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Ocular melanoma study can be applied to general population
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WAILEA, Hawaii — The Collaborative Ocular Melanoma Study is applicable to the general population that falls within its parameters, a surgeon said here.
 Andrew P. Schachat |
"Survival was the same if you were in the study or out of the study," Andrew P. Schachat, MD, said at Retina 2009. "The results of the trial seem to generalize to eligible patients who chose not to enroll."
Dr. Schachat discussed the external validity of the COMS and its ability to be applied to the general population not included in the study. External validity is achieved by having an adequate sample size so there is a reasonable chance that typical subjects and a broad spectrum of subjects with the condition will be sampled; proximity in time as things change over 30 years; and broad inclusion and narrow exclusion criteria.
"The COMS, fortunately, sampled about 50% of the patients around that time that had melanoma, and it has much greater chance that the external validity of that study is going to be there," he said.
Researchers collected data on 129 eligible patients who chose not to enroll in the COMS. Their baseline characteristics were the same as those included in COMS. The researchers then 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 and found results comparable to COMS.
"If you can do this analysis, then you can really have greater ammunition when you try and claim that your results are generalizable and speak to patients out in the community in general," Dr. Schachat said.