User involvement in the design and development of medical devices in Epilepsy: a systematic review

medRxiv - Neurology Pub Date : 2024-07-24 DOI:10.1101/2024.07.24.24310932

Joao Manuel Ferreira

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引用次数: 0

Abstract

Objective This systematic review aims to describe the involvement of persons with epilepsy (PWE), healthcare professionals (HP) and caregivers (CG) in the design and development of medical devices is epilepsy. Methods: A systematic review was conducted, adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Eligibility criteria included peer-reviewed research focusing on medical devices for epilepsy management, involving users (PWE, CG, and HP) during the MDD process. Searches were performed on PubMed, Web of Science, and Scopus, and a total of 55 relevant articles were identified and reviewed. Results: From 1999 to 2023, there was a gradual increase in the number of publications related to user involvement in epilepsy medical device development (MDD), highlighting the growing interest in this field. The medical devices involved in these studies encompassed a range of seizure detection tools, healthcare information systems, vagus nerve stimulation (VNS) and electroencephalogram (EEG) technologies reflecting the emphasis on seizure detection, prediction, and prevention. PWE and CG were the primary users involved, underscoring the importance of their perspectives. Surveys, usability testing, interviews, and focus groups were the methods employed for capturing user perspectives. User involvement occurs in four out of the five stages of MDD, with production being the exception. Significance User involvement in the MDD process for epilepsy management is an emerging area of interest holding a significant promise for improving device quality and patient outcomes. This review highlights the need for broader and more effective user involvement, as it currently lags in the development of commercially available medical devices for epilepsy management. Future research should explore the benefits and barriers of user involvement to enhance medical device technologies for epilepsy.

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用户参与癫痫医疗设备的设计和开发：系统综述

目的本系统综述旨在描述癫痫患者（PWE）、医疗保健专业人员（HP）和护理人员（CG）参与设计和开发癫痫医疗设备的情况：方法：根据《系统综述和元分析首选报告项目》（PRISMA）指南进行了系统综述。资格标准包括同行评议研究，重点关注用于癫痫管理的医疗设备，在 MDD 过程中涉及用户（PWE、CG 和 HP）。在 PubMed、Web of Science 和 Scopus 上进行了检索，共确定并审查了 55 篇相关文章：结果：从 1999 年到 2023 年，与用户参与癫痫医疗设备开发（MDD）相关的论文数量逐渐增加，表明人们对这一领域的兴趣日益浓厚。这些研究涉及的医疗设备包括一系列癫痫发作检测工具、医疗保健信息系统、迷走神经刺激（VNS）和脑电图（EEG）技术，反映了对癫痫发作检测、预测和预防的重视。PWE 和 CG 是所涉及的主要用户，这凸显了他们观点的重要性。调查、可用性测试、访谈和焦点小组是获取用户观点的方法。在 MDD 的五个阶段中，用户参与了其中的四个阶段，但生产阶段除外。意义用户参与癫痫管理的 MDD 过程是一个新兴的关注领域，对提高设备质量和患者治疗效果具有重大意义。本综述强调了更广泛、更有效的用户参与的必要性，因为目前在用于癫痫管理的商用医疗设备的开发过程中，用户参与还处于滞后状态。未来的研究应探讨用户参与的益处和障碍，以提高癫痫医疗设备技术。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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medRxiv - Neurology

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