OMERACT Core outcome measurement set for shared decision making in rheumatic and musculoskeletal conditions: a scoping review to identify candidate instruments

Florian Naye; Karine Toupin-April; Maarten de Wit; Annie LeBlanc; Olivia Dubois; Annelies Boonen; Jennifer L Barton; Liana Fraenkel; Linda C Li; Dawn Stacey; Lyn March; Claire E H Barber; Glen Stewart Hazlewood; Francis Guillemin; Susan J Bartlett; Dorthe B Berthelsen; Kate Mather; Laurent Arnaud; Akpabio Akpabio; Adewale Adebajo; Grayson Schultz; Victor S Sloan; Tiffany K Gill; Saurab Sharma; Marieke Scholte-Voshaar; Francesco Caso; Elena Nikiphorou; Samah Ismail Nasef; Willemina Campbell; Alexa Meara; Robin Christensen; Maria E Suarez-Almazor; Janet Elizabeth Jull; Rieke Alten; Esi M Morgan; Yasser El-Miedany; Jasvinder A Singh; Jennifer Burt; Arundathi Jayatilleke; Ihsane Hmamouchi; Francisco J Blanco; Anthony P Fernandez; Sarah Mackie; Allyson Jones; Vibeke Strand; Sara Monti; Simon R Stones; Rebecca R Lee; Sabrina Mai Nielsen; Vicki Evans; Hemalatha Srinivasalu; Thomas Gérard; Juliette LeBlanc Demers; Roxanne Bouchard; Théo Stefan; Michèle Dugas; Frédéric Bergeron; Dorcas Beaton; Lara J Maxwell; Peter Tugwell; Simon Décary

doi:10.1016/j.semarthrit.2023.152344

OMERACT Core outcome measurement set for shared decision making in rheumatic and musculoskeletal conditions: a scoping review to identify candidate instruments

Semin Arthritis Rheum. 2024 Apr:65:152344. doi: 10.1016/j.semarthrit.2023.152344. Epub 2023 Dec 16.

Authors

Florian Naye¹, Karine Toupin-April², Maarten de Wit³, Annie LeBlanc⁴, Olivia Dubois¹, Annelies Boonen⁵, Jennifer L Barton⁶, Liana Fraenkel⁷, Linda C Li⁸, Dawn Stacey⁹, Lyn March¹⁰, Claire E H Barber¹¹, Glen Stewart Hazlewood¹², Francis Guillemin¹³, Susan J Bartlett¹⁴, Dorthe B Berthelsen¹⁵, Kate Mather¹⁶, Laurent Arnaud¹⁷, Akpabio Akpabio¹⁸, Adewale Adebajo¹⁹, Grayson Schultz²⁰, Victor S Sloan²¹, Tiffany K Gill²², Saurab Sharma²³, Marieke Scholte-Voshaar²⁴, Francesco Caso²⁵, Elena Nikiphorou²⁶, Samah Ismail Nasef²⁷, Willemina Campbell²⁸, Alexa Meara²⁹, Robin Christensen³⁰, Maria E Suarez-Almazor³¹, Janet Elizabeth Jull³², Rieke Alten³³, Esi M Morgan³⁴, Yasser El-Miedany³⁵, Jasvinder A Singh³⁶, Jennifer Burt³⁷, Arundathi Jayatilleke³⁸, Ihsane Hmamouchi³⁹, Francisco J Blanco⁴⁰, Anthony P Fernandez⁴¹, Sarah Mackie⁴², Allyson Jones⁴³, Vibeke Strand⁴⁴, Sara Monti⁴⁵, Simon R Stones⁴⁶, Rebecca R Lee⁴⁷, Sabrina Mai Nielsen⁴⁸, Vicki Evans⁴⁹, Hemalatha Srinivasalu⁵⁰, Thomas Gérard¹, Juliette LeBlanc Demers⁵¹, Roxanne Bouchard⁵¹, Théo Stefan⁵¹, Michèle Dugas⁵¹, Frédéric Bergeron⁵², Dorcas Beaton⁵³, Lara J Maxwell⁵⁴, Peter Tugwell⁵⁵, Simon Décary⁵⁶

Affiliations

¹ Faculty of Medicine and Health Sciences, School of Rehabilitation, Research Centre of the CHUS, CIUSSS de l'Estrie-CHUS, Université de Sherbrooke, 3001, 12e Avenue Nord, Sherbrooke, Quebec J1H 5N4, Canada.
² School of Rehabilitation Sciences, Faculty of Health Sciences, University of Ottawa, Ottawa, Canada; Department of Pediatrics, Faculty of Medicine, University of Ottawa, Ottawa, Canada; Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada; Institut du savoir Montfort, Ottawa, Canada.
³ Patient Research Partner, Amsterdam, The Netherlands.
⁴ Department of Family Medicine and Emergency Medicine, Université Laval, Quebec City, Canada; VITAM Centre de recherche en santé durable, Quebec City, Canada.
⁵ Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute, Maastricht University, Maastricht, The Netherlands.
⁶ VA Portland Health Care System, Oregon Health & Science University, Portland, USA.
⁷ Department of Internal Medicine, Yale University, New Haven, USA.
⁸ Department of Physical Therapy, Arthritis Research Canada, University of British Columbia, Vancouver, Canada.
⁹ School of Nursing, University of Ottawa, Ottawa, Canada; The Ottawa Hospital Research Institute, Ottawa, Canada.
¹⁰ Department of Medicine, The University of Sydney, Sydney, Australia; Institute of Bone and Joint Research, Department of Rheumatology, Royal North Shore Hospital, Sydney, Australia.
¹¹ Department of Medicine, Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Canada.
¹² Department of Medicine, University of Calgary, Calgary, Canada.
¹³ INSPIIRE, Université de Lorraine, Inserm, Nancy, France.
¹⁴ Divisions of Clinical Epidemiology, Rheumatology and Respiratory Epidemiology and Clinical Trials Unit, McGill University, Canada; Research Institute - McGill University Health Centre, Canada; Johns Hopkins Medicine Division of Rheumatology, Montreal, Canada.
¹⁵ Section for Biostatistics and Evidence-Based Research, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen & Research Unit of Rheumatology, Department of Clinical Research, Odense & Department of Rehabilitation, Municipality of Guldborgsund, Odense University Hospital, University of Southern Denmark, Nykoebing, Denmark.
¹⁶ Patient Research Partner, Toronto, Canada.
¹⁷ Department of Rheumatology, CRMR RESO, University Hospitals of Strasbourg, France.
¹⁸ Royal National Hospital for Rheumatic Diseases, Bath, UK.
¹⁹ Faculty of Medicine, Dentistry and Health, University of Sheffield, UK.
²⁰ Patient Research Partner, Ohio, USA.
²¹ Sheng Consulting LLC, Flemington, NJ, USA; The Peace Corps, Washington, DC, USA.
²² Faculty of Health and Medical Sciences, Adelaide Medical School, The University of Adelaide, Australia.
²³ School of Health Sciences, Faculty of Medicine and Health, University of New South Wales, Sydney, Australia; Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia.
²⁴ Patient Research Partner, Department of Pharmacy and Department of Research & Innovation, Sint Maartenskliniek, Nijmegen, The Netherlands; Department of Pharmacy, Radboud university medical center, Nijmegen.
²⁵ Department of Clinical Medicine and Surgery, University of Naples Federico II, Italy.
²⁶ Centre for Rheumatic Diseases, King's College Hospital, School of Immunology and Microbial Sciences, King's College London, UK; Rheumatology Department, King's College Hospital, London, UK.
²⁷ Department of Rheumatology and Rehabilitation, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.
²⁸ Patient research partner, Toronto Western Hospital, University Health Network, Canada.
²⁹ Division of Rheumatology, The Ohio State University, Columbus, USA.
³⁰ Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, & Department of Rheumatology, Odense University Hospital, Denmark.
³¹ Department of General Internal Medicine, Section of Rheumatology and Clinical Immunology, University of Texas MD Anderson Cancer Center, Houston, USA.
³² School of Rehabilitation Therapy, Queen's University, Kingston, Canada.
³³ Department of Internal Medicine II, Rheumatology Research Center, Rheumatology, Clinical Immunology, Osteology, Physical Therapy and Sports Medicine, Schlosspark-Klinik, Charité, University Medicine Berlin, Berlin, Germany.
³⁴ Department of Pediatrics, University of Washington, Division of Rheumatology, Seattle Children's Hospital, Seattle, Washington, USA.
³⁵ Canterbury Christ Church University, King's College London, UK.
³⁶ University of Alabama at Birmingham, Birmingham, USA.
³⁷ Newfoundland and Labrador Health Services, St. Clare's Mercy Hospital, St John's, Newfoundland and Labrador, Canada.
³⁸ Lewis Katz School of Medicine, Temple University, Philadelphia, USA.
³⁹ Health Sciences Research Centre (CReSS), Faculty of Medicine, International University of Rabat (UIR), Rabat, Morocco.
⁴⁰ Departamento de Fisioterapia, Medicina y Ciencias Médicas, Universidad de A Coruña, A Coruña, Spain.
⁴¹ Departments of Dermatology and Pathology, Cleveland Clinic, Cleveland, Ohio, USA.
⁴² Leeds Institute of Rheumatic and Musculoskeletal Medicine, Chapel Allerton Hospital, University of Leeds, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
⁴³ Department of Physical Therapy, Faculty of Rehabilitation Medicine, University of Alberta, Edmonton, Canada.
⁴⁴ Division of Immunology/Rheumatology, Stanford University, Stanford, California, USA.
⁴⁵ Department of Rheumatology, Policlinico S. Matteo, IRCCS Fondazione, University of Pavia, Pavia, Italy.
⁴⁶ Patient research partner, Envision Pharma Group, Wilmslow, UK.
⁴⁷ Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK; National Institute for Health Research Biomedical Research Centre, Manchester University Hospital NHS Trust, Manchester, UK.
⁴⁸ Musculoskeletal Statistics Unit, The Parker Institute, Department of Rheumatology, Odense University Hospital, and University of Southern Denmark, Copenhagen, Demark, Copenhagen, Denmark.
⁴⁹ Patient Research Partner and Discipline of Optometry, Faculty of Health, University of Canberra, Canberra, Australia.
⁵⁰ Pediatric Rheumatology, Children's National Hospital, Washington DC, USA; GW School of Medicine, Washington DC, USA.
⁵¹ Department of Family Medicine and Emergency Medicine, Université Laval, Quebec City, Canada.
⁵² Université Laval, Quebec City, Canada.
⁵³ Institute for Work & Health, Toronto, Canada.
⁵⁴ Centre for Practice Changing Research, Ottawa Hospital Research Institute and Faculty of Medicine, University of Ottawa, Ottawa, Canada.
⁵⁵ Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.
⁵⁶ Faculty of Medicine and Health Sciences, School of Rehabilitation, Research Centre of the CHUS, CIUSSS de l'Estrie-CHUS, Université de Sherbrooke, 3001, 12e Avenue Nord, Sherbrooke, Quebec J1H 5N4, Canada. Electronic address: [email protected].

PMID: 38232625
DOI: 10.1016/j.semarthrit.2023.152344

Abstract

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.

Keywords: Core outcome measurement set; Measurement instruments; Musculoskeletal diseases; Rheumatic diseases; Shared decision making.

Publication types

Systematic Review
Review

MeSH terms

Decision Making, Shared*
Humans
Musculoskeletal Diseases*
Outcome Assessment, Health Care*
Patient Participation
Rheumatic Diseases*
Rheumatology / standards