Collecting sociodemographic and clinical data concerning @entity1 who choose not to enroll in a randomized clinical trial can be useful in assessing the feasibility of attaining sample size goals during the course of a trial. It can also aid in addressing the extent of generalizability of trial findings after a trial has ended. The @entity320 Study (COMS) consists of two multicenter randomized clinical trials to evaluate the effectiveness of radiotherapy in comparison to standard enucleation (removal of the affected eye) in prolonging survival of @entity1 with @entity320 . One trial is for @entity1 with large @entity5 and the other trial is for @entity1 with medium-sized @entity5 . The same baseline sociodemographic and clinical data were collected for both enrolled @entity1 and eligible @entity1 who did not enroll in the randomized trials during the first 3 years of @entity1 recruitment. Partial information on nonrandomized @entity1 was collected thereafter. Recruitment ended in the large @entity5 and medium @entity5 trials on December 31, 1994, and July 31, 1998, respectively. From November 1986 through July 1998, 6906 @entity1 with @entity320 were evaluated for the randomized trials, of whom 4191 (61%) were eligible for enrollment. Logistic regression methods were used to identify factors predictive of trial participation. Sociodemographic factors that appeared to be associated (p < 0.15) with participation in the univariable models in the medium @entity5 trial were age 60 years or older, less than college education, nonmanagerial occupation, current smoking, and residing in the same state as a COMS clinical center. In the large @entity5 trial, males, individuals who were not college-educated, and individuals residing in the same state as a COMS clinical center were more likely to enroll. In both trials, clinical determinants of participation were larger @entity5 dimensions and initial visual acuity worse than 20/20 in the study eye. In multivariable regression models, the variables that were significantly predictive of enrollment (p < 0.05) in at least one of the trials were older age, residence in the same state, larger @entity5 basal diameter, and worse initial visual acuity in the study eye. Knowledge of possible sociodemographic and clinical predictors of differentials in @entity1 participation for nonenrolled @entity1 may help to refine @entity1 education and recruitment strategies for future trials. @entity1 enrollment in clinical trials may be increased by heightened physician awareness of such predictors, strategies for addressing these differences, and enhanced communication between physicians and @entity1 .

Sociodemographic and clinical predictors of participation in two randomized trials: findings from the XXXX Study COMS report no. 7.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient', 'Patient'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor', 'tumors'] @entity320 :: ('MESH:D008545', 'Disease') :: ['Collaborative Ocular Melanoma', 'choroidal melanoma']
@entity320 :: (MESH:D008545,Disease) :: ['Collaborative Ocular Melanoma']
