[Study Designs for Effect Evaluation in Disease Prevention and Health Promotion - Meaning of Internal and External Validity in Intervention Studies]. / Studiendesigns zur Wirkungsevaluation in Prävention und Gesundheitsförderung ­ Die Bedeutung interner und externer Validität für die Evidenzbasierung in Lebenswelten.

BACKGROUND: Health promotion and disease prevention in Germany have become more important as a result of the Prevention Act that gives special attention to the setting. So far, however, there is neither a common understanding of the terms of this approach, nor are its potentials empirically derived. Therefore, a discussion about suitable evaluation and study concepts is required. AIMS AND METHODS: The aims of this study were to address the meaning of internal and external validity of intervention studies in health promotion and disease prevention. We provide an overview of the achievable bias control for different study designs and provide examples for the evaluation of setting-based approaches. RESULTS: Interventions in settings are often characterized by a multitude of measures, actors and intervention contexts. Methods of analysis from evidence-based medicine are viewed critically for health promotion and disease prevention in Germany. Such studies are considered to provide a high degree of internal validity, but the extrapolation of the results to "reality" is viewed as low. In contrast, the extrapolation of study results is not more of a challenge for setting projects than for any other research area. It is not limited by different contexts, but rather by different causal relationships. Impact assessment aims at causally attributing an observed outcome to the intervention. Thus, the epistemological requirements do not differ between studies that are designed for internal or external validity. The international discussion focuses on the refinement of (quasi)-experimental study designs. Examples for the evaluation of setting projects, mainly from Germany, illustrate that those alternative methods have already been used in evaluation practice. CONCLUSION: A challenge for health promotion and disease prevention in settings is to systematically assess the different needs for evidence-basing. At present, there is a wealth of findings in a large number of intervention fields. These findings must be compiled and analyzed to determine whether and to what extent further evaluations need to be initiated and by which methods.

[Expenditures of The German Statutory Health Insurance for Health Promotion and Disease Prevention 2012-2017: Positive Effects Due To The Disease Prevention Law?] / Ausgaben der gesetzlichen Krankenversicherung für Gesundheitsförderung und Prävention 2012­2017: Positive Effekte durch das Präventionsgesetz?

BACKGROUND: The German Prevention Act aims to strengthen health promotion and disease prevention. The law makes changes to the so-called "§20 measures". Target values were newly given for the expenditures of the health insurance funds in this area. The objective here was to examine how the prevention expenditures of the statutory health insurance developed in the period from 2012 to 2017, and whether the requirements of the Prevention Act were met. METHODS: The accounting results of the statutory health insurance funds were evaluated for the period 2012-2017. The expenditures per insured person were calculated and the changes in expenditures were analysed. The effect of the prevention law was highlighted by differentiation of the time periods 2012-2014 and 2014-2017. RESULTS: In 2017, about 2.5% of the total expenditure of the German statutory health insurance, around 5 billion euros, was accounted for in the reported prevention areas. Nearly 60% of these prevention expenditures were on early detection and vaccinations. Expenditure on "§20 measures" amounted to € 7.17 per insured person and thus reached the statutory guideline but accounted for less than 10% of all prevention expenditure. Although prevention expenditure per insured person increased over the period, the proportion of money spent on prevention measures as a whole had decreased since 2015. Expenditure on prevention measures that were directly aimed at the insured (individual approach, bonus programmes) and the setting approach (non-occupational settings, worksite health promotion) had hardly increased overall since the Prevention Act came into force. This effect is due to the equally strong decrease in bonuses for health-conscious behaviour among insured persons, despite the sharp increase in expenditure on company and noncompany settings. CONCLUSION: The proportion of money spent on disease prevention in total expenditure is still decreasing. The targets set by the Prevention Act, however, have been reached. Thus, target values have apparently proved to be an effective instrument for regulating prevention expenditure and have led to an increase in expenditure in the setting approach. Overall, there has been no expenditure effect in the area of disease prevention since the Prevention Act was enacted, as compensation was made at the expense of the non-setting measures without target values.

An analysis of sickness absence in chronically ill patients receiving complementary and alternative medicine: a longterm prospective intermittent study.

BACKGROUND: The popularity of complementary and alternative medicine (CAM) has led to a growing amount of research in this area. All the same little is known about the effects of these special treatments in every-day practice of primary care, delivered by general practitioners within the health insurance system. From 1994 to 2000 more than 20 German Company health insurances initiated the first model project on CAM according to the German social law. Aim of this contribution is to investigate the effectiveness of multi-modal CAM on chronic diseases within primary health care. METHODS: A long-term prospective intermittent study was conducted including 44 CAM practitioners and 1221 self-selected chronically ill patients (64% women) of whom 441 were employed. Main outcome measure is sick-leave, controlled for secular trends and regression-to-the mean and self-perceived health status. RESULTS: Sick-leave per year of 441 patients at work increased from 22 (SD +/- 45.2) to 31 (+/- 61.0) days within three years prior to intervention, and decreased to 24 (+/- 55.6) in the second year of treatment, sustaining at this level in the following two years. Detailed statistical analysis show that this development exceeds secular trends and the regression-toward-the-mean effect. Sick-leave reduction was corroborated by data on self-reported improvement of patients' health status. CONCLUSION: Results of this longterm observational study show a reduction of sick leave in chronically ill patients after a complex multimodal CAM intervention. However, as this is an uncontrolled observational study efficacy of any specific CAM treatment can not be proven. The results might indicate an general effectiveness of CAM in primary care, worthwhile further investigations. Future studies should identify the most suitable patients for CAM practices, the most appropriate and safe treatments, provide information on the magnitude of the effects to facilitate subsequent definitive randomised controlled studies that will help to position complementary and alternative medicine in health care.

Mortality of intentional and unintentional pesticide poisonings in Germany from 1980 to 2010.

Pesticide poisoning is a major public health issue especially in low-income countries. WHO figures show about 3 million pesticide poisonings occurring worldwide annually. A recent systematic review estimated that 360,000 fatalities result from self-poisoning with pesticides, accounting for approximately 30 per cent of all suicides worldwide. We analyzed the German cause-of-death registry with respect to pesticide-specific ICD codes. We present crude and age-standardized mortality rates plus the percentage of all suicides that are intentional pesticide poisonings. From 1980 to 2010 the number of fatal pesticide poisoning in Germany dropped from 506 to 39. The crude mortality rate decreased from 6.5 per 1 million inhabitants in 1980 to 0.5 in 2010. Reduced availability of toxic pesticides in Germany played the biggest role in the decline of fatal pesticide poisoning. We worry that declines in pesticide poisonings in industrialized countries are not matched in developing countries.