Development of a New Tool for Evaluating the Benefit of Preventive Treatments for Migraine on Functional Outcomes - The Migraine Functional Impact Questionnaire (MFIQ).
Development of a New Tool for Evaluating the Benefit of Preventive Treatments for Migraine on Functional Outcomes - The Migraine Functional Impact Questionnaire (MFIQ).
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作者：
Hareendran A;Skalicky A;Mannix S;Lavoie S;Desai P;Bayliss M;Thach AV;Mikol DD;Buse DC
本研究的目的是开发一种方法来评估预防偏头痛发作的干预措施的患者相关结果，随后评估一种新的患者报告结果（PRO）工具的内容效度：偏头痛功能影响问卷（MFIQ）。偏头痛预防治疗的目的不仅是减少偏头痛的频率，而且是恢复患者的功能和改善生活质量。遵循基于最佳实践方法和监管指南的多阶段过程，以确保PRO仪器的内容有效性，以评估治疗效果。定性概念启发访谈进行了解成人偏头痛的经验，巩固了该仪器的发展。最初阶段包括根据这些访谈的信息建立一个概念性疾病模型。该CDM用于识别利益概念（COI）以评估预防性治疗的结果。访谈的结果也用于第二阶段，以制定收集这些COI数据的测量框架。在第三阶段，对现有工具进行审查，以确定框架中概念的覆盖范围，并将概念引出的证据提高到饱和的程度，以支持内容有效性。在第四阶段，根据从访谈中收集的定性数据起草了一份文书，以评价框架中的概念。在临床和翻译专家的评论下，新仪器在第五阶段的成人偏头痛患者中进行了测试，使用了两轮认知访谈，并根据访谈反馈进行了修改。在最后阶段，对该文书进行了语言上的调整，使用了建议用于PRO文书的方法，以确保在国际研究中使用的语言版本在概念上是对等的。每种语言版本都通过认知访谈在至少5名母语人士中进行了测试。概念启发访谈的结果表明，偏头痛对功能的各个方面都有影响。基于对清洁发展机制的回顾，我们为选择的概念开发了一个评估功能结果的概念框架——身体和情感功能、日常活动和社会/休闲活动。现有的评价缺乏对概念框架中某些概念的覆盖，有不适合捕捉COI经验的回忆期，或者没有内容效度的证据。一种新的PRO仪器，MFIQ，被开发来解决这些差距。对9名成人偏头痛患者的认知访谈导致MFIQ的项目发生了微小的变化，最后一轮的8次访谈证实了这些变化是可接受的，并支持了其有效性。为测试语言适应性而进行的访谈证实了所评估的25个国家的概念等效性。MFIQ的开发遵循最佳测量实践，以确保内容有效性，并遵循PRO仪器的监管指南，以评估治疗的益处。MFIQ是为临床试验或临床实践设置而开发的，用于跟踪与成人偏头痛最相关的预防性治疗结果。
The objective of this study was to develop a method for evaluating patient‐relevant outcomes of interventions for preventing migraine attacks, followed by an assessment of the content validity of a new patient‐reported outcome (PRO) instrument: the Migraine Functional Impact Questionnaire (MFIQ). The aim of preventive treatments for migraine is not only to reduce migraine frequency, but also to restore patients’ ability to function and improve quality of life. A multi‐stage process based on best practice methods and regulatory guidelines for ensuring content validity of PRO instruments for evaluating treatment benefit was followed. Qualitative concept elicitation interviews conducted to understand the experiences of adults with migraine underpinned the development of the instrument. The initial stage included the development of a conceptual disease model (CDM) based on information from these interviews. This CDM was used to identify the concepts of interests (COI) to evaluate outcomes of preventive treatments. The results of the interviews were also used in stage 2, to develop a measurement framework for collecting data about these COI. In the third stage, existing instruments were reviewed for coverage of the concepts in the framework and evidence of concept elicitation to the point of saturation, to support content validity. In the fourth stage, an instrument was drafted to evaluate concepts in the framework, based on the qualitative data collected from the interviews. Following a review by clinical and translation experts, the new instrument was tested in adults with migraine in the fifth stage using 2 rounds of cognitive interviews, and was modified based on interview feedback. In the last stage, the instrument was linguistically adapted, using methods recommended for PRO instruments, to ensure conceptual equivalence of language versions for use in international studies. Each language version was tested in at least 5 native speakers using cognitive interviews. Results from the concept elicitation interviews suggested that migraine had an impact on various aspects of functioning. A conceptual framework for evaluating functional outcomes was developed for the concept selected based on a review of the CDM – physical and emotional functioning, every day activities, and social/leisure activities. Existing PROs lacked coverage of some concepts in the conceptual framework, had recall periods that were inappropriate for capturing the experience of COI or did not have evidence of content validity. A novel PRO instrument, the MFIQ, was developed to address these gaps. Cognitive interviews with 9 adults with migraine resulted in minor changes to the items of the MFIQ, and a final round of 8 interviews confirmed the changes were acceptable and supported its validity. The interviews conducted to test linguistic adaptations confirmed conceptual equivalence in the 25 countries evaluated. Development of the MFIQ followed best measurement practices to ensure content validity and followed regulatory guidelines for PRO instruments to evaluate benefits of treatments. The MFIQ was developed for use in clinical trials or clinical practice settings to track outcomes of preventive treatments that are most relevant to adults with migraine.
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