PROSIT

Abstract: Aims. To evaluate the structured PROSIT(R) disease management programme for high-risk diabetic patients in primary care with respect to the cardio-vascular risk profile and mortality. Subjects and Methods. Retrospectively 55 albuminuric Type 2 diabetic patients included into the PROSIT(R) programme from 1994 to 1999 (intervention group: age 66.6 +/- 10.5 years, known duration of diabetes 8.9 +/- 6.5 years) were compared with 58 albuminuric patients not participating in the PROSIT(R) programme (control group: age 68.5 +/- 10.4 years, known duration of diabetes 8.5 +/- 6.7 years). Within PROSIT(R) a structured multifactorial intervention programme was applied. The main characteristics of this intervention were strict follow-ups of the patients risk profile every three months and the use of quality management methods (definition of target values, structured documentation, central data feedback with diagnostic and therapeutic recommendations based on European guidelines). The cardio-vascular risk profile, therapeutic intervention, and secondary diabetic complications were compared between both groups in 1994 and 1999. Results. In the period from 1994 to 1999 the intervention group showed a significant improvement in the vascular risk profile, while the control group did not. In 1999 the mean arterial blood pressure was significantly lower compared to the control group (115 +/- 13 mm Hg vs. 125 +/- 16 mm Hg, p < 0.05). The HbA1c improved only in the intervention group and in 1999 it was significantly lower than in the control group (7.0 +/- 1.3 \% vs. 8.4 +/- 1.8 \%, p < 0.01). Moreover, the occurrence of clinical endpoints in the intervention group could be reduced: Both the mortalitly rate (14.5 \% vs. 34.5 \%, p < 0.05) and the rate of new myocardial infarctions (6 \% vs. 20 \%, p < 0.05) of the intervention group were significantly lower. Conclusions. Participation of albuminuric Type 2 diabetic patients and their physicians in a structured intervention programme showed positive effects on the cardio-vascular risk profile and endpoints compared with a group of non-participating patients and physicians.

 diabetes;  screening;  MICROALBUMINURIA;  clinical trial;  PROSIT;  

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Abstract: BACKGROUND AND OBJECTIVE: Even though there are simple and cost-effective means for the early diagnosis of diabetic nephropathy, only a small proportion of diabetics in Germany is regularly tests for microalbuminuria. On the basis of evidence-based knowledge and of international guidelines the PROSIT project (proteinuria screening and intervention) aims to make good this deficiency in the German Federal Republic by introducing nephropathy screening and a structured intervention to improve blood sugar and blood pressure regulation, optimizing lipid metabolism and nutritional intake. It was the aim of this study to assess with a computer-aided diabetes model the clinical value and cost-effectiveness of such an intervention. PATIENTS AND METHODS: From data collected for 589 diabetics who participated in the PROSIT project, the short-time effects after one year on HbA1c, systolic blood pressure and lipid levels were obtained and cost-effectiveness compared with that of standard care. Life expectancy, life-time costs to be met by health insurance and event frequency of the diabetic nephropathy stages were calculated with a Markov model for type 2 diabetics. RESULTS: PROSIT improved individual life expectancy by 0.23 years with reduction of life-time costs by DM 9,772 (ca. \$4,900). The cumulative incidence of microalbuminuria was lowered by 30.5\%, that of terminal renal failure by 55.9\%. Even after discounting the results (i.e. the inclusion of time preference for cost and benefit) and stepwise changes of all variables by +/- 10\%, PROSIT remained the more cost-effective variant. CONCLUSION: From a health economy viewpoint PROSIT is superior to standard management. Early recognition of albuminuria and the introduction of a multifactorial treatment strategy make it possible to delay progression to terminal renal failure. In addition to its clinical benefits, prevention of dialysis and transplantation would reduce the annual savings of the health care system by several billion DM.

 prevention;  diabetes;  ACEI;  nephropathy;  screening;  MICROALBUMINURIA;  economic evaluation;  PROSIT;  

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Abstract: The PROSIT (Proteinuria Screening and Intervention) Project started in 1993 in order to obtain data on the prevalence of micro- and macroalbuminuria in diabetic patients treated in primary care, to establish an easy screening programme for microalbuminuria, in which also diabetic patients can participate in self-responsibility, and to implement a specific intervention programme for incipient nephropathy. In 58 representative doctors offices 647 diabetic patients were included, who performed at home self-tests for microalbuminuria on three days within one week using the early morning urine and a newly developed qualitative immunologic test-strip for microalbuminuria. After storage they returned the same urine samples to their doctors offices for semiquantitative retesting with the immunologic test-strip Micral-Test II. In case of positive results the proteinuria dipstick Combur-9-Test was applied in order to exclude other causes of positive microalbuminuria (e.g. urinary tract infection). Data of 569 patients (6\% Type 1, 88\% Type 2 and 6\% secondary diabetes) could be analysed. Both qualitative self-testing for microalbuminuria at home and semiquantitative retesting in doctors offices were found to be feasible. Based on semiquantitative retesting the prevalences of microalbuminuria (macroalbuminuria) were 19.6\% (0\%) in Type 1 diabetes, 17.2\% (10.8\%) in Type 2 diabetes and 11.7\% (7.8\%) in secondary diabetes. Type 2 diabetic patients showed a clear correlation between albuminuria and diabetes duration, HbA1c, serum creatinine, triglycerides as well as micro- and macrovascular complications. 227 patients with micro- or macroalbuminuria were included into the ongoing PROSIT intervention programme.

 epidemiology;  diabetes;  screening;  MICROALBUMINURIA;  PROSIT;  

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