中医药临床研究方法与报告质量研究
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摘要
背景国家对中医药领域研究的资助力度逐年递增,其科技论文数量亦呈现高速增长的趋势。随着循证医学理念的不断深入,科研人员逐渐认识到,科技成果的质量才是重点。临床研究是临床实践的重要依据之一,但在方法设计与报告质量方面存在的问题大大降低了中医药临床研究的可靠性和真实性,导致其研究成果的利用率和转化率低下。因此,有必要对我国中医药临床研究在设计、实施与报告等各环节可能会影响其研究质量的各因素以及与国外研究存在的具体差异进行全面而系统的调查,确定需改进的重点环节和要素,以促进国内中医药临床研究质量的改善与提高。
目的1.通过文献计量学和质量评价的方法,对国内中医药临床研究(包括系统评价/Meta-分析和随机对照试验)的方法设计与报告质量研究现状、与国外同类研究之间存在的具体差异环节、要点和问题及其产生这些差异的原因,进行全面的回顾分析并进行对比分析,全面掌握我国中医药临床研究在方法与报告质量等方面存在的问题,以确定需改进的重点环节和要素。2.对国内中医药期刊“稿约”中对国际公认的不同类型临床研究报告规范的规定,今后对其引入和实施的计划,以及编辑的认知和应用现状进行问卷调查,以确定在论文发表阶段影响其报告质量的因素,为临床研究报告规范今后在我国的推广和实施提供针对性的参考依据。3.基于以上研究的结果,结合国内的实际情况和中医药研究的特性,提出建设性意见,以提高和改善中医药临床研究质量,促进其成果的利用和转化。
方法1.基于AMSTAR清单和PRISMA清单,回顾性分析国内中医药SRs/Meta-分析的研究现状、方法和报告质量。2.采用文献计量方法和质量评价方法,对比分析国内外针灸SRs/Meta-分析在方法设计与报告质量等重点环节的差异及其产生的原因。3.基于CONSORT清单和STRICTA清单被引入国内的不同时间段,回顾性分析国内针灸RCTs的方法和报告质量是否随着清单的引入而得到改善和提高。4.采用问卷调查的方法,对国内中医药期刊“稿约”中对国际公认的不同临床研究报告规范的规定,今后对其引入和实施的计划,以及编辑的认知和应用现状进行全面调查。采用频数、中位数和四分位距进行统计描述,SPSS18.0软件进行数据统计分析。
结果1.共纳入369篇国内中医药SRs/Meta-分析研究,突出表现的问题包括：45%的研究文献检索方法不全面甚至不正确(203篇/369篇)；97.3%(359篇/369篇)的研究未检索不同发表类型的研究；96.5%(356篇/369篇)的研究未提供排除文献的清单；42%(155篇/369篇)的研究纳入标准宽泛不具体、甚至存在错误；58.8%(217篇/369篇)的研究未采用双人独立机制对文献和数据进行筛选和提取：55%(203篇/369篇)的研究未详细描述文献筛选纳入全过程及排除原因；70.7%(261篇/369篇)的研究数据合并方法不恰当,其方法与报告质量普遍较低。另外,其总体引用率较低,引用率为零的研究占到46.1%(170篇/369篇),临床医生的参与率亦较低(49.9%,184篇/369篇)。
2.共纳入366篇国内外针灸SRs/Meta-分析研究,其中Chinese SRs共88篇,Other SRs共226篇,Ccohrane SRs共52篇。3种不同类型SRs研究在AMSTAR清单和PRISMA清单中符合率大于80%的条目所占的比例分别为：45%(Chinses SRs).vs73%(Other SRs).vs91%(Ccohrane SRs)和59%(Chinses SRs).vs74%(Other SRs).vs78%(Ccohrane SRs),其中Chinses SRs在两个清单中的符合率均最低。Chinese SRs与Other SRs和Cochrane SRs存在较大差距的方面主要包括：不同发表类型文献的纳入(2%.vs91%.vs100%)、广泛而全面的检索(40%.vs87%.vs100%)、相关利益冲突的说明(0%.vs61%.vs100%)、证据综合结果(23%.vs99%.vs96%)和计划书和注册信息(0%.vs4%.vs100%)等方面。此外,Chinese SRs, Other SRs和Cochrane SRs中被引次数为零的研究所占比例分别为53%.vs26%.vs40%,由临床医生完成的SRs所占比例分别为27%.vs63%.vs54%,进行更新的SRs所占比例分别为0%.vs3%.vs92%,可见Chinese SRs的被引率、临床医生的参与率方面亦最低。
3.共纳入1978篇国内针灸RCTs研究,1996年之前发表的为144篇其中针刺RCTs为122篇；1997年-2003年间发表为353篇,其中针刺RCTs为312篇;2004年-2012年间发表为1481篇,其中针刺RCTs为1301篇。虽然3个不同年代发表的针刺RCTs在STRICTA清单各条目上的符合率均略有提高,但其实际比例依然很低,包括①针刺治疗的具体类型(6.6%.vs9.9%.vs12.7%);②针刺治疗的理由和依据(0%.vs0.3%.vs1.0%);③每位受试对象每个治疗单元所用针的数目(0%.vs0.3%.vs0.2%);④对针刺组施加的其他干预措施描述(19.7%.vs30.1%.vs33.7%)；⑤对针灸师资质报告(0%.vs0%.vs0.4%)；⑥无研究报告有关对治疗师的操作指导及其给患者的信息和解释等。3个不同年代发表的针灸RCTs在CONSORT清单中符合率大于50%的条目所占的比例分别为：0%(≤1996年).vs8%(1997年-2003年).vs26%(2004年-2012年)。主要问题主要包括：①研究方法阐述过于简单,包括资料收集的场所和地点(12.5%.vs24.6%.vs69.7%)、样本量确定依据(0%.vs0%.vs1.2%)等；②随机方法不消楚,包括对产生随机序列的方法报告(1.4%.vs15%.vs26.3%)、隐蔽分组机制(0%.vs1.4%.vs4.9%)和盲法实施(0%.vs5.7%.vs9.1%)等；③结果部分内容描述不清甚至缺少,包括受试者流程(0%.vs11.6%.vs20.6%)、招募受试者时期和随访时间(0%.vs2.1%.vs2.8%)、基线资料的提供(9.0%.vs17.8%.vs34.8%)和结局效应估计值及95%CI的报告(18.1%.vs36%.vs50.7%)等。此外,无任何研究注册及阐明可能的利益冲突。
4.共纳入63种国内中医药期刊杂志,其中SCl收录2种,Medline/Embase收录8种,CSCD收录7种,统计源收录46种。仅3种杂志在其“稿约”中提及并要求作者按照CONSORT声明各条目来规范报告RCTs,且给出了具体的版本和网址。此外,仅1种期刊在其“稿约”中提及CONSORT扩展版。无任何期刊在其“稿约”中提及PRISMA、MOOSE、TREND、STARD和STROBE等其他类型研究的报告清单。通过电话和E-mail方式,对63种国内中医药期刊编审人员进行问卷调晒,54种期刊杂志给予回复,反馈率为85.7%,其中编辑为39人(占72.2%)、主编为3人(占5.6%)、编辑部主任为9人(16.7%)、其他人员为3名(占5.6%)。对于CONSORT声明，有8位编辑知道并子解,3位编辑仅听说过但不了解,其中仅3位编辑表示对投稿的RCTs,该期刊在作者投稿、编辑审稿及专家评审阶段均要求和遵循了CONSORT声明的要求,46%的编辑(25人)认为没有必要在“稿约”中引入CONSORT声明。对于PRISMA清单，仅2位编辑知道并了解,7位编辑仅听说过但不了解,表示对投稿的SRs/Meta-分析,在作者投稿、编辑审稿及专家评审阶段均未要求和遵循PRISMA清单的要求,65%的编辑(35人)认为没有必要在“稿约”中引入PRISMA清单。而对于其他类型临床研究报告清单,无任何人知晓并了解。
结论临床研究质量是影响其转化和利用的关键因素,只有高质量的研究才能为临床实践提供可靠的科学依据。我们的研究显示：尽管国内中医药,特别是针灸SRs/Meta-分析研究在研究的题目、摘要、纳入研究的特征和文献质量评价方法阐述等方面的符合率较好,但在影响其研究质量的关键因素，如文献检索方法不同发表情况的文献的纳入、对发表偏倚的评估、利益冲突的说明、文献筛选流程图的呈现、数据合并的合理性、研究间异质性或偏倚的分析以及对证据综合结果分析的的能力等方面,与国外同类研究存在较大差距。而对于国内针灸RCTs,尽管2003年之后发表的针刺RCTs的数量是之前所发表总数的3倍多,且各条目的符合率在不同的3个发表年代略有提高，但在多个条目上的实际符合比例上依然非常低,如随机序列的产生方法、隐蔽分组的机制和实施、盲法细则、样本量计算依据和资料收集场所和地点等方面,其质量并未随着STRICTA清单的引入而得到有效改善和提高。此外,国内中医药领域期刊“稿约”中对不同类型临床研究报告规范的应用情况不尽如人意,大部分期刊的编审人员对研究报告的规范、临床研究注册制度等信息的知晓率较低。而且,尽管大部分期刊有意愿在今后进入此类相关报告规范,以提高不同类型的临床研究报告质量,但均无任何具体的可操作的细则和时间规划。因此,我们强烈建议通过以下措施提高国内中医药临床研究的方法和报告质量：①国内医学期刊尽早在“稿约”中引入这些国际临床研究报告标准,以规范和提高国内临床研究的报告质量,提升临床研究水平；②从期刊协会层面制定相关制度,由鼓励和建议投稿作者、期刊编辑在文章投稿、编审和专家评审阶段遵循相关的临床研究报告规范,过渡到强制执行;③对期刊编审人员开展和加强与临床研究报告规范相关的知识培训,并建立考核机制,促进相关知识的掌握和更新；④将与临床研究报告规范相关的知识内容加入到医学继续教育课程中,由国家授权各地区具备资质的科研单位,对其服务地区的临床医生、科研人员进行全面的SRs/Meta-分析方法学的培训：⑤在医学在校教育中引入与临床研究报告规范相关的知识内容。
Background With the increasing of research funding from Nation in the field of TCM, the number of its scientific papers is quickly increasing as well.Moreover, with the development of the concept of evidence-based medicine, the researchers recognize that the scientific quality of research and the utilization and conversion of those research results is the key. However, some problems in the methods of design and reporting quality reduced the reliability of the clinical trisls. So, it is necessary to systematic review all the factors involved the Chinese medicine clinical research design, implementation and reporting that might affect their study quality, and find the important specific differences compared with the same field studies carried out in foreign countries in order to improve the quality of Chinese clinical trials.
Objective Investigating the status of methodology and reporting quality of in the research field of traditional Chinese medicine and randomized controlled trials and provided the policy advices to improve the quality of clinical trials of traditional Chinese medicine.
Methods1.To assess the quality of SRs/Meta-analysis of TCM intervention published in Chinese journals base on the AMSTAR and PRISMA checklist by bibliometrics.2.To compare the quality of domestic and foreign SRs/Meta-analysis of acupuncture intervention:A comparative study.3. To compare the quality RCTs of acupuncture intervention published in Chinese journals based on the different periods of checklists were introduced into China:A retrospective study.4. Endorsement of the different clinical trials reporting checklist by Chinese TCM journals:a survey of journal editors and journal. The SPSS18.0software was used for data analysis.
Results1.A total number of369SRs/Meta-analysis of TCM intervention published in Chinese journals was included, which showed that the methodology and reporting quality was poor. The important problems included the following context:①Retrieval searching method was not comprehensive(45%,203/369);②Not included different publish paper(97.3%,359/369);③Not provided excluding paper checklist(96.5%,356/369);④The inclusion criteria was broad not specific(42%,155/369);⑤Without using the double independent mechanism to select the literature and extract data(58.8%,217/369);⑥Without detailed description the process of included and excluded literature(55%,203/369);⑦The method merging data was not appropriate(70.7%,261/369). In addition, only half clinician take part in the research, the citation of nearly half paper was zero.
2. A total number of366SRs/Meta-analysis of acupuncture intervention were included, including88Chinese SRs,226Other SRs and52Cochrane SRs. The proportion of coincidence more than80%of three different types of SRs in AMSTAR and PRISMA checklist were45%(Chinses SRs).vs73%(Other SRs).vs91%(Ccohrane SRs) and59%(Chinses SRs).vs74%(Other SRs).vs78%(Ccohrane SRs), respectively. Compared with Other SRs and Cochrane SRs, there were many defect in Chinese SRs. Such as, included different published paper(2%.vs91%.vs100%), comprehensive retrieval searching(40%.vs87%.vs100%), conflict of interest(0%.vs61%.vs100%), evidence synthesis results(23%.vs99%.vs96%), protocol and register information(0%.vs4%.vs100%).
3. A total number of1978RCTs of acupuncture intervention published in Chinese journals were included. The quality of reporting in several important methodological components, including sample size calculation (0%vs.0%vs.1.2%), randomization sequence generation (1.4%vs.15%vs.26.3%) and implementation(0%vs.0%vs.1.3%), allocation concealment (0%vs.1.4%vs.4.9%), blinding (0%vs.5.7%vs.9.1%), has not improved. In addition, there were many defect in description of acupuncture intervention. Such as, the specific types of acupuncture therapy(6.6%.vs9.9%.vs12.7%);②reasons and basis of acupuncture therapy(0%.vs0.3%.vs1.0%);③subjects objects of each treatment unit number of needles used(0%.vs0.3%. vs0.2%);④describe other interventions(19.7%.vs30.1%.vs33.7%);⑤The acupuncturist qualification(0%.vs0%.vs0.4%).
4. A total number of63journals were included, which two journals were cited by SCI, eight journals were cited by Medline/Embase, seven journals were cited by CSCD. Only three journals require author to report RCTs based on CONSORT Statement,and gave the version and website link meanwhile. No journal mentioned the PRISMA, MOOSE, TREND, STARD and STROBE checklist so far. Besides, we surveyed sixty-three ditorial staffs of Chinese journal of TCM by E-mail and Telephone, fifty-four journals gave back. The feedback rate was85.7%, thirty-nine were editor, three were chief editor, nine were director. Of the eleven editors known the CONSORT Statement, three editors just heard and did not understand it at all. Out of three editors of fifty-four said that they required the author to report the RCT based on CONSORT Statement. And twenty five (46%) editors think that it was unnecessary to introduce it in its "Instruction to Authors" in the future. As for PRISMA checklist, only two editors understood it and seven editors just heard. They said that they did not require the author to report the SRs/Meta-analysis based on PRISMA checklist. Thirty-five (65%) editors think that it was unnecessary to introduce PRISMA checklist in its "Instruction to Authors". In addition, there was no any editor known the MOOSE, TREND, STARD, STROBE checklists.
Conclusion The quality of clinical study is the key factor to affect the transformation and utilization, only high quality clinical research to provide a reliable scientific basis for clinical practice. Even though the coincidence of reporting quality of TCM intervention in Title, Abstract, included study characteristic were well, the key factors that may impact the quality were still poor. As for the number of RCTs after published in2003were quickly increased, the coincidence in many items were still poor, and the reporting quality of RCTs of acupuncture intervention was not improved with the STRICTA checklist was introduced into China. In addition, the endorsement of clinical study reporting statement in "Instruction to Authors" of journals of traditional Chinese medicine (TCM) was worried. The reason might be that the standard for reports of medical research in China is not a mandatory requirement. We propose to improve the quality of clinical research quality through the following measures:①Endorsement of the different clinical trials reporting checklist into Chinese TCM journal to improve the quality of clinical study;②Encouraging author, editor and peer review to abide the clinical study reporting;③Carried out the training of knowledge about the reporting quality for editors;④Carried out the training of knowledge about SRs and Meta-analysis for clinician, researcher;⑤The clinical research report and related knowledge included into the school education.
目的1.通过文献计量学和质量评价的方法,对国内中医药临床研究(包括系统评价/Meta-分析和随机对照试验)的方法设计与报告质量研究现状、与国外同类研究之间存在的具体差异环节、要点和问题及其产生这些差异的原因,进行全面的回顾分析并进行对比分析,全面掌握我国中医药临床研究在方法与报告质量等方面存在的问题,以确定需改进的重点环节和要素。2.对国内中医药期刊“稿约”中对国际公认的不同类型临床研究报告规范的规定,今后对其引入和实施的计划,以及编辑的认知和应用现状进行问卷调查,以确定在论文发表阶段影响其报告质量的因素,为临床研究报告规范今后在我国的推广和实施提供针对性的参考依据。3.基于以上研究的结果,结合国内的实际情况和中医药研究的特性,提出建设性意见,以提高和改善中医药临床研究质量,促进其成果的利用和转化。
方法1.基于AMSTAR清单和PRISMA清单,回顾性分析国内中医药SRs/Meta-分析的研究现状、方法和报告质量。2.采用文献计量方法和质量评价方法,对比分析国内外针灸SRs/Meta-分析在方法设计与报告质量等重点环节的差异及其产生的原因。3.基于CONSORT清单和STRICTA清单被引入国内的不同时间段,回顾性分析国内针灸RCTs的方法和报告质量是否随着清单的引入而得到改善和提高。4.采用问卷调查的方法,对国内中医药期刊“稿约”中对国际公认的不同临床研究报告规范的规定,今后对其引入和实施的计划,以及编辑的认知和应用现状进行全面调查。采用频数、中位数和四分位距进行统计描述,SPSS18.0软件进行数据统计分析。
结果1.共纳入369篇国内中医药SRs/Meta-分析研究,突出表现的问题包括：45%的研究文献检索方法不全面甚至不正确(203篇/369篇)；97.3%(359篇/369篇)的研究未检索不同发表类型的研究；96.5%(356篇/369篇)的研究未提供排除文献的清单；42%(155篇/369篇)的研究纳入标准宽泛不具体、甚至存在错误；58.8%(217篇/369篇)的研究未采用双人独立机制对文献和数据进行筛选和提取：55%(203篇/369篇)的研究未详细描述文献筛选纳入全过程及排除原因；70.7%(261篇/369篇)的研究数据合并方法不恰当,其方法与报告质量普遍较低。另外,其总体引用率较低,引用率为零的研究占到46.1%(170篇/369篇),临床医生的参与率亦较低(49.9%,184篇/369篇)。
2.共纳入366篇国内外针灸SRs/Meta-分析研究,其中Chinese SRs共88篇,Other SRs共226篇,Ccohrane SRs共52篇。3种不同类型SRs研究在AMSTAR清单和PRISMA清单中符合率大于80%的条目所占的比例分别为：45%(Chinses SRs).vs73%(Other SRs).vs91%(Ccohrane SRs)和59%(Chinses SRs).vs74%(Other SRs).vs78%(Ccohrane SRs),其中Chinses SRs在两个清单中的符合率均最低。Chinese SRs与Other SRs和Cochrane SRs存在较大差距的方面主要包括：不同发表类型文献的纳入(2%.vs91%.vs100%)、广泛而全面的检索(40%.vs87%.vs100%)、相关利益冲突的说明(0%.vs61%.vs100%)、证据综合结果(23%.vs99%.vs96%)和计划书和注册信息(0%.vs4%.vs100%)等方面。此外,Chinese SRs, Other SRs和Cochrane SRs中被引次数为零的研究所占比例分别为53%.vs26%.vs40%,由临床医生完成的SRs所占比例分别为27%.vs63%.vs54%,进行更新的SRs所占比例分别为0%.vs3%.vs92%,可见Chinese SRs的被引率、临床医生的参与率方面亦最低。
3.共纳入1978篇国内针灸RCTs研究,1996年之前发表的为144篇其中针刺RCTs为122篇；1997年-2003年间发表为353篇,其中针刺RCTs为312篇;2004年-2012年间发表为1481篇,其中针刺RCTs为1301篇。虽然3个不同年代发表的针刺RCTs在STRICTA清单各条目上的符合率均略有提高,但其实际比例依然很低,包括①针刺治疗的具体类型(6.6%.vs9.9%.vs12.7%);②针刺治疗的理由和依据(0%.vs0.3%.vs1.0%);③每位受试对象每个治疗单元所用针的数目(0%.vs0.3%.vs0.2%);④对针刺组施加的其他干预措施描述(19.7%.vs30.1%.vs33.7%)；⑤对针灸师资质报告(0%.vs0%.vs0.4%)；⑥无研究报告有关对治疗师的操作指导及其给患者的信息和解释等。3个不同年代发表的针灸RCTs在CONSORT清单中符合率大于50%的条目所占的比例分别为：0%(≤1996年).vs8%(1997年-2003年).vs26%(2004年-2012年)。主要问题主要包括：①研究方法阐述过于简单,包括资料收集的场所和地点(12.5%.vs24.6%.vs69.7%)、样本量确定依据(0%.vs0%.vs1.2%)等；②随机方法不消楚,包括对产生随机序列的方法报告(1.4%.vs15%.vs26.3%)、隐蔽分组机制(0%.vs1.4%.vs4.9%)和盲法实施(0%.vs5.7%.vs9.1%)等；③结果部分内容描述不清甚至缺少,包括受试者流程(0%.vs11.6%.vs20.6%)、招募受试者时期和随访时间(0%.vs2.1%.vs2.8%)、基线资料的提供(9.0%.vs17.8%.vs34.8%)和结局效应估计值及95%CI的报告(18.1%.vs36%.vs50.7%)等。此外,无任何研究注册及阐明可能的利益冲突。
4.共纳入63种国内中医药期刊杂志,其中SCl收录2种,Medline/Embase收录8种,CSCD收录7种,统计源收录46种。仅3种杂志在其“稿约”中提及并要求作者按照CONSORT声明各条目来规范报告RCTs,且给出了具体的版本和网址。此外,仅1种期刊在其“稿约”中提及CONSORT扩展版。无任何期刊在其“稿约”中提及PRISMA、MOOSE、TREND、STARD和STROBE等其他类型研究的报告清单。通过电话和E-mail方式,对63种国内中医药期刊编审人员进行问卷调晒,54种期刊杂志给予回复,反馈率为85.7%,其中编辑为39人(占72.2%)、主编为3人(占5.6%)、编辑部主任为9人(16.7%)、其他人员为3名(占5.6%)。对于CONSORT声明，有8位编辑知道并子解,3位编辑仅听说过但不了解,其中仅3位编辑表示对投稿的RCTs,该期刊在作者投稿、编辑审稿及专家评审阶段均要求和遵循了CONSORT声明的要求,46%的编辑(25人)认为没有必要在“稿约”中引入CONSORT声明。对于PRISMA清单，仅2位编辑知道并了解,7位编辑仅听说过但不了解,表示对投稿的SRs/Meta-分析,在作者投稿、编辑审稿及专家评审阶段均未要求和遵循PRISMA清单的要求,65%的编辑(35人)认为没有必要在“稿约”中引入PRISMA清单。而对于其他类型临床研究报告清单,无任何人知晓并了解。
结论临床研究质量是影响其转化和利用的关键因素,只有高质量的研究才能为临床实践提供可靠的科学依据。我们的研究显示：尽管国内中医药,特别是针灸SRs/Meta-分析研究在研究的题目、摘要、纳入研究的特征和文献质量评价方法阐述等方面的符合率较好,但在影响其研究质量的关键因素，如文献检索方法不同发表情况的文献的纳入、对发表偏倚的评估、利益冲突的说明、文献筛选流程图的呈现、数据合并的合理性、研究间异质性或偏倚的分析以及对证据综合结果分析的的能力等方面,与国外同类研究存在较大差距。而对于国内针灸RCTs,尽管2003年之后发表的针刺RCTs的数量是之前所发表总数的3倍多,且各条目的符合率在不同的3个发表年代略有提高，但在多个条目上的实际符合比例上依然非常低,如随机序列的产生方法、隐蔽分组的机制和实施、盲法细则、样本量计算依据和资料收集场所和地点等方面,其质量并未随着STRICTA清单的引入而得到有效改善和提高。此外,国内中医药领域期刊“稿约”中对不同类型临床研究报告规范的应用情况不尽如人意,大部分期刊的编审人员对研究报告的规范、临床研究注册制度等信息的知晓率较低。而且,尽管大部分期刊有意愿在今后进入此类相关报告规范,以提高不同类型的临床研究报告质量,但均无任何具体的可操作的细则和时间规划。因此,我们强烈建议通过以下措施提高国内中医药临床研究的方法和报告质量：①国内医学期刊尽早在“稿约”中引入这些国际临床研究报告标准,以规范和提高国内临床研究的报告质量,提升临床研究水平；②从期刊协会层面制定相关制度,由鼓励和建议投稿作者、期刊编辑在文章投稿、编审和专家评审阶段遵循相关的临床研究报告规范,过渡到强制执行;③对期刊编审人员开展和加强与临床研究报告规范相关的知识培训,并建立考核机制,促进相关知识的掌握和更新；④将与临床研究报告规范相关的知识内容加入到医学继续教育课程中,由国家授权各地区具备资质的科研单位,对其服务地区的临床医生、科研人员进行全面的SRs/Meta-分析方法学的培训：⑤在医学在校教育中引入与临床研究报告规范相关的知识内容。
Background With the increasing of research funding from Nation in the field of TCM, the number of its scientific papers is quickly increasing as well.Moreover, with the development of the concept of evidence-based medicine, the researchers recognize that the scientific quality of research and the utilization and conversion of those research results is the key. However, some problems in the methods of design and reporting quality reduced the reliability of the clinical trisls. So, it is necessary to systematic review all the factors involved the Chinese medicine clinical research design, implementation and reporting that might affect their study quality, and find the important specific differences compared with the same field studies carried out in foreign countries in order to improve the quality of Chinese clinical trials.
Objective Investigating the status of methodology and reporting quality of in the research field of traditional Chinese medicine and randomized controlled trials and provided the policy advices to improve the quality of clinical trials of traditional Chinese medicine.
Methods1.To assess the quality of SRs/Meta-analysis of TCM intervention published in Chinese journals base on the AMSTAR and PRISMA checklist by bibliometrics.2.To compare the quality of domestic and foreign SRs/Meta-analysis of acupuncture intervention:A comparative study.3. To compare the quality RCTs of acupuncture intervention published in Chinese journals based on the different periods of checklists were introduced into China:A retrospective study.4. Endorsement of the different clinical trials reporting checklist by Chinese TCM journals:a survey of journal editors and journal. The SPSS18.0software was used for data analysis.
Results1.A total number of369SRs/Meta-analysis of TCM intervention published in Chinese journals was included, which showed that the methodology and reporting quality was poor. The important problems included the following context:①Retrieval searching method was not comprehensive(45%,203/369);②Not included different publish paper(97.3%,359/369);③Not provided excluding paper checklist(96.5%,356/369);④The inclusion criteria was broad not specific(42%,155/369);⑤Without using the double independent mechanism to select the literature and extract data(58.8%,217/369);⑥Without detailed description the process of included and excluded literature(55%,203/369);⑦The method merging data was not appropriate(70.7%,261/369). In addition, only half clinician take part in the research, the citation of nearly half paper was zero.
2. A total number of366SRs/Meta-analysis of acupuncture intervention were included, including88Chinese SRs,226Other SRs and52Cochrane SRs. The proportion of coincidence more than80%of three different types of SRs in AMSTAR and PRISMA checklist were45%(Chinses SRs).vs73%(Other SRs).vs91%(Ccohrane SRs) and59%(Chinses SRs).vs74%(Other SRs).vs78%(Ccohrane SRs), respectively. Compared with Other SRs and Cochrane SRs, there were many defect in Chinese SRs. Such as, included different published paper(2%.vs91%.vs100%), comprehensive retrieval searching(40%.vs87%.vs100%), conflict of interest(0%.vs61%.vs100%), evidence synthesis results(23%.vs99%.vs96%), protocol and register information(0%.vs4%.vs100%).
3. A total number of1978RCTs of acupuncture intervention published in Chinese journals were included. The quality of reporting in several important methodological components, including sample size calculation (0%vs.0%vs.1.2%), randomization sequence generation (1.4%vs.15%vs.26.3%) and implementation(0%vs.0%vs.1.3%), allocation concealment (0%vs.1.4%vs.4.9%), blinding (0%vs.5.7%vs.9.1%), has not improved. In addition, there were many defect in description of acupuncture intervention. Such as, the specific types of acupuncture therapy(6.6%.vs9.9%.vs12.7%);②reasons and basis of acupuncture therapy(0%.vs0.3%.vs1.0%);③subjects objects of each treatment unit number of needles used(0%.vs0.3%. vs0.2%);④describe other interventions(19.7%.vs30.1%.vs33.7%);⑤The acupuncturist qualification(0%.vs0%.vs0.4%).
4. A total number of63journals were included, which two journals were cited by SCI, eight journals were cited by Medline/Embase, seven journals were cited by CSCD. Only three journals require author to report RCTs based on CONSORT Statement,and gave the version and website link meanwhile. No journal mentioned the PRISMA, MOOSE, TREND, STARD and STROBE checklist so far. Besides, we surveyed sixty-three ditorial staffs of Chinese journal of TCM by E-mail and Telephone, fifty-four journals gave back. The feedback rate was85.7%, thirty-nine were editor, three were chief editor, nine were director. Of the eleven editors known the CONSORT Statement, three editors just heard and did not understand it at all. Out of three editors of fifty-four said that they required the author to report the RCT based on CONSORT Statement. And twenty five (46%) editors think that it was unnecessary to introduce it in its "Instruction to Authors" in the future. As for PRISMA checklist, only two editors understood it and seven editors just heard. They said that they did not require the author to report the SRs/Meta-analysis based on PRISMA checklist. Thirty-five (65%) editors think that it was unnecessary to introduce PRISMA checklist in its "Instruction to Authors". In addition, there was no any editor known the MOOSE, TREND, STARD, STROBE checklists.
Conclusion The quality of clinical study is the key factor to affect the transformation and utilization, only high quality clinical research to provide a reliable scientific basis for clinical practice. Even though the coincidence of reporting quality of TCM intervention in Title, Abstract, included study characteristic were well, the key factors that may impact the quality were still poor. As for the number of RCTs after published in2003were quickly increased, the coincidence in many items were still poor, and the reporting quality of RCTs of acupuncture intervention was not improved with the STRICTA checklist was introduced into China. In addition, the endorsement of clinical study reporting statement in "Instruction to Authors" of journals of traditional Chinese medicine (TCM) was worried. The reason might be that the standard for reports of medical research in China is not a mandatory requirement. We propose to improve the quality of clinical research quality through the following measures:①Endorsement of the different clinical trials reporting checklist into Chinese TCM journal to improve the quality of clinical study;②Encouraging author, editor and peer review to abide the clinical study reporting;③Carried out the training of knowledge about the reporting quality for editors;④Carried out the training of knowledge about SRs and Meta-analysis for clinician, researcher;⑤The clinical research report and related knowledge included into the school education.
引文
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