Title: Adaptability and Clinical applicability of UFS-QoL in Chinese Women with Uterine
Fibroid
Version: 1 Date: 06 Jun 2022
Reviewer's report:
Abstract
Methods, line 4. Unclear statement, a word may be missing. Was factor analysis and Cronbach’s
alpha completed with UFS-QOL only?
Methods, last sentence. Post-treatment would be 6 mo and 12 mo, correct? If so, please restate
this sentence.
Results, first sentence. Which measure/scale? What were the six resulting factors/underlying
constructs?
Results, second sentence. Need to state for the reader's understanding where the self-
consciouness and sexual functioning came from.
Results. I would suggest discussing the outcomes of the psychometric testing for UFS-QoL first
and then present its similarities with the SF-36.  Has the SF-36 been adapted for the Chinese
population?
Conclusion. Perhaps adaptation instead of adjustment to be consistent with the process and the
paper’s title.
Highlights:
#2. Again, I think adaptation is the appropriate word vs. adjustment.
#3  What is the benefit of such a scale to the patient? And, why is it important for the clinician
and researcher to use a QoL measure?
Introduction
Second paragraph, row 6. It is unclear what the word placed in quotes mean in this sentence,
and "researches" for patients with diverse cultures and language backgrounds.
Spell acronyms such as FDA at first use.
In this sentence, "However, as one of the major characteristics of PRO instruments reviewed by
FDA, the cross-cultural adaptability have not been evaluated, which will significantly impact
the application of the instrument in a different culture.[22]." I’m not sure what "cross-cultural
adaptability" means when the last sentence in prior paragraph implies that the measure has been
adapted and validated for various nationalities. If the measure has already been validated in a
Chinese population, how is this work different? Also, only 1 validation study has been cited and
referenced, but the sentence references more than one study. Please clarify.
Please clarify what is meant by adaptive barriers. Also, it would be helpful to explain what is
meant by “self-consciousness” and how might it be influenced by Chinese culture, social, and
linquistic factors. Also, did any of the other validation studies present low reliability with the
self-consciousness construct or is it limited to existing Chinese validation study?
In this sentence, "By comparing patients with UFs and healthy women..." Do you mean women
without UFs? Please clarify this entire sentence. What is the intended message? It is unclear if
you are making a point about patients with and without UFs or the validation and applications
or the identification of disease and symptoms. Also, in the results/discussion there is mention
of only UFs women being included. Needs clarification.
Given that the existing Chinese validation study showed issue with the self-consciousness
construct, I am unclear on why a second large study replicating what is already known is needed.
I’m not sure what this study adds beyond the existing study that also included pre- and post-
treatment assessments.
Last paragraph in the introduction. Please clarify which measurement properties. This study
implemented the UFS-QoL in a large sample without pretesting to address the limitation
identified in the prior study. If, having done  so, that might have addressed the applicability and
adaptivity aim of the study as stated here. This aims statement needs to be unpacked to clearly
depict what the paper’s goals are. There seems to be two main goals: test the psychometric
properties of the UFS-QoL in a large study sample and to describe pre/post treatment QoL  in
the sample, perhaps this paper should be broken into two papers.
Methods
Please spell out what is meant by HIFU in the paper at first use.
First paragraph, last sentence. Unclear
Paragraph on UFS-QoL. Are you saying that the UFS-QoL is comprised of the 8 severity
questions and another scale, the HRQL? It is unclear from the abstract, background section and
this section why the SF-36 has been added.
Statistical Analysis
Second paragraph is confusing because the paper’s aims do not include assessing the UFS-QoL
against the HRQL and earlier in the methods section you state that the HRQL is part of the UFS-
QoL. Please clarify.
This sentence is redundant in the methods section, "Scoring of the questionnaires was performed
according to the developers’ guidelines."
Results
This sentence is also somewhat redundant to the one above, "Through 6-month follow-up, 1,298
(95.93%) in the HIFU group, 557 (95.05%) in the myomectomy group, and 458 (97.03%) "
Please list all six subscales and present the respective ceiling effects. Would be beneficial to
explain what is meant by ceiling effects.
Is the goal of Table 3 to assess construct validity using SF-36? Has the SF-36 been validated
in the Chinese population?
In using the SF-36-1, a subjective measure, why not include clinical, objective measures or other
co-morbidities since you have access to medical records? Are you capturing fibroids symptoms
or other health conditions?
Results, last paragraph. Please clarify that the above paragraph considers the entire scale. In this
paragraph, was the goal to assess each subscale? This HRQL relative to the USF-QoL needs to be
clarified. This entire paragraph is unclear. Perhaps, the methods section needs to clearly outline
the analytical approach by each of the paper’s goals once clarified. Please spell out acronyms
at first use.
Discussion
- This paper seems to have two primary goals: implement the UFs-QoL in an existing cohort of
paper, test the scale’s psychometric properties of construct validity against the SF-36, internal
reliability using Cronbach alpha overall and by subscale, and changes in the patients’ QoL using
the UFS-QoL pre/post treatment. I do not see where “cross-cultural adaptation” of the measure
has been done.
- The previous Chinese study found that the UFS-QoL’s self consciousness subscale does not
have strong internal validity. This study seems to have just replicated and confirmed that finding.
- Considering all comments, reconsider this statement, "This study will help clinicians and
researchers in selecting an appropriate instrument for assessing the quality of life and symptom
burden in Chinese patients with uterine fibroid."
- Second paragraph: The methods and results sections do not show that this step was taken.
More discussion is needed about how or if this was done, which items, and the outcomes and
implications.
- Was any multi-ethnic assessment done? To me, this would address the cross-cultural adaptation
as well as add to the literature beyond reference 21
- I agree "to completely eliminate cultural differences are lacking. Therefore, before the
application of UFS-QoL in Chinese populations". Given that the limitation was already known
(ref 21), I wonder why this wasn’t done before implementing the scale in a large study sample.
- The following sentence should have been addressed in the methods section. ". Second, for
hysterectomy group, we had no follow-up to the UFS-QoL, because the instructions of the UFS-
QoL questionnaire are based on the presence of menstrual periods. " The rationale for why
hysterectom would be included and why there is no follow-up of any  aspect of QoL also need
explaining.
Conclusion:
To aid the reader, more consistency is needed in the labeling/reference of scales, subscales,
factors, domains etc. What about the clinical goal for the study; is there not a take-away message?
Table 3. Not sure why Activities and PF correlations are bolded
Table 5. Better presentation and more discussion of these results, esp why none of the other
subscales showed improvement after treatment.
Table S1. Unclear what the bolded alpha values mean and the details in other Supplemental
tables are not well referenced in the text.