目的:使用通过偏头痛临床结果评估系统(MiCOAS)项目进行的定性患者访谈获得的数据,更好地了解偏头痛周期各个阶段症状的广度和频率。
背景:偏头痛患者在头痛前期会出现一系列症状,头痛,头痛后,和偏头痛周期的发作期。尽管临床诊断标准和临床试验终点主要集中在主要症状或每月偏头痛日,偏头痛的症状要复杂得多.作为MiCOAS项目的一部分,我们进行了半结构化的定性访谈,以便从患者的角度更好地了解偏头痛相关症状.
方法:这项概念启发研究使用迭代有目的的抽样方法,选择40名自我报告的偏头痛患者进行访谈,这些访谈是通过仅音频网络会议进行的。与偏头痛症状相关的关键主题,包括情绪/情绪症状,是使用内容分析确定的。采访记录也被编码以反映正在讨论的偏头痛阶段,这样病人的经历就可以分阶段进行比较。
结果:40名参与者(50%,n=20发作性偏头痛;50%,n=20慢性偏头痛),年龄在21至70岁之间的人报告了总共60种独特症状,分为30个更广泛的症状类别。参与者报告了所有阶段的7至22种独特症状类别。在头痛和头痛之前,参与者报告的中位数为7.5(四分位距[IQR]=5.5)和8(IQR=4.0)不同的症状类别,而头痛后和发作间期为4(IQR=3.0)和1.5(IQR=2.5)。分别。头痛阶段的头痛是唯一普遍报道的症状(100%,n=40)。汇集所有阶段,其次报告最多的症状是光敏感(93%,n=37),恶心(88%,n=35),烦躁/不耐烦(83%,n=24),声音灵敏度(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症状,包括情绪/情绪症状。如焦虑(30%,n=12),抑郁症(18%,n=7),和愤怒(15%,n=6),以及主要症状,如光敏感度(13%,n=5)和恶心(13%,n=5)。
结论:患者在偏头痛周期的各个阶段经历一系列症状。结果通常与临床预期一致,但是在头痛阶段内外都报告了与偏头痛无关的症状,包括攻击之间。这些发现强调了在制定患者报告的偏头痛临床试验结果指标时评估一系列症状和时机的重要性。
OBJECTIVE: 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.
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.