Correlation of CT-based bone mineralization with drilling-force measurements in anatomical specimens is suitable to investigate planning of trans-pedicular spine interventions.

This interdisciplinary study examined the relationship between bone density and drilling forces required during trans-pedicular access to the vertebra using fresh-frozen thoraco-lumbar vertebrae from two female body donors (A, B). Before and after biomechanical examination, samples underwent high-resolution CT-quantification of total bone density followed by software-based evaluation and processing. CT density measurements (n = 4818) were calculated as gray values (GV), which were highest in T12 for both subjects (GVmaxA = 3483.24, GVmaxB = 3160.33). Trans-pedicular drilling forces F (Newton N) were highest in L3 (FmaxB = 5.67 N) and L4 (FmaxA = 5.65 N). In 12 out of 13 specimens, GVs significantly (p < 0.001) correlated with force measurements. Among these, Spearman correlations r were poor in two lumbar vertebrae, fair in five specimens, and moderately strong in another five specimens, and highest for T11 (rA = 0.721) and L5 (rB = 0.690). Our results indicate that CT-based analysis of vertebral bone density acquired in anatomical specimens is a promising approach to predict the drilling force appearance as surrogate parameter of its biomechanical properties by e.g., linear regression analysis. The study may be of value as basis for biomechanical investigations to improve planning of the optimal trajectory and to define safety margins for drilling forces during robotic-assisted trans-pedicular interventions on the spine in the future.

Prevalence and One-Year Survival of Selected Major Congenital Anomalies in Germany: A Population-Based Cohort Study.

INTRODUCTION: Congenital anomalies play an important role in infant mortality worldwide. The present study aims to present the current data on the prevalence rates and the 1-year survival rates for selected major congenital anomalies in Saxony-Anhalt, Germany. MATERIALS AND METHODS: The data were collected systematically by the Malformation Monitoring Centre Saxony-Anhalt. Cohort from 2000 to 2017 was retrospectively analyzed to determine the prevalence rates and the survival rates of nine major congenital anomalies. The survival analysis was conducted, including all pregnancy outcomes and various risk factors. RESULTS: In total, 1,012 cases of the selected congenital anomalies were registered. The total prevalence rates ranged from 2.5 (congenital diaphragmatic hernia [CDH]) to 5.8 (spina bifida [SB]) per 10,000. The live birth prevalence was lower. In total, 88.3% of live-born cases survived the first year. The 1-year survival rate of all cases, including fetal losses, was merely 61.7%. There was no continual improvement in survival during the study period noted. The 1-year survival rate was 35.7% for "genetic" malformations, 57.6% for "multiple congenital anomalies," and 68.6% for "isolated" cases, with 44.6% for prenatally detected anomalies and 85.2% for postnatally identified anomalies. Gestational age less than 31 weeks and birth weight below 1,000 g affected the survival rate adversely. CONCLUSION: The survival rate of infants suffering from congenital anomalies in Saxony-Anhalt is comparable to that reported by national and international studies. Registering all pregnancy outcomes irrespective of whether they result in a live birth, stillbirth, or fetal loss in a malformation register seems to be important as it affects the statistical survival analysis in general.

Can alternative liver function scores facilitate the establishment of an indication for radioablative therapy in patients with hepatocellular carcinoma?

BACKGROUND AND PURPOSE: ALBI and IBI are new scores to evaluate the liver function in patients with hepatocellular carcinoma (HCC). The purpose of this study was to evaluate the prognostic abilities of those scores in patients treated with interstitial brachytherapy (iBT). MATERIALS AND METHODS: 190 patients treated with iBT between 01.01.2006 and 01.01.2018 were included in this study. The clinical target dose was 15 Gy. The patients were all in Child-Pugh stadium A or B and across the Barcelona Clinic Liver Cancer (BCLC) Stages 0-C. Retrospectively ALBI and IBI were calculated pre- and post-therapeutic until 6 months after iBT. Hazards ratios were calculated, and p values corrected using the false discovery rate according to Benjamini and Hochberg. RESULTS: The median overall survival was 23.5 months (CI 19-28.5 months), and the median progression-free survival was 7.5 months (CI 6-9 months). Elevated ALBI showed a significantly higher risk to die with a hazard ratio (HR) of 2.010 (ALBI 2 vs. 1) and 4082 (ALBI 3 vs. 1), respectively. The IBI did also show a higher risk with an HR of 1.816 (IBI 1 vs. 0) and 4608 (IBI 2 vs. 0), respectively. Even 3 months after therapy elevated ALBI and IBI showed poor overall survival. Concerning progression-free survival, ALBI and IBI could not provide any relevant additional information. CONCLUSION: ALBI and IBI are useful tools to predict the overall survival in patients treated with iBT and might be helpful to assign the patients to the appropriate therapy.

Randomized Trial of a Supportive Psychotherapy for Parents of Adolescents and Young Adults With Hematologic Malignancies.

BACKGROUND: Cancer regularly disrupts health and developmental trajectories in adolescents and young adults (AYAs). Parents have been shown to have a substantial impact on the health and cancer survivorship activities of AYA patients in the form of symptom management. However, no randomized controlled trial has evaluated a coping support intervention (CSI) program for parents of AYAs with cancer aged 18 to 40 years. PATIENTS AND METHODS: From November 30, 2012, to August 29, 2016, parents of AYAs with hematologic malignancies were randomized in a phase III controlled trial (1:1 ratio, stratified sampling) to either the research-based CSI AYA-Parents group (CSI group; n=82) or the standard care (SC) group (n=70). CSI consisted of 5 sessions to achieve the enhancement of parental adaptive coping as the primary outcome (per the adaptive coping scale of the 28-item Brief COPE, a validated multidimensional self-assessment-questionnaire recommended for clinical cancer research). Measures of adaptive coping, depression, and mental health were collected at pre-CSI (measurement date T1), at the end of the intervention sessions (measurement date T2), and at follow-up (3 months). We calculated mean change scores in outcomes and estimated intervention effect sizes (Cohen's d) for changes from T1 to T2/T3, with 0.2 indicating a small effect, 0.5 a medium effect, and 0.8 a large effect. All statistical tests were 2-sided. RESULTS: In the intention-to-treat analysis, the CSI group significantly improved their adaptive coping compared with the SC group (95% CI, 0.30-2.54; P=.013; d=0.405), whereas adaptive coping in the SC group deteriorated. The CSI group also experienced a significant decrease in depressive symptoms and improved mental health with clinical significance (95% CI, -1.98 to -0.30; P=.008; d=0.433, and 95% CI, -0.19 to 3.97; P=.074; d=0.292, respectively). Sensitivity analyses confirmed the robustness of the main intention-to-treat analysis. CONCLUSIONS: CSI improved effectively adaptive coping and depression in parents of AYAs with hematologic malignancies. It may represent a novel family-based approach in AYA oncology care.

Metabolic effects of estradiol versus testosterone in complete androgen insensitivity syndrome.

PURPOSE: To study differences in metabolic outcomes between testosterone and estradiol replacement in probands with complete androgen insensitivity syndrome (CAIS). METHODS: In this multicentre, double-blind, randomized crossover trial, 26 women with CAIS were included of whom 17 completed the study. After a two-months run in phase with estradiol, probands either received transdermal estradiol followed by crossover to transdermal testosterone or vice versa. After six months, differences in lipids, fasting glucose, insulin, hematocrit, liver parameters and blood pressure between the treatment phases were investigated. RESULTS: Linear mixed models adjusted for period and sequence did not reveal major group differences according to treatment for the investigated outcomes. In each treatment group, there were however significant uniform changes in BMI and cholesterol. BMI increased significantly, following six months of estradiol ( + 2.7%; p = 0.036) as well as testosterone treatment ( + 2.8%; p = 0.036). There was also a significant increase in total ( + 10.4%; p = 0.001) and LDL-cholesterol ( + 29.2%; p = 0.049) and a decrease in HDL-cholesterol (-15.8%; p < 0.001) following six months of estradiol as well as six months of testosterone treatment (total cholesterol: + 14.6%; p = 0.008; LDL-cholesterol: + 39.1%; p = 0.005, HDL-cholesterol: -15.8%; p = 0.004). Other parameters remained unchanged. CONCLUSION: Transdermal estradiol as well as testosterone treatment in women with CAIS results in worsening in lipid profiles. Given the relatively small sample size, subtle group differences in other metabolic parameters may have remained undetected.

Monitoring excimer laser-guided cardiac lead extractions by uniportal video-assisted thoracoscopy: A single center experience.

BACKGROUND: Though laser guided extractions of cardiac implantable electronic devices leads have become a routine procedure, the severe complications are associated with a high mortality. Here, we report our single center experience using uniportal video-assisted thoracoscopy for laser lead extraction and compare it to stand-alone laser lead extraction. METHODS: The intraoperative data and postoperative clinical outcomes of patients undergoing laser lead extraction with concomitant thoracoscopy (N = 28) or without (N = 43) in our institution were analyzed retrospectively. RESULTS: Neither the median x-ray time (612.0 s for the thoracoscopy group vs. 495.5 s for the non-thoracoscopy group, p = 0.962), length of the operation (112.5 vs. 100.0 min, p = 0.676) or the median length of hospital stay (9.0 vs. 10.0 days, p = 0.990) differed significantly. The mean intensive care unit stay was longer for patients in the non-thoracoscopy group (0.8 vs. 2.5 days, p = 0.005). The 30-day-mortality in the thoracoscopy group was zero, whereas five patients died in the non-thoracoscopy group. Furthermore, four patients in the non-thoracoscopy group had encountered haemothorax, while none were observed in the thoracoscopy group (p = 0.148). CONCLUSIONS: The adoption of uniportal video-assisted thoracoscopy during laser-guided lead extraction of cardiac implantable electronic devices can be considered safe and does not lengthen the operating time or hospital stay. It might be useful in the detection of severe complications and, in experienced hands, possibly allow direct bleeding control.

Association of serum vitamin D levels with disease severity, systemic inflammation, prior lung function loss and exacerbations in a cohort of patients with chronic obstructive pulmonary disease (COPD).

BACKGROUND: Vitamin D deficiency has been associated with chronic disorders including chronic obstructive pulmonary disease (COPD) but the relationships with inflammation, exacerbations and disease progression remain unclear. METHODS: In this monocentric cross-sectional observational study we analyzed the disease status, systemic inflammation, prior exacerbation frequency and loss in lung function in relation to serum 25-hydroxyvitamin D (25-OHD) levels in a cohort of 94 patients with COPD. Serum 25-OHD, C-reactive protein, interleukin-6 and tumor necrosis factor-α were quantified. Exacerbation frequencies and sunlight exposure were assessed. These parameters were analyzed in correlation to the current forced expiratory volume in 1 s (FEV1), the individual average 3-year FEV1 decline and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage. RESULTS: We observed fair correlation between serum 25-OHD and the current FEV1 (r=0.38, P<0.001). Furthermore, mean serum 25-OHD was significantly altered between patients of GOLD stages I-IV (P=0.013). There was weak negative correlation of 25-OHD and the average annual change of the FEV1 (r=-0.26, P<0.05). Furthermore, we observed fair negative correlation between 25-OHD and C-reactive protein (r=-0.32, P<0.01) as well as weak negative correlation with interleukin-6 (r=-0.23, P<0.05). While the exacerbation frequency significantly differed between GOLD stages (P=0.04), there was no direct association between exacerbations and 25-OHD levels. CONCLUSION: Our data confirm frequent vitamin D deficiency in COPD and point out correlations between 25-OHD levels, systemic inflammation, disease severity and progression.

Evaluation of Vascular Patterns Using Contact Endoscopy and Narrow-Band Imaging (CE-NBI) for the Diagnosis of Vocal Fold Malignancy.

The endoscopic detection of perpendicular vascular changes (PVC) of the vocal folds has been associated with vocal fold cancer, dysplastic lesions, and papillomatosis, according to a classification proposed by the European Laryngological Society (ELS). The combination of contact endoscopy with narrow-band imaging (NBI-CE) allows intraoperatively a highly contrasted, real-time visualization of vascular changes of the vocal folds. Aim of the present study was to determine the association of PVC to specific histological diagnoses, the level of interobserver agreement in the detection of PVC, and their diagnostic effectiveness in diagnosing laryngeal malignancy. The evaluation of our data confirmed the association of PVC to vocal fold cancer, dysplastic lesions, and papillomatosis. The level of agreement between the observers in the identification of PVC was moderate for the less-experienced observers and almost perfect for the experienced observers. The identification of PVC during NBI-CE proved to be a valuable indicator for diagnosing malignant and premalignant lesions.

Oestrogen versus androgen in hormone-replacement therapy for complete androgen insensitivity syndrome: a multicentre, randomised, double-dummy, double-blind crossover trial.

BACKGROUND: Women with complete androgen insensitivity syndrome (CAIS) after gonadectomy have complained about reduced psychological wellbeing and sexual satisfaction. The aim of this study was to compare the effectiveness of hormone-replacement therapy with either androgen or oestrogen in women with 46,XY karyotype and CAIS after gonadectomy. METHODS: This national, multicentre, double-blind, randomised crossover trial was performed at three university medical centres and three specialised treatment institutions in Germany. Eligible participants were women aged 18-54 years with 46,XY karyotype, genetically diagnosed CAIS, and removed gonads. Participants were randomly assigned (14:12) by a central computer-based minimisation method to either oestradiol 1·5 mg/day for 6 months followed by crossover to testosterone 50 mg/day for 6 months (sequence A) or to testosterone 50 mg/day for 6 months followed by crossover to oestradiol 1·5 mg/day for 6 months (sequence B). Participants also received oestradiol or testosterone dummy to avoid identification of the active substance. All participants received oestradiol 1·5 mg/day during a 2 months' run-in phase. The primary outcome was mental health-related quality of life, as measured with the standardised German version of the SF-36 questionnaire. Secondary outcomes were psychological wellbeing, as measured with the Brief Symptom Inventory (BSI), sexual function, as measured with the Female Sexual Function Index (FSFI), and somatic effects, such as signs of virilisation and effects on metabolic blood values. The primary analysis included all patients who were available at least until visit 5, even if protocol violations occurred. The safety analysis included all patients who received at least oestradiol during the run-in phase. This trial is registered with the German Clinical Trials Register, number DRKS00003136, and with the European Clinical Trials Database, number 2010-021790-37. FINDINGS: We enrolled 26 patients into the study, with the first patient enrolled on Nov 7, 2011, and the last patient leaving the study on Jan 23, 2016. 14 patients were assigned to sequence A and 12 were assigned to sequence B. Ten participants were withdrawn from the study, two of whom attended at least five visits and so could be included in the primary analysis. Mental health-related quality of life did not differ between treatment groups (linear mixed model, p=0·794), nor did BSI scores for psychological wellbeing (global severity index, p=0·638; positive symptom distress index, p=0·378; positive symptom total, p=0·570). For the FSFI, testosterone was superior to oestradiol only in improving sexual desire (linear mixed model, p=0·018). No virilisation was observed, and gonadotrophin concentrations remained stable in both treatment groups. Oestradiol and testosterone concentrations changed substantially during the study in both treatment groups. 28 adverse events were reported for patients receiving oestradiol (23 grade 1 and five grade 2), and 38 adverse events were reported for patients receiving testosterone (34 grade 1, three grade 2, and one grade 3). One serious adverse event (fibrous mastopathy) and 20 adverse events (16 grade 1 and four grade 2) were reported during the run-in phase, and 12 adverse events during follow-up (nine grade 1 and three grade 2). INTERPRETATION: Testosterone was well tolerated and as safe as oestrogen for hormone-replacement therapy. Testosterone can be an alternative hormone substitution in CAIS, especially for woment with reduced sexual functioning. FUNDING: German Federal Ministry of Education and Research.

Serum bile acids and GLP-1 decrease following telemetric induced weight loss: results of a randomized controlled trial.

Bile acids (BAs) are increasingly recognised as metabolic regulators, potentially improving insulin sensitivity following bariatric surgery. However, physiological relevance of such observations remains unknown. Hence, we analysed serum BA composition and associated gut-derived hormone levels following lifestyle-induced weight loss in individuals with metabolic syndrome (MetS). 74 non-smoking men (45-55 yr) with MetS were randomised to a lifestyle-induced weight loss program (supervision via telemonitoring) or to a control arm. Before and after a 6 months intervention period clinical and laboratory parameters, body composition, serum BA profile, FGF-19, and GLP-1 concentrations were determined in fasting blood samples. 30 participants in the control and 33 participants in the treatment arm completed the study and were included in the data analysis. In participants of the treatment arm lifestyle-induced weight loss resulted in markedly improved insulin sensitivity. Serum levels of BA species and total GLP-1 decreased, while FGF-19 remained stable. Serum BA composition changed towards an increased 12α-hydroxylated/non-12α-hydroxylated ratio. None of these parameters changed in participants of the control arm. Our results demonstrate that improved metabolic control by lifestyle modifications lowers serum levels of BAs and GLP-1 and changes serum BA composition towards an increased 12α/non-12α ratio (ICTRP Trial Number: U1111-1158-3672).

Measurement of Procedure-Specific Irrigation-Fluid Absorption in Transurethral Therapy of Lower Urinary Tract Syndrome, Using Ethanolic Saline and Breath Alcometry.

INTRODUCTION: Transurethral resection risks excessive absorption of irrigating fluid with potentially severe or life-threatening consequences. We determined the amount of absorbed saline irrigation fluid during photoselective vaporisation of the prostate (PVP) and bipolar transurethral resection of the prostate (bTURP). PATIENTS AND METHODS: Patients at our institution treated by one of these methods were monitored by the alcometric method: ethanol is added to the irrigation fluid and blood alcohol is measured with a breathalyser. Various possible correlations were investigated. RESULTS: Data from 71 patients (36 PVP, 35 bTURP) were analysed. Detection of any absorption was more frequent under bTURP (71% of patients) than under PVP (39%; p = 0.006). Absorption in the volume range 500-1,000 ml was conspicuously more frequent in the bTURP procedure than in PVP. CONCLUSIONS: Presence of absorption was more frequent under bTURP than under PVP. However, high-volume absorption was more frequent during bTURP than in PVP.

Inability of shear-wave elastography to distinguish malignant from benign prostate tissue - a comparison of biopsy, whole-mount sectioning and shear-wave elastography.

AIM: This study was designed to assess the possible usefulness of shear-wave elastography in differentiating between benign and malignant tissue in prostate neoplasia. PATIENTS AND METHODS: A total of 120 prostate tissue samples were obtained from 10 patients treated by radical prostatectomy and investigated pre-operatively by ultrasound elastography followed by directed biopsy. After resection, whole-mount sectioning and histological examination was performed. The predictions based on shear-wave elastography were compared with biopsy and histological results. RESULTS: The comparison between the results of shear-wave elastography and those of biopsy was performed by receiver operating characteristic analysis, which suggested an optimum cut-off tissue elasticity value of 50 kPa, in agreement with earlier studies aimed at distinguishing between benign and malignant tissue. However, the diagnostic selectivity (and thus the diagnostic power) was poor (area under the curve 0.527, which hardly differs from the value of 0.500 that would correspond to a complete lack of predictive power); furthermore, application of this cut-off value to the samples led to a sensitivity of only 74% and a specificity of only 43%. An analogous comparison between the results of shear-wave elastography and those of whole-mount histology, which itself is more reliable than biopsy, gave an even poorer diagnostic selectivity (sensitivity of 62%, specificity of 35%). Meaningful association with Gleason score was not found for D'Amico risk groups (p = 0.35). CONCLUSIONS: The (negative) findings of this investigation add to the dissonance among results of studies investigating the possible value of shear-wave elastography as a diagnostic tool to identify malignant neoplasia. There is a clear need for further research to elucidate the diversity of study results and to identify the usefulness, if any, of the method in question.

New aspects in shear-wave elastography of prostate cancer.

AIM: This study was designed to evaluate the performance of shear-wave elastography as a diagnostic tool for prostate cancer in a larger cohort of patients than previously reported. PATIENTS AND METHODS: Seventy-three patients with suspected prostate carcinoma were investigated by ultrasound elastography followed by directed biopsy. The elastographic and histological results for all biopsies were compared. RESULTS: After exclusion of invalid and non-assessable results, 794 samples were obtained for which both a histological assessment and an elastometric result (tissue stiffness in kPa) were available: according to the histology 589 were benign and 205 were malignant. Tissue elasticity was found to be weakly correlated with patient's age, PSA level and gland volume. ROC analysis showed that, for the set of results acquired, elastometry did not fulfil literature claims that it could identify malignant neoplasia with high sensitivity and specificity. However, it did show promise in distinguishing between Gleason scores ≤6 and >6 when malignancy had already been identified. Unexpected observations were the finding of a smaller proportion of tumours in the lateral regions of the prostate than generally expected, and also the observation that the elasticity of benign prostate tissue is region-sensitive, the tissue being stiffest in the basal region and more elastic at the apex. CONCLUSIONS: Shear-wave elastography was found to be a poor predictor of malignancy, but for malignant lesions an elasticity cut-off of 80 kPa allowed a fairly reliable distinction between lesions with Gleason ≤6 and those with Gleason >6. We demonstrate an increase in elasticity of benign prostate tissue from the basal to the apical region.

Subjective need for psychological support (PsySupp) in parents of children and adolescents with disorders of sex development (dsd).

UNLABELLED: Disorders/diversity of sex development (dsd) is an umbrella term for congenital conditions often diagnosed within childhood. As most parents are unprepared for this situation, psychological support (PsySupp) is recommended. The aim of this study was to analyse the extent to which parents express a need for PsySupp. Three hundred twenty-nine parents of children with dsd were included; 40.4 % of the parents indicated to have a need for PsySupp, only 50 % of this group received it adequately. The diagnoses partial gonadal dysgenesis, partial androgen insensitivity syndrome (pAIS) and disorders of androgen synthesis are associated with a high need for PsySupp in parents (54, 65, and 50 %). Sex assignment surgery neither reduced nor increased the need for PsySupp. Taking a picture, radiography, laparoscopy, gonadal biopsy, gonadectomy and hormonal puberty induction are associated with a high need for PsySupp. There was no association between the need for PsySupp and the parents' perception of the appearance of the genitalia. CONCLUSION: Having a child with dsd is associated with a high need for PsySupp in parents. In particular, parents of children with XY-dsd with androgen effects other than hypospadias expressed a high need of PsySupp. PsySupp for parents should be an obligatory part of interdisciplinary care to reduce fears and concerns. What is known • In parents, having a child with dsd provokes insecurities and fears. Hence, psychological support is recommended as part of the interdisciplinary care. What is new • This is the first study investigating the subjective need for psychological support in a large sample of parents of children with dsd in Germany. We present data on the subjective need for psychological support of the parents, related diagnoses and factors, which should be considered in psychological counselling.

Utilization of health care services and satisfaction with care in adults affected by disorders of sex development (DSD).

BACKGROUND: Disorders of sex development (DSD) are a heterogeneous group of rare genetic disorders of sex determination or differentiation. Evidence-based guidelines concerning gender assignment and surgical and hormonal treatment are limited for many DSD entities, and health care is highly fragmented across various sub-specialties and settings. A lack of informed consent, secrecy about the condition, shame, and impaired sexual and psychosocial functioning may affect satisfaction with care. OBJECTIVES: The main goal of this study was to describe satisfaction with care in individuals with DSD and to identify factors associated with low satisfaction with care. METHODS/MAIN MEASURES: Using both biological (chromosomes) and social categories (sex of rearing), we classified participants according to the nomenclature of the European Society for Pediatric Endocrinology/Lawson Wilkins Pediatric Endocrine Society (ESPE/LWPES) consensus statement. We used standardized measures to assess satisfaction with care (CSQ-8), health-related quality of life (SF-36), psychological symptoms (BSI), and gender identity (FGI), in addition to self-constructed questionnaires probing experiences with health care and access to self-help groups. PARTICIPANTS: A total of 110 adults were recruited between January 2005 and December 2007 in four study centers in Germany, Austria, and German-speaking Switzerland. RESULTS: Reports of half the participants scored below the cut-off indicating low quality of care. Women with XX DSD conditions and virilization (i.e., congenital adrenal hyperplasia) reported the highest scores for satisfaction with care, and women with XY DSD conditions and complete lack of androgen effects reported the lowest scores. Satisfaction with care was positively associated with indicators of psychological well-being. CONCLUSIONS: Satisfaction with care is lowest among participants with the rarest conditions, highlighting the lack of evidence-based recommendations and the lack of coordination of care. Associations of satisfaction and well-being indicate the need to ensure access to mental health services.

Health-related quality of life in children with disorders of sex development (DSD).

UNLABELLED: Disorders of sex development (DSD) are rare genetic conditions resulting in atypical development of the sex organs. While some evidence is available on psychosexual outcomes, much less is known about the quality of life in this population, especially in children. Health-related quality of life (HRQOL) is a widely accepted endpoint for assessment and evaluation of interventions and medical care. Within the German DSD Network study, 86 children aged 8-12 years with several subtypes of DSD were recruited from Germany, Austria and Switzerland. Demographic, medical and psychosocial variables were collected through interviews of the attending physicians, the children and the parents. HRQOL was the primary outcome. It was assessed by the KINDL-R Questionnaire [2001]. Psychosexual determinants included gender identity/gender dysphoria, gender role behaviour, the child's knowledge about the condition and number/timing of genital surgery. A significant reduction of HRQOL was reported in children's self-report (p < 0.001), in particular in the area of self-esteem (p < 0.001), physical well-being (p < 0.01) and school functioning (p < 0.05). Girls with congenital adrenal hyperplasia who experienced gender dysphoria reported lower HRQOL scores compared to the study group at large. Atypical gender role behaviour was not associated with HRQOL. CONCLUSION: Psychosocial support of children with DSD and their families appears to be necessary in at least some cases and must be accessible for all patients.

A Randomised Phase II Trial Comparing Docetaxel Plus Prednisone with Docetaxel Plus Prednisone Plus Low-Dose Cyclophosphamide in Castration-Resistant Prostate Cancer.

BACKGROUND: Docetaxel plus prednisone is a standard treatment for castration-resistant prostate cancer. Cyclophosphamide may be an effective combination partner. METHODS: This randomised, multicentre, phase II trial compared the combination therapy of docetaxel plus prednisone plus cyclophosphamide with the standard therapy of docetaxel plus prednisone. RESULTS: Thirty-three patients received six 3-week treatment cycles (in total 171 cycles). During treatment, an adequate decline in prostate-specific antigen was seen in both groups (p = 0.068) without between-group differences (p = 0.683). No relevant differences between within-group changes were observed for blood pressure, weight, pain score, laboratory variables or quality of life. There were no serious side effects apart from leucopenia requiring treatment (docetaxel + prednisone + cyclophosphamide arm) and no drug-related withdrawals; all three fatalities were considered to be cancer related. CONCLUSIONS: The oncological effectiveness and tolerability of docetaxel plus prednisone were supported; an additional effect of cyclophosphamide was not detected. However, the small number of patients and short observation period restrict the generalisability of the results.

Satisfaction with genital surgery and sexual life of adults with XY disorders of sex development: results from the German clinical evaluation study.

BACKGROUND: Prenatal deficit of androgens or androgen action results in atypical genitalia in individuals with XY disorders of sex development (XY,DSD). XY,DSD include mainly disorders of gonadal development and testosterone synthesis and action. Previously, most XY,DSD individuals were assigned to the female sex. Constructive genital surgery allowing heterosexual intercourse, gonadectomy, and hormone therapy for feminization were often performed. However, outcome studies are scarce. OBJECTIVE: Our objective was evaluation of satisfaction with genital surgery and sexual life in adults with XY,DSD. DESIGN AND METHODS: We evaluated 57 individuals with XY,DSD from the German multicenter clinical evaluation study with a condition-specific questionnaire. The individuals were divided into subgroups reflecting the absence/presence of partial androgen effect or genital constructive surgery. RESULTS: Dissatisfaction with function of the surgical result (47.1%) and clitoral arousal (47.4%) was high in XY,DSD partially androgenized females after feminization surgery. Dissatisfaction with overall sex life (37.5%) and sexual anxieties (44.2%) were substantial in all XY,DSD individuals. Problems with desire (70.6%), arousal (52.9%), and dyspareunia (56.3%) were significant in XY,DSD complete females. 46,XY partially androgenized females reported significantly more often partners of female (9.1%) or both sexes (18.2%) and dyspareunia (56.5%) compared with controls. Individuals with complete androgen insensitivity syndrome stated significant problems with desire (81.8%), arousal (63.6%), and dyspareunia (70%). CONCLUSIONS: Care should be improved in XY,DSD patients. Constructive genital surgery should be minimized and performed mainly in adolescence or adulthood with the patients' consent. Individuals with DSD and their families should be informed with sensibility about the condition. Multidisciplinary care with psychological and nonprofessional support (parents, peers, and patients' support groups) is mandatory from child to adulthood.

The submucosal cushion does not improve the histologic evaluation of adenomatous colon polyps resected by snare polypectomy.

BACKGROUND & AIMS: Although the "submucosal cushion" technique or injection-assisted polypectomy (IAP) is often used to resect colon polyps, little is known on the influence of this technique on histologic interpretation. We aimed to evaluate whether the use of a submucosal cushion improves the histologic and margin evaluation of colon polyps. METHODS: Consecutive patients undergoing polypectomy with and without IAP were included. An experienced blinded gastrointestinal pathologist evaluated the specimens using standardized criteria. RESULTS: One hundred eleven sessile colon adenomas were analyzed (IAP, n = 65, standard, n = 46). Two-thirds of polyps ranged in size from 10 to 20 mm; the average polyp size was 13.2 mm for IAP and 9.9 mm for standard snare polypectomy (P = .001). The cautery degree, cautery amount, and margin evaluability, did not differ substantially with regard to the resection technique. For polyps ≥10-20 mm, the overall architecture quality was better in polyps resected with standard technique as compared with IAP. CONCLUSIONS: The utilization of IAP did not result in a better margin evaluability of the resected polyp. Overall, IAP does not result in a better histologic polyp evaluability.

Outcome after implantation of cardiac resynchronization/defibrillation systems in patients with congestive heart failure and left bundle-branch block.

OBJECTIVE: The implantation of cardiac resynchronization/defibrillation devices (CRT-Ds) increasingly is used in patients with congestive heart failure and left bundle-branch block. There are no data on the effects of anesthesia and surgery on outcome after implantation. DESIGN: A retrospective, observational study; postoperative survey. SETTING: University hospital. PARTICIPANTS: Three hundred forty-one patients (258 men/83 women, 63 +/- 9 years) with congestive heart failure and left bundle-branch block who underwent CRT-D implantation in 1996 to 2005. MEASUREMENTS AND MAIN RESULTS: Perioperative data were retrieved from the patients' records. Cardiologists caring for the patients were contacted to obtain information on current New York Heart Association (NYHA) status and mortality after CRT-D implantation. Preoperatively, 45 patients were classified as NYHA II, 246 as NYHA III, and 50 as NYHA IV. CRT was performed via thoracotomy in 100 and transvenously in 241 cases. General anesthesia (propofol or sevoflurane and remifentanil) was performed in 273 and local anesthesia (lidocaine) in 68 patients. Hypotension occurred mainly during general anesthesia (43% v 4%). The 30-day mortality was 0%. The postoperative survey started in 2006 and was completed by 215 patients. The mean survival time was 77 months; 151 patients survived the study period. Outcome was not influenced by local and general anesthesia. Presence of preoperative NYHA class >II (odds ratio [OR] = 1.6, confidence interval [CI] = 0.5-5.1), mitral regurgitation (OR = 2.5, CI = 1.2-5.5), and serum creatinine >1.1 mg/dL (OR = 3.0, CI = 1.5-6.2) resulted in an inferior prognosis. CONCLUSIONS: In patients with severely impaired cardiac function, general anesthesia for the implantation of a biventricular pacing device can be used with justifiable risk. The method of anesthesia did not influence outcome.