Nyström E, Sjöström M, Stenlund H, Samuelsson E
Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.
Department of Public Health and Clinical Medicine, Unit of Clinical Research Center - Östersund, Umeå University, Umeå, Sweden.
Neurourol Urodyn. 2015 Nov;34(8):747-51. doi: 10.1002/nau.22657. Epub 2014 Aug 22.
To determine whether changes in questionnaire scores on symptoms and condition-specific quality of life reflect clinically relevant improvements in women with stress urinary incontinence (SUI).
We retrospectively analyzed questionnaires collected during a randomized controlled trial in women with SUI, that received pelvic floor muscle training (PFMT) in two different formats. We included 218 women that answered validated self-assessment questionnaires at baseline and at a 4-month follow-up. We registered changes on two questionnaires, the International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and the Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol). We compared these score changes to responses from the Patient Global Impression of Improvement (PGI-I) questionnaire. Differences were analyzed with the Spearman rho and one-way-ANOVA. The minimum important difference (MID) was the mean change in score for women that experienced a small improvement.
The PGI-I correlated significantly to both the ICIQ-UI SF (r = 0.547, P < 0.0001) and ICIQ-LUTSqol (r = 0.520, P < 0.0001). Thus, larger reductions in symptoms or quality of life scores were associated with greater impressions of improvement. The changes in ICIQ-UI SF and ICIQ-LUTSqol scores were significant across all PGI-I groups from "no change" to "very much improved" (P < 0.05). The MIDs were 2.52 (SD 2.56) for ICIQ-UI SF and 3.71 (SD 4.95) for ICIQ-LUTSqol.
The change in ICIQ-UI SF and ICIQ-LUTSqol scores after PFMT reflected clinically relevant improvements in women with SUI. The MIDs established for this population may facilitate future research, treatment evaluations, and comparisons between studies.
确定压力性尿失禁(SUI)女性患者症状问卷评分及特定病情生活质量的变化是否反映出临床上的相关改善。
我们回顾性分析了一项针对SUI女性患者的随机对照试验中收集的问卷,这些患者接受了两种不同形式的盆底肌训练(PFMT)。我们纳入了218名在基线和4个月随访时回答了有效自评问卷的女性。我们记录了两份问卷的变化,即国际尿失禁咨询委员会模块化问卷-尿失禁简表(ICIQ-UI SF)和下尿路症状生活质量问卷(ICIQ-LUTSqol)。我们将这些评分变化与患者整体改善印象(PGI-I)问卷的回答进行比较。采用Spearman秩相关和单因素方差分析分析差异。最小重要差异(MID)是经历轻微改善的女性患者评分的平均变化。
PGI-I与ICIQ-UI SF(r = 0.547,P < 0.0001)和ICIQ-LUTSqol(r = 0.520,P < 0.0001)均显著相关。因此,症状或生活质量评分的更大降低与更大的改善印象相关。从“无变化”到“改善非常大”,所有PGI-I组的ICIQ-UI SF和ICIQ-LUTSqol评分变化均具有统计学意义(P < 0.05)。ICIQ-UI SF的MID为2.52(标准差2.56),ICIQ-LUTSqol的MID为3.71(标准差4.95)。
PFMT后ICIQ-UI SF和ICIQ-LUTSqol评分的变化反映了SUI女性患者临床上的相关改善。为该人群确定的MID可能有助于未来的研究、治疗评估以及研究间的比较。