PONE-D-25-42865 Comparing the Effects of Interactive and Conventional Video Education on Activation, Treatment Adherence and Weight Changes in Dialysis Patients: A Randomized Clinical Trial Protocol PLOS ONE

Dear Dr. Zare-Kaseb,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.   Both reviewers agree that this is a well-written protocol addressing an important question on improving patient activation and adherence in dialysis care through interactive and conventional video education. The study is relevant to the PLOS ONE scope and adheres to SPIRIT guidance. However, before the manuscript can be accepted, several issues must be addressed to ensure methodological rigour and clarity.   Required Revisions: 1.Cluster randomisation with three hospitals: The protocol assigns one hospital to each arm. With only three clusters, intervention effects may be confounded by site-level differences and cannot be reliably separated from cluster effects. Please provide a strong justification for this design, at least give detailed information on comparability of these 3 centers, acknowledge it explicitly as a limitation, and describe how intra-cluster correlation will be addressed in both the pilot-based sample size calculation and subsequent analysis.   2.Sample size and pilot study:  Reviewers requested further detail on the planned pilot. Please specify how the pilot will be conducted (sample, measures, anticipated effect size estimates) and clarify how these data will inform the main trial’s power calculation. In addition, explain the rationale for using 95% power, which is higher than common practice, and justify feasibility of achieving this with the proposed design.   3.Instructor bias and workshop imbalance: Reviewer #1 raised valid concerns that the Phase 2 workshops may introduce instructor-driven bias and are not provided to the control arm. Please describe standardisation measures (e.g., facilitator scripts, checklists) to minimise bias, and justify why the control arm does not receive an equivalent structured session.   4.Blinding of outcome assessment Reviewer #2 questioned why assessors are not blinded. Please provide justification for this choice and describe any measures you will use to minimise bias (e.g., independent assessors, scripted administration).   5. Content validation: Clarify why ICU nurses and anaesthesia specialists were selected to review programme content rather than dialysis-experienced nurses or nephrologists. If possible, expand content validation to include specialists directly involved in haemodialysis care.   6.Blinding of outcome assessment: Reviewer #2 questioned why assessors are not blinded. Please provide justification for this choice and describe any measures you will use to minimise bias (e.g., independent assessors, scripted administration).   7.Edits for clarity Replace all placeholders (e.g., “XXXX” for ethics approval and registration codes) with the correct identifiers. Revise Figure 3 to ensure baseline assessment is clearly shown to occur before intervention delivery.   For the recommended revisions, the authors should provide more detail on missing data handling (including assumptions for multiple imputation, number of imputations, and planned sensitivity analyses), clarify that interdialytic weight gain reflects both adherence and clinical factors and specify how potential confounders such as residual renal function and comorbidities will be addressed, ensure consistency of terminology by defining acronyms such as “PAM” at first use, review and streamline the introduction to focus on the specific evidence gap rather than extensive background epidemiology, and undertake minor grammatical edits to improve concision and clarity. The authors should also address the reviewers’ comments point by point in their rebuttal to ensure all issues raised have been adequately resolved. 

Please submit your revised manuscript by Oct 30 2025 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

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We look forward to receiving your revised manuscript.

Kind regards,

Jeerath Phannajit, M.D, Ph.D.

Academic Editor

PLOS ONE

Journal requirements:

When submitting your revision, we need you to address these additional requirements.

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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

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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: 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

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

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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: No

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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 #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.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: This study protocol addresses an important and timely question on how best to enhance patient activation and adherence in hemodialysis through interactive versus conventional video education. The design is rigorous, with a three-arm, cluster-randomized trial framework, but there are several methodological issues that need clarification to ensure validity and interpretability.

Major issues

• How will you decrease potential instructor bias in the interactive video education arm in Phase 2, given that the instructor facilitates critical discussions, guides extraction of salient clinical concepts, and synthesizes group findings? This process may introduce intervention bias by directing participants to retain knowledge specific to the PAM questions.

• Why is the 1-hour workshop implemented only in the interactive video and conventional video arms, while the usual care control arm does not receive a workshop?

• How will you ensure content equivalence across interventions, particularly in terms of detail and knowledge structure?

• How will you address possible contamination between patients within the same dialysis facility or even the same dialysis session?

• In Figure 3, should baseline assessment occur before the intervention?

Minor issues

• The abbreviation “PAM tool” is not mentioned before page 4, paragraph 2.

• Please provide the ethics committee code (XXXX) and ClinicalTrials.gov registration number (XXXX).

• Why will the program content be assessed by ICU nurses rather than hemodialysis nurses?

• How were the ten faculty members who validated the program content selected?

• Why were anesthesia specialists involved as key evaluators of the program content, rather than nephrologists or internists?

Reviewer #2: The research team plans a clinical trial to assess the impact of interactive and conventional video-based education on patient activation, treatment adherence, and inter-dialytic weight gain in a dialysis population.

1. Sample size will be determined based on a pilot study. However, there is a lack of pilot study information.

2. Please clarify why to use 95% power for the sample size calculation as it is much higher than the commonly used level.

3. Please provide some more details on the missing data imputation

4. Please clarify why outcome accessors will not be blinded as this may introduce the bias.

5. Please provide the justification for the feasibility to implement the study within four months as planned.

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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.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

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Comparing the effects of interactive and conventional video education on activation, treatment adherence, and weight changes in dialysis patients: a randomized clinical trial protocol

PONE-D-25-42865R1

Dear Dr. Zare-Kaseb,

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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If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Jeerath Phannajit, M.D, Ph.D.

Academic Editor

PLOS ONE

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

**********

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: Yes

**********

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

**********

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

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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: Yes

Reviewer #2: No

**********

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 #1: Yes

Reviewer #2: Yes

**********

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.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: I have reviewed the revised protocol and I accept the revision. I appreciate the authors’ responsiveness.

Reviewer #2: Thank you for satisfactorily addressing all the raised comments. I have no further concerns on this manuscript.

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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.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

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