Knowledge of HbA1c and LDL-C treatment goals, subjective level of disease-related information and information needs in patients with atherosclerotic cardiovascular disease.

BACKGROUND/HYPOTHESIS: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.

Self-care time and rating of health state in persons with diabetes: results from the population-based KORA survey in Germany.

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.

Clinical efficacy and safety outcomes of bempedoic acid for LDL-C lowering therapy in patients at high cardiovascular risk: a systematic review and meta-analysis.

OBJECTIVES: Bempedoic acid (BA) is a novel oral low-density lipoprotein cholesterol lowering drug. This systematic review and meta-analysis aims to assess efficacy and safety for clinical outcomes in high cardiovascular (CV) risk patients. DATA SOURCES: MEDLINE, Cochrane Central Register of Controlled Trials, Google Scholar, Embase, ClinicalTrials.gov, Clinical Trial Results and the American College of Cardiology web site were searched. STUDY SELECTION: Randomised controlled trials (RCTs) of BA versus placebo in high CV risk patients reporting clinical outcomes were included. MAIN OUTCOMES AND MEASURES: Primary efficacy outcomes were major adverse cardiovascular events (MACE), all-cause mortality, CV mortality and non-fatal myocardial infarction (MI). Safety outcomes included new onset or worsening of diabetes mellitus (DM), muscular disorders, gout and worsening of renal function. RESULTS: Six RCTs with a total of 3956 patients and follow-ups of four to 52 weeks were identified. Heterogeneity mainly derived from differing follow-up duration and baseline CV risk. No difference in MACE (OR 0.84; 95% CI 0.61 to 1.15), all-cause mortality (OR 2.37; CI 0.80 to 6.99) and CV mortality (OR 1.66; CI 0.45 to 6.04) for BA versus placebo was observed. BA showed beneficial trends for non-fatal MI (OR 0.57; CI 0.32 to 1.00) and was associated with a lower risk of new-onset or worsening of DM (OR 0.68; CI 0.49 to 0.94), but higher risk of gout (OR 3.29; CI 1.28 to 8.46) and a trend for muscular disorders (OR 2.60; CI 1.15 to 5.91) and worsening of renal function (OR 4.24; CI 0.98 to 18.39). CONCLUSION: BA in high CV risk patients showed no significant effects on major CV outcomes in short-term follow-up. Unfavourable effects on muscular disorders, renal function and gout sound a note of caution. Hence, further studies with longer term follow-up in carefully selected populations are needed to clarify the risk/benefit ratio of this novel therapy.

Thoughts about health and patient-reported outcomes among people with diabetes mellitus: results from the DiaDec-study.

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.

Health Care Use and Costs in Individuals With Diabetes With and Without Comorbid Depression in Germany: Results of the Cross-sectional DiaDec Study.

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.

Correction to: Information needs in people with diabetes mellitus: a systematic review.

Following publication of the original article [1], the authors opted to revise Table 1. Below is the updated version of the table.

Quantified patient preferences for lifestyle intervention programs for diabetes prevention-a protocol for a systematic review.

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.

How do patients with diabetes report their comorbidities? Comparison with administrative data.

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 <60%, except amputation (100%), hypertension (83.1%), and myocardial infarction (67.2%). A few positive predictive values were >90% (hypertension, myocardial infarction, and eye disease), and six were below 70%. Six negative predictive values were >90%, and two <70% (hypertension and eye disease). Total agreement was between 42.7% (eye disease) and 100% (dialysis and amputation). Overall, substantial agreement was observed for three morbidities (kappa 0.61-0.80: hypertension, myocardial infarction, and amputation). Moderate agreement (kappa 0.41-0.60) was estimated for angina pectoris, heart failure, stroke, peripheral neuropathy, and kidney disease. Factors associated with agreement were the number of comorbidities, diabetes duration, age, sex, and education. CONCLUSIONS: Myocardial infarction and amputation were well reported by patients as comorbidities; eye diseases and foot ulceration rather poorly, particularly in older, male, or less educated patients. Patient information needs improving.

Information needs in people with diabetes mellitus: a systematic review.

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 ).

[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.

Time cost of diabetes: Development of a questionnaire to assess time spent on diabetes self-care.

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.

Agreement found between self-reported and health insurance data on physician visits comparing different recall lengths.

OBJECTIVE: To analyze the impact of different recall lengths on agreement between self-reported physician visits and those documented in health insurance data applying an experimental design. STUDY DESIGN AND SETTING: We randomly assigned 432 patients with diabetes to one of two versions of a written survey, each asking about the number of physician visits over a 3- or 6-month recall period. Health insurance data were linked individually. RESULTS: In both groups, the mean number of self-reported physician visits per month was lower than in the insurance data, with a larger difference in the 6-month group (-0.9; 95% CI -1.0, -0.7) than in the 3-month group (-0.5; -0.7; -0.2), difference between the two groups: 0.4 (0.1-0.7; P = 0.009). The percentage of participants with correct reporting was small and did not differ largely between the two groups (6.5% and 9.3%). However, there was more overreporting in the 3-month group (25.6% vs. 11.1%). CONCLUSIONS: Shorter recall periods may produce more accurate results when estimating the mean number of physician visits. However, this may be driven not by a more accurate reporting, but by a higher proportion of respondents that overreported and a lower proportion of respondents that underreported, when compared to the longer reporting period.

Studies analysing the need for health-related information in Germany - a systematic review.

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.

Economic evaluation of brief psychodynamic interpersonal therapy in patients with multisomatoform disorder.

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.

Pre-test of questions on health-related resource use and expenditure, using behaviour coding and cognitive interviewing techniques.

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.

A new prize system for drug innovation.

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.

Within-trial economic evaluation of diabetes-specific cognitive behaviour therapy in patients with type 2 diabetes and subthreshold depression.

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).

Costs of dialysis--a regional population-based analysis.

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.