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用于随机临床试验SafeBoosC-III的近红外光谱监测在线培训模块的预试验。

Pilot test of an online training module on near-infrared spectroscopy monitoring for the randomised clinical trial SafeBoosC-III.

作者信息

Hansen Mathias Lühr, Rasmussen Marie Isabel, Rubin Snorre, Pellicer Adelina, Cheng Guoqiang, Xu Xin, Zhaoqing Yin, Zoffmann Vibeke, Greisen Gorm

机构信息

Department of Neonatology, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.

Section for Learning Technology, Center for HR, Kildegårdsvej 28, 2900, Hellerup, Capital Region of Denmark, Denmark.

出版信息

Trials. 2020 Apr 23;21(1):356. doi: 10.1186/s13063-020-4206-6.

Abstract

BACKGROUND

SafeBoosC-III is an international randomised clinical trial to evaluate the effect of treatment of extremely preterm infants during the first 3 days of life based on cerebral near-infrared spectroscopy (NIRS) monitoring versus treatment and monitoring as usual. To ensure high quality of the trial intervention as well as of patient care, we have developed a multilingual web-based training program to train relevant staff and test their competence. As we enter an under-explored area of e-learning, we have conducted a pilot study on the first of the five modules comprising the web-based training program to test the feasibility of developing such a program for an international trial with limited resources.

METHODS

The module in this study focuses on the principles and practice of NIRS monitoring. The pedagogical idea was to integrate training and certification. One-hundred doctors and nurses from five Neonatal Intensive Care Units across China, Spain and Denmark were invited to participate in the pilot study. Upon completion of the NIRS module, participants were invited to evaluate their experience by completing an online survey. Data from closed-ended questions were analysed using descriptive statistics while data from open-ended questions underwent thematic analysis.

RESULTS

In total, 81 of 100 invited staff members entered the training module and completed the online survey. The median time and the number of questions to pass the module was 15 minutes and seven questions, respectively. Most staff found the academic level of the learning material and quiz appropriate (85% and 93% of all staff members, respectively), as well as agreeing that the module was relevant to prepare them to 'use the NIRS device' (90%). Thematic analysis revealed issues such as a discrepancy between learning material and quiz questions, lack of clarity, and technical issues.

CONCLUSION

We provide evidence of the feasibility of developing a multilingual web-based training program for an international trial, despite challenges such as low budget, language barriers and possibly differences in the clinical training of staff. Exploring the integration of training and certification for international trials, the positive results of this study motivate further developments.

TRIAL REGISTRATION

ClinicalTrial.gov, NCT03770741. Registered 10 December 2018.

摘要

背景

SafeBoosC-III是一项国际随机临床试验,旨在评估基于脑近红外光谱(NIRS)监测在出生后前3天对极早产儿进行治疗的效果,与常规治疗和监测进行对比。为确保试验干预以及患者护理的高质量,我们开发了一个基于网络的多语言培训项目,以培训相关工作人员并测试他们的能力。由于我们进入了一个尚未充分探索的电子学习领域,我们对构成基于网络培训项目的五个模块中的第一个模块进行了一项试点研究,以测试在资源有限的情况下为一项国际试验开发这样一个项目的可行性。

方法

本研究中的模块聚焦于NIRS监测的原理与实践。教学理念是将培训与认证相结合。来自中国、西班牙和丹麦五个新生儿重症监护病房的100名医生和护士受邀参加试点研究。完成NIRS模块后,邀请参与者通过完成在线调查来评估他们的体验。对封闭式问题的数据进行描述性统计分析,而对开放式问题的数据进行主题分析。

结果

总共100名受邀工作人员中有81人进入培训模块并完成了在线调查。通过该模块的中位时间和问题数量分别为15分钟和7个问题。大多数工作人员认为学习材料和测验的学术水平合适(分别占所有工作人员的85%和93%),并且同意该模块与让他们“使用NIRS设备”的准备工作相关(90%)。主题分析揭示了诸如学习材料与测验问题之间存在差异、缺乏清晰度以及技术问题等情况。

结论

我们提供了证据,证明尽管存在预算低、语言障碍以及工作人员临床培训可能存在差异等挑战,但为一项国际试验开发基于网络的多语言培训项目是可行的。探索国际试验中培训与认证的整合,本研究的积极结果推动了进一步的发展。

试验注册

ClinicalTrial.gov,NCT03770741。2018年12月10日注册。

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