bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comparison of attitudes towards five end-of-life care interventions (active pain control, withdrawal of futile life-sustaining treatment, passive euthanasia, active euthanasia and physician-assisted suicide): a multicentred cross-sectional survey of Korean patients with cancer, their family caregivers, physicians and the general Korean population
Authors: Yun Young Ho , Kim Kyoung-Nam , Sim Jin-Ah , Yoo Shin Hye , Kim Miso , Kim Young Ae , Kang Beo Deul , Shim Hyun-Jeong , Song Eun-Kee , Kang Jung Hun , Kwon Jung Hye , Lee Jung Lim , Nam Eun Mi , Maeng Chi Hoon , Kang Eun Joo , Do Young Rok , Choi Yoon Seok , Jung Kyung Hae 
Published: September 2018

ObjectivesThis study determined attitudes of four groups—Korean patients with cancer, their family caregivers, physicians and the general Korean population—towards five critical end-of-life (EOL) interventions—active pain control, withdrawal of futile life-sustaining treatment (LST), passive euthanasia, active euthanasia and physician-assisted suicide.Design and settingWe enrolled 1001 patients with cancer and 1006 caregivers from 12 large hospitals in Korea, 1241 members of the general population and 928 physicians from each of the 12 hospitals and the Korean Medical Association. We analysed the associations of demographic factors, attitudes towards death and the important components of a ‘good death’ with critical interventions at EoL care.ResultsAll participant groups strongly favoured active pain control and withdrawal of futile LST but differed in attitudes towards the other four EoL interventions. Physicians (98.9%) favoured passive euthanasia more than the other three groups. Lower proportions of the four groups favoured active euthanasia or PAS. Multiple logistic regression showed that education (adjusted OR (aOR) 1.77, 95% CI 1.33 to 2.36), caregiver role (aOR 1.67, 95% CI 1.34 to 2.08) and considering death as the ending of life (aOR 1.66, 95% CI 1.05 to 1.61) were associated with preference for active pain control. Attitudes towards death, including belief in being remembered (aOR 2.03, 95% CI 1.48 to 2.79) and feeling ‘life was meaningful’ (aOR 2.56, 95% CI 1.58 to 4.15) were both strong correlates of withdrawal of LST with the level of monthly income (aOR 2.56, 95% CI 1.58 to 4.15). Believing ‘freedom from pain’ negatively predicted preference for passive euthanasia (aOR 0.69, 95% CI 0.55 to 0.85). In addition, ‘not being a burden to the family’ was positively related to preferences for active euthanasia (aOR 1.62, 95% CI 1.39 to 1.90) and PAS (aOR 1.61, 95% CI 1.37 to 1.89).ConclusionGroups differed in their attitudes towards the five EoL interventions, and those attitudes were significantly associated with various attitudes towards death.
Cross-cultural adaptation and psychometric properties of the Chinese version of the Communication Skills Attitude Scale among medical students in Liaoning province, China: a cross-sectional study
Authors: Zhang Yang , Jiang Gurong , Sun Yihan , Zhao Xia , Yu Xiaosong 
Published: September 2018

ObjectivesThe aims of this study were to develop the Chinese version of the Communication Skills Attitude Scale (CSAS-Ch) in order to test the psychometric properties of the modified instrument.DesignA cross-sectional study was conducted in September 2016 to evaluate the attitudes of Chinese medical students towards communication skills learning using CSAS at China Medical University.ParticipantsThe study recruited 510 fifth-year medical students by cluster sampling.MethodsCronbach’s α coefficients were calculated for the entire questionnaire and for the subscales to evaluate the internal consistency of the CSAS-Ch. In order to determine the structure underlying the CSAS, the scale was factor analysed using maximum likelihood extraction and the oblique rotation method.ResultsOf the 510 medical students, 492 (96.5%) completed the questionnaire. Cronbach’s α coefficient for the CSAS scale was 0.897. Exploratory factor analysis showed that the four-factor structure accounted for 59.8% of the variance and produced an acceptable fit to the data.ConclusionsThe modified CSAS-Ch can be used to evaluate attitudes towards communication skills. Further Future research for improving the teaching methods for communication skills should explore the relationship between medical students’ attitudes and the demographic characteristics.
Comparative effectiveness of first-line biological monotherapy use in rheumatoid arthritis: a retrospective analysis of the RECord-linkage On Rheumatic Diseases study on health care administrative databases
Authors: Silvagni Ettore , Bortoluzzi Alessandra , Carrara Greta , Zanetti Anna , Govoni Marcello , Scirè Carlo Alberto 
Published: September 2018

ObjectiveThese analyses aim to comparatively evaluate the persistence on treatment of different biological disease-modifying antirheumatic drugs (bDMARDs) when administered in monotherapy compared with combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in rheumatoid arthritis (RA) patients receiving first-line biologics.DesignThis is a retrospective observational study on Administrative Healthcare Databases.MethodsData were extracted from healthcare databases of the Lombardy Region, Italy (2004–2013), as a part of the RECord-linkage On Rheumatic Diseases study, on behalf of the Italian Society for Rheumatology. Analyses included patients with RA starting first-line approved course of bDMARDs and evaluated drug survival by using Cox proportional hazard models. Results are presented as HRs and 95% CI, crude and adjusted for prespecified confounders (age, sex, disease duration, Charlson Comorbidity Index (CCI), previous infections, use of concomitant glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs)).Results4478 patients with RA were included (17.84% monotherapy). Etanercept, adalimumab and infliximab were the most prescribed first-line biologics. bDMARD monotherapy was associated with longer disease duration, higher CCI, lower glucocorticoids and NSAIDs use. Compared with monotherapy, combination associated with a lower risk of failure (adjusted HR 0.79, 95% CI 0.72 to 0.88). Among monotherapies, considering etanercept as reference, adalimumab (1.28, 95% CI 1.03 to 1.59) and infliximab (2.41, 95% CI 1.85 to 3.15) had higher risk of failure. Concomitant methotrexate (0.78, 95% CI 0.70 to 0.87), leflunomide (0.80, 95% CI 0.65 to 0.98) or csDMARD combinations (0.77, 95% CI 0.68 to 0.87) reduced the risk of bDMARD withdrawal.ConclusionAdalimumab and infliximab monotherapies show lower retention rate compared with etanercept. The relatively small number of therapeutic courses different from tumour necrosis factor (TNF) inhibitors makes more difficult to achieve conclusive results with other biologics. Concomitant methotrexate, leflunomide and csDMARDs combination associate with longer survival on bDMARD. Our data confirm the effectiveness of the current practices in the choice of etanercept as first-line anti-TNF monotherapy and strengthen the currently recommended use of bDMARDs in combination with csDMARDs.
Role of cognitive ability in the association between functional health literacy and mortality in the Lothian Birth Cohort 1936: a prospective cohort study
Authors: Fawns-Ritchie Chloe , Starr John M , Deary Ian J 
Published: September 2018

ObjectivesWe investigated the role that childhood and old age cognitive ability play in the association between functional health literacy and mortality.DesignProspective cohort study.SettingThis study used data from the Lothian Birth Cohort 1936 (LBC1936) study, which recruited participants living in the Lothian region of Scotland when aged 70 years, most of whom had completed an intelligence test at age 11 years.Participants795 members of the LBC1936 with scores on tests of functional health literacy and cognitive ability in childhood and older adulthood.Primary and secondary outcome measuresParticipants were followed up for 8 years to determine mortality. Time to death in days was used as the primary outcome measure.ResultsUsing Cox regression, higher functional health literacy was associated with lower risk of mortality adjusting for age and sex, using the Shortened Test of Functional Health Literacy in Adults (HR 0.95, 95% CI 0.92 to 0.98), the Newest Vital Sign (HR 0.88, 95% CI 0.80 to 0.97) and a functional health literacy composite measure (HR 0.77, 95% CI 0.65 to 0.92), but not the Rapid Estimate of Adult Literacy in Medicine (HR 0.95, 95% CI 0.90 to 1.01). Adjusting for childhood intelligence did not change these associations. When additionally adjusting for fluid-type cognitive ability in older age, associations between functional health literacy and mortality were attenuated and non-significant.ConclusionsCurrent fluid ability, but not childhood intelligence, attenuated the association between functional health literacy and mortality. Functional health literacy measures may, in part, assess fluid-type cognitive abilities, and this may account for the association between functional health literacy and mortality.
Design and rationale of a randomised controlled trial comparing apixaban to phenprocoumon in patients with atrial fibrillation on chronic haemodialysis: the AXADIA-AFNET 8 study
Authors: Reinecke Holger , Jürgensmeyer Sabine , Engelbertz Christiane , Gerss Joachim , Kirchhof Paulus , Breithardt Günter , Bauersachs Rupert , Wanner Christoph 
Published: September 2018

IntroductionPatients with end-stage kidney disease requiring maintenance haemodialysis treatment experience a dramatic cardiovascular morbidity and mortality. Due to the high atherosclerotic and arteriosclerotic burden and profound alterations in haemostasis, they frequently suffer and die from both thromboembolic and bleeding events. This is a particular concern in patients on haemodialysis with atrial fibrillation (AF). Controlled trials on the optimal anticoagulation in patients with AF on haemodialysis are not available. The randomised controlled phase IIIb AXADIA–AFNET 8 trial will evaluate the safety and efficacy of the factor Xa inhibitor apixaban in patients with AF requiring haemodialysis.Methods and analysisA total of 222 patients will be randomised in an open-labelled, 1:1 design to receive either apixaban 2.5 mg twice daily or dose-adjusted vitamin K antagonist therapy (target international normalised ratio 2.0–3.0). All patients will be treated and followed up for a minimum of 6 months up to a maximum of 24 months. The primary outcome is major or clinically relevant, non-major bleedings or death of any cause. Secondary outcomes include stroke, cardiovascular death and other thromboembolic events, thus exploring the efficacy of apixaban. The first patient was randomised in June 2017.Ethics and disseminationThe study protocol was approved by the Ethical Committee of the Landesaertzekammer, Westfalen-Lippe and the Medical Faculty of the University of Muenster, Muenster, Germany (reference number: 2016-598 f-A). Written informed consent will be obtained from all patients prior to study participation, including their consent for long-term follow-up. AXADIA–AFNET 8 is an investigator-initiated trial. Sponsor is AFNET, Muenster, Germany. Study findings will be disseminated to Bristol-Myers Squibb, Munich, Germany, and Pfizer, Berlin, Germany, to the participating centres, at research conferences and in peer-reviewed journals.Trial registration numbersNCT02933697,Pre-results.
Study protocol for the MEXiletine hydrochloride administration trial: a placebo-controlled, randomised, double-blind, multicentre, crossover study of its efficacy and safety in spinal and bulbar muscular atrophy (MEXPRESS)
Authors: Yamada Shinichiro , Hashizume Atsushi , Hijikata Yasuhiro , Inagaki Tomonori , Ito Daisuke , Kinoshita Fumie , Nakatochi Masahiro , Kobayashi Yumiko , Hirakawa Akihiro , Nakamura Tomohiko , Katsuno Masahisa 
Published: September 2018

IntroductionSpinal and bulbar muscular atrophy (SBMA) is a slowly progressive neuromuscular disease. Cold exposure often leads to worsening of motor symptoms including paresis. Although mexiletine hydrochloride administration has been shown to be effective for the treatment of several muscular diseases, its effectiveness in SBMA has not been validated to date. The trial will test it as a symptomatic drug for cold paresis. This study is the first trial to evaluate the efficacy and safety of mexiletine hydrochloride administration in patients with SBMA.Methods and analysisA placebo-controlled, randomised, double-blind, multicentre, crossover clinical trial will be conducted to assess the safety and efficacy of mexiletine hydrochloride in patients with SBMA. The eligible patients will be assigned randomly in a 1:1 ratio to two groups in a double-blind manner. Participants will take mexiletine hydrochloride (300 mg/day) or a placebo orally three times a day for 4 weeks (period 1). After a 1-week washout period, participants will take the other drug for 4 weeks (period 2). The primary endpoint is the difference in distal latencies between room temperature and cold exposure conditions.Ethics and disseminationThis study will be conducted in compliance with the Helsinki Declaration and the Ethical Guidelines for Medical and Health Research Involving Human Subjects by the Japanese government and has been approved by the ethics committee of Nagoya University Graduate School of Medicine, as a central institutional review board, and by each facility. The results will be disseminated in peer-reviewed journals and at scientific conferences.Trial registration numberUMIN000026150; Pre-results.
Study protocol for a randomised controlled trial of consenting processes and their effects on patient decision-making when undergoing spinal injections: the Risks In Spinal Consenting for Surgery (RISCS) trial
Authors: Fletcher James W A , Khan Mohsin , Thorpe Paul L P J 
Published: September 2018

IntroductionThere are major differences between legal and medical approaches to informed consent. Medically, consent is obtained prospectively for an intended procedure, to inform the patient of choices, risks and benefits, and to manage expectations. Legally, consent is reviewed retrospectively, usually following unmet expectations and/or the occurrence of complications. Recent legal cases relating to clinical negligence define the establishment of causation and breach of duty related to informed consent. However, there is no prospective evidence to validate the current judicial perspectives on causation and thus clinical negligence. The aim of this randomised controlled trial (RCT) is to investigate whether variations in consenting processes for the same procedure lead to changes in patient decision-making related to consent for that procedure.Methods and analysisThe Risks In Spinal Consenting for Surgery trial is a single-centre, non-inferiority RCT, where 220 patients, aged over 18 years, receiving an elective, day case spinal injection, will be randomised to either a ‘legally styled’ consent form with 55 risks identified in the world literature, or a ‘medically styled’ consent form with the 13 serious or most common risks usually quoted by reference to specialist society guidelines. Following explanation of the medical reasons for considering an injection therapy and consent to the trial, participants will be randomly allocated to one of two groups (1:1). The patients are then given the opportunity to discuss any concerns relating to the procedure and/or risks with a single specialist practitioner. The primary outcome will be rates of consent withdrawal due to the risks explained. Secondary outcomes include scores from the State-Trait Anxiety Inventory, Visual Analogue Scale, EuroQol 5-dimension questionnaire and Oswestry Disability Index.Ethics and disseminationResults will be presented in peer-reviewed journals and at international conferences. This study is approved by the Health Research Authority: REC 16/SC/0510.Trial registration numberISRCTN67513618; Pre-results.
Features for medically serious suicide attempters who do not have a strong intent to die: a cross-sectional study in rural China
Authors: Sun Long , Zhang Jie , Lamis Dorian A 
Published: September 2018

ObjectivePrevious studies have implied that there were many Chinese suicide attempters who did not want to die by suicide. In the current study, we explored the factors which were associated with low levels of suicide intent. We also examined features for medically serious suicide attempters who do not have a strong intent to die in rural china.DesignCross-sectional study.SettingThe interviews occurred between May 2012 and July 2013 in 13 rural counties in Shandong and Hunan provinces, China.ParticipantsSubjects were 791 medically serious suicide attempters whose injury and wounds were so serious they required hospitalisation or immediate medical care.ResultsThe results supported that less years of education (β=−0.11, p=0.037), religious beliefs (β=1.20, p=0.005), living alone (β=1.92, p=0.017), negative life events (β=0.29, p=0.003), low levels of impulsivity (β=−0.10, p=0.013) and mental disorders (β=2.82, p<0.001) were associated with higher levels of suicide intent.ConclusionResults imply that there are some medically serious suicide attempters with a higher education and/or exhibit impulsivity who do not want to die by suicide. These findings can inform practice to prevent suicide in rural China.
What evidence is used to underpin the design of strength-based exercise interventions evaluated in randomised controlled trials for rheumatoid arthritis? A systematic review protocol
Authors: Boniface Graham , Norris Meriel , Williamson Esther , Gandhi Varsha , Kirtley Shona , O’Connell Neil 
Published: September 2018

IntroductionHealthcare researchers designing strength-based exercise interventions must choose an appropriate dose to test before evaluating its effect using a definitive/phase-III randomised controlled trial (RCT). Compared with early phase testing employed by pharmaceutical trials, it is questionable whether exercise-based trials employ the same rigour for establishing tolerated dosage. Consequently, it is unclear if participants are initially prescribed optimal doses of exercise, which may potentially impact on study outcomes. Using trials of strength-based exercise interventions in adults with rheumatoid arthritis (RA) as an exemplar, the aims of this review are to (1) identify the proportion of RCTs that use phase I/II trials with dose escalation methodology for setting prescription parameters, (2) determine type and level of evidence used to justify prescription parameters of strength-based exercise interventions evaluated by RCTs, (3) explore consistency and applicability of the evidence underpinning prescription parameters in RCTs and (4) explore if a relationship exists between risk of bias for RCTs evaluating strength-based interventions and the level of evidence used to underpin prescription parameters.Methods and analysisFocusing on RCT’s evaluating strength-based exercise interventions in adults with RA published after 2000, the following databases will be searched: Allied and Complementary Medicine Database, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, Excerpta Medica Database, Medline and Physiotherapy Evidence Database. For each RCT, we will identify the evidence used to underpin prescription parameters. Both trial and underpinning evidence will have key information about the intervention extracted using the template for intervention description and replication checklist. Risk of bias will be assessed according to Cochrane. Levels of evidence will be assessed against the Oxford Centre for Evidence-Based Medicine and relationships between RCT and underpinning evidence explored and described narratively. Two independent assessors will be involved throughout data selection and extraction with recourse to a third reviewer should agreement not be reached.Ethics and disseminationNo ethical issues are identified. Dissemination will be via publication.PROSPERO registration numberCRD42018090963.
Singing for people with aphasia (SPA): a protocol for a pilot randomised controlled trial of a group singing intervention to improve well-being
Authors: Tarrant Mark , Carter Mary , Dean Sarah Gerard , Taylor Rod S , Warren Fiona C , Spencer Anne , Adamson Jane , Landa Paolo , Code Chris , Calitri Raff 
Published: September 2018

IntroductionThe singing for people with aphasia (SPA) intervention aims to improve quality of life and well-being for people with poststroke aphasia. A definitive randomised controlled trial (RCT) is required to assess the clinical and cost effectiveness of SPA. The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design.Methods and analysisA two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation. Forty-eight participants discharged from clinical speech and language therapy will be individually randomised 1:1 to SPA (10 group sessions plus a resource booklet) or control (resource booklet only). Outcome assessment at baseline, 3 and 6 months postrandomisation include: ICEpop CAPability measure for adults, Stroke and Aphasia Quality of Life, EQ-5D-5L, modified Reintegration into Normal Living Index, Communication Outcome After Stroke, Very Short Version of the Minnesota Aphasia Test, Service Receipt Inventory and Care Related Quality of Life. Feasibility, acceptability and process outcomes include recruitment and retention rates, with measurement burden and trial experiences being explored in qualitative interviews (15 participants, 2 music facilitators and 2 music champions). Analyses include: descriptive statistics, with 95% CIs where appropriate; qualitative themes; intervention fidelity from videos and session checklists; rehearsal of health economic analysis.Ethics and disseminationNHS National Research Ethics Service and the Health Research Authority confirmed approval in April 2017; recruitment commenced in June 2017. Outputs will include: pilot data to inform whether to proceed to a definitive RCT and support a funding application; finalised intervention manual for multicentre replication of SPA; presentations at conferences, public involvement events; internationally recognised peer reviewed journal publications, open access sources and media releases.Trial registration numberNCT03076736.