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将眼内注射从医师转移到护士:一项随机单盲非劣效性研究。

Task shifting of intraocular injections from physicians to nurses: a randomized single-masked noninferiority study.

机构信息

Department of Ophthalmology, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.

Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway.

出版信息

Acta Ophthalmol. 2020 Mar;98(2):139-144. doi: 10.1111/aos.14184. Epub 2019 Jul 3.

Abstract

PURPOSE

To test if task shifting of intraocular injections to nurses in a real-world setting can result in similar visual function outcome with equal safety profile.

METHOD

All patients with either age-related macular degeneration, retinal vein occlusion or diabetic macular oedema remitted to intraocular injections at a tertiary ophthalmology department in Norway between March 2015 and May 2017, were asked to participate. The participants were randomized to either nurse- or physician-administered intraocular injections of anti-vascular endothelial growth factor. The primary outcome measure was change in best-corrected visual acuity from baseline to 1-year follow-up. The mean difference in the primary outcome between the groups was analysed by a noninferiority test with a margin of three letters in disfavour of the nurse group. Adverse events were recorded.

RESULTS

Three hundred and forty-two patients entered the study. Two hundred and fifty-nine completed the 1-year follow-up and were included in the study sample for the analysis of the primary outcome. Nurse-administered intraocular injections were noninferior to physician-administered injections with 0.7 and 1.6 letters gained, respectively (95% CI of the mean difference, -2.9 to 1.0; p = 0.019, one-sided t-test). Two thousand and seventy-seven injections and three ocular adverse events were recorded.

CONCLUSION

Task shifting of intraocular injections to nurses can be performed without increased risk to visual function. Such a task shift can alleviate the burden of performing intraocular injections in ophthalmology departments. To our knowledge, this is the first RCT on task shifting of a surgical procedure from physicians to nurses in a high-income country.

摘要

目的

检验在真实环境中将眼内注射操作交由护士执行是否能够达到与医生操作类似的视觉功能结果,且安全性相当。

方法

2015 年 3 月至 2017 年 5 月,所有在挪威一家三级眼科医院接受眼内注射治疗的年龄相关性黄斑变性、视网膜静脉阻塞或糖尿病性黄斑水肿患者均被邀请参与该项研究。参与者被随机分配至由护士或医生进行的眼内抗血管内皮生长因子注射。主要观察指标为自基线至 1 年随访时最佳矫正视力的变化。采用非劣效性检验对两组间的主要结局指标进行分析,以 3 个字母为界,偏向护士组。记录不良事件。

结果

342 例患者入组研究。259 例完成 1 年随访,被纳入主要结局分析的研究样本。护士执行的眼内注射与医生执行的注射相比,分别获得 0.7 和 1.6 个字母的提高(两组间平均差值的 95%置信区间为-2.9 至 1.0;p=0.019,单侧 t 检验)。共记录了 2077 次注射和 3 次眼部不良事件。

结论

将眼内注射操作交由护士执行不会增加视觉功能风险。这种操作分工的转变可以减轻眼科部门执行眼内注射的负担。据我们所知,这是首个在高收入国家将手术操作从医生转移到护士的随机对照试验。

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