Outcome Measures in Rheumatology - Interventions for medication Adherence (OMERACT-Adherence) Core Domain Set for Trials of Interventions for Medication Adherence in Rheumatology: 5 Phase Study Protocol
Ayano Kelly,
Allison Tong,
Kathleen Tymms,
Lyn March,
Jonathan C. Craig,
Mary De Vera,
Vicki Evans,
Geraldine Hassett,
Karine Toupin-April,
Bart van den Bemt,
Armando Teixeira-Pinto,
Rieke Alten,
Susan J. Bartlett,
Willemina Campbell,
Therese Dawson,
Michael Gill,
Renske Hebing,
Alexa Meara,
Robby Nieuwlaat,
Yomei Shaw,
Jasvinder A. Singh,
Maria Suarez-Almazor,
Daniel Sumpton,
Peter Wong,
Robin Christensen,
Dorcas Beaton,
Maarten de Wit,
Peter Tugwell,
On behalf of the OMERACT-Adherence Group
Affiliations
Ayano Kelly
Canberra Rheumatology
Allison Tong
Centre for Kidney Research, The Children’s Hospital at Westmead
Kathleen Tymms
Canberra Rheumatology
Lyn March
Department of Rheumatology, Royal North Shore Hospital
Jonathan C. Craig
Centre for Kidney Research, The Children’s Hospital at Westmead
Mary De Vera
Faculty of Pharmaceutical Sciences, The University of British Columbia
Vicki Evans
Patient Research Partner, Clear Vision Consulting
Geraldine Hassett
Department of Rheumatology, Liverpool Hospital
Karine Toupin-April
Children’s Hospital of Eastern Ontario Research Institute
Bart van den Bemt
Department of Pharmacy, Sint Maartenskliniek
Armando Teixeira-Pinto
Centre for Kidney Research, The Children’s Hospital at Westmead
Rieke Alten
Department of Rheumatology, Clinical Immunology, Osteology, Physical therapy and Sports Medicine, Schlosspark Klinik, Charité University Medicine
Susan J. Bartlett
Department of Medicine, McGill University
Willemina Campbell
Patient Research Partner, Toronto Western Hospital
Therese Dawson
Lord Street Specialist Centre
Michael Gill
Patient Research Partner, Dragon Claw
Renske Hebing
Amsterdam Rheumatology and Immunology Centre
Alexa Meara
The Ohio State University, Wexner Medical Center
Robby Nieuwlaat
Department of Clinical Epidemiology and Biostatistics, McMaster University
Yomei Shaw
National Data Bank for Rheumatic Diseases
Jasvinder A. Singh
Medicine Service, VA Medical Center
Maria Suarez-Almazor
Section of Rheumatology and Clinical Immunology, Department of General Internal Medicine, The University of Texas MD Anderson Cancer Center
Daniel Sumpton
Centre for Kidney Research, The Children’s Hospital at Westmead
Peter Wong
Mid-North Coast Arthritis Clinic
Robin Christensen
Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital
Dorcas Beaton
Musculoskeletal Health & Outcomes Research, Li Ka Shing Knowledge Institute, St. Michael’s Hospital
Abstract Background Over the last 20 years, there have been marked improvements in the availability of effective medications for rheumatic conditions such as gout, osteoporosis and rheumatoid arthritis (RA), which have led to a reduction in disease flares and the risk of re-fracture in osteoporosis, and the slowing of disease progression in RA. However, medication adherence remains suboptimal, as treatment regimens can be complex and difficult to continue long term. Many trials have been conducted to improve adherence to medication. Core domains, which are the outcomes of most relevance to patients and clinicians, are a pivotal component of any trial. These core domains should be measured consistently, so that all relevant trials can be combined in systematic reviews and meta-analyses to reach conclusions that are more valid. Failure to do this severely limits the potential for trial-based evidence to inform decisions on how to support medication adherence. The Outcome Measures in Rheumatology (OMERACT) – Interventions for Medication Adherence study by the OMERACT-Adherence Group aims to develop a core domain set for interventions that aim to support medication adherence in rheumatology. Methods/design This OMERACT-Adherence study has five phases: (1) a systematic review to identify outcome domains that have been reported in interventions focused on supporting medication adherence in rheumatology; (2) semi-structured stakeholder interviews with patients and caregivers to determine their views on the core domains; (3) focus groups using the nominal group technique with patients and caregivers to identify and rank domains that are relevant to them, including the reasons for their choices; (4) an international three-round modified Delphi survey involving patients with diverse rheumatic conditions, caregivers, health professionals, researchers and other stakeholders to develop a preliminary core domain set; and (5) a stakeholder workshop with OMERACT members to review, vote on and reach a consensus on the core domain set for interventions to support medication adherence in rheumatology. Discussion Establishing a core domain set to be reported in all intervention studies undertaken to support patients with medication adherence will enhance the relevance and the impact of these results and improve the lives of people with rheumatic conditions.
