Effectiveness of a novel digital patient education programme to support self-management of early rheumatoid arthritis: a randomised controlled trial.

OBJECTIVES: To evaluate the effectiveness of a novel digital patient education (PE) programme in improving self-management in patients newly diagnosed with rheumatoid arthritis (RA). METHODS: This was a parallel, open-label, two arms, randomised controlled trial with superiority design. Patients from five rheumatology clinics were randomised into digital PE (intervention) or face-to-face PE (control). The primary outcome was self-efficacy, measured by average difference in the Rheumatoid Arthritis Self-Efficacy (RASE) score from baseline to month 12. Secondary outcomes were RA knowledge, health literacy, adherence, and quality of life. Healthcare utilisation data and digital PE programme usage were recorded. Self-efficacy, knowledge, and health literacy data were analysed using mixed-effects repeated measures modelling; adherence using logistic regression, and quality of life and healthcare utilization using descriptive statistics with the Wilcoxon rank-sum test. RESULTS: Of the 180 patients randomised (digital PE, n = 89; face-to-face PE, n = 91), 175 had data available for analysis. Median age was 59.0 years, and 61% were women. The average difference in self-efficacy between groups from baseline to month 12 was significant by a -4.34 difference in RASE score, favouring the intervention group (95%CI -8.17 to -0.51; p= 0.026). RA knowledge, health literacy, and quality of life showed minor improvements over time but no difference between groups, except out-patient clinic contacts which were fewer in the intervention group. CONCLUSIONS: The findings suggest that digital PE is effective in improving self-efficacy and therefore self-management in patients with early RA. This intervention has potential to lower healthcare costs by decreasing out-patient clinic contacts. TRIAL REGISTRATION NUMBER: clinicaltrials.gov, NCT04669340.

Personalised care packages for people with rheumatoid arthritis: a mixed-methods study.

OBJECTIVES: Disease management in rheumatoid arthritis (RA) requires holistic assessment. We aimed to design personalised care packages suitable for people with RA. METHODS: This study was conducted using a mixed-methods approach and exploratory sequential design. Consensus workshops were held, involving people with RA and healthcare professionals (HCPs) treating them. Subsequently, an online survey sought views on future care packages for people with RA at relevant disease progression/stages, based on (1) results from previous quantitative data analyses (eg, socioeconomic/clinical factors), and (2) themes identified during workshops. RESULTS: Two conceptual care pathways were identified: (1) around the time of RA diagnosis, an early opportunity to influence the disease course; (2) for individuals with established RA, emphasising the importance of 'the right MDT member at the right time'.Three care packages were suggested: (1) early care package (around RA diagnosis): introduction to MDT; (2) continuity of care package (established RA): primary/secondary providers; and (3) personalised holistic care package: integral to packages 1 and 2, implemented alongside allied health professionals.The survey received 41 responses; 82.9% agreed that people with RA need a consistent 'early care package' at diagnosis. 85.4% approved of additional care packages tailored to individuals' clinical, psychological and social needs when moving to different stages of their long-term disease. Fleiss' Kappa calculations demonstrated fair level of agreement among respondents. CONCLUSION: Two care pathways, with three tailored care packages, were identified, with potential to improve management of people with RA. Future research will help to determine if such care packages can impact clinical (including patient-reported) outcomes.

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.

Nurse-led care for people with early rheumatoid arthritis: Interview study with thematic analysis.

AIMS: To develop an understanding of what comprises nurse-led care in early rheumatoid arthritis from the perspective of rheumatology nurse specialists in England. DESIGN: Qualitative study. METHODS: Semi-structured telephone interviews with rheumatology nurse specialists in England were conducted in Summer 2020. Interviews were audio-recorded, transcribed verbatim and analysed using reflexive thematic analysis. Reporting follows the appropriate elements of consolidated criteria for reporting qualitative research. RESULTS: Sixteen nurses were recruited and interviews lasted 30-60 min. Four themes with 14 subthemes were identified. A SPECIALIST SERVICE DELIVERED BY EXPERIENCED RHEUMATOLOGY NURSES: Specialist care is provided by experienced nurse specialists with a high degree of autonomy in the rheumatology multidisciplinary team context. ADDRESSING PATIENTS' COMPLEX CARE NEEDS: Care is evidence-based and aims to start treatment, keep in treatment, educate and support. Access to psychology expertise is needed. CARE WITH COMPASSION USING PERSON-CENTRED, HOLISTIC AND EMPATHETIC APPROACHES: Nurses create patient relationships and a positive therapeutic environment. Nurse-led telephone advice lines are essential for treatment adjustment, patient support and empowerment. CONTINUED EVALUATION AND DEVELOPMENT OF THE SERVICE: Consultations are reviewed, and patients are asked for feedback. The COVID-19 pandemic caused disruption, but changes streamlined procedures and improved documentation and communication. CONCLUSION: Nurse-led care in early rheumatoid arthritis is a specialist service delivered with compassion, addressing complex care needs and using person-centred approaches. This study identifies key aspects of care in early disease from the nurse perspective.

Access to Chronic Pain Services for Adults from Minority Ethnic Groups in the United Kingdom (UK): a Scoping Review.

BACKGROUND: Chronic pain services in the UK are required to provide services which meet the diverse needs of patients, but little is known about the access and use of these services by minority ethnic groups. OBJECTIVE: To assess the available evidence regarding the ethnic profile of adults who access secondary and tertiary chronic pain services in the UK. METHODS: A scoping review was conducted (August 2021-October 2021), comprising comprehensive literature searches using Embase, Medline and CINAHL databases and the grey literature. Studies were included if they reported on (i) access to chronic pain services in secondary and/or tertiary care in the UK, (ii) adults and (iii) stated the ethnicity of the involved participants. Studies were included if published between 2004 and 2021, as demographic data during this period would be broadly representative of the UK population, as per the 2021 UK census. A descriptive synthesis of the extracted data was performed. RESULTS: The search yielded 124 records after duplicates were removed. Following title and abstract screening, 44 full texts were screened, ten of which were included in the review. CONCLUSIONS: This is the first review to explore access to chronic pain services for adults from minority ethnic groups in the UK. Given the limited number of studies that met the inclusion criteria, the review highlights the need for routine collection of ethnicity data using consistent ethnic categories within UK chronic pain services and increased involvement of minority ethnic groups within chronic pain research. Findings should inform future research that aims to improve access to UK chronic pain services for adults from minority ethnic groups.

EULAR recommendations for the non-pharmacological management of systemic lupus erythematosus and systemic sclerosis.

OBJECTIVE: To develop evidence-based recommendations for the non-pharmacological management of systemic lupus erythematosus (SLE) and systemic sclerosis (SSc). METHODS: A task force comprising 7 rheumatologists, 15 other healthcare professionals and 3 patients was established. Following a systematic literature review performed to inform the recommendations, statements were formulated, discussed during online meetings and graded based on risk of bias assessment, level of evidence (LoE) and strength of recommendation (SoR; scale A-D, A comprising consistent LoE 1 studies, D comprising LoE 4 or inconsistent studies), following the European Alliance of Associations for Rheumatology standard operating procedure. Level of agreement (LoA; scale 0-10, 0 denoting complete disagreement, 10 denoting complete agreement) was determined for each statement through online voting. RESULTS: Four overarching principles and 12 recommendations were developed. These concerned common and disease-specific aspects of non-pharmacological management. SoR ranged from A to D. The mean LoA with the overarching principles and recommendations ranged from 8.4 to 9.7. Briefly, non-pharmacological management of SLE and SSc should be tailored, person-centred and participatory. It is not intended to preclude but rather complement pharmacotherapy. Patients should be offered education and support for physical exercise, smoking cessation and avoidance of cold exposure. Photoprotection and psychosocial interventions are important for SLE patients, while mouth and hand exercises are important in SSc. CONCLUSIONS: The recommendations will guide healthcare professionals and patients towards a holistic and personalised management of SLE and SSc. Research and educational agendas were developed to address needs towards a higher evidence level, enhancement of clinician-patient communication and improved outcomes.

Educational readiness among health professionals in rheumatology: low awareness of EULAR offerings and unfamiliarity with the course content as major barriers-results of a EULAR-funded European survey.

BACKGROUND: Ongoing education of health professionals in rheumatology (HPR) is critical for high-quality care. An essential factor is education readiness and a high quality of educational offerings. We explored which factors contributed to education readiness and investigated currently offered postgraduate education, including the European Alliance of Associations for Rheumatology (EULAR) offerings. METHODS AND PARTICIPANTS: We developed an online questionnaire, translated it into 24 languages and distributed it in 30 European countries. We used natural language processing and the Latent Dirichlet Allocation to analyse the qualitative experiences of the participants as well as descriptive statistics and multiple logistic regression to determine factors influencing postgraduate educational readiness. Reporting followed the Checklist for Reporting Results of Internet E-Surveys guideline. RESULTS: The questionnaire was accessed 3589 times, and 667 complete responses from 34 European countries were recorded. The highest educational needs were 'professional development', 'prevention and lifestyle intervention'. Older age, more working experience in rheumatology and higher education levels were positively associated with higher postgraduate educational readiness. While more than half of the HPR were familiar with EULAR as an association and the respondents reported an increased interest in the content of the educational offerings, the courses and the annual congress were poorly attended due to a lack of awareness, comparatively high costs and language barriers. CONCLUSIONS: To promote the uptake of EULAR educational offerings, attention is needed to increase awareness among national organisations, offer accessible participation costs, and address language barriers.

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.

Validation of the Korean Leeds satisfaction questionnaire in rheumatoid arthritis with Rasch models.

OBJECTIVES: We conducted the cross-cultural adaptation and validation of the Leeds Satisfaction Questionnaire (LSQ) for patients with rheumatoid arthritis (RA) in Korea. METHODS: The adaptation of the LSQ from English into Korean was based on guidelines for cross-cultural adaptation for self-report measures. Patients with RA were recruited from an outpatient clinic of a university hospital in South Korea. Validation of the Korean-LSQ with Rasch models was carried out using WINSTEPS. Model fit was determined by Infit and Outfit statistics (≥0.50 and ≤1.50), including the separation index (≥2.00) and reliability index (≥0.80). RESULTS: The data set comprised 125 patients (82.4% female), with median (interquartile range) age 49.0 (37-57) years, and disease duration of 2.5 (1.2-3.8) years. The total and subscale scores of the Korean-LSQ demonstrated excellent or good test-retest reliability (0.88 for total, 0.71-0.82 for subscales), and items in the scale also revealed a high internal consistency (α = 0.93). The six subscales of the Korean-LSQ were found to have a good fit to the Rasch model and good reliability (Person separation index = 2.63 and reliability index = 0.87; item separation index = 37.03 and reliability index >0.99). In addition, the unidimensionality of the scale was confirmed by the principal component analysis based on the Rasch residuals. CONCLUSION: Fit to the Rasch model confirmed that the construct validity, reliability, and unidimensionality of the LSQ were preserved following the adaptation into Korean. The Korean-LSQ is a valid and reliable tool for measuring satisfaction with care in Korean patients with RA.

Implementation of recommendations in rheumatic and musculoskeletal diseases: considerations for development and uptake.

A clinical guideline is a document with the aim of guiding decisions based on evidence regarding diagnosis, management and treatment in specific areas of healthcare. Specific to rheumatic and musculoskeletal diseases (RMDs), adherence to clinical guidelines recommendations impacts the outcomes of people with these diseases. However, currently, the implementation of recommendations is less than optimal in rheumatology.The WHO has described the implementation of evidence-based recommendations as one of the greatest challenges facing the global health community and has identified the importance of scaling up these recommendations. But closing the evidence-to-practice gap is often complex, time-consuming and difficult. In this context, the implementation science offers a framework to overcome this scenario.This article describes the principles of implementation science to facilitate and optimise the implementation of clinical recommendations in RMDs. Embedding implementation science methods and techniques into recommendation development and daily practice can help maximise the likelihood that implementation is successful in improving the quality of healthcare and healthcare services.

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.

Assessing acceptability and identifying barriers and facilitators to implementation of the EULAR recommendations for patient education in inflammatory arthritis: a mixed-methods study with rheumatology professionals in 23 European and Asian countries.

OBJECTIVES: To disseminate and assess the level of acceptability and applicability of the European Alliance of Associations for Rheumatology (EULAR) recommendations for patient education among professionals in rheumatology across Europe and three Asian countries and identify potential barriers and facilitators to their application. METHODS: A parallel convergent mixed-methods design with an inductive approach was used. A web-based survey, available in 20 different languages, was distributed to health professionals by non-probability sampling. The level of agreement and applicability of each recommendation was assessed by (0-10) rating scales. Barriers and facilitators to implementation were assessed using free-text responses. Quantitative data were analysed descriptively and qualitative data by content analysis and presented in 16 categories supported by quotes. RESULTS: A total of 1159 completed the survey; 852 (73.5%) were women. Most of the professionals were nurses (n=487), rheumatologists (n=320), physiotherapists (n=158). For all recommendations, the level of agreement was high but applicability was lower. The four most common barriers to application were lack of time, lack of training in how to provide patient education, not having enough staff to perform this task and lack of evaluation tools. The most common facilitators were tailoring patient education to individual patients, using group education, linking patient education with diagnosis and treatment and inviting patients to provide feedback on patient education delivery. CONCLUSIONS: This project has disseminated the EULAR recommendations for patient education to health professionals across 23 countries. Potential barriers to their application were identified and some are amenable to change, namely training patient education providers and developing evaluation tools.