Does Palatoplasty in Patients with Cleft Palate Really Improve Otitis Media with Effusion?

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

The question to be answered in this paper is: does the VPF outcome after palatoplasty relate with the resolution of OME in our cleft palate patients? Their study also contributes new information of relevance from a clinical point of view, but, it is incomplete. On particular points:

Study design limitations – The sample size is small and retrospective, lacking a control or comparison with untreated cases. Statistical power is insufficient for detecting subtle associations (e.g., p = 0.097 interpreted as a trend).

Measurement of VPF – The assessment relies solely on speech-language and blowing tests. Quantitative or instrumental evaluations (nasometry, endoscopy, acoustic nasalance) would make conclusions more convincing.

Interpretation – The statement that “palatoplasty had a certain effect on OME improvement” is descriptive but not statistically demonstrated; please moderate the wording.

Bias and confounding – Surgical technique choice was subjective; acknowledge possible surgeon-related and case-selection bias more explicitly.

Future directions – A multi-center prospective study with standardized VPF assessment and objective otologic endpoints (tympanometry, audiometry) would be valuable.

Although clinically relevant the paper is not sufficiently well-designed or novel to be of interest to a general audience. Since this is a retrospective study, is single-center and has a small sample, its authors choose not to make final statements regarding the benefit on improvement of OME after palatoplasty. In addition, the conclusions largely support what is already generally known, and do not provide novel mechanistic or methodological information.

Author Response

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Reviewer 2 Report

Comments and Suggestions for Authors

Dear Authors,

Thank you for the opportunity to review your manuscript. The topic is clinically relevant and addresses an important question in the management of children with cleft palate. The manuscript is generally clear and the overall structure is appropriate; however, several methodological, analytical, and reporting issues limit the strength of your conclusions. Below I provide detailed comments.

 

Introduction

The introduction outlines the prevalence of OME in cleft palate patients and appropriately references previous studies on risk factors and surgical considerations. However, the specific knowledge gap that your study aims to fill should be more clearly articulated. You state that few reports have examined the relationship between improvement of VPF and improvement of OME, but the limitations of existing studies and how your work addresses them are not sufficiently explained. Strengthening the rationale and clarifying the novelty of the study will help readers understand its contribution. Additionally, there is some systematic reviews on the topic that has not been discussed.

 

Methods

Several methodological aspects need greater detail to ensure reproducibility and transparency. First, it is not clear how patients were selected for inclusion beyond being treated in your department; explicit inclusion and exclusion criteria should be added. You note that 26 patients were included but only 23 had evaluable OME outcomes at 36 months; reasons for this attrition should be explained to assess potential bias. Additionally, the choice between Furlow and Pushback techniques was based on surgeon decision, which introduces selection bias and limits the interpretability of comparisons between surgical groups. This limitation should be clearly acknowledged and further justification of its selection should be added.

The assessment of VPF requires more methodological detail. Both the speech-language assessment and blowing test appear to rely on patient cooperation and subjective evaluation. It would be helpful to describe how many evaluators were involved, whether they were calibrated or trained according to a standardized protocol, and whether any reliability assessments (e.g., inter-rater agreement) were performed. Providing more specificity about the validated components of the Miura et al. protocol would also enhance the methodological clarity.

Regarding OME assessment, the criteria used by otolaryngologists to diagnose “good prognosis” versus “recurrence” should be described explicitly. It is not clear whether diagnosis was standardized (e.g., based on otoscopy, tympanometry, audiometry) or varied between clinicians, and such variability could affect outcome classification. Finally, the status of ventilation tubes is described descriptively, but the clinical meaning of tube retention, removal, or extrusion in relation to OME outcomes should be more clearly integrated into the analysis.

 

Statistical Analysis

The analytical approach is limited to chi-square tests, which may not be appropriate given the small sample sizes and low cell counts in several comparisons (remember the conditions when this test is appropriate). Fisher’s exact test would be more suitable in such cases. Moreover, no adjustment for confounding variables was attempted, even though factors such as cleft type, surgical technique, and comorbidities (e.g., adenoid hypertrophy) may influence both VPF and OME outcomes. As a result, the observed lack of associations may simply reflect insufficient power or uncontrolled confounding. You should acknowledge the risk of type II error more explicitly and consider revising the conclusions accordingly.

 

Results

While the results are generally clear, several aspects could be streamlined for clarity. Some figures (e.g., Figures 2 and 4) convey overlapping information, and combining or simplifying visual elements may improve readability. Additionally, the narrative occasionally repeats descriptive data from the figures without further analytical interpretation. Providing more focused descriptions that highlight clinically meaningful findings would strengthen this section.  Please reduce the figure to a maximum of 2-3, with the most relevant findings of your work, the remaining results can be descriptively displayed.

The presentation of VPF results in relation to OME recurrence should also be interpreted with caution, given the small number of patients in each category. For example, the “Severe” VPF group includes only two patients, making statistical comparison unreliable. Explicitly acknowledging these limitations within the results or discussion would be helpful.

 

Discussion

The discussion summarises your findings but would benefit from a more cautious interpretation. Because all patients underwent palatoplasty with ventilation tube insertion, and no untreated or comparative group was included, it is not possible to conclude that palatoplasty itself “had a certain effect” on OME improvement. Your current statement suggests a causal inference that the study design cannot support. Instead, the findings should be framed descriptively, noting the observed proportion of patients with improved outcomes.

Your discussion of VPF limitations is appropriate, but the manuscript would benefit from a more robust exploration of measurement challenges, potential misclassification, and the implications for interpretation. Additionally, the mention of a modified Furlow technique in your recent practice appears disconnected from the main narrative unless further elaborated; consider expanding or removing this section.

Finally, you briefly mention the need for multicenter or prospective studies; highlighting specific methodological improvements (e.g., standardized OME diagnostic criteria, objective measures of Eustachian tube function, surgical techniques, and so on) would strengthen your conclusion.

 

Minor Issues

Several typographical, phrasing, and formatting inconsistencies should be addressed, including the inconsistent use of abbreviations and occasional grammatical issues. Adherence to STROBE guidelines for observational research would also help improve the reporting quality, particularly in relation to patient flow, missing data, operational definitions, and biases.

Author Response

Thank you very much for reviewing my paper.

I have attached a file containing my responses and actions taken regarding your comments.

Please see the attachment.

Author Response File: Author Response.pdf

Reviewer 3 Report

Comments and Suggestions for Authors

As for submitted scientific manuscript the authors should provide more detailed information regarding the sample. The age, surgical and orthodontic protocol should be described in the methods. Exclusion criteria: syndromic clefts, general diseases also should be added. The conclusions must be improved , percentages should be in results rather then in conclusions. Strong limitation is the number of cases ( also different clefts ) 

Author Response

Thank you very much for reviewing my paper.

I have attached a file containing my responses and actions taken regarding your comments.

Please see the attachment.

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Reviewer 4 Report

Comments and Suggestions for Authors

Thank you for submitting your manuscript reviewing the impact of cleft repair on OME in children with cleft lip and/or palate.

You initially recruited 26 patients but only 23 patients were followed up. What happened to the other 3 patients?

You discuss the rates of OME and ventillation tube status between surgical technique groups. Did you compare rates between different cleft types? Do you think the risk of OME recurrence is related to the procedure or to the nature of the initial cleft?

The rate of VPF would be expected to be higher in patients with wider clefts, those would be more likely to have a pushback rather than a Furlow repair. This does not seem to be the case in your series, with most patients in both groups having mild VPI at 36 months.  

Author Response

Thank you very much for reviewing my paper.

I have attached a file containing my responses and actions taken regarding your comments.

Please see the attachment.

Author Response File: Author Response.pdf

Reviewer 5 Report

Comments and Suggestions for Authors

Congratulations to the Authors for this very interesting manuscript  about effects of Palatoplasty  on the improvement of OME. 

The manuscript is well written and  shows a good methodological soundness. The discussion and conclusions are clear. The authors showed the limitations of the study and I agree with them about future further studies with a larger sample.

I have only a few comments and suggestions  to improve the manuscript.

 

• The Authors should describe shortly the surgical techniques reported in the study:

        Furlow, Pushback and Langenbeck.

 

• Pag 7, line 212 > … but with no significant > …significant difference ???
• Pag 8, line 222 > …with no significant > …significant difference ???

 

Author Response

Thank you very much for reviewing my paper.

I have attached a file containing my responses and actions taken regarding your comments.

Please see the attachment.

Author Response File: Author Response.pdf

Round 2

Reviewer 2 Report

Comments and Suggestions for Authors

Dear authors,

Thank you for your comprehensive answer on every comment that I have made. I'd really like how you addressed those points. I only have one suggestion to the manuscript, so I can accept it. When you write "As the choice of the technique was made on an individual case by a surgeon’s decision, there was a high degree of bias in the choice of technique." You should be more "nuanced" in the degree of bias. I suggest you to change it to "As the choice of the technique was made on an individual case by a surgeon’s decision, a risk of selection bias should be acknowledged".

Well done!

Author Response

Thank you very much for reviewing my paper once again.

I have attached a file containing my responses and actions taken regarding your comments.

Please see the attachment.

Author Response File: Author Response.pdf

Reviewer 3 Report

Comments and Suggestions for Authors

Please try to work on proper conclusions, because most of readers read only this part. There is three repetitions of the word" palatoplasty" in the first sentence. Second sentence also need proper English language corretion to make it more clear.

The Tables should have a title ( above the table ), not the legend below.

Author Response

Thank you very much for reviewing my paper once again.

I have attached a file containing my responses and actions taken regarding your comments.

Please see the attachment.

Author Response File: Author Response.pdf

Reviewer 4 Report

Comments and Suggestions for Authors

Thank you for submit your revised manuscript which has addresses the questions raised previously. 

Author Response

Thank you very much for reviewing my paper once again.

I have attached a file containing my responses and actions taken regarding your comments.

Please see the attachment.

Author Response File: Author Response.pdf