基于PRIO-harms的中医药系统评价再评价报告规范研究
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摘要
目的评价已发表的中医药系统评价再评价(overview of systematic reviews,Overviews)报告的规范性。方法计算机检索中国知网、中国生物医学文献数据库及万方数据库,收集已发表的中医药相关的Overviews,检索时限为建库至2018年4月23日。应用Overviews优先报告条目(preferred reporting items for overview of systematic reviews,PRIO-harms)评价其报告的规范性。结果检索共获得题录968条,经筛选后共纳入21篇中医药相关的Overviews。纳入的Overviews包含的系统评价/Meta数目为5～69个,合计纳入362个系统评价。PRIO-harms报告规范评估结果显示条目5 "计划书与注册"(0/21)、条目10 "原始研究的补充检索"(0/21)、条目14 "Meta偏倚"(0/21)、条目18 "重复"(0/21)被完全忽视,完全报告占比最高的为条目7 "信息来源"(8/21),有38%。其余条目,尤其在涉及利害关系的条目中多为部分报告。结论中医药Overviews对不利指标及利害关系报告不明确,整体报告规范有待提高。建议参照PRIO-harms条目进行报告,以提高报告的完整性和透明度。
Objective To evaluate reporting condition of the published overview of systematic reviews of traditional Chinese medicine(TCM).Methods The published Chinese medicine related Overviews were collected and identified by searching China Knowledge Network(CNKI),China Biomedical Literature Database(CBM) and Wanfang Database from inception to 23 April 2018.The Preferred Reporting Items for Overview of systematic reviews(PRIO-harms) was used to assess the reporting condition.Results The searching identified 968 records and 21 were eligible for analysis finally.The included Overviews consisted of 5 to 69 systematic reviews,with a total of 362 systematic reviews.The PRIO-harms reporting quality assessment showed that the reporting of item 5 "protocol and registration"(0/21),item 10 "additional search for primary studies"(0/21),item 14 "Meta-bias(es) "(0/21)and item 18 "overlapping"(0/21) were totally neglected,while item 7 "information sources"(8/21) occupied the highest proportion 38% of all reports.The remaining items,especially for those involving harms,were mostly partreported.Conclusion The reporting specification of overviews of TCM was generally unclear,especially for those harm-related items,and the overall reporting specifications need to be improved.The PRIO-harms checklist should be applied as a guideline in reporting Overviews,so as to improve their integrity and transparency.
Objective To evaluate reporting condition of the published overview of systematic reviews of traditional Chinese medicine(TCM).Methods The published Chinese medicine related Overviews were collected and identified by searching China Knowledge Network(CNKI),China Biomedical Literature Database(CBM) and Wanfang Database from inception to 23 April 2018.The Preferred Reporting Items for Overview of systematic reviews(PRIO-harms) was used to assess the reporting condition.Results The searching identified 968 records and 21 were eligible for analysis finally.The included Overviews consisted of 5 to 69 systematic reviews,with a total of 362 systematic reviews.The PRIO-harms reporting quality assessment showed that the reporting of item 5 "protocol and registration"(0/21),item 10 "additional search for primary studies"(0/21),item 14 "Meta-bias(es) "(0/21)and item 18 "overlapping"(0/21) were totally neglected,while item 7 "information sources"(8/21) occupied the highest proportion 38% of all reports.The remaining items,especially for those involving harms,were mostly partreported.Conclusion The reporting specification of overviews of TCM was generally unclear,especially for those harm-related items,and the overall reporting specifications need to be improved.The PRIO-harms checklist should be applied as a guideline in reporting Overviews,so as to improve their integrity and transparency.
引文
[1]张俊华,李幼平,张伯礼.循证中医药学:理论与实践[J].中国中药杂志,2018,43(1):1-7.
[2]杨克虎,刘雅莉,袁金秋,等.发展和完善中的“系统评价再评价”[J].中国循证儿科杂志,2011,6(1):321-324.
[3]刘建平,王弘午.循证医学[M].北京:中国中医药出版社,2017:65-66.
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[5]徐蕴,魏琦,王会梅,等.《中国针灸》发表Meta分析的质量评价[J].中国循证医学杂志,2017,17(6):719-725.
[6]高玮,胡明.抗心绞痛类中成药疗效及安全性系统评价的再评价[J].中国循证医学杂志,2017,17(4):440-449.
[7]钟娟,郑芸,李刚,等.中草药治疗变应性鼻炎系统评价再评价[J].中华中医药杂志,2017,32(1):263-266.
[8]王秋华,刘兵兵,曹恒斌,等.复方丹参滴丸治疗冠心病心绞痛系统评价/Meta分析的方法学质量评价[J].浙江中西医结合杂志,2017,27(6):536-539.
[9]厉玉婷.中医药治疗慢性萎缩性胃炎的系统评价/Meta分析的再评价[D].南京:南京中医药大学,2017.
[10]杨敏,蒋立,徐桂华.中医药治疗腰椎间盘突出症的系统评价/Meta分析的再评价[J].中华中医药学刊,2016,34(12):2897-2901.
[11]翁湘涛,胡伟雄,周倩仪,等.补阳还五汤治疗中风的系统综述/Meta分析的方法学质量评价[J].中国实验方剂学杂志,2016,22(14):217-221.
[12]蒋立,李丹丹,杨敏,等.补阳还五汤治疗中风的系统评价再评价[J].中国实验方剂学杂志,2016,22(16):199-204.
[13]孙亚男,于长禾,黄小波.中医药治疗帕金森病系统评价再评价[J].北京中医药,2016,35(5):430-435.
[14]周倩仪,黄超原,翁湘涛,等.疏血通治疗中风的系统评价/Meta分析的方法学质量评价[J].中国实验方剂学杂志,2016,22(13):182-186.
[15]刘玥,闫盈盈,翟所迪.注射用丹参多酚酸盐治疗心绞痛的系统评价再评价[J].中国临床药理学杂志,2016,32(6):560-562.
[16]顾露,吴冬梅,谢坪.中药联合肝动脉化疗栓塞术治疗原发性肝癌系统评价的再评价[J].中国药房,2016,27(15):2073-2076.
[17]尹秀平,谢雁鸣,廖星,等.中药注射剂治疗冠心病的系统评价再评价[J].中国中药杂志,2016,41(22):4259-4266.
[18]翁湘涛,张诗静,周倩仪,等.醒脑静治疗中风的系统综述/Meta分析的方法学质量评价[J].中国实验方剂学杂志,2015,21(20):213-217.
[19]安光辉,赵毅,姚斐,等.脊柱推拿治疗腰背及颈部疼痛的疗效和安全性的系统评价再评价[J].中国循证医学杂志,2015,15(9):1010-1017.
[20]郑鹏禹.中医药治疗慢性肾小球肾炎系统评价再评价[D].沈阳:辽宁中医药大学,2015.
[21]杨衍涛,马莉,杨晓霞,等.中医药治疗原发性高血压系统评价的再评价[J].中国循证医学杂志,2014,14(9):1070-1076.
[22]张伟,孙建华,裴丽霞,等.中医药治疗肠易激综合征的系统评价/Meta分析的再评价[J].世界华人消化杂志,2014,22(12):1747-1755.
[23]汪慧琪,魏林,吴伟,等.中医药治疗慢性肾功能衰竭的系统评价再评价[J].中草药,2014,45(5):738-744.
[24]耿劲松,董建成,倪衡建,等.中药注射液不良反应系统评价的再评价[J].中国医院药学杂志,2012,32(12):994-996.
[25]石磊,黎波,杜元灏,等.针灸治疗中风病系统再评价研究[J].时珍国医国药,2010,21(1):198-201.
[26]SHEA BJ,GRIMSHAW JM,WELLS GA,et al. Development of AMSTAR:A measurement tool to assess systematic reviews[J]. BMC Med Res Methodology,2007,7(10):1-10.
[27]OXMAN AD. Checklists for review articles[J]. BMJ,1994,309(6955):648-651.
[28]MOHER D,LIBERATI A,TETZLA J,et al. Preferred reporting items for systematic reviews and meta-analyses:the PRISMA statement[J]. PLo S Med,2009,6(7):e1000097.
[29]BALSHEM H, HELFAND M, SCHNEMANN HJ,et al. GRADE guidelines:3. Rating the quality of evidence[J]. J Clin Epidemiol,2011,64(4):401-406.
[30]The Periodic Health Examination. Canadian Task Force on the Periodic Health Examination[J]. Can Med Assoc J,1979,121(19):1193-1254.
[31]张燕,于丹丹,崔德华,等.《中国中药杂志》发表的干预类系统评价/Meta分析的报告质量评价研究[J].中国中药杂志,2018,43(6):1254-1260.
[32]CHALMERS I,BRACKEN MB,DJULBEGOVIC B,et al. How to increase value and reduce waste when research priorities are set.[J]. Lancet, 2014, 383(9912):156-165.
[33]SHOJANIA KG,SAMPSON M,ANSARI MT,et al. How quickly do systematic reviews go out of date? A survival analysis[J]. Ann Intern Med,2007,147(4):224-233.
[34]BALLARD M,MONTGOMERY P. Risk of bias in overviews of reviews:a scoping review of methodological guidance and four-item checklist[J]. Res Synth Methods,2017,8(1):92-108.
[35]BCHTER RB,PIEPER D. Most overviews of Cochrane reviews neglected potential biases from dual authorship[J]. J Clin Epidemiol,2016,77:91-94. doi:10. 1016/j.jclinepi. 2016. 04. 008.
[36]丁泓帆,吴琼芳,杨楠,等.评估系统评价偏倚风险的ROBISIS工具实例解读[J].中国循证医学杂志,2016,16(1):115-121.
[37]HAIDICH AB,BIRTSOU C,DARDAVESSIS T,et al.The quality of safety reporting in trials is still suboptimal:survey of major general medical journals[J]. J Clin Epidemiol,2011,64(2):124-135.
[38]MAHADY SE,SCHLUB T,BERO L,et al. Side effects are incompletely reported among systematic reviews in gastroenterology[J]. J Clin Epidemiol,2015,68(2):144-153.
[2]杨克虎,刘雅莉,袁金秋,等.发展和完善中的“系统评价再评价”[J].中国循证儿科杂志,2011,6(1):321-324.
[3]刘建平,王弘午.循证医学[M].北京:中国中医药出版社,2017:65-66.
[4]BOUGIOUKAS KI,LIAKOS A,TSAPAS A,et al. Preferred Reporting Items for Overviews of systematic reviews including harms checklist:A pilot tool to be used for balanced reporting of benefits and harms[J]. J Clin Epidemiol,2018,93:9-24. doi:10. 1016/j. jclinepi.2017. 10. 002.
[5]徐蕴,魏琦,王会梅,等.《中国针灸》发表Meta分析的质量评价[J].中国循证医学杂志,2017,17(6):719-725.
[6]高玮,胡明.抗心绞痛类中成药疗效及安全性系统评价的再评价[J].中国循证医学杂志,2017,17(4):440-449.
[7]钟娟,郑芸,李刚,等.中草药治疗变应性鼻炎系统评价再评价[J].中华中医药杂志,2017,32(1):263-266.
[8]王秋华,刘兵兵,曹恒斌,等.复方丹参滴丸治疗冠心病心绞痛系统评价/Meta分析的方法学质量评价[J].浙江中西医结合杂志,2017,27(6):536-539.
[9]厉玉婷.中医药治疗慢性萎缩性胃炎的系统评价/Meta分析的再评价[D].南京:南京中医药大学,2017.
[10]杨敏,蒋立,徐桂华.中医药治疗腰椎间盘突出症的系统评价/Meta分析的再评价[J].中华中医药学刊,2016,34(12):2897-2901.
[11]翁湘涛,胡伟雄,周倩仪,等.补阳还五汤治疗中风的系统综述/Meta分析的方法学质量评价[J].中国实验方剂学杂志,2016,22(14):217-221.
[12]蒋立,李丹丹,杨敏,等.补阳还五汤治疗中风的系统评价再评价[J].中国实验方剂学杂志,2016,22(16):199-204.
[13]孙亚男,于长禾,黄小波.中医药治疗帕金森病系统评价再评价[J].北京中医药,2016,35(5):430-435.
[14]周倩仪,黄超原,翁湘涛,等.疏血通治疗中风的系统评价/Meta分析的方法学质量评价[J].中国实验方剂学杂志,2016,22(13):182-186.
[15]刘玥,闫盈盈,翟所迪.注射用丹参多酚酸盐治疗心绞痛的系统评价再评价[J].中国临床药理学杂志,2016,32(6):560-562.
[16]顾露,吴冬梅,谢坪.中药联合肝动脉化疗栓塞术治疗原发性肝癌系统评价的再评价[J].中国药房,2016,27(15):2073-2076.
[17]尹秀平,谢雁鸣,廖星,等.中药注射剂治疗冠心病的系统评价再评价[J].中国中药杂志,2016,41(22):4259-4266.
[18]翁湘涛,张诗静,周倩仪,等.醒脑静治疗中风的系统综述/Meta分析的方法学质量评价[J].中国实验方剂学杂志,2015,21(20):213-217.
[19]安光辉,赵毅,姚斐,等.脊柱推拿治疗腰背及颈部疼痛的疗效和安全性的系统评价再评价[J].中国循证医学杂志,2015,15(9):1010-1017.
[20]郑鹏禹.中医药治疗慢性肾小球肾炎系统评价再评价[D].沈阳:辽宁中医药大学,2015.
[21]杨衍涛,马莉,杨晓霞,等.中医药治疗原发性高血压系统评价的再评价[J].中国循证医学杂志,2014,14(9):1070-1076.
[22]张伟,孙建华,裴丽霞,等.中医药治疗肠易激综合征的系统评价/Meta分析的再评价[J].世界华人消化杂志,2014,22(12):1747-1755.
[23]汪慧琪,魏林,吴伟,等.中医药治疗慢性肾功能衰竭的系统评价再评价[J].中草药,2014,45(5):738-744.
[24]耿劲松,董建成,倪衡建,等.中药注射液不良反应系统评价的再评价[J].中国医院药学杂志,2012,32(12):994-996.
[25]石磊,黎波,杜元灏,等.针灸治疗中风病系统再评价研究[J].时珍国医国药,2010,21(1):198-201.
[26]SHEA BJ,GRIMSHAW JM,WELLS GA,et al. Development of AMSTAR:A measurement tool to assess systematic reviews[J]. BMC Med Res Methodology,2007,7(10):1-10.
[27]OXMAN AD. Checklists for review articles[J]. BMJ,1994,309(6955):648-651.
[28]MOHER D,LIBERATI A,TETZLA J,et al. Preferred reporting items for systematic reviews and meta-analyses:the PRISMA statement[J]. PLo S Med,2009,6(7):e1000097.
[29]BALSHEM H, HELFAND M, SCHNEMANN HJ,et al. GRADE guidelines:3. Rating the quality of evidence[J]. J Clin Epidemiol,2011,64(4):401-406.
[30]The Periodic Health Examination. Canadian Task Force on the Periodic Health Examination[J]. Can Med Assoc J,1979,121(19):1193-1254.
[31]张燕,于丹丹,崔德华,等.《中国中药杂志》发表的干预类系统评价/Meta分析的报告质量评价研究[J].中国中药杂志,2018,43(6):1254-1260.
[32]CHALMERS I,BRACKEN MB,DJULBEGOVIC B,et al. How to increase value and reduce waste when research priorities are set.[J]. Lancet, 2014, 383(9912):156-165.
[33]SHOJANIA KG,SAMPSON M,ANSARI MT,et al. How quickly do systematic reviews go out of date? A survival analysis[J]. Ann Intern Med,2007,147(4):224-233.
[34]BALLARD M,MONTGOMERY P. Risk of bias in overviews of reviews:a scoping review of methodological guidance and four-item checklist[J]. Res Synth Methods,2017,8(1):92-108.
[35]BCHTER RB,PIEPER D. Most overviews of Cochrane reviews neglected potential biases from dual authorship[J]. J Clin Epidemiol,2016,77:91-94. doi:10. 1016/j.jclinepi. 2016. 04. 008.
[36]丁泓帆,吴琼芳,杨楠,等.评估系统评价偏倚风险的ROBISIS工具实例解读[J].中国循证医学杂志,2016,16(1):115-121.
[37]HAIDICH AB,BIRTSOU C,DARDAVESSIS T,et al.The quality of safety reporting in trials is still suboptimal:survey of major general medical journals[J]. J Clin Epidemiol,2011,64(2):124-135.
[38]MAHADY SE,SCHLUB T,BERO L,et al. Side effects are incompletely reported among systematic reviews in gastroenterology[J]. J Clin Epidemiol,2015,68(2):144-153.