[Position Paper of The AG Digital Health DNVF on Digital Health Applications: Framework Conditions For Use in Health Care, Structural Development and Science]. / Digitale Gesundheitsanwendungen ­ Rahmenbedingungen zur Nutzung in Versorgung, Strukturentwicklung und Wissenschaft ­ Positionspapier der AG Digital Health des DNVF.

The term "digital health" is currently the most comprehensive term that includes all information and communication technologies in healthcare, including e-health, mobile health, telemedicine, big data, health apps and others. Digital health can be seen as a good example of the use of the concept and methodology of health services research in the interaction between complex interventions and complex contexts. The position paper deals with 1) digital health as the subject of health services research; 2) digital health as a methodological and ethical challenge for health services research. The often-postulated benefits of digital health interventions should be demonstrated with good studies. First systematic evaluations of apps for "treatment support" show that risks are higher than benefits. The need for a rigorous proof applies even more to big data-assisted interventions that support decision-making in the treatment process with the support of artificial intelligence. Of course, from the point of view of health services research, it is worth participating as much as possible in data access available through digital health and "big data". However, there is the risk that a noncritical application of digital health and big data will lead to a return to a linear understanding of biomedical research, which, at best, accepts complex conditions assuming multivariate models but does not take complex facts into account. It is not just a matter of scientific ethical requirements in health services care research, for instance, better research instead of unnecessary research ("reducing waste"), but it is primarily a matter of anticipating the social consequences (system level) of scientific analysis and evaluation. This is both a challenge and an attractive option for health services research to present itself as a mature and responsible scientific discipline.

Exposure to second-hand smoke and direct healthcare costs in children - results from two German birth cohorts, GINIplus and LISAplus.

BACKGROUND: Although the negative health consequences of the exposure to second hand tobacco smoke during childhood are already known, evidence on the economic consequences is still rare. The aim of this study was to estimate excess healthcare costs of exposure to tobacco smoke in German children. METHODS: The study is based on data from two birth cohort studies of 3,518 children aged 9-11 years with information on healthcare utilisation and tobacco smoke exposure: the GINIplus study (German Infant Study On The Influence Of Nutrition Intervention Plus Environmental And Genetic Influences On Allergy Development) and the LISAplus study (Influence of Life-Style Factors On The Development Of The Immune System And Allergies In East And West Germany Plus The Influence Of Traffic Emissions And Genetics). Direct medical costs were estimated using a bottom-up approach (base year 2007). We investigated the impact of tobacco smoke exposure in different environments on the main components of direct healthcare costs using descriptive analysis and a multivariate two-step regression analysis. RESULTS: Descriptive analysis showed that average annual medical costs (physician visits, physical therapy and hospital treatment) were considerably higher for children exposed to second-hand tobacco smoke at home (indoors or on patio/balcony) compared with those who were not exposed. Regression analysis confirmed these descriptive trends: the odds of positive costs and the amount of total costs are significantly elevated for children exposed to tobacco smoke at home after adjusting for confounding variables. Combining the two steps of the regression model shows smoking attributable total costs per child exposed at home of €87 [10-165] (patio/balcony) and €144 [6-305] (indoors) compared to those with no exposure. Children not exposed at home but in other places showed only a small, but not significant, difference in total costs compared to those with no exposure. CONCLUSIONS: This study shows adverse economic consequences of second-hand smoke in children depending on proximity of exposure. Tobacco smoke exposure seems to affect healthcare utilisation in children who are not only exposed to smoke indoors but also if parents reported exclusively smoking on patio or balcony. Preventing children from exposure to second-hand tobacco smoke might thus be desirable not only from a health but also from an economic perspective.

Is prevention of atopic eczema with hydrolyzed formulas cost-effective? A health economic evaluation from Germany.

OBJECTIVE: The German Infant Nutritional Intervention (GINI) trial, a prospective, randomized, double-blind intervention, enrolled children with a hereditary risk for atopy. When fed with certain hydrolyzed formulas for the first 4 months of life, the risk was reduced by 26-45% in PP and 8-29% in intention-to-treat (ITT) analyses compared with children fed with regular cow's milk at age 6. The objective was to assess the cost-effectiveness of feeding hydrolyzed formulas. PATIENTS AND METHODS: Cost-effectiveness was assessed with a decision tree model programmed in TreeAge. Costs and effects over a 6-yr period were analyzed from the perspective of the German statutory health insurance (SHI) and a societal perspective at a 3% effective discount rate followed by sensitivity analyses. RESULTS: The extensively hydrolyzed casein formula would be the most cost-saving strategy with savings of 478 € per child treated in the ITT analysis (CI95%: 12 €; 852 €) and 979 € in the PP analysis (95%CI: 355 €; 1455 €) from a societal perspective. If prevented cases are considered, the partially whey hydrolyzed formula is cost-saving (ITT -5404 €, PP -6358 €). From an SHI perspective, the partially whey hydrolyzed formula is cost-effective, but may also be cost-saving depending on the scenario. An extensively hydrolyzed whey formula also included into the analysis was dominated in all analyses. CONCLUSIONS: For the prevention of AE, two formulas can be cost-effective or even cost-saving. We recommend that SHI should reimburse formula feeding or at least the difference between costs for cow's milk formula and the most cost-effective formula.

Relative weight-related costs of healthcare use by children--results from the two German birth cohorts, GINI-plus and LISA-plus.

Obesity among children and adolescents is a growing public health burden. According to a national reference among German children and adolescents aged 3-17 years, 15% are overweight (including obese) and 6.3% are obese. This study aims to assess the economic burden associated with overweight and obesity in children based on a cross-sectional survey from two birth cohort studies: the GINI-plus - German Infant Nutritional Intervention plus Non-Intervention study (3287 respondents aged 9 to <12 years) and the LISA-plus study - Influence of life-style factors on the development of the immune system and allergies in East and West Germany (1762 respondents aged 9 to <12 years). Using a bottom-up approach, we analyse direct costs induced by the utilisation of healthcare services and indirect costs emerging from parents' productivity losses. To investigate the impact of Body Mass Index (BMI) on costs, we perform various descriptive analyses and estimate a two-part regression model. Average annual total direct medical costs of healthcare use are estimated to be €418 (95% CI [346-511]) per child, split between physician (22%), therapist (29%), hospital (41%) and inpatient rehabilitation costs (8%). Bivariate analysis shows considerable differences between BMI groups: €469 (severely underweight), €468 (underweight), €402 (normal weight), €468 (overweight) and €680 (obese). Indirect costs make up €101 per year on average and tend to be higher for obese children, although this was not statistically significant. Drawing on these results, differences in healthcare costs between BMI groups are already apparent in children.

Regional and socio-economic differences in food, nutrient and supplement intake in school-age children in Germany: results from the GINIplus and the LISAplus studies.

OBJECTIVE: To describe regional differences between eastern and western Germany with regard to food, nutrient and supplement intake in 9-12-year-old children, and analyse its association with parental education and equivalent income. DESIGN: Data were obtained from the 10-year follow-up of the two prospective birth cohort studies - GINIplus and LISAplus. Data on food consumption and supplement intake were collected using an FFQ, which had been designed for the specific study population. Information on parental educational level and equivalent income was derived from questionnaires. Logistic regression modelling was used to analyse the effect of parental education, equivalent income and region on food intake, after adjusting for potential confounders. SETTING: Germany. SUBJECTS: A total of 3435 children aged 9-12 years. RESULTS: Substantial regional differences in food intake were observed between eastern and western Germany. Intakes of bread, butter, eggs, pasta, vegetables/salad and fruit showed a significant direct relationship with the level of parental education after adjusting for potential confounders, whereas intakes of margarine, meat products, pizza, desserts and soft drinks were inversely associated with parental education. Equivalent income had a weaker influence on the child's food intake. CONCLUSIONS: Nutritional education programmes for school-age children should therefore account for regional differences and parental education.

Hospital admission in children up to the age of 2 years.

The description and analysis of the utilisation of medical services is of particular importance reflecting childhood morbidity. Therefore, our aim was to describe episode- and person-based rates of hospital admission in Germany, by focusing on the three most important clinically relevant categories, accident injuries, respiratory and digestive diseases in children up to the age of 2 years. The analysis was based on data from the LISA-study, a prospective population based birth cohort study including 3097 full-term infants. Information was collected by parent questionnaires and data was analysed concerning gender, region and social status. In the age-group 7-24 months, 14.5% of all children were at least once hospitalised, 2.5% for accident injuries, 3.0% for respiratory and 4.7% for digestive diseases. More boys than girls were admitted to hospital due to respiratory diseases (4.2% vs. 1.7%) and more children from East compared to West Germany due to digestive diseases (7.2% vs. 3.5%). In families with median or low level education more children were admitted for digestive diseases than with high (6.5% and 6.5% vs. 3.6%). The number of hospitalisation episodes per person showed that most children were hospitalised only once during the period from 7 to 24 months. In conclusion this analysis shows that hospital admission is common and not equally distributed concerning sex, parental education and region in German children. Physicians should pay special attention to these susceptive subgroups and differences in health related behaviour and in the distribution of health facilities have to be reduced. Additionally, multiple admissions play only a minor role concerning hospital admission in children up to the age of 2 years.

Contribution of smoking and air pollution exposure in urban areas to social differences in respiratory health.

BACKGROUND: Socio-economic status, smoking, and exposure to increased levels of environmental air pollution are associated with adverse effects on respiratory health. We assessed the contribution of occupational exposures, smoking and outdoor air pollution as competing factors for the association between socio-economic status and respiratory health indicators in a cohort of women from the Ruhr area aged 55 at the time of investigation between 1985 and 1990. METHODS: Data of 1251 women with spirometry and complete questionnaire information about respiratory diseases, smoking and potential confounders were used in the analyses. Exposure to large-scale air pollution was assessed with data from monitoring stations. Exposure to small-scale air pollution was assessed as traffic-related exposure by distance to the nearest major road. Socio-economic status was defined by educational level. Multiple regression models were used to estimate the contribution of occupational exposures, smoking and outdoor air pollution to social differences in respiratory health. RESULTS: Women with less than 10 years of school education in comparison to more than 10 years of school education were more often occupationally exposed (16.4% vs. 10.1%), smoked more often (20.3% vs. 13.9%), and lived more often close to major roads (26.0% vs. 22.9%). Long-term exposure to increased levels of PM10 was significantly associated with lower school education. Women with low school education were more likely to suffer from respiratory symptoms and had reduced lung function. In the multivariate analysis the associations between education and respiratory health attenuated after adjusting for occupational exposure, smoking and outdoor air pollution. The crude odds ratio for the association between the lung function indicator FEV1 less than 80% of predicted value and educational level (<10 years vs. >10 years of school education) was 1.83 (95% CI: 1.22-2.74). This changed to 1.56 (95% CI: 1.03-2.37) after adjusting for occupational exposure, smoking and outdoor air pollution. CONCLUSION: We found an association between socio-economic status and respiratory health. This can partly be explained by living conditions indicated by occupational exposure, smoking behaviour and ambient air pollution. A relevant part of the social differences in respiratory health, however, remained unexplained.

Preschool children's health and its association with parental education and individual living conditions in East and West Germany.

BACKGROUND: Social inequalities in health exist globally and are a major public health concern. This study focus on a systematic investigation into the associations between health indicators, living conditions and parental educational level as indicator of the social status of 6-year-old children living in West and East Germany in the decade after re-unification. Explanations of observed associations between parental education and health indicators were examined. METHODS: All boys and girls entering elementary school and living in predefined areas of East and West Germany were invited to participate in a series of cross-sectional surveys conducted between 1991 and 2000. Data of 28,888 German children with information on parental education were included in the analysis. Information about educational level of the parents, individual living conditions, symptoms and diagnoses of infectious diseases and allergies were taken from questionnaire. At the day of investigation, atopic eczema was diagnosed by dermatologists, blood was taken for the determination of allergen-specific immuno-globulin E, height and weight was measured and lung function tests were done in subgroups. Regression analysis was applied to investigate the associations between the health indicators and parental educational level as well as the child's living conditions. Gender, urban/rural residency and year of survey were used to control for confounding. RESULTS: Average response was 83% in East Germany and 71% in West Germany. Strong associations between health indicators and parental education were observed. Higher educated parents reported more diagnoses and symptoms than less educated. Children of higher educated parents were also more often sensitized against grass pollen or house dust mites, but had higher birth weights, lower airway resistance and were less overweight at the age of six. Furthermore, most of the health indicators were significantly associated with one or more living conditions such as living as a single child, unfavourable indoor air, damp housing condition, maternal smoking during pregnancy or living near a busy road. The total lung capacity and the prevalence of an atopic eczema at the day of investigation were the only health indicators those did not show associations with any of the predictor variables. CONCLUSION: Despite large differences in living conditions and evidence that some poor health outcomes were directly associated with poor living conditions, only few indicators demonstrated poorer health in social disadvantaged children. These were in both parts of Germany increased levels of overweight, higher airway resistance and, in East Germany only, reduced height in children with lower educated parents compared to those of higher education. In both East and West Germany, higher prevalence of airway symptoms was associated with a damp housing condition, and lower birth weight, reduced height and increased airway resistance at the age of six were associated with maternal smoking during pregnancy. The latter explained to a large extent the difference in birth weight and airway resistance between the educational groups.

Changes in social inequality with respect to health-related living conditions of 6-year-old children in East Germany after re-unification.

BACKGROUND: Since Germany re-unified in 1990, substantial social and economic changes have happened in East Germany, the former socialist German Democratic Republic (GDR). The aim of this study was to investigate the influence of these socio-economic changes in East Germany on the association between social status, measured by parental educational level, and health-related living conditions of children during the ten-year period after re-unification. METHODS: In total, 25,864 6-year-old school beginner children (51.2% male and 48.8% female) participated in cross-sectional studies which have been repeated every year from 1991 to 2000 in East Germany. Parental educational level as a social indicator was the independent variable. Dependent variables included not employed parents, small living space and health-related living conditions (e. g. damp housing, single oven heating and living at busy road). The relationships were described by odds ratios using logistic regression. RESULTS: A large overall effect of parental educational level on health-related living conditions was observed. The time trends showed that the situation regarding small living space, damp housing conditions and single oven heating improved from 1991 to 2000, while regarding not employed parents (1996-2000) and living at busy road (1991-2000) did not, but even deteriorated. 6-year old children with low parental educational level, who lived at the time of re-unification, were often under damp housing conditions and with single oven heating at homes. Nevertheless, this social inequality has almost vanished ten years later. In contrast, we found an increasing gap between low and high parental educational level with respect to the proportion of parents who were not employed (22%: 4% gain), or lived under cramped housing conditions (22%: 37% reduction), or close to a busy road (7% gain: 2% reduction). CONCLUSION: The social inequalities which already existed under the socialist system in East Germany persisted in the system of social market economy between 1991 and 2000. 6-year-old children from families with the lowest social status were living under the worst domestic conditions (e. g. living at busy road, having damp housing conditions, single oven heating and small living space) and for some conditions (e. g. living at busy road and having small living space) the gap betweenlow and high social status was even bigger in 2000 than in 1991.