Verbitskaya E V
Int J Risk Saf Med. 2015;27 Suppl 1:S89-90. doi: 10.3233/JRS-150702.
Meta-analysis is a powerful tool to identify Evidence Based medical technologies (interventions) for use in every day practice. Meta-analysis uses statistical approaches to combine results from multiple studies in an effort to increase power (over individual studies), improve estimates of the size of the effect and/or to resolve uncertainty when reports disagree. Meta-analysis is a quantitative, formal study design used to systematically assess previous research studies to derive conclusions from this research. Meta-analysis may provide more precise estimate of the effect of treatment or risk factor for a disease, or other outcomes, than any individual study contributing to the pooled analysis.We have quite a substantial number of Russian medical publications, but not so many Meta-Analyses published in Russian. Russian publications are cited in English language papers not so often. A total of 90% of clinical studies included in published Meta-Analyses incorporate only English language papers. International studies or papers with Russian co-authors are published in English language.
The main question is: what is the problem with inclusion of Russian medical publications in Meta-Analysis?
The main reasons for this are the following: 1) It is difficult to find Russian papers, difficult to work with them and to work with Russian journals:a. There are single Russian Biomedical Journals, which are translated into English and are included in databases (PubMed, Scopus and other), despite the fact that all of them have English language abstracts.b. The majority the meta-analyses authors use in their work different citation management software such as the Mendeley, Reference Manager, ProCite, EndNote, and others. These citation management systems allow scientists to organize their own literature databases with internet searches and have adds-on for the Office programs what makes process of literature citation very convenient. The Internet sites of the majority of International Journals have built-in tools for saving citations to reference manager software. The majority of articles in Russian journals cannot be captured by citation management systems: they do not have special coding of articles descriptors.c. Some journals still have PDF files of the whole journal issue without dividing it into articles and do not provide any descriptors, making manual time-consuming input of information the only possibility. Moreover the context search of the article content is unavailable for search engines.2) The quality of research. This problem has been discussed for more than twenty years already. Still we have too many publications of poor quality of study design and statistical analysis. With the exception of pharmacological clinical tails, designed and supervised by international Pharma industry, many interventional studies, conducted in Russia, have methodological flaws inferring a high risk of bias:a. Absence of adequate control,b. No standard endpoints, duration of therapy and follow up,c. Absence of randomization and blinding,d. Low power of studies: sample sizes are calculated (if calculated at all) in such a way, that the main goal is to have as small sample size as possible. Very often statisticians have to solve the problem how to substantiate a small number of subjects, that sponsor could afford, instead of calculating the needed sample size to reach enough power.e. No standards of statistical analysis.f. Russian journals do not have standards for description and presentation of study results, in particular, results of statistical analysis (a reader even cannot see what is presented: standard deviation (SD) or standard error of the mean (SEM).We have a long standing experience in analysis of methodological and statistical quality of Russian biomedical publications and have found up to 80% publications with statistical and methodological errors and high risk of bias.In our practice, we had tried to perform two Meta-analyses for two local pharmaceutical products for prevention of stroke recurrence. For the first product, we did not found even two single Russian language studies suitable for the analysis (incomparable populations, different designs, endpoints, doses etc.). For the second product, only four studies had comparable populations and standard internationally approved scales for effectiveness analysis. However, the combinations of scales, the length of treatment and follow up differed widely, so that we could combine the results of only 2 or 3 studies for each end point.
Russian researchers have to follow internationally recognised standards in study design, selection of endpoint, timelines and therapy regimens, data analysis and presentation of results. Russian journals need to develop consolidate rules for authors of clinical trials and epidemiological research of result reporting close to international standards. In this case the international Network EQUATOR (Enhancing the QUAlity and Transparency Of health Research http://www.equator-network.org/) is one to be taken into account. In addition, Russian Journals have to improve their online information for better interaction with search engines and citation managers.
荟萃分析是一种强大的工具,可用于识别日常实践中基于证据的医学技术(干预措施)。荟萃分析采用统计方法整合多项研究的结果,以增强效力(相对于单个研究)、改进对效应大小的估计,和/或在报告结果不一致时解决不确定性问题。荟萃分析是一种定量的、正式的研究设计,用于系统地评估以往的研究,以便从这些研究中得出结论。与纳入汇总分析的任何单个研究相比,荟萃分析可能会对治疗效果、疾病风险因素或其他结果提供更精确的估计。我们有相当数量的俄罗斯医学出版物,但用俄语发表的荟萃分析却不多。俄语出版物在英语论文中的引用频率也不高。已发表的荟萃分析中纳入的临床研究,总计90%仅包含英文论文。国际研究或有俄罗斯合著者的论文均以英文发表。
主要问题是:将俄罗斯医学出版物纳入荟萃分析存在哪些问题?
主要原因如下:1)难以找到俄语论文,难以处理这些论文以及俄罗斯期刊:a. 有少数俄罗斯生物医学期刊被翻译成英文并纳入数据库(如PubMed、Scopus等),尽管它们都有英文摘要。b. 大多数荟萃分析作者在工作中使用不同的文献管理软件,如Mendeley、Reference Manager、ProCite、EndNote等。这些文献管理系统使科学家能够通过互联网搜索来组织自己的文献数据库,并且有适用于办公软件的插件,这使得文献引用过程非常便捷。大多数国际期刊的网站都有内置工具,可将引用保存到文献管理软件中。俄罗斯期刊中的大多数文章无法被文献管理系统收录:它们没有文章描述符的特殊编码。c. 一些期刊仍然只有整个期刊期的PDF文件,没有将其分成文章,也不提供任何描述符,这使得手动耗时输入信息成为唯一可能。此外,搜索引擎无法对文章内容进行上下文搜索。2)研究质量。这个问题已经讨论了二十多年。我们仍然有太多研究设计和统计分析质量较差的出版物。除了由国际制药行业设计和监督的药理学临床试验外,俄罗斯进行的许多干预性研究存在方法学缺陷,存在较高的偏倚风险:a. 缺乏充分的对照,b. 没有标准的终点、治疗持续时间和随访,c. 缺乏随机化和盲法,d. 研究效力低:样本量的计算方式(如果计算的话)往往是,主要目标是使样本量尽可能小。统计学家常常不得不解决如何为资助方所能承担的少量受试者提供依据的问题,而不是计算达到足够效力所需的样本量。e. 没有统计分析标准。f. 俄罗斯期刊没有描述和呈现研究结果的标准,特别是统计分析结果(读者甚至无法看出呈现的是什么:标准差(SD)还是均值标准误(SEM))。我们在分析俄罗斯生物医学出版物的方法学和统计质量方面有长期经验,发现高达80%的出版物存在统计和方法学错误以及较高的偏倚风险。在我们的实践中,我们曾试图对两种用于预防中风复发的本地药品进行两项荟萃分析。对于第一种产品,我们甚至找不到两篇适合分析的俄语研究(人群不可比、设计不同、终点不同、剂量不同等)。对于第二种产品,只有四项研究有可比的人群和国际认可的标准有效性分析量表。然而,量表的组合、治疗和随访的时长差异很大,因此每个终点我们只能合并2或3项研究的结果。
俄罗斯研究人员在研究设计、终点选择、时间安排和治疗方案、数据分析以及结果呈现方面必须遵循国际认可的标准。俄罗斯期刊需要为临床试验和流行病学研究的作者制定接近国际标准的结果报告统一规则。在这种情况下,国际网络EQUATOR(提高卫生研究的质量和透明度,网址:http://www.equator-network.org/)是一个需要考虑的对象。此外,俄罗斯期刊必须改进其在线信息,以便更好地与搜索引擎和文献管理软件进行交互。