Resource utilisation and direct costs in patients with recently diagnosed fibromyalgia who are offered one of three different interventions in a randomised pragmatic trial

The purpose of this study is to understand the course of costs over a 2-year period in a cohort of recently diagnosed fibromyalgia (FM) patients receiving different treatment strategies. Following the diagnosis, patients were randomly assigned to a multidisciplinary programme (MD), aerobic exercise (AE) or usual care (UC) without being aware of alternative interventions. Time between diagnosis and start of treatment varied between patients. Resource utilisation, health care costs and costs for patients and families were collected through cost diaries. Mixed linear model analyses (MLM) examined the course of costs over time. Linear regression was used to explore predictors of health care costs in the post-intervention period. Two hundred three participants, 90 % women, mean (SD) age 41.7 (9.8) years, were included in the cohort. Intervention costs per patient varied from €864 to 1392 for MD and were €121 for AE. Health care costs (excluding intervention costs) decreased after diagnosis, but before the intervention in each group, and increased again afterwards to the level close to the diagnostic phase. In contrast, patient and family costs slightly increased over time in all groups without initial decrease immediately after diagnosis. Annualised health care costs post-intervention varied between €1872 and 2310 per patient and were predicted by worse functioning and high health care costs at diagnosis. In patients with FM, health care costs decreased following the diagnosis by a rheumatologist. Offering patients a specific intervention after diagnosis incurred substantial costs while having only marginal effects on cost

Nursing sensitive outcomes in patients with rheumatoid arthritis: A systematic literature review

© 2017 Elsevier Ltd Background Although rheumatology nursing has been shown to be effective in managing patients with rheumatoid arthritis, patient outcomes sensitive to nursing interventions (nursing sensitive outcomes) have not been systematically studied. Objectives The objective of this study was to identify and delineate relevant patient outcomes measured in studies that reported nursing interventions in patients with rheumatoid arthritis. Design A systematic search was conducted from 1990 to 2016. Inclusion criteria were (i) patients with rheumatoid arthritis, (ii) adult population age ≥16 years, (iii) nurse as part of the care team or intervention delivery, (iv) primary research only, (v) English language, and (vi) quantitative studies with nursing sensitive outcomes. Data sources Medline, CINAHL, Ovid nursing, Cochrane library and PsycINFO databases were searched for relevant studies. Review methods Using the predetermined inclusion/exclusion criteria, nine reviewers working in pairs assessed the eligibility of the identified studies based on titles and abstracts. Papers meeting the inclusion criteria were retrieved and full texts were further assessed. Critical Appraisal Skills Programme tools were used to assess the quality of the included studies. Data on nursing sensitive outcomes were extracted independently by two reviewers. The Outcome Measures in Rheumatology comprehensive conceptual framework for health was used to contextualise and present findings. Results Of the 820 articles retrieved, 7 randomised controlled trials and 3 observational studies met the inclusion criteria. Seventeen nursing sensitive outcomes were identified (disease activity, clinical effects, pain, early morning stiffness duration, fatigue, patient safety issues, function, knowledge, patient satisfaction, confidence in care received, mental health status, self-efficacy, patient attitude/perception of ability to control arthritis, quality of life, health utility, health care resources, death). These fitted into 10 health intervention domains in keeping with the pre-specified conceptual framework for health: disease status, effectiveness, safety, function, knowledge, satisfaction, psychological status, quality of life, cost, death. A total of 59 measurement instruments were identified comprising patient reported outcome measures (n = 31), and biologic measures and reports (n = 28). Conclusions This review is notable in that it is the first to have identified, and reported, a set of multidimensional outcome measures that are sensitive to nursing interventions in rheumatology specifically. Further research is required to determine a core set of outcomes to be used in all rheumatology nursing intervention studies

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 EULAR recommendations for patient education among rheumatology professionals across Europe and 3 Asian countries, and identify potential barriers and facilitators to their application.Methods: A parallel convergent mixed methods research 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 to 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 participants 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

EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update

Objectives: To provide an update of the European League Against Rheumatism (EULAR) rheumatoid arthritis (RA) management recommendations to account for the most recent developments in the field. Methods: An international task force considered new evidence supporting or contradicting previous recommendations and novel therapies and strategic insights based on two systematic literature searches on efficacy and safety of disease-modifying antirheumatic drugs (DMARDs) since the last update (2016) until 2019. A predefined voting process was applied, current levels of evidence and strengths of recommendation were assigned and participants ultimately voted independently on their level of agreement with each of the items. Results: The task force agreed on 5 overarching principles and 12 recommendations concerning use of conventional synthetic (cs) DMARDs (methotrexate (MTX), leflunomide, sulfasalazine); glucocorticoids (GCs); biological (b) DMARDs (tumour necrosis factor inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, rituximab, tocilizumab, sarilumab and biosimilar (bs) DMARDs) and targeted synthetic (ts) DMARDs (the Janus kinase (JAK) inhibitors tofacitinib, baricitinib, filgotinib, upadacitinib). Guidance on monotherapy, combination therapy, treatment strategies (treat-to-target) and tapering on sustained clinical remission is provided. Cost and sequencing of b/tsDMARDs are addressed. Initially, MTX plus GCs and upon insufficient response to this therapy within 3 to 6 months, stratification according to risk factors is recommended. With poor prognostic factors (presence of autoantibodies, high disease activity, early erosions or failure of two csDMARDs), any bDMARD or JAK inhibitor should be added to the csDMARD. If this fails, any other bDMARD (from another or the same class) or tsDMARD is recommended. On sustained remission, DMARDs may be tapered, but not be stopped. Levels of evidence and levels of agreement were mostly high. Conclusions: These updated EULAR recommendations provide consensus on the management of RA with respect to benefit, safety, preferences and cost

EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update

Recent insights in rheumatoid arthritis (RA) necessitated updating the European League Against Rheumatism (EULAR) RA management recommendations. A large international Task Force based decisions on evidence from 3 systematic literature reviews, developing 4 overarching principles and 12 recommendations (vs 3 and 14, respectively, in 2013). The recommendations address conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) (methotrexate (MTX), leflunomide, sulfasalazine); glucocorticoids (GC); biological (b) DMARDs (tumour necrosis factor (TNF)-inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, rituximab, tocilizumab, clazakizumab, sarilumab and sirukumab and biosimilar (bs) DMARDs) and targeted synthetic (ts) DMARDs (Janus kinase (Jak) inhibitors tofacitinib, baricitinib). Monotherapy, combination therapy, treatment strategies (treat-to-target) and the targets of sustained clinical remission (as defined by the American College of Rheumatology-(ACR)-EULAR Boolean or index criteria) or low disease activity are discussed. Cost aspects were taken into consideration. As first strategy, the Task Force recommends MTX (rapid escalation to 25 mg/week) plus short-term GC, aiming at >50% improvement within 3 and target attainment within 6 months. If this fails stratification is recommended. Without unfavourable prognostic markers, switching to—or adding—another csDMARDs (plus short-term GC) is suggested. In the presence of unfavourable prognostic markers (autoantibodies, high disease activity, early erosions, failure of 2 csDMARDs), any bDMARD (current practice) or Jak-inhibitor should be added to the csDMARD. If this fails, any other bDMARD or tsDMARD is recommended. If a patient is in sustained remission, bDMARDs can be tapered. For each recommendation, levels of evidence and Task Force agreement are provided, both mostly very high. These recommendations intend informing rheumatologists, patients, national rheumatology societies, hospital officials, social security agencies and regulators about EULAR's most recent consensus on the management of RA, aimed at attaining best outcomes with current therapies

Development of the role and scope of an academic mentorship network for health professionals working with people with rheumatological and musculoskeletal conditions across Europe

In 2014, the European HPs in Rheumatology identified academic mentoring as a key development opportunity for the European League Against Rheumatism (EULAR) HP community. The rationale for developing a EULAR academic mentorship programme included:• To support EULAR HPs to develop academic skills;• To share the academic expertise across EULAR HPmembers;• To continue the development of a EULAR communityof HPs;• To continue the development of mentorship skills in rheumatology care across Europe. An academic mentorship working party of HPs from different professional backgrounds and different European countries was convened in December 2014 (JA, RG, RM, YvE). Objectives were defined by the working party included:• To consider and develop a working definition of the role and scope of a EULAR HP mentor;• To identify the various possible approaches and components for mentorship to enable a tailored approach for potential mentees• To provide a guide for the qualities and qualifications of a potential EULAR HP mentor• To discuss how to establish a potential mechanism for identifying mentees.<br/

Using mixed methods in health services research:A review of the literature and case study

Objective To provide an overview of the challenges of conducting mixed methods research (MMR) in the context of health services research (HSR) and to discuss a case study example of the triangulation procedures used in a MMR study on task-shifting in the Netherlands. Method A narrative literature review of publications between January 2000 and February 2020 on the use of mixed methods in the context of HSR and a description of the triangulation procedures in an HSR study with a MMR design on task shifting in the Netherlands. Results The narrative review identified eight challenges. Those related to publishing and appraisal of MMR within HSR were most frequently reported (e.g. 'lack of MMR examples', 'lack of recognition' and 'triangulation issues'). Also, practical problems for conducting MMR within HSR were identified (e.g. 'lack or resources', 'teamwork' and 'lack of quality criteria'). Methodological challenges (e.g. 'sampling' and 'paradigm wars') were less frequently reported as a challenge. Conclusion While increasing in popularity, there remain a range of challenges for the design, conduct and reporting of MMR designs in HSR. Using a triangulation protocol can potentially help address some of these challenges

Predictors for health improvement in patients with fibromyalgia: a 2-year follow-up study

Fibromyalgia (FM) has a high impact on all aspects of health. The effect from interventions is usually small and characterized by uncertainty. Better insight in predictors for improved health is essential. The present study aimed to understand predictors for patient global impression of change and changes in overall health. Data from a longitudinal cohort of recently diagnosed FM patients (n = 203) were used. Within this cohort, patients were pre-randomized to either a multidisciplinary (n = 108) or an, aerobic exercise (n = 47) program, or usual care (n = 48). Only a limited number of patients started with the programs (n = 86) or participated fully, i.e., attended >70 % of the scheduled sessions (n = 68). Patients completed questionnaires covering all components of the International Classification of Functioning, Disability and Health (ICF) bio-psycho-social model of health, which was used as a framework to structure potential predictors. Principal component analysis was used to reduce the number of potential predictors. Regression analyses were used to explore associations with the outcome variables. Principal component analysis yielded five factors representing areas that covered different ICF components and chapters. "Being employed" and "full participation in a program" were independently associated with a better global impression of change. A longer duration of FM-related symptoms and more limitations in physical areas of body functions were independently associated with a worse impression of overall health. Higher levels of perceived limitations in physical and mental activities were associated with "starting to participate in a program" and with "full participation in a program." Recently diagnosed FM patients that report fewer physical limitations may experience more improvement in health if they are at work and have a positive attitude towards participating in an offered health-care intervention. These findings give support to an active rather than to a care-avoiding attitude of health-care workers in their contacts to these patient

Challenges in demonstrating the effectiveness of multidisciplinary treatment on quality of life, participation and health care utilisation in patients with fibromyalgia: a randomised controlled trial

This study aimed to examine the effectiveness of a multidisciplinary intervention with aftercare (MD) compared to aerobic exercise (AE) and usual care (UC) in recently diagnosed patients with fibromyalgia (FM). In a Zelen-like design, eligible patients from the outpatient rheumatology clinics of three medical centres in the South of the Netherlands were consecutively recruited and pre-randomised to MD (n = 108), AE (n = 47) or UC (n = 48). MD consisted of a 12-week course of sociotherapy, physiotherapy, psychotherapy and creative arts therapy (three half days per week), followed by five aftercare meetings in 9 months. AE was given twice a week in a 12-week course. UC varied but incorporated at least education and lifestyle advice. Primary outcomes were health-related quality of life (HR-Qol), participation and health care utilisation. Secondary outcome was the Fibromyalgia Impact Questionnaire (FIQ). Total follow-up duration of the study was 21-24 months. As willingness t