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).

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).

[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.

[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.

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.

[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.

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).

[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.

[Reduction of Days in Inpatient Care in Psychiatric Hospitals with Flexible and Integrated Treatment for Patient-Centered Care with a Global Budget - Results with Three-Year Follow-up from the Evaluation Study EVA64]. / Verringerung vollstationärer Behandlungstage in psychiatrischen Kliniken mit Modellvorhaben zur patientenzentrierten Versorgung mit globalem Budget (§â€Š64b SGB V).

OBJECTIVE: This analysis describes the development of the duration of inpatient and daycare treatment as well as contacts in outpatient PIA in hospitals with flexible and integrated treatment (FIT) over a three-year follow-up period. METHODS: Patients with treatment in the first year after FIT-onset and a follow-up period of three years were examined for 12 FIT-hospitals and compared with matched patients from hospitals providing routine care. RESULTS: 11,536 patients were analyzed. In the year after first treatment, the number of inpatient days was lower in almost all FIT-hospitals compared to routine care. On the other hand, the number of daycare treatment days was mostly higher than in routine care. FIT hospitals with a pre-existing FIT-like structure showed stronger effects. PIA utilization differed between FIT-hospitals. CONCLUSION: This analysis supports evidence-based health policy decisions on the adoption of patient-centered global budget care concepts.

Effectiveness of Global Treatment Budgets for Patients With Mental Disorders-Claims Data Based Meta-Analysis of 13 Controlled Studies From Germany.

Background: Individuals with mental disorders need continuous and efficient collaboration between different sectors of care. In 2012, a new law in Germany enabled the implementation of novel budgets in psychiatry (flexible and integrated treatment = FIT). Hospitals implementing FIT programs have been evaluated in controlled cohort studies. We present first results based on a meta-analysis from 13 FIT hospitals. Methods/Design: We undertook a series of claims-data-based controlled cohort studies. Data from over 70 statutory health insurance (SHI) funds in Germany were analyzed. All patients insured by any of the participating SHI funds and treated in one of the FIT hospitals for any of 16 predefined mental disorders were compared with matched control patients from routine care. The patient collective was subdivided into hospital-new and hospital-known patients. Analyses included utilization of inpatient care, day care, outpatient PIA (psychiatrische Institutsambulanz) care, outpatient care with established practitioners, and durations of sick leave. Individual treatment effects of the 13 FIT hospitals were pooled in a random-effects meta-analysis. Meta-regression analysis was used to explore potential reasons for heterogeneity in model effectiveness. Results: The meta-analysis revealed a significant reduction by over 5 days of inpatient care in hospital-new patients in FIT hospitals compared to control hospitals. This effect was stronger among FIT hospitals with a preexisting FIT-like environment. There was no overall significant effect regarding sick leave between the two groups. Further meta-regression for hospital-new patients revealed a significantly reduced duration of sick leave by almost 13 days for patients in FIT hospitals with a preexisting FIT-like contract compared to FIT hospitals without such a contract. Conclusions: This study suggests positive effects of FIT programs for patients with mental disorders pointing toward a shorter duration of inpatient treatment. Furthermore, contracts already existent prior to initialization of FIT programs appear to have facilitated the transition into the new treatment environment. For FIT hospitals without such contracts, supposedly there is a certain implementation phase for effects to be apparent. The results should still be interpreted with caution as this manuscript only covers the first year of the 5 year evaluation period in 13 of 18 FIT hospitals. Clinical Trial Registration: This study was registered in the database "Health Services Research Germany" (trial number: VVfD_EVA64_15_003713).

[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.

[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 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 ).

Breast cancer and exposure to aircraft, road, and railway-noise: a case-control study based on health insurance records.

Objectives Aircraft, road, and rail traffic noise can cause sleep disturbances. Since night work and shorter sleep durations have been linked to increased risks of breast cancer, we examined if 24-hour, or day- or night-time traffic noise exposure may also increase the risk of breast cancer. Methods To investigate the noise-related risks of breast cancer, the pseudonymized insurance records of three large statutory health companies (2005-2010) for women aged ≥40 years living in the region surrounding the Frankfurt international airport were analyzed with address-specific acoustic data representing aircraft, road, and rail-traffic noise. Noise exposure among women with incident breast cancer (N=6643) were compared with that of control subjects (N=471 596) using logistic regression and adjusting for age, hormone replacement therapy, education and occupation (only available for 27.9%), and a regional proportion of persons receiving long-term unemployment benefits as an ecological indicator of socioeconomic level. Analyses were also stratified according to estrogen receptor (ER) status. Results An increased odds ratio (OR) was observed for ER negative (ER-) tumors at 24-hour aircraft noise levels 55-59 dB [OR 55-59 dB 1.41, 95% confidence interval (CI) 1.04-1.90] but not for ER positive (ER+) breast cancers (OR 55-59 dB 0.95, 95% CI 0.75-1.20). Clear associations between road and rail traffic noise were not observed. Conclusions The results indicate increased aircraft noise may be an etiologic factor for ER- breast cancers. However, information regarding potential confounding factors was largely unattainable. Further research is required to understand how environmental noise may be involved in the pathogenesis of ER- breast cancers.

Early comprehensive care of preterm infants-effects on quality of life, childhood development, and healthcare utilization: study protocol for a cohort study linking administrative healthcare data with patient reported primary data.

BACKGROUND: About 9 % of all children in Germany are born preterm. Despite significant improvements of medical care, preterm infants are at a greater risk to develop short and long term health complications. Negative consequences of preterm birth include neurodevelopmental disabilities, behavioral problems or learning disorders. Most data on effects of prematurity are derived from single or multi-center studies and not population-based. Since some of the long term problems of preterm delivery are associated with a disturbed parent-child interaction originating in the neonatal period, several intervention programs became available aiming to strengthen the early parent-child relationship. However, there is insufficient knowledge regarding the psychosocial and socioeconomic impact of these interventions. Prior to introducing them into routine care, those effects have to be rigorously evaluated. The population-based cohort study EcoCare-PIn (Early comprehensive Care of Preterm Infants-effects on quality of life, childhood development, and healthcare utilization) will investigate the following primary research questions: 1) What are the short- and long-term consequences of preterm birth with regard to parental stress, parent-child relationship, childhood development, quality of life and healthcare utilization including costs? 2) Does early family-centered psychosocial care prevent the hypothesized negative consequences of preterm birth on the above mentioned outcomes? METHODS/DESIGN: EcoCare-PIn examines the research questions by means of a linkage of a) pseudonymized administrative individual-level claims data from the German statutory health insurance AOK PLUS on approximately 140,000 children born between 2007 and 2013 in Saxony, and b) primary data collected from the parents/caregivers of all very low birth weight (<1,500 g; n = 1,000) and low birth weight infants (1,500 to 2,500 g; n = 5,500) and a matched sample of infants above 2,500 g birth weight (n = 10,000). DISCUSSION: In Saxony, approximately 50 % of all individuals are insured at the AOK PLUS. The linkage of patient-level administrative and primary data is a novel approach in neonatal research and probably the only way to overcome shortcomings of studies solely relying on one data source. The study results are based on an observation period of up to 8 years and will directly inform perinatal healthcare provision in Saxony and Germany as a whole.

Cohort profile: the lidA Cohort Study-a German Cohort Study on Work, Age, Health and Work Participation.

The lidA Cohort Study (German Cohort Study on Work, Age, Health and Work Participation) was set up to investigate and follow the effects of work and work context on the physical and psychological health of the ageing workforce in Germany and subsequently on work participation. Cohort participants are initially employed people subject to social security contributions and born in either 1959 (n = 2909) or 1965 (n = 3676). They were personally interviewed in their homes in 2011 and will be visited every 3 years. Data collection comprises socio-demographic data, work and private exposures, work ability, work and work participation attitudes, health, health-related behaviour, personality and attitudinal indicators. Employment biographies are assessed using register data. Subjective health reports and physical strength measures are complemented by health insurance claims data, where permission was given. A conceptual framework has been developed for the lidA Cohort Study within which three confirmatory sub-models assess the interdependencies of work and health considering age, gender and socioeconomic status. The first set of the data will be available to the scientific community by 2015. Access will be given by the Research Data Centre of the German Federal Employment Agency at the Institute for Employment Research (http://fdz.iab.de/en.aspx).