【作者】 张玲；

【导师】 陈清；

【作者基本信息】 南方医科大学 ， 流行病与卫生统计学， 2012， 硕士

【摘要】 背景和目的随着我国临床科研的发展,临床试验文献数量不断增多,阅读此类文献成为医务工作者增长临床知识的重要途径,同时也为循证医学提供了充分的研究素材。但同时也发现,临床试验文献,尤其是随机对照试验文献,存在着质量高低不齐的现象,低质量的试验报告在很大程度上影响了研究结果的真实性与可靠性。因此越来越多的流行病学家开始关注对临床试验文献的方法学评价,尝试着运用各种评价工具对数量众多的临床研究进行评价,筛选出高质量、有价值的临床试验文献,进而规范医务工作者写作,促进临床科研水平的发展。自20世纪80年代发展至今,共出现两类评价工具,一种是评价量表,另一种是评价清单。两者的区别是评价量表的每个评价条目都有一个量化的评分,最后以总分来评价该临床试验的质量；而评价清单没有总分,只能逐个项目进行评价。目前国际上使用较多的评价量表包括Jadal量表、Chalmers量表,使用较多的评价清单包括CONSORT(consolidated standards of reporting trials)声明、Delphi清单。国内的文献评价工作起步较晚,始于50年代,80年代后才逐渐开始标准化,但多针对某种疾病收集相关的临床论著进行研究评价,或者针对某份期刊就某个时间范围内发表的所有临床论著进行评价,少见对某学科临床试验文献进行系统、全面评价的研究。故本研究选择神经病学与精神病学专业4份代表性期刊,就其2009～2011年发表的全部临床试验文献进行系统评价。所选期刊分别是《中华神经科杂志》、《中国神经精神疾病杂志》、《中华精神科杂志》及《中华神经医学杂志》,在2008年北京大学图书馆核心期刊目录中排名分别为第一、二、三及第九,代表了我国神经病学与精神病学专业顶尖级期刊及优秀期刊水准。研究运用的评价量表依托CONSORT声明并结合国内临床试验文献实际情况设计而成,符合临床流行病学/DME方法学的原则和方法,保留了声明中核心评价指标,省略了部分国内临床试验文献普遍缺失且重要性相对较低的项目。分级及评分标准参考天津医科大学周登远硕士毕业论文《临床试验文献质量评价量表的制作及应用》。目的在于初步了解神经病学与精神病学专业临床试验文献质量情况及由此反映的学科发展现状,为规范临床工作者今后的论文写作,推动学科发展提供参考。研究对象与方法1研究对象研究选择《中华神经科杂志》、《中国神经精神疾病杂志》、《中华精神科杂志》及《中华神经医学杂志》2009-2011年刊登的全部临床试验文献,涉及专业包括颅脑损伤、脑血管疾病、神经系统肿瘤、神经系统功能性疾病、精神系统疾病、临床心理学、遗传学等方面。采用手工检索方法,逐篇筛选4份杂志2009～2011年符合要求的文献,排除综述、非临床试验及动物实验,病例报告和短篇临床论著(文章长度小于1500字)办不在本次评价的范围之内。2研究方法研究先就文献获基金资助及作者单位分布、有无不同单位间合作、作者人数等基本情况做一简单统计,再运用本研究设计的量表对每篇文献进行评价。量表共20个项目,满分100分,分为前言、材料与方法、结果、讨论四部分,评价内容主要包括文献的样本量确定方法、随机方法、对照和盲法的应用情况、入组对象纳入及排除标准、随访、失访及不良反应的报告、统计学方法的应用等。最后根据总的评分横向分析4份杂志临床试验文献3年来的发展趋势,纵向比较同一年度4份杂志之间的不同现状；整体分析神经病学与精神病学领域临床试验文献存在的优势与不足。结果1文献基本情况研究共纳入1183篇临床试验文献,基本情况评价结果显示,神经病学与精神病学专业4份核心期刊近3年来发展稳定,获重大基金资助率文献整体比例较高,整个学科文献作者分布以大城市高等医学院校附属医院为主,级别较高,多单位合作开展的多中心、大样本量研究也较多,其中以《中华精神科杂志》最为显著。2量表评分结果该结果显示,4份杂志总评分均偏低,分值最高的为《中华精神科杂志》,3年平均得分为61.2；其次为《中国神经精神疾病杂志》,3年平均得分为54.8；排第三位的是《中华神经科杂志》,3年平均得分为53.9；最后一位为《中华神经医学杂志》,3年平均得分为51.7。34份杂志自身纵向比较结果4份杂志2009～2011年间发展均较稳定,未出现较大的上升或下降,评分略有升高的是《中华神经科杂志》、《中华精神科杂志》与《中华神经医学杂志》,2010、2011年分别较上一年上升了0.1、0.2分；0.3、0.1分及0.9、1.2分。评分唯一略有下降的是《中国神经精神疾病杂志》,2010、2011年分别较上一年下降了1.1、0.1分。4量表中各项目价结果研究同时发现,4份杂志刊登文献中评分较高、报告形式较为规范的项目为：研究背景、研究目的、伦理委员会同意及患者知情同意(《中华神经医学杂志》除外)、对照设置、各试验组人口学和临床基线资料、干预措施、主要结局指标和次要结局指标、比较组间主要结局指标的统计学方法、主要结局的统计分析结果。评分明显偏低的项目主要包括随机方法的应用、盲法的应用、样本量的计算、随访时间、失访描述、重要不良事件及副反应、依从性描述、局限性讨论及试验结果推广性介绍。结论总的来说,神经病学与精神病学领域临床试验文献数量稳定,近3年未出现较大的上升或下降；统计学方法描述及应用正确率高；但文献总体质量偏低,随机对照试验比例低,盲法(主要指双盲)的应用程度低；随访、失访报告率低,缺乏长期随访的终点指标,在结果的统计学计算中忽视对失访病例的正确处理；重要不良事件及副反应报告率偏低。对这些问题的重视与改进,将在很大程度上提高该领域论文写作水平,促进学科的发展与成果展示。更多还原

【Abstract】 Background and ObjectiveThe numbers of reports of clinic trials has been increasing with the development of clinic scientific researches. Reading such documents has become a very important way to enrich knowledge about clinics for medical workers, and it has also provided enough elements for evidence-based medicine. However, reports of clinic trials, especially those of random contrast trials, are on various quality levels. Reports of low quality have significant impact on the authenticity and reliability of research results. That’s why more and more epidemiologists start to pay attention on the methodological appraisal of reports of clinic trials, and they try to apply various appraisal tools to evaluating mounts of clinic researches, and screening reports of high and valuable quality, so as to standard the writings of medical workers and promote the development of clinic scientific researches.Science from the80s of last century, two kinds of appraisal tools have been used, one is appraisal scale, the other is appraisal list. The appraisal scale scores each item and then the total scores are counted to evaluate the quality of clinic trials; while the appraisal list scores item by item without total scores, that is the differences between the two tools. Jadal questionnaire and Chalmers scale are the most common appraisal scales used internationally at present, while Delphi list and CONSORT statement are the appraisal lists. The appraisal of reports of clinic trials began at the50s and became standard at the80s; the majority of them were written to evaluate the reports of clinic trials of some specific diseases, or to evaluate all the reports of clinic trials published in the journal during some certain time; those written to evaluate reports of a specific field in a systemic and whole-scale way are rare. In this study,"Chinese Journal of Neurology","Chinese Journal of Nervous and Mental Diseases","Chinese Journal of Psychiatry" and "Chinese Journal of Neuromedicine" are4magazines which are chosen to systemically evaluate all the reports of clinic trials published on them between2009and2011. These4journals represent the top level of journals of Psychiatry and Neurology in China, and they separately rank1,2,3,9in core journals list in Peking University Library. The appraisal scale used in the study is based on the CONSORT statement and reports of clinic trials at home, and it accords to the principles and methods of Clinical Epidemiology, keeps the main appraisal index in the statement and excludes the items which are not that important and less mentioned in most of the reports at home."The Development and Application of the Scale for Assessing the Report Quality of Clinical Trials" by Zhou Dengyuan graduated from Tianjin Medical School are referred to making the standards of classification and score. This study aims to know the quality of reports of clinic trials in Neurology and Psychiatry and so as to reflect the situation of this discipline; aims to regulate the paper writing for clinic workers and provide a reference to promote the development of this discipline.Objects and Methods1Objects All the reports of clinic trials published during2009and2011in the "Chinese Journal of Neurology","Chinese Journal of Nervous and Mental Diseases’"Chinese Journal of Psychiatry" and "Chinese Journal of Neuromedicine" are the subjects of this study. It involves in such fields as brain damage, the blood vessel of brain diseases, the nervous system tumor, and functional disorders of nervous system, mental disorders, clinic psychology and genetics. We retrieved the reports of the4journals mentioned above published between2009and2011, and excluded reviews, reports of animal trials and non-clinic trials, reports of cases and those less than1500words.2MethodsWe first grasped the information about foundation, the organization for the authors, the cooperation between different organizations, the number of authors, then evaluated each report with the special scale designed in the study. There are20items in our scale and the total score is100points. Each report is consisted of introduction, materials, results and discussion, and each part is evaluated by the scale. The followings are evaluated:the methods used to make sure the sample, the application of random, control and blindness, the standards to include or exclude subjects, follow-up, the lost of follow-up and the report of adverse reaction, and the application of statistic methods, etc. Based on the total scores, we take the horizontal analysis of the developing trends of reports of clinic trials published in the4journals during3years, and take the longitudinal analysis of the different states of4journals in the same year.Results1The general situation of reports1,183reports were included in this study, and results of appraisal showed that the4journals chosen in the study develop stably in the last3years. The rate of reports of clinic trials supported by major foundation keeps high, and reports are mostly authored by those with high titles working in high medical school affiliated hospitals in cities; and some of the reports sourced from these programs performed by several hospitals with huge sample. Reports published in "Chinese Journal of Psychiatry" are especially of the features mention above.2The scale appraisal resultsResults of the study show that, the total scores of the4journals are low."Chinese Journal of Psychiatry" scores highest, whose average score is61.2from2009to2011;"Chinese Journal of Nervous and Mental Diseases" ranks secondly, with average score of54.8;"Chinese Journal of Neurology" ranks thirdly with average score of53.9; and "Chinese Journal of Neuromedicine" ranks in the last place with average score of51.7.3The results of comparison among4journalsThe scores of the4journals keep stable from2009to2011. The scores of "Chinese Journal of Neurology","Chinese Journal of Psychiatry" and "Chinese Journal of Neuromedicine" in2010respectively increased0.1,0.2and0.3compared to those in2009, while the scores of the3journals respectively increased0.1,0.9and1.2compared to those in2010. The scores of "Chinese Journal of Nervous and Mental Diseases" decreased1.1compared to those in2009, and the scores of this journal decreased0.1compared to those in2010.4The appraisal results of items in the scaleIn this study, the following items score high in the4journals:background, aims, the Ethics Committee consent and inform consent form of patients (except the Chinese Journal of Neuromedicin), control, demography and clinic baseline data of each subject group, the interference measures, the main and minor index of outcomes, the statistic methods and results. But some other items score low as well, such as the application of random, blindness, the calculation of sample, the time to follow up, the description of the lost of follow-up, the important adverse events and side effect, the description of compliance, the discussion of limitation and of the application of the trial results.ConclusionsIn general, the number of reports of clinic trials of Neurology and Psychiatry is stable and it has changed little in the last3years; the authors of those reports take good advantage of statistics methods. But the total quality of reports is low, and the rate of trials which use random contrast method is low; the rate of lost follow-up which has been reported is low and there is no tenninal index for long-term follow-up; and the rate of significant adverse events and side effect events which are reported is low. The attitudes and the resolutions to the problems mentioned above will enhance the level of paper writing in the field, which will promote the development of this field and its results presenting.更多还原