Scope of Outcomes in Trials and Observational Studies of Interventions Targeting Medication Adherence in Rheumatic Conditions: A Systematic Review

Ayano Kelly; Luke Crimston-Smith; Allison Tong; Susan J Bartlett; Charlotte L Bekker; Robin Christensen; Mary A De Vera; Maarten de Wit; Vicki Evans; Michael Gill; Lyn March; Karine Manera; Robby Nieuwlaat; Shahrzad Salmasi; Marieke Scholte-Voshaar; Jasvinder A Singh; Daniel Sumpton; Karine Toupin-April; Peter Tugwell; Bart van den Bemt; Suzanne Verstappen; Kathleen Tymms

doi:10.3899/jrheum.190726

Scope of Outcomes in Trials and Observational Studies of Interventions Targeting Medication Adherence in Rheumatic Conditions: A Systematic Review

J Rheumatol. 2020 Oct 1;47(10):1565-1574. doi: 10.3899/jrheum.190726. Epub 2019 Dec 15.

Authors

Ayano Kelly¹, Luke Crimston-Smith², Allison Tong³, Susan J Bartlett⁴, Charlotte L Bekker⁵, Robin Christensen⁶, Mary A De Vera⁷, Maarten de Wit⁸, Vicki Evans⁹, Michael Gill¹⁰, Lyn March¹¹, Karine Manera³, Robby Nieuwlaat¹², Shahrzad Salmasi¹³, Marieke Scholte-Voshaar¹⁴, Jasvinder A Singh¹⁵, Daniel Sumpton¹⁶, Karine Toupin-April¹⁷, Peter Tugwell¹⁸, Bart van den Bemt¹⁹, Suzanne Verstappen²⁰, Kathleen Tymms²¹

Affiliations

¹ A. Kelly, Clinical Associate Lecturer, Australian National University, MBBS, FRACP, College of Health and Medicine, Australian National University, and Canberra Rheumatology, Canberra, and Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia; ayano.kelly@anu.edu.au.
² L. Crimston-Smith, BN, College of Health and Medicine, Australian National University, and Canberra Rheumatology, Canberra, Australia.
³ A. Tong, PhD, Professor, K. Manera, MIPH, Centre for Kidney Research, The Children's Hospital at Westmead, and Sydney School of Public Health, The University of Sydney, Sydney, Australia.
⁴ S.J. Bartlett, PhD, Professor, Department of Medicine, McGill University and Research Institute, McGill University Health Centres, Montreal, Quebec, Canada, and Division of Rheumatology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.
⁵ C.L. Bekker, PhD, Department of Pharmacy, Radboud University Medical Centre, Nijmegen, the Netherlands.
⁶ R. Christensen, PhD, Professor of Biostatistics and Clinical Epidemiology, Musculoskeletal Statistics Unit, the Parker Institute, Copenhagen University Hospital, Copenhagen, and Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denmark.
⁷ M.A. De Vera, PhD, Assistant Professor, Collaboration for Outcomes Research and Evaluation, Faculty of Pharmaceutical Sciences, The University of British Columbia, Vancouver, and Arthritis Research Canada, Richmond, British Columbia, Canada.
⁸ M. de Wit, PhD, OMERACT Patient Research Partner, the Netherlands.
⁹ V. Evans, PhD, Clear Vision Consulting, Canberra, and OMERACT Patient Research Partner, and Discipline of Optometry, University of Canberra, Canberra, Australia.
¹⁰ M. Gill, BA, Dragon Claw, Sydney, Australia, and OMERACT Patient Research Partner.
¹¹ L. March, PhD, Professor, Institute of Bone and Joint Research, Kolling Institute of Medical Research, and Department of Rheumatology, Royal North Shore Hospital, and Northern Clinical School, The University of Sydney, Sydney, Australia.
¹² R. Nieuwlaat, PhD, Associate Professor, Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
¹³ S. Salmasi, MSc, Collaboration for Outcomes Research and Evaluation, Faculty of Pharmaceutical Sciences, The University of British Columbia, Vancouver, and Arthritis Research Canada, Richmond, British Columbia, Canada.
¹⁴ M. Scholte-Voshaar, MSc, Department of Psychology, Health and Technology, University of Twente, Enschede, the Netherlands and OMERACT Patient Research Partner.
¹⁵ J.A. Singh, Professor, MD, Medicine Service, VA Medical Center, and Department of Medicine, School of Medicine, University of Alabama, and Division of Epidemiology, School of Public Health, University of Alabama, Birmingham, Alabama, USA.
¹⁶ D. Sumpton, MBBS, FRACP, Centre for Kidney Research, The Children's Hospital at Westmead, and Sydney School of Public Health, The University of Sydney, and Department of Rheumatology, Concord Hospital, Sydney, Australia.
¹⁷ K. Toupin-April, PhD, Associate Scientist, Children's Hospital of Eastern Ontario Research Institute, and Assistant Professor, Department of Pediatrics and School of Rehabilitation Sciences, University of Ottawa, Ottawa, Ontario, Canada.
¹⁸ P. Tugwell, MD, Professor, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
¹⁹ B. van den Bemt, PhD, Assistant Professor, Department of Pharmacy, Radboud University Medical Centre, Nijmegen, and Department of Pharmacy, Sint Maartenskliniek, Ubbergen, the Netherlands.
²⁰ S. Verstappen, PhD, Reader, Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, and NIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
²¹ K. Tymms, MBBS, FRACP, Associate Professor, College of Health and Medicine, Australian National University, and Canberra Rheumatology, and Department of Rheumatology, Canberra Hospital, Canberra, Australia.

PMID: 31839595
DOI: 10.3899/jrheum.190726

Abstract

Objective: Nonadherence to medications is common in rheumatic conditions and associated with increased morbidity. Heterogeneous outcome reporting by researchers compromises the synthesis of evidence of interventions targeting adherence. We aimed to assess the scope of outcomes in interventional studies of medication adherence.

Methods: We searched electronic databases to February 2019 for published randomized controlled trials and observational studies of interventions with the primary outcome of medication adherence including adults with any rheumatic condition, written in English. We extracted and analyzed all outcome domains and adherence measures with prespecified extraction and analysis protocols.

Results: Overall, 53 studies reported 71 outcome domains classified into adherence (1 domain), health outcomes (38 domains), and adherence-related factors (e.g., medication knowledge; 32 domains). We subdivided adherence into 3 phases: initiation (n = 13 studies, 25%), implementation (n = 32, 60%), persistence (n = 27, 51%), and phase unclear (n = 20, 38%). Thirty-seven different instruments reported adherence in 115 unique ways (this includes different adherence definitions and calculations, metric, and method of aggregation). Forty-one studies (77%) reported health outcomes. The most frequently reported were medication adverse events (n = 24, 45%), disease activity (n = 11, 21%), bone turnover markers/physical function/quality of life (each n = 10, 19%). Thirty-three studies (62%) reported adherence-related factors. The most frequently reported were medication beliefs (n = 8, 15%), illness perception/medication satisfaction/satisfaction with medication information (each n = 5, 9%), condition knowledge/medication knowledge/trust in doctor (each n = 3, 6%).

Conclusion: The outcome domains and adherence measures in interventional studies targeting adherence are heterogeneous. Consensus on relevant outcomes will improve the comparison of different strategies to support medication adherence in rheumatology.

Keywords: clinical trials; medication adherence; outcome assessment (health care); patient compliance; rheumatic diseases; systematic review.

Publication types

Research Support, Non-U.S. Gov't
Systematic Review

MeSH terms

Adult
Humans
Medication Adherence
Quality of Life*
Research Design
Rheumatic Diseases* / drug therapy