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PONE-D-20-21277

Patient-reported physical functioning is limited in almost half of critical illness survivors 1-year after ICU-admission: a retrospective single-center study

PLOS ONE

Dear Dr. Beumeler,

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

Additional Editor Comments:

There multiple methodological and at least one research ethics concern pointed out in the reviewers' critiques. These will need to be specifically, clearly and thoroughly addressed in a MAJOR REVISION of the manuscript, to be further considered for potential publication.

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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

Reviewer #3: Yes

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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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

Reviewer #3: 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: No

Reviewer #3: 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: I applaud the authors for investigating a noteworthy issue that, up until recent, has received little scientific attention. The overall findings are not surprising given the results of other studies assessing similar long-term outcomes among ICU patients. While the study is credible, it lacks the methodological prowess to create results that build upon existing literature.

I am unsure why objective, in-person physical function data was collected at discharge and 3 months, but not at 12 months. The robustness of the data would have been increased if the authors hadn’t relied solely on self-report at 12 months.

Also, the sample size would have been improved if some sort of proxy measure was taken to reflect physical function and recovery of those unable to return to the clinic. For instance, the SF-36 could have been completed over the phone.

Did the authors have any contact with the participants between the 3 and 12 month period? If so, this should be outlined in the the methods. If not, perhaps this would have helped decrease loss to follow-up over the course of the study.

The way the authors have the methods written makes it difficult to keep track of what measures were collected when. A diagram illustrating some sort of timeline (ie admission, discharge, 3-months, 12-months) along with the measures collected at each time point would be helpful.

Again, the overall aim of this study is worthwhile; however, the study holds substantial methodological limitations that make it worthy of publication.

Reviewer #2: In their manuscript “Patient-reported physical functioning is limited in almost half of critical illness survivors 1-year after ICU-admission: a retrospective single-center study” the authors report on recovery/non-recovery of ICU survivors and explore the role of potential risk factors. The data presented are interesting and can advance knowledge in the area. However, some points need to be further addressed.

1. The title of the study does not sound to be in line with aim (lines 101-102, to identify risk factors for long-term non-recovery at various time points from baseline to three months post-ICU discharge) and, in part, conclusions. The authors might consider rephrasing.

2. What was the hypothesis to contact this study?

3. The aim may better get rephrased to suggest that factors in relation to various time points (from baseline to three months post ICU-discharge) were considered for long-term (1 year) non-recovery.

4. Line 107. ‘were invited’ may be more appropriate than ‘are invited’.

5. Lines 133-134. Pls consider defining NR and R-group.

6. Results, #3.1. Pls consider also reporting PF values at 12 months for both groups, as this is a major variable to report.

7. Results, #3.4. This section refers to correlations of various variables with PF-score at 12 months; however, it seems to be written as referring in between-group comparisons (already done in #3.2.). Pls consider rephrasing. Also, at lines 218, 222 the authors mention tendency but report significant p values. Pls clarify.

8. Figure 3. Nice figure to graphically represent r coefficients.

9. Results, #3.5. The authors might include a table to report values (OR, CI, p) for all variables employed in the regression model. Also, what is meant by “pooled results”? Are they results corrected for missing values?

10. Both last paragraph of discussion (lines 302-315) and #5 refer to study limitations. What is the reason for separating? Pls clarify.

11. Conclusions, lines 327-330. This phrase might be more appropriate to include in discussion than conclusions, as it refers to future studies.

12. The authors might consider including in discussion a comment on the necessity to identify factors and sub-groups not only at 3 months after but also at hospital discharge to potentially facilitate rehabilitation interventions as early as possible.

Reviewer #3: Review:

Patient-reported physical functioning is limited in almost half of critical illness survivors 1-year after ICU-admission: a retrospective single-center study

Corresponding Author: Lise Frieda Elisabeth Beumeler

General:

I thank the authors for the opportunity to read their manuscript “Patient-reported physical functioning is limited in almost half of critical illness survivors 1-year after ICU-admission: a retrospective single-center study”. The authors investigated the post-intensive care recovery with a survey assessed by patients (Dutch-RAND 36-item Short Form).

1. I am very concerned about the study design. What is “retrospective” in this study? Study design sound more like an observational study. Which leads to the question “How did the study get submitted to the ethics committee”. As a retrospective study? Which does not correspond to the real study design. It seems questionable that an ethic committee waived the need for informed consent of an observational study. Even, when patient-related data were used and study-related procedures were used (Hand Grip strength, 6-MWT and BBS at discharge from ICU AND 3 month post-discharge). Please provide the correspondence to your local ethic committee including the study protocol (translated in English).

As it can be assumed that the study was submitted to the ethics committee as "retrospective", which does not correspond to the real study design. Please clarify this.

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Reviewer #1: No

Reviewer #2: Yes: Eleftherios Karatzanos PhD

Reviewer #3: No

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Patient-reported physical functioning is limited in almost half of critical illness survivors 1-year after ICU-admission: a retrospective single-center study

PONE-D-20-21277R1

Dear Dr. Beumeler,

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,

Scott Brakenridge, M.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

The editor believes the ethical concerns raised by the reviewers have been clarified and other major critiques regarding analyses and interpretation addressed.

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 #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 #2: Yes

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

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 #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 #2: Yes

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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 #2: Beumeler et al have improved the quality of their submitted manuscript.

All comments mentioned have been adequately addressed.

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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.

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 #2: Yes: Eleftherios Karatzanos, PhD