PONE-D-24-06214Protocol for a Feasibility Randomised Controlled Trial of the ‘Outdoor’ Mobility Intervention for Older Adults after Hip FracturePLOS ONE

Dear Dr. Sheehan,

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Academic Editor

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[We are grateful to the input from patient and public members of the involvement group TROOP (https://www.ppitroop.co.uk/) for their support in the design of this trial, to the participants in the qualitative interview studies and intervention development workshops which underpin the intervention, and to the volunteers who supported the development of the peer video. We acknowledge the study Principal Investigators are Nicola Sinclair, Stephanie Tuck, Zita Lodge, Rebecca Wood, and Jonathan Evans. Sandra Houston, Amina Mourad, and Rhian Milton-Cole will serve as Associate Principal Investigators. This work acknowledges the support of the National Institute for Health Research Barts Biomedical Research Centre (NIHR203330).]

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 [This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number NIHR204040) and The Royal Osteoporosis Society (Grant Reference Number 518) awarded to KS, EG, CS, SL, SC, CH, FCM, and TS. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The funder has no competing interests, has had no substantial influence on the planning of the trial, and they will not influence the conduct or reporting of the trial. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. For the purpose of open access, the author has applied a Creative Commons Attribution (CC BY) licence to any Author Accepted Manuscript version arising from this submission. Sponsors URL: http://www.kcl.ac.uk/index.aspx and https://improvinglivesnw.org.uk/about-us/our-nhs-integrated-care-board-icb/.]

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[I have read the journal's policy and the authors of this manuscript have the following competing interests: The authors have received grants from the National Institutes of Health Research (NIHR) related to this work. This funding provides salary support for DB, and partial salary support for SC, CH, SL, CS, EG and KS. KS receives funding from UKRI for hip fracture health services research. KS is Chair of the Scientific and Publications Committee at the Falls and Fragility Fracture National Audit programme and the Chair-elect of the Scientific Committee of the Fragility Fracture Network. CS, TS, SC receive funding from the National Institutes of Health Research for research not related to the current study. SC is partially supported by the National Institute for Health Research Applied Research Collaboration South West Peninsula. DS, SG, SP, FM declare no additional conflicts of interest. ]. 

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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: 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: 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?

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Reviewer #1: Yes

Reviewer #2: Yes

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5. Is the manuscript presented in an intelligible fashion and written in standard English?

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Reviewer #1: Yes

Reviewer #2: No

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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: - Figure 1 attachment is not systematically displayed. Figure 2 is number 1 displayed

- Design: to describe it, explain the pragmatic parallel group allocation.

- I did not see how the assessors will be blinded. Please clarify this section

- 135 - 137: the highlight of the figure is confusing to the reader. I suggest it is added under the figure itself not in text.

- 186: participants changed from home discharge to nursing home will be withdrawn "and not replaced" - will this not reduce the sample size?

- Settings: Description of the study settings is unclear.

- 351 - 354: Check the number of brackets used

- 406: Fullstop before the reference

Reviewer #2: The study/protocol addresses an important issue in senior wellness. I have a few clarifying questions/comments:

1. L78

An analysis of the National Hip Fracture Database (England, Wales and Northern Ireland) reported 74% of patients had outdoor mobility pre-fracture, but only 9% of these individuals recovered this mobility by 30 days post-fracture…

- It would be useful to give a brief explanation of what the National Hip Fracture Database is (and relevance to this study)

- Who are the 9%, 26% that are mobilizing outdoors by 30 days, 120 days? Some description of these profiles is important in building the rationale for this work. E.g., how does age feature in this? Are the 9%, 26% younger with fewer or no comorbidities?

2. L255

The authors state, “trained therapists” - who are/could be the trained therapists who will deliver the intervention? Please specify eg, physios, OTs, PTA, PT/OT Assistants, etc.

3. Line (L) 253 - L257 The rationale for starting the intervention 30 days after return home is not stated.

Also, to clarify, the duration of the intervention will be a maximum of 6 visits within a maximum of 12 weeks unless the end-goal is achieved before then. Is this correct?

If so, please clarify this; it’s a bit confusing.

4. “Sixty-years of age was selected to align with the National Hip Fracture Databases definition of the target population(20).”

What is National Hip Fracture Databases rationale for selecting 60 years as the target population age? How do risk factors for falls change with advancing age? And if 60 years is an important for comparison purposes, how is this likely (or not) to bias the results. These issues have not been adequately addressed in the protocol.

5. There’s inconsistency in the spelling of “accelerometry”

6. Semi-structured interview and focus group guides were not provided.

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Reviewer #1: Yes: Dr Nontembiso Magida, University of Pretoria

Reviewer #2: No

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Protocol for a Feasibility Randomised Controlled Trial of the ‘Outdoor’ Mobility Intervention for Older Adults after Hip Fracture

PONE-D-24-06214R1

Dear Dr. Sheehan,

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,

Diphale Joyce Mothabeng, PhD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Thank you for addressing reviewer comments with diligence. The journal will revert back to you about the next steps regarding publication.

Reviewers' comments: