Methotrexat-Versorgung vor dem Einsatz von Biologika bei rheumatoider Arthritis: Eine Analyse der Leitliniengerechtigkeit

Background: With the introduction of biologics the treatment landscape for patients with rheumatoid arthritis (RA) has rapidly expanded; however, according to German and European treatment guidelines the use of biologic disease-modifying antirheumatic drugs (bDMARD) is only indicated after insufficient response under methotrexate (MTX) doses of at least 20 mg/week (first-line treatment). The aim of the study was to analyze the guideline compliance of MTX prescription in the outpatient sector prior to treatment with biologics. Material and methods: Claims data from the AOK Lower Saxony from 2013 to 2016 were provided for all insured patients with a diagnosis of RA and bDMARD prescription during the study period. Within a patient-specific observational period of 180 days prior to the first bDMARD prescription, the maximum prescribed MTX dosage was examined. Results: Data from 90 incident and 315 prevalent RA patients were analyzed. A maximum MTX prescription of < 20 mg/week was observed in 60.0% of incident patients and in 67.0% of prevalent patients. Men had a higher mean MTX maximum dose (17.1 ± 4.8 mg) than women (14.9 ± 5.0 mg; p < 0.0001). Of the study population 29.6% received oral only prescriptions during the observational period. In 12.4% of patients a switch to parenteral administration was made. Discussion: Targeted use of the full spectrum of therapies provided prior to initiation of bDMARD treatment may contribute to cost-effective RA care. This study showed indications for potential deficits in outpatient MTX prescription practice and can raise awareness for efficient treatment.Hintergrund: Seit vielen Jahren erweitern Biologika die Therapieoptionen bei rheumatoider Arthritis (RA). Der Einsatz dieser biologischen „disease-modifying antirheumatic drugs“ (bDMARDs) ist gemäß deutscher und europäischer Behandlungsleitlinien jedoch erst bei Ausschöpfung der Methotrexat (MTX)-Erstlinientherapie von mindestens 20 mg/Woche indiziert. Ziel der Studie ist es, die Leitliniengerechtigkeit der MTX-Verordnung im ambulanten Sektor vor der Biologikatherapie zu überprüfen. Methodik: Es wurden Routinedaten der AOK-Niedersachsen der Jahre 2013 bis 2016 für alle Versicherten zur Verfügung gestellt, die im Studienzeitraum eine RA-Diagnose sowie eine bDMARD-Verordnung aufweisen. Innerhalb eines patientenindividuellen Beobachtungszeitraums von 180 Tagen vor der ersten bDMARD-Verordnung wurde die maximal verordnete MTX-Dosierung untersucht. Ergebnisse: Die Studienpopulation umfasst 405 Patienten (90 inzident, 315 prävalent). Bei 60,0 % der inzidenten Patienten und 67,0 % der prävalenten Patienten wurde eine maximale MTX-Verordnung von < 20 mg/Woche beobachtet. Männer weisen im Mittel mit 17,1 ± 4,8 mg eine höhere MTX-Maximaldosierung als Frauen auf (14,9 ± 5,0 mg; p < 0,0001); 29,6 % der Studienpopulation erhielten im Beobachtungszeitraum ausschließlich orale Verordnungen. Umstellungen auf eine parenterale Applikationsform wurden bei 12,4 % der Patienten festgestellt. Diskussion: Ein gezielter Einsatz des gesamten vorgesehenen Therapiespektrums vor der Initiierung einer bDMARD-Therapie kann zu einer kosteneffizienten Versorgung der RA beitragen. Die Studie zeigt Indizien für mögliche Defizite in der ambulanten MTX-Verordnungspraxis auf und kann für eine effiziente Therapie sensibilisieren

Delegation ärztlicher Leistungen an rheumatologische Fachassistenten: Effekte auf Depression und Angst bei Patienten mit rheumatoider Arthritis

Background: At least 1 comorbidity occurs in 80% of patients with rheumatoid arthritis (RA). In addition to cardiovascular comorbidities psychological comorbid conditions are common. The prevalence of depression and anxiety is higher in patients than in the general population. Screening for comorbidities is crucial. A shortage of outpatient specialist care barely allows resources for this. The implementation of team-based care holds the potential to improve the standard of care while simultaneously working against the shortage of care. Objective: The aim of the study was to examine the effects of care on the course of depression and anxiety in patients with seropositive RA and active disease. Material and methods: A multicenter pragmatic randomized controlled trial was conducted over the course of 1 year with 224 patients. After baseline, five more visits followed. In the intervention group (IG), three were initially carried out by qualified rheumatological assistants. Depression, anxiety and patient satisfaction with outpatient care were looked at in detail. Results: In the IG the anxiety symptoms significantly improved over 12 months (p = 0.036). The proportions of patients with anxiety also significantly changed in the IG (p < 0.001), while there was no change in the control group between baseline and month 12. The values of the depression scale did not differ significantly (p = 0.866). In terms of the information dimension of the satisfaction questionnaire, patients in the IG felt significantly better informed after 6 months (p = 0.013) and 12 months (p = 0.003). Conclusion: A positive effect of team-based care on the course of depression and anxiety in patients with seropositive RA and active disease could be shown.Hintergrund: Bei 80 % der Patienten mit einer rheumatoiden Arthritis (RA) tritt mindestens eine Komorbidität auf. Neben kardiovaskulären Komorbiditäten sind psychische Erkrankungen häufig. Die Prävalenz von Depression und Angst ist bei Betroffenen höher als in der Allgemeinbevölkerung. Ein Screening auf Komorbidität ist hoch relevant. Die Unterversorgung im fachärztlichen Bereich lässt dies kaum zu. Die Implementierung einer Visite durch die rheumatologische Fachassistenz (RFA) bietet Potenzial, die Versorgung zu verbessern und der Unterversorgung zu begegnen. Fragestellung: Ziel ist, Auswirkungen einer teambasierten Versorgung auf den Verlauf von Depression und Angst bei Patienten mit einer seropositiven RA im Krankheitsschub zu untersuchen. Material und Methoden: Es handelt sich um eine multizentrische, pragmatische, randomisierte, kontrollierte Studie über 1 Jahr mit 224 Patienten. Nach Baseline folgen 5 Visiten. In der Interventionsgruppe (IG) fanden 3 zunächst bei der RFA statt. Depression, Angst und Behandlungszufriedenheit werden genauer betrachtet. Ergebnisse: In der IG hat sich die ängstliche Symptomatik über 12 Monate signifikant verbessert (p = 0,036). Auch die Anteile der Patienten mit Ängstlichkeit verändern sich signifikant in der Interventionsgruppe (p < 0,001), während es in der Kontrollgruppe im Vergleich zwischen Baseline und Monat 12 zu keiner Veränderung kam. Die Werte der Depressionsskala unterschieden sich nicht signifikant (p = 0,866). Bei der Dimension „Information“ des Zufriedenheitsfragebogens haben sich die Patienten in der IG nach 6 (p = 0,013) und 12 Monaten (p = 0,003) signifikant besser informiert gefühlt. Diskussion: Ein positiver Effekt der teambasierten Versorgung auf den Verlauf von Depression und Angst bei Patienten mit einer seropositiven RA im Krankheitsschub konnte gezeigt werden

A rare disease patient-reported outcome measure: revision and validation of the German version of the Systemic Sclerosis Quality of Life Questionnaire (SScQoL) using the Rasch model

Background: Rare disease patient-reported outcome measures (PROMs) require linguistic adaptation to overcome the challenge of geographically dispersed patient populations. Importantly, PROMs such as health-related quality of life (HRQoL) should accurately capture responses to patient-identified concerns. The Systemic Sclerosis Quality of Life Questionnaire (SScQoL) is a 29-item tool validated in six languages. Previous evaluation of the German version revealed problems with dichotomous responses. This study aimed to revise the German SScQoL, extend the response structure, and evaluate content and construct validity, reliability and unidimensionality. Methods: The instrument validation study involved revising the German SScQoL response structure, cognitive debriefing with patients and validation using Rasch analysis. The revised SScQoL was completed by Swiss-German-speaking patients with SSc within the Swiss MANagement Of Systemic Sclerosis (MANOSS) study. Rasch analysis was employed to test the validity, reliability and unidimensionality of the revised instrument. Results: Based on cognitive debriefing with patients (n = 6) dichotomous items were extended to a polytomous 4-point response structure. A total of 78 patients completed the revised SScQoL. Initial analysis of the 29 items suggested the scale lacked fit to the model (χ2 = 51.224, df = 29, p = 0.007). Grouping items into five domains resulted in an adequate fit to the Rasch model (χ2 = 5.343, df = 5, p = 0.376) and unidimensionality (proportion of significant independent t tests: 0.045, 95% CI 0.016–0.114). Overall, the scale was well targeted, had high internal consistency (Person Separation Index, PSI = 0.931) and worked consistently in patients with different demographic and clinical characteristics. Conclusions: The revised German SScQoL has a 4-point response structure and is a valid, reliable measure. Rasch analysis is useful for validating continuous response structure of quality of life measures. Further evaluation of measurement equivalence with other German-speaking cultures is required for multinational comparisons and data pooling

2023 EULAR recommendations for the management of fatigue in people with inflammatory rheumatic and musculoskeletal diseases

OBJECTIVES: Fatigue is prevalent in people with inflammatory rheumatic and musculoskeletal diseases (I-RMDs) and recognised as one of the most challenging symptoms to manage. The existence of multiple factors associated with driving and maintaining fatigue, and the evidence about what improves fatigue has led to a multifaceted approach to its management. However, there are no recommendations for fatigue management in people with I-RMDs. This lack of guidance is challenging for those living with fatigue and health professionals delivering clinical care. Therefore, our aim was to develop EULAR recommendations for the management of fatigue in people with I-RMDs. METHODS: A multidisciplinary taskforce comprising 26 members from 14 European countries was convened, and two systematic reviews were conducted. The taskforce developed the recommendations based on the systematic review of evidence supplemented with taskforce members' experience of fatigue in I-RMDs. RESULTS: Four overarching principles (OAPs) and four recommendations were developed. OAPs include health professionals' awareness that fatigue encompasses multiple biological, psychological and social factors which should inform clinical care. Fatigue should be monitored and assessed, and people with I-RMDs should be offered management options. Recommendations include offering tailored physical activity and/or tailored psychoeducational interventions and/or, if clinically indicated, immunomodulatory treatment initiation or change. Patient-centred fatigue management should consider the individual's needs and preferences, their clinical disease activity, comorbidities and other psychosocial and contextual factors through shared decision-making. CONCLUSIONS: These 2023 EULAR recommendations provide consensus and up-to-date guidance on fatigue management in people with I-RMDs

Calculation of Direct Antiretroviral Treatment Costs and Potential Cost Savings by Using Generics in the German HIV ClinSurv Cohort

BACKGROUND/AIM OF THE STUDY: The study aimed to determine the cost impacts of antiretroviral drugs by analysing a long-term follow-up of direct costs for combined antiretroviral therapy, cART, -regimens in the nationwide long-term observational multi-centre German HIV ClinSurv Cohort. The second aim was to develop potential cost saving strategies by modelling different treatment scenarios. Antiretroviral regimens (ART) from 10,190 HIV-infected patients from 11 participating ClinSurv study centres have been investigated since 1996. Biannual data cART-initiation, cART-changes, surrogate markers, clinical events and the Centre of Disease Control- (CDC)-stage of HIV disease are reported. Treatment duration was calculated on a daily basis via the documented dates for the beginning and end of each antiretroviral drug treatment. Prices were calculated for each individual regimen based on actual office sales prices of the branded pharmaceuticals distributed by the license holder including German taxes. During the 13-year follow-up period, 21,387,427 treatment days were covered. Cumulative direct costs for antiretroviral drugs of €812,877,356 were determined according to an average of €42.08 per day (€7.52 to € 217.70). Since cART is widely used in Germany, the costs for an entire regimen increased by 13.5%. Regimens are more expensive in the advanced stages of HIV disease. The potential for cost savings was calculated using non-nucleotide-reverse-transcriptase-inhibitor, NNRTI, more frequently instead of ritonavir-boosted protease inhibitor, PI/r, in first line therapy. This calculation revealed cumulative savings of 10.9% to 19.8% of daily treatment costs (50% and 90% substitution of PI/r, respectively). Substituting certain branded drugs by generic drugs showed potential cost savings of between 1.6% and 31.8%. Analysis of the data of this nationwide study reflects disease-specific health services research and will give insights into the cost impacts of antiretroviral therapy, and might allow a more rational allocation of resources within the German health care system

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

2023 EULAR recommendations for the management of fatigue in people with inflammatory rheumatic and musculoskeletal diseases

Objectives: Fatigue is prevalent in people with inflammatory rheumatic and musculoskeletal diseases (I-RMDs) and recognised as one of the most challenging symptoms to manage. The existence of multiple factors associated with driving and maintaining fatigue, and the evidence about what improves fatigue has led to a multifaceted approach to its management. However, there are no recommendations for fatigue management in people with I-RMDs. This lack of guidance is challenging for those living with fatigue and health professionals delivering clinical care. Therefore, our aim was to develop EULAR recommendations for the management of fatigue in people with I-RMDs.Methods: A multidisciplinary taskforce comprising 26 members from 14 European countries was convened, and two systematic reviews were conducted. The taskforce developed the recommendations based on the systematic review of evidence supplemented with taskforce members’ experience of fatigue in I-RMDs.Results: Four overarching principles (OAPs) and four recommendations were developed. OAPs include health professionals’ awareness that fatigue encompasses multiple biological, psychological and social factors which should inform clinical care. Fatigue should be monitored and assessed, and people with I-RMDs should be offered management options. Recommendations include offering tailored physical activity and/or tailored psychoeducational interventions and/or, if clinically indicated, immunomodulatory treatment initiation or change. Patient-centred fatigue management should consider the individual’s needs and preferences, their clinical disease activity, comorbidities and other psychosocial and contextual factors through shared decision-making.Conclusions: These 2023 EULAR recommendations provide consensus and up-to-date guidance on fatigue management in people with I-RMDs

Role-Specific Target-Systems in Professional Bureaucracies: A Qualitative Analysis in the OR

This paper firstly discusses the initial situation and problems. Afterward, it defines professional bureaucracies and shows their impact for the OR-work. The OR-center and its actors are shown. Finally, the paper provides the empiric design for detecting the target systems of the different work groups within the OR, the quality criteria in qualitative research and empirical results. It is shown that different groups have different targets in their daily work and that helps for a better understanding. More precisely, by detecting the target systems of these experts, we can ‘bridge’ the different points of view to create a common basis for the work in the OR. One of the aims was to find bridges to overcome separating factors. This paper describes the situation in Germany focusing the Hannover Medical School. It can be assumed that the results can be transferred to other countries using the DRG-System (Diagnosis Related Groups)

Fachkräfteentwicklung in der Rheumatologie

Background and objective!#!Health workforce shortage in German rheumatology has been identified as a healthcare service and delivery problem. Health policy has increased staffing targets, yet effective intervention strategies are lacking. This research aimed to systematically map the rheumatology workforce to improve the evidence for interventions and explore possibilities for more effective health workforce management.!##!Methods!#!The WHO National Health Workforce Accounts provided a conceptual framework for the mapping exercise. Four major sets of indicators were selected, comprising staffing levels, health labor market flows, composition and education/training. A comparison of age groups and time series was applied to explore trends. Public statistics and other secondary sources served our analysis using descriptive methodology.!##!Results!#!In Germany there are 1076 physicians specialized in internal medical rheumatology. Absolute numbers have nearly doubled (91%) since 2000 but with a strong demographic bias. Between 2000 and 2019 numbers markedly increased in the group aged 50 years and older but only by 9% in the younger group under 50 years; since 2010 the group aged 40-50 years even faces a decrease. In 2019, the absolute numbers of rheumatologists in retirement age exceeded those aged 40 years and under. Since 2015 an expanding workforce trend has overall flattened but this was strongest in the hospital sector; the numbers in resident training did not show any relevant growth.!##!Conclusion!#!Health workforce trends reveal that an available number of rheumatologists cannot meet new health policy planning targets. There is a need for effective health workforce management, focusing on innovation in resident training, improved task delegation and gender equality