掩蔽 5%聚维酮碘处理的效果：减少腺病毒感染患者天数的研究。

Success of Masking 5% Povidone-Iodine Treatment: The Reducing Adenoviral Patient Infected Days Study.

机构信息

Illinois Eye and Ear Infirmary, University of Illinois at Chicago, Chicago, Illinois.

Department of Ophthalmology and Visual Sciences, Washington University, St. Louis, Missouri.

出版信息

Optom Vis Sci. 2021 May 1;98(5):469-475. doi: 10.1097/OPX.0000000000001691.

DOI:10.1097/OPX.0000000000001691

PMID:33973917

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8665724/

Abstract

SIGNIFICANCE

The effectiveness of masking is rarely evaluated or reported in single- or double-masked clinical trials. Knowledge of treatment assignment by participants and clinicians can bias the assessment of treatment efficacy.

PURPOSE

This study aimed to evaluate the effectiveness of masking in a double-masked trial of 5% povidone-iodine for the treatment of adenoviral conjunctivitis.

METHODS

The Reducing Adenoviral Patient Infected Days study is a double-masked, randomized trial comparing a one-time, in-office administration of 5% povidone-iodine with artificial tears for the treatment of adenoviral conjunctivitis. Masking was assessed by asking participants and masked clinicians at designated time points if they believed the treatment administered was povidone-iodine or artificial tears, or if they were unsure. Adequacy of masking was quantified using a modified Bang Blinding Index.

RESULTS

Immediately after treatment, 34% of participants who received povidone-iodine and 69% of those who received artificial tears guessed incorrectly or were unsure of their treatment (modified Bang Indices of 0.31 and -0.38, respectively). On day 4, 38% of the povidone-iodine participants and 52% of the artificial tear participants guessed incorrectly or were unsure of their treatment (modified Bang Indices of 0.24 and -0.05, respectively), indicating adequate and ideal masking. On days 1, 4, 7, 14, and 21, masked clinicians guessed incorrectly or were unsure of treatment in 53%, 50%, 40%, 39%, and 42% among povidone-iodine participants compared with 44%, 35%, 38%, 35%, and 39% among artificial tears participants, respectively. The modified Bang Indices for clinician masking in the povidone-iodine group ranged from -0.05 to 0.25 and from 0.13 to 0.29 in the artificial tears group.

CONCLUSIONS

Masking of participants and clinicians was adequate. Successful masking increases confidence that subjective measurements are not biased. We recommend quantitative assessment and reporting the effectiveness of masking in ophthalmic clinical trials.

摘要

意义

在单盲或双盲临床试验中，很少评估或报告掩蔽的效果。参与者和临床医生对治疗分配的了解可能会影响对治疗效果的评估。

目的

本研究旨在评估 5%聚维酮碘治疗腺病毒结膜炎的双盲试验中掩蔽的效果。

方法

减少腺病毒患者感染天数研究是一项双盲、随机对照试验，比较了一次在办公室给予 5%聚维酮碘与人工泪液治疗腺病毒结膜炎。通过在指定时间点询问参与者和掩蔽临床医生他们是否认为给予的治疗是聚维酮碘还是人工泪液，或者他们是否不确定，来评估掩蔽效果。使用改良的 Bang 掩蔽指数定量评估掩蔽的充分性。

结果

治疗后立即，接受聚维酮碘治疗的 34%的参与者和接受人工泪液治疗的 69%的参与者猜错或不确定他们的治疗（改良 Bang 指数分别为 0.31 和-0.38）。第 4 天，38%的聚维酮碘组参与者和 52%的人工泪液组参与者猜错或不确定他们的治疗（改良 Bang 指数分别为 0.24 和-0.05），表明掩蔽充分且理想。在第 1、4、7、14 和 21 天，掩蔽临床医生在聚维酮碘组中猜错或不确定治疗的比例分别为 53%、50%、40%、39%和 42%，而在人工泪液组中分别为 44%、35%、38%、35%和 39%。聚维酮碘组的改良 Bang 指数范围为-0.05 至 0.25，人工泪液组的改良 Bang 指数范围为 0.13 至 0.29。