bluuebunny/crossref_metadata_2025_split huggingface dataset:
Pre-emptive scalp infiltration with ropivacaine plus methylprednisolone versus ropivacaine alone for relief of postoperative pain after craniotomy in children (RP/MP vs RP): a study protocol for a randomised controlled trial
Authors: Zhao Chunmei , Jia Yitong , Jia Zipu , Xiao Xiong , Luo Fang 
Published: June 2019

IntroductionPre-emptive scalp infiltration with local anaesthetics is the simplest and most effective method to prevent postoperative incisional pain. However, local infiltration of an anaesthetic only provides relatively short-term pain relief. Methylprednisolone (MP) treatment, administered as an adjuvant at the wound site, has been shown to provide satisfactory pain management after lumbar laminectomy. However, there is no evidence regarding the efficacy of MP infiltration for the relief of postoperative pain after craniotomy. Currently, postoperative pain after craniotomy in children is undertreated. Therefore, we aim to investigate whether pre-emptive scalp infiltration with ropivacaine (RP) plus MP is superior to RP alone to improve postoperative pain after craniotomy in children.Methods and analysisThe RP/MP versus RP trial is a prospective, single-centre, randomised, parallel-group study of 100 children aged 8–18 years undergoing intracranial surgery. Participants will be randomly allocated to receive pre-emptive scalp infiltration with either RP plus MP or RP alone. The primary outcome will be the cumulative fentanyl dose administered by patient-controlled intravenous analgesia within 24 hours postoperatively. The secondary outcomes will include postoperative Numerical Rating Scale scores, pain control satisfaction scores, length of stay and adverse events. Data will be analysed by the intention-to-treat principle.Ethical approval and disseminationThe study protocol has been approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (Approval Number: KY 2018-066-02). The results will be disseminated in international academic meetings and published in peer-reviewed journals.Trial registration numberNCT03636165; Pre-results.
Intermittent preventive treatment of pregnant women in Kintampo area of Ghana with sulphadoxine-pyrimethamine (SP): trends spanning 2011 and 2015
Authors: Oppong Felix Boakye , Gyaase Stephaney , Zandoh Charles , Nettey Obed Ernest A , Amenga-Etego Seeba , Anane Edward Apraku , Adda Robert , Dosoo David Kwame , Owusu-Agyei Seth , Asante Kwaku Poku 
Published: June 2019

ObjectiveIn Ghana, intermittent preventive treatment during pregnancy with sulphadoxine-pyrimethamine (IPTp-SP) is recommended for the prevention of malaria-related adverse outcomes. This study demonstrates the coverage of IPTp-SP use among pregnant women over a period (2011–2015) and the impact of various sociodemographic groups on the uptake of IPTp-SP.DesignRetrospective analysis using data from all pregnant women in the Kintampo Health and Demographic Surveillance System area on the uptake of IPTp-SP.SettingKintampo North Municipality and Kintampo South District of Ghana.ParticipantsAll pregnant women in the Kintampo Health and Demographic Surveillance System area.Primary and secondary outcome measuresThe number of doses of IPTp-SP taken by pregnant women were examined. Logistic regression was used to assess the determinant of uptake of IPTp-SP while adjusting for within-subject correlation from women with multiple pregnancies.ResultsData from 2011 to 2015 with a total of 17 484 pregnant women were used. The coverage of the recommended three or more doses of IPTp-SP among all pregnant women was 40.6%, 44.0%, 45.9%, 20.9% and 32.4% in 2011, 2012, 2013, 2014 and 2015, respectively. In the adjusted analysis, age, household size, education, religion, number of antenatal care visits, ethnicity, marital status, wealth index and place of residence were significantly associated with the uptake of three or more doses of IPTp-SP. Having middle school education or higher, aged 20 years and above, visiting antenatal care five times or more (OR 2.83, 95% CI 2.64 to 3.03), being married (OR 1.10, 95% CI 1.02 to 1.19) and those in higher wealth quintiles were significantly more likely to take three or more doses of IPTp-SP.ConclusionThe uptake of the recommended three or more doses of IPTp-SP is low in the study area. We recommend a community-based approach to identify women during early pregnancy and to administer IPTp-SP.
Prostate cancer with bone metastasis in Beijing: an observational study of prevalence, hospital visits and treatment costs using data from an administrative claims database
Authors: Zhuo Lin , Cheng Yinchu , Pan Yuting , Zong Jihong , Sun Wentao , Xu Lin , Soriano-Gabarró Montse , Song Yi , Lu Jian , Zhan Siyan 
Published: June 2019

ObjectivesTo estimate the prevalence of prostate cancer with bone metastasis in Beijing, and to estimate hospital visits and direct treatment costs among male urban employees with the disease in Beijing.DesignCross-sectional observational study.Setting and participantsPatients with prostate cancer and bone metastasis from the Urban Employee Basic Medical Insurance database covering the employed population of Beijing, China, from 2011 to 2014.Primary and secondary outcome measuresPrevalence, treatment costs and healthcare visits of patients with prostate cancer and bone metastasis.ResultsA total of 1672 individuals were identified as having prostate cancer. Of these, 737 (44.1%) had bone metastasis, and among these, this was already present at the time of initial prostate cancer diagnosis in 27.0% (199/737). Mean age was 74.6 years (SD ±9.1). Prevalence of prostate cancer with bone metastasis increased from 5.3 per 100 000 males in 2011 to 8.3 per 100 000 males in 2014. The total annual health expenditure per patient (in 2014 American dollars) during the study period was $15 772.1 (SD=$16 942.6) ~$18 206.3 (SD=$18 700.2); 88% of these costs were reimbursed by insurance. Medication accounted for around 50% of total healthcare costs. Western drugs accounted for over 80% of medical costs with endocrine therapy being the most commonly prescribed treatment. There was an average 6.7% increase in expenditure related to diagnostical and therapeutical procedures over study years.ConclusionsThe increase in the prevalence of prostate cancer with bone metastasis and associated healthcare costs in China reveals the growing clinical and economical burden of this disease. The high prevalence of bone metastasis among patients with prostate cancer seen in our study suggests that efforts may be needed to improve symptoms awareness and promote early help-seeking behaviour among the Chinese population.
Models predicting survival to guide treatment decision-making in newly diagnosed primary non-metastatic prostate cancer: a systematic review
Authors: Thurtle David , Rossi Sabrina H , Berry Brendan , Pharoah Paul , Gnanapragasam Vincent J 
Published: June 2019

ObjectivesMen diagnosed with non-metastatic prostate cancer require standardised and robust long-term prognostic information to help them decide on management. Most currently-used tools use short-term and surrogate outcomes. We explored the evidence base in the literature on available pre-treatment, prognostic models built around long-term survival and assess the accuracy, generalisability and clinical availability of these models.DesignSystematic literature review, pre-specified and registered on PROSPERO (CRD42018086394).Data sourcesMEDLINE, Embase and The Cochrane Library were searched from January 2000 through February 2018, using previously-tested search terms.Eligibility criteriaInclusion required a multivariable model prognostic model for non-metastatic prostate cancer, using long-term survival data (defined as ≥5 years), which was not treatment-specific and usable at the point of diagnosis.Data extraction and synthesisTitle, abstract and full-text screening were sequentially performed by three reviewers. Data extraction was performed for items in the CHecklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling Studies checklist. Individual studies were assessed using the new Prediction model Risk Of Bias ASsessment Tool.ResultsDatabase searches yielded 6581 studies after deduplication. Twelve studies were included in the final review. Nine were model development studies using data from over 231 888 men. However, only six of the nine studies included any conservatively managed cases and only three of the nine included treatment as a predictor variable. Every included study had at least one parameter for which there was high risk of bias, with failure to report accuracy, and inadequate reporting of missing data common failings. Three external validation studies were included, reporting two available models: The University of California San Francisco (UCSF) Cancer of the Prostate Risk Assessment score and the Cambridge Prognostic Groups. Neither included treatment effect, and both had potential flaws in design, but represent the most robust and usable prognostic models currently available.ConclusionFew long-term prognostic models exist to inform decision-making at diagnosis of non-metastatic prostate cancer. Improved models are required to inform management and avoid undertreatment and overtreatment of non-metastatic prostate cancer.
Interventional bundle for venous thromboembolism prevention: ensuring quality and effectiveness
Authors: Shapiro Susan , Dunnigan Anna , Keen Sarah , Clarke Penney 
Published: June 2019

Hospital-associated thromboses (HATs) are a potentially preventable cause of morbidity and mortality. Oxford University Hospitals NHS Foundation Trust was designated a Venous Thromboembolism (VTE) Exemplar Centre by NHS England in 2014. However, following delayed reporting of a potentially preventable HAT in 2015, a benchmarking exercise suggested HATs were being under-reported, and also that the established hospital-wide audits of VTE prevention had significant limitations. The aim of this interventional bundle was to ensure high-quality data for key VTE prevention measures across the hospital, to identify areas for improvement and demonstrate a reduction in the number of potentially preventable HATs over a 2-year period.The project team engaged with hospital leadership and collaborated with hospital-wide stakeholders. A multifaceted approach was taken and ‘Plan Do Study Act’ cycles were used to test interventions with continuous evaluation of impact. The percentage of inpatients receiving appropriate thromboprophylaxis progressively increased from 94% to 98%. The project did not achieve its secondary aim of a reduction in the number of potentially preventable HATs. Revision of the HAT reporting process resulted in better detection and an initial increase in reporting of potentially preventable HATs, although data suggest that the level of harm from errors is now reducing.The improvement in overall appropriate thromboprophylaxis is considered to be due to robust audits of appropriate thromboprophylaxis, upskilling of ward pharmacists, improved detection of potentially preventable HATs resulting in additional safety nets such as linking the ‘outcome recommendation’ of the electronic VTE risk assessment directly to electronic prescribing, and increased awareness and education. Combining low-cost actions in a coordinated interventional bundle has produced measurable improvements in our VTE management programme, enhancing patient safety. We believe the model to be sustainable and replicable in other general hospitals.
Driving stroke quality improvement at scale in EDs across a nationwide network of hospitals: strategies and interventions
Authors: Shpak Max , Korwek Kimberly , Nadasdy Zoltan , Ramakrishnan Anurekha , Cowperthwaite Matthew , Ankrom Kristen , Jennings Jon , Moody Ashley , Orndorff Kevin , Fanale Christopher 
Published: June 2019

ObjectivesReducing the treatment time while increasing the proportion of eligible stroke patients who receive intravenous tissue plasminogen activator (tPA) has been a priority for many quality improvement efforts. Recent studies have primarily focused on identifying interventions that reduce door-to-needle (DTN) time, while comparatively little has been done to determine whether these interventions also improve tPA rates.MethodsIn order to investigate interventions related to process improvements, an electronic dashboard serving as a stroke performance tool was implemented to store and retrieve patient outcome data. These data were used to study the efficacy of interventions designed to facilitate triage of stroke patients in the ED, and determine the individual interventions associated with the most significant improvements in the fraction of patients receiving tPA and in reducing the DTN time. Stroke performance data from the dashboard collected over a 2-year period (2015–2017) from 89 US hospitals were analysed with respect to interventions implemented by individual facilities, as verified by a hospital survey.ResultsA statistically significant association was found between increases in the fraction of patients receiving tPA and reductions in DTN time over the study period. These improvements in outcomes were most strongly associated with process interventions that allocate stroke-specific physical and human resources in the ED, most notably a designated emergency room space for stroke, and with workflows that decrease the time to key checkpoints for determining a patient’s eligibility for tPA.ConclusionsData from the stroke performance tool was leveraged to identify the programmes and process interventions that lead to improved patient outcomes and allow EDs to better prioritise process interventions and resources.
Derivation and validation of a risk score for predicting mortality among inpatients following rapid response team activation
Authors: White Kyle , Bernard Anne , Scott Ian 
Published: June 2019

AbstractPurpose of the studyDespite mature rapid response systems (RRS) for clinical deterioration, individuals activating RRS have poor outcomes, with up to one in four dying in hospital. We aimed to derive and validate a risk prediction tool for estimating risk of 28-day mortality among hospitalised patients following rapid response team (RRT) activation.Study designAnalysis of prospectively collected data on 1151 consecutive RRT activations involving 800 inpatients at a tertiary adult hospital. Patient characteristics, RRT triggers and actions, and mortality were ascertained from medical records and death registries. A multivariable risk prediction regression model, derived from 600 randomly selected patients, was validated in the remaining 200 patients. Main outcome was accuracy of weighted risk score (measured by area under receiver operator curve (AUC)) and performance characteristics for various cut-off scores.ResultsAt 28 days, 150 (18.8%) patients had died. Increasing age, emergency admission, chronic liver disease, chronic kidney disease, malignancy, after-hours RRT activation, increasing National Early Warning Score, major/intense RRT intervention and multiple RRT activations were predictors of mortality. The risk score (0–105) in derivation and validation cohorts had AUCs 0.86 (95% CI 0.82 to 0.89) and 0.82 (95% CI 0.75 to 0.90), respectively. In the validation cohort, cut-off score of 32.5 or higher maximised sensitivity: 81.6% (95% CI 68.4% to 92.1%), specificity: 56.2% (95% CI 49.4% to 63.6%), positive likelihood ratio (LR): 1.9 (95% CI 1.5 to 2.3) and negative LR: 0.3 (95% CI 0.2 to 0.6).ConclusionA validated risk score predicted risk of post-RRT death with more than 80% accuracy, helping to identify patients for whom targeted rescue care may improve survival.
Classification of Driver Distraction: A Comprehensive Analysis of Feature Generation, Machine Learning, and Input Measures
Authors: McDonald Anthony D. , Ferris Thomas K. , Wiener Tyler A. 
Published: June 2019

Objective The objective of this study was to analyze a set of driver performance and physiological data using advanced machine learning approaches, including feature generation, to determine the best-performing algorithms for detecting driver distraction and predicting the source of distraction. Background Distracted driving is a causal factor in many vehicle crashes, often resulting in injuries and deaths. As mobile devices and in-vehicle information systems become more prevalent, the ability to detect and mitigate driver distraction becomes more important. Method This study trained 21 algorithms to identify when drivers were distracted by secondary cognitive and texting tasks. The algorithms included physiological and driving behavioral input processed with a comprehensive feature generation package, Time Series Feature Extraction based on Scalable Hypothesis tests. Results Results showed that a Random Forest algorithm, trained using only driving behavior measures and excluding driver physiological data, was the highest-performing algorithm for accurately classifying driver distraction. The most important input measures identified were lane offset, speed, and steering, whereas the most important feature types were standard deviation, quantiles, and nonlinear transforms. Conclusion This work suggests that distraction detection algorithms may be improved by considering ensemble machine learning algorithms that are trained with driving behavior measures and nonstandard features. In addition, the study presents several new indicators of distraction derived from speed and steering measures. Application Future development of distraction mitigation systems should focus on driver behavior–based algorithms that use complex feature generation techniques.
A Critical Analysis of Medicare Claims for Otolaryngology Procedures
Authors: Youssef Stephanie J. , Vyas Krishna S. 
Published: June 2019

ObjectiveThis study was performed to outline and analyze the overall Medicare landscape with respect to otolaryngologists and beneficiaries, services, and reimbursements.MethodsThis is a retrospective analysis of publicly available Medicare utilization and payment data for all otolaryngologists in facility and nonfacility practice settings who provided services to Medicare beneficiaries between January 1, 2012, and December 31, 2016.ResultsIn 2016, a total of $701,195,375 was distributed to 8572 otolaryngology physician providers for 815 unique Healthcare Common Procedure Coding System codes for 13,942,536 procedure claims. Of specialty care, otolaryngology ranks 20th among 54 subspecialties for total Medicare payments. The average number of services coded per provider was 1627. The average otolaryngologist was paid $81,800.67. Thirty‐two percent of otolaryngologists did not receive reimbursement for services from Medicare in 2016.DiscussionIn 2016, the most significant contributors to Medicare payments to otolaryngologists were large‐scale, low‐cost events that are relatively short procedures done in clinic. Utilization of nasal endoscopy was up trending from 2012 to 2016. Some of the Current Procedural Terminology codes with the greatest discrepancies between submitted charge and Medicare payment among nonfacility otolaryngology providers are more involved than simple office procedures.Implications for PracticeIt is increasingly valuable for physicians to know factors that affect reimbursement for procedures and operations in different settings and to be aware of the trends in variation in their specialty. Otolaryngologists should communicate with policy makers in efforts toward sustainable reimbursement models.
Minimizing the surgical approach for a rare disease: transanal endoscopic microsurgery for rectal schwannoma
Authors: Guaglio Marcello , Belli Filiberto , Cesa Bianchi Alessandro , Sorrentino Luca , Battaglia Luigi 
Published: June 2019

Objective: Rectal schwannomas are extremely rare tumors and their surgical treatment is widely variable in literature. Transanal endoscopic microsurgery (TEM) approach could be a reasonable option for such lesions, offering an organ-sparing strategy, but evidence is scarce. Methods: We report a 69-year-old man with a rectal submucosal lesion at 10 cm from the anal verge, treated by TEM. A systematic literature review on surgical approaches in rectal schwannoma was performed. Results: The patient was successfully treated by TEM, with adequate excision of the submucosal lesion. Histopathology revealed a rectal schwannoma. No recurrence was found at 1-year endoscopic follow-up. Previous studies reported 23 cases of rectal schwannoma and several treatment options, but only 2 cases were treated by TEM. Anterior rectal resection was generally adopted in cases of large, symptomatic masses with inconclusive preoperative biopsy, while lesions with features suggestive of stromal tumors were preferentially treated by endoscopy or, if located in distal rectum, by transanal approaches. Conclusions: An organ-sparing minimally invasive approach should be the standard of care for rectal schwannomas. TEM could extend the indication for their endoscopic treatment, providing adequate excision even for larger schwannomas of the middle–upper rectum.
Eptinezumab for prevention of chronic migraine: A randomized phase 2b clinical trial
Authors: Dodick David W , Lipton Richard B , Silberstein Stephen , Goadsby Peter J , Biondi David , Hirman Joe , Cady Roger , Smith Jeff 
Published: June 2019

Background Calcitonin gene-related peptide plays an important role in migraine pathophysiology. We evaluated eptinezumab, an intravenous (IV) anti-calcitonin gene-related peptide monoclonal antibody, for the prevention of chronic migraine. Objective To determine the safety, tolerability, and effectiveness of four dose levels of eptinezumab and to inform the phase 3 development program. Methods This was a phase 2b, parallel-group, double-blind, randomized, placebo-controlled, dose-ranging clinical trial. Men and women (N = 616) aged 18–55 years were included if they had a diagnosis of chronic migraine, with onset at age ≤35 years and history of chronic migraine ≥1 year. During the 28-day screening period, patients must have had ≥15 headache days, including ≥8 migraine days, with ≥5 migraine attacks as recorded in the electronic diary. Patients were assigned in a 1:1:1:1:1 ratio to eptinezumab 300, 100, 30, 10 mg or placebo, administered as a single IV infusion. The primary endpoint was the percentage of patients with a ≥75% decrease in monthly migraine days over weeks 1–12 compared with the 28-day screening period. Results The ≥75% migraine responder rates over weeks 1–12 for eptinezumab 300, 100, 30, and 10 mg were 33.3%, 31.4%, 28.2%, and 26.8%, respectively, versus 20.7% for placebo ( p = 0.033, 0.072, 0.201, 0.294 vs. placebo). Secondary efficacy endpoints (e.g. ≥50% responder rate, change from baseline in frequency of migraine/headache days, and percentage of severe migraines) had results favoring the three higher eptinezumab doses versus placebo. Eptinezumab was well tolerated and adverse event rates were similar to placebo. Conclusions The results of this trial demonstrate that eptinezumab appears effective and well-tolerated for the preventive treatment of chronic migraine and justifies the conduct of pivotal phase 3 trials for migraine prevention. Trial Registration ClinicalTrials.gov identifier: NCT02275117.