Title: Quantitative analysis of the effect of docetaxel-induced edema on quality of life in patients
with breast cancer and related factors: a prospective cohort study
Version: 1 Date: 18 Dec 2023
Reviewer:  Luz-Ma-Adriana Balderas-Pena
Reviewer's report:
The manuscript presents an interesting way to evaluate edema as one of the factors influencing
health-related quality of life; however, the manuscript must be enhanced to be published. This
reviewer has the following comments:
Globally: Some grammatical and typos could be corrected.
It is convenient to have style correction done by a native language expert.
ABSTRACT
A relevant issue in your abstract is:
1. Why did you use OR if your methodological design is a prospective cohort?
2. Why did you not use Cox Regression to estimate hazard risk or relative risk?
INTRODUCTION
Is it only diet?, Does another systemic alteration conditioning edema exist? Do you evaluate
protein profile and albumin? Or Do you analyze the influence of kidney and heart functioning
on conditioning edema in your cohort?
PATIENTS AND METHODS
1. Do you evaluate the role of kidney or cardiac functioning in edema?
2. Is the questionnaire validated for Japanese women?
3. If the questionnaire uses a score of 22 to 110, how do you determine health-related quality
of life through the instrument?
4. Does a separate score exist for each subscale?
5. Each subscale is based on multi-item scales.
6. Statistical analysis must be described in a more detailed way.
7. You'll need to explain your criteria to visually evaluate edema to the readers (maybe in a table
of the CTCAE v.5 for edema). You must explain how you decided or determined the normal
values for total body water or if your body composition analyzer can distinguish between extra-
cellular and intracellular body water.
8. It would be best if you enhanced the statistical analysis description:
9. How did you separate the cohort?
10. What are the exposed and not exposed groups?
11. What is your dependent variable or response variable?
12. Is it edema?
13. Which risk factors are you considering for edema development?
14. Did you perform a correlation analysis between independent and dependent variables (risk
factors and edema)?
15. What kind of correlation did you perform?
16. How did you select variables such as risk factors?
17. Why did you perform logistic regression, not Cox regression, or logistic regression and
survival analysis with log-rank if your sample size is small?
RESULTS
If the administration of dexamethasone is part of the treatment protocol, this paragraph must be
in the material and methods section.
In general, your results must be enhanced according to the suggestions that you decide to
consider.
This reviewer suggests in table 1:
1. To separate women in a group with edema and another group without edema and separate
the variables in categorical and numerical, presenting for the categorical the number of
patients and their percentage and numerical mean and standard deviation if the variable has a
normal or parametrical distribution; for variables with non-parametrical distribution median and
interquartile interval, adding the p-value to identify differences between groups.
Table 2:
You should separate the women in the abovementioned groups and present the values in means
and standard deviations (median and interquartile interval for nonparametric distribution)  or
number and percentage, as corresponded.
You could add Table 3 to present the logistic regression and justify why it is a logistic
regression.d
You can add survival graphics for the Kaplan-Meier method, calculating log-rank through the
follow-up.
Finally, the tables in supplementary material must be in the body of the manuscript with the
following recommendations:
In this reviewer's opinion, the way the table is presented can be enhanced.
You could group the women in women with edema and without edema in the columns together
with the p-value to identify differences between groups and in the rows, the scores for a) vitality,
physical aspect, mental aspect, social aspect, and total QOL score.
You can use the proposed table as a template if you think it's worthwhile.