Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.
Department of Public Health and Clinical Medicine, Unit of Research, Education, and Development - Östersund, Umeå University, Umeå, Sweden.
BMC Womens Health. 2024 Feb 14;24(1):118. doi: 10.1186/s12905-024-02947-x.
This study aimed to evaluate clinically relevant improvement after conservative self-management of urinary incontinence via a mobile app. It further aimed to establish Minimum Important Differences (MIDs) based on the severity and type of urinary incontinence.
Data was collected in a prospective cohort study that evaluated the freely available app Tät®. The app provided pelvic floor muscle training (PFMT) and life-style advice. Non-pregnant, non-postpartum women (≥ 18 years) who downloaded the app to treat urinary incontinence were included, if they completed the Patient Global Impression of Improvement (PGI-I) question at the 3-month follow-up (n = 1,733). Participants answered the International Consultation on Incontinence Questionnaire (ICIQ-UI SF) at baseline and after 3 months. The score change was analysed for correlation (Spearman) with the PGI-I. We then analysed one-way ANOVAs to determine whether there were significant differences between the groups based on the answers to the PGI-I. The MID was set to the mean change of the group that selected the answer "a little better" to the PGI-I question.
The one-way ANOVA showed significant differences between PGI-I groups (p < 0.001). The MID for the general group was set to 1.46 (95% Confidence Interval [CI] 1.26-1.67). In the sub-group analyses, a MID for the group with slight incontinence could not be determined. For the group with moderate severity the MID was determined to be 1.33 (95% CI 1.10-1.57) and for the severe/very severe group it was 3.58 (95% CI 3.08-4.09). Analysis of different types of incontinence showed no difference in MIDs.
The MID for self-management via a mobile app was lower than previously established MIDs, but differed depending on baseline severity. This study shows that MIDs need adjustment for baseline severity and treatment intensity when interpreting clinical trial results. If using MIDs as exact numbers, the study population and the treatment must be comparable.
本研究旨在评估通过移动应用程序进行保守性自我管理后尿失禁的临床相关改善，并基于尿失禁的严重程度和类型建立最小临床重要差异（MID）。
该研究采用前瞻性队列研究收集数据，评估了免费的应用程序 Tät®。该应用程序提供了骨盆底肌肉训练（PFMT）和生活方式建议。纳入年龄≥18 岁、下载该应用程序治疗尿失禁且在 3 个月随访时完成患者整体改善印象（PGI-I）问题的非妊娠、非产后女性（n=1733）。参与者在基线和 3 个月后回答国际尿失禁咨询问卷（ICIQ-UI SF）。分析评分变化与 PGI-I 的相关性（Spearman）。然后我们进行单因素方差分析，根据 PGI-I 的回答确定组间是否存在显著差异。MID 设定为选择 PGI-I 问题“稍好”答案的组的平均变化。
单因素方差分析显示 PGI-I 组间存在显著差异（p<0.001）。普通组的 MID 设定为 1.46（95%置信区间[CI]1.26-1.67）。在亚组分析中，无法确定轻度尿失禁组的 MID。对于中度严重程度组，MID 确定为 1.33（95% CI 1.10-1.57），对于严重/非常严重组，MID 为 3.58（95% CI 3.08-4.09）。对不同类型尿失禁的分析显示，MID 无差异。
通过移动应用程序进行自我管理的 MID 低于先前建立的 MID，但因基线严重程度而异。本研究表明，在解释临床试验结果时，需要根据基线严重程度和治疗强度调整 MID。如果将 MID 用作确切数字，则研究人群和治疗必须具有可比性。
