[Skin cancer screening in the aging population in Saxony-Anhalt : Utilization, facilitating, and hindering factors]. / Hautkrebsfrüherkennung in der alternden Bevölkerung Sachsen-Anhalts : Inanspruchnahme sowie förderliche und hinderliche Faktoren.

BACKGROUND: Statutory skin cancer screening (gHKS) can counteract severe courses of various types of skin cancer. The example of malignant melanoma shows that screening is important for older adults in view of the average age of onset of this disease: 62 (women) and 68 years (men). For Saxony-Anhalt (ST), as a state particularly affected by demographic change, little gHKS data are available regarding its usage. OBJECTIVES: For the study, gHKS participation rates for persons aged 55 and older are presented for ST in comparison to the rest of Germany. Reasons for and barriers to participation from those eligible as well as possible fields of action are shown. MATERIALS AND METHODS: For the target group, outpatient billing data from the Central Institute for Statutory Health Insurance Physicians in Germany (Zi) on gHKS from 2011-2020 are cross-sectionally and longitudinally analysed. Guideline-based telephone interviews with 18 residents using qualitative content analysis according to Kuckartz serve to identify reasons for and barriers to the use of gHKS. RESULTS: The gHKS was rarely and irregularly used in ST and other federal states of Germany from 2011-2020; the annual utilisation rate was about 8.0% (national average: 8.4%). Between 2011 and 2020, 50% of eligible people aged 55 years and older did not participate in the gHKS. The highest utilisation rates were among men aged 70-79 years. In addition to district-specific differences, which indicate possible gaps in care, information deficits appear to be the main reason for low participation. CONCLUSION: The low utilisation of gHKS, partly due to a lack of information among those entitled to it, requires target group-specific information services.

VersKiK: Study protocol of an observational registry-based study on the current state of follow-up care and adherence to follow-up guidelines after cancer in childhood or adolescence.

BACKGROUND: This article describes the study design of the quantitative part of the VersKiK study, The primary objectives of this study are to examine the occurrence of late effects in survivors of childhood or adolescent cancer (module 1), investigate health-related vulnerabilities and medical service utilization within this survivor group (modules 1 and 3), and assess the alignment between documented follow-up care for cardiological and audiological late effects with guideline recommendations, along with evaluating the extent of adherence among paediatric cancer survivors (module 3). METHODS: This is a non-interventional retrospective observational cohort study. It is based on stochastically linked insurance claims data from approximately 150,000 statutory insured persons with information concerning around 25,000-30,000 cancer survivors recorded in the German Childhood Cancer Register (GCCR). To explore adherence to selected follow-up guidelines, intention to treat treatment data from clinical study groups for particular diagnostic entities will be additionally included. DISCUSSION: The growing group of survivors after cancer in childhood and adolescence is representing a special population with an increasing demand for life-long healthcare services through relative high probability of late effects. Currently, there is a limited evidence in Germany on utilization of corresponding medical services and adherence to follow-up guidelines. With this study design, we are aiming to address these gaps and, consequently, suggest improvements to existing follow-up guidelines and follow-up care provision in Germany.

A validated HPLC-MS/MS method for simultaneously analyzing curcumin, demethoxycurcumin, bisdemethoxycurcumin, tetra-hydrocurcumin and piperine in human plasma, urine or feces.

Background: The spice curcumin is supposed to have many different beneficial health effects. To understand the complete pharmacokinetics of curcumin we need an analytical method to determine curcumin and its metabolites in human plasma, urine or feces. We have developed an HPLC-MS/MS method for the simultaneous analysis of curcumin, demethoxycurcumin, bisdemethoxycurcumin, tetrahydrocurcumin and piperine in human plasma, urine or feces. Methods: Sample pretreatment involved a simple liquid-liquid extraction with tert-butyl methyl ether. Conjugated curcumin and analogs can be measured after enzymatic hydrolysis. Reversed-phase chromatography with a linear gradient of 50-95% methanol in 0.1% formic acid was used. Total run time is 15 min. The method was validated with regards to stability, specificity, sensitivity, linearity, accuracy, repeatability and reproducibility. The applicability of the method was tested using actual patients samples. Results: The LLOQ in plasma, urine and feces for curcumin, demethoxycurcumin, bisdemethoxycurcumin, tetrahydrocurcumin and piperine ranged from 1 to 5 nM. Whereas all compounds could be quantified on a linear range between 2 and 400 nM. Plasma and feces recovery of curcumin was 97.1 ± 3.7% and 99.4 ± 16.2%, whereas urine showed a recovery of 57.1 ± 9.3%. All compounds had acceptable in-between day or between day variability in the different matrixes. Conclusion: A HPLC-MS/MS method was developed and validated for the simultaneous quantification of curcumin, demethoxycurcumin, bisdemethoxycurcumin, tetrahydrocurcumin and piperine in human plasma, urine or feces. This method will aid in critically verifying the pharmacokinetics of curcumin made by supplement manufacturers and help us to provide insight in the claimed bioavailability of curcumin supplements.

Long-term care, care needs and wellbeing of individuals after cancer in childhood or adolescence (VersKiK): study protocol of a large scale multi-methods non-interventional study.

BACKGROUND: It has been shown previously that a relevant proportion of childhood cancer survivors suffers from late effects, which are often directly related to the cancer itself or its therapy, resulting in particular follow-up needs, additionally burdening healthcare systems. Being diagnosed with cancer at a vulnerable stage of development, this group of cancer survivors is at comparatively higher risk of relapse or subsequent cancer. Although national and international follow-up guidelines based on treatment modalities have been developed, their implementation seems to leave room for improvement. Additionally, they lack a sufficient consideration of the survivors' psychosocial needs, affecting their adherence to them. The aim of the VersKiK study is to provide representative information on late effects in childhood and adolescence cancer survivors in Germany. The main research objectives are: (1) to describe the state of follow-up care among survivors after a cancer diagnosis in childhood or adolescence; (2) to quantify the occurrence of late effects among this group of survivors; (3) to examine the adherence to selected audiological and cardiological follow-up guidelines and to identify factors affecting it; (4) to explore actual follow-up needs of paediatric cancer survivors; (5) to review selected follow-up guidelines with the aim to improve and expand them. METHODS: VersKiK is designed as a mixed-methods non-interventional study. We will use claims data from statutory health insurance companies in combination with individually linked population-based registry data from the German Childhood Cancer Registry (GCCR). This data base will permit us to quantify diagnoses and procedures in comparison to the general population as well as the adherence to existing follow-up guidelines. Additional information will be obtained through interviews with childhood and adolescence cancer survivors and their informal caregivers, as well as in focus groups with healthcare professionals. DISCUSSION: The present study aims to research the actual needs of individuals after cancer diagnosis and treatment in childhood or adolescence - physical, psychological and organisational - in order to improve existing follow-up guidelines. These improvements might further positively affect not only actual care provided to paediatric cancer survivors, but also benefit healthcare systems in general while decreasing consequent medical visits in this group of patients. TRIAL REGISTRATION: Registered at German Clinical Trial Register (ID: DRKS00025960 and DRKS00026092).

The use of online support by people with intellectual disabilities living independently during COVID-19.

BACKGROUND: During the COVID-19 outbreak, service providers in the Netherlands had to switch towards providing remote support for people with intellectual disabilities living independently. This study aims to provide insight into the use of online support during the outbreak. METHODS: We analysed quantitative data on planned and unplanned contacts between the online support service DigiContact and its service users. RESULTS: The results indicate that the COVID-19 outbreak and the related containment measures had a strong impact on online support use, specifically on the unplanned use of online support. CONCLUSION: Offering online support as a standard component of services for independently living people with intellectual disability enables service providers to be flexible and responsive towards fluctuations in both support needs and onsite support availability during a social crisis such as COVID-19.

Correction to: Exposure-survival analyses of pazopanib in renal cell carcinoma and soft tissue sarcoma patients: opportunities for dose optimization.

In the original publication of the article, the second author name has been misspelled.

Sorafenib administered using a high-dose, pulsatile regimen in patients with advanced solid malignancies: a phase I exposure escalation study.

BACKGROUND: (Pre)clinical evidence is accumulating that intermittent exposure to increased doses of protein kinase inhibitors may improve their treatment benefit. In this phase I trial, the safety of high-dose, pulsatile sorafenib was studied. PATIENTS AND METHODS: High-dose sorafenib was administered once weekly in exposure escalation cohorts according to a 3 + 3 design. Drug monitoring was performed in weeks 1-3 and doses were adjusted to achieve a predefined target plasma area under the curve (AUC)(0-12 h). The effect of low gastric pH on improving sorafenib exposure was investigated by intake of the acidic beverage cola. RESULTS: Seventeen patients with advanced malignancies without standard treatment options were included. Once weekly, high-dose sorafenib exposure was escalated up to a target AUC(0-12 h) of 125-150 mg/L/h, achieving a twofold higher Cmax compared to standard continuous dosing. Dose-limiting toxicity was observed in three patients: grade 3 duodenal perforation (2800 mg sorafenib), grade 5 multiorgan failure (2800 mg sorafenib) and grade 5 biliary tract perforation (3600 mg sorafenib). The mean difference between observed and target AUC(0-12 h) was 45% (SD ± 56%) in week 1 using a fixed starting dose of sorafenib compared to 2% (SD ± 32%) in week 3 as a result of drug monitoring (P = 0.06). Dissolving sorafenib in cola, instead of water, did not improve sorafenib exposure. Clinical benefit with stable disease as the best response was observed in two patients. CONCLUSION: Treatment with high-dose, once weekly sorafenib administration resulted in dose-limiting toxicity precluding dose escalation above the exposure cohort of 125-150 mg/L/h. Drug monitoring was a successful strategy to pursue a target exposure.

[Identification of Control Hospitals for the Implementation of the Nationwide and Standardized Evaluation of Model Projects According to § 64b SGB V: Analysis of Data from Structured Quality Reports]. / Auswahl geeigneter Kontrollkliniken für die Durchführung der bundesweiten und einheitlichen Evaluation von Modellvorhaben nach § 64b SGB V. Analyse von Daten der Strukturierten Qualitätsberichte.

BACKGROUND: Health care needs of mentally ill patients make special demands on cross-sectoral health care structures. § 64b SGB V enables care of mentally ill patients through model projects that are multi-professional, work across treatment periods and sectors and implement new forms of financing. These model projects in their hospitals (case hospitals) need to be evaluated and compared with standard treatment methods. OBJECTIVES: The aim of this analysis is to identify matching hospitals according to a priori defined criteria for the establishment of a control group (control hospitals) using secondary data. MATERIALS AND METHODS: A systematic analysis was conducted based on structured quality reports according to §+137 SGB V and matched data from the Federal Institute for Research on Building, Urban Affairs and Spatial Development (BBSR). Based on a priori defined knock-out criteria, criteria based on patients (weighting 50%), structural features of hospitals (25%) and environmental factors (25%), a weighted similarity score was calculated for each of the 13 case hospitals, which could reach the maximum of 100 points (perfect match). RESULTS: 10 control hospitals per case hospital were identified according to the weighted similarity score. The median of the total deviation of potential control hospitals from the case hospitals was 34.3 (range: 17.6-66.7). The median of the 10 selected control hospitals per case hospital was 30.9 (range: 17.6-40.8). DISCUSSION: The defined algorithm could be used to identify similar control hospitals. The method using the mentioned databases and derivation of specific criteria of structural similarity are generally suitable in controlled designs for the evaluation of complex interventions based on routine data.

[Polypharmacy after Discharge from Hospital: An Analysis Using Data of the Statutory Health Insurance (AOK) of Saxony-Anhalt]. / Polypharmazie in der nachstationären Versorgung: Eine Analyse mit Daten der AOK Sachsen-Anhalt.

INTRODUCTION AND AIM: The growing number of people suffering from chronic diseases and multimorbidity is associated with an increased risk of polypharmacy. The aims of the study are to estimate the prevalence of polypharmacy and to analyse its determinants in the transition from in- to outpatient care. Furthermore, we estimate the risk of a potential inappropriate medication (PIM) and its determinants. METHODS: The analyses are based on the data of a German statutory health insurance (AOK Saxony-Anhalt) of the third quarter of 2009. The analyses include all insured persons aged 60 years and older who were discharged from hospital within the study period and had filled at least one prescription at the pharmacy (n=21 041). After the analysis of prevalence rates of polypharmacy within 30 days after discharge from hospital, we used binary logistic regression models to estimate the effect of determinants of polypharmacy and PIM. In addition, interaction effects between the number of diseases and the number of practitioners involved in the therapy were calculated. RESULTS: Our analyses show a significant effect of the number of diseases and the number of practitioners on the risk of polypharmacy. Furthermore, patients who are treated with 5 or more drugs have a significantly higher risk of a PIM prescription. The interaction model illustrates a disproportional rise of polypharmacy risk in women with multiple chronic conditions with an increase in the number of doctors treating them. CONCLUSION: The results suggest that polypharmacy is not a result of increasing morbidity alone. Furthermore, the remarkable effect of the number of physicians treating a patient points to an unsolved problem in communication and coordination in outpatient pharmacotherapy and shows the need for centralized medication monitoring.

Linking primary study data with administrative and claims data in a German cohort study on work, age, health and work participation: is there a consent bias?

OBJECTIVES: We analysed the degree and impact of consent bias in the prospective study 'leben in der Arbeit (lidA)' after linking primary interview data with claims data from German statutory health insurance funds as well as with administrative data provided by the German Federal Employment Agency. STUDY DESIGN: Prospective cohort study. METHODS: Within two study waves (2011, 2014) primary data were collected based on computer-assisted personal interviews. During interview informed consent to data linkage was obtained. We used binary logistic regression analyses with participants' consent for record linkage as the dependent variable calculating odds ratios (ORs) and 95% confidence intervals (95% CIs) for independent variables. Several sociodemographic, socio-economic and work-related factors were modelled as potential determinants of consent. RESULTS: A total of 4244 participants took part in both waves. After excluding invalid consent, 4178 participants were included in the analysis. About 3918 (93.8%) of these participants gave their consent to link their primary data with data from at least one source. Within regression analyses only moderate bias was found due to region of residence, apprenticeship, professional affiliations, income and number of diseases. Participants from former West Germany were less likely to have their study data linked with both data sources (OR 0.63 [95% CI 0.42-0.96]) than those from the former East Germany. Participants with no information on income were more likely to refuse consent to both data sources compared to the reference group (net income: under EUR 1000; OR 0.15 [95% CI 0.08-0.30]). Respondents with two (OR 1.37 [95% CI 1.06-1.77]) or three and more diseases (OR 1.30 [95% CI 1.02-1.66]) diagnosed by a doctor agreed more frequently to linking both data sources than participants without disease. There is just a small proportion of variance in consenting explained by the models (R2: 0.063-0.085). Also, only small changes of factors' prevalence were observed in consenters. CONCLUSIONS: For the first time in Germany, the lidA-study links primary survey data with health claims and administrative employment data. We conclude that there is only a minor relation between the analysed factors and consent behaviour of the participants. A linked data set may be used in further analyses without substantial biases.

Pharmacokinetics of Anidulafungin in Critically Ill Intensive Care Unit Patients with Suspected or Proven Invasive Fungal Infections.

Echinocandins, such as anidulafungin, are the first-line treatment for candidemia or invasive candidiasis in critically ill patients. There are conflicting data on the pharmacokinetic properties of anidulafungin in intensive care unit (ICU) patients. Adult ICU patients (from 3 hospitals) receiving anidulafungin for suspected or proven fungal infections were included in the present study. Patients were considered evaluable if a pharmacokinetic curve for day 3 could be completed. Twenty-three of 36 patients (7 female and 16 male) were evaluable. The median (range) age and body weight were 66 (28 to 88) years and 76 (50 to 115) kg, respectively. Pharmacokinetic sampling on day 3 (n = 23) resulted in a median anidulafungin area under the concentration-time curve from 0 to 24 h (AUC0-24) of 72.1 (interquartile range [IQR], 61.3 to 94.0) mg · h · liter-1, a median daily trough concentration (C24) of 2.2 (IQR, 1.9 to 2.9) mg/liter, a median maximum concentration of drug in serum (Cmax) of 5.3 (IQR, 4.1 to 6.0) mg/liter, a median volume of distribution (V) of 46.0 (IQR, 32.2 to 60.2) liters, and a median clearance (CL) of 1.4 (IQR, 1.1 to 1.6) liters · h-1 Pharmacokinetic sampling on day 7 (n = 13) resulted in a median AUC0-24 of 82.7 (IQR, 73.0 to 129.5) mg · h · liter-1, a median minimum concentration of drug in serum (Cmin) of 2.8 (IQR, 2.2 to 4.2) mg/liter, a median Cmax of 5.9 (IQR, 4.6 to 8.0) mg/liter, a median V of 39.7 (IQR, 32.2 to 54.4) liters, and a median CL of 1.2 (IQR, 0.8 to 1.4) liters · h-1 The geometric mean ratio for the AUCday7/AUCday3 term was 1.13 (90% confidence interval [CI], 1.03 to 1.25). The exposure in the ICU patient population was in accordance with previous reports on anidulafungin pharmacokinetics in ICU patients but was lower than that for healthy volunteers or other patient populations. Larger cohorts of patients or pooled data analyses are necessary to retrieve relevant covariates. (This study has been registered at ClinicalTrials.gov under identifier NCT01438216.).

A Consensus German Reporting Standard for Secondary Data Analyses, Version 2 (STROSA-STandardisierte BerichtsROutine für SekundärdatenAnalysen).

Although secondary data analyses have been established in recent years in health research, explicit recommendations for standardized, transparent and complete reporting of secondary data analyses do not exist as yet. Therefore, between 2009 and 2014, a first proposal for a specific reporting standard for secondary data analysis was developed (STROSA 1). Parallel to this national process in Germany, an international reporting standard for routine data analysis was initiated in 2013 (RECORD). Nevertheless, because of the specific characteristics of the German health care system as well as specific data protection requirements, the need for a specific German reporting standard for secondary data analyses became evident. Therefore, STROSA was revised and tested by a task force of 15 experts from the working group Collection and Use of Secondary Data (AGENS) of the German Society for Social Medicine and Prevention (DGSMP) and the German Society for Epidemiology (DGEpi) as well as from the working group Validation and Linkage of Secondary Data of the German Network for Health Services Research (DNVF). The consensus STROSA-2 checklist includes 27 criteria, which should be met in the reporting of secondary data analysis from Germany. The criteria have been illustrated and clarified with specific explanations and examples of good practice. The STROSA reporting standard aims at stimulating a wider scientific discussion on the practicability and completeness of the checklist. After further discussions and possibly resulting modifications, STROSA shall be implemented as a reporting standard for secondary data analyses from Germany. This will guarantee standardized and complete information on secondary data analyses enabling assessment of their internal and external validity.

Long-Term Protection against Diphtheria in the Netherlands after 50 Years of Vaccination: Results from a Seroepidemiological Study.

BACKGROUND AND AIMS: To evaluate the National Immunisation Programme (NIP) a population-based cross-sectional seroepidemiological study was performed in the Netherlands. We assessed diphtheria antitoxin levels in the general Dutch population and in low vaccination coverage (LVC) areas where a relatively high proportion of orthodox Protestants live who decline vaccination based on religious grounds. Results were compared with a nationwide seroepidemiological study performed 11 years earlier. METHODS: In 2006/2007 a national serum bank was established. Blood samples were tested for diphtheria antitoxin IgG concentrations using a multiplex immunoassay for 6383 participants from the national sample (NS) and 1518 participants from LVC municipalities. A cut-off above 0.01 international units per ml (IU/ml) was used as minimum protective level. RESULTS: In the NS 91% of the population had antibody levels above 0.01 IU/ml compared to 88% in the 1995/1996 serosurvey (p<0.05). On average, 82% (vs. 78% in the 1995/1996 serosurvey, p<0.05) of individuals from the NS born before introduction of diphtheria vaccination in the NIP and 46% (vs. 37% in the 1995/1996 serosurvey, p = 0.11) of orthodox Protestants living in LVC areas had antibody levels above 0.01 IU/ml. Linear regression analysis among fully immunized individuals (six vaccinations) without evidence of revaccination indicated a continuous decline in antibodies in both serosurveys, but geometric mean antibodies remained well above 0.01 IU/ml in all age groups. CONCLUSIONS: The NIP provides long-term protection against diphtheria, although antibody levels decline after vaccination. As a result of natural waning immunity, a substantial proportion of individuals born before introduction of diphtheria vaccination in the NIP lack adequate levels of diphtheria antibodies. Susceptibility due to lack of vaccination is highest among strictly orthodox Protestants. The potential risk of spread of diphtheria within the geographically clustered orthodox Protestant community after introduction in the Netherlands has not disappeared, despite national long-term high vaccination coverage.

[Association of hand grip strength with subjective health and work ability. results of the baseline survey of the lidA study]. / Assoziation der Handgreifkraft mit subjektiver Gesundheit und Arbeitsfähigkeit. Ergebnisse der Baseline-Erhebung der lidA-Studie.

AIM: In the BMBF-funded lidA study - leben in der Arbeit - hand grip strength is taken as an objective measure for describing the health of the study population. The aim is to analyse the association of grip strength with characteristics of subjective health and work ability. METHODS: During the 1(st) investigation in 2011 there were 6 585 interviews with employed persons born in 1959 and 1965 and subject to social insurance contributions. The survey included aspects of employment and health. The maximum isometric hand grip strength was determined with a dynamometer from a series of 4 measurements. The examination refers to 6 195 employed persons who approved the realisation of the grip strength test. The determinants of grip strength are analysed bivariately based on non-parametric methods and examined concerning their relative importance using a multiple linear regression. RESULTS: In the descriptive analyses statistically significant median differences (p<0.05) appear between men and women as well as persons of the younger and older cohort. After excluding implausible values some statistically significant differences in grip strength can be observed between the categories of current health condition, physical and mental work ability and the number of pain localisations. The trend for the larger grip strength occurrences can be noted in the categories of better health and work ability plus a smaller number of pain localisations. From the combined analysis of the explanatory variables of age, BMI, health and work ability within the estimated regression model results a corrected R² of 0.036 for men or, respectively, 0.05 for women. CONCLUSION: Between the categories of selected health and work ability related variables some statistically significant differences of grip strength (± 0.0-4.0 kg) were observed. However, the variability of grip strength cannot be explained sufficiently by the data used. Although the results obtained support the preliminary assumptions, the relevance of this matter could not be resolved adequately with the data under consideration. Given that analysing grip strength is important in the individual temporal process, the results will be extended by longitudinal analyses to facilitate the analysis of hand grip strength as predictor of the development of individual health.

[Data linkage - respondents consent without selectivity?]. / Zustimmung von Befragten zur Verknüpfung von Daten - selektionsfrei?

OBJECTIVE: The lidA Study is designed as a longitudinal survey. The respondent's consent is mandatory for storing sample data. Moreover, the survey data shall be linked with social security data of the Federal Employment Agency and individual's health insurance claims data in case of the respondent's written consent. This essay pursues the issue of whether this methodologically challenging objective of obtaining 3 consents within one study could be met without any selectivity. METHODOLOGY: The data basis is a cohort study with 2 cohorts of a representative sample of employed individuals subject to social security contributions. The sample was interviewed for the first time in 2011. The analysis dataset comprises 6 585 respondents. RESULTS: Selectivity analyses prove that the realisation of the first measurement's sample turned out to be representative as well as unbiased. As expected, more respondents stated their willingness to remain in the panel and also consented to linkage of social security data than those who consented to linkage of health insurance claims data. All 3 consents were given without resulting in any bias. Even linking all 3 consents does result in minimal effects of a few subgroups only. CONCLUSION: A significant number of respondents can be motivated to participate due to proper placement of the questions concerning consent and the provision of insight into the use of the data.

[Good Practice of Secondary Data Analysis (GPS): guidelines and recommendations]. / Gute Praxis Sekundärdatenanalyse (GPS): Leitlinien und Empfehlungen.

In 2005, the Working Group for the Survey and Utilisation of Secondary Data (AGENS) of the German Society for Social Medicine and Prevention (DGSMP) and the German Society for Epidemiology (DGEpi) first published "Good Practice in Secondary Data Analysis (GPS)" formulating a standard for conducting secondary data analyses. GPS is intended as a guide for planning and conducting analyses and can provide a basis for contracts between data owners. The domain of these guidelines does not only include data routinely gathered by statutory health insurance funds and further statutory social insurance funds, but all forms of secondary data. The 11 guidelines range from ethical principles and study planning through quality assurance measures and data preparation to data privacy, contractual conditions and responsible communication of analytical results. They are complemented by explanations and practical assistance in the form of recommendations. GPS targets all persons directing their attention to secondary data, their analysis and interpretation from a scientific point of view and by employing scientific methods. This includes data owners. Furthermore, GPS is suitable to assess scientific publications regarding their quality by authors, referees and readers. In 2008, the first version of GPS was evaluated and revised by members of AGENS and the Epidemiological Methods Working Group of DGEpi, DGSMP and GMDS including other epidemiological experts and had then been accredited as implementation regulations of Good Epidemiological Practice (GEP). Since 2012, this third version of GPS is on hand and available for downloading from the DGEpi website at no charge. Especially linguistic specifications have been integrated into the current revision; its internal consistency was increased. With regards to contents, further recommendations concerning the guideline on data privacy have been added. On the basis of future developments in science and data privacy, further revisions will follow.

[Individual linkage of primary data with secondary and registry data within large cohort studies - capabilities and procedural proposals]. / Individuelle Datenverknüpfung von Primärdaten mit Sekundär- und Registerdaten in Kohortenstudien: Potenziale und Verfahrensvorschläge.

Some German cohort studies have already linked secondary and registry data with primary data from interviews and medical examinations. This offers the opportunity to obtain more valid information by taking advantage of the strengths of these data synergistically and overcome their individual weaknesses at the same time. The potential and the requirements for linking secondary and registry data with primary data from cohort studies is described generally and illustrated by the example of the "German National Cohort" (GNC). The transfer and usage of secondary and registry data require that administrative and logistic efforts be made over the whole study period. In addition, rigid data protection regulations for using social data have to be observed. The particular strengths of secondary and registry data, namely their objectivity and independence from recall bias, add to the strengths of newly collected primary data and improve the assessment of morbidity endpoints, exposure history and need of patient care. Moreover, new insights on quality and on the added value of linking different data sources may be obtained.