McGinley James S, Mangrum Rikki, Gerstein Maya T, McCarrier Kelly P, Houts Carrie R, Buse Dawn C, Bryant Alexandra L, Wirth R J, Lipton Richard B
Vector Psychometric Group, LLC, Chapel Hill, North Carolina, USA.
Patient Centered Outcomes, Open Health Group, Bethesda, Maryland, USA.
Headache. 2025 Feb;65(2):303-314. doi: 10.1111/head.14817. Epub 2024 Sep 2.
To better understand the breadth and frequency of symptoms across the phases of the migraine cycle using data captured from qualitative patient interviews conducted through the Migraine Clinical Outcome Assessment System (MiCOAS) project.
People living with migraine experience a range of symptoms across the pre-headache, headache, post-headache, and interictal phases of the migraine cycle. Although clinical diagnostic criteria and clinical trial endpoints focus largely on cardinal symptoms or monthly migraine days, migraine symptom profiles are far more complex. As a part of the MiCOAS project, semi-structured qualitative interviews were undertaken to better understand the migraine-related symptomology from the patient's viewpoint.
This concept elicitation study used iterative purposeful sampling to select 40 people with self-reported medical diagnosis of migraine for interviews that were conducted via audio-only web conferencing. Key topics related to migraine symptoms, including mood/emotion symptoms, were identified using content analysis. Interview transcripts were also coded to reflect the phase of migraine under discussion, so that patient experiences could be compared by phase.
Forty participants (50%, n = 20 episodic migraine; 50%, n = 20 chronic migraine), aged from 21 to 70 years old reported a total of 60 unique symptoms, which were categorized into 30 broader symptom categories. Participants reported between 7 and 22 unique symptom categories across all phases. During pre-headache and headache, participants reported a median of 7.5 (interquartile range [IQR] = 5.5) and 8 (IQR = 4.0) different symptom categories compared to 4 (IQR = 3.0) and 1.5 (IQR = 2.5) for the post-headache and interictal periods, respectively. Head pain during the headache phase was the only universally reported symptom (100%, n = 40). Pooling across all phases, the next most reported symptoms were light sensitivity (93%, n = 37), nausea (88%, n = 35), irritability/impatience (83%, n = 24), sound sensitivity (80%, n = 32), and fatigue/exhaustion (80%, n = 32). One or more interictal symptoms were reported by 73% (n = 29) of participants and included mood/emotion symptoms, such as anxiety (30%, n = 12), depression (18%, n = 7), and anger (15%, n = 6), as well as cardinal symptoms, such as light sensitivity (13%, n = 5) and nausea (13%, n = 5).
Patients experience a range of symptoms across the phases of the migraine cycle. Results often aligned with clinical expectations, but non-cardinal migraine-related symptoms were reported both inside and outside the headache phase, including between attacks. These discoveries highlight the importance of assessing a range of symptoms and timing when developing patient-reported outcome measures for migraine clinical trials.
通过偏头痛临床结局评估系统（MiCOAS）项目收集的定性患者访谈数据，更好地了解偏头痛周期各阶段症状的范围和频率。
偏头痛患者在偏头痛周期的头痛前、头痛、头痛后和发作间期会经历一系列症状。尽管临床诊断标准和临床试验终点主要关注主要症状或每月偏头痛天数，但偏头痛症状谱要复杂得多。作为MiCOAS项目的一部分，进行了半结构化定性访谈，以从患者角度更好地了解偏头痛相关症状。
本概念引出研究采用迭代目的抽样法，选择40名自我报告有偏头痛医学诊断的患者进行仅通过音频的网络会议访谈。使用内容分析确定与偏头痛症状相关的关键主题，包括情绪/情感症状。访谈记录也进行编码，以反映所讨论的偏头痛阶段，以便按阶段比较患者的经历。
40名参与者（50%，n = 20例发作性偏头痛；50%，n = 20例慢性偏头痛），年龄在21至70岁之间，共报告了60种独特症状，这些症状被归类为30个更广泛的症状类别。参与者在所有阶段报告的独特症状类别为7至22种。在头痛前和头痛期间，参与者报告的不同症状类别中位数分别为7.5（四分位间距[IQR]=5.5）和8（IQR = 4.0），而头痛后和发作间期分别为4（IQR = 3.0）和1.5（IQR = 2.5）。头痛阶段的头痛是唯一普遍报告的症状（100%，n = 40）。综合所有阶段，接下来报告最多的症状是对光敏感（93%，n = 37）、恶心（88%，n = 35）、易怒/不耐烦（83%，n = 24）、对声音敏感（80%，n = 32）和疲劳/疲惫（80%，n = 32）。73%（n = 29）的参与者报告了一种或多种发作间期症状，包括情绪/情感症状，如焦虑（30%，n = 12）、抑郁（18%，n = 7）和愤怒（15%，n = 6），以及主要症状，如对光敏感（13%，n = 5）和恶心（13%，n = 5）。
患者在偏头痛周期各阶段会经历一系列症状。结果通常与临床预期一致，但与偏头痛相关的非主要症状在头痛阶段内外均有报告，包括发作间期。这些发现凸显了在为偏头痛临床试验制定患者报告结局测量指标时评估一系列症状及其发生时间的重要性。
