Lifestyle interventions for patients with non-alcoholic steato-hepatitis-Design, rationale and protocol of the study "target group-specific optimisation of lifestyle interventions for behavior change in non-alcoholic steato-hepatitis (OPTI-NASH)"

BACKGROUND: Non-alcoholic steato-hepatitis (NASH) is the inflammatory, progressive form of non-alcoholic fatty liver disease (NAFLD). A delayed diagnose interval is typical for the majority of the patients because of the asymptomatic natural course. However, serious sequelae may develop such as cirrhosis or hepatocellular carcinoma. NASH is also associated with an increased risk of metabolic diseases. Obesity developed due to a lack of exercise or a disadvantageous diet often leads to NAFLD or NASH, thereby interventions including enhanced physical activity and calorie reduction form the actual gold standard of treatment. To date, patients rarely use these. The project aims to model lifestyle interventions based on the preferences of the NASH patients. METHODS: Based on a systematic review and focus group discussions, two discrete choice experiments (DCE) will be designed, one on aspects influencing successful uptake of lifestyle interventions and one to analyses parameters contributing to long-term participation. An online survey will be used to elicit patient's preferences on program design and on motivational aspects in a cross-sectional design. The recruitment will take place in nine certified specialist practices and hospital outpatient clinics aiming to reach a sample size of n = 500 which is also required for the DCE design. DISCUSSION: The results will provide an overview of the NASH patient's preferences regarding the successful uptake and long-term implementation of lifestyle interventions. Recommendations for optimized lifestyle change programs will be derived and an intervention manual will be developed to facilitate target group-specific inclusion in programs in practice.</p

Exploring the status of and demand for palliative day-care clinics and day hospices in Germany: a protocol for a mixed-methods study

Background: To date, the establishment and development of palliative day-care clinics and day hospices in Germany have been completely unsystematic. Research is needed to gain insight into these services and to ensure their accessibility and quality. Accordingly, the ABPATITE research project aims at: (1) identifying the characteristics of palliative day-care clinics and day hospices in Germany, (2) determining demand and preferences for these services, and (3) proposing recommendations (with expert agreement) for the needs-based establishment and development of these services. Methods: The research is a multi-perspective, prospective, observational study following a mixed-methods approach across three study phases. In phase 1a, qualitative expert interviews will be conducted to capture the facility-related characteristics of palliative day-care clinics and day hospices in Germany; the results will feed into a questionnaire sent to all such institutions identified nationwide. In phase 1b, a questionnaire will be sent to local statutory health insurance providers, to gain insight into their contracts and accounting and remuneration models. In phase 2a, a service preference survey will be conducted with patients and family caregivers. In phase 2b, semi-structured interviews with management staff will explore the factors that promote and hinder the provision of service. In phase 2c, the external perspective will be surveyed via focus groups with local actors involved in hospice and palliative care. In phase 3a, focus groups with representatives from relevant areas will be conducted to develop recommendations. Finally, in phase 3b, recommendations will be agreed upon through a Delphi survey. Discussion: The empirically developed recommendations should enable the establishment and development of day hospices and palliative day-care clinics in Germany to be better managed, more oriented to actual demand, and more effectively integrated into wider health care services. Importantly, the findings are expected to optimize the overall development of hospice and palliative care services. Trial registratio

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

Cost-Effectiveness of Treating Hepatitis C with Sofosbuvir/Ledipasvir in Germany.

Infections with the hepatitis C virus (HCV) are a global public health problem. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. Newly introduced direct acting antivirals, especially interferon-free regimens, have improved rates of sustained viral response above 90% in most patient groups and allow treating patients who were ineligible for treatment in the past. These new regimens have replaced former treatment and are recommended by current guidelines. However, there is an ongoing discussion on high pharmaceutical prices. Our aim was to assess the long-term cost-effectiveness of treating hepatitis C genotype 1 patients with sofosbuvir/ledipasvir (SOF/LDV) treatment in Germany.We used a Markov cohort model to simulate disease progression and assess cost-effectiveness. The model calculates lifetime costs and outcomes (quality-adjusted life years, QALYs) of SOF/LDV and other strategies. Patients were stratified by treatment status (treatment-naive and treatment-experienced) and absence/presence of cirrhosis. Different treatment strategies were compared to prior standard of care. Sensitivity analyses were performed to evaluate model robustness.Base-case analyses results show that in treatment-naive non-cirrhotic patients treatment with SOF/LDV dominates the prior standard of care (is more effective and less costly). In cirrhotic patients an incremental cost-effectiveness ratio (ICER) of 3,383 €/QALY was estimated. In treatment-experienced patients ICERs were 26,426 €/QALY and 1,397 €/QALY for treatment-naive and treatment-experienced patients, respectively. Robustness of results was confirmed in sensitivity analyses.Our analysis shows that treatment with SOF/LDV is cost-effective compared to prior standard of care in all patient groups considering international costs per QALY thresholds

Methotrexat-Versorgung vor dem Einsatz von Biologika bei rheumatoider Arthritis

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 &amp;lt; 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 &amp;lt; 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

Deterministic Sensitivity Analysis Results.

<p>Deterministic Sensitivity Analysis Results.</p

Impact of psychologically tailored hand hygiene interventions on nosocomial infections with multidrug-resistant organisms: results of the cluster-randomized controlled trial PSYGIENE

Abstract Background Professional hand hygiene compliance represents a multifaceted behaviour with various determinants. Thus, it has been proposed to apply psychological frameworks of behaviour change to its promotion. However, randomized controlled trials of such approaches, which also assess nosocomial infections (NIs), are rare. This study analyses data of the PSYGIENE-trial (PSYchological optimized hand hyGIENE promotion), which has shown improvements in compliance after interventions tailored based on the Health Action Process Approach (HAPA), on rates of NIs with multidrug-resistant organisms (MDROs). Methods A parallel-group cluster-randomized controlled trial was conducted on all 10 intensive care units and two hematopoietic stem cell transplantation units at Hannover Medical School, a German tertiary care hospital. Educational training sessions for physicians and nurses (individual-level intervention) and feedback discussions with clinical managers and head nurses (cluster-level) were implemented in 2013. In the “Tailoring”-arm (n = 6 wards), interventions were tailored based on HAPA-components, which were empirically assessed and addressed by behaviour change techniques. As active controls, n = 6 wards received untailored educational sessions of the local “Clean Care is Safer Care”-campaign (Aktion Saubere Hände: “ASH”-arm). From 2013 to 2015 compliance was assessed by observation following the World Health Organization, while alcohol-based hand rub usage (AHRU) and NIs with multidrug-resistant gram-negative bacteria, Methicillin-resistant Staphylococcus aureus or Vancomycin-resistant Enterococcus were assessed following national surveillance protocols. Data were analysed at cluster-level. Results In the “Tailoring”-arm, interventions led to a decrease of 0.497 MDRO-infections per 1000 inpatient days from 2013 to 2015 (p = 0.015). This trend was not found in the “ASH”-arm (− 0 . 022 infections; p = 0.899). These patterns corresponded inversely to the trends in compliance but not in AHRU. Conclusions While interventions tailored based on the HAPA-model did not lead to a significantly lower incidence rate of MDRO-infections compared to control wards, a significant reduction, compared to baseline, was found in the second follow-up year in the “Tailoring”- but not the "ASH"-arm. This indicates that HAPA-tailored hand hygiene interventions may contribute to the prevention of NIs with MDRO. Further research should focus on addressing compliance by interventions tailored not only to wards, but also leaders, teams, and individuals. Trial registration German Clinical Trials Register/International Clinical Trials Registry Platform, DRKS00010960. Registered 19 August 2016-Retrospectively registered, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00010960. http://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00010960

Base-Case Analysis Results.

<p>Base-Case Analysis Results.</p

Treatment regimens.

<p>Treatment regimens.</p

Model inputs.

<p>Model inputs.</p