Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials
Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials
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DOI：
10.1016/j.jclinepi.2003.12.010
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发表时间：
2004-06-01
影响因子：
7.2
通讯作者：
Ravaud, P
中科院分区：
文献类型：
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作者：
Boutron, I;Tubach, F;Ravaud, P
目的：比较评估髋关节或膝骨关节炎的药物 (PT) 和非药物治疗 (NPT) 的试验中盲法的可行性和揭盲的感知风险。研究设计和设置：两名独立评审员评估了对患者、护理人员和结果评估者进行盲法的可行性、揭盲的感知风险以及 110 份报告中是否报告了盲法。 评估髋关节或膝关节骨关节炎患者的 PT 和 NPT 的随机对照试验 (RCT)。结果：与 PT 试验相比，NPT 试验中对患者（42% vs. 96%；P < .001）、护理人员（12 vs. 96%；P < .001）和结果评估者（34 vs. 98%；P < .001）采用盲法的可能性较低。当判断盲法可行时，对于患者（35 vs. 14%，P = .02）和结果评估者（44 vs. 10%，P = .0004），NPT 试验中的揭盲感知风险通常被认为是中等或重要，而不是 PT 试验。当判断盲法可行时，NPT 报告中对患者（46 vs. 98%，P < .001）、护理提供者（43 vs. 83%，P = .03）和结果评估者（72 vs. 98%，P = .0006）的报道较少。结论：盲法似乎更难实现，并且在 NPT 试验中比 PT 试验中揭盲可能更常见。 (C) 2004 Elsevier Inc. 保留所有权利。
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.