Aix Marseille Univ, Inserm, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, ISSPAM, Marseille, France.
Faculté de Médecine, Inserm UMR 1252 SESSTIM, Aix-Marseille Univ, 27 Bd Jean Moulin, 13385, Marseille, France.
Qual Life Res. 2024 Jun;33(6):1527-1540. doi: 10.1007/s11136-024-03622-2. Epub 2024 Apr 5.
Patient Reported Outcomes Quality of Life survey for HCV (PROQOL-HCV) is a specific tool developed to assess health-related quality of life (HRQoL) in patients with chronic hepatitis C receiving direct-acting antivirals (DAA). Thresholds for clinically meaningful changes in PROQOL-HCV scores should be documented to improve the tool's use in clinical practice. This study aimed to estimate the minimal clinically important differences (MCIDs) in PROQOL-HCV scores before and after HCV cure by DAA among participants in the prospective cohort ANRS-CO22 HEPATHER.
Data from 460 chronic HCV patients were collected at DAA initiation (baseline) and 24 weeks after treatment end. MCIDs were estimated for the six HRQoL dimensions (Physical Health (PH), Emotional Health (EH), Future Uncertainty (FU), Intimate Relationships (IR), Social Health (SH), and Cognitive Functioning (CF)) using two approaches: anchor-based and score distribution-based. Each MCID was estimated for improvement/deterioration both globally and separately for patients with a baseline PRQoL-HCV score ≤ 50 (group1) and patients with a baseline PRQoL-HCV score > 50 (group2).
The pooled MCIDs for improvement/deterioration globally, in group1, and in group2, respectively, were as follows: 8.8/- 7.6, 9.7/- 9.5, and 6.0/- 6.9 for PH; 7.1/- 4.6, 7.7/- 9.6, and 6.6/- 6.7 for EH; 6.7/- 6.7, 8.2/- 8.2, and 6.0/- 6.0 for FU; 7.0/- 7.0, 5.4/- 5.4, and 6.2/- 6.2 for IR; 7.7/- 7.7, 8.6/- 8.6, and 6.5/- 6.5 for SH; 7.3/- 5.6, 9.1/- 8.0, and 6.5/- 6.3 for CF.
The overall MCID for the PROQOL-HCV scores ranged from 6.7 to 8.8 for improvement and from - 7.7 to - 4.6 for deterioration. The effect of DAA on PROQOL-HCV scores seemed particularly beneficial for patients with lower baseline scores. This subgroup could be motivated to take DAA if they are informed of the benefits for their HRQoL.
患者报告的 HCV 生存质量调查问卷（PROQOL-HCV）是一种专门用于评估慢性丙型肝炎患者接受直接作用抗病毒药物（DAA）治疗后健康相关生存质量（HRQoL）的工具。为了提高该工具在临床实践中的应用价值，应记录 PROQOL-HCV 评分中临床有意义变化的阈值。本研究旨在通过前瞻性队列研究 ANRS-CO22 HEPATHER 中的参与者，估计 HCV 经 DAA 治愈前后 PROQOL-HCV 评分的最小临床重要差异（MCID）。
在 DAA 起始时（基线）和治疗结束后 24 周，收集了 460 例慢性 HCV 患者的数据。使用锚定和评分分布两种方法，对六个 HRQoL 维度（身体状况（PH）、情绪健康（EH）、未来不确定性（FU）、亲密关系（IR）、社会健康（SH）和认知功能（CF））的 MCID 进行估计。对于全球范围以及基线 PROQOL-HCV 评分≤50（组 1）和基线 PROQOL-HCV 评分>50（组 2）的患者，分别对改善/恶化的每个 MCID 进行了估计。
总体而言，改善/恶化的 MCID 分别为 8.8/-7.6、9.7/-9.5 和 6.0/-6.9，用于 PH；改善/恶化的 MCID 分别为 7.1/-4.6、7.7/-9.6 和 6.6/-6.7，用于 EH；改善/恶化的 MCID 分别为 6.7/-6.7、8.2/-8.2 和 6.0/-6.0，用于 FU；改善/恶化的 MCID 分别为 7.0/-7.0、5.4/-5.4 和 6.2/-6.2，用于 IR；改善/恶化的 MCID 分别为 7.7/-7.7、8.6/-8.6 和 6.5/-6.5，用于 SH；改善/恶化的 MCID 分别为 7.3/-5.6、9.1/-8.0 和 6.5/-6.3，用于 CF。
PROQOL-HCV 评分的总体 MCID 范围为改善时的 6.7 至 8.8，恶化时的-7.7 至-4.6。DAA 对 PROQOL-HCV 评分的影响似乎对基线评分较低的患者特别有益。如果告知这些患者 HRQoL 的获益，那么该亚组可能会被激励接受 DAA 治疗。
