bluuebunny/crossref_metadata_2025_split huggingface dataset:
Development of a core outcome set for lower limb orthopaedic surgical interventions in ambulant children and young people with cerebral palsy: a study protocol
Authors: Almoajil Hajar , Dawes Helen , Hopewell Sally , Toye Francine , Jenkinson Crispin , Theologis Tim 
Published: March 2020

IntroductionMusculoskeletal deformities and gait deviations are common features in ambulatory cerebral palsy (CP). Deformity correction through lower limb orthopaedic surgery is the standard form of care aimed at improving or preserving motor function. Current research on CP care does not always take into account individual patients’ expectations and needs. There is a wide range of outcome domains and outcome measures used to assess outcome from treatment. This can lead to reporting bias and make it difficult to compare and contrast studies. A core outcome set (COS) would enhance the efficiency, relevance and overall quality of CP orthopaedic surgery research. The aim of this study is to establish a standardised COS for use in evaluating lower limb orthopaedic surgery for ambulatory children and young people with CP.Methods/analysisA set of outcomes domains and outcome measures will be developed as follows: (1) a qualitative evidence synthesis to identify relevant outcomes from children and young people and family perspective; (2) a scoping review to identify relevant outcomes and outcome measures; (3) qualitative research to explore the experience of key stakeholders; (4) prioritisation of outcome domains will be achieved through a two-round Delphi process with key stakeholders; (5) a final COS will be developed at a consensus meeting with representation from key stakeholder groups.Ethics and disseminationEthical approval for this study was granted in the UK by the Oxfordshire Research Ethics Committee B (REC reference 19/SC/0357). Informed consent will be obtained from participants taking part in the qualitative research and Delphi process. Study findings will be published in an open access journal and presented at relevant national and international conferences. Charities and associations will be engaged to promote awareness of the project COS results.Trial registration numberCOMET registration: 1236.PROSPERO registration numberCRD42018089538.
Distance as a barrier to obstetric care among indigenous women in Panama: a cross-sectional study
Authors: Acevedo Paloma , Martinez Sebastian , Pinzon Leonardo , Sanchez-Monin Emmanuelle , Winters Solis 
Published: March 2020

ObjectivesWe assess the relationship between distance to a woman’s assigned health clinic and obstetric care utilisation.DesignWe employ a cross-sectional study design using baseline data from the evaluation of a conditional cash transfer programme to promote greater utilisation of maternal and infant health services. Data were collected between December 2016 and January 2017.SettingThe study is conducted in Ngäbe Buglé, the largest of Panama’s three indigenous territories, where maternal mortality is three times the national average.ParticipantsWe analyse a representative sample of 1336 indigenous women with a birth in the 12 months prior to the survey.Primary and secondary outcome measuresPrimary outcomes include obstetric care utilisation measures for prenatal, childbirth and postpartum events. Secondary outcomes include reasons for not receiving prenatal care, alarming symptoms, child weight at birth and stillbirths or miscarriages.ResultsCompared with women in closest geographic proximity to a health centre (top quintile, Q1), women who lived farthest from a health centre (bottom quintile, Q5) had significantly lower obstetric care utilisation outcomes for critical prenatal, childbirth and postpartum events. Mothers in Q5 were 36 percentage points less likely to have had at least one prenatal care appointment in a hospital, health centre or clinic compared with mothers in Q1 (p<0.01), and 52 percentage points less likely to attend an institutional first appointment (p<0.01). The gap in institutional delivery and postnatal care between mothers in Q1 and Q5 was about 35 percentage points (p<0.01). All utilisation outcomes were negatively correlated with distance, and differences in obstetric care utilisation persisted even when controlling for household wealth, maternal age and maternal education.ConclusionDistance is an important barrier to obstetric care utilisation, with women in more distant locations suffering significantly lower use of prenatal, childbirth and postpartum care compared with women in closer vicinity to a health establishment. Expanding the supply of healthcare and implementing demand side incentives to promote the use of health services in remote communities are relevant policies to reduce disparities in obstetric care utilisation.Trial registration numberAEA Registry (RCT ID AEARCTR-0001751).
Community treatment orders and associations with readmission rates and duration of psychiatric hospital admission: a controlled electronic case register study
Authors: Barkhuizen Wikus , Cullen Alexis E , Shetty Hitesh , Pritchard Megan , Stewart Robert , McGuire Philip , Patel Rashmi 
Published: March 2020

ObjectivesLimited evidence is available regarding the effect of community treatment orders (CTOs) on mortality and readmission to psychiatric hospital. We compared clinical outcomes between patients placed on CTOs to a control group of patients discharged to voluntary community mental healthcare.Design and settingAn observational study using deidentified electronic health record data from inpatients receiving mental healthcare in South London using the Clinical Record Interactive Search (CRIS) system. Data from patients discharged between November 2008 and May 2014 from compulsory inpatient treatment under the Mental Health Act were analysed.Participants830 participants discharged on a CTO (mean age 40 years; 63% male) and 3659 control participants discharged without a CTO (mean age 42 years; 53% male).Outcome measuresThe number of days spent in the community until readmission, the number of days spent in inpatient care in the 2 years prior to and the 2 years following the index admission and mortality.ResultsThe mean duration of a CTO was 3.2 years. Patients receiving care from forensic psychiatry services were five times more likely and patients receiving a long-acting injectable antipsychotic were twice as likely to be placed on a CTO. There was a significant association between CTO receipt and readmission in adjusted models (HR: 1.60, 95% CI 1.42 to 1.80, p<0.001). Compared with controls, patients on a CTO spent 17.3 additional days (95% CI 4.0 to 30.6, p=0.011) in a psychiatric hospital in the 2 years following index admission and had a lower mortality rate (HR: 0.66, 95% CI 0.50 to 0.88, p=0.004).ConclusionsMany patients spent longer on CTOs than initially anticipated by policymakers. Those on CTOs are readmitted sooner, spend more time in hospital and have a lower mortality rate. These findings merit consideration in future amendments to the UK Mental Health Act.
Development of screening tools to predict the risk of recurrence and related complications following anal fistula surgery: protocol for a prospective cohort study
Authors: Mei Zubing , Li Yue , Zhang Zhijun , Zhou Haikun , Liu Suzhi , Han Ye , Du Peixin , Qin Xiufang , Shao Zhuo , Ge Maojun , Wang Qingming , Yang Wei 
Published: March 2020

IntroductionPostoperative recurrence and related complications are common and related to poor outcomes in patients with anal fistula (AF). Due to being associated with short-term and long-term cure rates, perioperative complications have received widespread attention following AF surgery. This study aims to identify a set of predictive factors to develop risk prediction models for recurrence and related complications following AF surgery. We plan to develop and validate risk prediction models, using information collected through a WeChat patient-reported questionnaire system combined with clinical, laboratory and imaging findings from the perioperative period until 3–6 months following AF surgery.Methods and analysisThis is a prospective hospital-based cohort study using a linked database of collected health data as well as the follow-up outcomes for all adult patients who suffered from AF at a tertiary referral hospital in Shanghai, China. We will perform logistic regression models to predict anal fistula recurrence (AFR) as well as related complications (eg, wound haemorrhage, faecal impaction, urinary retention, delayed wound healing and unplanned hospitalisation) during and after AF surgery, and machine learning approaches will also be applied to develop risk prediction models. This prospective study aims to develop the first risk prediction models for AFR and related complications using multidimensional variables. These tools can be used to warn, motivate and empower patients to avoid some modifiable risk factors to prevent postoperative complications early. This study will also provide alternative tools for the early screening of high-risk patients with AFR and related complications, helping surgeons better understand the aetiology and outcomes of AF in an earlier stage.Ethics and disseminationThe study was approved by the Institutional Review Board of Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine (approval number: 2019-699-54-01). The results of this study will be submitted to international scientific peer-reviewed journals or conferences in surgery, anorectal surgery or anorectal diseases.Trial registration numberChiCTR1900025069; Pre-results.
Primary care treatment of insomnia: study protocol for a pragmatic, multicentre, randomised controlled trial comparing nurse-delivered sleep restriction therapy to sleep hygiene (the HABIT trial)
Authors: Kyle Simon D , Madigan Claire , Begum Nargis , Abel Lucy , Armstrong Stephanie , Aveyard Paul , Bower Peter , Ogburn Emma , Siriwardena Aloysius , Yu Ly-Mee , Espie Colin A 
Published: March 2020

IntroductionInsomnia is a prevalent sleep disorder that negatively affects quality of life. Multicomponent cognitive-behavioural therapy (CBT) is the recommended treatment but access remains limited, particularly in primary care. Sleep restriction therapy (SRT) is one of the principal active components of CBT and could be delivered by generalist staff in primary care. The aim of this randomised controlled trial is to establish whether nurse-delivered SRT for insomnia disorder is clinically and cost-effective compared with sleep hygiene advice.Methods and analysisIn the HABIT (Health-professional Administered Brief Insomnia Therapy) trial, 588 participants meeting criteria for insomnia disorder will be recruited from primary care in England and randomised (1:1) to either nurse-delivered SRT (plus sleep hygiene booklet) or sleep hygiene booklet on its own. SRT will be delivered over 4 weekly sessions; total therapy time is approximately 1 hour. Outcomes will be collected at baseline, 3, 6 and 12 months post-randomisation. The primary outcome is self-reported insomnia severity using the Insomnia Severity Index at 6 months. Secondary outcomes include health-related and sleep-related quality of life, depressive symptoms, use of prescribed sleep medication, diary and actigraphy-recorded sleep parameters, and work productivity. Analyses will be intention-to-treat. Moderation and mediation analyses will be conducted and a cost-utility analysis and process evaluation will be performed.Ethics and disseminationEthical approval was granted by the Yorkshire and the Humber - Bradford Leeds Research Ethics Committee (reference: 18/YH/0153). We will publish our primary findings in high-impact, peer-reviewed journals. There will be further outputs in relation to process evaluation and secondary analyses focussed on moderation and mediation. Trial results could make the case for the introduction of nurse-delivered sleep therapy in primary care, increasing access to evidence-based treatment for people with insomnia disorder.Trial registration numberISRCTN42499563
Endovascular versus surgical treatment for improvement of oculomotor nerve palsy caused by unruptured posterior communicating artery aneurysms
Authors: Signorelli Francesco , Pop Raoul , Ganau Mario , Cebula Helene , Scibilia Antonino , Gallinaro Paolo , Zaed Ismail , Todeschi Julien , Lefevre Etienne , Nannavecchia Beniamino , Severac Francois , Coca Hugo Andres , Turjman Francis , Maduri Rodolfo , Beaujeux Rémy , Proust Francois , Chibarro Salvatore 
Published: March 2020

BackgroundThere is no consensus regarding the best treatment option for unruptured aneurysms of the posterior communicating artery (PCom) presenting with oculomotor nerve palsy (ONP). We aimed to assess predictors of ONP recovery in a multicenter series of consecutive patients.Materials and methodsA retrospective review of prospective databases in three tertiary neurosurgical centers was carried out, selecting patients with ONP caused by unruptured PCom aneurysms, treated by surgical clipping or embolization, between January 2006 and December 2013. Patient files and imaging studies were used to extract ophthalmological assessments, treatment outcomes, and follow-up data. Predictors of ONP recovery during follow-up were explored using univariate and multivariate analyses.ResultsWe identified 55 patients with a median ONP duration before treatment of 11 days (IQR 4.5–18); the deficit was complete in 27 (49.1%) and incomplete in 28 (50.9%) cases. Median aneurysm size was 7 mm (IQR 5–9). Twenty-four (43.6%) patients underwent surgical clipping and 31 (56.4%) embolization as the primary treatment. Overall, ONP improved in 40 (72.7%) patients and persisted/recurred in 15 (27.3 %). Surgery, interval to complete treatment <4 weeks, aneurysm recurrence during follow-up, and retreatment during follow-up were significantly correlated with ONP outcome in the univariate analysis. In the multivariate analysis, independent predictors of ONP improvement were interval to complete treatment <4 weeks (OR 5.15, 95% CI 1.37 to 23.71, p=0.015) and aneurysm recurrence during follow-up (OR 0.1, 95% CI 0.02 to 0.47, p=0.003).ConclusionThere was no significant difference in ONP recovery between surgical clipping and embolization. The best predictor for ONP recovery was timely, complete, and durable aneurysm exclusion.
Contemporary trends in use of mechanical circulatory support in patients with acute MI and cardiogenic shock
Authors: Helgestad Ole Kristian Lerche , Josiassen Jakob , Hassager Christian , Jensen Lisette Okkels , Holmvang Lene , Udesen Nanna Louise Junker , Schmidt Henrik , Berg Ravn Hanne , Moller Jacob Eifer 
Published: March 2020

ObjectivesTo describe the contemporary trends in the use of mechanical circulatory support (MCS) in patients with acute myocardial infarction and cardiogenic shock (AMICS). To evaluate survival benefit with early application of intra-aortic balloon pump (IABP) or Impella CP.MethodsA cohort study of all consecutive patients with AMICS undergoing percutaneous coronary intervention (PCI) <24 hours of symptom onset (early PCI) in southeastern Denmark from 2010 to 2017. A matched case–control study comparing 30-day mortality between patients receiving early-IABP or early-Impella CP and their respective control group. Controls were matched on age, left ventricular ejection fraction, arterial lactate, estimated glomerular filtration rate and cardiac arrest before PCI. Early-IABP/Impella CP was defined as applied before PCI if shock developed pre-PCI, or immediately after PCI if shock developed during PCI.Results903 patients with AMICS undergoing early PCI were identified. Use of MCS decreased from 50% in 2010 to 25% in 2017, p for trend of <0.001. The IABP was abandoned in 2012 and replaced mostly by Impella CP. Patients receiving MCS in 2013–2017 had more compromised haemodynamics compared with patients receiving MCS in 2010–2012. 40 patients received early IABP, and 40 patients received early Impella CP. Only the group receiving early Impella CP was associated with lower 30-day mortality compared with their matched control group (30-day mortality 40% vs 77.5%,plog-rankof<0.001).ConclusionUse of MCS decreased by 50% from 2010 to 2017. Patients receiving MCS had more compromised haemodynamics in recent years. Early application of Impella CP was associated with reduced 30-day mortality compared with a matched control group.
Mechanical adaptations of skinned cardiac muscle in response to dietary-induced obesity during adolescence in rats
Authors: Boldt Kevin , MacDonald Graham , Joumaa Venus , Herzog Walter 
Published: March 2020

Childhood obesity is a major risk factor for heart disease during adulthood, independent of adulthood behaviours. Therefore, it seems that childhood obesity leads to partly irreversible decrements in cardiac function. Little is known about how obesity during maturation affects the mechanical properties of the heart. The purpose of this study was to evaluate contractile properties in developing hearts from animals with dietary-induced obesity (high-fat high-sucrose diet). We hypothesized that obesity induced during adolescence results in decrements in cardiac contractile function. Three-week-old rats (n = 16) were randomized into control (chow) or dietary-induced obesity (high-fat high-sucrose diet) groups. Following 14 weeks on the diet, skinned cardiac trabeculae fibre bundle testing was performed to evaluate active and passive force, maximum shortening velocity, and calcium sensitivity. Rats in the high-fat high-sucrose diet group had significantly larger body mass and total body fat percentage. There were no differences in maximal active or passive properties of hearts between groups. Hearts from the high-fat high-sucrose diet rats had significantly slower maximum shortening velocities and lower calcium sensitivity than controls. Decreased shortening velocity and calcium sensitivity in hearts of obese animals may constitute increased risk of cardiac disease in adulthood. Novelty Cardiac muscle from animals exposed to an obesogenic diet during development had lower shortening velocity and calcium sensitivity than those from animals fed a chow diet. These alterations in mechanical function may be a mechanism for the increased risk of cardiac disease observed in adulthood.
Quantification of mitochondrial membrane potential in the isolated rat lung using rhodamine 6G
Authors: Audi Said H. , Cammarata Anthony , Clough Anne V. , Dash Ranjan K. , Jacobs Elizabeth R. 
Published: March 2020

Mitochondrial membrane potential (Δψm) plays a key role in vital mitochondrial functions, and its dissipation is a hallmark of mitochondrial dysfunction. The objective of this study was to develop an experimental and computational approach for estimating Δψmin intact rat lungs using the lipophilic fluorescent cationic dye rhodamine 6G (R6G). Rat lungs were excised and connected to a ventilation-perfusion system. The experimental protocol consisted of three single-pass phases, loading, washing, and uncoupling, in which the lungs were perfused with R6G-containing perfusate, fresh R6G-free perfusate, or R6G-free perfusate containing the mitochondrial uncoupler FCCP, respectively. This protocol was carried out with lung perfusate containing verapamil vehicle or verapamil, an inhibitor of the multidrug efflux pump P-glycoprotein (Pgp). Results show that the addition of FCCP resulted in an increase in R6G venous effluent concentration and that this increase was larger in the presence of verapamil than in its absence. A physiologically based pharmacokinetic (PBPK) model for the pulmonary disposition of R6G was developed and used for quantitative interpretation of the kinetic data, including estimating Δψm. The estimated value of Δψm[−144 ± 24 (SD) mV] was not significantly altered by inhibiting Pgp with verapamil and is comparable with that estimated previously in cultured pulmonary endothelial cells. These results demonstrate the utility of the proposed approach for quantifying Δψmin intact functioning lungs. This approach has potential to provide quantitative assessment of the effect of injurious conditions on lung mitochondrial function and to evaluate the impact of therapies that target mitochondria.NEW & NOTEWORTHY A novel experimental and computational approach for estimating mitochondrial membrane potential (Δψm) in intact functioning lungs is presented. The isolated rat lung inlet-outlet concentrations of the fluorescent cationic dye rhodamine 6G were measured and analyzed by using a computational model of its pulmonary disposition to determine Δψm. The approach has the potential to provide quantitative assessment of the effect of injurious conditions and their therapies on lung mitochondrial function.
Kinetic analyses as a tool to examine physiological exercise responses in a large sample of patients with COPD
Authors: Buekers Joren , Aerts Jean-Marie , Theunis Jan , Houben-Wilke Sarah , Franssen Frits M. E. , Uszko-Lencer Nicole H. M. K. , Wouters Emiel F. M. , Simons Sami , De Boever Patrick , Spruit Martijn A. 
Published: March 2020

Kinetic features such as oxygen uptake (V̇o2) mean response time (MRT), and gains of V̇o2, carbon dioxide output (V̇co2), and minute ventilation (V̇e) can describe physiological exercise responses during a constant work rate test of patients with chronic obstructive pulmonary disease (COPD). This study aimed to establish simple guidelines that can identify COPD patients for whom kinetic analyses are (un)likely to be reliable and examined whether slow V̇o2 responses and gains of V̇o2, V̇co2, and V̇e are associated with ventilatory, cardiovascular, and/or physical impairments. Kinetic features were examined for 265 COPD patients [forced expiratory volume in 1 s (FEV1): 54 ± 19%predicted] who performed a constant work rate test (duration > 180 s) with breath-by-breath measurements of V̇o2, V̇co2, and V̇e. Negative/positive predictive values were used to define cutoff values of relevant clinical variables below/above which kinetic analyses are (un)likely to be reliable. Kinetic feature values were unreliable for 21% (= 56/265) of the patients and for 79% (= 19/24) of the patients with a peak work rate (WRpeak)< 45 W. Kinetic feature values were considered reliable for 94% (= 133/142) of the patients with an FEV1 > 1.3 L. For patients exhibiting reliable kinetic feature values, V̇o2 MRT was associated with ventilatory (e.g., FEV1 %predicted: P < 0.001; r = −0.35) and physical (e.g., V̇o2peak %predicted: P = 0.009; r = −0.18) impairments. Gains were mainly associated with cardiac function and ventilatory constraints, representing both response efficiency and limitation. Kinetic analyses are likely to be unreliable for patients with a WRpeak < 45 W. Whereas gains enrich analyses of physiological exercise responses, V̇o2 MRT shows potential to serve as a motivation-independent, physiological indicator of physical performance. NEW & NOTEWORTHY A constant work rate test that is standardly performed during a prerehabilitation assessment is unable to provide reliable kinetic feature values for chronic obstructive pulmonary disease (COPD) patients with a peak work rate below 45 W. For patients suffering from less severe impairments, kinetic analyses are a powerful tool to examine physiological exercise responses. Especially oxygen uptake mean response time can serve as a motivation-independent, physiological indicator of physical performance in patients with COPD.