Priority acute and preventive migraine treatment benefits: Results of the Migraine Clinical Outcome Assessment System (MiCOAS) qualitative study of people living with migraine.
Priority acute and preventive migraine treatment benefits: Results of the Migraine Clinical Outcome Assessment System (MiCOAS) qualitative study of people living with migraine.
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优先急性和预防性偏头痛治疗益处：偏头痛临床结果评估系统 (MiCOAS) 对偏头痛患者的定性研究结果。
作者：
Mangrum,Rikki;Gerstein,MayaT;Hall3rd,CalvinJ;Buse,DawnC;Houts,CarrieR;McGinley,JamesS;McCarrier,KellyP;Lipton,RichardB;Wirth,RJ
背景：在偏头痛治疗结果的确定、定义和优先排序中重新强调纳入患者。目的直接了解偏头痛患者的治疗重点。方法作为偏头痛临床结果评估系统项目的一部分，共进行了40次定性访谈，该项目是美国食品和药物管理局资助的一个项目，旨在为偏头痛临床试验开发一套以患者为中心的核心结果测量方法。访谈包括一个结构化的练习，参与者对急性和预防性偏头痛治疗的潜在益处进行排序。40名报告被临床医生诊断为偏头痛的研究参与者对益处进行了排名，并解释了他们的理由。结果研究参与者一致将缓解疼痛或消除疼痛作为急性治疗的首要任务。缓解/没有其他偏头痛症状和改善功能也是优先考虑的。对于预防性治疗，参与者优先考虑减少偏头痛频率、症状严重程度和发作持续时间。在发作性偏头痛患者和慢性偏头痛患者之间几乎没有发现差异。然而，慢性偏头痛患者的“发作的可预见性增加”的排名远远高于发作性偏头痛患者。参与者的排名受到先前对偏头痛治疗的期望和经验的影响，这导致许多参与者认为期望的益处是不现实的。参与者还确定了几个额外的优先事项，包括在急性和预防性治疗中限制副作用和可靠的治疗效果。研究结果显示，参与者优先考虑的治疗益处与偏头痛研究中使用的现有核心临床结果一致，但也重视非典型评估的益处，如可预测性。当参与者认为治疗不太可能带来这些结果时，他们也会放弃重要的益处。
BackgroundThere is renewed emphasis on including patients in determining, defining, and prioritizing outcomes for migraine treatment.ObjectivesTo obtain insights directly from people living with migraine on their priorities for treatment.MethodsA total of 40 qualitative interviews were conducted as part of the Migraine Clinical Outcome Assessment System project, a United States Food and Drug Administration grant‐funded program to develop a core set of patient‐centered outcome measures for migraine clinical trials. Interviews included a structured exercise in which participants rank‐ordered pre‐defined lists of potential benefits for acute and preventive migraine therapy. The 40 study participants who reported being diagnosed with migraine by a clinician ranked the benefits and explained their rationale.ResultsStudy participants consistently ranked either pain relief or absence of pain as their top priority for acute treatment. Relief/absence of other migraine symptoms and improved functioning were also prioritized. For preventive treatment, participants prioritized reductions in migraine frequency, symptom severity, and attack duration. Few differences were found between participants with episodic migraine and those with chronic migraine. However, participants with chronic migraine ranked “increased predictability of attacks” much higher than those with episodic migraine. Participants' rankings were influenced by prior expectations and experiences of migraine treatments, which caused many participants to deprioritize desired benefits as unrealistic. Participants also identified several additional priorities, including limited side‐effects and reliable treatment efficacy in both acute and preventive treatments.ConclusionThe results showed the participants prioritized treatment benefits aligned with existing core clinical outcomes used in migraine research, but also valued benefits that are not typically assessed, such as predictability. Participants also deprioritized important benefits when they believed treatment was unlikely to deliver those outcomes.