bluuebunny/crossref_metadata_2025_split huggingface dataset:
Development and validation of a prediction model for the probability of responding to placebo in antidepressant trials: a pooled analysis of individual patient data
Authors: Shinohara Kiyomi , Tanaka Shiro , Imai Hissei , Noma Hisashi , Maruo Kazushi , Cipriani Andrea , Yamawaki Shigeto , Furukawa Toshi A 
Published: February 2019

BackgroundIdentifying potential placebo responders among apparent drug responders is critical to dissect drug-specific and nonspecific effects in depression.ObjectiveThis project aimed to develop and test a prediction model for the probability of responding to placebo in antidepressant trials. Such a model will allow us to estimate the probability of placebo response among drug responders in antidepressants trials.MethodsWe identified all placebo-controlled, double-blind randomised controlled trials (RCTs) of second generation antidepressants for major depressive disorder conducted in Japan and requested their individual patient data (IPD) to pharmaceutical companies. We obtained IPD (n=1493) from four phase II/III RCTs comparing mirtazapine, escitalopram, duloxetine, paroxetine and placebo. Out of 1493 participants in the four clinical trials, 440 participants allocated to placebo were included in the analyses. Our primary outcome was response, defined as 50% or greater reduction on Hamilton Rating Scale for Depression at study endpoint. We used multivariable logistic regression to develop a prediction model. All available candidate of predictor variables were tested through a backward variable selection and covariates were selected for the prediction model. The performance of the model was assessed by using Hosmer-Lemeshow test for calibration and the area under the ROC curve for discrimination.FindingsPlacebo response rates differed between 31% and 59% (grand average: 43%) among four trials. Four variables were selected from all candidate variables and included in the final model: age at onset, age at baseline, bodily symptoms, and study-level difference. The final model performed satisfactorily in terms of calibration (Hosmer-Lemeshow p=0.92) and discrimination (the area under the ROC curve (AUC): 0.70).ConclusionsOur model is expected to help researchers discriminate individuals who are more likely to respond to placebo from those who are less likely so.Clinical implicationsA larger sample and more precise individual participant information should be collected for better performance. Examination of external validity in independent datasets is warranted.Trial registration numberCRD42017055912.
Beta-cell sensitivity to insulinotropic gut hormones is reduced after gastric bypass surgery
Authors: Salehi Marzieh , Gastaldelli Amalia , D’Alessio David A 
Published: February 2019

ObjectivePostprandial hyperinsulinaemia after Roux-en Y gastric bypass (GB) has been attributed to rapid nutrient flux from the gut, and an enhanced incretin effect. However, it is unclear whether surgery changes islet cell responsiveness to regulatory factors. This study tested the hypothesis that β-cell sensitivity to glucagon like-peptide 1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) is attenuated after GB.DesignTen non-diabetic subjects with GB, and 9 body mass index (BMI)-matched and age-matched non-surgical controls (CN) with normal glucose tolerance had blood glucose clamped at ~7.8 mM on three separate days. Stepwise incremental infusions of GLP-1 (15, 30, 60, 120 and 300 ng/LBkg/h), GIP (75, 150, 300, 600 and 1200 ng/LBkg/h) or saline were administered from 90 to 240 min and insulin secretion measured.ResultsGB subjects had similar fasting glucose levels but lower fasting insulin compared with CN, likely due to increased insulin clearance. The average insulin secretion rates (ISRs) to 7.8 mM glucose were ~30% lower in GB relative to CN subjects. However, incretin-stimulated ISRs, adjusted for insulin sensitivity and glucose-stimulated insulin secretion, were even more attenuated in the GB subjects, by threefold to fourfold (AUCISR(90−240 min)during GLP-1 and GIP: 47±8 and 44±12 nmol in GB and 116±16 and 161±44 in CN; p<0.01).ConclusionAfter GB, the sensitivity of insulin secretion to both glucose and incretins is diminished.
Trends in surgical and catheter interventions for isolated congenital shunt lesions in the UK and Ireland
Authors: Farooqi Mehreen , Stickley John , Dhillon Rami , Barron David J , Stumper Oliver , Jones Timothy J , Clift Paul F , Brawn William J , Drury Nigel E 
Published: February 2019

ObjectiveTo evaluate time trends in the use of catheter and surgical procedures, and associated survival in isolated congenital shunt lesions.MethodsNationwide, retrospective observational study of the UK National Congenital Heart Disease Audit database from 2000 to 2016. Patients undergoing surgical or catheter procedures for atrial septal defect (including sinus venosus defect), patent foramen ovale, ventricular septal defect and patent arterial duct were included. Temporal changes in the frequency of procedures, and survival at 30 days and 1 year were determined.Results40 911 procedures were performed, 16 604 surgical operations and 24 307 catheter-based interventions. Transcatheter procedures increased over time, overtaking surgical repair in 2003–2004, while the number of operations remained stable. Trends in interventions differed according to defect type and patient age. Catheter closure of atrial septal defects is now more common in children and adults, although surgical interventions have also increased. Patent foramen ovale closure in adults peaked in 2009–2010 before falling significantly since. Surgery remains the mainstay for ventricular septal defect in infants and children. Duct ligation is most common in neonates and infants, while transcatheter intervention is predominant in older children. Excluding duct ligation, survival following surgery was 99.4% and ≈98.7%, and following catheter interventions was 99.7% and ≈99.2%, at 30 days and 1 year, respectively.ConclusionsTrends in catheter and surgical techniques for isolated congenital shunt lesions plot the evolution of the specialty over the last 16 years, reflecting changes in clinical guidelines, technology, expertise and reimbursement, with distinct patterns according to lesion and patient age.
Valve area and the risk of overestimating aortic stenosis
Authors: González-Mansilla Ana , Martinez-Legazpi Pablo , Prieto Andrea , Gomá Elena , Haurigot Pilar , Pérez del Villar Candelas , Cuadrado Victor , Delgado-Montero Antonia , Prieto Raquel , Mombiela Teresa , Pérez-David Esther , Rodríguez González Elena , Benito Yolanda , Yotti Raquel , Pérez-Vallina Manuel , Fernández-Avilés Francisco , Bermejo Javier 
Published: February 2019

ObjectiveTo obtain reference values of aortic valve area (AVA) in a large population and to infer the risk of overestimating aortic stenosis (AS) when focusing on flow-corrected indices of severity.MethodsWe prospectively measured indices of AS in all consecutive echocardiograms performed in a large referral cardiac imaging laboratory for 1 year. We specifically analysed the distribution of AVA, indexed AVA and velocity ratio (Vratio) in patients with and without AS, the latter defined as the coexistence of valvular outflow obstruction (Vmax ≥2.5 m/s) and morphological findings of valve degeneration.Results16 156 echocardiograms were analysed, 14 669 of which did not show valvular obstruction (peak jet velocity <2.5 m/s). In the latter group, AVA was 2.6±0.7 cm2in 8190 studies with normal valves and 2.3±0.7 cm2in 6479 studies with aortic sclerosis (AScl). There was a relatively wide overlap between values of AVA, indexed AVA and velocity ratio between studies of patients with AScl and AS. Values of AVA ≤1.0 cm2were found in 0.5% of studies with normal valves and 1.8% of studies with AScl. These proportions were 3.1% and 9.3% for AVA ≤1.5 cm2, respectively. Vratio ≤0.25 were found in 0.1% of patients without obstruction. Risk factors for a small AVA in patients without obstruction were AScl, female sex, small body surface area, low ejection fraction and mitral regurgitation.ConclusionsNormal values of continuity-equation derived AVA are smaller than previously considered. AVA values below cutoffs of moderate or severe AS can be found in patients without the disease. Flow-corrected indices may overestimate AS in patients with low gradients, particularly in the presence of well-identified risk factors.
Spatio-temporal analysis of colorectal cancer using a geographic information system in the Iranian military community during the period 2007–2016
Authors: Khoshdel Alireza , Alimohammadi M , Sepandi M , Alimohamadi Y , Jalali P , Janani M 
Published: February 2019

IntroductionColorectal cancer (CRC) is one of the most prevalent cancers among Iranian people. The study of spatio-temporal distribution of disease has an important role in the design of disease prevention programmes. The purpose of the current study was to describe the spatio-temporal distribution of CRC in the Iranian military community as a sample of the Iranian population.MethodsIn the current ecological study, all registered cancer cases in the Iranian military community during the period 2007–2016 were considered. To identify hotspots, Getis-Ord Gi statistics were used. All analyses were performed using ArcGIS 10.5 and Excel 2010.ResultsThe highest incidences of CRC in 2007–2008, 2009–2010 and 2011–2012 were recorded in Kermanshah province. The highest incidences of CRC in 2013–2014 were seen in Kermanshah, Ghilan, Tehran and North Khorasan. In 2007–2008 and 2009–2010, hotspots were detected in West Azarbayjan. In 2011–2012, hotspots were detected in Zanjan and Qazvin. In 2013–2014, a hotspot was detected in Qazvin. Finally, West Azerbaijan was the hotspot for CRC in 2015–2016.ConclusionsThe incidence of CRC in men was higher than in women. Also it appeared that North and North West Iran were risk areas for this disease, and so these areas should be considered in the design of disease prevention programme for this cancer type. Additionally, the determination of individual risk factors in the aforementioned geographical areas can play an important role in the prevention of this type of cancer.
Using patient-reported outcome measures for primary percutaneous coronary intervention
Authors: Kwong Esther , Neuburger Jenny , Petersen Steffen Erhard , Black Nick 
Published: February 2019

IntroductionRoutine measurement of the outcome of myocardial infarction is usually limited to immediate morbidity and mortality. Our aim was to determine the response to patient-reported outcome measures (PROMs) 3 months later, identify response bias and explore the feasibility of comparing outcome with their recalled view of their prior health state.MethodsPatients admitted with ST-segment-elevation myocardial infarction (STEMI) to five percutaneous coronary intervention centres were invited to complete a retrospective questionnaire containing the EQ-5D-3L and short form Seattle Angina Questionnaire (SAQ-7). Response rate for a 3-month mailed follow-up questionnaire and potential response biases were assessed. Patients’ outcomes were compared with their baseline using χ2and paired t-test to assess for differences.ResultsOf 392 patients contacted, 260 (66.3%) responded. Responders were more likely to be older, female, more affluent and have a higher EQ-5D at baseline. Three months after surgery, patients’ SAQ-7 and angina symptom subscale returned to their baseline score. The physical limitation subscale score was worse than at baseline (79.9 vs 73.2, p=0.002), whereas the quality-of-life subscale was better (66.6 vs 73.9; p<0.001). The EQ-5D-3L index score was similar at 3 months to baseline (0.82 vs 0.79). Evidence of bias arising from responders being in better general health at baseline needs further investigation and, if confirmed, needs to be taken into account in interpreting PROMs data.ConclusionIt is feasible to use PROMs routinely to assess the impact of emergency admissions of patients with STEMI. A larger demonstration project with more sites is needed to confirm these findings.
Productivity costs of cardiovascular disease mortality across disease types and socioeconomic groups
Authors: Carter Hannah Elizabeth , Schofield Deborah , Shrestha Rupendra 
Published: February 2019

BackgroundCardiovascular disease (CVD) is the single largest contributor to global mortality. Premature mortality due to CVD results in a loss of productivity, with associated economic and policy implications that are often overlooked.MethodsA human capital approach was adopted to project the long-term impacts of Australian CVD deaths in 2003 on labour force participation and the present value of lifetime income (PVLI) forgone. Impacts were modelled to the year 2030 and accounted for individual characteristics at the time of death including age, sex and socioeconomic status.ResultsPremature deaths due to CVD in 2003 accounted for 51 659 working years and $2.69 billion in PVLI forgone when modelled to 2030 (95% CI $2.63 billion to $2.75 billion). The labour force impacts were highest for individuals aged between 35 and 64 at the time of death, and male deaths accounted for 87% of the total PVLI loss. The most costly disease type was ischaemic heart disease, followed by stroke and inflammatory heart disease. Deaths occurring in individuals residing in the most socioeconomically disadvantaged areas at the time of death had a disproportionately large impact on the total PVLI loss.ConclusionsThis study quantifies the relative productivity costs of CVD mortality across a range of disease types and socioeconomic groups. The magnitude of these costs highlights the scope for investments in effective healthcare interventions to provide positive economic returns and may assist decision makers in allocating resources among competing priorities.
Subarachnoid block with continuous TAP catheter analgesia produces less chronic pain and better functional outcome after inguinal hernioplasty: a randomized controlled observer-blinded study
Authors: Thiyagarajan Sivashanmugam , Velraj Jaya , Hussain Ahmed M I , Murugesan Ravishankar 
Published: February 2019

Background and objectivesThe major concern after inguinal hernioplasty is chronic postsurgical pain and impaired quality of life due to central sensitization. Preoperative, intraoperative, and postoperative pre-emptive analgesia using regional techniques may help prevent the development of central sensitization. This study evaluated the effect of regional anesthesia followed by continuous regional analgesia on postoperative pain and functional outcome following inguinal hernioplasty.MethodsSeventy-two consecutive patients scheduled to undergo open mesh inguinal hernioplasty were randomly allocated to one of three groups: subarachnoid block alone (group SAB), general anesthesia alone (group GA), or subarachnoid block combined with a continuous transverse abdominis plane block (group TAP). Pain and functional outcome was assessed before and 6 months following the surgery using the Core Outcome Measures Index score adapted for patients with hernia (COMI-hernia). During the first 72 hours postoperatively, pain was assessed at rest and during five different activities using the numerical rating scale.ResultsSix months following the surgery, the COMI-hernia score was lower in group TAP than in group GA or group SAB (0.54±0.41 vs 0.88±0.43 and 1.00±0.54, respectively; p<0.02). Pain at rest (p<0.02) and during activities (p<0.001) was lowest in group TAP during the first 72 hours postoperatively.ConclusionsA subarachnoid block combined with continuous postoperative analgesia via a transverse abdominis plane catheter provided better pain control and functional outcome 6 months following inguinal hernioplasty as well as better postoperative analgesia.Clinical trial registrationCTRI/2016/09/007238.
Comparison of programmed intermittent bolus infusion and continuous infusion for postoperative patient-controlled analgesia with thoracic paravertebral block catheter: a randomized, double-blind, controlled trial
Authors: Chen Lulu , Wu Yiquan , Cai Yaoyao , Ye Yingchao , Li Li , Xia Yun , Papadimos Thomas J , Xu Xuzhong , Wang Quanguang 
Published: February 2019

Background and objectivesIn this randomized, double-blind, controlled study, we hypothesized that programmed intermittent bolus infusion (PIBI) of local anesthetic for continuous paravertebral block (PVB), combined with patient-controlled analgesia (PCA), provided better pain control, better patient satisfaction, and decreased in local anesthetic consumption when compared with a continuous infusion (CI) combined with PCA, after video-assisted thoracoscopic unilateral lung resection surgery.MethodsPreoperatively, patients undergoing video-assisted thoracoscopic unilateral lung resection surgery received ipsilateral paravertebral catheters inserted at the level of thoracic vertebrae 4 and 5. All the subjects received an initial bolus of 15 mL 0.375% ropivacaine via the catheters. Subjects were randomized to receive 0.2 % ropivacaine 8 mL/h as either PIBI (n=17) or CI (n=17) combined with a PCA pump. The pain scores, frequency of PCA, local anesthetic consumption, patient satisfaction, and the need for rescue analgesia with tramadol were recorded until 48 hours postoperative.ResultsThe numeric rating scale scores in the PIBI group were significantly lower than the CI group at 4, 8, 12 hours and 4, 8, 12, 24 hours postoperatively, at rest, and during coughing, respectively. PCA local anesthetic consumption (30 mg (20–60 mg) vs 120 mg (70–155 mg), p=0.000) and frequency of PCA use over 48 hours (3 (2–6) vs 12 (7–15.5), p=0.000) was lower in the PIBI group as compared with the CI group. Additionally, the PIBI group showed greater patient satisfaction. The need for tramadol rescue was similar in the two groups.ConclusionsIn PVBs, local anesthetic administered as a PIBI in conjunction with PCA provided superior postoperative analgesia to a CI combined with PCA in patients undergoing video-assisted thoracoscopic unilateral lung resection surgery.Clinical trial registrationChiCTR-IOR-17011253.
Twelve-month analgesia and rescue, by cooled radiofrequency ablation treatment of osteoarthritic knee pain: results from a prospective, multicenter, randomized, cross-over trial
Authors: Davis Tim , Loudermilk Eric , DePalma Michael , Hunter Corey , Lindley David A , Patel Nileshkumar , Choi Daniel , Soloman Marc , Gupta Anita , Desai Mehul , Cook Elizabeth , Kapural Leonardo 
Published: February 2019

Background and objectivesAs a follow-up to the 6-month report,12 this study investigated the analgesic effect of cooled radiofrequency ablation (CRFA) in patients with knee osteoarthritis (OA) 12 months postintervention and its ability to provide pain relief in patients who experienced unsatisfactory effects of intra-articular steroid injection (IAS).MethodsSeventy-eight per cent (52/67) of patients originally treated with CRFA were evaluated at 12 months, while at 6 months post-IAS, 82% (58/71) of those patients crossed over to CRFA and assessed 6 months later.ResultsAt 12 months, 65% of the original CRFA group had pain reduction ≥50%, and the mean overall drop was 4.3 points (p<0.0001) on the numeric rating scale. Seventy-five per cent reported ‘improved’ effects. The cross-over group demonstrated improvements in pain and functional capacity (p<0.0001). No unanticipated adverse events occurred.ConclusionsThis study demonstrates that analgesia following CRFA for OA knee pain could last for at least 12 months and could rescue patients who continue to experience intolerable discomfort following IAS.Clinical trial registrationThe ClinicalTrials.gov registration number for this study isNCT02343003.
Assessment of tobacco imagery and compliance with tobacco-free rules in popular Indian films
Authors: Kulkarni Muralidhar M , Kamath Veena Ganesh , Cranwell Jo , Britton John , Nazar Gaurang P , Arora Monika , Ballal Kirthinath , Kamath Asha 
Published: February 2019

BackgroundExposure to smoking in films causes smoking uptake among adolescents. Investigation of the extent to which tobacco imagery appears, or tobacco control laws are complied with in Indian films is limited, and especially so for films in regional languages. This study presents an analysis of tobacco content and compliance with tobacco control laws in popular films in several languages from the Karnataka state of India.MethodsWe used 5 min interval coding to measure actual tobacco use, implied tobacco use, tobacco paraphernalia and tobacco branding in the top 10 films identified from national box office ratings and regional distributor reports in Karnataka in 2015 and 2016. We also assessed compliance with tobacco-free film rules in India.FindingsA total of 47 films, in English, Hindi, Malayalam, Tamil, Telugu and Tulu languages were coded. Any tobacco imagery was observed in 72% of films, and actual tobacco use in 50%. Tobacco imagery was equally prevalent in films classified as suitable for universal viewing (U category) or at age 12 or more (U/A category) films; and significantly more common in films made in regional than national language (Hindi). None of the films were fully compliant with legal requirements on health spots, audiovisual disclaimers and health warnings.ConclusionsTobacco content was common in films classified as suitable for viewing by children, more among regional than national languages. Compliance with tobacco control laws was low. Stricter enforcement of tobacco-free film rules will protect children and adolescents from exposure to tobacco use on screen.
Categorising characteristics of counterfeit Marlboro cigarettes: a systematic review of tobacco industry documents
Authors: Kurti Marin K , von Lampe Klaus , He Yi , Khanzada Hiba , Kostara Konstantina , Da Qin , Schroth Kevin R J 
Published: February 2019

BackgroundThere is scant research on methods used to identify counterfeit Marlboro cigarettes.MethodsSystematic analysis of internal tobacco industry documents characteristics of counterfeit Marlboro cigarettes.ResultsIn the industry documents we identified as relevant, there were 42 characteristics of counterfeit Marlboro cigarettes. Overall, physical characteristics (88.1%) were the most commonly identified features across all locations, with the pack blank, cardboard shell of the cigarette pack, as the dominant site (30.9%). Some of the physical characteristics included offset lithography printing, incorrect font and colour. Overall, light microscopy was identified as the main method of forensic analysis for detecting counterfeits.ConclusionIndependent researchers employing litter pack and pack swap surveys are encouraged to use the characteristics identified in the study to gauge the prevalence of counterfeit Marlboro cigarettes and compare against industry estimates.