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Background/Objective: To examine maternal physical and mental health-related quality of life (HRQoL) and depression after early and late preterm and term births in the early postpartum period. Method: In a prospective pilot study, three groups of women whose newborns had to be treated in the neonatal ward during the immediate postpartum period were established and compared with each other: 20 women with extremely to very preterm birth, 20 with moderate to late preterm birth and 20 women with term birth. All participants completed the Short Form-12 Health Survey (SF-12) to measure HRQoL, and the Edinburgh Postnatal Depression Scale (EPDS) to detect depressive symptoms combined with independently developed questions to evaluate anxiety and psychological distress. Results: Maternal psychological HRQoL was significantly worse in the very preterm birth group compared to moderate to late preterm birth ( p < 0.001) and full-term birth groups ( p = 0.004). There were no differences between the birth groups in depressive symptoms ( p = 0.083), anxiety ( p = 0.238), perceived stress ( p = 0.340) and the general psychological distress values ( p = 0.755). In the EPDS, the depression screening instrument 30 to 65% were beyond the cut-off-value to detect major depression. Conclusions: During the early postpartum period, an extensive medical care focussing on acute stress, HRQoL parameters and depression may be a good step to improving maternal well-being., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Mautner, Stern, Avian, Deutsch, Schöll and Greimel.)

Substantial sex differences have been reported in the physiological response to stress at multiple levels, including the release of the stress hormone, cortisol. Here, we explore the genomic variants in 93 females and 196 males regulating the initial transcriptional response to cortisol via glucocorticoid receptor (GR) activation. Gene expression levels in peripheral blood were obtained before and after GR-stimulation with the selective GR agonist dexamethasone to identify differential expression following GR-activation. Sex stratified analyses revealed that while the transcripts responsive to GR-stimulation were mostly overlapping between males and females, the quantitative trait loci (eQTLs) regulation differential transcription to GR-stimulation was distinct. Sex-stratified eQTL SNPs (eSNPs) were located in different functional genomic elements and sex-stratified transcripts were enriched within postmortem brain transcriptional profiles associated with Major Depressive Disorder (MDD) specifically in males and females in the cingulate cortex. Female eSNPs were enriched among SNPs linked to MDD in genome-wide association studies. Finally, transcriptional sensitive genetic profile scores derived from sex-stratified eSNPS regulating differential transcription to GR-stimulation were predictive of depression status and depressive symptoms in a sex-concordant manner in a child and adolescent cohort (n = 584). These results suggest the potential of eQTLs regulating differential transcription to GR-stimulation as biomarkers of sex-specific biological risk for stress-related psychiatric disorders., (© 2021. The Author(s).)

Reward and punishment processing are subject to substantial developmental changes during youth. However, little is known about the neurophysiological correlates that are associated with these developmental changes, particularly with regard to both anticipatory and outcome processing stages. Thus, the aim of this study was to address this research gap in a sample of typically developing children and adolescents. Fifty-four children and adolescents (8-18 years) performed a Monetary Incentive Delay Task comprising a monetary reward and punishment condition. Using event-related brain potential recordings, the cue-P3 and the stimulus-preceding negativity (SPN) were analyzed during the anticipation phase, while the Reward Positivity and the feedback-P3 were analyzed during the outcome phase. When anticipating monetary loss or no gain, SPN amplitude in the right hemisphere decreased with age. Moreover, exploratory analyses revealed a decrease in feedback-P3 amplitudes in response to monetary loss with increasing age. No other group differences were observed. Age-related changes in the SPN and fP3 component suggest that sensitivity to negative outcomes decreases from childhood to late adolescence, supporting the notion that adolescence is associated with reduced harm-avoidance. Longitudinal research including young adults is needed to substantiate our findings and its clinical implications regarding disturbed developmental trajectories in psychiatric populations., (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Introduction: Minimal important differences (MIDs) are useful for interpreting changes or differences in health-related quality of life scores in terms of clinical importance. There are currently no MID guidelines for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) specific to ovarian cancer. This study aims to estimate MIDs for interpreting group-level change of EORTC QLQ-C30 scores in ovarian cancer., Methods: Data were derived from four EORTC published trials. Clinical anchors for each EORTC QLQ-C30 scale were selected using correlation strength and clinical plausibility. MIDs for within-group change and between-group differences in change over time were estimated via mean change method and linear regression respectively. For each EORTC QLQ-C30 scale, MID estimates from multiple anchors were summarized via weighted-correlation. Distribution-based MIDs were also examined as supportive evidence., Results: Anchor-based MIDs were determined for deterioration in 7 of the 14 EORTC QLQ-C30 scales assessed, and in 11 scales for improvement. Anchor-based MIDs for within-group change ranged from 4 to 19 (improvement) and - 9 to -4 (deterioration). Between-group MIDs ranged from 3 to 13 (improvement) and - 11 to -4 (deterioration). Generally, absolute anchor-based MIDs for most scales ranged from 4 to 10 points., Conclusions: Our findings will aid interpretation of EORTC QLQ-C30 scores in ovarian cancer and inform sample size calculations in future ovarian cancer trials with endpoints that are based on EORTC QLQ-C30 scales., Competing Interests: Declaration of Competing Interest None declared., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: There is limited information about the impact of radical surgery including pelvic and para-aortic lymphadenectomy and subsequent platinum-based chemotherapy on sexuality in patients with advanced ovarian cancer., Objective: To evaluate the impact of radical surgery including pelvic and para-aortic lymphadenectomy and subsequent platinum-based chemotherapy on sexuality in patients with advanced ovarian cancer as a sub-protocol of the prospectively randomized LION trial., Methods: The Sexual Activity Questionnaire was applied to assess sexual function according to its sub-scales activity, pleasure, and discomfort. The 'orgasm' sub-scale from the Female Sexual Function Index was also added. The questionnaire was administered in combination with the EORTC QLQ-C30 questionnaire at baseline prior surgery, after 6, 12, and 24 months. The primary endpoint was changes in sexual function., Results: Overall, 495 patients received the questionnaires. 254 (51%) responded at baseline. Of these, 55 (22%) patients were sexually active, 182 (72%) were sexually inactive, and for 17 (7%) patients' data were not available. There was a total of 55/495 (11%) patients at 6 months, 139 (28%) patients at 12 months, and 81 (16%) patients at 24 months. Median age was 60.5 years (range 21.4-75.8). At baseline, sexually active responders were significantly younger (median age 51.5 years,) than sexually inactive responders (median age 61.8 years) and tended to have a better performance status. Discomfort evaluated as dryness of the vagina and pain during sexual intercourse was significantly worse at 12 months than at baseline (p<0.001); however, the surgical variable, lymphadenectomy, did not have any impact on this. The orgasm sub-scale showed diverging results with a deterioration from baseline to 12 months in the lymphadenectomy group compared with the no-lymphadenectomy group (p=0.02)., Conclusion: The majority of patients were sexually inactive; however, in those who were sexually active, pain during intercourse was worse at 12 months. In addition, the orgasm sub-scale demonstrated worse results in patients who underwent complete lymphadenectomy. The study suggests that surgery in the retroperitoneal space may influence sexual function., Competing Interests: Competing interests: AH reports personal fees from Astra Zeneca, personal fees from MedConcept, personal fees from MedUpdate, personal fees from Pfizer, personal fees from Roche, personal fees from Streamedup!GmbH, personal fees from Pharma Mar, personal fees from Tesaro, outside the submitted work; BS reports grants and personal fees from Roche, grants and personal fees from AstraZeneca, grants and personal fees from Tesaro, personal fees from Clovis, personal fees from MSD, personal fees from Ethicon, outside the submitted work; SM reports personal fees from AbbVie, grants and personal fees from AstraZeneca, personal fees from Clovis, personal fees from GSK, grants and personal fees from Medac, personal fees from MSD, personal fees from Novartis, personal fees from OLYMPUS Europa, grants and personal fees from PharmaMar, grants and personal fees from Roche, personal fees from Sensor Kinesis, grants and personal fees from Tesaro, personal fees from Teva, outside the submitted work; AdB reports personal fees from Roche, personal fees from Clovis, personal fees from Astra Zeneca/MSD, personal fees from GSK/Tesaro, personal fees from BIOCAD, personal fees from Genmab/seattle genetics, personal fees from Pfizer, outside the submitted work; PH reports grants and personal fees from Astra Zeneca, grants and personal fees from Roche, personal fees from Sotio, grants and personal fees from Tesaro, personal fees from Stryker, personal fees from Zai Lab, personal fees from MSD, grants and personal fees from public funding (ASCO, DKH, DFG), personal fees from Clovis, personal fees from Immunogen, grants from GSK, grants from Boehringer Ingelheim, grants from Medac, grants from Genmab, outside the submitted work., (© IGCS and ESGO 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Major depression (MD) often has its onset during adolescence and is associated with significant morbidity and mortality. One important factor for the development and maintenance of adolescent MD are disturbances in emotion regulation and the underlying neural processes. Cognitive reappraisal (CR) is a particular adaptive emotion regulation strategy. Previously, it has been shown in healthy adults that a task-based training in CR is efficient to reduce negative affect, and that these effects translate into everyday life.This randomised controlled trial examines for the first time whether a task-based training in CR proves effective in MD adolescents. Specifically, we will investigate whether the CR training improves the ability to downregulate negative affect in MD individuals as assessed by behavioural and neurobiological indices, and whether training effects generalise outside the laboratory., Methods and Analysis: Adolescents with MD will be randomly allocated to a group that either receives a task-based training in CR or a control training. Both involve four training sessions over a time period of 2 weeks. In the CR training, participants will be instructed to downregulate negative affective responses to negative pictures via CR, while the control training involves picture viewing. During the training sessions, the Late Positive Potential, gaze fixations on negative picture aspects and affective responses to pictures will be collected. Before and after the training programmes, and at a 2-week follow-up, overall negative and positive affect, rumination and perceived stress will be assessed as primary outcomes. Analyses of variance will be conducted to test the effectiveness of the CR training with regard to both primary outcomes and task-based behavioural and neurobiological parameters., Ethics and Dissemination: The study was approved by the Ethics Committee of the Medical Faculty of the LMU Munich, Germany. The results will be published in peer-reviewed journals and disseminated through conferences, social media and public events., Trial Registration Details: ClinicalTrials.gov NCT03957850, registered 21 st May 2019; URL: https://clinicaltrials.gov/ct2/show/NCT03957850., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: A deficit in empathy has repeatedly been described in individuals with conduct disorder (CD), and in particular in those with callous unemotional traits. Until now, little is known about the neural basis of empathy in children and adolescents with early onset conduct disorder. The aim of this study was to examine neural responses during empathizing in children and adolescents with CD with a task that allowed to differentiate between the judgment of the emotional states of other people and the own emotional response to other people's emotional state. Moreover, we investigated associations of callous-unemotional traits and neural activations during empathizing. Methods: Using functional magnetic resonance imaging (fMRI) we investigated 14 boys with early onset CD and 15 typically developing (TDC) age matched controls between 8 and 16 years of age. Happy and sad faces were presented, and participants were asked to either infer the emotional state from the face (other-task) or to judge their own emotional response (self-task). A perceptual decision on faces was used as a control task. Individual empathic abilities and callous unemotional traits were assessed. Results: During the other task, TDC boys showed significantly larger right amygdala responses than CD boys. Higher empathic abilities (as assessed with the Bryant Index of Empathy) were associated with higher responses in the right amygdala within the CD boys and across the entire sample. Moreover, across the entire sample, callous-unemotional traits were negatively related to the BOLD-response in the right amygdala. CD boys showed larger responses in the dorsal and ventral medial prefrontal cortex across tasks and increased activation in dorsal medial prefrontal cortex specifically during the self-conditions, which were also related to empathic abilities within the CD boys. Conclusions: The data emphasize the important role of the amygdala in empathy related emotional processing. Diminished amygdala responses and their association with low empathy suggest a pivotal influence of impaired amygdala processing in early-onset CD, in particular for deficits in empathic behavior and related callous-unemotional-traits. Elevated response in the medial prefrontal cortex in boys with CD point toward increased involvement of brain areas related to self-referential processing and cognitive empathy during empathizing., (Copyright © 2020 von Polier, Greimel, Konrad, Großheinrich, Kohls, Vloet, Herpertz-Dahlmann and Schulte-Rüther.)

Background: Severe adverse life events, such as traumatic experiences, are well-known stressors implicated in (youth) major depression (MD). However, to date, far less is known about the role of more common psychosocial stressors in the context of MD, which are part of everyday life during youth. In addition, it is not well-understood whether and how distinct stressors interact with protective factors in youths diagnosed with MD. Thus, the present study aimed at examining several specific psychosocial stressors implicated in a first-episode juvenile MD and addressed the question whether protective factors might moderate the relationship between stressors and a diagnosis of MD., Methods: One-hundred male and female youths with MD and 101 typically developing (TD) controls (10-18 years) were included. A large number of qualitatively different psychosocial stressors occurring in various areas of life were assessed via self-report. Moreover, we also investigated sociodemographic and pre- and postnatal stressors, as well as the presence of familial affective disorders via parental-report. Social support and a positive family climate were conceptualized as protective factors and were assessed via self-report., Results: Results showed that the proportion of youths experiencing specific psychosocial stressors was higher in the MD than in the TD group. In particular, the proportion of youths indicating changes at home or at school, experiences of violence, delinquent behavior, as well as the proportion of youths who were exposed to sociodemographic stressors was higher in the MD than in the TD group. Moreover, the percentage of youths with a family history of an affective disorder, or whose mothers experienced psychological burdens during/after pregnancy was elevated in the MD group. Youths with MD experienced less social support and a less positive family climate than their TD peers. These factors, however, did not buffer the influence of specific stressors on MD., Conclusion: We could show that next to more severe adverse life events, more common psychosocial stressors are linked to youth MD. Importantly, by identifying distinct stressors in youth MD, our results can increase treatment and prevention efforts aiming to improve the outcomes in youths affected by MD or in at-risk individuals., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s) 2020.)

Autism spectrum disorder (ASD) is a prevalent and fast-growing pervasive neurodevelopmental disorder worldwide. Despite the increasing prevalence of ASD and the breadth of research conducted on the disorder, a conclusive etiology has yet to be established and controversy still exists surrounding the anatomical abnormalities in ASD. In particular, structural asymmetries have seldom been investigated in ASD, especially in subcortical regions. Additionally, the majority of studies for identifying structural biomarkers associated with ASD have focused on small sample sizes. Therefore, the present study utilizes a large-scale, multi-site database to investigate asymmetries in the amygdala, hippocampus, and lateral ventricles, given the potential involvement of these regions in ASD. Contrary to prior work, we are not only computing volumetric asymmetries, but also shape asymmetries, using a new measure of asymmetry based on spectral shape descriptors. This measure represents the magnitude of the asymmetry and therefore captures both directional and undirectional asymmetry. The asymmetry analysis is conducted on 437 individuals with ASD and 511 healthy controls using T1-weighted MRI scans from the Autism Brain Imaging Data Exchange (ABIDE) database. Results reveal significant asymmetries in the hippocampus and the ventricles, but not in the amygdala, in individuals with ASD. We observe a significant increase in shape asymmetry in the hippocampus, as well as increased volumetric asymmetry in the lateral ventricles in individuals with ASD. Asymmetries in these regions have not previously been reported, likely due to the different characterization of neuroanatomical asymmetry and smaller sample sizes used in previous studies. Given that these results were demonstrated in a large cohort, such asymmetries may be worthy of consideration in the development of neurodiagnostic classification tools for ASD., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: The PENELOPE trial evaluated pertuzumab added to chemotherapy for biomarker-selected platinum-resistant ovarian cancer. As previously reported, pertuzumab did not statistically significantly improve progression-free survival (primary end point: HR 0.74, 95% CI 0.50 to 1.11), although results in the paclitaxel and gemcitabine cohorts suggested activity. Here, we report final overall survival and patient-reported outcomes., Patients and Methods: Eligible patients had ovarian carcinoma that progressed during/within 6 months of completing ≥4 platinum cycles, low tumor human epidermal growth factor receptor 3 (HER3) mRNA expression, and ≤2 prior chemotherapy lines. Investigators selected single-agent topotecan, gemcitabine or weekly paclitaxel before patients were randomized to either placebo or pertuzumab (840→420 mg every 3 weeks), stratified by selected chemotherapy, prior anti-angiogenic therapy, and platinum-free interval. Final overall survival analysis (key secondary end point) was pre-specified after 129 deaths. Patient-reported outcomes (secondary end point) were assessed at baseline and every 9 weeks until disease progression., Results: At database lock (June 9, 2016), 130 (83%) of 156 randomized patients had died. Median follow-up was 27 months in the pertuzumab arm versus 26 months in the control arm. In the intent-to-treat population there was no overall survival difference between treatment arms (stratified HR 0.90, 95% CI 0.61 to 1.32; p=0.60). Results in subgroups defined by stratification factors indicated heterogeneity similar to previous progression-free survival results. Updated safety was similar to previously published results. Compliance with patient-reported outcomes questionnaire completion was >75% for all validated patient-reported outcomes measures. Pertuzumab demonstrated neither beneficial nor detrimental effects on patient-reported outcomes compared with placebo, except for increased diarrhea symptoms., Discussion: Consistent with the primary results, adding pertuzumab to chemotherapy for low tumor HER3 mRNA-expressing platinum-resistant ovarian cancer did not improve overall survival, but showed trends in some cohorts. Except for increased diarrhea symptoms, pertuzumab had no impact on patient-reported outcomes. ClinicalTrials.gov: ClinicalTrials.gov: NCT01684878., Competing Interests: Competing interests: DL has participated in advisory boards for Roche, AstraZeneca, Clovis, Merck and Tesaro; her institution has received research support from Clovis, PharmaMar and Merck. FH has a consultant and advisory relationship with Roche, AstraZeneca and MSD. AGM has consulting and advisory relationships with Roche, Tesaro, AstraZeneca, Pfizer, Clovis, PharmaMar and ImmunoGen. PO has a consulting or advisory role with Novartis, GSK, MSD, Clovis and Tesaro. FS has served as a consultant for Roche and Tesaro. NC has received personal fees from AstraZeneca, Clovis, Tesaro, Roche, PharmaMar, Takeda and Pfizer. BP has participated in advisory boards for Clovis and Tesaro. IV has participated in advisory boards for Advaxis Inc, Eisai Inc, MSD Belgium, Roche NV, Genmab A/S, F. Hoffmann-La Roche Ltd, PharmaMar, Millennium Pharmaceuticals, Clovis Oncology Inc, AstraZeneca NV, Novocure GMBH, Morphotek Inc, Mateon Therapeutics Inc, Immunogen Inc, Eli Lilly Benelux NV, Amgen Inc, Pfizer Inc, Vifor Pharma België NV, Novartis Pharma AG, Oxigene Inc, Nektar Therapeutics and Bayer Pharma AG, has contract research (via K U Leuven) with Oncoinvent AS and Genmab A/S – Genmab B.V., has received grants for corporate-sponsored research from Amgen and Roche, and has received accommodation/travel expenses from Takeda Oncology, PharmaMar, Genmab, Roche and AstraZeneca. AR has consultant and advisory roles with Roche, Tesaro, AstraZeneca, Clovis, PharmaMar, Amgen, Lilly and Novartis, and research funding from Roche, PharmaMar and Eisai. AC and LB-T are employees of and shareholders in Roche. AdB has a consulting and advisory relationship with AstraZeneca, Roche, Tesaro, Pfizer, Clovis, PharMar and Genmab. CK has a consultant and advisory relationships with Roche, AstraZeneca, Tesaro and Genomic Health. All remaining authors have declared no conflicts of interest., (© IGCS and ESGO 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Identifying risk factors for major depression and depressive symptoms in youths could have important implications for prevention efforts. This study examined the association of polygenic risk scores (PRSs) for a broad depression phenotype derived from a large-scale genome-wide association study (GWAS) in adults, and its interaction with childhood abuse, with clinically relevant depression outcomes in clinical and epidemiological youth cohorts., Methods: The clinical cohort comprised 279 youths with major depression (mean age=14.76 years [SD=2.00], 68% female) and 187 healthy control subjects (mean age=14.67 years [SD=2.45], 63% female). The first epidemiological cohort included 1,450 youths (mean age=13.99 years [SD=0.92], 63% female). Of those, 694 who were not clinically depressed at baseline underwent follow-ups at 6, 12, and 24 months. The replication epidemiological cohort comprised children assessed at ages 8 (N=184; 49.2% female) and 11 (N=317; 46.7% female) years. All cohorts were genome-wide genotyped and completed measures for major depression, depressive symptoms, and/or childhood abuse. Summary statistics from the largest GWAS to date on depression were used to calculate the depression PRS., Results: In the clinical cohort, the depression PRS predicted case-control status (odds ratio=1.560, 95% CI=1.230-1.980), depression severity (β=0.177, SE=0.069), and age at onset (β=-0.375, SE=0.160). In the first epidemiological cohort, the depression PRS predicted baseline depressive symptoms (β=0.557, SE=0.200) and prospectively predicted onset of moderate to severe depressive symptoms (hazard ratio=1.202, 95% CI=1.045-1.383). The associations with depressive symptoms were replicated in the second epidemiological cohort. Evidence was found for an additive, but not an interactive, effect of the depression PRS and childhood abuse on depression outcomes., Conclusions: Depression PRSs derived from adults generalize to depression outcomes in youths and may serve as an early indicator of clinically significant levels of depression.

Objective: Major Depression (MD) results from a complex interplay between environmental stressors and biological factors. Previous studies in adults have shown that adverse life events interact with genetic variation in FKBP5, a gene implicated in the stress-response system, to predict depressive symptoms and MD. This is the first study to investigate interactions between FKBP5 variants and a range of environmental stressors in adolescents with a clinical diagnosis of MD., Method: 148 male and female adolescents with MD and 143 typically developing (TD) controls (13-18 years) were included in the present study. For self-reported environmental stressors, subjective severity was assessed to allow a classification of these factors as mild, moderate and severe. Sociodemographic stressors were assessed via parental-report., Results: With a heightened number of sociodemographic, moderate and total number of stressors, participants carrying at least one copy of the FKBP5 CATT haplotype or at least one minor allele of various FKBP5 SNPs had the highest risk for being in the MD group. No genetic main effects were found. Sociodemographic stressors as well as self-reported mild, moderate, and severe stressors were more common in depressed than in TD adolescents., Conclusion: This is the first study to show interactions between genetic variation in FKBP5 and environmental stressors in a sample of clinically depressed adolescents. The current study provides important starting-points for preventive efforts and highlights the need for a fine-grained analysis of different forms and severities of environmental stressors and their interplay with genetic variation for understanding the complex etiology of (youth) MD., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Objective: To examine the impact of different treatment strategies - surgical treatment or watchful waiting- on sexual activity, psychosocial distress, and fear of progression in women with Human Papillomavirus (HPV)-associated premalignant genital lesions., Study Design: Observational cohort study of women diagnosed with HPV-associated premalignant lesions of the cervix, vagina or vulva. Patients were stratified into two groups depending on the severity of their premalignancy: surgical treatment or watchful waiting. Validated patient administered questionnaires, i.e. Fear of Progression questionnaire (FoP-Q), Cervical Dysplasia Distress Questionnaire (CDDQ), and Sexual Activity Questionnaire (SAQ) were completed after clinical evaluation (baseline), at 6- and 12-months follow-ups., Results: 209 women treated with surgery (N = 125) were compared with women who were monitored in regular intervals (N = 82). During an observational period of 12 months there were no significant differences in fear of progression, psychosocial distress, and sexual activity (p > 0.05). The level of concerns and anxiety about the future, and fear of progression were present, mostly at baseline. While there was a small increase of tension from visit to visit in both groups, patients generally were able to cope with their clinical situation quite well., Conclusions: Fear of progression, psychosocial distress and sexual activity in women with precancerous HPV- associated premalignant genital lesions seem to be independent from type of treatment. Both treatment strategies may be applied without major psychological sequelae, as long as adequate information is provided., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Introduction: The aim of this study was to explore maternal health-related quality of life (HRQoL) and depression following intrauterine interventions in complicated monochorionic twin pregnancies at the Medical University Graz., Material and Methods: In a cross-sectional questionnaire survey, women with at least one liveborn infant following intrauterine intervention during 2011 and 2015 were matched with uncomplicated monochorionic and dichorionic pregnancies. All completed the 12-Item Short Form Health Survey to measure HRQoL and the Patient Health Questionnaire-9 to measure depression. Results were compared with local normative values., Results: There were no differences in physical and mental HRQoL as compared to those with uncomplicated pregnancy. However, the whole study population had significantly lower HRQoL scores (p < 0.001) than the normative sample. Additionally, 11% of the whole study population experienced moderate (6.2%) or moderately severe (4.6%) depression. Women following uncomplicated dichorionic pregnancy revealed more depressive symptoms compared to women with intervention., Discussion: Women with at least one surviving infant following intervention in complicated monochorionic twin pregnancy do not seem to have an impaired HRQoL as compared to women following uncomplicated monochorionic or dichorionic pregnancies. However, twin pregnancy itself appears to impair HRQoL, at least in the first 4 postnatal years., (© 2018 S. Karger AG, Basel.)

Objective: Greater relative right- than left-frontal cortical activity has been frequently found in adults with major depression (MD). As the few studies in adolescents with MD have been inconclusive, the aim of this study was to assess frontal alpha asymmetry (FAA) in an adolescent sample with MD whilst taking into account possible confounding variables such as disease state and comorbid anxiety disorder., Methods: An 8-minute resting frontal EEG was assessed in 34 healthy controls (HCs), 16 adolescents with MD in remission without comorbid anxiety disorder (rMDa-), 22 adolescents with acute depression without comorbid anxiety disorder (MDa-), and 23 adolescents with acute depression and comorbid anxiety disorder (MDa+). Alpha power was analyzed over corresponding frontal Regions of Interests., Results: Compared to HCs, MDa+ adolescents demonstrated more left- than right-sided EEG alpha power, indicating greater right-than left-frontal cortical activity. No other group differences emerged., Conclusions: The results suggest that greater relative right-frontal cortical activity in adolescent MD is not a result of disease state but can be attributed to comorbid anxiety disorder., Significance: Results suggest that FAA is not linked to adolescent depression per se and highlight the importance of considering comorbid disorders when examining asymmetry patterns in adolescent MD., (Copyright © 2018 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.)

Background: Although patients experience radiation proctitis post radiotherapy no internationally tested instruments exist to measure these symptoms. This Phase IV study tested the scale structure, reliability and validity and cross-cultural applicability of the EORTC proctitis module (QLQ-PRT23) in patients who were receiving pelvic radiotherapy., Methods: Patients (n = 358) from six countries completed the EORTC QLQ-C30, QLQ-PRT23 and EORTC Quality of Life Group debriefing questions. Clinicians completed the EORTC Radiation Therapy Oncology Group scale. Questionnaires were completed at four time-points. The module's scale structure was examined and validated using standard psychometric analysis techniques., Results: Three items were dropped from the module (QLQ-PRT23 → QLQ-PRT20). Factor analysis identified five factors in the module: bowel control; bloating and gas; emotional function/lifestyle; pain; and leakage. Inter-item correlations were within r = 0.3-0.7. Test-Retest reliability was high. All multi-item scales discriminated between patients showing symptoms and those without symptomology. The module discriminated symptoms from the clinician completed scoring and for age, gender and comorbidities., Conclusion: The EORTC QLQ-PRT20 is designed to be used in addition to the EORTC QLQ-C30 to measure quality of life in patients who receive pelvic radiotherapy. The EORTC QLQ-PRT20 is quick to complete, acceptable to patients, has good content validity and high reliability., Trial Registration: Australian and New Zealand Clinical Trials Registry (ANZCTR) ACTRN12609000972224 .

Objectives: Vulva cancer (VC) treatment carries a high risk of severe late effects that may have a negative impact on quality of life (QoL). Patient-reported outcome measures (PROMs) are increasingly used when evaluating disease- and treatment-specific effects. However, the adequacy of measures used to assess sequelae and QoL in VC remains unclear. The aims of the present study were to evaluate disease- and treatment-related effects as measured by PROMs in VC patients and to identify available VC-specific PROMs., Methods/materials: A systematic literature search from 1990 to 2016 was performed. The inclusion criterion was report of disease- and treatment-related effects in VC patients using PROMs in the assessment. Methodological and reporting quality was in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. This systematic review was performed as part of phase 1 of the development of a European Organisation for Research and Treatment of Cancer QoL questionnaire for VC patients., Results: The search revealed 2299 relevant hits, with 11 articles extracted including a total of 535 women with VC; no randomized controlled trials were identified. The selected studies exhibited great heterogeneity in terms of PROMs use. Twenty-one different instruments assessed QoL. Most of the questionnaires were generic. Different issues (sexuality, lymphedema, body image, urinary and bowel function, vulva-specific symptoms) were reported as potentially important, but the results were not systematically collected. Only one VC-specific questionnaire was identified but did not allow for assessment and reporting on a scale level., Conclusions: Vulva cancer treatment is associated with considerable morbidity deteriorating QoL. To date, there is no validated PROM available that provides adequate coverage of VC-related issues. The study confirms the need for a VC-specific QoL instrument with sensitive scales that allows for broad cross-cultural application for use in clinical trials.

Objective: Event-related potential (ERP) studies have revealed abnormal neurophysiological patterns underlying selective attention in patients with Major Depression (MD). Only few included both patients in acute and remitted state to address the question whether these abnormalities are state- or trait- dependent and none focused on adolescent MD. Thus, the aim of our study was to address this question in an adolescent sample., Methods: 22 adolescents with acute MD, 20 adolescents with remitted MD (rMD) and 32 healthy controls (HC) performed a standard two-tone auditory oddball task while ERPs (N100, P200, N200, P300) were collected., Results: Adolescents with rMD showed a reduced N200 amplitude to target tones across frontal, central and parietal recording sites. Adolescents with MD exhibited a reduced N200 amplitude to targets in the frontal region compared to HC. No differences emerged between rMD and the MD group., Conclusions: The reduced N200 amplitude in adolescents with rMD and MD presumably reflects difficulties in stimulus classification and response selection. Our results indicate that this neurophysiological characteristic is a trait marker of adolescent depression., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Aims: The Patient Global Index of Severity (PGI-S) and the Patient Global Index of Improvement (PGI-I) are global impression questionnaires developed in English and validated in women with stress urinary incontinence (SUI). This validation study tested the psychometric properties of German-language versions of the two questionnaires in German-speaking women with SUI., Methods: The German-language PGI-S and PGI-I were psychometrically tested and validated using the SF-12 questionnaire, the Kinǵs Health Questionnaire (KHQ), clinical parameters, incontinence episode frequency and pad use in 311 patients before and 3 months after receiving a TVT-O or TVT tape for SUI., Results: At baseline and 3 months postoperatively there was a positive correlation between PGI-S response categories and clinical parameters, IEF and pad use, and nearly all KHQ subscales. There were no correlations between response categories of PGI-S at baseline and PGI-I at 3 months and the SF-12 scales PCS-12 and MCS-12., Conclusion: Our results demonstrated good psychometric properties of the German-language PGI-S and PGI in German-speaking women with SUI., (© 2017 Wiley Periodicals, Inc.)

The brain's reward system undergoes major changes during adolescence, and an increased reactivity to social and nonsocial incentives has been described as a typical feature during this transitional period. Little is known whether there are sex differences in the brain's responsiveness to social or monetary incentives during adolescence. The aim of this event-related potential (ERP) study was to compare the neurophysiological underpinnings of monetary and social incentive processing in adolescent boys versus girls. During ERP recording, 38 adolescents (21 females, 17 males; 13-18 years) completed an incentive delay task comprising (a) a reward versus punishment condition and (b) social versus monetary incentives. The stimulus-preceding negativity (SPN) was recorded during anticipation of reward and punishment, and the feedback P3 (fP3) along with the feedback-related negativity (FRN) after reward/punishment delivery. During anticipation of social punishment, adolescent boys compared with girls exhibited a reduced SPN. After delivery, male adolescents exhibited higher fP3 amplitudes to monetary compared with social incentives, whereas fP3 amplitudes in girls were comparable across incentive types. Moreover, whereas in boys fP3 responses were higher in rewards than in punishment trials, no such difference was evident in girls. The results indicate that adolescent boys show a reduced neural responsivity in the prospect of social punishment. Moreover, the findings imply that, once the incentive is obtained, adolescent boys attribute a relatively enhanced motivational significance to monetary incentives and show a relative hyposensitivity to punishment. The findings might contribute to our understanding of sex-specific vulnerabilities to problem behaviors related to incentive processing during adolescence.

Anorexia nervosa (AN) has been suggested to be associated with abnormalities in facial emotion recognition. Most prior studies on facial emotion recognition in AN have investigated adult samples, despite the onset of AN being particularly often during adolescence. In addition, few studies have examined whether impairments in facial emotion recognition are specific to AN or might be explained by frequent comorbid conditions that are also associated with deficits in emotion recognition, such as depression. The present study addressed these gaps by investigating recognition of emotional facial expressions in adolescent girls with AN (n = 26) compared to girls with major depression (MD; n = 26) and healthy girls (HC; n = 37). Participants completed one task requiring identification of emotions (happy, sad, afraid, angry, neutral) in faces and two control tasks. Neither of the clinical groups showed impairments. The AN group was more accurate than the HC group in recognising afraid facial expressions and more accurate than the MD group in recognising happy, sad, and afraid expressions. Misclassification analyses identified subtle group differences in the types of errors made. The results suggest that the deficits in facial emotion recognition found in adult AN samples are not present in adolescent patients., (Copyright © 2017 Elsevier B.V. All rights reserved.)

To develop and pretest an European Organization for the Research and Treatment of Cancer Sexual Health Questionnaire (EORTC SHQ-22) for the assessment of physical, psychological, and social aspects of sexual health (SH) in male and female cancer patients and survivors. Questionnaire construction started with creating a list of relevant SH issues based on a comprehensive literature review. Issues were subsequently evaluated for relevance and prioritization by 78 healthcare professionals (HCP) and 107 patients from 12 countries during in-depth interviews (phase 1). Extracted issues were operationalized into items (phase 2). Phase 3 focused on pretesting the preliminary questionnaire in a cross-cultural patient sample (n = 171) using debriefing interviews. Psychometric properties were preliminary determined using a principal component analysis and Cronbach's alpha. We derived 53 relevant SH issues from the literature. Based on HCP and patient interviews, 22 of these 53 issues were selected and operationalized into items. Testing the preliminary 22-item short questionnaire resulted in a change of wording in five items and two communication-related items; no items were removed. Preliminary psychometric analysis revealed a two-factor solution and 11 single items; both scales showed good reliability indicated by a Cronbach's alpha of 0.87 (sexual satisfaction) and 0.82 (sexual pain). Cross-cultural pretesting of the preliminary EORTC SH questionnaire has indicated excellent applicability, patient acceptance, and comprehensiveness as well as good psychometric properties. The final development phase, that is psychometric validation (phase four) including large-scale, cross-cultural field testing of the EORTC SHQ-22, has commenced., (© 2018 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Objective: Rejection sensitivity (RS) is defined as the disposition to anxiously expect rejection, to perceive it as likely, and to overreact to it. Former studies showed heightened RS in clinically depressed adults and identified it as a predictor for symptoms of depression in adolescents. However, to date there are no studies examining RS as a disposition in adolescents with clinical Depression., Method: In the present study, we compared differences in RS and behavioral intentions in depressive and healthy adolescents after a rejection situation. We included n = 28 adolescents with depression and n = 32 healthy control participants between the ages of 12–17 and applied a German version of the Children’s Rejection Sensitivity Questionnaire “CRSQ”., Results: It was found that, compared to controls, depressive adolescents show higher RS, are more anxious about rejection, and rate the likelihood of being rejected higher. Furthermore, adolescents with depression more often indicated to resign to rejection and blame themselves for it than their healthy counterparts., Conclusions: Our results are in concordance with the clinical picture and with cognitive theories of the disorder. In future studies, it would be important to examine whether corresponding interventions can have a positive impact on the course of the disease.

More right-sided frontal brain resting activity has been postulated to be a correlate of major depression in adults. In children and adolescents, more right-sided activity (as indicated by more left-sided alpha activity) seems to be associated with psychosocial risk factors. However, an association of frontal asymmetry and manifest unipolar depression has not been shown in adolescents so far. We analyzed frontal asymmetry in 20 adolescents (12-17 years) with unipolar depression (12 with first episode, 8 with recurrent depression) and 31 healthy age-matched controls. We found significantly less left-sided alpha power over frontal Regions of Interest in patients, while controls exhibited no asymmetry. In the control group, more left-sided frontal alpha correlated with higher depression scores, which was not observed in the patient group. Our results suggest developmental effects on frontal asymmetry, and prompt further investigations in adolescents to clarify the role of frontal asymmetry in adolescent major depression., (Copyright © 2018 Elsevier B.V. All rights reserved.)

The endometrial cancer (EC)-specific Quality of Life module of the European Organization for Research and Treatment of Cancer (EORTC QLQ-EN24), was developed and validated in one study. We independently validated and assessed the psychometric properties of the instrument. Two hundred and eight women with EC before surgery, during adjuvant treatment and follow-up; in three different cancer centres completed the EORTC QLQ-C30 and the EN24. The questionnaire's completion rate was 100%, except sexuality items, that were answered by 35% of patients. All item-scale correlations for the multi-item scales exceeded the .4 criterion and correlated well with their own scale, while correlations with the other scales were low. The internal consistency of all multi-item scales were satisfactory (Cronbach's alpha coefficients ranging from .77 to .97). Discriminance for single-item scales was low. The QLQ-EN24 module discriminated well between clinically different patients, and there were no differences in quality of life questionnaire scales between patients with body mass index ≤30 when compared to those with >30. This validation study supports the reliability, as well as convergent and divergent validity of the EORTC QLQ-EN24. The module is a useful instrument for the assessment of QOL in patients with EC. However, data concerning sexuality should be interpreted with caution., (© 2017 John Wiley & Sons Ltd.)

Introduction: In the process of translating patient-reported outcomes measures (forward translation(s), reconciliation, back translation(s), review, pilot-testing, review, final translation), there is a general consensus amongst the key players in the field that the back translation review is an important step. Despite this, there has been little guidance published on how to perform it. Areas covered: Having assessed the most recent back translation reports reviewed by the Translation Unit at the European Organisation for Research and Treatment of Cancer (EORTC) in Brussels, we have identified two concepts to help guide the back translation review process: the underlying issue (the problem that the item measures) and the structure (the linguistic and formal construction of the item). This paper presents these concepts and how they are used in the review process. Expert commentary: Despite certain difficulties it might pose, back translation review remains one of the standard steps to assure concept equivalence. This paper aims at starting a much-needed exchange of experience and knowledge among people who perform reviews as part of the process of translating patient-reported outcomes measures.

Background: To assess emotional distress, anxiety and stress reactions in breast cancer (BC) patients before the follow-up visits., Study Design: Between September 2009 and December 2011 a total of 284 patients completed the BC-psychosocial assessment screening scale (PASS) and a questionnaire about their views of follow-up after treatment for BC., Results: Of the patients 64% reported low level of distress on the BC-PASS. The mean scores on the physical well-being scale was 5.3, the satisfaction/sense of coherence scale 7.4, and the emotional distress scale 8.1. Women rated mammography as the most important component (71%), followed by breast ultrasound (63%) and the consultation with the physician (60%). Of the patients 94% were satisfied with the current follow-up regimen., Conclusions: In this series BC patients were satisfied with their aftercare. Mammography was thought to be the most important component of aftercare. Patient-reported outcomes should be taken into account when planning follow-up.

Purpose: Communication between patients and professionals is one major aspect of the support offered to cancer patients. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) has developed a cancer-specific instrument for the measurement of different issues related to the communication between cancer patients and their health care professionals., Methods: Questionnaire development followed the EORTC QLG Module Development Guidelines. A provisional questionnaire was pre-tested (phase III) in a multicenter study within ten countries from five cultural areas (Northern and South Europe, UK, Poland and Taiwan). Patients from seven subgroups (before, during and after treatment, for localized and advanced disease each, plus palliative patients) were recruited. Structured interviews were conducted. Qualitative and quantitative analyses have been performed., Results: One hundred forty patients were interviewed. Nine items were deleted and one shortened. Patients' comments had a key role in item selection. No item was deleted due to just quantitative criteria. Consistency was observed in patients' answers across cultural areas. The revised version of the module EORTC QLQ-COMU26 has 26 items, organized in 6 scales and 4 individual items., Conclusions: The EORTC COMU26 questionnaire can be used in daily clinical practice and research, in various patient groups from different cultures. The next step will be an international field test with a large heterogeneous group of cancer patients.

Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes data in cancer randomised trials. This Personal View discusses the reasons why this project was initiated, the rationale for the planned work, and the expected benefits to cancer research, patient and provider decision making, care delivery, and policy making., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

The present study explored the neurophysiological correlates of perception and recognition of emotional facial expressions in adolescent anorexia nervosa (AN) patients using event-related potentials (ERPs). We included 20 adolescent girls with AN and 24 healthy girls and recorded ERPs during a passive viewing task and three active tasks requiring processing of emotional faces in varying processing depths; one of the tasks also assessed emotion recognition abilities behaviourally. Despite the absence of behavioural differences, we found that across all tasks AN patients exhibited a less pronounced early posterior negativity (EPN) in response to all facial expressions compared to controls. The EPN is an ERP component reflecting an automatic, perceptual processing stage which is modulated by the intrinsic salience of a stimulus. Hence, the less pronounced EPN in anorexic girls suggests that they might perceive other people's faces as less intrinsically relevant, i.e. as less "important" than do healthy girls., (Copyright © 2016 Elsevier B.V. All rights reserved.)

Background: The salutogenic model has been established as a health promoting resource that is related to a strong sense of coherence (SOC), positive subjective health and quality of life (QoL). The aim of the study was to compare internal and external resources, life style factors, perceived health and QoL in Japan and Austria and to determine associations among these factors., Methodology and Principal Findings: A survey was conducted in a Japanese (N = 460) and an Austrian (N = 421) student sample using the following self-report health questionnaires: Sense of Coherence Scale (SOC-13), Social and Gender Role Scale, Multidimensional Scale of Perceived Social Support (MSPSS), Dutch Eating Behaviour Questionnaire (DEBQ), SF-12 Health Survey, and the Cross-cultural Health Survey. Analyses of data showed that age (ß -0.12), and stress (ß -0.21) were negatively related and SOC (ß 0.47), family support are (ß -0.35) positively related to mental QoL. Significant predictors for emotional strain, were female gender (ß -0.24), older age (ß-0.14), lower SOC (ß 0.28), less traditional gender and social role patterns (ß 0.10), more restrained eating (ß -0.20), more alcohol intake (ß -0.16), and more stress (ß -0.25) explaining 42% of the variance in Austrian students. In Japan stress (ß -0.38) was negatively related and SOC (ß 0.37) positively related to mental QoL. Older age (ß -0.20), lower SOC (ß 0.29) and more stress (ß -0.33) were identified as significant predictors explaining 35% of the variance in Japanese students., Conclusions and Significance: SOC and stress are strongly associated with QoL and perceived health in Austria as well as in Japan. SOC seems to be a crucial predictor for stress, and emotional health independent of the cultural context. A major challenge of cross-cultural research is to understand perceived health and QoL and the extent in which it is individually, socially, or culturally determined.

To date, little is known about sex differences in the neurophysiological correlates underlying auditory information processing. In the present study, auditory evoked potentials were evoked in typically developing male (n = 15) and female (n = 14) adolescents (13-18 years) during an auditory oddball task. Girls compared to boys displayed lower N100 and P300 amplitudes to targets. Larger N100 amplitudes in adolescent boys might indicate higher neural sensitivity to changes of incoming auditory information. The P300 findings point toward sex differences in auditory working memory and might suggest that adolescent boys might allocate more attentional resources when processing relevant auditory stimuli than adolescent girls.

Introduction: Genital human papillomavirus (HPV) infections are very common in women 18 to 30 years old and substantially affect women's sexual health., Aim: To examine sexual activity, psychosexual distress, and fear of progression in women diagnosed with HPV-related precancerous genital lesions., Methods: In this observational study, women diagnosed with premalignant lesions of the cervix, vagina, or vulva were recruited from a university hospital-based colposcopy clinic., Main Outcome Measures: Quantitative data from three validated patient-administered questionnaires (Sexual Activity Questionnaire, German version of the Cervical Dysplasia Distress Questionnaire, and Fear of Progression Questionnaire) were compared within the study population, according to the location of the genital lesion, and with relevant reference populations. Qualitative data from two written open-ended questions about women's thoughts regarding diagnosis and information were analyzed., Results: Two-hundred nine women completed the questionnaires. Seventy-eight percent of women (n = 162) were referred for evaluation of suspect lesions of the cervix, 8% (n = 17) of the vagina, and 14% (n = 30) of the vulva. There were no significant differences in questionnaire results among the three patient groups, except for sexual consequences (Cervical Dysplasia Distress Questionnaire) and recent sexual activity (Sexual Activity Questionnaire). Women with vulvar lesions were most likely to worry about sexual consequences (ie, being unable to have children, being sexually less attractive, or infecting a sexual partner; P = .04). The Sexual Activity Questionnaire subscales sexual pleasure (P = .15) and sexual habits (P = 1.00) were similar to those in a healthy control population, whereas sexual discomfort (P = .51) was comparable to that in a reference population of women who survived cervical cancer. The subscale partner-specific concerns (Fear of Progression Questionnaire) was similar to that in a reference population of patients with cancer (P = .28)., Conclusion: HPV-related precancerous genital lesions, especially of the vulva, are likely to cause concerns about sexual health. Effective information and communication are important to lessen negative sexual consequences and anxiety., (Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Background: The European Organisation for Research and Treatment of Cancer (EORTC) Patient-Reported Outcomes and Behavioural Evidence (PROBE) initiative was established to investigate critical topics to better understand health-related quality of life (HRQOL) of cancer patients and to educate clinicians, policy makers, and healthcare providers., Methods: The aim of this paper is to review the major research outcomes of the pooled analysis of HRQOL data along with the clinical data. We identified 30 pooled EORTC randomized controlled trials (RCTs), 18 NCIC-Clinical Trials Group RCTs, and two German Ovarian Cancer Study Group RCTs, all using the EORTC QLQ-C30. All statistical tests were two-sided., Results: Evidence was found that HRQOL data can offer prognostic information beyond clinical measures and improve prognostic accuracy in cancer RCTs (by 5.9%-8.3%). Moreover, models that considered both patient- and clinician-reported scores gained more prognostic overall survival accuracy for fatigue (P < .001), vomiting (P = .01), nausea (P < .001), and constipation (P = .01). Greater understanding of the association between symptom and/or functioning scales was developed by identifying physical, psychological, and gastrointestinal clusters. Additionally, minimally important differences in interpreting HRQOL changes for improvement and deterioration were found to vary across different patient populations and disease stages. Finally, HRQOL scores are statistically significantly affected by deviations from the intended time point at which the questionnaire is completed., Conclusions: The use of existing pooled data shows that it is possible to learn about general aspects of cancer HRQOL and methodology. Our work shows that setting up international pooled datasets holds great promise for understanding patients' unmet psychosocial needs and calls for additional empirical investigation to improve clinical care and understand cancer through retrospective HRQOL analyses., (© The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)

Background: Cancer incidence increases exponentially with advancing age, cancer patients live longer than in the past, and many new treatments focus on stabilizing disease and HRQOL. The objective of this study is to examine how cancer affects patients' HRQOL and whether their HRQOL is age-dependent., Methods: Data from 25 EORTC randomized controlled trials was pooled. EORTC QLQ-C30 mean scores for the cancer cohort and five general population cohorts were compared to assess the impact of cancer on patients' HRQOL. Within the cancer cohort, multiple linear regressions (two-sided level P-value = 0.05 adjusted for multiple testing.) were used to investigate the association between age and HRQOL, adjusted for gender, WHO performance status (PS), distant metastasis and stratified by cancer site. A difference of 10 points on the 0-100 scale was considered clinically important., Results: Cancer patients generally have worse HRQOL compared to the general population, but the specific HRQOL domains impaired vary with age. When comparing the cancer versus the general population, young cancer patients had worse financial problems, social and role functioning, while the older cancer groups had more appetite loss. Within the cancer cohort, HRQOL was worse with increasing age for physical functioning and constipation, and better with increasing age for social functioning, insomnia and financial problems (all p < 0.05)., Conclusion: HRQOL is impaired in cancer patients compared to the general population, but the impact on specific HRQOL domains varies by age. Within the cancer population, some HRQOL components improve with age while others deteriorate. Optimal care for older cancer patients should target HRQOL domains most relevant to this population., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Objectives: Cysts and abscesses of the Bartholin glands are a common occurrence in gynecologic or general practice. Little is known about restrictions in patient's daily life and sexual activity during treatment of Bartholin's cysts in general and especially with the Word catheter. This study is to assess the Quality of Life and Sexual Activity during treatment of Bartholin cyst's and abscesses with the Word-catheter., Study Design: Between March 2013 and May 2014 30 women were included in the study. Pain before treatment and during catheter insertion and removal was assed using a standardized VAS scale. Health-related quality of life was assessed with the Short-Form-12-Health-Survey. Fallowfield's Sexual Activity Questionnaire was administered to investigate sexual limitations. During treatment patient self-reported to a pain-diary (VAS 0-10)., Results: Pain levels decreased from a 3 [0-10] on day 1 to 0 [0-6] on day 6 with the median staying at 0 for the remaining treatment period. Discomfort and pain during sexual activity decreased significantly from initial presentation to end of treatment. The mental component summary score of the SF 12 increased significantly from 46.94±10.23 before treatment to 50.58±7.16 after treatment (p=0.016); the physical component summary score did not change significantly., Conclusions: The Word catheter is well tolerated for the treatment of Bartholin's cysts and abscesses with few and no serious side effects and little impingement of sexual health. A more relevant informed consent ahead of treatment, specifically with regard to pain in the first few days after catheter placement, might further increase acceptance of the catheter and adjust patient expectations., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Background: The aim of the study is to describe the development of a comprehensive European Organisation for Research and Treatment of Cancer (EORTC) questionnaire to assess sexual health of female and male cancer patients and for cancer survivors., Methods: According to the EORTC guidelines, the development of an EORTC sexual health questionnaire is typically organised in four phases. The first phases comprise a literature search following interviews with patient and health care professionals (HCPs) (phase 1) and the operationalization into items (phase 2). The translation process is formally conducted according to the EORTC QLG Translation guidelines with a rigorous forward-backward procedure supported by native speakers., Results: Studies on sexuality in oncology patients which were identified by a literature search predominantly focused on issues of activity, experiences of sexual dysfunction, and satisfaction with sexual functioning. The literature review identified themes beyond these aspects. In total 53 potentially relevant issues were presented to 107 patients and 83 HCPs, different evaluations were found., Conclusions: A questionnaire that includes physical, psychological, and social aspects of sexuality of cancer survivors will be needed. Pre-testing and validation of the questionnaire will be done in future (phases 3 and 4). Divergent ratings of patients and professionals should be further investigated.

Background: Major depression (MD) is associated with deficits in selective attention. Previous studies in adults with MD using event-related potentials (ERPs) reported abnormalities in the neurophysiological correlates of auditory selective attention. However, it is yet unclear whether these findings can be generalized to MD in adolescence. Thus, the aim of the present ERP study was to explore the neural mechanisms of auditory selective attention in adolescents with MD., Methods: 24 male and female unmedicated adolescents with MD and 21 control subjects were included in the study. ERPs were collected during an auditory oddball paradigm., Results: Depressive adolescents tended to show a longer N100 latency to target and non-target tones. Moreover, MD subjects showed a prolonged latency of the P200 component to targets. Across groups, longer P200 latency was associated with a decreased tendency of disinhibited behavior as assessed by a behavioral questionnaire., Limitations: To be able to draw more precise conclusions about differences between the neural bases of selective attention in adolescents vs. adults with MD, future studies should include both age groups and apply the same experimental setting across all subjects., Conclusions: The study provides strong support for abnormalities in the neurophysiolgical bases of selective attention in adolecents with MD at early stages of auditory information processing. Absent group differences in later ERP components reflecting voluntary attentional processes stand in contrast to results reported in adults with MD and may suggest that adolescents with MD possess mechanisms to compensate for abnormalities in the early stages of selective attention., (Copyright © 2014 Elsevier B.V. All rights reserved.)

Background: Recent studies have proposed the process of emotion regulation as a promising target to study the neurophysiological basis of adolescent depression. Emotion regulation has repeatedly been studied with emotional go/no-go paradigms. To date, no study has examined if the left-frontal hypoactivation associated with depression generalizes to active tasks. The aim of this study was therefore to investigate the hemispheric asymmetry of the N2 component in depressed adolescents in an emotion regulation paradigm., Methods: Twenty-four adolescents diagnosed with major depression (age 11-18) and 30 healthy controls (age 11-18) performed two emotional go/no-go tasks exhibiting negative faces as go trials and positive faces as no-go trials and vice versa., Results: On the behavioral level, no significant group differences emerged. On the neural level, we found a more right-lateralized N2-amplitude in depressed subjects, while it was more left-lateralized in controls. Furthermore, both groups showed a less negative N2-amplitude to positive no-go stimuli., Conclusion: This study provides strong support for a general left-frontal hypoactivity in adolescent depression, which also applies to active emotional go/no-go paradigms. Furthermore, the less negative N2 to positive stimuli is consistent with a generally enhanced impulsivity of adolescents toward appetitive stimuli, which is possibly the base of the differential clinical pattern of adolescent in contrast to adult depression., (© 2014 The Authors. Journal of Child Psychology and Psychiatry. © 2014 Association for Child and Adolescent Mental Health.)

Background: Quality of life (QoL) in endometrial cancer (EC) is understudied. Incorporation of QoL questionnaires and patient-reported outcomes in clinical trials has been inconsistent, and the tools and interpretation of these measures are unfamiliar to most practitioners. In 2012, the Gynecologic Cancer InterGroup Symptom Benefit Working Group convened for a brainstorming collaborative session to address deficiencies and work toward improving the quality and quantity of QoL research in women with EC., Methods: Through literature review and international expert contributions, we compiled a comprehensive appraisal of current generic and disease site-specific QoL assessment tools, strengths and weaknesses of these measures, assessment of sexual health, statistical considerations, and an exploration of the unique array of histopathologic and clinical factors that may influence QoL outcomes in women with EC., Results: This collaborative composition is the first publication specific to EC that addresses methodology in QoL research and the components necessary to achieve high quality QoL data in clinical trials. Future recommendations regarding (1) the incorporation of patient-reported outcomes in all clinical trials in EC, (2) definition of an a priori hypothesis, (3) utilization of validated tools and consideration of new tools corresponding to new therapies or specific symptoms, (4) publication within the same time frame as clinical outcome data, and (5) attempt to correct for disease site-specific potential confounders are presented., Conclusions: Improved understanding of methodology in QoL research and an increased undertaking of EC-specific QoL research in clinical trials are imperative if we are to improve outcomes in women with EC.

Findings on face identity and facial emotion recognition in autism spectrum disorder (ASD) are inconclusive. Moreover, little is known about the developmental trajectory of face processing skills in ASD. Taking a developmental perspective, the aim of this study was to extend previous findings on face processing skills in a sample of adolescents and adults with ASD. N = 38 adolescents and adults (13-49 years) with high-functioning ASD and n = 37 typically developing (TD) control subjects matched for age and IQ participated in the study. Moreover, n = 18 TD children between the ages of 8 and 12 were included to address the question whether face processing skills in ASD follow a delayed developmental pattern. Face processing skills were assessed using computerized tasks of face identity recognition (FR) and identification of facial emotions (IFE). ASD subjects showed impaired performance on several parameters of the FR and IFE task compared to TD control adolescents and adults. Whereas TD adolescents and adults outperformed TD children in both tasks, performance in ASD adolescents and adults was similar to the group of TD children. Within the groups of ASD and control adolescents and adults, no age-related changes in performance were found. Our findings corroborate and extend previous studies showing that ASD is characterised by broad impairments in the ability to process faces. These impairments seem to reflect a developmentally delayed pattern that remains stable throughout adolescence and adulthood.

In typical development, empathic abilities continue to refine during adolescence and early adulthood. Children and adolescents with autism spectrum disorders (ASD) show deficits in empathy, whereas adults with ASD may have developed compensatory strategies. We aimed at comparing developmental trajectories in the neural mechanisms underlying empathy in individuals with ASD and typically developing control (TDC) subjects. Using an explicit empathizing paradigm and functional magnetic resonance imaging, 27 participants with ASD and 27 TDC aged 12-31 years were investigated. Participants were asked to empathize with emotional faces and to either infer the face's emotional state (other-task) or to judge their own emotional response (self-task). Differential age-dependent changes were evident during the self-task in the right dorsolateral prefrontal cortex, right medial prefrontal cortex, right inferior parietal cortex, right anterior insula and occipital cortex. Age-dependent decreases in neural activation in TDC were paralleled by either increasing or unchanged age-dependent activation in ASD. These data suggest ASD-associated deviations in the developmental trajectories of self-related processing during empathizing. In TDC, age-dependent modulations of brain areas may reflect the 'fine-tuning' of cortical networks by reduction of task-unspecific brain activity. Increased age-related activation in individuals with ASD may indicate the development of compensatory mechanisms., (© The Author (2013). Published by Oxford University Press. For Permissions, please email: journals.permissions@oup.com.)

Aim: The aim for this study is to investigate the methodological quality and potential impact on clinical decision making of patient reported outcome (PRO) assessment in randomised controlled trials (RCTs) in the gynaecological cancer sites., Methods: A systematic review identified RCTs published between January 2004 and June 2012. Relevant studies were evaluated using a pre-determined extraction form which included: (1) Trial demographics and clinical and PRO characteristics; (2) level of PRO reporting and (3) bias, assessed using the Cochrane Risk of Bias tool. All studies were additionally analysed in relation to their relevance in supporting clinical decision making., Results: Fifty RCTs enrolling 24,991 patients were identified. In eight RCTs (16%) a PRO was the primary end-point. Twenty-one studies (42%) were carried out in a multi-national context. Where statistically significant PRO differences between treatments were found, it related in most cases to both symptoms and domains other than symptoms (n=17, 57%). The majority of studies (n=42, 84%) did not mention the mode of administration nor the methods of collecting PRO data. Statistical approaches for dealing with missing data were only explicitly mentioned in nine RCTs (18%). Sixteen RCTs (32%) were considered to be of high-quality and thus able to inform clinical decision making. Higher-quality PRO studies were generally associated with RCTs that were at a low risk of bias., Conclusion: This study showed that RCTs with PROs were generally well designed and conducted. In a third the information was very informative to fully understand the pros and cons of PROs treatment decision-making., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

The aim of our study was to undertake a prospective validation study of the Polish version of the EORTC cervical cancer (EORTC QLQ-CX24) module used alongside the EORTC core measure. The translated module was pilot-tested according to the established EORTC guidelines. Patients with histological confirmation of cervical cancer were eligible for the study. All patients filled out the Polish version of the EORTC QLQ-CX24 module in addition to EORTC QLQ-C30 and a demographic questionnaire. Standardised validity and reliability analyses were performed. One hundred and seventy-one patients were enrolled into the study, mean age ± SD: 52.1 ± 9.6. Cronbach alpha coefficients, range 0.81-0.88, showed positive internal consistency. Re-test was undertaken with 40 patients (23.4%). Interclass correlations for the EORTC QLQ-CX24 ranged from 0.85 to 0.89 and proved appropriate test-retest reliability. Satisfactory convergent and discriminant validity in multi-trait scaling analyses was seen. Concluding, the Polish version of the EORTC QLQ-CX24 module is a reliable and valid tool for measuring HRQoL in patients with cervical cancer. It can be fully recommended for use in clinical and epidemiological settings in the Polish population., (© 2013 John Wiley & Sons Ltd.)

Background: The objective of this study was to examine the prognostic value of baseline health-related quality of life (HRQOL) for survival with regard to different cancer sites using 1 standardized and validated patient self-assessment tool., Methods: In total, 11 different cancer sites pooled from 30 European Organization for Research and Treatment of Cancer (EORTC) randomized controlled trials were selected for this study. For each cancer site, univariate and multivariate Cox proportional hazards modeling was used to assess the prognostic value (P< .05) of 15 HRQOL parameters using the EORTC Core Quality of Life Questionnaire (QLQ-C30). Models were adjusted for age, sex, and World Health Organization performance status and were stratified by distant metastasis., Results: In total, 7417 patients completed the EORTC QLQ-C30 before randomization. In brain cancer, cognitive functioning was predictive for survival; in breast cancer, physical functioning, emotional functioning, global health status, and nausea and vomiting were predictive for survival; in colorectal cancer, physical functioning, nausea and vomiting, pain, and appetite loss were predictive for survival; in esophageal cancer, physical functioning and social functioning were predictive for survival; in head and neck cancer, emotional functioning, nausea and vomiting, and dyspnea were predictive for survival; in lung cancer, physical functioning and pain were predictive for survival; in melanoma, physical functioning was predictive for survival; in ovarian cancer, nausea and vomiting were predictive for survival; in pancreatic cancer, global health status was predictive for survival; in prostate cancer, role functioning and appetite loss were predictive for survival; and, in testis cancer, role functioning was predictive for survival., Conclusions: The current results demonstrated that, for each cancer site, at least 1 HRQOL domain provided prognostic information that was additive over and above clinical and sociodemographic variables., (© 2013 American Cancer Society.)