Brief intervention to reduce fatigue impact in patients with inflammatory arthritis: design and outcomes of a single-arm feasibility study.

OBJECTIVES: Patients with inflammatory arthritis report that fatigue is challenging to manage. We developed a manualised, one-to-one, cognitive-behavioural intervention, delivered by rheumatology health professionals (RHPs). The Fatigue - Reducing its Effects through individualised support Episodes in Inflammatory Arthritis (FREE-IA) study tested the feasibility of RHP training, intervention delivery and outcome collection ahead of a potential trial of clinical and cost-effectiveness. METHODS: In this single-arm feasibility study, eligible patients were ≥18 years, had a clinician-confirmed diagnosis of an inflammatory arthritis and scored ≥6/10 on the Bristol Rheumatoid Arthritis Fatigue (BRAF) Numerical Rating Scale (NRS) Fatigue Effect. Following training, RHPs delivered two to four sessions to participants. Baseline data were collected before the first session (T0) and outcomes at 6 weeks (T1) and 6 months (T2). The proposed primary outcome was fatigue impact (BRAF NRS Fatigue Effect). Secondary outcomes included fatigue severity and coping, disease impact and disability, and measures of therapeutic mechanism (self-efficacy and confidence to manage health). RESULTS: Eight RHPs at five hospitals delivered 113 sessions to 46 participants. Of a potential 138 primary and secondary outcome responses at T0, T1 and T2, there were 13 (9.4%) and 27 (19.6%) missing primary and secondary outcome responses, respectively. Results indicated improvements in all measures except disability, at either T1 or T2, or both. CONCLUSIONS: This study showed it was feasible to deliver the intervention, including training RHPs, and recruit and follow-up participants with high retention. While there was no control group, observed within-group improvements suggest potential promise of the intervention and support for a definitive trial to test effectiveness.

Rheumatology patients' perceptions of patient activation and the Patient Activation Measure: A qualitative interview study.

INTRODUCTION: An important aspect of self-management is patient activation (the skills, abilities and confidence someone uses to actively manage their health). The dominant method of capturing patient activation is the Patient Activation Measure (PAM) which has been integrated into many aspects of clinical practice in musculoskeletal care. However, limited research has investigated how rheumatology patients understand and perform patient activation, and how closely their perceptions align with the PAM. METHODS: Seventeen patients from two rheumatology departments in South West England participated in semi-structured interviews at two timepoints. They discussed how they actively managed their health and their views on the PAM. Data on activation were analysed using framework analysis and data on the PAM were analysed using content analysis. RESULTS: Participants self-managed with determination, finding ways to make small, sustainable behaviour changes and effectively navigate the healthcare system. They reported the value of knowing what self-management techniques suited them individually and reported benefitting from positive perceptions of their own health and good social support. Participants noted that the PAM did not always capture the fluctuating nature of their inflammatory arthritis and the collaborative nature of healthcare. CONCLUSIONS: Patients' perceptions and experiences of patient activation covered a wide range of skills, behaviours and beliefs. However, these are not always captured by the PAM. Therefore, its use as a clinical tool is best accompanied by dialogue with patients to understand their self-management.

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 < 0.001) and the control interventions (-0.88 units; p < 0.004). Regression analysis showed a difference between treatment arms in favour of the RAFT programme [adjusted mean difference -0.59 units, 95% confidence interval (CI) -1.11 to -0.06 units; p = 0.03, effect size 0.36], and this was sustained over 2 years (-0.49 units, 95% CI -0.83 to -0.14 units; p = 0.01). At 26 weeks, further fatigue differences favoured the RAFT programme (BRAF-MDQ fatigue impact: adjusted mean difference -3.42 units, 95% CI -6.44 to - 0.39 units, p = 0.03; living with fatigue: adjusted mean difference -1.19 units, 95% CI -2.17 to -0.21 units, p = 0.02; and emotional fatigue: adjusted mean difference -0.91 units, 95% CI -1.58 to -0.23 units, p = 0.01), and these fatigue differences were sustained over 2 years. Self-efficacy favoured the RAFT programme at 26 weeks (Rheumatoid Arthritis Self-Efficacy Scale: adjusted mean difference 3.05 units, 95% CI 0.43 to 5.6 units; p = 0.02), as did BRAF-NRS coping over 2 years (adjusted mean difference 0.42 units, 95% CI 0.08 to 0.77 units; p = 0.02). Fatigue severity and other clinical outcomes were not different between trial arms and no harms were reported. Satisfaction with the RAFT programme was high, with 89% of patients scoring ≥ 8 out of 10, compared with 54% of patients in the control arm rating the booklet (p < 0.0001); and 96% of patients and 68% of patients recommending the RAFT programme and the booklet, respectively, to others (p < 0.001). There was no significant difference between arms for total societal costs including the RAFT programme training and delivery (mean difference £434, 95% CI -£389 to £1258), nor QALYs gained (mean difference 0.008, 95% CI -0.008 to 0.023). The probability of the RAFT programme being cost-effective was 28-35% at the National Institute for Health and Care Excellence's thresholds of £20,000-30,000 per QALY. Tutors felt that the RAFT programme's CB approaches challenged their usual problem-solving style, helped patients make life changes and improved tutors' wider clinical practice. LIMITATIONS: Primary outcome data were missing for 25 patients; the EQ-5D-5L might not capture fatigue change; and 30% of the 2-year economic data were missing. CONCLUSIONS: The RAFT programme improves RA fatigue impact beyond usual care alone; this was sustained for 2 years with high patient satisfaction, enhanced team skills and no harms. The RAFT programme is < 50% likely to be cost-effective; however, NHS costs were similar between treatment arms. FUTURE WORK: Given the paucity of RA fatigue interventions, rheumatology teams might investigate the pragmatic implementation of the RAFT programme, which is low cost. TRIAL REGISTRATION: Current Controlled Trials ISRCTN52709998. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 57. See the NIHR Journals Library website for further project information.

Rheumatoid arthritis (RA) is a lifelong inflammatory condition affecting multiple joints, with fatigue as a major consequence. Cognitive­behavioural therapy (CBT) helps patients work out links between symptoms, behaviours and thoughts driving those behaviours (e.g. why someone pushes on when exhausted), and understanding these links helps patients make changes. A CBT programme for groups of RA patients, facilitated by a psychologist, reduces fatigue impact. However, few rheumatology teams have psychologists. The study tested whether or not rheumatology nurses and occupational therapists (OTs) could facilitate the programme [named RAFT, i.e. Reducing Arthritis Fatigue by clinical Teams using cognitive­behavioural (CB) approaches] after brief training. The study compared the RAFT programme with usual care for RA fatigue (i.e. a short discussion of an arthritis fatigue booklet). All 333 patients received usual care, and then half of the patients were allocated (by chance) to also attend the seven-session RAFT programme. The study compared the RAFT programme with usual care for effects on fatigue, quality of life, cost and value for money. In addition, the rheumatology nurse and OT RAFT tutors were interviewed for their views on the RAFT programme. The study found that patients' fatigue impact was reduced by both the RAFT programme and usual care at 6 months and 2 years, but patients undertaking the RAFT programme improved significantly more than those receiving usual care alone. Differences were seen for improvements in fatigue impact, fatigue coping, emotional fatigue and living with fatigue. Patients were very satisfied with the RAFT programme and attended most of the sessions. The study found no significant difference between the NHS costs of the RAFT programme and usual care. Neither the RAFT programme nor usual care changed quality of life; therefore, standard value-for-money tests showed no difference between them. Tutors found that the CB questioning approach of the RAFT programme was different from their usual problem-solving style, but helped patients make life changes, and the new CB skills improved tutors' wider clinical practice. In conclusion, the trial has shown that the RAFT programme has a small to medium effect on reducing fatigue impact in patients with RA and is a potentially low-cost intervention that can be delivered by rheumatology nurses and OTs rather than a psychologist.

Diagnosis and initial management in psoriatic arthritis: a qualitative study with patients.

OBJECTIVES: PsA is an inflammatory condition that can cause pain, fatigue, swelling and joint stiffness. The consequences include impaired physical function, a high psychosocial burden, reduced quality of life and work disability. The presenting symptoms can be non-specific and varied, leading to delays in diagnosis or referral to specialist teams. The aim of this study was to explore patients' experiences of being diagnosed and the initial management of PsA. METHODS: The study used a qualitative design, with data collected in one-to-one, face-to-face semi-structured interviews. RESULTS: Fifteen newly diagnosed patients (<24 months) from three hospital sites in the southwest of England participated. Interviews were transcribed, anonymized and analysed using inductive thematic analysis. The following two main themes with sub-themes represent the data: symptom onset to specialist care: 'it was the blind leading the blind' (making sense of symptoms; mis-diagnosis and missed opportunities; and fast and easy access to expertise); and diagnosis as a turning point: 'having somebody say you've got something wrong with you, I was euphoric' (validation and reassurance; weighing up treatment options; taking on self-management; and acknowledging loss and change). CONCLUSION: Participants were already dealing with functional limitations and were highly distressed and anxious by the time they received their diagnosis. Physical and mental outcomes could be improved by the implementation of existing psoriasis management guidelines and strategies for earlier referral from primary care to rheumatology and by the development of guidelines on educational, self-management and psychological support provision soon after diagnosis.

Training and delivery of a novel fatigue intervention: a qualitative study of rheumatology health-care professionals' experiences.

OBJECTIVES: Successful, non-pharmacological research interventions are challenging to implement in clinical practice. The aim of the study was to understand the experiences of rheumatology nurses and occupational therapists (tutors) delivering a novel fatigue intervention in a trial setting, and their views on requirements for clinical implementation. After training, tutors delivered courses of a manualized group cognitive-behavioural intervention to patients with RA in a seven-centre randomized controlled trial [Reducing Arthritis Fatigue by clinical Teams using cognitive-behavioural approaches (RAFT)], which demonstrated reduced fatigue impact at 2 years. METHODS: Fourteen tutors participated in interviews, and eight tutors also participated in a focus group. Data were audio-recorded, transcribed and analysed using inductive thematic analysis. RESULTS: The following five main themes were identified: 'exciting but daunting' reflected the mixture of excitement and anxiety in intervention training and delivery; 'skills practice and demonstrations were essential' captured the value of learning and practising together, even though the process could be uncomfortable; 'an individual approach to a standardized intervention' showed how tutors negotiated adherence to the manual with delivery using their own words; 'becoming a better practitioner' described how participation enhanced tutors' wider clinical practice; and 'pragmatic and flexible' highlighted practical adaptations to facilitate training and intervention roll out. CONCLUSION: These insights inform strategies for clinical implementation of an evidence-based intervention that addresses a patient priority, with implications for other successful research interventions. Tutors believed that the skills acquired during RAFT enhanced their wider clinical practice, which highlights the benefits of upskilling members of clinical teams to provide self-management support to patients.

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.

Psychometric properties and cross-language equivalence of the revised Bristol Rheumatoid Arthritis Fatigue and the Rheumatoid Arthritis Impact of Disease scales in rheumatoid arthritis.

OBJECTIVE: To assess psychometric properties and cross-language measurement equivalence of six versions of the Bristol Rheumatoid Arthritis Fatigue Scale (BRAF-MDQ) and the Rheumatoid Arthritis Impact of Disease Score (RAID in rheumatoid arthritis (RA). METHODS: Both questionnaires were completed by French (n = 206), German (n = 206), Dutch (n = 317), Spanish (n = 157), Swedish (n = 170) and UK (n = 210) RA patients. The presence of cross-language differential item functioning (DIF) was examined using the generalized partial credit model. The impact of DIF on the item and total scores was examined by comparing DIF unadjusted and DIF adjusted expected item and scale scores. IRT-based methods were used to assess psychometric properties of the instruments. RESULTS: 11 of the 20 BRAF-MDQ (55%) and 4 of the 7 RAID items (57%) exhibited significant DIF in at least one of the six countries. The mean number of items with DIF per country was 2.6 for BRAF-MDQ and 1.1 for RAID. However, the impact of DIF on the total RAID and BRAF-MDQ scores, as well as the BRAF subscales, was found to be negligible at the group level. Only for the BRAF physical subscale was there evidence of minor DIF. Marginal reliabilities of BRAF-MDQ (0.93) and RAID (0.89) were excellent, and precise scores could be obtained across the spectrum of disease impact and fatigue scores measured by these PROMs. CONCLUSION: This study supports the cross-language measurement equivalence of BRAF-MDQ and RAID and provides further support for the psychometric properties of these measures in RA.

Investigating Dimensions of Stiffness in Rheumatoid and Psoriatic Arthritis: The Australian Rheumatology Association Database Registry and OMERACT Collaboration.

OBJECTIVE: It is not known how the experience of stiffness varies between diagnoses or how best to measure stiffness. The aims of our study were to (1) compare stiffness in psoriatic arthritis (PsA) and rheumatoid arthritis (RA) using patient-reported outcomes, (2) investigate how dimensions of stiffness are associated with each other and reflect the patient experience, and (3) analyze how different dimensions of stiffness are associated with physical function. METHODS: An online survey was sent to Australian Rheumatology Association Database participants (158 PsA, and 158 age- and sex-matched RA), assessing stiffness severity, duration, impact, importance, coping, and physical function [modified Health Assessment Questionnaire (mHAQ)]. Scores were compared between diagnoses and correlations among stiffness dimensions calculated. Multivariate regression was performed for stiffness severity, impact, and duration on mHAQ, adjusting for age, sex, disease duration, obesity, and pain. Cognitive debriefing was conducted through semistructured telephone interviews. RESULTS: Overall, 240/316 (75.9%) responded [124/158 RA (78.5%) and 116/158 PsA (73.4%)], with no significant difference in stiffness ratings between diagnoses. Scores for all stiffness dimensions were strongly correlated (r = 0.52-0.89), and severity and impact were associated with mHAQ in both diagnoses. Stiffness duration was not associated with mHAQ in RA. In cognitive debriefing, participants described stiffness severity and impact by their effect on daily activities (10/16 and 14/16 participants, respectively). CONCLUSION: Stiffness ratings were similar between PsA and RA. Different dimensions of stiffness were strongly correlated. Stiffness severity and impact both independently predicted mHAQ. Stiffness was important to participants; however, measuring multiple dimensions of stiffness may have minimal additive value.

Correction to: Important Treatment Outcomes for Patients with Psoriatic Arthritis: A Multisite Qualitative Study.

The Open Access license, which previously read.

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

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 (p<0.0001). CONCLUSION: Multiple RA fatigue impacts can be improved for 2 years by rheumatology teams delivering a group programme using cognitive behavioural approaches. TRIAL REGISTRATION NUMBER: ISRCTN52709998.

Protocol for a multicentre randomised controlled parallel-group trial to compare the effectiveness of remotely delivered cognitive-behavioural and graded exercise interventions with usual care alone to lessen the impact of fatigue in inflammatory rheumatic diseases (LIFT).

INTRODUCTION: Fatigue remains pervasive, disabling and challenging to manage across all inflammatory rheumatic diseases (IRDs). Non-pharmacological interventions, specifically cognitive-behavioural approaches (CBAs) and graded exercise programmes designed to support and increase exercise, are valuable treatments which help patients with IRD to manage their fatigue. Yet, healthcare systems have encountered substantial barriers to the implementation of these therapeutic options. Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases: a Randomised Trial (LIFT) is designed to give insights into the effectiveness of a remotely delivered standardised intervention for a range of patients with IRD. It will also enable the exploration of putative moderating factors which may allow for the future triage of patients and to investigate the precise mediators of treatment effect in IRD-related fatigue. METHODS AND ANALYSIS: LIFT is a pragmatic, multicentre, three-arm randomised, controlled trial, which will test whether adapted CBA and personalised exercise programme interventions can individually reduce the impact and severity of fatigue. This will be conducted with up to 375 eligible patients diagnosed with IRD and interventions will be delivered by rheumatology healthcare professionals, using the telephone or internet-based audio/video calls. ETHICS APPROVAL AND DISSEMINATION: Ethical approval has been granted by Wales REC 7 (17/WA/0065). Results of this study will be disseminated through presentation at scientific conferences and in scientific journal. A lay summary of the results will be sent to participants. TRIAL REGISTRATION NUMBER: NCT03248518; Pre-results.

Dose reduction of biologic therapy in inflammatory arthritis: A qualitative study of patients' perceptions and needs.

OBJECTIVE: Successful biologic disease-modifying anti-rheumatic drug (bDMARD) dose reduction appears increasingly possible from clinical trials. The present study aimed to understand the patient perspective of bDMARD dose reduction. METHODS: Patients with rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis who were self-administering subcutaneous bDMARDs therapy at two National Health Service trusts participated in semi-structured interviews. To capture multiple experiences, patients were purposefully sampled for a range of age, gender, disease duration, reducing/not reducing bDMARDs and either within 3-12 months of bDMARD initiation or ≥12 months and in remission/low disease activity. Inductive thematic analysis was utilized. RESULTS: Fifteen patients were interviewed (six on dose reduction). Five overarching themes were identified. When thinking about dose reduction, patients reflected on their difficult life before bDMARDs ("Where I was then") compared with their transformative effects ("Where I am now"). All raised concerns that a dose reduction would take them back to where they used to be ("Fears for the future") and most believed it to be a cost-cutting exercise. Most had "Hopes for the future", that a reduction would lower their risk of side effects, and release funds for other patients. They wanted a clear rationale for reduction, collaborative decision making, and control over flexible dosing ("Information needs"). CONCLUSION: Patients were fearful of reducing the dose of their bDMARDs, having previously experienced uncontrollable symptoms. However, most were willing to try, provided that there was a clear rationale and that it was in their best interests, with opportunities for collaboration and dose control. These patient perspectives will inform the provision of patient information to guide clinical discussions.

The Portuguese Rheumatoid Arthritis Impact of Disease (RAID) score and its measurement equivalence in three countries: validation study using Rasch Models.

PURPOSE: The Rheumatoid Arthritis Impact of Disease (RAID) score assesses seven impact domains of interest for people with RA. This study aimed to test patients' understanding of the Portuguese RAID and evaluate its cross-cultural validity for use in Portugal. METHODS: This was a mixed methods study comprising two phases: (i) cognitive debriefing to determine patient's comprehension of the Portuguese RAID and (ii) cross-cultural validation using Rasch analysis. Construct validity was determined by fit to the model, invariance culture (compared with France and UK datasets) and evidence of convergent and divergent validity. RESULTS: Patients' input (n = 38) led to minor changes in the phrasing of two items to ensure conceptual equivalence between the Portuguese and the original RAID. In Rasch analysis (n = 288), two items 'Sleep' and 'Physical well-being' in the Portuguese dataset did not adequately fit the model specifications, suggesting multidimensionality (sleep-not necessarily associated with RA) and redundancy (physical well-being overlapping with functional disability). Despite the imperfections, the scale had high internal consistency, evidence of convergent and divergent validity and invariance to culture (compared to France n = 195 and UK n = 205 datasets). The scale was well targeted for patients with different levels of disease impact. CONCLUSIONS: The RAID has been successfully adapted into Portuguese and it can be used with confidence in clinical practice. Further research will be required to ensure it captures the full range of sleep problems in RA. Meanwhile, data across the three countries (Portugal, France and the UK) are comparable except for the two items (sleep and physical well-being).

Multinational Qualitative Research Study Exploring the Patient Experience of Raynaud's Phenomenon in Systemic Sclerosis.

OBJECTIVE: Raynaud's phenomenon (RP) is the most common manifestation of systemic sclerosis (SSc). RP is an episodic phenomenon, not easily assessed in the clinic, leading to reliance on self-report. A thorough understanding of the patient experience of SSc-RP is essential to ensuring that patient-reported outcome (PRO) instruments capture domains important to the target patient population. We report the findings of an international qualitative research study investigating the patient experience of SSc-RP. METHODS: Focus groups of SSc patients were conducted across 3 scleroderma centers in the US and UK, using a topic guide and a priori purposive sampling framework devised by qualitative researchers, SSc patients, and SSc experts. Focus groups were audio recorded, transcribed, anonymized, and analyzed using inductive thematic analysis. Focus groups were conducted until thematic saturation was achieved. RESULTS: Forty SSc patients participated in 6 focus groups conducted in Bath (UK), New Orleans (Louisiana), and Pittsburgh (Pennsylvania). Seven major themes were identified that encapsulate the patient experience of SSc-RP: physical symptoms, emotional impact, triggers and exacerbating factors, constant vigilance and self-management, impact on daily life, uncertainty, and adaptation. The interrelationship of the 7 constituent themes can be arranged within a conceptual map of SSc-RP. CONCLUSION: We have explored the patient experience of SSc-RP in a diverse and representative SSc cohort and identified a complex interplay of experiences that result in significant impact. Work to develop a novel PRO instrument for assessing the severity and impact of SSc-RP, comprising domains/items grounded in the patient experiences of SSc-RP identified in this study, is underway.

Exploring the illness representations of people with psoriatic arthritis: a secondary analysis of focus group data.

BACKGROUND: PsA is an inflammatory arthritis associated with psoriasis, affecting the joints and connective tissue. According to the common-sense model (CSM), patients develop illness beliefs when faced with new symptoms, which determine their emotional and behavioural response to the condition. The CSM includes five beliefs: identity, consequence, cause, time line and control. These are important determinants of outcomes and have been shown to influence adherence to medication. METHODS: A secondary analysis of eight focus groups held across five hospital sites and including 41 participants was undertaken. Participants were sampled for a range of phenotypes and domains of disease activity: men = 20 and women = 21; mean (s.d.): age = 58 (11.4) years; disease duration = 9 (8.3) years; and HAQ = 1 (0.7). RESULTS: The analysis provided evidence to support the existence of the five illness beliefs among patients with PsA and evidence that these representations affected the way patients engaged with their condition. The results showed that many participants experienced high levels of uncertainty in relationship to the illness representation. The role of external social and environmental factors was also shown to influence participants' illness representations and the way they made sense of their PsA. CONCLUSION: This research highlights a new theme of uncertainty within illness representations and how this impacts on the way in which people living with PsA manage their condition. A greater understanding of the uncertainty that patients might have about their condition and its treatment could provide clinicians with an opportunity to address misinformed illness representations.

Coping Strategies, Psychological Impact, and Support Preferences of Men With Rheumatoid Arthritis: A Multicenter Survey.

OBJECTIVE: To investigate the existence and distribution of 2 typologies (termed "factors") of men with rheumatoid arthritis (RA) identified through our previous Q-methodology study (n = 30) in a larger sample of men with RA, and whether differences in psychosocial impact or support preferences exist between the 2 factors, and between men and women with RA. METHODS: A postal survey was sent to 620 men with RA from 6 rheumatology units across England, and the support preferences section of the survey was given to 232 women with RA. RESULTS: A total of 295 male patients (47.6%) and 103 female patients (44.4%) responded; 15 male participants had missing data, and thus 280 were included in the analysis. Of these, 61 (22%) were assigned to factor A ("accept and adapt"), 120 (35%) were assigned to factor B ("struggling to match up"), and 99 (35%) were unassigned. The two factors differed significantly, with factor B reporting more severe disease, less effective coping strategies, and poorer psychological status. For support, men favored a question and answer session with a consultant (54%) or specialist nurse (50%), a website for information (69%), a talk by researchers (54%), or a symptom management session (54%). Overall, women reported more interest in support sessions than men, with ≥50% of women reporting interest in nearly every option provided. CONCLUSION: Some men accept and adapt to their RA, but others (43%) report severe disease, less effective coping, and poor psychological status. Men's preferences for support are practical, with a focus on expanding their knowledge.

Development and testing of candidate items for inclusion in a new rheumatoid arthritis stiffness patient-reported outcome measure.

Objective: To qualitatively develop and test a set of candidate items for a new RA stiffness patient-reported outcome measure (PROM) that capture the patient perspective. This is an essential first step in PROM development, prior to quantitative development, assessment and validation. Methods: Focus groups further examined the previously developed stiffness conceptual model and explored the patient perspective regarding stiffness assessment. Data were analysed using thematic analysis. An iterative process of item development was then performed by the expert study team of researchers, patients and clinicians, based on the two qualitative datasets and informed by measurement theory and guidelines. Finally, these candidate items were tested using formal cognitive interview methodology and subsequently refined. Results: Sixteen RA patients from the UK participated in focus groups. Data confirmed the conceptual model of the RA patient experience of stiffness and provided insight into stiffness assessment, including suggestions regarding patient-relevant stiffness assessment categories such as impact, location and timing. These data informed the development of 77 candidate stiffness PROM items, including multiple formats for some. Eleven RA patients participated in cognitive interviews. Minor changes were made to items to enhance understanding and 32 items were removed, resulting in 45 candidate PROM items. Conclusion: Rigorous qualitative methodology and considerable patient involvement has underpinned items for a new RA stiffness PROM with strong content validity. Crucially, patient involvement broadened assessment beyond early morning stiffness duration, which may address existing PROM limitations. Items are now suitable for quantitative item reduction, structural development of the final PROM and validation.

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.

'Everyone assumes a man to be quite strong': Men, masculinity and rheumatoid arthritis: A case-study approach.

Current literature has overlooked the impact of chronic illness on masculine identity. We therefore aimed to investigate the impact of rheumatoid arthritis (a long term condition, affecting more women than men) on masculine identity. Six focus groups with 22 men with rheumatoid arthritis (RA) (data reported elsewhere) followed by five one-to-one interviews with men (English, mean age: 59 years) sampled to reflect a heterogeneous experience of life with RA based on knowledge gained from the focus groups. Transcripts were analysed using thematic analysis and are presented as individual case studies. Whilst the case studies provide five distinct experiences, common themes can be drawn across them, such as the importance of paid work. The men needed to renegotiate their masculine identity to deal with their RA. Two dealt with this by pushing through pain to retain masculine activities, two replaced masculine roles they could no longer do with other roles, and one rejected masculinity completely. Men with long term conditions may need to re-write their masculinity scripts to enable them to accept and adapt to their condition. However, some men struggle with this, which should be taken into consideration when designing self-management services for men with long term conditions.

Prevalence, impact and care of foot problems in people with rheumatoid arthritis: results from a United Kingdom based cross-sectional survey.

BACKGROUND: Foot symptoms in rheumatoid arthritis (RA) derive from a combination of inflammation, altered foot mechanics, deformity and secondary skin lesions. Guidelines recommend regular review of patients' feet, but the extent to which the general population of RA patients report foot symptoms and access foot care has not been established. The aims of this study were to determine the prevalence, impact and care of foot problems in all patients with RA in one geographical area and identify factors associated with accessing foot care. METHODS: Cross-sectional survey of a random sample of patients with RA, who resided within a single community-based National Health Service (NHS) podiatry service. The questionnaire collected demographic data (age, gender, local deprivation score), clinical data (disease duration, arthritis medications, disability (Health Assessment Questionnaire (HAQ)), current foot problems, foot care accessed (podiatry, orthotics and/or orthopaedics) and care received, measures of impact (Foot Impact Scale) and ability to work. RESULTS: Of 1003 total eligible patients in the target population, 739 were posted survey packs. Of these 413 (56%) replied. Responders and non-responders had similar age (63.5 yr. vs.61.5 yr), gender (74.1%F vs. 75.2%F), and highest deprivation category (13.3% vs.15.9%). Of the responders 92.1% reported current foot problems: articular 73.8%, cutaneous lesions 65.4%, structural 57.6%, extra-articular 42.6%. Responders' median (IQR) disease duration 10 (5-20) years, HAQ 1.5 (0.75-2.0), FISIF 10 (6-14) and FISAP 16 (7-23) and 37.8% reported impacts on work. While 69.5% had accessed foot care there were differences in the route of access (by gender and whether independent or NHS provision) and were older (64.9 yr. vs 60.4 yr. p = 0.001), had longer disease duration (12 yr. vs 7 yr. p < 0.001) and had a greater proportion of females (72.2% vs 61.7% p = 0.04) than those who had not accessed care. CONCLUSIONS: Current foot problems were reported by 92.1% of the study sample and substantially impacted on life and work. While overall access to foot care was higher than anticipated, routes of access differed and extent of current problems suggests the provision of effective, timely and targeted care is a pressing need.