Comparison of three forms of teaching - a prospective randomized pilot trial for the enhancement of adherence.

OBJECTIVE: Adherence of young adults to preventive programmes is low. The following study compares three different educational concepts to increase toothbrushing adherence in young adults. METHODS: Nine vocational school classes (157 young adults) were randomly assigned to three different 60-min approaches: (I) Education by a dentist, (II) Peer-teaching and (III) 'Adherence triangle concept' uniting dentists, teachers and participants as equal partners in intervention planning combined with peer teaching. Follow-up was 1 week for approaches I and II, and 1 week, 3 and 9 months for approach III. Adherence was defined as reported change from the childhood toothbrushing technique to adult technique. Adherence was evaluated using anonymous questionnaires and by diary analysis. RESULTS: After instruction, 90% of participants (approaches I-III) showed the desired behaviour in practice and theory. Reported adherence after 1 week with approach I was 28.5%, with approach II 39% and with approach III 95%. Prolonged follow-up of approach III yielded 76% after 3 months and 68% after 9 months. Adherence using approach III was significantly higher (P ≤ 0.001) than using approach I and II after 1 week. Adherence rates with approach III after 9 months were still higher than those of approaches I and II after 1 week. CONCLUSIONS: The 'adherence triangle' concept enhanced reported adherence significantly in comparison with previous studies and the one-dimensional concepts of approaches I and II. The tools of the adherence triangle concept seem worthwhile to be considered when planning new preventive action.

Myocardial protection in cardiac surgery patients requiring prolonged aortic cross-clamp times: a single-center evaluation of clinical outcomes comparing two blood cardioplegic strategies.

AIM: The aim of this study was to evaluate the impact of intermittent warm (IWC) versus intermittent cold blood cardioplegia (ICC) in high-risk patients that require prolonged periods of aortic cross-clamping during on-pump cardiac surgery. METHODS: From 3527 consecutive patients undergoing on-pump cardiac surgery, 520 patients were retrospectively identified that required prolonged aortic cross-clamp ≥ 75 min. Myocardial protection was performed with ICC (N.=280) or IWC (N.=240). Groups were compared regarding clinical outcomes, myocardial injury (CK-MB, cTnT) and multivariate analysis was performed to assess the impact of applied cardioplegia on 30-day all-cause mortality, cardiac death, perioperative myocardial injury (PM) and major adverse cardiac events (MACE). RESULTS: Demographic data, mean logistic Euroscore, aortic-cross-clamping and CPB time were comparable between groups. Patients with ICC needed more intraoperative defibrillations, had more postoperative blood transfusions and a prolonged hospital stay when compared to the IWC-group (P < 0.05). Thirty-day all-cause mortality tended to be higher in IWC (11% vs. 6%; P = 0.083) with significantly higher cardiac mortality (9% vs. 4%; P=0.015) compared to ICC. Myocardial injury was more pronounced in the IWC-group with a higher incidence of PMI (IWC: 17% vs. ICC:6%; P < 0.05) and MACE (IWC:37% vs. ICC:25%; P < 0.05). Groups did not differ regarding other postoperative clinical outcomes. Multivariate analysis revealed IWC to be independently predictive (P < 0.05) for 30-day all-cause mortality (OR:2.42; 95% CI:1.04-5.05), cardiac death (OR:3.57; 95% CI:1.49-8.85), MACE (OR:1.87; 95% CI:1.22-2.87) and PMI (OR:3.46; 95% CI:1.86-6.41). CONCLUSION: ICC results in less myocardial damage and reduced postoperative cardiac mortality and morbidity in patients requiring extended periods of aortic-cross-clamping during on-pump cardiac surgery, suggesting superior cardioprotection when compared to IWC.

Human fetal adiponectin and retinol-binding protein (RBP)-4 levels in relation to birth weight and maternal obesity.

Recent studies suggest that the perinatal period is a sensitive part in human development with respect to the pathogenesis of metabolic diseases in adulthood. Neonates, who are either small or large for gestational age (SGA or LGA) have a greater risk of developing obesity and insulin resistance in later life. The term "perinatal priming" is used to describe this phenomenon. Therefore, in the present study we first aimed to investigate if birth weight influences fetal adiponectin and RBP-4 metabolism. Umbilical cord blood was obtained form 40 neonates born on term+/-4 weeks and the adipokine concentrations in the serum were measured. In this analysis adiponectin but not RBP-4 levels showed a positive significant correlation to birth weight. Since maternal preconceptional obesity is associated with an increased birth weight and the risk for LGA neonates, we further aimed to investigate, if the maternal nutritional state influences fetal adiponectin and RBP-4. Therefore umbilical cord blood levels of the adipokines were correlated to maternal preconceptional BMI. In this analysis, neither adiponectin nor RBP-4 levels showed a significant correlation. Taken together, in the present study for the first time we directly compare fetal adiponectin and RBP-4 levels in respect to birth weight and maternal preconceptional BMI. Our data suggest that (1) adiponectin is more likely to have a role in perinatal priming of obesity and insulin resistance than RBP-4 and (2) that birth weight has a greater impact on fetal adipokine serum levels than maternal preconceptional obesity.

[Prophylaxis of contrast-induced nephropathy with N-acetylcysteine]. / N-Acetylcystein in der Prophylaxe der Kontrastmittel-induzierten Nephropathie.

PURPOSE: Clinical trials evaluating N-acetylcysteine (NAC) for the prevention of radiocontrast-induced nephropathy (RCN) have reported mixed results. Despite formerly published meta-analyses and due to currently published RCTs, time has come to re-evaluate the current evidence of preventing RCN by administering NAC. METHODS: We performed a computerized search without restricted to a language to identify relevant published randomized clinical trials that evaluated N-acetylcysteine for the prevention of radiocontrast-induced nephropathy. Abstracted data from each trial included assessments of clinical outcomes, trial quality, and additional characteristics. The primary outcome of interest was the incidence of nephropathy after contrast administration. Data were combined using random effects models with the performance of standard tests to assess for heterogeneity and publication bias. Subgroup analyses were also performed. RESULTS: Twenty-eight trials involving 3 604 patients met our inclusion criteria. Trials varied in patient demographic characteristics, inclusion criteria, dosing regimens, and trial quality. The summary risk ratio for contrast-related nephropathy was 0.69 (95 % confidence interval: 0.57 to 0.82; P = 0.02), a statistically significant trend towards benefit in patients treated with N-acetylcysteine. This effect varied, however, across the 28 trials, and only eight of the 28 trials demonstrated significant results although higher-quality trials demonstrated a stronger benefit for N-acetylcysteine in general, few reported important elements of study design, such as concealment of allocation, placebo-controls, or double-blinding. Heterogenity was unexplained by subgroup analyses. SUMMARY AND CONCLUSIONS: N-acetylcysteine (NAC) may reduce the incidence of contrast-related nephropathy, but this finding is reported inconsistently across currently available trials. Large high-quality, clinical trials are needed before the application of N-acetylcysteine can be recommended in general for this indication.

What is the value of available risk-scores in predicting postoperative complications after aorto-iliac surgery? A prospective non randomized study.

AIM: With an aging population, atherosclerotic manifestations are steadily increasing. Beside the anatomical and pathophysiological preoperative risk-factors accompanying perioperative risk-factors like patient's age, length of operation, blood loss and skill of the surgeon, all need to be accounted for when assessing the risk of morbidity and mortality after vascular surgery. The demand for cost effectiveness may make a risk-score system useful. The aim of the present study was, therefore, to prospectively apply various scoring systems in order to estimate outcome in patients undergoing aortobifemoral surgery due to arterial occlusive disease at the aorto-iliac level. METHODS: A prospective non randomized study was carried out. The SPSS 9.0 statistical package for Windows and, for nominal data, chi-squared-tests were used to compare rates between groups. For continuous data analysis of variance (ANOVA) was performed. When appropriate, a multivariate analysis with binary-regression by Wald was used. Sensitivity and specificity was done using ROC-curves. P < 0.05 was considered significant. From May 1996 to June 2000, 107 patients were included in the study. Besides basic data, all postoperative complications were noted according to a specific definition. Four different risk-scoring systems were used: ASA-classification; the acute physiology and chronic health evaluation (APACHE-II) system; the physiological and operative severity score for enumeration of mortality and morbidity (POSSUM) classification and, finally, the simplified acute physiology score (SAPS) classification. RESULTS: We found no significant correlation between risk-scores and outcome. None of the scoring systems used was able to predict mortality. The independent factors that influenced the postoperative complication rate were operating time, blood loss, intraoperative assisted ventilation time and age. The endpoint using the relative operating characteristic (ROC) curves analysis was either mortality or morbidity. CONCLUSIONS: It can be concluded that none of the systems analyzed separately was useful for determining morbidity and mortality. We still lack a system, that can be used preoperatively in an individual case and the vascular surgeon still has to build up his own clinical judgement or to transfer a clinical judgement.

Endotension is influenced by wall compliance in a latex aneurysm model.

OBJECTIVES: Even though endovascular aneurysm repair (EVAR) creates a closed chamber except for patent branches, the intra-sac pressure is never zero. This study was designed to investigate whether, and to what extent, aneurysm wall compliance influences intra-sac pressure. DESIGN: In vitro experimental study. METHODS: Aneurysm models with six and 12 latex layers were produced, resulting in elastic and stiff circumferential compliance (3.5 +/- 0.5 and 0.9 +/- 0.3%/100 mmHg, respectively). The models with an 18 mm internal neck and maximum aneurysm diameter of 60 mm were inserted into an in vitro circulation system. The systemic mean pressure (SPmean) was varied from 50 to 120 mmHg. After the aneurysm was excluded with a knitted polyethylene graft, aneurysm sac mean pressure (ASPmean) and aneurysm sac pulse pressure (ASPpulse) were measured. Data are presented as mean +/- SD. Statistics were performed using repeated measurements of variance; p<0.05 was considered significant. RESULTS: In the model EVAR created a closed chamber without endoleak, but with an aneurysm sac pressure related to wall compliance. In the elastic aneurysm model with six latex coats the aneurysm sac mean pressure (ASPmean) and the aneurysm sac pulse pressure (ASPpulse) at all systemic pressures were significantly lower than they were in the stiffer model with 12 latex coats (p<0.05). At a SPmean of 90 mmHg, the ASPmean was 21.0 +/- 0.9 mmHg (six latex coats) and 26.0 +/- 0.2 mmHg (12 latex coats) (p<0.05), the ASPpulse was 5.7 +/- 0.2 mmHg (six latex coats) and 8.8 +/- 0.3 mmHg (12 latex coats) (p<0.05). CONCLUSIONS: This in vitro model demonstrated that the aneurysm sac mean pressure (ASPmean) and the aneurysm sac pulse pressure (ASPpulse) were significantly influenced by the compliance of the aneurysm wall. These data highlight the need for further studies regarding endotension.

Endotension as a result of pressure transmission through the graft following endovascular aneurysm repair--an in vitro study.

BACKGROUND: endovascular aneurysm repair (EVAR) significantly reduces, but does not abolish aneurysm sac pressure, possibly because of trans-fabric transmission. OBJECTIVE: to investigate how blood pressure is transmitted through different types of grafts into the aneurysm sac. DESIGN: experimental study, in vitro. METHODS: a latex aneurysm was inserted into an in vitro circulation model. The systemic mean pressure (SPmean) was varied from 50 to 120 mmHg. The grafts used for aneurysm exclusion were: thin wall polyethylene (PE), thick wall polyethylene (PE) and thin wall ePTFE. Mean aneurysm sac pressure (ASPmean) was measured, as was pulse pressure (ASPpulse). RESULTS: at an SPmean of 70 mmHg, the ASPmean was 34 +/- 0.8 mmHg (polyethylene knitted, thick wall), 30 +/- 1.0 mmHg (polyethylene woven, thin wall), and 17 +/- 0.6 mmHg (thin wall ePTFE). The ASPmean increased with SPmean, the relationship depending on the graft material. Stiffer grafts were associated with lower ASPmean and ASPpulse (p<0.001). CONCLUSIONS: the relationship between aneurysm sac mean pressure and systemic pressure (SP) depends on the graft material. These data highlights the need for further studies regarding endotension.

Recombinant human erythropoietin, epoetin beta, in patients with relapsed lymphoma treated with aggressive sequential salvage chemotherapy--results of a randomized trial.

The aim of the study was to investigate the effects of erythropoietin (epoetin beta) on red blood cell (RBC) transfusions, hemoglobin (Hb) levels, and quality of life (QOL) in patients with relapsed lymphoma treated with an aggressive sequential salvage chemotherapy (SSCT) regimen. Sixty patients with early or late relapsed Hodgkin's disease ( n=39) or first relapse of aggressive non-Hodgkin's lymphoma ( n=21) were randomized to receive epoetin beta 10,000 IE subcutaneously three times a week or no epoetin during salvage chemotherapy. Patients in both study arms received two cycles of DHAP (dexamethasone, high-dose cytarabine, cisplatin); patients in partial remission (PR) or complete remission (CR) then received cyclophosphamide, followed by peripheral blood stem cell (PBSC) harvest, methotrexate plus vincristine, and etoposide. The final myeloablative course was BEAM (carmustine, etoposide, cytarabine, and melphalan) followed by autologous stem cell support. The primary endpoint of the study was the number of RBC units needed during SSCT. In addition, Hb levels and QOL were measured. The mean number of RBC units given in the epoetin beta arm was 4.5 compared to 8.3 in the control arm ( P=0.0134). The mean Hb levels during therapy were 10.4 g/dl in the epoetin beta arm and 9.7 g/dl in the control ( P=0.018). From baseline until BEAM therapy QOL (EORTC QLQ C30) and fatigue (MFI) assessment showed little QOL worsening or stable levels in both arms with a steeper increase of fatigue levels in the control group. Patients with relapsed lymphoma undergoing aggressive chemotherapy and stem cell support benefited from epoetin beta therapy, with a decrease of RBC transfusion requirements and lower rise of fatigue levels.

Gravity and light effects on the circadian clock of a desert beetle, Trigonoscelis gigas.

Circadian function is affected by exposure to altered ambient force environments. Under non-earth gravitational fields, both basic features of circadian rhythms and the expression of the clock responsible for these rhythms are altered. We examined the activity rhythm of the tenebrionid beetle, Trigonoscelis gigas, in conditions of microgravity (microG; spaceflight), earth's gravity (1 G) and 2 G (centrifugation). Data were recorded under a light-dark cycle (LD), constant light (LL), and constant darkness (DD). Free-running period (tau) was significantly affected by both the gravitational field and ambient light intensity. In DD, tau was longer under 2 G than under either 1 G or microG. In addition, tauLL was significantly different from tauDD under microG and 1 G, but not under 2 G.

Epidemiology of Peyronie's disease.

Francois Gigot de la Peyronie, surgeon to Louis XV of France, has become synonymous with the rather enigmatic though not uncommon condition of Peyronie's disease (PD), a localized connective tissue disorder of the penile tunica albuginea. The true prevalence of Peyronie's disease is unknown. Therefore, we decided to perform an evaluation of existing epidemiological data. A prevalence rate of 3.2% was determined in male inhabitants of the greater Cologne area. This is much higher than revealed by the data reported up to now, thus rendering the accepted prevalence rates of 0.3% to 1% untenable. The actual prevalence of Peyronie's disease may be even higher, considering many patients' reluctance to report this embarrassing condition to their physicians. Along these lines, most clinicians note that the number of Peyronie's patients has increased since the advent of oral sildenafil. Comparably high prevalences are known for diabetes and urolithiasis, suggesting a greater frequency of this rare disease than formerly believed.

ACE and angiotensinogen gene genotypes and left ventricular mass in athletes.

BACKGROUND: Genetic factors may be important in modifying heart size due to long-term athletic training. The significance of polymorphisms of genes of the renin-angiotensin system in myocardial mass in a population of athletes participating in different disciplines is not known. METHODS: The angiotensin I-converting enzyme gene insertion/deletion (I/D) polymorphism, angiotensinogen gene M235T polymorphism and angiotensin II type 1 receptor gene A1166C polymorphism were determined in 83 male Caucasian endurance athletes and associated with left ventricular mass. RESULTS: No association with left ventricular mass was found for the polymorphisms of angiotensin I-converting enzyme gene I/D, angiotensinogen gene M235T and angiotensin II type 1 gene A1166C when studied separately. However, combined analysis of the angiotensin I-converting enzyme gene I/D polymorphism and angiotensinogen gene M235T polymorphism genotypes suggested an association with left ventricular mass (g m(-2)) (P = 0.023). Athletes with the angiotensin I-converting enzyme gene DD/angiotensinogen gene TT genotype combination had greater left ventricular mass compared with all other genotype combinations (179.8 +/- 26.1 g m(-2) vs. 145.2 +/- 27.3 g m(-2), P = 0.003). CONCLUSIONS: These results suggest an association of combined angiotensin I-converting enzyme gene I/D polymorphism genotypes, and angiotensinogen gene M235T polymorphism genotypes with left ventricular hypertrophy due to long-term athletic training. A synergistic effect of angiotensin I-converting enzyme gene DD genotype and angiotensinogen gene TT genotype on left ventricular mass in endurance athletes appears to occur.

Detection of porcine bone lesions and fissures: comparing digital selenium, digital luminescence, and analog film-screen radiography.

OBJECTIVE: The purpose of our study was to compare the diagnostic performance of a digital selenium detector (Thoravision) with that of analog film-screen systems and digital luminescence radiography in skeletal radiography for the detection of fissures and lesions in porcine bones. MATERIALS AND METHODS: One hundred bones taken from domestic pigs (50 ribs and 50 femurs) were divided into two equal groups. Fissures and bone lesions were created in 50 bones and 50 served as controls. The bones were examined using film-screen systems, digital luminescence radiography, and digital selenium radiography at various doses. Digital selenium radiography exposure values were adapted to the image geometry differing from the reference methods with a detector focus distance of 2.15 m. Four radiologists independently evaluated image quality and detectability of fissures and lesions on a five-point scale of confidence. Statistical evaluation was based on receiver operating characteristic curve analysis. RESULTS: Fissures and bone lesions were detected most reliably using the mammography film-screen system, but the difference in the results of the analog and digital reference images did not achieve statistical significance. CONCLUSION: Compared with analog film-screen systems, the lower spatial resolution of the digital selenium and digital luminescence radiography systems does not affect detectability of fissures and bone lesions in porcine bone. Selenium is effective in skeletal radiography for detecting fissures and bone lesions. With digital selenium and digital luminescence radiography, the surface dose can be cut to half that required for 200-speed film-screen systems without losing any diagnostically relevant information.

Image quality of digital chest X-rays: wet versus dry laser printers.

The aim of this study was to compare the image quality of digital chest x-rays (Thoravision) obtained with 2 "wet" laser imagers of different matrix sizes and a "dry" system. Fifty chest x-rays in 2 planes were printed out in normal (100%) and reduced (61%) format using 3 different systems: 2 "wet" laser imagers (Agfa Matrix LR 3300, 4256 x 5174 pixels, 315 dpi; Agfa Scopix LR 5200, 8512 x 10348 pixels, 630 dpi), and one "dry" system (Agfa Drystar 3000,4352 x 5295 pixels, 330 dpi). All tests yielded normal findings. Anonymous images were evaluated by 4 independent reviewers on record forms rating the detectability of predefined anatomic structures. When the image quality of diagnosis-relevant, anatomic structures was evaluated on digital chest x-rays reproduced in normal and reduced format, the wet laser imagers did not show significant advantages over the dry system, Agfa Drystar 3000. The Agfa Drystar 3000 system is a feasible alternative for reproducing digital images, particularly for decentralized archives.

Hypertension guidelines and their limitations--the impact of physicians' compliance as evaluated by guideline awareness.

OBJECTIVE: The initial step of an optimal therapeutic strategy for patients with arterial hypertension is the recognition and acceptance of new recommendations by the physicians themselves. This guideline awareness of the physicians has never been evaluated in detail. DESIGN: The awareness of content of current recommendations in hypertension diagnosis, treatment and treatment control was therefore assessed in primary care physicians using a questionnaire. The guidelines of the German Hypertension Society were used as the reference standard. PARTICIPANTS: A total of 24 899 German physicians, including all internists, all cardiologists and 22% of general practitioners were contacted in a nationwide survey. MAIN OUTCOME MEASURES: The number of answers in agreement with the guideline was used as a measure of guideline awareness. Adequate awareness of content of guideline recommendations was defined as the correct answer to five out of eight questions; the correct answers had to include the appropriate definition of hypertension. RESULTS: The analysis was based on 11 547 returned questionnaires (47.1%). An adequate guideline awareness was found in 23.7% of the total study population, especially in 37.1% of cardiologists, in 25.6% of internists and in 18.8% of general practitioners. While the guideline awareness was significantly influenced by the duration of private practice, regional and municipal factors had only minor influence on the results. CONCLUSION: The impact of hypertension guidelines on actual medical knowledge is modest. Thus, the information strategies about current treatment guidelines must be improved and tailored to the needs of physicians in clinical practice to ultimately improve patient care.

A new and accurate prediction model for growth response to growth hormone treatment in children with growth hormone deficiency.

OBJECTIVE: To identify parameters which predict individual growth response to recombinant human GH (rhGH) therapy and to combine these parameters in a prediction model. DESIGN: Fifty-eight prepubertal patients with GH deficiency (17 females) participated in this prospective multicenter trial with 1 year of follow-up. METHODS: Auxological measurements, parameters of GH status and markers of bone metabolism were measured at baseline and at 1, 3 and 6 months after the start of rhGH treatment. Correlations with height velocity during the first 12 months of treatment (HV+12) were calculated. Prediction models were derived by multiple regression analysis. RESULTS: The model which best predicted HV+12 combined the following parameters: pretreatment bone age retardation as a fraction of chronological age, pretreatment serum levels of IGF-I, urinary levels of deoxypyridinoline (a marker of bone resorption) after 1 month of treatment and height velocity after 3 months of treatment. This model explained 89% of the variation in HV+12 with a standard deviation of the residuals of 0.93 cm/year. Defining successful rhGH therapy as a doubling of pretreatment height velocity, the model had a specificity of 90% and a sensitivity of 100% in predicting therapeutic success. CONCLUSIONS: This model is an accurate and practicable tool to predict growth response in GH-deficient children. It may help to optimize rhGH therapy by individual dose adjustment and contribute to improved overall outcomes.

Perioperative treatment with filgrastim stimulates granulocyte function and reduces infectious complications after esophagectomy.

We investigated the effects of recombinant G-CSF (Filgrastim) on the function of neutrophils and the rate of infectious complications in an open-label, nonrandomized study of patients with esophageal cancer undergoing esophagectomy. In this single-center phase-II trial 20 sequential patients (19 evaluable) received Filgrastim at standard doses (300 microg or 480 microg) subcutaneously for 2 days prior to and up to 7 days after surgery. The phagocytotic activity of neutrophils and the oxidative burst in the study group and in an experimental control group (n=27) were measured on days -2, 2, and 10. Neutrophil function was enhanced in the Filgrastim-treated group by factor 1.2 for phagocytosis (p=0.016) and 1.4 for oxidative burst (p)=0.154). Leukocyte counts increased from 7.6 x 10(9)/l (day -2) to a maximum of 45 x 10(9)/l on day 6. No infection was reported in the study group (mean age 59.7 years; 13 men, seven women) up to 10 days after surgery. In contrast, 23 patients (29.9%) in a historical control group (mean age 56 years; 67 men, ten women) treated at the same center developed infections within the first 10 days (p = 0.008). In addition, no postoperative deaths occurred in the study group, compared with 9.1% in the group of historical controls. Thus, in this study, administration of Filgrastim stimulated neutrophil function in patients undergoing esophagectomy, and it might be effective in reducing infectious complications related to the surgical procedure.

Influence of puberty on muscle area and cortical bone area of the forearm in boys and girls.

The aim of the current study is to analyze the interaction of the muscle and bone system (muscle-bone unit) during puberty in males and females by computed tomography of the nondominant forearm. The data presented here are the first results from 318 healthy children (159 boys and 159 girls), aged 6-22 yr, and 336 adults (parents) participating in the DONALD Study (Dortmund Nutritional and Anthropometric Longitudinally Designed Study). Cortical area (CA) of the radius representing bone strength and muscle area (MA) representing muscle strength were measured with peripheral quantitative computed tomography (XCT 2000; Stratec, Pforzheim, Germany). A single slice measurement at a site corresponding to 65% of the ulnar length proximal to the radial endplate was used. MA and CA of the radius have been determined by a built-in software algorithm using density differences. There was a strong correlation between MA (x) and CA (y) in all children, adolescents, and adults (y = 0.019x + 10.93; r2 = 0.77). Before puberty, boys and girls displayed a similar relation between MA and CA. CA in relation to MA was greater in girls than in boys during puberty. Analysis of covariance was performed investigating the dependency of CA on MA, five pubertal stages, sex, and interaction of sex and pubertal stages. MA representing muscle strength was the strongest predictor of CA (P < 0.001) representing bone mass. Pubertal stage (P < 0.001) and interaction of pubertal stage*sex (P = 0.002) also had a significant influence on CA. r2 of the model was 0.85. These data suggest that in pubertal girls and women rather than in pubertal boys and men an additional factor shifts the relationship between MA and CA to higher values of cortical area. The present data confirm previous studies of the influence of puberty and estrogens or related factors on the muscle-bone interaction.

Epidemiology of erectile dysfunction: results of the 'Cologne Male Survey'.

The last few decades have seen a marked increase in mean life expectancy in Central Europe. This has made elderly people and their quality of life a matter of ever-increasing medical concern. Available data from the United States and Scandinavia relating to erectile dysfunction (ED) do not enable us to draw valid conclusions about the current situation in Germany. The aim of the present study was to evaluate the epidemiology of male sexuality in Germany, and the proportion of men who need medical treatment because of increased suffering from this.A newly developed and validated questionnaire on male erectile dysfunction was mailed to a representative population sample of 8000 men, 30-80 y of age in the Cologne urban district. The response included 4489 evaluable replies (56.1%). The response rates in different age groups ranged from 49.2% to 68.4%. Regular sexual activity was reported by 96.0% (youngest age group) to 71.3% (oldest group). There were 31.5%-44% of responders who were dissatisfied with their current sex life. The prevalence of ED was 19.2%, with a steep age-related increase (2.3-53.4%) and a high co-morbidity of ED with hypertension, diabetes, pelvic surgery and 'lower urinary tract symptoms'. When treatment need was defined by co-occurrence of ED and dissatisfaction with sex life, 6.9% men required treatment for ED. Oral treatment of ED was preferred by 73.8% of respondents. There were 46.2% respondents who were willing to contribute more than DM 50 (25 Euro) per month for ED treatment. We conclude that regular sexual activity is a normal finding in advanced age. ED is a frequent disorder, contributing to dissatisfaction with sex life in a considerable proportion of men. The high burden of ED is reflected in willingness to pay for treatment. ED is frequently associated with chronic diseases. Therefore adequate diagnostic workup is essential, to offer patients individually adapted treatment. General non-reimbursability of treatment for ED appears to be unacceptable.

Resampling-based methods for the analysis of multiple endpoints in clinical trials.

We consider multivariate tests for comparing two treatments with multiple endpoints. The test decision is drawn from the simultaneous consideration of the univariate tests for the single endpoints. A general class of these tests, called cut-off tests, can be given, which, however, can lead to highly conservative procedures because the dependencies among the endpoints are not taken into account. In applying resampling-based methods considerable improvements for these tests can be achieved. Resampling-based cut-off tests are proposed which are sensitive against a treatment difference in a single endpoint, in a subgroup of endpoints, or in all endpoints. The results of Monte Carlo simulations demonstrate that a remarkable gain in statistical power as compared to the crude simultaneous consideration can be reached. In particular, for the multivariate one-sided test situation the proposed tests can be recommended. As an example the application of the tests is demonstrated by data from a clinical trial.