Office of Research in Women's Health, Office of the Director, National Institutes of Health, Bethesda, Maryland; Office of the Clinical Director, National Eye Institute, National Institutes of Health, Bethesda, Maryland.
Ophthalmology. 2013 Oct;120(10):2151-9. doi: 10.1016/j.ophtha.2013.03.019. Epub 2013 May 25.
To compare participants' responses to Web-based and paper-and-pencil versions of an ophthalmic, patient-reported outcome (PRO) questionnaire.
Questionnaire development.
Matched subjects with ocular surface disease (OSD) (n = 68) and without OSD (controls, n = 50).
Subjects completed a standard, paper-and-pencil and a Web-based version of the same questionnaire in randomized order. The administered questionnaire included several ophthalmic PRO subscales: the National Eye Institute's (NEI's) Refractive Error Quality of Life Instrument's Clarity of Vision, Near Vision, Far Vision, Glare, Symptoms, Worry, and Satisfaction with Correction subscales; the Ocular Surface Disease Index's (OSDI's) Symptoms subscale; and the NEI's Visual Function Questionnaire's Driving subscale. Possible scores for each subscale ranged from 0 (no difficulty) to 100 (most difficulty). Agreement of subscale scores between modes of administration was assessed using the Bland-Altman approach and multivariable logistic regression.
Subscale scores and an unweighted average total score for each mode of administration.
Mean differences in scores between modes of administration ranged from -2.1 to +2.3 units. Although no differences were found to be statistically significant, the Worry and Satisfaction with Correction subscales approached statistical significance (P = 0.07 and 0.08, respectively). Although most subscale mean differences in score did not differ significantly by gender, age (≥40 vs. <40 years), disease status (OSD vs. control), order of administration, or time between completion of the questionnaires, women had slightly greater score differences than men for the Driving (P = 0.04) and Clarity of Vision (P = 0.03) subscales; those with OSD had greater score differences for Clarity of Vision than did controls (P = 0.0006); and those aged ≥40 years had slightly greater differences in OSDI Symptoms subscale than those aged <40 years (P = 0.04).
To our knowledge, this Food and Drug Administration and NEI collaboration is the first study to evaluate the equivalence of Web-based and paper versions of ophthalmic PRO questionnaires. We found no evidence of clinically significant differences between scores obtained by the 2 modes for any of the examined subscales. A Web-based instrument should yield scores equivalent to those obtained by standard methods, providing a useful tool that may facilitate ophthalmic innovation.
FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.
比较基于网络和纸质版的眼科患者报告结局(PRO)问卷中参与者的反应。
问卷开发。
匹配患有眼表疾病(OSD)的患者(n=68)和无 OSD 的患者(对照组,n=50)。
参与者以随机顺序完成标准的纸质版和基于网络的相同问卷。所使用的问卷包括几个眼科 PRO 子量表:美国国立卫生研究院(NIH)屈光不正生活质量量表的视力清晰度、近视力、远视力、眩光、症状、担忧和矫正满意度子量表;眼表疾病指数(OSDI)的症状子量表;以及 NIH 视觉功能问卷的驾驶子量表。每个子量表的可能得分范围为 0(无困难)至 100(最困难)。使用 Bland-Altman 方法和多变量逻辑回归评估两种管理模式的子量表评分的一致性。
每种管理模式的子量表评分和未加权总分。
管理模式之间的评分差异平均值在-2.1 到+2.3 单位之间。尽管没有发现统计学上的显著差异,但担忧和矫正满意度子量表接近统计学意义(分别为 P=0.07 和 0.08)。尽管大多数子量表的评分差异在性别、年龄(≥40 岁与<40 岁)、疾病状态(OSD 与对照组)、管理顺序或完成问卷之间的时间方面没有显著差异,但女性在驾驶(P=0.04)和视力清晰度(P=0.03)子量表方面的评分差异略大于男性;患有 OSD 的患者在视力清晰度方面的评分差异大于对照组(P=0.0006);年龄≥40 岁的患者在 OSDI 症状子量表上的差异略大于年龄<40 岁的患者(P=0.04)。
据我们所知,这项食品和药物管理局与 NIH 的合作是首次评估眼科 PRO 问卷的基于网络和纸质版本的等效性的研究。我们没有发现两种模式获得的任何检查子量表的分数存在临床显著差异的证据。基于网络的工具应产生与标准方法获得的分数相当的分数,提供一个可能促进眼科创新的有用工具。
作者没有与本文讨论的任何材料有任何专有或商业利益。