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The research aimed to investigate back pain ( BP) prevalence in a large cohort of young athletes with respect to age, gender, and sport discipline. BP (within the last 7 days) was assessed with a face scale (face 1-2 = no pain; face 3-5 = pain) in 2116 athletes (m/f 61%/39%; 13.3 ± 1.7 years; 163.0 ± 11.8 cm; 52.6 ± 13.9 kg; 4.9 ± 2.7 training years; 8.4 ± 5.7 training h/week). Four different sports categories were devised (a: combat sports, b: game sports; c: explosive strength sport; d: endurance sport). Analysis was described descriptively, regarding age, gender, and sport. In addition, 95% confidence intervals ( CI) were calculated. About 168 (8%) athletes were allocated into the BP group. About 9% of females and 7% of males reported BP. Athletes, 11-13 years, showed a prevalence of 2-4%; while prevalence increased to 12-20% in 14- to 17-year olds. Considering sport discipline, prevalence ranged from 3% (soccer) to 14% (canoeing). Prevalences in weight lifting, judo, wrestling, rowing, and shooting were ≥10%; in boxing, soccer, handball, cycling, and horse riding, ≤6%. 95% CI ranged between 0.08-0.11. BP exists in adolescent athletes, but is uncommon and shows no gender differences. A prevalence increase after age 14 is obvious. Differentiated prevention programs in daily training routines might address sport discipline-specific BP prevalence. [ABSTRACT FROM AUTHOR]

Purpose: To describe the implementation process of a computer-adaptive test (CAT) for measuring health-related quality of life (HRQoL) of children and adolescents in two pediatric clinics in Germany. The study focuses on the feasibility and user experience with the Kids-CAT, particularly the patients' experience with the tool and the pediatricians' experience with the Kids-CAT Report.Methods: The Kids-CAT was completed by 312 children and adolescents with asthma, diabetes or rheumatoid arthritis. The test was applied during four clinical visits over a 1-year period. A feedback report with the test results was made available to the pediatricians. To assess both feasibility and acceptability, a multimethod research design was used. To assess the patients' experience with the tool, the children and adolescents completed a questionnaire. To assess the clinicians' experience, two focus groups were conducted with eight pediatricians.Results: The children and adolescents indicated that the Kids-CAT was easy to complete. All pediatricians reported that the Kids-CAT was straightforward and easy to understand and integrate into clinical practice; they also expressed that routine implementation of the tool would be desirable and that the report was a valuable source of information, facilitating the assessment of self-reported HRQoL of their patients.Conclusions: The Kids-CAT was considered an efficient and valuable tool for assessing HRQoL in children and adolescents. The Kids-CAT Report promises to be a useful adjunct to standard clinical care with the potential to improve patient-physician communication, enabling pediatricians to evaluate and monitor their young patients' self-reported HRQoL. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has caused unprecedented changes in the lives of 1.6 billion children and adolescents. First non-representative studies from China, India, Brazil, the US, Spain, Italy, and Germany pointed to a negative mental health impact. The current study is the first nationwide representative study to investigate the impact of the COVID-19 pandemic on health-related quality of life (HRQoL) and mental health of children and adolescents in Germany from the perspective of children themselves. A representative online survey was conducted among n = 1586 families with 7- to 17-year-old children and adolescents between May 26 and June 10. The survey included internationally established and validated instruments for measuring HRQoL (KIDSCREEN-10), mental health problems (SDQ), anxiety (SCARED), and depression (CES-DC). Results were compared with data from the nationwide, longitudinal, representative BELLA cohort study (n = 1556) conducted in Germany before the pandemic. Two-thirds of the children and adolescents reported being highly burdened by the COVID-19 pandemic. They experienced significantly lower HRQoL (40.2% vs. 15.3%), more mental health problems (17.8% vs. 9.9%) and higher anxiety levels (24.1% vs. 14.9%) than before the pandemic. Children with low socioeconomic status, migration background and limited living space were affected significantly more. Health promotion and prevention strategies need to be implemented to maintain children's and adolescents' mental health, improve their HRQoL, and mitigate the burden caused by COVID-19, particularly for children who are most at risk., (© 2021. The Author(s).)

Background: The drastic changes during the COVID-19 pandemic may have a negative impact on the psychological wellbeing of children and adolescents., Objectives: COPSY is the first national, representative German study to examine mental health and quality of life of children and adolescents during the pandemic. Results are compared with data of the representative longitudinal BELLA study conducted before the pandemic., Materials and Methods: Internationally established instruments for measuring health-related quality of life and mental health (including anxiety and depressive symptoms) were administered to n = 1586 parents with 7‑ to 17-year-old children and adolescents, of whom n = 1040 11- to 17-year-olds also provided self-reports, from 26 May to 10 June 2020. Data were analyzed using descriptive statistics and bivariate tests., Results: Seventy-one percent of the children and adolescents and 75% of the parents felt burdened by the first wave of the COVID-19 pandemic. Compared to the time before the pandemic, the children and adolescents reported a lower health-related quality of life, the percentage of children and adolescents with mental health problems almost doubled, and their health behavior worsened. Socially disadvantaged children felt particularly burdened by the COVID-19 pandemic. Two-thirds of the parents would like to receive support in coping with their child during the pandemic., Conclusions: The COVID-19 pandemic poses a mental health risk to children and adolescents. Schools, doctors, and society are called to react by providing low-threshold and target-group-specific prevention and mental health promotion programs., (© 2021. The Author(s).)

Objective: Children and adolescents with a low socioeconomic status (SES) are significantly more often affected by mental health problems than their peers with a high SES. So far, little is known about the association between family's SES and utilization of mental health care. This study examines the mental health care utilization by children and adolescents depending on their SES and symptoms of mental health problems as well as the impact of mental health problems., Methods: The analysis comprisesd data from the population-based BELLA-study, which investigates mental health in a representative subsample of the German Health Interview and Examination Survey for Children and Adolescents (KiGGS). Between 2014 and 2017, 1,580 participants aged 7 to 17 years were examined. SES was measured by the indicators of household income, parental educational attainment and parental occupation status. Symptoms and impairment of mental health problems were measured using the Strength and Difficulties Questionnaire (SDQ and SDQ-Impact). To investigate mental health care, the consultation of child and adolescent psychiatrists, medical and psychological psychotherapists and psychologists was considered. A hierarchic binary logistic regression model was calculated predicting mental health care use. In addition, effects of SES-indicators on associations between symptoms and impairment as well as mental health care utilization (moderator analysis) were investigated., Results: Children and adolescents with a low SES were more likely to utilize mental health care services than their peers with a high SES. Mental health care utilization was significantly predicted by symptoms of mental health problems (OR=1.15, p≤0.001) as well as by the impairment caused by these problems (OR=1.68, p≤0.001); we found no significant moderation effects for household income, parental education or parental occupation., Conclusion: The probability of mental health care utilization by children and adolescents is significantly predicted by the symptoms and the impairments caused by mental health problems, but not by household income, parental education or parental occupation., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Mental health and well-being are of great interest in health policy and research. Longitudinal surveys are needed to provide solid population-based data. We describe the design and methods of an 11-year follow-up of the German BELLA study in children, adolescents and young adults, and we report on age- and gender-specific courses of general health and well-being, long-term health-related outcomes of mental health problems, and mental health care use. The BELLA study is the module on mental health and well-being within the German Health Interview and Examination Survey for Children and Adolescents (KiGGS). Standardised measures were used at each of the five measurement points of the BELLA study. In the 11-year follow-up, young people aged 7-31 years participated (n = 3492). Individual growth modelling, linear regression and descriptive analyses were conducted. Self-reported general health and well-being were both better in younger (vs. older) and in male (vs. female) participants according to the data from all five measurement points. Mental health problems in childhood and adolescence (measured at baseline) predicted impaired health outcomes at 6-year and 11-year follow-ups. Approximately one out of four children with a diagnosed mental disorder was not undergoing mental health treatment. With its 11-year follow-up, the prospective longitudinal BELLA study provides new and solid data on mental health and well-being from childhood to adulthood in Germany, and these data are important for health promotion and prevention practices. These results are consistent with previous findings. Promising future analyses are planned., (© 2020. The Author(s).)

Background: Aseptic meningitis epidemics may pose various health care challenges., Methods: We describe the German enterovirus meningitis epidemics in the university hospital centers of Düsseldorf, Cologne and Berlin between January 1st and December 31st, 2013 in order to scrutinize clinical differences from other aseptic meningitis cases., Results: A total of 72 enterovirus (EV-positive) meningitis cases were detected in our multicenter cohort, corresponding to 5.8% of all EV-positive cases which were voluntarily reported within the National Enterovirus surveillance (EVSurv, based on investigation of patients with suspected aseptic meningitis/encephalitis and/or acute flaccid paralysis) by physicians within this period of time. Among these 72 patients, 38 (52.8%) were enterovirus positive and typed as echovirus (18 pediatric and 20 adult cases, median age 18.5 years; echovirus 18 (1), echovirus 2 (1), echovirus 30 (31), echovirus 33 (1), echovirus 9 (4)). At the same time, 45 aseptic meningitis cases in our cohort were excluded to be due to enteroviral infection (EV-negative). Three EV-negative patients were tested positive for varicella zoster virus (VZV) and 1 EV-negative patient for herpes simplex virus 2. Hospitalization was significantly longer in EV-negative cases. Cerebrospinal fluid analysis did not reveal significant differences between the two groups. After discharge, EV-meningitis resulted in significant burden of sick leave in our pediatric cohort as parents had to care for the children at home., Conclusions: Voluntary syndromic surveillance, such as provided by the EVSurv in our study may be a valuable tool for epidemiological research. Our analyses suggest that EV-positive meningitis predominantly affects younger patients and may be associated with a rather benign clinical course, compared to EV-negative cases.

Background: The basis for healthy development is established during the first years of one's life. In this early phase, parents can significantly influence the health conditions under which their child grows up. Parental education can play a key role in this regard. This study examines the association of maternal education with health and health behavior in infants., Methods: A subsample of the representative German KiGGS study (Wave 1, 2009-2012) on the health of children and adolescents was investigated. Data from 1727 mothers who reported on health-specific characteristics of their infants (0 to 2 years), on their own educational background, and on characteristics of the family were analyzed. The influence of maternal education on indices of health and health behavior in infants was investigated by means of logistic regression; additional predictors were considered in regression models., Results: Higher maternal education was associated with better health behavior, but not with overall infant health. The impact of maternal education on health behavior remained significant when considering other predictors (financial worries, low maternal age at childbirth, premature birth/low birth weight). Overall, low maternal education was accompanied by an accumulation of additional risks., Conclusions: Higher maternal education can help infants have a good start in their lives. The impact of poor health behavior on infant health may not become apparent until later in their lives. For prevention and intervention, it is important to identify sensitive stages of development during childhood and the underlying mechanisms of the relationship between maternal education and infant health behavior.

Background: Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders in childhood worldwide, and causes significant impairments in overall functioning. In order to develop effective prevention and intervention programs, knowledge of the determinants that have an impact on the onset and development of ADHD symptoms is essential. So far, little is known about factors affecting ADHD symptoms in children and adolescents over time. Therefore, this study investigates potential psychosocial risk and protective factors for ADHD symptoms based on cross-sectional and longitudinal data of a German population-based study., Methods: Data on children and adolescents (n = 1,384 aged 11 to 17 years) were collected at three measurement points (baseline, 1-year and 2-year follow-ups) covering a period of two years. We used latent growth modelling to investigate effects of parental mental health problems (risk factor) and self-efficacy, family climate and social support (protective factors) on symptoms of ADHD based on cross-sectional as well as longitudinal data. Sociodemographic factors, pre- and postnatal factors, and comorbid symptoms of internalizing and externalizing mental health problems were considered as covariates., Results: At baseline, male gender, younger age, stronger aggressive behavior, and stronger parental mental health problems were related to more ADHD symptoms. Longitudinal analyses showed that female gender, migration status, increasing symptoms of generalized anxiety, increasing aggressive behavior and increasing parental mental health problems were associated with stronger increase of ADHD symptoms over time. However, improving family climate was related to decreasing ADHD symptoms over time. We further found moderator effects for social support., Conclusion: The findings of the study provide important information concerning risk and protective factors in the context of ADHD. Hence, the results may be integrated into the planning and implementation of future prevention and early intervention strategies that target affected children and adolescents., Competing Interests: The authors have declared that no competing interests exist.

Aim: Children and adolescents with low socioeconomic status (SES) suffer from mental health problems more often than their peers with high SES. The aim of the current study was to investigate the direct and interactive association between commonly used indicators of SES and the exposure to stressful life situations in relation to children's mental health problems., Methods: The prospective BELLA cohort study is the mental health module of the representative, population-based German National Health Interview and Examination Survey for children and adolescents (KiGGS). Sample data include 2,111 participants (aged 7-17 years at baseline) from the first three measurement points (2003-2006, 2004-2007 and 2005-2008). Hierarchical multiple linear regression models were conducted to analyze associations among the SES indicators household income, parental education and parental unemployment (assessed at baseline), number of stressful life situations (e.g., parental accident, mental illness or severe financial crises; 1- and 2-year follow-ups) and parent-reported mental health problems (Strength and Difficulties Questionnaire; 2-year follow-up)., Results: All indicators of SES separately predicted mental health problems in children and adolescents at the 2-year follow-up. Stressful life situations (between baseline and 2-year follow-up) and the interaction of parental education and the number of stressful life situations remained significant in predicting children's mental health problems after adjustment for control variables. Thereby, children with higher educated parents showed fewer mental health problems in a stressful life situation. No moderating effect was found for household income and parental employment. Overall, the detected effect sizes were small. Mental health problems at baseline were the best predictor for mental health problems two years later., Conclusions: Children and adolescents with a low SES suffer from multiple stressful life situations and are exposed to a higher risk of developing mental health problems. The findings suggest that the reduction of socioeconomic inequalities and interventions for families with low parental education might help to reduce children's mental health problems., Competing Interests: The authors have declared that no competing interests exist.

Objective: This study served to establish German norms for the Strengths and Difficulties Questionnaire self-report (SDQ-S) by using data from a representative epidemiological sample from the German National Health Interview and Examination Survey for Children and Adolescents (KiGGS study). Although the German version of the SDQ has been widely used and normative data for the parent version (SDQ-P) exist, no German norms for the self-report version have been reported, so that practitioners had to rely on the available British norms. In addition, we investigated whether sex- and age-specific norms are necessary., Methods: At the baseline of the KiGGS study, SDQ-S ratings were collected from n = 6,726 children and adolescents between 11 and 17 years (n = 3,440 boys und n = 3,286 girls). We assessed the internal consistency and age/sex effects of the SDQ-S. Confirmatory factor analysis was conducted to assess the factor structure of the SDQ-S. Banding scores were developed to differentiate children and adolescents with levels of difficulties and categorized them as "normal," "borderline," and "abnormal." General as well as age- and sex-specific bandings were created for both total score and subscales of SDQ-S. In addition, the German norms of the SDQ-S were compared with those of the UK, Norway, and Thailand., Results: The five-factor solution of the SDQ-S (including Emotional symptoms, Conduct problems, Hyperactivity/Inattention, Peer problems, and Prosocial behavior) provided a satisfactory fit to the data. Moderate internal consistencies (Cronbach's α) were observed for the scales Emotional symptoms, Hyperactivity/Inattention, and Total difficulties score, whereas insufficient internal consistency was found for the scales Peer problems and Conduct problems. However, using McDonald's ω as a more appropriate measure of homogeneity, internal consistencies were found to be satisfactory for all subscales and for Total difficulties. Normative banding scores were established conservatively to avoid producing too many false positives in the category "abnormal." In line with previous research, girls showed more emotional problems but fewer Peer problems than boys. German normative bandings of SDQ-S were similar to the original British bandings and those of other countries., Conclusions: This study of the German SDQ-S in a large representative epidemiological sample presents evidence of partly moderate to good psychometric properties. It also supports the usefulness of SDQ-S as an effective and efficient instrument for child and adolescent mental health problems in Germany. German normative banding scores of SDQ-S established in this study were comparable with the original British norms as well as with those of other countries, so that SDQ-S can be recommended as a psychopathological broadband-screening tool.

Rationale: Mental health problems in children and adolescents are widespread and are a primary public health concern worldwide. During childhood and adolescence different challenges must be met. Whether the corresponding developmental tasks can be mastered successfully and in a psychologically healthy manner depends on the availability of resources., Objective: The aim of the current study was to examine the benefits of maternal education on the development of mental health in children and adolescents., Method: Data from 2810 participants (48.7% female, 7- to 19-years old) of the longitudinal BELLA study (mental health module of the representative German KiGGS study) were analyzed from up to four measurement points (2003-2012). Individual growth modeling was employed to estimate the benefits of maternal education (Comparative Analysis of Social Mobility in Industrial Nations, CASMIN) for the trajectories of mental health problems (parent-reported Strengths and Difficulties Questionnaire, SDQ) in children and adolescents., Results: Children of mothers with low education had significantly more mental health problems compared to children of mothers with high education. This difference due to maternal education applied for girls as well as boys and especially for participants who did not live with both biological parents. Further, the difference in mental health problems due to varying maternal education decreased with increasing age of the participants., Conclusion: Prevention programs should focus on children of mothers with lower education who additionally live in single- or step-parent families as a high-risk group. Knowledge of the underlying mechanism between education and mental health is highly important., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Background: Little data are available on health-related quality of life (HRQOL) of children in Germany at the age of school enrollment., Objective: Aim of this study was to investigate the HRQOL of children during school enrollment and to determine its predictors with special focus on environmental factors., Methods: Data from the fifth survey of the Health-Monitoring-Units (GME) conducted in Bavaria (2010/2011) were analyzed. Parent-reported data on HRQOL using the KINDL-R(evised), the Strength and Difficulties Questionnaire (SDQ), socio-demographic characteristics and characteristics of the living environment were assessed., Results: The sample included a total of 3,744 children (45.9% female; mean age: 6.0; SD=0.4). Girls had significantly higher values than boys in total HRQOL (83.7 vs. 82.4, p ≤0.0001) and in all KINDL-R subscales except "psychological well-being" and "physical well-being". For the latter, boys had significantly higher values than girls (84.1 vs. 82.9, p=0.0103). Multiple linear regression analysis showed that parental annoyance with air or noise pollution, possibility for children to safely play outside and the time a child is outside on weekdays in the summertime were significant predictors of total HRQOL measured by the KINDL-R. Obesity was not linked to HRQOL. Children with migration background had significantly higher values in the subscales "family" and "friends"., Conclusions: Environmental factors are associated with HRQOL in children at the age of school enrollment but only partially of relevant use. Although they show significant associations, their explanatory power of the variability observed is rather limited., Competing Interests: Die Autoren geben an, dass kein Interessenkonflikt besteht., (© Georg Thieme Verlag KG Stuttgart · New York.)

Stigmatization of mental illness is a societal problem, and is also relevant for help-seeking. In a qualitative interview study, the role of stigma in help-seeking was examined from the perspective of parents with mental illness, their children and other relatives. Parents with mental illness assigned an important role to stigma for help-seeking processes. Children rarely made explicit statements about this, but an implicit awareness of stigma can be assumed., Competing Interests: Interessenkonflikt: Die Autoren geben an, dass kein Interessenskonflikt besteht. Das Projekt wird durch das Bundesministerium für Bildung und Forschung (BMBF) unter dem Förderkennzeichen 01EL1424B gefördert (Zeitraum: 01.03.2015-28.02.2018)., (© Georg Thieme Verlag KG Stuttgart · New York.)

The consequences of traumatic brain injury (TBI) for health-related quality of life (HRQoL) are still poorly understood, and no TBI-specific instrument has hitherto been available. This paper describes in detail the psychometrics and validity of the German version of an internationally developed, self-rated HRQoL tool after TBI-the QOLIBRI (Quality of Life after Brain Injury). Factors associated with HRQoL, such as the impact of cognitive status and awareness, are specifically reported. One-hundred seventy-two participants after TBI were recruited from the records of acute clinics, most of whom having a Glasgow Coma Scale (GCS) 24-hour worst score and a Glasgow Outcome Scale (GOSE) score. Participants had severe (24%), moderate (11%) and mild (56%) injuries as assessed on the GCS, 3 months to 15 years post-injury. The QOLIBRI uses 37 items to measure "satisfaction" in the areas of "Cognition", "Self", "Daily Life and Autonomy", and "Social Relationships", and "feeling bothered" by "Emotions"and "Physical Problems". The scales meet standard psychometric criteria (α = .84 to .96; intra-class correlation-ICC = .72 to .91). ICCs (0.68 to 0.90) and αs (.83 to .96) were also good in a subgroup of participants with lower cognitive performance. The six-subscale structure of the international sample was reproduced for the German version using confirmatory factor analyses and Rasch analysis. Scale validity was supported by systematic relationships observed between the QOLIBRI and the GOSE, Patient Competency Rating Scale for Neurorehabilitation (PCRS-NR), Hospital Anxiety and Depression Scale (HADS), Profile of Mood States (POMS), Short Form 36 (SF-36), and Satisfaction with Life Scale (SWLS). The German QOLIBRI contains novel information not provided by other currently available measures and has good psychometric criteria. It is potentially useful for clinicians and researchers, in post-acute and rehabilitation studies, on a group and individual level.

Background: Conduction of and participation in clinical trials is a major challenge for surgical departments especially as job performance in hospitals has increased immensely during the last few years due to economic aspects. Only 11.7 % of published clinical studies are randomized controlled trials. As more and more treatment procedures in medicine have an evidence-based design the aim must be to present randomized controlled trials with an evidence level 1 for an increasing number of surgical therapies. Since 2006 the German National Surgical Trial Network (CHIR-Net) has been established and funded by the Federal Ministry of Education and Research (BMBF) in order to promote the realization of clinical trials in surgery. Thus the basis for the execution of high quality clinical studies in surgery has been extended further. In the individual CHIR-Net centers clinical trials are planned, organized and supervised which requires extensive knowledge of prevalent international standards. Teaching them to rotating physicians is one of the tasks of CHIR-Net. Therefore, a special curriculum for physicians has been developed which is evaluated in this study., Materials and Methods: From December 2010 to March 2011 an online survey of physicians who had previously rotated in the CHIR-Net was conducted, starting from the Surgical Regional Center (CRZ) Witten-Herdecke/Cologne. A total of 19 partly open and partly closed questions concerning the person, training, duration of the rotation, the funding applied for and the generated scientific output were surveyed. In addition, the curriculum for physicians and rotation time was checked by means of 17 questions in an evaluation matrix., Results: In this article the results of the rotating physician evaluation are presented. The satisfaction of physicians with the training during the rotation is presented as well as an analysis of how many of the submitted publications were directly supported by CHIR-Net. It was also evaluated how many rotating physicians requested funding and what the type of funding was., Conclusion: With the rotating physician model of CHIR-Net a working concept for the training of surgeons in clinical research and the realization of randomized surgical trials was established as a viable solution for the difficult situation of clinical research in the surgical disciplines with the double burden of research and clinical practice.

Background: Results from studies with a combination of oral morphine and oxycodone in postsurgical patients demonstrate significant analgesia and a tolerability profile comparable to other pain medications at morphine-equivalent doses. However, an intravenous (IV) combination has not previously been studied., Objective: This study evaluated the efficacy and tolerability of IV morphine versus a combination of IV morphine and IV oxycodone in a 1:1 ratio., Methods: This was a 2-center, randomized, double-blind, active-controlled pilot trial of 40 patients who had undergone total hip replacement. After surgery, when pain levels reached ≥4 (on the 11-point Numerical Pain Rating Scale), patients were randomized to 1 of 2 treatment groups. In part 1 of the study, patients were dosed every 5 minutes for the first 65 minutes (up to 13 doses) with study drug, provided that vital signs criteria were met. After an initial loading dose of either morphine 1.5 mg coadministered with oxycodone 1.5 mg or morphine 3 mg alone, patients received IV morphine 1.5 mg or IV morphine 0.75 mg/IV oxycodone 0.75 mg every 5 minutes. If patients achieved a pain score of 2 or experienced intolerable adverse events to drug when stable, they were permitted to enter part 2. In part 2, patients received blinded study medication (IV morphine plus IV oxycodone [0.5 mg/0.5 mg] or 1 mg IV morphine alone) via patient-controlled analgesia (PCA) for 47 hours., Results: At baseline, treatment groups were comparable except for a higher proportion of females in the IV morphine group. Baseline pain intensity averaged 7 on the Numerical Pain Rating Scale of 0 to 10. One patient in the morphine group and 2 patients in the morphine/oxycodone group discontinued the study. The sum of the pain intensity differences from baseline to 65 minutes during the dose-titration phase was 1.8 for morphine alone versus 2.7 for morphine/oxycodone (P = 0.12); these values occurred at the same median number of doses (12) for each group. In part 2 (PCA dosing) of the study, similar levels of analgesia were achieved. During the study, 24% of the IV morphine/oxycodone group and 37% of the IV morphine group experienced nausea, and 10% of the IV morphine/oxycodone group and 16% of the IV morphine group had emesis. Two patients in the IV morphine/oxycodone group and 4 in the IV morphine alone group experienced oxygen desaturation., Conclusions: The combination of IV morphine and oxycodone provided pain relief with an acceptable tolerability profile in these patients experiencing moderate to severe postoperative pain. However, as an explorative pilot study, the power was not adequate to demonstrate statistical significance for differences between IV morphine/oxycodone and IV morphine alone. European Clinical Trials Data Base registration code: EudraCT-No. 2008-008527-14., (Copyright © 2012 Elsevier HS Journals, Inc. All rights reserved.)

Background: Local corticosteroid injections can have serious septic and aseptic complications., Methods: From 2005 to 2009, medical expert committees and mediation boards reviewed 1528 cases of alleged treatment errors relating to injections., Results: 278 cases were identified in which complications arose after local glucocorticosteroid injections. The injections were intra-articular, paravertebral, intramuscular, and at other sites. In 39.6% of cases, treatment errors or patient information errors of the following types were found: aseptic technique was not maintained, injections were performed in the absence of an indication, time intervals between injections were too short, excessive doses were administered, infections were not diagnosed, erroneous injections were performed, patients were not informed of the risks, and there were errors of organization and documentation., Conclusions: Injections of glucocorticosteroids must be performed in strict adherence to the manufacturer's instructions with respect to the composition of the solution to be injected, the quantity per injection, and the intervals between injections. Repeated injections with too little time between them raise the risk of infection. Physicians should pay more attention to this fact, particularly when deciding on the indication for paravertebral injections. Aseptic technique should be strictly maintained. The indication for the injection should be clearly documented. When glucocorticosteroids are injected into small joints and tendon spaces, the introduction of crystals into the subcutaneous tissue and adipose tissue should be avoided. The intramuscular administration of depot glucocorticosteroids should be avoided. Patients should be informed of the risk of infection and/or tissue atrophy, as well as of alternative forms of treatment.

Background: Based on the general approach of locus of control, health locus of control (HLOC) concerns control-beliefs due to illness, sickness and health. HLOC research results provide an improved understanding of health related behaviour and patients' compliance in medical care. HLOC research distinguishes between beliefs due to Internality, Externality powerful Others (POs) and Externality Chance. However, evidences for differentiating the POs dimension were found. Previous factor analyses used selected and predominantly clinical samples, while non-clinical studies are rare. The present study is the first analysis of the HLOC structure based on a large representative general population sample providing important information for non-clinical research and public health care., Methods: The standardised German questionnaire which assesses HLOC was used in a representative adult general population sample for a region in Northern Germany (N = 4,075). Data analyses used ordinal factor analyses in LISREL and Mplus. Alternative theory-driven models with one to four latent variables were compared using confirmatory factor analysis. Fit indices, chi-square difference tests, residuals and factor loadings were considered for model comparison. Exploratory factor analysis was used for further model development. Results were cross-validated splitting the total sample randomly and using the cross-validation index., Results: A model with four latent variables (Internality, Formal Help, Informal Help and Chance) best represented the HLOC construct (three-dimensional model: normed chi-square = 9.55; RMSEA = 0.066; CFI = 0.931; SRMR = 0.075; four-dimensional model: normed chi-square = 8.65; RMSEA = 0.062; CFI = 0.940; SRMR = 0.071; chi-square difference test: p < 0.001). After excluding one item, the superiority of the four- over the three-dimensional HLOC construct became very obvious (three-dimensional model: normed chi-square = 7.74; RMSEA = 0.059; CFI = 0.950; SRMR = 0.079; four-dimensional model: normed chi-square = 5.75; RMSEA = 0.049; CFI = 0.965; SRMR = 0.065; chi-square difference test: p < 0.001). Results were confirmed by cross-validation. Results based on our large community sample indicated that western general populations separate health-related control-beliefs concerning formal and informal assistance., Conclusions: Future non-clinical HLOC studies in western cultures should consider four dimensions of HLOC: Internality, Formal Help, Informal Help and Chance. However, the standardised German instrument needs modification. Therefore, confirmation of our results may be useful. Future research should compare HLOC structure between clinical and non-clinical samples as well as cross-culturally.

Aim: The clinical trial is the link between research and medical practice and facilitates evidence-based therapies. There are specific difficulties to be faced when executing clinical trials related to surgical services (learning curve of the surgeon, blinding etc.). As a result, surgical randomised controlled clinical trials (RCT) are underrepresented in the total number of RCTs., Method: To make it easier to implement surgical RCT, the Clinical Trial Unit for Orthopaedics and Trauma Surgery was established. Training of the supporting physicians was reached by rotations in the structures of CHIR-Net, a BMBF-funded network created to build up a region-wide surgical research infrastructure., Result/conclusion: Supported by the regional CHIR-Net Center and the regional Clinical Trial Center, a research institute was thus founded with the aim of contributing to a long-term improvement in clinical research in orthopaedics and trauma surgery.

Aim: The temporomandibular function of patients after orthognathic surgery was evaluated with the Helkimo index (D 0-III) and compared with a normal population., Patients and Methods: Temporomandibular disorders (TMD) were evaluated with the Helkimo index (D 0-III) in a group of patients (n=105, F=69, M=36) after osteotomies. The average follow-up time was 47 months (9-141 months). The osteotomies performed were as follows: 58 bilateral sagittal split osteotomies, 12 Le Fort I osteotomies, 22 bimaxillary osteotomies, and 13 segment-osteotomies. A control group (n=202, F=114, M=88, age 20-39 years) was examined in an epidemiological study. The statistical analysis was performed using Windows software SPSS 10.0., Result: In 82.8% of the patients no symptoms or mild dysfunction were found. The comparison between the patient group (31.4%) and the control group (31.7%) revealed a similar frequency. The most frequent dysfunction was a reduced mobility of the mandible, which determined the statistical significance (p<0,05) between the patients and the control group for the dysfunction group D II and D III. The chi-square test could not detect any difference between sex and the kind of osteotomy with regard to dysfunction.

Background: During the past few decades, orthognathic surgery has become routine in oral and maxillofacial surgery. As these surgical interventions are elective, the goal is a low complication rate. The aim of this study was to analyze the intraoperative and postoperative complications after orthognathic surgery without considering orthodontic relapse., Patients and Methods: The medical files of 507 patients were reviewed who had been treated in the department of oral maxillofacial surgery at the Martin-Luther-Universität in Halle-Wittenberg during a period of 51 years. The indication for orthognathic surgery was mandibular hyperplasia in 314 cases (61.9%), mandibular hypoplasia in 69 cases (13.6%), mandibular hyperplasia with a frontal open bite in 53 cases (10.5%), maxillary hyperplasia with a cleft in 30 cases (5.9%), maxillary hyperplasia in 22 cases (4.3%), severe laterognathia in 10 cases (2.1%), and isolated frontal open bite in 9 cases (1.5%). The surgical procedures were as follows: bilateral sagittal split osteotomy (n = 336, 66%), Le Fort I osteotomy (n = 29, 5.9%), bimaxillary osteotomy (n = 35, 6.3%), and segment osteotomy (n = 107, 21.1%). Rigid fixation was used in 147 patients., Results: In 55% of the patients a postoperative neurosensory deficit of the inferior alveolar nerve was observed, which was only found in 28% after 1 year. Inflammatory wound healing was found in 5.3% of the patients., Conclusion: Due to antibiotic perioperative prophylaxis and modern rigid osteosynthesis devices, orthognathic surgery has become a routine method in maxillofacial surgery with predictable surgical results.

We describe design and baseline data of the Prevention Education Program (PEP), a home-based and family-oriented intervention program, aimed to assess and improve cardiovascular risk factors in school children and their families during an intervention period of 10 years. Started in 1994 in the German town of Nuremberg, currently 37 elementary schools (22 control and 15 intervention schools) are enrolled including 1740 families (1740 first graders, 3046 parents, and 1521 siblings). Major cardiovascular risk factors as well as dietary behavior are evaluated yearly using structured interview, physical examination, laboratory analysis, and seven-day-dietary protocols. The intervention package is applied to all families from intervention schools using regular home visits, health curricula and group sessions. Primary outcome is any reduction in cardiovascular risk factors by dietary intervention and health education compared to the control group getting only written information on the individual risk profile. The presented baseline data showing a high prevalence of cardiovascular risk factors in adults and in their children underline the need for such an intervention program in Germany.

The maxim governing the accomplishment of medical tasks by the Medical Service of the Bundeswehr stipulates that the soldiers will, in case of illness, accident or injury, receive medical treatment to the standard they can expect in the Federal Republic of Germany. In this context the introduction of telemedical applications into the Medical Service will improve the quality of the medical care through better and faster access for the medical officer assigned to a unit or a ship for requesting support to expert knowledge from military facilities or the civilian sector. The telemedical system is based on a high-class commercial PC. This workstation can be extended as needed with medical devices (x-ray film digitizer, dermatoscope, otoscope) and allows linkage to other imaging methods (e.g., videocamera, ultrasound). Currently this system is under evaluation in a multi centre trial. The participants of this telemedical network communicate via EURO ISDN lines with sufficient bandwidth. If terrestrial lines are not available the communication will be based on satellite capacity. The application of internet-technology additionally provides access to medical data bases respectively allows civil-military co-operation and the interoperability between medical services of allied armed forces. This future-orientated telemedical approach with its modular upwards-compatibility will provide, especially in its mobile version and by using communication standards, the possibility to support necessary civil-military co-operation in the area of disaster relief and missions outside of Germany in the future.