Study protocol for an observational research study with an embedded N-of-1 design: Increasing the availability of goal-oriented cognitive rehabilitation for people living with dementia in Ireland

PONE-D-24-37236

Dear Dr. Lydon,

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Kind regards,

Ioannis Liampas, MD. PhD

Academic Editor

PLOS ONE

Journal Requirements:

1. Thank you for stating the following financial disclosure:

“The current research is funded by the Alzheimer Society of Ireland under the Dementia Awards Scheme.”

Please state what role the funders took in the study. If the funders had no role, please state: "The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript."

If this statement is not correct you must amend it as needed.

Please respond by return e-mail so that we can amend your financial disclosure and competing interests on your behalf.

2. Your ethics statement should only appear in the Methods section of your manuscript. If your ethics statement is written in any section besides the Methods, please delete it from any other section.

3. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information.

Additional Editor Comments (optional):

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: Yes

Reviewer #2: Yes

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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: The study objectives and methods are well planned, comprehensive and evidence-based. Provided the results/analysis of the study is positive/encouraging, similar approach can be applied to resource-limited settings or with diseased specific population with mild cognitive impairment. I suggest submission of result manuscript be submitted at this journal too.

Reviewer #2: The research design employed small sample approach to intervene early-stage dementia patients, and tried to establish a new practice model for students.

Although single-case experimental design is to be used, the research methodology is comprehensive and could make causal inferences. The new model can supply with practical component in traditional teaching, enhancing clinical practice of psychological interns. The research design can achieve the experimental objective and has practical applicational value.

The authors need to ensure experimental methods to guarantee the validity of causal inference in the study. For example, conducting measurements from multiple sources, randomized multiple baselines, etc.

In subsequent statistical analysis, the authors may consider using statistical inference methods for small samples, such as Bayesian approaches.

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Reviewer #1: Yes:  Norhamizan Hamzah

Reviewer #2: No

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