Protocol for the economic evaluation of individualised (early) patient-directed rehabilitation versus standard rehabilitation after surgical repair of the rotator cuff of the shoulder (RaCeR 2)

Manca, Andrea; Premji, Shainur; GC, Vijay; Chen, Tao; Mazuquin, Bruno; Fakis, Apostolos; Bateman, Marcus; Moffatt, Maria; Littlewood, Chris

Abstract

Introduction. RaCeR 2 is a pragmatic multi-centre, open-label, randomised controlled trial, with full economic evaluation. The primary aim is to assess whether individualised (early) patient-directed rehabilitation (EPDR) results in less shoulder pain and disability at 12 weeks post-randomisation following surgical repair of full-thickness tears of the rotator cuff of the shoulder compared to current standard (delayed) rehabilitation. This paper provides the protocol for the RaCeR 2 health economic evaluation.

Methods and analysis. The health economic analysis of RaCeR 2 is made up of three phases: 1) development of an initial state-transition model structure, 2) within-trial cost consequences analysis, and 3) long-term model-based cost-effectiveness analysis (CEA) from the National Health Service and Personal Social Service perspective in England. Descriptive statistics (e.g. mean, standard deviation, 95% confidence intervals, and minimum and maximum values) will be reported for within-trial resource use, costs, and health-related quality of life (HRQoL). Health state-specific costs and HRQoL will be estimated using regression model approaches and used to inform a state-transition simulation model designed to quantify the long-term costs and quality-adjusted life years (QALYs) experienced by the patients over the model’s time horizon. Where appropriate, final CEA results will be reported as cost per QALY gained for individualised EPDR versus standard (delayed) rehabilitation. Model assumptions and overall parameter uncertainty will be tested using probabilistic sensitivity analysis and scenario analyses. All regression analyses will be adjusted for baseline participant demographic and symptomatic characteristics.

Ethics and dissemination. A favourable ethical review was granted by London-Stanmore Research Ethics Committee (23/LO/0195) on 13th April 2023. Findings will be disseminated in peer-reviewed journals, at scientific conferences, and via the study website.

Trial registration number. ISRCTN11499185.

• Journal Article Type: Article
• Acceptance Date: May 30, 2025
• Deposit Date: Jun 5, 2025
• Electronic ISSN: 2044-6055
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed