Medical Affairs, Astellas Pharma, 1 Astellas Way, Northbrook, IL, 60062, USA.
Medical Affairs, Astellas Pharma Europe Ltd, Addlestone, UK.
Health Qual Life Outcomes. 2023 Nov 21;21(1):126. doi: 10.1186/s12955-023-02206-x.
Women with vasomotor symptoms (VMS) due to menopause frequently experience poor sleep quality. The Patient-Reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD-SF-8b) has been developed to assess sleep disturbance. The study objective was to use data from the fezolinetant SKYLIGHT 1 and 2 studies in individuals with VMS to assess the psychometric properties of the PROMIS SD-SF-8b.
Individuals (aged ≥ 40-≤65 years) with moderate-to-severe VMS (≥ 7 hot flashes/day) were enrolled. Besides PROMIS SD-SF-8b, eight other patient-reported outcome (PRO) measures were used for the psychometric evaluation. All the PRO assessments were completed at weeks 4 and 12 during the treatment period and most were completed at baseline. Psychometric analyses included factor analysis and reliability, construct validity, and sensitivity to change assessments. The within-patient threshold for a clinically meaningful change in sleep disturbance was derived.
Overall, 1022 individuals were included from the SKYLIGHT 1 and 2 studies. Mean PROMIS SD-SF-8b total score at baseline was 26.80, which decreased to 22.68 at week 12, reflecting improved sleep disturbance. The confirmatory factor analysis supported the proposed PROMIS SD-SF-8b domain structure. Internal consistency was excellent, with Cronbach's alpha values of 0.915 and 0.935 and a McDonald's omega of 0.917. Item-to-item and item-total correlations were sufficient and moderate test-retest reliability was noted. The construct validity assessments showed that moderate Spearman rank correlations (r: 0.608 to 0.651) were observed between PROMIS SD-SF-8b total scores and measures of sleep disturbance and sleep-related impairment, and that significant differences were noted in the total scores across PRO categories. The responsiveness of PROMIS SD-SF-8b total scores was supported by the results from the correlations in change scores and comparisons of mean change scores by PRO categories. Statistically significant differences in mean scores were observed between responder and non-responder PRO groups. A PROMIS SD-SF-8b total score of 8 points was identified as the within-patient threshold to use to confirm a meaningful change in sleep disturbance.
The psychometric properties of the PROMIS SD-SF-8b support its use to measure sleep disturbance in women with VMS due to menopause.
ClinicalTrials.gov numbers: NCT04003155 and NCT04003142.
由于绝经而出现血管舒缩症状（VMS）的女性经常会出现睡眠质量差的情况。患者报告的结局测量信息系统睡眠障碍-短表 8b（PROMIS SD-SF-8b）已被开发用于评估睡眠障碍。本研究的目的是使用来自 fezolinetant SKYLIGHT 1 和 2 研究中 VMS 个体的数据，评估 PROMIS SD-SF-8b 的心理测量特性。
年龄在 40 岁至 65 岁之间、有中度至重度 VMS（≥7 次热潮红/天）的个体被纳入研究。除了 PROMIS SD-SF-8b 外，还使用了其他八项患者报告的结局（PRO）措施进行心理测量评估。所有 PRO 评估均在治疗期间的第 4 周和第 12 周进行，大多数在基线时完成。心理测量分析包括因子分析和可靠性、结构效度和对变化的敏感性评估。睡眠障碍有临床意义的变化的患者内阈值是通过推导得出的。
总体而言，来自 SKYLIGHT 1 和 2 研究的 1022 名个体被纳入研究。基线时 PROMIS SD-SF-8b 的总分为 26.80，在第 12 周降至 22.68，表明睡眠障碍得到改善。验证性因子分析支持了 PROMIS SD-SF-8b 提出的领域结构。内部一致性极好，克朗巴赫 α 值为 0.915 和 0.935，麦克唐纳 ω 值为 0.917。项目间和项目总分之间的相关性足够，且有适度的重测信度。结构效度评估显示，PROMIS SD-SF-8b 总分与睡眠障碍和与睡眠相关的损害的测量值之间存在中度斯皮尔曼等级相关（r：0.608 至 0.651），并且在 PRO 类别中，总评分存在显著差异。从变化评分的相关性和按 PRO 类别比较平均变化评分的结果中，可以支持 PROMIS SD-SF-8b 总分的反应性。在应答者和非应答者 PRO 组之间观察到平均评分的统计学显著差异。PROMIS SD-SF-8b 总分为 8 分被确定为患者内的阈值，用于确认睡眠障碍的有意义变化。
PROMIS SD-SF-8b 的心理测量特性支持其用于测量绝经后因 VMS 而出现的女性的睡眠障碍。
ClinicalTrials.gov 编号：NCT04003155 和 NCT04003142。
