TY - JOUR
T1 - Sociodemographic and clinical predictors of participation in two randomized trials
T2 - Findings from the Collaborative Ocular Melanoma Study COMS Report No. 7
AU - Diener-West, M.
AU - Hawkins, B. S.
AU - Moy, C. S.
AU - Earle, J. D.
N1 - Funding Information:
This work was supported by the National Eye Institute and the National Cancer Institute under cooperative agreement EY-06287 National Institutes of Health, Bethesda, Maryland. Preliminary analyses of some of the findings reported herein were presented to the Society for Clinical Trials (Controlled Clin Trials 1991;12:657 and the Association for Research in Vision and Ophthalmology (Invest Ophthalmol Vis Sci 1991;34:980). The authors acknowledge the contributions of Diane M. Willis, PhD, in the early development of this work.
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2001
Y1 - 2001
N2 - Collecting sociodemographic and clinical data concerning patients 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 Collaborative Ocular Melanoma 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 patients with choroidal melanoma. One trial is for patients with large tumors and the other trial is for patients with medium-sized tumors. The same baseline sociodemographic and clinical data were collected for both enrolled patients and eligible patients who did not enroll in the randomized trials during the first 3 years of patient recruitment. Partial information on nonrandomized patients was collected thereafter. Recruitment ended in the large tumor and medium tumor trials on December 31, 1994, and July 31, 1998, respectively. From November 1986 through July 1998, 6906 patients with choroidal melanoma 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 tumor 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 tumor 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 tumor 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 tumor basal diameter, and worse initial visual acuity in the study eye. Knowledge of possible sociodemographic and clinical predictors of differentials in patient participation for nonenrolled patients may help to refine patient education and recruitment strategies for future trials. Patient 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 patients.
AB - Collecting sociodemographic and clinical data concerning patients 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 Collaborative Ocular Melanoma 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 patients with choroidal melanoma. One trial is for patients with large tumors and the other trial is for patients with medium-sized tumors. The same baseline sociodemographic and clinical data were collected for both enrolled patients and eligible patients who did not enroll in the randomized trials during the first 3 years of patient recruitment. Partial information on nonrandomized patients was collected thereafter. Recruitment ended in the large tumor and medium tumor trials on December 31, 1994, and July 31, 1998, respectively. From November 1986 through July 1998, 6906 patients with choroidal melanoma 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 tumor 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 tumor 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 tumor 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 tumor basal diameter, and worse initial visual acuity in the study eye. Knowledge of possible sociodemographic and clinical predictors of differentials in patient participation for nonenrolled patients may help to refine patient education and recruitment strategies for future trials. Patient 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 patients.
KW - Enrollment
KW - Informed consent
KW - Ocular melanoma
KW - Participation
KW - Randomized trial
UR - http://www.scopus.com/inward/record.url?scp=0034808145&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0034808145&partnerID=8YFLogxK
U2 - 10.1016/S0197-2456(01)00157-X
DO - 10.1016/S0197-2456(01)00157-X
M3 - Article
C2 - 11578786
AN - SCOPUS:0034808145
SN - 0197-2456
VL - 22
SP - 526
EP - 537
JO - Controlled clinical trials
JF - Controlled clinical trials
IS - 5
ER -