bluuebunny/crossref_metadata_2025_split huggingface dataset:
Observational retrospective study of US national utilisation patterns and live birth rates for various ovarian stimulation protocols for in vitro fertilisation
Authors: Kushnir Vitaly A , Darmon Sarah K , Barad David H , Gleicher Norbert 
Published: November 2018

ObjectiveAlternative ovarian stimulation protocols for in vitro fertilisation (IVF) have grown in popularity. Yet, patient populations best suited for these protocols have not been defined. Our objective was, therefore, to determine national IVF utilisation patterns and live birth rates of various ovarian stimulation protocols.DesignRetrospective cohort study.SettingAcademic-affiliated private fertility centre.ParticipantsAggregate data published by Society for Assisted Reproductive Technology for autologous IVF cycles performed in the USA during 2014 and 2015 were analysed. IVF cycles were stratified based on ovarian stimulation protocol: 205 705 conventional stimulations, 4397 minimal stimulations, 2785 natural cycles and 514 in vitro maturation (IVM) cycles. Repeat cycles could not be determined in this analysis.Outcome measuresUtilisation patterns and age-specific live birth rates for various ovarian stimulation protocols.ResultsWith advancing female age, utilisation of conventional stimulation protocols decreased, while minimal stimulation and natural cycle IVF increased. Diminished ovarian reserve diagnoses were in all age groups less prevalent in patients undergoing conventional stimulation than with all other protocols. Live birth rates were highest with conventional stimulation at 42.4%, 33.1%, 22.1%, 11.7% and 3.9% for <35, 35–37, 38–40, 41–42 and >42 female age groups, respectively. The difference in live birth rates between conventional stimulation and other protocols widened with advancing age from 1.6-fold to 3.9-fold among women <35 years of age, reaching 4.4-fold to 6.6-fold among women >42 years of age.ConclusionsIn comparison to conventional stimulation IVF—minimal stimulation, natural cycle IVF and IVM protocols offer lower but still acceptable live birth rates among young women. These alternative protocols are frequently used in older women and those with diminished ovarian reserve, despite their lower live birth rates. The reasons for this apparent incongruity warrant further careful exploration.
Efficacy and safety of sodium-glucose cotransporter 2 inhibitors (SGLT-2is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) in patients with type 2 diabetes: a systematic review and network meta-analysis study protocol
Authors: Hussein Humaira , Zaccardi Francesco , Dhalwani Nafeesa N , Davies Melanie J , Khunti Kamlesh , Gray Laura J 
Published: November 2018

IntroductionSodium-glucose cotransporter 2 inhibitors (SGLT-2is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) are two classes of glucose-lowering drugs gaining popularity in the treatment of type 2 diabetes mellitus (T2DM). Current guidelines suggest patient-centred approaches when deciding between available hyperglycaemia drugs with no indication to which specific drug should be administered. Despite systematic reviews and meta-analyses being conducted within SGLT-2is and GLP-1RAs, differences across these classes of drugs have not been investigated. Therefore, this systematic review and network meta-analysis (NMA) will aim to compare the efficacy and safety profiles across and within SGLT-2is and GLP-1RAs.MethodsPubMed, the Cochrane Central Register of Controlled Trials and ISI Web of Science will be searched from inception for published randomised controlled trials conducted in patients with T2DM, with at least two arms consisting of SGLT-2is, GLP-1RAs or control/placebo. Title and abstracts will be screened by two independent reviewers with conflicts resolved by a third. Data will be extracted by the primary researcher, a random sample will be checked by an independent reviewer. Risk of bias will be assessed using the Cochrane Risk of Bias Tool and overall quality of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.Study characteristics, participants baseline characteristics, mean change in cardiometabolic outcomes and number of adverse events will be extracted for each study. Primary outcome will be the mean change in glycated haemoglobin (HbA1c) (%, mmol/mol). Initial random-effects pairwise meta-analysis will be conducted for each unique treatment comparison where heterogeneity will be assessed. A Bayesian NMA approach will be adopted where random-effects generalised linear models will be fitted in WinBUGS. Sensitivity analysis will be conducted to assess choices of prior distributions and length of burn-in and sample.Ethics and disseminationEthics approval is not required for this study. Results from this study will be published in a peer-review journal.PROSPERO registration numberCRD42018091306.
Educational disparities in perinatal health in Denmark in the first decade of the 21st century: a register-based cohort study
Authors: Bilsteen Josephine Funck , Andresen Josefine Bernhard , Mortensen Laust Hvas , Hansen Anne Vinkel , Andersen Anne-Marie Nybo 
Published: November 2018

ObjectiveTo investigate socioeconomic differences in six perinatal health outcomes in Denmark in the first decade of the 21st century.DesignA population-based cohort study.SettingDanish national registries.ParticipantsA total of 646 829 live born children and 3076 stillborn children (≥22+0 weeks of gestation) born in Denmark from 2000 to 2009. We excluded children with implausible relations between birth weight and gestational age (n=644), children without information on maternal country of origin (n=138) and implausible values of maternal year of birth (n=36).Main outcome measuresWe investigated the following perinatal health outcomes: stillbirth, neonatal and postneonatal mortality, small-for-gestational age, preterm birth grated into moderate preterm, very preterm and extremely preterm, and congenital anomalies registered in the first year of life.ResultsMaternal educational level was inversely associated with all adverse perinatal outcomes. For all examined outcomes, the risk association displayed a clear gradient across the educational levels. The associations remained after adjustment for maternal age, maternal country of origin and maternal year of birth. Compared with mothers with vocational education, mothers with more than 15 years of education had an adjusted risk ratio for stillbirth of 0.64(95% CI 0.56 to 0.72). The corresponding adjusted risk ratios for neonatal mortality, postneonatal mortality, congenital anomalies, moderate preterm birth and small-for-gestational age were, respectively, 0.79(95% CI 0.67 to 0.93), 0.57(95% CI 0.42 to 0.78), 0.87(95% CI 0.83 to 0.91), 0.80(95% CI 0.77 to 0.83) and 0.83(95% CI 0.81 to 0.85).ConclusionSubstantial educational inequalities in perinatal health were still present in Denmark in the first decade of the 21st century.
‘People like you?’: how people with hypertension make sense of future cardiovascular risk—a qualitative study
Authors: Marshall Iain J , Wolfe Charles D A , McKevitt Christopher 
Published: November 2018

ObjectivesCardiovascular disease (CVD) prevention guidelines recommend that patients’ future CVD risk (as a percentage) is estimated and used to inform shared treatment decisions. We sought to understand the perspectives of patients with hypertension on their future risk of CVD.DesignQualitative, semistructured interviews and thematic analysis.ParticipantsPeople with hypertension who had not experienced a cardiovascular event recruited from primary care.SettingParticipants were purposively sampled from two primary care practices in South London. Interviews were transcribed, and a thematic analysis was conducted.Results24 people participated; participants were diverse in age, sex, ethnicity and socioeconomic status. Younger working-aged people were under-represented. Contrasting with probabilistic risk, many participants understood future CVD as binary and unknowable. Roughly half of participants avoided contemplating future CVD risk; for some, lifestyle change and medication obviated the need to think about CVD risk. Some participants identified with one portion of the probability fraction (‘I’d be one ofthoseones.’). Comparison with peers (typically partners, siblings and friends of a similar age, including both ‘healthy’ and ‘unhealthy’ people) was most frequently used to describe risk, both among those who engaged with and avoided risk discussion. This contrasts with current risk scores, which describe probabilities in people with similar risk factors; many participants did not identify with such a group, and hence did not find these probabilities meaningful, even where correctly understood.ConclusionsRisk as typically calculated and communicated (eg, the risk of ‘100 people like you’) may not be meaningful for patients who do not identify with the denominator. Comparing an individual’s risk with their peers could be more meaningful.
Assessing the impact of care pathways on potentially preventable complications and costs for spinal trauma patients: protocol for a data linkage study using cohort study and administrative data
Authors: Vaikuntam Bharat Phani , Middleton James W , McElduff Patrick , Pearse Jim , Walsh John , Cameron Ian D , Sharwood Lisa Nicole 
Published: November 2018

IntroductionTraumatic spinal cord injuries have significant consequences both for the injured individual and the healthcare system, usually resulting in lifelong disability. Evidence has shown that timely medical and surgical interventions can lead to better patient outcomes with implicit cost savings. Potentially preventable secondary complications are therefore indicators of the effectiveness of acute care following traumatic injury. The extent to which policy and clinical variation within the healthcare service impact on outcomes and acute care costs for patients with traumatic spinal cord injury (TSCI) in Australia is not well described.Methods and analysisA comprehensive data set will be formed using record linkage to combine patient health and administrative records from seven minimum data collections (including costs), with an existing data set of patients with acute TSCI (Access to Care Study), for the time period June 2013 to June 2016. This person-level data set will be analysed to estimate the acute care treatment costs of TSCI in New South Wales, extrapolated nationally. Subgroup analyses will describe the associated costs of secondary complications and regression analysis will identify drivers of higher treatment costs. Mapping patient care and health service pathways of these patients will enable measurement of deviations from best practice care standards and cost-effectiveness analyses of the different pathways.Ethics and disseminationEthics approval has been obtained from the New South Wales Population and Health Services Research Ethics Committee. Dissemination strategies include peer-reviewed publications in scientific journals and conference presentations to enable translation of study findings to clinical and policy audiences.
Randomised controlled trial to assess the impact of a lifestyle intervention (ActWELL) in women invited to NHS breast screening
Authors: Anderson Annie S , Craigie Angela Mary , Gallant Stephanie , McAdam Chloe , Macaskill E Jane , Mutrie Nanette , Neilson Aileen Rae , O’Carroll Ronan E , Rauchhaus Petra , Sattar Naveed , Stead Martine , Treweek Shaun 
Published: November 2018

IntroductionIn Scotland, the incidence of breast cancer is predicted to rise significantly in the next few decades and while there are measures to support reductions in morbidity and mortality, the breast cancer community is currently exploring preventative opportunities including supporting weight management programmes in postmenopausal women. This study aims to assess the effectiveness and cost-effectiveness of a theory-based, community delivered, minimal contact, weight management (diet, physical activity and behaviour change techniques) programme (ActWELL) in women with a body mass index (BMI) >25 kg/m2attending routine breast cancer screening appointments.Methods and analysisThe study will be a four-centre, 1:1 parallel group randomised controlled trial of a 12-month weight management intervention initiated in breast cancer screening centres, delivered by trained Breast Cancer Now lifestyle coaches in community settings. The intervention programme involves two intervention meetings with coaches plus (up to) nine telephone contacts over 12 months. The programme will focus on personalised diet (including alcoholic and sugary drinks) and physical activity habits. Behaviour change techniques include self-monitoring, goal setting, implementation intentions, action and coping plans. The study has a sample size of 414 women with a BMI >25 kg/m2attending routine National Health Service breast cancer screening appointments. Measures will be taken at baseline, 12 weeks and at 12-month follow-up, complemented by qualitative interviews exploring perceived acceptability and impact on habitual behaviours. The two co-primary outcomes are mean change in measured body weight and change in physical activity between groups to 12 months. Secondary outcomes are changes in eating habits, alcohol intake, sedentary time, quality of life, waist circumference, lipid, haemoglobin A1c and insulin profiles, blood pressure and cost-effectiveness of the intervention.Ethics and disseminationThe protocol has been approved by East of Scotland Research Ethics Committee (17/ES/0073). All participants provide written informed consent. Dissemination will be through peer-reviewed publication and conference presentations.Trial registration numberISRCTN11057518; Pre-results.
Cohort profile of the Biomarkers of Acute Serious Illness in Children (BASIC) study: a prospective multicentre cohort study in critically ill children
Authors: Feinstein Yael , Walker Jennifer Claire , Peters Mark J , Nadel Simon , Pathan Nazima , Edmonds Naomi , Herberg Jethro , Kaforou Myrsini , Wright Victoria , Levin Michael , Ramnarayan Padmanabhan 
Published: November 2018

PurposeDespite significant progress, challenges remain in the management of critically ill children, including early identification of infection and organ failure and robust early risk stratification to predict poor outcome. The Biomarkers of Acute Serious Illness in Children study aims to identify genetic and biological pathways underlying the development of critical illness in infections and organ failure and those leading to poor outcome (death or severe disability) in children requiring emergency intensive care.ParticipantsWe recruited a prospective cohort of critically ill children undergoing emergency transport to four paediatric intensive care units (PICUs) in Southeast England between April 2014 and December 2016.Findings to dateDuring the study period, 1017 patients were recruited by the regional PICU transport team, and blood and urine samples were obtained at/around first contact with the patient by the transport team. Consent for participation in the study was deferred until after PICU admission and 674 parents/carers were consented. Further samples (blood, urine, stool and throat swabs) were collected after consent. Samples were processed and stored for genomic, transcriptomic, proteomic and metabolomic analyses. Demographic, clinical and laboratory data at first contact, during PICU stay and at discharge, were collected, as were detailed data regarding infectious or non-infectious aetiology. In addition, 115 families have completed 12-month validated follow-up questionnaires to assess quality of life and child behaviour.The first phase of sample analyses (transcriptomic profiling) is currently in progress.Future plansStored samples will be analysed using genomic, proteomic and metabolic profiling. Advanced bioinformatics techniques will be used to identify biomarkers for early diagnosis of infection, identification of organ failure and risk stratification to predict poor outcome (death/severe disability).Trial registration numberNCT03238040.
Smartphone problem-solving and behavioural activation therapy to reduce fear of recurrence among patients with breast cancer (SMartphone Intervention to LEssen fear of cancer recurrence: SMILE project): protocol for a randomised controlled trial
Authors: Akechi Tatsuo , Yamaguchi Takuhiro , Uchida Megumi , Imai Fuminobu , Momino Kanae , Katsuki Fujika , Sakurai Naomi , Miyaji Tempei , Horikoshi Masaru , Furukawa Toshi A , Iwata Hiroji , Uchitomi Yosuke 
Published: November 2018

IntroductionOne of the most common distressing conditions experienced by breast cancer survivors is fear of cancer recurrence (FCR). There is, however, no standard intervention for ameliorating FCR. Our clinical experience and previous studies have suggested the potential benefits of problem-solving therapy (PST) and behavioural activation (BA). Given the huge number of cancer survivors and limited number of therapists to competently conduct PST and BA, we have developed PST and BA smartphone applications. This study aimed to evaluate the efficacy of the smartphone-based PST (Kaiketsu-App) and BA (Genki-App) apps in reducing FCR in patients with breast cancer.Methods and analysisThe SMartphone Intervention to LEssen fear of cancer recurrence project is an open-label, individually randomised, parallel-group trial. Allocation will be managed by a central server using a computer-generated random allocation sequence provided by an independent data centre. Participants will be randomised to smartphone-based intervention plus treatment as usual (TAU) or waitlist control with TAU alone. The primary endpoint of the study is the Japanese version of the Concerns About Recurrence Scale, which will be administered as an electronic patient-reported outcome on the patients’ smartphone after 8 weeks.Ethics and disseminationThe present study is subject to the ethical guidelines for clinical studies published by Japan’s Ministry of Education, Science and Technology and Ministry of Health, Labour and Welfare and the modified Act on the Protection of Personal Information as well as the ethical principles established for research on humans stipulated in the Declaration of Helsinki and further amendments thereto. The protocol was approved by the Institutional Review Board of Nagoya City University on 15 January 2018 (ID: 60-00-1171).Trial statusThe randomised trial, which commenced on 2 April 2018, currently enrols participants. The estimated end date for this study is in March 2020.Trial registration numberUMIN000031140; Pre-results.
Establishing the prevalence of healthcare-associated infections in Australian hospitals: protocol for the Comprehensive Healthcare Associated Infection National Surveillance (CHAINS) study
Authors: Russo Philip L , Stewardson Andrew , Cheng Allen C , Bucknall Tracey , Marimuthu Kalisvar , Mitchell Brett G 
Published: November 2018

IntroductionA healthcare-associated infection (HAI) data point prevalence study (PPS) conducted in 1984 in Australian hospitals estimated the prevalence of HAI to be 6.3%. Since this time, there have been no further national estimates undertaken. In the absence of a coordinated national surveillance programme or regular PPS, there is a dearth of national HAI data to inform policy and practice priorities.Methods and analysisA national HAI PPS study will be undertaken based on the European Centres for Disease Control method. Nineteen public acute hospitals will participate. A standardised algorithm will be used to detect HAIs in a two-stage cluster design, random sample of adult inpatients in acute wards and all intensive care unit patients. Data from each hospital will be collected by two trained members of the research team. We will estimate the prevalence of HAIs, invasive device use, single room placement and deployment of transmission-based precautions.Ethics and disseminationEthics approval was obtained from the Alfred Health Human Research Ethics Committee (HREC/17/Alfred/203) via the National Mutual Assessment. A separate approval was obtained from the Tasmanian Health and Medical Human Research Committee (H0016978) for participating Tasmanian hospitals. Findings will be disseminated in individualised participating hospital reports, peer-reviewed publications and conference presentations.
Variations in hospital inpatient palliative care service use: a retrospective cohort study
Authors: Assareh Hassan , Stubbs Joanne M , Trinh Lieu T T , Greenaway Sally , Agar Meera , Achat Helen M 
Published: November 2018

ObjectiveUse of palliative care in hospitals for people at end of life varies. We examined rate and time of in-hospital palliative care use and associated interhospital variations.MethodsWe used admissions from all hospitals in New South Wales, Australia, within a 12-month period, for a cohort of adults who died in 73 public acute care hospitals between July 2010 and June 2014. Receiving palliative care and its timing were based on recorded use.ResultsAmong 90 696 adults who died, 27% received palliative care, and the care was initiated 7.6 days (mean; SD: 3.3 days) before death. Over the 5-year period, the palliative care rate rose by 58%, varying extent across chronic conditions. The duration of palliative care before death declined by 7%. Patient (demographics, morbidities and service use) and hospital factors (size, location and availability of palliative care unit) explained half of the interhospital variation in outcomes: adjusted IQR in rate and duration of palliative care among hospitals were 23%–39% and 5.2–8.7 days, respectively. Hospitals with higher rates often initiated palliative care earlier (correlation: 0.39; p<0.01).ConclusionDespite an increase over time in the palliative care rate, its initiation was late and of brief duration. Palliative care use was associated with patient and hospital characteristics; however, half of the between hospital variation remained unexplained. The observed suboptimal practices and variability indicate the need for expanded and standardised use of palliative care supported by assessment tools, service enhancement and protocols.