The measurement of patient-reported outcomes of refractive surgery: The refractive status and vision profile

Purpose: To develop a questionnaire, the Refractive Status and Vision Profile (RSVP), to assess health-related quality of life associated with refractive error and its correction. Methods: The published literature on patient report of visual and overall function was reviewed, and the RSVP was self-administered by 550 participants with refractive error. Cross-sectional validation was performed using standard psychometric techniques. The responsiveness of the RSVP to surgical intervention was assessed prospectively in a subset of 176 patients. The principal outcome measures were scores on the overall RSVP scale (S) and on 8 RSVP subscales (functioning, driving, concern, expectations, symptoms, glare, optical problems, problems with corrective lenses). Results: The RSVP (S) and its subscales demonstrated very good internal consistency (Cronbach's alpha, 0.70-0.93). S and several subscale scores were independently associated with satisfaction with vision and were more correlated with satisfaction with vision than with either visual acuity or refractive error. Higher refractive error was associated with lower scores on S and on 5 subscales. In the prospective surgical cohort, 15% of patients had some worsening in their total RSVP score; however, substantial variation was seen in the individual subscales where worsening ranged from 7% (problems with corrective lenses) to 41% (driving). The effect size (measure of responsiveness) of the RSVP and most of its subscales was very high. Approximately 14% of patients had significant worsening in 3 or more subscales, and this outcome was found to be independently associated with being dissatisfied with vision following surgery (OR, 5.84; 95% CI, 1.88, 8.13). Conclusions: The RSVP has been validated as a questionnaire that measures patient-reported quality of life related to refractive error and its correction. It is responsive to surgical intervention and provides important information regarding patient outcomes not available from standard clinical measurements.