针灸系统评价和随机对照试验质量及报告规范认知程度的研究
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摘要
背景：中医药创新发展是我国建设创新型国家的需要。针灸以经络学说为理论基础,其传统中医药的理论有别于西医理论体系。针灸系统评价(SRs)/meta分析(MAs)和随机对照试验(RCTs)发表数量逐年增加,其方法学质量和报告质量现状如何,存在什么问题,针灸科研、临床工作者对相关报告的认知程度如何,针灸临床研究报告信息是否满足证据使用者的需求,都值得深入研究。这对于中医药领域的研究和实践具有重要实践意义。
目的：1)评价针灸SRs/MAs及其纳入RCTs的质量。2)调查相关医学报告规范在我国的认知程度及针灸从业者对针灸信息报告的需求。3)探讨针灸创新发展的方法学瓶颈及针灸临床研究质量和知识转化的改进措施建议。
方法：1)循证理念、标准和方法；2)系统评价；3)综合定性和定量分析；4)问卷调查。旨在利用PICOS要素构建研究问题,系统检索中、英文数据库。通过系统评价的方法评估针灸SRs/MAs的方法学质量,利用“系统评价/meta分析优先报告条目(PRISMA声明)”和自拟针灸特征信息清单评估针灸SRs/MAs报告质量。依据CONSORT声明和STRICTA评估针灸RCTs报告质量。设计调查问卷,调查针灸科研和临床工作人员对PRISMA声明的知晓程度及针灸从业者对“针灸临床研究报告信息需求”情况。采用SPSS13.0统计软件处理数据。
结果：1)本研究最终分析了327个针灸SRs/MAs及其纳入的363个RCTs,二者的报告质量均普遍较低。风险偏倚评估工具在2009年后并未广泛用于针灸SRs/MAs中。即使用了风险偏倚报告工具的SRs/MAs,其报告信息也小完整。PRISMA评分结果提示CSR最高,外文与中文期刊SRs/MAs报告率相似。针灸特征信息报告率三组差别有统计学意义(P=0.000),由高到低依次为CSR、外文期刊和中义期刊SRs/MAs。PRISMA和针灸特征信息评分SCI期刊均高于非SCI期刊(P=0.000)。对针灸SRs/MAs纳入的363个中、英文RCTs,其CONSORT报告率2006-2010年英文RCTs高于中文(P=0.000),而STRICTA评分报告率中、英文相似(P=0.440)。中、英文RCTs的CONSORT报告率2006-2010年均比2001-2005年高(中文P=0.011；英文P=0.001)。STRICTA评分2006-2010年与2001-2005年中、英文RCTs相比均相似(中文P=0.853；英文P--0.317)。
2)被调查人员对于报告规范的认知程度不高,被调查的针灸从业者对针灸临床证据报告信息的需求较高,当前针灸临床证据报告信息尚不能完全满足针灸从业人员的需求。
3)针灸临床证据质量和知识转化的政策建议可从以下几个方面逐步展开、完善。立项研究、建立规范、培训转化、后效评价、现场验收、共识后推广、扩大验证、后效评价、持续改进。
结论：研究报告质量的高低直接影响读者对研究结果真实性、重要性及实用性的正确理解和评价。本研究纳入针灸SRs/MAs及RCTs均存在不同程度的质量问题,报告质量普遍较低。“系统评价/Meta分析优先报告的条目”在我国的知晓率较低,当前针灸临床研究报告信息尚不能完全满足针灸从业人员的需求。今后针灸SRs/MAs和RCTs的研究者应特别重视对研究的科学设计、严谨实施和完整规范报告,加强对医学研究报告规范的了解和应用,进一步促进针灸SRs/MAs和RCTs等高质量证据的生产和转化,以满足针灸科研和临床实践的需要,更好的为针灸循证临床决策提供参考依据。
Background China's own needs for innovation-oriented country construction calls for the innovation and development of Traditional Chinese Medicine (TCM). Based on the rationale of Meridian theory, theoretical system of TCM theory is different from that of western medicine.The increasing number of systematic reviews/meta-analysis (SRs/MAs) and randomized controlled trials (RCTs) in Chinese and international journals, what are their methodological and reporting quality? Has the information in clinical evidence on acupuncture met the needs of clinician on acupuncture? Questions like these are all worthy of further study, which has important significance for researches and practices in the field of TCM.
Objective1) To evaluate the quality of SRs/MAs and the reporting characteristic of their included randomized controlled trials (RCTs) of acupuncture.2) To investigate the cognition of relevant reporting guideline for researchers and the requirement of the acupuncture-specific information for clinician of acupuncture.3) To discuss the bottle-neck problems that has limited its innovation and development of acupuncture, possible measures for the improvements of the quality of clinical studies of acupuncture and knowledge translation.
Methods1) Evidence-based Practice conception and strategies;2) Systematic review;3) Scientific combination of qualitative and quantitative research methods.4) Use of questionnaires. Research questions were formulated by using the PICOS method. Relevant SRs/MAs were comprehensively collected in Chinese and English databases through internet searching. The quality of methodology was assessed by developing a systematic review. Reporting quality was assessed based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklists and checklists for SRs/MAs on acupuncture-specific information. We assessed the reporting quality of included RCTs of acupuncture by using the checklist of Consolidated Standards of Reporting Trials (CONSORT) and Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). We also designed questionnaires which were later taken by researchers and clinician of acupuncture. The content of questionnaires was mainly on "the cognition of Preferred Reporting Items for Systematic Reviews and Meta-Analyses" and "the requirement of reporting information of clinical evidence of acupuncture". Finally, data were analyzed via SPSS software.
Results1) A total number of327SRs/MAs of Acupuncture&Moxibustion and their included363RCTs were identified in this study, which showed that their reporting quality was poor. The Cochrane "risk of bias" tool has not been used in all SRs/MAs of acupuncture since2009. Even whenthe ROB tool was used, reporting of relevant information was still incomplete. Scores of the PRISMA showed a significant difference among the SRs/MAs in CSRs, international journals and Chinese journals. Scores of the PRISMA of CSRs are higher than those in Chinese journals and international journals. There was significant difference (P=0.000) in scores of the information of acupuncture characteristic among the CSRs, Chinese journals and International Journals. Their scores of information of acupuncture characteristics in CSRs were the highest, while scores in Chinese journals were the lowest (P=0.000). Scores of the PRISMA and the information of acupuncture characteristic of SRs/MAs in SCI journals were higher than those in non-SCI journals (P=0.000). As for the included363Chinese's and English RCTs of acupuncture, scores of CONSORT of RCTs in2006-2010were higher in English than in Chinese (P=0.000). However, scores of STRICTA in2006-2010in English RCTs were similar to these in Chinese RCTs (P=0.440). Compared with these in2001-2005, scores of CONSORT in2006-2010were significantly higher than in both English and Chinese RCTs (Chinese:P=0.011; English: P=0.001). Besides, scores of STRICTA in both English and Chinese RCTs in2006-2010were similar to RCTs in2001-2010(Chinese:P=0.853; English:P=0.317).
2) Few interviewers knew PRISMA statement and their content well. Although there was a high requirement of acupuncture-specific information from clinician of acupuncture. The reporting and requirement information of clinical evidence has not met the need of clinician on acupuncture.
3) Suggestions for policy on the quality of clinical evidence and knowledge translation include a gradually development of following factors:Research projects, standard establishment, training transformation, afte-effect evaluation, site inspection and acceptance, promotion after consensus, validation expansion, after-effect evaluationand continuous improvement.
Conclusions This study showed that the quality of SRs/MAs and reporting quality of their included RCTs of acupuncture were very poor. Meanwhile, it is hard for readers to understand and assess the validity, reliability and practicality of results due to poor reporting quality. The fact that only a few people in China know the PRISMAS statement and the reporting information can not meet the need of clinician on acupuncture. So researchers should pay more attention to scientifical design, scrupulous implementation and comprehensive reporting. We should learn and use those reporting guideline to improve the quality of SRs/MAs and RCTs on acupuncture, to develop a reporting guideline based on acupuncture practice, which can then be used for clinical practice and provide a reference for evidence-based on clinical decision making.
目的：1)评价针灸SRs/MAs及其纳入RCTs的质量。2)调查相关医学报告规范在我国的认知程度及针灸从业者对针灸信息报告的需求。3)探讨针灸创新发展的方法学瓶颈及针灸临床研究质量和知识转化的改进措施建议。
方法：1)循证理念、标准和方法；2)系统评价；3)综合定性和定量分析；4)问卷调查。旨在利用PICOS要素构建研究问题,系统检索中、英文数据库。通过系统评价的方法评估针灸SRs/MAs的方法学质量,利用“系统评价/meta分析优先报告条目(PRISMA声明)”和自拟针灸特征信息清单评估针灸SRs/MAs报告质量。依据CONSORT声明和STRICTA评估针灸RCTs报告质量。设计调查问卷,调查针灸科研和临床工作人员对PRISMA声明的知晓程度及针灸从业者对“针灸临床研究报告信息需求”情况。采用SPSS13.0统计软件处理数据。
结果：1)本研究最终分析了327个针灸SRs/MAs及其纳入的363个RCTs,二者的报告质量均普遍较低。风险偏倚评估工具在2009年后并未广泛用于针灸SRs/MAs中。即使用了风险偏倚报告工具的SRs/MAs,其报告信息也小完整。PRISMA评分结果提示CSR最高,外文与中文期刊SRs/MAs报告率相似。针灸特征信息报告率三组差别有统计学意义(P=0.000),由高到低依次为CSR、外文期刊和中义期刊SRs/MAs。PRISMA和针灸特征信息评分SCI期刊均高于非SCI期刊(P=0.000)。对针灸SRs/MAs纳入的363个中、英文RCTs,其CONSORT报告率2006-2010年英文RCTs高于中文(P=0.000),而STRICTA评分报告率中、英文相似(P=0.440)。中、英文RCTs的CONSORT报告率2006-2010年均比2001-2005年高(中文P=0.011；英文P=0.001)。STRICTA评分2006-2010年与2001-2005年中、英文RCTs相比均相似(中文P=0.853；英文P--0.317)。
2)被调查人员对于报告规范的认知程度不高,被调查的针灸从业者对针灸临床证据报告信息的需求较高,当前针灸临床证据报告信息尚不能完全满足针灸从业人员的需求。
3)针灸临床证据质量和知识转化的政策建议可从以下几个方面逐步展开、完善。立项研究、建立规范、培训转化、后效评价、现场验收、共识后推广、扩大验证、后效评价、持续改进。
结论：研究报告质量的高低直接影响读者对研究结果真实性、重要性及实用性的正确理解和评价。本研究纳入针灸SRs/MAs及RCTs均存在不同程度的质量问题,报告质量普遍较低。“系统评价/Meta分析优先报告的条目”在我国的知晓率较低,当前针灸临床研究报告信息尚不能完全满足针灸从业人员的需求。今后针灸SRs/MAs和RCTs的研究者应特别重视对研究的科学设计、严谨实施和完整规范报告,加强对医学研究报告规范的了解和应用,进一步促进针灸SRs/MAs和RCTs等高质量证据的生产和转化,以满足针灸科研和临床实践的需要,更好的为针灸循证临床决策提供参考依据。
Background China's own needs for innovation-oriented country construction calls for the innovation and development of Traditional Chinese Medicine (TCM). Based on the rationale of Meridian theory, theoretical system of TCM theory is different from that of western medicine.The increasing number of systematic reviews/meta-analysis (SRs/MAs) and randomized controlled trials (RCTs) in Chinese and international journals, what are their methodological and reporting quality? Has the information in clinical evidence on acupuncture met the needs of clinician on acupuncture? Questions like these are all worthy of further study, which has important significance for researches and practices in the field of TCM.
Objective1) To evaluate the quality of SRs/MAs and the reporting characteristic of their included randomized controlled trials (RCTs) of acupuncture.2) To investigate the cognition of relevant reporting guideline for researchers and the requirement of the acupuncture-specific information for clinician of acupuncture.3) To discuss the bottle-neck problems that has limited its innovation and development of acupuncture, possible measures for the improvements of the quality of clinical studies of acupuncture and knowledge translation.
Methods1) Evidence-based Practice conception and strategies;2) Systematic review;3) Scientific combination of qualitative and quantitative research methods.4) Use of questionnaires. Research questions were formulated by using the PICOS method. Relevant SRs/MAs were comprehensively collected in Chinese and English databases through internet searching. The quality of methodology was assessed by developing a systematic review. Reporting quality was assessed based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklists and checklists for SRs/MAs on acupuncture-specific information. We assessed the reporting quality of included RCTs of acupuncture by using the checklist of Consolidated Standards of Reporting Trials (CONSORT) and Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). We also designed questionnaires which were later taken by researchers and clinician of acupuncture. The content of questionnaires was mainly on "the cognition of Preferred Reporting Items for Systematic Reviews and Meta-Analyses" and "the requirement of reporting information of clinical evidence of acupuncture". Finally, data were analyzed via SPSS software.
Results1) A total number of327SRs/MAs of Acupuncture&Moxibustion and their included363RCTs were identified in this study, which showed that their reporting quality was poor. The Cochrane "risk of bias" tool has not been used in all SRs/MAs of acupuncture since2009. Even whenthe ROB tool was used, reporting of relevant information was still incomplete. Scores of the PRISMA showed a significant difference among the SRs/MAs in CSRs, international journals and Chinese journals. Scores of the PRISMA of CSRs are higher than those in Chinese journals and international journals. There was significant difference (P=0.000) in scores of the information of acupuncture characteristic among the CSRs, Chinese journals and International Journals. Their scores of information of acupuncture characteristics in CSRs were the highest, while scores in Chinese journals were the lowest (P=0.000). Scores of the PRISMA and the information of acupuncture characteristic of SRs/MAs in SCI journals were higher than those in non-SCI journals (P=0.000). As for the included363Chinese's and English RCTs of acupuncture, scores of CONSORT of RCTs in2006-2010were higher in English than in Chinese (P=0.000). However, scores of STRICTA in2006-2010in English RCTs were similar to these in Chinese RCTs (P=0.440). Compared with these in2001-2005, scores of CONSORT in2006-2010were significantly higher than in both English and Chinese RCTs (Chinese:P=0.011; English: P=0.001). Besides, scores of STRICTA in both English and Chinese RCTs in2006-2010were similar to RCTs in2001-2010(Chinese:P=0.853; English:P=0.317).
2) Few interviewers knew PRISMA statement and their content well. Although there was a high requirement of acupuncture-specific information from clinician of acupuncture. The reporting and requirement information of clinical evidence has not met the need of clinician on acupuncture.
3) Suggestions for policy on the quality of clinical evidence and knowledge translation include a gradually development of following factors:Research projects, standard establishment, training transformation, afte-effect evaluation, site inspection and acceptance, promotion after consensus, validation expansion, after-effect evaluationand continuous improvement.
Conclusions This study showed that the quality of SRs/MAs and reporting quality of their included RCTs of acupuncture were very poor. Meanwhile, it is hard for readers to understand and assess the validity, reliability and practicality of results due to poor reporting quality. The fact that only a few people in China know the PRISMAS statement and the reporting information can not meet the need of clinician on acupuncture. So researchers should pay more attention to scientifical design, scrupulous implementation and comprehensive reporting. We should learn and use those reporting guideline to improve the quality of SRs/MAs and RCTs on acupuncture, to develop a reporting guideline based on acupuncture practice, which can then be used for clinical practice and provide a reference for evidence-based on clinical decision making.
引文
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