BackgroundDisease 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.MethodsAll 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.Results92 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.ConclusionThe 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 RegistrationCurrent 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 diseasemanagement-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.
The discrepancy between serum CEA levels and CEA tissue expression in patients with breast cancer is well known. Whereas immunohistochemistry shows positive CEA expression in 70-90%, the serum CEA levels are often within the normal range. We performed immunoscintigraphy and SPECT with a Tc-99m labelled anti-CEA monoclonal antibody (MAb BW 431/26) in 46 women with suspected breast cancer or recurrence. The results of anti-CEA immunoscintigraphy, mammography, serum CEA levels and immunohistochemistry were evaluated according to the histology of the tumor. Histology verified breast cancer or recurrence (pT1 [n = 7], pT2 [n = 17], pT3 [n = 3], pT4 [n = 3]) in 30 out of 46 patients; benign breast disease such as fibrocystic disease, fibroadenoma, fatty necrosis or chronic mastitis was responsible for suspicious mammographic findings in 16 patients. Immuno-SPECT showed 25 true-positive, 5 false-negative, 11 true-negative and 5 false-positive findings (sensitivity 83%, specificity 69%). Anti-CEA immuno-SPECT of 2 patients with bone metastasis showed all lesions previously detected by bone scintigraphy to be CEA-expressing metastases. In contrast, serum CEA levels were slightly elevated in only 5 out of 30 patients with histologically verified breast cancer (sensitivity 17%). The results of immuno-histochemistry were surprising; tissue CEA expression could be demonstrated in only 5 patients with breast cancer. According to our experiences with this Tc-99m labelled anti-CEA MAb, immuno-SPECT is a suitable additional method for the diagnosis of breast cancer and especially of recurrence. Pre-operative serum CEA levels give no support for the differentiation between benign and malignant breast tumors.
The results of this multicenter randomized controlled study provide significant evidence for benefit by participation in a structured educational program. Positive effects seem to be mediated by better adherence and life style changes due to higher levels of information and patient empowerment. Therefore, educational strategies should be considered as standard of care for hypertensive patients.
Antiphospholipid antibodies--both the lupus anticoagulant and anticardiolipin antibodies--are closely associated with arterial and venous thrombosis. In this prospective trial the IgM- and IgG-anticardiolipin antibodies in serum were determined in acute and chronic coronary artery disease. Seventy-four unselected males (34-87 years, mean 60) were included in the study. All patients underwent coronary angiography; infectious and autoimmune diseases were exclusion criteria. Sixteen patients had coronary artery disease (group A), 34 showed coronary stenoses with prior infarction (B), and 14 had survived an acute myocardial infarction (C), whereas 10 patients revealed no significant coronary narrowing (D; controls). The major risk factors were the same for all groups. Neither the IgM- nor the IgG-anticardiolipin antibody levels showed any significant difference in the four groups. The severity of coronary artery disease did not correlate to these antibodies. Furthermore, no correlation was found between elevated anticardiolipin antibodies and thrombocyte levels. Thus, a higher anticardiolipin level does not appear to be a marker for recurrent cardiovascular events.
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