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开发一种维生素B12缺乏症患者报告的临床实践和研究结果指标
Kim I M Suijker1,2, Clara H M Plattel1,3, Catherine H Seage4
1B12 Institute Research Foundation, Rotterdam, the Netherlands.
Food and nutrition bulletin
|July 10, 2024
概括
由于症状重叠,诊断维生素B12缺乏是具有挑战性的. 开发了一种新的患者报告结果指标 (PROM),用于评估症状严重程度和帮助治疗监测.
科学领域:
- 医学研究 医学研究
- 临床诊断 临床诊断 临床诊断
- 患者报告的结果
背景情况:
- 维生素B12缺乏的诊断是复杂的,因为症状变化和快速正常化的生物标志物.
- 这种诊断挑战可能会推迟治疗,并阻碍对B12治疗有效性的有效监测.
- 需要一种新的临床结果测量方法,以便在临床环境和研究研究中实际使用.
研究的目的:
- 开发一种患者报告结果测量 (PROM),专门设计用于量化与维生素B12缺乏相关的症状的严重程度.
主要方法:
- B12 PROM是通过专家咨询和文献审查创建的,以建立一个概念模型.
- 来自医疗保健专业人员,研究人员和患者的输入告知了项目生成和响应选择.
- 项目精细化涉及非专业人士的反,测试采访,患者认知采访和翻译.
主要成果:
- 维生素B12 PROM包括8个症状类别中的62个项目:一般性,感官,思维,四肢/面部,运动,情绪,口腔/腹部和尿道/生殖器官.
- 认知面试证实了PROM的可理解性和对相关症状的全面覆盖.
结论:
- 这项研究代表了疾病特异性PROM的初步开发阶段,用于评估维生素B12缺乏症症状负担.
- 在广泛的临床和研究应用之前,进一步验证和可靠性测试是必不可少的.
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