Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA.
School of Social Work, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Headache. 2022 May;62(5):588-595. doi: 10.1111/head.14315. Epub 2022 May 6.
The objective of this study was to describe treatment preferences and perceived quality of existing outcome measures among children and adolescents with migraine and their caregivers.
Across disciplines, there is increasing recognition of the value of direct input from stakeholders. Little empirical work has been done to determine what outcomes matter most to pediatric patients with migraine and their caregivers.
In this qualitative study, we recruited participants from the multicenter, prospective Pediatric Migraine Registry. We used stratified purposive sampling to recruit children and adolescents of varied ages and headache frequency. Patients with migraine and their caregivers completed semistructured interviews targeting treatment preferences and perceived quality of existing outcome measures. Emergent themes and subthemes were identified using conventional content analysis.
Thirty dyads of children/adolescents and their caregivers were enrolled and completed 59 interviews (n = 29 children/adolescent interviews and n = 30 caregiver interviews). Three themes emerged. (1) Symptom relief: Looking beyond headache resolution: Participants described the value of outcomes in addition to pain relief, including a reduction in migraine intensity and improvement in non-pain symptoms. (2) Trade-offs between side effects and relief: Participants described cost-benefit analyses that can occur with headache treatment and acknowledged the impact of drug side effects on daily life and medication adherence. (3) Child-centered treatment: Participants described medication attributes salient to the pediatric context, including age-appropriate routes of administration and adequate safety data.
Children, adolescents, and caregivers impacted by migraine value outcomes in addition to traditionally studied migraine endpoints. Participants valued decreased pain severity, even in the absence of pain resolution. Participants also prioritized the absence of side effects and key medication attributes, including fast onset and age-appropriate routes of administration. These results highlight an opportunity to design patient-centered clinical trials, develop drugs, and support product labeling that align with the outcomes valued most by children and adolescents with migraine and their caregivers.
本研究旨在描述偏头痛患儿及其照护者对现有结局测量指标的治疗偏好和感知质量。
跨学科领域越来越认识到利益相关者直接参与的价值。很少有实证工作来确定偏头痛患儿及其照护者最关注的结果是什么。
在这项定性研究中，我们从多中心前瞻性儿科偏头痛登记处招募了参与者。我们采用分层目的抽样招募了不同年龄和头痛频率的儿童和青少年患者。偏头痛患儿及其照护者完成了针对治疗偏好和感知现有结局测量指标质量的半结构式访谈。使用常规内容分析识别出主题和子主题。
30 对患儿/青少年及其照护者参与并完成了 59 次访谈（n=29 次患儿/青少年访谈和 n=30 次照护者访谈）。出现了 3 个主题。（1）症状缓解：超越头痛缓解：参与者描述了除缓解疼痛之外的结果的价值，包括减轻偏头痛强度和改善非疼痛症状。（2）副作用与缓解之间的权衡：参与者描述了可能发生的头痛治疗的成本效益分析，并承认药物副作用对日常生活和药物依从性的影响。（3）以患儿为中心的治疗：参与者描述了在儿科背景下对药物属性的重视，包括适合年龄的给药途径和充分的安全性数据。
受偏头痛影响的儿童、青少年和照护者重视除传统研究的偏头痛终点之外的结局。参与者重视疼痛严重程度的降低，即使没有疼痛缓解。参与者还优先考虑无副作用和关键药物属性，包括起效快和适合年龄的给药途径。这些结果突显了设计以患儿为中心的临床试验、开发药物和支持与偏头痛患儿及其照护者最重视的结果相一致的产品标签的机会。
