Factors influencing the outcomes of non-pharmacological interventions for managing fatigue across the lifespan of people living with musculoskeletal (MSK) conditions: a scoping review protocol.

INTRODUCTION: Fatigue is an important and distressing symptom for many people living with chronic musculoskeletal (MSK) conditions. Many non-pharmacological interventions have been investigated in recent years and some have been demonstrated to be effective in reducing fatigue and fatigue impact, however, there is limited guidance for clinicians to follow regarding the most appropriate management options. The objective of this scoping review is to understand and map the extent of evidence in relation to the factors that relate to the outcome of non-pharmacological interventions on MSK condition-related fatigue across the lifespan. METHODS AND ANALYSIS: This scoping review will include evidence relating to people of all ages living with chronic MSK conditions who have been offered a non-pharmacological intervention with either the intention or effect of reducing fatigue and its impact. Databases including AMED, PsycINFO, CINAHLPlus, MEDLINE, EMBASE and Scopus will be searched for peer-reviewed primary research studies published after 1 January 2007 in English language. These findings will be used to identify factors associated with successful interventions and to map gaps in knowledge. ETHICS AND DISSEMINATION: Ethical approval was not required for this review. Findings will be disseminated by journal publications, conference presentations and by communicating with relevant healthcare and charity organisations.

Qualitative interview study of rheumatology patients' experiences of COVID-19 shielding to explore the physical and psychological impact and identify associated support needs.

OBJECTIVE: Many clinically extremely vulnerable rheumatology patients have only recently ceased shielding from COVID-19, while some continue to minimise in-person contact. The objective of this study was to understand the impact of shielding and associated support needs in patients with rheumatic conditions and to understand how rheumatology teams can meet these needs both currently and in future pandemics. DESIGN, PARTICIPANTS AND SETTING: The study was conducted in the Southwest of England using a case-study design. The participants were 15 patients with rheumatic conditions who were advised to shield and/or chose to shield at any time during the COVID-19 pandemic. METHODS: Qualitative data collected via telephone and online semi-structured interviews and analysed using reflexive thematic analysis. RESULTS: Fifteen interviews were conducted. Three main themes represent the data:'Just shove them over there in the corner' captures changes in patients' self-perception. They felt different to most other people, vulnerable and left behind. The initial sense of shock was followed by a sense of loss as changes became long term.'A long and lonely road' captures patients' psychological isolation due to a perceived lack of understanding and support. This included having to prove their health status and justify their shielding behaviours, which impacted their relationships. At times, they felt abandoned by their healthcare providers.'You can't just flip a switch' captures the difficulty of getting back to pre-pandemic normal after shielding. Patients did not recognise themselves physically and mentally. They wanted to collaborate with health professionals and identified the need for specific guidance to support their recovery. CONCLUSION: Patients are dealing with lasting physical and mental effects from shielding and consequences of delayed healthcare. Health professionals need time and resources to ask about patients' well-being, identify their health needs and refer/signpost to appropriate sources of support.

Validation of a patient-reported outcome measure for giant cell arteritis.

OBJECTIVES: GCA is systemic vasculitis manifesting as cranial, ocular or large vessel vasculitis. A prior qualitative study developed 40 candidate items to assess the impact of GCA on health-related quality of life (HRQoL). This study aimed to determine final scale structure and measurement properties of the GCA patient reported outcome (GCA-PRO) measure. METHODS: Cross-sectional study included UK patients with clinician-confirmed GCA. They completed 40 candidate items for the GCA-PRO at times 1 and 2 (3 days apart), EQ-5D-5L, ICECAP-A, CAT-PROM5 and self-report of disease activity. Rasch and exploratory factor analyses informed item reduction and established structural validity, reliability and unidimensionality of the final GCA-PRO. Evidence of validity was also established with hypothesis testing (GCA-PRO vs other PRO scores, and between participants with 'active disease' vs those 'in remission') and test-retest reliability. RESULTS: The study population consisted of 428 patients: mean (s.d.) age 74.2 (7.2), 285 (67%) female; 327 (76%) cranial GCA, 114 (26.6%) large vessel vasculitis and 142 (33.2%) ocular involvement. Rasch analysis eliminated 10 candidate GCA items and informed restructuring of response categories into four-point Likert scales. Factor analysis confirmed four domains: acute symptoms (eight items), activities of daily living (seven items), psychological (seven items) and participation (eight items). The overall scale had adequate Rasch model fit (χ2 = 25.219, degrees of freedom = 24, P = 0.394). Convergent validity with EQ5D-5L, ICECAP-A and Cat-PROM5 was confirmed through hypothesis testing. Internal consistency and test-retest reliability were excellent. CONCLUSION: The final GCA-PRO is a 30-item, four-domain scale with robust evidence of validity and reliability in measuring HRQoL in people with GCA.

Validation of a new glucocorticoid-specific Patient-Reported Outcome Questionnaire (the Steroid PRO).

OBJECTIVES: Glucocorticoids used in the treatment of inflammatory rheumatic conditions can impact on health-related quality of life. An underpinning qualitative study developed a long-list of candidate items for a treatment-specific patient-reported outcome (PRO) measure. The objective of this paper is to determine scale structure and psychometric properties of the Steroid PRO. METHODS: A cross-sectional survey of adults from the UK, USA, Australia and New Zealand, taking glucocorticoids for a rheumatic disease. Initial survey collected demographics, clinical information, 40 Steroid PRO candidate items and EuroQol-5 Dimensions- 5 levels (EQ-5D-5L). Follow-up, 3-5 days later, collected Steroid PRO candidate items and a condition-change ('transition') question. Analysis included Rasch measurement model, exploratory factor analysis (EFA), and hypothesis testing for discriminative validity, convergence validity and test-retest reliability. RESULTS: Total responses 946: UK n=743 (79%); USA n=139 (15%); Australia/New Zealand n=64 (7%); mean age 57.6 (SD=13.6); 833 (88%) women. Participants with inflammatory arthritis n=197 (21%), connective tissue disease and/or vasculitis n=402 (42%), giant cell arteritis and/or polymyalgia rheumatica n=347 (37%). Twenty-five items were removed due to lack of fit to Rasch model. Of the remaining items, EFA suggested four subscales: Social impact (4 items); Impact on appearance (3 items); Psychological impact (5 items); Treatment concerns (3 items). Rasch modelling supported a four-subscale structure and total score, confirming construct validity and reliability. Hypothesis testing confirmed discriminant and convergence validity. Intraclass correlation coefficient (total score) was 0.809 demonstrating excellent (test-retest) reliability. CONCLUSIONS: The Steroid PRO is a 15-item, valid and reliable scale for measuring the impact of glucocorticoid therapy in people with rheumatic diseases.

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.

2023 EULAR recommendations for the management of fatigue in people with inflammatory rheumatic and musculoskeletal diseases.

OBJECTIVES: Fatigue is prevalent in people with inflammatory rheumatic and musculoskeletal diseases (I-RMDs) and recognised as one of the most challenging symptoms to manage. The existence of multiple factors associated with driving and maintaining fatigue, and the evidence about what improves fatigue has led to a multifaceted approach to its management. However, there are no recommendations for fatigue management in people with I-RMDs. This lack of guidance is challenging for those living with fatigue and health professionals delivering clinical care. Therefore, our aim was to develop EULAR recommendations for the management of fatigue in people with I-RMDs. METHODS: A multidisciplinary taskforce comprising 26 members from 14 European countries was convened, and two systematic reviews were conducted. The taskforce developed the recommendations based on the systematic review of evidence supplemented with taskforce members' experience of fatigue in I-RMDs. RESULTS: Four overarching principles (OAPs) and four recommendations were developed. OAPs include health professionals' awareness that fatigue encompasses multiple biological, psychological and social factors which should inform clinical care. Fatigue should be monitored and assessed, and people with I-RMDs should be offered management options. Recommendations include offering tailored physical activity and/or tailored psychoeducational interventions and/or, if clinically indicated, immunomodulatory treatment initiation or change. Patient-centred fatigue management should consider the individual's needs and preferences, their clinical disease activity, comorbidities and other psychosocial and contextual factors through shared decision-making. CONCLUSIONS: These 2023 EULAR recommendations provide consensus and up-to-date guidance on fatigue management in people with I-RMDs.

Efficacy of 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 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 adults with I-RMDs conducted according to the Cochrane Handbook. Search strategy ran in Medline, Embase, Cochrane Library, CINAHL Complete, PEDro, OTseeker and PsycINFO. Only randomised controlled trials (RCTs) or controlled clinical trials were eligible. Assessment of risk of bias, data extraction and synthesis performed by two reviewers independently and in duplicate. Data pooled in statistical meta-analyses. RESULTS: From 4151 records, 455 were selected for full-text review, 99 fulfilled the inclusion criteria and 19 RCTs were included in meta-analyses. Adalimumab was superior to placebo in reducing fatigue at 12 and 52 weeks in rheumatoid arthritis (RA) (n=3 and 2 RCTs; mean difference (MD)= -3.03, p<0.001; MD=-2.25, p=0.03, respectively). Golimumab (n=2 RCTs; 24 weeks: MD=-5.27, p<0.001), baricitinib (n=2 RCTs; 24 weeks: MD=-4.06, p<0.001), sarilumab (n=2 RCTs; 24 weeks: MD=-3.15, p<0.001), tocilizumab (n=3 RCTs; 24 weeks: MD=-3.69, p<0.001) and tofacitinib (n=3 RCTs; 12 weeks: MD=-4.44, p<0.001) were also superior to placebo in reducing fatigue in RA. A dose/effect relationship was observed for sarilumab, tocilizumab and tofacitinib. In spondyloarthritis (excluding psoriatic arthritis), secukinumab was superior to placebo in reducing fatigue at 16 weeks (n=2 RCTs; MD=-4.15, p<0.001), with a dose/effect relationship also observed. The narrative results of the RCTs not included in the meta-analysis indicated that several other pharmacological interventions were efficacious in reducing fatigue, with reassuring safety results. CONCLUSIONS: Several pharmacological interventions are efficacious and generally safe for managing fatigue in people with I-RMDs.

Patient Experiences of Brachytherapy for Locally Advanced Cervical Cancer: Hearing the Patient Voice Through Qualitative Interviews.

PURPOSE: Brachytherapy for gynecological cancer is reported to cause pain, anxiety, and distress with no clear guidance for optimizing patient experiences. The aim of this study was to explore patient experiences of brachytherapy and views on improvement. METHODS AND MATERIALS: Semistructured interviews were undertaken with patients who had received brachytherapy for locally advanced cervical cancer. Two cohorts were recruited: cohort 1 had recently had brachytherapy, and cohort 2 was a year post brachytherapy. Four recruitment sites were selected, where brachytherapy is given in different ways, some with short day case procedures and others having 1 or 2 overnight stays with applicators in place. Consecutive patients were invited to interview. Participants were asked to retell their brachytherapy story, with views on their care and ideas for improvement. Interviews were audio recorded, transcribed, and data analyzed following Braun and Clarke's method for reflexive thematic analysis. RESULTS: Thirty-five interviews were conducted (20 in cohort 1 and 15 in cohort 2). Participant's ages ranged from 28 to 87 years. The interview duration ranged from 22 to 78 minutes. Difficult and traumatic experiences were reported, including periods of severe pain and perceptions of poor care. However, some participants described positive experiences and what went well. Three themes were developed: (1) how the patient got through it, (2) unpleasantness, discomfort, and the aftermath, and (3) emotional consequences and trauma. Some aspects of medium and long duration brachytherapy were found to be more problematic compared with short duration brachytherapy. Exploring experiences at 1-year post brachytherapy has provided insights into the long-lasting impact of brachytherapy experiences. CONCLUSIONS: Hearing the patient voice has demonstrated that further work is needed to improve patient care in modern brachytherapy techniques using different regimens and durations, to minimize difficult and traumatic patient experiences. Study insights will inform future work to develop clinical care recommendations.

Non-pharmacological fatigue interventions for patients with a primary brain tumour: a scoping review protocol.

INTRODUCTION: Fatigue is the most prevalent symptom for patients with a primary brain tumour (PBT), significantly reducing quality of life and limiting daily activities. Currently, there are limited options for managing cancer-related fatigue (CRF) in patients with a PBT, using non-pharmacological methods. The objective of this scoping review is to identify current and emerging evidence in relation to non-pharmacological CRF interventions for patients with a PBT. METHODS AND ANALYSIS: Electronic databases OVID and EBSCO platforms: MEDLINE, EMBASE and CINAHL will be searched. In addition, PROSPERO, The Cochrane Library and ISI Web of Science will be searched. Trials registries CENTRAL and the International Clinical Trials Registry platform will also be searched for ongoing research. INCLUSION CRITERIA: studies from 2006 onwards, primary research on non-pharmacological interventions in patients with a PBT (>18 years). A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram will be utilised to summarise the screening process and results.Quantitative data will be analysed descriptively, while content analysis will be used for qualitative data.Findings will map the existing and emerging evidence on non-pharmacological interventions for CRF in patients with PBTs. This will provide insights into the extent and nature of the evidence in this evolving field, identifying gaps in knowledge and research priorities, and guide further investigations in this area. ETHICS AND DISSEMINATION: Ethical approval is not required for this scoping review. Findings will be disseminated via relevant peer-reviewed journals, PhD thesis, conference presentations, and shared with relevant charities and health professionals.

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.

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 (ADL). 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 (IADL) 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.

Cost-effectiveness of cognitive behavioural and personalized exercise interventions for reducing fatigue in inflammatory rheumatic diseases.

OBJECTIVES: To estimate the cost-effectiveness of a cognitive behavioural approach (CBA) or a personalized exercise programme (PEP), alongside usual care (UC), in patients with inflammatory rheumatic diseases who report chronic, moderate to severe fatigue. METHODS: A within-trial cost-utility analysis was conducted using individual patient data collected within a multicentre, three-arm randomized controlled trial over a 56-week period. The primary economic analysis was conducted from the UK National Health Service (NHS) perspective. Uncertainty was explored using cost-effectiveness acceptability curves and sensitivity analysis. RESULTS: Complete-case analysis showed that, compared with UC, both PEP and CBA were more expensive [adjusted mean cost difference: PEP £569 (95% CI: £464, £665); CBA £845 (95% CI: £717, £993)] and, in the case of PEP, significantly more effective [adjusted mean quality-adjusted life year (QALY) difference: PEP 0.043 (95% CI: 0.019, 0.068); CBA 0.001 (95% CI: -0.022, 0.022)]. These led to an incremental cost-effectiveness ratio (ICER) of £13 159 for PEP vs UC, and £793 777 for CBA vs UC. Non-parametric bootstrapping showed that, at a threshold value of £20 000 per QALY gained, PEP had a probability of 88% of being cost-effective. In multiple imputation analysis, PEP was associated with significant incremental costs of £428 (95% CI: £324, £511) and a non-significant QALY gain of 0.016 (95% CI: -0.003, 0.035), leading to an ICER of £26 822 vs UC. The estimates from sensitivity analyses were consistent with these results. CONCLUSION: The addition of a PEP alongside UC is likely to provide a cost-effective use of health care resources.

Measuring the impact of steroid therapy on health-related quality of life in patients with rheumatic diseases: international development of a glucocorticoid treatment-specific patient-reported outcome measure.

OBJECTIVES: Glucocorticoids (GCs) ('steroids') are used to treat rheumatic diseases but adverse effects are common. We aimed to explore the impact of GC therapy on health-related quality of life (HRQoL), to inform the development of a treatment-specific patient-reported outcome measure (PROM) for use in clinical trials and practice. METHODS: Semi-structured qualitative interviews were conducted with patients from the UK, USA and Australia, treated for a rheumatic condition with GCs in the last 2 years. Purposive sampling was used to select participants with a range of demographic and disease features. An initial conceptual framework informed interview prompts and cues. Interviews elicited GC-related physical and psychological symptoms and salient aspects of HRQoL in relation to GC therapy. Interview data were analysed inductively to develop initial individual themes and domains. Candidate questionnaire items were developed and refined. RESULTS: Sixty semi-structured qualitative interviews were conducted (UK n = 34, USA n = 10, Australia n = 16). The mean age was 58 years; 39/60 were female; and 18 rheumatic diseases were represented. Some 126 individual themes were identified and organized into six domains: physical symptoms; psychological symptoms; psychological impact of steroids; impact of steroids on participation; impact of steroids on relationships; and benefits of steroids. Candidate questionnaire items were tested and refined by piloting with patient research partners, iterative rounds of cognitive interviews and linguistic translatability assessment, informing a draft questionnaire. CONCLUSION: We describe an international qualitative study to develop candidate items for a treatment-specific PROM for patients with rheumatic diseases. A future survey will enable the validation of a final version of the PROM.

Health professionals' perspectives on psychological distress and meeting patients' support needs in rheumatology care settings: A qualitative study.

BACKGROUND: Patients with inflammatory rheumatic diseases (IRDs) face challenges including pain, fatigue and disease flares. Evidence suggests their levels of anxiety and depression are higher compared to the general population. Rheumatology teams report psychologically distressed patients have additional support needs and require more clinical time. Little is currently known about models of support and their integration into care pathways. AIM: To understand rheumatology health professionals' perspectives on patients' psychological distress and ways to meet support needs. METHODS: The study used a qualitative design, with data collected in telephone semi-structured interviews. Inductive thematic analysis was used to analyse the data. RESULTS: Fifteen interviews were conducted. Two main themes with sub-themes represent the data: Theme 1: 'No one shoe fits all'-the many manifestations of distress in patients (sub-themes: recognising distress, dealing with distress, dealing with life events alongside an IRD) and Theme 2: 'If rheumatology could be interwoven with psychological principles'-the need to attend to the psychological impact of IRDs, alongside the physical impact (sub-themes: priority given to physical health, working together to help patients in distress, how should patient distress be measured?, the need for extra time and resources). CONCLUSION: Distress can be obvious or hidden, cause issues for patients and health professionals and lead to poor engagement with care provision. Health professionals described the powerful link between physical and mental distress. This study suggests psychological support provision should be embedded within the rheumatology team and that patients' emotional wellbeing should be given equal priority to their physical wellbeing.

Informal caregiver training for people with chronic pain in musculoskeletal services (JOINT SUPPORT): protocol for a feasibility randomised controlled trial.

INTRODUCTION: Chronic musculoskeletal (bone, joint or muscle) pain is disabling. People with it frequently have difficulties in managing everyday activities. Individuals may rely on family members or friends to support them. These people are known as informal caregivers. No interventions have previously addressed the health needs of people with chronic musculoskeletal pain and their caregivers. In response, the JOINT SUPPORT programme was developed. In this study, we will assess the feasibility and acceptability of conducting a pragmatic, multicentre, randomised controlled trial (RCT) to test the clinical and cost-effectiveness of the JOINT SUPPORT programme to support these individuals. METHODS AND ANALYSIS: This will be a mixed-methods feasibility RCT. We will recruit 80 patients with chronic musculoskeletal pain with their informal caregivers. Patients will be randomised to usual National Health Service (NHS) care OR usual NHS care plus a caregiver-patient dyad training programme (JOINT SUPPORT). This programme comprises of five, 1-hour, group-based sessions for patients and caregivers, delivered by trained physiotherapists or occupational therapists. It includes developing skills in: understanding pain, pacing, graded activity, fear avoidance and goal-setting, understanding benefits of physical activity and skills in medication management. This will be re-enforced with a workbook. After the group-based sessions, patients and caregivers will be supported through three telephone sessions with a therapist. Data collected at baseline and 3 months will include: screening logs, intervention logs, fidelity checklists and clinical outcomes on quality of life, physical and emotional outcomes, adverse events and resource use. Qualitative research with 24 patient-caregiver dyads and 12 healthcare professionals will explore the acceptability of trial processes. Stop-go criteria will inform the progression to a full trial. ETHICS AND DISSEMINATION: Ethical approval was obtained on 22 February 2022 (National Research Ethics Committee Number: 22/NW/0015). Results will be reported at conferences, peer-review publications and across social media channels. TRIAL REGISTRATION NUMBER: ISRCTN78169443.

Remotely delivered cognitive behavioural and personalised exercise interventions for fatigue severity and impact in inflammatory rheumatic diseases (LIFT): a multicentre, randomised, controlled, open-label, parallel-group trial.

Background: Chronic fatigue is a poorly managed problem in people with inflammatory rheumatic diseases. Cognitive behavioural approaches (CBA) and personalised exercise programmes (PEP) can be effective, but they are not often implemented because their effectivenesses across the different inflammatory rheumatic diseases are unknown and regular face-to-face sessions are often undesirable, especially during a pandemic. We hypothesised that remotely delivered CBA and PEP would effectively alleviate fatigue severity and life impact across inflammatory rheumatic diseases. Methods: LIFT is a multicentre, randomised, controlled, open-label, parallel-group trial to assess usual care alongside telephone-delivered CBA or PEP against usual care alone in UK hospitals. Patients with any stable inflammatory rheumatic disease were eligible if they reported clinically significant, persistent fatigue. Treatment allocation was assigned by a web-based randomisation system. CBA and PEP sessions were delivered over 6 months by trained health professionals in rheumatology. Coprimary outcomes were fatigue severity (Chalder Fatigue Scale) and impact (Fatigue Severity Scale) at 56 weeks. The primary analysis was by full analysis set. This study was registered at ClinicalTrials.gov (NCT03248518). Findings: From Sept 4, 2017, to Sept 30, 2019, we randomly assigned and treated 367 participants to PEP (n=124; one participant withdrew after being randomly assinged), CBA (n=121), or usual care alone (n=122), of whom 274 (75%) were women and 92 (25%) were men with an overall mean age of 57·5 (SD 12·7) years. Analyses for Chalder Fatigue Scale included 101 participants in the PEP group, 107 in the CBA group, and 107 in the usual care group and for Fatigue Severity Scale included 101 in PEP, 106 in CBA, and 107 in usual care groups. PEP and CBA significantly improved fatigue severity (Chalder Fatigue Scale; PEP: adjusted mean difference -3·03 [97·5% CI -5·05 to -1·02], p=0·0007; CBA: -2·36 [-4·28 to -0·44], p=0·0058) and fatigue impact (Fatigue Severity Scale; PEP: -0·64 [-0·95 to -0·33], p<0·0001; CBA: -0·58 [-0·87 to -0·28], p<0·0001); compared with usual care alone at 56 weeks. No trial-related serious adverse events were reported. Interpretation: Telephone-delivered CBA and PEP produced and maintained statistically and clinically significant reductions in the severity and impact of fatigue in a variety of inflammatory rheumatic diseases. These interventions should be considered as a key component of inflammatory rheumatic disease management in routine clinical practice. Funding: Versus Arthritis.

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

Objective: Fatigue is a challenging feature of all inflammatory rheumatic diseases. LIFT (Lessening the Impact of Fatigue in inflammatory rheumatic diseases: a randomized Trial) included remotely delivered personalized 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 personalized exercise programme (PEP) and cognitive-behavioural approach (CBA) interventions took part in semi-structured telephone interviews. Results: Seventeen therapists (13 women and 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 for reference. 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 talk about their fatigue and challenge their beliefs. In 'Challenges in delivering the LIFT intervention', therapists struggled to work in partnership with patients who lacked motivation or stopped engaging. Finally, in 'LIFT developing clinical skills', therapists gained confidence and professional satisfaction, seeing patients' fatigue improve over time. Conclusion: The findings support the provision of training for rheumatology health professionals to remotely deliver fatigue-management interventions. Insights from these trials can be used to better improve clinical practice and service provision.

Acceptability of a brief fatigue intervention for inflammatory arthritis: a qualitative process evaluation.

Objectives: We developed a brief cognitive behavioural, one-to-one intervention to reduce fatigue impact for patients with inflammatory arthritis. This qualitative process evaluation explored intervention acceptability and potential refinements from the perspective of patients who attended sessions and rheumatology health professionals (RHPs) who delivered the intervention. Methods: Interviews were conducted with patients and RHPs from five National Health Service (NHS) sites. Data were analysed using inductive thematic analysis. Results: Twenty-two patients and 11 RHPs participated. Patient themes: Collaborative, non-judgemental consultations: patients valued having space to reflect, where their fatigue was validated. Relevant content, but not ground-breaking: patients appreciated the opportunity to tailor content to individual priorities. Daily diaries were useful to visualize fatigue. Self-awareness: patients reported increased acceptance, sense of control, and confidence to manage fatigue. Degrees of openness to change: sessions prompted patients to engage in behaviour change. For some, complicated lives made it difficult to plan for change. RHP themes: Engagement with intervention: RHPs liked training face to face, and sessions were more enjoyable with experience of delivery. Research vs clinical practice: RHPs expressed concern about fitting sessions into NHS clinic appointments. It was difficult to offer follow-up sessions within 2 weeks. Collaborating with patients: RHPs reported that patients engaged with the tools and strategies. Some RHPs followed the manual in a linear way, whereas others used it flexibly. Conclusion: There is potential for this brief fatigue intervention to benefit patients. Future research will focus on flexibility to fit with local services and creating educational resources to use in a range of contexts.

Remotely delivered cognitive-behavioural and personalized exercise interventions to lessen the impact of fatigue: a qualitative evaluation.

Objectives: Fatigue can be a disabling symptom of inflammatory rheumatic diseases. LIFT (Lessening the Impact of Fatigue in inflammatory rheumatic diseases: a randomized Trial) is a randomized trial of remotely delivered cognitive-behavioural approach or personalized exercise programme interventions, compared with usual care. The aim of this nested qualitative study was to evaluate participants' experiences of taking part in the intervention, including their ideas about future service delivery. Methods: Semi-structured telephone interviews were conducted with a subgroup of LIFT participants to discuss their views and experiences of the interventions. Results: Forty-three participants (30 women) from six sites who had participated in the cognitive-behavioural approach (n = 22) or personalized exercise programme (n = 21) interventions took part. Five themes were identified in the thematic analysis. In the theme 'not a miracle cure, but a way to better manage fatigue', LIFT could not cure fatigue; however, most felt better able to manage after participating. Participants valued 'building a therapeutic relationship' with the same therapist throughout the intervention. In 'structure, self-monitoring and being accountable', participants liked the inclusion of goal-setting techniques and were motivated by reporting back to the therapist.After taking part in the interventions, participants felt 'better equipped to cope with fatigue'; more confident and empowered. Lastly, participants shared ideas for 'a tailored programme delivered remotely', including follow-up sessions, video calling, and group-based sessions for social support. Conclusion: Many participants engaged with the LIFT interventions and reported benefits of taking part. This suggests an important future role for the remote delivery of fatigue self-management.