迹象和症状:与绝育装置相关的不良事件
1Department of Public Health, Simmons University, 300 The Fenway, Boston, MA, 02115, USA.
Social science & medicine (1982)
|May 17, 2024
概括
埃苏尔杀菌设备造成了患者的重大痛苦,医生经常忽视. 这项研究强调了需要更好的医疗器械监管和患者护理.
科学领域:
- 医疗器械安全 医疗器械安全
- 生殖健康 生殖健康
- 患者报告的结果
背景情况:
- 女性绝育是美国常见的避孕方法.
- 绝育装置有助于避孕程序的增加.
- 埃苏尔是一种广泛使用的永久避孕装置.
研究的目的:
- 检查Essure灭菌装置的不良事件报告.
- 分析患者报告的症状及其对日常生活的影响.
- 调查与Essure相关的医疗保健经验和医生互动.
主要方法:
- 混合方法研究分析了2500份美国食品和药物管理局 (FDA) 的不良事件报告 (2006-2017年).
- 患者问题 (疼痛,出血) 的定量编码.
- 对症状对生活和医疗保健经验的影响进行定性编码.
主要成果:
- 疼痛和出血是最常见的患者问题.
- 当主观症状缺乏客观临床迹象时,患者面临挑战.
- 医生经常忽视或转移患者的担忧,影响护理.
结论:
- 患者报告的与Essure相关的症状需要彻底调查.
- 与设备相关问题的诊断可能因缺乏客观发现而复杂化.
- 这项研究提出了关于医疗器械监管和患者倡导的关键问题.
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