bluuebunny/crossref_metadata_2025_split huggingface dataset:
Enhancing Social Interaction in Depression (SIDE study): protocol of a randomised controlled trial on the effects of a Cognitively Based Compassion Training (CBCT) for couples
Authors: Aguilar-Raab Corina , Jarczok Marc N , Warth Marco , Stoffel Martin , Winter Friederike , Tieck Maria , Berg Judith , Negi Lobsang Tenzin , Harrison Tim , Pace Thaddeus W W , Ditzen Beate 
Published: October 2018

IntroductionPositive social interactions (PSIs) and stable relationships can exert substantial benefits on health. However, patients suffering from depression benefit less from these health-promoting effects. Moreover, relationship quality and even partners’ health has been found to be negatively affected by depressive symptomatology, which may result in overall impairments in social functioning of a romantic couple. Psychobiological research indicates that these impairments may be accompanied by a maladaptive regulation of the patient’s neuroendocrine response to external stressors. Concerning the improvement of social functioning, first studies showed promising results of “Cognitively Based Compassion Training (CBCT®)”. However, randomised trials are still scarce. Previous programmes did not involve participation of the patient’s romantic partner. Therefore, the present study aims to investigate whether a CBCT® programme adapted for couples (CBCT®-fC) can improve depressive symptoms, distress, social interaction skills and the neurobiological regulation of stress.Methods and analysisCouples with the female partner suffering from depression will be invited to participate in a pre-to-post intervention assessment on two consecutive days, respectively, involving a standardised PSI task, eye-tracking, ECG recordings, saliva-sampling, blood-sampling and questionnaire data. After baseline assessment, participating couples will be randomised to either a 10 week CBCT®-fC or to a treatment as usual control condition. The primary endpoint is the reduction of depressive symptoms measured by the Hamilton Depression Rating Scale. Secondary outcomes encompass self-rated depression (Beck Depression Inventory), attention towards the partners face during PSI (eye tracking), stress-related biomarkers (cortisol, α-amylase, interleukin (IL)-1ß/IL-6, heart rate variability), methylation of oxytocin-receptor-genes and serotonin-transporter-genes and self-ratings of psychological constructs such as relationship quality and empathy.Ethics and disseminationEthical approval has been obtained by the Ethics Committee of the Medical Faculty Heidelberg. Results will be presented in international, peer-reviewed journals and on conferences in the field of clinical psychology and psychiatry.Trial registration numberNCT03080025.
Legacy effects of statins on cardiovascular and all-cause mortality: a meta-analysis
Authors: Nayak Agnish , Hayen Andrew , Zhu Lin , McGeechan Kevin , Glasziou Paul , Irwig Les , Doust Jenny , Gregory Gabriel , Bell Katy 
Published: October 2018

ObjectivesTo assess evidence for ‘legacy’ (post-trial) effects on cardiovascular disease (CVD) mortality and all-cause mortality among adult participants of placebo-controlled randomised controlled trials (RCTs) of statins.DesignMeta-analysis of aggregate data.Setting/ParticipantsPlacebo-controlled statin RCTS for primary and secondary CVD prevention.MethodsData sources: PubMed, Embase from inception and forward citations of Cholesterol Treatment Trialists’ Collaborators RCTs to 16 June 2016.Study selection: Two independent reviewers identified all statin RCT follow-up reports including ≥1000 participants, and cardiovascular and all-cause mortality.Data extraction and synthesis: Two independent reviewers extracted data in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.Main outcomes: Post-trial CVD and all-cause mortality.ResultsWe included eight trials, with mean post-trial follow-up ranging from 1.6 to 15.1 years, and including 13 781 post-trial deaths (6685 CVD). Direct effects of statins within trials were greater than legacy effects post-trials. The pooled data from all eight studies showed no evidence overall of legacy effects on CVD mortality, but some evidence of legacy effects on all-cause mortality (p=0.01). Exploratory subgroup analysis found possible differences in legacy effect for primary prevention trials compared with secondary prevention trials for both CVD mortality (p=0.15) and all-cause mortality (p=0.02). Pooled post-trial HR for the three primary prevention studies demonstrated possible post-trial legacy effects on CVD mortality (HR=0.87; 95% CI 0.79 to 0.95) and on all-cause mortality (HR=0.90; 95% CI 0.85 to 0.96).ConclusionsPossible post-trial statin legacy effects on all-cause mortality appear to be driven by the primary prevention studies. Although these relative benefits were smaller than those observed within the trial, the absolute benefits may be similar for the two time periods. Analysis of individual patient data from follow-up studies after placebo-controlled statin RCTs in lower-risk populations may provide more definitive evidence on whether early treatment of subclinical atherosclerosis is likely to be beneficial.
Practice of informed consent in Guangdong, China: a qualitative study from the perspective of in-hospital patients
Authors: Gong Ni , Zhou Yinhua , Cheng Yu , Chen Xiaoqiong , Li Xuting , Wang Xia , Chen Guiting , Chen Jingyu , Meng Hongyan , Zhang Meifen 
Published: October 2018

ObjectiveThis study aimed to investigate the practice of informed consent in China from the perspective of patients.DesignA qualitative study using in-depth interviews with in-hospital patients focusing on personal experience with informed consent.SettingGuangdong Province, China.Participants71 in-hospital patients in rehabilitation after surgical operations were included.ResultsMedical information is not actively conveyed by doctors nor effectively received by patients. Without complete and understandable information, patients are unable to make an autonomous clinical decision but must sign an informed consent form following the doctor’s medical arrangement. Three barriers to accessing medical information by patients were identified: (1) medical information received by patients was insufficient to support their decision-making, (2) patients lacked medical knowledge to understand the perceptions of doctors and (3) patient–doctor interactions were insufficient in clinical settings.ConclusionsInformed consent is implemented as an administrative procedure at the hospital level in China. However, it has not been embedded in doctors’ clinical practices because, from the perspective of patients, doctors do not fulfil the obligation of medical information provision. As a result, the informed part of informed consent was neglected by individual doctors in China. Reforming medical education, monitoring the process of informed consent in clinical settings and redesigning medical institutional arrangements are pathways to restoring the practice of informed consent and patient-centred models in China.
Association of neighbourhood socioeconomic status and diabetes burden using electronic health records in Madrid (Spain): the HeartHealthyHoods study
Authors: Bilal Usama , Hill-Briggs Felicia , Sánchez-Perruca Luis , Del Cura-González Isabel , Franco Manuel 
Published: October 2018

ObjectiveTo study the association between neighbourhood socioeconomic status and diabetes prevalence, incidence, and control in the entire population of northeastern Madrid, Spain.SettingElectronic health records of the primary-care system in four districts of Madrid (Spain).Participants269 942 people aged 40 or older, followed from 2013 to 2014.ExposureNeighbourhoodsocioeconomic status (NSES), measured using a composite index of seven indicators from four domains of education, wealth, occupation and living conditions.Primary outcome measuresDiagnosis of diabetes based on ICPC-2 codes and glycated haemoglobin (HbA1c %).ResultsIn regression analyses adjusted by age and sex and compared with individuals living in low NSES neighbourhoods, men living in medium and high NSES neighbourhoods had 10% (95% CI: 6% to 15%) and 29% (95% CI: 25% to 32%) lower prevalence of diabetes, while women had 27% (95% CI: 23% to 30%) and 50% (95% CI: 47% to 52%) lower prevalence of diabetes. Moreover, the hazard of diabetes in men living in medium and high NSES neighbourhoods was 13% (95% CI: 1% to 23%) and 20% (95% CI: 9% to 29%) lower, while the hazard of diabetes in women living in medium and high NSES neighbourhoods was 17% (95% CI: 3% to 29%) and 31% (95% CI: 20% to 41%) lower. Individuals living in medium and high SES neighbourhoods had 8% (95% CI: 2% to 15%) and 15% (95% CI: 9% to 21%) lower prevalence of lack of diabetes control, and a decrease in average HbA1c % of 0.05 (95% CI: 0.01 to 0.10) and 0.11 (95% CI: 0.06 to 0.15).ConclusionsDiabetes prevalence, incidence and lack of control increased with decreasing NSES in a southern European city. Future studies should provide mechanistic insights and targets for intervention to address this health inequity.
Smoking as a risk factor for lung cancer in women and men: a systematic review and meta-analysis
Authors: O’Keeffe Linda M , Taylor Gemma , Huxley Rachel R , Mitchell Paul , Woodward Mark , Peters Sanne A E 
Published: October 2018

ObjectivesTo investigate the sex-specific association between smoking and lung cancer.DesignSystematic review and meta-analysis.Data sourcesWe searched PubMed and EMBASE from 1 January 1999 to 15 April 2016 for cohort studies. Cohort studies before 1 January 1999 were retrieved from a previous meta-analysis. Individual participant data from three sources were also available to supplement analyses of published literature.Eligibility criteria for selecting studiesCohort studies reporting the sex-specific relative risk (RR) of lung cancer associated with smoking.ResultsData from 29 studies representing 99 cohort studies, 7 million individuals and >50 000 incident lung cancer cases were included. The sex-specific RRs and their ratio comparing women with men were pooled using random-effects meta-analysis with inverse-variance weighting. The pooled multiple-adjusted lung cancer RR was 6.99 (95% Confidence Interval (CI) 5.09 to 9.59) in women and 7.33 (95% CI 4.90 to 10.96) in men. The pooled ratio of the RRs was 0.92 (95% CI 0.72 to 1.16; I2=89%; p<0.001), with no evidence of publication bias or differences across major pre-defined participant and study subtypes. The women-to-men ratio of RRs was 0.99 (95% CI 0.65 to 1.52), 1.11 (95% CI 0.75 to 1.64) and 0.94 (95% CI 0.69 to 1.30), for light, moderate and heavy smoking, respectively.ConclusionsSmoking yields similar risks of lung cancer in women compared with men. However, these data may underestimate the true risks of lung cancer among women, as the smoking epidemic has not yet reached full maturity in women. Continued efforts to measure the sex-specific association of smoking and lung cancer are required.
Acceptance and Commitment Therapy for Muscle Disease (ACTMus): protocol for a two-arm randomised controlled trial of a brief guided self-help ACT programme for improving quality of life in people with muscle diseases
Authors: Rose Michael R , Norton Sam , Vari Chiara , Edwards Victoria , McCracken Lance , Graham Christopher D , Radunovic Aleksandar , Chalder Trudie 
Published: October 2018

IntroductionIn adults, muscle disease (MD) is often a chronic long-term condition with no definitive cure. It causes wasting and weakness of the muscles resulting in a progressive decline in mobility, alongside other symptoms, and is typically associated with reduced quality of life (QoL). Previous research suggests that a psychological intervention, and in particular Acceptance and Commitment Therapy (ACT), may help improve QoL in MD. ACT is a newer type of cognitive behavioural treatment that aims to improve QoL by virtue of improvement in a process called psychological flexibility. The primary aim of this randomised controlled trial (RCT) is to evaluate the efficacy of a guided self-help ACT programme for improving QoL in people with MD. Main secondary outcomes are mood, symptom impact, work and social adjustment and function at 9-week follow-up.Methods and analysisAcceptance and Commitment Therapy for Muscle Disease is an assessor-blind, multicentre, two-armed, parallel-group RCT to assess the efficacy of ACT plus standard medical care (SMC) compared with SMC alone. Individuals with a diagnosis of one of four specific MDs, with a duration of at least 6 months and with mild to moderate anxiety or depression (Hospital Anxiety and Depression Scale score ≥8) will be recruited from UK-based MD clinics and MD patient support organisations. Participants will be randomised to either ACT plus SMC or SMC alone by an independent randomisation service. Participants will be followed up at 3, 6 and 9 weeks. Analysis will be intention to treat, conducted by the trial statistician who will be blinded to treatment allocation.Ethics and disseminationThe study has received full ethical approval. Study results will be disseminated via peer-reviewed publications, conference presentations and journal articles. Data obtained from the trial will enable clinicians and health service providers to make informed decisions regarding the efficacy of ACT for improving QoL for patients with MD.Trial registration numberNCT02810028.Protocol versionV.11 (4 April 2017).
Work-related mobility and experiences of gender-based violence among female sex workers in Iringa, Tanzania: a cross-sectional analysis of baseline data from Project Shikamana
Authors: Hendrickson Zoé Mistrale , Leddy Anna M , Galai Noya , Mbwambo Jessie K , Likindikoki Samuel , Kerrigan Deanna L 
Published: October 2018

ObjectivesTo examine how work-related mobility among female sex workers (FSWs) is associated with gender-based violence (GBV) in Iringa, Tanzania.DesignCross-sectional analyses were conducted on baseline data gathered between October 2015 and April 2016 from FSWs participating in Project Shikamana, a community empowerment-based combination HIV prevention intervention.SettingParticipants were recruited for the baseline study using venue-based time-location sampling in two communities in Iringa, Tanzania.ParticipantsFSWs were eligible for participation if they were 18 years or older and had exchanged sex for money within the past month. Four-hundred ninety-six FSWs participated in the baseline survey.Primary and secondary outcome measuresAny recent experience of GBV was examined by recent work-related mobility among FSWs. Any recent experience of GBV was also disaggregated by severity for analyses. All bivariate and multivariate binary and multinomial logistic regressions adjusted for intraclass correlations among women recruited from the same venues.ResultsForty per cent of participants experienced recent physical or sexual violence, and 30% recently experienced severe physical or sexual violence. Thirty-three per cent of participants recently exchanged sex for money outside of their district or region, and 12% were both intraregionally and inter-regionally mobile for sex work. Intraregionally and inter-regionally mobile FSWs had 1.9 times greater odds of reporting recent GBV (adjusted OR: 1.89; 95% CI: 1.06 to 3.38; p=0.031) compared with non-mobile FSWs and a 2.5 times higher relative risk for recent experience of severe GBV relative to no recent GBV (relative risk ratio: 2.51; 95% CI: 1.33 to 4.74; p=0.005).ConclusionsMobility for sex work may increase FSWs’ exposure to GBV, particularly more severe GBV. The vulnerability of mobile FSWs to violence, particularly severe forms, demands inclusive services that are accessible to mobile FSWs.
Improving sensitivity to eye gaze cues in autism using serious game technology: study protocol for a phase I randomised controlled trial
Authors: Scherf K. Suzanne , Griffin Jason W , Judy Brian , Whyte Elisabeth M , Geier Charles F , Elbich Daniel , Smyth Joshua M 
Published: October 2018

IntroductionAutism spectrum disorder (ASD) is characterised by impairments in social communication. Core symptoms are deficits in social looking behaviours, including limitedvisual attention to facesandsensitivity to eye gaze cues.We designed an intervention game using serious game mechanics for adolescents with ASD. It is designed to train individuals with ASD to discover that the eyes, and shifts in gaze specifically, provide information about the external world. We predict that the game will increase understanding of gaze cues and attention to faces.Methods and analysisThe Social Games for Adolescents with Autism (SAGA) trial is a preliminary, randomised controlled trial comparing the intervention game with a waitlist control condition. 34 adolescents (10–18 years) with ASD with a Full-Scale IQ between 70 and 130 and a minimum second grade reading level, and their parents, will be randomly assigned (equally to intervention or the control condition) following baseline assessments. Intervention participants will be instructed to play the computer game at home on a computer for ~30 min, three times a week. All families are tested in the lab at baseline and approximately 2 months following randomisation in all measures. Primary outcomes are assessed with eye tracking to measure sensitivity to eye gaze cues and social visual attention to faces; secondary outcomes are assessed with questionnaires to measure social skills and autism-like behaviours. The analyses will focus on evaluating the feasibility, safety and preliminary effectiveness of the intervention.Ethics and disseminationSAGA is approved by the Institutional Review Board at Pennsylvania State University (00005097). Findings will be disseminated via scientific conferences and peer-reviewed journals and to participants via newsletter. The intervention game will be available to families in the control condition after the full data are collected and if analyses indicate that it is effective.Trial registration numberNCT02968225.
Effects of the Elbow Flexion Angle on the Radial Nerve Location around the Humerus: A Cadaver Study for Safe Installation of a Hinged External Fixator
Authors: Sukegawa Koji , Kuniyoshi Kazuki , Suzuki Takane , Matsuura Yusuke , Onuma Kenji , Kenmoku Tomonori , Takaso Masashi 
Published: October 2018

Background: This study aimed to investigate whether the distance between the radial nerve and rotational center of the elbow joint when observing from the lateral surface of the humerus changes according to passive elbow joint flexion for safe external fixation with a hinged fixator of the elbow joint. Methods: Twenty fresh-frozen cadaveric arms were dissected. The points where the radial nerve crosses over the posterior aspect of the humerus, crosses through the lateral center, and crosses over the anterior aspect of the humerus were defined in the lateral view of the elbow joint, using fluoroscopy, as R1, R2, and R3, respectively. The distances between the rotational center and each point on the radial nerve were measured when the flexion angle of the elbow joint was 10°, 50°, 90°, and 130°. Results: The distances between the rotational center and R1, R2, and R3 were 118 mm, 94 mm, and 65 mm, respectively, when the flexion angle was 10°; 112 mm, 93 mm, and 74 mm, respectively, for 50°; 108 mm, 93 mm, and 77 mm, respectively, for 90°; and 103 mm, 94 mm, and 83 mm, respectively, for 130°. The distance between the rotational center and R2 was constant regardless of the flexion angle. With elbow joint extension, the distances between R1 and R3 increased; the safe zone, a region where the radial nerve would not be located on the humerus, was the smallest in extension. When the elbow joint was flexed, the distances between R1 and R3 decreased; the safe zone was the largest in flexion. Conclusions: This study showed that the radial nerve location on the humerus varied based on the flexion angle of the elbow joint; the safe zone may change. A half-pin can be likely inserted safely, avoiding the elbow joint extension position.
Knockout of ClC-2 reveals critical functions of adherens junctions in colonic homeostasis and tumorigenicity
Authors: Jin Younggeon , Ibrahim Dina , Magness Scott T. , Blikslager Anthony T. 
Published: October 2018

Adherens junctions (AJs), together with tight junctions (TJs), form an apical junctional complex that regulates intestinal epithelial cell-to-cell adherence and barrier homeostasis. Within the AJ, membrane-bound E-cadherin binds β-catenin, which functions as an essential intracellular signaling molecule. We have previously identified a novel protein in the region of the apical junction complex, chloride channel protein-2 (ClC-2), that we have used to study TJ regulation. In this study, we investigated the possible effects of ClC-2 on the regulation of AJs in intestinal mucosal epithelial homeostasis and tumorigenicity. Mucosal homeostasis and junctional proteins were examined in wild-type (WT) and ClC-2 knockout (KO) mice as well as associated colonoids. Tumorigenicity and AJ-associated signaling were evaluated in a murine colitis-associated tumor model and in a colorectal cancer cell line (HT-29). Colonic tissues from ClC-2 KO mice had altered ultrastructural morphology of intercellular junctions with reduced colonocyte differentiation, whereas jejunal tissues had minimal changes. Colonic crypts from ClC-2 KO mice had significantly higher numbers of less-differentiated forms of colonoids compared with WT. Furthermore, the absence of ClC-2 resulted in redistribution of AJ proteins and increased β-catenin activity. Downregulation of ClC-2 in colorectal cells resulted in significant increases in proliferation associated with disruption of AJs. Colitis-associated tumors in ClC-2 KO mice were significantly increased, associated with β-catenin transcription factor activation. The absence of ClC-2 results in less differentiated colonic crypts and increased tumorigenicity associated with colitis via dysregulation of AJ proteins and activation of β-catenin-associated signaling.NEW & NOTEWORTHY Disruption of adherens junctions in the absence of chloride channel protein-2 revealed critical functions of these junctional structures, including maintenance of colonic homeostasis and differentiation as well as driving tumorigenicity by regulating β-catenin signaling.