PONE-D-23-00901Measuring the Effects of a Nurse-led Intervention on Frailty Status of Older People Living in the Community in Ethiopia: A Protocol for a Quasi-experimental StudyPLOS ONE

Dear Dr. Kasa,

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.

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Kind regards,

Azmeraw Ambachew Kebede, MSc

Academic Editor

PLOS ONE

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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: Partly

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: 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: You have clearly identified the rationale for the study. Developing an education package and delivering it is an ambitious project. I wish you well with this.

As a new program, I would think determining its acceptability and identifying any areas for modification are important outcomes. Yet I see no mention of acceptability/ adherence measures as outcomes.

How will the program’s acceptability with those delivering it and those reviewing it be assessed? Will you seek feedback on the training book? Will you measure adherence? If so, how? Meeting with the CHWs each month would be one measure. How do you determine compliance with the recommendations for exercise or diet? Or is this not possible?

Methods: Line 103

Please include the name of the instruments used to measure the primary outcome (frailty status) and the instruments used for the secondary measures. Table 3 lists and outlines the outcome measures (i.e. the score range, number of questions and a reference for the instrument). Maybe refer to this table earlier in the text in the methods, rather than later (in the data collection), or move text from this table into the methods section.

EDITS:

Line 123: as your sample calculation was an a priori analysis, change from future tense to past tense, i.e. sample size WILL be calculated, to sample size WAS calculated ….

Line 154 – change singular to plural, i.e. study participant’s to study participants’ involvement.

Reviewer #2: This single group study aims to design, implement, and evaluate a nurse-led intervention to reduce frailty among older people in Ethiopia. Data will be repeatedly collected, at baseline, immediately after intervention, and 12 weeks post-intervention. Data will be collected on frailty, nutrition status, activities of daily living, depression and quality of life.

Minor revisions:

1- Abstract: Grammatical error: Statistical

2- Line 126: Indicate the statistical testing method which achieves 95% power.

3- Line 220: Categorical data is typically summarized using both frequencies and percentages.

4- Line 220: State the statistical approach that will be used to test for normality of the data.

5- Since data will be collected at 3 time points, specifically indicate which outcomes and time points will be compared using Fisher’s exact tests, paired sample t-tests, and GLM with repeated measures ANVOVAs.

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Reviewer #1: No

Reviewer #2: No

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PONE-D-23-00901R1Measuring the Effects of a Nurse-led Intervention on Frailty Status of Older People Living in the Community in Ethiopia: A Protocol for a Quasi-experimental StudyPLOS ONE

Dear Dr. Kasa,

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.

Please submit your revised manuscript by Jan 05 2024 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.

Please include the following items when submitting your revised manuscript:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Azmeraw Ambachew Kebede, MSc

Academic Editor

PLOS ONE

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

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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 #3: Yes

Reviewer #4: 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 #3: Yes

Reviewer #4: 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 #3: Yes

Reviewer #4: No

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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 #3: Yes

Reviewer #4: 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 #3: Yes

Reviewer #4: 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 #3: The authors have responded well to comments of the reviewers. The manuscript is interesting and well-written.

Regarding reviewer 1, a simple measure of compliance could be the percentage of participants completing all 6 sessions as a secondary endpoint.

Minor comments:

1. Abstract: please specify the expected number of participants

2. Methods: I recommendend to add the number of falls among the secondary outcomes "number of falls in the 3 months prior to intervention, number of falls at 3 months, 6 months and 12 months").

3. Methods: non-inclusion criteria, replace "cognitive impairment" by "major cognitive impairment"

4. Methods: Student's t-test will be probably used to compare the level of frailty with categorical variables (sex, education etc). Add Student's t-test.

I recommend this manuscript for publication.

Best regards

Boucaud-Maitre Denis

Reviewer #4: 1.Line 111.6, it is unclear why the study was registered PROSPECTIVELY 3 months after data collection. Should it be RETROSPECTIVELY as registration of the study happened after the start of data collection?

2.Line 113-133, If the data is assumed to be normally distributed, why paired-t test is not used for sample size calculation? Also, please clarify the end point of the primary outcome for sample size calculation, either from T0 to T1 or T0 to T2. The author should state clearly which outcome measure is used for sample size calculation as the assumed effect size of 0.5 means it is assumed that the effect size of the intervention on the primary outcome of the study is 0.5, which should also be supported by evidence.

3.Line 137-144, it is unclear how the subjects will be recruited, either from the poster or CHW proactively to recruit subjects through the available list. More specifically, which sampling method will be used? The section Recruitment should place after the section on Eligibility.

4.Line 169, for the NLI program, the sessions can be distinct and interconnected (independent means they are unconnected)

5.Line 226. Some descriptions of the outcome measures should be provided in the text, rather than provided in the hypothesis under Study design and hypothesis. Moreover, some of the outcomes were not touched such as recent appetite. Acceptability of the program should also be measured from the perspectives of the participants on top of the interventionist (i.e., CHWs)

6.Line 272-285, Please group the points for two subsections of strengths and limitations of the study.

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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 #3: Yes: Boucaud-Maitre Denis

Reviewer #4: No

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[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

Measuring the Effects of a Nurse-led Intervention on Frailty Status of Older People Living in the Community in Ethiopia: A Protocol for a Quasi-experimental Study

PONE-D-23-00901R2

Dear Dr. Kasa,

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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Kind regards,

Azmeraw Ambachew Kebede, MSc

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments: