Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials

被引:216
作者
Boutron, I
Tubach, F
Giraudeau, B
Ravaud, P
机构
[1] Univ Paris 07, Fac Xavier Bichat, INSERM, EMI 0357,Dept Epidemiol Biostat & Rech Clin,Grp H, F-75877 Paris 18, France
[2] Fac Med Tours, INSERM, CIC 202, F-37032 Tours, France
关键词
randomized controlled trials; single-blind method; double-blind method; critical appraisal; masking;
D O I
10.1016/j.jclinepi.2003.12.010
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
Objective: To compare the feasibility of blinding and the perceived risk of unblinding in trials evaluating pharmacologic (PT) and nonpharmacologic treatments (NPT) of hip or knee osteoarthritis. Study Design and Setting: Two independent reviewers assessed the feasibility of blinding patients, care providers, and outcome assessors, the perceived risk of unblinding, and whether blinding was reported in 110 reports of randomized controlled trials (RCTs) evaluating PT and NPT in patients with hip or knee osteoarthritis. Results: Blinding was considered to be possible less often in NPT trials than in PT trials for patients (42 vs. 96%; P < .001), care providers (12 vs. 96%; P .001), and outcome assessors (34 vs. 98%; P < .001). When blinding was judged feasible, the perceived risk of unblinding was more often considered moderate or important in NPT than PT trials for patients (35 vs. 14%, P = .02) and outcome assessors (44 vs. 10%, P = .0004). When blinding was judged feasible, it was reported less often in NPT reports than in PT reports for patients (46 vs. 98%, P < .001), care providers (43 vs. 83%, P = .03), and outcome assessors (72 vs. 98%, P = .0006). Conclusion: Blinding appears to be more difficult to achieve and unblinding may occur more often in NPT than PT trials. (C) 2004 Elsevier Inc. All rights reserved.
引用
收藏
页码:543 / 550
页数:8
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