2009～2011年国内4种神经病学与精神病学杂志临床试验文献评价

发布时间：2018-04-23 19:07

本文选题：文献 + 评价　；参考：《南方医科大学》2012年硕士论文

【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。
[Abstract]:Background and Purpose

With the development of clinical scientific research in our country , the number of clinical trials has been increasing . It is an important way to study the clinical knowledge of medical workers and to provide sufficient research material for evidence - based medicine . At the same time , it has been found that the clinical trial literature , especially the randomized controlled trial literature , has a great influence on the authenticity and reliability of the research results .

Since the development of the 1980s , there are two types of evaluation tools , one is the evaluation scale and the other is the evaluation list . The difference between them is that each evaluation item of the evaluation scale has a quantitative score , and finally the quality of the clinical trial is evaluated by total score ;
There is no total score in the evaluation list and can only be evaluated one by one .

Based on CONSORT statement and combined with the actual situation of domestic clinical trial literature , the research and application evaluation scale has been designed in accordance with the principles and methods of clinical epidemiology / DME methodology .

Research objects and methods

1 Study Object

All clinical trials published in the Journal of Chinese Journal of Neurologic Diseases , Journal of Chinese Journal of Mental Disorders , Journal of Chinese Journal of Neuropsychiatric Diseases and Journal of Chinese Journal of Neuromedicine 2009 - 2011 were selected in the study . The literature , including craniocerebral injury , cerebrovascular disease , nervous system tumor , nervous system functional disease , mental system disease , clinical psychology , genetics and so on , were selected .

2 Study Methods

This paper makes a simple statistic on the basic information of the fund - funded and author - unit distribution , whether there is different inter - agency cooperation , the number of authors , etc . A total of 20 items are divided into the following four parts : the sample size determination method , the random method , the control and the blind method , the application of the statistical method , etc . Finally , according to the total score , the development trend of the clinical trial literature in the past three years is analyzed , and the different current situation between the four magazines in the same year is compared in the longitudinal direction .
Overall analysis of the advantages and disadvantages of clinical trial literature in the field of neurological and psychiatry .

Results

1 Basic Information of the Literature

A total of 1183 clinical trial literatures were included , and the results of basic condition evaluation showed that 4 core journals of neurological and psychiatric specialty developed steadily in recent 3 years , and the overall proportion of major fund - funded rate documents was higher . The distribution of the author of the whole subject was mainly distributed by the affiliated hospitals of major cities and higher medical colleges , with higher grade and multi - unit cooperation .

2 Scale score results

The results showed that the total score of 4 magazines was low , and the highest score was the Journal of Chinese Journal of Mental Science , and the average score of 3 years was 61.2 ;
The second is the Journal of neuropsychiatric disorders in China . The average score of 3 years is 54.8 ;
The third place is the Journal of the Chinese Journal of Neurosurgery , which has an average of 53.9 years in three years ;
The last one for the Journal of the Chinese Journal of Neuromedicine was divided into 51 . 7.34 magazine ' s longitudinal comparison results in 3 years

Four magazines were more stable between 2009 and 2011 . There was no significant increase or decrease in the scores . The scores of the magazines were slightly higher than that in the Journal of the Chinese Journal of the Journal of the Journal of the Chinese Journal of the Journal of the Journal of the Journal of the Chinese Journal of the Journal of the Journal of the Journal of the Chinese Journal of the Journal of the Journal of the Chinese Journal of Neurosurgery , 2010 and 2011 , which increased by 0.1 and 0.2 in 2011 , respectively ;
0 . 3 , 0 . 1 and 0 . 9 , 1 . 2 points . The only slight decrease in the score was the decrease of 1.1 , 0.1 in 2010 and 2011 , respectively , in the Journal of Neuropsychiatric Diseases in China .

4 Item price results in the scale

The study also found that the scores of the four magazines published in the literature were higher , and the more standardized items in the report form were : background of the study , study purpose , consent of the Ethics Committee and consent of the patient ( other than Chinese Journal of Neuromedicine ) , control settings , demographic and clinical baseline data , intervention measures , main outcome indicators and secondary outcome indicators of each trial group . The items mainly include the application of the randomized method , the application of the blind method , the calculation of the sample size , the follow - up time , the follow - up time , the follow - up description , the important adverse events and the side reactions , the compliance description , the limitation discussions and the introduction of the test results .

Conclusion

In general , there was no significant increase or decrease in the number of clinical trials in neurological and psychiatric fields .
The statistical methods are described and the application accuracy is high .
However , the overall quality of literature is low , the proportion of randomized controlled trial is low , the degree of blindness ( mainly double - blind ) is low ;
Follow - up , follow - up report rate is low , lack of end point index of long - term follow - up , in the statistical calculation of the result , neglect the right treatment to the case of lost follow - up ;
The importance and improvement of these problems will greatly improve the writing level of the papers in the field and promote the development of the discipline and the presentation of results .

【学位授予单位】：南方医科大学
【学位级别】：硕士
【学位授予年份】：2012
【分类号】：R741;R749

【参考文献】