A feasibility randomised controlled trial of a Fibromyalgia Self-management Programme for adults in a community setting with a nested qualitative study (FALCON).

BACKGROUND: Fibromyalgia is a condition associated with widespread musculoskeletal pain, fatigue and sleep problems. Fibromyalgia treatment guidelines recommend non-pharmacological interventions and the development of self-management skills. An example of a programme that fits these guidelines is the Fibromyalgia Self-management Programme (FSMP) which consists of one 2.5-hour weekly session over six successive weeks and includes education about fibromyalgia, goal setting, pacing, sleep hygiene and nutritional advice. The FSMP is currently provided in a secondary care hospital setting and co-delivered by a multidisciplinary team. Delivery in a primary care setting has the potential to improve the accessibility of the programme to people with fibromyalgia. Therefore, this feasibility study aimed to determine the practicality and acceptability of conducting a future definitive randomised controlled trial of the FSMP in a community setting. METHOD: An exploratory, parallel-arm, one-to-one, randomised controlled trial. Participants were recruited from general practices across South West England, and the FSMP was co-delivered by physiotherapists and occupational therapists across two community sites. To determine the outcome measures for a future definitive trial several were tested. The Revised Fibromyalgia Impact Questionnaire, Arthritis Self-Efficacy Scale-8, Chalder Fatigue Scale, Short form 36, 5-Level EQ-5D version and Jenkins Sleep Scale were collected at baseline, 6 weeks and 6 months. Semi-structured interviews were conducted with patient participants, occupational therapists and physiotherapists to explore the acceptability and feasibility of delivering the FSMP in a community setting. RESULTS: A total of 74 participants were randomised to the FSMP intervention (n = 38) or control arm (n = 36). Attrition from the trial was 42% (31/74) at 6 months. A large proportion of those randomised to the intervention arm (34%, 13/38) failed to attend any sessions with six of the 13 withdrawing before the intervention commenced. The proportion of missing values was small for each of the outcome measures. Three overarching themes were derived from the interview data; (1) barriers and facilitators to attending the FSMP; (2) FSMP content, delivery and supporting documentation; and (3) trial processes. CONCLUSION: It is feasible to recruit people with fibromyalgia from Primary Care to participate in a randomised controlled trial testing the FSMP in a community setting. However, improvement in trial attrition and engagement with the intervention is needed. TRIAL REGISTRATION: The trial is registered with ISRCTN registry and was assigned on 29/04/2019. The registration number is ISRCTN10824225.

Foundational Research Could Improve Future Transcutaneous Electrical Nerve Stimulation Evaluations.

Background and objectives: There is a lack of good quality evidence regarding the effectiveness of transcutaneous electrical nerve stimulation (TENS) for chronic musculoskeletal pain, including chronic low back pain. High quality randomised controlled trials (RCTs) have been called for to establish effectiveness over and above placebo and some guidance has already been offered regarding the design of such trials. This article expands the discussion regarding the design of future TENS trials. There is qualitative evidence of the complexity of TENS as an intervention which should be considered in future TENS evaluations. This complexity includes multiple benefits reported by patients, depending on their chosen contexts of TENS use. The ideal content and delivery of support for patients to optimise TENS use also lacks consensus. There is no evidence that a TENS education package has been designed to support the complex set of behaviours and choices which experienced users suggest are required to optimise TENS benefits. Finally, clinical and research outcomes have not been contextualised and related to the specific strategies of use. Conclusions: We suggest that research is required to develop consensus about the content and delivery of training in TENS use for patients who live with pain, informed by the experience of patients, clinicians, and researchers. Once a consensus about the content of TENS training has been reached, there is then a need to develop a TENS training course (TTC) based on this content. An effective and acceptable TTC is needed to develop the knowledge and skills required to optimise TENS use, supporting patients to build confidence in using TENS in everyday life situations with the aim of reducing the impact of chronic pain on function and quality of life. Further research is required to extend the evidence base regarding appropriate, contextualised TENS patient-reported outcomes.

Management of fatigue with physical activity and behavioural change support in vasculitis: a feasibility study.

OBJECTIVE: Patients with ANCA-associated vasculitis (AAV) experience high levels of fatigue, despite disease remission. This study assessed the feasibility and acceptability of a definitive randomized controlled trial of a behavioural-based physical activity intervention to support fatigue self-management in AAV patients. METHODS: AAV patients in disease remission with fatigue (Multidimensional Fatigue Inventory-20 general fatigue domain ≥14) were randomly allocated to intervention or standard care in this single-centre open-label randomized controlled feasibility study. The intervention lasted 12 weeks and comprised eight face-to-face physical activity sessions with a facilitator and 12 weekly telephone calls. Participants were encouraged to monitor their physical activity using a tracker device (Fitbit). Standard care involved sign-posting to fatigue websites. The primary outcome was feasibility of a phase III trial assessed against three stop/go traffic light criteria, (recruitment, intervention adherence and study withdrawal). A qualitative study assessed participant views about the intervention. RESULTS: A total of 248 patients were screened and 134 were eligible to participate (54%). Stop/go criteria were amber for recruitment; 43/134 (32%, 95% CI: 24, 40) eligible participants randomized, amber for adherence; 73% of participants attended all eight physical activity sessions, but only 11/22 (50%, 95% CI: 29, 71%) completed the intervention as per the intended schedule, and green for study withdrawal; 2/43 participants withdrew before 24 weeks (5%, 95% CI: 0, 11). Qualitative results suggested the intervention was acceptable. CONCLUSION: This study suggests a behavioural-based physical activity intervention targeting fatigue self-management was acceptable to patients with AAV, although recruitment and protocol adherence will need modification prior to a definitive trial. CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN11929227.

The role of non-pharmacological interventions in the management of rheumatoid-arthritis-related fatigue.

Non-pharmacological interventions may be beneficial in the management of rheumatoid arthritis related fatigue. A narrative review was undertaken, with a focus upon research published in the past 6 years. Seven studies were identified, four focusing upon physical activity, two on psychosocial interventions and one that investigated aromatherapy and reflexology. Findings supported previous evidence that physical activity and psychosocial interventions have potential to produce small to moderate reductions in fatigue related to rheumatoid arthritis. Reflexology and aromatherapy interventions also appeared promising. Limitations to the evidence included lack of consistency in fatigue measurement, and minimal data on long-term outcomes and cost effectiveness. The wide range of physical activity interventions prevent specific recommendations. For psychosocial interventions the strongest evidence is for group-based cognitive behavioural approaches. There was lack of consideration given to fatigue mechanisms and intervention design. Due to the complexity of fatigue, future research exploring personalized approaches is warranted.

Physiotherapy outcome measures of haemophilia acute bleed episodes: What matters to patients?

INTRODUCTION: The research was conducted at a UK teaching hospital and Haemophilia Comprehensive Care Centre (CCC) as part of a research programme investigating physiotherapy for acute bleed management. AIM: The aim of the study was to understand the perspectives of people with haemophilia (PWH) on validated outcome measures (OM) and whether these measures capture changes relevant to them whilst recovering from an acute bleed episode. METHODS: Any person with haemophilia registered to the CCC who reported an acute bleed within the past 2 years was invited to participate. Semi-structured interviews or workshops (activity-focused discussions with small groups) were conducted with PWH who had received physiotherapy treatment in the previous two years. These were used to explore opinions of PWH of commonly used outcome measures. RESULTS: Eight male PWH participated, mean age 61 years, ranging between 39 and 71. Seven participants had severe haemophilia A and 1 had von Willebrands. Participants described numerical rating scales of pain as abstract and expressed a preference for verbal or visual descriptors. In relation to function, the men generally found haemophilia-specific OM to be more relevant. The EuroQol 5-Dimension 5-Level (EQ5D-5L) and Haemophilia and Exercise Project Test Questionnaire (HEP-Test-Q) were considered as good measures due to brevity and ability to capture relevant changes promptly. CONCLUSION: Participants in this study reported a preference for short OMs that allow them to reference their ability during the acute bleed episode in comparison with their normal function.

Developing a group intervention to manage fatigue in rheumatoid arthritis through modifying physical activity.

BACKGROUND: Fatigue is a major symptom of rheumatoid arthritis (RA). There is some evidence that physical activity (PA) may be effective in reducing RA fatigue. However, few PA interventions have been designed to manage fatigue and there is limited evidence of end-user input into intervention development. The aim of this research was to co-design an intervention to support self-management of RA fatigue through modifying PA. METHODS: A series of studies used mixed methodological approaches to co-design a fatigue management intervention focused on modifying PA based on UK Medical Research Council guidance, and informed by the Behaviour Change Wheel theoretical framework. Development was based on existing evidence, preferences of RA patients and rheumatology healthcare professionals, and practical issues regarding intervention format, content and implementation. RESULTS: The resulting group-based intervention consists of seven sessions delivered by a physiotherapist over 12 weeks. Each session includes an education and discussion session followed by supervised PA chosen by the participant. The intervention is designed to support modification and maintenance of PA as a means of managing fatigue. This is underpinned by evidence-based behaviour change techniques that might support changes in PA behaviour. Intervention delivery is interactive and aims to enhance capability, opportunity and motivation for PA. CONCLUSION: This study outlines stages in the systematic development of a theory-based intervention designed through consultation with RA patients and healthcare professionals to reduce the impact of RA fatigue. The feasibility of future evaluation of the intervention should now be determined.

The revised Bristol Rheumatoid Arthritis Fatigue measures and the Rheumatoid Arthritis Impact of Disease scale: validation in six countries.

Objective: To evaluate the Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ), the revised Bristol Rheumatoid Arthritis Numerical Rating Scales (BRAF-NRS V2) and the Rheumatoid Arthritis Impact of Disease (RAID) scale in six countries. Methods: We surveyed RA patients in France, Germany, The Netherlands, Spain, Sweden and the UK, including the HAQ, 36-item Short Form Health Survey (SF-36) and potential revisions of the BRAF-NRS coping and Spanish RAID coping items. Factor structure and internal consistency were examined by factor analysis and Cronbach's α and construct validity by Spearman's correlation. Results: A total of 1276 patients participated (76% female, 25% with a disease duration <5 years, median HAQ 1.0). The original BRAF-MDQ four-factor structure and RAID single-factor structure were confirmed in every country with ⩾66% of variation in items explained by each factor and all item factor loadings of 0.71-0.98. Internal consistency for the BRAF-MDQ total and subscales was a Cronbach's α of 0.75-0.96 and for RAID, 0.93-0.96. Fatigue construct validity was shown for the BRAF-MDQ and BRAF-NRS severity and effect scales, correlated internally with SF-36 vitality and with RAID fatigue (r = 0.63-0.93). Broader construct validity for the BRAFs and RAID was shown by correlation with each other, HAQ and SF-36 domains (r = 0.46-0.82), with similar patterns in individual countries. The revised BRAF-NRS V2 Coping item had stronger validity than the original in all analyses. The revised Spanish RAID coping item performed as well as the original. Conclusion: Across six European countries, the BRAF-MDQ identifies the same four aspects of fatigue, and along with the RAID, shows strong factor structure and internal consistency and moderate-good construct validity. The revised BRAF-NRS V2 shows improved construct validity and replaces the original.

Biologic interventions for fatigue in rheumatoid arthritis.

BACKGROUND: Fatigue is a common and potentially distressing symptom for patients with rheumatoid arthritis (RA), with no accepted evidence-based management guidelines. Evidence suggests that biologic interventions improve symptoms and signs in RA as well as reducing joint damage. OBJECTIVES: To evaluate the effect of biologic interventions on fatigue in rheumatoid arthritis. SEARCH METHODS: We searched the following electronic databases up to 1 April 2014: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Current Controlled Trials Register, the National Research Register Archive, The UKCRN Portfolio Database, AMED, CINAHL, PsycINFO, Social Science Citation Index, Web of Science, and Dissertation Abstracts International. In addition, we checked the reference lists of articles identified for inclusion for additional studies and contacted key authors. SELECTION CRITERIA: We included randomised controlled trials if they evaluated a biologic intervention in people with rheumatoid arthritis and had self reported fatigue as an outcome measure. DATA COLLECTION AND ANALYSIS: Two reviewers selected relevant trials, assessed methodological quality and extracted data. Where appropriate, we pooled data in meta-analyses using a random-effects model. MAIN RESULTS: We identified 32 studies for inclusion in this current review. Twenty studies evaluated five anti-tumour necrosis factor (anti-TNF) biologic agents (adalimumab, certolizumab, etanercept, golimumab and infliximab), and 12 studies focused on five non-anti-TNF biologic agents (abatacept, canakinumab, rituximab, tocilizumab and an anti-interferon gamma monoclonal antibody). All but two of the studies were double-blind randomised placebo-controlled trials. In some trials, patients could receive concomitant disease-modifying anti-rheumatic drugs (DMARDs). These studies added either biologics or placebo to DMARDs. Investigators did not change the dose of the latter from baseline. In total, these studies included 9946 participants in the intervention groups and 4682 participants in the control groups. Overall, quality of randomised controlled trials was moderate with a low to unclear risk of bias in the reporting of the outcome of fatigue. We downgraded the quality of the studies from high to moderate because of potential reporting bias (studies included post hoc analyses favouring reporting of positive result and did not always include all randomised individuals). Some studies recruited only participants with early disease. The studies used five different instruments to assess fatigue in these studies: the Functional Assessment of Chronic Illness Therapy Fatigue Domain (FACIT-F), Short Form-36 Vitality Domain (SF-36 VT), Visual Analogue Scale (VAS) (0 to 100 or 0 to 10) and the Numerical Rating Scale (NRS). We calculated standard mean differences for pooled data in meta-analyses. Overall treatment by biologic agents led to statistically significant reduction in fatigue with a standardised mean difference of -0.43 (95% confidence interval (CI) -0.38 to -0.49). This equates to a difference of 6.45 units (95% CI 5.7 to 7.35) of FACIT-F score (range 0 to 52). Both types of biologic agents achieved a similar level of improvement: for anti-TNF agents, this stood at -0.42 (95% CI -0.35 to -0.49), equivalent to 6.3 units (95% CI 5.3 to 7.4) on the FACIT-F score; and for non-anti-TNF agents, it was -0.46 (95% CI -0.39 to -0.53), equivalent to 6.9 units (95% CI 5.85 to 7.95) on the FACIT-F score. In most studies, the double-blind period was 24 weeks or less. No study assessed long-term changes in fatigue. AUTHORS' CONCLUSIONS: Treatment with biologic interventions in patients with active RA can lead to a small to moderate improvement in fatigue. The magnitude of improvement is similar for anti-TNF and non-anti-TNF biologics. However, it is unclear whether the improvement results from a direct action of the biologics on fatigue or indirectly through reduction in inflammation, disease activity or some other mechanism.

The biology of cancer-related fatigue: a review of the literature.

PURPOSE: Understanding the etiology of cancer-related fatigue (CRF) is critical to identify targets to develop therapies to reduce CRF burden. The goal of this systematic review was to expand on the initial work by the National Cancer Institute CRF Working Group to understand the state of the science related to the biology of CRF and, specifically, to evaluate studies that examined the relationships between biomarkers and CRF and to develop an etiologic model of CRF to guide researchers on pathways to explore or therapeutic targets to investigate. METHODS: This review was completed by the Multinational Association of Supportive Care in Cancer Fatigue Study Group-Biomarker Working Group. The initial search used three terms (biomarkers, fatigue, cancer), which yielded 11,129 articles. After removing duplicates, 9145 articles remained. Titles were assessed for the keywords "cancer" and "fatigue" resulting in 3811 articles. Articles published before 2010 and those with samples <50 were excluded, leaving 75 articles for full-text review. Of the 75 articles, 28 were further excluded for not investigating the associations of biomarkers and CRF. RESULTS: Of the 47 articles reviewed, 25 were cross-sectional and 22 were longitudinal studies. More than half (about 70 %) were published recently (2010-2013). Almost half (45 %) enrolled breast cancer participants. The majority of studies assessed fatigue using self-report questionnaires, and only two studies used clinical parameters to measure fatigue. CONCLUSIONS: The findings from this review suggest that CRF is linked to immune/inflammatory, metabolic, neuroendocrine, and genetic biomarkers. We also identified gaps in knowledge and made recommendations for future research.

Behaviour change interventions to promote physical activity in rheumatoid arthritis: a systematic review.

Research has shown that people who have rheumatoid arthritis (RA) do not usually participate in enough physical activity to obtain the benefits of optimal physical activity levels, including quality of life, aerobic fitness and disease-related characteristics. Behaviour change theory underpins the promotion of physical activity. The aim of this systematic review was to explore behaviour change interventions which targeted physical activity behaviour in people who have RA, focusing on the theory underpinning the interventions and the behaviour change techniques utilised using specific behaviour change taxonomy. An electronic database search was conducted via EBSCOhost, PubMed, Cochrane Central Register of Controlled Trials and Web of Science databases in August 2014, using Medical Subject Headings and keywords. A manual search of reference lists was also conducted. Randomised control trials which used behaviour change techniques and targeted physical activity behaviour in adults who have RA were included. Two reviewers independently screened studies for inclusion. Methodological quality was assessed using the Cochrane risk of bias tool. Five studies with 784 participants were included in the review. Methodological quality of the studies was mixed. The studies consisted of behaviour change interventions or combined practical physical activity and behaviour change interventions and utilised a large variety of behaviour change techniques. Four studies reported increased physical activity behaviour. All studies used subjective methods of assessing physical activity with only one study utilising an objective measure. There has been varied success of behaviour change interventions in promoting physical activity behaviour in people who have RA. Further studies are required to develop and implement the optimal behaviour change intervention in this population.

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.

Patient perspectives of general practice consultation for musculoskeletal disorders: A qualitative study.

BACKGROUND: Musculoskeletal disorders (MSKDs) are a significant reason for general practice consultations in the United Kingdom. Current models of care include consultation with a General Practitioner (GP) or a First Contact Physiotherapy Practitioner (FCPP). Evidence suggests that FCPP led care is safe, yet it is unknown whether patients share this belief. PURPOSE: To explore patients' perspectives of general practice consultation for MSKDs, including views on safety, satisfaction and recommendations for future practice. METHODS: A secondary data analysis utilising qualitative data from the Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) questionnaire completed by 426 general practice patients who consulted with a MSKD between December 2019 and October 2022. Responses to the question 'What changes, if any, would you suggest to your GP surgery to make sure that health care is provided safely?' were analysed using content analysis. RESULTS: 606 responses across three timepoints were analysed. Two themes and six subthemes were identified; views on safety and satisfaction (inherent trust in the system, provision of face-to-face appointments, prompt access to care, person-centred care) and recommendations for future practice (appointment system: prompt access to face-to-face appointments, delivery of care: co-ordinated and collaborative person-centred care). CONCLUSIONS: Patients commented that FCPP consultations provided quick and accurate diagnoses and targeted advice. Recommendations for future practice included prompt access to face-to-face appointments, phone calls to be answered more quickly, improved communication for test results and follow ups, patients to feel listened to with a more individualised approach, and better continuity of care.

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.

First Contact Physiotherapy: An evaluation of clinical effectiveness and costs.

BACKGROUND: First Contact Physiotherapy Practitioners (FCPPs) are embedded within general practice, providing expert assessment, diagnosis and management plans for patients with musculoskeletal disorders (MSKDs), without the prior need for GP consultation. AIM: To determine the clinical effectiveness and costs of FCPP-led compared to GP-led models of care. DESIGN AND SETTING: Multiple site case study design. UK GP practices. METHOD: General Practice sites were recruited representing three models: 1. GP-led care; 2. FCPPs who could not prescribe/inject (Standard (St)); 3. FCPPs who could prescribe/inject (Additional Qualifications (AQ)). Patient participants from each site completed clinical outcome data at baseline, 3 and 6 months. The primary outcome was the SF-36v.2 Physical Component Score (PCS). Healthcare usage was collected for 6 months. RESULTS: N=426 adults were recruited from 46 practices across the UK. Non-inferiority analysis showed no significant difference in physical function (SF36-PCS) across all three arms at 6 months (p=0.999). At 3 months a significant difference in numbers improving was seen between arms: 54.7% GP consultees; 72.4% FCPP-St, 66.4% FCPP-AQ; (p=0.037). No safety issues were identified. Following initial consultation, a greater proportion of patients received medication (including opioids) in the GP-led arm (44.7%) compared with FCPP-St (17.5%) and FCPP-AQ (22.8%); (p<0.001). NHS costs (initial consultation and over 6 months follow up) were significantly higher in the GP-led model (median £105.50) vs FCPP-St (£41) and FCPP-AQ (£44); (p<0.001). CONCLUSION: FCPP led models provide safe, clinically effective and cost-beneficial management for patients with MSKDs in general practice and reduced opioid use in this cohort.

Cancer-related fatigue and its impact on functioning.

This article presents the contrasting European and American perspectives on cancer-related fatigue (CRF) and its impact on functioning in cancer survivors. The content is presented in 3 sections: state of the art, intervention studies, and future areas of research, followed by a discussion. Gaps identified include a lack of understanding of the etiology, definition, and measurement of CRF. Models to guide the study of CRF, selection of biomarkers, and design of interventions are needed. There is overlap between Europe and the United States concerning the future directions for research and collaboration related to CRF. The authors suggest the need for international consensus regarding the defining features of CRF in cancer survivors to identify phenotypes, a harmonized measurement of CRF outcomes using instruments that have demonstrated measurement equivalence across languages and cultures, and interventions (including exercise, rehabilitation, and psychoeducational) that have been manualized to permit intervention fidelity across diverse contexts. Coordinated intercontinental efforts would increase understanding of the biological, psychological, and social mechanisms underlying CRF and assist in the design of future intervention studies as well as revisions to clinical guidelines.

Reliability and sensitivity to change of the Bristol Rheumatoid Arthritis Fatigue scales.

OBJECTIVE: To examine the reliability (stability) and sensitivity of the Bristol Rheumatoid Arthritis Fatigue scales (BRAFs) and patient-reported outcome measures (PROMs) developed to capture the fatigue experience. The Multi-Dimensional Questionnaire (BRAF-MDQ) has a global score and four subscales (Physical Fatigue, Living with Fatigue, Cognitive Fatigue and Emotional Fatigue), while three numerical rating scales (BRAF-NRS) measure fatigue Severity, Effect and Coping. METHODS: RA patients completed the BRAFs plus comparator PROMs. Reliability (study 1): 50 patients completed questionnaires twice. A same-day test-retest interval (minimum 60 min) ensured both time points related to the same 7 days, minimizing the capture of fatigue fluctuations. Reliability (study 2): 50 patients completed the same procedure with a re-worded BRAF-NRS Coping. Sensitivity to change (study 3): 42 patients being given clinically a single high dose of i.m. glucocorticoids completed questionnaires at weeks 0 and 2. RESULTS: The BRAF-MDQ, its subscales and the BRAF-NRS showed very strong reliability (r = 0.82-0.95). BRAF-NRS Coping had lower moderate reliability in both wording formats (r = 0.62, 0.60). The BRAF-MDQ, its subscales and the BRAF-NRS Severity and Effect were sensitive to change, with effect sizes (ESs) of 0.33-0.56. As hypothesized, the BRF-NRS Coping was not responsive to the pharmaceutical intervention (ES 0.05). Preliminary exploration suggests a minimum clinically important difference of 17.5% for improvement and 6.1% for fatigue worsening. CONCLUSION: The BRAF scales show good reliability and sensitivity to change. The lack of BRAF-NRS Coping responsiveness to medication supports the theory that coping with fatigue is a concept distinct from severity and effect that is worth measuring separately.

Non-pharmacological interventions for fatigue in rheumatoid arthritis.

BACKGROUND: Fatigue is a common and potentially distressing symptom for people with rheumatoid arthritis with no accepted evidence based management guidelines. Non-pharmacological interventions, such as physical activity and psychosocial interventions, have been shown to help people with a range of other long-term conditions to manage subjective fatigue. OBJECTIVES: To evaluate the benefit and harm of non-pharmacological interventions for the management of fatigue in people with rheumatoid arthritis. This included any intervention that was not classified as pharmacological in accordance with European Union (EU) Directive 2001/83/EEC. SEARCH METHODS: The following electronic databases were searched up to October 2012, Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; AMED; CINAHL; PsycINFO; Social Science Citation Index; Web of Science; Dissertation Abstracts International; Current Controlled Trials Register; The National Research Register Archive; The UKCRN Portfolio Database. In addition, reference lists of articles identified for inclusion were checked for additional studies and key authors were contacted. SELECTION CRITERIA: Randomised controlled trials were included if they evaluated a non-pharmacological intervention in people with rheumatoid arthritis with self-reported fatigue as an outcome measure. DATA COLLECTION AND ANALYSIS: Two review authors selected relevant trials, assessed risk of bias and extracted data. Where appropriate, data were pooled using meta-analysis with a random-effects model. MAIN RESULTS: Twenty-four studies met the inclusion criteria, with a total of 2882 participants with rheumatoid arthritis. Included studies investigated physical activity interventions (n = 6 studies; 388 participants), psychosocial interventions (n = 13 studies; 1579 participants), herbal medicine (n = 1 study; 58 participants), omega-3 fatty acid supplementation (n = 1 study; 81 participants), Mediterranean diet (n = 1 study; 51 participants), reflexology (n = 1 study; 11 participants) and the provision of Health Tracker information (n = 1 study; 714 participants). Physical activity was statistically significantly more effective than the control at the end of the intervention period (standardized mean difference (SMD) -0.36, 95% confidence interval (CI) -0.62 to -0.10; back translated to mean difference of 14.4 points lower, 95% CI -4.0 to -24.8 on a 100 point scale where a lower score means less fatigue; number needed to treat for an additional beneficial outcome (NNTB) 7, 95% CI 4 to 26) demonstrating a small beneficial effect upon fatigue. Psychosocial intervention was statistically significantly more effective than the control at the end of the intervention period (SMD -0.24, 95% CI -0.40 to -0.07; back translated to mean difference of 9.6 points lower, 95% CI -2.8 to -16.0 on a 100 point scale, lower score means less fatigue; NNTB 10, 95% CI 6 to 33) demonstrating a small beneficial effect upon fatigue. For the remaining interventions meta-analysis was not possible and there was either no statistically significant difference between trial arms or findings were not reported. Only three studies reported any adverse events and none of these were serious, however, it is possible that the low incidence was in part due to poor reporting. The quality of the evidence ranged from moderate quality for physical activity interventions and Mediterranean diet to low quality for psychosocial interventions and all other interventions. AUTHORS' CONCLUSIONS: This review provides some evidence that physical activity and psychosocial interventions provide benefit in relation to self-reported fatigue in adults with rheumatoid arthritis. There is currently insufficient evidence of the effectiveness of other non-pharmacological interventions.

Strategies to enhance physical activity in people with Rheumatoid Arthritis: A Delphi survey.

INTRODUCTION: Managing symptoms, resisting functional decline and maintaining health and independence are key motivators for people with Rheumatoid Arthritis (RA) who successfully engage with physical activity (PA). To inform PA support for people with RA the aim was to determine whether the broader RA population share similar beliefs and strategies regarding PA to those who report successful engagement. METHODS: A modified two-stage Delphi approach. 200 patients from four National Health Service rheumatology departments received a postal questionnaire containing statements relating to engagement with PA derived from prior interview data from physically active individuals with RA. Statements rated as agree or strongly agree by >50% of respondents were retained and the same respondents asked to rate and prioritize potential PA intervention components. Ethical approval: Oxford C Research Ethics Committee (ref 13/SC/0418). RESULTS: Questionnaire one received 49 responses (11 males, 37 females, 1 unknown), mean age 65 years (range 29-82). Low levels of PA were reported by 60% of respondents. Questionnaire two responses (n = 36) indicated that a PA intervention should include information about prevention of RA symptoms worsening and benefits of PA for joints; help participants to achieve improved pain management and a feeling of being in control of their RA. For PA maintenance it was important that medication controlled symptoms, and PA instructors understood RA to ensure safety. CONCLUSIONS: A key factor to consider when designing a PA intervention for people with RA is that education from a knowledgeable instructor should underpin programme delivery alongside effective medication. Programmes may need tailoring based on demographics; this should be explored in future studies.

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.

Understanding the role of allied health professional support workers with exercise qualifications in the delivery of the NHS Long Term Plan within allied health professional services in England.

Demand modelling for the allied health professionals (AHPs) workforce showed that significant expansion would be needed to successfully deliver on the National Health Service (NHS) Long Term Plan. The aim was to explore the use of AHP support workers with exercise qualifications in AHP services and to understand their current and potential role in NHS commissioned AHP services in England. The project had two phases and took place between October 2020 and January 2021. In phase one, an electronic survey was carried out to identify the scope and variation of exercise professionals working in AHP support roles in NHS commissioned services. Semi-structured interviews were conducted in phase two to gain further understanding about the experiences of those involved in AHP commissioned services. Survey data were analysed using descriptive statistics and interview data were qualitatively analysed using thematic analysis. Recorded interviews were transcribed and initially coded. Coding was then refined and themes were identified. Support workers with exercise qualifications made a valued contribution to AHP services and were considered cost-effective in delivering a specialised exercise intervention. AHP support workers contributed to a range of tasks relating to clinical exercise prescription. Collated data highlighted inconsistency in the way AHP support workers with exercise qualifications identified themselves, despite similar roles. Variation existed in the level of autonomy for AHP support workers with exercise qualifications, even within the same NHS Agenda for Change band. Attempts to manage this disparity involved numerous governance processes to ensure safe, high-quality healthcare in the context of delegation to support workers. Limited training and development opportunities and the lack of career progression for support workers were consistently acknowledged as a source of frustration and hindrance to individuals fulfilling their potential. AHP support workers with exercise qualifications have potential to positively impact service delivery providing added value to the NHS workforce.