-->PONE-D-25-49650-->-->Educational strategies to improve health literacy for people with type 2 diabetes in low socio-economic communities: A realist review protocol-->-->PLOS One

Dear Dr.  Heine,

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Marwan Salih Al-Nimer, MD, PhD

Academic Editor

PLOS One

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Additional Editor Comments:

Major Revision

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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

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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: Partly

Reviewer #2: Partly

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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

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-->4. Have the authors described where all data underlying the findings will be made available when the study is complete?

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Reviewer #1: Yes

Reviewer #2: Yes

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Reviewer #1: Yes

Reviewer #2: 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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(Please upload your review as an attachment if it exceeds 20,000 characters)-->

Reviewer #1: The manuscript presents a generally valid and relevant rationale for the proposed study. The research problem is clearly articulated and addresses an important and timely gap in the existing literature. The study appears well-positioned to contribute meaningfully to the academic knowledge base while also offering potential implications for policy and practice. The background section adequately describes the significance of the topic and situates the study within ongoing scholarly and policy discussions.

That said, the rationale could be further strengthened by more explicitly linking the research questions to an overarching conceptual or theoretical framework. While the problem statement is clear, the manuscript would benefit from a clearer articulation of the theoretical lens guiding the inquiry. Explicitly connecting the research questions to established frameworks would enhance conceptual coherence and help readers better understand how the study advances knowledge beyond descriptive or exploratory objectives. In particular, the authors should clarify how this work builds upon, diverges from, or fills limitations in prior studies. A more explicit statement of the expected contribution—whether methodological, theoretical, empirical, or policy-oriented—would further strengthen the justification for the study.

From a broader global health perspective, the framing of the research questions could be enriched by aligning them with established health promotion principles. For instance, the framework articulated in the Ottawa Charter for Health Promotion emphasizes building healthy public policy, creating supportive environments, strengthening community action, developing personal skills, and reorienting health services. If the proposed study relates to systems strengthening, governance, prevention, or population-level interventions, explicitly situating the research within one or more of these action areas would enhance theoretical grounding and global relevance. Integrating such a perspective would also strengthen the manuscript’s policy implications and demonstrate alignment with internationally recognized public health principles.

Regarding technical soundness, the protocol appears generally well designed and capable of producing meaningful findings. However, greater methodological specificity is needed to ensure transparency and minimize undisclosed analytical flexibility. The manuscript would benefit from clearer specification of primary and secondary outcomes, particularly if multiple endpoints are anticipated. Precise operational definitions of key variables and outcomes would help reduce ambiguity and improve reproducibility.

In addition, the analytic strategy requires more detailed elaboration. The authors should specify the statistical or analytical models to be employed, the assumptions underlying these models, and the rationale for selecting them. It would be helpful to clarify which analyses are confirmatory (hypothesis-testing) and which are exploratory in nature. If certain analytic decisions will depend on the characteristics of the collected data, this should be explicitly acknowledged, along with predefined criteria guiding those decisions. Where applicable, inclusion of a statistical power calculation or justification of sample size would further strengthen the protocol’s rigor. If power analysis is not feasible due to the nature of the study design, the authors should provide a clear explanation.

The manuscript should also more clearly describe how potential sources of bias will be minimized. This includes selection bias, measurement bias, confounding factors, and analytical bias. Strategies for handling missing data, addressing potential floor or ceiling effects, and conducting sensitivity analyses (if applicable) should be outlined in advance. Providing this level of detail will enhance the credibility of the proposed research and ensure that readers can assess the robustness of the methodology.

If the study evaluates policy, system-level, or population-based interventions, it would be beneficial for the authors to explain how contextual variables and social determinants of health will be accounted for in the analysis. Health outcomes and implementation processes are often shaped by socioeconomic, environmental, and governance-related factors. Acknowledging and planning for these influences would align the study more closely with systems-based and equity-oriented approaches to public health research.

In terms of feasibility and replicability, the methodology is described in reasonable detail; however, additional clarification is needed to ensure full reproducibility. The authors should provide detailed inclusion and exclusion criteria, where applicable, and clarify the sampling strategy and recruitment procedures. If specific instruments or tools will be used for data collection, these should be described comprehensively, including information on their validity and reliability where available. Timelines and procedural steps should be clearly outlined to allow another researcher to replicate the workflow.

If the study involves qualitative methods or mixed methods approaches, details regarding coding frameworks, inter-rater reliability procedures, and validation processes should be included. If it is a review-based protocol, the search strategy should be fully specified, including databases to be searched, search strings, date limits, language restrictions, screening procedures, and data extraction methods. Clarifying whether screening and extraction will be conducted independently by multiple reviewers, and how disagreements will be resolved, is important for ensuring transparency. Explicit quality control mechanisms should be described to demonstrate rigor.

Data availability is another area that requires further clarification. The manuscript should include a detailed Data Availability Statement that aligns with PLOS Data Policy. The authors should clearly indicate where datasets will be deposited upon completion of the study, whether in a recognized public repository or as supplementary materials. They should specify whether data will be available without restriction and how supporting materials—such as analytic code, extraction sheets, instruments, or protocols—will be shared. If any restrictions apply, such as those related to participant privacy or third-party data agreements, these should be transparently described. For studies involving human participants, anonymization procedures and data protection safeguards should be explicitly outlined. Full compliance with open data requirements should be clearly articulated prior to acceptance.

In terms of presentation and language, the manuscript is generally intelligible and logically structured. The overall flow is coherent, and the sections follow a clear progression. However, minor revisions would improve clarity and readability. Some sentences are lengthy and could be simplified for precision. Reducing repetition in the introduction would improve conciseness. Consistent terminology should be used throughout, and all acronyms should be defined at first use. Careful proofreading is recommended to correct minor typographical and grammatical issues. Since PLOS ONE does not copyedit accepted manuscripts, ensuring linguistic clarity prior to publication is essential.

Overall, this protocol addresses an important and policy-relevant topic with strong potential to contribute to the evidence base. The research is timely and has the capacity to inform both academic discourse and practical implementation. To strengthen the manuscript prior to acceptance, the authors should enhance the conceptual framework, provide more detailed methodological specifications, clarify confirmatory versus exploratory analyses, include power calculations where applicable, strengthen the Data Availability statement, and refine the manuscript for clarity and consistency.

From a broader public health standpoint, explicit integration of health promotion and systems-thinking approaches would further enhance the manuscript’s global relevance. Consideration of equity implications and potential differential impacts across population subgroups would strengthen its policy applicability. Addressing social determinants, multisectoral coordination, and governance dimensions—where relevant—would further align the study with contemporary global health priorities.

In conclusion, the protocol demonstrates substantial promise but requires moderate revisions to ensure methodological transparency, reproducibility, and conceptual robustness. With these improvements, the study has the potential to make a meaningful and valuable contribution to the field.

Reviewer #2: This protocol addresses an important and relevant topic, and the use of a realist review is appropriate for examining how educational strategies improve health literacy in adults with type 2 diabetes in low socioeconomic communities. The rationale is clear, the objectives are meaningful, and the manuscript shows good alignment with realist review principles and RAMESES guidance.

However, the protocol would benefit from revision before publication. The main limitation is insufficient methodological detail. The search strategy is described only broadly; the manuscript should provide a more reproducible search approach, including clearer operationalisation of search terms, database strategy, and iterative search procedures. In addition, the processes for study selection, appraisal, and data extraction need sharper detail, particularly how relevance, richness, and rigour will be judged consistently across reviewers.

The analytic section would also be strengthened by clarifying how ICAMO configurations will be developed from extracted data and how competing explanations will be handled. Finally, the manuscript would benefit from minor language and formatting revision for consistency. Overall, this is a worthwhile protocol with potential value, but further clarification is needed to improve transparency and reproducibility before acceptance.

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Reviewer #1: No

Reviewer #2: Yes:  Mansuor A. Alanazi

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Educational strategies to improve health literacy for people with type 2 diabetes in low socio-economic communities: A realist review protocol

PONE-D-25-49650R1

Dear Dr. Martin Heine,

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.

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Kind regards,

Marwan Salih Al-Nimer, MD, PhD

Academic Editor

PLOS One

Additional Editor Comments (optional):

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