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Publication - Mr Nicholas Turner

    Reducing rheumatoid Arthritis Fatigue impact - clinical Teams using cognitive behavioural approaches (RAFT)

    randomised controlled trial with economic and qualitative evaluations

    Citation

    Hewlett, SE, Almeida, CJ, Ambler, N, Blair, P, Choy, E, Dures, EK, Hammond, A, Hollingworth, W, Kadir, B, Kirwan, JR, Plummer, ZE, Rooke, C, Thorn, J, Turner, NL, Pollock, J & , 2019, ‘Reducing rheumatoid Arthritis Fatigue impact - clinical Teams using cognitive behavioural approaches (RAFT): randomised controlled trial with economic and qualitative evaluations’. Health Technology Assessment.

    Abstract

    Background: Fatigue is a major problem in rheumatoid arthritis (RA). There is evidence for cognitive behavioural therapy (CBT) delivered by clinical psychologists but few rheumatology units have psychologists.

    Objectives: To compare clinical and cost-effectiveness of a group CBT programme for RA fatigue (RAFT) delivered by the rheumatology team in addition to usual care, versus usual care alone; to evaluate RAFT tutors’ experiences.

    Design: Randomised controlled trial. Central trials unit computerised randomisation in four consecutive cohorts within each of 7 centres. Nested qualitative evaluation.

    Setting: Seven hospital rheumatology units in England/Wales

    Participants: Adults with RA and fatigue severity >6/10; no recent changes in major RA medication/glucocorticoids.

    Interventions: RAFT: group CBT course delivered by rheumatology tutor pairs (nurses/occupational therapists). Usual care; brief discussion of an RA fatigue self-management booklet with the research nurse.

    Main outcome measures: Primary: Fatigue impact (Bristol RA Fatigue Numerical Rating Scale) at 26 weeks. Secondary: Fatigue severity/coping (BRAF-NRS), broader fatigue impact (BRAF Multi-Dimensional Questionnaire), self-reported clinical status, quality of life, mood, self-efficacy, satisfaction (26, 52, 78, 104 weeks). Intention-to-treat analysis conducted blind to allocation, adjusted for baseline scores and centre. Cost-effectiveness explored through intervention and RA-related health/social care costs, calculating quality-adjusted life-years (QALYs) with EQ-5D-5L. Tutor interviews/focus group analysed with inductive thematic analysis.

    Results: 308/333 patients completed 26 weeks (156/175 RAFT, 152/158 controls). At 26 weeks mean BRAF-NRS Impact was reduced for RAFT (-1.36, p<0.001) and controls (-0.88, p<0.004). Regression analysis showed a difference between arms in favour of RAFT of -0.59 BRAF-NRS units (95% CI -1.11, -0.06, p=0.03, effect size 0.36), sustained over two years (-0.49, CI -0.83, -0.14, p=0.01). At 26 weeks, further fatigue differences favoured RAFT: BRAF-MDQ fatigue impact -3.42 (CI -6.44, - 0.39, p=0.03); Living with Fatigue -1.19 (CI -2.17, -0.21, p=0.02); Emotional Fatigue -0.91 (CI -1.58, -0.23, p=0.01), sustained over two years. Self-efficacy favoured RAFT at 26 weeks (RASE 3.05, CI 0.43, 5.6, p=0.02), and BRAF-NRS Coping was on average different over two years (0.42, CI 0.08, 0.77, p=0.02). Fatigue severity and other clinical outcomes were not different between arms; no harms reported. RAFT satisfaction was high, with 89% patients scoring >8/10 (controls rating booklet 54%, p<0.0001); and 96%/68% recommending RAFT/booklet to others (p<0.001). There was no significant difference between arms for total societal costs including RAFT training/delivery (£434, CI £-389, +£1258) nor QALYs gained (0.008, CI -0.008, +0.023). The probability of RAFT being cost-effective was 28-35% at NICE thresholds of £20-30,000/QALY. Tutors felt RAFT’s CB approaches challenged their usual problem-solving habits but helped patients make life changes, and improved tutors’ wider clinical practice.

    Limitations: Primary outcome data missing for 25 patients; EQ-5D-5L might not capture fatigue change; 30% of 2-year economic data missing.

    Conclusions: RAFT improves RA fatigue impact beyond usual care alone, sustained for two years with high patient satisfaction, enhanced team skills and no harms. RAFT is <50% likely to be cost-effective but NHS costs were similar between arms.

    Future work: Given the paucity of RA fatigue interventions, rheumatology teams might investigate pragmatic implementation of RAFT, which is low-cost.

    Study registration: ISRCTN 52709998

    Full details in the University publications repository