Evaluating masking in a randomized, double-masked clinical trial in children with myopia.
Evaluating masking in a randomized, double-masked clinical trial in children with myopia.
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在一项针对近视儿童的随机双盲临床试验中评估遮蔽效果。
DOI：
10.1097/01.opx.0000195564.38235.39
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发表时间：
2006
期刊：
影响因子：
--
通讯作者：
Gwiazda,Jane
中科院分区：
文献类型：
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作者：
Dong,LiMing;Hyman,Leslie;Manny,RuthE;Thomas,Jennifer;Dias,Lynette;McLeod,Jennifer;Gwiazda,Jane
方法：在临床试验结果报告后和家庭被告知他们孩子的透镜分配之前，通过问卷调查评估儿童和父母的掩蔽成功率。以绝对或“相当肯定”的确定性正确猜测其任务的儿童和父母被视为未设盲。儿童的年龄，性别和种族在揭盲的作用进行了评估，使用逻辑回归。使用方差分析研究了揭盲对3年治疗效果的影响。成功的掩蔽的研究验光师进行了评估，在孩子的后续visits.Results.Overall收集的数据93%（436 469）的彗星儿童回答有关透镜分配和确定性的问题。37%（436名儿童中的163名）符合揭盲标准，父母的结果相似。163名“未戴面罩”儿童中的大多数（91%）报告称，他们的眼镜是透镜识别的主要原因。尽管基线时10至11岁的儿童比6至9岁的儿童更容易被揭露（44%比31%，p= 0.01），但男孩和女孩被揭露之间没有差异（p= 0.2）。设盲和未设盲儿童的治疗效果无差异（p= 0.69）。研究验光师成为揭盲的5名儿童在3年的follow-up.Conclusions的过程中，掩蔽成功地保持了研究验光师和大多数（63%）的彗星儿童。尽管一些儿童能够识别其透镜分配，但主要研究结局不受揭盲的影响。
Methods.The success of masking of children and parents was assessed by questionnaires administered after the clinical trial results were reported and before families were informed of their child's lens assignment. Children and parents who correctly guessed their assignment with absolute or “pretty sure” certainty were considered as unmasked. The role of children's age, gender, and ethnicity in unmasking was evaluated using logistic regression. The impact of unmasking on the treatment effect at 3 years was investigated using analysis of variance. The success of masking of the study optometrists was assessed by data collected at the child's follow-up visits.Results.Overall 93%(436 of 469) of the COMET children responded to the questions about lens assignment and certainty. Thirty-seven percent (163 of 436) of children met the criteria for being unmasked with similar results from the parents. The majority (91%) of the 163 “unmasked” children reported that their glasses were the main reason for lens identification. Although children 10 to 11 years at baseline became unmasked more often than did children 6 to 9 years (44% vs. 31%, p= 0.01), there was no difference between boys and girls becoming unmasked (p= 0.2). The treatment effect did not differ between the masked and unmasked children (p= 0.69). The study optometrists became unmasked for five children over the course of 3-year follow up.Conclusions.Masking was successfully maintained for the study optometrists and the majority (63%) of COMET children. Although some children were able to identify their lens assignment, the primary study outcome was not affected by unmasking.