Fletcher A E, Ellwein L B, Selvaraj S, Vijaykumar V, Rahmathullah R, Thulasiraj R D
Department of Epidemiology and Population Sciences, London School of Hygiene and Tropical Medicine, England.
Arch Ophthalmol. 1997 Jun;115(6):767-74. doi: 10.1001/archopht.1997.01100150769013.
To develop and validate vision function (VF) and quality of life (QOL) instruments in patients with cataracts in the context of large volume surgery in a developing country.
The instruments were developed using a consensus approach. One hundred patients who were undergoing cataract surgery at Aravind Eye Hospital, Madurai, India, were interviewed preoperatively and 3 and 12 months postoperatively. Standard clinical procedures were followed, including measurement of visual acuity. Between-interviewer reproducibility was measured by repeated administration of the preoperative questionnaire. Within-interviewer reproducibility was measured preoperatively in a separate study of 50 patients.
Preoperative scores from the VF and QOL instruments were significantly associated with visual acuity (r = 0.4). Internal reliability (Cronbach alpha) was greater than .9. Both instruments showed large changes after surgery, with effect sizes of 3 or greater for most VF scales (range, 1.8-3.7) and 1 or greater for QOL scales (range, 1.0-2.2). Changes in visual acuity after surgery were correlated with changes in the VF (r = 0.44) and QOL (r = 0.41) scale scores. Between-interviewer reproducibility was acceptable (total VF scale, Spearman r = 0.7; total QOL scale; r = 0.74). The kappa values were lower for within-interviewer reproducibility.
The study provided strong evidence for the validity, reproducibility, and responsiveness of the instruments, and for the feasibility of using them in the setting of a large volume of cataract surgery in a developing country.
在一个发展中国家进行大规模手术的背景下,开发并验证白内障患者的视觉功能(VF)和生活质量(QOL)评估工具。
采用共识法开发这些评估工具。对印度马杜赖阿拉文德眼科医院100例接受白内障手术的患者在术前、术后3个月和12个月进行访谈。遵循标准临床程序,包括测量视力。通过重复发放术前问卷来测量访谈者间的可重复性。在另一项对50例患者的研究中,术前测量访谈者内的可重复性。
VF和QOL评估工具的术前评分与视力显著相关(r = 0.4)。内部信度(Cronbach α)大于0.9。两种评估工具在术后均显示出较大变化,大多数VF量表的效应大小为3或更大(范围为1.8 - 3.7),QOL量表的效应大小为1或更大(范围为1.0 - 2.2)。术后视力变化与VF(r = 0.44)和QOL(r = 0.41)量表评分变化相关。访谈者间的可重复性可接受(总VF量表,Spearman r = 0.7;总QOL量表,r = 0.74)。访谈者内可重复性的kappa值较低。
该研究为评估工具的有效性、可重复性和反应性,以及在发展中国家大量白内障手术环境中使用这些工具的可行性提供了有力证据。