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 ShawJasvinder A. Singh, Maria Suarez-Almazor, Daniel Sumpton, Peter Wong, Robin Christensen, Dorcas Beaton, Maarten de Wit, Peter Tugwell, OMERACT-Adherence Group

Research output: Contribution to journalArticlepeer-review

14 Citations (Scopus)


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.

Original languageEnglish
Article number204
Number of pages13
Issue number1
Publication statusPublished - 27 Mar 2018
Externally publishedYes

Bibliographical note

Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License CC-BY (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. © The Author(s). 2018.


  • Adherence
  • Clinical trials
  • Compliance
  • Core domain set
  • Medication Adherence
  • Outcomes research
  • Patient-centred outcomes
  • Persistence
  • Rheumatology


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