Core Outcome Measures in Effectiveness Trials

Developing a Core Domain Set for Trials of Interventions for Medication Adherence in Rheumatology: Outcome Measures in Rheumatology - Interventions for Medication Adherence (OMERACT-Adherence)

General Information

Summary:
Background: Over the last 20 years, rheumatic conditions such as gout, osteoporosis and rheumatoid arthritis (RA) have seen marked improvement in the availability of effective medications, which have led to reduction in disease flares, risk of re-fracture in osteoporosis and 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 by consistent measurements so all relevant trials can be combined in systematic reviews and meta-analyses to reach more valid conclusions. 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 aimed to support medication adherence in rheumatology.

Methods: This OMERACT-Adherence study involves 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 core domains; 3) focus groups using Nominal Group Technique (NGT) 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 and reach 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 to improve the lives of people with rheumatic conditions.

Contributors:
Principal Investigator: Ayano Kelly 1,2,3,4

Steering Committee: Allison Tong4,5, Kathleen Tymms1,2,3, Lyn March6,7,8, Mary De Vera9,10, Vicki Evans11, Geraldine Hassett12,13, Karine Toupin-April14,15, Bart van den Bemt16,17, Marieke Scholte-Voshaar18, Susan J. Bartlett19,20

Supervisors: Allison Tong4,5, Kathleen Tymms1,2,3, Lyn March6,7,8, Peter Tugwell21

Affiliations:
1 Canberra Rheumatology, Canberra, ACT, Australia
2 Department of Rheumatology, Canberra Hospital, Canberra, ACT, Australia
3 College of Medicine, Biology and Environment, Australian National University, Canberra, ACT, Australia
4 Centre for Kidney Research, The Children’s Hospital at Westmead, Sydney, NSW, Australia
5 Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia
6 Department of Rheumatology, Royal North Shore Hospital, Sydney, NSW, Australia
7 Institute of Bone and Joint Research, Kolling Institute of Medical Research, Sydney, NSW, Australia
8 Northern Clinical School, The University of Sydney, Sydney, NSW, Australia
9 Faculty of Pharmaceutical Sciences, The University of British Columbia, Vancouver, British Columbia, Canada
10 Arthritis Research Centre of Canada, Richmond, British Columbia, Canada
11 Patient Research Partner, Clear Vision Consulting, Canberra, ACT, Australia
12 Department of Rheumatology, Liverpool Hospital, Sydney, NSW, Australia
13 Ingham Institute of Applied Medical Research, Sydney, NSW, Australia
14 Children’s Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada
15 Department of Pediatrics and School of Rehabilitation Sciences, University of Ottawa, Ottawa, Ontario, Canada
16 Department of Pharmacy, Sint Maartenskliniek, Ubbergen, Netherlands
17 Radboud University Medical Center, Nijmegen, Netherlands
18 University of Twente, Enschede, Netherlands
19 Department of Medicine, McGill University, Montreal, Canada
20 Division of Rheumatology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA
21 Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada

Further Study Information

Current Stage:
Ongoing
Date:
December 2016 - 2020
Funding source(s):
Arthritis Australia 2018 grant Private grant from Professor Stephen Hall

Health Area

Disease Category
Rheumatology

Disease Name
Rheumatic diseases

Target Population

Age Range
0 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus conference
Consensus meeting
Delphi process
Focus group(s)
Interview
Nominal group technique (NGT)
Semi structured discussion
Systematic review

This OMERACT-Adherence study involves 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 core domains; 3) focus groups using Nominal Group Technique (NGT) 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 and reach consensus on the core domain set for interventions to support medication adherence in rheumatology


Stakeholders Involved

Clinical experts
Conference participants
Consumers (caregivers)
Consumers (patients)
Epidemiologists
Families
Governmental agencies
Methodologists
Patient/ support group representatives
Pharmaceutical industry representatives
Researchers
Statisticians

Study Type

COS for clinical trials or clinical research

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