-->PONE-D-26-15953-->

THESES-M: protocol for the development of a reporting guideline for medical theses

-->PLOS One

Dear Dr. López-Ortiz,

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ACADEMIC EDITOR:  The reviewers asked minor revisions of the manuscript

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Reviewers' comments:

Reviewer's Responses to Questions

-->Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.-->

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Partly

Reviewer #5: Yes

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-->2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.-->

Reviewer #1: Yes

Reviewer #2: Partly

Reviewer #3: No

Reviewer #4: Partly

Reviewer #5: Yes

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-->3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.-->

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: No

Reviewer #4: Yes

Reviewer #5: Yes

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

Reviewer #4: Yes

Reviewer #5: No

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: Yes

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-->6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

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Reviewer #1: This manuscript presents a structured and methodologically sound protocol for developing the THESES-M reporting guideline, addressing the important gap of standardized reporting criteria in medical theses. The rationale is well-supported by relevant literature.

The methodology adheres to EQUATOR Network recommendations and includes a systematic literature review, Delphi rounds, predefined consensus criteria, and a structured consensus meeting, enhancing its robustness. Pilot testing ensures the checklist's feasibility and usability.

The methodology is detailed and reproducible, with transparent processes for literature review, item generation, expert selection, Delphi procedures, and data analysis. The combination of quantitative measures (median, IQR, Kendall’s W) and qualitative thematic analysis strengthens the consensus validity.

However, some areas need clarification:

1. Data Availability: Specify the repository for de-identified data to enhance transparency.

2. Literature Review Scope: Include more detail on inclusion/exclusion criteria and quality appraisal.

3. Expert Panel Diversity: Clarify how international representation beyond Mexico will be achieved.

4. Potential Bias: Discuss strategies to mitigate selection bias from relying on publicly available documents.

5. Minor Language Edits: Polishing some sections could improve readability.

Overall, this is a high-quality protocol following established standards and has potential contributions to medical education and research reporting. With minor revisions, it would be suitable for publication.

Reviewer #2: As a Reviewer, i believe Sample size justification for the Delphi panel needs strengthening. Literature review methodology lacks search strings and a systematic approach to institutional repositories. Also consensus thresholds (Kendall’s W ≥ 0.8) are too stringent; handling of scores 5–6 is ambiguous. Pilot testing design not mentioned appropriately.

Conflict of interest/disclosure is missing, qualitative analysis plan, patient/public involvement rationale.

Reference style is truncated (page 27).

Data availability statement does not comply with PLOS ONE policy (needs repository and timing clarification).

I recommend minor revision.

Reviewer #3: 1. Delphi Method - the protocol sets a threshold of more than 80% consensus. my recommendation is please define a clear "gray zone" management strategy. If an item receives 70–79% agreement, will it be automatically discarded, or will it be discussed in a virtual meeting? Defining the process for near-consensus items will prevent the loss of potentially valuable reporting standards.

2. Please specify the metrics for "feasibility." Will this be measured by the time it takes to complete the checklist, or by inter-rater reliability scores when two different evaluators use THESES-M to grade the same thesis? Strengthening the description of the pilot phase will provide more confidence in the guideline’s eventual validation.

3. LR - Please Include a "Knowledge Translation" or "Dissemination" section in the protocol. This could involve plans to develop an Explanation and Elaboration (E&E) document (similar to CONSORT or PRISMA) or strategies to partner with specific medical university networks to mandate the guideline’s use for graduation.

4. Please define a clear "gray zone" management strategy. If an item receives 70–79% agreement, will it be automatically discarded, or will it be discussed in a virtual meeting? Defining the process for near-consensus items will prevent the loss of potentially valuable reporting standards.

5. Please define an IQR ≤ 2 as the objective cutoff for consensus.

6. please measured dispersion (IQR) - Low IQR - please indicates the most experts ranting are clustered closed to gather (High consensus), High IQR - Please indicates that experts opinions are widely spread in low consensus.

7. Please add "change in IQR' alongside kendalls W to confirm when the the panel's opinion has stabilized

8. Please adding the percentage change in the IQR between rounds. If the IQR does not change significantly between Round 2 and Round 3, it proves "stability," meaning further rounds would not change the outcome. This adds a second layer of statistical rigor to your Delphi process.

9. please polishing the novelist

Reviewer #4: The manuscript is a study protocol describing the development of a guideline framework, THESES-M, with the intent to provide minimal standard requirements on consistency and evaluation of medical theses. The authors had identified this gap through the variability of how medical theses are evaluated and, especially, on the observation around the variability in how medical theses are structured, evaluated, and ultimately translated into scientific publications. The authors make the case that inconsistency in thesis quality may contribute to the relatively low rate of conversion into manuscripts, and their effort to develop a standardized framework is both timely and relevant. The strength of the work lies in its clear identification of this gap, as well as in the overall structured and replicable protocol presented. The inclusion of pilot testing with students is particularly valuable, as it grounds the framework in practical application and usability.

Several areas would benefit from greater clarity and refinement to strengthen the manuscript’s overall impact and generalizability. The scope and context of the work could be more explicitly framed at the outset. Because medical theses are not a universal requirement, it would be helpful for the introduction to clearly state upfront where and at what levels of medical education (e.g., undergraduate, graduate, residency) such theses are typically required – particularly in regions such as Europe, Asia, Africa, and Latin America. Relatedly, the authors should clarify how the proposed framework may be applicable, or adaptable, in settings where medical theses are not a standard requirement. Additional clarity and supporting context are also needed for the claim that master’s theses have low rates of conversion into publications.

Methodologically, the protocol is generally clear and well organized, but additional detail would improve transparency and reproducibility. For example, a brief explanation of the Delphi consensus process, including who participates, how meetings are facilitated, and how consensus is defined and managed if not reached, would strengthen the rigor of the approach. The rationale for providing participants with prior rankings should also be explained, along with any steps taken to mitigate potential bias across Delphi rounds. Similarly, the pilot study would benefit from clarification regarding the selection of the 20–25 students, whether participation to use the THESES-M guidelines was voluntary or mandatory, how consent was obtained, and how potential self-selection bias was considered. That is, were all eligible students required to use the THESES-M guidelines and were asked to volunteer to complete the survey?

Additional clarity in several areas is recommended:

1. The manuscript would benefit from clearer operational definitions, including concrete examples (e.g., what constitutes a “medical thesis”), and more specificity regarding purposive sampling (e.g., types of researchers and definitions of undergraduate versus postgraduate in this context).

2. The literature review process should specify the systematic procedures used (such as PRISMA), and the authors should clarify how documentation and data management will occur.

3. Additionally, the decision not to conduct a formal quality appraisal warrants justification.

4. Providing brief explanations of the statistical measures used, such as kappa and Kendall’s coefficients, would also improve accessibility for a broader audience.

5. The inclusion of a visual summary (e.g., a figure or flow diagram) of the protocol would help readers more readily grasp the overall process. Finally, while the framework is promising, it is currently limited to a single institutional context, and this should be acknowledged more explicitly as a limitation in terms of generalizability.

Overall, the study is feasible and addresses a meaningful gap in the field. With improved clarity in scope, enhanced methodological transparency, and some tightening to reduce repetition, the manuscript would be well positioned to make a valuable contribution to the standardization of medical thesis development and evaluation.

Reviewer #5: General Assessment The proposed protocol, THESES-M, aims to establish a reporting standard for medical theses, designed for inter-institutional application across various disciplines within the health sciences. This is a laudable goal that aligns perfectly with the rigorous, open-science mandate of PLOS ONE. Establishing these standards will be a highly beneficial undertaking for medical supervisors, researchers, and students globally, and their eventual publication in PLOS ONE will ensure the resulting guidelines are universally available.

Overall, the protocol is methodologically robust and closely adheres to the recognised guidance for guideline development set out by Moher et al. and the EQUATOR Network. It represents a strong candidate for publication. The following minor revisions and methodological clarifications are offered primarily for the benefit of the authors to further strengthen the study's reproducibility and psychometric transparency.

Major Comments

Protocol Timeline and PLOS ONE Compliance: It is understood from the text that data collection and the Delphi rounds have not yet commenced, which satisfies PLOS ONE’s prospective requirement for study protocols. However, to ensure immediate clarity for the editorial board and future readers regarding the prospective nature of the work, presenting the anticipated study timeline as a formal table or Gantt chart is highly recommended.

Considerations for the Likert Scale: The protocol proposes utilising a 10-point Likert-like scale to rate initial items, which is subsequently grouped into four operational categories. While there is precedent for wider scales in healthcare consensus methodologies (such as the 9-point RAND/UCLA appropriateness method), collapsing a 10-point ordinal scale into four distinct bins may introduce unnecessary variance and limit the granularity the scale was originally intended to capture. The authors might consider whether a more common 5- or 7-point scale would be more psychometrically stable for consensus thresholding. If the 10-point-to-4-bin structure is retained, a brief justification of its statistical validity and thresholding mechanism would strengthen the methodology.

Reproducibility of the Literature Review: To ensure the resulting guideline is truly applicable across diverse global institutions, the initial literature review phase should be explicitly defined in terms of its linguistic scope (e.g., clarifying whether Spanish or other non-English literature will be included). Furthermore, while a full formal scoping review may be out of scope for initial item generation, depositing the exact Boolean search strings, database limits, and search dates as a Supplementary File would greatly enhance the study's reproducibility.

Delphi Panel Attrition: Longitudinal Delphi panels frequently experience attrition across multiple rounds. While the protocol defines the intended initial panel size, it would benefit from a quantified a priori coping plan based on absolute numbers. To protect the statistical validity of the final consensus, the authors are encouraged to define their minimum acceptable absolute panel size (e.g., stating that consensus will not be considered valid if the panel drops below N = 20) rather than relying solely on optimal initial recruitment numbers.

Minor Comments

Data Availability: The authors state that de-identified data will be made available upon study completion, which is the correct approach for a study protocol prior to data collection. However, to ensure seamless compliance with PLOS ONE’s strict Data Availability policies, the authors should explicitly state where or how they intend to make this data available in the future (e.g., indicating that it will be deposited in a specific public repository such as OSF or Figshare, or published as Supplementary Information alongside the final manuscript).

Pilot Testing Phase: Please ensure that the pilot testing phase (Phase 4), which is mentioned in the abstract, is described with sufficient detail in the full text. Specifically, as this is likely a qualitative usability exercise, the protocol should note the target number of users anticipated to reach data saturation (e.g., 5-10 users) and detail the specific evaluation metrics (e.g., clarity, feasibility) that will be applied to the consensus-based checklist and the explanation and elaboration document.

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: Yes:  SAKINAH AWANGHARUN

Reviewer #4: No

Reviewer #5: Yes:  Francesco Bolstad

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Submitted filename: THESES-M_ protocol.pdf

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Submitted filename: Reviewer comments PLOS.docx

THESES-M: protocol for the development of a reporting guideline for medical theses

PONE-D-26-15953R1

Dear Dr. López-Ortiz,

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Kind regards,

Paolo Landa, Ph.D.

Academic Editor

PLOS One

Additional Editor Comments (optional):

the authors have well addressed all the questions raised by the reviewers.

Reviewers' comments: