Adipositas Care and Health Therapy (ACHT) after Bariatric-Metabolic Surgery: A Prospective, Non-Randomized Intervention Study.

INTRODUCTION: Almost 25% of German adults have obesity and numbers are rising, making it an important health issue. Bariatric-metabolic surgery reduces body weight and complications for persons with obesity, but therapeutic success requires long-term postoperative care. Since no German standards for follow-up by family physicians exist, follow-up is provided by surgical obesity centers, but they are reaching their limits. The ACHT study, funded by the German Innovation Fund, is designed to establish and evaluate the follow-up program, with local physicians following patients supported remotely by obesity centers. METHODS: ACHT is a multicenter, prospective, non-randomized control group study. The 18-month ACHT follow-up program is a digitally supported, structured, cross-sectoral, and close-to-home program to improve success after bariatric-metabolic surgery. Four groups are compared: intervention group 1 starts the program immediately (3 weeks) after Roux-en-Y gastric bypass or sleeve gastrectomy (months 1-18 postoperatively), intervention group 2 begins the program 18 months after surgery (months 19-36 postoperatively). Intervention groups are compared to respective control groups that had surgery 18 and 36 months previously. In total, 250 patients, enrolled in the intervention groups, are compared with 360 patients in the control groups, who only receive standard care. RESULTS: The primary endpoint to compare intervention and control groups is the adapted King's score, a composite tool evaluating physical, psychological, socioeconomic, and functional health status. Secondary endpoints include changes in care structures and care processes for the intervention groups. Multivariate regression analyses adjusting for confounders (including the type of surgery) are used to compare intervention and control groups and evaluate determinants in longitudinal analyses. The effect of the intervention on healthcare costs will be evaluated based on health insurance billing data of patients who had bariatric-metabolic surgery in the 3 years prior to the start of the study and of patients who undergo bariatric-metabolic surgery during the study period. CONCLUSIONS: ACHT will be the one of the first evaluated structured, close-to-home follow-up programs for bariatric surgery in Germany. It will evaluate the effectiveness of the implemented program regarding improvements in health status, mental health, quality of life, and the feasibility of such a program outside of specialized obesity centers.

An umbrella review of effectiveness and efficacy trials for app-based health interventions.

Health interventions based on mobile phone or tablet applications (apps) are promising tools to help patients manage their conditions more effectively. Evidence from randomized controlled trials (RCTs) on efficacy and effectiveness of such interventions is increasingly available. This umbrella review aimed at mapping and narratively summarizing published systematic reviews on efficacy and effectiveness of mobile app-based health interventions within patient populations. We followed a pre-specified publicly available protocol. Systematic reviews were searched in two databases from inception until August 28, 2023. Reviews that included RCTs evaluating integrated or stand-alone health app interventions in patient populations with regard to efficacy/effectiveness were considered eligible. Information on indications, outcomes, app characteristics, efficacy/effectiveness results and authors' conclusions was extracted. Methodological quality was assessed using the AMSTAR2 tool. We identified 48 systematic reviews published between 2013 and 2023 (35 with meta-analyses) that met our inclusion criteria. Eleven reviews included a broad spectrum of conditions, thirteen focused on diabetes, five on anxiety and/or depression, and others on various other indications. Reported outcomes ranged from medication adherence to laboratory, anthropometric and functional parameters, symptom scores and quality of life. Fourty-one reviews concluded that health apps may be effective in improving health outcomes. We rated one review as moderate quality. Here we report that the synthesized evidence on health app effectiveness varies largely between indications. Future RCTs should consider reporting behavioral (process) outcomes and measures of healthcare resource utilization to provide deeper insights on mechanisms that make health apps effective, and further elucidate their impact on healthcare systems.

Projected health and economic impacts of sugar-sweetened beverage taxation in Germany: A cross-validation modelling study.

BACKGROUND: Taxes on sugar-sweetened beverages (SSBs) have been implemented globally to reduce the burden of cardiometabolic diseases by disincentivizing consumption through increased prices (e.g., 1 peso/litre tax in Mexico) or incentivizing industry reformulation to reduce SSB sugar content (e.g., tiered structure of the United Kingdom [UK] Soft Drinks Industry Levy [SDIL]). In Germany, where no tax on SSBs is enacted, the health and economic impact of SSB taxation using the experience from internationally implemented tax designs has not been evaluated. The objective of this study was to estimate the health and economic impact of national SSBs taxation scenarios in Germany. METHODS AND FINDINGS: In this modelling study, we evaluated a 20% ad valorem SSB tax with/without taxation of fruit juice (based on implemented SSB taxes and recommendations) and a tiered tax (based on the UK SDIL) in the German adult population aged 30 to 90 years from 2023 to 2043. We developed a microsimulation model (IMPACTNCD Germany) that captures the demographics, risk factor profile and epidemiology of type 2 diabetes, coronary heart disease (CHD) and stroke in the German population using the best available evidence and national data. For each scenario, we estimated changes in sugar consumption and associated weight change. Resulting cases of cardiometabolic disease prevented/postponed and related quality-adjusted life years (QALYs) and economic impacts from healthcare (medical costs) and societal (medical, patient time, and productivity costs) perspectives were estimated using national cost and health utility data. Additionally, we assessed structural uncertainty regarding direct, body mass index (BMI)-independent cardiometabolic effects of SSBs and cross-validated results with an independently developed cohort model (PRIMEtime). We found that SSB taxation could reduce sugar intake in the German adult population by 1 g/day (95%-uncertainty interval [0.05, 1.65]) for a 20% ad valorem tax on SSBs leading to reduced consumption through increased prices (pass-through of 82%) and 2.34 g/day (95%-UI [2.32, 2.36]) for a tiered tax on SSBs leading to 30% reduction in SSB sugar content via reformulation. Through reductions in obesity, type 2 diabetes, and cardiovascular disease (CVD), 106,000 (95%-UI [57,200, 153,200]) QALYs could be gained with a 20% ad valorem tax and 192,300 (95%-UI [130,100, 254,200]) QALYs with a tiered tax. Respectively, €9.6 billion (95%-UI [4.7, 15.3]) and €16.0 billion (95%-UI [8.1, 25.5]) costs could be saved from a societal perspective over 20 years. Impacts of the 20% ad valorem tax were larger when additionally taxing fruit juice (252,400 QALYs gained, 95%-UI [176,700, 325,800]; €11.8 billion costs saved, 95%-UI [€6.7, €17.9]), but impacts of all scenarios were reduced when excluding direct health effects of SSBs. Cross-validation with PRIMEtime showed similar results. Limitations include remaining uncertainties in the economic and epidemiological evidence and a lack of product-level data. CONCLUSIONS: In this study, we found that SSB taxation in Germany could help to reduce the national burden of noncommunicable diseases and save a substantial amount of societal costs. A tiered tax designed to incentivize reformulation of SSBs towards less sugar might have a larger population-level health and economic impact than an ad valorem tax that incentivizes consumer behaviour change only through increased prices.

Forecasting the mortality burden of coronary heart disease and stroke in Germany: National trends and regional inequalities.

BACKGROUND: The decline of cardiovascular disease (CVD) mortality has slowed in many countries, including Germany. We examined the implications of this trend for future coronary heart disease (CHD) and stroke mortality in Germany considering persistent mortality inequalities between former East and West Germany. METHODS: We retrieved demographic and mortality data from 1991 to 2019 from the German Federal Statistical Office. Using a Bayesian age-period-cohort framework, we projected CHD and stroke mortality from 2019 to 2035, stratified by sex and German region. We decomposed annual changes in deaths into three components (mortality rates, population age structure and population size) and assessed regional inequalities with age-sex-standardized mortality ratios. RESULTS: We confirmed that declines of CVD mortality rates in Germany will likely stagnate. From 2019 to 2035, we projected fewer annual CHD deaths (114,600 to 103,500 [95%-credible interval: 81,700; 134,000]) and an increase in stroke deaths (51,300 to 53,700 [41,400; 72,000]). Decomposing past and projected mortality, we showed that population ageing was and is offset by declining mortality rates. This likely reverses after 2030 leading to increased CVD deaths thereafter. Inequalities between East and West declined substantially since 1991 and are projected to stabilize for CHD but narrow for stroke. CONCLUSIONS: CVD deaths in Germany likely keep declining until 2030, but may increase thereafter due to population ageing if the reduction in mortality rates slows further. East-West mortality inequalities for CHD remain stable but may converge for stroke. Underlying risk factor trends need to be monitored and addressed by public health policy.

Preferences of women in difficult life situations for a physical activity programme: protocol of a discrete choice experiment in the German NU-BIG project.

INTRODUCTION: The BIG project ('Bewegung als Investition in die Gesundheit', ie, 'Movement as Investment in Health') was developed in 2005 as a community-based participatory research programme to offer accessible opportunities for physical activity to women in difficult life situations. Since then, the programme has been expanded to eight sites in Germany. A systematic evaluation of BIG is currently being conducted. As part of this effort, we strive to understand the preferences of participating women for different aspects of the programme, and to analyse their willingness to pay. METHODS AND ANALYSIS: In this protocol, we describe the development and analysis plan of a discrete choice experiment (DCE) to investigate participants' preferences for a physical activity programme for women in difficult life situations. The experiment will be embedded in a questionnaire covering several aspects of participation in the programme (eg, reach, efficacy and further effects) and the socioeconomic characteristics of all active participants. After a thorough search of the literature, BIG documents review and expert interviews, we identified five important attributes of the programme: course times, travel time to the course venue, additional social activities organised by BIG, consideration of wishes and interests for the further planning of courses and costs per course unit. Thereafter, we piloted the experiment with a sample of participants from the target group. After data collection, the experiment will be analysed using a conditional logit model and a latent class analysis to assess eventual heterogeneity in preferences. ETHICS AND DISSEMINATION: Understanding women's preferences will provide useful insights for the further development of the programme and ultimately increase participation and retention. The questionnaire, the included DCE and the pretest on participants received ethical approval (application no. 20-247_1-B). We plan to disseminate the results of the DCE in peer-reviewed journals, national conferences and among participants and programme coordinators and organisers.

Health and economic impact of improved glucose, blood pressure and lipid control among German adults with type 2 diabetes: a modelling study.

AIMS/HYPOTHESIS: The aim of this study was to estimate the long-term health and economic consequences of improved risk factor control in German adults with type 2 diabetes. METHODS: We used the UK Prospective Diabetes Study Outcomes Model 2 to project the patient-level health outcomes and healthcare costs of people with type 2 diabetes in Germany over 5, 10 and 30 years. We parameterised the model using the best available data on population characteristics, healthcare costs and health-related quality of life from German studies. The modelled scenarios were: (1) a permanent reduction of HbA1c by 5.5 mmol/mol (0.5%), of systolic BP (SBP) by 10 mmHg, or of LDL-cholesterol by 0.26 mmol/l in all patients, and (2) achievement of guideline care recommendations for HbA1c (≤53 mmol/mol [7%]), SBP (≤140 mmHg) or LDL-cholesterol (≤2.6 mmol/l) in patients who do not meet the recommendations. We calculated nationwide estimates using age- and sex-specific quality-adjusted life year (QALY) and cost estimates, type 2 diabetes prevalence and population size. RESULTS: Over 10 years, a permanent reduction of HbA1c by 5.5 mmol/mol (0.5%), SBP by 10 mmHg or LDL-cholesterol by 0.26 mmol/l led to per-person savings in healthcare expenditures of €121, €238 and €34, and 0.01, 0.02 and 0.015 QALYs gained, respectively. Achieving guideline care recommendations for HbA1c, SBP or LDL-cholesterol could reduce healthcare expenditure by €451, €507 and €327 and gained 0.03, 0.05 and 0.06 additional QALYs in individuals who did not meet the recommendations. Nationally, achieving guideline care recommendations for HbA1c, SBP and LDL-cholesterol could reduce healthcare costs by over €1.9 billion. CONCLUSIONS/INTERPRETATION: Sustained improvements in HbA1c, SBP and LDL-cholesterol control among diabetes patients in Germany can lead to substantial health benefits and reduce healthcare expenditures.

A New Type 2 Diabetes Microsimulation Model to Estimate Long-Term Health Outcomes, Costs, and Cost-Effectiveness.

OBJECTIVES: This study aimed to develop a microsimulation model to estimate the health effects, costs, and cost-effectiveness of public health and clinical interventions for preventing/managing type 2 diabetes. METHODS: We combined newly developed equations for complications, mortality, risk factor progression, patient utility, and cost-all based on US studies-in a microsimulation model. We performed internal and external validation of the model. To demonstrate the model's utility, we predicted remaining life-years, quality-adjusted life-years (QALYs), and lifetime medical cost for a representative cohort of 10 000 US adults with type 2 diabetes. We then estimated the cost-effectiveness of reducing hemoglobin A1c from 9% to 7% among adults with type 2 diabetes, using low-cost, generic, oral medications. RESULTS: The model performed well in internal validation; the average absolute difference between simulated and observed incidence for 17 complications was < 8%. In external validation, the model was better at predicting outcomes in clinical trials than in observational studies. The cohort of US adults with type 2 diabetes was projected to have an average of 19.95 remaining life-years (from mean age 61), incur $187 729 in discounted medical costs, and accrue 8.79 discounted QALYs. The intervention to reduce hemoglobin A1c increased medical costs by $1256 and QALYs by 0.39, yielding an incremental cost-effectiveness ratio of $9103 per QALY. CONCLUSIONS: Using equations exclusively derived from US studies, this new microsimulation model achieves good prediction accuracy in US populations. The model can be used to estimate the long-term health impact, costs, and cost-effectiveness of interventions for type 2 diabetes in the United States.

Socioeconomic and risk-related drivers of compliance with measures to prevent SARS-CoV-2 infection: evidence from the Munich-based KoCo19 study.

OBJECTIVES: Although a growing share of the population in many countries has been vaccinated against the SARS-CoV-2 virus to different degrees, social distancing and hygienic non-pharmaceutical interventions still play a substantial role in containing the pandemic. The goal of this study was to investigate which factors are correlated with a higher compliance with these regulations in the context of a cohort study in the city of Munich, southern Germany, during the summer of 2020, i.e. after the first lockdown phase. METHODS: Using self-reported compliance with six regulations and personal hygiene rules (washing hands, avoiding touching face, wearing a mask, keeping distance, avoiding social gatherings, avoiding public spaces) we extracted two compliance factor scores, namely compliance with personal hygiene measures and compliance with social distancing regulations. Using linear and logistic regressions, we estimated the correlation of several socio-demographic and risk perception variables with both compliance scores. RESULTS: Risk aversion proved to be a consistent and significant driver of compliance across all compliance behaviors. Furthermore, being female, being retired and having a migration background were positively associated with compliance with personal hygiene regulations, whereas older age was related with a higher compliance with social distancing regulations. Generally, socioeconomic characteristics were not related with compliance, except for education, which was negatively related with compliance with personal hygiene measures. CONCLUSIONS: Our results suggest that for a targeted approach to improve compliance with measures to prevent SARS-CoV-2 infection, special attention should be given to younger, male and risk-prone individuals.

A spatial obesity risk score for describing the obesogenic environment using kernel density estimation: development and parameter variation.

BACKGROUND: Overweight and obesity are severe public health problems worldwide. Obesity can lead to chronic diseases such as type 2 diabetes mellitus. Environmental factors may affect lifestyle aspects and are therefore expected to influence people's weight status. To assess environmental risks, several methods have been tested using geographic information systems. Freely available data from online geocoding services such as OpenStreetMap (OSM) can be used to determine the spatial distribution of these obesogenic factors. The aim of our study was to develop and test a spatial obesity risk score (SORS) based on data from OSM and using kernel density estimation (KDE). METHODS: Obesity-related factors were downloaded from OSM for two municipalities in Bavaria, Germany. We visualized obesogenic and protective risk factors on maps and tested the spatial heterogeneity via Ripley's K function. Subsequently, we developed the SORS based on positive and negative KDE surfaces. Risk score values were estimated at 50 random spatial data points. We examined the bandwidth, edge correction, weighting, interpolation method, and numbers of grid points. To account for uncertainty, a spatial bootstrap (1000 samples) was integrated, which was used to evaluate the parameter selection via the ANOVA F statistic. RESULTS: We found significantly clustered patterns of the obesogenic and protective environmental factors according to Ripley's K function. Separate density maps enabled ex ante visualization of the positive and negative density layers. Furthermore, visual inspection of the final risk score values made it possible to identify overall high- and low-risk areas within our two study areas. Parameter choice for the bandwidth and the edge correction had the highest impact on the SORS results. DISCUSSION: The SORS made it possible to visualize risk patterns across our study areas. Our score and parameter testing approach has been proven to be geographically scalable and can be applied to other geographic areas and in other contexts. Parameter choice played a major role in the score results and therefore needs careful consideration in future applications.

Interim Evaluation of Germany's Sugar Reduction Strategy for Soft Drinks: Commitments versus Actual Trends in Sugar Content and Sugar Sales from Soft Drinks.

INTRODUCTION: A high intake of sugar, in particular from sugar-sweetened soft drinks, increases the risk for obesity, type 2 diabetes mellitus, and dental caries. Germany has pursued a national strategy for sugar reduction in soft drinks based on voluntary commitments by industry since 2015, but its effects are unclear. METHODS: We use aggregated annual sales data from Euromonitor International to assess trends in mean sales-weighted sugar content of soft drinks and per capita sugar sales from soft drinks in Germany from 2015 to 2021. We compare these trends to the reduction path set by Germany's national sugar reduction strategy and to data for the United Kingdom, which adopted a soft drinks tax in 2017 and which we selected as best practice comparison country based on pre-defined criteria. RESULTS: Between 2015 and 2021, the mean sales-weighted sugar content of soft drinks sold in Germany decreased by 2% from 5.3 to 5.2 g/100 mL, falling short of an interim 9% reduction target and a 29% reduction observed in the United Kingdom over the same period. Sugar sales from soft drinks in Germany decreased from 22.4 to 21.6 g/capita/day (-4%) between 2015 and 2021 but remain high from a public health perspective. CONCLUSIONS: Reductions observed under Germany's sugar reduction strategy fall short of stated targets and trends observed internationally under best practice conditions. Additional policy measures may be needed to support sugar reduction in soft drinks in Germany.

Cost-Effectiveness of a Collaborative Care Model Among Patients With Type 2 Diabetes and Depression in India.

OBJECTIVE: To assess the cost-effectiveness of collaborative versus usual care in adults with poorly controlled type 2 diabetes and depression in India. RESEARCH DESIGN AND METHODS: We performed a within-trial cost-effectiveness analysis of a 24-month parallel, open-label, pragmatic randomized clinical trial at four urban clinics in India from multipayer and societal perspectives. The trial randomly assigned 404 patients with poorly controlled type 2 diabetes (HbA1c ≥8.0%, systolic blood pressure ≥140 mmHg, or LDL cholesterol ≥130 mg/dL) and depressive symptoms (9-item Patient Health Questionnaire score ≥10) to collaborative care (support from nonphysician care coordinators, electronic registers, and specialist-supported case review) for 12 months, followed by 12 months of usual care or 24 months of usual care. We calculated incremental cost-effectiveness ratios (ICERs) in Indian rupees (INR) and international dollars (Int'l-$) and the probability of cost-effectiveness using quality-adjusted life-years (QALYs) and depression-free days (DFDs). RESULTS: From a multipayer perspective, collaborative care costed an additional INR309,558 (Int'l-$15,344) per QALY and an additional INR290.2 (Int'l-$14.4) per DFD gained compared with usual care. The probability of cost-effectiveness was 56.4% using a willingness to pay of INR336,000 (Int'l-$16,654) per QALY (approximately three times per-capita gross domestic product). The willingness to pay per DFD to achieve a probability of cost-effectiveness >95% was INR401.6 (Int'l-$19.9). From a societal perspective, cost-effectiveness was marginally lower. In sensitivity analyses, integrating collaborative care in clinical workflows reduced incremental costs by ∼47% (ICER 162,689 per QALY, cost-effectiveness probability 89.4%), but cost-effectiveness decreased when adjusting for baseline values. CONCLUSIONS: Collaborative care for patients with type 2 diabetes and depression in urban India can be cost-effective, especially when integrated in clinical workflows. Long-term cost-effectiveness might be more favorable. Scalability across lower- and middle-income country settings depends on heterogeneous contextual factors.

Self-care time and rating of health state in persons with diabetes: results from the population-based KORA survey in Germany.

BACKGROUND: The amount of empirical research on whether people in fact include health-related changes in leisure time into health state valuations is limited and the results are inconclusive. In this exploratory study, we analyse whether time aspects of diabetes self-care might explain the ratings of the health state (HSR) in addition to the effects of physical and mental health-related quality of life. METHODS: Using the data from participants with diagnosed type 2 diabetes in the population-based KORA FF4 study (n = 190, 60% Male, mean age 69 ± 10 years), multiple logistic regression models were fitted to explain HSR (good vs. poor) in terms of the SF-12 physical and mental component summary (PCS and MCS) scores, time spent on diabetes self-care and a number of background variables. RESULTS: There was no significant association between time spent on diabetes self-care and HSR in models without interaction. Significant interaction term was found between the SF-12 PCS score and time spent on self-care. In models with interaction self-care time has a small, but significant impact on the HSR. In particular, for a PCS score under 40, more time increases the chance to rate the health state as "good", while for a PCS score above 40 there is a reverse effect. CONCLUSIONS: The additional impact of self-care time on HSR in our sample is small and seems to interact with physical health-related quality of life. More research is needed on whether inclusion of health-related leisure time changes in the denominator of cost-effectiveness analysis is sufficient.

The effect of population-based blood pressure screening on long-term cardiometabolic morbidity and mortality in Germany: A regression discontinuity analysis.

BACKGROUND: Hypertension represents one of the major risk factors for cardiovascular morbidity and mortality globally. Early detection and treatment of this condition is vital to prevent complications. However, hypertension often goes undetected, and even if detected, not every patient receives adequate treatment. Identifying simple and effective interventions is therefore crucial to fight this problem and allow more patients to receive the treatment they need. Therefore, we aim at investigating the impact of a population-based blood pressure (BP) screening and the subsequent "low-threshold" information treatment on long-term cardiovascular disease (CVD) morbidity and mortality. METHODS AND FINDINGS: We examined the impact of a BP screening embedded in a population-based cohort study in Germany and subsequent personalized "light touch" information treatment, including a hypertension diagnosis and a recommendation to seek medical attention. We pooled four waves of the KORA study, carried out between 1984 and 1996 (N = 14,592). Using a sharp multivariate regression discontinuity (RD) design, we estimated the impact of the information treatment on CVD mortality and morbidity over 16.9 years. Additionally, we investigated potential intermediate outcomes, such as hypertension awareness, BP, and behavior after 7 years. No evidence of effect of BP screening was observed on CVD mortality (hazard ratio (HR) = 1.172 [95% confidence interval (CI): 0.725, 1.896]) or on any (fatal or nonfatal) long-term CVD event (HR = 1.022 [0.636, 1.641]) for individuals just above (versus below) the threshold for hypertension. Stratification for previous self-reported diagnosis of hypertension at baseline did not reveal any differential effect. The intermediate outcomes, including awareness of hypertension, were also unaffected by the information treatment. However, these results should be interpreted with caution since the analysis might not be sufficiently powered to detect a potential intervention effect. CONCLUSIONS: The study does not provide evidence of an effect of the assessed BP screening and subsequent information treatment on BP, health behavior, or long-term CVD mortality and morbidity. Future studies should consider larger datasets to detect possible effects and a shorter follow-up for the intermediate outcomes (i.e., BP and behavior) to detect short-, medium-, and long-term effects of the intervention along the causal pathway.

Economic evaluation of implementation science outcomes in low- and middle-income countries: a scoping review.

BACKGROUND: Historically, the focus of cost-effectiveness analyses has been on the costs to operate and deliver interventions after their initial design and launch. The costs related to design and implementation of interventions have often been omitted. Ignoring these costs leads to an underestimation of the true price of interventions and biases economic analyses toward favoring new interventions. This is especially true in low- and middle-income countries (LMICs), where implementation may require substantial up-front investment. This scoping review was conducted to explore the topics, depth, and availability of scientific literature on integrating implementation science into economic evaluations of health interventions in LMICs. METHODS: We searched Web of Science and PubMed for papers published between January 1, 2010, and December 31, 2021, that included components of both implementation science and economic evaluation. Studies from LMICs were prioritized for review, but papers from high-income countries were included if their methodology/findings were relevant to LMIC settings. RESULTS: Six thousand nine hundred eighty-six studies were screened, of which 55 were included in full-text review and 23 selected for inclusion and data extraction. Most papers were theoretical, though some focused on a single disease or disease subset, including: mental health (n = 5), HIV (n = 3), tuberculosis (n = 3), and diabetes (n = 2). Manuscripts included a mix of methodology papers, empirical studies, and other (e.g., narrative) reviews. Authorship of the included literature was skewed toward high-income settings, with 22 of the 23 papers featuring first and senior authors from high-income countries. Of nine empirical studies included, no consistent implementation cost outcomes were measured, and only four could be mapped to an existing costing or implementation framework. There was also substantial heterogeneity across studies in how implementation costs were defined, and the methods used to collect them. CONCLUSION: A sparse but growing literature explores the intersection of implementation science and economic evaluation. Key needs include more research in LMICs, greater consensus on the definition of implementation costs, standardized methods to collect such costs, and identifying outcomes of greatest relevance. Addressing these gaps will result in stronger links between implementation science and economic evaluation and will create more robust and accurate estimates of intervention costs. TRIAL REGISTRATION: The protocol for this manuscript was published on the Open Science Framework. It is available at: https://osf.io/ms5fa/ (DOI: 10.17605/OSF.IO/32EPJ).

Dietary behaviour and physical activity policies in Europe: learnings from the Policy Evaluation Network (PEN).

The European Policy Evaluation Network (PEN), initiated in autumn 2018, aimed at advancing the evidence base for public policies impacting dietary behaviour, physical activity and sedentary behaviours in Europe. This is needed because non-communicable diseases-the leading cause of global mortality-are substantially caused by physical inactivity and unhealthy dietary behaviours, which in turn are driven by upstream factors that have not yet been addressed effectively by prevention approaches. Thus, successful policy interventions are required that target entire populations and tackle the 'causes of the causes'. To advance our knowledge on the effective implementation of policies and their impact in terms of improving health behaviours, PEN focused on five research tasks: (i) Adaptation and implementation of a Food Environment Policy Index (Food-EPI) and development of a Physical Activity Environment Policy Index (PA-EPI); (ii) Mapping of health-related indicators needed for policy evaluation and facilitating a harmonized pan-European approach for surveillance to assess the impact of policy interventions; (iii) Refining quantitative methods to evaluate the impact of public policies; (iv) Identifying key barriers and facilitators of implementation of policies; and (v) Advance understanding the equity impact of the development, implementation and evaluation of policies aimed at promoting physical activity and a healthy diet. Finally, and in order to provide concrete evidence for policymaking, existing exemplary policies, namely sugar-sweetened beverages taxation, active transport policies and school policies on nutrition and physical activity were assessed in consideration of these five tasks. At the end of the PEN project's formal runtime, considerable advancements have been made. Here, we present an overview of the most important learnings and outputs.

Estimating the impact of nutrition and physical activity policies with quasi-experimental methods and simulation modelling: an integrative review of methods, challenges and synergies.

BACKGROUND: The promotion of healthy lifestyles has high priority on the global public health agenda. Evidence on the real-world (cost-)effectiveness of policies addressing nutrition and physical activity is needed. To estimate short-term policy impacts, quasi-experimental methods using observational data are useful, while simulation models can estimate long-term impacts. We review the methods, challenges and potential synergies of both approaches for the evaluation of nutrition and physical activity policies. METHODS: We performed an integrative review applying purposive literature sampling techniques to synthesize original articles, systematic reviews and lessons learned from public international workshops conducted within the European Union Policy Evaluation Network. RESULTS: We highlight data requirements for policy evaluations, discuss the distinct assumptions of instrumental variable, difference-in-difference, and regression discontinuity designs and describe the necessary robustness and falsification analyses to test them. Further, we summarize the specific assumptions of comparative risk assessment and Markov state-transition simulation models, including their extension to microsimulation. We describe the advantages and limitations of these modelling approaches and discuss future directions, such as the adequate consideration of heterogeneous policy responses. Finally, we highlight how quasi-experimental and simulation modelling methods can be integrated into an evidence cycle for policy evaluation. CONCLUSIONS: Assumptions of quasi-experimental and simulation modelling methods in policy evaluations should be credible, rigorously tested and transparently communicated. Both approaches can be applied synergistically within a coherent framework to compare policy implementation scenarios and improve the estimation of nutrition and physical activity policy impacts, including their distribution across population sub-groups.

Association of physical activity with utilization of long-term care in community-dwelling older adults in Germany: results from the population-based KORA-Age observational study.

BACKGROUND: Physical activity (PA) is a proven strategy to prevent chronic diseases and reduce falls. Furthermore, it improves or at least maintains performance of activities of daily living, and thus fosters an independent lifestyle in older adults. However, evidence on the association of PA with relevant subgroups, such as older adults with utilization of long-term care (LTC), is sparse. This knowledge would be essential for establishing effective, need-based strategies to minimize the burden on healthcare systems due to the increasing need for LTC in old age. METHODS: Data originate from the 2011/12 (t1) baseline assessment and 2016 (t2) follow-up of the population-based Cooperative Health Research in the Region of Augsburg (KORA-)Age study in southern Germany. In 4812 observations of individuals ≥65 years, the association between various types of PA (walking, exercise (i. e., subcategory of PA with the objective to improve or maintain one or more components of physical fitness), walking+exercise) and utilization of LTC (yes/no) was analyzed using generalized estimating equation logistic models. Corresponding models stratified by sex (females: 2499 observations; males: 2313 observations) examined sex-specific associations. Descriptive analyses assessed the proportion of individuals meeting the suggested minimum values in the German National Physical Activity Recommendations for older adults (GNPAR). RESULTS: All types of PA showed a statistically significant association with non-utilization of LTC in the entire cohort. "Walking+exercise" had the strongest association with non-utilization of LTC in the entire cohort (odds ratio (OR): 0.52, 95% confidence interval (CI): 0.39-0.70) and in males (OR: 0.41, CI: 0.26-0.65), whereas in females it was "exercise" (OR: 0.58; CI: 0.35-0.94). The proportion of individuals meeting the GNPAR was higher among those without utilization of LTC (32.7%) than among those with LTC (11.7%) and group differences were statistically significant (p ≤ 0.05). CONCLUSIONS: The GNPAR are rarely met by older adults. However, doing any type of PA is associated with non-utilization of LTC in community-dwelling older adults. Therefore, older adults should be encouraged to walk or exercise regularly. Furthermore, future PA programs should consider target-groups' particularities to reach individuals with the highest needs for support.

Selecting a target population for type 2 diabetes lifestyle prevention programs: A cost-effectiveness perspective.

AIMS: Cost-effectiveness (CE) of lifestyle change programs (LCP) for type 2 diabetes (T2D) prevention is influenced by a participant's risk. We identified the risk threshold of developing T2D in the intervention population that was cost-effective for three formats of the LCP: delivered in-person individually or in groups, or delivered virtually. We compared the cost-effectiveness across program formats when there were more than one cost-effective formats. METHODS: Using the CDC-RTI T2D CE Simulation model, we estimated CEs associated with 3 program formats in 8 population groups with an annual T2D incidence of 1% to 8%. We generated a nationally representative simulation population for each risk level using the 2011-2016 National Health and Nutrition Examination Survey data. We used an incremental cost-effectiveness ratio (ICER), cost per quality-adjusted life year (QALY) gained in 25-years, to measure the CEs of the programs. We took a health care system perspective. RESULTS: To achieve an ICER of $50,000/QALY or lower, the annual T2D incidence of the program participant needed to be ≥5% for the in-person individual program, ≥4% for the digital individual program, and ≥3% for the in-person group program. For those with T2D risk of ≥4%, the in-person group program always dominated the digital individual program. The in-person individual program was cost-effective compared with the in-person group program only among persons with T2D risk of ≥8%. CONCLUSIONS: Our findings could assist decision-makers in selecting the most appropriate target population for different formats of lifestyle intervention programs to prevent T2D.

Costs of Public Health Screening of Children for Presymptomatic Type 1 Diabetes in Bavaria, Germany.

OBJECTIVE: We sought to evaluate costs associated with public health screening for presymptomatic type 1 diabetes in 90,632 children as part of the Fr1da study in Bavaria and in forecasts for standard care. RESEARCH DESIGN AND METHODS: We report on resource use and direct costs for screening-related procedures in the Fr1da study coordination center and laboratory and in participating pediatric practices and local diabetes clinics. Data were obtained from Fr1da study documents, an online survey among pediatricians, and interviews and records of Fr1da staff members. Data were analyzed with tree models that mimic procedures during the screening process. Cost estimates are presented as they were observed in the Fr1da study and as they can be expected in standard care for various scenarios. RESULTS: The costs per child screened in the Fr1da study were €28.17 (95% CI 19.96; 39.63) and the costs per child diagnosed with presymptomatic type 1 diabetes were €9,117 (6,460; 12,827). Assuming a prevalence of presymptomatic type 1 diabetes of 0.31%, as in the Fr1da study, the estimated costs in standard care in Germany would be €21.73 (16.76; 28.19) per screened child and €7,035 (5,426; 9,124) per diagnosed child. Of the projected screening costs, €12.25 would be the costs in the medical practice, €9.34 for coordination and laboratory, and €0.14 for local diabetes clinics. CONCLUSIONS: This study provides information for the planning and implementation of screening tests for presymptomatic type 1 diabetes in the general public and for the analysis of the cost-effectiveness of targeted prevention strategies.

A Telemedicine-Guided Self-Collection Approach for PCR-Based SARS-CoV-2 Testing: Comparative Study.

BACKGROUND: Large-scale, polymerase chain reaction (PCR)-based SARS-CoV-2 testing is expensive, resource intensive, and time consuming. A self-collection approach is a probable alternative; however, its feasibility, cost, and ability to prevent infections need to be evaluated. OBJECTIVE: This study aims to compare an innovative self-collection approach with a regular SARS-CoV-2 testing strategy in a large European industrial manufacturing site. METHODS: The feasibility of a telemedicine-guided PCR-based self-collection approach was assessed for 150 employees (intervention group) and compared with a regular SARS-CoV-2 testing approach used for 143 employees (control group). Acceptance, ergonomics, and efficacy were evaluated using a software application. A simulation model was implemented to evaluate the effectiveness. An interactive R shiny app was created to enable customized simulations. RESULTS: The test results were successfully communicated to and interpreted without uncertainty by 76% (114/150) and 76.9% (110/143) of the participants in the intervention and control groups, respectively (P=.96). The ratings for acceptability, ergonomics, and efficacy among intervention group participants were noninferior when compared to those among control group participants (acceptability: 71.6% vs 37.6%; ergonomics: 88.1% vs 74.5%; efficacy: 86.4% vs 77.5%). The self-collection approach was found to be less time consuming (23 min vs 38 min; P<.001). The simulation model indicated that both testing approaches reduce the risk of infection, and the self-collection approach tends to be slightly less effective owing to its lower sensitivity. CONCLUSIONS: The self-collection approach for SARS-CoV-2 diagnosis was found to be technically feasible and well rated in terms of acceptance, ergonomics, and efficacy. The simulation model facilitates the evaluation of test effectiveness; nonetheless, considering context specificity, appropriate adaptation by companies is required.