Abstract：
To better understand the level of agreement among retina specialists on the role of inflammation in diabetic retinopathy (DR) and diabetic macular edema (DME), and the use of 0.19-mg fluocinolone acetonide (FAc) implant in DME treatment, a consensus survey was drafted and disseminated to retina specialists across the United States.
Using the modified Delphi method, a list of 12 consensus statements were generated by the coauthors based on short-answer responses to an initial survey. In total, 56 retina specialists completed the entire consensus survey. Except for two multiple-choice questions, there were 10 consensus statements that used a modified Likert scale to indicate their level of agreement to the statement: Agree = 3, Mostly Agree = 2, Mostly Disagree = 1, Disagree = 0. Percentage agreement and 95% confidence intervals (CIs) were calculated, and a consensus threshold was set at > 80% agreement for each statement.
Seven of 10 consensus statements using the modified Likert scale reached consensus, including those on the role of inflammation in pathophysiology of DR/DME, injection burden and patient adherence, and efficacy and safety of the FAc implant. The remaining three statements displayed high agreement with average scores > 80%, but the 95% CIs were below threshold. These included the impact of the FAc implant on DR progression, FAc as baseline therapy for DME, and the effectiveness of the steroid challenge to mitigate intraocular pressure risk after FAc use. Two multiple-choice questions focused on clinical situations in which corticosteroids would be used as baseline therapy for DME (pseudophakic eye [73%], recent stroke/myocardial infarction [66%], and pregnancy/breastfeeding [66%]) and which delivery route satisfies the steroid challenge for the FAc implant (intravitreal [100%], sub-tenon/periocular [73%], and topical [57%]).
Physicians highly agreed on the role of inflammation in pathophysiology of DR/DME, injection burden and patient adherence, and efficacy and safety of the FAc implant. However, full consensus was not found on the impact of the FAc implant on DR progression, FAc as baseline therapy for DME, and the effectiveness of the steroid challenge to mitigate intraocular pressure risk after FAc use. [Ophthalmic Surg Lasers Imaging Retina. 2023;54(3):166-173.].
Using the modified Delphi method, a list of 12 consensus statements were generated by the coauthors based on short-answer responses to an initial survey. In total, 56 retina specialists completed the entire consensus survey. Except for two multiple-choice questions, there were 10 consensus statements that used a modified Likert scale to indicate their level of agreement to the statement: Agree = 3, Mostly Agree = 2, Mostly Disagree = 1, Disagree = 0. Percentage agreement and 95% confidence intervals (CIs) were calculated, and a consensus threshold was set at > 80% agreement for each statement.
Seven of 10 consensus statements using the modified Likert scale reached consensus, including those on the role of inflammation in pathophysiology of DR/DME, injection burden and patient adherence, and efficacy and safety of the FAc implant. The remaining three statements displayed high agreement with average scores > 80%, but the 95% CIs were below threshold. These included the impact of the FAc implant on DR progression, FAc as baseline therapy for DME, and the effectiveness of the steroid challenge to mitigate intraocular pressure risk after FAc use. Two multiple-choice questions focused on clinical situations in which corticosteroids would be used as baseline therapy for DME (pseudophakic eye [73%], recent stroke/myocardial infarction [66%], and pregnancy/breastfeeding [66%]) and which delivery route satisfies the steroid challenge for the FAc implant (intravitreal [100%], sub-tenon/periocular [73%], and topical [57%]).
Physicians highly agreed on the role of inflammation in pathophysiology of DR/DME, injection burden and patient adherence, and efficacy and safety of the FAc implant. However, full consensus was not found on the impact of the FAc implant on DR progression, FAc as baseline therapy for DME, and the effectiveness of the steroid challenge to mitigate intraocular pressure risk after FAc use. [Ophthalmic Surg Lasers Imaging Retina. 2023;54(3):166-173.].
摘要：
目的：为了更好地了解视网膜专家对炎症在糖尿病性视网膜病变（DR）和糖尿病性黄斑水肿（DME）中的作用的共识水平，以及在DME治疗中使用0.19mg氟轻松（FAc）植入物，起草了一项共识调查,并分发给美国各地的视网膜专家.
方法：使用改进的Delphi方法，共同作者基于对初始调查的简短回答,生成了12份共识声明.总的来说,56位视网膜专家完成了整个共识调查。除了两个选择题,有10个共识声明使用了修改后的李克特量表来表明他们对声明的同意程度：同意=3，大多数同意=2，大多数不同意=1，不同意=0。计算了一致性百分比和95%置信区间(CI)，每个陈述的共识阈值设定为>80%。
结果：使用改进的李克特量表的10份共识声明中有7份达成共识，包括炎症在DR/DME病理生理学中的作用，注射负担和患者依从性，FAc植入物的有效性和安全性。其余三个陈述显示出较高的一致性，平均得分>80%，但95%CI低于阈值。这些包括FAc植入物对DR进展的影响，FAc作为DME的基线治疗，以及使用FAc后，类固醇激发减轻眼压风险的有效性。两个多项选择题集中在临床情况下，皮质类固醇将被用作DME的基线治疗（假晶状体眼[73％]，近期中风/心肌梗死[66%]，和妊娠/母乳喂养[66%]），以及哪种分娩途径满足FAc植入物的类固醇挑战（玻璃体内[100%]，下腱/眼周[73%]，和局部[57%])。
结论：医师高度认同炎症在DR/DME病理生理学中的作用，注射负担和患者依从性，FAc植入物的有效性和安全性。然而,对于FAc植入物对DR进展的影响未发现完全共识，FAc作为DME的基线治疗，以及使用FAc后，类固醇激发减轻眼压风险的有效性。[眼科手术激光成像视网膜。2023年；54（3）：166-173。].
方法：使用改进的Delphi方法，共同作者基于对初始调查的简短回答,生成了12份共识声明.总的来说,56位视网膜专家完成了整个共识调查。除了两个选择题,有10个共识声明使用了修改后的李克特量表来表明他们对声明的同意程度：同意=3，大多数同意=2，大多数不同意=1，不同意=0。计算了一致性百分比和95%置信区间(CI)，每个陈述的共识阈值设定为>80%。
结果：使用改进的李克特量表的10份共识声明中有7份达成共识，包括炎症在DR/DME病理生理学中的作用，注射负担和患者依从性，FAc植入物的有效性和安全性。其余三个陈述显示出较高的一致性，平均得分>80%，但95%CI低于阈值。这些包括FAc植入物对DR进展的影响，FAc作为DME的基线治疗，以及使用FAc后，类固醇激发减轻眼压风险的有效性。两个多项选择题集中在临床情况下，皮质类固醇将被用作DME的基线治疗（假晶状体眼[73％]，近期中风/心肌梗死[66%]，和妊娠/母乳喂养[66%]），以及哪种分娩途径满足FAc植入物的类固醇挑战（玻璃体内[100%]，下腱/眼周[73%]，和局部[57%])。
结论：医师高度认同炎症在DR/DME病理生理学中的作用，注射负担和患者依从性，FAc植入物的有效性和安全性。然而,对于FAc植入物对DR进展的影响未发现完全共识，FAc作为DME的基线治疗，以及使用FAc后，类固醇激发减轻眼压风险的有效性。[眼科手术激光成像视网膜。2023年；54（3）：166-173。].
