Effectiveness of a comprehensive support program for families with parental cancer (Family-SCOUT): results of a multicenter non-randomized controlled trial.

BACKGROUND: Cancer patients with minor children but also their families suffer from significant psychological distress and comorbidity. Protective factors predicting successful coping are well known. Corresponding systematic interventions are rare and limited by access barriers. We developed a comprehensive family-centered intervention for cancer patients with at least one dependent minor. PATIENTS AND METHODS: Family-SCOUT represents a multicentric, prospective, interventional, and controlled study for families with parental cancer and their minor children. In the intervention group (IG), all family members were addressed using a care and case management approach for nine months. Families in the control group (CG) received standard of care. Participating parents were asked to complete the Hospital-Anxiety-Depression-Scale (HADS) questionnaire at enrolment (T0) and after 9 months (T2). The primary outcome was a clinically relevant reduction of distress in at least one parent per family, measured as minimal important difference (MID) of ≥1.6 in the HADS total score. The percentage of families achieving MID is compared between the IG and CG by exact Fisher's test, followed by multivariate confounder analyses. RESULTS: T0-questionnaire of at least one parent was available for 424 of 472 participating families, T2-questionnaire after 9 months was available for 331 families (IG n = 175, CG n = 156). At baseline, both parents showed high levels of distress (HADS total: sick parents IG: 18.7 ± 8.1; CG: 16.0 ± 7.2; healthy partners: IG: 19.1 ± 7.9; CG: 15.2 ± 7.7). The intervention was associated with a significant reduction in parental distress in the IG (MID 70.4% in at least one parent) compared with the CG (MID 55.8%; P = 0.008). Adjustment for group differences from specific confounders retained significance (P = 0.047). Bias from other confounders cannot be excluded. CONCLUSIONS: Parental cancer leads to a high psychosocial burden in affected families. Significant distress reduction can be achieved through an optimized and structured care approach directed at the family level such as family-SCOUT.

Health care utilization and excess costs after pelvic fractures among older people in Germany.

Our study demonstrates a strong increase in utilization of inpatient health care and clear excess costs in older people in the first year after pelvic fracture, the latter even after adjustment for several confounders. Excess costs were particularly high in the first few months and mainly attributable to inpatient treatment. INTRODUCTION: We aimed to estimate health care utilization and excess costs in patients aged minimum 60 years up to 1 year after pelvic fracture compared to a population without pelvic fracture. METHODS: In this retrospective population-based observational study, we used routine data from a large statutory health insurance (SHI) in Germany. Patients with a first pelvic fracture between 2008 and 2010 (n=5685, 82% female, mean age 80±9 years) were frequency matched with controls (n=193,159) by sex, age at index date, and index month. We estimated health care utilization and mean total direct costs (SHI perspective) with 95% confidence intervals (CIs) using BCA bootstrap procedures for 52 weeks before and after the index date. We calculated cost ratios (CRs) in 4-week intervals after the index date by fitting mixed two-part models including adjustment for possible confounders and repeated measurement. All analyses were further stratified for men/women, in-/outpatient-treated, and major/minor pelvic fractures. RESULTS: Health care utilization and mean costs in the year after the index date were higher for cases than for controls, with inpatient treatment being particularly pronounced. CRs (95% CIs) decreased from 10.7 (10.2-11.1) within the first 4 weeks to 1.3 (1.2-1.4) within week 49-52. Excess costs were higher for inpatient than for outpatient-treated persons (CRs of 13.4 (12.9-13.9) and 2.3 (2.0-2.6) in week 1-4). In the first few months, high excess costs were detected for both persons with major and minor pelvic fracture. CONCLUSION: Pelvic fractures come along with high excess costs and should be considered when planning and allocating health care resources.

Time spent on self-management by people with diabetes: results from the population-based KORA survey in Germany.

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 < 58 mmol/mol (6.5% to < 7.5%) or lower quality of life, spent more time on self-management activities. For example, people without anti-hyperglycaemic medication invested 66 min/week in self-management, whereas those taking insulin and oral anti-hyperglycaemic drugs invested 269 min/week (adjusted ratio 4.34, 95% confidence interval 1.85-10.18). CONCLUSIONS: Time spent on self-management activities by people with diabetes was substantial and varied with an individual's characteristics. Because of the small sample size and missing values, the results should be interpreted in an explorative manner. Nevertheless, time needed for self-management activities should be routinely considered because it may affect diabetes self-care and quality of life.

[PROtocol-based MObilizaTION on intensive care units : Design of a cluster randomized pilot study]. / PROtokollbasierte MObilisierung auf IntensivstaTIONen : Design einer clusterrandomisierten Pilotstudie.

BACKGROUND: Despite convincing evidence for early mobilization of patients on intensive care units (ICU), implementation in practice is limited. Protocols for early mobilization, including in- and exclusion criteria, assessments, safety criteria, and step schemes may increase the rate of implementation and mobilization. HYPOTHESIS: Patients (population) on ICUs with a protocol for early mobilization (intervention), compared to patients on ICUs without protocol (control), will be more frequently mobilized (outcome). METHODS: A multicenter, stepped-wedge, cluster-randomized pilot study is presented. Five ICUs will receive an adapted, interprofessional protocol for early mobilization in randomized order. Before and after implementation, mobilization of ICU patients will be evaluated by randomized monthly one-day point prevalence surveys. Primary outcome is the percentage of patients mobilized out of bed, operationalized as a score of ≥3 on the ICU Mobility Scale. Secondary outcome parameters will be presence and/or length of mechanical ventilation, delirium, stay on ICU and in hospital, barriers to early mobilization, adverse events, and process parameters as identified barriers, used strategies, and adaptions to local conditions. EXPECTED RESULTS: Exploratory evaluation of study feasibility and estimation of effect sizes as the basis for a future explanatory study.

The Boehringer Ingelheim employee study (Part 2): 10-year cardiovascular diseases risk estimation.

BACKGROUND: Cardiovascular disease (CVD) may cause an economic burden to companies, but CVD risk estimations specific to working populations are lacking. AIMS: To estimate the 10-year CVD risk in the Boehringer Ingelheim (BI) employee cohort and analyse the potential effect of hypothetical risk reduction interventions. METHODS: We estimated CVD risk using the Framingham (FRS), PROCAM (PRS) and Reynolds (RRS) risk scores, using cross-sectional baseline data on BI Pharma employees collected from 2005 to 2011. Results were compared using Fisher's exact and Wilcoxon tests. The predictive ability of the score estimates was assessed using receiver-operating characteristics analyses. RESULTS: Among the 4005 study subjects, we estimated 10-year CVD risks of 35% (FRS), 9% (PRS) and 6% (RRS) for men and 10% (FRS), 4% (PRS) and 1% (RRS) for women. One hundred and thirty-four (6%) men and 111 (6%) women employees had current CVD. The best predictors of prevalent CVD were the FRS and the RRS for men [area-under-the-curve 0.62 (0.57-0.67) for both]. A hypothetical intervention that would improve systolic blood pressure, HbA1c (for diabetes), C-reactive protein, triglycerides and total and high-density lipoprotein cholesterol by 10% each would potentially reduce expected CVD cases by 36-41% in men and 30-45% in women, and if smoking cessation is incorporated, by 39-45% and 30-55%, respectively, depending on the pre-intervention risk score. CONCLUSIONS: There was a substantial risk of developing CVD in this working cohort. Occupational health programmes with lifestyle interventions for high-risk individuals may be an effective risk reduction measure.

[Prevention of Type 2 Diabetes: Evidence-Based Patient Information--A Randomised Controlled Trial]. / Effekt einer evidenzbasierten Patienteninformation zur Prävention von Typ 2-Diabetes.

The aim of this study was to compare the effect of our newly developed online evidence-based patient information (EBPI) vs. standard patient information about subthreshold elevated blood glucose levels and primary prevention of diabetes on informed patient decision-making. EBPI significantly improved knowledge about elevated glucose levels, but also increased decisional conflict and critical attitudes to screening and treatment options. The intention to undergo metabolic screening decreased as a result.

[Effect of Evidence-Based Risk Information on "Informed Choice" in Colorectal Cancer Screening: Randomised Controlled Trial]. / Effekt einer evidenzbasierten Verbraucherinformation zur Entscheidungsfindung beim kolorektalen Screening.

Evidence-based information is a prerequisite for informed choice. We compared the effect of evidence-based information on colorectal cancer screening with standard information in a randomised controlled trial. The primary endpoint was informed choice. We randomised 1,577 people insured by a large German statutory health insurance scheme, the Gmünder Ersatzkasse (GEK). The evidence-based information significantly increased informed choices: 44.0% vs. 12.8%; (difference 31.2%, 99% CI 25.7-36.7%; P<0.001).

[Diagnostic accuracy of a standardized carbohydrate-rich breakfast compared to an oral glucose tolerance test in occupational medicine]. / Diagnostische Genauigkeit eines standardisierten kohlenhydrathaltigen Frühstücks im Vergleich zum oralen Glukosetoleranztest in der betriebsmedizinischen Praxis.

BACKGROUND: Increasing prevalence of type 2 diabetes mellitus is not only a problem for the health care system but also impairs working environment. In order to reduce costs by illness and early retirement and the development of diabetic complications occupational medicine is important for early diabetes detection. However, the diagnostic gold standard, oral glucose tolerance test (oGTT), is rarely accepted. Aim of our investigation was to evaluate diagnostic accuracy of a standardizable and cost-effective test-breakfast in comparison to oGTT which might be accepted in workplace. METHODS: During a workplace health promotion program diagnostic accuracy (sensitivity and specificity) of a test-breakfast (index test) was analyzed in a random-cross-over-design with healthy volunteers in comparison to an oGTT (reference test). RESULTS: 278 subjects participated and rated the health promotion program to be useful (99%). 74% stated that they preferred the test-breakfast in contrast to the oGTT. Both screening methods showed comparable plasma glucose and insulin curves. The plasma glucose levels measured capillary and venously during test-breakfast and oGTT were very consistent. Differences were only seen for the 2 h plasma glucose values in the fully adjusted model. The test-breakfast demonstrated high sensitivity and specificity for diabetes diagnosis compared to the reference test with highly comparable results, i. e. 8 persons (2,9%) newly diagnosed with diabetes by the test-breakfast vs. 7 (2,5%) by oGTT. CONCLUSION: A test-breakfast seems to be a useful first screening instrument to increase the compliance of occupational health promotions and might improve early diabetes diagnosis.

Designing trials for pressure ulcer risk assessment research: methodological challenges.

For decades various pressure ulcer risk assessment scales (PURAS) have been developed and implemented into nursing practice despite uncertainty whether use of these tools helps to prevent pressure ulcers. According to current methodological standards, randomised controlled trials (RCTs) are required to conclusively determine the clinical efficacy and safety of this risk assessment strategy. In these trials, PURAS-aided risk assessment has to be compared to nurses' clinical judgment alone in terms of its impact on pressure ulcer incidence and adverse outcomes. However, RCTs evaluating diagnostic procedures are prone to specific risks of bias and threats to the statistical power which may challenge their validity and feasibility. This discussion paper critically reflects on the rigour and feasibility of experimental research needed to substantiate the clinical efficacy of PURAS-aided risk assessment. Based on reflections of the methodological literature, a critical appraisal of available trials on this subject and an analysis of a protocol developed for a methodologically robust cluster-RCT, this paper arrives at the following conclusions: First, available trials do not provide reliable estimates of the impact of PURAS-aided risk assessment on pressure ulcer incidence compared to nurses' clinical judgement alone due to serious risks of bias and insufficient sample size. Second, it seems infeasible to assess this impact by means of rigorous experimental studies since sample size would become extremely high if likely threats to validity and power are properly taken into account. Third, means of evidence linkages seem to currently be the most promising approaches for evaluating the clinical efficacy and safety of PURAS-aided risk assessment. With this kind of secondary research, the downstream effect of use of PURAS on pressure ulcer incidence could be modelled by combining best available evidence for single parts of this pathway. However, to yield reliable modelling results, more robust experimental research evaluating specific parts of the pressure ulcer risk assessment-prevention pathway is needed.

Diabetes incidence does not differ between subjects with and without high depressive symptoms--5-year follow-up results of the Heinz Nixdorf Recall Study.

AIMS: Cross-sectional studies have consistently reported evidence for an association between diabetes and depressive disorders. However, only limited prospective studies have examined this association, reporting conflicting results. In a population-based cohort study, we compared cumulative incidences of diabetes between participants with and without high depressive symptoms. METHOD: We analysed the 5-year follow-up data from the German Heinz Nixdorf Recall study of 3547 participants without diabetes at baseline [mean age 58.8 (sd 7.6) years, 47.5% male]. Depressive symptoms were defined using the Centre for Epidemiologic Studies Depression scale (cut point ≥ 17). Diabetes (diagnosed or previously undetected) was identified by self-reported physician-diagnosed diabetes, medication and high blood glucose levels. We estimated 5-year cumulative incidences with 95% confidence intervals and fitted multiple logistic regression models to calculate the odds ratios, adjusted for age, sex, physical activity, smoking, living with or without partner, and educational level. RESULTS: The cumulative incidence of diabetes was 9.2% (95% CI 6.3-12.8) in participants with high depressive symptoms at baseline and 9.0% (95% CI 8.0-10.0) in participants without these symptoms. The age- and sex-adjusted odds ratio of diabetes in participants with depressive symptoms compared with those without was 1.13 [95% CI 0.77-1.68; fully adjusted 1.11 (95% CI 0.74-1.65)]. These results did not substantially change in several additional sensitivity analyses. CONCLUSION: Our study did not show a significantly increased risk of developing diabetes in individuals with high depressive symptoms compared with those without high depressive symptoms during a 5-year follow-up period.

Blood glucose testing and primary prevention of Type 2 diabetes-evaluation of the effect of evidence-based patient information: a randomized controlled trial.

AIMS: To compare the effect of our newly developed online evidence-based patient information vs. standard patient information about sub-threshold elevated blood glucose levels and primary prevention of diabetes on informed patient decision making. METHODS: We invited visitors to the cooperating health insurance company, Techniker Krankenkasse, and the German Diabetes Center websites to take part in a web-based randomized controlled trial. The population after randomization comprised 1120 individuals aged between 40 and 70 years without known diabetes, of whom 558 individuals were randomly assigned to the intervention group receiving evidence-based patient information, and 562 individuals were randomly assigned to the control group receiving standard information from the Internet. The primary endpoint was acquired knowledge of elevated blood glucose level issues and the secondary outcomes were attitude to metabolic testing, intention to undergo metabolic testing, decisional conflict and satisfaction with the information. RESULTS: Overall, knowledge of elevated glucose level issues and the intention to undergo metabolic testing were high in both groups. Participants who had received evidence-based patient information, however, had significantly higher knowledge scores. The secondary outcomes in the evidence-based patient information subgroup that completed the 2-week follow-up period yielded significantly lower intention to undergo metabolic testing, significantly more critical attitude towards metabolic testing and significantly higher decisional conflict than the control subgroup (n=466). Satisfaction with the information was not significantly different between both groups. CONCLUSIONS: Evidence-based patient information significantly increased knowledge about elevated glucose levels, but also increased decisional conflict and critical attitude to screening and treatment options. The intention to undergo metabolic screening decreased. Future studies are warranted to assess uptake of metabolic testing and satisfaction with this decision in a broader population of patients with unknown diabetes.

Impact of earlier HAART initiation on the immune status and clinical course of treated patients on the basis of cohort data of the German Competence Network for HIV/AIDS.

PURPOSE: Hitherto, studies on highly active antiretroviral therapy (HAART) initiation have shown partly inconsistent results. Our study investigated the clinical course and course of immune status after HAART initiation at CD4-cell-count/µl of treated patients between 250 and 349 (group 1), compared to 350-449 (group 2), on the basis of the cohort of the Competence Network for HIV/AIDS (KompNet cohort). METHODS: Patients had to be HAART-naïve. Medication had to start at the earliest in 1996, being at least triple combination therapy. The primary endpoints of death, first AIDS-defining illness and first drop of CD4-cell-count/µl below 200 were evaluated as censored event times between the initiation of HAART (t (0)) and the date of the first event/date of last observation. Probabilities of event-free intervals since t (0) were calculated by Kaplan-Meier estimation, compared by logrank tests. The results were adjusted for confounders using Cox regression. Additionally, incidences were estimated. RESULTS: A total of 822 patients met the inclusion criteria (group 1: 526, group 2: 296), covering 4,133 patient years (py) overall. In group 1, 0.64 death cases/100 py were found, with the corresponding vale being 0.17 in group 2. In group 1, 1.38 AIDS-defining events/100 py occurred, whereas it was 0.78 in group 2. In group 1, 2.64 events of first drop of CD4-cell-count/µl below 200 occurred per 100 py, compared to 0.77 in group 2. Kaplan-Meier estimations showed borderline significant differences regarding death (p = 0.063), no differences regarding first AIDS-defining illness (p = 0.148) and distinct differences regarding the first drop of CD4-cell-count/µl below 200 (p = 0.0004). CONCLUSIONS: The results gave a strong hint for a therapy initiation at higher CD4-cell-count/µl regarding the outcome of death in treated patients. A distinct benefit was shown regarding the first decline of CD4-cell-count/µl below 200.

Clinical relevance of dietary salt intake on aldosterone and the aldosterone-to-renin ratio as screening parameters for primary aldosteronism.

AIMS: The recommendations for screening for primary aldosteronism (PA) are determination and interpretation of both plasma aldosterone and the aldosterone-renin ratio (ARR). Although it is known that oral sodium chloride intake has an important impact on plasma aldosterone and ARR, more detailed data of this impact are sparse. We evaluated the relevance of natriuresis as a parameter of oral sodium intake, as well as patient age and antihypertensive medication on the PA screening parameters in our hypertensive patient population. METHOD: Our cross-sectional, single-center study investigated the impact of natriuresis, patient age, body mass index, Ca-antagonists, beta-blockers, ACE inhibitors and/or AT1 blockers on aldosterone and ARR in 777 hypertensive patients (393 men, 384 women) with a mean age (± SD) of 49.5 ± 15.7 years and an endogenous creatinine clearance of at least 80 ml/min. A total of 401 patients (51.6%) were on antihypertensive therapy. The mean natriuresis of the total population was 206.7 ± 97.0 mmol/day. The potential impact factors on plasma aldosterone and ARR were analyzed in two separate univariate, bivariate, and multiple regression analyses, respectively, with natriuresis as the main impact factor. RESULTS: Natriuresis as well as patient age had a significant impact on both plasma aldosterone and ARR. In addition, beta-blockers, ACE inhibitors and/or AT1 blockers had a significant impact on ARR (p < 0.05). CONCLUSIONS: In addition to antihypertensive medication, natriuresis as well as patient age seem to need further consideration in the process of PA screening and interpretation of its results. Additional experimental studies are warranted to confirm and generalize our results.

Inpatient and outpatient health care utilization of children and adolescents with type 1 diabetes before and after introduction of DRGs.

OBJECTIVE: To analyze the frequency and length of hospital stays as well as the frequency of diabetes-associated outpatient visits of children and adolescents with type 1 diabetes before and after the introduction of DRGs (diagnosis-related groups) in German hospitals. METHODS: For this prospective cohort study, data from 2000 (before introduction of DRGs) to 2008 (after introduction) was extracted from the German diabetes documentation software DPV. Incidence rates of hospitalizations, length of hospital stays as well as the incidence rates of outpatient visits of 21,502 children and adolescents were estimated. The associations between the target parameters and DRG introduction, age, sex, diabetes duration, calendar year and migration background were estimated using generalized linear mixed models. RESULTS: Incidence of hospitalization was 0.45 (95% CI 0.44-0.45) per person-year (PY), mean number of hospital days 2.77/PY (95% CI: 2.76-2.79). Children had 5.3 (95% CI: 5.3-5.3) outpatient visits per PY on average. The number of hospital stays, inpatient days, and outpatient visits decreased significantly between 2000 and 2008. Time of introduction of DRGs was related to a significant rise in the number of hospital stays and outpatient visits (p<0.05). There was no significant relation to the number of hospital days. Compared with children younger than eleven years of age, 11- to 14-year-old children had significantly more, adolescents older than 14 years significantly less hospital stays (RR 1.2, 95% CI: 1.14-1.23 and 0.92, 95%, CI: 0.87-0.97, respectively). Migration background was significantly associated with worse results for all analyzed target variables (RR 1.21 for hospital stays, 1.26 for hospital days, 1.07 number of outpatient visits). CONCLUSIONS: The introduction of DRGs in the care of patients with pediatric diabetes mellitus resulted in a leveling of the reduction of the number of outpatient visits and hospital stays. Especially adolescents at the age of puberty and patients from families with migration background seem to require particular attention in health care.

B-type natriuretic peptide and severe heart failure at baseline predict overall mortality in incident dialysis patients.

AIMS: The B-type natriuretic peptide (BNP) has become increasingly important as a diagnostic and prognostic method for cardiovascular disease or death. To our knowledge no prospective studies exist to evaluate the value of baseline BNP and baseline heart failure as predictors of overall death in incident rather than prevalent hemodialysis patients with end-stage renal disease (ESRD). METHODS: 255 ESRD patients were included in our observational study with a median observation period of 1.11 years. A Kaplan-Meier survival curve was stratified by BNP concentration (< 340 pg/ml and > or = 340 pg/ml) to estimate the impact on the overall mortality rate. Univariate and multiple Cox regression models were fitted for a variety of covariables including severe heart failure (graded according to the New York Heart Association) to evaluate the independent predictors of death. Association between BNP and four explanatory variables was described in a multiple linear regression model. RESULTS: Survival analysis demonstrated a significantly higher mortality rate in patients with higher BNP values at baseline. The independent predictive value of high BNP concentration at baseline could be statistically confirmed by multiple Cox regression analysis. However, when including the covariates hemoglobin and severe heart failure, significantly associated with BNP, in the same model, severe heart failure rather than BNP becomes a significant predictor of overall death. CONCLUSIONS: A higher BNP level at baseline may be confirmed as an independent predictor of death in the incident dialysis population. However, severe heart failure may affect the impact of BNP on the overall survival rate and thus be a stronger predictor of death than BNP.

Incidence of lower-limb amputations in the diabetic compared to the non-diabetic population. findings from nationwide insurance data, Germany, 2005-2007.

INTRODUCTION: One major objective is to reduce the risk of lower limb amputation in diabetes mellitus. Nationwide data to incidences of amputations in the diabetic and non-diabetic populations in Germany as well as relative and attributable risks due to diabetes are lacking so far. MATERIAL AND METHODS: Using data of a nationwide statutory health insurance (1.6 million members), we assessed all first non-traumatic lower-limb amputations between 2005 and 2007. We estimated sex-age-specific and standardized incidences of amputations in the diabetic and non-diabetic populations, and relative and attributable risks due to diabetes. RESULTS: Of all subjects with a first amputation in the study period 2005-2007 (n=994), 66% had diabetes, 76% were male, mean age (SD) was 67 (13) years. Incidences per 100 000 person years (standardized to the 2004 German population) in the diabetic and the non-diabetic populations: 176.5 (95% confidence interval 156.0-196.9) and 20.0 (17.0-23.1) in men, and 76.9 (61.9-91.8) and 13.4 (10.7-16.2) in women. Standardized relative risks: 8.8 (7.3-10.7) in men and 5.7 (4.3-7.6) in women. Attributable risks among exposed: 0.89 and 0.83 and population attributable risks 0.59 and 0.40, each in men and women, respectively. DISCUSSION: In our first German nationwide study, we found the relative risk of lower limb amputation in the diabetic compared to the non-diabetic to be lower than in earlier regional studies in Germany, supporting results of regional reductions of the excess amputation risk due to diabetes. A repetition of the study is warranted to further evaluate trends according to the St. Vincent goals.

Impact of age, body mass index, insulin resistance and proteinuria on the kidney function in obese patients with Type 2 diabetes and renal insufficiency.

AIMS: To date, several different equations to predict the glomerular filtration rate (GFR) in patients with renal insufficiency have been developed for different patients groups. Our aim was to determine the prognostic factors of GFR in our homogenous patient group of obese, water-loaded patients with Type 2 diabetes and renal insufficiency, since we assumed that the endogenous creatinine clearance (ECC) alone may not be an accurate method to predict GFR. METHOD: We recruited 46 obese patients (37 men) with Type 2 diabetes and renal insufficiency in our nephrology center in Mettmann (Germany). However, two male patients were excluded from the analysis due to an outlying insulin level or low inulin clearance. The inulin clearance as a measure of renal function performed by the single shot method was compared with the GFR estimated by ECC, Cystatin C, and MDRD formula. Several multiple regression models were built to test the impact of the prognostic factors age, sex, body mass index (BMI), insulin resistance according to the homeostasis model assessment (HOMA), body water (TBW), brain natriuretic peptide (BNP), and proteinuria on the inulin clearance. In the main regression model to predict the inulin clearance by ECC, only the statistically significant prognostic factors of these models were selected, as well as the interaction between GFR predicted by ECC (GFR_ECC) and BMI. RESULTS: The prognostic factors GFR_ECC, age, BMI, HOMA and proteinuria had a statistically significant impact on the inulin clearance (the gold standard of the GFR) in our patient population (p < 0.05). However, the interaction of GFR_ECC and BMI was not significant (p = 0.06) in our model. The model was validated and considered well-fitted with a coefficient of determination (R2) of 0.69. CONCLUSIONS: The independent prognostic factors to determine GFR in obese, water-loaded diabetic patients are GFR_ECC, age, BMI, HOMA and proteinuria. However, our model should be revalidated and tested in a larger sample size to probably detect an interaction between GFR_ECC and BMI as an additional prognostic factor.

[Hip fracture incidence in Germany: analysis of the national hospital discharge registry 2004]. / Inzidenz von Hüftfrakturen in Deutschland - Auswertung der Krankenhausdiagnosestatistik 2004.

BACKGROUND AND AIMS: Actual population-based data describing the hip fracture risk in Germany are lacking. The aim of this study was to determine the hip fracture incidence in Germany in 2004, using the national hospital discharge register, and to analyze differences between eastern and western Germany. PATIENTS AND METHODS: We determined the annual incidence per 100,000 population, correcting for double registrations and recurrent admissions (correction factor 0.89). To compare eastern and western Germany, we standardized data to the 2004 whole German population. Using the Poisson regression with scale adjustment for over-dispersion, we obtained age/sex-adjusted differences between eastern and western Germany. RESULTS: In 2004, we found 116.281 patients with at least one hospital admission because of a hip fracture, corresponding to an incidence of 140.9 (95%; confidence interval 140.2-141.7) per 100,000 persons. As expected, the hip fracture incidence increased with increasing age. In younger age groups the incidence was higher in men, whereas in the elderly it was much higher in women. The hip fracture incidence tended to be lower in eastern than in western Germany (p=0.058). CONCLUSION: As in the previous decade, the hip fracture incidence in Germany in 2004 was higher than in southern than in eastern Europe. Our data gave a higher incidence than a recent analysis based on data from the statutory health insurance. The difference may be due to methodological reasons (selection of the insured population, choice of the correction factor for double registration and recurrent admissions). Differences in the hip fracture incidence between eastern and western Germany were lower in 2004 than in 1996. Further studies are warranted to achieve valid incidence measurements as a basis for planning and evaluating health care as well as specific measures of prevention.