Costs associated with insufficient physical activity in Germany: cross-sectional results from the baseline examination of the German national cohort (NAKO).

BACKGROUND: Insufficient physical activity (PA) is a leading risk factor for non-communicable diseases posing a significant economic burden to healthcare systems and societies. The study aimed to examine the differences in healthcare and indirect costs between sufficient and insufficient PA and the cost differences between PA intensity groups. METHODS: The cross-sectional analysis was based on data from 157,648 participants in the baseline examination of the German National Cohort (NAKO) study. Healthcare and indirect costs were calculated based on self-reported information on health-related resource use and productivity losses. PA in the domains leisure, transport, and work was assessed by the Global Physical Activity Questionnaire and categorized into sufficient/insufficient and intensity levels (very low/low/medium/high) based on PA recommendations of the World Health Organization. Two-part models adjusted for relevant covariates were used to estimate mean costs for PA groups. RESULTS AND CONCLUSION: Insufficiently active people had higher average annual healthcare costs (Δ €188, 95% CI [64, 311]) and healthcare plus indirect costs (Δ €482, 95% CI [262, 702]) compared to sufficiently active people. The difference was especially evident in the population aged 60 + years and when considering only leisure PA. An inverse association was observed between leisure PA and costs, whereas a direct association was found between PA at work and costs. Adjusting for the number of comorbidities reduced the differences between activity groups, but the trend persisted. The association between PA and costs differed in direction between PA domains. Future research may provide further insight into the temporal relationship between PA and costs.

Value-related attitudes towards mental health problems and help-seeking barriers: a sequential mixed-methods design investigating participants with reported depressive episodes in rural Northern Germany with and without treatment experience.

BACKGROUND: Seeking help for severe depressive symptoms remains a major obstacle for particular groups within the general population. Value-related attitudes might contribute to this treatment gap, particularly in rural regions with a low density of psychiatric-psychotherapeutic services. We aimed to investigate narratives of socialization, value systems, and barriers of help-seeking to better understand social milieus at increased risk for underuse of psychiatric-psychotherapeutic services in a rural area in East Germany. This could complement the explanatory power of classical socio-demographic determinants and provide guidance for possible interventions. METHOD: Based on results of an analysis of a population-based German cohort study (SHIP-TREND-1), 20 individual semi-structured interviews were conducted with participants who met criteria for having been moderately or severely depressed at least once in their life. Qualitative analyses of interview data were guided by grounded theory methodology. RESULTS: Participants with severe symptoms of depression were more frequent among non-responders of this study. We identified key aspects that influence help-seeking for mental health problems and seem to be characteristic for rural regions: family doctors serve as initial contact points for mental health problems and are considered as alternatives for mental health professionals; norms of traditional masculinity such as being more rational than emotional, needing to endure hardships, embodying strength, and being independent were frequently mentioned as inhibiting help-seeking by middle-aged men; anticipated adverse side-effects of therapy such as worsening of symptoms; a frequently expressed desire for less pathologically perceived treatment options. CONCLUSIONS: Our results suggest that barriers regarding help-seeking in rural regions are multifaceted and seem to be influenced by traditional norms of masculinity. We believe it is critical to strengthen existing and already utilized services such as family doctors and to implement and evaluate tailored interventions targeting the needs of the rural milieu.

Automated image quality assessment for selecting among multiple magnetic resonance image acquisitions in the German National Cohort study.

In magnetic resonance imaging (MRI), the perception of substandard image quality may prompt repetition of the respective image acquisition protocol. Subsequently selecting the preferred high-quality image data from a series of acquisitions can be challenging. An automated workflow may facilitate and improve this selection. We therefore aimed to investigate the applicability of an automated image quality assessment for the prediction of the subjectively preferred image acquisition. Our analysis included data from 11,347 participants with whole-body MRI examinations performed as part of the ongoing prospective multi-center German National Cohort (NAKO) study. Trained radiologic technologists repeated any of the twelve examination protocols due to induced setup errors and/or subjectively unsatisfactory image quality and chose a preferred acquisition from the resultant series. Up to 11 quantitative image quality parameters were automatically derived from all acquisitions. Regularized regression and standard estimates of diagnostic accuracy were calculated. Controlling for setup variations in 2342 series of two or more acquisitions, technologists preferred the repetition over the initial acquisition in 1116 of 1396 series in which the initial setup was retained (79.9%, range across protocols: 73-100%). Image quality parameters then commonly showed statistically significant differences between chosen and discarded acquisitions. In regularized regression across all protocols, 'structured noise maximum' was the strongest predictor for the technologists' choice, followed by 'N/2 ghosting average'. Combinations of the automatically derived parameters provided an area under the ROC curve between 0.51 and 0.74 for the prediction of the technologists' choice. It is concluded that automated image quality assessment can, despite considerable performance differences between protocols and anatomical regions, contribute substantially to identifying the subjective preference in a series of MRI acquisitions and thus provide effective decision support to readers.

Renal complications in chronic hypoparathyroidism - a systematic cross-sectional assessment.

Context: Although renal long-term complications are acknowledged in chronic hypoparathyroidism (HPT), standardized investigations are scarce. Objective: To systematically investigate renal complications and their predictors in hypoparathyroid patients compared to matched individuals. Design: Prospective observational study in 161 patients with chronic HPT. Methods: Patients received renal ultrasound, clinical and laboratory assessments. An individual 1:3 matching with participants from the German population-based Study of Health in Pomerania was performed. Results: Of 161 patients (92% postoperative HPT), prevalence of eGFR <60ml/min/1.73m2 was 21%, hypercalciuria 41%. Compared to healthy individuals, HPT patients had a significantly lower eGFR (74.2 vs. 95.7 ml/min/1.73m², p<0.01). Renal ultrasound revealed calcifications in 10% (nephrocalcinosis in 7% and calculi in 3%). Patients with renal calcifications had higher levels of 24-hour urine calcium excretion (8.34 vs. 5.08 mmol/d, p=0.02), spot urine calcium excretion (4.57 vs. 2.01 mmol/L, p=0.01) and urine calcium-to-creatinine ratio (0.25 vs. 0.16, p<0.01) than patients without calcifications. Albumin-corrected calcium, phosphate, calcium-phosphate product, 25-hydroxyvitamin D in serum, eGFR, daily calcium intake or disease duration were not significantly different between these two groups. Including patients receiving rhPTH therapy, a lower serum phosphate concentration (odds ratio 1.364 [95% confidence interval (CI) 1.049-1.776], p<0.05) and a longer disease duration of HPT (odds ratio 1.063 [95% CI 1.021-1.106], p<0.01) were significant predictors for renal calcifications. Excluding patients receiving rhPTH therapy, a higher 24-hour urine calcium excretion (odds ratio 1.215 [95% CI 1.058-1.396], p<0.01) was a significant predictor for renal calcifications but not serum magnesium or disease duration. Conclusions: Prevalence of impaired renal function among patients with chronic HPT is increased and independent from visible renal calcifications. Depending on exclusion of patients with rhPTH therapy, regression analysis revealed disease duration and serum phosphate or disease duration and 24-hour urinary calcium excretion as predictors for renal calcifications. Clin Trials Identifier: NCT05585593.

Associations of Migration, Socioeconomic Position and Social Relations With Depressive Symptoms - Analyses of the German National Cohort Baseline Data.

Objectives: We analyze whether the prevalence of depressive symptoms differs among various migrant and non-migrant populations in Germany and to what extent these differences can be attributed to socioeconomic position (SEP) and social relations. Methods: The German National Cohort health study (NAKO) is a prospective multicenter cohort study (N = 204,878). Migration background (assessed based on citizenship and country of birth of both participant and parents) was used as independent variable, age, sex, Social Network Index, the availability of emotional support, SEP (relative income position and educational status) and employment status were introduced as covariates and depressive symptoms (PHQ-9) as dependent variable in logistic regression models. Results: Increased odds ratios of depressive symptoms were found in all migrant subgroups compared to non-migrants and varied regarding regions of origins. Elevated odds ratios decreased when SEP and social relations were included. Attenuations varied across migrant subgroups. Conclusion: The gap in depressive symptoms can partly be attributed to SEP and social relations, with variations between migrant subgroups. The integration paradox is likely to contribute to the explanation of the results. Future studies need to consider heterogeneity among migrant subgroups whenever possible.

Universal salt iodization potentially contributes to health equity: socio-economic status of children does not affect iodine status.

OBJECTIVES: Many studies have shown that socio-economic status (SES) contributes to health inequalities, with nutrition as one of the major risk factors. Iodine intake entirely depends on external sources, and deficiencies are known to be more prevalent in lower social groups, especially in countries with limited access to iodized salt. This study aimed to determine the influence of SES on iodine status and iodine availability from household salt in North Macedonia. METHODS: Using cluster sampling, 1,200 children were recruited, and 1,191 children participated (response rate: 99.2%). Iodine status was assessed through urinary iodine concentration (UIC), and iodine availability through iodine content in household salt requested from participants. SES was assessed using standardized Family Affluence Score (FAS). RESULTS: No statistically significant correlation was found between FAS and iodine in salt. Median regression revealed no significant associations of middle vs. low FAS (ß=0.00; 95%-confidence interval (CI)=[-0.61, 0.62]; p=0.999) or high vs. low affluence (ß=0.48; 95% CI=[-1.37, 0.41]; p=0.291) with iodine content in household salt. UIC levels were significantly lower in middle FAS children compared to low FAS children (ß=-16.4; 95% CI=[-32.3, -0.5]; p=0.043). No statistically significant differences in UIC were found between children with high and low affluence (ß=-12.5; 95% CI=[-35.5, 10.5]; p=0.287), possibly due to lowered statistical power for this comparison. CONCLUSIONS: Universal salt iodization (USI) proves to be a cost-effective measure for appropriate iodine intake in healthy children and adults, irrespective of their social status. It can thus be concluded that USI contributes to reducing health inequalities related to iodine status among population of different social strata.

Whole-Body Magnetic Resonance Imaging in the Large Population-Based German National Cohort Study: Predictive Capability of Automated Image Quality Assessment for Protocol Repetitions.

BACKGROUND: Reproducible image quality is of high relevance for large cohort studies and can be challenging for magnetic resonance imaging (MRI). Automated image quality assessment may contribute to conducting radiologic studies effectively. PURPOSE: The aims of this study were to assess protocol repetition frequency in population-based whole-body MRI along with its effect on examination time and to examine the applicability of automated image quality assessment for predicting decision-making regarding repeated acquisitions. MATERIALS AND METHODS: All participants enrolled in the prospective, multicenter German National Cohort (NAKO) study who underwent whole-body MRI at 1 of 5 sites from 2014 to 2016 were included in this analysis (n = 11,347). A standardized examination program of 12 protocols was used. Acquisitions were carried out by certified radiologic technologists, who were authorized to repeat protocols based on their visual perception of image quality. Eleven image quality parameters were derived fully automatically from the acquired images, and their discrimination ability regarding baseline acquisitions and repetitions was tested. RESULTS: At least 1 protocol was repeated in 12% (n = 1359) of participants, and more than 1 protocol in 1.6% (n = 181). The repetition frequency differed across protocols (P < 0.001), imaging sites (P < 0.001), and over the study period (P < 0.001). The mean total scan time was 62.6 minutes in participants without and 67.4 minutes in participants with protocol repetitions (mean difference, 4.8 minutes; 95% confidence interval, 4.5-5.2 minutes). Ten of the automatically derived image quality parameters were individually retrospectively predictive for the repetition of particular protocols; for instance, "signal-to-noise ratio" alone provided an area under the curve of 0.65 (P < 0.001) for repetition of the Cardio Cine SSFP SAX protocol. Combinations generally improved prediction ability, as exemplified by "image sharpness" plus "foreground ratio" yielding an area under the curve of 0.89 (P < 0.001) for repetition of the Neuro T1w 3D MPRAGE protocol, versus 0.85 (P < 0.001) and 0.68 (P < 0.001) as individual parameters. CONCLUSIONS: Magnetic resonance imaging protocol repetitions were necessary in approximately 12% of scans even in the highly standardized setting of a large cohort study. Automated image quality assessment shows predictive value for the technologists' decision to perform protocol repetitions and has the potential to improve imaging efficiency.

Increase in Mental Disorders During the COVID-19 Pandemic-The Role of Occupational and Financial Strains.

BACKGROUND: Numerous studies have reported an increase in mental disorders during the COVID-19 pandemic, but the exact reasons for this development are not well understood. In this study we investigate whether pandemic-related occupational and financial changes (e.g., reduced working hours, working from home, financial losses) were associated with increased symptoms of depression and anxiety compared with the situation before the pandemic. METHODS: We analyzed data from the German National Cohort (NAKO) Study. Between May and November 2020, 161 849 study participants answered questions on their mental state and social circumstances. Their responses were compared with data from the baseline survey before the pandemic (2014-2019). Linear fixed-effects models were used to determine whether individual changes in the severity of symptoms of depression (PHQ-9) or anxiety (GAD-7) were associated with occupational/ financial changes (controlling for various covariates). RESULTS: The prevalence of moderate or severe symptoms of depression and anxiety increased by 2.4% and 1.5%, respectively, during the COVID-19 pandemic compared with the preceding years. The mean severity of the symptoms rose slightly. A pronounced increase in symptoms was observed among those who became unemployed during the pandemic (+ 1.16 points on the depression scale, 95% confidence interval [0.91; 1.41], range 0-27). Increases were also seen for reduced working hours with no short-time allowance, increased working hours, working from home, insecurity regarding employment, and financial strain. The deterioration in mental health was largely statistically explained by the occupational and financial changes investigated in the model. CONCLUSION: Depressive symptoms and anxiety disorders increased slightly in the study population during the first year of the COVID-19 pandemic. Occupational and financial difficulties were an essential contributory factor. These strains should be taken into account both in the care of individual patients and in the planning of targeted prevention measures.

Effects of whole-body MRI on outpatient health service costs: a general-population prospective cohort study in Mecklenburg-Vorpommern, Germany.

OBJECTIVE: Whole-body MRI (wb-MRI) is increasingly used in research and screening but little is known about the effects of incidental findings (IFs) on health service utilisation and costs. Such effects are particularly critical in an observational study. Our principal research question was therefore how participation in a wb-MRI examination with its resemblance to a population-based health screening is associated with outpatient service costs. DESIGN: Prospective cohort study. SETTING: General population Mecklenburg-Vorpommern, Germany. PARTICIPANTS: Analyses included 5019 participants of the Study of Health in Pomerania with statutory health insurance data. 2969 took part in a wb-MRI examination in addition to a clinical examination programme that was administered to all participants. MRI non-participants served as a quasi-experimental control group with propensity score weighting to account for baseline differences. PRIMARY AND SECONDARY OUTCOME MEASURES: Outpatient costs (total healthcare usage, primary care, specialist care, laboratory tests, imaging) during 24 months after the examination were retrieved from claims data. Two-part models were used to compute treatment effects. RESULTS: In total, 1366 potentially relevant IFs were disclosed to 948 MRI participants (32% of all participants); most concerned masses and lesions (769 participants, 81%). Costs for outpatient care during the 2-year observation period amounted to an average of €2547 (95% CI 2424 to 2671) for MRI non-participants and to €2839 (95% CI 2741 to 2936) for MRI participants, indicating an increase of €295 (95% CI 134 to 456) per participant which corresponds to 11.6% (95% CI 5.2% to 17.9%). The cost increase was sustained rather than being a short-term spike. Imaging and specialist care related costs were the main contributors to the increase in costs. CONCLUSIONS: Communicated findings from population-based wb-MRI substantially impacted health service utilisation and costs. This introduced bias into the natural course of healthcare utilisation and should be taken care for in any longitudinal analyses.

Association between thyroid function and assessment of hepatic fat and iron contents by magnetic resonance imaging.

The associations of thyroid function parameters with non-alcoholic fatty liver disease (NAFLD) and hepatic iron overload are not entirely clear. We have cross-sectionally investigated these associations among 2734 participants of two population-based cross-sectional studies of the Study of Health in Pomerania. Serum levels of thyroid-stimulating hormone (TSH), free tri-iodothyronine (fT3), and free thyroxine (fT4) levels were measured. Liver fat content (by proton-density fat fraction) as well as hepatic iron content (by transverse relaxation rate; R2*) were assessed by quantitative MRI. Thyroid function parameters were associated with hepatic fat and iron contents by median and logistic regression models adjusted for confounding. There were no associations between serum TSH levels and liver fat content, NAFLD, or hepatic iron overload. Serum fT4 levels were inversely associated with liver fat content, NAFLD, hepatic iron contents, and hepatic iron overload. Serum fT3 levels as well as the fT3 to fT4 ratio were positively associated with hepatic fat, NAFLD, hepatic iron contents, but not with hepatic iron overload. Associations between fT3 levels and liver fat content were strongest in obese individuals, in which we also observed an inverse association between TSH levels and NAFLD. These findings might be the result of a higher conversion of fT4 to the biologically active form fT3. Our results suggest that a subclinical hyperthyroid state may be associated with NAFLD, particularly in obese individuals. Furthermore, thyroid hormone levels seem to be more strongly associated with increased liver fat content compared to hepatic iron content.

Insufficient physical activity and multimorbidity was associated with low physical functional performance in older adults: a cross-sectional study / Atividade física insuficiente e multimorbidade foram associadas ao baixo desempenho físico funcional em idosos: um estudo transversal

Aging, physical inactivity, and chronic disease can decrease strength and muscle mass and affect mobility and autonomy in older adults. This study aimed to analyze the prevalence and associated factors of low physical functional performance among older adults in the city of Pomerode, in southern Brazil. Methods: This is a cross-sectional population-based study with data on 733 older adults from the Study of Health in Pomerode ­ SHIP-Brazil. Low functional physical performance was defined as handgrip strength ≤ 32 kg for men or ≤ 20 kg for women and/or a Timed Up and Go test ≥ 11 seconds for men or ≥ 13 seconds for women. Associations were analyzed by multiple logistic regression. Results: The prevalence of low physical functional performance was 43.7% (42.2% among women and 45.5% among men). Low physical functional performance was associated with the 70­79 years age group (odds ratio [OR] = 2.07) and insufficient physical activity (OR = 2.73) in men, and with the 70­79 years age group (OR = 2.09) and multimorbidity (OR = 1.87) in women. In general, older age, insufficient physical activity, and multimorbidity were associated with low physical functional performance in older adults.

O envelhecimento, o sedentarismo e as doenças crônicas podem diminuir a força e a massa muscular e afetar a mobilidade e a autonomia do idoso. O objetivo deste estudo foi analisar a prevalência e os fatores associados ao baixo desempenho funcional em idosos de uma cidade de origem pomerana no sul do Brasil. Metodologia: Estudo transversal de base populacional com dados de 733 idosos do Estudo Vida e Saúde em Pomerode ­ ShipBrazil. O baixo desempenho físico funcional foi definido como a força de preensão palmar ≤ 32 kg para os homens ou ≤ 20 kg para as mulheres e(ou) timed up and go ≥ 11 segundos para os homens ou ≥ 13 segundos para as mulheres. As associações foram analisadas por regressão logística múltipla. Resultados: A prevalência de baixo desempenho físico funcional foi de 43,7% (42,2% idosas e 45,5% idosos). O baixo desempenho físico funcional foi associado à idade, 70-79 anos (OR = 2,07), e à atividade física insuficiente (OR = 2,73) nos homens; e à idade, 70­79 anos (OR = 2,09), e à presença de multimorbidade (OR = 1,87) nas mulheres. Em geral, maior idade, atividade física insuficiente e multimorbidade foram associadas ao baixo desempenho físico funcional entre os idosos.

Association of glycated hemoglobin A1c levels with cardiovascular outcomes in the general population: results from the BiomarCaRE (Biomarker for Cardiovascular Risk Assessment in Europe) consortium.

BACKGROUND: Biomarkers may contribute to improved cardiovascular risk estimation. Glycated hemoglobin A1c (HbA1c) is used to monitor the quality of diabetes treatment. Its strength of association with cardiovascular outcomes in the general population remains uncertain. This study aims to assess the association of HbA1c with cardiovascular outcomes in the general population. METHODS: Data from six prospective population-based cohort studies across Europe comprising 36,180 participants were analyzed. HbA1c was evaluated in conjunction with classical cardiovascular risk factors (CVRFs) for association with cardiovascular mortality, cardiovascular disease (CVD) incidence, and overall mortality in subjects without diabetes (N = 32,496) and with diabetes (N = 3684). RESULTS: Kaplan-Meier curves showed higher event rates with increasing HbA1c levels (log-rank-test: p < 0.001). Cox regression analysis revealed significant associations between HbA1c (in mmol/mol) in the total study population and the examined outcomes. Thus, a hazard ratio (HR) of 1.16 (95% confidence interval (CI) 1.02-1.31, p = 0.02) for cardiovascular mortality, 1.13 (95% CI 1.03-1.24, p = 0.01) for CVD incidence, and 1.09 (95% CI 1.02-1.17, p = 0.01) for overall mortality was observed per 10 mmol/mol increase in HbA1c. The association with CVD incidence and overall mortality was also observed in study participants without diabetes with increased HbA1c levels (HR 1.12; 95% CI 1.01-1.25, p = 0.04) and HR 1.10; 95% CI 1.01-1.20, p = 0.02) respectively. HbA1c cut-off values of 39.9 mmol/mol (5.8%), 36.6 mmol/mol (5.5%), and 38.8 mmol/mol (5.7%) for cardiovascular mortality, CVD incidence, and overall mortality, showed also an increased risk. CONCLUSIONS: HbA1c is independently associated with cardiovascular mortality, overall mortality and cardiovascular disease in the general European population. A mostly monotonically increasing relationship was observed between HbA1c levels and outcomes. Elevated HbA1c levels were associated with cardiovascular disease incidence and overall mortality in participants without diabetes underlining the importance of HbA1c levels in the overall population.

Association of sex-specific differences in lipoprotein(a) concentrations with cardiovascular mortality in individuals with type 2 diabetes mellitus.

BACKGROUND: Compared to individuals without type 2 diabetes mellitus, the relative increase in cardiovascular mortality is much higher in women than in men in individuals with type 2 diabetes mellitus. METHODS: We evaluated data from 7443 individuals (3792 women, 50.9%), aged 20 to 81 years, from two independent population-based investigations, SHIP-0 and MONICA/KORA S3. We analyzed the longitudinal sex-specific associations of lipoprotein(a) with cardiovascular mortality in individuals with and without type 2 diabetes mellitus using Cox regression. RESULTS: During a median follow-up of 20.5 years (136,802 person-years), 657 participants (404 men and 253 women) died of cardiovascular causes. Among individuals without type 2 diabetes mellitus, men had a significantly higher risk for cardiovascular mortality compared to women in unadjusted model and after adjustment. On the other hand, in participants with type 2 diabetes mellitus, the risk for cardiovascular mortality was not different between men and women in the unadjusted model and after adjustment for age, body mass index, low-density lipoprotein-cholesterol, fasting status and study sample (SHIP-0, MONICA/KORA S3). Further adjustment for lipoprotein(a) concentrations had no impact on the hazard ratio (HR) for cardiovascular mortality comparing men versus women in individuals without type 2 diabetes mellitus [HR: 1.94; 95% confidence interval (CI) 1.63 to 2.32; p < 0.001]. In individuals with type 2 diabetes mellitus, however, further adjustment for lipoprotein(a) led to an increased risk for cardiovascular mortality in men and a decreased risk in women resulting in a statistically significant difference between men and women (HR: 1.53; 95% CI 1.04 to 2.24; p = 0.029). CONCLUSIONS: Women are described to have a stronger relative increase in cardiovascular mortality than men when comparing individuals with and without type 2 diabetes mellitus. Higher lipoprotein(a) concentrations in women with type 2 diabetes mellitus than in men with type 2 diabetes mellitus might partially explain this finding.

Benefits and Harms of a Prevention Program for Iodine Deficiency Disorders: Predictions of the Decision-Analytic EUthyroid Model.

Background: Iodine deficiency is one of the most prevalent causes of intellectual disability and can lead to impaired thyroid function and other iodine deficiency disorders (IDDs). Despite progress made on eradicating iodine deficiency in the last decades in Europe, IDDs are still prevalent. Currently, evidence-based information on the benefit/harm balance of IDD prevention in Europe is lacking. We developed a decision-analytic model and conducted a public health decision analysis for the long-term net benefit of a mandatory IDD prevention program for the German population with moderate iodine deficiency, as a case example for a European country. Methods: We developed a decision-analytic Markov model simulating the incidence and consequences of IDDs in the absence or presence of a mandatory IDD prevention program (iodine fortification of salt) in an open population with current demographic characteristics in Germany and with moderate ID. We collected data on the prevalence, incidence, mortality, and quality of life from European studies for all health states of the model. Our primary net-benefit outcome was quality-adjusted life years (QALYs) predicted over a period of 120 years. In addition, we calculated incremental life years and disease events over time. We performed a systematic and comprehensive uncertainty assessment using multiple deterministic one-way sensitivity analyses. Results: In the base-case analysis, the IDD prevention program is more beneficial than no prevention, both in terms of QALYs and life years. Health gains predicted for the open cohort over a time horizon of 120 years for the German population (82.2 million inhabitants) were 33 million QALYs and 5 million life years. Nevertheless, prevention is not beneficial for all individuals since it causes additional hyperthyroidism (2.7 million additional cases). Results for QALY gains were stable in sensitivity analyses. Conclusions: IDD prevention via mandatory iodine fortification of salt increases quality-adjusted life expectancy in a European population with moderate ID, and is therefore beneficial on a population level. However, further ethical aspects should be considered before implementing a mandatory IDD prevention program. Costs for IDD prevention and treatment should be determined to evaluate the cost effectiveness of IDD prevention.

Barriers Against Prevention Programs for Iodine Deficiency Disorders in Europe: A Delphi Study.

Background: Although substantial progress has been made in recent decades in eliminating iodine deficiency, iodine deficiency disorders (IDDs) are still prevalent in European countries. Challenges include ineffective public health programs and discontinuation of IDD prevention. However, the barriers against the implementation and continuation of prevention and monitoring of IDD remain unclear. Therefore, the objective of our study was to identify potential barriers against pan-European IDD prevention and monitoring programs and to find solutions for the different challenges. Methods: We conducted a Delphi study consisting of three rounds. We identified potential participants with expertise and experience in relevant fields from all European countries, including policy makers, health care professionals, health scientists, and patient representatives. The Delphi method was conducted with open-ended questions and item ranking to achieve group consensus on potential barriers against national and pan-European IDD prevention and monitoring programs and related solutions to overcome those barriers. The answers of the Delphi rounds were analyzed using qualitative content analysis and descriptive analysis methods. In addition, we conducted two expert interviews to analyze and discuss the study results. Results: Eighty experts from 36 countries and different fields of work participated in the first Delphi round, 52 in the second, and 46 in the third. Potential barriers include challenges in the fields of knowledge and information, implementation and management, communication and cooperation, political support, and differences between the European countries. Ranked solutions addressing these barriers include cooperation with different stakeholders, gaining knowledge, sharing information, the development of a European program with national specification, European guidelines/recommendations, and European monitoring. The ranking gives a first overview as to which of these barriers would need to be solved most urgently and which solutions may be most helpful. Conclusion: In our study, we derived key information and first insights with regard to barriers against IDD prevention programs from a broad range of stakeholders. Most barriers were found in the category of implementation and management. Also a lack of political support seems to play an important role. The findings of our study may help decision makers in health policy to develop more effective IDD prevention and monitoring strategies.

The economic impact of prevention, monitoring and treatment strategies for iodine deficiency disorders in Germany.

OBJECTIVE: More than 30% of the German population suffers from mild to moderate iodine deficiency causing goiter and other iodine deficiency disorders (IDDs). The economic burden of iodine deficiency is still unclear. We aimed to assess costs for prevention, monitoring and treatment of IDDs in Germany. DESIGN: We performed a comprehensive cost analysis. METHODS: We assessed direct medical costs and direct non-medical costs for inpatient and outpatient care of IDDs and costs for productivity loss due to the absence of work in 2018. Additionally, we calculated total costs for an IDD prevention program comprising universal salt iodization (USI). We performed threshold analyses projecting how many cases of IDDs or related treatments would need to be avoided for USI to be cost-saving. RESULTS: Annual average costs per case in the year of diagnosis were € 211 for goiter/thyroid nodules; € 308 for hyperthyroidism; and € 274 for hypothyroidism. Average one-time costs for thyroidectomy were € 4184 and € 3118 for radioiodine therapy. Average costs for one case of spontaneous abortion were € 916. Annual costs of intellectual disability were € 14,202. In the German population, total annual costs for USI would amount to 8 million Euro. To be cost-saving, USI would need to prevent, for example, 37,900 cases of goiter/thyroid nodules. CONCLUSION: USI potentially saves costs, if a minimum amount of IDDs per year could be avoided. In order to recommend the implementation of USI, a full health-economic evaluation including a comprehensive benefit-harm assessment is needed.

[Assessment of self-reported cardiovascular and metabolic diseases in the German National Cohort (GNC, NAKO Gesundheitsstudie): methods and initial results]. / Erfassung selbst berichteter kardiovaskulärer und metabolischer Erkrankungen in der NAKO Gesundheitsstudie: Methoden und erste Ergebnisse.

BACKGROUND: Data on self-reported cardiovascular and metabolic diseases are available for the first 100,000 participants of the population-based German National Cohort (GNC, NAKO Gesundheitsstudie). OBJECTIVES: To describe assessment methods and the frequency of self-reported cardiovascular and metabolic diseases in the German National Cohort. MATERIALS AND METHODS: Using a computer-based, standardized personal interview, 101,806 participants (20-75 years, 46% men) from 18 nationwide study centres were asked to use a predefined list to report medical conditions ever diagnosed by a physician, including cardiovascular or metabolic diseases. For the latter, we calculated sex-stratified relative frequencies and compared these with reference data. RESULTS: With regard to cardiovascular diseases, 3.5% of men and 0.8% of women reported to have ever been diagnosed with a myocardial infarction, 4.8% and 1.5% with angina pectoris, 3.5% and 2.5% with heart failure, 10.1% and 10.4% with cardiac arrhythmia, 2.7% and 1.8% with claudicatio intermittens, and 34.6% and 27.0% with arterial hypertension. The frequencies of self-reported diagnosed metabolic diseases were 8.1% and 5.8% for diabetes mellitus, 28.6% and 24.5% for hyperlipidaemia, 7.9% and 2.4% for gout, and 10.1% and 34.3% for thyroid diseases. Observed disease frequencies were lower than reference data for Germany. CONCLUSIONS: In the German National Cohort, self-reported cardiovascular and metabolic diseases diagnosed by a physician are assessed from all participants, therefore representing a data source for future cardio-metabolic research in this cohort.

Frequency of thyroid function tests and examinations in participants of a population-based study.

BACKGROUND: Thyroid disorders are common in the adult German population. Little is known about guideline implementation in clinical practice and the prevalence of diagnostic procedures in ambulatory care. The study aims to investigate the use of thyroid hormone measurements, thyroid ultrasound, thyroid scintiscan and associated costs in ambulatory care at population level. METHODS: Data were derived from two independent population-based cohorts of the Study of Health In Pomerania (SHIP). Ambulatory billing data from the Association of Statutory Health Insurance Physicians Mecklenburg-Vorpommern were individually linked for the period 2002-2016 with SHIP data. The main outcomes were the frequency of outpatient ultrasound, scintiscan, serum TSH level measurement, free triiodothyronine (fT3) and free thyroxine (fT4) measurement, TSH-receptor-antibodies and microsomal antibodies measurement within 1 year and 3 years prior to the study entrance of the participants. Multinomial logistic regression models were used to assess the association of age, sex, thyroid medication intake and Charlson-Comorbidity-Index with frequency of TSH measurements and ultrasound examinations. RESULTS: A total of 5552 participants (47% male, median age 55) were included in the analysis. 25% (1409/5552) had a diagnosed thyroid disorder or treatment, 40% (2191/5552) had clinical findings based on ultrasound or laboratory testing in SHIP only and 35% (1952/5552) neither a coded thyroid disorder or clinical finding nor thyroid medication. In the total study population 30% (1626/5552) received at least one TSH measurement, 6.8% (378/5552) at least one thyroid ultrasound and 2.6% (146/5552) at least one scintiscan within the past year before the study examination. Tests were performed more frequently in patients with thyroid medication and coded thyroid disorders. Hence, this group caused the highest expenditures. CONCLUSIONS: Given the high prevalence of thyroid disorders, diagnostic and monitoring tests should be used rationally with regard to costs. TSH levels should be monitored regularly in patients on thyroid medication. A consensus on monitoring frequency and iteration of monitoring of morphological thyroid disorders with TSH and ultrasound and specific guideline recommendations are needed. TRIAL REGISTRATION: Versorgungsforschung Deutschland (VfD_17_003880).

[Physical activity in the German National Cohort (NAKO): use of multiple assessment tools and initial results]. / Körperliche Aktivität in der NAKO Gesundheitsstudie: erste Ergebnisse des multimodalen Erhebungskonzepts.

BACKGROUND: Physical activity is a complex behavior that is difficult to measure validly and reliably in large, population-based studies. Data on physical activity are available for the initial 100,000 participants of the German National Cohort. OBJECTIVES: To describe the baseline physical activity assessment in the cohort and to present initial descriptive results. MATERIAL AND METHODS: Physical activity was assessed using a combination of tools, including two self-administered questionnaires, the Questionnaire on Annual Physical Activity Pattern (QUAP) and the Global Physical Activity Questionnaire (GPAQ); a computer-based 24­h physical activity recall (cpar24); and 7­day accelerometry (Actigraph GT3X/+; ActiGraph, Pensacola, FL, USA). RESULTS: The availability of data varied between assessment instruments (QUAP: n = 16,372; GPAQ: n = 90,900; cpar24: n = 23,989; accelerometry: n = 35,218). Analyses across measurement tools showed that on average, women spent 75 to 216 min/d, and men spent 73 to 224 min/d in moderate or higher intensity total physical activity. Persons aged 20-39 years spent 66 to 200 min/d, and persons aged 40-69 years spent 78 to 244 min/d in moderate or higher intensity total physical activity. CONCLUSIONS: Initial baseline analyses of physical activity in this cohort show the value of using a combination of questionnaires, 24­h recalls, and a movement sensor. The comprehensive data collection represents a valuable resource for future analyses and will improve our understanding of the association between physical activity and disease prevention.

[The baseline assessment of the German National Cohort (NAKO Gesundheitsstudie): participation in the examination modules, quality assurance, and the use of secondary data]. / Die Basiserhebung der NAKO Gesundheitsstudie: Teilnahme an den Untersuchungsmodulen, Qualitätssicherung und Nutzung von Sekundärdaten.

BACKGROUND: The German National Cohort (NAKO) is an interdisciplinary health study aimed at elucidating causes for common chronic diseases and detecting their preclinical stages. This article provides an overview of design, methods, participation in the examinations, and their quality assurance based on the midterm baseline dataset (MBD) of the recruitment. METHODS: More than 200,000 women and men aged 20-69 years derived from random samples of the German general population were recruited in 18 study centers (2014-2019). The data collection comprised physical examinations, standardized interviews and questionnaires, and the collection of biomedical samples for all participants (level 1). At least 20% of all participants received additional in-depth examinations (level 2), and 30,000 received whole-body magnet resonance imaging (MRI). Additional information will be collected through secondary data sources such as medical registries, health insurances, and pension funds. This overview is based on the MBD, which included 101,839 participants, of whom 11,371 received an MRI. RESULTS: The mean response proportion was 18%. The participation in the examinations was high with most of the modules performed by over 95%. Among MRI participants, 96% completed all 12 MRI sequences. More than 90% of the participants agreed to the use of complementary secondary and registry data. DISCUSSION: Individuals selected for the NAKO were willing to participate in all examinations despite the time-consuming program. The NAKO provides a central resource for population-based epidemiologic research and will contribute to developing innovative strategies for prevention, screening and prediction of chronic diseases.