Functional outcome and satisfaction after photorefractive keratectomy - Part 1: Development and validation of a survey questionnaire

Objective: The aim of this study was to develop a valid, reliable, and easy-to-administer instrument to assess patient satisfaction and perceived outcome after bilateral excimer laser photorefractive keratectomy. Design: Development and validation of a psychometric questionnaire. Participants: Consecutive patients who underwent bilateral excimer laser photorefractive keratectomy from May 1994 through May 1997 by 12 surgeons from four collaborating centers. To be eligible, a minimum of 4 months since the last surgery and a maximum of 30 months since the first surgery was required. Methods: The new instrument was derived in part from the Prospective Evaluation of Radial Keratotomy (PERK) study 10-year psychometric questionnaire and the Visual Functional Index (VF-14), an index of functional impairment in patients with cataract. Questions were grouped in seven scales, each covering a specific aspect of quality of vision. These included global satisfaction, quality of uncorrected vision, quality of corrected vision, quality of night vision, glare, daytime driving, and night driving. Main Outcome Measures: Acceptability, reliability, validity, and interpretability of the instrument, as well as its ease of administration. Results: The instrument scale structure was examined and scale scores were created. Item-discriminant validity ensured that questions belonged to their hypothesized scale, based on multitrait correlation analysis. The instrument was shown to be reliable by a high level of internal consistency, and all Cronbach's alpha coefficients were superior or equal to 0.83. Construct-related validity and interpretability were assessed based on correlations between scale scores and clinically recognized success criteria such as visual acuity and refraction. Respondent burden was shown to be minimal. Acceptability of the instrument was shown to be very good, with a participation rate of 74.3% (690 of 929 patients). The instrument is available in English and in French and the translation was shown to be reliable. Conclusions: The acceptability, reliability, and interpretability of the instrument, as well as its ease of administration, were shown to be adequate. This questionnaire appears clinically useful to document patient satisfaction after excimer laser photorefractive keratectomy. Ophthalmology 2000; 107:1783-1789 (C) 2000 by the American Academy of Ophthalmology.