PONE-D-22-14838Physical and psychological health in intern paramedics commencing shift work: Protocol for an exploratory longitudinal studyPLOS ONE

Dear Dr. Crowther,

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.

There are several suggestions made that once addressed, the manuscript would like meet the criteria for publication. I anticipate that the authors may not agree with all of these, and considered rebuttal would be acceptable. More detailed description of recruitment and sampling is necessary though. 

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Dylan A Mordaunt, MD, MPH, FRACP

Academic Editor

PLOS ONE

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2. Thank you for stating the following in the Competing Interests section: 

"ACR has received research grant funding from a variety of sources over the course of research relating to this manuscript, including the Sleep Health Foundation (including an unrestricted grant from Merck, Sharp & Dohme Australia and Carers Australia via the Sleep Health Foundation), Vanda Pharmaceuticals, Compumedics, the Australasian Sleep Association, the Hospital Research Foundation, Flinders Foundation, Safework SA, Sydney Trains, Arthritis Australia, Bundaberg Regional Council, Queensland Fire and Emergency Services and the Freemasons Foundation (SA). ACR has received personal fees for work related to her research from Sealy Australia and Teva Pharmaceuticals. Professor Robert Adams (RJA) reports grants from the Sleep Health Foundation, Philips Respironics, The National Health and Medical Research Council, ResMed Foundation, The Hospital Research Foundation, Flinders Foundation, Sydney Trains and the Research Network for Undersea Decision Superiority during the past 3 years.

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Additional Editor Comments:

Thank you for your submission.

1) We've received a single review that points to primarily issues either with method description, or with discussion of limitations of the method, mostly related to sampling.

2) It would be helpful for the authors to address with some detail the source population, approach to sampling (e.g. snowball, convenience etc) in a PICOT manner.

3) There are notable exclusions, and although explanations of exclusions aren't necessarily standard elements of reporting checklists for survey studies, a description of the rationale behind these criteria would fit with quality rating tools for other article types and I think would help improve the quality of the paper.

4) The reviewer also raises the issue of a framing effect or bias. The disclosures are noted and as stated the primary funder is an independent entity with a public health remit. I think the authors could consider their framing with regards to the broad readership of PLoS One, and aim to present a more neutral setup prior to establishing the case that they conclude from the data. This is not merely a semantic suggestion, since rating tools for assessed quality of prospective cohort studies include risk of bias assessments (e.g. https://methods.cochrane.org/risk-bias-2).

With specific regards to the criteria for publication:

1. The study appears to present the results of an original protocol (an accepted article type at PLoS One).

2. Results are not reported, as it's a protocol.

3. Experiments, statistics, and other analyses are performed to a reasonable technical standard but warrant attention to the areas described above and by the reviewer.

4. Conclusions are presented in an appropriate fashion and are supported by the data.

5. The article is presented in an intelligible fashion and is written in standard English.

6. The research meets all applicable standards for the ethics of experimentation and research integrity.

7. The article adheres to appropriate reporting guidelines and community standards for data availability, with the exception of the comments made above. I would suggest the authors consider the STROBE (https://www.equator-network.org/reporting-guidelines/strobe/) and SPIRIT checklists (https://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/), acknowledging that this study does not meet criteria for these, but could help improve the study protocol quality. As stated above, it might also be worth considering assessed bias in your design, through a risk of bias tool such as cited.

NB: I have noted a disclosure to the staff editor that some of the authors and I have shared affiliations. I am an employee of Southern Adelaide Local Health Network, a clinician (medical practitioner) and am affiliated with Flinders University, but have noted that I have no past, current or planned collaborations with any of the authors. This statement is included for transparency.

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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

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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

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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

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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

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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

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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: Thanks for the opportunity to review and apologies for the delay.

Congratulations on your protocol on this essential and currently increasingly evidenced area.

The aims and objectives are clearly defined. A hypothesis should be provided.

The risk of selection bias is always present in these types of studies, particularly when participation is voluntary. I do not see a way around this, but worth considering in the analysis/discussion.

The columns in table 1 should be changed to the actual times, not just T0,1,2,3,4

The caption in table 1 is to be moved to methods.

Table 2 lists the surveys to be used. This seems excessive and may result in high drop-out rates due to survey fatigue. Consideration about consolidating this list will likely lead to a more complete, although truncated data set.

The statistical analysis plan lacks details.

Reading the paper, I get the sense that the authors want to demonstrate the extent of the negative impact of shift work. Rather they could take a more unbiased approach and aim to determine how commencing shift work impacts health in any direction.

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Reviewer #1: No

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Physical and psychological health in intern paramedics commencing shift work: Protocol for an exploratory longitudinal study

PONE-D-22-14838R1

Dear Dr. Crowther,

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,

Jianhong Zhou

Staff Editor

PLOS ONE

Additional Editor Comments (optional):

Thank you for your resubmission. This now meets the criteria for publication.

Reviewers' comments: