-->PONE-D-26-02760-->-->Impact of a patient safety checklist on health literacy outcomes – A sub-study of a stepped wedge cluster randomized controlled trial-->-->PLOS One

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“The Norwegian Council of Nurses granted a doctoral scholarship to AKSA, through the Department of Anesthesia and Intensive Care, Haukeland University Hospital, Bergen, Norway, for this study. Kristin Harris (KH), Hilde Valen Wæhle (HVW), Anette Storesund (AS), Randi Julie Tangvik (RJT), and Arvid Steinar Haugen (ASH) are affiliated with the Stepped Wedge Cluster Randomized Controlled Trial of PASC, which is funded by the Norwegian Council of Research (ID:320475). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.”

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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?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. -->

Reviewer #1: Yes

Reviewer #2: Yes

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

Reviewer #1: Yes

Reviewer #2: No

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

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). 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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-->4. 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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-->5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)-->

Reviewer #1: As the statistical reviewer I will focus on methods and reporting

Major

1) The study had power problems because many participants scored at the very top of the health literacy scales, leaving little room to detect improvement, and the observed statistical power across outcomes was very low, meaning the study was unlikely to detect real differences even if they existed. Although the authors mention ceiling effects and note this may limit the ability to detect changes, they do not explicitly acknowledge that the study was under-powered overall, nor do they directly link the non‑significant findings to inadequate power. A driver of this was the very large assumed effect size.

2) report uncertainty in Cronbach's alpha, e.g. bootstrap.

3) no information as to how missing data were handled. all data were not complete I presume, so why weren't multiple imputation approaches used?

4) The analyses treated clusters as fixed covariates in a simple GLM rather than as random effects, which means the stepped‑wedge structure and within‑cluster correlation were not properly modelled. This is a methodological limitation because stepped‑wedge cluster trials typically require mixed‑effects models with random cluster effects to produce valid inferences. Can the authors expand on their choice?

5) Bonferroni corrections further reduce power, dramatically. this was not considered in the power calculations. effectively it compounds the problem severely.

6) the very high non response rate, and the risk of bias with younger/healthier patients less likely to respond is another problem. Arguably, sensitivivity analyses with multiple imputations and making assumptions for non-responders would provide some more information.

Minor

1) univariable (not univariate) regressions are mentioned but multivariable regressions are reported?

Reviewer #2: Title

Mentioning the tools in title is not common The title emphasizes the ("checklist") rather than the mechanism or outcome. In the context of a null result (which we see in the abstract), this title is particularly problematic. Its suggestion : Patient Activation and Preoperative Health Literacy: Findings from a Stepped-Wedge Randomized Trial OR Title: Change to remove "checklist" and adopt a more classic structure (e.g., "Effect of a Patient-Driven Preoperative Intervention on Health Literacy: A Stepped-Wedge Cluster Randomized Sub-Study").

Abstract

This is a strong opening in terms of scientific method (stating the hypothesis upfront). However, as a standalone abstract for a paper with null results, it sets a tone of "failure" that needs to be mitigated in the conclusion. No revision needed here

Typo: "delivered preoperatively (≤ eight weeks." -> Missing closing parenthesis: (≤ eight weeks)

"In each cluster, 50 patients were randomly drawn from 100 eligible patients, a total of 350 in each group."

This is a confusing description of sampling. If it's a sub-study of an RCT, were the 700 patients the entire trial cohort for this sub-study? Or were 700 drawn from a larger pool? The phrase "randomly drawn from 100 eligible" suggests a random selection process within clusters.

Results: Condense the 9 statistical lines into a single, clear summary sentence.

Conclusion

"The use of a patient-driven safety checklist did not lead to measurable improvements across health literacy questionnaire domains, and the hypothesis was not supported. The questionnaire tool had signs of ceiling effects, hence the checklist’s influence on patients’ health literacy remains unclear."

"The hypothesis was not supported." vs "The checklist's influence... remains unclear."

You cannot have it both ways in a single abstract. Either the intervention failed (null result) OR the measurement tool failed (inconclusive result).

Suggestion for Rewrite: "In this stepped-wedge cluster trial, a preoperative patient safety checklist did not improve health literacy scores compared to standard care. However, the high baseline scores (ceiling effect) and a 49% response rate limit definitive interpretation of the intervention's true effect. Further research should focus on patient populations with lower baseline health literacy or utilize more sensitive measurement tools."

Introduction

• Change "reveal" to "reveals" or "revealed".

• Add a sentence defining the specific domain of health literacy targeted.

• Verify and potentially update Reference [9] regarding recent interventions.

• Provide one concrete example of a PASC checklist item.

• Add a brief note acknowledging the measurement challenge in this specific cohort.

method

• Timeline Discrepancy: 2022 vs 2023 start date

• Correct the date in Abstract or Methods to match source data.

• Design Lack of detail on stepped wedge steps/duration Add 1-2 sentences clarifying the number and length of steps.

Sampling

• "Randomly drawn 50 from 100" - Justification missing Explain why random sub-sampling was used (resource/logistical constraint).

• ITT Analysis Unclear handling of missing data for 355 non-responders Specify: Complete Case Analysis or Imputation method

• Outcome Measure No mention of known ceiling effect in this population Add note about ceiling effect risk in Primary Outcome section.

• Typos Multiple minor spelling/formatting errors

Result

The Non-Responder Analysis is Flawed in Logic

"Non-responders were younger than responders (mean age 54.1 vs. 62.0 years; P = 0.025) and more likely to have ASA I classification (60.4% vs. 39.6%)."

The text states "Non-responders were... more likely to have ASA I classification."

But ASA I means healthy patient. The data says 60.4% of non-responders were ASA I vs 39.6% of responders.

So Healthier, younger patients were LESS likely to respond.

This is the opposite of typical survey bias. Usually, sicker patients are too tired to respond. Here, healthier patients (who likely have higher health literacy) ignored the survey.

Impact on Results: If the healthiest/highest literacy patients dropped out of the intervention group, the intervention effect might be underestimated. The authors MUST discuss this in the Limitations section (currently they only mention younger/healthier responded less, but don't connect the dots to health literacy bias). This is a major omission.

Discussion

"These findings suggest that there is no clear association... raising two possible explanations: either PASC did not directly affect health literacy domains, or the HLQ instrument lacked the sensitivity..."

This is the exact same sentence logic as the Abstract Conclusion. While consistency is good, the Discussion should expand on this, not repeat it verbatim. The first paragraph of a Discussion should summarize the main finding and then immediately pivot to interpretation.

Redundancy .please rewrite

The "Trend" Signal in Domain 2 is Ignored in the Discussion

Discussion mentions ceiling effects and qualitative findings but never addresses the near-significant 0.90 Beta in Domain 2.

[PASC is considered highly operational, context specific and oriented toward patient safety, and oriented toward patient safety

] “oriented toward patient safety” duplicated in one sentence delet one

Conclusion

The conclusion should synthesize the three key takeaways from the Discussion:

1. Primary Finding: No significant difference in HLQ scores.

2. Methodological Insight: Ceiling effects in this high-functioning Norwegian cohort likely masked any true effect; the HLQ may be inappropriate for this specific intervention evaluation.

3. Signal of Interest: The trend toward improved information management (Domain 2) aligns with qualitative feedback and warrants further investigation using more sensitive, context-specific tools.

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Reviewer #1: No

Reviewer #2: No

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Effect of a Patient-Driven Perioperative Intervention on Health Literacy: A Stepped-Wedge Cluster Randomized Sub-Study

PONE-D-26-02760R1

Dear Dr. Ann Kristin Sandsbakk Austarheim

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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Fatemeh Zarei, PhD

Academic Editor

PLOS One

Additional Editor Comments (optional):

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Reviewers' comments:

Reviewer's Responses to Questions

-->Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.-->

Reviewer #1: All comments have been addressed

Reviewer #2: All comments have been addressed

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

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. -->

Reviewer #1: Yes

Reviewer #2: Yes

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

Reviewer #1: Yes

Reviewer #2: Yes

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

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). 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: (No Response)

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: (No Response)

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-->6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)-->

Reviewer #1: I am satisfied with the authors' responses and the resulting changes to the paper. I have nothing else to add.

Reviewer #2: Thanks for efforts . It was satisfying. All commnets point by points were adressed clearly

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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.

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Reviewer #1: No

Reviewer #2: Yes:  Fatemeh Zarei

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