- Email: [email protected]
44P Participation in the IONDT: Race, gender, and age
102S
Abstracts
others axe still being followed. Ultimately, the development of the close-out unmasking protocol will be influenced by many factors including: * Degree of potential for bias * Timeline of the study * Type of treatment regimen * Expectations of the participants * Plans for follow-up care * Funding and staffing issues This presentation will describe the issues faced by the Postmenopausal Estrogen/Progestin Interventions (PEPI) investigators in developing a close-out unmasking protocol and the materials developed by the PEPI Coordinating Center to facilitate the documentation of the process and the presentation of this informa~on to each PEPI participant. 44P PARTICIPATION IN THE IONDT: RACE, GENDER, AND AGE Barbara E. Crawley, Roberta W. Scherer and the lschemic Optic Neuropathy Decompression Trial (IONDT)
Universily of Maryland at Balamore Baltimore, Maryland Studies funded by the federal government are under increased scrutiny and monitoring for particit~ion of minorities, females and the elderly. The IONDT, sponsoredby NEI, is a multicenter randomized clinical trial comparing optic nerve sheath decompression vs careful follow-up for improvement in vision in patients with non-arteritic ischemic optic neuropathy (NAION). Initial screening at one of the 26 Clinical Centers is based on a suspected diagnosis of HA[ON. Eligible patients must be _.> 50 years old and have had onset of visual symptoms within 14 days. The IONDT received referrals for 1,066 potential patients in the first 14 months, of these referrals, 688 patients were screened for entry. The overall enrollment rate of screened patients is 25% (170/688 screened); rates are similar for females (26 ~ (76/218)) and the elderly (27 % (39/146)), but vary with race (Asians, 0 % (0/9); Blacks, 9 % (2/22), Hispanics, 29 % (7/24); Whites, 25% (161/633)). All of the refusals to participate (n = 5) have been beth minorities (1 Black, 1 Hispanic, 3 Asians) and over the age of 75 yrs. Because of the small number of minorities, we are unable to detect patterns among the reasons for ineligibility. Six of the nine Asians were from the three clinics in California. Only 11 of the 26 sites have screened at least one Black patient. The racial makeup of the IONDT may be related to the natural history of NA[ON disease, recruitment practices, or patient eligibility. Recruitment practices may be associated with geographical locations of the Clinical Centers. Funded by NEI Grant No. U10 EY09608.
Abstracts
others axe still being followed. Ultimately, the development of the close-out unmasking protocol will be influenced by many factors including: * Degree of potential for bias * Timeline of the study * Type of treatment regimen * Expectations of the participants * Plans for follow-up care * Funding and staffing issues This presentation will describe the issues faced by the Postmenopausal Estrogen/Progestin Interventions (PEPI) investigators in developing a close-out unmasking protocol and the materials developed by the PEPI Coordinating Center to facilitate the documentation of the process and the presentation of this informa~on to each PEPI participant. 44P PARTICIPATION IN THE IONDT: RACE, GENDER, AND AGE Barbara E. Crawley, Roberta W. Scherer and the lschemic Optic Neuropathy Decompression Trial (IONDT)
Universily of Maryland at Balamore Baltimore, Maryland Studies funded by the federal government are under increased scrutiny and monitoring for particit~ion of minorities, females and the elderly. The IONDT, sponsoredby NEI, is a multicenter randomized clinical trial comparing optic nerve sheath decompression vs careful follow-up for improvement in vision in patients with non-arteritic ischemic optic neuropathy (NAION). Initial screening at one of the 26 Clinical Centers is based on a suspected diagnosis of HA[ON. Eligible patients must be _.> 50 years old and have had onset of visual symptoms within 14 days. The IONDT received referrals for 1,066 potential patients in the first 14 months, of these referrals, 688 patients were screened for entry. The overall enrollment rate of screened patients is 25% (170/688 screened); rates are similar for females (26 ~ (76/218)) and the elderly (27 % (39/146)), but vary with race (Asians, 0 % (0/9); Blacks, 9 % (2/22), Hispanics, 29 % (7/24); Whites, 25% (161/633)). All of the refusals to participate (n = 5) have been beth minorities (1 Black, 1 Hispanic, 3 Asians) and over the age of 75 yrs. Because of the small number of minorities, we are unable to detect patterns among the reasons for ineligibility. Six of the nine Asians were from the three clinics in California. Only 11 of the 26 sites have screened at least one Black patient. The racial makeup of the IONDT may be related to the natural history of NA[ON disease, recruitment practices, or patient eligibility. Recruitment practices may be associated with geographical locations of the Clinical Centers. Funded by NEI Grant No. U10 EY09608.