An intervention to support adherence to inhaled medication in adults with cystic fibrosis: the ACtiF research programme including RCT

Martin J Wildman ,Jon Nicholl ,Mónica Hernández Alava ,Chin Maguire ,Simon Waterhouse ,Alicia O’cathain ,Judy Bradley ,Elizabeth Lumley ,Susan Michie ,Paul Tappenden ,Rachel Elliott ,Laura Mandefield ,Iain Buchan ,Zhe Hui Hoo ,Stuart Elborn ,Sarah J Drabble ,Aline Navega Biz ,Louisa Robinson ,Daniel Hind ,Pauline Whelan ,Marlene Hutchings ,Daniel Beever ,Anne Scott ,John Ainsworth ,Stephen J Walters ,Laura Sutton ,Madelynne A Arden ,Alessandro Sasso

doi:10.3310/pgfar09110

Abstract

An intervention to support adherence to inhaled medication in adults with cystic fibrosis: the ACtiF research programme including RCT

Highlights

Within-trial economic evaluation alongside a clinical trialWithin-trial economic evaluation alongside a clinical trial methodsWithin-trial economic evaluation alongside a clinical trial resultsModel-based analysisModel structure and assumptions Resource costsModel evaluation methods ValidationModel-based analysis: results
Process evaluation – fidelity of intervention delivery was high, the intervention was acceptable to people with cystic fibrosis, participants engaged with the intervention [287/305 (94%) attended the first intervention visit], expected mechanisms of action were identified and contextual factors varied between randomised controlled trial sites
Qualitative interviews with 22 people with cystic fibrosis and 26 interventionists identified that people with cystic fibrosis welcomed the objective adherence data as proof of actions to self and others, and valued the relationship that they built with the interventionists

Summary

Introduction

Within-trial economic evaluation alongside a clinical trialWithin-trial economic evaluation alongside a clinical trial methodsWithin-trial economic evaluation alongside a clinical trial resultsModel-based analysisModel structure and assumptions Resource costsModel evaluation methods ValidationModel-based analysis: results. The World Health Organization states that poor adherence to medication is a worldwide problem associated with poor health outcomes and increased costs to health-care systems. This is problematic in chronic conditions including cystic fibrosis. Measured adherence levels in cystic fibrosis are estimated to be as low as 30–40%, as measured on dose-counting nebulisers. 2. For patients with a final EQ-5D-5L visit beyond the primary outcome cut-off, the patient’s EQ-5D-5L score was estimated at day 365 based on assumption 1. Total QALYs gained per patient were calculated by subtracting i.v.-related QALY losses from the background QALYs

Objectives

Methods

Results

Conclusion