Sepsis incidence, suspicion, prediction and mortality in emergency medical services: a cohort study related to the current international sepsis guideline.

PURPOSE: Sepsis suspicion by Emergency Medical Services (EMS) is associated with improved patient outcomes. This study assessed sepsis incidence and recognition by EMS and analyzed which of the screening tools recommended by the Surviving Sepsis Campaign best facilitates sepsis prediction. METHODS: Retrospective cohort study of claims data from health insurances (n = 221,429 EMS cases), and paramedics' and emergency physicians' EMS documentation (n = 110,419); analyzed outcomes were: sepsis incidence and case fatality compared to stroke and myocardial infarction, the extent of documentation for screening-relevant variables and sepsis suspicion, tools' intersections for screening positive in identical EMS cases and their predictive ability for an inpatient sepsis diagnosis. RESULTS: Incidence of sepsis (1.6%) was similar to myocardial infarction (2.6%) and stroke (2.7%); however, 30-day case fatality rate was almost threefold higher (31.7% vs. 13.4%; 11.8%). Complete vital sign documentation was achieved in 8.2% of all cases. Paramedics never, emergency physicians rarely (0.1%) documented a sepsis suspicion, respectively septic shock. NEWS2 had the highest sensitivity (73.1%; Specificity:81.6%) compared to qSOFA (23.1%; Sp:96.6%), SIRS (28.2%; Sp:94.3%) and MEWS (48.7%; Sp:88.1%). Depending on the tool, 3.7% to 19.4% of all cases screened positive; only 0.8% in all tools simultaneously. CONCLUSION: Incidence and mortality underline the need for better sepsis awareness, documentation of vital signs and use of screening tools. Guidelines may omit MEWS and SIRS as recommendations for prehospital providers since they were inferior in all accuracy measures. Though no tool performed ideally, NEWS2 qualifies as the best tool to predict the highest proportion of septic patients and to rule out cases that are likely non-septic.

Changes in patient care through flexible and integrated treatment programs in German psychiatric hospitals: meta-analyses based on a series of controlled claims-based cohort studies.

BACKGROUND: Global treatment budgets, i.e. predefined budgets for patients treated in hospital independent of the setting within the hospital, together with flexible and integrated treatment (FIT) have been introduced in some German psychiatric hospitals since 2013. We investigated pooled changes in inpatient, day-care, outpatient treatment, and continuity of care for patients with mental disorders in 12 FIT-hospitals. METHODS: We conducted a series of 12 controlled cohort studies regarding FIT hospitals using anonymized patient claims data from more than 70 German statutory health insurance funds. Each study compared one FIT-hospital to matched patients from equivalent non-FIT-hospitals (routine care). We included only those patients without treatment in the respective hospital within two years prior to first hospital treatment (either FIT or routine care). We contrasted results between the year prior to with the first and second year after patient's first treatment (treatment continuity: only group comparison) using multivariate multi-level models. To approximate the difference-in-difference effect in the meta-analysis, we used the interaction terms group (FIT hospital vs. routine care) x time (year before vs. first or second patient year after study inclusion) in the Poisson models. RESULTS: The 12 studies included 36,069 patients with 2,358 patients from a Department of child and adolescent psychiatry. The pooled effect revealed a 5.1 days lower increase in inpatient treatment in FIT-hospitals during the first patient year compared to routine care. Results were statistically significant for adult care FIT-hospitals but not for child and adolescent FIT-hospitals. Utilization of day-care treatment increased more in most FIT-hospitals during the first year, while outpatient contacts increased in some and decreased in others. The odds of treatment continuity increased by 1.4 in FIT-hospitals compared to non-FIT-hospitals. CONCLUSIONS: Global treatment budgets lead to the intended changes in mental health care in the majority of FIT-hospitals compared to routine care in this large real-world evidence study from Germany. For child and adolescent psychiatry, more evidence is needed to draw firm conclusions. TRIAL REGISTRATION: This study was registered in the database "Health Services Research Germany" (trial number: VVfD_EVA64_15_003713).

Understanding health care pathways of patients with sepsis: protocol of a mixed-methods analysis of health care utilization, experiences, and needs of patients with and after sepsis.

BACKGROUND: Sepsis is associated with about 20% of deaths worldwide. It often presents with non-specific initial symptoms, making its emergency treatment an interdisciplinary and cross-sectoral challenge. Three in four sepsis survivors suffers from new cognitive, psychological, or physical sequelae for which specific treatment concepts are scarce. The AVENIR project aims to improve the understanding of patient pathways, and subjective care experiences and needs along the entire healthcare pathway before, with and after sepsis. Based on this, concrete recommendations for the organization of care and patient information materials will be developed with close patient participation. METHODS: Mixed-methods study including (1) analysis of anonymized nationwide health claims data from Germany, (2) linkage of health claims data with patient care reports (PCR) of emergency medical services from study regions in two federal states within Germany, and (3) qualitative exploration of the patient, relative, and care provider perspective on sepsis care. In (1), we analyze inpatient and outpatient health care utilization until 30 days pre-sepsis; clinical sepsis care including intra- and inter-hospital transfers; and rehabilitation, inpatient and outpatient aftercare of sepsis survivors as well as costs for health care utilization until 24 months post-sepsis. We attempt to identify survivor classes with similar health care utilization by Latent Class Analyses. In (2), PCR are linked with health claims data to establish a comprehensive database outlining care pathways for sepsis patients from pre-hospital to follow-up. We investigate e.g., whether correct initial assessment is associated with acute (e.g., same-day lethality) and long-term (e.g., new need for care, long-term mortality) outcomes of patients. We compare the performance of sepsis-specific screening tools such as qSOFA, NEWS-2 or PRESEP in the pre-clinical setting. In (3), semi-structured interviews as well as synchronous and asynchronous online focus groups are conducted and analyzed using qualitative content analyses techniques. DISCUSSION: The results of the AVENIR study will contribute to a deeper understanding of sepsis care pathways in Germany. They may serve as a base for improvements and innovations in sepsis care, that in the long-term can contribute to reduce the personal, medical, and societal burden of sepsis and its sepsis sequelae. TRIAL REGISTRATION: Registered at German Clinical Trial Register (ID: DRKS00031302, date of registration: 5th May 2023).

[Determinants of the utilization of cancer screening among older adults in Saxony-Anhalt-What is the influence of health literacy?] / Determinanten der Inanspruchnahme der Krebsfrüherkennung von älteren Erwachsenen in Sachsen-Anhalt ­ Welchen Einfluss hat die Gesundheitskompetenz auf die Inanspruchnahme?

BACKGROUND: In order to preserve health and thus social participation, it is important for older people to make health-related decisions, such as those regarding the use of a secondary prevention service like cancer screening. National and international studies show that various predictors determine cancer screening participation. The aim of this study is to determine the cancer screening utilization of older people in a structurally weak region. METHODS: In 2021, a cross-sectional study in each of two urban and rural communities in Saxony-Anhalt surveyed individuals aged 55 years and older about determinants, reasons, and barriers to preventive service use (n = 954). Binary logistic regression analysis is used to analyze determinants of cancer screening use. RESULTS: Three quarters of the study population (76.6%) self-reported participating in a cancer screening service at least once. The multivariable analyses demonstrate factors that influence the utilization of cancer screening. Age, partial knowledge on cancer screening, cancer screening as a benefit offered by a statutory health insurances' bonus program, experience with cancer in the immediate environment, thoughts about one's own health, and the feeling of security that participation gives are factors that significantly influence the use of cancer screening. Descriptively, the physician's recommendation is the strongest factor for participation. CONCLUSION: The analyses show that cancer screenings are generally well received by older people in Saxony-Anhalt, but participation in them is not related to health literacy. In keeping with the National Cancer Plan, older people should generally be supported in making an informed decision, for example, through target-group-specific physician education.

Agreement between self-reports and statutory health insurance claims data on healthcare utilization in patients with mental disorders.

BACKGROUND: Data on resource use are frequently required for healthcare assessments. Studies on healthcare utilization (HCU) in individuals with mental disorders have analyzed both self-reports and administrative data. Source of data may affect the quality of analysis and compromise the accuracy of results. We sought to ascertain the degree of agreement between self-reports and statutory health insurance (SHI) fund claims data from patients with mental disorders. METHODS: Claims data from six German SHI and self-reports were obtained along with a cost-effectiveness analysis performed as a part of a controlled prospective multicenter cohort study conducted in 18 psychiatric hospitals in Germany (PsychCare), including patients with pre-defined psychiatric disorders. Self-reports were collected using the German adaption of the Client Sociodemographic and Service Receipt Inventory (CSSRI) questionnaire with a 6-month recall period. Data linkage was performed using a unique pseudonymized identifier. Missing responses were coded as non-use for all analyses. HCU was calculated for inpatient and outpatient care, day-care services, home treatment, and pharmaceuticals. Concordance was measured using Cohen's Kappa (κ) and intraclass correlation coefficient (ICC). Regression approaches were used to investigate the effect of independent variables on the agreements. RESULTS: In total 274 participants (mean age 47.8 [SD = 14.2] years; 47.08% women) were included in the analysis. No significant differences were observed between the linked and unlinked patients in terms of baseline characteristics. Total agreements values were 63.9% (κ = 0.03; PABAK = 0.28) for outpatient contacts, 69.3% (κ = 0.25; PABAK = 0.39) for medication use, 81.0% (κ = 0.56; PABAK = 0.62) for inpatient days and 86.1% (κ = 0.67; PABAK = 0.72) for day-care services. There was varied quantitative agreement between data sources, with the poorest agreement for outpatient care (ICC [95% CI] = 0.22 [0.10-0.33]) and the best for psychiatric day-care services (ICC [95% CI] = 0.72 [0.66-0.78]). Marital status and time since first treatment positively affected the chance of agreement on utilization of outpatient services. CONCLUSIONS: Although there were high levels of absolute agreement, the measures of concordance between administrative records and self-reports were generally minimal to moderate. Healthcare investigations should consider using linked or at least different data sources to estimate HCU for specific utilization areas, where unbiased information can be expected. TRIAL REGISTRATION: This study was part of the multi-center controlled PsychCare trial (German Clinical Trials Register No. DRKS00022535; Date of registration: 2020-10-02).

[Recommendations for the Utilization of Claims Data During a Pandemic: Lessons Learned from the Project EgePan-Unimed of the Netzwerk Universitätsmedizin (NUM)]. / Potentiale von und Empfehlungen zur Nutzung von GKV Routinedaten in einer pandemischen Versorgungslage ­ Erfahrungen aus dem Projekt egePan-Unimed des Netzwerk Universitätsmedizin (NUM).

For appropriate response to the COVID-19 pandemic, and for obtaining answers to various relevant research questions, empirical data are required. Claims data of health insurances are a valid data source in such a situation. Within the project egePan-Unimed of the Netzwerk Universitätsmedizin (NUM) we investigated five COVID-19-related research questions using German claims data of statutory health insurances. We studied the prevalence and relevance of risk factors for a severe course of COVID-19, the background incidence of cerebral venous sinus thrombosis and myocarditis, the frequency and symptoms of post-COVID as well as the care of people with a psychiatric condition during the COVID-19 pandemic. Based on these cases, context-specific recommendations regarding the use of German claims data for future pandemics or other public health emergencies were derived, namely that the utilization of established and interdisciplinary project teams enables a timely project start and furthermore, meta-analytic methods are a valuable way to pool aggregated results of claims data analyses when data protection regulations do not allow a consolidation of data sets from different statutory health insurances. Under these circumstances, claims data are a readily available and valid data source of empirical evidence base necessary for public health measures during a pandemic.

[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.

Apart from the Medical Complaints, Why do Patients Use Emergency Medical Services? Results of a Patient Survey.

INTRODUCTION: Many countries face an increased use of emergency medical services (EMS) with a decreasing percentage of life-threatening complaints. Though there is a broad discussion among experts about the cause, patients' self-perceived, non-medical reasons for using EMS remain largely unknown. METHODS: The written survey included EMS patients who had≥1 case of prehospital emergency care in 2016. Four German health insurance companies sent out postal questionnaires to 1312 insured patients. The response rate was 20%; 254 questionnaires were eligible for descriptive and interferential analyses (t-tests, chi2-tests, logistic models). RESULTS: The majority of respondents indicated that their EMS use was due to an emergency or someone else's decision (≥84%; multiple checks allowed); 56% gave need for a quick transport as a reason. Other frequently stated reasons addressed the health care system (e. g., complaints outside of physicians' opening hours) and insecurity/anxiety about one's state of health (>45% of the respondents). "Social factors" were similarly important (e. g., 42% affirming, "No one could give me a ride to the emergency department or doctor's office."). Every fifth person had contact with other emergency care providers prior to EMS use. Respondents negating an emergency as a reason were less likely to confirm wanting immediate medical care on site or quick transports compared to those affirming an emergency. Patients using EMS at night more often denied having an emergency compared to patients with access to care during the day. CONCLUSION: The study identified a bundle of reasons leading to EMS use apart from medical complaints. Attempts for needs-oriented EMS use should essentially include optimization of the health care and social support system and measures to reduce patients' insecurity.

Evaluation of a flexible and integrative psychiatric care model in a department of child and adolescent psychiatry in Tübingen, Germany: study protocol (EVA_TIBAS).

BACKGROUND: Model projects for flexible and integrated treatment (FIT) in Germany aim at advancing the quality of care for people with mental disorders. A new FIT model project was established in 2017 at the Department of child and adolescent psychiatry (KJP) of the University Hospital Tübingen (Universitätsklinikum Tübingen, UKT). The study design of EVA_TIBAS presented here describes the evaluation of the FIT model project at the KJP of the UKT. This evaluation aims at quantifying the anticipated FIT model project changes, which are to improve patients' cross-sectoral care at the same maximum cost as standard care. METHODS: EVA_TIBAS is a controlled cohort study using a mix of quantitative and qualitative methods. The FIT evaluation consists of three modules. In Module A, anonymized claims data of a statutory health insurance fund will be used to compare outcomes (duration of inpatient and day care psychiatric treatment, inpatient and day care psychiatric length of stay, outpatient psychiatric treatment in hospital, inpatient hospital readmission, emergency admission rate, direct medical costs) of patients treated in the model hospital with patients treated in structurally comparable control hospitals (estimated sample size = ca. 600 patients). In Module B, patient-reported outcomes (health related quality of life, symptom burden, return to psychosocial relationships (e.g. school, friends, hobbies), treatment satisfaction, societal costs) will be assessed quantitatively using validated questionnaires for the model and two control hospitals (estimated sample size = ca. 300 patients). A subsequent health economic evaluation will be based on cost-effectiveness analyses from both the insurance fund's and the societal perspective. In Module C, about 30 semi-structured interviews will examine the quality of offer, effects and benefits of the service offered by the social service of the AOK Baden-Württemberg (for stabilizing the overall situation of care in the family) in the model hospital. A focus group discussion will address the quality of cooperation between employees of the university hospital and the social services. DISCUSSION: The results of this evaluation will be used to inform policy makers whether this FIT model project or aspects of it should be implemented into standard care. TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov PRS (ID: NCT04727359 , date: 27 January 2021).

[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.

[Linking Health Claims Data and Records of Emergency Medical Services: Building a Bridge via Patient's Health Insurance Number?] / Verknüpfung von Abrechnungsdaten gesetzlicher Krankenkassen und Einsatzprotokollen des Rettungsdienstes: Brückenschlag durch Krankenversichertennummer?

INTRODUCTION: In Germany, Emergency Medical Services (EMS) were involved in a total of 7.3 million emergency cases in 2016/2017. Information on prehospital care is stored in several secondary data sources, yet combined analysis of these data at the level of individual patients or EMS cases happens rarely. Research is needed on which methods and variables are suitable for the linkage of these data sources. METHODS: We linked EMS records from five Bavarian emergency service districts to health claims data belonging to ten statutory health insurers (data from 2016). Two linkage approaches at the level of individual patient's EMS case/reimbursement case were demonstrated. First, a deterministic linkage was conducted based on the patient's unique identifying health insurance number. The second linkage was probabilistic. As linkage variables, it comprised the only partially available health insurance number plus several non-unique key variables, the latter being a patient's health insurance provider, sex, year of birth and distance travelled. In order to verify the deterministic and the probabilistic linkages' quality, rates of accordance of several variables present in both data sources were calculated. RESULTS: The starting point for our data linkage were 106,371 EMS records (independent of certain health insurance companies) and 432,693 EMS services reimbursed by health insurers (independent of specific EMS providers). 4,327 EMS records could be linked to health claims data - out of 5,921 EMS records that coded a health insurance company contributing claims data to Inno_RD. With a probabilistic linkage, it was possible to increase this number to a total of 5,379 linked EMS records. All checks carried out indicated a high linkage quality for both the deterministic and the probabilistic approach. CONCLUSION: A linkage of EMS records with health claims data is possible. In Inno_RD, a probabilistic approach has proven a valuable alternative to deterministic linkage via health insurance number since EMS records can be linked meaningfully even if the health insurance number is unavailable or where a minority of non-unique key variables show non-accordance or missing values.

[Health and Social Status in Hamburg's Urban Quarters - An Approach to Mapping Social Status with Health-Related Routine Data]. / Gesundheit und soziale Lage in Hamburger Quartieren ­ Ein Ansatz zur Abbildung von Soziallagen mit gesundheitsbezogenen Routinedaten.

AIM OF THE STUDY: The aim of this study was to test an innovative approach to the small-scale and social situation-sensitive localisation and analysis of health-related routine data. For this purpose, SHI billing data and deployment data of the ambulance service were supplemented with a small-scale neighbourhood-related indicator of the social situation of the place of residence and/or deployment as a proxy for the personal social situation. METHODS: Anonymised accounting data from three statutory health insurances and deployment data from the rescue service of the Hamburg fire brigade, each from the year 2017, were used. The social situation of the place of residence of the insured or transported persons (in the case of the rescue service data, also the deployment location) was mapped with the help of the so-called status index classes (high - medium - low - very low) of the Hamburg social monitoring. The allocation via the addresses of the persons concerned was carried out by the respective data owners with the help of an allocation procedure developed in the project. RESULTS: Exemplary results of descriptive analysis of accident occurrence and acute inpatient care of children and adolescents showed that known social situation dependencies from primary studies can also be depicted in the secondary data used. This would speak for the suitability of the social indicator, e. g. in the context of extended social and health reporting. CONCLUSION: The neighbourhood-based indicator we used seems promising and should be validated in further analyses. Based on this, approaches can be developed for its use in the context of health services research and health reporting as well as in the sense of a comprehensive health-in-all-policies strategy for designing health-promoting and needs-oriented political decisions and programmes.

[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.

[Methodological Challenges when Using Claims Data of more than 70 Statutory Health Insurances - A Progress Report from the EVA64 Study]. / Methodische Herausforderungen bei der Nutzung von Daten von mehr als 70 gesetzlichen Krankenkassen ­ Ein Werkstattbericht aus der EVA64-Studie.

AIM OF THE STUDY: The adequate and need-based medical care of mentally ill patients places special demands on psychiatric care. The §64b Social Code Book (SGB) V enables mentoring mentally ill people through multiprofessional, cross-sectoral model projects across the treatment phase and implementing new forms of financing. These model projects have been evaluated in a prospective and retrospective claims data-based controlled cohort study (EVA64) since 2015. METHODS: In September 2016 and since then annually, the data transfer of all statutory health insurance funds (SHI) involved in this evaluation took place for the first time on the basis of a consented data set description. For later analysis, the clear identification of the index hospital admission and the assignment to the model or control group are important. The methodological challenges of data provision by the data owner, the formal and content-related data preparation as well as the subsequent establishing of an evaluation data set are discussed in detail. RESULTS: So far, data from 71 SHI has been taken into account. In each case 20 tables with claims data from outpatient and inpatient care (including psychiatric institute outpatient departments [PIA]), drug and medical supplies as well as data from incapacity to work and personal data of the insurees. Not all tables could be filled completely by the SHIs. In addition, updates of the study designs require the adaptation of the data selection process. Even though data sets have been delievered regularly the data preparation process is still not routine. CONCLUSION: The scientific use of claims data of numerous SHIs in the context of an evaluation study represents a great challenge. In the absence of reference values for abnormalities and implausibilities, an a priori determination of test algorithms was limited; instead they had to be updated every year. The individual examination of the data of all health insurance companies remains very complex. The detailed documentation of these algorithms provides support for future comparable studies.

[The baseline assessment of the German National Cohort (NAKO Gesundheitsstudie): participation in the examination modules, quality assurance, and the use of secondary data]. / Die Basiserhebung der NAKO Gesundheitsstudie: Teilnahme an den Untersuchungsmodulen, Qualitätssicherung und Nutzung von Sekundärdaten.

BACKGROUND: The German National Cohort (NAKO) is an interdisciplinary health study aimed at elucidating causes for common chronic diseases and detecting their preclinical stages. This article provides an overview of design, methods, participation in the examinations, and their quality assurance based on the midterm baseline dataset (MBD) of the recruitment. METHODS: More than 200,000 women and men aged 20-69 years derived from random samples of the German general population were recruited in 18 study centers (2014-2019). The data collection comprised physical examinations, standardized interviews and questionnaires, and the collection of biomedical samples for all participants (level 1). At least 20% of all participants received additional in-depth examinations (level 2), and 30,000 received whole-body magnet resonance imaging (MRI). Additional information will be collected through secondary data sources such as medical registries, health insurances, and pension funds. This overview is based on the MBD, which included 101,839 participants, of whom 11,371 received an MRI. RESULTS: The mean response proportion was 18%. The participation in the examinations was high with most of the modules performed by over 95%. Among MRI participants, 96% completed all 12 MRI sequences. More than 90% of the participants agreed to the use of complementary secondary and registry data. DISCUSSION: Individuals selected for the NAKO were willing to participate in all examinations despite the time-consuming program. The NAKO provides a central resource for population-based epidemiologic research and will contribute to developing innovative strategies for prevention, screening and prediction of chronic diseases.

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.

[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.

The influence of cross-sectoral treatment models on patients with mental disorders in Germany: study protocol of a nationwide long-term evaluation study (EVA64).

BACKGROUND: Close, continuous and efficient collaboration between different professions and sectors of care is necessary to provide patient-centered care for individuals with mental disorders. The lack of structured collaboration between in- and outpatient care constitutes a limitation of the German health care system. Since 2012, a new law in Germany (§64b Social code book (SGB) V) has enabled the establishment of cross-sectoral and patient-centered treatment models in psychiatry. Such model projects follow a capitation budget, i.e. a total per patient budget of inpatient and outpatient care in psychiatric clinics. Providers are able to choose the treatment form and adapt the treatment to the needs of the patients. The present study (EVA64) will investigate the effectiveness, costs and efficiency of almost all model projects established in Germany between 2013 and 2016. METHODS/DESIGN: A health insurance data-based controlled cohort study is used. Data from up to 89 statutory health insurance (SHI) funds, i.e. 79% of all SHI funds in Germany (May 2017), on inpatient and outpatient care, pharmaceutical and non-pharmaceutical treatments and sick leave for a period of 7 years will be analyzed. All patients insured by any of the participating SHI funds and treated in one of the model hospitals for any of 16 pre-defined mental disorders will be compared with patients in routine care. Sick leave (primary outcome), utilization of inpatient care (primary outcome), utilization of outpatient care, continuity of contacts in (psychiatric) care, physician and hospital hopping, re-admission rate, comorbidity, mortality, disease progression, and guideline adherence will be analyzed. Cost and effectivity of model and routine care will be estimated using cost-effectiveness analyses. Up to 10 control hospitals for each of the 18 model hospitals will be selected according to a pre-defined algorithm. DISCUSSION: The evaluation of complex interventions is an important main task of health services research and constitutes the basis of evidence-guided advancement in health care. The study will yield important new evidence to guide the future provision of routine care for mentally ill patients in Germany and possibly beyond. TRIAL REGISTRATION: This study was registered in the database "Health Services Research Germany" (trial number: VVfD_EVA64_15_003713 ).