Applying the risk of bias tool in a systematic review of combination long-acting beta-agonists and inhaled corticosteroids for persistent asthma.
Applying the risk of bias tool in a systematic review of combination long-acting beta-agonists and inhaled corticosteroids for persistent asthma.
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DOI：
10.1371/journal.pone.0017242
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发表时间：
2011-02-24
期刊：
影响因子：
3.7
通讯作者：
Rowe BH
中科院分区：
文献类型：
--
作者：
Hartling L;Bond K;Vandermeer B;Seida J;Dryden DM;Rowe BH
偏倚风险（Risk of Bias, RoB）工具用于评估随机对照试验（RCTs）的内部效度。我们的目标是：1)评估RoB工具的内部一致性；2)确定获取补充学习信息的时间；3)将RoB工具与Jadad量表和Schulz分配隐藏（AC）进行比较；4)检验RoB与效应估计之间的关系。我们对成人持续性哮喘患者的长效β受体激动剂（LABA）联合吸入皮质类固醇（ICS）进行了系统评价。两位审稿人使用RoB、Jadad和AC独立评估了107项试验。一位审稿人搜索研究方案。我们使用加权Kappa （κ）评估评分者之间的一致性，使用Kendall's Tau （τ）评估工具之间的相关性。采用逆方差法和随机效应模型计算不同RoB的rct效应量的平均差异。试验的Jadad评分良好（中位数为4，IQR为3-4）；85%的人AC不清，87%的人RoB高。对RoB影响最大的因素是研究赞助者的潜在不适当影响（95%由行业资助）。罗布结构域的一致性为一般（κ = 0.40）至几乎完美（κ = 0.86），总体罗布的一致性为中等（κ = 0.41）。完成RoB评估的中位时间为21分钟（IQR 14-27）和12分钟（IQR 9-16）。5/42项研究（12%）确定了方案；3例选择性结果报告的评估发生改变。总体RoB与Jadad （τ = 0.04, p = 0.3）和AC （τ = - 0.02, p = 0.7）之间的相关性较低。比较效果估计和风险的分析没有显示出重要的模式。评估者之间对RoB评估的一致意见比以前报道的要好，这表明针对评估的指导方针很重要。RoB和Jadad之间的相关性较低，表明测量了不同的结构（偏倚风险与报告质量）。制药行业在LABA/ICS研究中的广泛参与应该引起对治疗效果潜在高估的关注。
The Risk of Bias (RoB) tool is used to assess internal validity of randomized controlled trials (RCTs). Our objectives were to: 1) evaluate inter-rater agreement of the RoB tool; 2) determine the time to access supplemental study information; 3) compare the RoB tool with the Jadad scale and Schulz allocation concealment (AC); and 4) examine the relationship between RoB and effect estimates. We conducted a systematic review of long-acting beta agonists (LABA) combined with inhaled corticosteroids (ICS) for adults with persistent asthma. Two reviewers independently assessed 107 trials using RoB, Jadad, and AC. One reviewer searched for study protocols. We assessed inter-rater agreement using weighted Kappa (κ) and the correlation between tools using Kendall's Tau (τ). Mean differences in effect sizes for RCTs with different RoB were calculated using inverse variance method and random effects model. Trials had good Jadad scores (median 4, IQR 3-4); however, 85% had unclear AC and 87% high RoB. The factor that most influenced RoB was the potential inappropriate influence of study sponsors (95% industry funded). Agreement on RoB domains was fair (κ = 0.40) to almost perfect (κ = 0.86), and moderate for overall RoB (κ = 0.41). Median time to complete RoB assessments was 21 minutes (IQR 14-27) and 12 minutes (IQR 9-16) to search for protocols. Protocols were identified for 5/42 studies (12%); in 3 cases the assessment of selective outcome reporting changed. There was low correlation between overall RoB vs. Jadad (τ = 0.04, p = 0.3) and AC (τ = −0.02, p = 0.7). Analyses comparing effect estimates and risk showed no important patterns. Inter-rater agreement on RoB assessments was better than previously reported suggesting that review-specific guidelines are important. The correlation between RoB and Jadad was low suggesting measurement of different constructs (risk of bias vs. quality of reporting). The extensive involvement of the pharmaceutical industry in this LABA/ICS research should raise concerns about potential overestimates of treatment effects.
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影响因子：
168.9
作者：
Moher, D;Pham, B;Klassen, TP
通讯作者：
Klassen, TP
影响因子：
3.2
作者：
Olivo, Susan Armijo;Macedo, Luciana Gazzi;Magee, David J.
通讯作者：
Magee, David J.
DOI：
10.1136/bmj.b4012
发表时间：
2009-10-19
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Hartling L;Ospina M;Liang Y;Dryden DM;Hooton N;Krebs Seida J;Klassen TP
通讯作者：
Klassen TP
影响因子：
7.7
作者：
Pildal, J.;Hrobjartsson, A.;Gotzsche, P. C.
通讯作者：
Gotzsche, P. C.
影响因子：
1.9
作者：
LANDIS, JR;KOCH, GG
通讯作者：
KOCH, GG