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| 1 | CONSORT 2010说明与详述:报告平行对照随机临床试验指南的更新显示文摘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。 | David Moher Sally Hopewell 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 | 2010 | 中西医结合学报2010，8，8： | 318 |
| 2 | 期刊与学术会议论文摘要中报告随机对照试验的CONSORT声明:说明与详述显示文摘背景:对于与随机对照试验(randomized controlled trial,RCT)有关的学术会议论文或期刊中发表的文章来说,清楚、明了、信息量充足的摘要是十分重要的,因为读者经常仅仅根据报告的摘要对一个临床试验作出评价。为此,我们需要对'临床试验报告的统一标准(Consolidated Standards of Reporting Trials,CONSORT)声明'进行扩充,制定一个期刊与学术会议论文摘要中报告RCT的必备条目清单。今后在任何期刊发表的论文或学术会议论文摘要中,作者对RCT结果的报告都要包含这些内容。方法与结果:我们根据现有的质量评价工具和基于经验的证据总结出一个条目清单。运用三轮修正式德尔菲法(modified-Delphi process)进行条目筛选。邀请共计109人参与电子网络调查,反馈率为61%。调查结果于2007年1月在加拿大蒙特贝罗举行的CONSORT小组会议中公布,与会的26人中有临床试验实施人员、统计学家、流行病学家以及生物医学编辑。经过讨论最终确定条目,随后对其进行修订以保证这些条目体现了会议期间以及会后的讨论思路。摘要CONSORT建议RCT报告的摘要需要有一个结构化的格式,其中应该包括具体的试验目的、试验设计(随机分配的方法、盲法或遮蔽等)、研究对象(对象描述、随机分组的样本量以及用于分析的样本量)、每组实施的干预、实施的干预对主要疗效结果的影响及其危害、试验结论、试验注册名称和编号以及资金来源。本文对每一条能够找到例子的纳入条目都配有良好报告范例、基本原理以及证据等,十分明了易懂,因此我们建议与清单同时使用。结论:摘要CONSORT旨在改善期刊与学术会议中发表的论文摘要的质量,这将有助于摘要提供详尽清晰的信息,这些信息能够帮助读者对试验的有效性和试验结果的适用性做出正确的评价。 | Sally Hopewell Mike Clarke David Moher Elizabeth Wager Philippa Middleton Douglas G.Altman Kenneth F.Schulz the CONSORT Group 李迅 刘建平 | 2008 | 中西医结合学报2008，6，3： | 23 |
| 3 | Use of secondary preventive medications in patients with atherosclerotic disease in urban China: a cross-sectional study of 16 860 patients显示文摘 | LI Jing CHEN Yi-ping LI Xi Jane Armitage FENG Fang LIU Jia-min GAO Yan ZHANG Hai-bo ZHANG Dan HUNDEI Wuhan-bilige CHEN Zheng-ming CHEN Fang Jemma C Hopewell Elsa Valdes-Marquez Martin Landray JIANG Li-xin | 2012 | Chinese Medical Journal2012，，24： | 10 |
| 4 | Household catastrophic payments for tuberculosis care in Nigeria: incidence, determinants, and policy implications for universal health coverage显示文摘Background:Studies on costs incurred by patients for tuberculosis(TB)care are limited as these costs are reported as averages,and the economic impact of the costs is estimated based on average patient/household incomes.Average expenditures do not represent the poor because they spend less on treatment compared to other economic groups.Thus,the extent to which TB expenditures risk sending households into,or further into,poverty and its determinants,is unknown.We assessed the incidence and determinants of household catastrophic payments for TB care in rural Nigeria.Methods:Data used were obtained from a survey of 452 pulmonary TB patients sampled from three rural health facilities in Ebonyi State,Nigeria.Using household direct costs and income data,we analyzed the incidence of household catastrophic payments using,as thresholds,the traditional>10%of household income and the≥40%of non-food income,as recommended by the World Health Organization.We used logistic regression analysis to identify the determinants of catastrophic payments.Results:Average direct household costs for TB were US$157 or 14%of average annual incomes.The incidence catastrophic payment was 44%;with 69%and 15%of the poorest and richest household income-quartiles experiencing catastrophic activity,respectively.Independent determinants of catastrophic payments were:age>40 years(adjusted odds ratio[aOR]3.9;95%confidence interval[CI],2.0,7.8),male gender(aOR 3.0;CI 1.8,5.2),urban residence(aOR 3.8;CI 1.9,7.7),formal education(aOR 4.7;CI 2.5,8.9),care at a private facility(aOR 2.9;1.5,5.9),poor household(aOR 6.7;CI 3.7,12),household where the patient is the primary earner(aOR 3.8;CI 2.2,6.6]),and HIV co-infection(aOR 3.1;CI 1.7,5.6).Conclusions:Current cost-lowering strategies are not enough to prevent households from incurring catastrophic out-of-pocket payments for TB care.Financial and social protection interventions are needed for identified at-risk groups,and community-level interventions may reduce inefficiencies in the care-seeking pathway.These observations should inform post-2015 TB strategies and influence policy-making on health services that are meant to be free of charge. | Kingsley Nnanna Ukwaja Isaac Alobu Seye Abimbola Philip Christy Hopewell | 2013 | Infectious Diseases of Poverty2013，2，1： | 7 |
| 5 | Impact of lipoprotein(a) levels and apolipoprotein(a) isoform size on risk of coronary heart disease显示文摘 | J. C. Hopewell U. Seedorf M. Farrall S. Parish T. Kyriakou A. Goel A. Hamsten R. Collins H. Watkins R. Clarke | 2014 | J Intern Med2014，，3： | 2 |
| 6 | Time and dose related changes in the white matter of the rat brain after single doses of X-rays显示文摘 | Calvo W Hopewell JW Reinehold HS | 1988 | Br J Biol1988，61，： | 1 |
| 7 | Radiation-therapy effects on bone density显示文摘 | Hopewell JW | 2003 | Med Pediatr Oncol2003，41，3： | 1 |
| 8 | Nonste- ruidal anti in flammatory drugs for pain in women with endometriosis 显示文摘 | Allen C Hopewell S Prentice A | 2009 | Co - chrane Database SystRev2009，2，： | 1 |
| 9 | Diagnosis of Pneumocystis carinii pneumonia显示文摘 | | 1988 | Infect Dis Clin North Am1988，2，2： | 1 |
| 10 | Genetic variants associated with Lp(a) lipoprotein level and coronary disease显示文摘 | Clarke R Peden JF Hopewell JC | 2009 | N Engl J Med2009，361，26： | 1 |
| 11 | Plastics recycling: challenges and opportunities显示文摘 | HOPEWELL J DVORAK R KOSIOR E | 2009 | Philosophical Transantions of the Royal Society B: Biological Sciences2009，364，1526： | 1 |
| 12 | Tuberculosis and latent tuberculosis infection in close contacts of people with pul- monary tuberculosis in low - income and middle - income countries: a systematic review and meta - analysis 显示文摘 | Morrison J Pal M Hopewell P C | 2008 | Lancet Infect Dis2008，8，6： | 1 |
| 13 | Impact of lipoprotein (a) levels and apolipoprotein (a) isoform size on risk of coronary heart disease 显示文摘 | Hopewell JC Seedorf U Farrall M | 2014 | J Intern Med2014，276，3： | 1 |
| 14 | A clinical view of tuberculosis 显示文摘 | Hopewell PC | 1995 | Radiol Clin North Am1995，33，： | 1 |
| 15 | Nonsteroidal anti-inflammatory drugs for pain in women with endometriosis显示文摘 | Allen C Hopewell S Prentice A | 2009 | Cochrane Database Syst Rev2009，，00： | 1 |
| 16 | The subependymal plate and the genesis of gliomas显示文摘 | Hopewell J W | 1975 | J Pathol1975，117，2： | 1 |
| 17 | Pathophysiologieal mechanisms leading to the development of late radiation-induced damage to the central nervous system显示文摘 | Hopewell JW Van der Kogel AJ | 1999 | Front Radiat T''ner Oncol1999，33，： | 1 |
| 18 | Latent tuberculosis infection显示文摘 | Jasmer PM Nahid p Hopewel PC | 2002 | N Engl J Med2002，547，25： | 1 |
| 19 | Genetic variants associ- ated with Lp(a) lipoprotein level and coronary disease显示文摘 | Clarke R Peden JF Hopewell JC | 2009 | N En- gl J Med2009，361，26： | 1 |
| 20 | Analysis of the kinetics and mechanism of the cure of a biamalaiemeide daimine thermoset 显示文摘 | J K Hopewell G A George D J T Hill | 2000 | Polymer2000，41，： | 1 |
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