Harding Gale, Coyne Karin S, Thompson Christine L, Spies James B
United BioSource Corporation, 7101 Wisconsin Ave, Suite 600, Bethesda, MD 20814, USA.
Health Qual Life Outcomes. 2008 Nov 12;6:99. doi: 10.1186/1477-7525-6-99.
A number of noninvasive alternatives to hysterectomy have become available as treatments for uterine fibroids. These alternative therapies, however, may not relieve all symptoms. Consequently, the need for patient-reported outcomes to assess symptom reduction of uterine fibroids has become increasingly important to evaluate the clinical success of patients who choose these alternative therapies. The purpose of the study was to examine the responsiveness of the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) with treatment of uterine fibroids.
The responsiveness of the UFS-QOL was assessed as a post-hoc analysis of patients treated with MRI-guided focused ultrasound thermal ablation (MRgFUS) for uterine fibroids. The UFS-QOL and SF-36 were completed at baseline and months 1, 3, and 6. Patient perceived overall treatment effect (OTE) was assessed at month 3, while satisfaction with treatment was collected at month 6. The responsiveness of the UFS-QOL was examined using effect sizes and change scores by patient-reported overall treatment effect and satisfaction.
A total of 102 women with complete UFS-QOL data were included in the analysis; the mean age was 45 years and 79% were Caucasian. From baseline to 6 months, significant improvements were observed in UFS-QOL Symptom Severity and all Health-Related Quality of Life (HRQL) subscale scores (p < 0.0001). When examining change in general health status over the 6-month follow-up period, significant improvements were noted in all 8 SF-36 subscales. The UFS-QOL was highly responsive with subscale effect sizes ranging from 0.74 for Sexual Function to -1.9 for Symptom Severity. Improvements in UFS-QOL subscales were associated with patient perceptions of perceived benefit and treatment satisfaction.
The UFS-QOL is responsive to treatment for uterine fibroids and is a useful outcome measure for uterine-sparing uterine fibroid treatments.
作为子宫肌瘤的治疗方法,出现了多种子宫切除术的非侵入性替代方案。然而,这些替代疗法可能无法缓解所有症状。因此,对于选择这些替代疗法的患者,通过患者报告的结果来评估子宫肌瘤症状减轻情况对于评估临床疗效变得越来越重要。本研究的目的是检验子宫肌瘤症状与健康相关生活质量问卷(UFS-QOL)对子宫肌瘤治疗的反应性。
作为对接受磁共振成像引导聚焦超声热消融(MRgFUS)治疗子宫肌瘤患者的事后分析,评估UFS-QOL的反应性。在基线、第1、3和6个月时完成UFS-QOL和SF-36问卷。在第3个月评估患者感知的总体治疗效果(OTE),在第6个月收集对治疗的满意度。通过患者报告的总体治疗效果和满意度,使用效应量和变化分数来检验UFS-QOL的反应性。
共有102名有完整UFS-QOL数据的女性纳入分析;平均年龄为45岁,79%为白种人。从基线到6个月,UFS-QOL症状严重程度及所有健康相关生活质量(HRQL)子量表得分均有显著改善(p<0.0001)。在6个月的随访期内检查总体健康状况的变化时,8个SF-36子量表均有显著改善。UFS-QOL反应性高,子量表效应量范围从性功能的0.74到症状严重程度的-1.9。UFS-QOL子量表的改善与患者对获益的感知和治疗满意度相关。
UFS-QOL对子宫肌瘤治疗有反应,是保留子宫的子宫肌瘤治疗的有用结局指标。