bluuebunny/crossref_metadata_2025_split huggingface dataset:
Simvastatin as a neuroprotective treatment for Parkinson’s disease (PD STAT): protocol for a double-blind, randomised, placebo-controlled futility study
Authors: Carroll Camille B , Webb Douglas , Stevens Kara Nicola , Vickery Jane , Eyre Vicky , Ball Susan , Wyse Richard , Webber Mike , Foggo Andy , Zajicek John , Whone Alan , Creanor Siobhan 
Published: October 2019

IntroductionParkinson’s disease (PD) is a progressive neurodegenerative condition affecting approximately 185,000 people in the UK. No drug has been proven to slow disease progression. Epidemiological and pre-clinical data support simvastatin, a widely used cholesterol-lowering drug with a well-established safety profile, having neuroprotective properties. The aim of this study (Simvastatin as a neuroprotective treatment for PD (PD STAT)) is to determine whether simvastatin has the potential to slow PD progression. The study is part of the International Linked Clinical Trials initiative coordinated by The Cure Parkinson’s Trust. This paper describes the protocol for the PD STAT study.Methods and analysisPD STAT is a double-blind, randomised, placebo-controlled, multi-centre, parallel group, futility trial in patients with PD of mild–moderate severity. 235 participants have been recruited and randomly allocated in a 1:1 ratio to receive either oral simvastatin or matched placebo. Treatment involves a 1-month low-dose phase (40 mg daily), followed by a 23-month high-dose phase (80 mg daily) and ends with a 2-month washout period. Participants are reviewed at clinic visits at 1 month, 6, 12, 18, 24 and 26 months post-baseline, with interim telephone follow-up to monitor for adverse events.The primary outcome is the change in the Movement Disorder Society Unified Parkinson’s Disease Rating Scale part III motor subscale score in the practically defined OFF medication state (OFF state) between baseline and 24 months. Primary analysis will be on a modified intention to treat basis and will include only those participants who progress to the high-dose phase of the study.Ethics and disseminationThe protocol has been approved by the North East–Newcastle and North Tyneside 2 Research Ethics Committee. The results will be disseminated via research articles in peer-reviewed journals and presentations at local, national and international scientific meetings, as well as disseminated via patient groups, websites and networks. A summary of the study findings will be posted to participants at the end of the study.Trial RegistrationISRCTN16108482(prospectively registered); EudraCT 2015-000148-40; ClinicalTrials.govNCT02787590; Pre-results.
Gendered relationship between HIV stigma and HIV testing among men and women in Mozambique: a cross-sectional study to inform a stigma reduction and male-targeted HIV testing intervention
Authors: Ha Judy H , Van Lith Lynn M , Mallalieu Elizabeth C , Chidassicua Jose , Pinho Maria Dirce , Devos Patrick , Wirtz Andrea L 
Published: October 2019

ObjectivesIncreasing and sustaining engagement in HIV care for people living with HIV are critical to both individual therapeutic benefit and epidemic control. Men are less likely to test for HIV compared with women in sub-Saharan African countries, and ultimately have delayed entry to HIV care. Stigma is known to impede such engagement, placing an importance on understanding and addressing stigma to improve HIV testing and care outcomes. This study aimed to assess the gendered differences in the relationship between stigma and HIV testing.Design and settingA cross-sectional, household probability survey was implemented between November and December 2016 in the Sofala province of Mozambique.ParticipantsData were restricted to men and women participants who reported no prior diagnosis of HIV infection (N=2731).MeasuresMeasures of sociodemographic characteristics, stigma and past exposure to HIV interventions were included in gender-stratified logistic regression models to estimate the relationship between stigma and recent testing for HIV, as well as to identify other relevant correlates.ResultsSignificantly fewer men (38.3%) than women (47.6%; p<0.001) had recently tested for HIV. Men who reported previous engagement in community group discussions about HIV had an increased odds of testing in the past 12 months compared to those who had not participated (adjusted OR (aOR)=1.92; 95% CI 1.51 to 2.44). Concerns about stigma were not a commonly reported barrier to HIV testing; however, men who expressed anticipated individual HIV stigma had a 35% lower odds of recent HIV testing (aOR=0.65; 95% CI 0.44 to 0.96). This association was not observed among women.ConclusionsMen have lower uptake of HIV testing in Mozambique when compared to women. Even amidst the beneficial effects of HIV messaging, individual stigma is negatively associated with recent HIV testing among men. Intervention efforts that target the unique challenges and needs of men are essential in promoting men’s engagement into the HIV care continuum in sub-Saharan Africa.
Validation study of health administrative data algorithms to identify individuals experiencing homelessness and estimate population prevalence of homelessness in Ontario, Canada
Authors: Richard Lucie , Hwang Stephen W , Forchuk Cheryl , Nisenbaum Rosane , Clemens Kristin , Wiens Kathryn , Booth Richard , Azimaee Mahmoud , Shariff Salimah Z 
Published: October 2019

ObjectivesTo validate case ascertainment algorithms for identifying individuals experiencing homelessness in health administrative databases between 2007 and 2014; and to estimate homelessness prevalence trends in Ontario, Canada, between 2007 and 2016.DesignA population-based retrospective validation study.SettingOntario, Canada, from 2007 to 2014 (validation) and 2007 to 2016 (estimation).ParticipantsOur reference standard was the known housing status of a longitudinal cohort of housed (n=137 200) and homeless or vulnerably housed (n=686) individuals. Two reference standard definitions of homelessness were adopted: the housing episode and the annual housing experience (any homelessness within a calendar year).Main outcome measuresSensitivity, specificity, positive and negative predictive values and positive likelihood ratios of 30 case ascertainment algorithms for detecting homelessness using up to eight health service databases.ResultsSensitivity estimates ranged from 10.8% to 28.9% (housing episode definition) and 18.5% to 35.6% (annual housing experience definition). Specificities exceeded 99% and positive likelihood ratios were high using both definitions. The most optimal algorithm estimates that 59 974 (95% CI 55 231 to 65 208) Ontarians (0.53% of the adult population) experienced homelessness in 2016, a 67.3% increase from 2007.ConclusionsIn Ontario, case ascertainment algorithms for identifying homelessness had low sensitivity but very high specificity and positive likelihood ratio. The use of health administrative databases may offer opportunities to track individuals experiencing homelessness over time and inform efforts to improve housing and health status in this vulnerable population.
Communities as ‘renewable energy’ for healthcare services? a multimethods study into the form, scale and role of voluntary support for community hospitals in England
Authors: Ellis Paine Angela , Kamerāde Daiga , Mohan John , Davidson Deborah 
Published: October 2019

ObjectiveTo examine the forms, scale and role of community and voluntary support for community hospitals in England.DesignA multimethods study. Quantitative analysis of Charity Commission data on levels of volunteering and voluntary income for charities supporting community hospitals. Nine qualitative case studies of community hospitals and their surrounding communities, including interviews and focus groups.SettingCommunity hospitals in England and their surrounding communities.ParticipantsCharity Commission data for 245 community hospital Leagues of Friends. Interviews with staff (89), patients (60), carers (28), volunteers (35), community representatives (20), managers and commissioners (9). Focus groups with multidisciplinary teams (8 groups across nine sites, involving 43 respondents), volunteers (6 groups, 33 respondents) and community stakeholders (8 groups, 54 respondents).ResultsCommunities support community hospitals through: human resources (average=24 volunteers a year per hospital); financial resources (median voluntary income = £15 632); practical resources through services and activities provided by voluntary and community groups; and intellectual resources (eg, consultation and coproduction). Communities provide valuable supplementary resources to the National Health Service, enhancing community hospital services, patient experience, staff morale and volunteer well-being. Such resources, however, vary in level and form from hospital to hospital and over time: voluntary income is on the decline, as is membership of League of Friends, and it can be hard to recruit regular, active volunteers.ConclusionsCommunities can be a significant resource for healthcare services, in ways which can enhance patient experience and service quality. Harnessing that resource, however, is not straight forward and there is a perception that it might be becoming more difficult questioning the extent to which it can be considered sustainable or ‘renewable’.
Effectiveness of social egg freezing: protocol for systematic review and meta-analyses
Authors: Wang Alex , Kumsa Fekede Asefa , Kaan Iain , Li Zhuoyang , Sullivan Elizabeth , Farquhar Cynthia M 
Published: October 2019

IntroductionSocial egg freezing is storing egg for the purpose of preserving fertility and delayed childbearing. Currently, little is known about the utilisation and effectiveness of this approach. This review aims to determine (1) the proportion of women who used their stored eggs, and (2) the egg survival rate through vitrification, and the clinical pregnancy rate and live birth rate per 100 women partaking in the procedure, and among women who stored their eggs for medical reasons.Methods and analysesThis systematic review will be done according to the items listed in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. PubMed, Embase, Scopus, The Cumulative Index to Nursing and Allied Health Literature (CINAHL) and the Cochrane Library and Health Technology Assessment databases will be searched to identify eligible studies published since 2012. Two reviewers will independently appraise the eligibility and quality of the studies based on preset checklists and extract the data using a data extraction template. Outcomes of interest are proportion of women who used their stored eggs, egg survival rate, pregnancy rate and live birth rates. We will determine the presence heterogeneity among studies using the Cochrane’s Q test. The percentage of total variation across studies, which is due to statistical heterogeneity, will be calculated using the I2statistics. Outcomes of interest will be pooled together using metaprop programme STATA V.14.Ethics and disseminationFor this review, ethical committee approval is not required. We will use publically available data from previously published studies. The final report of the review will be disseminated through publication on national or international journal, and it will be presented on different scientific conferences.PROSPERO registration numberCRD42018114254.
Patient perspectives on hypertension management in health system of Sri Lanka: a qualitative study
Authors: Perera Manuja , de Silva Chamini Kanatiwela , Tavajoh Saeideh , Kasturiratne Anuradhani , Luke Nathathasa Vihangi , Ediriweera Dileepa Senajith , Ranasinha Channa D , Legido-Quigley Helena , de Silva H Asita , Jafar Tazeen H 
Published: October 2019

IntroductionUncontrolled hypertension is the leading risk factor for mortality globally, including low-income and middle-income countries (LMICs). However, pathways for seeking hypertension care and patients’ experience with the utilisation of health services for hypertension in LMICs are not well understood.ObjectivesThis study aimed to explore patients’ perspectives on different dimensions of accessibility and availability of healthcare for the management of uncontrolled hypertension in Sri Lanka.SettingPrimary care in rural areas in Sri Lanka.Participants20 patients with hypertension were purposively sampled from an ongoing study of Control of Blood Pressure and Risk Attenuation in rural Bangladesh, Pakistan, Sri Lanka.MethodWe conducted in-depth interviews with patients. Interviews were audio-recorded and transcribed into local language (Sinhala) and translated to English. Thematic analysis was used and patient pathways on their experiences accessing care from government and private clinics are mapped out.ResultsOverall, most patients alluded to the fact that their hypertension was diagnosed accidentally in an unrelated visit to a healthcare provider and revealed lack of adherence and consuming alternatives as barriers to control hypertension. Referring to the theme ‘Accessibility and availability of hypertension care’, patients complained of distance to the hospitals, long waiting time and shortage of medicine supplies at government clinics as the main barriers to accessing health services. They often resorted to private physicians and paid out of pocket when they experienced acute symptoms attributable to hypertension. Considering the theme ‘Approachability and ability to perceive’, the majority of patients mentioned increasing public awareness, training healthcare professionals for effective communication as areas of improvement. Under the theme ‘Appropriateness and ability to engage’, few patients were aware of the names or purpose of their medications and reportedly missed doses frequently. Reminders from family members were considered a major facilitator to adherence to antihypertensive medications. Patients welcomed the idea of outreach services for hypertension and health education closer to home in the theme ‘Things the patients reported to improve the system’.ConclusionPatients identified several barriers to accessing hypertension care in Sri Lanka. Measures recommended improving hypertension management in Sri Lanka including public education on hypertension, better communication between healthcare professionals and patients, and efforts to improve access and understanding of antihypertensive medications.Trial registration numberNCT02657746.
Effectiveness of a multicomponent safe surgery intervention on improving surgical quality in Tanzania’s Lake Zone: protocol for a quasi-experimental study
Authors: Alidina Shehnaz , Kuchukhidze Salome , Menon Gopal , Citron Isabelle , Lama Tenzing N , Meara John , Barash David , Hellar Augustino , Kapologwe Ntuli A , Maina Erastus , Reynolds Cheri , Staffa Steven J , Troxel Alena , Varghese Asha , Zurakowski David , Ulisubisya Mpoki , Maongezi Sarah 
Published: October 2019

IntroductionEffective, scalable strategies for improving surgical quality are urgently needed in low-income and middle-income countries; however, there is a dearth of evidence about what strategies are most effective. This study aims to evaluate the effectiveness of Safe Surgery 2020, a multicomponent intervention focused on strengthening five areas: leadership and teamwork, safe surgical and anaesthesia practices, sterilisation, data quality and infrastructure to improve surgical quality in Tanzania. We hypothesise that Safe Surgery 2020 will (1) increase adherence to surgical quality processes around safety, teamwork and communication and data quality in the short term and (2) reduce complications from surgical site infections, postoperative sepsis and maternal sepsis in the medium term.Methods and analysisOur design is a prospective, longitudinal, quasi-experimental study with 10 intervention and 10 control facilities in Tanzania’s Lake Zone. Participants will be surgical providers, surgical patients and postnatal inpatients at study facilities. Trained Tanzanian medical data collectors will collect data over a 3-month preintervention and postintervention period. Adherence to safety as well as teamwork and communication processes will be measured through direct observation in the operating room. Surgical site infections, postoperative sepsis and maternal sepsis will be identified prospectively through daily surveillance and completeness of their patient files, retrospectively, through the chart review. We will use difference-in-differences to analyse the impact of the Safe Surgery 2020 intervention on surgical quality processes and complications. We will use interviews with leadership and surgical team members in intervention facilities to illuminate the factors that facilitate higher performance.Ethics and disseminationThe study has received ethical approval from Harvard Medical School and Tanzania’s National Institute for Medical Research. We will report results in peer-reviewed publications and conference presentations. If effective, the Safe Surgery 2020 intervention could be a promising approach to improve surgical quality in Tanzania’s Lake Zone region and other similar contexts.
Vitamin D deficiency or supplementation and the risk of human herpesvirus infections or reactivation: a systematic review protocol
Authors: Lin Liang-Yu , Bhate Ketaki , Forbes Harriet , Smeeth Liam , Warren-Gash Charlotte , Langan Sinéad 
Published: October 2019

IntroductionHuman herpesviruses induce lifelong latent infections and may reactivate as the immune system deteriorates. Recent studies have suggested that vitamin D, an essential element of bone health, may have some effect of protecting against infections, but investigations of its potential to prevent herpesvirus infection or reactivation are limited. We will review the current literature examining vitamin D and the risk of herpesvirus infections or reactivation.Methods and analysisOur systematic review will address two research questions: (1) Do deficient/insufficient serum vitamin D levels increase the risk of herpesvirus infections and (2) Does vitamin D supplementation protect against herpesvirus infections? We will include only intervention studies with control groups, cohort studies and case-control studies. We will use subject headings and keywords to search for synonyms of ‘vitamin D’ and ‘herpesviruses’ (including herpes simplex virus type 1 and 2, varicella-zoster virus, cytomegalovirus, Epstein-Barr virus and human herpesviruses type 6, 7 and 8) in Medline, Embase, Global Health, Web of Science, Scopus and Cochrane Central Register of Controlled Trials, and the grey literature databases Open Grey, EThOS and BASE from inception to 31 August 2019. References to the included articles and relevant systematic reviews will also be examined. Two reviewers will independently screen the study titles and abstracts, and examine the full texts to decide the final eligibility. They will independently extract data from the studies and assess bias using the Cochrane Collaboration approach. A third researcher will solve any discrepancies. The results will be narratively synthesised; if an adequate number of studies is included and the homogeneity between studies is acceptable, a meta-analysis will be performed. We will assess the quality of evidence using the Grading of Recommendations, Assessment, Development and Evaluation framework, and display the results in a summary of findings table.Ethics and disseminationEthical review is not required for a systematic review. We will publish the results in a peer-review journal. Any amendments to the protocol will be recorded in the supplementary section.PROSPERO registration numberCRD42019130153.
Ageing stereotypes and prodromal Alzheimer’s disease (AGING): study protocol for an ongoing randomised clinical study
Authors: Gauthier Kim , Morand Alexandrine , Dutheil Frederic , Alescio-Lautier Béatrice , Boucraut José , Clarys David , Eustache Francis , Girard Nadine , Guedj Eric , Mazerolle Marie , Paccalin Marc , de la Sayette Vincent , Zaréa Aline , Huguet Pascal , Michel Bernard F , Desgranges Béatrice ,   AGING consortium, Régner Isabelle 
Published: October 2019

IntroductionThe number of older people diagnosed with amnestic mild cognitive impairment (aMCI), the prodromal state of Alzheimer's disease (AD), is increasing worldwide. However, some patients with aMCI never convert to the AD type of dementia, with some remaining stable and others reverting to normal. This overdiagnosis bias has been largely overlooked and gone unexplained. There is ample evidence in the laboratory that negative ageing stereotypes (eg, the culturally shared belief that ageing inescapably causes severe cognitive decline) contribute to the deteriorating cognitive performances of healthy older adults, leading them to perform below their true abilities. The study described here is intended to test for the first time whether such stereotypes also impair patients’ cognitive performances during neuropsychological examinations in memory clinics, resulting in overdiagnosis of aMCI.Methods and analysisThe ongoing study is a 4-year randomised clinical trial comparing patients’ physiological stress and cognitive performances during neuropsychological testing in memory clinics. A total of 260 patients attending their first cognitive evaluation will be randomised to either a standard condition of test administration, assumed here to implicitly activate negative ageing stereotypes or a reduced-threat instruction condition designed to alleviate the anxiety arising from these stereotypes. Both groups will be tested with the same test battery and stress biomarkers. For 30 patients diagnosed with aMCI in each group (n=60), biomarkers of neurodegeneration and amyloidopathy will be used to distinguish between aMCI with normal versus abnormal AD biomarkers. A 9-month follow-up will be performed on all patients to identify those whose cognitive performances remain stable, deteriorate or improve.Ethics and disseminationThis protocol has been approved by the French National Agency for Medicines and Health Products Safety and the Sud-Est I French Ethics Committee (2017-A00946-47). Results will be published in peer-reviewed journals.Trial registration numberNCT03138018.
The impact of closing emergency departments on mortality in emergencies: an observational study
Authors: Knowles Emma , Shephard Neil , Stone Tony , Mason Suzanne M , Nicholl Jon 
Published: October 2019

BackgroundIn England the demand for emergency care is increasing, while there is also a staffing shortage. This has implications for quality of care and patient safety. One solution may be to concentrate resources on fewer sites by closing or downgrading emergency departments (EDs). Our aim was to quantify the impact of such reorganisation on population mortality.MethodsWe undertook a controlled interrupted time series analysis to detect the impact of closing or downgrading five EDs, which occurred due to concerns regarding sustainability. We obtained mortality data from 2007 to 2014 using national databases. To establish ED resident catchment populations, estimated journey times by road were supplied by the Department for Transport. Other major changes in the emergency and urgent care system were determined by analysis of annual NHS Trust reports in each geographical area studied. Our main outcome measures were mortality and case fatality for a set of 16 serious emergency conditions.ResultsFor residents in the areas affected by closure, journey time to the nearest ED increased (median change 9 min, range 0–25 min). We found no statistically reliable evidence of a change in overall mortality following reorganisation of ED care in any of the five areas or overall (+2.5% more deaths per month on average; 95% CI −5.2% to +10.2%; p=0.52). There was some evidence to suggest that, on average across the five areas, there was a small increase in case fatality, an indicator of the ‘risk of death’ (+2.3%, 95% CI +0.9% to+3.6%; p<0.001), but this may have arisen due to changes in hospital admissions.ConclusionsWe found no evidence that reorganisation of emergency care was associated with a change in population mortality in the five areas studied. Further research should establish the economic consequences and impact on patient experience and neighbouring hospitals.