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: 5 Phase Study Protocol
AU - and On behalf of the OMERACT-Adherence Group
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 - Scholte-Voshaar, Marieke
AU - AlMaqbali, Khoula
AU - Barcinella-Wong, Annica
AU - Cheung, Peter
AU - Crimston-Smith, Luke
AU - Cross, Marita
AU - Davey, Rebecca
AU - Emery, Paul
AU - Fallon, Kieran
AU - Flint, Sarah
AU - Graham, David
AU - Hall, Stephen
AU - Hermann, Susan
AU - Keen, Helen
AU - Koutsogianni, Katerina
AU - Lim, Irwin
AU - Nantel, Francois
AU - O'Neill, Sean
AU - O'Sullivan, Clare
AU - Sinnathurai, Premarani
AU - Zeljkovic, Biljana
PY - 2018
Y1 - 2018
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.
UR - https://www.scopus.com/pages/publications/85044544039
UR - https://www.ncbi.nlm.nih.gov/pubmed/29587864
U2 - 10.1186/s13063-018-2565-z
DO - 10.1186/s13063-018-2565-z
M3 - Article
C2 - 29587864
SN - 1745-6215
VL - 19
JO - Trials
JF - Trials
IS - 1
M1 - 204
ER -