神经根型颈椎病中医辨证护理随机对照试验文献质量报告评价

Evaluation of Literature Quality Report of Traditional Chinese Medicine Syndrome Differentiation and Nursing of Cervical Spondylotic Radiculopathy Randomized Controlled Trials

目的基于临床试验报告统一标准(consolidated standards of reporting trials,CONSORT)2010版及Cochrane系统评价手册5.1.0,评价国内外神经根型颈椎病(cervical spondylotic radiculopathy,CSR)中医辨证施护随机对照试验(randomized controlled trials,RCTs)的报告质量。方法计算机检索中国知识基础设施(China national knowledge infrastructure,CNKI)、中国生物医学文献数据库(China Biology Medicine disc,CBMdisc)、万方数据库(WanFang data)、维普中文期刊数据库(VIP)四大中文数据库,PubMed、Medline、Embase、the Cochrane Library、Web of Science五大英文数据库,检索时限均为建库至2020-09月,分别采用CONSORT 2010和Cochrane系统评价手册5.1.0对纳入研究进行报告质量评价。结果共纳入37篇RCTs中文研究,无英文文献纳入,从质量报告和方法学两个方面评价纳入研究,其中背景和原理解释(2a),研究目的和假设(2b),研究对象的入选标准(4a),随机分配序列的方法(8a),随机分配序列的方法(9),随机的实施(10),盲法的实施(11a),脱落、剔除人数原因(13b),招募和随访(14a),局限性、潜在偏倚(20),资助或其他支持(25)占文献自身报告比例不足50.00%。报告率不足10.00%的条目有随机化序列的产生(8a)、分配隐藏(9)、随机的实施(10)、受试者流动(13b)、资助情况等8个条目,其余条目报告率60.00%~100.00%。方法学质量评价显示,32.43%RCTs文献采用了合理的随机序列生成方法,但分配隐藏、盲法(受试者、干预者、结果测评者)及结果数据不完整仅有1篇文献报道,27.03%RCTs文献有选择偏倚。结论CSR中医辨证施护RCTs研究报告质量普遍较低,亟待科研设计严谨、方法正确的RCTs研究指导临床实践。

Objective To evaluate the report quality of randomized controlled trials(RCTs)traditional Chinese medicine syndrome differentiation and nursing of cervical spondylotic radiculopathy(CSR)in domestic and overseas based on consolidated standards of reporting trials(CONSORT)2010 and Cochrane handbook for systematic reviews of interventions-version 5.1.0.Methods China national knowledge infrastructure(CNKI),China Biology Medicine disc(CBMdisc),WanFang data,VIP,PubMed,Medline,Embase,the Cochrane Library and the Web of Science were searched by computer.The retrieval time was from the establishing date of those databases to September 2020.The quality of the included studies was estimated by CONSORT 2010 and Cochrane Handbook for Systematic Reviews of Interventions-version 5.1.0.Results A total of 37 RCTs Chinese studies were included,without English version.The included studies were assessed from two aspects of quality report and methodology.The background and principle of explanation(2a),the research purpose and hypothesis(2b),the research object of the inclusion criteria(4a),random sequence distribution(8a),random distribution method(9),the implementation of the random(10),the implementation of the blinded(11a),fall off,Reasons for eliminating numbers(13b),recruitment and follow-up(14a),limitations and potential bias(20),funding or other supports(25)were accounted for less than 50.00%of the literature’s own reports.The report rate of the items with less than 10.00% included 8 items,such as the generation of randomization sequence(8a),allocation hiding(9),random implementation(10),subject flow(13b),funding situation,etc,and the report rate of the rest items ranged from 60.00% to 100.00%.Methodological quality evaluation showed that the reasonable random sequence generation method was carried out on 32.43% RCTs literature,but only 1 literature was reported on assignment concealment,blind method(subjects,intervenors,outcome evaluators)and incomplete outcome data,and 27.03% RCTs literature had selection bias.Conclusion The quality of RCTs research reports on CSR syndrome differentiation is generally low,and it is urgent for RCTs research with rigorous research design and correct methods to help and guide clinical practice.