Cost-effectiveness of a telehealth intervention in rheumatoid arthritis: economic evaluation of the Telehealth in RA (TeRA) randomized controlled trial.

OBJECTIVE: Telehealth is rapidly gaining ground from usual treatment, not least because of coronavirus disease 2019 (COVID-19) measures. Within rheumatology, telehealth has been used for, inter alia, follow-up for patients with rheumatoid arthritis (RA) with low disease activity or in remission. This study aims to assess the cost-effectiveness of such a telehealth intervention. METHOD: In a randomized controlled trial, 294 patients were randomized into patient-reported outcome-based telehealth follow-up by either a nurse (PRO-TN) or a rheumatologist (PRO-TR) or to conventional outpatient follow-up (control). Cost-effectiveness was evaluated using costs per quality-adjusted life-year (QALY) gained. Individual-level healthcare and productivity costs were retrieved from national Danish registers. Incremental cost-effectiveness ratios were calculated for the intervention groups compared to the control group. Bootstrapping with 10 000 replications was used to obtain confidence intervals. Furthermore, cost-effectiveness acceptability curves were generated. RESULTS: The cost comparison showed that PRO-TR was significantly less costly than the control group, whereas the relative reduction in costs for PRO-TN was not significant. The telehealth groups experienced minor, non-significant declines in QALYs, whereas the control group experienced a slight, non-significant increase. The cost-effectiveness analysis showed that for PRO-TR, the willingness to accept a QALY loss was 89 328 EUR. A similar but smaller and non-significant result was seen for PRO-TN. CONCLUSION: PRO-TR and PRO-TN seem to cost less but provide broadly similar health outcomes compared with conventional follow-up. Between the intervention groups, PRO-TR was significantly less costly. More studies are needed to conclude whether rheumatologist- or nurse-led telehealth is more cost-effective than conventional follow-up.

Newly diagnosed with inflammatory arthritis (NISMA)-development of a complex self-management intervention.

BACKGROUND: Patients newly diagnosed with inflammatory arthritis (IA) request regular consultations and support from health professionals to manage physiological, emotional, and social challenges. Evidence suggests that providing a tailored multi-component self-management program may benefit disease management. However, there is a lack of evidence of effective interventions with multiple components targeting the needs of this group. Therefore, the aim of this study was to develop a self-management intervention targeting newly diagnosed patients with IA, following the Medical Research Council (MRC) framework for developing complex interventions. METHODS: The development of the complex self-management intervention covered three steps. First, the evidence base was identified through literature reviews, in which we described a preliminary nurse-led intervention. Secondly, we chose Social Cognitive Theory as the underlying theory along with Acceptance and Commitment Theory to support our communication strategy. Thirdly, the preliminary intervention was discussed and further developed in workshops to ensure that the intervention was in accordance with patients' needs and feasible in clinical practice. RESULTS: The developed intervention comprises a 9-month nurse-led intervention (four individual and two group sessions). A physiotherapist and an occupational therapist will attend the group sessions along with the nurse. All sessions should target IA-specific self-management with a particular focus on medical, role, and emotional management. CONCLUSION: Through the workshops, we involved all levels of the organization to optimize the intervention, but also to create ownership and commitment, and to identify barriers and shortcomings of the preliminary intervention. As a result, from the existing evidence, we believe that we have identified effective mechanisms to increase self-management in people newly diagnosed with IA. Further, we believe that the involvement of various stakeholders has contributed significantly to developing a relevant and feasible intervention. The intervention is a nurse-led complex self-management intervention embedded in a multidisciplinary team (named NISMA). The intervention is currently being tested in a feasibility study.

Validation of the Danish versions of the Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaires (BRAFs).

Objective: This study aimed to validate the Danish versions of the Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire (BRAF-MDQ) and BRAF Numerical Rating Scale version 2 (NRSv2).Method: We tested face and content validity, internal consistency, criterion validity, construct validity, and reproducibility for the BRAF-MDQ, and face and criterion validity and reproducibility for the BRAF-NRS.Results: In all, 224/236 patients (95%) completed the questionnaires [70% female, mean ± sd age 59 ± 13.04 years, disease duration 11.2 ± 9.49 years, Health Assessment Questionnaire (HAQ) 0.724 ± 0.70, and 28-joint Disease Activity Score-C-reactive protein 2.55 ± 1.24]. The unidimensionality for the physical and cognitive fatigue subscales was confirmed, whereas the living with fatigue and emotional fatigue subscales were not unidimensional. Cronbach's α was 0.94 for the BRAF-MDQ total and 0.78-0.92 for the four subscales. The correlations between BRAF-MDQ and various measures were: 36-item Short Form Health Survey (SF-36) vitality subscale, 0.75; Hospital Anxiety and Depression Scale (HADS) anxiety subscale, 0.65; HADS depression subscale, 0.62; visual analogue scale (VAS) pain, 0.62; VAS global, 0.73; and HAQ, 0.62. The intraclass correlation coefficient for agreement was 0.995. A Bland-Altman plot showed a mean ± sd difference of -1.9 ± 3.62 for BRAF-MDQ. Correlation coefficients between the BRAF-NRSv2 subscales and other subscales were: BRAF-MDQ subscales, 0.57-0.93; SF-36 vitality subscale, 0.54-0.68; and VAS fatigue, 0.66-0.82.Conclusions: The Danish BRAFs are considered valid and reliable for use among Danish patients with rheumatoid arthritis, despite the subscales living with fatigue and emotional fatigue not being unidimensional, as they are in the original version.

2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases.

To update the European League Against Rheumatism (EULAR) recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases (AIIRD) published in 2011. Four systematic literature reviews were performed regarding the incidence/prevalence of vaccine-preventable infections among patients with AIIRD; efficacy, immunogenicity and safety of vaccines; effect of anti-rheumatic drugs on the response to vaccines; effect of vaccination of household of AIIRDs patients. Subsequently, recommendations were formulated based on the evidence and expert opinion. The updated recommendations comprise six overarching principles and nine recommendations. The former address the need for an annual vaccination status assessment, shared decision-making and timing of vaccination, favouring vaccination during quiescent disease, preferably prior to the initiation of immunosuppression. Non-live vaccines can be safely provided to AIIRD patients regardless of underlying therapy, whereas live-attenuated vaccines may be considered with caution. Influenza and pneumococcal vaccination should be strongly considered for the majority of patients with AIIRD. Tetanus toxoid and human papilloma virus vaccination should be provided to AIIRD patients as recommended for the general population. Hepatitis A, hepatitis B and herpes zoster vaccination should be administered to AIIRD patients at risk. Immunocompetent household members of patients with AIIRD should receive vaccines according to national guidelines, except for the oral poliomyelitis vaccine. Live-attenuated vaccines should be avoided during the first 6 months of life in newborns of mothers treated with biologics during the second half of pregnancy. These 2019 EULAR recommendations provide an up-to-date guidance on the management of vaccinations in patients with AIIRD.

Antimalarials in the treatment of systemic lupus erythematosus: a registry-based cohort study in Denmark.

BACKGROUND: Evidence-based international guidelines for the treatment of systemic lupus erythematosus (SLE) recommend treatment with antimalarials (AMs) for all patients with SLE irrespective of disease activity. Only a few studies have investigated the use of AMs among newly diagnosed patients with SLE. OBJECTIVES: The objective of this paper is to analyze prescription patterns of AMs in newly diagnosed SLE patients in Denmark from 2000 to 2011. METHODS: Using the Danish Prescription Register (DNPR), we conducted a nationwide cohort study including all patients with a first-time diagnosis of SLE (the Danish National Registry of Patients (NPR)). We used Kaplan-Meier estimates to compute the cumulative probability of starting AM treatment within a year and Cox regression analysis to compare time to treatment between patient groups. RESULTS: AMs were prescribed to 37.7% of the newly diagnosed SLE patients within the first year of follow-up. Approximately 20% did not receive any medical treatment. Women were more likely than men to start AM (adjusted HR of 1.28 (95% CI 1.08-1.52)). Patients diagnosed with SLE between 2005 and 2011 were more likely to start treatment than patients diagnosed between 2000 and 2004 (HR of 1.21 (95% CI 1.07-1.36)). Patients with renal disease were less likely to start AM treatment than patients without this condition (adjusted HR of 0.50 (95% CI 0.36-0.68)). Current users of corticosteroids were more likely to start AM treatment than non-users (adjusted HR 1.81 (95% CI 1.59-2.06)). CONCLUSION: Time to start of AM treatment following SLE diagnosis could be further reduced, especially among patients with renal disease. However, our results showed that treatment practice in recent years has changed toward initiating AM treatment earlier.

Early referral of patients with suspected polymyalgia rheumatica - A systematic review.

INTRODUCTION: Prompt diagnosis and treatment of polymyalgia rheumatica (PMR) is crucial to prevent long-term complications and improve patient outcomes. However, there is currently no standardized approach to referral of suspected PMR patients to rheumatologists, leading to inconsistent management practices. The objective of this systematic review was to clarify the existing evidence regarding the following aspects of early management strategies in patients with suspected PMR: diagnostic strategies, GCA screening, glucocorticoid initiation prior to referral, value of shared care and value of fast track clinic. METHODS: Two authors performed a systematic literature search, data extraction and risk of bias assessment independently. The literature search was conducted in Embase, MEDLINE (PubMed) and Cochrane. Studies were included if they contained cohorts of suspected PMR patients and evaluated the efficacy of different diagnostic strategies for PMR, screening for giant cell arteritis (GCA), starting glucocorticoids before referral to secondary care, shared care, or fast-track clinics. RESULTS: From 2,437 records excluding duplicates, 14 studies met the inclusion criteria. Among these, 10 studies investigated the diagnostic accuracy of various diagnostic strategies with the majority evaluating different clinical approaches, but none of them showed consistently high performance. However, 4 studies on shared care and fast-track clinics showed promising results, including reduced hospitalization rates, lower starting doses of glucocorticoids, and faster PMR diagnosis. CONCLUSION: This review emphasizes the sparse evidence of early management and referral strategies for patients with suspected PMR. Additionally, screening and diagnostic strategies for differentiating PMR from other diseases, including concurrent GCA, require clarification. Fast-track clinics may have potential to aid patients with PMR in the future, but studies will be needed to determine the appropriate pre-referral work-up.

Factors associated with work outcome for survivors from haematological malignancies--a systematic literature review.

Recent years have seen a growing number of survivors from haematological malignancies. As biology and treatment for these malignancies differ from other malignancies, we performed a systematic literature review of factors associated with work outcome for these survivors. A systematic literature search was conducted. Eight studies with different methodology and characteristics met the inclusion criteria. Three prospective studies agreed, to a high extent, on their findings, whereas results of five cross-sectional studies collectively were inconclusive. Overall, this review - like reviews on other cancer survivors - found no certain association of single factors with work outcome. However, based on possible explanations of the converging findings, this review pinpointed a number of issues that may inform future studies. The design should preferably be prospective, including comparison with age-paired cancer-free individuals. The role of co-morbidity and of differences between haematological diagnoses ought to be established, and work outcomes must be well defined and recorded with valid methods. To establish cause-effect relations, factors possibly associated to work outcome should be evaluated at an early time point after diagnosis. Such studies would assist identification of individuals at increased risk of encountering work-related problems and would hence help establish knowledge on which rehabilitation measures could rest.

Time to methotrexate treatment in patients with rheumatoid arthritis referred to hospital.

OBJECTIVE: To describe time to methotrexate (MTX) treatment among patients with a first-time diagnosis of rheumatoid arthritis (RA) in a hospital-based department of rheumatology. METHODS: Using prescription data, we conducted a large cohort study in the County of Aarhus, Denmark, including all patients with a first-time diagnosis of RA. We used Kaplan-Meier estimates to compute the cumulative probability of MTX treatment start with follow-up starting on the date of referral. We defined early treatment start as MTX initiation within 90 days after referral. RESULTS: Among 1516 RA patients, a total of 703 (46%) started MTX treatment during the study period. The overall median time to treatment start was 120 days [interquartile range (IQR) 19-557]. Patients included in 2000-2006 had an earlier MTX treatment start compared with patients included in 1996-1999 [adjusted incidence rate ratio (IRR) 1.83, 95% confidence interval (CI) 1.55-2.16]. Patients with a C-reactive protein (CRP) level>300 nmol/L had an earlier MTX treatment start compared with patients with a moderate CRP level (adjusted IRR 1.36, 95% CI 1.16-1.73). Only 21% of the patients started MTX within 90 days after referral and those were mainly patients included in later years and patients with a high CRP. CONCLUSIONS: The data suggest that reduction in the time to start MTX treatment after referral to hospital could be improved, especially among patients with less severe symptoms. However, our results show that treatment practice in recent years has changed towards an earlier MTX treatment start.

Methotrexate compliance among patients with rheumatoid arthritis: the influence of disease activity, disease duration, and co-morbidity in a 10-year longitudinal study.

OBJECTIVE: To assess methotrexate (MTX) compliance among rheumatoid arthritis (RA) patients. METHODS: Using prescription data, we conducted a 10-year longitudinal study among RA patients who were first-time MTX users. MTX compliance was expressed as the continuous measure of medication gaps (CMG), that is the proportion of treatment gaps compared with the total observation period stratified by age, sex, C-reactive protein (CRP), haemoglobin, co-morbidity, concurrent medication, and disease duration. Multiple linear regression analysis was used to assess the influence of disease activity, disease duration, and co-morbidity on compliance. RESULTS: A total of 941 RA patients redeemed 7501 MTX prescriptions during our study period. Overall, the patients had gaps in 12.3% of the observation period corresponding to a mean period not covered with MTX of 1.5 months/year if all participants were followed for 1 year. Patients with CRP > 32 mg/L had a lower mean CMG than patients with CRP < 8 mg/L [adjusted CMG difference -0.04, 95% confidence interval (CI) -0.07 to - 0.02]. Patients with a disease duration < 1 year had a lower mean CMG than patients with a disease duration between 1 and 5 years (adjusted CMG difference 0.01, 95% CI -0.01 to 0.04). Patients with a diagnosis of ulcer/mild liver disease had a higher mean CMG than patients without this diagnosis (adjusted CMG difference 0.04, 95% CI 0.004-0.084). CONCLUSION: MTX compliance was generally high among RA patients. Compliance decreased with increasing disease duration, low to moderate disease activity, and the presence of a diagnosis of ulcer/mild liver disease.