开发用于临床实践和研究的维生素 B12 缺乏症患者报告结果衡量标准。

IF 1.8 4区 医学 Q3 FOOD SCIENCE & TECHNOLOGY Food and Nutrition Bulletin Pub Date : 2024-06-01 DOI:10.1177/03795721241236284
Kim I M Suijker, Clara H M Plattel, Catherine H Seage, Nicola Ward, Delyth H James, Jolande Y Vis
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引用次数: 0

摘要

背景:由于多种多样的临床症状与其他疾病重叠,且诊断生物标志物在治疗过程中会迅速恢复正常,因此很难识别维生素 B12 缺乏症并评估 B12 治疗的效果。这就带来了延误诊断的风险和统一监测 B12 治疗效果的挑战。因此需要一种适合临床实践和临床评估研究的新的临床结果测量方法:目的:开发一种患者报告结果测量法(PROM),用于测量维生素 B12 缺乏症状的严重程度:B12 PROM的开发方法包括:(1)收集专家意见和文献综述,以定义一个结构并建立一个概念模型;(2)处理医疗服务提供者、科学家和患者的意见,以开发项目和回答选项;(3)根据非专业人士的反馈、测试访谈、对患者的半结构化认知访谈以及正向和反向翻译(ENG-NL)改进项目:B12 PROM 包括 62 个项目,分为 8 类与维生素 B12 缺乏有关的症状(全身、感觉、思维、四肢和/或面部、运动、情绪、口腔和腹部、泌尿道和生殖器官)。认知访谈显示出良好的可理解性和全面性:这项研究是为维生素 B12 缺乏症开发疾病特异性 PROM 的第一步,目的是测量症状的负担。在将 PROM 应用于临床实践和研究之前,还需要进行进一步的验证和可靠性测试。
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Development of a Vitamin B12 Deficiency Patient-Reported Outcome Measure for Clinical Practice and Research.

Background: It is difficult to recognize vitamin B12 deficiency and to evaluate the effect of B12 treatment due to a broad range of variable clinical symptoms overlapping with other diseases and diagnostic biomarkers that quickly normalize during treatment. This poses a risk of delay in diagnosis and a challenge to uniformly monitor the effect of B12 treatment. There is a need for a new clinical outcome measure suitable for clinical practice and clinical evaluation studies.

Objective: To develop a Patient-Reported Outcome Measure (PROM) which measures the severity of vitamin B12 deficiency symptoms.

Methods: The B12 PROM was developed by (1) gathering input from experts and literature review to define a construct and develop a conceptual model, (2) processing input from health care providers, scientists, and patients to develop items and response options, and (3) improving items based on the feedback from laypersons, test interviews, semi-structured cognitive interviews with patients, and forward and backward translation (ENG-NL).

Results: The B12 PROM includes 62 items grouped into 8 categories of symptoms related to vitamin B12 deficiency (General, Senses, Thinking, In limbs and/or face, Movement, Emotions, Mouth & Abdomen, Urinary tract & Reproductive organs). Cognitive interviews demonstrated good comprehensibility and comprehensiveness.

Conclusions: This study is the first step in the development of a disease-specific PROM for vitamin B12 deficiency to measure the burden of symptoms. Further validation and reliability testing are necessary before the PROM can be applied in clinical practice and research.

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来源期刊
Food and Nutrition Bulletin
Food and Nutrition Bulletin 工程技术-食品科技
CiteScore
4.10
自引率
0.00%
发文量
31
审稿时长
18-36 weeks
期刊介绍: The Food and Nutrition Bulletin (FNB,) is a peer-reviewed, academic journal published quarterly by the Nevin Scrimshaw International Nutrition Foundation. The Journal is one of the leading resources used by researchers, academics, nutrition policy makers and planners in over 125 countries to obtain the most current research and policy information related to nutrition in developing countries.
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