OM t of c.iii - Vision Research Coordinating Center - Washington ...

2/22/96 Chapter 15 Coordinating Center page 15-6
Semi-Annual Data Monitoring and Oversight Committee Report
• At 6 month intervals and upon request, the Coordinating Center
completes extensive monitoring reports for the Data Monitoring and
Oversight Committee.;
• Report to the Data Monitoring and Oversight Committee includes a
summary of recurrent reports to the Clinics, to the CLEK Photography
Reading Center, and to the Coordinating Center as well as quality
assurance reports, recruitment and retention reports, and activity reports
for the Resource Centers;
• Monitoring data for validity of sample size assumptions; and
• Variability in keratometry readings and visual acuity measurements
between Clinics and within patients as an index for quality control.
15.4 Analysis of Baseline Data
• Monitor sample size assumptions;
• Monitor inter-grader and intra-grader reliability at the CPRC;
• Determine the agreement between Clinician and CPRC gradings for
habitual fit, corneal scarring, and FDACL;
• Analysis of Specific aims based on baseline data:
–characterize the association between best-corrected visual acuity and
visual quality of life;
–determine which measurement of visual acuity, best-corrected or
habitual, is most associated with visual quality of life;
–determine if the better eye, the worse eye, or bilateral habitual visual
acuity correlates with visual quality of life;
–characterize the association between corneal curvature as measured by
keratometry and corneal irregularity, corneal scarring, patient’s age,
whether the patient wears spectacles or contact lenses, and type of contact
lenses;