Abstract：
UNASSIGNED: 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.
UNASSIGNED: To develop a Patient-Reported Outcome Measure (PROM) which measures the severity of vitamin B12 deficiency symptoms.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: 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.
Plain language titleDevelopment of a Vitamin B12 Deficiency Questionnaire for Clinical Practice and ResearchPlain language summaryThis study is the first step in the development of a questionnaire for vitamin B12 deficiency to measure the severity of vitamin B12 deficiency symptoms. The questionnaire 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). Interviews with patients demonstrated good comprehensibility and comprehensiveness of the questionnaire. Further testing is necessary before the questionnaire can be applied in clinical practice and research.
UNASSIGNED: To develop a Patient-Reported Outcome Measure (PROM) which measures the severity of vitamin B12 deficiency symptoms.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: 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.
Plain language titleDevelopment of a Vitamin B12 Deficiency Questionnaire for Clinical Practice and ResearchPlain language summaryThis study is the first step in the development of a questionnaire for vitamin B12 deficiency to measure the severity of vitamin B12 deficiency symptoms. The questionnaire 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). Interviews with patients demonstrated good comprehensibility and comprehensiveness of the questionnaire. Further testing is necessary before the questionnaire can be applied in clinical practice and research.
摘要：
■由于广泛的可变临床症状与其他疾病和在治疗期间迅速恢复正常的诊断性生物标志物重叠，因此很难识别维生素B12缺乏症并评估B12治疗的效果。这带来了延迟诊断的风险和统一监测B12治疗效果的挑战。需要一种适用于临床实践和临床评估研究的新的临床结果度量。
■开发患者报告的结果测量（PROM），以测量维生素B12缺乏症状的严重程度。
■B12PROM是通过（1）收集专家和文献综述的输入来定义构造并开发概念模型，(2)处理来自医疗保健提供者的输入，科学家,和患者制定项目和反应选择，(3)根据外行人的反馈改进项目，测试面试,对患者进行半结构化认知访谈，以及向前和向后平移(ENG-NL)。
■B12PROM包括62个项目，分为与维生素B12缺乏相关的8类症状（一般，感官,思考,在四肢和/或面部，运动,情感,口和腹部,尿路和生殖器官）。认知访谈表现出良好的可理解性和全面性。
■这项研究是针对维生素B12缺乏的疾病特异性PROM发展的第一步，以测量症状的负担。在PROM可以应用于临床实践和研究之前，需要进一步的验证和可靠性测试。
简单的语言标题制定用于临床实践和研究的维生素B12缺乏问卷简单的语言摘要本研究是制定维生素B12缺乏问卷以衡量维生素B12缺乏症状严重程度的第一步。问卷包括62个项目，分为8类与维生素B12缺乏相关的症状（一般，感官,思考,在四肢和/或面部，运动,情感,口和腹部,尿路和生殖器官）。对患者的访谈表明问卷具有良好的可理解性和全面性。在将问卷应用于临床实践和研究之前，需要进一步的测试。
■开发患者报告的结果测量（PROM），以测量维生素B12缺乏症状的严重程度。
■B12PROM是通过（1）收集专家和文献综述的输入来定义构造并开发概念模型，(2)处理来自医疗保健提供者的输入，科学家,和患者制定项目和反应选择，(3)根据外行人的反馈改进项目，测试面试,对患者进行半结构化认知访谈，以及向前和向后平移(ENG-NL)。
■B12PROM包括62个项目，分为与维生素B12缺乏相关的8类症状（一般，感官,思考,在四肢和/或面部，运动,情感,口和腹部,尿路和生殖器官）。认知访谈表现出良好的可理解性和全面性。
■这项研究是针对维生素B12缺乏的疾病特异性PROM发展的第一步，以测量症状的负担。在PROM可以应用于临床实践和研究之前，需要进一步的验证和可靠性测试。
简单的语言标题制定用于临床实践和研究的维生素B12缺乏问卷简单的语言摘要本研究是制定维生素B12缺乏问卷以衡量维生素B12缺乏症状严重程度的第一步。问卷包括62个项目，分为8类与维生素B12缺乏相关的症状（一般，感官,思考,在四肢和/或面部，运动,情感,口和腹部,尿路和生殖器官）。对患者的访谈表明问卷具有良好的可理解性和全面性。在将问卷应用于临床实践和研究之前，需要进一步的测试。
