在前性研究中对皮肤色调评估的调查
Vanessa R Weir1, Katelyn Dempsey2, Judy Wawira Gichoya3
1Dermatology Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
NPJ digital medicine
|July 16, 2024
概括
像脉冲氧计这样的医疗设备在较暗的皮肤色调中显示出较低的准确性. 标准化皮肤色调评估对于提高设备性能和减少临床研究中的偏见至关重要.
科学领域:
- 生物医学工程 生物医学工程
- 医疗器械规则 医疗器械规则
- 健康 公平 卫生 公平
背景情况:
- 非侵入性医疗工具,包括脉冲氧计和AI诊断系统,在肤色较深的人群中显示出精度下降.
- 美国食品和药物管理局 (FDA) 正在调查监管策略,以提高各种肤色的设备性能.
- 目前在研究中评估皮肤色调的方法缺乏标准化和跨医学领域的一致验证.
研究的目的:
- 解决前性研究中关于皮肤色调评估方法的缺乏共识的问题.
- 突出需要标准化的方法来考虑医疗器械评估中的皮肤色调偏差.
- 为研究人员提出考虑,以提高针对皮肤色偏差的非侵入性工具的稳定性.
主要方法:
- 审查现有的皮肤色调评估工具 (视觉尺度和颜色测量设备).
- 影响精确皮肤色调测量因素的分析 (照明,环境,身体部位,患者状况).
- 讨论种族和民族作为皮肤色调的代理人的不足.
主要成果:
- 没有一个单一的皮肤色调评估工具在不同的医疗领域得到一致使用或验证.
- 准确的皮肤色调测量取决于标准化条件和适当的工具选择.
- 确定了导致不同肤色设备验证不足的系统因素.
结论:
- 标准化皮肤色调评估对于减轻非侵入性医疗器械偏差至关重要.
- 研究人员应在涉及受皮肤色调影响的设备的研究中采用一致的皮肤色调评估方法.
- 实施建议的考虑因素可以提高医疗保健中的设备可靠性和公平性.
- 未来的研究必须优先考虑所有肤色的医疗技术的包容性验证.
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