Parekh Prashant K, Folk James C, Gupta Priya, Russell Stephen R, Sohn Elliott H, Abràmoff Michael D
Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, Iowa.
The Surrey Eye Care Center, Surrey, British Columbia.
Ophthalmol Retina. 2018 Jul;2(7):659-666. doi: 10.1016/j.oret.2018.01.002. Epub 2018 Mar 9.
Fundus fluorescein angiography (FFA) is the standard modality to diagnose and manage choroidal neovascularization (CNV). However, FFA is costly and has considerable morbidity from allergic reactions and a mortality of 1 per 220 000. Since the advent of anti-vascular endothelial growth factor (VEGF) therapy for CNV, OCT has been used extensively to manage CNV, but FFA is still widely used. One recent study found the sensitivity and specificity of OCT compared with FFA in diagnosis of CNV were 100% and 80.8%, respectively. We hypothesize that FFA does not affect the management of patients initially suspected of having CNV to a clinically significant degree.
Evaluation of diagnostic test using vignettes.
A total of 99 patients (99 eyes) who had an initial presentation of later confirmed CNV.
We retrospectively extracted in de-identified form the FFA, OCT, and clinical histories of the subjects. Vignettes were created with a standard narrative clinical history, posterior-pole color fundus image, central B-scan OCT of the initial visit, and early, mid, and late FFA of the affected eye. Four masked retinal specialists reviewed, in randomized order, these vignettes without FFA images (FFA- arm) and answered a forced choice management question: observation, 3 consecutive anti-VEGF injections, or other. After re-randomization, experts again reviewed the vignettes with the addition of the FFA images (FFA+ arm).
Intraobserver and interobserver concordance and reliability statistics within and between specialists.
Among our retina specialists, intraobserver concordances were 89.7%, 88.7%, 88.7%, and 95.9% (average 90.7%, 95% confidence interval [CI], 83.7-97.6). The average interobserver concordance for the FFA- arm was 84.0% (95% CI, 72.6-95.4), and for the FFA+ arm, 81.8% (95% CI, 68.5-95.2); paired t testing demonstrated no significant difference between the FFA- and FFA+ arms: t = 0.6, P = 0.55.
Our data suggest a high degree of agreement in clinical decision making whether FFA was used or not. There was a similar level of agreement among specialists in the FFA- and FFA+ groups, albeit at higher, not statistically significant, variability. We believe these findings further support deferring the use of FFA in the initial management of CNV in AMD, except in treatment failures and nonstandard cases.
眼底荧光血管造影（FFA）是诊断和治疗脉络膜新生血管（CNV）的标准方法。然而，FFA成本高昂，且因过敏反应导致相当高的发病率，死亡率为每220000例中有1例。自从抗血管内皮生长因子（VEGF）疗法用于治疗CNV以来，光学相干断层扫描（OCT）已被广泛用于管理CNV，但FFA仍被广泛使用。最近的一项研究发现，与FFA相比，OCT诊断CNV的敏感性和特异性分别为100%和80.8%。我们假设FFA在临床上对最初怀疑患有CNV的患者的治疗管理没有显著影响。
使用病例 vignettes 对诊断测试进行评估。
共有99例患者（99只眼），最初表现为后来确诊的CNV。
我们以去识别形式回顾性提取了受试者的FFA、OCT和临床病史。通过标准的叙述性临床病史、后极彩色眼底图像、初诊时的中央B超OCT以及患眼的早期、中期和晚期FFA创建病例 vignettes。四位蒙面视网膜专家以随机顺序查看这些没有FFA图像的病例 vignettes（FFA-组），并回答一个强制选择的治疗管理问题：观察、连续3次抗VEGF注射或其他。重新随机分组后，专家们再次查看添加了FFA图像的病例 vignettes（FFA+组）。
专家内部和专家之间的观察者内一致性和可靠性统计。
在我们的视网膜专家中，观察者内一致性分别为89.7%、88.7%、88.7%和95.9%（平均90.7%，95%置信区间[CI]，83.7 - 97.6）。FFA-组的观察者间平均一致性为84.0%（
