Open Access

Hypothesis/Aims of study Many results related to the effectiveness of surgical and non-surgical proce- dures for treating urinary incontinence (UI) are reported in the literature. Following the principles of evidence based-practice, besides the interpreta- tion of study results based on statistical significance, authors should consid- er evaluating the clinical relevance of treatment effects in this field. The minimal important difference (MID) of clinical outcomes could be used to assess the clinical relevance of interventions. MID is defined as “the small- est difference in score in the domain of interest that patients perceive as important, either beneficial or harmful, and which would lead the clinician to consider a change in the patient’s management’’[1]. One common way to obtain MID for outcomes of interest is by using anchor-based methods. These methods apply one anchor that analyzes the change in the patient's health status according to the patient’s perception. However, MIDs should be provided according to appropriate calculations and methods and based on the definition of a MID. However, there are a lot of misconceptions and misunderstandings related to the MID. These mis- understandings have led to incorrect reports of these values. Moreover, it is still not known which criteria the authors considered during the analysis of the MID in the Women’s Health area. Therefore, with this preliminary re- port, we aimed to identify and report all anchor-based methods to estimate MIDs for outcomes measures related to UI available in the literature; and analyze which concepts and levels of improvement in the health status of the patient have been considered by the authors to calculate the MID. Study design, materials and methods This systematic review was conducted according to PRISMA guide- lines. The study protocol was registered in the PROSPERO database (CRD42022299686). A systematic search was performed using Ovid Med- line, Embase, Web of Science, and Scopus from May to June 2021. Any study generating MIDs for UI that included women with more than 18 years, stress urinary incontinence (SUI), urgency urinary incontinence (UUI) and/ or miXed urinary incontinence (MUI) was included. The primary outcome was the MID for outcomes related to UI. No limits were applied on the data- bases for the date, language or publication range. Studies were classified into three categories according to the level of im- provement in health status assessed by the anchor and considered by the authors during the MID calculation: 1) slight improvement: if authors in- cluded participants that evaluated their health status as “a little better” in their analysis; 2) moderate improvement: if authors considered women that reported a “better” or a “much better” status of the condition; or 3) strong imporvement: if all patients that improved (“very much better” or if authors grouped all the patients that improved in one single category) were consid- ered in one group against other group that did not report any improvement. After classifying the papers, we counted and reported how many studies were considering only the minimal level of improvement to reported the MID, according to previous definition and recommendation. The initial electronic search resulted in a total of 1,662. After removing du- plicates (n=719), 943 were screened, and at the end of the selection stages, nine papers that reported anchor-analysis were included in this preliminary report. Seven studies included women with SUI (total sample size= 2,436), while one study included only women with UUI (n=307), and the other one evaluated women with SUI and MUI (n=288). SiX studies analyzed data and provided the MID after a non-surgical treatment of UI, while three analyzed the results after surgery to correct UI. Eleven different questionnaires to measure the patient-related outcomes related to UI with their MIDs were identified. All the tools were related to measuring the impact, distress, or quality of life of women with UI. Different anchors were used to analyze MID, including scales that evaluated the improvement and satisfaction of the patient, and the visual analogue scale, measures of urinary leakage and questionnaires that measure the se- verity and impact of UI. The MID of siX tools was determined according to the smallest difference detected by the patients, using the Patient Global Im- pression of Improvement questionnaire and the self-reported satisfaction to assess the change of the condition. Most of the MIDs (n=28, 80%) were mis- calculated considering a moderate or a strong improvement of the patients, and not a minimal improvement as suggested by the literature (Table 1). Interpretation of results Although previous systematic reviews have reported the psychometric prop- erties of different questionnaires to measure UI outcomes, this is the first study to analyze methods of obtaining MIDs for UI outcomes from the pa- tients perspective (anchor based methods). All the tools with their respec- tives MIDs were related to the impact, distress, and/or quality of life of women with UI. The use of these outcomes measures is in line with the as- sociated impairments of social, psychological, financial, and sexual aspects of a women’s life produced by UI. Most of the authors in this field did not consider the smallest difference identified by the participants to calculate the MID, which does not follow the original definition of MID proposed by Jaeschke et al.,1 This could gen- erate underestimation or over-estimation of MID, which may directly im- pact the interpretation of the findings from the clinical trials[2] and biased interpretation of the results of the clinical significance from the interven- tions used to manage female UI. Therefore, the interpretation of the clinical significance related to UI outcomes should be done with caution. Concluding message Few studies that aimed to calculate the MID using anchor-based methods for outcomes related to female UI were found in the literature. Eleven different questionnaires to measure the outcomes related to UI with their MIDs were identified. However, most studies had not considered the smallest change of improvement (as perceived by the patients) in their analysis, which does not follow the definition of the MID. This could impact decision making. Future research should provide clear guidelines on how to calculate, report, and interpret MIDs in this field.

Background: Vaginal manometry is regarded as an objective method to assess pelvic floor muscles (PFM) function and can measure several variables during contraction. Objective: To determine which variables could differentiate women with/without a weak/ strong PFM contraction and determine their cut-off points. Methods: This is a diagnostic accuracy study performed on 156 women with a mean age of 40.4 (SD, 15.9) years. The reference test was vaginal palpation and the index test was vaginal manometry (PeritronTM manometer). Variables were pressure at rest, pressure achieved with maximal voluntary contraction (MVC), MVC average, duration, gradient, and area under the curve (AUCm). The Receiver Operating Curve (AUC/ROC) and logistic regression were used to analyze the data and obtain cut-off points.

This review presents a comprehensive summary and critical evaluation of Intention to Treat (ITT) analysis, with a particular focus on its application to randomized controlled trials (RCTs) within the field of rehabilitation. Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we conducted a methodological review that encompassed electronic and manual search strategies to identify relevant studies. Our selection process involved two independent reviewers who initially screened titles and abstracts and subsequently performed full-text screening based on established eligibility criteria. Additionally, we included studies from manual searches that were already cataloged within the first author’s personal database. The findings are synthesized through a narrative approach, covering fundamental aspects of ITT, including its definition, common misconceptions, advantages, disadvantages, and key recommendations. Notably, the health literature offers a variety of definitions for ITT, which can lead to misinterpretations and inappropriate application when analyzing RCT results, potentially resulting in misleading findings with significant implications for healthcare decision-making. Authors should clearly report the specific ITT definition used in their analysis, provide details on participant dropouts, and explain upon their approach to managing missing data. Adherence to reporting guidelines, such as the Consolidated Standards of Reporting Trials (CONSORT) for RCTs, is essential to standardize ITT information, ensuring the delivery of accurate and informative results for healthcare decision-making.