青少年偏头痛患者药物依从性的多模态评估：CHAMP 试验的辅助研究。

Multimodal Assessment of Medication Adherence Among Youth With Migraine: An Ancillary Study of the CHAMP Trial.

机构信息

Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, USA.

Department of Pediatrics, University of Cincinnati College of Medicine, USA.

出版信息

J Pediatr Psychol. 2022 Apr 8;47(4):376-387. doi: 10.1093/jpepsy/jsab123.

DOI:10.1093/jpepsy/jsab123

PMID:34865085

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9216483/

Abstract

OBJECTIVE

Examine preventive medication adherence among youth with migraine.

METHODS

Adherence (self-report, pill count, and blood serum drug levels) was assessed as an ancillary study that utilized data from 328 CHAMP Study participants (ages 8-17). CHAMP was a multisite trial of preventive medications. Participants completed a prospective headache diary during a six-month active treatment period during which youth took amitriptyline, topiramate, or placebo pill twice daily. Self-reported medication adherence was collected via daily diary. At monthly study visits, pill count measures were captured. At trial month 3 (trial midpoint) and 6 (end of active trial), blood serum drug levels were obtained. Self-report and pill count adherence percentages were calculated for the active trial period, at each monthly study visit, and in the days prior to participants' mid-trial blood draw. Percentages of nonzero drug levels were calculated to assess blood serum drug level data. Adherence measures were compared and assessed in context of several sociodemographic factors. Multiple regression analyses investigated medication adherence as a predictor of headache outcomes.

RESULTS

Self-report and pill count adherence rates were high (over 90%) and sustained over the course of the trial period. Serum drug level adherence rates were somewhat lower and decreased significantly (from 84% to 76%) across the trial period [t (198) = 3.23, p = .001]. Adherence measures did not predict headache days at trial end; trial midpoint serum drug levels predicted headache-related disability.

CONCLUSIONS

Youth with migraine can demonstrate and sustain relatively high levels of medication adherence over the course of a clinical trial.

摘要

目的

研究青少年偏头痛患者预防用药的依从性。

方法

本研究将利用 CHAMP 研究 328 名参与者（年龄 8-17 岁）的数据作为辅助研究，评估依从性（自我报告、药物计数和血清药物水平）。CHAMP 是一项预防药物的多中心试验。参与者在为期 6 个月的积极治疗期间完成了前瞻性头痛日记，在此期间，他们每天服用阿米替林、托吡酯或安慰剂两次。通过每日日记收集自我报告的药物依从性。每月研究访视时，记录药物计数测量值。在试验第 3 个月（试验中点）和第 6 个月（主动试验结束）时，获得血清药物水平。计算了活性试验期间、每次每月研究访视期间以及参与者中期血样采集前几天的自我报告和药物计数依从百分比。计算非零药物水平的百分比以评估血清药物水平数据。比较了各种社会人口因素背景下的依从性测量值。多元回归分析研究了药物依从性作为头痛结局的预测因子。