Dear Dr. Gecili,

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PLOS ONE

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This work was partially supported by an intramural grant by the Cincinnati Children’s Hospital Medical Center Place Outcomes Research Award. The research project that provided data from voice recordings (i.e. active injury surveillance) was funded by the Centers of Disease Control and Prevention and National Institute for Occupational Safety and Health (1R21OH010035-01A1).

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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: Partly

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: Partly

Reviewer #6: Yes

Reviewer #7: Yes

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

Reviewer #1: No

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: I Don't Know

Reviewer #5: No

Reviewer #6: I Don't Know

Reviewer #7: Yes

**********

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

The PLOS Data policy

Reviewer #1: No

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: No

Reviewer #5: Yes

Reviewer #6: No

Reviewer #7: Yes

**********

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: Yes

Reviewer #6: No

Reviewer #7: Yes

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Reviewer #1: Weaknesses and Recommendations:

1. Ambiguities in the Methods Section:

*Data Collection Period and Scope:

- The study mentions two different data collection periods:

-- The period for collecting employee safety reports (2014–2017)

-- The participant sampling and data collection period (2013–2015)

The rationale for this discrepancy is not explained. It remains unclear whether these different data collection processes are directly comparable.

**Recommendation: The integration of these datasets should be clarified to ensure consistency and comparability.

2. Insufficient Definition of Key Variables:

*Lack of a Clear Definition for Patient Aggression:

- Although patient aggression is a key variable in the statistical analysis, its definition (e.g., physical assault, verbal threats, etc.) is not clearly stated.

**Recommendation: A precise definition of patient aggression should be provided to ensure clarity and reproducibility of the findings.

3. Potential Over-adjustment in Statistical Models:

*Collinearity Between Independent Variables:

- The significance of patient aggression disappears when previous injuries are included in the same model, which may indicate an over-adjustment issue, potentially masking the true effect.

**Recommendation: Alternative modeling approaches should be considered to examine the independent effects of these variables. For instance, separate models could be tested for patient aggression and previous injuries to assess their individual contributions.

4. Sample Size and Generalizability Concerns:

*Single-hospital Sample:

- The study is based on data from a single pediatric hospital, which may limit the generalizability of the findings to other healthcare settings.

**Recommendation: The study’s limitations should be explicitly stated, and the need for future multi-center studies should be emphasized to improve external validity.

5. Limitations in Data Sharing:

*Restricted Data Access:

- The statement "The data that support the findings of this study are confidential and not publicly available." may raise concerns about the transparency and reproducibility of the study.

**Recommendation: If possible, summary statistics or anonymized datasets should be made available to enhance transparency and facilitate replication of the findings.

Reviewer #2: Unfortunately, I cannot recommend publication of the article due to several major shortcomings in both its design and its relevance and methodological rigor.

Temporal relevance of the data: Data collection in the study was conducted 10 years ago. This temporality presents a significant limitation since the results and conclusions of the study may have lost relevance in the current nursing context. Health and nursing research is constantly evolving, and old data may not reflect current conditions, needs, and practices in the discipline. This weakens the external validity of the study and its applicability to contemporary practice.

Few references and lack of updating: The article presents only 18 bibliographic references, and the most recent ones date from 2020. This limited number of references and the lack of updating in the bibliographic sources evidence a deficiency in the integration of the most recent advances in the scientific literature on the subject. This calls into question the completeness of the theoretical framework and the state of the art of the study, which is crucial to ensure that the research is well grounded in the most recent developments in the discipline.

Insufficiently detailed methodology: Although the study mentions that it uses mixed methods, no clear explanation of how the qualitative part of the research was conducted is provided. Nor is the qualitative part stated in the results.

Lack of information on the number of participants: The methodology does not specify the number of participants involved in the study. This omission is a serious problem since the number of participants is an essential factor in assessing the validity and reliability of the results. Without this information, it is impossible to judge the representativeness of the sample or the statistical power of the analyses, which directly affects the robustness of the findings.

Absence of reference to EQUATOR guidelines: The article does not explicitly mention which good practice guidelines and recommendations, such as those of EQUATOR, were followed during the design and execution of the study. The EQUATOR guidelines are fundamental to ensure that research is conducted following international ethical and methodological standards. The omission of this information suggests that the study may not have adhered to best practices in terms of transparency and methodological rigor.

Given the combination of these factors, I believe that the manuscript does not meet the minimum requirements of quality and relevance necessary to be published in a scientific nursing journal. I suggest that major revisions be made in terms of methodology, updating of references, and temporal relevance of the data before it is considered for publication.

Reviewer #3: This study investigates risk factors for employee injuries in a pediatric hospital setting through analysis of self-reported injury data, active surveillance via voice recording, and hospital unit measures. Using mixed effects logistic regression models, the authors identified several significant risk factors, including shifts exceeding 13 hours, patient aggression, and prior injury occurrences.

This research addresses a critical real-world issue with significant implications. Identifying risk factors for hospital worker injuries is essential for improving healthcare workplace environments and employee wellbeing.

However, there are several points author need to consider:

1. The authors have not provided essential descriptive information about the sample population. Details regarding the participants' gender, age, education level, job roles, and work experience would provide important context for interpreting the results and understanding the generalizability of the findings.

2.While the authors mention that their findings can "guide the development of targeted interventions," the manuscript would benefit from a more detailed discussion of specific strategies hospitals could implement based on these findings. For example, how might hospitals modify shift scheduling policies or address patient aggression more effectively?

3.The study appears to rely on pre-pandemic data, which limits its contemporary relevance. Given the significant impact of COVID-19 on healthcare work environments, the authors should include a discussion of how the pandemic may have altered risk factors and working conditions for healthcare employees, and how their findings might translate to the post-pandemic context.

4. The authors should provide more comprehensive information about their data processing methods, particularly regarding how they coded and analyzed the voice recordings from active surveillance. This additional methodological transparency would strengthen the validity and reproducibility of the research.

Reviewer #4: Thank you for the opportunity to review this work.

With this, I have a few questions:

For methods, I am curious as to the nature of the dataset in general (given that it isn't included in the supplemental materials). Typically for a study of this nature, the dataset itself is usually described (e.g. 'x' number of survey responses, with 'y' being excluded for 'z' reason, resulting in 'c' subjects left for analysis...). I would also indicate that this is a retrospective review of prospectively collected data (which is something I am assuming per line 167 in the manuscript). As such, there are usually variables that are missing in such data, and I would be interested to know if that resulted in subjects / responses being excluded.

In any case, I presume that the total population of survey results you are analyzing is 9446 (7929 without active surveillance predictors and 1517 with, per Table 1). My confusion stems from whether or not the with/without active surveillance predictor datasets are supposed to represent a case/control type analysis. And I presume the intent was to compare data from when the employees were encouraged to include near-misses in reporting, though the manuscript doesn't make clear what the exact difference between "with active surveillance" and "without active surveillance" means in terms of the study population.

Along with this, there does not appear to be any evaluation as to time-of-day an injury might occur. Correlating injury to time-of-shift may be helpful, as other papers have noted that "flex time" shifts (evening followed by daytime, for example) are a potential risk factor for injury. Given changes in circadian rhythm, this makes intuitive sense, but is not addressed in this paper.

In addition, although you show a forest plot with an indication that there is a significant (but small) odds ratio increase for longer shifts, there does not seem to be a dose-response to such ratios - which seems counter-intuitive if fatigue is the mechanism by which these injuries are thought to occur. Most notably, the percentage increase of over 13-hour shifts the same day did NOT show a corresponding statistically significant increase in reported injuries, similar to the lack of change with the percent (number?) shifts over 13h in past week. (I am not clear as to if the "N days in past week with % shifts > 13 h increased" refers to the percentage of shifts over 13 hours in a week, or the number of over-13 hour days in a given week as the variable).

As it stands, the data you are presenting suggest that scheduling 13-hour shifts increase injuries, while scheduling <8.5 hour shifts can reduce injuries - though that notion intuitively doesn't help when trying to schedule a provider for, as an example, three 13-hour shifts per week vs 5 or 6 8.5-hour shifts per week, as the at-risk work time exposure per individual worker is different.

On that note, I do wonder how your regression analysis was set up. Reviewing the tables, it's evident that the number of shifts is entered as a percentage variable, while the number of "days in past week" for three variables are set as an integer ("n"), along with injuries reported and near misses reported. Was there a reason to use "percentage" over integer values when noting numbers of shift lengths? If integer values were used, the conclusion would theoretically read "for every individual shift worked by unit staff over 13h there is an increased 'x' risk for injury", which is easier to understand. Conversely, a tighter association with fatigue might be present if "hours worked by staff 7 days prior" substituted for the shift variables - or at least "number of >13h shifts worked by unit staff in 7 days prior". I would argue that such dependent variables would be better, as they are not

I also note that your manuscript lists "percent NHPPD" and "Unit RN Vacancy" as potential risk factors. Those variables are not visibly noted in your regression. Is there a reason why these were left off?

I would also be interested to know how the data analysis was performed (e.g. SASS, STATA?). Your data collection and database analysis method isn't listed in the manuscript. Also, the use of a mixed-effect logistic regression was described, however the statistical analysis used in the univariate calculation of "injury from patient aggression" (line 251-252) was not described.

Finally, the issue of relevance to healthcare administrators with regards to this paper comes into question. Namely, is there data regarding the severity of the injuries encountered? One can argue that administrators would be more concerned about the long-term risk for injury, as it would be different between a potential blood-borne contact with no long-term sequelae vs an assault that resulted in worker-days lost. Given the nature of this analysis, my supposition is that the number of injuries sustained that were severe enough to result in a lost day at work were not enough to analyze properly - though I do wonder if the reason "injury reported in past week" variable was significant because it reflected a continuation of an injury sustained by a staff member the week prior.

As an aside, most trauma and injury prevention literature already utilize "ISS" as an abbreviation for "injury severity score". As this paper does not list the severity of injuries, rather than document the self-reported existence or absence of such, I'd suggest that your abbreviation should be changed to "IISS", for "institutional injury surveillance system", in order to avoid confusion.

As for formatting, including a legend embedded within your figures (vs having them within the body of the manuscript - see lines 234-240, for example) would be helpful. And is there a reason that your table of model results are only within the supplemental material, rather than as a table within the main manuscript?

Reviewer #5: A great article !

I have some reservations

Regarding the discussion, it needs to be more elaborate and please mention study populations. As this study dealt with pediatric.

Several factors differ.

As mentioned you have active and passive surveillance factors, I would want a bit of explanation on this regard.

on 224 line “unadjusted analyses”), a 1% = Bracket just appeared closed end, while there was no open ended.

Table 1 needs more explanation

Reviewer #6: This manuscript reports a study that aims to explore and quantify the risk factors associated with employee injuries on inpatient units. It appears that an additional aim was to explore the value of adding an active approach to incident surveillance – that of carrying a pocket voice recorder to more proactively capture near misses.

The study analyzed employee injury data self-reported to the institutional surveillance system, as well as incident reports collected from a sample of employees through active surveillance (voice recording), and hospital unit-based measures of patient density and employee workload as potential determinants of injury

The main findings were that shifts of >13 hours on the prior day and patient aggression are positively associated with injury likelihood and shifts <8.5 hours on the same day are negatively associated.

Overall, the work reported covers an important topic, reports new information from the paediatric setting, and appears to be a well conducted study.

Some sections of writing are too lengthy, omit important information, or are in the wrong section. Referencing is too thin throughout, particularly in the Introduction. Attention is also needed in the Discussion. Suggestions for improving the clarity and organisation of writing are given below.

Table 1 is not easy to follow and needs review of how information is presented to make clear what it is, and clean up a few inconsistencies. Statistical review is recommended.

Introduction

References are too thin throughout. All statements of fact need to be substantiated with evidence.

An introduction of the different types of incident surveillance system data collection methods (e.g., online, call centre, pocket recorder) etc is needed given the exploration of this aspect in the study.

Lines 102-119 are excessively wordy. Any justification for the study needs to be presented earlier in the section. Any postulation about the meaning and impact of the study needs to go in the Discussion. These paragraphs should be reduced to max 1-2 short sentences that state the study aim(s). Details of the methods should go in the Methods section.

Methods

Start by stating the study design. Identify a study reporting guideline appropriate to the study design, review your manuscript against this and attach the check list as an appendix, and note which guideline you used in the first paragraph of the methods.

Make clear that the study is conducted in a single hospital. (Mentioned in the aims at end of previous section – suggest move to Methods).

Clearer introduction of inclusion/exclusion criteria is needed. Definitions of some of the variables is needed. For example, how is ‘patient aggression’ defined and measured?

Regarding data collection, clearer reporting is needed of how data were extracted, from what systems in what format, by whom.

Line 167-76: There appears to be a staff population subgroup with separate method of data collection for a short period within the study timeframe. Is this the ‘Active surveillance’ data? Suggest give this a sub-heading. Introduce and justify. Please briefly describe the larger study from which this group was drawn and how potential participants for this study were identified and by whom they were invited. Clarify how this data is analysed.

Results

It would be helpful if the total number of staff, hours worked, and number of units from which data was drawn could be reported in the opening of the Results section.

Line 210-4: Judgement, opinion and other interpretation should be reserved for the discussion. Recommend remove from here ‘Notably’ and full sentence of Lines 212-4.

Table 1: Some of the values are presented in variable format and it is not clear what the % represent – i.e., of what total. Please review for clarity and completeness.

Discussion

Lines 305-8: A suggestion is for this sentence to form the beginning of the next paragraph

Line 323: Needs referencing

Reviewer #7: I commend the authors for their thorough work investigating the risk factors associated with hospital employee injuries. The authors effectively contextualized the present issue and described the need for this research. Clear descriptions of hospital injury procedures, variables of interest, and data analysis methodology are presented. The authors captured near-misses along with recorded injuries, which provides information not typically investigated when studying workplace safety. Potential over-adjustment of the statistical model and collinearity between variables were adequately addressed. Tables and figures provide are clear and provided all relevant data. Overall results demonstrate the importance of employee shift duration and prompt responses to injuries for employee safety. Based on their findings, the authors suggested several areas requiring improvements to healthcare management and administration to enhance employee safety.

A few minor suggestions are provided below to enhance clarity.

1. For clarity regarding the five metrics assessing risk factors for employees, the authors are recommended to provide more precise relationships between the measure and what the measure indicates. This was done for metrics 1, 2, and 3, however, readers may benefit from clearer descriptions for metrics 4 and 5. For metric 4, the authors are suggested to specify the value that may indicate decreased skill level or experience. For metric 5, the authors are suggested to specify that higher values may be an indicator of staff fatigue. These changes will improve clarity for readers.

2. In the results sections, the authors are recommended to specify variable units of measurement to clarify values for the reader. Although clearly described in the methods section, there is limited mention that measures were captured at the unit level. For example, in line 263–264, the authors could include that the number of near-misses were recorded for each unit (e.g., “The average number of near-misses reported in the past week was 0.65 (SD 1.53) per unit in the active surveillance dataset”). This addition would clarify the results for readers who may skip the methods section.

3. Table 1 has some inconsistent formatting and unnecessary characters that can be removed.

a. Percentages are not included in the table consistently across variables, which may confuse readers. For example, the categorical variable, Injury Occurrence, includes a percentage sign within the parentheses to denote that 477 is 6.02% of the 7929 participants included in the study. However, % shift > 13 h provides continuous data, but the use of a percent sign within the parentheses impedes reader understanding of whether the values within the parentheses for this variable are SDs for a mean or percentages for n cases. With percentages and Ns specified in the variables column and the table footnote providing additional information, the authors are recommended to remove the percentages from the table columns containing data.

b. Similarly, the use of “days” in the data columns (e.g., for the variable N days in the past week when % shifts >13 h increased over the previous day) is not necessary and can be removed as it adds noise to the table. The “days” qualifier has already been stated in the Variables column, which provides sufficient information for each variable.

c. The authors are recommended to write out the ADC acronym in the footnote.

These changes would improve readability as well as consistency with the supplemental table.

Overall, the authors provided novel data regarding hospital employee injury risk factors. Results were adequately presented and the study findings are adequately interpreted. Author concerns and study limitations were appropriately addressed throughout the manuscript and yielded opportunities to discuss the complexity of this field of research.

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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: No

Reviewer #3: No

Reviewer #4: Yes:  Julius D Cheng, MD MPH

Reviewer #5: No

Reviewer #6: Yes:  Miranda Buhler

Reviewer #7: Yes:  Sorina Andrei

**********

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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,

Mohamed Gamal Elsehrawy

Academic Editor

PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

Reviewer #3: All comments have been addressed

Reviewer #4: All comments have been addressed

**********

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

Reviewer #3: Yes

Reviewer #4: Yes

**********

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

Reviewer #3: Yes

Reviewer #4: I Don't Know

**********

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

The PLOS Data policy

Reviewer #3: Yes

Reviewer #4: Yes

**********

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

Reviewer #3: Yes

Reviewer #4: Yes

**********

Reviewer #3:  The authors have adequately addressed the concerns raised in the previous round of review. The revisions have improved the clarity and rigor of the manuscript. I have no further comments at this stage.

Reviewer #4:  Thank you for your responses to my concerns.

I would note that for the response re: R4.5 - "Thus, the observed associations may in fact be conservative: when more employees work shorter shifts, the denominator of workers at risk increases, yet the overall injury risk remains lower."

I'd argue that the converse is true - if the standard work-week is 40 hours, on a 10-RN unit (for example), an 8-hour shift system would require 42 FTE's to staff the 210 slots fully for one week, without overtime.

Conversely, a "39-for-40" system with 13-hour shifts (presuming half-hour overlap at each end) would require 47 nurses to cover the same unit over 140 slots, if there's no overtime. So there are more FTE's in the 12-hour-shift scenario needed vs the 8-hour.

**********

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

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Reviewer #3: No

Reviewer #4: Yes:  Julius D. Cheng, MD MPH

**********

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Hospital Unit Working Conditions and Risk for Employee Injury

PONE-D-25-05110R2

Dear Author,

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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Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

Reviewer #3: All comments have been addressed

Reviewer #4: All comments have been addressed

**********

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

Reviewer #3: Yes

Reviewer #4: Yes

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

Reviewer #3: Yes

Reviewer #4: I Don't Know

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

The PLOS Data policy

Reviewer #3: No

Reviewer #4: Yes

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

Reviewer #3: Yes

Reviewer #4: Yes

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Reviewer #3: The authors have properly addressed my concerns and comments and I don't have any further comments for this piece.

Reviewer #4: I appreciate the response with regards to staffing, thank you. Perhaps additional information with regards to specific "dose limits" as to work hours will show the actual optimal shift work-hour length in comparison to number of hand-off errors from a patient-safety standpoint.

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Reviewer #3: No

Reviewer #4: No

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