New prescription of antihyperglycemic agents among patients with diabetes in Germany: Moderate concordance between health insurance data and self-reports.

PURPOSE: To analyze the concordance of new prescription of antihyperglycemic agents between two data sources: patients' self-reports and statutory health insurance (SHI) data among patients with diabetes. METHODS: Within a cross-sectional study, 494 patients with diabetes were interviewed if and which new prescriptions of diabetes medication they received within the last 3 or 6 months. SHI data for 12 months were linked to cover these periods. For the agreement measurement, SHI data was set as reference, and kappa, positive predictive value (PPV), and sensitivity were calculated for single Anatomical Therapeutic Chemical (ATC) codes and cumulated code groups. RESULTS: The number of new prescriptions within 3 or 6 months was low, with 5.5% (n = 27) for Metformin/self-report being the highest. Contingency tables were unbalanced and showed large numbers in the no/no-cells. Regarding non-agreement, we found new prescriptions slightly more often in SHI data only than in self-reports only, with insulin and metformin representing an exception. Agreement results were moderate with large confidence intervals (CI). The values for cumulated "all drugs in diabetes" were: kappa = 0.58 (95% CI: 0.51-0.65), PPV = 62.0 (53.4-70.2), sensitivity = 55.6 (47.3-63.6). CONCLUSIONS: Patients reported a low number of new prescriptions within the last 3 or 6 months. In general we found moderate agreement and in case of non-agreement that self-report no/SHI yes was slightly more frequent than vice versa. These results were based on small case numbers, but could nevertheless be considered when collecting self-reported information on the prescription of antihyperglycemic agents.

Study on advance care planning in care dependent community-dwelling older persons in Germany (STADPLAN): protocol of a cluster-randomised controlled trial.

BACKGROUND: In Germany, advance care planning (ACP) was first introduced by law in 2015. However, ACP is still uncommon in Germany and only few people have advance directive forms. This study aims to evaluate an ACP program in care dependent community-dwelling persons, compared to optimised usual care. METHODS: A cluster-randomised controlled trial of 12 months duration will be conducted in 3 German study sites comparing the pretested ACP-counselling offered by trained nurses with a control group receiving optimised usual care. Using external concealed randomisation, 16 home care services each will be included in the intervention and the control group (30 participants per cluster; n = 960). Eligibility criteria for patients are: ≥60 years, somehow care dependent, adequate German language skills, assumed life-expectancy of ≥4 weeks, and cognitive ability for participation. ACP will be delivered by trained nurse facilitators of the respective home care services and communication will include proxy decision-makers. The primary endpoint will be patient activation, assessed by the Patient Activation Measure (PAM-13). Secondary endpoints include ACP-engagement, proportion of prepared advance directives, number and duration of hospitalisations, quality of life as well as depression and anxiety. Further, comprehensive economic and process evaluations will be conducted. DISCUSSION: STADPLAN is the first study in Germany that assesses an adapted ACP intervention with trained nurses in home care services and the first international study focusing on cost effectiveness of ACP in community-dwelling older persons. The results will help to improve the understanding and communicating of patients' preferences regarding medical treatment and care and thereby contribute to patients' autonomy. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00016886 (Date of registration: 04.06.2019).

Healthcare provision, functional ability and quality of life after proximal femoral fracture - 'ProFem': Study protocol of a population-based, prospective study based on individually linked survey and statutory health insurance data.

INTRODUCTION: Proximal femoral fractures (PFF) are among the most frequent fractures in older people. However, the situation of people with a PFF after hospital discharge is poorly understood. Our aim is to (1) analyse healthcare provision, (2) examine clinical and patient-reported outcomes (PROs), (3) describe clinical and sociodemographic predictors of these and (4) develop an algorithm to identify subgroups with poor outcomes and a potential need for more intensive healthcare. METHODS AND ANALYSIS: This is a population-based prospective study based on individually linked survey and statutory health insurance (SHI) data. All people aged minimum 60 years who have been continuously insured with the AOK Rheinland/Hamburg and experience a PFF within 1 year will be consecutively included (SHI data analysis). Additionally, 700 people selected randomly from the study population will be consecutively invited to participate in the survey. Questionnaire data will be collected in the participants' private surroundings at 3, 6 and 12 months after hospital discharge. If the insured person considers themselves to be only partially or not at all able to take part in the survey, a proxy person will be interviewed where possible. SHI variables include healthcare provision, healthcare costs and clinical outcomes. Questionnaire variables include information on PROs, lifestyle characteristics and socioeconomic status. We will use multiple regression models to estimate healthcare processes and outcomes including mortality and cost, investigate predictors, perform non-responder analysis and develop an algorithm to identify vulnerable subgroups. ETHICS AND DISSEMINATION: The study was approved by the ethics committee of the Faculty of Medicine, Heinrich-Heine-University Düsseldorf (approval reference 6128R). All participants including proxies providing written and informed consent can withdraw from the study at any time. The study findings will be disseminated through scientific journals and public information. TRIAL REGISTRATION NUMBER: DRKS00012554.

What information needs do people with recently diagnosed diabetes mellitus have and what are the associated factors? A cross-sectional study in Germany.

OBJECTIVES: This study aimed to identify: (1) information needs of people with recently diagnosed type 1 or type 2 diabetes mellitus (DM); (2) information needs within different subgroups; and (3) factors associated with information needs concerning DM such as current level of information, health-related quality of life or participation preferences. DESIGN: A mixed-method approach combining quantitative and qualitative methods was used. Information needs for different topics and estimated associated factors were described using logistic regression models. Additionally, a qualitative content analysis was performed. SETTING: Monocentre study. PARTICIPANTS: Information needs were assessed and analysed in 138 consecutive participants with DM who took part in the German Diabetes Study (54% type 2 diabetes, 64% male, mean age 46.3±12.3 years, known diabetes duration <1 year). RESULTS: Most participants displayed a need for information in all topics provided, especially in diabetes research (86%) and treatment/therapy (80%). Regarding those topics, participants wished for information regarding new treatments that simplify their everyday life. In general, participants preferred topics that focus on the management or handling of DM over topics related to clinical factors of DM, such as causes and complications. A low current level of information and treatment with antihyperglycaemic medication were significantly associated with higher information needs, and diabetes-related comorbidity and higher mental component summary score in the 36-Item Short-Form Health Survey (SF-36) with lower information needs. CONCLUSION: People with recently diagnosed DM display high information needs, which differ according to the current level of information, mode of diabetes treatment, diabetes-related comorbidity and mental component summary score in the SF-36. There appears to be a preference for information, which can help to simplify life with diabetes and for information that corresponds to their level of knowledge. This should be considered in patient information activities. TRIAL REGISTRATION NUMBER: NCT01055093.

Effects of the birthing room environment on vaginal births and client-centred outcomes for women at term planning a vaginal birth: BE-UP, a multicentre randomised controlled trial.

BACKGROUND: Caesarean sections (CSs) are associated with increased risk for maternal morbidity and mortality. The recommendations of the recently published German national health goal 'Health in Childbirth' (Gesundheit rund um die Geburt) promote vaginal births (VBs). This randomised controlled trial (RCT) evaluates the effects of a complex intervention pertaining to the birth environment, based on the sociology of technical artefacts and symbolic interactionism. The intervention is intended to foster an upright position and mobility during labour, which lead to a higher probability of VB. METHODS/DESIGN: This study is an active controlled superiority trial with a two-arm parallel design. The complex intervention involves making changes to the birthing room to encourage an upright position and mobility of women in labour and to relax them, which may help them to cope with labour and may increase self-determination. This may result in more VBs. Included in the study are primiparae and multiparae with a singleton foetus in cephalic presentation at term planning a VB. According to the sample size calculation, 3800 women in 12 obstetrical units are to be included. Randomisation will be performed centrally and controlled by an independent coordination centre. Blinding of participants and staff is not possible. Key outcomes are VB, episiotomy, perineal tears, epidural analgesia, critical outcome of newborn at term and maternal self-determination during birth. Additionally, a health economic evaluation will be performed. DISCUSSION: This is the first adequately powered multicentre RCT examining the effect of a redesigned birthing room on the probability of a VB and patient-centred physical and emotional outcomes. An increase in the number of VBs by 5% from a baseline of 74% to 79% would result in 21,000 women per year experiencing a VB rather than a CS in Germany. Expected benefits are greater self-determination during labour, improved physical and emotional client-centred outcomes, fewer medical interventions and a reduction in health-care costs. TRIAL REGISTRATION: German Clinical Trials Register (Deutsches Register Klinischer Studien), DRKS00012854 . Registered on 7 March 2018.

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.

Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): study protocol for a cluster-randomised controlled trial.

BACKGROUND: The majority of nursing home residents with dementia experience behavioural and psychological symptoms like apathy, agitation, and anxiety. According to analyses of prescription prevalence in Germany, antipsychotic drugs are regularly prescribed as first-line treatment of neuropsychiatric symptoms in persons with dementia, although guidelines clearly prioritise non-pharmacological interventions. Frequently, antipsychotic drugs are prescribed for inappropriate reasons and for too long without regular reviewing. The use of antipsychotics is associated with adverse events like increased risk of falling, stroke, and mortality. The aim of the study is to investigate whether a person-centred care approach, successfully evaluated in nursing homes in the United Kingdom, can be implemented in German nursing homes and, in comparison with a control group, can result in a clinically relevant reduction of the proportion of residents with antipsychotic prescriptions. METHODS/DESIGN: The study is a cluster-randomised controlled trial comparing an intervention group (two-day initial training on person-centred care and ongoing training and support programme) with a control group. Both study groups will receive, as optimised usual care, a medication review by an experienced psychiatrist/geriatrician providing feedback to the prescribing physician. Overall, 36 nursing homes in East, North, and West Germany will be randomised. The primary outcome is the proportion of residents receiving at least one antipsychotic prescription (long-term medication) after 12 months of follow-up. Secondary outcomes are residents' quality of life, agitated behaviour, as well as safety parameters like falls and fall-related medical attention. A health economic evaluation and a process evaluation will be performed alongside the study. DISCUSSION: To improve care, a reduction of the current high prescription rate of antipsychotics in nursing homes by the intervention programme is expected. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02295462.

Socioeconomic factors and effect of evidence-based patient information about primary prevention of type 2 diabetes mellitus--are there interactions?

BACKGROUND: Having shown in a recent randomized controlled trial that evidence-based patient information (EBPI) significantly increased knowledge on primary prevention of diabetes compared to standard patient information, we now investigated interaction between socioeconomic status (SES) and the effect of an EBPI. FINDINGS: 1,120 visitors (aged 40-70 years, without known diabetes) to the "Techniker Krankenkasse" and the "German Diabetes Center" websites were randomized. The intervention group received a newly developed on-line EBPI, the control group standard on-line information. The primary outcome measure was knowledge, classified as "good/average/poor". We analyzed associations of knowledge with socioeconomic variables (education, vocational training, employment, subjective social status) combined with intervention effect including interactions, adjusted for possible confounding by knowledge before intervention, self-reported blood glucose measurements, blood pressure, blood lipid levels, age and gender. Logistic regression models were fitted to the subpopulation (n = 647) with complete values in these variables.Education (high vs. low) was significantly associated with knowledge (good vs. average/poor); however, there was no significant interaction between education and intervention. After adjustment, the other socioeconomic variables were not significantly associated with knowledge. CONCLUSIONS: Socioeconomic variables did not significantly change the effect of the intervention. There was a tendency towards a lower effect where lower educated individuals were concerned. Possibly the power was too low to detect interaction effects. Larger studies using SES-specific designs are needed to clarify the effect of SES. We suggest considering the socioeconomic status when evaluating a decision aid, e.g. an EBPI, to ensure its effectiveness not only in higher socioeconomic groups. TRIAL REGISTRATION: Current Controlled Trials ISRCTN22060616 (Date assigned: 12 September 2008).

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.

Comparison of a fall risk assessment tool with nurses' judgement alone: a cluster-randomised controlled trial.

BACKGROUND: the impact of fall risk assessment tools on clinical endpoints is unknown. OBJECTIVE: we compared a standardised fall risk assessment tool alongside nurses' clinical judgement with nurses' judgement alone. DESIGN: a 12-month cluster-randomised controlled trial. SETTING: nursing homes in Hamburg (29 per study group). SUBJECTS: 1,125 residents (n = 574 intervention group, IG; n = 551 control group, CG). INTERVENTIONS: all homes received structured information on fall prevention before randomisation. The IG monthly administered the Downton Index, and the CG did not use a tool. Measurements were number of participants with at least one fall, falls, fall-related injuries and medical attention, fall preventive measures, physical restraints. RESULTS: the mean follow-up was 10.8 +/- 2.9 months in both groups: 105 (IG) and 114 (CG) residents died or moved away. There was no difference between the groups concerning the number of residents with at least one fall (IG: 52%, CG: 53%, mean difference -0.7, 95% confidence interval -10.3 to 8.9, P = 0.88) and the number of falls (n = 1,016 and n = 1,014). All other outcomes were also comparable between the IG and CG. CONCLUSIONS: application of a fall risk assessment tool in nursing homes does not result in the better clinical outcome than reliance on nurses' clinical judgement alone.

Hip fractures and area level socioeconomic conditions: a population-based study.

BACKGROUND: Only a limited number of studies have analyzed the association between hip fracture incidence and socioeconomic conditions. Most, but not all found an association, and results are in part conflicting. The aim of our study was to evaluate the association between hip fractures and socioeconomic conditions in Germany, from 1995 to 2004, on a census tract area level. METHODS: We used data from the national hospital discharge diagnosis register and data on socioeconomic and demographic characteristics of 131 census tracts from official statistics. Associations between the hip fracture incidence and socioeconomic conditions were analyzed by multiple Poisson regression models, taking overdispersion into account. RESULTS: The risk of hip fracture decreased by 4% with a 7% increase (about one interquartile range) of non-German nationals. It decreased by 10% with a 6% increased rate of unemployment, increased by 7% with a 2% increase of the proportion of welfare recipients, and also increased by 3% with an increase of the proportion of single parent families of 1.9%. CONCLUSION: Our results showed weak associations between indicators of socioeconomic conditions at area level and hip fracture risk; the varied by type of indicator. We conclude that hip fracture incidence might be influenced by the socioeconomic context of a region, but further analysis using more specific markers for deprivation on a smaller scale and individual-level data are needed.

Mixed-meal tolerance test versus glucagon stimulation test for the assessment of beta-cell function in therapeutic trials in type 1 diabetes.

OBJECTIVE: Beta-cell function in type 1 diabetes clinical trials is commonly measured by C-peptide response to a secretagogue in either a mixed-meal tolerance test (MMTT) or a glucagon stimulation test (GST). The Type 1 Diabetes TrialNet Research Group and the European C-peptide Trial (ECPT) Study Group conducted parallel randomized studies to compare the sensitivity, reproducibility, and tolerability of these procedures. RESEARCH DESIGN AND METHODS: In randomized sequences, 148 TrialNet subjects completed 549 tests with up to 2 MMTT and 2 GST tests on separate days, and 118 ECPT subjects completed 348 tests (up to 3 each) with either two MMTTs or two GSTs. RESULTS: Among individuals with up to 4 years' duration of type 1 diabetes, >85% had measurable stimulated C-peptide values. The MMTT stimulus produced significantly higher concentrations of C-peptide than the GST. Whereas both tests were highly reproducible, the MMTT was significantly more so (R(2) = 0.96 for peak C-peptide response). Overall, the majority of subjects preferred the MMTT, and there were few adverse events. Some older subjects preferred the shorter duration of the GST. Nausea was reported in the majority of GST studies, particularly in the young age-group. CONCLUSIONS: The MMTT is preferred for the assessment of beta-cell function in therapeutic trials in type 1 diabetes.

Widening of a social gradient in obesity risk? German national health surveys 1990 and 1998.

OBJECTIVE: Whether differences in obesity prevalences across social status levels have widened remains controversial. METHODS: We used German national health surveys (1990-1992 and 1998, n = 7,466 and 5,583, age 25-69 years) to estimate obesity prevalences and its associations with calendar year, age (25-39, 40-60, and 61-69), and educational level (low, middle, and high), as well as an interaction term (year x educational level) in men and women. We used multiple regression models, considering the sample design. RESULTS: Obesity prevalence in 1990 and 1998 was 18.1 (95% CI 16.5-19.7) and 19.9 (18.2-21.6) in men and 20.9 (19.2-22.6) and 21.6 (19.3-23.7) in women, with statistically significantly higher prevalences in higher age and lower education. A statistically significant increase of obesity prevalence was present only in men after adjustment for age and education. The increase seems to be highest in high-educated subjects. However, interaction was not statistically significant, except in middle compared to high-educated men (OR 0.67; 0.47-0.96). CONCLUSIONS: Obesity prevalence increased only moderately in Germany between 1990-1992 and 1998. There was a tendency of reduction of the social gradient in obesity instead of a widening.

Diabetes prevalence and association with social status--widening of a social gradient? German national health surveys 1990-1992 and 1998.

BACKGROUND: Widening of social inequality in health is often discussed. Data regarding trends of the association between diabetes prevalence and social status are lacking. METHODS: Using two German health surveys (age 25-69 years), we estimated diabetes prevalences in 1998 compared to 1990-1992. Interaction of secular time with educational level, adjusted for age and BMI, were estimated in men and women using multiple regression models, considering the sample design. RESULTS: Diabetes prevalences in 1990-1992 and 1998 were 5.1% (95% CI 4.1-6.0) and 4.3% (3.5-5.1) in men, and 4.7% (4.0-5.4) and 3.8% (3.0-4.6) in women. It was significantly higher in older subjects and in obese subjects, and tended to be higher in lower educated subjects. Overall, prevalence tended to be lower in 1998 compared to 1990-1992, however, not statistically significant after adjustment for education and BMI (odds ratio, 95% CI: men 0.73; 0.39-1.37; women 0.41; 0.17-1.03). On a descriptive level, in the lowest education group, the diabetes prevalence was higher in 1998 compared to 1990-1992, whereas, it has decreased in higher educated subjects. However, confidence intervals were large, and we found no statistically significant interaction between calendar year and the educational level. CONCLUSIONS: Diabetes prevalence tended to decrease in Germany during the 1990s. A widening of social disparity in diabetes risk might be present, but a significant increase could not be confirmed.

Trends in outpatient prescription drug costs in diabetic patients in Germany, 1994-2004.

OBJECTIVE: New antidiabetic medications have been introduced during the last decade, but their impact on health care cost is largely unknown. Prescription costs in diabetic patients in primary care in Germany were evaluated (1994-2004). RESEARCH DESIGN AND METHODS: A total of 46,017 diabetic patients and 46,017 age- and sex-matched control subjects in 400 nationwide practices (2004) were compared with 29,956 diabetic patients and 13,226 control subjects (361 practices) in 1994 (data from IMS HEALTH). Inflation-adjusted age- and sex-standardized costs (ex-manufacturer prices) were calculated. RESULTS: Mean annual total prescription costs per diabetic patient were 559 euros in 2004 (372 euros in 1994), equaling a 60% (standardized) increase (P < 0.01). Average costs for antidiabetic medication were 172 euros in 2004, a 100% increase (P < 0.01). The major antidiabetic cost factor was insulin and analogs, which accounted for 22% of total drug costs in diabetic patients in 2004 (17% in 1994). All oral antidiabetic drugs together accounted for 8% of total costs (6% in 1994). New drugs (glitazones, glinides, and insulins) accounted for 15% of total costs (40% of antidiabetic drugs) in 2004. A 40% increase (387 euros vs. 286) in all non-diabetes-related drugs was due mainly to cardiovascular and lipid-lowering drugs. In nondiabetic patients, only a 30% cost increase was found (210 euros vs. 147; P < 0.01). CONCLUSIONS: Prescription drug costs among diabetic patients increased 60% during the last decade, which was twofold higher than the increase in nondiabetic patients. New types of antidiabetic drugs accounted for a substantial cost share of the overproportional increase for diabetes treatment. Progress in pharmacological therapy is a key driver of drug expenditure growth in diabetes treatment.

Is inflammation a causal chain between low socioeconomic status and type 2 diabetes? Results from the KORA Survey 2000.

Low socioeconomic status (SES) is associated with type 2 diabetes. Inflammatory markers like C-reactive protein (CRP) are predictive of diabetes. It is unclear, whether inflammation may be a mechanism linking low SES to type 2 diabetes. In the population-based KORA Survey 2000, 766 men and 710 women aged 55 to 74 years were randomly selected in the Augsburg region (Southern Germany). An index for SES was defined using education, occupation, and income. In women but not in men, increased CRP concentrations were found with lower SES (p<0.01). This significant trend was no longer observed after adjusting for BMI and waist circumference (p=0.23). Low SES was significantly associated with the age-adjusted odds of having type 2 diabetes both in men (OR; 95%CI: 1.35; 1.14-1.60) and in women (2.01; 1.37-2.96). The risk of having diabetes associated with low SES was only slightly changed after adjusting for CRP, which was itself significantly related to diabetes. In multivariate analyses, adjusting for age, obesity, physical activity, smoking, alcohol intake, and CRP, low SES yielded only a borderline statistical significance in women (p=0.07), whereas no significant association with diabetes remained in men (p=0.14). After CRP was dropped from the full model, there was no change in the OR obtained for low SES (men: 1.30; 0.92-1.83; women: 1.54; 0.97-2.45). Low SES was not related to prediabetes (IFG, IGT), whereas CRP was significantly associated with diabetes precursors. In conclusion, inflammation appears not to play a major role linking low SES and type 2 diabetes in the elderly population.

Direct costs of care in germany for children and adolescents with diabetes mellitus in the early course after onset.

BACKGROUND AND OBJECTIVE: Prospective population-based cost-of-illness study to evaluate diabetes mellitus (DM)-related direct costs in German pediatric DM care in the early course after onset (perspective: statutory health insurers). PATIENTS AND METHODS: 573 patients with DM <15 years of age were followed for up to 2 years after onset. DM-related hospitalization and ambulatory care, insulin and self-testing regimen were ascertained. Costs per patient-year were estimated (2000 prices). Using multivariate regression, associations between costs and families' socioeconomic status was evaluated. RESULTS: Mean total costs per patient-year were 7,069 euro (interquartile range 5,414-8,127). Onset hospitalization accounted for the majority of costs (4,908 euro, 3,728-6,213). Within post-onset costs, most were attributable to blood glucose self measurement and hospitalization (36% and 32%). Costs were significantly higher in children from families with lower compared to highest educated parents and in children from non-German families (p <0.01). CONCLUSIONS: Among the direct medical costs of childhood DM in the early course after onset, the greatest economic burden was due to hospitalization, in particular at onset. Blood glucose self measurement accounted for the majority of the post-onset costs. Costs were associated with the socio-economic status. It is recommended to evaluate the cost-effectiveness of outpatient programs targeting children from families with lower social status.

Cost-effectiveness analysis of different screening procedures for type 2 diabetes: the KORA Survey 2000.

OBJECTIVE: To compare the cost-effectiveness of different type 2 diabetes screening strategies using population-based data (KORA Survey; Augsburg, Germany; subjects aged 55-74 years), including participation data. RESEARCH DESIGN AND METHODS: The decision analytic model, which had a time horizon of 1 year, used the following screening strategies: fasting glucose testing, the oral glucose tolerance test (OGTT) following fasting glucose testing in impaired fasting glucose (IFG) (fasting glucose + OGTT), OGTT only, and OGTT if HbA(1c) was >5.6% (HbA(1c) + OGTT), all with or without first-step preselection (p). The main outcome measures were costs (in Euros), true-positive type 2 diabetic cases, incremental cost-effectiveness ratios (ICERs), third-party payers, and societal perspectives. RESULTS: After dominated strategies were excluded, the OGTT and HbA(1c) + OGTT from the perspective of the statutory health insurance remained, as did fasting glucose + OGTT and HbA(1c) + OGTT from the societal perspective. OGTTs (4.90 per patient) yielded the lowest costs from the perspective of the statutory health insurance and fasting glucose + OGTT (10.85) from the societal perspective. HbA(1c) + OGTT was the most expensive (21.44 and 31.77) but also the most effective (54% detected cases). ICERs, compared with the next less effective strategies, were 771 from the statutory health insurance and 831 from the societal perspective. In the Monte Carlo analysis, dominance relations remained unchanged in 100 and 68% (statutory health insurance and societal perspective, respectively) of simulated populations. CONCLUSIONS: The most effective screening strategy was HbA(1c) combined with OGTT because of high participation. However, costs were lower when screening with fasting glucose tests combined with OGTT or OGTT alone. The decision regarding which is the most favorable strategy depends on whether the goal is to identify a high number of cases or to incur lower costs at reasonable effectiveness.