Title: Clinical outcomes of a digital musculoskeletal women’s pelvic health program: an
observational, longitudinal study with comparison group
Version: 1 Date: 15 Sep 2024
Reviewer's report:
Congratulations to the authors on conducting an engaging study and preparing an interesting
manuscript. However, some aspects require clarification and expansion to enhance the overall
quality of the manuscript.
Abstract:
- The methods section lacks details about the participants.
- There is hardly any information about the content of the program.
- While the results section discusses the changes in pain ratings in detail, the information
regarding other outcomes is minimal. In particular, the segment on depression is brief, and
anxiety is not mentioned at all.
Background/Methods:
- The discussion of chronic pain could benefit from referencing the ICD-11 definition for a more
comprehensive understanding.
Additionally, the definition of CPP defined as being present "for at least 6 months" seems not
to be considered any further (e.g. among inclusion criteria). In the Methods, inclusion criteria
state "experienced pelvic pain within the last 3 months", but there is no information about the
duration of painful symptoms.
There appears to be a lack of consistency in the terminology used throughout the manuscript.
While the introduction focuses on chronic pelvic pain, the inclusion criteria are not very specific.
This distinction could be clarified more explicitly in the discussion.
Methods:
-    A general inquiry: What were the reasons for not conducting this study as a randomized
controlled trial (RCT)?
- Participants:
It is noted that "employers offered the digital women's health program (...) to employees." Could
you specify which employers were selected to provide this program?
Upon comparing employment status, it is unclear if the employment situations of the two groups
are comparable, particularly given the significant differences in their education levels.
Later, the methods state that "intervention group participants were recruited from members who
had joined the digital women's health program within one week prior to recruitment". Was this
an additional way of recruiting?
Were all types of pelvic surgery excluded? How were cases like laparoscopy for endometriosis
handled?
What was the rationale behind excluding urinary disorders? How does the study address
conditions like chronic bladder pain?
Were comorbidities or causing conditions for CPP, e.g. endometriosis assessed?
- Data assessment:
Was all baseline data collected during the eligibility application questionnaire? Please clarify
the entire process for assessing baseline data and all baseline data assessed to aid reader
comprehension.
When referring to the use of "conservative and non-conservative healthcare services," it could
help to define these terms for greater clarity for readers.
Could this create a potential bias since surgery (as a part of non-conservative healthcare service)
was an exclusion criterion?
Why weren't participants surveyed on other influential factors such as lifestyle, sports, yoga,
etc., known to affect chronic pelvic pain (CPP)?
Does the NPRS score requirement for inclusion of at least 20/100 refer to average pain over the
past three months or the last 24 hours, similar to the baseline assessment?
Was this value used as a baseline measure?
In general, the primary outcome of pain intensity, assessed via NPRS, is well-described. It may
be beneficial to specify whether the measurement focused on maximum or average pain over
the past 24 hours.
How was "general health" evaluated?
- Program:
Could you define what "health coach" means in this context? Unlike physical therapists, is there
any standardized training for health coaches?
Could you elaborate on how individual goals were established?
Was the engagement with the program, including completed exercises and read educational
articles, monitored?
How frequently were participants seen by physical therapists?
Additionally, a more detailed description of the program itself would enhance the manuscript.
Was the educational material (the five articles) provided to the control group comparable to the
educational content offered in the program?
- Study Size: In line 175, you mention "international studies." Could you specify which studies
these refer to?
-    Statistical Methods:
Given the high attrition rate, could you explain in more detail how the maximum likelihood
estimation was applied to address missing data?
When adjusting for the duration of pain, did you investigate the potential impact of this factor
on the study outcomes?
Results:
-    Please include significance values for all tables and results presented. Additionally, specify
the statistical tests used for greater clarity. This information, e.g. mentioned in the legends,
would also facilitate a better understanding of the tables and figures without requiring readers
to search for details in the text.
The level of significance might help to understand the relevance of the effects of the intervention
and also to consider the baseline differences between the two groups.
- Usage of the app by intervention group:
Was the measurement of engagement with the app/program solely based on the number of
completed exercise sessions? How were time courses handled in the analysis?
Did participant engagement remain constant throughout the entire observation period?
Were there differences noted between participants who used the app frequently compared to
those who may have lost interest after a short period, such as two weeks?
Were there any correlations observed between the effect on pain reduction and the amount of
time spent using the app?
- Is all baseline data presented? What about e.g. duration of pain?
Discussion:
-    Are you confident in describing the two groups as "clinically similar," given that the results
indicate "all variables were significantly different between the groups at baseline"?