[Development of Decision Aids for Organized Cervical Carcinoma Screening in Germany]. / Entwicklung von Entscheidungshilfen für das organisierte Zervixkarzinom-Screening in Deutschland.

AIM OF THE STUDY: The Federal Joint Committee has decided to introduce organized cervical carcinoma screening in 2020. The present work describes the development of decision aids that will be sent to women in this program. METHODS: A systematic search for qualitative studies and surveys was conducted to gather information on experiences, attitudes and information needs. Furthermore, we searched for systematic reviews on advantages and disadvantages of screening. An existing decision analysis for cervical carcinoma screening in Germany was used. The designs were subjected to a qualitative test (focus groups with 26 women and 8 expert interviews), to a quantitative user test (online survey n=2,014 women) and to a public hearing. RESULTS: Most women found the decision aids informative and helpful. The majority would recommend the use of these materials to others. For many women, part of the information was new, although they had been involved in cervical cancer screening for some time. The presentation of the advantages and disadvantages was judged to be balanced. However, 10% changed their attitude towards participation and 70% of women would attend screening. CONCLUSION: The decision aids found a high acceptance among the users. They can help to reduce knowledge deficits on cervical carcinoma screening and support a informed decision making.

Patients' preferences in periodontal disease treatment elicited alongside an IQWiG benefit assessment: a feasibility study.

BACKGROUND AND PURPOSE: The German Institute for Quality and Efficiency in Health Care (IQWiG) previously tested two preference elicitation methods in pilot projects and regarded them as generally feasible for prioritizing outcome-specific results of benefit assessment. The present study aimed to investigate the feasibility of completing a discrete choice experiment (DCE) within 3 months and to determine the relative importance of attributes of periodontal disease and its treatment. PATIENTS AND METHODS: This preference elicitation was conducted alongside the IQWiG benefit assessment of systematic treatments of periodontal diseases. Attributes were defined based on the benefit assessment, literature review, and patients' and periodontologists' interviews. The DCE survey was completed by patients with a history of periodontal disease. Preferences were elicited for the attributes "tooth loss within next 10 years", "own costs for treatment, follow-up visits, re-treatment", "complaints and symptoms", and "frequency of follow-up visits". Patients completed a self-administered questionnaire including 12 choice tasks. Data were analyzed using a random parameters logit model. The relative attribute importance was calculated based on level ranges. RESULTS: Within 3 months, survey development, data collection among 267 patients, data analysis, and provision of a study report could be completed. The analysis showed that tooth loss (score 0.73) was the most important attribute in patients' decisions, followed by complaints and symptoms (0.22), frequency of follow-up visits (0.02), and costs (0.03) (relative importance scores summing up to 1). CONCLUSION: A preference analysis performing a DCE can be generally feasible within 3 months; however, a good research infrastructure and access to patients is required. Outcomes used in benefit assessments might need to be adapted to be used in preference analyses.

Estimation of Input Costs for a Markov Model in a German Health Economic Evaluation of Newer Antidepressants.

Background: Estimating input costs for Markov models in health economic evaluations requires health state-specific costing. This is a challenge in mental illnesses such as depression, as interventions are not clearly related to health states. We present a hybrid approach to health state-specific cost estimation for a German health economic evaluation of antidepressants. Methods: Costs were determined from the perspective of the community of persons insured by statutory health insurance ("SHI insuree perspective") and included costs for outpatient care, inpatient care, drugs, and psychotherapy. In an additional step, costs for rehabilitation and productivity losses were calculated from the societal perspective. We collected resource use data in a stepwise hierarchical approach using SHI claims data, where available, followed by data from clinical guidelines and expert surveys. Bottom-up and top-down costing approaches were combined. Results: Depending on the drug strategy and health state, the average input costs varied per patient per 8-week Markov cycle. The highest costs occurred for agomelatine in the health state first-line treatment (FT) ("FT relapse") with €506 from the SHI insuree perspective and €724 from the societal perspective. From both perspectives, the lowest costs (excluding placebo) were €55 for selective serotonin reuptake inhibitors in the health state "FT remission." Conclusion: To estimate costs in health economic evaluations of treatments for depression, it can be necessary to link different data sources and costing approaches systematically to meet the requirements of the decision-analytic model. As this can increase complexity, the corresponding calculations should be presented transparently. The approach presented could provide useful input for future models.

[Checklist for the Development and Assessment of Cost-of-Illness Studies]. / Checkliste zur Erstellung und Bewertung von Krankheitskostenstudien.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Decision making in Germany: is health economic evaluation as a supporting tool a sleeping beauty?

For many years, the legal situation within the statutory health insurance (SHI) system in Germany has allowed for health economic evaluations. There are various reasons why health economic evaluations have played virtually no role in decision making until now: to begin with, a method for the evaluation of the relation between benefits and costs which needed to be in accordance with the legal requirements had to be developed, the outcome of which was the efficiency frontier approach. Subsequent health care reforms have led to changing objectives and strategies. Currently, price negotiations of newly launched drugs are based on an early benefit assessment of dossiers submitted by pharmaceutical manufacturers. Other reasons might be the presently very comfortable financial situation of the statutory health insurance system as well as a historically grown societal fear and discomfort towards what is perceived to be a rationing of medicinal products. For the time being, it remains open how long the German health care system can afford to continue neglecting the benefits of health economic evaluations for drug and non-drug interventions, and when it will be time to wake this sleeping beauty.