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Abstract Number: 1231

Scope and Consistency of Adherence Related Outcomes in Randomized Controlled Trials of Interventions for Improving Medication Adherence

Ayano Kelly1,2,3,4, Daniel Sumpton3,5,6, Clare O'Sullivan2, Alexa Meara7, Robby Nieuwlaat8, Peter Tugwell9,10,11, Lyn March12,13,14, Allison Tong3,6, Karine Toupin-April15, Francois Nantel16, B.J.F. Van den Bemt (PharmD, PhD)17,18, Mary De Vera19, Vicki Evans20, Willemina Campbell21, Peter Wong22, Rebecca Davey23, Dorcas Beaton24,25,26, Maria Suarez-Almazor27,28,29,30, Geraldine Hassett31,32, Helen I. Keen33,34,35, Therese Dawson36, Luke Crimston-Smith37 and Kathleen Tymms38, 1Rheumatology, Canberra Rheumatology, Canberra, Australia, 2Rheumatology, The Canberra Hospital, Canberra, Australia, 3Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia, 4School of Medicine, Australian National University, Canberra, Australia, 5Department of Rheumatology, Concord Hospital, Sydney, Australia, 6Sydney School of Public Health, University of Sydney, Sydney, Australia, 7Internal Medicine/Rheumatology, The Ohio State University Wexner Medical Center, Columbus, OH, 8Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada, 9Center For Global Health, Institute of Population Health, Ottawa, ON, Canada, 10Institute of Population Health, Center For Global Health, University of Ottawa, Ottawa General Hospital, Ottawa, ON, Canada, 11Center For Global Health, Institute of Population Hlth, Ottawa, ON, Canada, 12Department of Rheumatology, Northern Clinical School, Institute of Bone and Joint Research, Kolling Institute, University of Sydney & Department of Rheumatology, Royal North Shore Hospital, St Leonards, Sydney, Australia, 13Rheumatology, Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, Australia, 14Rheumatology, University of Sydney, Insitute of Bone and Joint Research, Royal North Shore Hospital, St Leonards NSW, Australia, 15Children’s Hospital of Eastern Ontario Research Institute, Ottawa, ON, Canada, 16Medical Affairs, Janssen Inc., Toronto, ON, Canada, 17Pharmacy, Sint Maartenskliniek and Radboudumc, Nijmegen, Netherlands, 18Pharmacy, Sint Maartenskliniek, Nijmegen, Netherlands, 19Pharmaceutical Sciences, The University of British Columbia, Vancouver, BC, Canada, 20Clear Vision Consulting, Canberra, Australia, 21Rheumatology, Toronto Western Hospital, Toronto, ON, Canada, 22Mid-North Coast Arthritis Clinic and University of New South Wales Rural Clinical School, Coffs Harbour, Australia, 23Arthritis ACT, Canberra, Australia, 24Research, Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute, St. Michaels Hospital, Toronto, ON, Canada, 25Scientist, Institute for Work & Health, Toronto, ON, Canada, 26Mobility Program Clinical Research Unit, St Michael's Hospital, Toronto, ON, Canada, 27GIM, AT & EC, UT MD Anderson Cancer Center, Houston, TX, 28Section of Rheumatology and Clinical Immunology, Department of General Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA, Houston, TX, 29Section of Rheumatology and Clinical Immunology, Department of General Internal Medicine,, The University of Texas MD Anderson Cancer Center, Houston, TX, 30The University of Texas MD Anderson Cancer Center, Houston, TX, 31Rheumatology, Liverpool Hospital, Sydney, Australia, 32Ingham Institute, Sydney, Australia, 33Rheumatology, Royal Perth Hospital, Perth, Australia, 34Leeds, Leeds, United Kingdom, 35School of Medicine and Pharmacology, University of Western Australia, Perth, Australia, 36Rheumatology, Lord Street Specialist Centre, Port Macquarie, Australia, 37Australian National University, Canberra, Australia, 38ANU, Canberra, Australia

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: Compliance, outcome measures and outcomes

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Session Information

Date: Monday, November 6, 2017

Title: Patient Outcomes, Preferences, and Attitudes Poster II

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: Poor medication adherence attenuates optimal clinical benefits and reduces the overall effectiveness of health systems. A large number of interventions targeting medication adherence have been evaluated in randomized controlled trials (RCTs). However, there is no consensus on which adherence related outcomes should be used in these RCTs. We sought to assess the scope and consistency of adherence related outcome domains and measures in RCTs of medication adherence interventions.

Methods: Four reviewers independently extracted the adherence outcome domains and measures from RCTs included in the 2014 Cochrane review of interventions for enhancing medication adherence. Adherence as an outcome domain was classified into phases (using the ABC taxonomy these were divided into initiation, implementation, persistence or phase unclear). The time points, metric and method of aggregation of each outcome measure were also extracted. Contextual factors (any factor that may affect adherence but not measuring adherence itself) were also extracted.

Results: From 70 trials, the four adherence outcome domains (initiation, implementation, persistence and phase unclear) were measured using 68 different adherence measures, with a mean of 2 adherence measures per trial (range 1-5). For adherence outcome domains, implementation adherence was reported most frequently (61 trials [87%]), followed by persistence adherence (7 trials [10%]) and initiation adherence (2 trials [3%]). The phase of adherence being measured was unclear in 15 trials [21%]. There were 37 different contextual factors. The six most common contextual factors reported were disease knowledge (7 trials [10%]), medication knowledge (5 trials [7%]), lifestyle adherence (5 trials [7%]), medication satisfaction (4 trials [6%]), clinical care satisfaction (4 trials [6%]), and self efficacy (4 trials [6%]).

Conclusion: Implementation adherence is the primary type of adherence outcome domain reported. Adherence measures in RCTs are heterogeneous with a lack of uniformity. Many other factors that may be relevant to adherence are being reported in RCTs however their importance needs further evaluation. Additional work to ensure consistent reporting of robust outcome domains and measures that are relevant to all stakeholders, particularly patients, will improve the value of clinical trials in supporting evidence-based decision-making regarding medication adherence.


Disclosure: A. Kelly, None; D. Sumpton, None; C. O'Sullivan, None; A. Meara, None; R. Nieuwlaat, None; P. Tugwell, None; L. March, None; A. Tong, None; K. Toupin-April, None; F. Nantel, Janssen Inc., 3; B. J. F. Van den Bemt (PharmD, PhD), Pfizer Inc, 8,Abbvie, 8,Sandoz, 8,UCB, 8; M. De Vera, None; V. Evans, None; W. Campbell, None; P. Wong, Novartis Pharmaceutical Corporation, 5,Roche Pharmaceuticals, 5,Abbott Immunology Pharmaceuticals, 5; R. Davey, None; D. Beaton, None; M. Suarez-Almazor, Rheumatology Research Foundation, 2; G. Hassett, None; H. I. Keen, None; T. Dawson, None; L. Crimston-Smith, None; K. Tymms, None.

To cite this abstract in AMA style:

Kelly A, Sumpton D, O'Sullivan C, Meara A, Nieuwlaat R, Tugwell P, March L, Tong A, Toupin-April K, Nantel F, Van den Bemt (PharmD PhD) BJF, De Vera M, Evans V, Campbell W, Wong P, Davey R, Beaton D, Suarez-Almazor M, Hassett G, Keen HI, Dawson T, Crimston-Smith L, Tymms K. Scope and Consistency of Adherence Related Outcomes in Randomized Controlled Trials of Interventions for Improving Medication Adherence [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/scope-and-consistency-of-adherence-related-outcomes-in-randomized-controlled-trials-of-interventions-for-improving-medication-adherence/. Accessed .
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