School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia; Quality Use of Medicines and Pharmacy Research Centre, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia.
Department of Urology, Island Hospital, Penang, Malaysia.
Urology. 2019 Nov;133:91-95. doi: 10.1016/j.urology.2019.08.004. Epub 2019 Aug 12.
To estimate the minimum clinically important difference (MCID) of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and the International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) using both anchor-based and distribution-based methods for women with stress urinary incontinence undergoing nonsurgical treatment.
Data from a randomized clinical trial evaluating efficacy of a nonsurgical intervention in women with stress urinary incontinence were used for analyses. The overall score of ICIQ-UI SF ranges from 0 to 21, with greater values indicating increased severity. The ICIQ-LUTSqol ranges from 19 to 76, with greater values indicating increased impact on quality of life. Instruments used in the anchor-based method were the Patient Global Impression of Improvement, patient satisfaction, 1-hour pad test and the incontinence episode frequency. The distribution-based method used an effect size of 0.5 standard deviation. Triangulation of findings was used to converge on a single value of MCID.
At 12-month post-treatment, 106 (88.3%) participants completed the follow-up and were included in the analysis. Anchor-based MCIDs of the ICIQ-UI SF were between 3.4 and 4.4, while the distribution-based MCID was 1.7. Anchor-based MCIDs of the ICIQ-LUTSqol were between 4.8 and 6.9, while the distribution-based MCID was 5.2. Triangulation of findings showed that MCIDs of 4 for ICIQ-UI SF and 6 for ICIQ-LUTSqol were the most appropriate.
For women undergoing nonsurgical treatments for incontinence, reductions of 4 and 6 points in ICIQ-UI SF and ICIQ-LUTSqol, respectively are perceived as clinically meaningful.
使用基于锚定和基于分布的方法，估计行非手术治疗的压力性尿失禁女性的国际尿失禁咨询问卷-尿失禁简短问卷（ICIQ-UI SF）和国际尿失禁咨询问卷-下尿路症状生活质量问卷（ICIQ-LUTSqol）的最小临床重要差异（MCID）。
使用评估非手术干预对压力性尿失禁女性疗效的随机临床试验数据进行分析。ICIQ-UI SF 的总分范围为 0 至 21，分值越高表示严重程度越高。ICIQ-LUTSqol 的范围为 19 至 76，分值越高表示对生活质量的影响越大。基于锚定的方法中使用的工具包括患者总体改善印象、患者满意度、1 小时垫试验和失禁发作频率。基于分布的方法使用 0.5 标准差的效应量。使用发现的三角剖分来收敛到 MCID 的单个值。
在治疗后 12 个月，106 名（88.3%）参与者完成了随访并纳入分析。ICIQ-UI SF 的基于锚定的 MCID 在 3.4 和 4.4 之间，而基于分布的 MCID 为 1.7。ICIQ-LUTSqol 的基于锚定的 MCID 在 4.8 和 6.9 之间，而基于分布的 MCID 为 5.2。发现的三角剖分表明，ICIQ-UI SF 的 MCID 为 4 和 ICIQ-LUTSqol 的 MCID 为 6 是最合适的。
对于接受非手术治疗的失禁女性，ICIQ-UI SF 和 ICIQ-LUTSqol 分别降低 4 点和 6 点被认为具有临床意义。
