Comparison of survival among eligible patients not enrolled versus enrolled in the Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma.

PURPOSE: To compare survival between patients enrolled in the Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation therapy (PERT) for large choroidal melanoma and eligible patients who did not enroll. METHODS: COMS clinical center personnel prospectively reported to the COMS Coordinating Center all patients with choroidal melanoma examined between November 1986 and December 1994. Deaths of enrolled patients were reported prospectively by clinical center personnel. In a COMS ancillary study, we retrospectively searched medical records of participating clinical centers, the Social Security Death Index, and the National Death Index to determine vital status of eligible patients not enrolled. Cox proportional hazards analysis was used to compare survival within 10 years of baseline reporting and before July 31, 2000, of enrolled patients versus eligible patients not enrolled. RESULTS: Clinical centers that received local institutional review board approval to participate in this ancillary study prospectively reported on 129 of 299 eligible patients not enrolled in the COMS PERT trial. The baseline characteristics of the 129 patients included in this ancillary study were similar to those of the 170 patients not included; 73 patients were reported as deceased. Previously identified prognostic covariates, i.e., age and longest tumor diameter, were confirmed to predict survival in both enrolled patients and eligible patients not enrolled; trial enrollment was not predictive. After adjusting for prognostic covariates and stratifying by clinical center, the estimated hazard ratio (enrolled vs. not-enrolled) was 1.12 (95% confidence interval: 0.83 to 1.51). CONCLUSIONS: The results of the COMS PERT trial should be generalizable to all patients with choroidal melanoma meeting the eligibility criteria for that trial. While the methods we used may not be generalizable to all clinical trials because of unique features of the COMS, other researchers may be able to use similar methods to determine the generalizability of their trial results.

Patients' perceptions of the value of current vision: assessment of preference values among patients with subfoveal choroidal neovascularization--The Submacular Surgery Trials Vision Preference Value Scale: SST Report No. 6.

OBJECTIVE: To improve understanding and awareness of the impact of subfoveal choroidal neovascularization (CNV) on health-related quality of life, we sought to measure the preference value that patients with subfoveal CNV assigned to their health and vision status. PATIENTS AND METHODS: Patients with subfoveal CNV completed telephone interviews about their quality of life prior to enrollment and random treatment assignment in the Submacular Surgery Trials, a set of multicenter randomized controlled trials evaluating outcomes of submacular surgery compared with observation. The interviewers asked patients to rate their current vision on a scale from 0 (completely blind) to 100 (perfect vision). The interviewers also asked them to rate complete blindness and then perfect vision, assuming their health otherwise was the same as it was at the time of the interview, on a scale from 0 (dead) to 100 (perfect health with perfect vision). Scores were converted to a 0 to 1 preference value scale for health and vision status, where 0 represents death and 1 represents perfect health and vision. RESULTS: Of 1015 participants enrolled in the Submacular Surgery Trials, 996 completed interviews that included the rating questions, and 792 (80%) answered all 3 rating questions in a manner permitting calculation of a single overall preference value for their current health and vision status on a scale from 0 (dead) to 1 (perfect). The mean preference value was 0.64 (median, 0.68; interquartile range, 0.51-0.80). The preference values correlated with age (Pearson correlation coefficient, -0.11; P = .002), patients' self-rated perception of overall health (Spearman correlation coefficient, 0.36; P<.001), and self-reported perception of vision (Spearman correlation coefficient, 0.47; P<.001). The preference values were significantly lower with poorer visual acuity in the better eye and greater evidence of dysfunction on either the Hospital Anxiety and Depression Scale or the Physical or Mental Component Summary scales of the Short Form-36 Health Survey but did not differ significantly by gender or other baseline characteristics such as race, treatment assignment, or size of the CNV lesion. CONCLUSIONS: Vision loss from subfoveal CNV is associated with patient preference values that are as low as or lower than values previously reported for other serious medical conditions such as dialysis-dependent renal failure and AIDS, indicating that both unilateral and bilateral CNV have a profound impact on how patients feel about their overall health-related quality of life.