Loudon Sjoukje E, Fronius Maria, Looman Caspar W N, Awan Musarat, Simonsz Brigitte, van der Maas Paul J, Simonsz Huibert J
Department of Ophthalmology, University Medical Center Rotterdam, Rotterdam, The Netherlands.
Invest Ophthalmol Vis Sci. 2006 Oct;47(10):4393-400. doi: 10.1167/iovs.05-1428.
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.
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.
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.
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.
不依从是弱视遮盖治疗成功的限制因素之一。本研究采用电子监测来调查不依从的预测因素,并通过一项前瞻性随机临床试验确定一项教育计划的有效性。
对310名新诊断的弱视儿童每3个月进行为期1周的电子依从性测量。评估家庭人口统计学参数和儿童临床参数对依从性水平的影响。除了标准的视光学护理外,将儿童随机分为接受教育卡通故事、奖励贴纸和家长信息单(干预组),或彩色图片(参照组)。研究人员在家庭访视期间分发这些物品和电子设备。主要结局指标是两组的依从率(实际遮盖时间/规定遮盖时间)。次要结局指标是人口统计学和临床因素对依从性的影响。
依从性与父母的国语流利程度、原籍国、教育水平以及儿童的初始视力有关。在第一个为期1周的测量期内,干预组儿童的依从性优于参照组(78%±32%对57%±40%;P<0.0001),完全没有遮盖的儿童更少(参照组为3例,干预组为23例;P<0.0001)。在整个研究期间,这种差异一直存在。
父母国语流利程度差、教育水平低以及治疗开始时视力差是依从性低的预测因素。一项主要针对儿童的教育计划提高了依从性,并减少了完全不依从遮盖治疗的儿童数量。