Submacular surgery trials randomized pilot trial of laser photocoagulation versus surgery for recurrent choroidal neovascularization secondary to age-related macular degeneration: II. Quality of life outcomes submacular surgery trials pilot study report number 2.
(Clinical Trial;Journal Article;Multicenter Study)
PURPOSE: To summarize findings from health-related quality-of-life interviews with patients who had recurrent subfoveal choroidal neovascularization secondary to age-related macular degeneration and participated in a randomized pilot trial (focal confluent laser photocoagulation versus submacular surgery) that may assist in planning future assessments of health-related quality of life in patients with age-related macular degeneration. PATIENTS AND METHODS: Of 70 patients enrolled in the pilot trial, 54 were interviewed before random assignment to treatment and provided the data analyzed for this report. Patients were scheduled for follow-up interviews at 6, 12, and 24 months after enrollment. The 36-Item Short-Form Health Survey was used in all cases and was administered by an interviewer. The summary scales, Physical Component Summary and Mental Component Summary, were the focus of this analysis. RESULTS: Median Physical Component Summary and Mental Component Summary score at baseline were 47 and 53, respectively. Distributions of scores at baseline and throughout the 2-year follow-up period were similar in the two treatment arms and consistent with those of a sample of the general US population of similar age. Distributions of both Physical Component Summary scores and Mental Component Summary scores for individual patient subgroups at baseline suggested sensitivity to some measures of baseline vision. During 2 years of follow-up interviews, median changes in Physical Component Summary scores were decreases of six points in the laser arm and three points in the surgery arm; in both treatment arms, median change in Mental Component Summary scores was an increase of 2 points. Two-year changes in visual acuity had no discernible effect on Physical Component Summary scores or Mental Component Summary scores; baseline scores were the strongest predictors of 2-year changes in Physical Component Summary and Mental Component Summary scores. CONCLUSIONS: Overall, summary scores from the 36-Item Short-Form Health Survey and changes in scores over 2 years in this pilot trial were consistent with the ophthalmic outcome measures (reported elsewhere) that showed no important differences between the treatment arms. These health-related quality-of-life findings provided assurance that the similarity of ophthalmic outcomes in the two treatment arms did not mask changes potentially important to patients that were not captured as part of the clinical outcome data.
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