Reflections on the OECD guidelines for in vitro skin absorption studies.

At the 8th conference of Occupational and Environmental Exposure of the Skin to Chemicals (OEESC) (16-18 September 2019) in Dublin, Ireland, several researchers performing skin permeation assays convened to discuss in vitro skin permeability experiments. We, along with other colleagues, all of us hands-on skin permeation researchers, present here the results from our discussions on the available OECD guidelines. The discussions were especially focused on three OECD skin absorption documents, including a recent revision of one: i) OECD Guidance Document 28 (GD28) for the conduct of skin absorption studies (OECD, 2004), ii) Test Guideline 428 (TGD428) for measuring skin absorption of chemical in vitro (OECD, 2004), and iii) OECD Guidance Notes 156 (GN156) on dermal absorption issued in 2011 (OECD, 2011). GN156 (OECD, 2019) is currently under review but not finalized. A mutual concern was that these guidance documents do not comprehensively address methodological issues or the performance of the test, which might be partially due to the years needed to finalize and update OECD documents with new skin research evidence. Here, we summarize the numerous factors that can influence skin permeation and its measurement, and where guidance on several of these are omitted and often not discussed in published articles. We propose several improvements of these guidelines, which would contribute in harmonizing future in vitro skin permeation experiments.

Ongoing MRI remodeling 3-7 years after collagen meniscus implantation in stable knees.

PURPOSE: The purpose of the present study was to evaluate the clinical and radiological 3-7 years outcomes of patients who underwent collagen meniscus implantation in stable or stabilized knees. It was the hypothesis that using the collagen meniscus (CMI) good clinical 3-7 years outcomes with low pain levels are achieved. METHODS: Thirty-nine patients (male:female = 30:9, mean age 34 ± 10 years) underwent arthroscopic CMI after subtotal medial (n = 32) or lateral meniscectomy (n = 7). A 7-mm CMI was performed due to prophylactic (n = 25) or therapeutic indication (n = 14). IKDC score, Tegner score preinjury, preoperatively and at follow-up, Lysholm score and visual analogue scale for pain and satisfaction (follow-up rate 90%) were assessed. MRI scans were analyzed according to the Genovese criteria (n = 19). Implant failure was defined as infection or mechanical failure of the device. The minimum follow-up time was 36 months (range 36-84 months). RESULTS: The mean VAS satisfaction preoperatively and at follow-up was 4.0 ± 0 and 1.6 ± 1.0. The mean VAS pain was 4.3 ± 3.2 preoperatively and at last follow-up 2.1 ± 1.7. The median Tegner score preinjury was 7 (range 3-10), it decreased preoperatively to median 3.5 (range 1-8) and nearly reached the preinjury level at last follow-up 6 (range 3-10). The mean Lysholm score before surgery was 66 ± 20 and 91 ± 8 at last follow-up. Seven patients (38.9%) had a normal total IKDC score (A), 10 patients were nearly normal (B) and 1 patient slightly abnormal (C). In MRI the CMI was entirely resorbed in 4 patients (21%) and partially resorbed in 15 (79%). In 4 patients (21%) the CMI was isointense, in 14 (74%) slightly hyperintense and in 1 (5%) highly hyperintense. Ten patients (53%) showed marked signs of bone marrow edema. In 13 patients (68%) an extrusion of the meniscus > 3 mm at last follow-up was found. CONCLUSIONS: Meniscal substitution with the CMI showed good to excellent clinical 3-7 results. The CMI shows an ongoing remodelling with decreased signal intensity and decreased size. However, as meniscus extrusion remained at the same level and bone marrow edema decreased from 1 year to longer term follow-up, it appears that the remodeling comes to an end at about 5 years after CMI. LEVEL OF EVIDENCE: IV.

[Empirical health services research in emergency and acute medicine : Preliminary results of concomitant monitoring of patient recruitment and sample quality]. / Empirische Versorgungsforschung in der Notfall- und Akutmedizin : Erste Ergebnisse eines begleitenden Monitorings zur Patientenrekrutierung und Stichprobenqualität.

BACKGROUND: Up until now, research data on the implementation of empirical health services research in emergency departments in Germany are scarce. STUDY AIM: A monitoring instrument applied in a multicenter prospective cohort study in emergency departments (EDs) is described and discussed regarding requirements for the control and supervision of data collection. MATERIALS AND METHODS: Patients with cardiac diseases, respiratory tract infections, and hip fractures were recruited in eight EDs located in a central district of Berlin. Enrolment figures and nonresponder reasons were analyzed through descriptive statistics. Potential sample bias was examined in terms of response rates as well as the distribution of age and sex in the group of participants and nonresponders. Qualitative content analysis was applied to data from routine supervisory and feedback meetings with study nurses. RESULTS: Within the first 8 months of data collection, 61.1% of the aimed 1104 patients were recruited. Most frequently stated nonresponder reasons were the dense work and care processes in EDs (41.9%) and patients' disease burden (24.7%). Moreover, qualitative results revealed problems with identifying potentially eligible participants and difficulties because of missing research infrastructure in study centers. The response rate of 50.7% and approximately equal distribution of age and sex in participants and nonresponders do not indicate sample biases. DISCUSSION: The monitoring instrument has proven to be suited for empirical research in EDs and revealed optimization potential. We recommend using qualitative and quantitative data systematically.

The Genovese grading scale is not reliable for MR assessment of collagen meniscus implants.

BACKGROUND: The purpose of the study was to evaluate the intra- and inter-observer reliabilities of the Genovese grading on MRI in patients after collagen meniscus substitution. METHODS: 84 MRI images of 74 consecutive patients who underwent partial meniscus substitution using collagen meniscus implant (CMI) were assessed. MRIs were evaluated using the Genovese grading system. Furthermore, meniscal extrusion was assessed. Two observers performed the grading twice, blinded to each other and to the previous results, with a six weeks interval. The inter- and intra-observer reliabilities were assessed using kappa and weighted kappa values. RESULTS: The criterion "morphology/size" showed a weighted kappa value inter-observer reliability of 0.069 (rater 1)/0.352 (rater 2) and intra-observer reliability of 0.170 (1st rating)/0.582 (2nd rating). The criterion "signal intensity" showed a weighted kappa value inter-observer reliability of 0.175/0.284 and intra-observer reliability of 0.294/0.458. The criterion "cartilage lesions" showed a kappa value inter-observer reliability of 0.091/0.525 and intra-observer reliability of 0.409/0.413. The criterion "bone marrow edema" showed a kappa value inter-observer reliability of 0.667/0.808 and intra-observer reliability of 0.702/0.715. The criterion "cartilage lesions" showed a kappa value inter-observer reliability of 0.091/0.525 and intra-observer reliability of 0.409/0.413. Regarding meniscal extrusion kappa values for the inter-observer reliability were 0.625/0.940 and 0.625/0.889 for intra-observer reliability. CONCLUSIONS: Three of the four Genovese grading items showed only slight to moderate inter- and intra-observer reliabilities in evaluating CMI on MRI. Hence, such grading results need to be considered with all due care. Only the criteria "bone marrow edema" and "meniscal extrusion" showed a good agreement for both inter- and intra-observer reliabilities.

Early intervention of patients at risk for acute respiratory failure and prolonged mechanical ventilation with a checklist aimed at the prevention of organ failure: protocol for a pragmatic stepped-wedged cluster trial of PROOFCheck.

INTRODUCTION: Acute respiratory failure (ARF) often presents and progresses outside of the intensive care unit. However, recognition and treatment of acute critical illness is often delayed with inconsistent adherence to evidence-based care known to decrease the duration of mechanical ventilation (MV) and complications of critical illness. The goal of this trial is to determine whether the implementation of an electronic medical record-based early alert for progressive respiratory failure coupled with a checklist to promote early compliance to best practice in respiratory failure can improve the outcomes of patients at risk for prolonged respiratory failure and death. METHODS AND ANALYSIS: A pragmatic stepped-wedged cluster clinical trial involving 6 hospitals is planned. The study will include adult hospitalised patients identified as high risk for MV >48 hours or death because they were mechanically ventilated outside of the operating room or they were identified as high risk for ARF on the Accurate Prediction of PROlonged VEntilation (APPROVE) score. Patients with advanced directives limiting intubation will be excluded. The intervention will consist of (1) automated identification and notification of clinician of high-risk patients by APPROVE or by invasive MV and (2) checklist of evidence-based practices in ARF (Prevention of Organ Failure Checklist-PROOFCheck). APPROVE and PROOFCheck will be developed in the pretrial period. Primary outcome is hospital mortality. Secondary outcomes include length of stay, ventilator and organ failure-free days and 6-month and 12-month mortality. Predefined subgroup analysis of patients with limitation of aggressive care after study entry is planned. Generalised estimating equations will be used to compare patients in the intervention phase with the control phase, adjusting for clustering within hospitals and time. ETHICS AND DISSEMINATION: The study was approved by the institutional review boards. Results will be published in peer-reviewed journals and presented at international meetings. TRIAL REGISTRATION NUMBER: NCT02488174.

The placebo effect: From concepts to genes.

Despite its initial treatment as a nuisance variable, the placebo effect is now recognized as a powerful determinant of health across many different diseases and encounters. This is in light of some remarkable findings ranging from demonstrations that the placebo effect significantly modulates the response to active treatments in conditions such as pain, anxiety, Parkinson's disease, and some surgical procedures. Here, we review pioneering studies and recent advances in behavioral, neurobiological, and genetic influences on the placebo effect. Consistent with recent conceptualizations, the placebo effect is presented as the product of a general expectancy learning mechanism in which verbal, conditioned, and social cues are centrally integrated to change behaviors and outcomes. Examples of the integration of verbal and conditioned cues, such as instructed reversal of placebo effects are also incorporated into this model. We discuss neuroimaging studies that have identified key brain regions and modulatory mechanisms underlying placebo effects using well-established behavioral paradigms. Finally, we present a synthesis of recent genetics studies on the placebo effect, highlighting a promising link between genetic variants in the dopamine, opioid, serotonin, and endocannabinoid pathways and placebo responsiveness. Greater understanding of the behavioral, neurobiological, and genetic influences on the placebo effect is critical for evaluating medical interventions and may allow health professionals to tailor and personalize interventions in order to maximize treatment outcomes in clinical settings.

The Hippo pathway is controlled by Angiotensin II signaling and its reactivation induces apoptosis in podocytes.

The Hippo pathway fulfills a crucial function in controlling the balance between proliferation, differentiation and apoptosis in cells. Recent studies showed that G protein-coupled receptors (GPCRs) serve as upstream regulators of Hippo signaling, that either activate or inactivate the Hippo pathway via the large tumor suppressor kinase (LATS) and its substrate, the co-transcription factor Yes-associated protein (YAP). In this study, we focused on the Angiotensin II type 1 receptor (AT1R), which belongs to the GPCR family and has an essential role in the control of blood pressure and water homeostasis. We found that Angiotensin II (Ang II) inactivates the pathway by decreasing the activity of LATS kinase; therefore, leading to an enhanced nuclear shuttling of unphosphorylated YAP in HEK293T cells. This shuttling of YAP is actin-dependent as disruption of the actin cytoskeleton inhibited dephosphorylation of LATS and YAP. Interestingly, in contrast to HEK293T cells, podocytes, which are a crucial component of the glomerular filtration barrier, display a predominant nuclear YAP localization in vivo and in vitro. Moreover, stimulation with Ang II did not alter Hippo pathway activity in podocytes, which show a deactivated pathway. Reactivation of the LATS kinase activity in podocytes resulted in an increased cytoplasmic YAP localization accompanied by a strong induction of apoptosis. Thus, our work indicates that the control of LATS activation and subsequent YAP localization is important for podocyte homeostasis and survival.

[Stroke occurence in Germany - on the comparability of insurance data and registry-based data]. / Schlaganfallgeschehen in Deutschland - Zur Vergleichbarkeit von Krankenkassen-, Register- und DRG-Daten.

PURPOSE: This article presents epidemiological data regarding stroke frequency in Germany based on nationwide statutory health insurance data (Deutsche BKK) and aims to analyse them in the context of current research. The comparability of the most important resources of stroke frequency data - stroke registers, DRG data and insurance data - is initially discussed in order to assess the presented data adequately. METHODS: The study cohort comes from a population of about 1 000 000 people insured with BKK and consists of all persons who were treated for a stroke in an acute care hospital in 2007 (n = 4,843). Data were subjected to statistical secondary analysis including uni- and bivariate statistics and t tests. Reference studies for the observation period include data from GEK and AOK health insurances, from quality assurances Hessen and Bayern, from the ADSR, and hospital DRG data. The different study types are compared regarding their inclusion/exclusion criteria and the resulting effects on reported prevalences. RESULTS: Different inclusion criteria and accordingly different operationalisations of "stroke" impede the comparability of existing German data resources regarding stroke. The inclusion of TIA, non-traumatic subdural haemorrhage (I62), and the frequency of unspecified strokes (I64) is especially inconsistent. In addition, recurrent strokes and the definition of first-ever strokes are treated differently. The study cohort reveals no major discrepancies regarding aetiological subgroups compared to previous results, only the percentage of women (60.3 %) seems exceptionally high. CONCLUSIONS: The gender effect is attributed to the BKK member structure, and especially the high proportion of women in the older age groups. Discussion of stroke frequency in Germany needs to take structural differences between study types into account. There are two vulnerable groups that tend to be underrepresented: TIA patients with a high risk of recurrent strokes, and high-risk patients who have already had a stroke and are care-dependent, which are often unspecifically coded. In the future, study designs should include the whole range of stroke coding, thus enabling differentiated analyses.

Genetic effects on information processing speed are moderated by age--converging results from three samples.

Information processing is a cognitive trait forming the basis of complex abilities like executive function. The Trail Making Test (TMT) is a well-established test of information processing with moderate to high heritability. Age of the individual also plays an important role. A number of genetic association studies with the TMT have been performed, which, however, did not consider age as a moderating factor. We report the results of genome-wide association studies (GWASs) on age-independent and age-dependent TMT performance in two population-representative community samples (Munich Antidepressant Response Signature, MARS: N1 = 540; Ludwig Maximilians University, LMU: N2 = 350). Age-dependent genome-wide findings were then evaluated in a third sample of healthy elderly subjects (Sydney Memory and Ageing Study, Sydney MAS: N3 = 448). While a meta-analysis on the GWAS findings did not reveal age-independent TMT associations withstanding correction for multiple testing, we found a genome-wide significant age-moderated effect between variants in the DSG1 gene region and TMT-A performance predominantly reflecting visual processing speed (rs2199301, P(meta-analysis) = 1.3 × 10(-7)). The direction of the interaction suggests for the minor allele a beneficial effect in younger adults turning into a detrimental effect in older adults. The detrimental effect of the missense single nucleotide polymorphism rs1426310 within the same DSG1 gene region could be replicated in Sydney MAS participants aged 70-79, but not in those aged 80 years and older, presumably a result of survivor bias. Our findings demonstrate opposing effects of DSG1 variants on information processing speed depending on age, which might be related to the complex processes that DSG1 is involved with, including cell adhesion and apoptosis.

[Physio- and occupational therapy pathways of stroke patients and stroke mortality]. / Physio- und ergotherapeutische Versorgungsverläufe und Mortalität im ersten Jahr nach Schlaganfall.

AIMS: This study examines the relationship between adherence to clinical guidelines and survival time in the first year after stroke. METHODS: The sample comprises all clients of the Deutsche BKK, a large German health insurance company, who received acute inpatient care for stroke in 2007, who survived the hospital stay by at least 14 days, and who had motor deficits at the end of their acute treatment (n=1 791). 3 types of treatment that differ in the degree of adherence to clinical guidelines are identified ("Frühreha-Plus">"Standard-Plus">"Nur Akut"). RESULTS: There is a positive relationship between adherence to clinical guidelines and survival time, even when relevant covariates are controlled. The hazard-ratios are 0.49 for "Frühreha-Plus" and 0.65 for "Standard-Plus" compared to "Nur Akut". CONCLUSIONS: Healthcare processes should be organized on the basis of cross-sector collaboration and in line with the recommendations of the guidelines.

[A cross-sectorial analysis of physio and occupational therapy pathways after stroke]. / Physio- und ergotherapeutische Versorgungsverläufe bei Schlaganfallbetroffenen - von der Akut- über die Rehabilitationsbehandlung bis zur ambulanten Heilmittelversorgung.

PURPOSE: This article examines the provision of physiotherapy and occupational therapy for stroke patients from a cross-sectorial perspective, from acute to rehabilitative care to outpatient services. METHODS: The sample comprises all clients of the Deutsche BKK, a large German health insurance company, who received acute care for stroke in 2007, who survived the initial hospital stay, and who had a secondary diagnosis of motor deficits (n = 1 929). RESULTS: For 60.4% of these stroke patients, no further treatment was provided after acute care. The odds of receiving early rehabilitation treatment while in hospital stay decreased by 1% with each year of life. Only 18.8% of patients received a form of treatment that was largely in line with current recommendations for stroke care, beginning with early rehabilitation and including further treatment in the context of rehabilitation measures or outpatient care. Patients who were in long-term nursing care before stroke were at increased risk of not being placed on this treatment pathway, which has been positively evaluated. 20.7% of patients did not receive any early rehabilitation treatment, but received further rehabilitation treatment and/or outpatient services after hospital discharge. CONCLUSIONS: We recommend that receipt of long-term nursing care should routinely be regarded as a risk factor for underprovision of treatment after stroke (yellow flag).

[Privacy: a most important dimension for the quality of life of nursing home residents]. / Die Intimsphäre : Eine wichtige Dimension der Lebensqualität von Pflegeheimbewohnern.

BACKGROUND: A fundamental aim of social science and for practitioners is the improvement of the quality of life of inpatients residing in long-term care homes. This research aims to determine aspects of their privacy in the context of quality of life from the residents' perspective, which has long been neglected. MATERIALS AND METHOD: A total of 42 narrative interviews with nursing home residents were conducted and analyzed using the documentary method. RESULTS: Four dimensions of privacy were identified. Intimate areas concern personal hygiene and toilet matters, non-intimate areas included mainly eating and the residents' private living area. Violations of privacy are associated with unpleasant feelings such as shame and disgust and are often subject to taboos. Respondents tended to be more open to talk about taboo subjects the less the topic referred to their own body. CONCLUSION: Privacy is perceived as a significant aspect of the respondents' quality of life. To be able to address inhibition thresholds and shameful topics, a good relationship between patient and personnel is required. This postulates that the caregivers are also aware of their own inhibition threshold and negative feelings.

One-year clinical and MR imaging outcome after partial meniscal replacement in stabilized knees using a collagen meniscus implant.

PURPOSE: The purpose of the study was to evaluate the clinical and radiological outcomes after medial/lateral collagen meniscus substitution (CMI) at 12 months postoperatively. METHODS: Sixty-seven patients (m:f = 47:20, mean age 36 ± 10 years) underwent arthroscopic CMI after previous subtotal medial (n = 55) or lateral meniscectomy (n = 12) due to persistent joint line pain (n = 25) or to prophylactic reasons (n = 42). Clinical follow-up consisted of IKDC score, Tegner score, Lysholm score, and visual analog scale for pain and satisfaction (preinjury, preoperatively, and 12 months postoperatively; follow-up rate 90 %). MRI scans were analyzed according to the Genovese criteria. RESULTS: Nineteen patients (29 %) showed a normal (A), 35 nearly normal (B), 5 abnormal (C), and 1 patient severely abnormal total IKDC score (D). The median Tegner preinjury score was 7 (range 2-10) and at follow-up 6 (range 2-10). The mean Lysholm score before surgery was 68 ± 20 and 93 ± 9 at follow-up. Preoperatively, the mean VAS pain was 4.4 ± 3.1 and 2.0 ± 1.0 at follow-up. Clinical failure of the CMI occurred in 3 patients (n = 1 infection, n = 1 failure of the implant, n = 1 chronic synovitis). On MRI, the CMI was completely resorbed in 3 patients (5 %), partially resorbed in 55 (92 %), and entirely preserved in 3 (5 %) patients. In 5 patients (8 %) the CMI was isointense, in 54 (90 %) slightly and 1 (2 %) highly hyperintense. 43 (72 %) patients showed an extrusion of the CMI implant of more than 3 mm. CONCLUSIONS: Significant pain relief and functional improvement throughout all scores at 1 year was noted. The CMI undergoes significant remodeling, degradation, resorption, and extrusion in most of the patients. No difference in outcomes between the medial and lateral CMI was observed. LEVEL OF EVIDENCE: Prospective therapeutic study, Level IV.

[Are complaints an element for health-care monitoring? Analysis of the user statistics of the federal commissioner for patient issues between 2004 and 2007]. / Beschwerden als Baustein eines gesundheitlichen Versorgungsmonitorings? Eine Nutzeranalyse des Amtes der Bundespatientenbeauftragten für den Zeitraum 2004 bis 2007.

BACKGROUND: The inclusion of patient perceptions in the assessment of health-care quality has gained in importance in recent years. The main instruments applied for this purpose are different types of patient interviews. Complaint data have rarely been used thus far. METHODS: On the basis of 19 117 complaints and inquiries to the office of the federal government commissioner for patient issues, this article examines to what extent this data source can be systematically used in health-care research and describes which groups of persons addressed their concerns to the commissioner for patient issues between the years 2004 and 2007. In this context, an investigation is done to determine whether reported or reconstructed data on sociodemographic characteristics are sufficient for analysis. A comparison with population-wide data also indicates to what extent the results can be considered representative for the concerns of patients or insurants in Germany. The letters and inquiries were subjected to a quantitative content analysis. RESULTS: The terms "gender", "region" and "insurance status" can be consistently encoded in a high percentage of those who make complaints and inquiries. The items "age" and "employment status" can be reconstructed to a lesser degree. However, a structural comparison of "responders" and "non-responders" shows that the results from the sample with these characteristics can be generalised for all concerns addressed. Data on the education and migration background were insufficient for analysis. Compared to the general population, a disproportionately high number of older and/or retired people (EM/EU pension) as well as unemployed persons and persons from Berlin and the new federal states contact the commissioner for patient issues. However, changes over time show a successive approach to population-wide distributions. CONCLUSIONS: The results recommend this unique data source for continuous coverage. The data documentation should thus be further standardised and integrated into a complaint management system that includes all relevant complaint offices in Germany.

[Knowledge and evaluation of health-system reforms as reflected in social determinants]. / Kenntnisstand und Bewertung gesundheitspolitischer Reformen im Spiegel sozialer Determinanten.

Significant reforms have been instituted in Germany's health system in recent years. Although a number of studies have examined the population's knowledge of and attitudes towards the new regulations, little information is available on status-specific differences. This article examines the extent to which knowledge and evaluation of health policy measures is influenced by social determinants. The analysis draws on a survey conducted by the National Association of Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung, 2009) based on a sample representative of the German population. In this context, 2 032 respondents aged between 18 and 79 years were interviewed on health-care policy issues. Results of bivariate analysis and logistic regression show that knowledge of the reform measures is significantly associated with educational level, age, and nationality. For example, respondents with the lowest level of formal education have an approximately four times higher risk as those with a higher level of formal education of not knowing about the health fund, and non-Germans have around twice the risk as Germans of not knowing about the reform measures. The main difference to emerge in respondents' EVALUATION of the reform measures is between East and West Germans. West Germans are significantly more likely than East Germans to evaluate the reform measures in negative terms. These status-specific differences in respondent knowledge can be attributed at least to some extent to the information asymmetry between patients and physicians/health-care providers. There is an urgent need for policy makers and care providers to render the reform measures transparent, accessible and comprehensible - especially to disadvantaged groups - to facilitate their effective implementation and positive evaluation.

[Planning and controlling care services for elderly migrants--an analysis of health-care reporting in nursing homes and at home]. / Planung und Steuerung der Pflegeversorgung auch für Migranten und Migrantinnen?--Eine Analyse der Pflege- und Gesundheitsberichterstattung in der ambulanten und stationären Altenpflege.

Elderly migrants are a rapidly growing group in Germany. Well-grounded health and nursing care reports which deal with the situation of migrants are therefore necessary to secure an appropriate local and national planning of care for elderly migrants. Also quality control and development need substantiated data in order to ensure proper nursing care services for this segment of the population. This contribution explores whether and to what extent data sources provide information about access, quality and use of care services by migrants. The result: the major data sources for regional and national care planning and quality control render no specific information about migrants. This is problematic since several studies indicate severe deficits in nursing care services for this group.

Is there a further acceleration in the age at onset of menarche? A cross-sectional study in 1840 school children focusing on age and bodyweight at the onset of menarche.

OBJECTIVE: More than 30 years ago Frisch and Revelle proposed a body weight threshold for the onset of menarche. Based on this hypothesis, a further acceleration of age at menarche can be expected in times of childhood obesity. DESIGN: A cross-sectional study of 1840 healthy school girls (Berlin school children's cohort, BSCOC) within the age groups 10-15 years was conducted in 2006-2007. METHODS: Median age of menarche was calculated by Kaplan-Meier survival analysis. Bi- and multivariate analyses were performed to analyze the associations between menarche age and weight status. A locally weighted regression was used to analyze the relationship respectively between height, weight, and body mass index (BMI)-SDS and age stratified by menarche status. RESULTS: Nine hundred and thirty six (50.9%) girls had already experienced menarche at a median age of 12.8 years. Two hundred and thirty six of these girls reached their menarche recently. Obese/overweight girls reached menarche significantly earlier (12.5 years), than normal weight (12.9 years), and underweight girls (13.7 years). The mean total body weight was similar in all girls at menarche irrespective of age (mean 51.1 kg, s.d. 8.1) and height. BMI-SDS remained the only significant factor for onset of menarche within a multiple regression model for early menarche (OR 2.1, 95% confidence interval 1.3-3.3, P=0.002). CONCLUSIONS: Age at onset of menarche did not accelerate even in a childhood population with more than 10% obesity prevalence. Nevertheless, a negative correlation of BMI-SDS with age at onset of menarche exists.

[Oral hygiene. KIGGS data on caries preventative behaviour]. / Mundhygiene. Daten des KiGGS zum Karies-präventiven Verhalten.

The present analysis deals with the identification of populations at risk with regard to oral hygiene and the prevention of caries in children and adolescents in Germany. Using a written questionnaire, which constituted a part of the KIGGS Survey for children and adolescents, 17,641 participants aged between 0 to 17 years were asked about how frequently they brushed their teeth, and how often they had dental check-ups. During a standardised medical interview caries preventative medications were recorded. In consideration of socio-demographic factors, risk populations for insufficient dental hygiene and caries prophylaxis were identified by means of logistic regression. Determinants for insufficient dental hygiene are male sex (odds ratio (OR) 1.6), low social status (OR 2.2) and migrational background (OR 2.3). The social and culture-specific determinancy is also mirrored in the insufficient utilisation of dental check-ups. In addition, there are significant differences between East and West Germany (OR West 1.3) and urban residence (OR 1.9). Age (0-2 years OR 10.4), social and migrational status proved to be significant factors influencing use of tablet fluoridation. These results stress the necessity of preventative measures for these specific target groups to improve dental hygiene and health.

[Children and adolescents in Germany with a migration background. Methodical aspects in the German Health Interview and Examination Survey for Children and Adolescents (KiGGS)]. / Kinder und Jugendliche mit Migrationshintergrund in Deutschland. Methodische Aspekte im Kinder- und Jugendgesundheitssurvey (KiGGS).

A migration-specific approach was used in the German Health Interview and Examination Survey for Children and Adolescents (KiGGS) and thus it was possible for the first time to include children with a migration background in a nationwide health survey in Germany in a number corresponding to their percentage of the population. This article presents the migration-specific approach used in KiGGS as well as a definition of the term "migrant" and its operationalisation. In addition, we analyse the representativity of the migrant subsample and present data on its composition. Altogether 2,590 children and adolescents with a migration background (both parents) took part in the study; in the weighted sample they account for 17.1% of all children and adolescents. Another 8.3% of the children and adolescents have one parent with a migration background. The two largest groups among the migrant children are Germans from Russia (29.9%) and children and adolescents of Turkish origin (28.2%). There are differences between migrants and non-migrants related to socio-economic status and place of living (rural/urban and East/West). Analyses of the representativity of the migrant sample show that children and adolescents with a lower level of education are under-represented, whereas there were no differences with regard to sex, the fathers' occupation or the mothers' smoking status. Non-respondents rate their children's health better than respondents. Since the successful integration of children and adolescents with a migration background into the KiGGS study brings with it a sufficiently large number of cases and since KiGGS covers a wide range of health-related topics, comprehensive migration-specific analyses can be performed. Thus, KiGGS will contribute to filling some of the current gaps in our knowledge of migrant children's health.