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J. L. Keltner, K. E. Cello, L. J. Balcer, P. A. Calabresi, C. E. Markowitz, J. S. Werner; OCT Quality Control in Two Multi-Center Multiple Sclerosis (MS) Therapeutic Trials. Invest. Ophthalmol. Vis. Sci. 2010;51(13):656.
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© ARVO (1962-2015); The Authors (2016-present)
To report the influence of Optical Coherence Tomography (OCT) quality control (QC) procedures on rates of test parameter and shipping errors in 2 multi-center MS therapeutic trials.
The UC Davis OCT Reading Center evaluated 10,910 OCT scans from 534 subjects enrolled in two MS therapeutic trials. 2,178 scans from 40 patients were evaluated in Trial 1, and 8,732 scans from 494 subjects were evaluated in Trial 2. Trial 1 involved secondary progressive MS patients while Trial 2 involved relapsing-remitting MS patients. Technicians were certified for OCT in Trial 1 and submitted OCT data in accordance with the Center’s protocol. There was no technician certification/ongoing monitoring in Trial 2. The QC system addressed 2 areas of clinic performance: test parameter and shipping errors. Test parameter errors included; signal strength < 7, exported data missing, missing scans, extra scans performed, scans requiring redraws, and scans performed on the wrong instrument.
22% (1,926/8,732) of the scans had signal strength < 7 in Trial 2, while only 3.7% (81/2,178) had a signal strength < 7 in Trial 1. Trial 2 had 10.3% (897/8,732) of the scans missing exported data;Trial 1 had 0 scans with the same error. Trial 1 contained 191 (2.2%) missing scans while Trial 2 contained only 34 (1.6%). The technicians in Trial 1 performed 1,040 (11.9%) extra scans while Trial 2 technicians performed only 29 (1.3%). Trial 2 had 67 scans (1%) performed on the wrong instrument and 64 scans (1%) required a redraw of the analysis line, while Trial 1 had neither error.
Technicians who are trained and certified in standard fashion help reduce poor quality OCT data in MS trials. Prompt transmission of OCT data to the Reading Center for ongoing and intensive QC monitoring and rapid feedback to technicians helps to reduce the frequency of incorrect testing parameter and shipping errors in large multicenter trials.
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