bluuebunny/crossref_metadata_2025_split huggingface dataset:
Smartphone-delivered self-management for first-episode psychosis: the ARIES feasibility randomised controlled trial
Authors: Steare Thomas , O’Hanlon Puffin , Eskinazi Michelle , Osborn David , Lloyd-Evans Brynmor , Jones Rebecca , Rostill Helen , Amani Sarah , Johnson Sonia 
Published: August 2020

ObjectivesTo test the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate a Smartphone-based self-management tool in Early Intervention in Psychosis (EIP) services.DesignA two-arm unblinded feasibility RCT.SettingSix NHS EIP services in England.ParticipantsAdults using EIP services who own an Android Smartphone. Participants were recruited until the recruitment target was met (n=40).InterventionsParticipants were randomised with a 1:1 allocation to one of two conditions: (1) treatment as usual from EIP services (TAU) or (2) TAU plus access to My Journey 3 on their own Smartphone. My Journey 3 features a range of self-management components including access to digital recovery and relapse prevention plans, medication tracking and symptom monitoring. My Journey 3 use was at the users’ discretion and was supported by EIP service clinicians. Participants had access for a median of 38.1 weeks.Primary and secondary outcome measuresFeasibility outcomes included recruitment, follow-up rates and intervention engagement. Participant data on mental health outcomes were collected from clinical records and from research assessments at baseline, 4 months and 12 months.Results83% and 75% of participants were retained in the trial at the 4-month and 12-month assessments. All treatment group participants had access to My Journey 3 during the trial, but technical difficulties caused delays in ensuring timely access to the intervention. The median number of My Journey 3 uses was 16.5 (IQR 8.5 to 23) and median total minutes spent using My Journey 3 was 26.8 (IQR 18.3 to 57.3). No serious adverse events were reported.ConclusionsRecruitment and retention were feasible. Within a trial context, My Journey 3 could be successfully delivered to adults using EIP services, but with relatively low usage rates. Further evaluation of the intervention in a larger trial may be warranted, but should include attention to implementation.Trial registrationISRCTN10004994.
Developing and implementing a culturally informed FAmily Motivational Engagement Strategy (FAMES) to increase family engagement in first episode psychosis programs: mixed methods pilot study protocol
Authors: Oluwoye Oladunni , Dyck Dennis , McPherson Sterling M , Lewis-Fernández Roberto , Compton Michael T , McDonell Michael G , Cabassa Leopoldo J 
Published: August 2020

IntroductionDespite the proven effectiveness of coordinated specialty care (CSC) programmes for first episode psychosis in the USA, CSC programmes often have low levels of engagement in family psychoeducation, and engagement of racial and ethnic minority family members is even lower than that for non-Latino white family members. The goal of this study is to develop and evaluate a culturally informed FAmily Motivational Engagement Strategy (FAMES) and implementation toolkit for CSC providers.Methods and analysisThis protocol describes a mixed methods, multi-phase study that blends intervention mapping and the Promoting Action on Research in Health Services framework to develop, modify and pilot-test FAMES and an accompanying implementation toolkit. Phase 1 will convene a Stakeholder Advisory Committee to inform modifications based on findings from phases 1 and 2. During phase 1, we will also recruit approximately 200 family members to complete an online survey to assess barriers and motivation to engage in treatment. Phase 2 we will recruit five family members into a 3-month trial of the modified FAMES and implementation toolkit. Results will guide the advisory committee in refining the intervention and implementation toolkit. Phase 3 will involve a 16-month non-randomised, stepped-wedge trial with 50 family members from five CSC programmes in community-based mental health clinics to examine the acceptability, feasibility and initial impact of FAMES and the implementation toolkit.Ethics and disseminationThis study received Institutional Review Board approval from Washington State University, protocol #17 812–001. Results will be disseminated via peer review publications, presentations at national and international conferences, and to local community mental health agencies and committees.Trial registration numberClinicalTrials.gov Registry (NCT04188366).
Gravidity, parity, blood pressure and mortality among women in Bangladesh from the HEALS cohort
Authors: Shih Yu-Hsuan , Scannell Bryan Molly , Parvez Faruque , Uesugi Keriann Hunter , Shahriar Mohammed , Ahmed Alauddin , Islam Tariqul , Ahsan Habibul , Argos Maria 
Published: August 2020

ObjectivesDespite a hypothesised connection of reproductive history with hypertension and mortality, the nature of this association is poorly characterised. We evaluated the association of parity and gravidity with blood pressure, hypertension and all-cause mortality.DesignProspective cohort study.SettingHealth Effects of Arsenic Longitudinal Study cohort in rural Bangladesh.ParticipantsThere were 21 634 Bangladeshi women recruited in 2000–2002, 2006–2008 and 2010–2014 included in the present analysis.MethodsReproductive history was ascertained through an interviewer-administered questionnaire at the baseline visit. Blood pressure was measured by a trained study physician following a standard protocol at the baseline visit. Vital status was ascertained at the biennial follow-up of study participants through June 2017. Linear and logistic regression models estimated the relationship between parity and gravidity with blood pressure and hypertension, respectively. Cox proportional hazards models estimated the relationship with all-cause mortality only among women aged >45 years.ResultsDiastolic blood pressure was lowest in women with parity one (reference) and elevated in nulliparous women (adjusted % change=3.12; 95% CI 1.93 to 4.33) and women with parity>2 (adjusted % change=1.71; 95% CI 1.12 to 2.31). The associations with nulliparity were stronger for women aged >45 years. Similar association patterns were observed with hypertension. Further, in nulliparous women aged >45 years, 265 deaths (6.6%) were ascertained during the follow-up period (median follow-up time=8 years), and we observed suggestive elevated risks of all-cause mortality (adjusted HR 3.83; 95% CI 0.74 to 19.78). The relationships between reproductive history, blood pressure, hypertension and mortality were similar when modelling reproductive history as gravidity rather than parity.ConclusionsFor women in rural Bangladesh, nulliparity and nulligravidity appear to be associated with higher blood pressure and subsequent elevated risk of mortality.
“Are you ready?” Validation of the Hospital Change Readiness (HCR) Questionnaire
Authors: Pomare Chiara , Ellis Louise A , Long Janet C , Churruca Kate , Tran Yvonne , Braithwaite Jeffrey 
Published: August 2020

ObjectiveOrganisational change in hospitals is a frequent, seemingly inevitable occurrence. A critical precursor to successful organisational change is change readiness. This paper presents the adaptation of a self-report measure of change readiness for hospital staff, examines its reliability and validity, and evaluates the relationship between hospital change readiness (HCR) and staff well-being.MethodsThe questionnaire was piloted among 153 staff from a large metropolitan, public hospital in Sydney, Australia. The hospital was undergoing a major change involving a multimillion-dollar development project that included a new building and new models of care. Construct validity was evaluated by confirmatory factor analysis (CFA) and reliability was assessed by internal consistency. Differences between professional groups were examined using regression analyses and structural equation modelling (SEM) was used to test the relationship between change readiness and staff well-being (job satisfaction and burnout).ResultsThe HCR Questionnaire was found to reflect theoretically derived and empirically observed domains and have high internal reliability. CFA identified that a two-factor structure demonstrated excellent fit. Cronbach’s alpha for the two subscales (appropriateness and change efficacy) was 0.85 and 0.75, respectively. No statistically significant differences of HCR were identified between professional groups. SEM revealed that perceiving change as appropriate was significantly positively related to job satisfaction (0.33) and significantly negatively related to burnout (−0.30), and feeling capable in implementing the change was significantly negatively related to burnout (−0.40).ConclusionsThe HCR Questionnaire provides reliable information on how prepared hospital staff felt for organisational change and showed significant relationships with staff well-being. This questionnaire is validated for the Australian hospital context, particularly in the case of hospital redevelopment. It can be used to help manage times of hospital organisational change with minimal disruption to the quality and safety of patient care.
Has the reporting quality of published randomised controlled trial protocols improved since the SPIRIT statement? A methodological study
Authors: Tan Zet Wei , Tan Aidan Christopher , Li Tom , Harris Ian , Naylor Justine M , Siebelt Michiel , van Tiel Jasper , Pinheiro Marina , Harris Laura , Chamberlain Kira , Adie Sam 
Published: August 2020

ObjectivesTo determine the reporting quality of published randomised controlled trial (RCT) protocols before and after the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement (2013), and any association with author, trial or journal factors.DesignMethodological study.Data sourcesMEDLINE, Embase and CENTRAL were electronically searched using optimised search strategies.Eligibility criteriaProtocols written for an RCT of living humans, published in full text in a peer-reviewed journal and published in the English language.Main outcomePrimary outcome was the overall proportion of checklist items which were adequately reported in RCT protocols published before and after the SPIRIT statement.Results300 RCT protocols were retrieved; 150 from the period immediately before the SPIRIT statement (9 July 2012 to 28 December 2012) and 150 from a recent period after the SPIRIT statement (25 January 2019 to 20 March 2019). 47.9% (95% CI, 46.5% to 49.3%) of checklist items were adequately reported in RCT protocols before the SPIRIT statement and 56.7% (95% CI, 54.9% to 58.5%) after the SPIRIT statement. This represents an 8.8% (95% CI, 6.6% to 11.1%; p<0.0001) mean improvement in the overall proportion of checklist items adequately reported since the SPIRIT statement. While 40% of individual checklist items had a significant improvement in adequate reporting after the SPIRIT statement, 11.3% had a significant deterioration and there were no RCT protocols in which all individual checklist items were complete. The factors associated with higher reporting quality of RCT protocols in multiple regression analysis were author expertise or experience in epidemiology or statistics, multicentre trials, longer protocol word length and publicly reported journal policy of compliance with the SPIRIT statement.ConclusionThe overall reporting quality of RCT protocols has significantly improved since the SPIRIT statement, although a substantial proportion of individual checklist items remain poorly reported. Continued and concerted efforts are required by journals, editors, reviewers and investigators to improve the completeness and transparency of RCT protocols.
Is there an association between subjective sleep quality and daily delirium occurrence in critically ill adults? A post hoc analysis of a randomised controlled trial
Authors: Duprey Matthew S , Devlin John W , Skrobik Yoanna 
Published: August 2020

ObjectivesWhether and how delirium and sleep quality in the intensive care unit (ICU) are linked remains unclear. A recent randomised trial reported nocturnal low-dose dexmedetomidine (DEX) significantly reduces incident ICU delirium. Leeds Sleep Evaluation Questionnaire (LSEQ) scores were similar between intervention (DEX; n=50) and control (placebo (PLA); n=50) groups. We measured the association between morning LSEQ and delirium occurrence in the prior 24 hours (retrospective analysis) and the association between morning LSEQ and delirium occurrence in the following 24 hours (predictive analysis).DesignPost hoc analysis of randomised controlled trial data.ParticipantsAdult ICU patients (n=100) underwent delirium screening twice a day using the Intensive Care Delirium Screening Checklist (ICDSC) if Richmond Agitation Sedation Scale (RASS) was ≥−3 and patient-reported sleep quality evaluations at 09:00 daily with the LSEQ if RASS was ≥−1.OutcomesThe analysis included all 24-hour study periods with LSEQ documentation and matched delirium screening in coma-free patients. Separate logistic regression models controlling for age, baseline Acute Physiology and Chronic Health Evaluation II score and DEX/PLA allocation evaluated the association between morning LSEQ and delirium occurrence for both retrospective and predictive analyses.ResultsThe 100 patients spent 1115 24-hour periods in the ICU. Coma, delirium and no delirium occurred in 130 (11.7%), 114 (10.2%) and 871 (78.1%), respectively. In the retrospective analysis, when an LSEQ result was preceded by an ICDSC result (439/985 (44.6%) 24-hour periods), delirium occurred during 41/439 (9.3%) periods. On regression analysis, the LSEQ score had no relationship to prior delirium occurrence (OR (per every 1 point average LSEQ change) 0.97, 95% CI 0.72 to 1.31). For the predictive analysis, among the 387/985 (39.1%) 24-hour periods where an LSEQ result was followed by an ICDSC result, delirium occurred during 56/387 (14.5%) periods. On regression analysis, the LSEQ score did not predict subsequent delirium occurrence (OR (per 1 point LSEQ change) 1.02, 95% CI 0.99 to 1.05).ConclusionsThe sleep quality ICU patients perceive neither affects nor predicts delirium occurrence.Trial registration numberNCT01791296
Retrospective analysis of high flow nasal therapy in COVID-19-related moderate-to-severe hypoxaemic respiratory failure
Authors: Patel Maulin , Gangemi Andrew , Marron Robert , Chowdhury Junad , Yousef Ibraheem , Zheng Matthew , Mills Nicole , Tragesser Lauren , Giurintano Julie , Gupta Rohit , Gordon Matthew , Rali Parth , D'Alonso Gilbert , Fleece David , Zhao Huaqing , Patlakh Nicole , Criner Gerard 
Published: August 2020

Invasive mechanical has been associated with high mortality in COVID-19. Alternative therapy of high flow nasal therapy (HFNT) has been greatly debated around the world for use in COVID-19 pandemic due to concern for increased healthcare worker transmission.This was a retrospective analysis of consecutive patients admitted to Temple University Hospital in Philadelphia, Pennsylvania, from 10 March 2020 to 24 April 2020 with moderate-to-severe respiratory failure treated with HFNT. Primary outcome was prevention of intubation. Of the 445 patients with COVID-19, 104 met our inclusion criteria. The average age was 60.66 (+13.50) years, 49 (47.12 %) were female, 53 (50.96%) were African-American, 23 (22.12%) Hispanic. Forty-three patients (43.43%) were smokers. Saturation to fraction ratio and chest X-ray scores had a statistically significant improvement from day 1 to day 7. 67 of 104 (64.42%) were able to avoid invasive mechanical ventilation in our cohort. Incidence of hospital-associated/ventilator-associated pneumonia was 2.9%. Overall, mortality was 14.44% (n=15) in our cohort with 13 (34.4%) in the progressed to intubation group and 2 (2.9%) in the non-intubation group. Mortality and incidence of pneumonia was statistically higher in the progressed to intubation group.ConclusionHFNT use is associated with a reduction in the rate of invasive mechanical ventilation and overall mortality in patients with COVID-19 infection.
Ethical issues related to the COVID-19 pandemic in patients with cancer: experience and organisations in a French comprehensive cancer centre
Authors: Blot François , Dumont Sarah N , Vigouret-Viant Laurence , Verotte Nelly , Rossignol Julien , Rieutord André , Fournier-Bidoz Nathalie , De Jésus Anne , Dauchy Sarah , Chardonnet Florent , Baldini Capucine , Altea Anna 
Published: August 2020

BackgroundThe COVID-19 pandemic has aggressively reached the most vulnerable, not only the elderly but also patients with chronic conditions such as cancer. In this study, we present the outlines of ethical thinking and the measures implemented to try to respect our basic values of care, in the specific environment of an oncology hospital.MethodsOur ethics committee created an ethical watch system based on 24/7 shifts to assist practitioners in their daily decisions. We discuss the challenges faced by patients with cancer during the pandemic, such as access to critical care and ethical dilemmas in the context of resource scarcity, as well as the issue of isolation of patients. We also debate the restrictions in access to oncology care in a health context strongly ‘prioritised’ against COVID-19.ResultsIn all areas of an ethical dilemma, either for sorting out access to critical care or for the dramatic consequences of prolonged isolation of patients, our common thread was our attempt to protect, whenever possible, the principles of deontological ethics by strictly resisting utilitarian pressure. Respecting democratic health decision-making processes is a cornerstone of ethically relevant decisions, including in the context of a sanitary crisis.ConclusionThe role of an ethics committee related to real-life situations includes not only a reflexive perspective in respect of fundamental principles, but also the help to enlighten and resolve ethical dilemmas in complex clinical situations. This ethical watch team assists physicians in decision-making, promoting the supportive and palliative dimension of care with a holistic approach.
‘Sorry doctor….I didn’t hear that….’: phenomenological analysis of medical students’ experiences of simulated hearing impairment through virtual reality
Authors: McLaughlin Niamh , Rogers Janet , D’Arcy John , Gormley Gerard 
Published: August 2020

IntroductionHearing impairment is a common condition that can have a significant impact on an individual. Ineffective communication between such individuals and doctors remains an important barrier. There is a need to provide medical students with a deeper understanding of such challenges. Increasingly, simulation is being used to develop empathy skills. In this study, we aimed to seek a deep understanding of medical students’ experiences of being placed in the role of a hearing-impaired patient by means of a virtual reality (VR) simulation.MethodsA multidisciplinary group developed a 360° VR video-learning experience. This experience portrayed a consultation with a doctor from a hearing-impaired individual’s perspective. A qualitative study approach, using hermeneutic phenomenology, was conducted. Following the VR experience, students were interviewed, and transcripts of interviews were analysed using a Template Analysis approach.ResultsAnalysis yielded four main themes: (1) ‘much more than just watching a video’: a VR experience of hearing impairment; (2) ‘hearing through their ears’: experiencing a person’s world with hearing impairment; (3) ‘not just what you can’t hear…but how it makes you feel’: reactions evoked by a VR hearing impairment experience and (4) redirecting my future professional self?DiscussionThis study provides an insight into medical students’ experiences of a novel VR hearing impairment simulation. VR simulation has the potential to provide a novel complementary training method for medical students. By providing an immersive learning experience, VR can offer an empathic stepping into the ears of those that live with hearing impairment.
Worksite intervention study to prevent diabetes in Nepal: a randomised trial protocol
Authors: Pyakurel Prajjwal , Shrestha Archana , Karmacharya Biraj M , Budhathoki Shyam S , Chaudhari Rajendra Kumar , Tamrakar Dipesh , Shrestha Abha , Karmacharya Robin M , Shrestha Anmol , Sharma Sumitra , Sharma Sanjib Kumar , Spiegelman Donna 
Published: August 2020

IntroductionIn Nepal, approximately 31% of adult industrial employees have diabetes. While the prevention of type 2 diabetes through behavioural intervention has been disseminated, worksite could be an effective platform for the translation of this knowledge into action as employed adults spend most of their workday waking hours at workplaces.Methods and analysisWe will conduct a randomised controlled trial to assess the effectiveness of a behavioural and a canteen intervention on diabetes risk reduction among those who are prediabetic at two worksites in eastern Nepal. We will recruit 162 adult full-time factory workers with haemoglobin A1c (HbA1c) of 5.7%–6.4% at baseline or fasting blood sugar of 100–125 mg/dL. The 8–14 months’ control period will be followed by the behavioural intervention where half of the participants will be randomised to receive the behavioural intervention and half will act as a control and will not receive any intervention. Then, all participants will receive the canteen intervention. The analysis will be intent-to-treat, comparing the difference in the change in HbA1c% between the behavioural intervention group and the control group using a two-sample t-test. The within-participant changes in HbA1c after 6 or more months on the canteen intervention among those not randomised to the behavioural intervention in the previous period will be assessed using the paired t-test.Ethics and disseminationEthical approval was obtained from the Institutional Review Board at Yale School of Public Health, New Havens, USA and the Nepal Health Research Council.Trial registration numberNCT04161937.