埃博拉病毒在眼部组织和体液中持续存在(EVICT)研究的实施:塞拉利昂视力健康系统加强的经验教训。

Implementation of the Ebola Virus Persistence in Ocular Tissues and Fluids (EVICT) study: Lessons learned for vision health systems strengthening in Sierra Leone.

机构信息

Emory Eye Center, Emory University School of Medicine, Atlanta, Georgia, United States of America.

National Institute for Allergy and Infectious Disease, Bethesda, Maryland, United States of America.

出版信息

PLoS One. 2021 Jul 9;16(7):e0252905. doi: 10.1371/journal.pone.0252905. eCollection 2021.

Abstract

BACKGROUND

Following the West African Ebola virus disease (EVD) outbreak of 2013-2016 and more recent EVD outbreaks in the Democratic Republic of Congo, thousands of EVD survivors are at-risk for sequelae including uveitis, which can lead to unremitting inflammation and vision loss from cataract. Because of the known risk of Ebola virus persistence in ocular fluid and the need to provide vision-restorative, safe cataract surgery, the Ebola Virus Persistence in Ocular Tissues and Fluids (EVICT) Study was implemented in Sierra Leone. During implementation of this multi-national study, challenges included regulatory approvals, mobilization, community engagement, infection prevention and control, and collaboration between multiple disciplines. In this report, we address the multifacted approach to address these challenges and the impact of implementation science research to address an urgent clinical subspecialty need in an outbreak setting.

METHODOLOGY/PRINCIPAL FINDINGS: Given the patient care need to develop a protocol to evaluate ocular fluid for Ebola virus RNA persistence prior to cataract surgery, as well as protocols to provide reassurance to ophthalmologists caring for EVD survivors with cataracts, the EVICT study was designed and implemented through the work of the Ministry of Health, Sierra Leone National Eye Programme, and international partnerships. The EVICT study showed that all 50 patients who underwent ocular fluid sampling at 19 and 34 months, respectively, tested negative for Ebola virus RNA. Thirty-four patients underwent successful cataract surgery with visual acuity improvement. Here we describe the methodology for study implementation, challenges encountered, and key issues that impacted EVD vision care in the immediate aftermath of the EVD outbreak. Key aspects of the EVICT study included defining the pertinent questions and clinical need, partnership alignment with key stakeholders, community engagement with EVD survivor associations, in-country and international regulatory approvals, study site design for infection prevention and control, and thorough plans for EVD survivor follow-up care and monitoring. Challenges encountered included patient mobilization owing to transportation routes and distance of patients in rural districts. Strong in-country partnerships and multiple international organizations overcame these challenges so that lessons learned could be applied for future EVD outbreaks in West and Central Africa including EVD outbreaks that are ongoing in Guinea and Democratic Republic of Congo.

CONCLUSIONS/SIGNIFICANCE: The EVICT Study showed that cataract surgery with a protocol-driven approach was safe and vision-restorative for EVD survivors, which provided guidance for EVD ophthalmic surgical care. Ophthalmologic care remains a key aspect of the public health response for EVD outbreaks but requires a meticulous, yet partnered approach with international and local in-country partners. Future efforts may build on this framework for clinical care and to improve our understanding of ophthalmic sequelae, develop treatment paradigms for EVD survivors, and strengthen vision health systems in resource-limited settings.

摘要

背景

2013 年至 2016 年西非埃博拉病毒病(EVD)爆发以及刚果民主共和国最近的几次 EVD 爆发后,数千名 EVD 幸存者面临后遗症的风险,包括葡萄膜炎,这可能导致白内障引起的持续炎症和视力丧失。由于已知埃博拉病毒在眼液中持续存在的风险,以及需要提供恢复视力的、安全的白内障手术,因此在塞拉利昂实施了埃博拉病毒在眼组织和液中的持续存在(EVICT)研究。在实施这项多国研究时,面临的挑战包括监管批准、动员、社区参与、感染预防和控制以及多学科之间的合作。在本报告中,我们将介绍解决这些挑战的多方面方法,以及实施科学研究对解决暴发环境中紧急临床专科需求的影响。

方法/主要发现:鉴于为白内障手术前评估眼液中埃博拉病毒 RNA 持续存在而制定方案的患者护理需求,以及为眼科医生为患有白内障的 EVD 幸存者提供护理提供方案的需求,EVICT 研究通过塞拉利昂卫生部、塞拉利昂国家眼科计划以及国际合作伙伴的工作进行了设计和实施。EVICT 研究表明,分别在 19 个月和 34 个月时对 50 名接受眼液取样的患者进行了检测,结果均为埃博拉病毒 RNA 阴性。34 名患者成功接受了白内障手术,视力得到了改善。在这里,我们描述了研究实施的方法、遇到的挑战以及对 EVD 爆发后立即对 EVD 视力护理产生影响的关键问题。EVICT 研究的关键方面包括定义相关问题和临床需求、与主要利益相关者建立伙伴关系、与 EVD 幸存者协会进行社区参与、获得国内外监管批准、为感染预防和控制设计研究地点,以及为 EVD 幸存者的随访护理和监测制定全面计划。遇到的挑战包括由于交通路线和农村地区患者的距离而导致的患者动员。强有力的国内伙伴关系和多个国际组织克服了这些挑战,以便将经验教训应用于未来西非和中非的 EVD 爆发,包括在几内亚和刚果民主共和国持续发生的 EVD 爆发。

结论/意义:EVICT 研究表明,白内障手术采用方案驱动的方法是安全且可恢复 EVD 幸存者视力的,为 EVD 眼科手术护理提供了指导。眼科护理仍然是 EVD 爆发公共卫生应对的一个关键方面,但需要与国际和国内合作伙伴进行细致、合作的方法。未来的工作可以在此临床护理框架的基础上,进一步提高我们对眼科后遗症的认识,为 EVD 幸存者制定治疗模式,并加强资源有限环境中的视力健康系统。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1de1/8270115/6e1d118bf738/pone.0252905.g001.jpg

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