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  • 1
    Publication Date: 2018-02-23
    Description: Objectives Endovascular mechanical thrombectomy is an effective but expensive therapy for acute ischaemic stroke with proximal anterior circulation occlusion. This study aimed to determine the cost-effectiveness of mechanical thrombectomy in China, which is the largest developing country. Design A combination of decision tree and Markov model was developed. Outcome and cost data were derived from the published literature and claims database. The efficacy data were derived from the meta-analyses of nine trials. One-way and probabilistic sensitivity analyses were performed in order to assess the uncertainty of the results. Setting Hospitals in China. Participants The patients with acute ischaemic stroke caused by proximal anterior circulation occlusion within 6 hours. Interventions Mechanical thrombectomy within 6 hours with intravenous tissue plasminogen activator (tPA) treatment within 4.5 hours versus intravenous tPA treatment alone. Outcome measures The benefit conferred by the treatment was assessed by estimating the cost per quality-adjusted life-year (QALY) gained in the long term (30 years). Results The addition of mechanical thrombectomy to intravenous tPA treatment compared with standard treatment alone yielded a lifetime gain of 0.794 QALYs at an additional cost of CNY 50 000 (US$7700), resulting in a cost of CNY 63 010 (US$9690) per QALY gained. The probabilistic sensitivity analysis indicated that mechanical thrombectomy was cost-effective in 99.9% of the simulation runs at a willingness-to-pay threshold of CNY 125 700 (US$19 300) per QALY. Conclusions Mechanical thrombectomy for acute ischaemic stroke caused by proximal anterior circulation occlusion within 6 hours was cost-effective in China. The data may be used as a reference with regard to medical resources allocation for stroke treatment in low-income and middle-income countries as well as in the remote areas in the developed countries.
    Keywords: Open access, Health economics
    Electronic ISSN: 2044-6055
    Topics: Medicine
    Published by BMJ Publishing
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  • 2
    Publication Date: 2018-06-23
    Description: Introduction Paraquat (PQ) is a widely used herbicide which is inexpensive and easily accessible for people in rural areas. A small amount of PQ ingestion could be lethal, yet currently, the optimal treatment is still controversial. Extracorporeal therapies (ECTR) have been practised in PQ poisoning management, though limited evidence could be obtained to suggest its superiority over conservative therapy. Haemodialysis (HD) and haemoperfusion (HP) are most commonly used, while some institutions also choose HP–HD concurrent therapy. The object of the present trial is to investigate whether haemopurification therapy can reduce mortality compared with conservative therapy. Methods and analysis This is a planned single-centre, non-blinded, randomised controlled trial. Acute PQ poisoned adults who have orally ingested PQ within 24 hours would be recruited. A total of 360 patients would be recruited and randomly assigned to four groups, that is, HP, HD, concurrent HP–HD and control, at a 1:1:1:1 ratio. Subjects would be also stratified by their urine dithionite test results. Primary outcome is 28-day all-cause mortality. Secondary outcomes include survival time, all-cause mortality at the 3rd, 7th and 60th day, rate of major complications, Acute Physiologic and Chronic Health Evaluation score and Poisoning Severity Score, etc. Ethics and dissemination The protocol and informed consent documents have been approved by the Ethics Committee of The First Affiliated Hospital of Zhengzhou University in September 2017 (approval number: 2017-KY-10). The result of this trial would be submitted to peer-reviewed journal. Trial registration number NCT03314909 ; Pre-results.
    Keywords: Open access, Emergency medicine
    Electronic ISSN: 2044-6055
    Topics: Medicine
    Published by BMJ Publishing
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  • 3
    Publication Date: 2018-05-07
    Description: Introduction Atrial fibrillation (AF) is a worldwide healthcare burden that is associated with the ageing population. Elderly patients with AF with multiple comorbidities usually present with a high risk of thromboembolism and bleeding. Limited prospective data are available from Asian cohorts on the epidemiology and complications of AF. The present prospective cohort study aims to explore contemporary antithrombotic strategies among the elderly Chinese population in the new era of non-vitamin K antagonist oral anticoagulants and to compare the clinical characteristics and outcomes between Chinese and European AF populations. Methods and analysis The Optimal Thromboprophylaxis in Elderly Chinese Patients with Atrial Fibrillation (ChiOTEAF) registry will recruit 5000 patients with AF over 65 years of age in China. AF-related risks, including stroke/systemic thromboembolism and bleeding outcomes, will be assessed. Medical history, risk factors, demographic information and management will be collected at baseline, and clinical events during 1 year follow-up will be recorded. Follow-up will be conducted for at least 1 year and then annually thereafter. As our registry has a common protocol to the European Society of Cardiology EURObservational Research Programme AF general registry programme, preplanned analyses comparing the clinical profiles and outcomes will be performed. The ChiOTEAF registry offers an opportunity to provide a better understanding of the clinical profiles and adverse outcomes of patients with AF in China and allow for comparisons with a contemporary European population. Ethics and dissemination Ethics approval was granted by the Central Medical Ethic Committee of Chinese PLA General Hospital (approval no S2014-065-01). The (inter)national research presentations, peer-reviewed publications and media coverage of the research will be sued for dissemination of the results.
    Keywords: Open access, Epidemiology
    Electronic ISSN: 2044-6055
    Topics: Medicine
    Published by BMJ Publishing
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  • 4
    Publication Date: 2018-06-02
    Description: Introduction High blood pressure (BP) affects over 40% of adults over the age of 25 worldwide and is the leading global risk factor for death or disability. Hypertension is also the most important risk factor for endovascular atherosclerosis, which, when combined with other cardiovascular risk factors, leads to atherosclerotic cardiovascular disease (ASCVD). Statins are one of the most widely used drugs for the prevention of ASCVD. The recently announced study of Heart Outcomes Prevention Evaluation-3 suggests that cholesterol-lowering agents combined with antihypertensive therapy can prevent cardiovascular events and reduce the combined endpoint. We plan to conduct a systematic review and meta-analysis to evaluate whether combined antihypertensive and statin therapy is more beneficial than antihypertensive therapy alone in patients with hypertension without complications. Methods and analysis We will perform a comprehensive search for randomised controlled trials evaluating combined antihypertensive and statin therapy for the treatment of patients with hypertension. The following English electronic databases will be searched: The Cochrane Library, EMBASE and PubMed. Outcomes will be categorised as short-term (≤6 months) or long-term (〉6 months). When evaluating the effects of combined antihypertensive and statin therapy, a short-term outcome is usually defined as a change in BP or lipid levels, while a long-term outcome is usually defined as cardiovascular benefits or risks. The data screening and extraction will be conducted by two different reviewers. The quality of the RCTs will be assessed according to the Cochrane handbook risk of bias tool. Ethics and dissemination This review does not require ethics approval and the results of the meta-analysis will be submitted to a peer-review journal. PROSPERO registration number CRD 42017071935 .
    Keywords: Open access, Cardiovascular medicine
    Electronic ISSN: 2044-6055
    Topics: Medicine
    Published by BMJ Publishing
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  • 5
    Publication Date: 2018-04-28
    Description: Objective To describe and analyse the hospitalisation cost of patients with hip fracture under the influence of various factors and to provide references for Chinese national medical insurance policy. Materials and methods All data were collected from the Chinese National Medical Data Centre database, which contained the hospitalisation data of 73 tertiary hospitals from 24 provinces. The included patients were first hospitalised with the main diagnosis of femoral neck or intertrochanteric fracture, and were discharged between 1 January 2014 and 31 December 2015. Secondary hospitalisation, multiple trauma or pathologic fracture (except for osteoporotic fracture) patients or patients with missing data were excluded. The impact of various factors on the cost was investigated using analysis of variance and multivariable linear regression analysis. The Gross Domestic Product per capita and average annual disposable income were obtained from the website of the National Bureau of Statistics. Results 27 205 cases were included in the study. The mean cost of all patients was ¥53 440. 60–69 years age group had a significantly higher cost compared with 80 years and above age group. The mean cost of femoral neck fractures was lower than that of the patients with intertrochanteric fractures; the mean cost of hip replacement was higher than that of internal fixation, which showed a strong effect of the surgical approach to the cost. Patients in low-income provinces spent less than those in high-income provinces, while the gap between high-income and middle-income provinces were relatively small. Conclusion The hospitalisation cost of hip fracture has become a great burden to the patients’ families. The Chinese medical insurance policy may need further consideration of the demographic and economic factors.
    Keywords: Open access, Health economics
    Electronic ISSN: 2044-6055
    Topics: Medicine
    Published by BMJ Publishing
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  • 6
    Publication Date: 2018-04-29
    Description: Purpose We established the China Respiratory Illness Surveillance among Pregnant women (CRISP) to conduct active surveillance for influenza-associated respiratory illness during pregnancy in China from 2015 to 2018. Among annual cohorts of pregnant women, we assess the incidence of acute respiratory illness (ARI), influenza-like illness (ILI), laboratory-confirmed influenza virus infection and the seroconversion proportion during the winter influenza season. We also plan to examine the effect of influenza virus infection on adverse pregnancy, delivery and infant health outcomes with cumulative data from the three annual cohorts. Participants Cohort nurses enrol pregnant women in different trimesters of pregnancy from prenatal care facilities in Suzhou, Jiangsu Province, eastern China. Pregnant women who plan to deliver in the study facilities are eligible. Pregnant women who are seeking care for anything other than routine prenatal care, such as confirmation of low progesterone and threatened miscarriage, are excluded. At enrolment, study nurses collect baseline information on demographics, education-level attained, underlying medical conditions, seasonal influenza vaccination receipt, risk factors for influenza infection, gravidity and parity and contact information. For each participant, cohort nurses conduct twice weekly follow-up contacts, one phone call and one WeChat message (free instant messaging), from the time of enrolment until delivery or termination of pregnancy. During follow-up, study nurses ask about symptoms, timing and characteristics of ARI, healthcare-seeking behaviour and medications taken for participants reporting respiratory illness since the last contact. In addition, we collect combined nasal and throat swabs for identified ARI to test for influenza viruses. We collect paired sera before and after the influenza season. Active respiratory illness surveillance and seroinfection data during pregnancy of participants are linked to their medical record and the Suzhou Maternal Child Information System for detailed information on clinical treatment for respiratory illness, pregnancy, delivery and infant health outcomes. Findings to date In 2015–2016, of 4915 pregnant women approached, 192 (4%) refused to participate, 91 (2%) were ineligible because they did not plan to deliver in one of the study hospitals or because their visit was for anything other than routine prenatal care and 4632 (94%) were enrolled, 46% during their first trimester of pregnancy (range 5–12 weeks), 48% during the second trimester (range 13–27 weeks) and 6% during the third trimester (range 28–37 weeks). The median age of the enrollees was 27 years (range 16–45) and two (0.04%, 95% CI 0.01% to 0.17%) reported influenza vaccination in the previous 12 months before pregnancy, while zero reported influenza vaccination in the previous 12 months during pregnancy. During the observation time of 648 518 person-days, 1355 ARI episodes were identified. Among 1127 swabs collected (for 83% of all ARIs), 68 (6%) tested positive for influenza virus, for a laboratory-confirmed influenza incidence of 0.31 (95% CI 0.25 to 0.40) per 100 person-months during pregnancy in the study cohort. Future plans Results will be used to describe influenza disease burden in this population to model potential numbers of influenza illnesses averted if influenza vaccination coverage were increased and to support enhanced influenza prevention and control strategies among pregnant women in China. We also plan to enrol and follow three cohorts of pregnant women over three influenza seasons during 2015–2018 which will allow an analysis of the effect of influenza virus infection during pregnancy on adverse pregnancy, delivery and infant outcomes.
    Keywords: Open access, Epidemiology
    Electronic ISSN: 2044-6055
    Topics: Medicine
    Published by BMJ Publishing
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  • 7
    Publication Date: 2018-05-17
    Description: Objective We aimed to perform a systematic review and meta-analysis to clarify the association between white matter hyperintensities (WMHs) and carotid artery (CA) stenosis. Study design Systematic review and meta-analysis. Participants CA stenosis was set at ≥50%, and WMHs were assessed by MRI and evaluated quantitatively or semiquantitatively. Data sources A comprehensive literature search was performed in PubMed, EMBASE and Cochrane Library for studies evaluating the association between WMHs and CA stenosis ≥50% from inception to 13 September 2017. Main outcomes and measures Standardised mean difference (SMD) with 95% CI was used to evaluate the association between WMHs and CA stenosis. Results were presented in a forest plot with a fixed-effects model or random-effects model. We assessed the quality of included studies using the Newcastle-Ottawa Scale. Funnel plots and Egger’s and Begg’s tests were conducted to assess publication bias. Sensitivity analysis was performed to evaluate the influence of each individual study. Results Eight studies enrolling 677 patients were included. There was a positive relationship between the total WMHs and CA stenosis, with a pooled fixed-effects SMD of 0.326 (95% CI 0.194 to 0.459, p=0.000). Heterogeneity and publication bias were low among these studies. Subgroup analysis of three studies enrolling 225 patients showed an association between periventricular WMHs and CA stenosis, with a pooled fixed-effects SMD of 0.412 (95% CI 0.202 to 0.622, p=0.000). Conclusion This meta-analysis showed that the total WMHs and periventricular WMHs were associated with CA stenosis. WMHs may be considered as an individual risk stratification score when choosing a proper plan for therapy of CA stenosis.
    Keywords: Open access, Neurology
    Electronic ISSN: 2044-6055
    Topics: Medicine
    Published by BMJ Publishing
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  • 8
    Publication Date: 2018-03-06
    Description: Objective To compare the effectiveness of five kinds of selenium supplementation for the treatment of patients with Kashin-Beck disease, and rank these selenium supplementations based on their performance. Design We searched for all publications between 1 January 1966 and 31 March 2017 using seven electronic databases. GRADE system to network meta-analyses (NMAs) was applied to rate the quality of the evidence. We conducted a random effects model NMA in STATA 12.1 to determine comparative effectiveness of each intervention. Rankings were obtained by using the surface under the cumulative ranking curve (SUCRA) values and mean ranks. Results A total of 15 randomised controlled trials involving 2931 patients were included. After assessment of the overall quality of the evidence, we downgraded our primary outcomes from high to low or very low quality. NMAs showed that all five kinds of selenium supplementation had higher metaphysis X-ray improvement which were superior to placebo. Ranking on efficacy indicated that selenium salt was ranked the highest, followed by sodium selenite + vitamin E, selenium enriched yeast, sodium selenite and then sodium selenite + vitamin C. Conclusions Based on the results of NMA, all five types of selenium supplements are more effective than placebo and so that selenium supplementation is of help in repairing metaphyseal lesions. Since the overall quality of the evidence was low or very low, the SUCRA values may be misleading and should be considered jointly with the The Grading of Recommendations Assessment, Development and Evaluation (GRADE) confidence in the estimates for each comparison. The quality of the evidence is insufficient to draw a conclusion about what method of selenium supplementation is most effective. PROSPERO registration number CRD42016051874 .
    Keywords: Open access, Evidence based practice
    Electronic ISSN: 2044-6055
    Topics: Medicine
    Published by BMJ Publishing
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  • 9
    Publication Date: 2018-03-06
    Description: Introduction Provisional stenting (PS) for simple coronary bifurcation lesions is the mainstay of treatment. A systematic two-stent approach is widely used for complex bifurcation lesions (CBLs). However, a randomised comparison of PS and two-stent techniques for CBLs has never been studied. Accordingly, the present study is designed to elucidate the benefits of two-stent treatment over PS in patients with CBLs. Methods and analysis This DEFINITION II study is a prospective, multinational, randomised, endpoint-driven trial to compare the benefits of the two-stent technique with PS for CBLs. A total of 660 patients with CBLs will be randomised in a 1:1 fashion to receive either PS or the two-stent technique. The primary endpoint is the rate of 12-month target lesion failure defined as the composite of cardiac death, target vessel myocardial infarction (MI) and clinically driven target lesion revascularisation. The major secondary endpoints include all causes of death, MI, target vessel revascularisation, in-stent restenosis, stroke and each individual component of the primary endpoints. The safety endpoint is the occurrence of definite or probable stent thrombosis. Ethics and dissemination The study protocol and informed consent have been approved by the Institutional Review Board of Nanjing First Hospital, and accepted by each participating centre. Written informed consent was obtained from all enrolled patients. Findings of the study will be published in a peer-reviewed journal and disseminated at conferences. Trial registration number NCT02284750 ; Pre-results.
    Keywords: Open access, Cardiovascular medicine
    Electronic ISSN: 2044-6055
    Topics: Medicine
    Published by BMJ Publishing
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  • 10
    Publication Date: 2018-02-21
    Description: Objectives To investigate the awareness and knowledge level of breast cancer among Chinese participants. Design Case–control study. Settings This study was based on the database of the minister-affiliated hospital key project of the Ministry of Health of the People’s Republic of China that included 21 Chinese hospitals between April 2012 and April 2013. Participants Matched study was designed among 2978 participants with Han ethnicity aged between 25 and 70. Primary and secondary outcome measures Student’s t-test, Pearson’s 2 test, reliability analysis, exploratory factor analysis, and univariate and multivariate logistic regression analyses were performed to know the level of breast cancer knowledge and find the breast cancer awareness-associated factors. Results 80.0% (2383/2978) of the participants had poor awareness level of breast cancer. In-depth knowledge of breast cancer such as early symptoms and risk factors was poorly found among them. Television broadcast and relatives or friends with breast cancers were the main sources of information about breast cancer. Of all participants, 72.8% (2167/2978) had heard about breast cancer as a frequent cancer affecting women, and 63.3% (1884/2978) knew that family history of breast cancer was a risk factor for breast cancer. Over half of them were aware that a breast lump could be a symptom of breast cancer. Multivariate analysis identified the following variables that predicted awareness of breast cancer: young age (OR=0.843, 95% CI 0.740 to 0.961), occupation (agricultural worker) (OR=12.831, 95% CI 6.998 to 23.523), high household social status (OR=0.644, 95% CI 0.531 to 0.780), breast hyperplasia history (OR=1.684, 95% CI 1.273 to 2.228), high behavioural prevention score (OR=4.407, 95% CI 3.433 to 5.657). Conclusion Most women were aware of breast cancer as a disease, but their in-depth knowledge of it was poor. More publicity and education programmes to increase breast cancer awareness are necessary and urgent, especially for the ageing women and agricultural workers.
    Keywords: Open access, Public health
    Electronic ISSN: 2044-6055
    Topics: Medicine
    Published by BMJ Publishing
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