Introduction Multiple sclerosis is a chronic inflammatory, degenerative disease of the central nervous system manifesting at first with relapses in about 85% of cases. In Germany, intravenous therapy with high-dose corticosteroids is the treatment standard of acute relapses. The treatment leads to a faster reduction of symptoms in about 25 of 100 treated patients but has no proven long-term benefits over placebo treatment. Intravenous treatment is not superior to oral treatment. Therefore, informed decisions on relapse management are required. An earlier randomised controlled trial showed that evidence-based patient information and education on relapse management leads to more informed decisions and more relapses not treated or treated with oral corticosteroids. This study aims to evaluate whether a web-based relapse management programme will positively change relapse management and strengthen autonomy in people with multiple sclerosis. Methods The pragmatic double-blind randomised controlled trial is accompanied by a mixed-methods process evaluation and a health economic evaluation and follows the UK Medical Research Council guidance on developing and evaluating complex interventions. A total of 188 people with possible or relapsing-remitting multiple sclerosis with ≥ 1 relapse within the last year and/or ≥ 2 relapses within the last 2 years will be recruited and randomised using blocks. The intervention group receives a web- and dialogue-based decision aid on relapse management, a nurse-led webinar and access to a monitored chat forum. The control group receives standard information, which will be made available via the same online platform as the intervention. The primary endpoint is the proportion of relapses not treated or treated with oral corticosteroids. Key secondary endpoints are the annualised relapse rate, decision-making, empowerment, quality of life and cost-effectiveness. Facilitators and barriers will be assessed by mixed-methods process evaluation measures. The study ends when 81 relapses have been documented or after 24 months of observation per individual patient. Analyses will follow the intention-to-treat principle. Discussion We hypothesise that the intervention will enhance patient empowerment and have a positive impact on patients’ relapse management. Trial registration ClinicalTrials.govNCT04233970. Registered on 18 January 2020

Background Frailty in elderly patients is associated with an increased risk of poor health outcomes, including falls, delirium, malnutrition, hospitalisation, and mortality. Because polypharmacy is recognised as a possible major contributor to the pathogenesis of geriatric frailty, reducing inappropriate medication exposure is supposed to be a promising approach to improve health-related quality of life and prevent adverse outcomes. A major challenge for the process of deprescribing of inappropriate polypharmacy is to improve the communication between general practitioner (GPs), patient and family carer. This study investigates the effects of a complex intervention in frail elderly patients with polypharmacy living at home. Methods This is a cluster randomised controlled trial including 136 GPs and 676 patients. Patients with a positive clinical screening for frailty are eligible if they are aged 70 years or older, receiving family or professional nursing care at home, and taking in five or more drugs per day. Exclusion criteria are higher grade of dementia and life expectancy of 6 months or less. The GPs of the intervention group receive an educational training promoting a deprescribing guideline and providing information on how to conduct a family conference focussing on prioritisation of treatment goals concerning drug therapy. During the 1-year intervention, GPs are expected to perform a total of three family conferences, each including a structured medication review with patients and their family carers. GPs of the control group will receive no training and will deliver care as usual. Geriatric assessment of all patients will be performed by study nurses during home visits at baseline and after 6 and 12 months. The primary outcome is the hospitalisation rate during the observation period of 12 months. Secondary outcomes are number and appropriateness of medications, mobility, weakness, cognition, depressive disorder, health-related quality of life, activities of daily living, weight, and costs of health care use. Discussion This study will provide evidence for a pragmatic co-operative and patient-centred educational intervention using family conferences to improve patient safety in frail elderly patients with polypharmacy. Trial registration German Clinical Trials Register, DRKS00015055 (WHO International Clinical Trials Registry Platform [ICTRP]). Registered on 6 February 2019.

Zusammenfassung Hintergrund und Zielsetzung Kostenberechnungen sind ein wesentlicher Bestandteil gesundheitsökonomischer Evaluationen, weisen jedoch für den deutschen Versorgungskontext teilweise große Unterschiede im methodischen Vorgehen auf. Zielsetzung der vorliegenden Artikelserie ist es, einen konsentierten Vorschlag zu den Vorgehensweisen der Kostenberechnungen in verschiedenen Versorgungssektoren zu präsentieren und mit diesem einführenden Artikel allgemeine, Sektoren-unspezifische Aspekte in der Durchführung von Kostenberechnungen zu beschreiben. Methodik In der Arbeitsgruppe „Standardkosten“ des Ausschusses „Ökonomische Evaluation und Entscheidungsfindung“ haben sich Wissenschaftlerinnen und Wissenschaftler von Universitäten und Entscheidungsträgern im Gesundheitswesen zusammengeschlossen, um die bestehenden Probleme bei Kostenberechnungen im Rahmen gesundheitsökonomischer Forschungen zu diskutieren und ein einheitliches Vorgehen zu erarbeiten. Zur Entwicklung der Empfehlungen fanden drei Arbeitstreffen sowie weitere Telefonkonferenzen statt. Die vorläufigen Ergebnisse wurden auf der 11. Jahrestagung der dggö der Fachöffentlichkeit vorgestellt. Ergebnisse Im vorliegenden ersten Artikel einer zunächst fünf Artikel umfassenden Serie werden grundsätzliche Themen der Perspektivwahl, des Preis-Mengengerüstes, der Studienarten, der Kostenkomponenten, der Datenquellen, der Anpassung von Kostendaten über die Zeit oder über Ländergrenzen hinweg sowie der Umgang mit Unsicherheit behandelt und Empfehlungen zu diesen Themen gegeben. Des Weiteren wird die Gliederung von später folgenden vier Artikeln zu den Berechnungsmethoden in einzelnen Versorgungssektoren beschrieben.

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Background Families with minor children affected by parental cancer are at risk of considerable emotional and organizational stress that can severely burden all family members. So far, there has been a lack of comprehensive support services for affected families. The aim of this project is to implement and evaluate a complex psychosocial intervention for these families by providing advice, information, and care on an emotional, psycho-social, and communicative level during and after the cancer experience and across healthcare sectors. Methods Family-SCOUT is a project supported by the German Innovation Fund (https://innovationsfonds.g-ba.de/). The evaluation is based on a mixed-methods quasi-experimental design with the intervention and control groups. A standardized postal survey at three measurement points (T0: study enrollment; T1: 3 months of follow-up; T2: 9 months of follow-up), secondary data from the participating health insurance funds, and semi-structured qualitative interviews are used for summative and formative evaluation. The study aim is to include n=560 families. Data will be analyzed according to the intention-to-treat principle. The primary analysis is the comparison of the Hospital Anxiety and Depression Scale (HADS) response rates (minimal important difference (MID) ≥ 1.6 in at least one of the two parents) at T2 between the intervention and control group using Fisher’s exact test. The conduct of the study as well as the development and implementation of the intervention will be accompanied by comprehensive study monitoring following the principles of an effectiveness-implementation hybrid study. Discussion The results will allow to test the effectiveness and efficiency of the intervention for the target group. The first experience with the implementation of the intervention in model regions will be available. The evaluation results will serve as the basis to assess the need of including the intervention in the catalog of services of the statutory health insurance funds in Germany. Trial registration ClinicalTrials.gov, NCT04186923. Retrospectively registered on 4 December 2019.