Are there associations between hip geometry and bone quality? An analysis on 3074 adults from a general population.

INTRODUCTION: Patients with reduced bone mineral density and altered hip geometry are susceptible for hip pathologies. Knowledge on associations between bone properties and hip geometric parameters might facilitate identification of patients at risk for hip pathologies. The aim of the present study was to identify associations of bone properties assessed by quantitative ultrasound (QUS) at the heel and hip geometric parameters like center-edge angle (CE), neck-shaft angle (NSA) and alpha angle. MATERIALS AND METHODS: Hip geometric parameters (CE, NSA and alpha angle) of 3074 participants from the population-based Study of Health in Pomerania were assessed on magnetic resonance imaging. QUS was performed on both calcanei providing broadband ultrasound attenuation (BUA), speed of sound (SOS) and stiffness-index. Based on the stiffness-index the individual osteoporotic fracture risk (low, moderate or high) was determined. Associations between QUS-based and hip geometric parameters were calculated in linear regression models adjusted for age, sex, body height and weight. Interactions of QUS markers with age and sex on hip geometric parameters were tested. RESULTS: Significant inverse associations between BUA (ß = - 0.068), SOS (ß = - 0.024) as well as stiffness-index (ß = - 0.056) and CE were present, while fracture risk was positively associated with CE (ß for high = 1.28 and moderate = 2.54 vs. low fracture risk). Interactions between BUA and sex as well as between SOS and age were detected in the models for CE. Furthermore, there was an inverse relation between fracture risk and NSA that was restricted to the moderate risk (ß for moderate vs. low fracture risk = - 0.60). There were no significant associations between QUS parameters and alpha angle. CONCLUSIONS: In the general population, several associations between QUS-based bone properties or fracture risk and hip geometry are present. Less dysplastic hips had a lower stiffness-index and a higher fracture risk, whereas more valgus hips had a lower fracture risk.

Reference values and influencing factors of the glenohumeral subluxation index: a study on 3004 participants.

BACKGROUND: The primary objective of this study was to examine the glenohumeral subluxation index (GHSI) in a large general population cohort and to define reference values. Glenohumeral subluxation is important in the development and prediction of pathological states of the shoulder joint and in total shoulder arthroplasty. Therefore, another objective was to examine the influence of age, sex, body mass index, and body height and weight on GHSI. METHODS: GHSI according to Walch was measured on bilateral magnetic resonance imaging of 3004 participants of the Study of Health in Pomerania (SHIP, aged 21-90 years). SHIP drew a sample of the adult general population of Pomerania (Northeastern Germany). Reference values for GHSI were assessed by quantile regression models. Associations of sex, age, and anthropometric markers with the GHSI were calculated by linear regression models. RESULTS: A reference range between 42% and 55% for men with a mean of 49% ± 4% was defined, while the upper reference limit for women was 1% higher (mean, 50% ± 4%). Age was inversely associated with the GHSI in males (P < 0.001), while no significant association in females was observed (P = .625). Body weight and body mass index were positively associated (P < .001) without effect modification by sex. Heavy mechanical oscillations on the upper extremity showed no significant association with GHSI (P = .268). CONCLUSION: The reference values for GHSI were expanded to a range of 42%-57% on magnetic resonance imaging. Several associations between GHSI and anthropometric properties are present. According to these associations, adjusted formulas are provided to enable individual, patient-specific diagnostics and therapy. Nevertheless, the clinical picture cannot be neglected.

Monitoring and management of chronic kidney disease in ambulatory care - analysis of clinical and claims data from a population-based study.

BACKGROUND: Although chronic kidney disease (CKD) is highly prevalent in the general population, little research has been conducted on CKD management in ambulatory care. Objective was to assess management and quality of care by evaluating CKD coding in ambulatory care, patient diagnosis awareness, frequency of monitoring and whether appropriate patients are referred to nephrology. METHODS: Clinical data from the population-based cohort Study of Health in Pomerania (SHIP-START) were matched with claims data of the Association of Statutory Health Insurance Physicians. Quality of care was evaluated according international and German recommendations. RESULTS: Data from 1778 participants (56% female, mean age 59 years) were analysed. 10% had eGFR < 60 ml/min/1.73m2 (mean age 74 years), 15% had albuminuria. 21% had CKD as defined by KDIGO. 20% of these were coded and 7% self-reported having CKD. Coding increased with GFR stage (G3a 20%, G3b 61%, G4 75%, G5 100%). Serum creatinine and urinary dip stick testing were billed in the majority of all participants regardless of renal function. Testing frequency partially surpassed recommendations. Nephrology consultation was billed in few cases with stage G3b-G4. CONCLUSION: CKD coding increased with stage and was performed reliably in stages ≥ G4, while CKD awareness was low. Adherence to monitoring and referral criteria varied, depending on the applicability of monitoring criteria. For assessing quality of care, consent on monitoring, patient education, referral criteria and coordination of care needs to be established, accounting for patient related factors, including age and comorbidity. TRIAL REGISTRATION: This study was prospectively registered as DRKS00009812 in the German Clinical Trials Register (DRKS).

Quality of life and sleep in individuals with irritable bowel syndrome according to different diagnostic criteria and inflammatory bowel diseases: A comparison using data from a population-based survey.

BACKGROUND: A proportion of irritable bowel syndrome (IBS) affected patients does not fulfil Rome criteria despite considerable impairment similarly to that in patients with organic gastrointestinal diseases.This investigation aims to examine differences regarding Mental (MQoL), Physical Quality of Life (PQoL), and sleep between IBS according to Rome III (IBS Rome), clinically defined IBS, inflammatory bowel diseases (IBD), and non-IBS/non-IBD individuals. METHODS: Data from SHIP-Trend (Study of Health in Pomerania, 2008-2012), a population-based cohort study in Germany, were used. RESULTS: Response was 50.1% (N = 4420). Prevalence was 3.5% for IBS Rome (95% confidence interval (CI): 3.0 - 4.1%, n = 148), 0.6% for clinically defined IBS (CI: 0.4 - 0.9%, n = 27), and 0.8% for IBD (CI: 0.6 - 1.1%, n = 34). Individuals with IBS Rome (4.54 (CI: -5.92; -3.17)) and clinically defined IBS (4.69 (CI: -7.82; -1.56)) had lower scores for MQoL compared to the non-IBS/non-IBD group. PQoL scores were lowered in IBS Rome (6.39 (CI: -7.89; -4.88)) and IBD (5.37 (CI: -8.51; -2.22)), but not in clinically defined IBS compared to the non-IBS/non-IBD group. IBS Rome was the only gastroenterological condition with higher odds of sleeping problems (odds ratio (OR) "falling asleep": 1.74; CI: 1.29; 2.36; OR "remaining asleep": 1.73; CI: 1.26; 2.38). CONCLUSIONS: IBS Rome is associated with reduced MQoL, PQoL, and sleep problems. Clinically defined IBS is associated only with reduced MQoL. Heterogeneity within IBS affected patients should be considered in clinical routine and screening for daily life impairment should be performed.

Salivary metabolites associated with a 5-year tooth loss identified in a population-based setting.

BACKGROUND: Periodontitis is among the most common chronic diseases worldwide, and it is one of the main reasons for tooth loss. Comprehensive profiling of the metabolite content of the saliva can enable the identification of novel pathways associated with periodontitis and highlight non-invasive markers to facilitate time and cost-effective screening efforts for the presence of periodontitis and the prediction of tooth loss. METHODS: We first investigated cross-sectional associations of 13 oral health variables with saliva levels of 562 metabolites, measured by untargeted mass spectrometry among a sub-sample (n = 938) of the Study of Health in Pomerania (SHIP-2) using linear regression models adjusting for common confounders. We took forward any candidate metabolite associated with at least two oral variables, to test for an association with a 5-year tooth loss over and above baseline oral health status using negative binomial regression models. RESULTS: We identified 84 saliva metabolites that were associated with at least one oral variable cross-sectionally, for a subset of which we observed robust replication in an independent study. Out of 34 metabolites associated with more than two oral variables, baseline saliva levels of nine metabolites were positively associated with a 5-year tooth loss. Across all analyses, the metabolites 2-pyrrolidineacetic acid and butyrylputrescine were the most consistent candidate metabolites, likely reflecting oral dysbiosis. Other candidate metabolites likely reflected tissue destruction and cell proliferation. CONCLUSIONS: Untargeted metabolic profiling of saliva replicated metabolic signatures of periodontal status and revealed novel metabolites associated with periodontitis and future tooth loss.

Facilitating harmonized data quality assessments. A data quality framework for observational health research data collections with software implementations in R.

BACKGROUND: No standards exist for the handling and reporting of data quality in health research. This work introduces a data quality framework for observational health research data collections with supporting software implementations to facilitate harmonized data quality assessments. METHODS: Developments were guided by the evaluation of an existing data quality framework and literature reviews. Functions for the computation of data quality indicators were written in R. The concept and implementations are illustrated based on data from the population-based Study of Health in Pomerania (SHIP). RESULTS: The data quality framework comprises 34 data quality indicators. These target four aspects of data quality: compliance with pre-specified structural and technical requirements (integrity); presence of data values (completeness); inadmissible or uncertain data values and contradictions (consistency); unexpected distributions and associations (accuracy). R functions calculate data quality metrics based on the provided study data and metadata and R Markdown reports are generated. Guidance on the concept and tools is available through a dedicated website. CONCLUSIONS: The presented data quality framework is the first of its kind for observational health research data collections that links a formal concept to implementations in R. The framework and tools facilitate harmonized data quality assessments in pursue of transparent and reproducible research. Application scenarios comprise data quality monitoring while a study is carried out as well as performing an initial data analysis before starting substantive scientific analyses but the developments are also of relevance beyond research.

Bidimensional structure and measurement equivalence of the Patient Health Questionnaire-9: sex-sensitive assessment of depressive symptoms in three representative German cohort studies.

BACKGROUND: The Patient Health Questionnaire-9 (PHQ-9) has been proposed as a reliable and valid screening instrument for depressive symptoms with one latent factor. However, studies explicitly testing alternative model structures found support for a two-dimensional structure reflecting a somatic and a cognitive-affective dimension. We investigated the bidimensional structure of the PHQ-9, with a somatic (sleeping problems, fatigability, appetitive problems, and psychomotor retardation) and a cognitive-affective dimension (lack of interest, depressed mood, negative feelings about self, concentration problems, and suicidal ideation), and tested for sex- and regional-differences. METHODS: We have included data from the GEnder-Sensitive Analyses of mental health trajectories and implications for prevention: A multi-cohort consortium (GESA). Privacy-preserving analyses to provide information on the overall population and cohort-specific information and analyses of variance to compare depressive, somatic and cognitive-affective symptoms between sexes and cohorts were executed in DataSHIELD. In order to determine the dimensionality and measurement invariance of the PHQ-9 we tested three models (1 factor, 2 correlated factors, and bifactor) via confirmatory analyses and performed multi-group confirmatory factor analysis. RESULTS: Differences between sex and cohorts exist for PHQ-9 and for both of its dimensions. Women reported depressive symptoms in general as well as somatic and cognitive-affective symptoms more frequently. For all tested models an acceptable to excellent fit was found, consistently indicating a better model fit for the two-factor and bifactor model. Scalar measurement invariance was established between women and men, the three cohorts, and their interaction. CONCLUSIONS: The two facets of depression should be taken into account when using PHQ-9, while data also render support to a general factor. Somatic and cognitive-affective symptoms assessed by the PHQ-9 can be considered equivalent across women and men and between different German populations from different regions.

Pragmatic MDR: a metadata repository with bottom-up standardization of medical metadata through reuse.

BACKGROUND: The variety of medical documentation often leads to incompatible data elements that impede data integration between institutions. A common approach to standardize and distribute metadata definitions are ISO/IEC 11179 norm-compliant metadata repositories with top-down standardization. To the best of our knowledge, however, it is not yet common practice to reuse the content of publicly accessible metadata repositories for creation of case report forms or routine documentation. We suggest an alternative concept called pragmatic metadata repository, which enables a community-driven bottom-up approach for agreeing on data collection models. A pragmatic metadata repository collects real-world documentation and considers frequent metadata definitions as high quality with potential for reuse. METHODS: We implemented a pragmatic metadata repository proof of concept application and filled it with medical forms from the Portal of Medical Data Models. We applied this prototype in two use cases to demonstrate its capabilities for reusing metadata: first, integration into a study editor for the suggestion of data elements and, second, metadata synchronization between two institutions. Moreover, we evaluated the emergence of bottom-up standards in the prototype and two medical data managers assessed their quality for 24 medical concepts. RESULTS: The resulting prototype contained 466,569 unique metadata definitions. Integration into the study editor led to a reuse of 1836 items and item groups. During the metadata synchronization, semantic codes of 4608 data elements were transferred. Our evaluation revealed that for less complex medical concepts weak bottom-up standards could be established. However, more diverse disease-related concepts showed no convergence of data elements due to an enormous heterogeneity of metadata. The survey showed fair agreement (Kalpha = 0.50, 95% CI 0.43-0.56) for good item quality of bottom-up standards. CONCLUSIONS: We demonstrated the feasibility of the pragmatic metadata repository concept for medical documentation. Applications of the prototype in two use cases suggest that it facilitates the reuse of data elements. Our evaluation showed that bottom-up standardization based on a large collection of real-world metadata can yield useful results. The proposed concept shall not replace existing top-down approaches, rather it complements them by showing what is commonly used in the community to guide other researchers.

[Making COVID-19 research data more accessible-building a nationwide information infrastructure]. / COVID-19-Forschungsdaten leichter zugänglich machen ­ Aufbau einer bundesweiten Informationsinfrastruktur.

Public health research and epidemiological and clinical studies are necessary to understand the COVID-19 pandemic and to take appropriate action. Therefore, since early 2020, numerous research projects have also been initiated in Germany. However, due to the large amount of information, it is currently difficult to get an overview of the diverse research activities and their results. Based on the "Federated research data infrastructure for personal health data" (NFDI4Health) initiative, the "COVID-19 task force" is able to create easier access to SARS-CoV-2- and COVID-19-related clinical, epidemiological, and public health research data. Therefore, the so-called FAIR data principles (findable, accessible, interoperable, reusable) are taken into account and should allow an expedited communication of results. The most essential work of the task force includes the generation of a study portal with metadata, selected instruments, other study documents, and study results as well as a search engine for preprint publications. Additional contents include a concept for the linkage between research and routine data, a service for an enhanced practice of image data, and the application of a standardized analysis routine for harmonized quality assessment. This infrastructure, currently being established, will facilitate the findability and handling of German COVID-19 research. The developments initiated in the context of the NFDI4Health COVID-19 task force are reusable for further research topics, as the challenges addressed are generic for the findability of and the handling with research data.

Hidden analyses: a review of reporting practice and recommendations for more transparent reporting of initial data analyses.

BACKGROUND: In the data pipeline from the data collection process to the planned statistical analyses, initial data analysis (IDA) typically takes place between the end of the data collection and do not touch the research questions. A systematic process for IDA and clear reporting of the findings would help to understand the potential shortcomings of a dataset, such as missing values, or subgroups with small sample sizes, or shortcomings in the collection process, and to evaluate the impact of these shortcomings on the research results. A clear reporting of findings is also relevant when making datasets available to other researchers. Initial data analyses can provide valuable insights into the suitability of a data set for a future research study. Our aim was to describe the practice of reporting of initial data analyses in observational studies in five highly ranked medical journals with focus on data cleaning, screening, and reporting of findings which led to a potential change in the analysis plan. METHODS: This review was carried out using systematic search strategies with eligibility criteria for articles to be reviewed. A total of 25 papers about observational studies were selected from five medical journals published in 2018. Each paper was reviewed by two reviewers and IDA statements were further discussed by all authors. The consensus was reported. RESULTS: IDA statements were reported in the methods, results, discussion, and supplement of papers. Ten out of 25 papers (40%) included a statement about data cleaning. Data screening statements were included in all articles, and 18 (72%) indicated the methods used to describe them. Item missingness was reported in 11 papers (44%), unit missingness in 15 papers (60%). Eleven papers (44%) mentioned some changes in the analysis plan. Reported changes referred to missing data treatment, unexpected values, population heterogeneity and aspects related to variable distributions or data properties. CONCLUSION: Reporting of initial data analyses were sparse, and statements on IDA were located throughout the research articles. There is a lack of systematic reporting of IDA. We conclude the article with recommendations on how to overcome shortcomings in the practice of IDA reporting in observational studies.

The effects of incidental findings from whole-body MRI on the frequency of biopsies and detected malignancies or benign conditions in a general population cohort study.

Magnetic resonance imaging (MRI) yields numerous tumor-related incidental findings (IFs) which may trigger diagnostics such as biopsies. To clarify these effects, we studied how whole-body MRI IF disclosure in a population-based cohort affected biopsy frequency and the detection of malignancies. Laboratory disclosures were also assessed. Data from 6753 participants in the Study of Health in Pomerania (SHIP) examined between 2008 and 2012 were utilized. All underwent laboratory examinations and 3371 (49.9%) a whole-body MRI. Electronic biopsy reports from 2002 to 2017 were linked to participants and assigned to outcome categories. Biopsy frequency 2 years pre- and post-SHIP was investigated using generalized estimating equations with a negative-binomial distribution. Overall 8208 IFs (laboratory findings outside reference limits: 6839; MRI: 1369) were disclosed to 4707 participants; 2271 biopsy reports belonged to 1200 participants (17.8%). Of these, 938 biopsies occurred pre-SHIP; 1333 post-SHIP (event rate/100 observation years = 6.9 [95% CI 6.5; 7.4]; 9.9 [9.3; 10.4]). Age, cancer history, recent hospitalization, female sex, and IF disclosure were associated with higher biopsy rates. Nonmalignant biopsy results increased more in participants with disclosures (post-/pre-SHIP rate ratio 1.39 [95% CI 1.22; 1.58]) than without (1.09 [95% CI 0.85; 1.38]). Malignant biopsy results were more frequent post-SHIP (rate ratio 1.74 [95% CI 1.27; 2.42]). Biopsies increased after participation in a population-based cohort study with MRI and laboratory IF disclosure. Most biopsies resulted in no findings and few malignancies were diagnosed, indicating potential overtesting and overdiagnosis. A more restrictive policy regarding IF disclosure from research findings is required.

Evaluation of an ambulatory geriatric rehabilitation program - results of a matched cohort study based on claims data.

BACKGROUND: Ambulatory geriatric rehabilitation (AGR) is a multidisciplinary outpatient prevention program designed to decrease hospitalisation and dependence on nursing care in multimorbid patients ≥70 years of age. We evaluated the effectiveness of AGR compared to usual care on progression of nursing care levels, nursing home admissions, hospital admissions, incident fractures, mortality rate and total cost of care during a one-year follow-up period. METHODS: Analyses were based on claims data from the health insurance company AOK Nordost. Propensity Score matching was used to match 4 controls to each person receiving the AGR intervention. RESULTS: A total of 632 AGR participants and 2528 matched controls were included. The standardized mean difference of matching variables between cases and controls was small (mean: + 1.4%; range: - 4.4/3.9%). In AGR patients, the progression of nursing care levels (+ 2.2%, 95%CI: - 0.9 /5.3), nursing home admissions (+ 1.7%, 95%CI: - 0.1/3.5), hospital admissions (+ 1.1%, 95%CI: - 3.2/5.4), incident fractures (+ 11.1%, 95%CI: 7.3/15) and mortality rate (+ 1.2%, p = 0.20) showed a less favourable course compared to controls. The average total cost per AGR participant was lower than in the control group (- 353€, 95%CI: - 989€/282€), not including costs for AGR. CONCLUSIONS: Analysis based on claims data showed no clinical benefit from AGR intervention regarding the investigated outcomes. The slightly worse outcomes may reflect limitations in matching based on claims data, which may have insufficiently reflected morbidity and psychosocial factors. It is possible that the intervention group had poorer health status at baseline compared to the control group. TRIAL REGISTRATION: German Clinical Trials Register DRKS00008926, registered 29.07.2015.

[Frequencies of musculoskeletal symptoms and disorders in the population-based German National Cohort (GNC)]. / Häufigkeiten muskuloskelettaler Symptome und Erkrankungen in der bevölkerungsbezogenen NAKO Gesundheitsstudie.

BACKGROUND: Musculoskeletal diseases and symptoms are very common in the general population. They lead to high healthcare costs and pose a significant burden to the national economy. OBJECTIVES: Based on data from the population-based German National Cohort (GNC), frequencies of musculoskeletal symptoms and diseases are reported, including back pain, osteoporosis, osteoarthritis, and arthritis. MATERIALS AND METHODS: Data were collected from March 2014 to March 2017 in adults aged 20-75 years during the first half of the baseline survey of the GNC. The sample comprised 101,779 interviewed subjects, including 9370 subjects who underwent clinical musculoskeletal examinations. The interview included questions about specific musculoskeletal disorders. A clinical examination of the hand provided information about palpable swollen joints and pressure-sensitive joints. Resting pain of the knees and hips was also assessed by a clinical examination. Frequencies were standardized to the German standard population of the year 2011. RESULTS: Having ever been diagnosed with recurrent back pain (22.5%) or osteoarthritis (20.6%) were the most common complaints reported in the interview; osteoporosis (2.9%) and rheumatoid arthritis (1.9%) were stated more seldom. According to the hand examination, 6.0% of all participants experienced pain in at least one finger joint. Resting pain was present in at least one knee among 8.2% and in at least one hip among 5.1% of the participants as assessed during the clinical examination. Women were more likely to report musculoskeletal disorders and symptoms than men. The proportion of adults affected by musculoskeletal diseases increased strongly with age. CONCLUSION: Musculoskeletal disorders and symptoms occur frequently. The burden of complaints and diagnoses is comparable to previous population-based surveys.

[Design and quality control of the oral health status examination in the German National Cohort (GNC)]. / Design und Qualitätskontrolle der zahnmedizinischen Untersuchung in der NAKO Gesundheitsstudie.

BACKGROUND: Caries and periodontitis are highly prevalent worldwide. Because detailed data on these oral diseases were collected within the framework of the German National Cohort (GNC), associations between oral and systemic diseases and conditions can be investigated. OBJECTIVES: The study protocol for the oral examination was designed to ensure a comprehensive collection of dental findings by trained non-dental staff within a limited examination time. At the mid-term of the GNC baseline examination, a first quality evaluation was performed to check the plausibility of results and to propose measures to improve the data quality. MATERIALS AND METHODS: A dental interview, saliva sampling and oral diagnostics were conducted. As part of the level­1 examination, the number of teeth and prostheses were recorded. As part of the level­2 examination, detailed periodontal, cariological and functional aspects were examined. All examinations were conducted by trained non-dental personnel. Parameters were checked for plausibility and variable distributions were descriptively analysed. RESULTS: Analyses included data of 57,967 interview participants, 56,913 level­1 participants and 6295 level­2 participants. Percentages of missing values for individual clinical parameters assessed in level 1 and level 2 ranged between 0.02 and 3.9%. Results showed a plausible distribution of the data; rarely, implausible values were observed, e.g. for measurements of horizontal and vertical overbite (overjet and overbite). Intra-class correlation coefficients indicated differences in individual parameters between regional clusters, study centres and across different examiners. CONCLUSIONS: The results confirm the feasibility of the study protocol by non-dental personnel and its successful integration into the GNC's overall assessment program. However, rigorous dental support of the study centres is required for quality management.

[Effect of ambulatory geriatric rehabilitation on polypharmacy and potentially inappropriate medication-an observational study]. / Effekt der ambulanten geriatrischen Komplexbehandlung auf Polypharmazie und potenziell inadäquate Arzneimittel ­ eine Beobachtungsstudie.

BACKGROUND: Ambulatory geriatric rehabilitation (AGR) is a prevention program for multimorbid patients with the contractual agreement to prevent the need for care and hospital admissions and to promote self-sufficiency. It provides an opportunity to reduce the prevalence of polypharmacy and to discontinue potentially inadequate medication (PIM). AIM: The study investigated the effect of AGR on the number of drugs and PIM. MATERIAL AND METHODS: The observational longitudinal study was based on claims data from the statutory health insurance AOK Nordost. A comparison of the prescribed drugs with the PRISCUS list was performed. The study investigated the effect of AGR on the number of drugs prescribed and PIM in the period of two quarterly periods before and two quarterly periods after AGR. The numbers of prescribed statins, opioids, antidementia drugs, proton pump inhibitors and antidepressants were assessed and grouped into further prescriptions, new prescriptions and discontinued drug prescriptions. RESULTS: Out of 699 participants 682 (73% women, mean age 79 years, SD ± 5 years) were analyzed. The number of substances and PIM remained at the same levels after AGR. Psycholeptic, antiphlogistic and psychoanaleptic drugs were the most frequently prescribed PIM. The majority of statins, opioids, antidementia drugs, proton pump inhibitors and antidepressants were prescribed further. Antidementia drugs were the medication with the most newly started prescriptions. CONCLUSION: The AGR has no influence on the number of prescribed drugs and PIM. A structured drug review and a conversation with the general practitioner should be strengthened to improve drug safety and reduce polypharmacy as well as undertreatment.

Prevalence and association analysis of obstructive sleep apnea with gender and age differences - Results of SHIP-Trend.

Identification of obstructive sleep apnea and risk factors is important for reduction in symptoms and cardiovascular risk, and for improvement of quality of life. The population-based Study of Health in Pomerania investigated risk factors and clinical diseases in a general population of northeast Germany. Additional polysomnography was applied to measure sleep and respiration with the objective of assessing prevalence and risk factors of obstructive sleep apnea in a German cohort. One-thousand, two-hundred and eight people between 20 and 81 years old (54% men, median age 54 years) underwent overnight polysomnography. The estimated obstructive sleep apnea prevalence was 46% (59% men, 33% women) for an apnea-hypopnea index ≥5%, and 21% (30% men, 13% women) for an apnea-hypopnea index ≥ 15. The estimated obstructive sleep apnea syndrome prevalence (apnea-hypopnea index ≥5; Epworth Sleepiness Scale >10) was 6%. The prevalence of obstructive sleep apnea continuously increased with age for men and women with, however, later onset for women. Gender, age, body mass index, waist-to-hip ratio, snoring, alcohol consumption (for women only) and self-reported cardiovascular diseases were significantly positively associated with obstructive sleep apnea, whereas daytime sleepiness was not. Diabetes, hypertension and metabolic syndrome were positively associated with severe obstructive sleep apnea. The associations became non-significant after adjustment for body mass. Women exhibited stronger associations than men. The prevalence of obstructive sleep apnea was high, with almost half the population presenting some kind of obstructive sleep apnea. The continuous increase of obstructive sleep apnea with age challenges the current theory that mortality due to obstructive sleep apnea and cardiovascular co-morbidities affect obstructive sleep apnea prevalence at an advanced age. Also, gender differences regarding obstructive sleep apnea and associations are significant for recognizing obstructive sleep apnea mechanisms and therapy responsiveness.

Guidelines and recommendations for ensuring Good Epidemiological Practice (GEP): a guideline developed by the German Society for Epidemiology.

OBJECTIVE: To revise the German guidelines and recommendations for ensuring Good Epidemiological Practice (GEP) that were developed in 1999 by the German Society for Epidemiology (DGEpi), evaluated and revised in 2004, supplemented in 2008, and updated in 2014. METHODS: The executive board of the DGEpi tasked the third revision of the GEP. The revision was arrived as a result of a consensus-building process by a working group of the DGEpi in collaboration with other working groups of the DGEpi and with the German Association for Medical Informatics, Biometry and Epidemiology, the German Society of Social Medicine and Prevention (DGSMP), the German Region of the International Biometric Society (IBS-DR), the German Technology, Methods and Infrastructure for Networked Medical Research (TMF), and the German Network for Health Services Research (DNVF). The GEP also refers to related German Good Practice documents (e.g. Health Reporting, Cartographical Practice in the Healthcare System, Secondary Data Analysis). RESULTS: The working group modified the 11 guidelines (after revision: 1 ethics, 2 research question, 3 study protocol and manual of operations, 4 data protection, 5 sample banks, 6 quality assurance, 7 data storage and documentation, 8 analysis of epidemiological data, 9 contractual framework, 10 interpretation and scientific publication, 11 communication and public health) and modified and supplemented the related recommendations. All participating scientific professional associations adopted the revised GEP. CONCLUSIONS: The revised GEP are addressed to everyone involved in the planning, preparation, execution, analysis, and evaluation of epidemiological research, as well as research institutes and funding bodies.

[Prevalence of Cardiovascular Risk Factors at The Population Level: A Comparison of Ambulatory Physician-Coded Claims Data With Clinical Data From A Population-Based Study]. / Untersuchung der Prävalenz kardiologischer Risikofaktoren in der Allgemeinbevölkerung: Ein Vergleich ambulanter ärztlicher Abrechnungsdaten mit Daten einer populationsbasierten Studie.

OBJECTIVE: The study assesses the validity of ICD-10 coded cardiovascular risk factors in claims data using gold-standard measurements from a population-based study for arterial hypertension, diabetes, dyslipidemia, smoking and obesity as a reference. METHODS: Data of 1941 participants (46 % male, mean age 58±13 years) of the Study of Health in Pomerania (SHIP) were linked to electronic medical records from the regional association of statutory health insurance physicians from 2008 to 2012 used for billing purposes. Clinical data from SHIP was used as a gold standard to assess the agreement with claims data for ICD-10 codes I10.- (arterial hypertension), E10.- to E14.- (diabetes mellitus), E78.- (dyslipidemia), F17.- (smoking) and E65.- to E68.- (obesity). RESULTS: A higher agreement between ICD-coded and clinical diagnosis was found for diabetes (sensitivity (sens) 84%, specificity (spec) 95%, positive predictive value (ppv) 80%) and hypertension (sens 72%, spec 93%, ppv 97%) and a low level of agreement for smoking (sens 18%, spec 99%, ppv 89%), obesity (sens 22%, spec 99%, ppv 99%) and dyslipidemia (sens 40%, spec 60%, ppv 70%). Depending on the investigated cardiovascular risk factor, medication, documented additional cardiovascular co-morbidities, age, sex and clinical severity were associated with the ICD-coded cardiovascular risk factor. CONCLUSION: The quality of ICD-coding in ambulatory care is highly variable for different cardiovascular risk factors and outcomes. Diagnoses were generally undercoded, but those relevant for billing were coded more frequently. Our results can be used to quantify errors in population-based estimates of prevalence based on claims data for the investigated cardiovascular risk factors.

[Effectiveness of a risk-tailored short intervention to prevent chronic low back pain : A cluster-randomized study in general practice]. / Effekte einer risikoadaptierten Kurzintervention zur Prävention der Chronifizierung bei akuten Rückenschmerzen : Eine clusterrandomisierte Studie in Hausarztpraxen.

BACKGROUND: A subgroup of patients with acute low back pain (LBP) will develop chronic LBP. Risk factors summarized as yellow flags are fear-avoidance beliefs, depression, catastrophizing, and work-related problems. OBJECTIVE: The aim was to evaluate the effectiveness of screening for yellow flags in general practice followed by a risk-tailored group intervention compared to care as usual. METHODS: This is a cluster-randomized controlled trial in 35 general practices with 354 patients with acute LBP. Information or a standardized group intervention was offered to patients in the intervention group according to the screening algorithm with a short questionnaire for physical and psychosocial risk factors for chronic LBP. Standardized group information contained education concerning back pain and strategies for physical activities and planning of actions. Primary outcome was functional capacity assessed after 6 and 12 months with a questionnaire. Secondary outcomes were pain severity, fear avoidance beliefs, depression score, self-rated health and health service utilization. RESULTS: The intervention had no clinically relevant effect on the primary outcome functional capacity and secondary outcomes, although the course was consistently slightly better. Adherence to the offered intervention was low. Health service utilization was not altered to a relevant extent. A subgroup analysis comparing adherent and non-adherent patients showed a consistently better course of adherent patients. CONCLUSIONS: A risk-tailored short intervention to prevent chronic LBP in general practice had no significant impact on the clinical course compared to care as usual. A subgroup analysis comparing adherent and non-adherent patients suggests that it is possible to have a positive impact on patient-relevant outcomes.

[Course of Treatment and Sustainability of Ambulatory Geriatric Rehabilitation - An Analysis of 128 Geriatric Patients]. / Behandlungsverläufe und Nachhaltigkeit der Ambulanten Geriatrischen Komplexbehandlung ­ eine Analyse von 128 geriatrischen Patienten.

AIM OF THE STUDY: The observational study aims to investigate the course of clinical outcomes of geriatric, multimorbid patients who received ambulatory geriatric rehabilitation (AGR) for four weeks. METHODS: Analyses were based on data from 128 patients. Basic geriatric assessment tests and the EQ5D-Scale were used before, directly after the intervention, as well as after 6 and 12 months. Data were analyzed using Mixed-Effects Regression-Models. RESULTS: AGR improved self-dependence, mobility, balance, risk of falls and general state of health. The cognitive conditions reduced slightly. CONCLUSIONS: The patient-related clinical endpoints indicate a positive influence of functional deficits.