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Report of Instrument Development

Astrid E. Fletcher, PhD; Leon B. Ellwein, PhD; S. Selvaraj, MSc; V. Vijaykumar, MSc; Raheem Rahmathullah; R. D. Thulasiraj, MBA

Arch Ophthalmol. 1997;115(6):767-774.

Abstract
Objective
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.

Materials and Methods
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. Withininterviewer reproducibility was measured preoperatively in a separate study of 50 patients.

Results
Preoperative scores from the VF and QOL instruments were significantly associated with visual acuity (r=0.4). Internal reliability (Cronbach ) 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. Betweeninterviewer reproducibility was acceptable (total VF scale, Spearman r=0.7; total QOL scale, r=0.74). The values were lower for within-interviewer reproducibility.

Conclusions
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.

Author Affiliations
From the Department of Epidemiology and Population Sciences, London School of Hygiene and Tropical Medicine, London, England (Dr Fletcher); the National Eye Institute, National Institutes of Health, Bethesda, Md (Dr Ellwein); and Aravind Eye Hospital, Madurai, India (Messrs Selvaraj, Vijaykumar, Rahmathullah, and Thulasiraj).

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