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Zusammenfassung Bei Menschen mit chronischen Erkrankungen können häufige negative Gedanken einerseits mit ungünstigen Gesundheitsoutcomes, andererseits mit positiven Outcomes wie gesundheitsförderndem Verhalten in Verbindung stehen. Wir berichten die Ergebnisse einer Studie, die sich mit Gedanken an Gesundheit bei Menschen mit Diabetes befasst. Wir untersuchten Häufigkeit, Valenz und Zusammenhang solcher Gedanken mit gesundheitsbezogener Lebensqualität, diabetesbezogenen Belastungen und depressiven Symptomen.

Risk factor control of diabetes mellitus (DM) and especially dyslipidemia remains unsatisfactory in patients with atherosclerotic cardiovascular disease (ASCVD). We aimed to analyze the knowledge of low-density lipoprotein cholesterol (LDL-C) and glycated hemoglobin (HbA1c) treatment goals, subjective level of information, and information needs in very high-risk patients with ASCVD.ASCVD patients (n = 210; 75 ± 9 years; 71.4% male; 89.5% coronary disease) with DM (96.7% type 2) completed a questionnaire assessing knowledge of HbA1c and LDL-C treatment goals and subjective level of information and information needs on disease-related topics of DM and ASCVD. Serum LDL-C and HbA1c were measured.HbA1c goal (7.0% in 60.6%) was attained more frequently than LDL-C goal (70 mg/dl in 39.9%; p .01). Significantly more participants named the correct goal for HbA1c compared to LDL-C (52.9% vs. 2.4%; p .01). Subjective levels of information were higher and information needs were lower for DM than for ASCVD (p .01 for all topics). No associations of knowledge of treatment goals and level of information with the attainment of treatment goals for HbA1c and LDL-C were found. However, in multivariate regression, higher levels of education were associated with knowledge of treatment goals (HbA1c: odds ratio [OR] 1.32, 95% confidence interval [CI] 1.01-1.72, p = .04; LDL-C: OR 2.32, 95% CI 1.07-5.03; p = .03).In very high-risk patients with ASCVD, a deficit of knowledge of treatment goals to control dyslipidemia exists when compared to DM, patients felt significantly better informed for topics of DM than for ASCVD and display higher information needs for topics of ASCVD.

Background The amount of empirical research on whether people in fact include health-related changes in leisure time into health state valuations is limited and the results are inconclusive. In this exploratory study, we analyse whether time aspects of diabetes self-care might explain the ratings of the health state (HSR) in addition to the effects of physical and mental health-related quality of life. Methods Using the data from participants with diagnosed type 2 diabetes in the population-based KORA FF4 study (n = 190, 60% Male, mean age 69 ± 10 years), multiple logistic regression models were fitted to explain HSR (good vs. poor) in terms of the SF-12 physical and mental component summary (PCS and MCS) scores, time spent on diabetes self-care and a number of background variables. Results There was no significant association between time spent on diabetes self-care and HSR in models without interaction. Significant interaction term was found between the SF-12 PCS score and time spent on self-care. In models with interaction self-care time has a small, but significant impact on the HSR. In particular, for a PCS score under 40, more time increases the chance to rate the health state as “good”, while for a PCS score above 40 there is a reverse effect. Conclusions The additional impact of self-care time on HSR in our sample is small and seems to interact with physical health-related quality of life. More research is needed on whether inclusion of health-related leisure time changes in the denominator of cost-effectiveness analysis is sufficient.

Mit dem Gesetz zur Neuordnung des Arzneimittelmarktes in der gesetzlichen Krankenversicherung (AMNOG) kam es in Deutschland zu einem Paradigmenwechsel im Umgang mit Arzneimittelinnovationen. Deren Erstattungsbetrag hangt nun von einer Nutzenbewertung ab. Alle offentlich verfugbaren Dokumente des IQWiG (Institut fur Qualitat und Wirtschaftlichkeit im Gesundheitswesen) und des G‑BA (Gemeinsamer Bundesausschuss) zu den Nutzenbewertungen von Antidiabetika wurden ausgewertet. Bis 01.02.2019 wurden 35 Verfahren abgeschlossen, davon endeten 9 mit einer Beendigung des Vertriebs in Deutschland. Vom G‑BA wurden 110 Patientensubgruppen, die fur den mischkalkulatorisch verhandelten Erstattungsbetrag relevant sind, gebildet. Nur 13 davon (12 %) erhielten als Ergebnis einen Zusatznutzen (4 einen betrachtlichen und 9 einen geringen), womit im Vergleich zu den Ergebnissen fur alle Indikationen mit ca. 60 % ohne Zusatznutzen Antidiabetika signifikant schlechter abschnitten. Damit lag die Chance fur Antidiabetika, im Vergleich zu allen Indikationsgruppen keinen Zusatznutzen zu erhalten, bei 4,613. Dies ist v. a. auf methodische Grunde wie die Umsetzung der Therapieregime, indirekte Vergleiche und Wertigkeiten von Surrogatendpunkten zuruckzufuhren. Generische Vergleichstherapien bedingen daruber hinaus bei dem Ergebnis kein Zusatznutzen hohe Preisabschlage. Schwer uberwindbare methodische Hurden fuhren zu einem Bewertungsdilemma zwischen Zulassung und erforderlicher Evidenz fur die Nutzenbewertung. Ein Modus Vivendi zur Uberbruckung der Zeit von oft auf Surrogaten fusenden Erstbewertungen bis zur Neubewertung auf Basis harter Endpunktstudien ohne Marktaustritt sollte gefunden werden.

Background There is considerable evidence that repetitive negative thoughts are often associated with adverse health outcomes. The study aims are (i) to identify the frequency and valence of thoughts about health in people with diabetes mellitus using questions based on the day reconstruction method (DRM) and (ii) to analyse associations between thoughts about health and health-related quality of life (HRQoL), diabetes-related distress and depressive symptoms. Methods Cross-sectional study of a random sample of a German statutory health insurance population with diabetes aged between 18 and 80 linking questionnaire and claims data. Associations between frequency and valence of thoughts about health on a previous day and HRQoL assessed by a 12-Item Short-Form Health Survey, diabetes-related distress assessed using the Problem Areas in Diabetes scale and depressive symptoms assessed by Patient Health Questionnaire-9 were analysed using linear and logistic regression analysis, adjusting for sociodemographic and clinical characteristics. Results Thoughts about health were analysed in 726 participants (86% type 2 diabetes, 62% male, mean age 67.6 ± 9.7 years). A total of 46% had not thought about their health the day before, 17.1% reported low frequency and negative thoughts, 21.4% low frequency and positive thoughts, 12.1% high frequency and negative thoughts and 3.4% high frequency and positive thoughts. The presence of thoughts about health irrespective of their frequency and valence is associated with a lower physical and mental component summary score of the 12-Item Short-Form Health Survey. Negative thoughts are associated with high diabetes-related distress. Frequent or negative thoughts are associated with depressive symptoms. Conclusions Thoughts about health are a part of everyday life for a substantial number of people with diabetes. Surprisingly, even positive thoughts are associated with poorer HRQoL in our study. Further research within the DRM paradigm is needed to understand how thoughts about health may affect people’s (assessment of) state of health. Thoughts about health should be considered in diabetes education and patient counselling with a view to preventing and treating emotional disorders. More attention should be paid to the outcomes of interventions that may themselves lead to an increase in the frequency of thoughts about health.

OBJECTIVE Increased health care use and costs have been reported in individuals with diabetes with comorbid depression. Knowledge regarding cost differences between individuals with diabetes alone and those with diabetes and diagnosed/undiagnosed depression is, however, scarce. We therefore compared use and costs for patients with diabetes and no depression and patients with diabetes and documented depression diagnosis or self-reported depression symptoms for several cost components, including mental health care costs. RESEARCH DESIGN AND METHODS Data from a 2013 cross-sectional survey of randomly sampled members of a nationwide German statutory health insurance (SHI) provider with diabetes (n = 1,634) were linked individually with SHI data covering four quarters before and after the survey. Self-reported depression symptoms were assessed with the Patient Health Questionnaire-9, with depression diagnosis taken from SHI data. We analyzed health care use and costs, using regression analysis to calculate cost ratios (CRs) with adjustment for sociodemographic/socioeconomic factors and comorbidities for two groups: 1) those with no symptoms and no diagnosis and 2) those with symptoms or diagnosis. In our explorative subanalysis we analyzed subgroups with either symptoms or diagnosis separately. RESULTS Annual mean total health care costs were higher for patients with comorbid depression (EUR 5,629 [95% CI 4,987–6,407]) than without (EUR 3,252 [2,976–3,675], the CR being 1.25 [1.14–1.36]). Regression analysis showed that excess costs were highly associated with comorbidities. Mental health care costs were very low for patients without depression (psychotherapy EUR 2; antidepressants EUR 4) and still relatively low for those with depression (psychotherapy EUR 111; antidepressants EUR 76). CONCLUSIONS Costs were significantly higher when comorbid depression was present either as symptoms or diagnosed. Excess costs for mental health services were rather low.

Background Bempedoic acid (BA) is a novel oral low-density lipoprotein cholestrol (LDL-C) lowering drug. Its efficacy and safety for clinical outcomes in high cardiovascular risk patients remains unknown. Objectives and methods A systematic review was performed and randomized controlled trials (RCTs) of BA vs. placebo in high cardiovascular risk patients reporting clinical efficacy and safety outcomes were included in a meta-analysis. Cumulative odds ratios (OR) and mean differences with 95% confidence intervals (CI) were reported as summary statistics. Results Six RCTs with a total of 3,956 patients and follow-ups of four to 52 weeks were identified. There was no difference in MACE (OR 0.84; CI 0.61, 1.15), all-cause mortality (OR 2.37; CI 0.80, 6.99) and cardiovascular mortality (OR 1.66; CI 0.45, 6.04) for BA vs. placebo. BA showed beneficial trends for nonfatal myocardial infarction (OR 0.57; CI 0.32, 1.00) and was associated with a lower risk of new-onset or worsening of diabetes mellitus (OR 0.68; CI 0.49, 0.94) and non-coronary revascularization (OR 0.41; CI 0.18, 0.95), but higher risk of gout (OR 3.29; CI 1.28, 8.46) and a trend for worsening of renal function (OR 4.24; CI 0.98, 18.39) and muscular disorders (OR 2.60; CI 1.15, 5.91). Conclusion Bempedoic acid in high cardiovascular risk patients showed no significant effects on major cardiovascular outcomes in short-term follow-up. Unfavourable effects on muscular disorders, renal function and the incidence of gout sound a note of caution. Hence, further studies with longer-term follow-up are needed to clarify the risk/benefit ratio of this novel therapy. Funding Acknowledgement Type of funding sources: None.

AIMS Time needed for health-related activities in people with diabetes is assumed to be substantial, yet available data are limited. Time spent on self-management and associated factors was analysed using cross-sectional data from people with diagnosed diabetes enrolled in a population-based study. METHODS Mean total time spent on self-management activities was estimated using a questionnaire for all participants with diagnosed diabetes in the KORA FF4 study (n = 227, 57% men, mean age 69.7, sd 9.9 years). Multiple two-part regression models were fitted to evaluate associated factors. Multiple imputation was performed to adjust for bias due to missing values. RESULTS Some 86% of participants reported spending time on self-management activities during the past week. Over the entire sample, a mean of 149 (sd 241) min/week were spent on self-management-activities. People with insulin or oral anti-hyperglycaemic drug treatment, better diabetes education, HbA1c 48 to

Mit dem GKV-Versorgungsstarkungsgesetz erhielt der Gemeinsame Bundesausschuss den Auftrag, neue Versorgungsformen und -forschungsprojekte zu fordern. Als Forderkriterien werden u.a. die Versorgungseffizienz und die Verhaltnismasigkeit von Implementierungskosten und dem damit verbundenen Nutzen genannt. Fur die Versorgungsforschung bedeutet dies, dass auch gesundheitsokonomische Studien nun an Relevanz gewinnen. Dabei wirken der sozialrechtlich verankerte ordnungspolitische Rahmen uber das Wirtschaftlichkeitsgebot und die Beitragssatzstabilitat als Determinanten der Effizienzbewertung. Allerdings ist die Evaluation komplexer Interventionen wie neue Versorgungsformen auch mit entsprechenden methodischen Herausforderungen verknupft. Die aktuellen nationalen und internationalen Studienbeispiele zu komplexen Interventionen verdeutlichen das Potenzial und den Beitrag der gesundheitsokonomischen Disziplin zur Effizienzsteigerung in der Versorgung. Evaluating Efficiency within the Act to improve the he...

Zusammenfassung Hintergrund Krankheitskostenstudien sind wichtige Instrumente, um die sozioökonomische Krankheitslast für definierte Erkrankungen abzuschätzen. Sie liefern der Versorgungsforschung sowie der Gesundheitspolitik wichtige Informationen zur Kostenstruktur einer Erkrankung, dem sich daraus ableitenden Forschungsbedarf, Ansätze zur Versorgungsoptimierung sowie zu den monetären Auswirkungen aus unterschiedlichen Perspektiven. Aufgrund der Heterogenität verfügbarer Krankheitskostenstudien entwickelte die Arbeitsgemeinschaft (AG) Gesundheitsökonomie des Deutschen Netzwerks Versorgungsforschung (DNVF) e.V. in Abstimmung mit der Deutschen Gesellschaft für Gesundheitsökonomie (DGGÖ) e.V. für Deutschland ein Instrument zur Planung/Durchführung und Beurteilung von Krankheitskostenstudien. Methodik Aufbau und Inhalt der generischen Checkliste wurden von der AG konzipiert, konsentiert und nachfolgend in einem Pretest überprüft. Die Checkliste basiert auf einer systematischen Literaturrecherche zu nationalen und bereits vorliegenden internationalen Checklisten sowie Leitlinien und Empfehlungen für die Erstellung und Bewertung von Krankheitskostenstudien und gesundheitsökonomischen Evaluationen. Ergebnis Aus der Literaturrecherche (N=2 454) konnten 58 Referenzen zur Identifizierung und Begründung von Kriterien für die Erstellung der Checkliste genutzt werden. Nach Durchführung und Auswertung des Pretests wurden 6 Dimensionen in die Checkliste einbezogen: (i) Allgemeine Aspekte, (ii) Identifikation der Ressourcen, (iii) Beschreibung und Quantifizierung der Ressourcenverbräuche, (iv) Bewertung der Ressourcen (v) Auswertung und Ergebnisdarstellung sowie (vi) Diskussion und Schlussfolgerung. Insgesamt werden die einzelnen Dimensionen über 37 Kriterien operationalisiert. Schlussfolgerung Die Checkliste ist ein erster Ansatz, die transparente Darstellung und das Verständnis von Krankheitskostenstudien im Hinblick auf Ausmaß, Zusammensetzung und Entwicklung der sozioökonomischen Krankheitslast ausgewählter Erkrankungen zu verbessern. Sie unterstützt die Vergleichbarkeit verschiedener Analysen und erleichtert die Studienkonzeption.

The purpose of this study was to identify and analyse currently available knowledge on information needs of people with diabetes mellitus, also considering possible differences between subgroups and associated factors.Twelve databases including MEDLINE, EMBASE and the Cochrane Library were searched up until June 2015. Publications that addressed self-reported information needs of people with diabetes mellitus were included. Each study was assessed by using critical appraisal tools, e.g. from the UK National Institute for Health and Care Excellence. Extraction and content analysis were performed systematically.In total, 1993 publications were identified and 26 were finally included. Nine main categories of information needs were identified, including 'treatment-process', 'course of disease', 'abnormalities of glucose metabolism' and 'diabetes through the life cycle'. Differences between patient subgroups, such as type of diabetes or age, were sparsely analysed. Some studies analysed associations between information needs and factors such as participation preferences or information seeking. They found, for example, that information needs on social support or life tasks were associated with information seeking in Internet forums.Information needs in people with diabetes mellitus, appear to be high, yet poorly investigated. Research is needed regarding differences between diverse diabetes populations, including gender aspects or changes in information needs during the disease course.The review protocol has been registered at Prospero ( CRD42015029610 ).

Aim To develop a questionnaire suitable for assessing the information needs of individuals with diabetes mellitus types 1 and 2 in diverse healthcare settings (e.g. primary care or long-term care) and at different time points during the course of the disease. Methods The initial questionnaire was developed on the basis of literature search and analysis, reviewed by clinical experts, and evaluated in two focus groups. The revised version was pilot-tested on 39 individuals with diabetes type 2, type 1 and gestational diabetes. Results The final questionnaire reveals the most important information needs in diabetes. A choice task, a rating task and open-ended questions are combined. First, participants have to choose three topics that interest them out of a list with 12 general topics and specify in their own words their particular information needs for the chosen topics. They are then asked how informed they feel with regard to all topics (4-point Likert-scale), and whether information is currently desired (yes/no). The questionnaire ends with an open-ended question asking for additional topics of interest. Conclusions Careful selection of topics and inclusion of open-ended questions seem to be essential prerequisites for the unbiased assessment of information needs. The questionnaire can be applied in surveys in order to examine patterns of information needs across various groups and changes during the course of the disease. Such knowledge would contribute to more patient-guided information, counselling and support.

Background The 20–70% participation of diabetes patients in lifestyle interventions (LSI) worldwide seems to be rather sub-optimal, in spite of all intents of such interventions to delay further progress of the disease. Positive effects through LSI are expected in particular for patients who suffer less from diabetes-related limitations or other chronic diseases. Seeing that diabetes prevalence and with it mortality are increasing, LSI have become an inherent part of diabetes treatment standards. Various qualitative studies have been carried out to identify participation barriers for LSI. However, these have not resulted in more detailed knowledge about the relative importance of factors with an inhibiting impact on participation. Since it cannot be assumed that all of the influencing factors have equivalent values, it is necessary to investigate their individual importance with regard to a positive or negative decision about participating. There are no systematic reviews on patient preferences for LSI programs in diabetes prevention. As a result, the main objectives of this systematic review are to (i) identify existing patient preference elicitation studies related to LSI for diabetic patients, (ii) summarize the methods applied and findings, and (iii) appraise the reporting and methodological quality of such studies. Methods We will perform systematic literature searches to identify suitable studies from 14 electronic databases. Retrieved study records will be included based on predefined eligibility criteria as defined in this protocol. We will run abstract and full-text screenings and then extract data from all selected studies by filling in a predefined data extraction spreadsheet. We will undertake a descriptive, narrative synthesis of findings to address the study objectives, since no pooling for quantified preferences is for methodological reasons implementable. We will pay special attention to aspects of methodological quality of preference elicitation by applying established evaluation criteria of the ISPOR and some own developed criteria for different elicitation techniques. All critical stages within the screening, data extraction, and synthesis processes will be conducted by two pairs of authors. This protocol adheres to PRISMA and PRISMA-P standards. Discussion The proposed systematic review will provide an overview of the methods used and current practice in the elicitation and quantification of patients’ preferences for diabetes prevention lifestyle interventions. Furthermore, the methodological quality of the identified studies will be appraised as well. Systematic review registration PROSPERO CRD42018086988 Electronic supplementary material The online version of this article (10.1186/s13643-018-0884-5) contains supplementary material, which is available to authorized users.

Jonas Hoffmann,1,* Burkhard Haastert,2,* Manuela Brüne,1 Matthias Kaltheuner,3 Alexander Begun,1 Nadja Chernyak,4 Andrea Icks1,4,5 1Institute of Health Services Research and Health Economics, German Diabetes Center, Düsseldorf, Germany; 2mediStatistica, Neuenrade, Germany; 3Specialized Diabetes Practice Leverkusen, Leverkusen, Germany; 4Faculty of Medicine, Centre for Health and Society, Institute of Health Services Research and Health Economics, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany; 5German Center for Diabetes Research, Ingolstädter Neuherberg, Germany *These authors contributed equally to this work Aims: Patients with diabetes are probably often unaware of their comorbidities. We estimated agreement between self-reported comorbidities and administrative data. Methods: In a random sample of 464 diabetes patients, data from a questionnaire asking about the presence of 14 comorbidities closely related to diabetes were individually linked with statutory health insurance data. Results: Specificities were >97%, except cardiac insufficiency (94.5%), eye diseases (93.8%), peripheral arterial disease (92.6%), hypertension (90.9%), and peripheral neuropathy (85.8%). Sensitivities were 90% (hypertension, myocardial infarction, and eye disease), and six were below 70%. Six negative predictive values were >90%, and two

Background The purpose of this study was to identify and analyse currently available knowledge on information needs of people with diabetes mellitus, also considering possible differences between subgroups and associated factors. Methods Twelve databases including MEDLINE, EMBASE and the Cochrane Library were searched up until June 2015. Publications that addressed self-reported information needs of people with diabetes mellitus were included. Each study was assessed by using critical appraisal tools, e.g. from the UK National Institute for Health and Care Excellence. Extraction and content analysis were performed systematically. Results In total, 1993 publications were identified and 26 were finally included. Nine main categories of information needs were identified, including ‘treatment-process’, ‘course of disease’, ‘abnormalities of glucose metabolism’ and ‘diabetes through the life cycle’. Differences between patient subgroups, such as type of diabetes or age, were sparsely analysed. Some studies analysed associations between information needs and factors such as participation preferences or information seeking. They found, for example, that information needs on social support or life tasks were associated with information seeking in Internet forums. Conclusion Information needs in people with diabetes mellitus, appear to be high, yet poorly investigated. Research is needed regarding differences between diverse diabetes populations, including gender aspects or changes in information needs during the disease course. Systematic review registration The review protocol has been registered at Prospero (CRD42015029610). Electronic supplementary material The online version of this article (10.1186/s13643-018-0690-0) contains supplementary material, which is available to authorized users.

Cost-of-illness (CoI) studies are important instruments for estimating the socioeconomic burden of specified diseases. CoI studies provide important information about the cost structure of a disease, the resulting research need, approaches to improve aspects of care and, monetary consequences from different perspectives. This information can be useful for healthcare research and health policy. Due to heterogeneity of available Cost-of-Illness studies, the working group 'Health Economics' of the German Network for Healthcare Research (DNVF) in accordance with the German Society for Health Economics (DGGÖ) developed an instrument for the planning, conduct and assessment of CoI studies.The checklist was developed based on a systematic literature search of published national and international checklists as well as guidelines and recommendations for development and assessment of CoI studies and health economic evaluations. Structure and subject matter of the generic checklist was designed, approved and, finally, examined in a pretest by the working group.Based on the results of the literature search (n=2 454), 58 articles were used for the identification of relevant criteria for the checklist. With respect to the results of the pretest, 6 dimensions were included in the checklist: (i) general aspects, (ii) identification of resources, (iii) description and quantification of resource consumption, (iv) valuation of resources (v) analysis and presentation of results and (vi) discussion and conclusion. In total, the 6 dimensions were operationalized through 37 items.This checklist is an initial approach to improve transparency and understanding of CoI studies in terms of the extent, structure and development of the socioeconomic burden of diseases. The checklist supports the comparability of different studies and facilitates study conception.Krankheitskostenstudien sind wichtige Instrumente, um die sozioökonomische Krankheitslast für definierte Erkrankungen abzuschätzen. Sie liefern der Versorgungsforschung sowie der Gesundheitspolitik wichtige Informationen zur Kostenstruktur einer Erkrankung, dem sich daraus ableitenden Forschungsbedarf, Ansätze zur Versorgungsoptimierung sowie zu den monetären Auswirkungen aus unterschiedlichen Perspektiven. Aufgrund der Heterogenität verfügbarer Krankheitskostenstudien entwickelte die Arbeitsgemeinschaft (AG) Gesundheitsökonomie des Deutschen Netzwerks Versorgungsforschung (DNVF) e.V. in Abstimmung mit der Deutschen Gesellschaft für Gesundheitsökonomie (DGGÖ) e.V. für Deutschland ein Instrument zur Planung/Durchführung und Beurteilung von Krankheitskostenstudien.Aufbau und Inhalt der generischen Checkliste wurden von der AG konzipiert, konsentiert und nachfolgend in einem Pretest überprüft. Die Checkliste basiert auf einer systematischen Literaturrecherche zu nationalen und bereits vorliegenden internationalen Checklisten sowie Leitlinien und Empfehlungen für die Erstellung und Bewertung von Krankheitskostenstudien und gesundheitsökonomischen Evaluationen.Aus der Literaturrecherche (N=2 454) konnten 58 Referenzen zur Identifizierung und Begründung von Kriterien für die Erstellung der Checkliste genutzt werden. Nach Durchführung und Auswertung des Pretests wurden 6 Dimensionen in die Checkliste einbezogen: (i) Allgemeine Aspekte, (ii) Identifikation der Ressourcen, (iii) Beschreibung und Quantifizierung der Ressourcenverbräuche, (iv) Bewertung der Ressourcen (v) Auswertung und Ergebnisdarstellung sowie (vi) Diskussion und Schlussfolgerung. Insgesamt werden die einzelnen Dimensionen über 37 Kriterien operationalisiert.Die Checkliste ist ein erster Ansatz, die transparente Darstellung und das Verständnis von Krankheitskostenstudien im Hinblick auf Ausmaß, Zusammensetzung und Entwicklung der sozioökonomischen Krankheitslast ausgewählter Erkrankungen zu verbessern. Sie unterstützt die Vergleichbarkeit verschiedener Analysen und erleichtert die Studienkonzeption.

Purpose– In Germany, the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG)) makes recommendations for reimbursement prices of drugs based on an evaluation of the relationship between incremental costs and effects. In 2009, the German government (“Koalitionsvertrag”) announced its intention to evaluate the transparency and acceptability of IQWiG's work. The purpose of this paper is to conduct a survey of a sample of the German population: to check the acceptance of the IQWiG's decision rule compared to a decision rule used in countries such as England and Wales; and to test if the way the IQWiG's decision rule is presented affects its acceptance.Design/methodology/approach– A questionnaire was developed eliciting acceptability of IQWiG's decision rule and a single cost-effectiveness threshold applying to all diseases (i.e. absolute rule (AR)). To check for a framing effect IQWiG's decision rule was presented in two ways. One version presented it, based on IQWiG's official publication, as a constant ratio between incremental costs and effects within a therapeutic area (proportional rule (PR), Version 1). The other version presented it in terms of a proportional relationship between costs and effects within a therapeutic area (PR, Version 2).χ2goodness of fit test and two-proportionz-test tested for differences between acceptance rates of decision rules.Findings– A sample of 108 persons from the general public (average age: 41 years, 48 per cent male) filled out the questionnaire. Acceptance rates for AR, PR Version 1, and PR Version 2 were 33, 48, and 39 per cent, respectively. Direct comparisons show that acceptance of PR Version 1 was significantly higher than acceptance of AR (p=0.026) and that there was a clear trend towards higher acceptance of PR Version 1 compared to Version 2 (p=0.22). The difference between PR Version 2 and AR was not significant (p=0.32).Research limitations/implications– In our study, different presentations of the IQWiG decision rule did not significantly alter its acceptance, although there was a clear trend towards accepting IQWiG's official version. Furthermore, the acceptance of the IQWiG's official version was significantly higher than AR. Because of the relevance of the research question we recommend additional research for confirmation and explanation of the choices made.Originality/value– This is one of the few studies on the impact of framing on allocation preferences in health care.

To estimate medication costs in individuals with diagnosed diabetes, undetected diabetes, impaired glucose regulation and normal blood glucose values in a population-based sample by age and sex. Using the KORA F4 follow-up survey, conducted in 2006–2008 (n=2611, age 40–82 years), we identified individuals’ glucose tolerance status by means of an oral glucose tolerance test. We assessed all medications taken regularly, calculated age-sex specific medication costs and estimated cost ratios for total, total without antihyperglycemic drugs, and cardiovascular medication, using multiple 2-part regression models. Compared to individuals with normal glucose values, costs were increased in known diabetes, undetected diabetes and impaired glucose regulation, which was more pronounced in participants aged 40–59 years than in those aged 60–82 years (cost ratios for all medications: 40–59 years: 2.85; 95%-confidence interval: 1.78–4.54, 2.00; 1.22–3.29 and 1.53; 1.12–2.09; 60–82 years: 2.04; 1.71–2.43, 1.17; 0.90–1.51 and 1.09; 0.94–1.28). Compared to individuals with diagnosed diabetes, costs were significantly lower among individuals with impaired glucose regulation across all age and sex strata, also when antihyperglycemic medication was excluded (40–59 years: 0.60; 0.36–0.98, 60–82 years: 0.74; 0.60–0.90; men: 0.72; 0.56–0.93; women: 0.72; 0.54–0.96). We could quantify age- and sex-specific medication costs and cost ratios in individuals with diagnosed diabetes, undetected diabetes and impaired glucose regulation compared to those with normal glucose values, using data of a population-based sample, with oral glucose tolerance test-based identification of diabetes states. These results may help to validly estimate cost-effectiveness of screening and early treatment or prevention of diabetes.

Aims Patient time costs have been described to be substantial; however, data are highly limited. We estimated patient time costs attributable to outpatient and inpatient care in study participants with diagnosed diabetes, previously undetected diabetes, impaired glucose regulation and normal glucose tolerance. Methods Using data of the population-based KORA S4 study (55–74 years, random sample of n = 350), we identified participants' stage of glucose tolerance by oral glucose tolerance test. To estimate mean patient time costs per year (crude and standardized with respect to age and sex), we used data regarding time spent with ambulatory visits including travel and waiting time and with hospital stays (time valued at a 2011 net wage rate of €20.63/h). The observation period was 24 weeks and data were extrapolated to 1 year. Results Eighty-nine to 97% of participants in the four groups (diagnosed diabetes, undetected diabetes, impaired glucose regulation and normal glucose tolerance.) had at least one physician contact and 4–14% at least one hospital admission during the observation period. Patient time [h/year (95% CI)] was 102.0 (33.7–254.8), 53.8 (15.0–236.7), 59.3 (25.1–146.8) and 28.6 (21.1–43.7), respectively. Age–sex standardized patient time costs per year (95% CI) were €2447.1 (804.5–6143.6), €880.4 (259.1–3606.7), €1151.6 (454.6–2957.6) and €589.2 (435.8–904.8). Conclusions Patient time costs were substantial—even higher than medication costs in the same study population. They are higher in participants with diagnosed diabetes, but also in those with undetected diabetes and impaired glucose regulation compared with those with normal glucose tolerance. Research is needed in larger populations to receive more precise and certain estimates that can be used in health economic evaluation.

Diabet. Med. 29, 1327–1334 (2012) Abstract Aims To estimate direct costs of paediatric Type 1 diabetes care and associated factors in Germany for the year 2007 and to compare results with the costs for the year 2000. Methods Our study includes clinical data and charges for any diabetes-related health care service of 14 185 continually treated subjects with paediatric diabetes aged

We propose a new prize (reward) system for drug innovation which pays a price based on the value of health benefits accrued over time. Willingness to pay for a unit of health benefit is determined based on the cost-effectiveness ratio of palliative/nursing care. We solve the problem of limited information on the value of health benefits by mathematically relating reward size to the uncertainty of information including information on potential drug overuse. The proposed prize system offers optimal incentives to invest in research and development because it rewards the innovator for the social value of drug innovation. The proposal is envisaged as a non-voluntary alternative to the current patent system and reduces excessive marketing of innovators and generic drug producers.

Die Pravalenz des Typ-2-Diabetes mellitus (T2DM) nimmt weltweit zu. Die Erkrankung hat wegen ihrer individuellen und sozialen Belastungen hohe gesundheitswissenschaftliche Relevanz. Es konnte gezeigt werden, dass bei Patienten mit einer pradiabetischen Situation die Manifestation des T2DM durch geeignete Praventionsmasnahmen (medikamentose Interventionen, Lebensstilanderung) verhindert bzw. verzogert werden kann. Neben der Frage der Effektivitat verschiedener Masnahmen stellt sich auch die Frage der Kosteneffektivitat dieser Interventionen. Im vorliegenden Beitrag werden die Ergebnisse einer systematischen Literaturrecherche zur Kosteneffektivitat von Masnahmen zur Primarpravention des T2DM dargestellt. Es konnten 11 relevante Publikationen identifiziert werden. In allen Studien wurde berichtet, dass die Primarpravention des T2DM kosteneffektiv sein kann. Hierbei zeigten sich Unterschiede bezuglich der Kosteneffektivitat der Interventionen, die v. a. auf die verschiedenen Studiendesigns und Studienpopulationen zuruckzufuhren sind.

Komorbide Depression bei Personen mit Diabetes ist im Vergleich zu diabetischen Patienten ohne Depression mit ungunstigen Erkrankungsereignissen, erhohten medizinischen Kosten und Arbeitsunfahigkeit assoziiert. Die Betreuung dieser Patientengruppe erfordert integrierte Versorgungsmodelle. Um solche Modelle effizient zu implementieren, sind Kenntnisse uber die Kosteneffektivitat verschiedener Interventionen zur Behandlung von Depressionen bei Patienten mit Diabetes, moglichst unter Alltagsbedingungen, erforderlich. Bis jetzt haben nur wenige amerikanische Studien die Kosteneffektivitat antidepressiver Interventionen bei diabetischen Patienten untersucht. Die Ubertragbarkeit der Studienergebnisse aus den USA auf Deutschland ist jedoch fraglich. Erste Ergebnisse aus deutschen gesundheitsokonomischen Studien, die die Kosteneffektivitat von Interventionen bei Diabetes und Depressivitat evaluieren, sind Ende 2011 zu erwarten.

Der Typ-2-Diabetes hat wegen seiner individuellen und sozialen Belastungen hohe gesundheitswissenschaftliche Relevanz und nimmt weltweit zu. Es konnte gezeigt werden, dass bei Patienten mit einer pradiabetischen Situation die Manifestation des Typ-2-Diabetes durch Praventionsmasnahmen wie Lebensstilanderung und medikamentose Interventionen verhindert bzw. verzogert werden kann. Neben der Frage der Effektivitat verschiedener Masnahmen stellt sich auch die Frage der Kosteneffektivitat dieser Interventionen. Der vorliegende Beitrag zeigt Studien zur Kosteneffektivitat von Masnahmen zur Primarpravention des Typ-2-Diabetes, die in einer systematischen Literaturrecherche identifiziert wurden. In allen 11 Studien wurde berichtet, dass die Primarpravention des Typ-2-Diabetes sowohl mittels Lebensstilintervention als auch durch medikamentose Intervention kosteneffektiv sein kann.

On August 30, 2010, the German Network for Health Services Research [Deutsches Netzwerk Versorgungsforschung e.V. (DNVF e.V.)] approved the Memorandum III "Methods for Health Services Research", supported by the member societies mentioned as authors and published in this Journal [Gesundheitswesen 2010; 72: 739-748]. The present paper focuses on methodological issues of economic evaluation of health care technologies. It complements the Memorandum III "Methods for Health Services Research", part 2. First, general methodological principles of the economic evaluations of health care technologies are outlined. In order to adequately reflect costs and outcomes of health care interventions in the routine health care, data from different sources are required (e.g., comparative efficacy or effectiveness studies, registers, administrative data, etc.). Therefore, various data sources, which might be used for economic evaluations, are presented, and their strengths and limitations are stated. Finally, the need for methodological advancement with regard to data collection and analysis and issues pertaining to communication and dissemination of results of health economic evaluations are discussed., Das Deutsche Netzwerk Versorgungsforschung e. V. (DNVF e. V.) hat am 30.08.2010 getragen von den genannten im DNVF organisierten Fachgesellschaften und Organisationen, das Memorandum III „Methoden für die Versorgungsforschung” Teil 2 verabschiedet, das in dieser Zeitschrift publiziert wurde [Gesundheitswesen 2010; 72: 739-748]. Die vorliegende Publikation fokussiert auf die Methodik der ökonomischen Evaluation der Gesundheitstechnologien bzw. Interventionen und stellt eine Vertiefung zu dem Memorandum III „Methoden für die Versorgungsforschung” Teil 2 dar. Zunächst werden allgemeine methodische Standards gesundheitsökonomischer Evaluationen, d. h. Studien, die die Kosten-Nutzen Relation (Wirtschaftlichkeit) von Interventionen untersuchen, kurz dargestellt. Um Versorgungsrealität adäquat zu reflektieren, müssen zur Ermittlung der Interventionskosten und -effekte oft mehrere Datenquellen, z. B. Wirksamkeitsstudien, Register, administrative Quellen usw., verwendet werden. Daher werden für die gesundheitsökonomischen Evaluationen im Rahmen der Versorgungsforschung potenziell geeignete Datenquellen vorgestellt, ihre Vorteile und Limitationen genannt. Anschließend wird der Weiterentwicklungsbedarf der Methodik im Hinblick auf die Datenerhebung, und -auswertung sowie die Kommunikation und Dissemination der Ergebnisse diskutiert.

BACKGROUND Population-based estimates of costs of renal replacement therapy are scarce in the literature. The aim of our study was to calculate the costs of long-term dialysis in 2006 on the basis of patient-specific data from a well-defined population in a region in western Germany (n = 310,757). METHODS Cost estimation was performed from the perspective of the statutory health insurance. All dialysis patients from the study region (n = 344, 54% male, mean age (+/-SD) 69 +/- 13 years, 42% diabetic) were assessed for the costs of the dialysis procedures, dialysis-related hospital admissions, outpatient contacts outside of our dialysis center, dialysis-related medication, patient transportation and related costs (e.g. reimbursement fees on the basis of the German diagnosis-related group system, price scales). We estimated the cumulative cost per patient year in 2006 (in Euros), along with the 10th and 90th percentiles and the 95% confidence intervals (CI) by using bootstrapping procedures. RESULTS The mean total dialysis-related cost in 2006 was 54,777 Euros (95% CI, 51,445-65,705) per patient year. The largest part of the costs (55%) was caused by the dialysis procedures, followed by the costs of medication (22%), hospitalization (14%) and transportation (8%). The total cost increased significantly with increasing age. No significant association was found between total cost and sex, dialysis strategy, end-stage renal disease duration and diabetes. CONCLUSIONS We present for the first time a cost estimation of dialysis in Germany on the basis of patient-level data in a population-based sample. Except age, patient characteristics were not significantly associated with costs. The largest part of the costs was caused by the dialysis procedures themselves; however, other dialysis-specific health care utilization also strongly contributed to the total cost.

Background Methods to measure patient time spent on health-related activities are currently not well elaborated or standardized. Aim The purpose of this study was to develop a recall questionnaire measuring patient time devoted to diabetes self-care and to examine its feasibility and validity under field conditions. Methods The initial questionnaire was developed on the basis of instruments frequently used to assess self-care behavior in patients with diabetes, evaluated in two focus groups with patients with type 2 diabetes (N=15) and tested in a random sample of patients with type 2 diabetes (N=178). To assess the validity of the questionnaire, four hypotheses about expected differences in self-care time across various patient sub-groups were tested. Results The final questionnaire includes thirteen items estimating time spent on regular diabetes-related activities undertaken in the previous seven days. 78% of respondents completed the questionnaire without item non-response or other evident problems. As hypothesized, respondents receiving insulin treatment, those with poor self-rated health and those with diabetes-related emotional distress (PAID-5 score ≥8) reported spending more time on diabetes self-care than the rest of the sample. Contrary to our assumption, no differences in time spent on diabetes self-care between employed and retired individuals were detected by the questionnaire. Conclusion The recall questionnaire measuring patient time devoted to a broad range of regular diabetes self-care activities was developed and its feasibility was proved under field conditions. Ideally, the questionnaire should be further validated within a variety of populations. Exploration of the convergent validity between the recall method and prospective diary may be also useful.

Background Exploring health-related information needs is necessary to better tailor information. However, there is a lack of systematic knowledge on how and in which groups information needs has been assessed, and which information needs have been identified. We aimed to assess the methodology of studies used to assess information needs, as well as the topics and extent of health-related information needs and associated factors in Germany. Methods A systematic search was performed in Medline, Embase, Psycinfo, and all databases of the Cochrane Library. All studies investigating health-related information needs in patients, relatives, and the general population in Germany that were published between 2000 and 2012 in German or English were included. Descriptive content analysis was based on predefined categories. Results We identified 19 studies. Most studies addressed cancer or rheumatic disease. Methods used were highly heterogeneous. Apart from common topics such as treatment, diagnosis, prevention and health promotion, etiology and prognosis, high interest ratings were also found in more specific topics such as complementary and alternative medicine or nutrition. Information needs were notable in all surveyed patient groups, relatives, and samples of the general population. Younger age, shorter duration of illness, poorer health status and higher anxiety and depression scores appeared to be associated with higher information needs. Conclusion Knowledge about information needs is still scarce. Assuming the importance of comprehensive information to enable people to participate in health-related decisions, further systematic research is required. Electronic supplementary material The online version of this article (doi:10.1186/s12913-015-1076-9) contains supplementary material, which is available to authorized users.

Background A brief psychodynamic interpersonal therapy (PIT) in patients with multisomatoform disorder has been recently shown to improve health-related quality of life. Aims To assess cost-effectiveness of PIT compared to enhanced medical care in patients with multisomatoform disorder. Method An economic evaluation alongside a randomised controlled trial (International Standard Randomised Controlled Trial Number ISRCTN23215121) conducted in 6 German academic outpatient centres was performed. Incremental cost-effectiveness ratio (ICER) was calculated from the statutory health insurance perspective on the basis of quality adjusted life years (QALYs) gained at 12 months. Uncertainty surrounding the cost-effectiveness of PIT was presented by means of a cost-effectiveness acceptability curve. Results Based on the complete-case analysis ICER was 41840 Euro per QALY. The results did not change greatly with the use of multiple imputation (ICER = 44222) and last observation carried forward (LOCF) approach to missing data (ICER = 46663). The probability of PIT being cost-effective exceeded 50% for thresholds of willingness to pay over 35 thousand Euros per QALY. Conclusions Cost-effectiveness of PIT is highly uncertain for thresholds of willingness to pay under 35 thousand Euros per QALY.

Undetected diabetes and prediabetes are common (1–3). In decision analytic models of diabetes prevention and screening in particular, the differentiation in costs of detected, undetected, and prediabetic cases are important (4). To the best of our knowledge, no study has determined costs using population-based data with oral glucose tolerance test (OGTT)–based diabetes diagnosis. We used the population-based Cooperative Health Research in the Region of Augsburg (KORA) follow-up survey, conducted in 2006–2008 in southern Germany (2,3) ( n = 2,611, aged 40–82 years). By means of participants’ self report and an OGTT, we identified individuals with previously diagnosed diabetes ( n = 233, 57.9% male, mean age 67.8 ± 8.7), undetected diabetes ( n = 109, 56.9% male, mean age 65.3 ± 10.4), and prediabetes (i.e., impaired glucose tolerance and/or impaired fasting glucose) ( n = 489, 53.2% male, mean age 63.7 ± 10.4), and those with normal …

Background Validated instruments collecting data on health-related resource use are lacking, but required, for example, to investigate predictors of healthcare use or for health economic evaluation. The objective of the study was to develop, test and refine a questionnaire collecting data on health-related resource use and expenditure in patients with diabetes. Methods The questionnaire was tested in 43 patients with diabetes mellitus types 1 and 2 in Germany. Response behaviour suggestive of problems with questions (item non-response, request for clarification, comments, inadequate answer, “don’t know”) was systematically registered. Cognitive interviews focusing on information retrieval and comprehension problems were carried out. Results Many participants had difficulties answering questions pertaining to frequency of visits to the general practitioner (26%), time spent receiving healthcare services (39%), regular medication currently taken (35%) and out of pocket expenditure on medication (42%). These difficulties seem to result mainly from poor memory. A number of comprehension problems were established and relevant questions were revised accordingly. Conclusion The questionnaire on health-related resource use and expenditure for use in diabetes research in Germany was developed and refined after careful testing. Ideally, the questionnaire should be externally validated for different modes of administration and recall periods within a variety of populations.

Background Depression and elevated depression symptoms are more prevalent in patients with type 2 diabetes than in those without diabetes and are associated with adverse health outcomes and increased total healthcare utilization. This suggests that more effective depression treatment might not only improve health outcome, but also reduce costs. However, there is a lack of evidence on (cost-) effectiveness of treatment options for minor and mild-major depression in patients with type 2 diabetes. In this paper we describe the design and methods of the economic evaluation, which will be conducted alongside the MIND-DIA trial (Cognitive behaviour therapy in elderly type 2 diabetes patients with minor or mild-major depression). The objective of the economic evaluation (MIND-DIA CEA) is to examine incremental cost-effectiveness of a diabetes specific cognitive behaviour group therapy (CBT) as compared to intensified treatment as usual (TAU) and to a guided self-help group intervention (SH). Methods/Design Patients will be followed for 15 months. During this period data on health sector costs, patient costs and societal productivity/time costs will be collected in addition to clinical data. Person-years free of moderate/severe major depression, quality adjusted life years (QALYs), and cumulative costs will be estimated for each arm of the trial (CBT, TAU and SH). To determine cost-effectiveness of the CBT, differences in costs and effects between the CBT group and TAU/SH group will be calculated. Discussion CBT is a potentially effective treatment option to improve quality of life and to avoid the onset of a moderate/severe major depression in elderly patients with type 2 diabetes and minor or mild-major depression. This hypothesis will be evaluated in the MIND-DIA trial. Based on these results the associated economic evaluation will provide additional evidence on the cost-effectiveness of CBT in this target population. Methodological strengths and weaknesses of the planned economic evaluation are discussed. Trial registration The MIND-DIA study has been registered at the Current Controlled Trials Register (ISRCTN58007098).

Background Despite the high prevalence of subthreshold depression in patients with type 2 diabetes, evidence on cost-effectiveness of different therapy options for these patients is currently lacking. Methods/Design Within-trial economic evaluation of the diabetes-specific cognitive behaviour therapy for subthreshold depression. Patients with diabetes and subthreshold depression are randomly assigned to either 2 weeks of diabetes-specific cognitive behaviour group therapy (n = 104) or to standard diabetes education programme only (n = 104). Patients are followed for 12 months. During this period data on total health sector costs, patient costs and societal productivity costs are collected in addition to clinical data. Health related quality of life (the SF-36 and the EQ-5D) is measured at baseline, immediately after the intervention, at 6 and at 12 months after the intervention. Quality adjusted life years (QALYs), and cumulative costs will be estimated for each arm of the trial. Cost-effectiveness of the diabetes-specific cognitive behaviour group therapy will be analysed from the perspective of the German statutory health insurance and from the societal perspective. To this end, incremental cost-effectiveness ratio (ICER) in terms of cost per QALY gained will be calculated. Discussion Some methodological issues of the described economic evaluation are discussed. Trial registration The trial has been registered at the Clinical Trials Register (NCT01009138).