Amgen, 1 Amgen Center Dr, Thousand Oaks, CA, 91320, USA.
IQVIA, 4820 Emperor Blvd, Durham, NC, 27703, USA.
BMC Neurol. 2022 Mar 18;22(1):103. doi: 10.1186/s12883-022-02626-0.
To establish content validity of a single-item, migraine-specific symptom severity questionnaire for completion by migraine patients, key family members (KFMs) of migraine patients, and Healthcare Professionals (HCPs) who treat migraine patients.
Migraine is a common disabling primary headache disorder with high prevalence and significant socioeconomic burden and personal impacts. There is a need for a global assessment of migraine symptom severity to evaluate potential new therapies from multiple perspectives.
The migraine Global Impression Item (mGI-I) was drafted and tested in a non-interventional, qualitative study comprising telephone interviews with 15 migraine patients, 15 KFMs of migraine patients, and 15 migraine treating HCPs. The mGI-I was drafted with two different item stem options and two different response scale options to ask about the patient's migraine from the perspective of each respondent. Cognitive interviews were conducted to test comprehensiveness, clarity and ease of completion of the different versions of the mGI-I iteratively in three sequential waves of respondents.
Revisions were made to the draft mGI-I after Wave 1 and Wave 2 of the interviews. Changes were made to simplify the item stem (removing unnecessary text), make language more patient-friendly (e.g. use of "migraine attack"), and add clarity to the item stem for consistent interpretation (include descriptive language of migraine attacks). Across both waves there was a preference for a 5-point response scale compared to a 7-point scale. In Wave 3, all respondents found the revised instructions, item stem, and 5-point response scale comprehensive, easy to understand and to answer. No further changes to the mGI-I were made after Wave 3.
This qualitative study of 45 total respondents across 3 subpopulations, established the content validity and appropriateness of the mGI-I in migraine patients, KFMs, and migraine-treating HCPs. The study specifically confirmed that the mGI-I is comprehensive, easily understood and answered for each respondent population.
为偏头痛患者、偏头痛患者的主要家庭成员（KFMs）和治疗偏头痛患者的医疗保健专业人员（HCPs）设计一个单项目、偏头痛特异性症状严重程度问卷，以确定其内容效度。
偏头痛是一种常见的使人丧失能力的原发性头痛障碍，其患病率高，具有显著的社会经济负担和个人影响。需要从多个角度评估偏头痛症状的严重程度，以评估潜在的新疗法。
采用非干预性定性研究方法，对 15 名偏头痛患者、15 名偏头痛患者的主要家庭成员和 15 名偏头痛治疗 HCPs 进行电话访谈，起草并测试偏头痛全球印象项目（mGI-I）。mGI-I 的草案有两个不同的项目起始选项和两个不同的反应量表选项，以便从每个受访者的角度询问患者的偏头痛情况。认知访谈在三个连续的受访者波次中，迭代地测试不同版本的 mGI-I 的全面性、清晰度和完成的难易程度。
在访谈的第 1 波和第 2 波之后，对草案 mGI-I 进行了修订。对项目起始进行了修改，以简化项目起始（删除不必要的文本），使语言更适合患者（例如使用“偏头痛发作”），并为项目起始添加清晰度以进行一致的解释（包括偏头痛发作的描述性语言）。在这两波中，与 7 分制相比，受访者更倾向于使用 5 分制。在第 3 波中，所有受访者都认为经过修订的说明、项目起始和 5 分制反应量表全面、易于理解和回答。在第 3 波之后，mGI-I 没有进行进一步修改。
本研究对来自 3 个亚人群的 45 名总受访者进行了定性研究，确定了 mGI-I 在偏头痛患者、KFMs 和偏头痛治疗 HCPs 中的内容效度和适宜性。该研究特别证实，mGI-I 对每个受访者群体都是全面的、易于理解和回答的。
