[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.

Twelve-Month Outcomes after Metabolic and Bariatric Surgery among Youths Participating in a Structured Preparation and Follow-Up Program: Results of the Youth with Extreme Obesity Study.

INTRODUCTION: While invasive and associated with risks, metabolic and bariatric surgery (MBS) can promote sustained weight loss and substantial health benefits in youths with extreme obesity. The path toward informed decision making for or against MBS is poorly characterized and postoperative follow-up to assess risks and benefits is inconsistent. In youths with extreme obesity, we aimed to evaluate decision making toward MBS, as well as MBS outcomes and adherence with follow-up and recommendations in the setting of a structured pre- and post-MBS program. METHODS: Participants were recruited in the setting of the multicenter "Youth with Extreme Obesity Study" (YES). YES is a cohort study in adolescents and young adults aged 14-24 years with obesity (BMI ≥30.0 kg/m2) who were recruited at four medical centers and one job center in Germany between 2012 and 2018. Participants at two medical centers with BMI ≥35 kg/m2, aged 14-24 years, and interested in pursuing MBS were included in the subproject 3 "Safety and effectiveness of weight loss surgery in adolescents with severe obesity within a structured pre- and post-surgery treatment program - an observational study" that comprised a 2-months pre- and 12-months post-MBS program. RESULTS: Twenty-eight of 169 youths (17%) with BMI ≥35 kg/m2 were interested in MBS. Twenty-six fulfilled published eligibility criteria for MBS and participated in the structured pre-MBS preparation program. Of these, 9 participants (2 females) decided against, and 17 (n = 11 females) decided for MBS (sleeve gastrectomy). The 12-month follow-up rate was high (16/17 [94%]) and all participants achieved significant weight reduction (ΔBMI: -16.1 ± 5.6 kg/m2). Eleven of 16 participants (69%) reported taking the prescribed dietary supplements in the first year after MBS, but only five of them (31%) did so daily. In contrast to the high 12-month retention rate, follow-up after completion of the structured program was low at 24-months (9/16 [56%]) and at 36-months (5/15 [36%]), respectively. CONCLUSION: Participants demonstrated active decision making for or against MBS and high adherence with the structured pre- and 12 months post-MBS program, but participation was low thereafter. These findings endorse the need for longer term structured post-MBS programs to capture long-term outcomes and provide adequate care in this vulnerable group at the transition to adulthood.

Symptoms in unilateral vestibular hypofunction are associated with number of catch-up saccades and retinal error: results from the population-based KORA FF4 study.

Objective: The presence and intensity of symptoms vary in patients with unilateral vestibular hypofunction. We aimed to determine which saccadic and vestibulo-ocular reflex parameters best predict the presence of symptoms in unilateral vestibular hypofunction in order to better understand vestibular compensation and its implications for rehabilitation therapy. Methods: Video head impulse test data were analyzed from a subpopulation of 23 symptomatic and 10 currently symptom-free participants with unilateral vestibular hypofunction, embedded in the KORA (Cooperative Health Research in the Region of Augsburg) FF4 study, the second follow-up of the KORA S4 population-based health survey (2,279 participants). Results: A higher number of catch-up saccades, a higher percentage of covert saccades, and a larger retinal error at 200 ms after the onset of the head impulse were associated with relevant symptoms in participants with unilateral vestibular hypofunction (p = 0.028, p = 0.046, and p = 0.038, respectively). After stepwise selection, the number of catch-up saccades and retinal error at 200 ms remained in the final logistic regression model, which was significantly better than a null model (p = 0.014). Age, gender, saccade amplitude, saccade latency, and VOR gain were not predictive of the presence of symptoms. Conclusion: The accuracy of saccadic compensation seems to be crucial for the presence of symptoms in unilateral vestibular hypofunction, highlighting the role of specific gaze stabilization exercises in rehabilitation. Early saccades, mainly triggered by the vestibular system, do not seem to compensate accurately enough, resulting in a relevant retinal error and the need for more as well as more accurate catch-up saccades, probably triggered by the visual system.

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.

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.

Basic Determinants of Disease Knowledge in COPD Patients: Results from COSYCONET.

Introduction: In many chronic diseases, including COPD, the patients' basic knowledge of the disorder has been shown to be relevant for the course of the disease. We studied which clinical and functional characteristics were related to this knowledge as well as the patients' satisfaction with their knowledge about COPD. Methods: The study population comprised 645 patients of GOLD grades 1-4 who participated in Visit 6 of the COSYCONET cohort (COPD and Systemic Consequences - Comorbidities Network). The assessments covered a broad panel of clinical and functional characteristics, including generic and disease-specific quality of life and the COPD Assessment Test (CAT). The study aim was addressed by two questions, referring to patients' knowledge of the meaning of FEV1 and the overall satisfaction with their knowledge of COPD. Results: Knowledge of FEV1 was higher in patients of higher spirometric GOLD grades or exacerbation risk, in males, with higher educational level, and after participation in a prior educational training on COPD. Patients with more detailed knowledge showed a higher satisfaction with their knowledge. Satisfaction was associated with higher generic quality of life and a lower CAT score. Furthermore, satisfaction was higher in patients with a treatment plan but lower in patients with cardiac comorbidities. It appeared that females with basic education, high burden from COPD and low quality of life had the greatest knowledge deficits. Discussion: The results suggest room for education programs adapted to the educational level of the participants. They also emphasize the major role of a disease management plan for the patients.

BreathEase: rationale, design and recruitment of a randomised trial and embedded mixed-methods study of a multiprofessional breathlessness service in early palliative care.

BACKGROUND: The Munich Breathlessness Service has adapted novel support services to the German context, to reduce burden in patients and carers from breathlessness in advanced disease. It has been evaluated in a pragmatic fast-track randomised controlled trial (BreathEase; NCT02622412) with embedded qualitative interviews and postal survey. The aim of this article is to describe the intervention model and study design, analyse recruitment to the trial and compare sample characteristics with other studies in the field. METHODS: Analysis of recruitment pathways and enrolment, sociodemographic and clinical characteristics of participants and carers. RESULTS: Out of 439 people screened, 253 (58%) were offered enrolment and 183 (42%) participated. n=97 (70%) carers participated. 186 (42%) people did not qualify for inclusion, mostly because breathlessness could not be attributed to an underlying disease. All participants were self-referring; 60% through media sources. Eligibility and willingness to participate were associated to social networks and illness-related activities as recruitment routes. Mean age of participants was 71 years (51% women), with COPD (63%), chronic heart failure (8%), interstitial lung disease (9%), pulmonary hypertension (6%) and cancer (7%) as underlying conditions. Postal survey response rate was 89%. Qualitative interviews were conducted with 16 patients and nine carers. CONCLUSION: The BreathEase study has a larger and more heterogeneous sample compared to other trials. The self-referral-based and prolonged recruitment drawing on media sources approximates real-world conditions of early palliative care. Integrating qualitative and quantitative components will allow a better understanding and interpretation of the results of the main effectiveness study.

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.

Genetic Variation and Cardiovascular Risk Factors: A Cohort Study on Migrants from the Former Soviet Union and a Native German Population.

Resettlers are a large migrant group of more than 2 million people in Germany who migrated mainly from the former Soviet Union to Germany after 1989. We sought to compare the distribution of the major risk factors for cardiovascular disease (CVD) and to investigate the overall genetic differences in a study population which consisted of resettlers and native (autochthone) Germans. This was a joint analysis of two cohort studies which were performed in the region of Augsburg, Bavaria, Germany, with 3363 native Germans and 363 resettlers. Data from questionnaires and physical examinations were used to compare the risk factors for cardiovascular diseases between the resettlers and native Germans. A population-based genome-wide association analysis was performed in order to identify the genetic differences between the two groups. The distribution of the major risk factors for CVD differed between the two groups. The resettlers lead a less active lifestyle. While female resettlers smoked less than their German counterparts, the men showed similar smoking behavior. SNPs from three genes (BTNL2, DGKB, TGFBR3) indicated a difference in the two populations. In other studies, these genes have been shown to be associated with CVD, rheumatoid arthritis and osteoporosis, respectively.

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.

The Long-Term Public Health Impact of a Community-Based Participatory Research Project for Health Promotion Among Socially Disadvantaged Women-A Case Study Protocol.

Introduction: Community-based participatory research (CBPR) is considered to be of high potential for health promotion among socially disadvantaged groups. However, the long-term implementation and transfer of these approaches remain challenging, and the public health impact they achieve is difficult to study. This also pertains to the potential health effects and cost-effectiveness of CBPR. This study protocol describes the follow-up case study (NU-BIG) after 15 years of the BIG project ("movement as investment in health"), a project to promote physical activity among socially disadvantaged women. Through a participatory approach, BIG empowers the addressed women to plan and implement low-threshold physical activity offers. Since the project started in 2005, it was transferred to 17 communities in Germany. Materials and Analysis: NU-BIG intends to examine the long-term effects, including economic aspects, of the BIG project on individual and structural levels at all project sites, as well as its long-term implementation and transfer. NU-BIG is a cross-sectional and longitudinal study using a mixed method approach. For the longitudinal section, we re-analyze existing data from former BIG evaluations. For cross-sectional data collection, we use questionnaires and conduct qualitative interviews and focus groups. Women who take part in BIG program offers are part of the research team and will use the photo-voice approach to report on the effects of BIG. The study population consists of about 800 women who participate in BIG project offers and 50 persons involved in the implementation of the BIG project at local sites. Discussion: The expected results from NU-BIG are highly relevant for studying the long-term public health impact of CBPR. In particular, this project intends to answer questions on how the transfer of such projects can succeed and which factors determine if a CBPR project can be sustained at the community level. Eventually, these results can contribute to the further development of participatory approaches to provide effective health promotion among socially disadvantaged groups. Conclusion: Although CBPR is seen of having the potential to reduce health disparities, there is still a lack of research on its long-term effects and public health impact. NU-BIG aims at generating knowledge about the economic effects, reach, efficacy, adoption, implementation, and maintenance of a CBPR project. The expected results could be of high interest for BIG and other CBPR-projects.

Treatment of COPD Groups GOLD A and B with Inhaled Corticosteroids in the COSYCONET Cohort - Determinants and Consequences.

BACKGROUND: In COPD patients of GOLD groups A and B, a high degree of treatment with inhaled corticosteroids (ICS) has been reported, which is regarded as overtreatment according to GOLD recommendations. We investigated which factors predict ICS use and which relationship it has to clinical and functional outcomes, or healthcare costs. METHODS: We used pooled data from visits 1 and 3 of the COSYCONET cohort (n=2741, n=2053, interval 1.5 years) including patients categorized as GOLD grades 1-4 and GOLD group A or B at both visits (n=1080). Comparisons were performed using ANOVA, and regression analyses using propensity matching and inverse probability weighting to adjust for differences between ICS groups. These were defined as having ICS at both visits (always) vs no ICS at both visits (never). Measures were divided into predictors of ICS treatment and outcomes. RESULTS: Among 1080 patients, 608 patients were eligible for ICS groups (n=297 never, n=311 always). Prior to matching, patients with ICS showed significantly (p<0.05 each) impaired lung function, symptoms and exacerbation history. After matching, the outcomes generic quality of life and CO diffusing capacity were increased in ICS patients (p<0.05 each). Moreover, costs for respiratory medication, but not total health care costs, were significantly elevated in the ICS group by 780€ per year. CONCLUSION: ICS therapy in COPD GOLD A/B patients can have small positive and negative effects on clinical outcomes and health care costs, indicating that the clinical evaluation of ICS over-therapy in COPD requires a multi-dimensional approach.

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.

Impact of Education on COPD Severity and All-Cause Mortality in Lifetime Never-Smokers and Longtime Ex-Smokers: Results of the COSYCONET Cohort.

Background: Beyond smoking, several risk factors for the development of chronic obstructive pulmonary disease (COPD) have been described, among which socioeconomic status including education is of particular interest. We studied the contribution of education to lung function and symptoms relative to smoking in a group of never-smokers with COPD compared to a group of long-time ex-smokers with COPD. Methods: We used baseline data of the COSYCONET cohort, including patients of GOLD grades 1-4 who were either never-smokers (n=150, age 68.5y, 53.3% female) or ex-smokers (≥10 packyears) for at least 10 years (n=616, 68.3y, 29.9% female). Socioeconomic status was analyzed using education level and mortality was assessed over a follow-up period of 4.5 years. Analyses were performed using ANOVA and regression models. Results: Spirometric lung function did not differ between groups, whereas CO diffusing capacity and indicators of lung hyperinflation/air-trapping showed better values in the never-smoker group. In both groups, spirometric lung function depended on the education level, with better values for higher education. Quality of life and 6-MWD were significantly different in never-smokers as well as patients with higher education. Asthma, alpha-1-antitrypsin deficiency, and bronchiectasis were more often reported in never-smokers, and asthma was more often reported in patients with higher education. Higher education was also associated with reduced mortality (hazard ratio 0.46; 95% CI 0.22-0.98). Conclusion: Overall, in the COSYCONET COPD cohort, differences in functional status between never-smokers and long-time ex-smokers were not large. Compared to that, the dependence on education level was more prominent, with higher education associated with better outcomes, including mortality. These data indicate that non-smoking COPD patients' socioeconomic factors are relevant and should be taken into account by clinicians.

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.

Differences in therapy and survival between lung cancer patients treated in hospitals with high and low patient case volume.

BACKGROUND: In light of political discussions about minimum case volumes and certified lung cancer centers, this observational study investigates differences in therapy and survival between high vs. low patient volume hospitals (HPVH vs. LPVH). METHODS: We identified 12,374 lung cancer patients treated in HPVH (>67 patients) and LPVH in 2013 from German health insurance claims. Stratified by metastasis status (no metastases, nodal metastases, systemic metastases), we compared HPVHs and LPVHs regarding likelihood of resection and systemic therapy, type of systemic therapy, and surgical outcomes, using multivariate logistic models. Three-year survival was modeled using Cox regression. We adjusted all regression models for age, gender, comorbidity, and residence area, and included a cluster variable for the hospital. RESULTS: Around 24 % of patients were treated in HPVHs. Irrespective of stratum and subgroup, three-year survival was significantly better in HPVHs. In patients with systemic metastases (OR = 1.84, CI=[1.22,2.76]) and without metastases (OR = 3.28, CI=[2.13, 5.04]), resection was more likely in HPVHs. Among patients with systemic therapy, the odds of receiving pemetrexed was higher in HPVHs, in patients with nodal metastases (OR = 1.57, CI=[1.01,2.45]). In resected patients without metastases the odds ratio of receiving a thoracoscopic lobectomy was 2.28 (CI=[1.04,4.99]) in HPVHs. CONCLUSION: Our data suggests that case volume is clinically relevant in resected and non-resected lung cancer patients, but optimal minimum case volumes may differ for subgroups.