Development of a Complex Biofeedback-Based Intervention to Improve Methotrexate Adherence in Rheumatoid Arthritis: A COM-B Model Informed Qualitative Study

Hannah Shafi,1 Christopher J Armitage,2 Suzanne M M Verstappen,3,4 Anne Barton,1,4 Rebecca R Lee,2,3 James Bluett1,4 1Versus Arthritis Centre for Genetics and Genomics, Centre for Musculoskeletal Research, the University of Manchester, Manchester, UK; 2Manchester Centre for Health Psychology, Division of Psychology and Mental Health, NIHR Greater Manchester Patient Safety Research Collaboration, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK; 3The Centre for Epidemiology, the Centre for Musculoskeletal Research, the Division of Musculoskeletal and Dermatological Sciences, the Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK; 4NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UKCorrespondence: Hannah Shafi, Versus Arthritis Centre for Genetics and Genomics, Centre for Musculoskeletal Research, the University of Manchester, Manchester, UK, Tel +441613061249, Email hannahshafi@manchester.ac.ukIntroduction: Methotrexate (MTX) is one of the first-line treatments for Rheumatoid arthritis (RA) but sub-optimal adherence to MTX is common. Adherence can be challenging to detect in the clinic but can be assessed objectively using a MTX biochemical adherence test measuring levels of MTX in the blood. However, it remains unknown how to use the results of MTX biochemical adherence tests to improve adherence. COMMIT (development of a COMplex Methotrexate adherence IntervenTion utilising biofeedback) is a qualitative study designed to explore adherence to MTX in RA patients and aid the development of a behaviour change intervention that can be delivered alongside MTX biochemical adherence testing.Methods: Potential participants were identified from the Rheumatoid Arthritis Medications Study (RAMS), a large national study of patients with RA commencing MTX. An interview topic guide was developed using the Capability, Opportunity and Motivation to Behaviour (COM-B) model and the Theoretical Domains Framework (TDF). Consenting participants took part in a 1:1 semi-structured telephone interview. Transcripts were inductively analysed and mapped to themes.Results: Seventeen participants treated with MTX for a mean 3 years (range 3– 20) took part in the semi-structured interviews. Five overarching themes were identified and mapped to behaviour change techniques. Themes included 1. Knowledge of MTX and its impact, 2. Motivators versus barriers for continuation of MTX, 3. The healthcare approach in shaping patient adherence, 4. Creating habits and routines 5. MTX biochemical adherence blood tests and external monitoring of behaviour.Conclusion: This study has identified many of the key facilitators and barriers that influence adherence to methotrexate in RA patients. Through identifying the capabilities, opportunities, and motivations that shape engagement with MTX biochemical adherence testing, we can select targeted behaviour change techniques to address these factors. This theory-driven approach offers a novel pathway to improving uptake of MTX adherence testing.Keywords: biochemical adherence, qualitative research, methotrexate, self-management