Efficacy of non-pharmacological interventions: a systematic review informing the 2023 EULAR recommendations for the management of fatigue in people with inflammatory rheumatic and musculoskeletal diseases

OBJECTIVE: To identify the best evidence on the efficacy of non-pharmacological interventions in reducing fatigue in people with inflammatory rheumatic and musculoskeletal diseases (I-RMDs) and to summarise their safety in the identified studies to inform European Alliance of Associations for Rheumatology recommendations for the management of fatigue in people with I-RMDs. METHODS: Systematic review of randomised controlled trials (RCTs) including adults with I-RMDs conducted according to the Cochrane Handbook. Search strategy ran in Medline, Embase, Cochrane Library, CINAHL Complete, PEDro, OTseeker and PsycINFO. Assessment of risk of bias, data extraction and synthesis were performed by two reviewers independently. Data were pooled in meta-analyses. RESULTS: From a total of 4150 records, 454 were selected for full-text review, 82 fulfilled the inclusion criteria and 55 RCTs were included in meta-analyses. Physical activity or exercise was efficacious in reducing fatigue in rheumatoid arthritis (RA) (standardised mean differences (SMD)=-0.23, 95% CI=-0.37 to -0.1), systemic lupus erythematosus (SLE) (SMD=-0.54, 95% CI=-1.07 to -0.01) and spondyloarthritis (SMD=-0.94, 95% CI=-1.23 to -0.66); reduction of fatigue was not significant in Sjögren's syndrome (SMD=-0.83, 95% CI=-2.13 to 0.47) and systemic sclerosis (SMD=-0.66, 95% CI=-1.33 to 0.02). Psychoeducational interventions were efficacious in reducing fatigue in RA (SMD=-0.32, 95% CI=-0.48 to -0.16), but not in SLE (SMD=-0.19, 95% CI=-0.46 to 0.09). Follow-up models in consultations (SMD=-0.05, 95% CI=-0.29 to 0.20) and multicomponent interventions (SMD=-0.20, 95% CI=-0.53 to 0.14) did not show significant reductions of fatigue in RA. The results of RCTs not included in the meta-analysis suggest that several other non-pharmacological interventions may provide a reduction of fatigue, with reassuring safety results. CONCLUSIONS: Physica activity or exercise and psychoeducational interventions are efficacious and safe for managing fatigue in people with I-RMDs

Therapists’ experiences of remotely delivering cognitive-behavioural or graded-exercise interventions for fatigue: a qualitative evaluation

Objectives: Fatigue is a challenging feature of all inflammatory rheumatic diseases. LIFT (Lessening the Impact of Fatigue in inflammatory rheumatic diseases: a randomised Trial) included remotely delivered personalised exercise programme (PEP) or cognitive-behavioural approach (CBA) interventions. The aim of this nested qualitative evaluation was to understand rheumatology health professionals (therapists’) perspectives of delivering the interventions in the LIFT trial. Methods: A subgroup of therapists who had delivered the PEP and CBA interventions took part in semi-structured telephone interviews. Results: Seventeen therapists (13 women, 4 men) who delivered PEP (n = 8) or CBA (n = 9) interventions participated. Five themes were identified: In ‘The benefits of informative, structured training’, therapists described how they were able to practice their skills, and the convenience of having the LIFT manual to refer to. When ‘Getting into the swing of it’, supporting patients gave therapists the confidence to tailor the content of the manual to each patient. Clinical supervision supported therapists to gain feedback and request assistance when required. In ‘Delivering the intervention’ therapists reported that patients valued the opportunity to address their fatigue and challenge their own beliefs. ‘Challenges in delivering the LIFT intervention’ therapists struggled to work collaboratively with patients who lacked motivation or stopped engaging. Finally, ‘Lift developing clinical skills’ therapists gained confidence and professional satisfaction seeing patients’ fatigue improve. Conclusion: Findings support the value of skills training for rheumatology health professionals to deliver a remote fatigue management intervention tested in the LIFT trial. These insights can inform service provision and clinical practice Lay summary What does this mean for patients ? Fatigue can be a challenge in inflammatory rheumatic diseases (IRDs). The LIFT study (Lessening the Impact of Fatigue in inflammatory rheumatic diseases: a randomized Trial) explored interventions to support people with fatigue. These were: a cognitive-behavioural approach (CBA), a personalized exercise programme (PEP), or usual care. People with IRDs were chosen randomly to take part in seven sessions of CBA, seven sessions of PEP or usual care. All sessions (aside from the first PEP session) were delivered over the phone. The aim of this study was to explore therapists' experiences of delivering the intervention. Seventeen therapists (13 women and 4 men) took part; eight had delivered the PEP intervention, and 9 delivered the CBA intervention. Therapists who delivered LIFT told us they enjoyed the chance to practice their skills, and that the LIFT manual gave them the confidence to tailor the intervention to each patient. Clinical supervision was valued. Therapists also shared that LIFT improved their skills and they were happy to see patients' fatigue improve over time. These new results can inform clinical practice, and how services are provided

Jaw claudication and jaw stiffness in giant cell arteritis: secondary analysis of a qualitative research dataset

Objective Jaw symptoms can be a vital clue to the diagnosis of GCA. Guidelines recommend more intensive treatment if jaw claudication is present. We sought to explore how patients with GCA described their jaw symptoms. Methods We carried out a secondary, qualitative analysis of interview data from 36 participants from the UK (n = 25) and Australia (n = 11), originally collected in order to develop a patient-reported outcome measure for GCA. In all cases, GCA had been confirmed by biopsy/imaging. Interview transcripts were organized within QSR NVivo 12 software and analysed using template analysis. Themes were refined through discussion among the research team, including a patient partner. Results Twenty of 36 participants reported jaw symptoms associated with GCA. The median age of these 20 participants was 76.5 years; 60% were female. Five themes were identified: physical sensations; impact on function; impact on diet; symptom response with CSs; and attribution to other causes. Physical sensations included ache, cramp, stiffness and ‘lockjaw’. Functional impacts included difficulty in eating/chewing, cleaning teeth, speaking or opening the mouth. Dietary impacts included switching to softer food. Response to CSs was not always immediate. Jaw symptoms were initially mis-attributed by some participants to arthritis, age or viral illnesses; or by health-care professionals to a dental cavity, ear infection or teeth-grinding. Conclusion Jaw symptoms in GCA are diverse and can lead to diagnostic confusion with primary temporomandibular joint disorder, potentially contributing to delay in GCA diagnosis. Further research is needed to determine the relationship of jaw stiffness to jaw claudication

Group cognitive–behavioural programme to reduce the impact of rheumatoid arthritis fatigue: The RAFT RCT with economic and qualitative evaluations

BACKGROUND: Fatigue is a major problem in rheumatoid arthritis (RA). There is evidence for the clinical effectiveness of cognitive-behavioural therapy (CBT) delivered by clinical psychologists, but few rheumatology units have psychologists. OBJECTIVES: To compare the clinical effectiveness and cost-effectiveness of a group CBT programme for RA fatigue [named RAFT, i.e. Reducing Arthritis Fatigue by clinical Teams using cognitive-behavioural (CB) approaches], delivered by the rheumatology team in addition to usual care (intervention), with usual care alone (control); and to evaluate tutors' experiences of the RAFT programme. DESIGN: A randomised controlled trial. Central trials unit computerised randomisation in four consecutive cohorts within each of the seven centres. A nested qualitative evaluation was undertaken. SETTING: Seven hospital rheumatology units in England and Wales. PARTICIPANTS: Adults with RA and fatigue severity of ≥ 6 [out of 10, as measured by the Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scale (BRAF-NRS)] who had no recent changes in major RA medication/glucocorticoids. INTERVENTIONS: RAFT - group CBT programme delivered by rheumatology tutor pairs (nurses/occupational therapists). Usual care - brief discussion of a RA fatigue self-management booklet with the research nurse. MAIN OUTCOME MEASURES: Primary - fatigue impact (as measured by the BRAF-NRS) at 26 weeks. Secondary - fatigue severity/coping (as measured by the BRAF-NRS); broader fatigue impact [as measured by the Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ)]; self-reported clinical status; quality of life; mood; self-efficacy; and satisfaction. All data were collected at weeks 0, 6, 26, 52, 78 and 104. In addition, fatigue data were collected at weeks 10 and 18. The intention-to-treat analysis conducted was blind to treatment allocation, and adjusted for baseline scores and centre. Cost-effectiveness was explored through the intervention and RA-related health and social care costs, allowing the calculation of quality-adjusted life-years (QALYs) with the EuroQol-5 Dimensions, five-level version (EQ-5D-5L). Tutor and focus group interviews were analysed using inductive thematic analysis. RESULTS: A total of 308 out of 333 patients completed 26 weeks (RAFT, n/N = 156/175; control, n/N = 152/158). At 26 weeks, the mean BRAF-NRS impact was reduced for the RAFT programme (-1.36 units; p

Rheumatology clinicians’ experiences of brief training and implementation of skills to support patient self-management

BACKGROUND: Self-management of arthritis requires informed, activated patients to manage its physical and psychosocial consequences. Patient activation and self-management can be enhanced through the use of cognitive-behavioural approaches, which have a strong evidence base and provide insight into the variation in outcome of patients with ostensibly the same degree of disease activity. However, training for rheumatology health professionals in theory and skills underpinning the facilitation of self-management is not widely available. To develop such training, this study explored rheumatology clinicians’ experiences of a variety of brief skills training courses to understand which aspects were helpful or unhelpful, and to identify the barriers and facilitators of applying the skills in clinical practice. METHODS: 16 clinicians who had previously attended communication and self-management skills training participated in semi-structured interviews: 3 physicians, 3 physiotherapists, 4 nurses, 6 occupational therapists. Transcripts were analysed (ED) using a hybrid inductive and deductive thematic approach, with a subset independently analysed (SH, RG-H, RJ). RESULTS: 3 overarching themes captured views about training undertaken and subsequent use of approaches to facilitate self-management. In ‘putting theory into practice’, clinicians felt that generic training was not as relevant as rheumatology-specific training. They wanted a balance between theory and skills practice, and identified the importance of access to ongoing support. In ‘challenging professional identity’, models of care and working cultures influenced learning and implementation. Training often challenged a tendency to problem-solve on behalf of patients and broadened clinicians’ remit from a primary focus on physical symptoms to the mind and body interaction. In ‘enhanced practice’, clinicians viewed consultations as enhanced after training. Focus had shifted from clinicians’ agendas to those of patients, and clinicians reported eliciting patients’ priorities and the use of theoretically-driven strategies such as goal-setting. CONCLUSIONS: To varying extents, clinicians were able to learn and implement new approaches to support patient self-management after brief training. They believed that cognitive behavioural and communication skills to facilitate self-management enhanced their practice. To optimise self-management support in routine care brief, skills-based, rheumatology-specific training needs to be developed, alongside ongoing clinical supervision. Further research should examine patients’ perspectives of care based on these approaches

Caregiving for older people living with chronic pain : analysis of the English Longitudinal Study of Ageing and Health Survey for England

BACKGROUND: Chronic pain is a disabling condition. Many people with chronic pain seek informal support for everyday activities of daily living. However there remains uncertainty on the type of people with chronic pain who access this support, what types of support they need and who provides such support. The purpose of this analysis was to answer these uncertainties. METHODS: Data from the Health Survey for England (HSE) and English Longitudinal Study of Ageing (ELSA) were accessed. People who reported chronic pain (moderate or above for minimum of 12 months) were identified. From these cohorts, we determined if individuals self-reported receiving informal care. Data on caregiver profiles and caregiving activities were reported through descriptive statistics. Logistic regression analyses were performed to compare health status outcomes between people with pain who received and who did not receive informal care. RESULTS: 2178 people with chronic pain from the ELSA cohort and 571 from the HSE cohort were analysed. People who received care were frequently female, older aged with several medical morbidities including musculoskeletal diseases such as arthritis. People with chronic pain received informal care for several diverse tasks. Most frequently these related to instrumental activities of daily living such as shopping and housework. They were most frequently provided by partners or their children. Although they reported greater disability and symptoms (p<0.001), people who received care did not report differences in health status, loneliness or wellbeing (p=0.27; p=0.46). CONCLUSIONS: Whilst it may be possible to characterise people living in chronic pain who receive informal care, there is some uncertainty on the impact of informal caregiving on their health and wellbeing. Consideration should now be made on how best to support both care recipients and informal caregivers, to ensure their health and quality of life is promoted whilst living with chronic pain

Reducing arthritis fatigue impact: Two-year randomised controlled trial of cognitive behavioural approaches by rheumatology teams (RAFT)

© Author(s) (or their employer(s)) 2019. Objectives To see if a group course delivered by rheumatology teams using cognitive-behavioural approaches, plus usual care, reduced RA fatigue impact more than usual care alone. Methods Multicentre, 2-year randomised controlled trial in RA adults (fatigue severity>6/10, no recent major medication changes). RAFT (Reducing Arthritis Fatigue: Clinical Teams using CB approaches) comprises seven sessions, codelivered by pairs of trained rheumatology occupational therapists/nurses. Usual care was Arthritis Research UK fatigue booklet. Primary 26-week outcome fatigue impact (Bristol RA Fatigue Effect Numerical Rating Scale, BRAF-NRS 0-10). Intention-to-treat regression analysis adjusted for baseline scores and centre. Results 308/333 randomised patients completed 26 week data (156/175 RAFT, 152/158 Control). Mean baseline variables were similar. At 26 weeks, the adjusted difference between arms for fatigue impact change favoured RAFT (BRAF-NRS Effect-0.59, 95% CI -1.11 to -0.06), BRAF Multidimensional Questionnaire (MDQ) Total-3.42 (95% CI -6.44 to -0.39), Living with Fatigue-1.19 (95% CI -2.17 to -0.21), Emotional Fatigue-0.91 (95% CI -1.58 to -0.23); RA Self-Efficacy (RASE, +3.05, 95% CI 0.43 to 5.66) (14 secondary outcomes unchanged). Effects persisted at 2 years: BRAF-NRS Effect-0.49 (95% CI-0.83 to -0.14), BRAF MDQ Total-2.98 (95% CI-5.39 to -0.57), Living with Fatigue-0.93 (95% CI-1.75 to -0.10), Emotional Fatigue-0.90 (95% CI-1.44, to -0.37); BRAF-NRS Coping +0.42 (95% CI 0.08 to 0.77) (relevance of fatigue impact improvement uncertain). RAFT satisfaction: 89% scored ≥ 8/10 vs 54% controls rating usual care booklet (

Stiffness is more than just duration and severity: A qualitative exploration in people with rheumatoid arthritis

Objective. Stiffness is internationally recognized as an important indicator of inflammatory activity in RA but is poorly understood and difficult to measure. The aim of this study was to explore the experience of stiffness from the patient perspective. Methods. Semi-structured interviews conducted with 16 RA patients were analysed independently by researchers and pat.ient partners using inductive thematic analysis. Results. Six themes were identified. Part of having RA identified stiffness as a normal consequence of RA, perceived as associated with disease-related aspects such as fluctuating disease activity, other RA symptoms and disease duration. Local and widespread highlighted stiffness occurring not only in joints, but also over the whole body, being more widespread during the morning or flare. Linked to behaviour and environment illustrated factors that influence stiffness, including movement, medications and weather. Highly variable captured the fluctuating nature of stiffness within and between patients and in relation to temporality, duration and intensity. Impacts on daily life emphasized the effect of stiffness on a range of domains, including physical function, quality of life, psychological well-being, activities of daily living and participation in work and leisure activities. Requires self-management detailed self-management strategies targeting both the symptom and its consequences. Conclusion. Patients’ experiences of stiffness were varied, complex and not exclusive to the morning period. Importantly, stiffness was reported in terms of impact rather than the traditional measurement concepts of severity or duration. Based on these findings, further research is needed to develop a patient-centred measure that adequately reflects inflammatory activity

Successful strategies supporting recruitment, intervention delivery and retention targets in a randomized controlled trial of a complex intervention

Background: Complex interventions are widely used in modern health care practice and are defined as those having potentially interacting components. Evaluation can be challenging due to difficulties in logistics, standardisation and delivery. In addition, there can be difficulty recruiting to time and to target (particularly in multicentre studies) and minimising attrition and data loss. We report how the RAFT study [a seven-centre randomized controlled trial (RCT) comparing a complex group cognitive-behavioural (CB) intervention with standard care for the reduction of fatigue impact in patients with RA) is implementing successful strategies to meet recruitment, intervention delivery and retention targets. The study requires patients to make a substantial commitment over a 2 year period and for the intervention to be delivered by routine clinical staff trained for this purpose. Methods: The following strategies were agreed upon during the planning and design phase: Maximising recruitment: Funded research nurse time at all seven sites; mailshot option for approach; recruitment posters for clinics; flexible and pragmatic approach to session attendance; telephone, email and postal contact; newsletter and regular knowledge exchange between the central trial management team and sites; weekly recruitment updates and reviews. Ensuring intervention delivery: Flexible course dates and times set by each site, regular communication with the central management team to discuss foreseeable issues and preventative actions, provision of real-time clinical supervision and full-time telephone/email support. Minimising attrition and data loss: Primary outcome collection by telephone, ensuring regular personal contact; secondary data collection by postal questionnaire, reducing the number of hospital visits; telephone reminders; partial withdrawal options; personalized letters and thank you cards. Patient involvement: We had a number of acceptability and feasibility consultations with our two patient partners. Both partners had prior experience attending the intervention, were co-applicants on the grant proposal and continue to provide a patient perspective as members of the trial management group. Results: Our target was to recruit 300 participants with no recent medication changes and a fatigue level ≥6 (on a 1–10 scale where 10 is totally exhausted). During the 2 year recruitment phase, 333 participants were randomized (11% over target). All 28 programmes successfully delivered, with 7/7 sites and 14/15 tutors remaining fully engaged with the study. Retention at 6 months is currently 92.5% (sample size allows for 20% attrition). Data returned by those reaching the 6 month time point are 100% for the primary outcome and 97% for secondary outcomes. Conclusion: Advanced planning and consistent application of these strategies has ensured success so far. A flexible and pragmatic approach, regular communication between local and central teams, personal contact with participants and extensive patient partner input are key components