Dear Dr. Höckelmann,

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Academic Editor

PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

Reviewer #1: Partly

Reviewer #2: Yes

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2. Has the statistical analysis been performed appropriately and rigorously? -->?>

Reviewer #1: Yes

Reviewer #2: Yes

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3. Have the authors made all data underlying the findings in their manuscript fully available??>

The PLOS Data policy

Reviewer #1: Yes

Reviewer #2: Yes

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

Reviewer #1: Yes

Reviewer #2: Yes

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Reviewer #1: The purpose of this research was to investigate the effectiveness and acceptability of an information leaflet including an information video compared to a formal information letter in patient recruitment in acute care.

Accordingly the investigators conducted a cluster-randomised controlled trial embedded in a cross sectional study (“Sleep Acute host study”) addressing patients’ sleep in hospitals. They allocated selected wards either to the intervention group (information leaflet including a link to an information video) or the control group (formal information letter) using external concealed randomization. The design was well thought out and the methodology was well described.

The primary endpoint was recruitment success measured by the participation rate in the Sleep Acute host study. The secondary endpoint was acceptability of the written study information. Persons involved in the analyses were blinded concerning group allocation.

Due to the study’s exploratory nature, there was no formal sample size calculation for the embedded cRCT, given that the sample size is constrained by the number of participants approached in the Sleep Acute host study, although a more rigorous hypothesized effect size would have been ideal . Also given the exploratory and mostly descriptive nature of the presentation it appears that the number per group (analyzed and participated) is adequate for the descriptive results reported.

Analysis was quantitative and qualitative. To analyze the primary endpoint ‘participation’, they used random effects logistic regression adjusted for cluster. Exactly what was the random effect or was it cluster? The odds ratios indicated no difference between the two groups. They also conducted bivariate linear regressions with the secondary endpoint . The explanation of the approaches was reasonable for this type of data. Qualitative data analysis involved the usual open-ended questions in a structured process. Comparison across questions is noted in Table 3. Differences of acceptability was not evident examining the confidence intervals of the slopes.

They do conclude that the use of an information leaflet does appear to improve participant recruitment. In terms of acceptability, they found some indications that study participants perceive certain elements of an information leaflet positively. Such was the mainly descriptive nature of the cautionary presentation.

Reviewer #2: Thank you for the opportunity to comment on this interesting, nested study (it is not a formal SWAT as the host study is not a trial). It is clearly described and the methods look rigorous, and is based on a large sample of wards and patients (although the sample was smaller than expected). I only had a few comments. The study is interesting as it is in a hospital context.

The first line of the introduction seems to define ‘recruitment’ to include ‘retention’, whereas these are generally distinguished in the literature.

Can they clarify the consent procedures for the nested study? It is mentioned 3 times (page 4, 7 and 8). I think they just need to state in one place that people consented to the sleep survey, but not the embedded study.

On page 7, they suggest that extensive development is a basis for validity. I am not sure that is the consensus view and I do not think they need to make that claim. They just need to be clear what they did do for validity assessment, and what they did not do – and let readers judge the validity.

Can they clarify the proportion of patients who received the information one day before, and those who got it on the day (page 6)? I think that would be useful context.

I think it would be useful to comment on the baseline level of participation (which I think is 20% of eligible patients being approached at all, and around 50% of those approached taking part). Am I right in thinking that the ‘window’ for people to take part once asked was 24 hours (‘same or following day’)? That might have limited the potential impact of the intervention.

Do they know how many people visited the website through the QR code? I think that would be useful information to provide. If they do not have that (and I have been in that position), I would be explicit.

I think it would help if the intervention was better labelled. The title says ‘information leaflet’ and does not mention the full intervention. I think many readers may assume that a ‘leaflet’ is pretty standard and it would be helpful to label the intervention in such a way that highlights its differences from ‘usual care’ (which I assume is length/detail, and the QR link).

Apologies for the self-citation but Madurasinghe et al. BMC Med. 2023 Nov 8;21(1):425. doi: 10.1186/s12916-023-03081-5 might be a relevant comparison as these studies involved links to multimedia.

Can they clarify the reason for the missing data in Table 1? Is it right that they did not have age and gender data for all patients?

There is a statement in the discussion (page 15) which talk about ‘potential impact’ and the abstract says that the intervention group showed larger effects but that it was ‘not significant’. Formally this is true, but it is a particular framing – ‘no statistically significant effect of the intervention’ would be equally valid. I would go for the most neutral framing possible I think

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what does this mean? ). If published, this will include your full peer review and any attached files.

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Reviewer #1: No

Reviewer #2: Yes:  Peter Bower

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Effects of a non-standard information leaflet on patient recruitment in acute care: Embedded cluster-randomised controlled trial

PONE-D-25-02678R1

Dear Dr. Höckelmann,

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,

Maher Abdelraheim Titi

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

The authors successfully addressed all comments from both reviewers, demonstrating that they were able to resolve all concerns raised during the peer review process.

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

Reviewer #1: All comments have been addressed

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2. Is the manuscript technically sound, and do the data support the conclusions??>

Reviewer #1: (No Response)

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3. Has the statistical analysis been performed appropriately and rigorously? -->?>

Reviewer #1: (No Response)

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4. Have the authors made all data underlying the findings in their manuscript fully available??>

The PLOS Data policy

Reviewer #1: (No Response)

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

Reviewer #1: (No Response)

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Reviewer #1: (No Response)

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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

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