PURPOSE:Noncompliance is one of the limiting factors in the success of occlusion therapy for amblyopia. Electronic monitoring was used to investigate predictors of noncompliance, and, in a prospective randomized clinical trial, determined the effectiveness of an educational program. METHODS:Compliance was measured electronically during 1 week every 3 months in 310 newly diagnosed amblyopic children. The family's demographic parameters and the child's clinical parameters were assessed for their influence on the level of compliance. In addition to standard orthoptic care, children were randomized to receive an educational cartoon story, reward stickers, and an information sheet for the parents (intervention group), or a picture to color (reference group). These and the electronic device were distributed during home visits by researchers. The primary outcome measure was the percentage of compliance (actual/prescribed occlusion time) in the two groups. The secondary outcome measure was the influence of demographic and clinical factors on compliance. RESULTS:Compliance was associated with parental fluency in the national language, country of origin, level of education, and initial visual acuity of the child. During the first 1-week measurement period children in the intervention group had better compliance than the reference group had (78% +/- 32% vs. 57% +/- 40%; P < 0.0001), and fewer children were not occluded at all (3 vs. 23 in the reference group; P < 0.0001). This difference remained throughout the study period. CONCLUSIONS:Poor parental fluency in the national language, a low level of education, and poor acuity at the start of treatment were predictors of low compliance. An educational program primarily aimed at the child improved compliance and reduced the number of children who did not comply with occlusion at all.

译文

目的:不依从性是弱视闭塞治疗成功的限制因素之一。电子监控用于调查违规行为的预测因素,并在一项前瞻性随机临床试验中确定了教育计划的有效性。
方法:在310名新诊断的弱视儿童中,每3个月以电子方式测量其依从性,每3个月一次。评估了家庭的人口统计学参数和孩子的临床参数对依从性水平的影响。除了标准的矫正照护外,还对儿童进行随机分组,以接受教育性卡通故事,奖励贴纸和针对父母的信息表(干预组),或为图片着色(参考组)。这些和电子设备是在研究人员进行家庭访问时分发的。主要结局指标是两组的依从性百分比(实际/规定的咬合时间)。次要结果指标是人口统计学和临床​​因素对依从性的影响。
结果:依从性与父母的母语,母语,原籍国,受教育程度以及孩子的初始视敏度有关。在最初的1周测量期间,干预组的孩子比对照组的依从性更好(78%/-32%vs. 57%/-40%; P <0.0001),并且完全没有被闭塞的儿童更少(参考组中3 vs. 23; P <0.0001)。在整个研究期间,这种差异仍然存在。
结论:父母母语流利程度低,教育程度低以及治疗开始时的敏锐度低是依从性低的预示因素。一项主要针对儿童的教育计划提高了依从性,并减少了完全不遵守闭塞的儿童人数。

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