MediStatistica

Neuenrade, Germany

MediStatistica

Neuenrade, Germany
SEARCH FILTERS
Time filter
Source Type

Nauck M.A.,Diabeteszentrum Bad Lauterberg | Haastert B.,MediStatistica | Trautner C.,Ostfalia University of Applied Sciences | Muller U.A.,Jena University Hospital | And 2 more authors.
Diabetologia | Year: 2014

Aims/hypothesis: We evaluated whether self-monitoring of blood glucose (SMBG) leads to better glycaemic control (HbA1c) in patients with type 2 diabetes on conventional insulin regimens. Methods: Patients with type 2 diabetes on a conventional insulin regimen (basal or premixed insulin with or without additional oral glucose-lowering agents) were recruited at study centres led by members of the German Diabetes Association. In a randomised, prospective, open 2∈×∈2 factorial design, the once-weekly performance of four-point glucose profiles (SMBG +; n=151 patients) was compared with no SMBG (SMBG -; n=149), and the measuring and transmitting of HbA 1c results to the study centres (HbA1c +; n=158, of these 82 SMBG - and 76 SMBG +) was compared with HbA1c measurement without disclosure of results (HbA1c -; n=142, of these 67 SMBG - and 75 SMBG +). Randomised allocation was carried out by a central office, using sequentially numbered, sealed envelopes. The primary endpoint was the reduction of HbA1c compared with baseline after 12 months. Secondary analyses were of therapy intensification in response to higher blood or urinary glucose or HbA1c. Participants and caregivers were not blinded as to the allocation of interventions, whereas the laboratory determining HbA1c remained blinded. Results: Patient characteristics were balanced across groups. A total of 56 patients dropped out. In completers, HbA1c was reduced in the SMBG + group from 7.3% to 7.0%, i.e. by 0.3% (0.1%, 0.5%) vs SMBG - from 7.3% to 7.0% and 0.3% (0.2%, 0.5%), respectively, the difference being 0.0% (-0.2%, 0.2%) (p=0.93). The disclosure of HbA1c results had no significant influence, with a difference of 0.1% (-0.1%, 0.4%) (p=0.28). Values above are mean (95% CI). The ORs for therapy intensification significantly rose as the following increased: proportions of urine samples testing positive for glucose, HbA1c concentrations, and fasting or postprandial glucose concentrations. No important adverse events were associated with the interventions. Conclusions/interpretation: SMBG profiles once weekly or the disclosure of HbA1c results did not improve glycaemic control in patients with type 2 diabetes on conventional insulin treatment, although indicators of hyperglycaemia increased the likelihood of therapy intensification. Greater intensification may be necessary to impact on glycaemic control. Trial registration:: www.clinicaltrials.gov (registration code NCT00688363) Funding:: Deutsche Diabetes-Gesellschaft, Deutsche Diabetes-Stiftung, Bayer Vital GmbH © 2014 Springer-Verlag Berlin Heidelberg.


Mann E.,General Practice and Institute for Health Services Research | Meyer G.,Witten/Herdecke University | Haastert B.,MediStatistica | Icks A.,Bielefeld University
BMC Public Health | Year: 2010

Background: Several studies evaluated variations in hip fracture incidences, as well as trends of the hip fracture incidences. Comparisons of trends are lacking so far. We compared the incidence rates and, in particular, its trends between Austria and Germany 1995 to 2004 analysing national hospital discharge diagnosis register data. Methods: Annual frequencies of hip fractures and corresponding incidences per 100,000 person years were estimated, overall and stratified for sex and age, assuming Poisson distribution. Multiple Poisson regression models including country and calendar year, age and sex were used to analyse differences in incidence and trend. The difference of annual changes between the two countries was explored using an interaction term (calender year * country). Results: Overall, the increase of hip fracture risk was 1.31 fold higher (95% CI 1.29-1.34) in Austria compared to Germany, adjusted for age, sex, and calendar year. The risk increase was comparable for both sexes (males: RR 1.35 (1.32-1.37), females: RR 1.31 (1.29-1.33)). Hip fracture trend from 1995 to 2004 indicates an increase in both countries without a statistically significant difference between Austria and Germany (interaction term: p = 0.67). Conclusion: In this study comparing hip fracture incidences and its trend using pooled data, the incidence in Austria was 30% higher compared to its neighbouring country Germany. For both countries a similar increasing trend of hip fracture incidence over the 10-year study period was calculated. The results need confirmation by other studies. © 2010 Mann et al; licensee BioMed Central Ltd.


Morbach S.,Marienkrankenhaus | Furchert H.,Marienkrankenhaus | Groblinghoff U.,Marienkrankenhaus | Hoffmeier H.,Marienkrankenhaus | And 11 more authors.
Diabetes Care | Year: 2012

OBJECTIVE - There is a dearth of long-term data regarding patient and limb survival in patients with diabetic foot ulcers (DFUs). The purpose of our study was therefore to prospectively investigate the limb and person survival of DFU patients during a follow-up period of more than 10 years. RESEARCH DESIGN AND METHODS - Two hundred forty-seven patients with DFUs and without previous major amputation consecutively presenting to a single diabetes center between June 1998 and December 1999 were included in this study and followed up until May 2011. Mean patient age was 68.8 ± 10.9 years, 58.7% were male, and 55.5%had peripheral arterial disease (PAD). Times to first major amputation and to death were analyzed with Kaplan- Meier curves and Cox multiple regression. RESULTS - A first major amputation occurred in 38 patients (15.4%) during follow-up. All but one of these patients had evidence of PAD at inclusion in the study, and 51.4% had severe PAD [anklebrachial pressure index ≤0.4]). Age (hazard ratio [HR] per year, 1.05 [95% CI, 1.01-1.10]), being on dialysis (3.51 [1.02-12.07]), and PAD (35.34 [4.81-259.79]) were significant predictors for first major amputation. Cumulative mortalities at years 1, 3, 5, and 10 were 15.4, 33.1, 45.8, and 70.4%, respectively. Significant predictors for death were age (HR per year, 1.08 [95% CI, 1.06-1.10]), male sex ([1.18-2.32]), chronic renal insufficiency (1.83 [1.25-2.66]), dialysis (6.43 [3.14-13.16]), and PAD (1.44 [1.05-1.98]). CONCLUSIONS - Although long-term limb salvage in this modern series of diabetic foot patients is favorable, long-term survival remains poor, especially among patients with PAD or renal insufficiency. © 2012 by the American Diabetes Association.


Kopke S.,University of Hamburg | Kopke S.,University of Lübeck | Muhlhauser I.,University of Hamburg | Gerlach A.,University of Hamburg | And 4 more authors.
JAMA - Journal of the American Medical Association | Year: 2012

Context: Despite unambiguous legal regulation and evidence for lack of effectiveness and safety, physical restraints are still frequently administered in nursing homes. Objective: To reduce physical restraint prevalence in nursing homes using a guideline- and theory-based multicomponent intervention. Design, Setting, and Participants: Cluster randomized controlled trial of 6months'duration conducted in 2 German cities between February 2009 and April 2010. Nursing homes were eligible if they had 20% or more residents with physical restraints. Using external concealed randomization, 18 nursing home clusters were included in the intervention group (2283 residents) and 18 in the control group (2166 residents). Intervention: The intervention was based on a specifically developed evidencebased guideline and applied the theory of planned behavior. Components were group sessions for all nursing staff; additional training for nominated key nurses; and supportive material for nurses, residents, relatives, and legal guardians. Control group clusters received standard information. Main Outcomes Measures: Primary outcome was percentage of residents with physical restraints (bilateral bed rails, belts, fixed tables, and other measures limiting free body movement) at 6 months, assessed through direct unannounced observation by blinded investigators on 3 occasions during 1 day. Secondary outcomes included restraint use at 3 months, falls, fall-related fractures, and psychotropic medication prescriptions. Results: All nursing homes completed the study and all residents were included in the analysis. At baseline, 30.6% of control group residents had physical restraints vs 31.5% of intervention group residents. At 6 months, rates were 29.1% vs 22.6%, respectively, a difference of 6.5% (95% CI, 0.6% to 12.4%; cluster-adjusted odds ratio, 0.71; 95% CI, 0.52 to 0.97; P=.03). All physical restraint measures were used less frequently in the intervention group. Rates were stable from 3 to 6 months. There were no statistically significant differences in falls, fall-related fractures, and psychotropic medication prescriptions. Conclusion: A guideline- and theory-based multicomponent intervention compared with standard information reduced physical restraint use in nursing homes. Trial Registration isrctn.org Identifier: ISRCTN34974819. ©2012 American Medical Association. All rights reserved.


Koch M.,Nephrologisches Zentrum Mettmann | Kohnle M.,Nephrologisches Zentrum Mettmann | Trapp R.,Nephrologisches Zentrum Mettmann | Haastert B.,Medistatistica | And 2 more authors.
Nephrology Dialysis Transplantation | Year: 2012

Background.The impact of dialysis modality on outcome, especially on infection early in the course of dialysis, in unplanned acute dialysis initiation has not been well evaluated. The aim of the study was to compare the rates and causes of mortality and morbidity in incident dialysis patients started unplanned acute peritoneal dialysis (PD) or haemodialysis (HD). Patients and methods.In this observational cohort study, incident dialysis patients with initiation of unplanned and acute PD (n = 66) or HD (n = 57) at a single centre from March 2005 to June 2010 were included and followed up for 6 months (0-183 days, mean follow-up time 4.72 months). For PD, surgically placed Tenckhoff catheters were used. All HD patients were dialysed with a central venous catheter (non-tunnelled or tunnelled). There were no significant differences in terms of gender, age and prevalence of diabetes mellitus in either group. The prevalence of heart failure [New York Heart Association (NYHA) Stage III-IV] was significantly higher in the PD group (73 versus 46% in HD group, P < 0.01). The population was stratified to PD and HD comparing mortality, infection, bacteraemia and hospitalization. Results.Of the 123 patients who commenced acute and unplanned dialysis, n = 44 (35.8%) died during the follow-up period of 0-183 days. There were no significant difference in half-year mortality in n = 20 PD patients (30.3%) versus n = 24 HD patients (42.1%) (P = 0.19). The cardiovascular mortality in PD and HD patients were 9.1 and 10.5%, respectively (P = 1.00). Overall mortality due to infection was higher in the HD (17.5%) versus in the PD group (9.1%), however, not significant (P = 0.19). HD patients had significantly higher probability of bacteraemia in the first 183 days compared to PD patients (21.1 versus 3.0%, P < 0.01). Group comparison by Poisson regression analyses showed that the relative risk of bacteraemia in the PD group versus HD group was 0.16 (95% confidence interval, 0.05-0.57, P = 0.005). The significant difference was not affected by the confounder's patient age at time of dialysis, male sex, heart failure (NYHA III-IV), diabetes, malignancy and peripheral arterial occlusive disease Stage IV. There were high proportions of hospitalization after the initiation of dialysis in both groups (PD 75.0% and HD 67.3%, P = 0.40). Univariate and multiple regression analyses revealed only age at initiation of dialysis to be significantly associated with overall mortality (P < 0.05). Conclusions.Dialysis modality (PD versus HD) in an acute unplanned dialysis setting showed, in our population, no significant influence on survival. HD patients had a significantly higher risk of bacteraemia, perhaps due to central venous dialysis catheter. PD seems to be a safe and efficient, at least comparable, alternative to HD in acute unplanned dialysis settings. © 2011 The Author.


Richter T.,University of Hamburg | Mann E.,General practice and Institute for Health Services Research | Meyer G.,Witten/Herdecke University | Haastert B.,MediStatistica | Kopke S.,University of Hamburg
Journal of the American Medical Directors Association | Year: 2012

Background: Despite increasing knowledge about the limited effectiveness and severe adverse effects, the prescription rate of psychotropic medications in frail elderly persons remains high. Prescriptions are mainly made to control behavioral and psychological symptoms of dementia, although factors associated with prescriptions are rarely reported. However, such information is a prerequisite to develop intervention programs aiming to safely reduce psychotropic medication in nursing home residents. Methods: We report the comparison of cross-sectional data of psychotropic medication prescription rates from 3 large studies including nursing home residents in Germany and Austria. We aimed to compare the prevalence of (1) psychotropic medication, (2) different classes of psychotropic medication, (3) psychotropic medication administered for bedtime use, and (4) associations between prescription of psychotropics and institutional and residents' characteristics. Confidence intervals of prevalences and multiple logistic regression analyses were adjusted for cluster correlation. Results: Data from 5336 residents in 136 long term care facilities were included. In Austria, 74.6% (95% CI 72.0-77.2%) of all residents had a prescription of at least one psychotropic medication compared to Germany with about 51.8% (95% CI 48.3-55.2%) and 52.4% (95% CI 48.7-56.1%). Of all antipsychotics, 66% (Austria) and 47% (Germany) were prescribed for bedtime use. Most prescriptions were conventional, low-potency antipsychotics. In all 3 studies, there was no statistically significant association between psychotropic medication prescription and nursing home characteristics. On the level of residents, consistent positive associations were found for higher level of care dependency and permanent restlessness. Consistent negative associations were found for older age and male gender. Conclusion: Frequency of psychotropic and especially antipsychotic medication is substantial in nursing home residents in Germany and Austria. The high number of prescriptions is likely to be an indicator for a perceived or actual lack of strategies to handle behavioral and psychological symptoms of dementia. © 2012 American Medical Directors Association, Inc.


Icks A.,Heinrich Heine University Düsseldorf | Arend W.,Heinrich Heine University Düsseldorf | Becker C.,Robert Bosch GmbH | Rapp K.,Robert Bosch GmbH | And 2 more authors.
Archives of Osteoporosis | Year: 2013

We analyzed hip fracture incidence trends in Germany in 1995-2010, using national hospital discharge register. Overall, after age-sex-region adjustment, there was no significant trend. However, stratified analyses showed a significant decrease in younger people. In the elderly, there was a moderate increase in men and decrease in women. Incidences were still higher in Western Germany (each significant). Background: Whereas most studies from US and European countries found trends of a decreasing hip fracture incidence in the last years, in Germany, an increase has been still observed up to 2003. Methods: Analysis of annual hip fracture incidences in Germany was carried out using the national hospital discharge register and a correction factor of 0.89. Estimate of age-sex-adjusted changes was determined using the Poisson regression (incidence rate ratios, IRR; with 95 % confidence intervals, CI), overall and in age-sex-region strata. Results: The number of patients with at least one hospital admission for hip fracture increased (1995: n = 99,146; 2010: n = 128,240). Overall, after adjustment for age, sex, and region, there was no significant trend during the observation period. However, in stratified analyses, a significant decrease was seen in people aged less than 40 years in both sexes and regions. Also, in women aged 60 years or older, the incidence decreased (Western Germany p = 0.001) or remained (Eastern Germany p = 0.053) (IRR 1995-2010, 95 % CI: 0.95, 0.92-0.98; and 1.05, 0.999-1.11). In contrast, the incidence in men 40-59 and 60 years older increased in both regions (West: 1.03, 0.97-1.09; and 1.11, 1.07-1.14; East: 1.12, 1.01-1.25; and 1.29, 1.22-1.36). While incidences were still significantly higher in Western Germany overall and in most strata, they tended to converge. Conclusions: In line with most European countries, the overall hip fracture incidence in Germany no longer increases. However, differences between age, sex, and region exist. © 2013 International Osteoporosis Foundation and National Osteoporosis Foundation.


Koch M.,Nephrologisches Zentrum Mettmann | Koch M.,Heinrich Heine University Düsseldorf | Haastert B.,MediStatistica | Kohnle M.,Nephrologisches Zentrum Mettmann | And 4 more authors.
European Journal of Heart Failure | Year: 2012

Aims The aim of the study was to evaluate the efficacy and clinical outcome of peritoneal dialysis (PD) treatment in patients with severe refractory heart failure (HF) and chronic kidney disease (CKD). Methods and results The PD treatment was performed in 118 patients [49.2% New York Heart Association (NYHA) III and 50.8% NYHA IV] with a mean age of 73.2 ± 11.4 years as an in-centre-based and intermittent automated PD at least three times per week for 12 h per session and followed up for 1.11 ± 1.17 years. The functional status of those surviving for 6 months improved (P < 0.0001): 18 (32.1%) of all 60 patients with NYHA IV at baseline died within 6 months, 3 (5.4%) converted to NYHA III, 33 (58.9%) to NYHA II, and 2 (3.6%) to NYHA I. In all 58 patients with NYHA III at baseline, 14 (25.0%) died within 6 months, 27 (48.2%) converted to NYHA II, 12 (21.4%) to NYHA I, and 3 (5.4%) showed no improvement. In those surviving for 6 months, fluid overload was significantly reduced as body weight decreased, from 78.7 [95% confidence interval (CI) 75.8-81.7] to 74.7 (71.5-77.9) after 6 months after multiple imputation (P < 0.001). The overall survival rates after 3, 6, and 12 months were 77% (95% CI 70-85), 71% (95 CI 62-79), and 55% (95 CI 45-64). In the multivariate analyses, age, diabetes mellitus, serum urea, and brain natriuretic peptide were significantly associated with mortality. The incidence of peritonitis and catheter dysfunction was 0.053 (95% CI 0.014-0.093) and 0.084 (95% CI 0.034-0.133), respectively. Conclusion The data suggest that PD is a safe, efficient, and well tolerated therapeutic tool for patients with refractory chronic HF and CKD. © 2012 The Author.


Mehlhorn J.,Heinrich Heine University Düsseldorf | Haastert B.,MediStatistica | Rehkamper G.,Heinrich Heine University Düsseldorf
Journal of Experimental Biology | Year: 2010

Homing pigeons (Columba livia f.d.) are well-known for their homing abilities, and their brains seem to be functionally adapted to homing as exemplified, e.g. by their larger hippocampi and olfactory bulbs. Their hippocampus size is influenced by navigational experience, and, as in other birds, functional specialisation of the left and right hemispheres ('lateralisation') occurs in homing pigeons. To show in what way lateralisation is reflected in brain structure volume, and whether some lateralisation or asymmetry in homing pigeons is caused by experience, we compared brains of homing pigeons with and without navigational experience referring to this. Fourteen homing pigeons were raised under identical constraints. After fledging, seven of them were allowed to fly around the loft and participated successfully in races. The other seven stayed permanently in the loft and thus did not share the navigational experiences of the first group. After reaching sexual maturity, all individuals were killed and morphometric analyses were carried out to measure the volumes of five basic brain parts and eight telencephalic brain parts. Measurements of telencephalic brain parts and optic tectum were done separately for the left and right hemispheres. The comparison of left/right quotients of both groups reveal that pigeons with navigational experience show a smaller left mesopallium in comparison with the right mesopallium and pigeons without navigational experience a larger left mesopallium in comparison with the right one. Additionally, there are significant differences between left and right brain subdivisions within the two pigeon groups, namely a larger left hyperpallium apicale in both pigeon groups and a larger right nidopallium, left hippocampus and right optic tectum in pigeons with navigational experience. Pigeons without navigational experience did not show more significant differences between their left and right brain subdivisions. The results of our study confirm that the brain of homing pigeons is an example for mosaic evolution and indicates that lateralisation is correlated with individual life history (experience) and not exclusively based on heritable traits. © 2010. Published by The Company of Biologists Ltd.


Steckelberg A.,University of Hamburg | Hulfenhaus C.,University of Hamburg | Haastert B.,MediStatistica | Muhlhauser I.,University of Hamburg
BMJ | Year: 2011

Objective: To compare the effect of evidence based information on risk with that of standard information on informed choice in screening for colorectal cancer. Design: Randomised controlled trial with 6 months' followup. Setting: German statutory health insurance scheme. Participants: 1577 insured people who were members of the target group for colorectal cancer screening (age 50-75, no history of colorectal cancer). Interventions: Brochure with evidence based risk information on colorectal cancer screening and two optional interactive internet modules on risk and diagnostic tests; official information leaflet of the German colorectal cancer screening programme (control). Main outcome measure: The primary end point was "informed choice," comprising "knowledge," "attitude," and "combination of actual and planned uptake." Secondary outcomes were "knowledge" and "combination of actual and planned uptake." Knowledge and attitude were assessed after 6 weeks and combination of actual and planned uptake of screening after 6 months. Results: The response rate for return of both questionnaires was 92.4% (n=1457). 345/785 (44.0%) participants in the intervention group made an informed choice, compared with 101/792 (12.8%) in the control group (difference 31.2%, 99% confidence interval 25.7% to 36.7%; P<0.001). More intervention group participants had "good knowledge" (59.6% (n=468) v 16.2% (128); difference 43.5%, 37.8% to 49.1%; P<0.001). A "positive attitude" towards colorectal screening prevailed in both groups but was significantly lower in the intervention group (93.4% (733) v 96.5% (764); difference -3.1%, -5.9% to -0.3%; P<0.01). The intervention had no effect on the combination of actual and planned uptake (72.4% (568) v 72.9% (577); P=0.87). Conclusions: Evidence based risk information on colorectal cancer screening increased informed choices and improved knowledge, with little change in attitudes. The intervention did not affect the combination of actual and planned uptake of screening. Trial registration Current Controlled Trials ISRCTN47105521.

Loading MediStatistica collaborators
Loading MediStatistica collaborators