PONE-D-21-03696

Evaluation of patients’ satisfaction with bronchoscopy procedure.

PLOS ONE

Dear Dr. Faber,

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.

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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?

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: 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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Reviewer #1: No

Reviewer #2: Yes

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Reviewer #1: Yes

Reviewer #2: No

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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: This study reported patient satisfaction with elective bronchoscopy and factors related to the bronchoscopy-related anxiety and satisfaction after the procedure. Authors found that low patient anxiety before bronchoscopy, less discomfort during the procedure, amnesia due to premedication and less complications are associated with a higher patient satisfaction after bronchoscopy. However, multivariate regression analysis revealed anxiety prior to BS (standardized regression coefficient β=0.243, p=0.003), discomfort (β=0.186, p=0.021) and complications (β=0.239, p=0.003) as the only significant factors affecting patient satisfaction with bronchoscopy.

There are some issues as below.

Major points

1. On primary endpoint

Authors aimed to identify factors influencing patients’ satisfaction with BS. However, they did sample size calculations for correlation analysis to show that a sample size of 85 patients would provide 80% statistical power to detect weak (r=0.3) correlation (alpha = 0.05, beta = 0.20). In general, sample size calculation should be used to clarify the main objective. I wonder why they use correlation analysis to detect weak (r=0.3) correlation. Furthermore, did they do this sample size calculation in order to find out which factors correlated with which factors?

2. Among the results of this manuscript, I think the result of multivariate regression analysis which described in line 246 is most important information. Authors concluded this result in the Conclusions session in line 379. However, they included “amnesia due to premedication” in Discussion session in line 276 to 278. If they included “amnesia due to premedication” from the results of Table 3, I think that “amnesia due to premedication” should be deleted because Table 3 included lots of confounds.

3. I think the result of multivariate regression analysis which described in line 246 should be presented by additional table.

4. In Statistical analysis and sample size calculation, the authors should present more detail on methods of multivariate regression analysis. That is, how they excluded the dependent factors from the selected factors and how they chose the best model among candidate models as final multivariate model.

5. In this study, questionnaire S1and S2 are very important. Questionnaire S1 include only two VAS on anxiety Q7, Q8. Questionnaire S2 include only one VAS on anxiety Q1. Authors used VAS for only anxiety scale. Other items were type of multiple-choice question. In case of multiple-choice question or Likert type question, they should validate them in order to detect the appropriate answers. Therefore, authors should give us the results of validation on these items.

Minor points

1) Line 74; “it is safe and severe complications are rare [1],”→Reference No.1 is too old. Please replace recent reference and recent information.

2) Line 78; “bronchoscopy is most commonly related to related to cough, dyspnea, chest pain or nausea” Is under lined part misprinted or not? Please correct the under lined part.

3) Line 99; Does “elective bronchoscopy” mean “only diagnostic bronchoscopy”? If this is correct it should be defined in the text at first use.

4) Line 108; Authors mentioned “The inclusion to the study was not limited by the type of the procedure”. Considering statistical view, I think they should balance the type of the procedure when they enrolled patients.

5) Line 129; Outcome points had two points. Which is primary endpoint? Which is secondary endpoint?

6) Line 136; “Importantly, the staff had not been informed which patients were included to the study.” Why had the staff not been informed? Please explain this is important.

7) Line 157 and 159; I think Table S3 and S4 are the clinical report form for bronchoscopists and attending physicians not questionnaire.

8) Line 182 to 193; Authors mentioned background characteristics in this part. Please provide the table of “background characteristics” in text or Supporting Information.

9) Line 200 to 204; “Rigid bronchoscopy was performed in 6 patients (4%)”. Therefore, it would better that authors should compare only between flexible (fiberoptic) bronchoscopy without EBUS and that without EBUS.

10) In Table 1 “Satisfaction with BS in VAS”; Please consider the significant digits. “0 – 4.375” means they measured the degree of tens μm.

11) Line 215 to 217 and 337; How many patients achieved the conscious sedation? Depth of anesthesia is very important to evaluation the satisfaction with BS. Please provide depth of sedation by use of sedation score.

12) Line 221; Authors defined VAS > 6/10 as “very unsatisfied”. However, in Table 3 and Figure 2, they defined VAS ≥ 5-10 as “unsatisfied”. I think there is discrepancy. Please explained it. Furthermore, how did they define these cutoff-value?

13) Line 223 and 238 to 240; Was “correlation between satisfaction and willingness for future bronchoscopy” basis for setting for sample size calculations? Or was “correlation between dissatisfaction with bronchoscopy and the level of anxiety before the procedure” basis for setting for sample size calculations? Or was “correlation between dissatisfaction with bronchoscopy and patients discomfort during the procedure” basis for setting for sample size calculations? Which of them were basis for setting for sample size calculations? Was it primary endpoint?

14) Line 371; “Secondly, the study group was rather small due to single-center study, inclusion criteria and short period of study, however the number of included patient was based on sample size calculation.” If authors set the main objective as sample size calculation, sample size of the study group would seem to be more appropriate size. Why did they use correlation analysis to detect weak (r=0.3) correlation?

Reviewer #2: The authors have done a good work in trying to identify the factors that affect patient satisfaction during bronchoscopy in their study titled "Evaluation of patients’ satisfaction with bronchoscopy procedure". The topic and contents have been appropriately dealt with but the authors need to do some minor revisions for the article to be more suitable. First of all, there are many grammatical errors in the text that needs to be corrected. Secondly, the authors in justifying the use of oral route for bronchoscopy, made a statement of the nasal route being causing more discomfort. This justification is not accurate and the authors should just limit their statement to oral route being their preference. Thank you

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Reviewer #1: Yes: Yuichiro Takeda

Reviewer #2: Yes: Adamu Issaka

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PONE-D-21-03696R1Evaluation of patients’ satisfaction with bronchoscopy procedure.PLOS ONE

Dear Dr. Katarzyna Faber,

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 Dec 23 2021 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: 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,

Yuichiro Takeda, M.D., Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments:

There are still some issues as below.

1, Primary outcome: The authors set “a relationship (correlation) between patients’ anxiety and satisfaction with bronchoscopy as the primary outcome. They based their sample size calculation on a study by Bujang MA and Baharum N and provided this article to references. In this provided reference, Bujang MA and Baharum N used Pearson coefficient for correlation analysis. Did they check null hypothesis is equal to zero in this study population? Even if null hypothesis is equal to zero, I wonder why they use Mann Whitney U test or Kruskal- Wallis test that are non-parametric test. Why did they delete Kruskal- Wallis test in Statistical analysis of revised manuscript?

2, Primary outcome: I guess the authors described the result of primary outcome in Line 274 of Manuscript - revised manuscript, clean version.

The authors should describe this study met the primary outcome in Results or Discussion part.

3, Author should describe how to perform the multivariate analysis in this study more detail in in Statistical analysis part. what parameters were they screening by univariate analyses, selection criteria of parameters, how to find independent parameters, how to select best model. Please describe this process in Statistical analysis part.

4. In revised manuscript, you mention only regression model in univariate and multivariate. There are lots of regression method. I think you should not delete “logistic”.

5. In general, univariate analyses are only the screening test for model construction. Table 3 should include multivariate model like below table. However, you should check statistical and clinical independency between “Anxiety before BS” and “Discomfort during what”.

Parameters Univariate Analyses Multivariate Analysis

Beta Standard error P-value Beta Standard error P-value

Anxiety before BS 0.306 0.086 0.0006 0.264 0.086, 0.003

Discomfort during ? 0.255 0.087 0.004 0.366, 0.087 0.00017

Age of patient 0.015 0.090 0.864 NI

Duration of BF 0.039 0.092 0.674 NI

Satisfaction with

information about the BF-0.096 0.090 0.288 NI

Not remembering BF -0.136 0.090 0.135 NI

Abbreviations: NI, not included in the best multivariate logistic regression model.

6. Table 4 is “Differences between satisfied and unsatisfied patients” Why did not authors check all parameters in table 4 by univariate analyses? I think authors should be screening all parameters in table 4. And then they construct some models for the multivariate models. After that, they choose best model and analyze this model as the result. How is it?

7. Although author added the limitation, it is serious issue that they did not validate questionnaires used in the study.

8. There are lots of reports that depth of anesthesia is very important to evaluation the satisfaction with BS. It is serious issue that they did not use sedation score during the study. At least, they should add this point to the study Limitations.

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Reviewers' comments:

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Attachments

Attachment

Submitted filename: Reviced paper_Commets and decision for author 20211106.docx

PONE-D-21-03696R2Evaluation of patients’ satisfaction with bronchoscopy procedure.PLOS ONE

Dear Dr. Faber,

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 February 25, 2022. 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.

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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,

Yuichiro Takeda, M.D., Ph.D.

Academic Editor

PLOS ONE

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

Additional Editor Comments:

I think your manuscript improved now.

Minor points

1) “In our study neither the satisfaction from bronchoscopy (BS) nor anxiety before BS have a normal distribution of values (line 203). Thus we changed the correlation coefficient for Spearman (line 209 and 287, 288) and we used non-parametric tests.”

Does this mean sample size calculation was incorrect in your study? You should include this information as a limitation. This is very important.

2) “The primary outcome of the study was a week positive correlation between dissatisfaction with bronchoscopy and the level of anxiety before the procedure (Spearman coefficient r=0.276, p=0.0014) or patients’ discomfort during the procedure (r=0.309, p=0.0005)” Although the correlation between dissatisfaction with bronchoscopy and the level of anxiety before the procedure was statistically significant, coefficient rho was 0.276 that was below 0.3. On the other hand, the correlation between dissatisfaction with bronchoscopy and patients’ discomfort during the procedure was statistically significant and its coefficient rho was 0.309 that was beyond 0.3. Is the latter the only one that met the main outcome? You should explain this result in the discussion part.

3) I think the coefficient is generally rho (ρ) in the Spearman rank test.

4) Although PLOS one is an open-access journal, the discussion part is slightly long. Can you summarize it?

5) I have a comment for your future study. There is a book that explained how to use Multivariable Analysis: A Practical Guide for Clinicians and Public Health Researchers Second edition by Mitchell H. Katz. He said as below: Whenever possible, "do not use variable selection technique." This is because there is a danger that any variable selection method will select confounders into the model and remove variables that are causally related to the outcome. Also, in both the forward and the backward selection, each variable is evaluated individually, so there is a possibility that two variables that start out as a set and have an important effect on the outcome will not be selected as a set in the final model. There is also the possibility that a variable that is very important in explaining the outcome may not be selected for the model because it is related to a variable that has already been adopted in the model. My opinion is the same as above.

6) This manuscript still has some grammatical errors in the text that needs to be corrected. Please check English in the text carefully.

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Reviewers' comments:

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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.

PONE-D-21-03696R3Evaluation of patients’ satisfaction with bronchoscopy procedure.PLOS ONE

Dear Dr. Katarzyna,

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 April 7, 2022. 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: 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,

Yuichiro Takeda, M.D., Ph.D.

Academic Editor

PLOS ONE

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

Additional Editor Comments (if provided):

Still, a few issues were raised in your manuscript.

#1; In Manuscript – revised version. February 2022.

Line 260 to 262; “There was a positive correlation between satisfaction and willingness for future bronchoscopy (r=0.487, p<0.0001)”.

I wonder if this “r” is Spearman coefficient rho or not. Please correct or explain it.

#2; And you also need clear and correct Figures and Tables without any misprints (“diabetes; diabetes mellitus,” “arhytmia; arrhythmia,” “asthma; bronchial asthma” in Supplementary Figure 2 and so on) or any additional linear (Q1 in S2 table and so on) to publish. Therefore, you should check all figures and tables and supplementary tables and figures again.

#3; According to Submission Guidelines, manuscripts must be submitted in English. Your supporting information included the Polish version of the S1 Table to S4 Table. Therefore, you should delete them.

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Reviewers' comments:

[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.

Evaluation of patients’ satisfaction with bronchoscopy procedure.

PONE-D-21-03696R4

Dear Dr. Faber,

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,

Yuichiro Takeda, M.D., Ph.D.

Guest Editor

PLOS ONE

Additional Editor Comments (optional):

Through several revisions, I think your manuscript has improved.

ACADEMIC EDITOR:

congratulations to the authors and thanks to the reviewers for the suggestions provided which really helped improve the quality of the manuscript

Silvia Fiorelli

Plos One

Academic Editor