[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.

[Good Practice Data Linkage]. / Gute Praxis Datenlinkage (GPD).

Individual data linkage of different data sources for research purposes is being increasingly used in Germany in recent years. However, generally accepted methodological guidance is missing. The aim of this article is to define such methodological standards for research projects. Another aim is to provide readers with a checklist for critical appraisal of research proposals and articles. Since 2016, an expert panel of members of different German scientific societies have worked together and developed 7 guidelines with a total of 27 practical recommendations. These recommendations include (1) research aims, questions, data sources and resources, (2) infrastructure and data flow, (3) data privacy, (4) ethics, (5) key variables and type of linkage, (6) data validation/quality assurance and (7) long-term use for future research questions. The authors provide a rationale for each recommendation. Future revisions will include any new developments in science and data privacy.

[Quo Vadis Data Linkage in Germany? An Initial Inventory]. / Quo vadis Datenlinkage in Deutschland? Eine erste Bestandsaufnahme.

In recent years, linking different data sources, also called data linkage or record linkage, to address scientific questions, is being increasingly used in Germany. However, there are very few published reports and new projects develop the necessary tools independently of each other. Therefore, a team of researchers joined together to exchange their experiences on data linkage and to give suggestions on how linkage could be done for scientists, reviewers as well as members of data privacy boards and ethics committees. It is the aim of this article to assist future projects that want to link German data on an individual level. In addition to the legal framework conditions (data privacy), also examples of types of data linkage, their fields of application und potential pitfalls as well as the methods of preventing them will be described in an application-oriented fashion.

Comparing routine administrative data with registry data for assessing quality of hospital care in patients with myocardial infarction using deterministic record linkage.

BACKGROUND: Assessment of quality of care in patients with myocardial infarction (MI) should be based on data that effectively enable determination of quality. With the need to simplify measurement techniques, the question arises whether routine data can be used for this purpose. We therefore compared data from a German sickness fund (AOK) with data from the Berlin Myocardial Infarction Registry (BMIR). METHODS: We included patients hospitalised for treatment of MI in Berlin from 2009-2011. We matched 2305 patients from AOK and BMIR by using deterministic record linkage with indirect identifiers. For matched patients we compared the frequency in documentation between AOK and BMIR for quality assurance variables and calculated the kappa coefficient (KC) as a measure of agreement. RESULTS: There was almost perfect agreement in documentation between AOK and BMIR data for matched patients for: catheter laboratory (KC: 0.874), ST elevation MI (KC: 0.826), diabetes (KC: 0.818), percutaneous coronary intervention (KC: 0.860) and hospital mortality (KC: 0.952). The remaining variables compared showed moderate or less than moderate agreement (KC < 0.6), and were grouped in Category II with less frequent documentation in AOK for risk factors and aspects of patients' history; in Category III with more frequent documentation in AOK for comorbidities; and in Category IV for medication at and after hospital discharge. CONCLUSIONS: Routine data are primarily collected and defined for reimbursement purposes. Quality assurance represents merely a secondary use. This explains why only a limited number of variables showed almost perfect agreement in documentation between AOK and BMIR. If routine data are to be used for quality assessment, they must be constantly monitored and further developed for this new application. Furthermore, routine data should be complemented with registry data by well-established methods of record linkage to realistically reflect the situation - also for those quality-associated variables not collected in routine data.

Implementation of the ESC STEMI guidelines in female and elderly patients over a 20-year period in a large German registry.

AIMS: We investigated the implementation of new guidelines in ST-segment elevation myocardial infarction (STEMI) patients in a large real-world patient population in the metropolitan area of Berlin (Germany) over a 20-year period. METHODS: From January 2000 to December 2019, a total of 25 792 patients were admitted with STEMI to one of the 34 member hospitals of the Berlin-Brandenburg Myocardial Infarction Registry (B2HIR) and were stratified for sex and age < 75 and ≥ 75 years. RESULTS: The median age of women was 72 years (IQR 61-81) compared to 61 years in men (IQR 51-71). PCI treatment as a standard of care was implemented in men earlier than in women across all age groups. It took two years from the 2017 class IA ESC STEMI guideline recommendation to prefer the radial access route rather than femoral until > 60% of patients were treated accordingly. In 2019, less than 60% of elderly women were treated via a radial access. While the majority of patients < 75 years already received ticagrelor or prasugrel as antiplatelet agent in the year of the class IA ESC STEMI guideline recommendation in 2012, men ≥ 75 years lagged two years and women ≥ 75 three years behind. Amongst the elderly, in-hospital mortality was 22.6% (737) for women and 17.3% (523) for men (p < 0.001). In patients < 75 years fatal outcome was less likely with 7.2% (305) in women and 5.8% (833) in men (p < 0.001). After adjustment for confounding variables, female sex was an independent predictor of in-hospital mortality in patients ≥ 75 years (OR 1.37, 95% CI 1.12-1.68, p = 0.002), but not in patients < 75 years (p = 0.076). CONCLUSION: In-hospital mortality differs considerably by age and sex and remains highest in elderly patients and in particular in elderly females. In these patient groups, guideline recommended therapies were implemented with a significant delay.

Health situation of adults in Germany - Results for selected indicators from GEDA 2019/2020-EHIS.

In this article, we examine selected health indicators for the adult population aged 18 years and older in Germany (n=22,708) from the German Health Update (GEDA 2019/2020-EHIS) conducted between April 2019 and September 2020. These indicators include those of self-assessed health and depressive symptoms as well as chronic physical diseases and conditions. In young adulthood (18 to 44 years), over 80% of participants report good or very good subjective health. During this phase of life, most chronic diseases and conditions are rare, although allergies are frequent, and bronchial asthma and depressive symptoms are not uncommon. From mid adulthood (45 years and older), there is a gradual increase in the prevalence of chronic diseases such as cardiovascular disease, diabetes, chronic obstructive pulmonary disease and osteoarthritis. Over 60% of older adults (65 years and older) report a chronic disease or long-term health problem, while only half continue to report good or very good subjective health. During this stage of life, allergies and depressive symptoms become less prevalent. For some diseases, there are also differences according to gender and level of education. This article demonstrates the high public health relevance of age-associated chronic physical diseases and health related limitations in everyday life in an ageing society as well as the need to provide care for certain health conditions already in young adulthood.

Changes in treatment for NSTEMI in women and the elderly over the past 16 years in a large real-world population.

AIMS: This study investigates the changes in therapy for Non-ST-Elevation Myocardial Infarction (NSTEMI) over the past 16 years in a large German registry. In particular, the high-risk population of female and elderly patients was analyzed. METHODS: In total, 19.383 patients presenting with NSTEMI were included in this study. Patients were stratified by age groups <75 years and ≥75 years and by sex. Four different time periods from 2000-2004, 2005-2008, 2009-2012 and 2013-2016 were compared. Influence on hospital mortality as the primary outcome measure was assessed by logistic regression analysis. Secondary outcome measures included percutaneous coronary intervention (PCI), the use of drug eluting stents (DES), radial access route and major adverse cardiovascular events (MACE), defined as all-cause mortality, stroke, re-infarction, percutaneous re-intervention, intervention-related bleeding, cardiopulmonary resuscitation and new onset of cardiogenic shock or need for mechanical ventilation. RESULTS: Mortality decreased in all age groups between the initial time period and the most recent one (8.9% vs. 4.5%, p < 0.01), particularly in female patients ≥75 years (18.2% in 2000-2004 vs. 7.9% in 2013-2016, p < 0.01). Revascularization rates differed by gender (68.3% in women vs. 78.1% in men, p < 0.01) and by age (64.2% for ≥75 years vs. 80.9% for <75 years, p < 0.01). PCI rates in elderly female patients increased from 28.7% to 69.8% (p < 0.01) from the initial to the latest period. CONCLUSIONS: The present study demonstrates, that revascularization rates improved in all patient groups over the study period. However, females and elderly patients still remain less likely to be treated according to current guidelines.

Good Practice Data Linkage (GPD): A Translation of the German Version.

The data linkage of different data sources for research purposes is being increasingly used in recent years. However, generally accepted methodological guidance is missing. The aim of this article is to provide methodological guidelines and recommendations for research projects that have been consented to across different German research societies. Another aim is to endow readers with a checklist for the critical appraisal of research proposals and articles. This Good Practice Data Linkage (GPD) was already published in German in 2019, but the aspects mentioned can easily be transferred to an international context, especially for other European Union (EU) member states. Therefore, it is now also published in English. Since 2016, an expert panel of members of different German scientific societies have worked together and developed seven guidelines with a total of 27 practical recommendations. These recommendations include (1) the research objectives, research questions, data sources, and resources; (2) the data infrastructure and data flow; (3) data protection; (4) ethics; (5) the key variables and linkage methods; (6) data validation/quality assurance; and (7) the long-term use of data for questions still to be determined. The authors provide a rationale for each recommendation. Future revisions will include new developments in science and updates of data privacy regulations.

Does diabetes mellitus explain the higher hospital mortality of women with acute myocardial infarction? Results from the Berlin Myocardial Infarction Registry.

BACKGROUND: Women with acute myocardial infarction (AMI) exhibit greater hospital mortality than do men. In general, diabetes mellitus is one of the major factors influencing the outcome of patients with AMI. The aim of this study was to analyze the interaction between diabetes and gender, specifically with regard to the higher hospital mortality of female AMI patients aged < or = 75 years. METHODS: We prospectively collected data from 3,715 patients aged < or = 75 (2,794 men, 921 women) with acute myocardial infarction who were treated in 25 hospitals in Berlin, Germany, from 1999 to 2002. In a multivariate analysis, we specifically studied the interaction between the factors diabetes mellitus and gender in their effects on hospital mortality. RESULTS: After adjustment in multivariate analysis, the interaction between gender and diabetes was statistically significant, and the estimated odds ratios were as follows: female diabetic patients compared with male diabetic patients, odds ratio (OR) = 2.28 (95% confidence interval [CI] 1.42-3.68); female diabetic patients compared with male nondiabetic patients, OR = 2.90 (95% CI 1.90-4.42); and female diabetic patients compared with female nondiabetic patients, OR = 2.92 (95% CI 1.75-4.87). There was no statistically significant difference between the risk of dying for female nondiabetic patients or for male diabetic patients when compared with male nondiabetic patients. CONCLUSIONS: In AMI patients aged < or = 75 years, female gender alone is not an independent predictor of hospital mortality. Detailed, multivariate analysis reveals that specifically diabetic women demonstrate higher hospital mortality than do men. Special attention should be provided to these female diabetic patients.

The Emergency Medical Care of Patients With Acute Myocardial Infarction.

BACKGROUND: Optimizing the emergency medical care chain might shorten the time to treatment of patients with ST-elevation myocardial infarction (STEMI). The initial care by a physician, and, in particular, correct ECG interpretation, are critically important factors. METHODS: From 1999 onward, data on the care of patients with myocardial infarction have been recorded and analyzed in the Berlin Myocardial Infarction Registry. In the First Medical Contact Study, data on initial emergency medical care were obtained on 1038 patients who had been initially treated by emergency physicians in 2012. Their pre-hospital ECGs were re-evaluated in a blinded fashion according to the criteria of the European Society of Cardiology. RESULTS: The retrospective re-evaluation of pre-hospital ECGs revealed that 756 of the 1038 patients had sustained a STEMI. The emergency physicians had correctly diagnosed STEMI in 472 patients (62.4%), and they had correctly diagnosed ventricular fibrillation in 85 patients (11.2%); in 199 patients (26.3%), the ECG interpretation was unclear. The pre-hospital ECG interpretation was significantly associated with the site of initial hospitalization and the ensuing times to treatment. In particular, the time from hospital admission to cardiac catheterization was longer in patients with an unclear initial ECG interpretation than in those with correctly diagnosed STEMI (121 [54; 705] vs. 36 [19; 60] minutes, p <0.001). After multivariate adjustment, this corresponded to a hazard ratio* of 2.67 [2.21; 3.24]. CONCLUSION: Pre-hospital ECG interpretation in patients with STEMI was a trigger factor with a major influence on the time to treatment in the hospital. The considerable percentage of pre-hospital ECGs whose interpretation was unclear implies that there is much room for improvement.

Antithrombotic therapy in patients with atrial fibrillation and acute coronary syndrome in the real world: Data from the Berlin AFibACS Registry.

BACKGROUND: Guidelines for the management of atrial fibrillation (AFib) recommend antithromboembolic treatment strategies for patients with AFib and acute coronary syndrome (AFibACS). Our study assessed how current guidelines are implemented in the metropolitan area of Berlin and which therapeutic options were chosen in light of stroke and bleeding riskin everyday practice. METHODS AND RESULTS: Between April 2008 and January 2012, we included 1,295 AFibACS patients in the AFibACS Registry, as part of the Berlin Myocardial Infarction Registry. Meanage of the patients was 76 years with numerous comorbidities (15.4% former stroke, 35.0% renal failure, 43.5% diabetes, 92.8% hypertension). Of all the patients, 888 were treated with stent implantation, 91 with balloon angioplasty, and 316 conservatively. Overall mortality was 11.6%, and 8.3% in stented patients. At hospital discharge, triple therapy was administered to 49.9% of stented cases. After adjustment, odds of receiving triple therapy were lower within creasing age and renal failure. Odds were higher after stent implantation, with a higher CHA2DS2-VASc score, and with any AFib category compared to initially diagnosed AFib. Between 2008 and 2011, triple therapy increased from 33.3% to 49.8% for stented patients and did not change significantly for those treated conservatively or with balloon angioplasty. CONCLUSIONS: These data suggest that in AFibACS patients, antithrombotic treatment focused on dual antiplatelet therapy for ACS, rather than on anticoagulation therapy for stroke prevention. Factors influencing therapy at discharge were age, renal failure, stent implantation, AFib category, and CHA2DS2-VASc score. During the study period, triple therapy increased for stented patients.

Routine early invasive strategy and in-hospital mortality in women with non-ST-elevation myocardial infarction: results from the Berlin Myocardial Infarction Registry (BMIR).

BACKGROUND: It is under discussion whether female patients with non-ST-elevation myocardial infarction (NSTEMI) benefit from routine invasive treatment strategy. We accordingly applied our data from the Berlin Myocardial Infarction Registry (BMIR) to analyze the association between early percutaneous coronary intervention (PCI) and hospital mortality in NSTEMI patients. METHODS: Data prospectively collected in the BMIR between 2004 and 2008 from 2808 patients (m=1820/w=988) directly admitted to hospitals with 24-h PCI facilities were included in the analysis. After adjustment for confounding variables, we compared in-hospital mortality for patients of both sexes with vs. without early PCI. RESULTS: Women with NSTEMI were, on average, 7years older than men and demonstrated significantly more comorbidities. A GPIIb/IIIa antagonist was applied in women less often than in men (31.4% vs. 38.4%, p=0.001), and an early PCI was also performed less often in women than in men (64.0% vs. 76.2%, p<0.001). In-hospital mortality was higher in women than in men (5.4% vs. 3.6%, p=0.027). In female patients with NSTEMI, after adjustment for differences in patients' characteristics, hospital mortality did not differ between those treated with early PCI and those managed conservatively (OR: 1.24, 95% CI 0.53-2.91). In contrast, hospital mortality in male patients was lower in those treated with an early PCI (OR: 0.41, 95% CI 0.21-0.78). CONCLUSION: In our clinical registry, early PCI in female patients with NSTEMI was not associated with lower hospital mortality. Further randomized-controlled trials are needed to better understand which women may benefit from early invasive therapy, and under which conditions such benefits are possible.

Time of admission, quality of PCI care, and outcome of patients with ST-elevation myocardial infarction.

OBJECTIVE: Our study aimed to analyse the hospital mortality of patients admitted in- and off-regular working hours with ST-elevation myocardial infarction (STEMI) within the special logistical setting of the urban area of the city of Berlin. BACKGROUND: There is a debate whether patients with acute myocardial infarction admitted to hospital outside regular working hours experience higher mortality rates than those admitted within regular working hours. METHODS: This study analyses data from the Berlin Myocardial Infarction Registry and comprises 2,131 patients with STEMI and treated with percutaneous coronary intervention (PCI) in 2004-2007. Data of patients admitted during in- and off-regular working hours were compared. RESULTS: There was significant difference in door-to-balloon time (median in-hours: 79 min; median off-hours: 90 min, p < 0.001) and in hospital mortality (in-hours: 4.3%; off-hours: 6.8%, p = 0.020) between STEMI patients admitted in- and off-hours for treatment with PCI. After adjustment, admission off-hours remained an independent predictor for in-hospital death for patients (OR = 2.50; 95% CI 1.38-4.56). In patients with primary care from physician-escorted Emergency Medical Services (EMS), door-to-balloon time was reduced by 10 min for in-hours as well as off-hours patients. The difference in hospital mortality between off-hour and in-hour admission was reduced to a non-significant OR = 1.61 (95% CI 0.79-3.27). CONCLUSIONS: In conclusion, patients admitted off-hours experienced longer door-to-balloon times and higher hospital mortality than did those admitted in-hours. The differences observed between patients admitted in-hours and off-hours were reduced through physician-escorted EMS reflecting the influence of optimized STEMI care.

Improved therapy and outcome for patients with acute myocardial infarction--data of the Berlin Myocardial Infarction Registry from 1999 to 2004.

BACKGROUND: Guidelines for treatment of patients with myocardial infarction (MI) have been regularly updated. In addition, a new definition for acute MI has been recently established. The aim of our study was to evaluate development of treatment and effects on patient outcome. METHODS: We prospectively collected data from MI patients who were treated in 22 hospitals in Berlin, Germany, during the years 1999 to 2004. In the study we consecutively included 6080 MI patients presenting with (STEMI, n=4314) and without persistent ST-segment elevation (NSTEMI, n=1766). RESULTS: STEMI and NSTEMI patients showed an increase over time in arterial hypertension, smoking, hypercholesterolaemia, history of congestive heart failure, and renal failure. The application of acute percutaneous coronary intervention increased from 15.3% to 62.3% (p<0.001) for NSTEMI and from 24.7% to 71.8% (p<0.001) for STEMI patients. Concomitant therapy with beta-blockers, ACE inhibitors, statins, GP IIb/IIIa, and aspirin increased in parallel in both groups. The decrease in hospital mortality was more pronounced for NSTEMI (13.5% vs. 4.6%, p<0.001) than with STEMI patients (13.0% vs. 9.4%, p=0.005). CONCLUSIONS: Adherence to guidelines has led to a higher level of hospital care for NSTEMI and STEMI patients. Hospital mortality decreased for both groups, with a greater impact on NSTEMI patients.

Present treatment of acute myocardial infarction in patients over 75 years--data from the Berlin Myocardial Infarction Registry (BHIR).

AIMS: Guidelines issued by European and German cardiology societies clearly define procedures for treatment of acute myocardial infarction (AMI). These guidelines, however, are based on clinical studies in which older patients are underrepresented. Older patients, on the other hand, represent a large and growing portion of the infarction population. It was our goal in the present paper to analyse the present treatment of AMI patients over 75 years of age in the city of Berlin, Germany, with data gained from the Berlin Myocardial Infarction Registry (BHIR). METHODS: We prospectively collected data from 5079 patients (3311 men and 1768 women, mean age 65.6) with acute myocardial infarction who were treated in 25 hospitals in Berlin during the period 1999-2003. 1319 patients (25.9%) were older than 75 (mean age 82.5 years). RESULTS: Overall hospital mortality rate was 11.6%. In patients over 75, this rate was 23.9%; among the younger infarction population, it was 7.3%. In contrast to the younger AMI patients, the majority of those over 75 were female (62.5 vs 25.1% for the younger) and demonstrated a significantly higher frequency of all prognostically meaningful comorbidities (heart failure 14.4% vs. 3.5%; renal failure 11.5 vs 3.9%; diabetes 37.3 vs 24.3%). Clinical signs of severe infarction, moreover, were more common among the aged patients (pulmonary congestion 45.4 vs 19.7%; left bundle branch block 12.7 vs 3.6%). Pre-hospital time was prolonged (2.8 vs 2 h) and guideline-recommended therapy was applied significantly less frequently to AMI patients over 75 (reperfusion therapy 39.8 vs 71.7%, beta-blockers 62.8 vs 78.3%, statins 26.5 vs 45.5%). Multivariate analysis revealed the following factors to be independent predictors of hospital mortality in patients over 75: age (OR 1.05 per year), acute heart failure (OR 2.39), pre-hospital resuscitation (OR 10.6), cardiogenic shock (OR 2.73), pre-hospital delay >12 h (OR 1.68), and ST elevation in the first ECG (OR 2.09). Independent predictors of a favourable hospital course were as follows: admission to a hospital >600 beds (OR 0.64), reperfusion therapy (OR 0.63), early betablocker treatment (OR 0.46), and early application of ACE inhibitors (OR 0.48). CONCLUSION: Infarction patients over 75 have a very high hospital complication and mortality rate. They are typically treated with delay, and with less adherence to relevant guidelines than are younger patients. Reperfusion therapy, early administration of beta-blockers and ACE inhibitors, as well as admission to large medical centres are all factors that contribute to a favourable prognosis of high-aged AMI patients.