-->PONE-D-26-11670-->-->Association between gastroesophageal reflux symptoms and sleep quality among medical students at a private university in Lima, Peru: a cross-sectional study-->-->PLOS One

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Reviewers' comments:

Reviewer's Responses to Questions

-->Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. -->

Reviewer #1: Yes

Reviewer #2: Partly

Reviewer #3: Partly

Reviewer #4: Yes

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-->2. Has the statistical analysis been performed appropriately and rigorously? -->

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

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-->3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.-->

Reviewer #1: No

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

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-->4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.-->

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

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-->5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)-->

Reviewer #1: In the methods section, consider presenting the sample size calculation first, then the recruitment approach, and finally how incomplete records were handled.

The study does not report the number of students approached or the number who declined participation

The definition of poor sleep quality requires clarification. The manuscript classifies poor sleep as a PSQI score ≥5; however, the validated cutoff defines poor sleep quality as a global PSQI score >5, with scores ≤5 indicating good sleep quality. The authors should clarify/justify the use of this alternative threshold

The link between multicollinearity assessment (VIF) and the decision to categorize age into tertiles requires clarification. VIF is used to detect collinearity among predictors. Please clarify the methodological basis for this decision.

Given the findings of reference 14, the incremental contribution of this study is not immediately clear. The discussion should explicitly articulate how this study advances existing knowledge, including any novel population-specific insights or methodological contributions.

Reviewer #2: In this work, Alvaro F. Montalvo-Peralta and colleagues conducted a cross-sectional study to examine the association between gastroesophageal reflux symptoms and sleep quality among medical students at a private university in Lima, Peru. Their findings highlight the alarming burden of GERD and Poor sleep quality among medical students and the significant association between GERD symptoms and poor sleep quality. The data is interesting, and the topic is relevant, and I want to congratulate the authors for their work. However, I have several comments for the authors to improve the clarity of the manuscript.

General comment

• Overall, check for grammatical flow and sentence formation of the entire manuscript, as some of the sentences are long, vague, and not up to the scientific standard.

Title and Abstract

• Limit abbreviations in the abstract section.

Introduction

• The authors didn’t clearly describe what is already known regarding the association (and its degree) b/n sleep quality and GERD symptoms, particularly in the study population (medical students)?

• Which gaps in the literature does the current study aim to narrow?

Methods

• In the first paragraph of the methods section, “An analytical cross-sectional study was conducted among medical students from a private university (Universidad Peruana Unión) in Lima, Peru, during 2024”.

o The study period should be stated (eg, from October 27 to November 28, 2024)

• Inclusion and exclusion criteria should be clearly delineated and justified.

o Given that the study population is medical students (who are most likely more than or somewhere around 18 years old), what is the rationale for using the 18-year-old age cutoff for inclusion?

o Were the exclusion criteria limited to participants with incomplete data? Please mention if any additional exclusion was used? This is important for clarity and transparency.

o What defines incomplete data in the study?

• In participant selection, why do you prefer to include only students attending an in-person academic event? This can introduce a potential selection bias because students with frequent GERD symptoms and poor sleep may have increased absenteeism, which could lead to their exclusion and underrepresentation in the study.

• Why did you prefer to use non-probabilistic convenience sampling? Even though non-probabilistic convenience sampling can be useful for pilot studies or exploratory research, in analytical studies like this, it can pose a significant limitation. The authors should clarify these points and acknowledge them as limitations if necessary.

• Was block sampling by academic year used to affirm the balanced distribution of participants across academic years?

• Was sample size calculation for detecting associations performed?

• The dependent variable in the study was sleep quality, specifically “during the last month”. Do you use a similar time frame for the independent variable (GERD symptoms)? This is critical to ensure a temporal association between GERD symptoms and sleep quality

• How do you select covariates? Some relevant confounders based on prior literature seem to be missing. This includes

o Use of symptomatic treatments for GERD, like PPIs

o Comorbidities, including psychiatric illness and other medical conditions known to impact sleep quality

o Self-reported depression and anxiety symptoms

o Physical activity

• It is good that the authors use Poisson regression with robust variance instead of logistic regression, given the outcome prevalence is common (>10 -15%). In describing the statistical analysis (model) used (for effect measure reporting), clearly justify your model choice, including why robust variance was used for technical clarity, and report the confidence interval (not mentioned).

o Suggested description: Given the high prevalence of the outcome, the association between GERD and sleep quality was evaluated using Poisson regression with robust variance to calculate crude prevalence ratios (cPR) and adjusted prevalence ratios (aPR) with 95% confidence intervals. Robust (sandwich) estimators were applied to account for potential overdispersion.

• The authors stated, “for inclusion of variables in the adjusted model, we followed an epidemiological approach by including all potential confounders of the association”.

o Authors should clearly state how confounders were selected. Mention whether clinical relevance (based on literature and biological plausibility, statistical criteria (variables with P < 0.2 in bivariate analysis), or a combination of both) was used to include the covariates within the model.

Results

• The authors stated, "Initially, 176 students were surveyed, of whom 5 did not meet the inclusion criteria; therefore, 171 participants were finally analyzed."

o Why were students who don’t meet the inclusion criteria surveyed in the first place? Rather, specific exclusion criteria should have been used to exclude patients.

o Modify the description accordingly.

• While doing descriptive statistics like in Table 1 (Characteristics of medical students from a private university in Lima, Peru), in addition to frequency values for all students, it would be better and more informative if participant characteristics were reported categorized for students with GERD and without GERD to account for group differences.

• The prevalence of GERD (76.6%) in your study is extremely high compared with previous studies, both in the general population and among medical students.

o What are the possible explanations? This should be clearly discussed in the discussion section.

Discussion and conclusion

• The alarmingly high prevalence of GERD compared with previous studies needs better discussion.

o Put the potential reasons for the previous studies’ higher, lower, and similar findings compared to your study separately.

• The authors stated that “Previous studies among Peruvian university students have reported similar or even lower prevalences of GERD,” referencing two studies. However, the statement is vague and inaccurate because, although the observed prevalence of GERD in the current study (76.6%) was comparable to that of Antenor Orrego Private University, Trujillo – Peru (75%), it was significantly higher than that of Huacho School of Human Medicine (42%).

o Given the significantly high GERD prevalence observed in the current study, the finding needs better comparison with those studies and contextualization.

• Moreover, the authors tried to forward potential reasons for the high prevalence of GERD, stating “high frequency of unhealthy dietary and behavioral habits identified in the sample, such as excessive consumption of coffee and energy drinks, use of NSAIDs, and intake of spicy foods, factors previously associated with an increased risk of GERD symptoms.”

o However, we don’t know whether the mentioned behaviors are more common in those students with or without GERD.

o As I mentioned before in the results section, reporting participant characteristics categorized for students with GERD and without GERD to account for group differences might be beneficial to give some perspective.

• While discussing the high prevalence of poor sleep, the authors stated: “This high frequency could be attributed to the intense academic workload, sustained stress, high prevalence of depression and anxiety, irregular schedules for studying and resting, and frequent use of electronic devices at night, factors that disrupt circadian rhythms and compromise both sleep duration and quality.”

o However, some of the factors mentioned (eg, depression and anxiety, frequent use of electronic devices at night) could have been measured in the study, which would also have mitigated the confounding factors in assessing the association between GERD and poor sleep.

• In the final paragraph, while discussing the association between GERD/GER symptoms with poor sleep, the authors have focused on describing findings from previous studies rather than discussing findings from the current study and analytically comparing it with previous reports. The whole paragraph needs to be modified accordingly.

Reviewer #3: The research question is timely and the use of adjusted Poisson regression is methodologically appropriate for this outcome. With revisions addressing the validity of the FSSG cut-off in this population, more transparent reporting of participation rates, inclusion of mental health covariates or explicit acknowledgment of their absence as a primary limitation, and more cautious interpretation of prevalence estimates and the dose–response magnitude, this work has the potential to make a meaningful contribution to the literature on student health in Latin America.

The cross-sectional design is appropriate for an initial exploration of this association, and the use of validated instruments (PSQI and FSSG) strengthens the methodological rigor. However, the reliance on convenience sampling and self-reported data introduces potential selection and reporting biases, which should be more explicitly acknowledged and discussed in terms of their impact on internal and external validity.

The FSSG cut-off of >8 was validated in a Japanese clinical population, not in Peruvian university students; authors must either cite a validated adaptation or reframe results as "GERD symptom burden" rather than clinical GERD prevalence.

A 1% prevalence increase per one-point FSSG increment is statistically significant but clinically modest; the authors should illustrate the magnitude by comparing predicted prevalence between a student at the GERD threshold (score 8) and one with moderate-severe burden (score ~30).

Reviewer #4: Refer to attached document for clarity.

Major comments for Authors – Action required)

1. Clarify and strengthen the knowledge gap (Abstract & Introduction)

The manuscript does not clearly articulate what is unknown in the specific context of Peruvian or Latin American medical students.

✔ Action required:

• Explicitly state the knowledge gap, e.g. lack of context-specific evidence in Peru

• Clearly define how this study adds to existing literature

2. Improve study setting description (Methods)

The study setting is described only as:

“a private university (Universidad Peruana Unión) in Lima, Peru”

This lacks sufficient contextual detail.

✔ Action required:

• Describe the institution (type, size, structure of medical program, student distribution)

3. Provide complete and reproducible sample size calculation (Methods)

The manuscript reports:

“minimum required sample size of 160 participants”

But omits:

• Allowable error (precision, e.g., 0.05)

• Formula used

• Finite population correction

• Non-response adjustment

✔ Action required:

• Provide full sample size formula and parameters

4. Address incomplete confounder adjustment (Critical Issue)

The manuscript includes lifestyle variables but omits:

• Mental health (stress, anxiety, depression)

• Medications affecting sleep

Yet later discusses:

“academic stress… depression and anxiety”

✔ Action required:

• Either:

o Include these variables in analysis (if available)

o OR strongly emphasize as a major limitation affecting validity

5. Correct misunderstanding of multicollinearity (Methods)

The manuscript states:

“age was categorized into tertiles to avoid multicollinearity”

✔ Action required:

• Revise this statement

• Provide correct approach to assessing multicollinearity (e.g., VIF)

6. Add data quality control procedures (Methods)

Data were collected via:

“Microsoft Forms… and WhatsApp”

But no mention of:

• Duplicate checks

• Missing data handling

• Validation procedures

✔ Action required:

• Describe data quality assurance measures

7. Improve statistical reporting in Results

Example:

“prevalence was significantly higher… (p=0.016)”

✔ Issues:

• Over-reliance on p-values

• No effect size in Table 2

✔ Action required:

• Include crude prevalence ratios (cPR) with 95% CI in Table 2

• Reduce emphasis on p-values alone

8. Improve Table clarity and completeness

• Table 2 lacks effect size

• Legend does not specify which test was used for each variable

• Table 1 does not clearly separate counts and percentages

✔ Action required:

• Add cPR and CI

• Clarify statistical tests per variable

• Improve formatting

9. Remove interpretation from Results section

Example:

“a linear and directly proportional relationship was observed…”

✔ Action required:

• Replace with neutral wording (e.g., “a positive association was observed”)

10. Avoid overinterpretation in Discussion

Example:

“could be explained by unhealthy dietary and behavioral habits…”

✔ Issue:

• Implies causal mechanisms

✔ Action required:

• Use cautious language (“may be associated with”)

11. Clearly state study contribution (Discussion)

The manuscript compares findings but does not explicitly state:

• What this study adds

✔ Action required:

• Add a clear statement of contribution

12. Separate implications and recommendations

The section:

“Implications and recommendations”

mixes interpretation and action.

✔ Action required:

• Separate into:

o Implications

o Recommendations

13. Strengthen limitations section

The current section does not fully reflect:

• Selection bias due to recruitment method

• Online survey limitations

• Lack of local validation of FSSG

• Residual confounding

✔ Action required:

• Expand limitations to explicitly include:

o Recruitment bias (health-conscious participants)

o Online survey bias

o Measurement limitations

o Missing confounders

14. Major Comments on Limitations (For Authors – Action Required)

1. Selection bias not sufficiently specified

The manuscript states:

“Convenience sampling may limit external validity and generate selection bias.”

This is too general and does not reflect the actual recruitment approach:

• In-person academic/health-related event

• Online dissemination via WhatsApp

Issue:

• Likely overrepresentation of:

o More engaged

o More health-conscious students

This may bias:

• GERD prevalence (76.6%)

• Poor sleep quality (84.8%)

✔ Action required:

• Explicitly describe how recruitment method may have introduced selection bias

2. Online survey limitations not explicitly acknowledged

Although reporting bias is mentioned:

“students experiencing these problems may have been more likely to respond…”

The manuscript does not explicitly state that:

• Data were collected via an online self-administered questionnaire

Missing:

• Self-report bias

• Recall bias

• Lack of supervision

• Potential duplicate or careless responses

✔ Action required:

• Add a clear limitation related to online data collection and data quality

3. Residual confounding underemphasized (critical issue)

The manuscript states:

“variables such as academic stress or other mental health variables were not measured…”

This is appropriate but understated

Issue:

• Mental health factors:

o Strongly affect both GERD and sleep quality

• Their omission is a major threat to internal validity

✔ Action required:

• Emphasize this as a key limitation that may bias results

4. Omission of medications affecting sleep

The study includes:

• NSAIDs

But does not mention omission of:

• Sleep medications

• Antidepressants

• Stimulants

Issue:

• These are important confounders influencing sleep outcomes

✔ Action required:

• Add this as a limitation contributing to residual confounding

5. Lack of local validation of measurement tools

The manuscript states:

“validated and widely used instruments were employed…”

However:

• PSQI → validated locally ✔

• FSSG → not clearly validated in Peruvian population

Issue:

• Possible measurement bias or cultural misclassification

✔ Action required:

• Acknowledge limited local validation of FSSG

6. Reporting bias explanation needs strengthening

The manuscript states:

“students experiencing these problems may have been more likely to respond…”

This is valid but incomplete

✔ Action required:

• Link explicitly to:

o Voluntary participation

o Online format

o Recruitment strategy

14. Make recommendations actionable (Conclusion)

Current statement:

“implementing systematic screening… and developing timely interventions…”

✔ Issue:

• Too vague

✔ Action required:

• Specify:

o Screening tools (PSQI, GERD tools)

o Lifestyle interventions (diet, caffeine reduction)

o Clinical pathways (student health services)

Minor Comments (For Authors – Action Required)

1. Title refinement

• Reduce redundancy (“association between” + “cross-sectional study”)

2. Keywords

• Remove study design

• Focus on content terms (GERD, sleep quality, students, Peru)

3. Abstract

• Add:

o Knowledge gap

o Contribution

o Effect estimates (aPR with CI)

4. Reporting of missing data

• No mention of:

o Missing values

o Handling approach

✔ Add this to Methods/Results

5. High prevalence values

• GERD (76.6%) and poor sleep (84.8%) are very high

✔ Briefly acknowledge possible reasons (selection bias, measurement)

6. Strengths section

• Expand to include:

o Appropriate analytical approach (PR instead of OR)

o Use of standardized tools

7. Minor Comments on Limitations

1. Screening tools vs diagnosis

The manuscript states:

“FSSG and PSQI are screening instruments…”

✔ Appropriate

Could be improved by adding:

• Risk of misclassification bias

2. Balance of strengths vs limitations

• Limitations are present but:

o Not sufficiently detailed

• Strengths somewhat overstated relative to limitations

✔ Suggest improving balance

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

Reviewer #4: Yes: Evelyn Kigenyi Zalwango

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Attachments

Attachment

Submitted filename: Sleep quality and GERD 1.docx

<p>Gastroesophageal reflux symptoms and sleep quality among medical students at a private university in Lima, Peru: a cross-sectional study

PONE-D-26-11670R1

Dear Dr. Soriano-Moreno,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Taeyun Kim

Academic Editor

PLOS One

Additional Editor Comments (optional):

All comments have been adequately addressed in this revision.

Reviewers' comments:

Reviewer's Responses to Questions

-->Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.-->

Reviewer #2: All comments have been addressed

Reviewer #4: All comments have been addressed

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-->2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. -->

Reviewer #2: Yes

Reviewer #4: Yes

**********

-->3. Has the statistical analysis been performed appropriately and rigorously? -->

Reviewer #2: Yes

Reviewer #4: Yes

**********

-->4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.-->

Reviewer #2: Yes

Reviewer #4: Yes

**********

-->5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.-->

Reviewer #2: Yes

Reviewer #4: Yes

**********

-->6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)-->

Reviewer #2: The authors have done a remarkable work in revising the manuscript based on the reviewers comments. I believe the manuscript is now ready for acceptance to publication after proofreading for some minor issues.

Some minor issues:

- Defining abbreviation on first encounter: eg. TRPV1 (Transient Receptor Potential Vanilloid 1) in introduction section.

- In the Introduction section: Their is no need of stating the CI for the results from the referenced studies. Just mentioning the degree of the observed association and whether it was significant association is enough. This will improve the conciseness and readability.

- In the conclusion section: "These findings highlight the use of simple screening tools for GERD symptoms and sleep quality in university health settings and the implementation of targeted interventions focused on sleep hygiene and reduction of reflux-related behaviors." The sentence is imprecise and seems to overstate conclusions.

The phrase "highlight the use of" could be misleading here as your study doesn't assess the validity or use of screening tools and the use of implementing targeted interventions. Rather use alternative phrases like "highlight the need for", "Emphasize the need for".

Carefully search for similar wording problems which may mislead readers from capturing what you are really trying to express.

Reviewer #4: Thank you for your thorough and thoughtful responses to the reviewer comments. You have addressed all concerns satisfactorily, and the manuscript has improved significantly in clarity, coherence, quality, and scientific contribution. Well done.

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-->7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

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Reviewer #2: No

Reviewer #4: Yes: Eva Kigenyi Zalwango

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