TY - JOUR
T1 - Participation in the Ischemic Optic Neuropathy Decompression Trial
T2 - Sex, race, and age
AU - Crawley, Barbara
AU - Scherer, Roberta
AU - Langenberg, Patricia
AU - Dickersin, Kay
N1 - Funding Information:
The Ischemic Optic Neuropathy DecompressionTrial (IONDT) was supported by grants from the National Eye Institute (EYog608, EYog545, EY09556, EYo9555, EYo9554, EYo9576, EYo9565, EYo9551, EYo9599, EYo9584, EYo9578, EYo9572, EYo9575, EY09567, EYo9598, EYo9550, EYo9553, EYo9566, EYo9569, EYw79, EYo9571, EYo9568, EYom7, EYo9552, EYo9570, EYo9582, EYo9626). The authors would like to thank Dr. Joanne Katz for providing data on the prevalence ofNA1oN from the Baltimore Eye Survey; Don Everett, NEI Project Officer for the data from the NEI registry of clinical trials; and Dr. Lenworth Johnson and Dr. Steven Feldon for thoughtful review of this document. In addition,we would like to thank the principal investigators of the
PY - 1997
Y1 - 1997
N2 - BACKGROUND. The Ischemic Optic Neuropathy Decompression Trial (IONDT) is a randomized, single masked, multicenter trial designed to assess the safety and efficacy of optic nerve decompression surgery compared with careful follow-up in patients 50 years or older with non-arteritic anterior ischemic neuropathy (NAION). OBJECTIVES. To examine and evaluate the sex, race, and age distributions of the screened, and subsequently enrolled, IONDT population, especially the proportions of female, minority, and elderly patients, and demographic characteristics of clinical center investigators, the geographical location of IONDT Clinical Centers, and the referral patterns of local physicians. SETTING. Twenty-five U.S. clinical centers. PARTICIPANTS. There were 1681 referrals to the Clinical Centers; an Eligibility Screening Form providing demographic information was completed for 1152. FINDINGS. Forty-three percent (495/1152) of screened cases were women. Seven percent (85/1152) were minorities: 33 African-Americans, 34 Hispanics, 17 Asians, and 1 Native-American. The average age was 66 ± 10 years with a range of 22-92 years of age. Of the 1152 referred patients, 305 were eligible for randomization; 258 (85%) of these agreed to participate in the trial. The demographic makeup of the randomized IONDT patients was similar to that of the screened population. CONCLUSIONS. Women and the elderly are well represented in the IONDT. Because the number of participating minorities was low, we cannot reliably assess their level of participation. Both a low incidence of NAION in minorities and a low referral rate of minorities to clinical trials are plausible explanations for our findings.
AB - BACKGROUND. The Ischemic Optic Neuropathy Decompression Trial (IONDT) is a randomized, single masked, multicenter trial designed to assess the safety and efficacy of optic nerve decompression surgery compared with careful follow-up in patients 50 years or older with non-arteritic anterior ischemic neuropathy (NAION). OBJECTIVES. To examine and evaluate the sex, race, and age distributions of the screened, and subsequently enrolled, IONDT population, especially the proportions of female, minority, and elderly patients, and demographic characteristics of clinical center investigators, the geographical location of IONDT Clinical Centers, and the referral patterns of local physicians. SETTING. Twenty-five U.S. clinical centers. PARTICIPANTS. There were 1681 referrals to the Clinical Centers; an Eligibility Screening Form providing demographic information was completed for 1152. FINDINGS. Forty-three percent (495/1152) of screened cases were women. Seven percent (85/1152) were minorities: 33 African-Americans, 34 Hispanics, 17 Asians, and 1 Native-American. The average age was 66 ± 10 years with a range of 22-92 years of age. Of the 1152 referred patients, 305 were eligible for randomization; 258 (85%) of these agreed to participate in the trial. The demographic makeup of the randomized IONDT patients was similar to that of the screened population. CONCLUSIONS. Women and the elderly are well represented in the IONDT. Because the number of participating minorities was low, we cannot reliably assess their level of participation. Both a low incidence of NAION in minorities and a low referral rate of minorities to clinical trials are plausible explanations for our findings.
KW - Eye diseases
KW - Ischemic optic neuropathy
KW - Minorities
KW - Randomized clinical trial
KW - Recruitment
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U2 - 10.3109/09286589709115723
DO - 10.3109/09286589709115723
M3 - Article
C2 - 9377284
AN - SCOPUS:0030698737
VL - 4
SP - 157
EP - 173
JO - Ophthalmic Epidemiology
JF - Ophthalmic Epidemiology
SN - 0928-6586
IS - 3
ER -