Shoulder osteoarthritis most commonly affects older adults, causing pain, reduced function and quality of life. Total shoulder replacements (TSRs) are indicated once other non-surgical options no longer provide adequate pain relief. Two main types of TSRs are widely used: anatomic TSR (aTSR) and reverse TSR (rTSR). It is not clear whether one TSR type provides better short- or long-term outcomes for patients, and which, if either, is more cost-effective for the National Health Service (NHS).
RAPSODI-UK is a multi-centre, pragmatic, two-parallel arm, superiority randomised controlled trial comparing the clinical- and cost-effectiveness of aTSR versus rTSR for adults aged 60+ with a primary diagnosis of osteoarthritis, an intact rotator cuff and bone stock suitable for TSR. Participants in both arms of the trial will receive usual post-operative rehabilitation. We aim to recruit 430 participants from approximately 28 NHS sites across the UK. The primary outcome is the Shoulder Pain and Disability Index (SPADI) at 2 years post-randomisation. Outcomes will be collected at 3, 6, 12, 18 and 24 months after randomisation. Secondary outcomes include the pain and function subscales of the SPADI, the Oxford Shoulder Score, health-related quality of life (EQ-5D-5L), complications, range of movement and strength, revisions and mortality. The between-group difference in the primary outcome will be derived from a constrained longitudinal data analysis model. We will also undertake a full health economic evaluation and conduct qualitative interviews to explore perceptions of acceptability of the two types of TSR and experiences of recovery with a sample of participants.
Ethics committee approval for this trial was obtained (London - Queen Square Research Ethics Committee, Rec Reference 22/LO/0617) on 4 October 2022. The results of the main trial will be submitted for publication in a peer-reviewed journal and using other professional and media outlets.
Refugees experience significant health needs and well-being inequities. Smoking tobacco, nutrition disorders, alcohol use and physical inactivity are potential contributors to developing non-communicable diseases and mental health conditions. This study aims to explore refugees’ health promotion needs in a regional town in New South Wales (NSW), Australia, suggest appropriate health promotion methods, and co-design a health promotion intervention. Privileging refugees’ voices and experiences is central to co-designing appropriate health promotion interventions.
We will employ a two-phase participatory qualitative co-design method. As there is a lack of knowledge about refugees’ health needs, a participatory research design has the potential to explore the topics holistically. The social–ecological model and the behaviour change wheel model will guide this study. During Phase 1, a semistructured interview guide will be used for in-depth interviews and focus group discussions with refugees. A deductive reflexive thematic analysis will be applied to analyse data using NVivo. In Phase 2, two workshops will be conducted with refugees and health professionals. A reflexive thematic analysis will be performed to identify the top health promotion strategies.
Ethical approval was obtained from the Human Research Ethics Committee (HREC) of the North Coast NSW Local Health District (HREA370 2023/ETH00444). The Human Research Ethics Committee approved a minimisation of duplication at a regional university in Australia (SCU HREC 2024/106). Study findings will be disseminated through embedding chapters in the PhD thesis, publishing high-quality papers and presenting at conferences, lay reports, newsletters and media.