[Research Data Center on Health - Vision for Further Development from the Research Perspective]. / Forschungsdatenzentrum Gesundheit ­ Vision für eine Weiterentwicklung aus Sicht der Forschung.

The German research data center for health will provide claims data of statutory health insurances. The data center was set up at the medical regulatory body BfArM pursuant to the German data transparency regulation (DaTraV). The data provided by the center will cover about 90% of the German population, supporting research on healthcare issues, including questions of care supply, demand and the (mis-)match of both. These data support the development of recommendations for evidence-based healthcare. The legal framework for the center (including §§ 303a-f of Book V of the Social Security Code and two subsequent ordinances) leaves a considerable degree of freedom when it comes to organisational and procedural aspects of the center's operation. The present paper addresses these degrees of freedom. From the point of view of researchers, ten statements show the potential of the data center and provide ideas for its further and sustainable development.

[What do We Mean by Secondary Data? - A Keynote Contribution to the Terminological Classification and Definition]. / Was verstehen wir unter Sekundärdaten? ­ Ein Grundsatzbeitrag zur terminologischen Einordnung und Definition.

Data are both material and product for health services research. As a "substrate" or starting point for health-related analyses, they have gained immense importance in recent decades. Data are an essential raw material for the assessment of services in the health care system, for its control and development. In everyday scientific life and in research work that uses this raw material, the meaning of the term "data" - especially "secondary data" - is often neglected. This article aims to shed more light on the context of meaning of the two terms and to attempt to classify the term "secondary data" terminologically.

[Now is the Time to Establish an Efficient Health Research Data Centre]. / Jetzt die Weichen stellen für ein leistungsfähiges Forschungsdatenzentrum Gesundheit.

Based on sections 303a to 303f social code book V, the course is currently being set for an innovative and high-performance national information and data platform. This requires short-term provision of current and relevant data on the health care system, especially process data on statutory health insurance and other social insurance carriers, using established methodological standards as well as taking into account data protection regulations. From the point of view of future users, expectations regarding an "ideal" research health data centre are formulated in ten recommendations. The present article is an offer from health services researchers intended to support decision-makers in the field of politics and self-administration in the German health system in their task of establishing and further development of a research health data centre.

[Dementia prevention and primary care: Estimation of the target population]. / Demenzprävention und hausärztliche Versorgung: Schätzung der Zielpopulation.

BACKGROUND: The prevention of dementia, especially the cardiovascular prevention of cognitive disorders, is increasingly coming into the focus of health services research. The aim of this study is to determine the possible target population for dementia prevention approaches as well as frequency of health examinations (HE) in individual general practitioner offices (GP). METHOD: 987 GP practices, which are covered by the nationwide IMS Disease Analyzer database (IQVIA) have been investigated for the prevalence of the following diagnoses, which are considered risk factors for the development of dementia Hypertension, obesity, hearing loss in each age group 45-65 and diabetes and depression in the age group 65 and older. In addition, it was recorded how many of these patients received a HE). RESULTS: In a sample of 2,398,405 patients receiving primary care, the target population relevant for dementia prevention measures in 2018 consisted of 191,883 patients with hypertension, 23,308 with obesity, 5,059 with hearing loss, 120,200 with diabetes and 43,233 with depression. More than a quarter of these patients have already had a HE. In 2018, patients with hypertension (N=51), diabetes (N=30.5) and depression (N=11.3) were the most frequently treated patients, less frequently patients with obesity (N=8.2) and hearing loss (N=1.6). CONCLUSION: On the basis of defined diagnoses in certain phases of life, a manageable group of patients can be identified who are eligible for specific dementia preventive interventions. The implementation of dementia preventive interventions in practices will be more difficult for the less frequent treatment diagnoses obesity and hearing loss than for the much more frequent treatment diagnoses hypertension, diabetes and depression.

[Linkage of Clinical and Claims Data in the Evaluation of Post-Stroke Care - SeDaStro: Experiences from the Tyrolian StrokeCard Program]. / Linkage von klinischen Primärdaten und Krankenkassenabrechnungsdaten in der Evaluation der Schlaganfallversorgung ­ SeDaStro: Erfahrungen aus dem Tiroler StrokeCard-Programm.

AIMS AND OBJECTIVES: Data linkage is of paramount importance in the evaluation of treatment regimens for chronic diseases where different health care sectors are involved. A comprehensive picture of long-term treatment effects and, in particular, the cost-effectiveness ratio of treatment approaches can only be drawn when data from various sources are merged and analyzed together. METHODOLOGICAL PROBLEMS AND CHALLENGES: Regarding post-acute stroke care, the present study gives an example of an exact deterministic data linkage procedure including clinical patient records and claims data of TGKK, the main Tyrolean statutory health insurance fund. Typical problems known from other data linkage projects also emerged in the so-called StrokeCard program conducted at the Medical University of Innsbruck. Distinctive Austrian features (the majority of the Austrian population benefits from a mandatory social insurance system without freedom of choice) facilitated the feasibility of the data linkage procedures. RESULTS: Over the recruitment period 01/2014-12/2015, 540 patients could be assigned to the operative dataset. Of these, 367 patients were part of the StrokeCard group (i. e. the treatment group), and 173 belonged to the usual care group (i. e. the control group); 11 patients did not complete the one-year follow-up period (7 treatment group patients vs. 4 control group patients); 7 of them died during the study (5 treatment group patients vs. 2 control group patients). For all 540 patients, TGKK claims data were available for the time-frames of one year before recruitment and one year after discharge from the University hospital. All data could be used in the health-economic evaluation of the StrokeCard program. CONCLUSIONS: The linking of clinical patient records with data collected by SHI funds opens a window of opportunities for analyses of medical care. Counter-intuitively, Austrian health services research activities have limited experience in data linkage approaches, alhough studies based on the linkage of clinical patient records and claims data are indispensable for the evaluation of complex multi-sectoral treatment schemes. The current project proves the feasibility of data linkage mechanisms in the Austrian context. This should be regarded as an impetus for extending data linkage principles to evaluation studies in the future.

[Memorandum Registry for Health Services Research: Update 2019]. / Memorandum Register für die Versorgungsforschung: Update 2019.

Health registries could be used to analyze questions concerning routine practice in healthcare. Therefore, registries are a core method in health services research. The German Network for Health Services Research (Deutsches Netzwerk Versorgungsforschung, DNVF) promotes the quality of registries by scientific exchange, organization of advanced training, and recommendations in the form of a memorandum "Registry for Health Services Research". The current recommendations are an update of the memorandum's first version of 2010. The update describes the capabilities and aims of registries in health services research. Furthermore, it illustrates the state-of-the-art in designing and implementing health registries. The memorandum provides developers the methodological basis to ensure high quality health registries. It further provides users of health registries with insights that enable assessing the quality of data and results of health registries. Finally, funding agencies and health policy actors can use the quality criteria to establish a framework for the financing and legislative requirements for health registries. The memorandum provides first a definition of health registries and presents an overview of their utility in health services research and health care improvement. Second, several areas of methodological importance for the development and operation of health registries are presented. This includes the conceptual and preliminary design, implementation, technical organization of a health registry, statistical analysis, reporting of results, and data protection. From these areas, criteria are deduced to allow the assessment of the quality of a health registry. Finally, a checklist is presented.

Epidemiology and health care utilization of patients suffering from Huntington's disease in Germany: real world evidence based on German claims data.

BACKGROUND: Huntington's disease (HD) is a rare, genetic, neurodegenerative and ultimately fatal disease with no cure or progression-delaying treatment currently available. HD is characterized by a triad of cognitive, behavioural and motor symptoms. Evidence on epidemiology and management of HD is limited, especially for Germany. This study aims to estimate the incidence and prevalence of HD and analyze the current routine care based on German claims data. METHODS: The source of data was a sample of the Institute for Applied Health Research Berlin (InGef) Research Database, comprising data of approximately four million insured persons from approximately 70 German statutory health insurances. The study was conducted in a retrospective cross-sectional design using 2015 and 2016 as a two-year observation period. At least two outpatient or inpatient ICD-10 codes for HD (ICD-10: G10) during the study period were required for case identification. Patients were considered incident if no HD diagnoses in the 4 years prior to the year of case identification were documented. Information on outpatient drug dispensations, medical aids and remedies were considered to describe the current treatment situation of HD patients. RESULTS: A 2-year incidence of 1.8 per 100,000 persons (95%-Confidence interval (CI): 1.4-2.4) and a 2-year period prevalence of 9.3 per 100,000 persons (95%-CI: 8.3-10.4) was observed. The prevalence of HD increased with advancing age, peaking at 60-69 years (16.8 per 100,000 persons; 95%-CI: 13.4-21.0) and decreasing afterwards. The most frequently observed comorbidities and disease-associated symptoms in HD patients were depression (42.9%), dementia (37.7%), urinary incontinence (32.5%), extrapyramidal and movement disorders (30.5%), dysphagia (28.6%) and disorders of the lipoprotein metabolism (28.2%). The most common medications in HD patients were antipsychotics (66.9%), followed by antidepressants (45.1%). Anticonvulsants (16.6%), opioids (14.6%) and hypnotics (9.7%) were observed less frequently. Physical therapy was the most often used medical aid in HD patients (46.4%). Nursing services and speech therapy were used by 27.9 and 22.7% of HD patients, respectively, whereas use of psychotherapy was rare (3.2%). CONCLUSIONS: Based on a representative sample, this study provides new insights into the epidemiology and routine care of HD patients in Germany, and thus, may serve as a starting point for further research.

Algorithms to identify COPD in health systems with and without access to ICD coding: a systematic review.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) causes significant morbidity and mortality worldwide. Estimation of incidence, prevalence and disease burden through routine insurance data is challenging because of under-diagnosis and under-treatment, particularly for early stage disease in health care systems where outpatient International Classification of Diseases (ICD) diagnoses are not collected. This poses the question of which criteria are commonly applied to identify COPD patients in claims datasets in the absence of ICD diagnoses, and which information can be used as a substitute. The aim of this systematic review is to summarize previously reported methodological approaches for the identification of COPD patients through routine data and to compile potential criteria for the identification of COPD patients if ICD codes are not available. METHODS: A systematic literature review was performed in Medline via PubMed and Google Scholar from January 2000 through October 2018, followed by a manual review of the included studies by at least two independent raters. Study characteristics and all identifying criteria used in the studies were systematically extracted from the publications, categorized, and compiled in evidence tables. RESULTS: In total, the systematic search yielded 151 publications. After title and abstract screening, 38 publications were included into the systematic assessment. In these studies, the most frequently used (22/38) criteria set to identify COPD patients included ICD codes, hospitalization, and ambulatory visits. Only four out of 38 studies used methods other than ICD coding. In a significant proportion of studies, the age range of the target population (33/38) and hospitalization (30/38) were provided. Ambulatory data were included in 24, physician claims in 22, and pharmaceutical data in 18 studies. Only five studies used spirometry, two used surgery and one used oxygen therapy. CONCLUSIONS: A variety of different criteria is used for the identification of COPD from routine data. The most promising criteria set in data environments where ambulatory diagnosis codes are lacking is the consideration of additional illness-related information with special attention to pharmacotherapy data. Further health services research should focus on the application of more systematic internal and/or external validation approaches.

The bone evaluation study (BEST): patient care and persistence to treatment of osteoporosis in Germany.

OBJECTIVE: Data on fracture frequency and medical care of patients with osteoporosis are still insufficient. We aimed to analyze frequency of osteoporosis-related fractures and multiple fractures, re-fracture rates, treatment prevalence, and persistence to osteoporosis-related medication in Germany. METHODS AND MATERIALS: Using claims data of a state health insurer (2006 - 2009), we performed a retrospective "real world" analysis. Inclusion criteria were age of 50 years or older and an osteoporosis diagnosis or a prescription for defined osteoporosis-related medication. We assessed fractures, frequencies, and the number of multiple fractures per patient as well as time to follow-up fracture and drug persistence using Kaplan-Meier analysis. RESULTS: Within the observation period, 27% of the osteoporosis patients sustained fractures; of those with fractures, 69% had multiple fractures. For patients with multiple fractures, re-fracture rate after 360 days was between 69% for patients who received parathyroid hormone and 85% for patients who received no anti-osteoporotic medication 360 days before follow-up fracture. In the patient population, persistence rates after 1 year were between 58% for parathyroid hormone and 2% for other osteoporosis-specific drugs (alfacalcidol, fluorides, nandrolone, calcitonin). CONCLUSIONS: In Germany, the number of patients with osteoporosis-attributable fractures is high. There are still deficits in proper treatment as well as in drug persistence. Low persistence lead to a relatively high proportion of patients with follow-up fractures.

Preferences for and use of oral anticoagulants for stroke prevention in atrial fibrillation under real-world conditions in Germany: A survey among physicians.

In Germany, there is little real-world evidence on physicians' choice of oral anticoagulants (OACs). Our study aimed at assessing preferences for and prescribing patterns of treatment options for stroke prevention in atrial fibrillation in clinical practice in Germany. We conducted a nationwide quantitative online survey among office-based physicians in Germany. Physicians were asked about their preference for and use of treatment options as well as factors influencing their choice of a specific OAC. A total of n = 953 physicians was surveyed in September and October 2020 (general physicians: 36.0%; internists: 37.3%; cardiologists: 23.7%; neurologists: 10.5%; multiple specialties possible). Preference and use were highest for non-vitamin K oral anticoagulants (NOACs); followed by vitamin K antagonists (VKAs). Most preferred OACs were apixaban (39.3%), rivaroxaban (28.5%) and edoxaban (14.7%). Most used OACs were apixaban (24.3%), rivaroxaban (21.2%) and phenprocoumon (21.4%). NOACs were preferred more often than used (85.6% > 68.6%). VKAs were preferred less often than used (9.6% < 23.5%). OAC attributes and patient characteristics related to efficacy and safety, as well as patients' kidney function were most important when selecting a specific OAC. Federal and regional governance instruments likely influenced treatment decision-making. We found a high divergence between preferences for and use of available treatment options in clinical practice. Further exploration of the importance of OAC attributes, patient characteristics as well as federal and regional governance instruments for physicians' choice of a specific OAC may help to further optimize the healthcare of patients with atrial fibrillation in the long-term.