Shaping a suitable EU HTA dossier template: why the German template is not fit for purpose.

From 2025, Health Technology Developers (HTDs) have to submit EU HTA dossiers. The joint clinical assessment (JCA) aims to streamline HTA processes and access to medicinal products across Europe. Currently, German HTA bodies IQWiG and G-BA actively shape the JCA methodology. Here we examine if German HTA dossier requirements are suitable for the JCA. We compare the number of safety endpoint and subgroup analyses in German dossiers with analyses considered in IQWIG's benefit assessment and evaluate if these analyses were considered by the G-BA. We further investigated how the number of analyses was affected by the latest change in the German dossier template. With the current template, HTDs report in median 2.6 times more analyses on adverse events (AE) and 1.1 times more subgroup categories than in the previous template. IQWiG does not consider 33% of AE analyses and 73% of the subgroup categories presented by the HTD under the current template. G-BA considered the same AE as IQWiG in 76% of cases. Subgroups were uncommented by G-BA in most cases, independent of the template (previous: 93%, current 85%) and unconsidered in the conclusion on additional benefit (previous: 77%, current 69%). Thus, changes in the dossier template drastically increased HTD workload, but additional analyses seem unconsidered by the HTA bodies. With a broader scope in JCA, this effect could be amplified. To mitigate duplicative efforts and ensure prompt availability of medicinal products as envisioned by the HTAR, we suggest well-chosen and precise dossier requirements, early consultations, and early HTD engagement.

Pathways of Parental Education on Children's and Adolescent's Body Mass Index: The Mediating Roles of Behavioral and Psychological Factors.

Aim: The increasing body mass index (BMI) often followed by overweight and obesity is a global health problem of the 21st century. Children and adolescents with lower socioeconomic status are more affected than their counterparts. The mechanisms behind these differences must be well understood to develop effective prevention strategies. This analysis aims at examining the association of parental education as an indicator of the socioeconomic status on children's and adolescent's body mass index and the role of behavioral and psychological risk factors for a higher BMI longitudinally. Methods: The analysis was based on a nationwide sample of N = 460 children and adolescents, aged 11 to 17 at baseline (2009-2012), who took part in the representative BELLA study, the mental health module of the German National Health Interview and Examination Survey among Children and Adolescents (KiGGS). A follow-up was conducted 5 years later. Using mediation analyses, the mediating effects of breakfast consumption, consumption of sugar-sweetened beverages, screen time, physical activity, mental health problems (Strengths and Difficulties Questionnaire), and health-related quality of life (KIDSCREEN-10) on the association of parent's years of education on their children's BMI were investigated. Results: A lower level of parental education was significantly associated with a higher BMI in children and adolescents 5 years later. The association was partially mediated by breakfast consumption and total screen time, with breakfast consumption mediating 16.7% and total screen time 27.8% of the association. After controlling for age, gender, and migration status, only breakfast consumption remained a partial mediator (8.5%). Other included variables had no mediating effects. Conclusions: Preventive measures should be mainly targeted at children and adolescents of parents with lower educational levels. Tailored strategies to prevent the development of overweight and obesity in this population among children and adolescents should promote daily breakfast consumption at home and reducing screen time.

Change in Physical Activity after Diagnosis of Diabetes or Hypertension: Results from an Observational Population-Based Cohort Study.

Background: Chronic diseases like diabetes mellitus or hypertension are a major public health challenge. Irregular physical activity (PA) is one of the most important modifiable risk factors for chronic conditions and their complications. However, engaging in regular PA is a challenge for many individuals. The literature suggests that a diagnosis of a disease might serve as a promising point in time to change health behavior. This study investigates whether a diagnosis of diabetes or hypertension is associated with changes in PA. Methods: Analyses are based on 4261 participants of the population-based KORA S4 study (1999-2001) and its subsequent 7-and 14-year follow-ups. Information on PA and incident diagnoses of diabetes or hypertension was assessed via standardized interviews. Change in PA was regressed upon diagnosis with diabetes or hypertension, using logistic regression models. Models were stratified into active and inactive individuals at baseline to avoid ceiling and floor effects or regression to the mean. Results: Active participants at baseline showed higher odds (OR = 2.16 [1.20;3.89]) for becoming inactive after a diabetes diagnosis than those without a diabetes diagnosis. No other significant association was observed. Discussion: As PA is important for the management of diabetes or hypertension, ways to increase or maintain PA levels in newly-diagnosed patients are important. Communication strategies might be crucial, and practitioners and health insurance companies could play a key role in raising awareness.

Are primary school children attending full-day school still engaged in sports clubs?

PURPOSE: Schools and organized sports both offer great chances to promote physical activity among children. Full-day schools particularly allow for extensive participation in extra-curricular physical activities. However, due to time reasons, full-day schools may also prevent children from engagement in organized sports outside school. There is only little national and international research addressing the possible competition of full-day schools and providers of organized sports outside school and the potential effects on children's physical activity behavior. In Germany's educational system, a transformation towards more full-day schools is currently taking place. The existence of both, half-day and full-day schools, gave occasion to the following research question: Do students attending half-day and full-day school differ with respect to a) sports club membership rate and b) weekly amount of sports club training? METHODS: Data were collected in eleven German primary schools. Selected schools offered both half-day and full-day (minimum three days/week with at least seven hours) care. 372 students' data (grades 1-4; N = 153 half-day, N = 219 full-day; 47.4% male, 8.8±1.2y) were eligible for analyses. We assessed sports club membership and weekly training duration via questionnaire. Statistical analyses included Chi-square and Mann-Whitney-U-Tests. RESULTS: 83% of half-day school students and 67% of full-day school students were sports club members (χ2(1) = 12.31, p<.001). Weekly duration of training in sports clubs among sports club members (N = 266) also differed between the groups (mdn = 150 min in half-day, mdn = 120 min in full-day school students; z = -2.37, p = .018). Additional analyses stratified for age and gender showed similar results. CONCLUSION: Primary school students attending full-day schools engage less in organized sports outside school than half-day school students, regardless of age and gender. Future studies should examine if the detected lower engagement in sports club physical activity is compensated by physical activities in other settings such as school or non-organized leisure time.

Clustering of Health-Related Behavior Patterns and Demographics. Results From the Population-Based KORA S4/F4 Cohort Study.

Background: Health behaviors are of great importance for public health. Previous research shows that health behaviors are clustered and do not occur by chance. The main objective of this study was to investigate and describe the clustering of alcohol consumption, nutrition, physical activity and smoking while also considering the influence of sex, age and education. Methods: Using data from the population-based KORA S4/F4 cohort study, latent class regression analysis was undertaken to identify different clusters of health behavior patterns. The clusters were described according to demographics. Furthermore, the clusters were described regarding health-related quality of life at baseline and at a 7 year follow-up. Results: Based on a sample of 4,238 participants, three distinct classes were identified. One overall healthy class and two heterogeneous classes. Classes varied especially according to sex, indicating a healthier behavior pattern for females. No clear association between healthier classes and age, education or physical and mental health-related quality of life was found. Discussion: This study strengthens the literature on the clustering of health behaviors and additionally describes the identified clusters in association with health-related quality of life. More research on associations between clustering of health behaviors and important clinical outcomes is needed.

Trends in Motor Performance of First Graders: A Comparison of Cohorts from 2006 to 2015.

BACKGROUND: Motor performance is an important factor for health. Already in childhood, motor performance is associated with, e.g., obesity and risk factors for cardiovascular diseases. It is widely believed that the motor performance of children has declined over recent years. However, this belief is lacking clear evidence. The objective of this study was to examine trends in motor performance of first grade students during a period of 10 years (2006-2015). We examined trends in (a) aerobic fitness, (b) strength, (c) speed, and (d) balance for boys and girls separately and considered body mass index (BMI) as a potential confounder. METHODS: From 2006 to 2015, we tested 5,001 first graders [50.8% boys; mean age 6.76 (0.56) years] of 18 primary schools in Germany. Each year between 441 and 552 students of the same schools were surveyed. Performance tests were taken from the Motorik-Module Study and the "German Motor Ability Test": "6-min run," "push-ups," "20-m sprint," and "static stand." Linear regression models were conducted for statistical analysis. RESULTS: A slightly negative trend in aerobic fitness performance was revealed in boys (ß = -0.050; p = 0.012) but not in girls. In the strength performance test no trend over time was detected. Performance in speed (boys: ß = -0.094; girls: ß = -0.143; p ≤ 0.001) and balance tests (boys: ß = -0.142; girls: ß = -0.232; p ≤ 0.001) increased over time for both boys and girls. These findings held true when BMI was considered. CONCLUSION: This study only partly supported the assumption that motor performance of children has declined: in our study, aerobic fitness declined (only in boys), while strength remained stable and speed and balance even increased in both sexes. Moreover, it seems as if BMI can explain changes in performance only to a small extent. Changed lifestyles might be a substantial cause. Further research on recent trends of motor performance and interacting variables is needed to support the results of our study and to provide more knowledge on causes of these trends.

The longitudinal association between change in physical activity, weight, and health-related quality of life: Results from the population-based KORA S4/F4/FF4 cohort study.

INTRODUCTION: Longitudinal evidence on the association between physical activity (PA) or weight and health-related quality of life (HRQL) is sparse and studies describe inconclusive results. The aim of this study was to examine longitudinal associations between change in PA and HRQL as between change in weight and HRQL respectively. METHODS: Analyses are based on data from the KORA S4 cohort study (1999-2001; n = 4,261, mean age 49.0 ± 13.3 years) and the two follow-up examinations (F4: 2006-2008; FF4: 2013-2014). Information on PA was collected in standardized interviews. Weight was measured objectively. Mental and physical components of HRQL were assessed via the SF-12 questionnaire. First, change in HRQL was regressed on change in PA and weight. Second, hierarchical linear models were fitted, which allowed estimation of between-subject and within-subject effects. Analyses were adjusted for the covariates sex, baseline diseases, and education. RESULTS: A change to a physically more active lifestyle is positively associated with physical and mental HRQL. Although weight gain is associated with impairments in physical HRQL, the data show an inverse relationship between weight gain and mental HRQL. The results were consistent for both the change score analyses and the hierarchical linear models. DISCUSSION: Our findings stress the importance of interventions on PA/weight. Nonetheless, more research is needed to reveal the causal relationship between PA/weight and HRQL.