PONE-D-20-24690

Temporal auricular temperature measurements versus bladder temperature in critically ill patients, a prospective observational study

PLOS ONE

Dear Dr. Cox,

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.

Please submit your revised manuscript by Oct 24 2020 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

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: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols

We look forward to receiving your revised manuscript.

Kind regards,

Matthew John Meyer, M.D.

Academic Editor

PLOS ONE

Additional Editor Comments:

Thank you for your submission and your hard work on this study and manuscript.

Please answer our reviewer's questions as well as these few questions and re-submit for further consideration:

1) Were the examiners blinded (TAT 1 and TAT 2) to each other and to the bladder temperature?

2) What is “moisture” included alongside of vasopressors and heating in table?

3) Did you compare the absolute values of the differences between the two methods of temperature evaluation? It seems the mean is close to zero but the SD are quite large. And the absolute magnitude of the deviation is at least as meaningful as the direction (too hot / too cold) of the deviation. If not, I would like to see it run as a post-hoc analysis.

Journal Requirements:

When submitting your revision, we need you to address these additional requirements.

1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at

https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and

https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf

2. Please describe in your methods section how capacity to consent was determined for the participants in this study.

3.  Please provide additional details regarding participant consent. In the ethics statement in the Methods and online submission information, please ensure that you have specified what type you obtained (for instance, written or verbal, and if verbal, how it was documented and witnessed). If your study included minors, state whether you obtained consent from parents or guardians. If the need for consent was waived by the ethics committee, please include this information.

4. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions.

In your revised cover letter, please address the following prompts:

a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent.

b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories.

We will update your Data Availability statement on your behalf to reflect the information you provide.

[Note: HTML markup is below. Please do not edit.]

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

**********

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

Reviewer #1: Yes

**********

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

**********

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

**********

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: Peer Review for manuscript titled: Temporal auricular temperature measurements versus bladder temperature in critically ill patients, a prospective observational study

Thank you for submitting this manuscript for the method-comparison study aimed to evaluate the degree and limits of agreement between temporal artery temperature (TAT) and bladder temperature (BT) measurements. This study found good agreement between these thermometry methods with a mean difference (bias) of 0.12° C within the a priori set clinically meaningful threshold of < 0.5° C and the poor limit of agreement (precision) with a SD ± 0.61° C (95% CI -1.08°C, 1.32°C). This was a well-designed and executed study that addresses a gap in the method-comparison literature regarding thermometry methods used in hospitalized and critically ill patients, especially when non-invasive methods are preferred to reduce device-associated risk of harm to patients. I have primarily minor recommendations for the authors regarding the manuscript regarding clarifications of the methods, design, and result figures requiring attention prior to acceptance for publication.

1. Terminology/definitions throughout the manuscript: 1) The title and a few times in the manuscript, temporal auricular temperature or “auricular” is used (title, line 116, figure 2). I am not sure if this is a typo or misuse of the name of the thermometry method. Recommend using what is used in the literature, “Temporal Artery Temperature” when TAT is referred to. 2) TAT is obtained via a non-invasive method and is a peripheral temperature. Urinary bladder temperatures are obtained via an invasive method and is considered a core temperature (very good agreement with the gold standard pulmonary artery blood temperature obtained from a PA catheter with a thermistor). It is not customary to refer to BTs as semi-invasive than PA catheter rather these are either invasive or non-invasive.

2. Study design: this is a method-comparison study design. You reference Bland & Altman (1999) –they also have more current design/analysis publications on method-comparison studies.

3. Line 86: Recommend adding a statement with the rationale for conducting the subgroup analysis comparing vasopressor to non-vasopressor use.

4. Methods: 1) Was TBI considered an exclusion criteria? It is not listed in the methods section, yet was referred to as a reason for exclusion in the Results section. 2) Measurement: Excellent that you were able to include 2 observers to test for inter-rater reliability issues. Check for a typo in line 113 (intra-rater vs inter-rater). 3) Consider adding a description of how the TAT is obtained since there are more than one procedure in the literature (temporal artery forehead scan vs temporal artery forehead along face to behind ear scan techniques –see Lawson L, Bridges EJ, et al (2007) and Carroll E, et al (2004).

5. Results: 1) Although you collected 2 sets of data per patient (TAT1 and TAT2) for the inter-rater reliability test, it is unclear if there is a need to present the data in Figure 2 (scatter plots of correlations –which is not relevant to inter-rater reliability). The correlation result of r = 0.94 analyzed with the Pearson Correlation Coefficient demonstrates excellent inter-rater reliability.

2) Figure 3: Bland Altman plots: Although described in the legion, it would be preferred to have the LOA values in the figure aside the dashed lines.

6. Discussion: 1) Line 217-220: typo and consider use of standard reference for “mean difference” (bias) as the quantified degree of agreement and “limits of agreement” (precision) as SD and the 95% LOAs. 2) Line 240 –this statement re: “…although this was not statistically significant” was not clear to me. 3) Line 266-270: recommend using hypothermic and febrile range temperatures. Want to not confuse hyperthermic conditions with fever/febrile conditions.

7. References: Recommend a review of literature for more current references

8. General grammar/typo/etc:

a. Line 71-72: “shock resistant” is not clear –is this a shock state of the patient or a device characteristic?

b. Line 144: clinically acceptable

c. Line 167 –I believe you mean perspiring rather than transpiring.

d. Line 185-186: reword this important result statement to ensure that it is clear that the proportion of measurement differences that were ≥ 0.5°C was 36%. Same recommendation for Line 190-191.

**********

6. 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.

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: Yes: Hildy M. Schell-Chaple

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

Temporal artery temperature measurements versus bladder temperature in critically ill patients, a prospective observational study

PONE-D-20-24690R1

Dear Dr. Cox,

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.

An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org.

If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Yu Ru Kou, PhD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

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

**********

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

**********

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

Reviewer #1: Yes

**********

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: Yes

**********

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

**********

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: Thank you for revising the manuscript.

**********

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.

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: Yes: Hildy Schell-Chaple, PhD, RN, CCNS