[Development of two questionnaires for the assessment of knowledge and self-management in patients with chronic-obstructive pulmonary disease (COPD)]. / Entwicklung zweier Fragebögen zum Krankheitswissen und Umgang mit der Erkrankung für Patienten mit chronisch-obstruktiver Lungenerkrankung (COPD).

INTRODUCTION: As with other chronic diseases, the course of chronic obstructive pulmonary disease (COPD) can be expected to be positively influenced if patients are well informed about their disease and undertake appropriate self-management. Assessments of the level of knowledge and management that are comparable should benefit from structured, systematically developed questionnaires. These, however, have not been published in Germany. METHODS: A total of 310 patients with COPD were recruited from three pneumological practices and one hospital to develop the questionnaires. Based on statistical criteria and content assessments by medical specialists, two questionnaires on knowledge (17 questions) and self-management (25 questions) were developed by selecting and modifying questions from published studies and training programs. In addition, two short versions with 5 and 3 questions were created to enable a quick assessment of the patients' knowledge and self-management. All questionnaires also included a visual analogue scale for self-assessment of knowledge and self-management. The statistical procedures for systematically guided selection comprised correlation and regression analyses. RESULTS: The questionnaires revealed considerable knowledge deficits in many patients and remarkably unsystematic, incoherent knowledge. The extent of this knowledge was negatively correlated with higher age and positively correlated with participation in training programs; this also applied to self-management. Correlations between the answers to the knowledge questions were higher in patients who had participated in training programs. The visual analogue scales for self-assessment of knowledge and management always correlated with the total number of correct answers. DISCUSSION: The questionnaires on knowledge and self-management in patients with COPD could be used in outpatient settings, including by non-medical staff, in order to quickly identify and correct deficits or as a reason to recommend training programs. The short versions and the analogue scales for self-assessment can give at least first hints. Potentially, training programs should focus more on promoting the coherence of knowledge through better understanding, as this presumably favors long-term knowledge. Older patients and those with a low level of education appear to be particularly in need of specially adapted training programs.

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.

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.

Costs of Pharmacological and Non-Pharmacological Interventions in Interstitial Lung Disease Management in Germany.

INTRODUCTION: Interstitial lung diseases (ILDs) are associated with a high economic burden, yet prospective data of the German healthcare system are sparse. OBJECTIVE: We assessed average ILD-related costs of pharmacological and non-pharmacological (hospitalizations, outpatient, rehabilitation, physiotherapy, and medical aids) interventions in ILD. METHODS: We used data from the multicenter, observational, prospective Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases registry to evaluate adjusted per capita costs and cost drivers for ILD-related healthcare costs over 4 years, using generalized estimating equation regression models. RESULTS: Idiopathic pulmonary fibrosis (IPF) had the highest annual pharmacological costs >EUR 21,000, followed by connective tissue disease-associated ILD (CTD-ILD) averaging EUR 6,000. Other idiopathic interstitial pneumonias and hypersensitivity pneumonitis averaged below EUR 2,400 and sarcoidosis below EUR 400. There were no significant differences in pharmacological costs over time. Trends in non-pharmacological costs were statistically significant. At year 1, CTD-ILD had the highest costs (EUR 7,700), while sarcoidosis had the lowest (EUR 2,547). By year 4, these declined to EUR 3,218 and EUR 232, respectively. Regarding cost drivers, the ILD subtype had the greatest impact with 75 times higher pharmacological costs in IPF and 4 times higher non-pharmacological costs in CTD-ILD, compared to the reference. Pulmonary hypertension (PH) and gastroesophageal reflux disease (GERD) triggered higher pharmacological costs, and higher values of forced vital capacity % predicted were associated with lower pharmacological and non-pharmacological costs. CONCLUSION: Stabilizing lung function and reducing the impact of PH and GERD are crucial in reducing the economic burden of ILD. There is an urgent need for effective treatment options, especially in CTD-ILD.

Comparison of cardiovascular risk factors between children and adolescents with classes III and IV obesity: findings from the APV cohort.

OBJECTIVE: Obesity is associated with many cardiovascular risk factors (CVRF) in childhood. There is an ongoing discussion whether there is a linear relationship between degree of overweight and deterioration of CVRFs justifying body mass index (BMI) cut-offs for treatment decisions. METHODS: We studied the impact of BMI-SDS on blood pressure, lipids, and glucose metabolism in 76,660 children (aged 5-25 years) subdivided in five groups: overweight (BMI-SDS 1.3 to <1.8), obesity class I (BMI-SDS 1.8 to <2.3), class II (BMI-SDS 2.3-2.8), class III (BMI-SDS > 2.8-3.3), and class IV (BMI-SDS > 3.3). Analyses were stratified by age and sex. RESULTS: We found a relationship between BMI-SDS and blood pressure, triglycerides, HDL cholesterol, liver enzymes, and the triglycerides-HDL-cholesterol ratio at any age and sex. Many of these associations lost significance when comparing children with obesity classes III and IV: In females < 14 years and males < 12 years triglycerides and glucose parameters did not differ significantly between classes IV and III obesity. Prevalence of dyslipidemia was significantly higher in class IV compared to class III obesity only in females ≥ 14 years and males ≥ 12 years but not in younger children. In girls < 14 years and in boys of any age, the prevalences of type 2 diabetes mellitus did not differ between classes III and IV obesity. CONCLUSIONS: Since a BMI above the highest BMI cut-off was not associated consistently with dyslipidemia and disturbed glucose metabolism in every age group both in boys and girls, measurements of CVRFs instead of BMI cut-off seem preferable to guide different treatment approaches in obesity such as medications or bariatric surgery.

Cost drivers in the pharmacological treatment of interstitial lung disease.

INTRODUCTION: Treatments of interstitial lung diseases (ILDs) mainly focus on disease stabilization and relief of symptoms by managing inflammation or suppressing fibrosis by (in part costly) drugs. To highlight economic burden of drug treatment in different ILD-subtypes we assessed cost trends and therewith-associated drivers. METHODS: Using data from the German, observational HILDA study we estimated adjusted mean medication costs over 36-month intervals using one- and two-part Generalized Estimating Equation (GEE) regression models with a gamma distribution and log link. Next, we determined factors associated with costs. RESULTS: In Idiopathic pulmonary fibrosis (IPF) mean per capita medication costs increased from €1442 before to €11,000€ at the end of study. In non-IPF subtypes, the increase took place at much lower level. Mean per capita ILD-specific medication costs at the end of the study ranged between €487 (other ILD) and €9142 (IPF). At baseline, higher FVC %predicted values were associated with lower medication costs in IPF (-9%) and sarcoidosis (-1%). During follow up higher comorbidity burden escalated costs in progressive fibrosing ILD (PF-ILD) (+52%), sarcoidosis (+60%) and other ILDs (+24%). The effect of disease duration was not uniform, with cost savings in PF-ILD (-8%) and sarcoidosis (-6%), but increased spending in IPF (+11%). CONCLUSION: Pharmacological management of ILD, in particular of IPF imposes a substantial economic burden on the healthcare system. Strategies to reduce comorbidity burden and early treatment may reduce the impact of ILDs on the healthcare system.

Utility Decrements Associated With Diabetes and Related Complications: Estimates From a Population-Based Study in Germany.

OBJECTIVES: Health utility decrement estimates for diabetes and complications are needed for parametrization of simulation models that aim to assess the cost-utility of diabetes prevention and care strategies. This study estimates health utility decrements associated with diabetes and cardiovascular and microvascular complications from a population-based German study. METHODS: Data were obtained from the population based cross-sectional KORA (Cooperative Health Research in the Augsburg Region) health questionnaire 2016 and comprised n = 1072 individuals with type 2 diabetes and n = 7879 individuals without diabetes. Health utility was assessed through the EQ-5D-5L. We used linear regression models with interaction terms between type 2 diabetes and different cardiovascular and microvascular complications while adjusting for demographic and socio-economic factors and other comorbidities. RESULTS: Type 2 diabetes (ß = -0.028, standard error [SE] = 0.014), stroke (ß = -0.070, SE = 0.010), cardiac arrhythmia (ß = -0.031, SE = 0.006), heart failure (ß = -0.073, SE = 0.009), coronary heart disease (ß = -0.028, SE = 0.010), myocardial infarction (ß = -0.020, SE = 0.011, estimates of main effect), and neuropathy (ß = -0.067, SE = 0.020), diabetic foot (ß = -0.042, SE = 0.030), nephropathy (ß = -0.032, SE = 0.025), and blindness (ß = -0.094, SE = 0.056, estimates of interaction terms) were negatively associated with health utility. The interaction term for diabetes x stroke (ß = -0.052, SE = 0.021) showed that the utility decrement for stroke is significantly larger in people with type 2 diabetes than in people without diabetes. CONCLUSIONS: Diabetes, cardiovascular, and microvascular conditions are associated with significant health utility decrements. Utility decrements for some conditions differ between people with and without type 2 diabetes. These results are of high relevance for the parametrization of decision analytic simulation models and applied health economic evaluations in the field of prevention and management of type 2 diabetes in Germany.

Deterioration and Mortality Risk of COPD Patients Not Fitting into Standard GOLD Categories: Results of the COSYCONET Cohort.

BACKGROUND: Patients with COPD-specific symptoms and history but FEV1/FVC ratio ≥0.7 are a heterogeneous group (former GOLD grade 0) with uncertainties regarding natural history. OBJECTIVE: We investigated which lung function measures and cutoff values are predictive for deterioration according to GOLD grades and all-cause mortality. METHODS: We used visit 1-4 data of the COSYCONET cohort. Logistic and Cox regression analyses were used to identify relevant parameters. GOLD 0 patients were categorized according to whether they maintained grade 0 over the following 2 visits or deteriorated persistently into grades 1 or 2. Their clinical characteristics were compared with those of GOLD 1 and 2 patients. RESULTS: Among 2,741 patients, 374 GOLD 0, 206 grade 1, and 962 grade 2 patients were identified. GOLD 0 patients were characterized by high symptom burden, comparable to grade 2, and a restrictive lung function pattern; those with FEV1/FVC above 0.75 were unlikely to deteriorate over time into grades 1 and 2, in contrast to those with values between 0.70 and 0.75. Regarding mortality risk in GOLD 0, FEV1%predicted and age were the relevant determinants, whereby a cutoff value of 65% was superior to that of 80% as proposed previously. CONCLUSIONS: Regarding patients of the former GOLD grade 0, we identified simple criteria for FEV1/FVC and FEV1% predicted that were relevant for the outcome in terms of deterioration over time and mortality. These criteria might help to identify patients with the typical risk profile of COPD among those not fulfilling spirometric COPD criteria.

[Validation of the FIMA Questionnaire for Health-Related Resource Use Against Medical Claims Data: The Role Played by Length of Recall Period]. / Validierung des FIMA-Fragebogens zur Inanspruchnahme von Versorgungsleistungen anhand von Routinedaten der Krankenversicherung: Welchen Einfluss hat der Erinnerungszeitraum?

AIM TO VALIDATE: the questionnaire on health-related resource use in an elderly population (FIMA). METHODS: Self-reported health care use of 1,552 participants was validated against medical claims data. Reliability was measured by intraclass correlation coefficient (ICC), sensitivity, specificity, and Cohen's Kappa. Linear regression models were used to investigate the association between validity and individual characteristics, health state, recall period (3, 6, or 12 months), or frequency of resource use. RESULTS: On average, participants were 74 years old; 95% rated the questionnaire as easy. The number of physician contacts was underestimated depending on recall period by 9 to 28% and the ICC was moderate (3/6/12 months, ICC 0.46/0.48/0.55), whereas contacts with physiotherapists were remembered quite well (ICC>0.75). Remembering the number of days in rehabilitation and hospital differed by recall periods (3/6/12 months); rehabilitation ICC=0.88/0.51/0.87; hospital ICC=0.69/0.88/0.66. Very good reliability of self-reported long-term care insurance benefits was found for all recall periods (Kappa>0.90) while agreement in self-reported medical aid was poor (Kappa<0.30); agreement in intake of medication was good (Kappa>0.40). The chance of agreement between self-reports and claims data significantly decreased with the number of contacts. Individuals with better health had a significantly higher chance of reporting contacts with physiotherapists accurately. CONCLUSION: The FIMA largely demonstrated good reliability. The FIMA is a coherent and valid instrument to collect health-related resource use in health economic studies in an elderly population.

Determinants of health-related quality of life decline in interstitial lung disease.

BACKGROUND: Health-related quality of life (HRQL) in interstitial lung disease (ILD) patients is impaired. We aimed to identify baseline predictors for HRQL decline within a 12-month observation period. METHODS: We analyzed 194 ILD patients from two German ILD-centers in the observational HILDA study. We employed the disease-specific King's Brief Interstitial Lung Disease questionnaire (K-BILD) with the subdomains 'psychological impact', 'chest symptoms' and 'breathlessness and activities', and the generic EQ-5D Visual Analog Scale (VAS). We evaluated how many patients experienced a clinically meaningful decline in HRQL. Subsequently, we investigated medical and sociodemographic factors as potential predictors of HRQL deterioration. RESULTS: Within the study population (34.0% male, Ø age 61.7) mean HRQL scores hardly changed between baseline and follow up (K-BILD: 52.8 vs. 52.5 | VAS: 60.0 vs. 57.3). On the intra-individual level, 30.4% (n = 59) experienced a clinically relevant deterioration in K-BILD total score and 35.4% (n = 68) in VAS. Lower baseline forced vital capacity (FVC) % predicted determined HRQL decline in K-BILD total score (ß-coefficient: - 0.02, p = 0.007), VAS (ß-coefficient: - 0.03, p < 0.0001), and in the subdomain 'psychological impact' (ß-coefficient: - 0.02, p = 0.014). Lower baseline diffusing capacity of carbon monoxide (DLCO) % predicted determined deterioration in 'breathlessness and activities' (ß-coefficient: - 0.04, p = 0.003) and 'chest symptoms' (ß-coefficient: - 0.04, p = 0.002). Additionally, increasing age predicted decline in 'psychological impact' (ß-coefficient: 0.06, p < 0.007). CONCLUSION: Around a third of ILD patients experienced a clinically relevant HRQL deterioration in a 12-month period, which was associated with baseline lung function values in all K-BILD domains. As lung function values are time-dependent variables with possible improvements, in contrast to age and ILD subtype, it, thus, seems important to improve lung function and prevent its decline in order to maintain HRQL on the possibly highest level.

Malnutrition and related risk factors in older adults from different health-care settings: an enable study.

OBJECTIVE: The origin of malnutrition in older age is multifactorial and risk factors may vary according to health and living situation. The present study aimed to identify setting-specific risk profiles of malnutrition in older adults and to investigate the association of the number of individual risk factors with malnutrition. DESIGN: Data of four cross-sectional studies were harmonized and uniformly analysed. Malnutrition was defined as BMI < 20 kg/m2 and/or weight loss of >3 kg in the previous 3-6 months. Associations between factors of six domains (demographics, health, mental function, physical function, dietary intake-related problems, dietary behaviour), the number of individual risk factors and malnutrition were analysed using logistic regression. SETTING: Community (CD), geriatric day hospital (GDH), home care (HC), nursing home (NH). PARTICIPANTS: CD older adults (n 1073), GDH patients (n 180), HC receivers (n 335) and NH residents (n 197), all ≥65 years. RESULTS: Malnutrition prevalence was lower in CD (11 %) than in the other settings (16-19 %). In the CD sample, poor appetite, difficulties with eating, respiratory and gastrointestinal diseases were associated with malnutrition; in GDH patients, poor appetite and respiratory diseases; in HC receivers, younger age, poor appetite and nausea; and in NH residents, older age and mobility limitations. In all settings the likelihood of malnutrition increased with the number of potential individual risk factors. CONCLUSIONS: The study indicates a varying relevance of certain risk factors of malnutrition in different settings. However, the relationship of the number of individual risk factors with malnutrition in all settings implies comprehensive approaches to identify persons at risk of malnutrition early.

Health-related quality of life associates with change in FEV1 in COPD: results from the COSYCONET cohort.

BACKGROUND: Forced expiratory volume in one second (FEV1) characterizes the pathophysiology of COPD and different trajectories of FEV1 decline have been observed in patients with COPD (e.g. gradual or episodic). There is limited information about the development of patient-reported health-related quality of life (HRQL) over the full range of the natural history of COPD. We examined the longitudinal association between change in FEV1 and change in disease-specific and generic HRQL. METHODS: We analysed data of 1734 patients with COPD participating in the COSYCONET cohort with up to 3 years of follow-up. Patients completed the Saint George's Respiratory Questionnaire (SGRQ) and the EQ-5D Visual Analog Scale (EQ VAS). Change score models were used to investigate the relationship between HRQL and FEV1 and to calculate mean changes in HRQL per FEV1 change categories [decrease (≤ - 100 ml), no change, increase (≥ 100 ml)] after 3 years. Applying hierarchical linear models (HLM), we estimated the cross-sectional between-subject difference and the longitudinal within-subject change of HRQL as related to a FEV1 difference or change. RESULTS: We observed a statistically significant deterioration in SGRQ (total score + 1.3 units) after 3 years, which was completely driven by the activity component (+ 4 units). No significant change was found for the generic EQ VAS. Over the same period, 58% of patients experienced a decrease in FEV1, 28% were recorded as no change in FEV1, and 13% experienced an increase. The relationship between HRQL and FEV1 was found to be approximately linear with decrease in FEV1 being statistically significantly associated with a deterioration in SGRQ (+ 3.20 units). Increase in FEV1 was associated with improvements in SGRQ (- 3.81 units). The associations between change in FEV1 and the EQ VAS were similar. Results of the HLMs were consistent and highly statistically significant, indicating cross-sectional and longitudinal associations. The largest estimates were found for the association between FEV1 and the SGRQ activity domain. CONCLUSIONS: Difference and change in FEV1 over time correlate with difference and change in disease-specific and generic HRQL. We conclude, that deterioration of HRQL should induce timely re-examination of physical status and lung function and possibly reassessment of therapeutic regimes. TRIAL REGISTRATION: NCT01245933. Date of registration: 18 November 2010.

Do adolescents with extreme obesity differ according to previous treatment seeking behavior? The Youth with Extreme obesity Study (YES) cohort.

OBJECTIVES: Adolescent extreme obesity is associated with somatic and psychiatric comorbidity, low quality of life, and social dysfunction. Nevertheless, few adolescents seek obesity treatment, thus many may elope appropriate care. We examine whether previous treatment seeking relates to disease burden, and whether previously non-treatment seeking adolescents accept diagnostic and therapeutic offers. This information is important to inform intervention strategies. METHODS: The Youth with Extreme obesity Study (YES) is a prospective, multicenter cohort study. We developed a novel recruitment strategy to span medical and vocational ascertainment settings and directly compare previously treatment seeking and non-treatment seeking youth. Participants aged 14-24 years; BMI ≥ 30 kg/m2 were enrolled at four medical- and one job centers. We present comorbidity and psycho-social baseline data by sex, obesity WHO grade I-III, and treatment-seeking status, defined as self-reported previous participation in a weight-loss program. RESULTS: Of 431 participants, 47% were male; mean age 16.6 (standard deviation 2.3) years, BMI 39.2 (7.5) kg/m2. Somatic comorbidity increased with obesity grade, p < 0.05: hypertension (42, 55, 64%), dyslipidemia (28, 24, 37%,), dysglycemia (9, 19, 20%,), elevated transaminases (15, 26, 30%). Quality of life (EQ5 D) decreased (74, 71, 70). Rates of psychiatric disorders were stable: depression 11%, attention deficit disorder 6%, substance use disorder 2%, self-injurious behavior 5%, suicide attempt 3%. Only 63% (56, 64, 69%) reported previous treatment seeking. Acceptance of the diagnostic (89%) or therapeutic (28%) program, medical or psychosocial situation did not differ by treatment seeking status. Acceptance of the therapeutic program was generally low, but high at the job center (92%). CONCLUSION: Irrespective of previous treatment seeking, adolescent extreme obesity was associated with high comorbidity and psychosocial burden. Acceptance of the diagnostic program overall and the therapeutic program at the job center were high. This underscores the need of innovative, accessible programs beyond the currently offered care.

Psychometric properties and minimal important differences of SF-36 in Idiopathic Pulmonary Fibrosis.

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a rare disease with a median survival of 3-5 years after diagnosis with limited treatment options. The aim of this study is to assess the psychometric characteristics of the Short Form 36 Health Status Questionnaire (SF-36) in IPF and to provide disease specific minimally important differences (MID). METHODS: Data source was the European IPF Registry (eurIPFreg). The psychometric properties of the SF-36 version 2 were evaluated based on objective clinical measures as well as subjective perception. We analysed acceptance, feasibility, discrimination ability, construct and criterion validity, responsiveness and test-retest-reliability. MIDs were estimated via distribution and anchor-based approaches. RESULTS: The study population included 258 individuals (73.3% male; mean age 67.3 years, SD 10.7). Of them 75.2% (194 individuals) had no missing item. The distribution of several items was skewed, although floor effect was acceptable. Physical component score (PCS) correlated significantly and moderately with several anchors, whereas the correlations of mental component score (MCS) and anchors were only small. The tests showed mainly significant lower HRQL in individuals with long-term oxygen therapy. Analyses in stable individuals did not show significant changes of HRQL except for one dimension and anchor. Individuals with relevant changes of the health status based on the anchors had significant changes in all SF-36 dimensions and summary scales except for the dimension PAIN. PCS and MCS had mean MIDs of five and six, respectively. Mean MIDs of the dimensions ranged from seven to 21. CONCLUSION: It seems that the SF-36 is a valid instrument to measure HRQL in IPF and so can be used in RCTs or individual monitoring of disease. Nevertheless, the additional evaluation of longitudinal aspects and MIDs can be recommended to further analyse these factors. Our findings have a great potential impact on the evaluation of IPF patients. TRIAL REGISTRATION: The eurIPFreg and eurIPFbank are listed in https://clinicaltrials.gov ( NCT02951416 ).

The effect of bariatric surgery on health care costs: A synthetic control approach using Bayesian structural time series.

Surgical measures to combat obesity are very effective in terms of weight loss, recovery from diabetes, and improvement in cardiovascular risk factors. However, previous studies found both positive and negative results regarding the effect of bariatric surgery on health care utilization. Using claims data from the largest health insurance provider in Germany, we estimated the causal effect of bariatric surgery on health care costs in a time period ranging from 2 years before to 3 years after bariatric intervention. Owing to the absence of a control group, we employed a Bayesian structural forecasting model to construct a synthetic control. We observed a decrease in medication and physician expenditures after bariatric surgery, whereas hospital expenditures increased in the post-intervention period. Overall, we found a slight increase in total costs after bariatric surgery, but our estimates include a high degree of uncertainty.

Status quo bias and health behavior: findings from a cross-sectional study.

BACKGROUND: Status quo bias (SQB) has often been referred to as an important tool for improving public health. However, very few studies were able to link SQB with health behavior. METHODS: Analysis were based on data from the population-based KORA S4 study (1999-2001, n = 2309). We operationalized SQB through two questions. The first asked whether participants switched their health insurance for financial benefits since this was enabled in 1996. Those who did were assigned a 'very low SQB' (n = 213). Participants who did not switch were asked a second hypothetical question regarding switching costs. We assigned 'low SQB' to those who indicated low switching costs (n = 1035), 'high SQB' to those who indicated high switching costs (n = 588), and 'very high SQB' to those who indicated infinite switching costs (n = 473). We tested the association between SQB and physical activity, diet, smoking, alcohol consumption, the sum of health behaviors, and body mass index (BMI) using logistic, Poisson and ordinary least square regression models, respectively. Models were adjusted for age, sex, education, income, satisfaction with current health insurance and morbidity. RESULTS: SQB was associated with a higher rate of physical inactivity [OR = 1.22, 95% CI (1.11; 1.35)], a higher sum of unhealthy lifestyle factors [IRR = 1.05, 95% CI (1.01; 1.10)] and a higher BMI [ß = 0.30, 95% CI (0.08; 0.51)]. CONCLUSION: A high SQB was associated with unfavorable health behavior and higher BMI. Targeting SQB might be a promising strategy for promoting healthy behavior.

[Psychosocial Characteristic and Health Care for Unemployed Youths with Extreme Obesity - A Model Project]. / Psychosoziale Charakterisierung und Integrative Versorgung arbeitsloser Jugendlicher mit extremer Adipositas ­ ein Modellprojekt.

INTRODUCTION: In clinical care, unemployed youths have limited access to available obesity treatments including obesity surgery. With the implementation of a specialized obesity outpatient unit in cooperation with five German job-centers we aim to prove whether unemployed youths are interested in obesity treatment and how they adhere to a multilevel obesity treatment in terms of participation rates. MATERIALS AND METHODS: Youths (aged 15.0-24.9 years) with a body-mass-index (BMI) ≥30 kg/m2 were initially offered an individualized patient information concerning obesity treatment on the premises of the job-center. If interested, youths were included in the multicomponent treatment program (6 sessions). Those who participated in a minimum of 5 out of 6 treatment sessions were offered access to a preparation course (4 sessions) and an individualized evaluation of the indication for obesity surgery. RESULTS: Between 2012 and 2017, 83 youths (mean age 21.1 years, BMI 48.1 kg/m2, BMI 35.0-39.9 kg/m2: N=7, ≥40 kg/m2: N=71) were enrolled in the treatment program. 34 participated in ≥5/6 sessions in the multicomponent obesity treatment and 20 expressed an interest in obesity surgery. To date, 11 adolescents underwent obesity surgery with a mean BMI reduction of 14.3 kg/m2 between 3 and 36 months after obesity surgery (excess weight loss 27.3%) vs. 3.8 kg/m2 between 6 and 48 months after treatment initiation in the group of youths who did not receive obesity surgery. 13 youths were integrated in the primary labor market. DISCUSSION: Several unemployed youths accepted our treatment program and improved their health and vocational status in the course of their participation. CONCLUSIONS: The implementation of a specialized obesity outpatient unit within German job-centers is a successful strategy to characterize this high-risk-group and to determine their individual treatment needs. This finding must be confirmed with a larger sample size and by evaluating the long-term course of treatment.

Compatibility of medication with PRISCUS criteria and identification of drug interactions in a large cohort of patients with COPD.

Patients with COPD are often of advanced age and have a high number of medications due to their lung disease and comorbidities. Thus they are at risk for unwanted effects from drugs, either due to age or due to interactions between drugs. These issues are not clarified. We therefore assessed the number of medications and potential adverse effects in a large cohort of patients with COPD. The analysis was performed in 2741 patients of the German COPD cohort COSYCONET, using baseline data (visit 1) and follow-up data after about 1.5 years (visit 3). Spirometric GOLD grades 1-4 were found in 8/35/32/9% of patients and GOLD groups ABCD in 7/25/4/48% of patients, while the remaining patients (n = 450, 16.4%) could not be classified according to GOLD criteria. The compatibility of medication with age was evaluated via the PRISCUS list, drug interactions via the AiD clinic system, whereby only drug combinations occurring in at least 10 patients were considered (nine unwanted interactions, one wanted interaction). The median numbers of medications were 5 or more in all patient categories, among them 3 or more non-respiratory medications. In the total population there were 153 patients (10.2%) aged ≥65 years who had any medication of the PRISCUS list with intermediate or low risk. Serious adverse combinations of drugs according to AiD occurred in 114 patients (4.2%), while the number of unwanted but only potentially clinically relevant combinations was 175 (6.4%). The number of wanted combinations was 219 (8.0%). These numbers did not markedly change when restricting the analysis to patients of GOLD grades 1-4. Moreover, the results were similar for visit 1 and visit 3. We conclude that in a large cohort of COPD patients about 10% of patients aged at least 65 years had medications that could interfere with their age and that the proportions of patients with either unwanted or wanted drug interactions were both in the range of 8-10%. These results suggest that problems arising from the high number of medications were not very frequent in the COPD cohort analysed.

Catastrophic expenditures and impoverishment due to out-of-pocket health payments in Kosovo.

BACKGROUND: The current health system reforms in Kosovo aim to improve health status through universal health coverage. Risk pooling and ensuring access to necessary care without financial hardship are envisaged through compulsory health insurance. We measure the level of financial risk protection through two commonly applied concepts: catastrophic health expenditures and impoverishment. METHODS: Data from the 2014 Kosovo Household Budget Survey were used to estimate catastrophic health expenditures as a percentage of household consumption expenditures at different thresholds. Poverty head counts and gaps were estimated before and after out-of-pocket (OOP) health payments. RESULTS: Approximately 80% of the households in Kosovo incurred OOP health payments. Most of these expenditures were for medicine, pharmaceutical products and medical devices, followed by diagnostic and outpatient services. Hospital services and treatment abroad were less frequent but highly costly. Although households from the upper consumption groups spent more, households from the lower consumption groups spent a greater share of their consumption expenditures on healthcare. The catastrophic health expenditure head count showed an increase, while the impoverishment and poverty gap remained stable compared to 2011. Regression analysis showed that age of the household head, insurance coverage, household size, belonging to the lowest consumption expenditure quintiles, and having disabled and aged household members were significant predictors of the probability of experiencing catastrophic health expenditures. CONCLUSIONS: Ongoing financing reforms should target the lower income quintiles and vulnerable groups, pharmaceutical policies should be revisited, and the internal referral system should be strengthened to overcome excessive spending for treatment abroad.

Rural versus urban differences in end-of-life care for lung cancer patients in Germany.

PURPOSE: To assess rural-urban differences in healthcare utilization and supportive care at the end-of-life in German lung cancer patients. METHODS: We identified 12,929 patients with incident lung cancer in 2009 from claims data and categorized them to four district types (major city, urban, rural, remote rural). We compared site of death, unplanned hospitalizations, hospital days, outpatient doctor, general practitioner (GP) and home visits, structured palliative care, therapy with antidepressants, pain relief medication and chemotherapy, and therapeutic puncturing in the last 30 and 14 days of life using mixed models with logistic link function for binary outcomes and log link function for count data. We adjusted all models by age, sex, comorbidities, metastases location and presence of multiple tumors at diagnosis, survival in months, and type of tumor-directed treatment. RESULTS: We found significant differences in two of the outcomes measured. The likelihood of > 14 hospital days in the last 30 days was significantly higher in rural districts than in remote rural districts (1.27 [1.05, 1.52], p = 0.0003). The number of visits to the GP in the last 30 days of life was significantly lower in urban districts than in remote rural districts (ß = - 0.19 [- 0.32, - 0.06], p = <0.0001). No other endpoints were associated with regional differences. Triggering factors for high and low utilization of healthcare were mostly age, comorbidities, and prior anticancer treatment. CONCLUSION: Healthcare utilization and supportive care did not differ significantly between different district types. Results reject the hypothesis of regional inequity in end-of-life care of lung cancer patients in Germany.