老年抗感染领域药物干预系统评价中随机对照试验方法学质量的横断面调查

A cross-sectional study on the quality of the randomized controlled trials(RCTs) included in the systematic review in the anti-infection field in the elderly

目的评价老年抗感染领域药物干预系统评价纳入的随机对照试验(randomized controlled trial,RCT)的方法学质量。方法计算机检索PubMed、EMbase、CNKI、The Cochrane Library、WanFang Data、VIP和CBM数据库,搜集国内外老年抗感染领域的系统评价或Meta分析,检索时限均为建库至2020年2月17日。对纳入的系统评价/Meta分析中RCT的方法学质量进行分析。结果共纳入8篇系统评价,包括19篇RCT,6735例老年人。纳入RCT的样本量为23~2538例,发表时间为1980~2020年。RCT关注疾病涉及老年人术后感染、泌尿道感染、艰难梭状芽胞杆菌感染等。纳入的RCT均不同程度存在方法学质量问题,其中选择性偏倚(随机序列生成)、选择性偏倚(分配隐藏)维度的低风险评价比例最低(47.4%、36.8%)且评价结果为不清楚的比例(42.1%、52.6%)最高。测量偏倚和实施偏倚维度的高风险评价比例最高,均为21.1%。结论老年抗感染领域RCT质量有待进一步提升,今后应开展高质量的老年抗感染RCT,以更好地指导临床实践。

Objective To analyze the quality of the randomized controlled trials(RCTs)included in the systematic review in the anti-infection field in the elderly.Methods A comprehensive and systematic literature search in PubMed,EMbase,CNKI,The Cochrane Library,WanFang Data,VIP and CBM was conducted to collect systematic review or meta-analysis which involoved anti-infection RCTs in the elderly from inception to February 17th,2020.The results of Cochrane risk of bias assessment of the included RCTs were analyzed.Results A total of 8 systematic reviews were included,involving 19 RCTs and 6735 participants.The sample size of the RCTs ranged from 23 to 2538,and the published date were from 1980 to 2020.The included RCTs focused on postoperative infection,urinary tract infection,Clostridium Difficile infection and so on.The included RCTs had methodological quality issues.Among the assessment results of low risk of bias,the domains of selection bias(random sequence generation)and selection bias(allocation hiding)had the lowest proportion(47.3%,36.8%).Among the assessment results of unclear risk of bias,the domains of selection bias(random sequence generation)and selection bias(allocation hiding)had the highest proportion(42.1%,52.6%).Among the assessment results of high risk of bias,the domains of measurement bias and performance bias had the highest proportion(21.1%,21.1%).Conclusions The quality of RCTs in the field of anti-infection in the elderly requires further improvement.High-quality anti-infection RCTs for the elderly should be developed in future to better guide clinical practice.