Title: Effect of group education and person-centered support in primary health care on mental
health and quality of life in women aged 45-60 years with symptoms commonly associated with
stress. A randomized controlled trial.
Version: 3 Date: 22 Sep 2022
Reviewer:  Jean Damascene Makuza
Reviewer's report:
Thank you for the opportunity to review this article, I hope my contribution will improve it
for its publication. This is a good article aimed at assessing the effect of group education and
person-centered support in primary health care (PHC) on mental health and quality of life for
women in menopause with symptoms that are usually associated with stress using an RCT study
design. This is an important study as it comes to adding up the gaps in conducted studies in this
area. The strengths of this study include the big sample size, the type of study design, and the
combination of several interventions as exposures. However, before its publication, the authors
may address the gaps shown below.
In general, the ideas are not well aligned in different parts of the manuscripts especially
the methodology and the discussion. Furthermore, there is a need for more literature in the
introduction to discuss various concepts in this study, then in discussion, they need to discuss
more findings. Finally, results need to be expressed in figures not only in tables but also in the
main text. You will find in detail my comments.
Abstract:
-Methods: There is a need to summarize the model used for assessing the association between
exposure and outcome. I will recommend that the authors summarize all the theories related to
the definition of exposure and outcome and get the place for model description.
- Results: findings need to be explained in numbers, I recommend that authors put the OR and
95% CI for the key findings and try summarizing other theories in the results.
- Conclusion: Please include the summary of recommendations according to the findings.
Introduction
- Menopausal symptoms: As shown by some symptoms like mental exhaustion and sleep
disorders, it is good to be specific for metabolic syndrome introduced in this paragraph.
In this part, it is good to explore how the problem of mental health and quality of life for women
in menopause with symptoms that are usually associated with stress worldwide, in Europe or
other countries in the same setting as Sweden, as well as in Ukraine.
Methods
-Participants: It is good to know how the sample size was calculated if the possible author could
give details on this part of the method.
-It is good that interventions were defined in methods, but the outcome is not, I will recommend
authors move the definition of the outcome from data collection and describe it as its own sub-
part in methods.
-Data collection: covariates described in this section could be separated and take their part as
covariates or risk factors of the outcome.
Sample size and power calculation need to be near the participant part.
Results
For the first paragraph of this part, I will suggest constructing a flowchart showing how
participants were selected and how they were distributed in different intervention groups. This
could be placed in tables and figures and cited here.
In the second and third paragraphs, the authors could be systematic and similarly present all
data: n(%), Median(IQR), and Mean(SD).
The changes in health at 6 and 12 months could be detailed by showing the critical differences
in numbers.
Effect of GE and PCS at 6 and 12 months
In this part, the sentences are incomplete and lack figures(OR and 95%CI) supporting the
association. The association could be between exposure and outcome, and in this part, we find
only exposure without an outcome associated with it. Example: “PCS showed a statistically
significantly positive effect at 6 months that was further reinforced at the 12-month follow-up”.
Discussion
Strengths and limitations
I recommend authors place strengths and limitations at the end of the discussion.
In the third paragraph, recruitment as the advertisement was reported as a strength or a limitation
but the way this could be a strength or limitation was not described.
It is good that the authors give explanations about the findings but most of the time, they do
not give a comparison to other findings. The only comparison with other study findings was
shown only for Urogenital health, and even only one study was cited. Authors could find more
research, which could be compared with their results.
In general, the English used needs to be improved.