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.

[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.

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.).

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.

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.

[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.

[The significance of a large number of health insurance funds and fusions for health services research with statutory health insurance data in Germany - experiences of the lidA study]. / Viele Krankenkassen, Fusionen und deren Bedeutung für die Versorgungsforschung mit Daten der Gesetzlichen Krankenversicherung in Deutschland - Erfahrungen aus der lidA-(leben in der Arbeit)-Studie.

Since 1970 the health insurance system in Germany has shrunk by more than 90% to 132 statutory health insurance funds (SHI) at present. For studies using data from different SHI, this development means a reduction of contacts and a higher workload when requesting data. The latter is due to the fact that fusions bind resources in the health insurance funds. In order to avoid selection in studies among the insured, all SHI must be contacted. Additionally, 15 controlling institutions on the state and national level have to agree as determined in § 75 of the German Social Code number 10. The lidA study - a German cohort study on work, age and health intends to link primary and secondary data from all SHI of those insured who have given their agreement for participation. Since the beginning of the study in 2009 the number of SHI has been reduced by 70. Of the 6 585 interviews in 2011 approximately half of the interviewees agreed in written form that their individual health insurance data can be linked. This portion of the insured is dispersed among 95 SHI. At this point, 11 contracts with SHI are realised (approximately 50% of the insured) and 8 data controlling authorities have been contacted. The problems involved in the fusion of SHI and its meaning for research are explained in this article. The fusion of SHI makes sense for the long term. It will lead to a reduction of contacts and contracts that researchers have to establish in order to analyse the data. Therefore, this article also discusses the alternative of creating a meta-data set of all the data from the different SHI combined.

[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.

[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.

[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.

[Analysis of extent and quality of treatment of arthrosis patients based on routine data from German statutory health insurance]. / Analyse von Versorgungsumfang und -qualität bei Arthrosepatienten anhand von GKV-Routinedaten.

BACKGROUND: In an epidemiological context arthrosis is becoming more important due to demographic changes. This study describes the routine medical treatment of patients with arthrosis. METHODS: Claims data of a German statutory health insurance fund for the period from 2005 to 2008 were analyzed. All insured patients aged 60 years and older residing in Kinzigtal were included. In detail all 1,551 insured persons with a validated ambulatory diagnosis of gonarthrosis or coxarthrosis (ICD-10: M16/M17) were analyzed. RESULTS: The treatment prevalence of arthrosis documented by practice-based physicians rose from 14 % (60-69 years old) to 25 % (80 years and older). At least one hospital admission between 2006 and 2008 was documented for two thirds of the patients whereby 86 and 95 patients were admitted because of coxarthrosis or gonarthrosis, respectively. A total of 112 and 96 insured patients received an implantation or revision of an endoprosthesis of the hip or knee, respectively. The need for nursing care did not decrease in cases of surgical compared to conservative treatment. CONCLUSION: Claims data allow a differentiated analysis of medical treatment and quality of care as well as a comparison of alternatives of medical care for patients with arthrosis. Results of such analyses can be used to identify patients with increased vulnerability.

[Data linkage of primary and secondary data: a gain for small-area health-care analysis?]. / Datenlinkage von Primär- und Sekundärdaten : Ein Zugewinn auch für die kleinräumige Versorgungsforschung in Deutschland?

In Germany, research on health-care services addresses many topics within a regional context, and it predominantly uses a single (typically secondary) data sources for this purpose. The specific disadvantages and methodological challenges associated with these data sources may limit analysis. Various data sources break the data down by region and may be of interest in regional health-care research. Linking multiple data sources (data linkage) could therefore expand analysis options in this area. Researchers in this field are currently discussing various approaches for using data linkage to overcome the respective weaknesses of primary and secondary data. This contribution covers the various types of data linkage (on an aggregate or individual level) and their potentials and limitations in small area health services research. The focus lies on individual data linkage, which requires written informed consent. Taking into account methodological and particularly data protection challenges, conclusions are drawn regarding future application areas and options of small area health services research and specific examples are provided.

[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.

[Outcome evaluation of a health promotion among the elderly]. / Ergebnis-Evaluation einer Gesundheitsförderungsmaßnahme für ältere Menschen.

The programme "active health promotion in old age" focuses on responsible self determination in old age (empowerment) and places special emphasis on physical activity and nutrition. The intervention, successfully conducted in an urban setting (Hamburg), was tested in a rural area (Kinzigtal, Baden-Wuerttemberg). In this paper we present the results of the outcome evaluation. The intervention group consisted of older people, without care need and without cognitive impairment who lived in their own home (N=468). For the evaluation of the results a pre-post comparison was conducted (2 measuring points within an interval of 12 months). 4 out of 5 participants reported changes in their behaviour after the intervention. However, the pre-post comparison shows significant changes only for nutrition behaviour, but not of physical activity. Health related quality of life (SF-36) did not change after 12 months. These findings indicate that health promotion in old age may lead to changes in nutrition behaviour.

[Patient safety culture - knowledge and knowledge needs of medical students]. / Patientensicherheitskultur - Wissen und Wissensbedarf bei Medizinstudenten.

INTRODUCTION: Ten years after the publication of "To Err is Human" in November1999, the development of patient safety efforts has been summa-rised in the statement "Ten years later, a million lives lost, billions of dollars wasted." This leads to the question why, despite evidence-based mea-sures for greater patient safety, they are not implemented or only implemented on a small scale. One approach to promote patient safety is the implementation of a safety culture. Such a safety culture is based on knowledge of employees about safe behaviour and their willingness to implement it. In this context it is interesting to explore the knowledge and the needs of medical students concerning patient safety. MATERIAL AND METHODS: At the University of -Magdeburg 354 medical students in their clinical semesters were asked about their knowledge of specific recommendations on patient safety and about their attitude to patient safety and risk man-agement as well as their subjective need for knowledge on this subject. RESULTS: Only 16.7 % of the PJ (practical year) students and 11.7 % of students in all other clinical semester indicated to know the recommenda-tions for patient safety. This correlated with the answers to questions about single recommenda-tions. The importance of risk management during medical education was considered to be important by 53.3 % of the students of all clinical semesters and in particular 80.6 % of the surveyed PJ students. The answers to most questions showed a high demand for general information on patient safety. This is seen throughout all questions, especially with increasing clinical experience, and the need for information on single recommendations, such as critical incident reporting systems (CIRS), or Team Time Out. DISCUSSION: The establishment of a safety culture is described as a useful way to fewer patient injuries. This includes knowledge on recommendations for patient safety, which may contribute to the implementation of a safety culture to reduce medical errors. Our survey shows the necessity need for information on patient safety and the students desire to acquire this knowledge. Specific courses on patient safety in first-year student education and then continuing in the post-university training seems to be the right way for an improved safety culture and fewer patient injuries, which should be further evaluated.

[Methodological considerations for data linkage of primary and secondary data in occupational epidemiology studies]. / Methodische Überlegungen für das Datenlinkage von Primär- und Sekundärdaten im Rahmen arbeitsepidemiologischer Studien.

Within the scope of an aging population, the topic age, work and health becomes more and more important. So far, research in occupational epidemiology utilizes various primary or secondary data sources. However, data linkage has rarely been used as an instrument in this field. The study presented here combines two large databases within a so-called "age-work matrix", stratified by sex, age group and occupational group. This matrix is based on the German classification of occupations and uses its occupation codes as a key variable. The first database is the representative BIBB/BAuA employment survey for employees of all occupations in Germany 2005/06. The second database consists in sickness absence data of the insurees of a German statutory health insurance fund. Using the matrix approach, the study investigates associations of reported subjectively perceived psychosocial work strains and health impairments provided by health insurance claims data. These claims data offer sickness absence data as an indicator for health impairments. Usability of sickness absence data for studies in occupational epidemiology, their methodological challenges and the solutions realized in this study are discussed.

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.

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.