bluuebunny/crossref_metadata_2025_split huggingface dataset:
A randomised controlled pilot trial evaluating feasibility and acceptability of a computer-based tool to identify and reduce harmful and hazardous drinking among adolescents with alcohol-related presentations in Canadian pediatric emergency departments
Authors: Newton Amanda S , Dow Nadia , Dong Kathryn , Fitzpatrick Eleanor , Cameron Wild T , Johnson David W , Ali Samina , Colman Ian , Rosychuk Rhonda J 
Published: August 2017

ObjectiveThis study piloted procedures and obtained data on intervention acceptability to determine the feasibility of a definitive randomised controlled trial (RCT) of the effectiveness of a computer-based brief intervention in the emergency department (ED).DesignTwo-arm, multi-site, pilot RCT.Setting and participantsAdolescents aged 12–17 years presenting to three Canadian pediatric EDs from July 2010 to January 2013 for an alcohol-related complaint.InterventionsStandard medical care plus computer-based screening and personalised assessment feedback (experimental group) or standard care plus computer-based sham (control group). ED and research staff, and adolescents were blinded to allocation.OutcomesMain: change in alcohol consumption from baseline to 1- and 3 months post-intervention. Secondary: recruitment and retention rates, intervention acceptability and feasibility, perception of group allocation among ED and research staff, and change in health and social services utilisation.ResultsOf the 340 adolescents screened, 117 adolescents were eligible and 44 participated in the study (37.6% recruitment rate). Adolescents allocated to the intervention found it easy, quick and informative, but were divided on the credibility of the feedback provided (agreed it was credible: 44.4%, disagreed: 16.7%, unsure: 16.7%, no response: 22.2%). We found no evidence of a statistically significant relationship between which interventions adolescents were allocated to and which interventions staff thought they received. Alcohol consumption, and health and social services data were largely incomplete due to modest study retention rates of 47.7% and 40.9% at 1- and 3 months post-intervention, respectively.ConclusionsA computer-based intervention was acceptable to adolescents and delivery was feasible in the ED in terms of time to use and ease of use. However, adjustments are needed to the intervention to improve its credibility. A definitive RCT will be feasible if protocol adjustments are made to improve recruitment and retention rates; and increase the number of study sites and research staff.Trial registrationclinicaltrials.govNCT01146665
Speak-up culture in an intensive care unit in Hong Kong: a cross-sectional survey exploring the communication openness perceptions of Chinese doctors and nurses
Authors: Ng George Wing Yiu , Pun Jack Kwok Hung , So Eric Hang Kwong , Chiu Wendy Wai Hang , Leung Avis Siu Ha , Stone Yuk Han , Lam Chung Ling , Lai Sarah Pui Wa , Leung Rowlina Pui Wah , Luk Hing Wah , Leung Anne Kit Hung , Au Yeung Kin Wah , Lai Kang Yiu , Slade Diana , Chan Engle Angela 
Published: August 2017

ObjectivesDespite growing recognition of the importance of speaking up to protect patient safety in critical care, little research has been performed in this area in an intensive care unit (ICU) context. This study explored the communication openness perceptions of Chinese doctors and nurses and identified their perceptions of issues in ICU communication, their reasons for speaking up and the possible factors and strategies involved in promoting the practice of speaking up.DesignA mixed-methods design with quantitative and sequential qualitative components was used.Setting and participantsEighty ICU staff members from a large public hospital in Hong Kong completed a questionnaire regarding their perceptions of communication openness. Ten clinicians whose survey responses indicated support for open communication were then interviewed about their speak-up practices.ResultsThe participating ICU staff members had similar perceptions of their openness to communication. However, the doctors responded more positively than the nurses to many aspects of communication openness. The two groups also had different perceptions of speaking up. The interviewed ICU staff members who indicated a high level of communication openness reported that their primary reasons for speaking up were to seek and clarify information, which was achieved by asking questions. Other factors perceived to influence the motivation to speak up included seniority, relationships and familiarity with patient cases.ConclusionsCreating an atmosphere of safety and equality in which team members feel confident in expressing their personal views without fear of reprisal or embarrassment is necessary to encourage ICU staff members, regardless of their position, to speak up. Because harmony and saving face is valued in Chinese culture, training nurses and doctors to speak up by focusing on human factors and values rather than simply addressing conflict management is desirable in this context.
Randomised feasibility trial into the effects of low-frequency electrical muscle stimulation in advanced heart failure patients
Authors: Ennis Stuart , McGregor Gordon , Hamborg Thomas , Jones Helen , Shave Robert , Singh Sally J , Banerjee Prithwish 
Published: August 2017

ObjectivesLow-frequency electrical muscle stimulation (LF-EMS) may have the potential to reduce breathlessness and increase exercise capacity in the chronic heart failure population who struggle to adhere to conventional exercise. The study’s aim was to establish if a randomised controlled trial of LF-EMS was feasible.Design and settingDouble blind (participants, outcome assessors), randomised study in a secondary care outpatient cardiac rehabilitation programme.ParticipantsPatients with severe heart failure (New York Heart Association class III–IV) having left ventricular ejection fraction <40% documented by echocardiography were eligible.InterventionsParticipants were randomised (remotely by computer) to 8 weeks (5×60 mins per week) of either LF-EMS intervention (4 Hz, continuous, n=30) or sham placebo (skin level stimulation only, n=30) of the quadriceps and hamstrings muscles. Participants used the LF-EMS straps at home and were supervised weeklyOutcome measuresRecruitment, adherence and tolerability to the intervention were measured during the trial as well as physiological outcomes (primary outcome: 6 min walk, secondary outcomes: quadriceps strength, quality of life and physical activity).ResultsSixty of 171 eligible participants (35.08%) were recruited to the trial. 12 (20%) of the 60 patients (4 LF-EMS and 8 sham) withdrew. Forty-one patients (68.3%), adhered to the protocol for at least 70% of the sessions. The physiological measures indicated no significant differences between groups in 6 min walk distance(p=0.13) and quality of life (p=0.55) although both outcomes improved more with LF-EMS.ConclusionPatients with severe heart failure can be recruited to and tolerate LF-EMS studies. A larger randomised controlled trial (RCT) in the advanced heart failure population is technically feasible, although adherence to follow-up would be challenging. The preliminary improvements in exercise capacity and quality of life were minimal and this should be considered if planning a larger trial.Trial registration numberISRCTN16749049
Comparative efficacy and acceptability of antidepressants, psychological interventions, and their combination for depressive disorder in children and adolescents: protocol for a network meta-analysis
Authors: Zhou Xinyu , Cipriani Andrea , Zhang Yuqing , Cuijpers Pim , Hetrick Sarah E , Weisz John R , Pu Juncai , Giovane Cinzia Del , Furukawa Toshiaki A , Barth Jürgen , Coghill David , Leucht Stefan , Yang Lining , Ravindran Arun V , Xie Peng 
Published: August 2017

IntroductionDepressive disorder is common in children and adolescents, with important consequences and serious impairments in terms of personal and social functioning. While both pharmacological and psychological interventions have been shown to be effective, there is still uncertainty about the balance between these and what treatment strategy should be preferred in clinical practice. Therefore, we aim to compare and rank in a network meta-analysis (NMA) the commonly used psychological, pharmacological and combined interventions for depressive disorder in children and adolescents.Methods and analysisWe will update the literature search of two previous NMAs for the identification of trials of antidepressant and psychotherapy alone for depressive disorder in children and adolescents. For identification of trials of combination interventions, seven databases (PubMed, EMBASE, CENTRAL (Cochrane Central Register of Controlled Trials), Web of Science, PsycINFO, CINAHL, LiLACS) will be searched from date of inception. We will also search ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform and check relevant reports on the US Food and Drug Administration website for unpublished data. Building on our previous findings in the field, we will include any commonly prescribed oral antidepressants and any manualised or structured psychotherapies, as well as their combinations. Randomised controlled trials assessing any active intervention against active comparator or pill placebo/psychological controls in acute treatment for depressive disorder in children and adolescents will be included. The primary outcomes will be efficacy (mean change in depressive symptoms), and acceptability of treatment (dropout rate due to any cause). The secondary outcomes will be remission rate, tolerability of treatment (dropouts for adverse events), as well as suicide-related outcomes (suicidal behaviour or ideation). We will perform Bayesian NMAs for all relative outcome measures. Subgroup analyses and sensitivity analyses will be conducted to assess the robustness of the findings.DisseminationThis NMA will provide the most up to date and clinically useful information about the comparative efficacy and acceptability of antidepressants, psychological intervention and their combination in the acute treatment of children and adolescents with depressive disorder. This is the newest NMA and therefore these results are very important in terms of evidence-based medicine. The results will be disseminated through peer-reviewed publication.Protocol registrationPROSPERO CRD42015020841.
Effect of Community ART Groups on retention-in-care among patients on ART in Tete Province, Mozambique: a cohort study
Authors: Decroo Tom , Telfer Barbara , Dores Carla Das , White Richard A , Santos Natacha Dos , Mkwamba Alec , Dezembro Sergio , Joffrisse Mariano , Ellman Tom , Metcalf Carol 
Published: August 2017

ObjectivesEstimate the effect of participation in Community ART Groups (CAG) versus individual care on retention-in-care (RIC) on antiretroviral therapy (ART).DesignRetrospective cohort study.SettingHigh levels of attrition (death or loss-to-follow-up (LTFU) combined) on ART indicate that delivery models need to adapt in sub-Saharan Africa. In 2008, patients more than 6 months on ART began forming CAG, and took turns to collect ART refills at the health facility, in Tete Province, Mozambique,.Participants2406 adult patients, retained in care for at least 6 months after starting ART, during the study period (date of CAG introduction at the health facility—30 April 2012).MethodsData up to 30 April 2012 were collected from patient records at eight health facilities. Survival analysis was used to compare RIC among patients in CAG and patients in individual care, with joining a CAG treated as an irreversible time-dependent variable. Multivariable Cox regression was used to estimate the effect of CAG on RIC, adjusted for age, sex and health facility type and stratified by calendar cohort.Results12-month and 24-monthRIC from the time of eligibility were, respectively, 89.5% and 82.3% among patients in individual care and 99.1% and 97.5% among those in CAGs (p<0.0001). CAG members had a greater than fivefold reduction in risk of dying or being LTFU (adjusted HR: 0.18, 95% CI 0.11 to 0.29).ConclusionsAmong patients on ART, RIC was substantially better among those in CAGs than those in individual care. This study confirms that patient-driven ART distribution through CAGs results in higher RIC among patients who are stable on ART.
Baseline data from a planned RCT on attitudes to female genital cutting after migration: when are interventions justified?
Authors: Wahlberg Anna , Johnsdotter Sara , Selling Katarina Ekholm , Källestål Carina , Essén Birgitta 
Published: August 2017

ObjectivesTo present the primary outcomes from a baseline study on attitudes towards female genital cutting (FGC) after migration.DesignBaseline data from a planned cluster randomised, controlled trial. Face-to-face interviews were used to collect questionnaire data in 2015. Based on our hypothesis that established Somalis could be used as facilitators of change among those newly arrived, data were stratified into years of residency in Sweden.SettingSweden.Participants372 Somali men and women, 206 newly arrived (0–4 years), 166 established (>4 years).Primary outcome measuresWhether FGC is acceptable, preferred for daughter and should continue, specified on anatomical extent.ResultsThe support for anatomical change of girls and women’s genitals ranged from 0% to 2% among established and from 4% to 8% among newly arrived. Among those supporting no anatomical change, 75%–83% among established and 53%–67% among newly arrived opposed all forms of FGC, with the remaining supporting pricking of the skin with no removal of tissue. Among newly arrived, 37% stated that pricking was acceptable, 39% said they wanted their daughter to be pricked and 26% reported they wanted pricking to continue being practised. Those who had lived in Sweden ≤ 2 years had highest odds of supporting FGC; thereafter, the opposition towards FGC increased over time after migration.ConclusionA majority of Somali immigrants, including those newly arrived, opposed all forms of FGC with increased opposition over time after migration. The majority of proponents of FGC supported pricking. We argue that it would have been unethical to proceed with the intervention as it, with this baseline, would have been difficult to detect a change in attitudes given that a majority opposed all forms of FGC together with the evidence that a strong attitude change is already happening. Therefore, we decided not to implement the planned intervention.Trial registration numberTrial registration numberNCT02335697;Pre-results.
Changes in prevalence of workplace violence against doctors in all medical specialties in Norway between 1993 and 2014: a repeated cross-sectional survey
Authors: Johansen Ingrid Hjulstad , Baste Valborg , Rosta Judith , Aasland Olaf G , Morken Tone 
Published: August 2017

ObjectivesThe aim of this study was to investigate whether reported prevalence of experienced threats, real acts of violence and debilitating fear of violence among Norwegian doctors have increased over the last two decades.DesignRepeated cross-sectional survey.SettingAll healthcare levels and medical specialties in Norway.ParticipantsRepresentative samples of Norwegian doctors in 1993 (n=2628) and 2014 (n=1158).Main outcome measuresRelative risk (RR) of self-reported prevalence of work-time experiences of threats and real acts of violence, and of being physically or psychologically unfit during the last 12 months due to fear of violence, in 2014 compared with 1993, adjusted by age, gender and medical specialty.ResultsThere were no differences in self-reported threats (adjusted RR=1.01, 95% CI 0.95 to 1.08) or real acts (adjusted RR=0.90, 95% CI 0.80 to 1.03) of violence when comparing 2014 with 1993. The proportion of doctors who had felt unfit due to fear of violence decreased from 1993 to 2014 (adjusted RR=0.53, 95% CI 0.39 to 0.73). Although still above average, the proportion of doctors in psychiatry who reported real acts of violence decreased substantially from 1993 to 2014 (adjusted RR=0.75, 95% CI 0.60 to 0.95).ConclusionsA substantial proportion of doctors experience threats and real acts of violence during their work-time career, but there was no evidence that workplace violence has increased over the last two decades. Still, the issue needs to be addressed as part of the doctors’ education and within work settings.
Responses to assisted suicide requests: an interview study with Swiss palliative care physicians
Authors: Gamondi Claudia , Borasio Gian Domenico , Oliver Pam , Preston Nancy , Payne Sheila 
Published: August 2017

ObjectivesAssisted suicide in Switzerland is mainly performed by right-to-die societies. Medical involvement is limited to the prescription of the drug and certification of eligibility. Palliative care has traditionally been perceived as generally opposed to assisted suicide, but little is known about palliative care physicians’ involvement in assisted suicide practices. This paper aims to describe their perspectives and involvement in assisted suicide practices.MethodsA qualitative interview study was conducted with 23 palliative care physicians across Switzerland. Thematic analysis was used to interpret data.ResultsSwiss palliative care physicians regularly receive assisted suicide requests while none reported having received specific training in managing these requests. Participants reported being involved in assisted suicide decision making most were not willing to prescribe the lethal drug. After advising patients of the limits on their involvement in assisted suicide, the majority explored the origins of the patient’s request and offered alternatives. Many participants struggled to reconcile their understanding of palliative care principles with patients’ wishes to exercise their autonomy. The majority of participants had no direct contact with right-to-die societies, many desired better collaboration. A desire was voiced for a more structured debate on assisted suicide availability in hospitals and clearer legal and institutional frameworks.ConclusionsThe Swiss model of assisted suicide gives palliative care physicians opportunities to develop roles which are compatible with each practitioner’s values, but may not correspond to patients’ expectations. Specific education for all palliative care professionals and more structured ways to manage communication about assisted suicide are warranted.
Determining the Mechanisms of Dietary Turnip Rapeseed Oil on Cholesterol Metabolism in Men with Metabolic Syndrome
Authors: Saarinen Harri Juhani , Sittiwet Chaiyasit , Simonen Piia , Nissinen Markku J , Stenman Ulf-Håkan , Gylling Helena , Palomäki Ari 
Published: August 2017

We have earlier reported the reduction of total cholesterol, low-density lipoprotein (LDL) cholesterol and oxidized LDL caused by short-term modification of diet with cold-pressed turnip rapeseed oil (CPTRO) instead of butter. The aim of this supplementary study was to determine whether the beneficial effects resulted from altered cholesterol metabolism during the intervention. Thirty-seven men with metabolic syndrome (MetS) completed an open, randomized and balanced crossover study. Subjects' usual diet was supplemented with either 37.5 g of butter or 35 mL of CPTRO for 6–8 weeks. Otherwise normal dietary habits and physical activity were maintained without major variations. Serum non-cholesterol sterols were assayed with gas–liquid chromatography and used as surrogate markers of whole-body cholesterol synthesis and absorption efficiency. Serum proprotein convertase subtilisin/kexin type 9 (PCSK9) concentration was analyzed with Quantikine ELISA Immunoassay. Serum cholesterol synthesis markers and serum cholestanol (absorption marker), all as ratios to cholesterol, did not differ between the periods. Serum campesterol and sitosterol ratios to cholesterol were significantly increased after the administration of CPTRO resulting from the increased intake of 217 mg/day of plant sterols in CPTRO. Serum PCSK9 concentration did not differ between CPTRO and butter periods. The reduction in serum cholesterol by 7.2% after consumption of rapeseed oil could not be explained by changes in cholesterol absorption, synthesis or PCSK9 metabolism in MetS.
Breast Cancer Immunotherapy: Facts and Hopes
Authors: Emens Leisha A. 
Published: August 2017

Abstract
Immunotherapy is revolutionizing the management of multiple solid tumors, and early data have revealed the clinical activity of programmed cell death-1/programmed death ligand-1 (PD-1/PD-L1) antagonists in small numbers of patients with metastatic breast cancer. Clinical activity appears more likely if the tumor is triple negative, PD-L1+, and/or harbors higher levels of tumor-infiltrating leukocytes. Responses to atezolizumab and pembrolizumab appear to be durable in metastatic triple-negative breast cancer (TNBC), suggesting that these agents may transform the lives of responding patients. Current clinical efforts are focused on developing immunotherapy combinations that convert nonresponders to responders, deepen those responses that do occur, and surmount acquired resistance to immunotherapy. Identifying biomarkers that can predict the potential for response to single-agent immunotherapy, identify the best immunotherapy combinations for a particular patient, and guide salvage immunotherapy in patients with progressive disease are high priorities for clinical development. Smart clinical trials testing rational immunotherapy combinations that include robust biomarker evaluations will accelerate clinical progress, moving us closer to effective immunotherapy for almost all patients with breast cancer. Clin Cancer Res; 24(3); 511–20. ©2017 AACR.
Simultaneous Targeting of Two Distinct Epitopes on MET Effectively Inhibits MET- and HGF-Driven Tumor Growth by Multiple Mechanisms
Authors: Grandal Michael M. , Havrylov Serhiy , Poulsen Thomas T. , Koefoed Klaus , Dahlman Anna , Galler Gunther R. , Conrotto Paolo , Collins Sara , Eriksen Karsten W. , Kaufman Dafna , Woude George F.Vande , Jacobsen Helle J. , Horak Ivan D. , Kragh Michael , Lantto Johan , Bouquin Thomas , Park Morag , Pedersen Mikkel W. 
Published: August 2017

AbstractIncreased MET activity is linked with poor prognosis and outcome in several human cancers currently lacking targeted therapies. Here, we report on the characterization of Sym015, an antibody mixture composed of two humanized IgG1 antibodies against nonoverlapping epitopes of MET. Sym015 was selected by high-throughput screening searching for antibody mixtures with superior growth-inhibitory activity against MET-dependent cell lines. Synergistic inhibitory activity of the antibodies comprising Sym015 was observed in several cancer cell lines harboring amplified MET locus and was confirmed in vivo. Sym015 was found to exert its activity via multiple mechanisms. It disrupted interaction of MET with the HGF ligand and prompted activity-independent internalization and degradation of the receptor. In addition, Sym015 induced high levels of CDC and ADCC in vitro. The importance of these effector functions was confirmed in vivo using an Fc-effector function–attenuated version of Sym015. The enhanced effect of the two antibodies in Sym015 on both MET degradation and CDC and ADCC is predicted to render Sym015 superior to single antibodies targeting MET. Our results demonstrate strong potential for use of Sym015 as a therapeutic antibody mixture for treatment of MET-driven tumors. Sym015 is currently being tested in a phase I dose escalation clinical trial (NCT02648724). Mol Cancer Ther; 16(12); 2780–91. ©2017 AACR.