Title: Minimum Important Difference of the ICIQ-UI SF Score after Self-management of
Urinary Incontinence
Version: 3 Date: 29 May 2023
Reviewer's report:
This is an interesting study that aimed to determine the MID of the ICIQ-SF by applying a
conservative strategy of treatment using an App. Although the topic is relevant and needs urgent
discussion, the manuscript has some gaps that need to be reviewed.
Introduction and objective
Responsiveness is a psychometric property reported by the COSMIN guidelines and it does not
measure the same construct as MID reported by anchor-based methods. I suggest that authors
review the concepts of both proprieties and update the manuscript.
Line 73: There are more studies about MID in the literature, including surgery, pharmacological
interventions, behavioral therapy and vaginal pessary. Please check the literature and update the
manuscript.
Methods
If it is a secondary analysis, please add the reference of the primary trial/protocol registration,
so the reader can have access to more details related with the study.
The age range of the sample size is too broad.
Line 97-99: “All participants that submitted the 98-follow-up questionnaire were included,
regardless of whether they had performed PFMT with 99 the app or not, but no questionnaire
was sent if the user did not open the app.”
I understood that authors did not check the fidelity with the treatment. Could it have influence
in the outcome, especially according to the self-perception of improvement?
Line 111: authors already presented the acronym PROM in the introduction section, there is no
need to write it here again.
Outcome measures: There are no details in the manuscript about the procedures of outcome
measures. Therefore, it is unclear to the reader how authors conducted the study. Some simple
questions that should be answer in the methods section:
How participants were assessed?
How many researchers were responsible for data collection?
What was the exact question used when applying the PGI-I?
When the follow-up was measured?
What was the intervention/instruction provided by the app?
What was the frequency that participants used to receive the instructions by the app?
And other methodological questions.
Line 116: It is also not clear how authors stratified PGI-I categories to classify participants that
reported their condition as “a little better”. Please provide the classification and the reference
used.
Line 124: although authors provided references about the stratification that they used; it is easier
for the reader if they describe in the main manuscript that was the classification that they applied
here.
Statistical analysis:
The correlation of the anchor and the PROM was analyzed and reported. Afterwards, authors
performed a statistical test to compare the subgroups of severity and type of UI.
Currently, it is recommended to also provide the scores of the correlation between anchor and
PROM considering the post-treatment score and the score change (comparison between initial
and post assessment).
This is a tentative to avoid memory bias, especially in trials that perform evaluations after a long
time period, example of your study that assessed participants after 89-135 days.
Line 137: From what I understood, authors considered the “mean” of the ICIF-SF to determine
the MID. What does the “mean” represents? Is it the mean change? Is it the mean among the
participants in different subgroups? Please specify and clarify the analysis.
Line 141: It is very unlikely that one study with 1,733 participants do not have any missing
data. Is it the case here or authors have considered in their analysis only participants that had the
questionnaires complete during baseline and post-treatment? Please clarify in the manuscript.
Results
Line 148 and Table 1: authors have collected different sociodemographic information; however,
it was not mention in the methods section. Please add a brief description in the previous section.
Line 151: how about the scores at the post-treatment?
Line 155: Authors reported the general correlation between PROM and “TOTAL GROUP”,
different types and severity. The correlation between anchor and PROM for the mixed UI was <
0.30 and, therefore, MID can not be determined/considered. Therefore, the results that authors
have reported for this calculation cannot be considered.
Figure 1 needs to be improved. It is not self-explained and it is confused to interpret. I suggest
that authors add the values of each MID and CI in the points that they are presented in the figure,
only the symbols do not add anything to the reader.
Table 3 and 4: Why authors have used different letters to report the same result “No significant
differences between these categories”? Is there any different between symbols? Please specify.
Table 3: the CI of the MID related to the “slight” UI is including the number 0. Could this result
be considered significant?
Discussion
This section needs to be improved. Authors should consider the following headlines in order
to organize the section: main findings, possible reasons for the main findings, comparison with
previous studies, strengths, limitations, implication to clinical practice.
Paragraphs are not in order and authors lacked to compare their results with previous literature.
They also should add more explanations about their results.
Moreover, there are some information that are confused: 1) hey mentioned the “intervention as a
real-world” for the first time, what does it mean?; 2) They did not discuss the fact that the fidelity
and frequency that participants have accessed the app could be related with the variability of
their results; 3) they mentioned that slight symptoms could not be larger improvements (line
235), which is not reasonable as participants could be cured; 4) there are previous studies that
have reported MID for populations with SUI, UUI and MUI and authors have not added these
studies to their discussion.