2017), other from Ad Board Lecture: GRADE (Lilly, DK; 2017), other from Consultancy Report: GRADE (Celgene, 2018), other from Lecture: Network MA's (LEO; 2020), outside the submitted work; and Musculoskeletal Statistics Unit, The Parker Institute is grateful for the financial support received from public and private foundations, companies and private individuals over the years. The Parker Institute is supported by a core grant from the Oak Foundation; The Oak Foundation is a group of philanthropic organizations that, since its establishment in 1983, has given grants to not-for-profit organizations around the world. Annelies Boonen reports grants from Abbvie, grants from Celgene, other from UCB, other from Galapagos, other from Eli Lilly, outside the submitted work. Lyn March reports personal fees from Pfizer Australia, personal fees from Abbvie Australia, grants from Janssen Australia, outside the submitted work; Dr March is a member of OMERACT executive that receives arms-length funding from 9 companies. Willemina Campbell received OMERACT funded travel to a conference to attend meetings in regard to this paper. Sophie Hill is the Coordinating Editor of the Cochrane Consumers and Communication Group which publishes reviews of the evidence on shared decision making. Jasvinder Singh reports personal fees from Crealta/Horizon, Medisys, Fidia, UBM LLC, Trio health, Medscape, WebMD, Adept Field Solutions, Clinical Care options, Clearview healthcare partners, Putnam associates, Focus forward, Navigant consulting, Spherix, Practice Point communications, the National Institutes of Health and the American College of Rheumatology, personal fees from Simply Speaking, other from Vaxart pharmaceuticals and Charlotte's Web Holdings (current); Amarin, Viking, and Moderna (previously owned), non-financial support from FDA Arthritis Advisory Committee, non-financial support from Steering committee of OMERACT, an international organization that develops measures for clinical trials and receives arms’ length funding from 12 pharmaceutical companies, non-financial support from Veterans Affairs Rheumatology Field Advisory Committee, non-financial support from Editor and the Director of the UAB Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis, outside the submitted work. Francisco J. Blanco reports grants from Abbvie, grants and personal fees from Pfizer, grants from UCB, grants from Bristol-Mayers Squibb, grants from Roche, grants from Servier, grants from Bioiberica, grants from Sanofie, grants from Grunenthal, grants from GlaxoSmithKline, grants from Lilly, grants from Janssen, grants from Regeneron, grants from Amgen, grants from TRB Chemedica, outside the submitted work. Anthony P. Fernandez reports personal fees and other from AbbVie, grants, personal fees and other from Novartis, grants, personal fees and other from Mallinkrodt, other from Corbus, other from Pfizer, outside the submitted work. Sarah Mackie reports other from Roche Chugai, non-financial support from Roche, other from Sanofi, outside the submitted work; and Patron of the patient charity PMRGCAuk. Elena Nikiphorou reports personal fees and other from AbbVie, personal fees and other from Eli-Lilly, personal fees and other from Gilead, personal fees and other from Celltrion, personal fees and other from Pfizer, other from Sanofi, outside the submitted work. Victor S. Sloan reports having served as paid consultant to various pharmaceuticalcompanies and healthcare consultancies providing advice on clinicalresearch and advisory committee preparation outside the scope of thesubmitted work. Shareholder in UCB Pharma. Vibeke Strand reports consulting fees from AbbVie, Amgen, Arena, AstraZeneca, BMS, Boehringer Ingelheim, Celltrion, CORRONA, Crescendo/Myriad, Equillium, Genentech/Roche, GSK, Horizon, Inmedix, Janssen, Eli Lilly, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Samsung, Sandoz, Sanofi, TwoXAR and UCB, outside the submitted work., (Copyright © 2021 Elsevier Inc. All rights reserved.)

To assess rheumatologists' views and practices related to shared decision-making (SDM) in gout treatment. We performed a cross-sectional electronic survey of rheumatologists at U.S. Veterans Affairs (VA) medical centers, assessing views and practices related to SDM in gout. Of the 154 VA rheumatology providers eligible, 90 responded (response rate, 58%). Fifty-eight percent were female, the mean age was 51 years (standard deviation, 9.6), 42% had > 20 years of experience in medical practice. Rheumatologists reported routinely offering a choice to their patients for (1) starting urate-lowering therapy (ULT) for gout vs. doing nothing (70%); (2) choosing NSAIDs, corticosteroids, or colchicine for the treatment of acute flares (67%); and (3) choosing NSAIDs, corticosteroids, or colchicine for anti-inflammatory prophylaxis when starting ULT (51%). Very few rheumatologists offered choice regarding (4) choosing allopurinol vs. febuxostat as the first ULT (16%) and (5) taking daily ULT long-term vs. intermittently (15%). Rheumatologists perceived that a large proportion of patients were often or sometimes unsure of the best choice for these five decisions, 34%, 76%, 76%, 52%, and 54%, respectively. Similar proportions of rheumatologists felt that patients were uninformed about both medication benefits and risks, unclear about the personal importance of the benefits and risks, and unsupported in decision-making. For the five decisions respectively, rheumatologists supported SDM with patients in 76%, 56%, 58%, 27%, and 25%. The majority of VA rheumatologists incorporated SDM in several gout treatment decisions. Rheumatologists also recognized that patients need better support to participate in SDM in gout. Key Points: • Rheumatologists offered shared decision-making to gout patients for 3 key treatment decisions. • Rheumatologists perceived that many patients were unsure of the best choice for these decisions. • Rheumatologists felt that patients were uninformed about medication benefits/risks and unsupported in decision-making.

Objectives: The Outcome Measures in Rheumatology Initiative established the Contextual Factors Working Group to guide the understanding, identification and handling of contextual factors for clinical trials. In clinical research, different uses of the term 'contextual factors' exist. This study explores the perspectives of researchers (including clinicians) and patients in defining 'contextual factor' and its related terminology, identifying such factors and accounting for them in trials across rheumatology., Methods: We conducted individual semistructured interviews with researchers (including clinicians) who have experience within the field of contextual factors in clinical trials or other potentially relevant areas, and small focus group interviews with patients with rheumatic conditions. We transcribed the interviews and applied qualitative content analysis., Results: We interviewed 12 researchers and 7 patients. Researcher's and patient's descriptions of contextual factors were categorised into two broad themes, each comprising two contextual factors types. The 'treatment effect' theme focused on factors explaining variations in treatment effects (A) among patients and (B) among studies. The 'outcome measurement' theme focused on factors that explain (C) variations in the measurement result itself (apart from actual changes/differences in the outcome) and (D) variations in the outcome itself (beside treatment of interest). Methods for identifying and handling contextual factors differed among these themes and types., Conclusions: Two main themes for contextual factors with four types of contextual factors were identified based on input from researchers and patients. This will guide operationalisation of contextual factors. Further research should refine our findings and establish consensus among relevant stakeholders., Competing Interests: Competing interests: AB received a research grant from Abbvie, and an honorarium for lecture or advisory boards from UCB, Galapagos and Lilly; all financial support was paid to her department. DB reports that she is on the executive of OMERACT (Outcome Measurement in Rheumatological Research) and chair its methodology group; this did not influence this current written work. DEF reports grant/research support from Corbus, Galapagos Golead, GSK, NIH, Pfizer, Talaris, CSL Behring, as well as consultant for Abbvie, Amgen, Corbus, Galapagos, Gilead, Novartis, Pfizer, Roche/Genentech, Talaris, CSL Behring, Boehringer Ingelheim. JSS reports grants from Abbvie, AstraZeneca, Janssen, Lilly, Merck Sharpe and Dohme, Pfizer, and Roche, from AbbVie, Amgen, AstraZeneca, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Gilead, ILTOO Pharma, Janssen, Lilly, Merck Sharp and Dohme, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi, and UCB., outside the submitted work. RC reports non-financial support from Board membership, grants from Consultancy (AbbVie, Amgen, Axellus A/S, Biogen, Bristol-Myers Squibb, Cambridge Weight Plan, Celgene, Eli Lilly, Hospira, MSD, Norpharma, Novartis, Orkla Health, Pfizer, Roche, Sobi, Takeda), personal fees from Employment (Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark), non-financial support from Expert testimony, grants from Grants/grants pending (Axellus A/S, AbbVie, Cambridge Weight Plan, Janssen, MSD, Mundipharma, Novartis, and Roche), grants from Payment for lectures including service on speakers bureaus (Abbott, Amgen, Axellus, Bayer HealthCare Pharmaceuticals, Biogen Idec, Bristol-Myers Squibb, Cambridge Weight Plan, Ipsen, Janssen, Laboratoires Expanscience, MSD, Mundipharma, Norpharma, Novartis, Pfizer, Roche, Rottapharm-Madaus, Sobi, and Wyeth), grants from Payment for manuscript preparation (Axellus, Bristol-Myers Squibb, and Cambridge Weight Plan, Aleris-Hamlet (via Norpharma)), non-financial support from Patents (planned, pending or issued), non-financial support from Royalties, grants from Payment for development of educational presentations (Bristol-Myers Squibb, MSD, Pfizer), non-financial support from Stock/stock options, grants from Travel/accommodations/meeting expenses unrelated to activities listed (Abbott, AbbVie, Axellus, Biogen, Bristol-Myers Squibb, Cambridge Weight Plan, Celgene, Laboratoires Expanscience, Norpharma, Novartis, Pfizer, Roche, Rottapharm-Madaus, and Wyeth), non-financial support from Other (err on the side of full disclosure), outside the submitted work; and he is involved in many health-care initiatives and research that could benefit from wide uptake of this publication (including Cochrane, OMERACT, IDEOM, RADS, and the GRADE Working Group); 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. PT reports other from Amgen, Astra Zeneca, Bristol Myers Squibb, Celgene, Eli Lilly, Genentech/ Roche, Genzyme / Sanofi, Horizon Pharma Inc., Merck, Novartis, Pfizer, PPD, Quintiles, Regeneron, Savient, Takeda Pharmaceutical, UCB Group, Vertex, Forest, Bioiberica, personal fees from UCB Biopharma and SPRL, Parexel International, Prahealth Sciences, personal fees from CHEOR Solutions (Canada), Innovative Science Solutions, Reformulary Group, other from Elsevier, Little Brown, Wolters Kluwer and John Wiley & Sons, other from Abbott, Roche, Schering Plough/Merck, UCB, BMS, outside the submitted work; and Peter Tugwell is the recipient of Canada Research Chair in Health Equity (Tier 1-2016–2024) from the Canadian Institutes of Health Research., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: A 2017 systematic review suggested patient engagement in clinical trials has been limited, with little active engagement in trial design or data analysis, interpretation or dissemination. Additionally, there remains limited sex/gender reporting in clinical trial research., Objectives: The overall goal of this project was to disseminate sex/gender knowledge and build capacity for patient engagement in clinical trials. Specific objectives were to (1) create capacity and identify opportunities for patient engagement in clinical trials and sponsor- or investigator-led activities (e.g. clinical trial design and conduct); and (2) enhance new/early investigator sex/gender knowledge and skills related to patient-oriented research (POR)., Methods: We used the Canadian Institutes of Health Research Strategy for Patient-Oriented Research (SPOR) Capacity Development Framework and the SPOR Patient Engagement Framework to guide three phases of this project: (1) conduct a scoping review using methods described by the Evidence for Policy and Practice Information (EPPI) and the Coordinating Centre at the Institute of Education (Phase 1); (2) host a 1-day POR consultation workshop (Phase 2); and (3) deliver a new/early investigator POR training day (Phase 3). Six electronic databases (CINAHL, MEDLINE, EMBASE, PsychInfo, the Cochrane Library, and AMED) were searched from 1996 using keywords and Medical Subject Heading (MeSH) terms in accordance with the International Association for Public Participation (IAP2) and the search criteria in the bibliographic databases. Standard approaches were used to search the grey literature., Results: A total of 79 studies and over 150 websites were subject to data abstraction by team members, capturing information on sex/gender and SPOR's patient engagement guiding principles of inclusiveness, support, mutual respect, and co-building. Results were presented to 32 key stakeholders at the consultation workshop and input was sought on next steps using nominal group techniques. Based on the plethora of existing POR resources, relevant POR information from the scoping review was collated into two decision aids (patient and investigator) to determine readiness to engage with/as a patient partner in a clinical trial. The decision aids were presented at a POR training day with 88 new/early investigators, clinicians, patient partners and decision makers. The decision aids showed 'good' usability, assessed using the System Usability Scale (SUS). Attendees thought the decision aids were engaging, they increased their understanding of sex/gender, patient engagement and POR, and they would recommend them to others. POR principles and practices were integrated across all phases of the project. Patient partners (1) identified research priorities/search terms; (2) collected/analyzed data; (3) designed the patient partner decision aid; and (4) disseminated the results through presentation., Conclusion: Our digital patient partner and investigator decision aids are the first to provide information technology to deliver sex/gender, POR knowledge, and decision support beyond the traditional decision aids used for health screening and/or treatment decisions. The decision aids have the potential to make a significant contribution to Canada's Strategy for POR and support the collaborative efforts of patients and investigators to build a sustainable, accessible and equitable health care system.

Aims: This study explored decisional needs of patients with type 2 diabetes in China when considering treatment intensification to achieve good glycemic control, from both the patient's and practitioners' perspectives., Methods: Interviews were conducted with 35 patients, and individual interviews and focus groups with 28 practitioners in Beijing, China. Topic guides based on the Ottawa Decisional Support Framework were modified for the Chinese context. Two interviewers independently extracted and coded transcripts of their notes into-overarching themes. Content analysis was performed to analyze participants' responses., Results: Patients (34/35) reported having tried different medications and some (15/35) visited multiple hospitals and consulted different doctors. Patients' knowledge of medications was suboptimal (26/35), and most patients were not aware of their glucose levels (23/35). Although most were receptive to add-on medications, both patients and practitioners reported a range of uncertainty about the decision, and patients wanted more reliable information. Patients (15/35) and practitioners (19/28) recognized the importance of a trusting relationship when adding medications. Both reported similar values and preferences, but these were rarely discussed when adding medications. Although most patients (32/35) reported that they were capable of making a decision on adding medications, few practitioners (6/28) perceived their patients were capable., Conclusions: Findings suggest a need for reliable information, more discussion about values and preferences and decision support to help engage patients and practitioners in a shared decision-making process. Decision support tools may facilitate the process for patients with type 2 diabetes in China considering add-on medications., 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 © 2020. Published by Elsevier B.V.)

Background: Youths with juvenile idiopathic arthritis (JIA) often experience pain, which reduces their quality of life. A diversity of pain management options exists for these patients, but few discussions happen in clinical settings. Our team is developing a web-based patient decision aid (PDA) to help youths with JIA, parents, and their health care providers (HCPs) make informed and preference-based decisions about pain management options., Objective: The objective of this study was to develop a paper-based prototype of the web-based PDA and to assess its acceptability., Methods: We developed a paper-based prototype of the PDA, called the JIA Option Map, using an iterative process following the International Patient Decision Aid Standards and based on the Ottawa Decision Support Framework. We held three consensus meetings and a follow-up online survey followed by discussions among team members to agree on the format and content of the PDA. We then evaluated acceptability through interviews with 12 youth with JIA (aged 8-18 years), 12 parents, and 11 HCPs. Participants from rheumatology clinics in Canada and the USA reviewed the PDA and assessed its usefulness, content, and format. Interviews were audiotaped, transcribed verbatim, and analyzed using simple descriptive content analysis., Results: The PDA contains an assessment of pain and current treatments, a values-clarification exercise, a list of 33 treatment options with evidence-based information, and a goal-setting exercise. All participants agreed that it would be a useful tool for making decisions about pain management. Participants appreciated the incorporation of scientific evidence and visuals to demonstrate the benefits of treatment options but suggested describing the source of the evidence more thoroughly. Participants suggested adding complementary medicine and nutrition to the available treatment options and removing options that are primarily used to reduce inflammation. Most participants preferred an interactive web-based version of the PDA that would show a few options consistent with their preferences, followed by a discussion with HCPs., Conclusion: The PDA was deemed acceptable to all participants, with a few modifications. This feedback was used to improve the PDA by simplifying and clarifying the information and adjusting the number of treatment options presented. Work is underway to develop an interactive web-based version with an algorithm to present options tailored to each user.

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

Objectives: To identify questionnaires assessing the use of complementary health approaches (CHA) in pediatrics, describe their content, and appraise the methodological quality of the studies and the measurement properties of the questionnaires., Method: Major electronic databases were searched from 2011 to 2020. Studies which aimed to assess the use of CHA and studies which reported developing and validating CHA questionnaires in pediatrics were included. Two reviewers independently screened the studies, extracted the data, and rated the methodological quality of the studies and measurement properties of the questionnaires using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. When consensus was not reached, a third reviewer was consulted., Results: Thirty-eight studies were included. From these studies, 35 CHA questionnaires with a variety of different items were identified. Only two studies aimed to evaluate the measurement properties of two questionnaires. One questionnaire, available as a self- and proxy-report, was initially validated in children with juvenile idiopathic arthritis, and the other, available as an interviewer-administered questionnaire, was validated in children with cancer. According to the COSMIN, the methodological quality of both studies was inadequate or doubtful, and both questionnaires was not thoroughly validated., Conclusion: This systematic review showed a lack of a thoroughly validated CHA questionnaire in pediatrics. However, two questionnaires were found to hold promise. To address this gap, one of the existing questionnaires should be adapted and further validated., (Copyright © 2020 Elsevier Ltd. All rights reserved.)