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

OMERACT-Adherence Group

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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.

Original languageEnglish
Article number204
JournalTrials
Volume19
Number of pages13
ISSN1745-6215
DOIs
Publication statusPublished - 27. Mar 2018
Externally publishedYes

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Medication Adherence
Rheumatology
Outcome Assessment (Health Care)
Caregivers
Focus Groups
Meta-Analysis
Consensus
Research Personnel
Interviews
Education

Keywords

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

Cite this

@article{5127b482a2c948d9adca0470bed1e710,
title = "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",
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.",
keywords = "Adherence, Clinical trials, Compliance, Core domain set, Medication Adherence, Outcomes research, Patient-centred outcomes, Persistence, Rheumatology",
author = "Ayano Kelly and Allison Tong and Kathleen Tymms and Lyn March and Craig, {Jonathan C} and {De Vera}, Mary and Vicki Evans and Geraldine Hassett and Karine Toupin-April and {van den Bemt}, Bart and Armando Teixeira-Pinto and Rieke Alten and Bartlett, {Susan J} and Willemina Campbell and Therese Dawson and Michael Gill and Renske Hebing and Alexa Meara and Robby Nieuwlaat and Yomei Shaw and Singh, {Jasvinder A} and Maria Suarez-Almazor and Daniel Sumpton and Peter Wong and Robin Christensen and Dorcas Beaton and {de Wit}, Maarten and Peter Tugwell and {OMERACT-Adherence Group}",
year = "2018",
month = "3",
day = "27",
doi = "10.1186/s13063-018-2565-z",
language = "English",
volume = "19",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",

}

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. / OMERACT-Adherence Group.

In: Trials, Vol. 19, 204, 27.03.2018.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - Outcome Measures in Rheumatology - Interventions for medication Adherence (OMERACT-Adherence) Core Domain Set for Trials of Interventions for Medication Adherence in Rheumatology

T2 - 5 Phase Study Protocol

AU - Kelly, Ayano

AU - Tong, Allison

AU - Tymms, Kathleen

AU - March, Lyn

AU - Craig, Jonathan C

AU - De Vera, Mary

AU - Evans, Vicki

AU - Hassett, Geraldine

AU - Toupin-April, Karine

AU - van den Bemt, Bart

AU - Teixeira-Pinto, Armando

AU - Alten, Rieke

AU - Bartlett, Susan J

AU - Campbell, Willemina

AU - Dawson, Therese

AU - Gill, Michael

AU - Hebing, Renske

AU - Meara, Alexa

AU - Nieuwlaat, Robby

AU - Shaw, Yomei

AU - Singh, Jasvinder A

AU - Suarez-Almazor, Maria

AU - Sumpton, Daniel

AU - Wong, Peter

AU - Christensen, Robin

AU - Beaton, Dorcas

AU - de Wit, Maarten

AU - Tugwell, Peter

AU - OMERACT-Adherence Group

PY - 2018/3/27

Y1 - 2018/3/27

N2 - 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.

AB - 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.

KW - Adherence

KW - Clinical trials

KW - Compliance

KW - Core domain set

KW - Medication Adherence

KW - Outcomes research

KW - Patient-centred outcomes

KW - Persistence

KW - Rheumatology

U2 - 10.1186/s13063-018-2565-z

DO - 10.1186/s13063-018-2565-z

M3 - Journal article

C2 - 29587864

VL - 19

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 204

ER -