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CONSORT 2010说明与详述:报告平行对照随机临床试验指南的更新 被引量:358
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作者 David Moher Sally Hopewell +9 位作者 Kenneth F Schulz Victor Montori Peter C Gφtzsche P J Devereaux Diana Elbourne Matthias Egger Douglas G Altman 周庆辉 卞兆祥 刘建平 《中西医结合学报》 CAS 2010年第8期701-741,共41页
大量证据显示随机对照临床试验(randomised controlled trial,RCT)的报告质量不理想。报告不透明,则读者既不能评判试验结果是否真实可靠,也不能从中提取可用于系统综述的信息。最近的方法学分析表明,报告不充分和设计不合理与对治疗效... 大量证据显示随机对照临床试验(randomised controlled trial,RCT)的报告质量不理想。报告不透明,则读者既不能评判试验结果是否真实可靠,也不能从中提取可用于系统综述的信息。最近的方法学分析表明,报告不充分和设计不合理与对治疗效果产生评价偏倚有关。这种系统误差对RCT损害严重,而RCT正是以其能减少或避免偏倚而被视为评价干预措施的金标准。为了提高RCT的报告质量,一个由专家和编辑组成的工作组制定了临床试验报告的统一标准(Consolidated Standards of Reporting Trials,CONSORT)声明。CONSORT声明于1996年首次发表,并于2001年更新。声明由对照检查清单和流程图组成,供作者在报告RCT时使用。许多核心医学期刊和主要国际性编辑组织都已认可CONSORT声明。该声明促进了对RCT的严格评价和解释。2001年,在对CONSORT进行修订时,人们就已经清楚地认识到,解释和说明制定CONSORT声明的原理,有助于研究人员等撰写或评价临床试验报告。一篇CONSORT说明与详述文章于2001年同2001版CONSORT声明一起发表。2007年1月的专家会议之后,对CONSORT声明作了进一步修订并已发表,即"CONSORT2010声明"。这次更新对原版对照检查清单作了文字上的修改,使其更为明晰,并收入了与一些新近才认识到的主题相关的建议,如选择性报告结局产生的偏倚。说明与详述文件旨在加强人们对CONSORT声明的理解、应用和传播,这次也作了大量修订,对每一项新增或更新的清单条目的含义和增改理由进行了解释,提供了优秀的报告实例,还尽可能地提供了相关的经验性研究的参考文献。文中收入了若干流程图实例。"CONSORT2010声明"、其说明与详述文件,以及相关网站(www.consort-statement.org),对于改进随机临床试验报告必将有所裨益。 展开更多
关键词 临床试验 随机对照试验 指南 CONSORT
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CONSORT指南:整群随机试验扩展版 被引量:5
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作者 Marion K Campbell Diana R Elbourne +3 位作者 Douglas G Altman 杜亮 姚巡 周吉祥 《中国循证医学杂志》 CSCD 2006年第6期451-458,共8页
关键词 CONSORT 群随机试验 指南 随机对照试验 试验报告 受试者 流程图 修订 条目
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Cumulative logit model in the analysis of endometrial cancer under a matched pair case-control design
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作者 Shyam S. Ganguly 《Open Journal of Epidemiology》 2013年第4期153-159,共7页
Background: Binary as well as polytomous logistic models are widely used for estimating odds ratios when the exposure of prime interest assumes unordered multiple levels under matched pairs case-control design. In our... Background: Binary as well as polytomous logistic models are widely used for estimating odds ratios when the exposure of prime interest assumes unordered multiple levels under matched pairs case-control design. In our previous studies, we have shown that the use of a polytomous logistic model for estimating cumulative odds ratios when the outcome (response) variable is ordinal (in addition to being polytomous) under matched pairs case-control design. The cumulative odds ratios were estimated based on separate fitting of the model at each of the cutpoint level as compared to less than equal to that level. In this paper we propose an alternative method of estimating the cumulative odds ratios and reanalyze the Los Angeles Endometrial Cancer data in the context of dose levels of conjugated oestrogen exposure and development of endometrial cancer under the matched pair case-control design. Methods: In the present study, the cumulative logit model is fitted using a single multinomial logit model for the data. For this, the full maximum likelihood estimation procedure is adopted. A test for equality of the cumulative odds ratios across the exposure levels is proposed. Results: The analysis revealed that there is a strong evidence of risk for developing endometrial cancer due to oestrogen exposure above each of the three dose level as compared to less than equal to that level. The estimated values at the three cutpoint levels were found to be 6.17, 3.60 and 5.16 respectively. Conclusions: The odds of developing endometrial cancer are very high for the users of any amount of oestrogen, even if it is the least dose, as compared to the non-users. 展开更多
关键词 Logistic Model Matched PAIRS CASE-CONTROL Design Odds Ratio ORDINAL Response Regression ANALYSIS
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Cytokine gene polymorphisms in idiopathic pulmonary fibrosis
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作者 Martina Vasakova Martina Sterclova +4 位作者 Libor Kolesar Antonij Slavcev Jelena Skibova Martina Langova Ilja Striz 《World Journal of Respirology》 2013年第1期1-7,共7页
AIM: To characterize cytokine gene polymorphisms in patients with idiopathic pulmonary fibrosis(IPF) compared to healthy controls.METHODS: Fifty-six IPF patients were involved in the study. The control population cons... AIM: To characterize cytokine gene polymorphisms in patients with idiopathic pulmonary fibrosis(IPF) compared to healthy controls.METHODS: Fifty-six IPF patients were involved in the study. The control population consisted of 144 healthy volunteers without history of lung disease.All of the patients were diagnosed with IPF according to the American Thoracic Society/European Respiratory Society consensus statement. Polymorphisms in the interleukin(IL)-1, IL-1, IL-1R, IL-1RA, IL-2, IL-4, IL-6, IL-10, IL-12, tumour necrosis factor, interferon, transforming growth factor, IL-1, IL-2, IL-4 and IL-4RA genes were characterized by polymerase chain reaction with sequence-specific primers. Statistical analysis was performed using the Med Calc statistical software. A Bonferroni correction of significance at an alpha of 0.05 was used for multiple analyses. A corrected P value less than 0.0023(0.05/22) was considered significant. RESULTS: We found significant differences in the IL-4 promoter region polymorphisms between IPF patients and controls. Namely, polymorphisms of IL-4(-590) [computed tomography(CT) in 32 of 56 patients vs 27 of 144 controls; P < 0.0001] and IL-4(-33)(CT in 25 of 56 patients vs 27 of 144 controls; P = 0.0006) differed between both groups. With regard to haplotypes, we found differences in the frequencies for haplotype 1 of IL-4(-1098)(-590)(-33) between IPF and controls(TCC in 23 of 56, TTC in 10 of 56, and TTT in 21 of 56 patients vs TCC in 112 of 144, TTC in 0 of 144, and TTT in 32 of 144 controls; P < 0.0001). We did not find significant differences in gene polymorphism frequencies of other cytokines in the IPF group vs the controls. CONCLUSION: We hypothesize that IL-4 promoter polymorphisms could be involved in the pathogenesis of IPF, likely via enhancement of the Th2 cytokine milieu with exaggerated fibroproliferative healing. 展开更多
关键词 CYTOKINE genes IDIOPATHIC PULMONARY FIBROSIS Th2-type immune response
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Associations between C-Reactive Protein and Apolipoproteins, Lipoprotein (a) and Conventional Serum Lipids in Outpatients: Correlations and Time Trends
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作者 Christian Lowbeer Lena Martensson +1 位作者 Elisabeth Berg Hans Wallinder 《Open Journal of Clinical Diagnostics》 2015年第2期33-40,共8页
Background: Correlations between CRP and serum lipids are weak, and there are conflicting and incomplete results in the literature. The aim of the present study was to clarify the strength and independence of relation... Background: Correlations between CRP and serum lipids are weak, and there are conflicting and incomplete results in the literature. The aim of the present study was to clarify the strength and independence of relationships between CRP and serum lipids in outpatients. Methods: Inclusion criteria were outpatients where all the following analyses were requested in clinical routine: high sensitivity CRP, total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol, ApoB, ApoA-1 and Lp(a). Data for patients meeting the above criteria during a period of six years (2004-2010) were copied from Aleris Medilab’s Laboratory Information System to the software Statistica. Basic statistics and correlations were calculated for 2771 patients. In patients with two (n = 959) or more sampling times changes over time were calculated. The study was a quality assurance project without access to patient files. Results: Median age was 59 years and median serum CRP concentration was 1.5 mg/L. The strongest correlations (Spearman R) were seen between CRP and triglycerides (0.25), ApoB/ApoA-1 ratio (0.21) and HDL-cholesterol (&minus;0.18). Stepwise regression analysis showed that ApoB, total cholesterol, log triglycerides and log Lp(a) together explained 8% of the variation in log CRP. Unfavourable time trends for CRP and triglycerides counteracted a significant decrease in LDL-cholesterol and total cholesterol. Conclusion: In a large cohort of outpatients CRP showed stronger correlation with triglycerides and ApoB/ApoA-1 ratio than with LDL-cholesterol and Lp(a). LDL-cholesterol concentrations changed favorably over time whereas CRP and triglycerides did not. 展开更多
关键词 CRP Cholesterol LDL HDL APOB APOA-1 TRIGLYCERIDES Lp(a) OUTPATIENTS Risk Factors
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Relationship between nitrate headache and outcome in patients with acute stroke: results from the efficacy of nitric oxide in stroke (ENOS) trial
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作者 Lucy Beishon Lisa J Woodhouse +12 位作者 Daniel Bereczki Hanne K Christensen Ronan Collins John Gommans Christina Kruuse George Ntaios Serefnur Ozturk Stephen Phillips Stuart Pocock Szabolcs Szatmari Joanna Wardlaw Nikola Sprigg Philip M Bath 《Stroke & Vascular Neurology》 SCIE CSCD 2021年第2期180-186,共7页
Introduction Nitrate-induced headache is common and may signify responsive cerebral vasculature.We assessed the relationship between nitrate headache and outcome in patients with acute stroke.Materials and methods Pat... Introduction Nitrate-induced headache is common and may signify responsive cerebral vasculature.We assessed the relationship between nitrate headache and outcome in patients with acute stroke.Materials and methods Patients were those randomised to glyceryl trinitrate(GTN)versus no GTN in the efficacy of nitric oxide in stroke trial.Development of headache by end of treatment(day 7),and functional outcome(modified Rankin Scale,primary outcome)at day 90,were assessed.Analyses are adjusted for baseline prognostic factors and give OR and mean difference(MD)with 95%CI.Results In 4011 patients,headache was more common in GTN than control(360,18.0% vs 170,8.5%;p<0.001).Nitrate-related headache was associated with:younger age,female sex,higher diastolic blood pressure,non-total anterior circulation syndrome,milder stroke and absence of dysphasia(p<0.05).Nitrate headache was not associated with improved functional outcome(OR 0.90,95% CI 0.73 to 1.10,p=0.30)or death(day 90)(HR 0.64,95% CI 0.40 to 1.02,p=0.062),but reduced death or deterioration(day 7)(OR 0.45,95% CI 0.25 to 0.82),death in hospital(OR 0.44,95% CI 0.22 to 0.88)and improved activities of daily living(Barthel index,MD 3.7,95% CI 0.3 to 7.1)and cognition(telephone interview cognitive screen,MD 2.0,95% CI 0.7 to 3.3)(day 90).Non-nitrate headache was not associated with death,disability or cognition.Discussion and conclusion Development of a nitrate headache by day 7 after stroke may be associated with improved activities of daily living and cognitive impairment at day 90,which was not seen with non-nitrate headache. 展开更多
关键词 HEADACHE PATIENTS NITRATE
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研究方法学 如何解读临床试验报告中的统计图
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作者 Stuart J Pocock Thomas G Travison +2 位作者 Lisa M Wruck 王淳秀(译) 单广良(校) 《英国医学杂志中文版》 2008年第4期231-236,共6页
一个统计图可能会胜过千言万语,但在医学研究中。
关键词 临床试验报告 统计图 研究方法学 解读 医学研究
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