bluuebunny/crossref_metadata_2025_split huggingface dataset:
Quality of evidence considered by Health Canada in granting full market authorisation to new drugs with a conditional approval: a retrospective cohort study
Authors: Lexchin Joel 
Published: April 2018

ObjectivesThis study examines the characteristics of studies that Health Canada uses to grant full marketing authorisation for products given a conditional approval between 1 January 1998 and 30 June 2017.DesignCohort study.Data sourcesJournal articles listing drugs that fulfilled their conditions and received full marketing authorisation, Notice of Compliance database, Notice of Compliance with conditions website, Qualifying Notices listing required confirmatory studies, clinicaltrials.gov, PubMed, Embase, companies making products being analysed, journal articles resulting from confirmatory studies.InterventionsNone.Primary and secondary outcome measuresCharacteristics of studies—study design (randomised controlled trials, observational), primary outcome used (clinical, surrogate), blinding, number of patients in studies, patient median age, number of men and women.ResultsEleven companies confirmed 36 publications for 19 products (21 indications). Twenty-nine out of the 36 studies were randomised controlled trials (RCTs) but only 10 stated if they were blinded. Twenty used surrogate outcomes. The median age of patients was 56 (IQR 44–61). The median number of men per study/trial was 184 (IQR 58–514) versus women 141 (IQR 46–263).ConclusionsPostmarket studies required by Health Canada had more rigorous methodology than those required by either the Food and Drug Administration or the European Medicines Agency. There were still deficiencies in these studies. The absence of blinding in the majority of RCTs may introduce bias in their results. The use of surrogate outcomes especially in oncology trials means that improvements in survival are not available. The relatively young age of patients, even for products for cancer, means that predicting how the elderly will respond is often unknown. The almost universal finding that men outnumbered women may make it hard to differentiate responses by sex. These results raise potential concerns about the quality of evidence that Health Canada accepts.
Should surgery be delayed in patients taking direct oral anticoagulants who suffer a hip fracture? A retrospective, case-controlled observational study at a UK major trauma centre
Authors: Mullins Barry , Akehurst Harold , Slattery David , Chesser Tim 
Published: April 2018

ObjectiveTo determine whether not waiting for the elimination of direct oral anticoagulants (DOACs) has an effect on the amount of perioperative bleeding in patients who undergo operative treatment of a hip fracture.DesignObservation, retrospective case–control study.SettingA single UK major trauma centre.ParticipantsPatients who sustained a hip fracture were identified using the National Hip Fracture Database (NHFD). All those found to be taking a DOAC at the time of fracture were identified (n=63). A matched group not taking a DOAC was also identified from the NHFD (n=62).Main outcomePerioperative drop in haemoglobin concentration.ResultsThere was no relationship between admission to operation interval and perioperative change in haemoglobin concentration in patients taking DOACs (regression coefficient=−0.06 g/L/hour; 95% CI −0.32–0.20; p=0.64). No relationship was found between the time from admission to operation interval and the probability of transfusion (OR=0.94; 95% CI 0.85 to 1.90; p=0.16) or reoperation (OR=1.04; 95% CI 0.93 to 1.16; p=0.49). One mortality was recorded in the DOAC group within 30 days of admission, and this compared with five in the matched group of patients (p=0.2).ConclusionsDelaying surgery in patients who sustain a hip fracture who are taking a DOAC drug has not been shown to reduce perioperative bleeding or affect their mortality in this study.
Does practice analysis agree with the ambulatory care sensitive conditions’ list of avoidable unplanned admissions?: a cross-sectional study in the East of England
Authors: Fleetcroft Robert , Hardcastle Antonia , Steel Nicholas , Price Gill M , Purdy Sarah , Lipp Alistair , Myint Phyo Kyaw , Howe Amanda 
Published: April 2018

ObjectivesTo use significant event audits (SEAs) in primary care to determine which of a sample of emergency (unplanned) admissions were potentially avoidable; and compare with the National Health Service (NHS) list of ambulatory care sensitive conditions (ACSCs).DesignAnalysis of unplanned medical admissions randomly identified in secondary care.SettingPrimary care in the East of England.Participants20 general practice teams trained to use SEA on unplanned admissions to identify potentially preventable factors.InterventionsSEA of admissions.Main outcome measuresLevel of agreement between those admissions identified as potentially preventable by SEA and the NHS ACSC list.Results132 (26%) of randomly selected patients with unplanned admissions gave consent and an SEA was performed by their primary practice team. 130 SEA reports had sufficient data for our analysis. Practices concluded that 17 (13%) admissions were potentially preventable. The NHS ACSC list identified 36 admissions (28%) as potentially preventable. There was a low level of agreement between the practices and the NHS list as to which admissions were preventable (kappa=0.253). The ACSC list consisted mainly of respiratory admissions whereas the practice list identified a wider range of cases and identified context-specific factors as important.ConclusionsThere was disagreement between the NHS list and practice conclusions of potentially avoidable admissions. The SEAs suggest that the pathway into unplanned admission may be less dependent on the condition than on context-specific factors, and the assumption that unplanned admissions for ACSCs are reasonable indicators of performance for primary care may not be valid.
Soil-transmitted helminth infections and nutritional status in Ecuador: findings from a national survey and implications for control strategies
Authors: Moncayo Ana L , Lovato Raquel , Cooper Philip J 
Published: April 2018

ObjectiveThe estimation of prevalence and intensity of soil-transmitted helminth (STH) infections at a country-level is an essential prerequisite for the implementation of a rational control programme. The aim of this present study was to estimate the prevalence and distribution of STH infections and malnutrition in school-age children in rural areas of Ecuador.DesignCross-sectional study from October 2011 to May 2012.SettingEighteen rural schools were randomly selected from the three ecological regions of Ecuador (coastal, highlands and Amazon basin).Participants920 children aged 6–16 years.Main outcome measuresPrevalence and intensity of STH infections associated with malnutrition (thinness/wasting or stunting).ResultsThe results showed that 257 (27.9%) children were infected with at least one STH parasite. The prevalence ofTrichuris trichiura,Ascaris lumbricoidesand hookworm was 19.3%, 18.5% and 5.0%, respectively. Malnutrition was present in 14.2% of children and most common was stunting (12.3%). Compared with other regions, schoolchildren in the Amazon region had the highest STH prevalence (58.9%) of which a greater proportion of infections were moderate/heavy intensity (45.6%) and had the highest prevalence of malnutrition (20.4%). A positive association was observed between moderate to heavy infections withA. lumbricoidesand malnutrition (adjusted OR 1.85, 95% CI 1.04 to 3.31, p=0.037).ConclusionsOur estimate of the prevalence of STH infections of 27.9% at a national level in Ecuador is lower than suggested by previous studies. Our data indicate that schoolchildren living in the Amazon region have a greater risk of STH infection and stunting compared with children from other regions. The implementation of school-based preventive chemotherapy and nutritional supplement programmes within the Amazon region should be prioritised. Long-term control strategies require improvements in water, sanitation and hygiene.
Post-treatment surveillance testing of patients with colorectal cancer and the association with survival: protocol for a retrospective cohort study of the Surveillance, Epidemiology, and End Results (SEER)-Medicare database
Authors: Hines Robert B , Jiban Md Jibanul Haque , Choudhury Kanak , Loerzel Victoria , Specogna Adrian V , Troy Steven P , Zhang Shunpu 
Published: April 2018

IntroductionAlthough the colorectal cancer (CRC) mortality rate has significantly improved over the past several decades, many patients will have a recurrence following curative treatment. Despite this high risk of recurrence, adherence to CRC surveillance testing guidelines is poor which increases cancer-related morbidity and potentially, mortality. Several randomised controlled trials (RCTs) with varying surveillance strategies have yielded conflicting evidence regarding the survival benefit associated with surveillance testing. However, due to differences in study protocols and limitations of sample size and length of follow-up, the RCT may not be the best study design to evaluate this relationship. An observational comparative effectiveness research study can overcome the sample size/follow-up limitations of RCT designs while assessing real-world variability in receipt of surveillance testing to provide much needed evidence on this important clinical issue. The gap in knowledge that this study will address concerns whether adherence to National Comprehensive Cancer Network CRC surveillance guidelines improves survival.Methods and analysisPatients with colon and rectal cancer aged 66–84 years, who have been diagnosed between 2002 and 2008 and have been included in the Surveillance, Epidemiology, and End Results-Medicare database, are eligible for this retrospective cohort study. To minimise bias, patients had to survive at least 12 months following the completion of treatment. Adherence to surveillance testing up to 5 years post-treatment will be assessed in each year of follow-up and overall. Binomial regression will be used to assess the association between patients’ characteristics and adherence. Survival analysis will be conducted to assess the association between adherence and 5-year survival.Ethics and disseminationThis study was approved by the National Cancer Institute and the Institutional Review Board of the University of Central Florida. The results of this study will be disseminated by publishing in the peer-reviewed scientific literature, presentation at national/international scientific conferences and posting through social media.
Spatial and temporal variation in the community prevalence of antibiotic resistance in Bangladesh: an integrated surveillance study protocol
Authors: Rousham Emily , Unicomb Leanne , Wood Paul , Smith Michael , Asaduzzaman Muhammad , Islam Mohammad Aminul 
Published: April 2018

IntroductionIncreasing antibiotic resistance (ABR) in low-income and middle-income countries such as Bangladesh presents a major health threat. However, assessing the scale of the health risk is problematic in the absence of reliable data on the community prevalence of antibiotic-resistant bacteria. We describe the protocol for a small-scale integrated surveillance programme that aims to quantify the prevalence of colonisation with antibiotic-resistant bacteria and concentrations of antibiotic-resistant genes from a ‘One Health’ perspective. The holistic assessment of ABR in humans, animals and within the environment in urban and rural Bangladesh will generate comprehensive data to inform human health risk.Methods and analysisThe study design focuses on three exposure-relevant sites where there is enhanced potential for transmission of ABR between humans, animals and the environment: (1) rural poultry-owning households, (2) commercial poultry farms and (3) urban live-bird markets. The comparison of ABR prevalence in human groups with high and low exposure to farming and poultry will enable us to test the hypothesis that ABR bacteria and genes from the environment and food-producing animals are potential sources of transmission to humans.Escherichia coliis used as an ABR indicator organism due to its widespread environmental presence and colonisation in both the human and animal gastrointestinal tract.Ethics and disseminationThe study has been approved by the Institutional Review Board of the International Centre for Diarrhoeal Disease Research, Bangladesh, and Loughborough University Ethics Committee. Data for the project will be stored on the open access repository of the Centre for Ecology and Hydrology, Natural Environment Research Council. The results of this study will be published in peer-reviewed journals and presented at national and international conferences.
Paediatric traumatic cardiac arrest: a Delphi study to establish consensus on definition and management
Authors: Rickard Annette C , Vassallo James , Nutbeam Tim , Lyttle Mark D , Maconochie Ian K , Enki Doyo G , Smith Jason E 
Published: April 2018

AimsPaediatric traumatic cardiac arrest (TCA) is associated with low survival and poor outcomes. The mechanisms that underlie TCA are different from medical cardiac arrest; the approach to treatment of TCA may therefore also need to differ to optimise outcomes. The aim of this study was to explore the opinion of subject matter experts regarding the diagnosis and treatment of paediatric TCA, and to reach consensus on how best to manage this group of patients.MethodsAn online Delphi study was conducted over three rounds, with the aim of achieving consensus (defined as 70% agreement) on statements related to the diagnosis and management of paediatric TCA. Participants were invited from paediatric and adult emergency medicine, paediatric anaesthetics, paediatric ICU and paediatric surgery, as well as Paediatric Major Trauma Centre leads and representatives from the Resuscitation Council UK. Statements were informed by literature reviews and were based on elements of APLS resuscitation algorithms as well as some concepts used in the management of adult TCA; they ranged from confirmation of cardiac arrest to the indications for thoracotomy.Results73 experts completed all three rounds between June and November 2016. Consensus was reached on 14 statements regarding the diagnosis and management of paediatric TCA; oxygenation and ventilatory support, along with rapid volume replacement with warmed blood, improve survival. The duration of cardiac arrest and the lack of a response to intervention, along with cardiac standstill on ultrasound, help to guide the decision to terminate resuscitation.ConclusionThis study has given a consensus-based framework to guide protocol development in the management of paediatric TCA, though further work is required in other key areas including its acceptability to clinicians.
Man with hand pain
Authors: Jansson Paul S , Lee Stella J , Samuels-Kalow Margaret E 
Published: April 2018

Clinical introductionA right-hand dominant man was transferred to our institution for evaluation by the hand surgery service. He reported that the day prior he had been sliding a sheet of plywood across the ground when he lost his grip, causing the board to slide across his left hand. He presented to an outside hospital where local exploration of the wound did not reveal any foreign body. On arrival, he complained only of mild pain in his hand. Physical examination revealed erythema and swelling over the thenar eminence and a small open area without any drainage. Radiographs (figure 1) and ultrasonography (figures 2 and 3, online supplementary video 1 and 2) were performed.Supplementary dataFigure 1Radiograph of the hand.Figure 2Long-axis ultrasonography of the hand.Figure 3Short-axis ultrasonography of the hand.QuestionWhat is you diagnosis?Fracture of the metacarpal of the thumb.Cellulitis of the thenar eminence.Abscess of the thenar eminence.Retained foreign body.
Direct mechanical thrombectomy in tPA-ineligible and -eligible patients versus the bridging approach: a meta-analysis
Authors: Kaesmacher Johannes , Mordasini Pasquale , Arnold Marcel , López-Cancio Elena , Cerdá Neus , Boeckh-Behrens Tobias , Kleine Justus F , Goyal Mayank , Hill Michael D , Pereira Vitor Mendes , Saver Jeffrey L , Gralla Jan , Fischer Urs 
Published: April 2018

BackgroundWhether pretreatment with intravenous thrombolysis prior to mechanical thrombectomy (IVT+MTE) adds additional benefit over direct mechanical thrombectomy (dMTE) in patients with large vessel occlusions (LVO) is a matter of debate.MethodsThis study-level meta-analysis was presented in accord with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Pooled effect sizes were calculated using the inverse variance heterogeneity model and displayed as summary Odds Ratio (sOR) and corresponding 95% confidence interval (95% CI). Sensitivity analysis was performed by distinguishing between studies including dMTE patients eligible for IVT (IVT-E) or ineligible for IVT (IVT-IN). Primary outcome measures were functional independence (modified Rankin Scale≤2) and mortality at day 90, successful reperfusion, and symptomatic intracerebral hemorrhage.ResultsTwenty studies, incorporating 5279 patients, were included. There was no evidence that rates of successful reperfusion differed in dMTE and IVT+MTE patients (sOR 0.93, 95% CI 0.68 to 1.28). In studies including IVT-IN dMTE patients, patients undergoing dMTE tended to have lower rates of functional independence and had higher odds for a fatal outcome as compared with IVT+MTE patients (sOR 0.78, 95% CI 0.61 to 1.01 and sOR 1.45, 95% CI 1.22 to 1.73). However, no such treatment group effect was found when analyses were confined to cohorts with a lower risk of selection bias (including IVT-E dMTE patients).ConclusionThe quality of evidence regarding the relative merits of IVT+MTE versus dMTE is low. When considering studies with lower selection bias, the data suggest that dMTE may offer comparable safety and efficacy as compared with IVT+MTE. The conduct of randomized-controlled clinical trials seems justified.
Burden of lung cancer attributable to occupational diesel engine exhaust exposure in Canada
Authors: Kim Joanne , Peters Cheryl E , Arrandale Victoria H , Labrèche France , Ge Calvin B , McLeod Christopher B , Song Chaojie , Lavoué Jérôme , Davies Hugh W , Nicol Anne-Marie , Pahwa Manisha , Demers Paul A 
Published: April 2018

ObjectiveTo estimate the population attributable fraction (PAF) and number of incident and fatal lung cancers in Canada from occupational exposure to diesel engine exhaust (DEE).MethodsDEE exposure prevalence and level estimates were used with Canadian Census and Labour Force Survey data to model the exposed population across the risk exposure period (REP, 1961–2001). Relative risks of lung cancer were calculated based on a meta-regression selected from the literature. PAFs were calculated using Levin’s equation and applied to the 2011 lung cancer statistics obtained from the Canadian Cancer Registry.ResultsWe estimated that 2.4% (95% CI 1.6% to 6.6%) of lung cancers in Canada are attributable to occupational DEE exposure, corresponding to approximately 560 (95% CI 380 to 1570) incident and 460 (95% CI 310 to 1270) fatal lung cancers in 2011. Overall, 1.6 million individuals alive in 2011 were occupationally exposed to DEE during the REP, 97% of whom were male. Occupations with the highest burden were underground miners, truck drivers and mechanics. Half of the attributable lung cancers occurred among workers with low exposure.ConclusionsThis is the first study to quantify the burden of lung cancer attributable to occupational DEE exposure in Canada. Our results underscore a large potential for prevention, and a large public health impact from occupational exposure to low levels of DEE.
Availability, price and promotions for cigarettes and non-cigarette tobacco products: an observational comparison of US Air Force bases with nearby tobacco retailers, 2016
Authors: Kong Amanda Y , Golden Shelley D , Myers Allison E , Little Melissa A , Klesges Robert , Talcott Wayne , Vandegrift Sara M , Cassidy Daniel G , Ribisl Kurt M 
Published: April 2018

Introduction
Active duty military personnel have higher cigarette and smokeless tobacco use rates than civilian populations. Although US Airmen (called Airmen regardless of gender or rank) are required to be tobacco-free during initial training, many resume use once this period ends, perhaps as a result of easy access to cheap tobacco products.

Methods
Between July and September 2016, we collected tobacco product, price and promotion information by visiting on-base (n=28) and off-base (n=80) tobacco retailers near the eight technical training bases where approximately 99% of Airmen attend training. We conducted mixed linear effects models to examine on-base versus off-base differences.

Results
Cigarette packs were 11%–12% cheaper at on-base retailers compared with off-base retailers. Newport Menthol and Marlboro Red cigarette packs were $0.87 and $0.80 lower on-base (p<0.001) while the cheapest pack available was $0.54 lower on-base (p<0.01). Copenhagen smokeless tobacco was also significantly cheaper on-base (B=−0.65, p<0.01). Interior price promotions were more common on-base.

Conclusions
Retail stores located on Air Force bases sell cigarettes and smokeless tobacco products at prices well below those in nearby off-base retailers: the vast majority of these retailers feature interior price promotions for these products. Federal policies regulating prices of on-base tobacco sales, if implemented more effectively, have the potential to protect the health of Airmen by helping them remain tobacco-free after technical training.
Project-based learning and information and communication technology’s integration: Impacts on motivation
Authors: Belagra Mammar , Draoui Belkacem 
Published: April 2018

The purpose of this research was to study the impact of project-based learning and information and communication technologies on students’ motivation. Two second-year classes in electrical engineering at the University Tahri Mohamed in Béchar, Algeria, were involved in the study. The experiment compared the level to which one class of students mastered goals without the use of information and communication technologies, to the mastery achieved by a second class which participated in a tutorial that has a technological tool built into the project-based approach. The subject of power electronics was chosen for this study because of its different knowledge, which is strongly represented in difficult learning contents for students. A questionnaire about motivation was used to collect data within an experimental research plan. After three months of conducting the study, the results demonstrated that the integration of the tutorial with the project-based approach is likely to increase students’ motivation to learn and to master the subject of power electronics.