Coyne Karin S, Harrington Amanda, Currie Brooke M, Chen Jun, Gillard Patrick, Spies James B
, Evidera, 7101 Wisconsin Avenue, Suite 1400, Bethesda, MD, 20814, USA.
Allergan plc, Irvine, CA, USA.
J Patient Rep Outcomes. 2019 Aug 23;3(1):57. doi: 10.1186/s41687-019-0146-x.
To evaluate the psychometric characteristics of the 1-month recall Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFS-QOL), including the Revised Activities subscale.
VENUS I and II were phase III, randomized, double-blind, placebo-controlled trials of ulipristal acetate in women with uterine fibroids (UF) and abnormal uterine bleeding. Women completed the 1-month recall UFS-QOL at baseline and after 12 weeks' treatment. Uterine bleeding was assessed via a daily diary (both studies); the Patient Global Impression of Improvement scale (PGI-I) was completed in VENUS II. Psychometric analyses examined internal consistency reliability and construct validity of the UFS-QOL; confirmatory factor analysis (CFA) compared model fit of the original and Revised Activities subscales. Analyses were conducted separately for VENUS I and II.
One hundred and fifty-seven patients in VENUS I and 429 in VENUS II were included. Changes in mean Symptom Severity and health-related quality of life (HRQoL) scale scores indicated symptom burden reductions and HRQoL improvements. Cronbach's alpha coefficients were high at baseline and after 12 weeks' treatment (all ≥0.76, meeting the >0.70 threshold), demonstrating strong internal consistency reliability. Correlations between UFS-QOL scores and bleeding diary responses (range: -0.35 to -0.63), and UFS-QOL scores and PGI-I responses (range: -0.48 to -0.70), ranged from moderate to strong after 12 weeks' treatment (all p < 0.0001). Patients with absence of bleeding or controlled bleeding after 12 weeks' treatment scored significantly better (p < 0.001) on each UFS-QOL scale than patients not achieving those end points, supporting construct validity. CFA confirmed model fit for the Revised Activities subscale.
The 1-month recall UFS-QOL, including the Revised Activities subscale, is a valid, reliable measure to assess UF symptoms and their impact on HRQoL.
ClinicalTrials.gov, NCT02147197 . Registered May 26, 2014; retrospectively registered. ClinicalTrials.gov, NCT02147158 . Registered May 26, 2014; retrospectively registered.
评估1个月回忆性子宫肌瘤症状与健康相关生活质量问卷（UFS-QOL）的心理测量学特征，包括修订后的活动分量表。
VENUS I和II是醋酸乌利司他治疗子宫肌瘤（UF）和异常子宫出血女性的III期随机、双盲、安慰剂对照试验。女性在基线时和治疗12周后完成1个月回忆性UFS-QOL。通过每日日记评估子宫出血情况（两项研究均如此）；在VENUS II中完成患者总体改善印象量表（PGI-I）。心理测量学分析检验UFS-QOL的内部一致性信度和结构效度；验证性因子分析（CFA）比较原始活动分量表和修订后活动分量表的模型拟合度。对VENUS I和II分别进行分析。
VENUS I纳入157例患者，VENUS II纳入429例患者。症状严重程度和健康相关生活质量（HRQoL）量表平均得分的变化表明症状负担减轻，HRQoL改善。在基线时和治疗12周后，克朗巴哈系数均较高（均≥0.76，达到>0.70的阈值），表明内部一致性信度较强。治疗12周后，UFS-QOL得分与出血日记反应之间的相关性（范围：-0.35至-0.63）以及UFS-QOL得分与PGI-I反应之间的相关性（范围：-0.48至-0.70）从中度到强度不等（所有p<0.0001）。治疗12周后无出血或出血得到控制的患者在每个UFS-QOL量表上的得分显著高于未达到这些终点的患者（p<0.001），支持结构效度。CFA证实修订后活动分量表的模型拟合度良好。
1个月回忆性UFS-QOL，包括修订后的活动分量表，是评估UF症状及其对HRQoL影响的有效、可靠指标。
ClinicalTrials.gov，NCT02147197。2014年5月26日注册；追溯注册。ClinicalTrials.gov，NCT02147158。2014年5月26日注册；追溯注册。
