Clinical Study

临床研究
  • 文章类型: Systematic Review
    背景:报告质量是健康科学中的一个关键问题。采用报告指南已被批准为提高临床研究报告质量和透明度的有效途径。2012年,我们发现中国只有7种(7/1221,0.6%)期刊采用了合并报告标准(CONSORT)声明。本研究的目的是了解CONSORT和其他临床研究报告指南在中国的实施情况。
    方法:进行横断面文献计量学研究。系统检索了八个医学数据库,在中国大陆出版的1039种医学期刊,香港,澳门,台湾也包括在内。基本特征,包括主题,语言,出版地点,期刊索引数据库,并提取期刊影响因素。经修改的5级评价工具评估了对报告准则的认可,即i)积极活跃,ii)积极弱,iii)被动适度,iv)被动弱和v)无。
    结果:在包含的期刊中,24.1%认可的CONSORT,和0.8%认可CONSORT延期。对于STROBE(加强流行病学观察研究的报告),PRISMA(系统评价和荟萃分析的首选报告项目),STARD(报告诊断准确性研究的最新基本项目清单),护理(CASE报告指南),背书比例分别为17.2%、16.6%、16.4%和14.8%。SPIRIT的认可比例(标准协议项目:干预试验建议),TRIPOD(用于个体预后或诊断的多变量预测模型的透明报告),同意(准则评估,Research,和评估),RIGHT(医疗保健实践指南的报告项目)低于0.7%。
    结论:我们的结果表明,报告指南的执行率很低。我们建议采取以下举措,包括i)提高期刊对报告指南的认可水平;ii)加强作者之间的合作,审稿人,编辑,和其他利益相关者;iii)为利益相关者提供培训课程;iv)在中国建立报告指南网络的基础;v)在中国期刊协会(CPA)的政策中采用对报告指南的认可;vi)促进中国医学期刊进入国际评估体系并以英文出版。
    Reporting quality is a critical issue in health sciences. Adopting the reporting guidelines has been approved to be an effective way of enhancing the reporting quality and transparency of clinical research. In 2012, we found that only 7 (7/1221, 0.6%) journals adopted the Consolidated Standards of Reporting Trials (CONSORT) statement in China. The aim of the study was to know the implementation status of CONSORT and other reporting guidelines about clinical studies in China.
    A cross-sectional bibliometric study was conducted. Eight medical databases were systematically searched, and 1039 medical journals published in mainland China, Hong Kong, Macau, and Taiwan were included. The basic characteristics, including subject, language, publication place, journal-indexed databases, and journal impact factors were extracted. The endorsement of reporting guidelines was assessed by a modified 5-level evaluation tool, namely i) positive active, ii) positive weak, iii) passive moderate, iv) passive weak and v) none.
    Among included journals, 24.1% endorsed CONSORT, and 0.8% endorsed CONSORT extensions. For STROBE (STrengthening the Reporting of Observational Studies in Epidemiology), PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses), STARD (An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies), CARE (CAse REport guidelines), the endorsement proportion were 17.2, 16.6, 16.4, and 14.8% respectively. The endorsement proportion for SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials), TRIPOD (Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis), AGREE (Appraisal of Guidelines, Research, and Evaluation), and RIGHT (Reporting Items for Practice Guidelines in Healthcare) were below 0.7%.
    Our results showed that the implementation of reporting guidelines was low. We suggest the following initiatives including i) enhancing the level of journal endorsement for reporting guidelines; ii) strengthening the collaboration among authors, reviewers, editors, and other stakeholders; iii) providing training courses for stakeholders; iv) establishing bases for reporting guidelines network in China; v) adopting the endorsement of reporting guidelines in the policies of the China Periodicals Association (CPA); vi) promoting Chinese medical journals into the international evaluation system and publish in English.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    BACKGROUND: Melatonin exerts multiple biological effects with potential impact on human diseases. This is underscored by genetic studies that demonstrated associations between melatonin receptor type 2 gene (MTNR1B) polymorphisms and characteristics of type 2 diabetes. We set out to test the hypothesis whether genetic variants at MTNR1B are also relevant for other disease phenotypes within the cardiovascular continuum. We thus investigated single nucleotide polymorphisms (SNPs) of MTNR1B in relation to blood pressure (BP) and cardiac parameters in hypertensive patients.
    METHODS: Patients (n=605, mean age 56.2±9.4years, 82.3% male) with arterial hypertension and cardiac ejection fraction (EF) ≥40% were studied. Cardiac parameters were assessed by echocardiography.
    RESULTS: The cohort comprised subjects with coronary heart disease (73.1%) and myocardial infarction (48.1%) with a mean EF of 63.7±8.9%. Analysis of SNPs rs10830962, rs4753426, rs12804291, rs10830963, and rs3781638 revealed two haplotypes 1 and 2 with frequencies of 0.402 and 0.277, respectively. Carriers with haplotype 1 (CTCCC) showed compared to non-carriers a higher mean 24-hour systolic BP (difference BP: 2.4mmHg, 95% confidence interval (CI): 0.3 to 4.5mmHg, p=0.023). Haplotype 2 (GCCGA) was significantly related to EF with an absolute increase of 1.8% (CI: 0.45 to 3.14%) in carriers versus non-carriers (p=0.009).
    CONCLUSIONS: Genetics of MTNR1B point to impact of the melatonin signalling pathway for BP and left ventricular function. This may support the importance of the melatonin system as a potential therapeutic target.
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