[The methods within the evaluation of disease management programmes in control-group designs using the example of diabetes mellitus - a systematic literature review]. / Die Methoden der Evaluation von Disease Management Programmen im Kontrollgruppendesign am Beispiel Diabetes mellitus - Eine systematische Übersicht.

BACKGROUND: Disease management programmes (DMPs) were implemented in Germany in 2002. Their evaluation is required by law. Beyond the mandatory evaluation, a growing number of published studies evaluate the DMP for diabetes mellitus type 2 in a control-group design. As patients opt into the programme on a voluntary basis it is necessary to adjust the inherent selection bias between groups. The aim of this study is to review published studies which evaluate the diabetes DMP using a control-group design with respect to the methods used. METHODS: A systematic literature review of electronic databases (PUBMED, Cochrane Library, EMBASE, MEDPILOT) and a hand search of reference lists of the relevant publications was conducted to identify studies evaluating the DMP diabetes mellitus in a control-group design. RESULTS: 8 studies were included in the systematic literature review. 4 studies gathered retrospective claims data from sickness funds, one from physician's records, one study used prospective data from ambulatory care, and 2 studies were based on one patient survey. Methods used for adjustment of selection bias included exact matching, matching using propensity score methods, age-adjusted and sex-separated analysis, and adjustment in a regression model/analysis of covariance. One study did not apply adjustment methods. The intervention period ranged from 1 day to 4 years. Considered outcomes of studies (surrogate parameter, diabetes complications, mortality, quality of life, and claim data) depended on the database. CONCLUSION: In the evaluation of the DMP diabetes mellitus based on a control-group design neither the database nor the methods used for selection bias adjustment were consistent in the available studies. Effectiveness of DMPs cannot be judged based on this review due to heterogeneity of study designs. To allow for a comprehensive programme evaluation standardised minimum requirements for the evaluation of DMPs in the control group design are required.

Primary tobacco prevention in China--a systematic review.

OBJECTIVES: This systematic review of randomized controlled trials aims to identify and describe primary tobacco prevention programs conducted in China and to evaluate their quality and effectiveness. METHODS: Published studies in English or Chinese were searched in MEDLINE, EMBASE, GLOBAL HEALTH, PsycINFO, Wanfang and CNKI. Eligible studies were randomized controlled trials tailored for a Chinese population. Primary preventive non-pharmacological interventions for smoking cessation or reduction were evaluated. Trials were included if they applied at least one predefined outcome suited for measuring the reduction of smoking rates or the reduction of smoking related morbidity. Two reviewers independently assessed studies for inclusion. The risk of bias in individual studies was evaluated by determining the adequacy of methodological quality criteria. RESULTS: A total of 21 eligible studies investigating 53,520 patients (range 88 - 30,544) an age between 9.6 and 65 years were identified. All interventions were based on some kind of health education programs. In most cases standard health advice was given and booklets were distributed. The overall methodological quality of the studies was low. Seven studies (33%) showed a statistical significant effect of the described intervention in all predefined outcomes. CONCLUSION: The documentation of smoking prevention interventions in China is not sufficient to develop effective and reliable action programs. A lack of quality in the design can be discerned rather than a lack in starting interventions. We therefore recommend future interventions to be planned, implemented and conducted in compliance with high quality standards for example Guideline for Good Clinical Practice. Furthermore for preparing reports of RCT findings we recommend the Consolidated Standards of Reporting Trials.

[Analysis of selection inventives for health insurances after introduction of the morbidity-oriented risk compensation scheme: an empirical analysis]. / Analyse von Selektionsanreizen für Krankenkassen nach Einführung des morbiditätsorientierten Risikostrukturausgleichs: Eine empirische Analyse.

BACKGROUND: The risk compensation scheme (RCS) in the Statutory Health Insurance (SHI) was implemented in 1994 to discourage risk selection between sickness funds. However, several expertise papers have concluded since then that the sociodemographic risk adjusters in place could not adequately curb risk selection. To minimise incentives for risk selection in the Statutory Health Insurance (SHI) further, the RCS was refined in 2009 by adding 80 diseases as additional risk adjusters. In spite of the better compensation of differences in morbidity, however, incentives for risk selection may still persist. In this study, we investigated the association of indicators such as region (number of inhabitants in the city), income, level of education and family status (children in the household) with health care costs to determine if risk selection is still attractive for sickness funds under the refined RCS. METHOD: The analysis is based on a 2002 cross-section survey comprising 75,122 individuals. Health expenditures were estimated using self-documented utilisation data and were standardised for age, sex and diagnoses covered by the risk adjustment scheme. We included costs for inpatient care, outpatient care, pharmaceuticals, rehabilitation, and medical devices. To assess the effects of the above-mentioned individual characteristics on health-care expenditure, regression analyses and analyses of variances were performed. RESULTS: Full documentation was available for 52,484 individuals (69.86%). From these the variables "family status (children in the household)", "higher educational level", and "higher income" were associated with lower costs for individuals without chronic conditions. For individuals with chronic conditions, results were mixed. "Family status", "education" and "income" showed no clear association with lower or higher costs and were not statistically significant. The variable "region" was neither significantly associated with chronically ill nor for healthy individuals. DISCUSSION: With respect to age, sex, and morbidity, individuals with high income and education and without chronic diseases apparently cause lower costs. Thus, health status, income and education remain as possible selection criteria for sickness funds in Germany. However, the refined RCS compensates for the largest proportion of cost differences between insured with and without chronic disease. Possible causes of the small but remaining differences and whether improving preventive programmes or providing awareness campaigns may be appropriate strategies to tackle this issue should be investigated in future research.

Contrast enhanced MRI and intravital fluorescence microscopy indicate improved tumor microcirculation in highly vascularized melanomas upon short-term anti-VEGFR treatment.

Anti-angiogenic therapy by blocking VEGF signalling combined with standard chemotherapy is a novel strategy for clinical cancer treatment. The mechanisms for enhanced antitumoral effects are still a matter of controversial debate. Tumor vessel "normalization" upon anti-angiogenic therapy leading to improved drug delivery has been proposed as possible mechanism. Therefore, aim of the study was to investigate tumor microvascular function upon anti-VEGFR treatment in highly vascularized melanomas. A detailed intravital-microscopic analysis of tumor microcirculation including the distribution pattern of vessel diameters and blood flow velocities was performed in melanomas grown in dorsal skinfold chambers of hamsters. Animals with highly vascularized established tumors were treated by a VEGFR tyrosin kinase inhibitor (SU5416) on 3 repetitive days. Tumor tissue oxygenation was measured by phosphorescence quenching technique. Overall tumor microcirculation of subcutaneous tumors was investigated by contrast enhanced MRI (CE-MRI). Vessel density was significantly decreased in treated animals. A significant shift in the distribution patterns towards increased vessel diameters and faster red blood cell velocities in remaining tumor vessels was observed upon anti-VEGF treatment, compensating reduced vascular density. Moreover, a trend towards elevated pO(2) levels in treated tumors was observed. Compared to controls, inflow kinetics of tumors quantified by CE-MRI as well as overall uptake of contrast agent in tumor tissue were significantly increased following short-term SU5416 treatment. In conclusion the results confirm temporarily improved tumor microvascular function in highly vascularized melanomas upon short term anti-VEGFR treatment leading to enhanced tumor blood supply and oxygenation potentially improving the efficacy of simultaneous chemo- or radiotherapy.