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Background Type 2 diabetes is a chronic disease associated with poorer health outcomes and decreased health related quality of life (HRQoL). The aim of this analysis was to explore the impact of a disease management programme (DMP) in type 2 diabetes on HRQoL. A multilevel model was used to explain the variation in EQ-VAS. Methods A cluster-randomized controlled trial—analysis of the secondary endpoint HRQoL. Our study population were general practitioners and patients in the province of Salzburg. The DMP “Therapie-Aktiv” was implemented in the intervention group, and controls received usual care. Outcome measure was a change in EQ-VAS after 12 months. For comparison of rates, we used Fisher’s Exact test; for continuous variables the independent T test or Welch test were used. In the multilevel modeling, we examined various models, continuously adding variables to explain the variation in the dependent variable, starting with an empty model, including only the random intercept. We analysed random effects parameters in order to disentangle variation of the final EQ-VAS. Results The EQ-VAS significantly increased within the intervention group (mean difference 2.19, p = 0.005). There was no significant difference in EQ-VAS between groups (mean difference 1.00, p = 0.339). In the intervention group the improvement was more distinct in women (2.46, p = 0.036) compared to men (1.92, p = 0.063). In multilevel modeling, sex, age, family and work circumstances, any macrovascular diabetic complication, duration of diabetes, baseline body mass index and baseline EQ-VAS significantly influence final EQ-VAS, while DMP does not. The final model explains 28.9% (EQ-VAS) of the total variance. Most of the unexplained variance was found on patient-level (95%) and less on GP-level (5%). Conclusion DMP “Therapie-Aktiv” has no significant impact on final EQ-VAS. The impact of DMPs in type 2 diabetes on HRQoL is still unclear and future programmes should focus on patient specific needs and predictors in order to improve HRQoL. Trial registration Current Controlled trials Ltd., ISRCTN27414162

Aim. Testing the effectiveness of peer support additionally to a disease management programme (DMP) for type 2 diabetes patients.Methods. Unblinded cluster-randomised controlled trial (RCT) involving 49 general practices, province of Salzburg, Austria. All patients enrolled in the DMP were eligible,n=337participated (intervention: 148 in 19 clusters; control: 189 in 20 clusters). The peer support intervention ran over 24 months and consisted of peer supporter recruitment and training, and group meetings weekly for physical exercise and monthly for discussion of diabetes related topics.Results. At two-year follow-up, adjusted analysis revealed a nonsignificant difference inHbA1cchange of 0.14% (21.97 mmol/mol) in favour of the intervention (95% CI −0.08 to 0.36%,p=0.22). Baseline values were 7.02 ± 1.25% in the intervention and 7.08 ± 1.25 in the control group. None of the secondary outcome measures showed significant differences except for improved quality of life (EQ-5D-VAS) in controls (4.3 points on a scale of 100; 95% CI 0.08 to 8.53,p=0.046) compared to the intervention group.Conclusion. Our peer support intervention as an additional DMP component showed no significant effect onHbA1cand secondary outcome measures. Further RTCs with a longer follow-up are needed to reveal whether peer support will have clinically relevant effects.Trial Registration. This trial has been registered with Current Controlled Trials Ltd. (ISRCTN10291077).

We evaluated the disease management programme (DMP) “Therapie Aktiv” for diabetes mellitus type 2 during the first year of implementation in a cluster-randomised controlled trial (RCT), which revealed an improvement of process quality, but only insignificant effects on HbA1c. To further analyse the effects of the DMP we followed up participants of the RCT for another year. After completion of the RCT, the study was continued as an open observational trial. By patient’s choice, three groups were formed. Group 1 (DMP/DMP): interventions of the RCT (DMP), who remained in the DMP; group 2 (Control/DMP): controls of the RCT (usual care), who participated in the DMP during the second year; group 3 (Control/Control): controls of the RCT (usual care), who remained as controls. Primary outcome measure: HbA1c. Secondary outcome measures: BMI, lipids, blood pressure and measures of process quality. Only 801 of 1,489 RCT participants completed the study (53.8 %). Group 1: n = 355; group 2: n = 335; group 3: n = 111. After 2 years, pre-post-analysis revealed a significant reduction of HbA1c (0.37 %, p

Winkler, H. and Kampichler, C. 2000. Local and regional species richness in communities of surface-dwelling grassland Collembola: indication of species saturation. ‐ Ecography 23: 385‐392. The relationship of local (LSR) versus regional species richness (RSR) provides an insight into patterns of species diversity. We examined communities of surfacedwelling Collembola in ten differently sized, temperate dry grasslands. To register genuine manifestations of saturation or proportional sampling, accurate determination of species pools is essential. Therefore, we applied the first-order jackknife as a species-richness estimator for LSR and introduce here a method for defining a range within which the real RSR probably lies. Our data exhibited similar levels of local Collembolan species richness across all regions, largely independent of regional richness. This curvilinear relationship between LSR and RSR indicates that a limit is present for the number of species that can locally coexist, suggesting local interactions and community saturation. We discuss several conditions that may cause pseudo-proportionality or pseudosaturation, i.e. artificial relationships between LSR and RSR. Furthermore, we test the LSR-RSR relationship for possible effects of autocorrelation.

INTRODUCTION: Diabetes mellitus type 2 plays an important role in population health worldwide, and diabetes care has been shown to be insufficient. Disease management programmes (DMPs) have been designed to overcome these deficiencies, but data on their effectiveness are inconclusive. One reason for the inconsistent extent of effects may be selection bias. Voluntary programmes might recruit preferably highly motivated patients who are already quite successful in managing diabetes. Other programmes enrol primarily patients with poor metabolic control which may lead to the demonstration of fairly large effects due to regression to the mean. We therefore investigated the baseline characteristics of patients willing to enrol in the Austrian DMP for diabetes mellitus type 2 ("Therapie aktiv"), and their quality of care. METHODS: We offered the study to all GPs and internists in the province of Salzburg. The physicians were asked to recruit all patients with type 2 diabetes according to WHO/ADA-criteria willing to participate in the Austrian DMP "Therapie aktiv". For all patients, data regarding metabolic control, medication, cardiovascular risk factors and diabetes complications were recorded and then analysed to detect deficiencies in care. RESULTS: One thousand Four hundred and eighty-nine patients (mean age 65.4 ± 10.4 years; 47.8% women) were recruited by 92 physicians. 24.3% of all participants (28.3% of the men and 20.1% of the women) had at least one diabetes-related complication with a significantly higher rate of cardiovascular complications in the male study population. 80.7% of all patients were treated with oral antidiabetics, insulin or both. With regards to quality of care 5% of all patients with an HbA1c above 7.5% did not receive any antidiabetic medication at all. 15.3% of the study population with high blood pressure was not supplied with any antihypertensive medication and 36.6% of the study participants with cardiovascular disease were not treated with a statin. CONCLUSION: Our results indicate that the majority of the patients receive treatment in adherence to current guidelines. Nevertheless there are deficits in care and hence room for improvement by implementation of the DMP.

Background Disease management programmes (DMPs) are costly and impose additional work load on general practitioners (GPs). Data on their effectiveness are inconclusive. We therefore conducted a cluster-randomised controlled trial to evaluate the effectiveness of the Austrian DMP for diabetes mellitus type 2 on HbA1c and quality of care for adult patients in primary care. Methods All GPs of Salzburg-province were invited to participate. After cluster-randomisation by district, all patients with diabetes type 2 were recruited consecutively from 7-11/2007. The DMP, consisting mainly of physician and patient education, standardised documentation and agreement on therapeutic goals, was implemented in the intervention group while the control group received usual care. We aimed to show superiority of the intervention regarding metabolic control and process quality. The primary outcome measure was a change in HbA1c after one year. Secondary outcomes were days in the hospital, blood pressure, lipids, body mass index (BMI), enrolment in patient education and regular guideline-adherent examination. Blinding was not possible. Results 92 physicians recruited 1489 patients (649 intervention, 840 control). After 401 ± 47 days, 590 intervention-patients and 754 controls had complete data. In the intention to treat analysis (ITT) of all 1489 patients, HbA1c decreased 0.41% in the intervention group and 0.28% in controls. The difference of -0.13% (95% CI -0.24; -0.02) was significant at p = 0.026. Significance was lost in mixed models adjusted for baseline value and cluster-effects (adjusted mean difference -0.03 (95% CI -0.15; 0.09, p = 0.607). Of the secondary outcome measures, BMI and cholesterol were significantly reduced in the intervention group compared to controls in ITT after adjustments (-0.53 kg/m²; 95% CI -1.03;-0.02; p = 0.014 and -0.10 mmol/l; 95% CI -0.21; -0.003; p = 0.043). Additionally, more patients received patient education (49.5% vs. 20.1%, p < 0.0001), eye- (71.0% vs. 51.2%, p < 0.0001), foot examinations (73.8% vs. 45.1%, p < 0.0001), and regular HbA1c checks (44.1% vs. 36.0%, p < 0.01) in the intervention group. Conclusion The Austrian DMP implemented by statutory health insurance improves process quality and enhances weight reduction, but does not significantly improve metabolic control for patients with type 2 diabetes mellitus. Whether the small benefit seen in secondary outcome measures leads to better patient outcomes, remains unclear. Trial Registration Current Controlled trials Ltd., ISRCTN27414162.

Background Due to its rising prevalence type 2 diabetes plays an important role concerning population health in Austria and other western countries. In various studies deficiencies in the care of diabetic patients have been revealed. These deficiencies may be overcome by disease-management-programmes (DMPs), but international experience shows that the effectiveness of DMPs is inconsistent. In particular large programmes designed by state-affiliated public health insurances have not been evaluated in randomized controlled trials (RCTs). We are therefore conducting a large scale RCT of the Austrian DMP for type 2 diabetic patients in the province of Salzburg to evaluate the programme regarding its effects on metabolic control, guideline adherent care and the quality of life of diabetic patients. Methods/Design The study is open for participation to all GPs and internists in the province of Salzburg. Physicians are randomized before recruitment of patients with the districts of Salzburg as clusters of randomisation. A total of over 1200 patients with type 2 diabetes will then be recruited. In the intervention group the DMP is applied for one year. Controls receive usual care. Endpoints are a decrease in HbA1c in the intervention group > 0,5% compared to controls, a higher percentage of patients with required diagnostic measures according to guidelines, improved cardiovascular risk profile and higher quality of life scores within one year. Current status of the study 98 Physicians agreed to participate in the study. 96 of them recruited 1494 patients, 654 in the intervention and 840 in the control group. Trail Registration This trial has been registered with Current Controlled Trials Ltd. (ISRCTN27414162).

Einleitung DMPs sind trotz umstrittener Effektivität weit verbreitet. Selektionsbias und Regression zur Mitte führen in nicht-randomisierten Studien zur Überschätzung der Effekte. Das österreichische DMP für Diabetes mellitus Typ 2 zeigte in einer randomisiert kontrollierten Studie zwar eine Verbesserung der Prozessqualität, jedoch keinen relevanten Einfluss auf die Stoffwechselkontrolle als Outcomeparameter. Ein Durchbruch in der Versorgung chronisch Kranker ist durch DMPs nach derzeitigem Wissensstand nicht zu erwarten, sodass neue Wege wie Patienten-Selbstmanagement und Peer Support entwickelt werden sollten.

Background: Disease Management Programmes (DMPs) are proposed to enhance the quality of care, to improve health outcomes and to reduce costs. Yet, the evidence regarding the effectiveness of such structured approaches remains uncertain. Randomized controlled trials (RCTs) represent the gold standard of evaluation for complex interventions. However, most of the evidence derives from non-randomized or even uncontrolled trials. We therefore tried to assess the impact of a randomized control group on the interpretation of DMP effectiveness. Methods: We analyzed the data of a RCT on a DMP for diabetes type 2 by creating two scenarios. The first solely includes data of the intervention group ( n = 649), representing an ‘uncontrolled pre-test–post-test analysis’. The second comprehends all data ( n = 1489) of the ‘randomized controlled analysis’. HbA1c was used as the primary outcome measure for metabolic control in diabetes. Depending on either scenario, we calculated relative and absolute risk reduction regarding clinically relevant endpoints and estimated costs by extrapolating our results according to the UK Prospective Diabetes Study (UKPDS) findings. Results: The HbA1c reduction attributed to the DMP was 0.41% (uncontrolled analysis) vs. 0.13% (controlled comparison). Estimations of relative risk reduction for cardiovascular disease were 4.6% vs. 1.4%. The estimated numbers needed to treat (NNT) to avoid one myocardial infarction within 10 years differed from 125 (uncontrolled analysis) to 417 patients (controlled comparison), which led to a substantial scenario-dependent difference in cost estimations. Conclusion: Uncontrolled pre-test–post-test evaluation might lead to crucial overestimation of DMP effectiveness. We therefore recommend randomized controlled evaluations prior to long-term implementation.