發(fā)布時間：2018-04-23 19:07

  本文選題：文獻 + 評價��； 參考：《南方醫(yī)科大學(xué)》2012年碩士論文

【摘要】：背景和目的 隨著我國臨床科研的發(fā)展,臨床試驗文獻數(shù)量不斷增多,閱讀此類文獻成為醫(yī)務(wù)工作者增長臨床知識的重要途徑,同時也為循證醫(yī)學(xué)提供了充分的研究素材。但同時也發(fā)現(xiàn),臨床試驗文獻,尤其是隨機對照試驗文獻,存在著質(zhì)量高低不齊的現(xiàn)象,低質(zhì)量的試驗報告在很大程度上影響了研究結(jié)果的真實性與可靠性。因此越來越多的流行病學(xué)家開始關(guān)注對臨床試驗文獻的方法學(xué)評價,嘗試著運用各種評價工具對數(shù)量眾多的臨床研究進行評價,篩選出高質(zhì)量、有價值的臨床試驗文獻,進而規(guī)范醫(yī)務(wù)工作者寫作,促進臨床科研水平的發(fā)展。 自20世紀80年代發(fā)展至今,共出現(xiàn)兩類評價工具,一種是評價量表,另一種是評價清單。兩者的區(qū)別是評價量表的每個評價條目都有一個量化的評分,最后以總分來評價該臨床試驗的質(zhì)量；而評價清單沒有總分,只能逐個項目進行評價。目前國際上使用較多的評價量表包括Jadal量表、Chalmers量表,使用較多的評價清單包括CONSORT(consolidated standards of reporting trials)聲明、Delphi清單。國內(nèi)的文獻評價工作起步較晚,始于50年代,80年代后才逐漸開始標(biāo)準化,但多針對某種疾病收集相關(guān)的臨床論著進行研究評價,或者針對某份期刊就某個時間范圍內(nèi)發(fā)表的所有臨床論著進行評價,少見對某學(xué)科臨床試驗文獻進行系統(tǒng)、全面評價的研究。故本研究選擇神經(jīng)病學(xué)與精神病學(xué)專業(yè)4份代表性期刊,就其2009～2011年發(fā)表的全部臨床試驗文獻進行系統(tǒng)評價。所選期刊分別是《中華神經(jīng)科雜志》、《中國神經(jīng)精神疾病雜志》、《中華精神科雜志》及《中華神經(jīng)醫(yī)學(xué)雜志》,在2008年北京大學(xué)圖書館核心期刊目錄中排名分別為第一、二、三及第九,代表了我國神經(jīng)病學(xué)與精神病學(xué)專業(yè)頂尖級期刊及優(yōu)秀期刊水準。 研究運用的評價量表依托CONSORT聲明并結(jié)合國內(nèi)臨床試驗文獻實際情況設(shè)計而成,符合臨床流行病學(xué)/DME方法學(xué)的原則和方法,保留了聲明中核心評價指標(biāo),省略了部分國內(nèi)臨床試驗文獻普遍缺失且重要性相對較低的項目。分級及評分標(biāo)準參考天津醫(yī)科大學(xué)周登遠碩士畢業(yè)論文《臨床試驗文獻質(zhì)量評價量表的制作及應(yīng)用》。目的在于初步了解神經(jīng)病學(xué)與精神病學(xué)專業(yè)臨床試驗文獻質(zhì)量情況及由此反映的學(xué)科發(fā)展現(xiàn)狀,為規(guī)范臨床工作者今后的論文寫作,推動學(xué)科發(fā)展提供參考。 研究對象與方法 1研究對象 研究選擇《中華神經(jīng)科雜志》、《中國神經(jīng)精神疾病雜志》、《中華精神科雜志》及《中華神經(jīng)醫(yī)學(xué)雜志》2009-2011年刊登的全部臨床試驗文獻,涉及專業(yè)包括顱腦損傷、腦血管疾病、神經(jīng)系統(tǒng)腫瘤、神經(jīng)系統(tǒng)功能性疾病、精神系統(tǒng)疾病、臨床心理學(xué)、遺傳學(xué)等方面。采用手工檢索方法,逐篇篩選4份雜志2009～2011年符合要求的文獻,排除綜述、非臨床試驗及動物實驗,病例報告和短篇臨床論著(文章長度小于1500字)辦不在本次評價的范圍之內(nèi)。 2研究方法 研究先就文獻獲基金資助及作者單位分布、有無不同單位間合作、作者人數(shù)等基本情況做一簡單統(tǒng)計,再運用本研究設(shè)計的量表對每篇文獻進行評價。量表共20個項目,滿分100分,分為前言、材料與方法、結(jié)果、討論四部分,評價內(nèi)容主要包括文獻的樣本量確定方法、隨機方法、對照和盲法的應(yīng)用情況、入組對象納入及排除標(biāo)準、隨訪、失訪及不良反應(yīng)的報告、統(tǒng)計學(xué)方法的應(yīng)用等。最后根據(jù)總的評分橫向分析4份雜志臨床試驗文獻3年來的發(fā)展趨勢,縱向比較同一年度4份雜志之間的不同現(xiàn)狀；整體分析神經(jīng)病學(xué)與精神病學(xué)領(lǐng)域臨床試驗文獻存在的優(yōu)勢與不足。 結(jié)果 1文獻基本情況 研究共納入1183篇臨床試驗文獻,基本情況評價結(jié)果顯示,神經(jīng)病學(xué)與精神病學(xué)專業(yè)4份核心期刊近3年來發(fā)展穩(wěn)定,獲重大基金資助率文獻整體比例較高,整個學(xué)科文獻作者分布以大城市高等醫(yī)學(xué)院校附屬醫(yī)院為主,級別較高,多單位合作開展的多中心、大樣本量研究也較多,其中以《中華精神科雜志》最為顯著。 2量表評分結(jié)果 該結(jié)果顯示,4份雜志總評分均偏低,分值最高的為《中華精神科雜志》,3年平均得分為61.2；其次為《中國神經(jīng)精神疾病雜志》,3年平均得分為54.8；排第三位的是《中華神經(jīng)科雜志》,3年平均得分為53.9；最后一位為《中華神經(jīng)醫(yī)學(xué)雜志》,3年平均得分為51.7。34份雜志自身縱向比較結(jié)果 4份雜志2009～2011年間發(fā)展均較穩(wěn)定,未出現(xiàn)較大的上升或下降,評分略有升高的是《中華神經(jīng)科雜志》、《中華精神科雜志》與《中華神經(jīng)醫(yī)學(xué)雜志》,2010、2011年分別較上一年上升了0.1、0.2分；0.3、0.1分及0.9、1.2分。評分唯一略有下降的是《中國神經(jīng)精神疾病雜志》,2010、2011年分別較上一年下降了1.1、0.1分。 4量表中各項目價結(jié)果 研究同時發(fā)現(xiàn),4份雜志刊登文獻中評分較高、報告形式較為規(guī)范的項目為：研究背景、研究目的、倫理委員會同意及患者知情同意(《中華神經(jīng)醫(yī)學(xué)雜志》除外)、對照設(shè)置、各試驗組人口學(xué)和臨床基線資料、干預(yù)措施、主要結(jié)局指標(biāo)和次要結(jié)局指標(biāo)、比較組間主要結(jié)局指標(biāo)的統(tǒng)計學(xué)方法、主要結(jié)局的統(tǒng)計分析結(jié)果。評分明顯偏低的項目主要包括隨機方法的應(yīng)用、盲法的應(yīng)用、樣本量的計算、隨訪時間、失訪描述、重要不良事件及副反應(yīng)、依從性描述、局限性討論及試驗結(jié)果推廣性介紹。 結(jié)論 總的來說,神經(jīng)病學(xué)與精神病學(xué)領(lǐng)域臨床試驗文獻數(shù)量穩(wěn)定,近3年未出現(xiàn)較大的上升或下降；統(tǒng)計學(xué)方法描述及應(yīng)用正確率高；但文獻總體質(zhì)量偏低,隨機對照試驗比例低,盲法(主要指雙盲)的應(yīng)用程度低；隨訪、失訪報告率低,缺乏長期隨訪的終點指標(biāo),在結(jié)果的統(tǒng)計學(xué)計算中忽視對失訪病例的正確處理；重要不良事件及副反應(yīng)報告率偏低。對這些問題的重視與改進,將在很大程度上提高該領(lǐng)域論文寫作水平,促進學(xué)科的發(fā)展與成果展示。
[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 .

【學(xué)位授予單位】：南方醫(yī)科大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2012
【分類號】：R741;R749

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