Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, People's Republic of China.
Invest Ophthalmol Vis Sci. 2011 Dec 28;52(13):9674-83. doi: 10.1167/iovs.11-8052.
Although event analysis (EA) and trend analysis (TA) have been widely adopted to evaluate glaucoma progression in clinical trials, there is poor agreement between the strategies and no consensus on strategy selection in clinical practice. With computer simulation of progressive loss of the retinal nerve fiber layer (RNFL), the authors compared the performance of TA and EA for the detection of glaucoma progression.
RNFL progression was modeled with reference to the individual's test-retest variability and the pattern and rate of progression. The sensitivity and specificity of each scenario were computed from 5000 simulated datasets. Simulation results were validated with longitudinal RNFL measurements obtained from 107 glaucoma and glaucoma suspect patients who had a median follow-up period of 38 months.
TA generally attained a sensitivity ≥80% earlier than EA, although EA with a group reproducibility coefficient had a higher sensitivity than TA for eyes with a large test-retest variability in the early follow-up period, albeit at a lower specificity. The specificity of TA was 95% and ranged between 80% and 100% for EA. Independent of test-retest variability and the pattern and rate of progression, TA had an accuracy ≥80% earlier than EA. In the longitudinal study, the detection rate was 42%, 35%, and 3% for TA, whereas it was 11% to 40%, 12% to 28%, and 3% to 23% for EA at 36 months of follow-up in eyes with small, average, and large test-retest variabilities, respectively.
Although test-retest variability is an important determinant in progression analysis, TA generally outperformed EA for the detection of RNFL progression in glaucoma.
尽管事件分析（EA）和趋势分析（TA）已广泛应用于临床试验中评估青光眼的进展，但这两种策略之间的一致性较差，临床实践中也没有关于策略选择的共识。通过对视网膜神经纤维层（RNFL）渐进性丧失的计算机模拟，作者比较了 TA 和 EA 检测青光眼进展的性能。
参照个体的测试-重测变异性以及进展的模式和速度，对 RNFL 进展进行建模。从 5000 个模拟数据集计算每种情况下的敏感性和特异性。通过对 107 例青光眼和疑似青光眼患者进行的纵向 RNFL 测量进行验证，这些患者的中位随访时间为 38 个月。
TA 通常比 EA 更早地达到≥80%的敏感性，尽管在早期随访期间具有较大测试-重测变异性的眼睛中，EA 具有组重现系数，但其敏感性高于 TA，但特异性较低。TA 的特异性为 95%，EA 的范围为 80%至 100%。无论测试-重测变异性以及进展的模式和速度如何，TA 的准确性都比 EA 更早达到≥80%。在纵向研究中，在随访 36 个月时，TA 的检出率分别为 42%、35%和 3%，而在具有较小、平均和较大测试-重测变异性的眼中，EA 的检出率分别为 11%至 40%、12%至 28%和 3%至 23%。
尽管测试-重测变异性是进展分析中的一个重要决定因素，但 TA 通常比 EA 更能检测青光眼的 RNFL 进展。
