Eli Lilly and Company, 893 Delaware St, Indianapolis, IN, 46225, USA.
TechData Services Company, King of Prussia, PA, USA.
J Patient Rep Outcomes. 2023 Apr 4;7(1):34. doi: 10.1186/s41687-023-00552-4.
No available studies demonstrate validity and meaningful change thresholds of Work Productivity and Activity Impairment (WPAI) questionnaire in patients with migraine. In this post-hoc analysis, we assessed reliability, validity, responsiveness, and meaningful within-patient change from baseline to Month 3 for Work Productivity and Activity Impairment (WPAI) domain scores in patients with episodic migraine (EM) or chronic migraine (CM).
The Phase 3, multicenter, randomized, double-blind, placebo-controlled CONQUER study (NCT03559257, N = 462) enrolled patients with EM or CM who failed two to four categories of prior preventive medication in past ten years. The analyses were performed for WPAI domain scores (absenteeism, presenteeism, overall work productivity, and non-work-related activity impairment). Migraine Specific Quality of Life Questionnaire version 2.1 (MSQv2.1) domain scores (Role Function-Restrictive [RFR] and Role Function-Preventive [RFP]), and monthly migraine headache days were used as anchors. Responder criteria were changes from baseline to Month 3 for each of these anchors and were defined as: increase in MSQ-RFR by ≥ 25.71 points and MSQ-RFP by ≥ 20.00 points and a 50% reduction in monthly migraine headache days. Assessments were performed for overall population, and patients with EM or CM. The meaningful change threshold was determined based on Youden index, Phi coefficient and sensitivity.
Of 462 randomized patients, 444 who completed WPAI questionnaire were included in post-hoc analysis. Test-retest reliability over 3 months in a stable subgroup revealed moderate correlations for non-work-related Activity Impairment (ICC = 0.446) presenteeism (ICC = 0.438) and a fair correlation for overall work productivity loss (ICC = 0.360). At baseline, all correlations between WPAI domain scores and continuous anchor variables exceeded recommended threshold of ≥ 0.30, except for WPAI domain scores with number of monthly migraine headache days. Patients achieving pre-specified responsiveness thresholds for monthly migraine headache days, and MSQ-RFP, MSQ-RFR from baseline to Month 3 (responders) showed significant improvements in WPAI domain scores compared with non-responders (P < 0.001). The meaningful change thresholds of -20 (% unit) were identified for WPAI domain scores.
In conclusion, WPAI has sufficient validity, reliability, responsiveness, and appropriate interpretation standards to assess the impact of EM or CM on presenteeism and overall work productivity loss and non-work-related activity impairment.
NCT number of CONQUER study, NCT03559257.
目前尚无研究证明偏头痛患者工作生产力和活动障碍（WPAI）问卷的效度和有意义的变化阈值。在这项事后分析中，我们评估了发作性偏头痛（EM）或慢性偏头痛（CM）患者基线至第 3 个月 WPAI 各领域评分的可靠性、有效性、反应性和有意义的患者内变化。
这项多中心、随机、双盲、安慰剂对照的 3 期 CONQUER 研究（NCT03559257，N=462）纳入了过去 10 年内使用 2 至 4 种预防药物失败的 EM 或 CM 患者。分析了 WPAI 各领域评分（旷工、在职病假、整体工作生产力和非工作相关活动障碍）。偏头痛特定生活质量问卷 2.1 版（MSQv2.1）各领域评分（受限角色功能-R（RFR）和预防角色功能-P（RFP））和每月偏头痛头痛天数用作锚定标准。反应标准为每个锚定标准的基线至第 3 个月的变化，定义为：MSQ-RFR 增加≥25.71 分，MSQ-RFP 增加≥20.00 分，每月偏头痛头痛天数减少 50%。对总体人群和 EM 或 CM 患者进行了评估。有意义的变化阈值是根据 Youden 指数、Phi 系数和敏感性确定的。
在 462 名随机患者中，444 名完成 WPAI 问卷的患者被纳入事后分析。稳定亚组中 3 个月的测试-重测可靠性显示，非工作相关活动障碍（ICC=0.446）、在职病假（ICC=0.438）的中度相关性，以及整体工作生产力损失的相关性（ICC=0.360）。在基线时，WPAI 各领域评分与连续锚定变量之间的所有相关性均超过了≥0.30 的建议阈值，除了 WPAI 各领域评分与每月偏头痛头痛天数的相关性。从基线到第 3 个月达到每月偏头痛头痛天数、MSQ-RFP 和 MSQ-RFR 预定反应性阈值的患者（反应者）与非反应者相比，WPAI 各领域评分显著改善（P<0.001）。确定了 WPAI 各领域评分的-20（%单位）有意义变化阈值。
总之，WPAI 具有足够的有效性、可靠性、反应性和适当的解释标准，可评估 EM 或 CM 对在职病假和整体工作生产力损失以及非工作相关活动障碍的影响。
CONQUER 研究的 NCT 编号，NCT03559257。
