Comprehensive assessment of a nationwide simulation-based course for artificial life support

Mateusz Puslecki; Marek Dabrowski; Marcin Ligowski; Bishoy Zakhary; Ahmed S. Said; Kollengode Ramanathan; Elaine Cooley; Lukasz Puslecki; Sebastian Stefaniak; Piotr Ziemak; Ilona Kiel-Puslecka; Agata Dabrowska; Tomasz Klosiewicz; Maciej Sip; Radoslaw Zalewski; Malgorzata Ladzinska; Wojciech Mrowczynski; Piotr Ladzinski; Lidia Szlanga; Konrad Baumgart; Piotr Kupidlowski; Lukasz Szarpak; Marek Jemielity; Bartlomiej Perek

doi:10.1371/journal.pone.0257162

Peer Review History

Original SubmissionMay 6, 2021
9 Jul 2021 Decision Letter - Marcel Pikhart, Editor PONE-D-21-14816 Efficacy of nationwide simulation based Artificial Life Support training during the COVID-19 pandemic year PLOS ONE Dear Authors, 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 8 August 2021. 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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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 provide additional details regarding participant consent. In the ethics statement in the Methods and online submission information, please ensure that you have specified (1) whether consent was informed and (2) 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. If you are reporting a retrospective study of medical records or archived samples, please ensure that you have discussed whether all data were fully anonymized before you accessed them and/or whether the IRB or ethics committee waived the requirement for informed consent. If patients provided informed written consent to have data from their medical records used in research, please include this information. Once you have amended this/these statement(s) in the Methods section of the manuscript, please add the same text to the “Ethics Statement” field of the submission form (via “Edit Submission”). For additional information about PLOS ONE ethical requirements for human subjects research, please refer to http://journals.plos.org/plosone/s/submission-guidelines#loc-human-subjects-research. 3. Please include additional information regarding the survey or questionnaire used in the study and ensure that you have provided sufficient details that others could replicate the analyses. For instance, if you developed a questionnaire as part of this study and it is not under a copyright more restrictive than CC-BY, please include a copy, in both the original language and English, as Supporting Information. If the original language is written in non-Latin characters, for example Amharic, Chinese, or Korean, please use a file format that ensures these characters are visible. 4. Please state whether you validated the questionnaire prior to testing on study participants. Please provide details regarding the validation group within the methods section. 5. In your Data Availability statement, you have not specified where the minimal data set underlying the results described in your manuscript can be found. PLOS defines a study's minimal data set as the underlying data used to reach the conclusions drawn in the manuscript and any additional data required to replicate the reported study findings in their entirety. All PLOS journals require that the minimal data set be made fully available. For more information about our data policy, please see http://journals.plos.org/plosone/s/data-availability. Upon re-submitting your revised manuscript, please upload your study’s minimal underlying data set as either Supporting Information files or to a stable, public repository and include the relevant URLs, DOIs, or accession numbers within your revised cover letter. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. Any potentially identifying patient information must be fully anonymized. Important: If there are ethical or legal restrictions to sharing your data publicly, please explain these restrictions in detail. Please see our guidelines for more information on what we consider unacceptable restrictions to publicly sharing data: http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. Note that it is not acceptable for the authors to be the sole named individuals responsible for ensuring data access. We will update your Data Availability statement to reflect the information you provide in your cover letter. 6. Thank you for stating the following in the Funding Section of your manuscript: [The project was awarded funding from a POWER competitive national grant (POWR.05.04.00-IP.05-00-006/18) by the Polish Ministry of Health for a total of 2,750,000 USD (PLN 10,974,708.60).Main reason was to develop a course about “Artificial Life Support with ECMO” offered to 264 physicians from Poland implemented in 2019-2021 at the Poznan University of Medical Sciences (PUMS). This paper includes also findings from the research project financed by the research grant of the National Science Centre (Poland) awarded based on the decision no. DEC-2015/19/D/HS4/0041.Ahmed S. Said acknowledges research support from the Children’s Discovery Institute Faculty Development Award at Washington University in St. Louis.] We note that you have provided funding information that is not currently declared in your Funding Statement. However, funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form. Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows: [Yes. The project was awarded funding from a POWER competitive national grant (POWR.05.04.00-IP.05-00-006/18) by the Polish Ministry of Health for a total of 2,750,000 USD (PLN 10,974,708.60). Main reason was to develop a course about “Artificial Life Support with ECMO” offered to 264 physicians from Poland implemented in 2019-2021 at the Poznan University of Medical Sciences (PUMS).] Please include your amended statements within your cover letter; we will change the online submission form on your behalf. 7. We note that the grant information you provided in the ‘Funding Information’ and ‘Financial Disclosure’ sections do not match. When you resubmit, please ensure that you provide the correct grant numbers for the awards you received for your study in the ‘Funding Information’ section. 8. Please amend your list of authors on the manuscript to ensure that each author is linked to an affiliation. Authors’ affiliations should reflect the institution where the work was done (if authors moved subsequently, you can also list the new affiliation stating “current affiliation:….” as necessary). 9. Your ethics statement should only appear in the Methods section of your manuscript. If your ethics statement is written in any section besides the Methods, please move it to the Methods section and delete it from any other section. Please ensure that your ethics statement is included in your manuscript, as the ethics statement entered into the online submission form will not be published alongside your manuscript. 10. Please upload a new copy of Figure 6 as the detail is not clear. Please follow the link for more information: https://blogs.plos.org/plos/2019/06/looking-good-tips-for-creating-your-plos-figures-graphics/" https://blogs.plos.org/plos/2019/06/looking-good-tips-for-creating-your-plos-figures-graphics/ 11. We noticed you have some minor occurrence of overlapping text with the following previous publication(s), which needs to be addressed: - https://www.hindawi.com/journals/emi/2021/6633208/ -https://www.sciencedirect.com/science/article/abs/pii/S0735675718303127?via%3Dihub -https://onlinelibrary.wiley.com/doi/abs/10.1111/aor.13332 In your revision ensure you cite all your sources (including your own works), and quote or rephrase any duplicated text outside the methods section. Further consideration is dependent on these concerns being addressed. [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: No Reviewer #2: Yes Reviewer #3: Yes Reviewer #4: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: N/A Reviewer #2: No Reviewer #3: No Reviewer #4: 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 Reviewer #2: Yes Reviewer #3: Yes Reviewer #4: 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 Reviewer #2: Yes Reviewer #3: Yes Reviewer #4: No ****** 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: Introduction 1 Were the aims/objectives of the study clear? The title is somewhat complex and makes the article less interesting additionally it refers to a general concept, that dose does not reflect the aim of the paper well. Abstract and introduction are well-formed, address the issue directly, and sufficient to the aim of the study. However, there are many typos to be revised by a native speaker. Methods There are many problems in the method section that threaten the validity of the study and its results: 1- There is no mention of the method used to invite the participants to this study. 2- Assessment tools used in this study are not described well: no validity test or reference to any articles that used it before. 3- ELSO is the same organization that made the assessment tool and the course guideline, which cast doubt on the validity of the assessment tools. 4- Used ELSO assessment tools are not provided. - Sample size was fairly enough and the population was clearly defined. - Study method was described well, which enable a researcher to repeat it. - Main problem is that the Cardiopulmonary assessment tool is not described enough: who assesses the practical part is it the same one, who provides the feedback or not which implies a huge effect on the results. - Which tool is used to evaluate: mean depth, mean rate (/min), chest recoil (%) - Result: - The basic data was adequately described - Analysis should be address populations that have previous experience with the study topic, which represent half of the population. - These are immediate results of this intervention, which means we need more time to judge the real effect on clinical practice. Even though this was mentioned in the limitation section, this limitation makes this study less interesting and yields something that is already predictable. Discussion - Conclusions are not fully justified by the results but - limitations of the study were discussed well. Reviewer #2: This manuscript provided information on the utility of simulation as an educational approach in this pandemic era. Overall, this paper is well written. However following issues should be resolved to make it scientifically sound: 1. Use abbreviation with the first use of the word. Like the words Chest decompression appeared first in line 129, but abbreviated form was used from line 275. Similar use is applicable for abstract too. 2. As it was a before and after study (Quasi-experimental trial) it should be mentioned in the methodology and methodology section should be re-organized accordingly. 3. In methodology section you have mentioned Mann-Whitney U test was used in the study. But, your study design is not appropriate for this test. 4. Box and whisker plots were used in Figure 1-5. But in the results sectioned mean values were presented (But the data were not normally distributed). Use only the median (IQR) values for the presentation and analysis of data which were not normally distributed. 5. Rewrite the discussion chapter. Sections 4.3 to 4.8 are not relevant with the study, especially in the discussion part. Reviewer #3: Interesting paper However, please revise based on the following comments: A. Statistical analysis: Please revise some analysis and presentation for clarity 1. In method section, Revised according and include all analyses conducted. Descriptive analysis: Categorical data using frequency (n) and percentage (%). Continuous data using mean with standard deviation (SD) or median with interquartile range (IQR). Categorical data was not included and check the spelling for "interquartile" Pre-post test: Paired t test for normally distributed data. What is the role of Mann-Whitney U test here? 2. In result section Table 2: please revise to frequency (n) instead if count Rearrange again all categorical ordinal data accordingly to show the order. Example clinical practice duration, ECMO practice. Revise the range of each category. Example for clinical practice duration , there are 5-10 years, 10-15 years and 15-20 years categories. Where do participants with practice of 10 years and 15 years belong to?? Was it? <5 5-10 >10-15 >15-20 >20 Please check all variables i.e ECMO experience, Hospital ECMO experience, Annual ECMO volume etc Table 3 Add the SD for all variables mean accordingly Suggest omit Table 4 as knowledge has been presented graphically Figure 1, 2 and 3 Omit the "mean" box-whisker in each section A since this box-whisker is repeated in Section B. Furthermore, each item of cognitive, behaviour and technical was described with median (IQR). Having the "mean" box-whisker here is confusing. Please revise the test for Section A (median: Wilcoxon signed rank test) and Section B (mean: paired t test) Figure 4: Revise test (mean knowledge: paired t test) Please provide detail values [ie. mean (SD), median (IQR) etc] for cognitive, behaviour and technical (total and each item). This can be as supplementary table and include detail values of knowledge as well (Table 4). This values are important for other researchers' reference in the future. Figure 6. not available in the manuscript B. Discussion The discussion is acceptable and related to the objective and findings of the study up to 4.3 only. Starting from 4.4 onwards till 4.8, it is more of a narrative review. This should be written and submitted separately. Reviewer #4: The study meets the aims set out to evaluate the results of training. The study design does this to some extent. I have 3 main comments: 1. are about about what 'results' of training are expected to be - you would expect enhancement in knowledge (and cannot as the limitations note - evaluate on practice and impact until the medium or long term) - but it would be useful to know what is the comparator? 2. What was the 'input' or resource use for this training? This is important for an international readership 3. How can this be scaled up? Minor comments: 1. I found some of the sentences hard to understand - I have highlighted some instances in the enclosed. 2. There is an excessive amount of descriptive content which can be better summarized leaving more space for analytic discussion. Thank you for the opportunity to review this work. ****** 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: Ahmad Altom Reviewer #2: No Reviewer #3: No Reviewer #4: Yes:** Raheelah Ahmad [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. Attachments Attachment Submitted filename: PONE-D-21-14816_reviewer - comments 6 July 2021.pdf https://doi.org/10.1371/journal.pone.0257162.r001
Revision 1
29 Jul 2021 Author Response Efficacy of nationwide simulation based Artificial Life Support training during the COVID-19 pandemic year New title “Comprehensive assessment of a nationwide simulation-based course for artificial life support” Dear Editor and Reviewers, Thank you very much for your valuable remarks. We really appreciate the effort of all comments to have better manuscript published. We have agreed with all of them. All recommended corrections have been described below and are highlighted (written in red) in the revised version of our manuscript. 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 Response: Manuscript was upgraded for PLOS ONE’s style requirements – Title page, manuscript, tables and figures and references. 2. Please provide additional details regarding participant consent. In the ethics statement in the Methods and online submission information, please ensure that you have specified (1) whether consent was informed and (2) 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. If you are reporting a retrospective study of medical records or archived samples, please ensure that you have discussed whether all data were fully anonymized before you accessed them and/or whether the IRB or ethics committee waived the requirement for informed consent. If patients provided informed written consent to have data from their medical records used in research, please include this information. Once you have amended this/these statement(s) in the Methods section of the manuscript, please add the same text to the “Ethics Statement” field of the submission form (via “Edit Submission”). For additional information about PLOS ONE ethical requirements for human subjects research, please refer to http://journals.plos.org/plosone/s/submission-guidelines#loc-human-subjects-research. Response: Ethics statement: Each candidate, after accepting the application, completed a study participation form and a written consent. According to the rules of Local Bioethical Committee of Poznan University of Medical Sciences the Statement of Ethics Approval is not required. 3. Please include additional information regarding the survey or questionnaire used in the study and ensure that you have provided sufficient details that others could replicate the analyses. For instance, if you developed a questionnaire as part of this study and it is not under a copyright more restrictive than CC-BY, please include a copy, in both the original language and English, as Supporting Information. If the original language is written in non-Latin characters, for example Amharic, Chinese, or Korean, please use a file format that ensures these characters are visible. Response: All assessment questionnaires before and after the course as well as tests before and after the course were made available by ELSO as part of the accreditation as - ELSO endorsed comprehensive course. Supplementary material Pre and Post assessment tools were added (Supplementary material 1 and 5). 4. Please state whether you validated the questionnaire prior to testing on study participants. Please provide details regarding the validation group within the methods section. Response: The questions were developed for this purpose. They have been developed and initially tested in several US based ELSO endorsed courses before using them in the polish courses. This data is currently presented in a submitted manuscript under review for publication. 5. In your Data Availability statement, you have not specified where the minimal data set underlying the results described in your manuscript can be found. PLOS defines a study's minimal data set as the underlying data used to reach the conclusions drawn in the manuscript and any additional data required to replicate the reported study findings in their entirety. All PLOS journals require that the minimal data set be made fully available. For more information about our data policy, please see http://journals.plos.org/plosone/s/data-availability. Upon re-submitting your revised manuscript, please upload your study’s minimal underlying data set as either Supporting Information files or to a stable, public repository and include the relevant URLs, DOIs, or accession numbers within your revised cover letter. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. Any potentially identifying patient information must be fully anonymized. Important: If there are ethical or legal restrictions to sharing your data publicly, please explain these restrictions in detail. Please see our guidelines for more information on what we consider unacceptable restrictions to publicly sharing data: http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. Note that it is not acceptable for the authors to be the sole named individuals responsible for ensuring data access. We will update your Data Availability statement to reflect the information you provide in your cover letter. Response: All assessment questionnaires before and after the course as well as tests before and after the course were made available by ELSO as part of the accreditation as - ELSO endorsed comprehensive course. The courses assessment and results were prepared according to ELSOed education Committee. Data Availability – NO, all assessment questionnaires before and after the course as well as tests before and after the course were made available by ELSO as part of the accreditation as - ELSO endorsed comprehensive course. The courses assessment and results were prepared according to ELSOed education Committee. Supplementary material Pre and Post assessment tools were added (Supplementary material 1 and 5). 6. Thank you for stating the following in the Funding Section of your manuscript: [The project was awarded funding from a POWER competitive national grant (POWR.05.04.00-IP.05-00-006/18) by the Polish Ministry of Health for a total of 2,750,000 USD (PLN 10,974,708.60). Main reason was to develop a course about “Artificial Life Support with ECMO” offered to 264 physicians from Poland implemented in 2019-2021 at the Poznan University of Medical Sciences (PUMS). This paper includes also findings from the research project financed by the research grant of the National Science Centre (Poland) awarded based on the decision no. DEC-2015/19/D/HS4/0041.Ahmed S. Said acknowledges research support from the Children’s Discovery Institute Faculty Development Award at Washington University in St. Louis.] We note that you have provided funding information that is not currently declared in your Funding Statement. However, funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form. Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows: [Yes. The project was awarded funding from a POWER competitive national grant (POWR.05.04.00-IP.05-00-006/18) by the Polish Ministry of Health for a total of 2,750,000 USD (PLN 10,974,708.60). Main reason was to develop a course about “Artificial Life Support with ECMO” offered to 264 physicians from Poland implemented in 2019-2021 at the Poznan University of Medical Sciences (PUMS).] Please include your amended statements within your cover letter; we will change the online submission form on your behalf. Response: Funding information: The project was awarded funding from a POWER competitive national grant (POWR.05.04.00-IP.05-00-006/18) by the Polish Ministry of Health for a total of 2,750,000 USD (PLN 10,974,708.60) (MP, MD, ML). Main reason was to develop a course about “Artificial Life Support with ECMO” offered to 264 physicians from Poland implemented in 2019-2021 at the Poznan University of Medical Sciences (PUMS). This paper includes also findings from the research project financed by the research grant of the National Science Centre (Poland) awarded based on the decision no. DEC-2015/19/D/HS4/0041 (LP). Acknowledges research support from the Children’s Discovery Institute Faculty Development Award at Washington University in St. Louis (ASS). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. That part is included in cover letter and was removed from manuscript. 7. We note that the grant information you provided in the ‘Funding Information’ and ‘Financial Disclosure’ sections do not match. When you resubmit, please ensure that you provide the correct grant numbers for the awards you received for your study in the ‘Funding Information’ section. Response: Funding information is included. The authors declared that no competing interests exist and there is no any financial disclosure. 8. Please amend your list of authors on the manuscript to ensure that each author is linked to an affiliation. Authors’ affiliations should reflect the institution where the work was done (if authors moved subsequently, you can also list the new affiliation stating “current affiliation:….” as necessary). Response: All authors are linked to an affiliation. 9. Your ethics statement should only appear in the Methods section of your manuscript. If your ethics statement is written in any section besides the Methods, please move it to the Methods section and delete it from any other section. Please ensure that your ethics statement is included in your manuscript, as the ethics statement entered into the online submission form will not be published alongside your manuscript. Response: Ethic statement is only in Methods section. Ethics statement: Each candidate, after accepting the application, completed a study participation form and a written consent. According to the rules of Local Bioethical Committee of Poznan University of Medical Sciences the Statement of Ethics Approval is not required. 10. Please upload a new copy of Figure 6 as the detail is not clear. Please follow the link for more information: https://blogs.plos.org/plos/2019/06/looking-good-tips-for-creating-your-plos-figures-graphics/" https://blogs.plos.org/plos/2019/06/looking-good-tips-for-creating-your-plos-figures-graphics/ Response: Figure 6 file was uploaded successfully. 11. We noticed you have some minor occurrence of overlapping text with the following previous publication(s), which needs to be addressed: -https://www.hindawi.com/journals/emi/2021/6633208/ -https://www.sciencedirect.com/science/article/abs/pii/S0735675718303127?via%3Dihub -https://onlinelibrary.wiley.com/doi/abs/10.1111/aor.13332 In your revision ensure you cite all your sources (including your own works), and quote or rephrase any duplicated text outside the methods section. Further consideration is dependent on these concerns being addressed. Response: Discussion part was shorted and rephrased. All indicated publications are cited in manuscript. Reviewers' comments: Reviewer #1: Introduction 1 Were the aims/objectives of the study clear? The title is somewhat complex and makes the article less interesting additionally it refers to a general concept, that dose does not reflect the aim of the paper well. Response: “Comprehensive assessment of a nationwide simulation based course for artificial life support” Abstract and introduction are well-formed, address the issue directly, and sufficient to the aim of the study. However, there are many typos to be revised by a native speaker. Response: Manuscript was revised by a English native speaker. Methods There are many problems in the method section that threaten the validity of the study and its results: 1- There is no mention of the method used to invite the participants to this study. Response: It is included in Methods, Participants: The recruitment was voluntary and open to all physicians in Poland, regardless of their experience. After accepting the application, each candidate completed a study participation form and a written consent. 2- Assessment tools used in this study are not described well: no validity test or reference to any articles that used it before. Response: All assessment questionnaires before and after the course as well as tests before and after the course were made available by ELSO as part of the accreditation as - ELSO endorsed comprehensive course. The courses assessment and results were prepared according to ELSOed education Committee. Supplementary material Pre and Post assessment tools were added (Supplementary material 1 and 5). 3- ELSO is the same organization that made the assessment tool and the course guideline, which cast doubt on the validity of the assessment tools. Response: ELSO ECMOed Taskforce was created and charged with identifying global ECMO educational needs and outlining mechanisms for international collaboration and standardization. The Taskforce listed four categories encompassing seven educational workgroups. Different workgroups created the course guidelines, the assessment tools and the certification components. The assessment tools are directly prepared by ELSO the same for every education ELSO center in the world. Zakhary B, Shekar K, Diaz R, Badulak J, Johnston L, Roeleveld PP, Alinier G, Lai PCK, Ramanathan K, Moore E, Hassan I, Agerstrand C, Ngai WC, Salazar L, Raman L, Bembea MM, Davidson M, Gomez-Gutierrez RD, Mateo-Sidrón JAR, Kukutschka J, Antonini MV, Dickstein ML, Schmidt M, Abrams D, Ogino MT; Extracorporeal Life Support Organization (ELSO) ECMOed Taskforce. Position Paper on Global Extracorporeal Membrane Oxygenation Education and Educational Agenda for the Future: A Statement From the Extracorporeal Life Support Organization ECMOed Taskforce. Crit Care Med. 2020 Mar;48(3):406-414. doi: 10.1097/CCM.0000000000004158. PMID: 31833901. 4- Used ELSO assessment tools are not provided. Response: All assessment questionnaires before and after the course as well as tests before and after the course were made available by ELSO as part of the accreditation as - ELSO endorsed comprehensive course. The courses assessment and results were prepared according to ELSOed education Committee. Supplementary material Pre and Post assessment tools were added (Supplementary material 1 and 5). - Sample size was fairly enough and the population was clearly defined. - Study method was described well, which enable a researcher to repeat it. Response: We thank the reviewer for the comments. - Main problem is that the Cardiopulmonary assessment tool is not described enough: who assesses the practical part is it the same one, who provides the feedback or not which implies a huge effect on the results. Response: Participants performed the test A: 2-minute trial without preview – verification of the current state of Quality of CPR and B: 2-minute test with QCPR preview (quality improvement). Parameters were monitored with Session Viewer Software 6.2.6400 (SimVentures 2019). - Which tool is used to evaluate: mean depth, mean rate (/min), chest recoil (%) Response: Sentence was included into Methods: During the test, the following parameters were monitored with Session Viewer Software 6.2.6400 (SimVentures 2019): compression rate, depth and recoil percentage. Result: - The basic data was adequately described - Analysis should be address populations that have previous experience with the study topic, which represent half of the population. Response: Use of ECMO as advanced life support is not a routine procedure in Poland in intensive care units, even of the highest reference. Apart from places in Poland where such treatment is carried out as part of bottom-up initiatives, there is no systemic solution. Additionally, there is lack of proper education programs that ensure easy access to this therapy. - These are immediate results of this intervention, which means we need more time to judge the real effect on clinical practice. Even though this was mentioned in the limitation section, this limitation makes this study less interesting and yields something that is already predictable. Response: We agree that publication presents early results and efficiency of simulation based training in artificial techniques. In the future, the authors together with ELSO plan to carry out a prospective assessment of the long-term outcomes in the terms of number of new and active ECMO centres in Poland, the total number of supported patients and successful transportations as well as the final outcomes of the treated individuals. The sentences in limitations was added: The publication presents early results and efficiency of simulation based training in artificial techniques. In the future, the authors together with ELSO plan to carry out a prospective assessment of the long-term outcomes in the terms of number of new and active ECMO centres in Poland, the total number of supported patients and successful transportations as well as the final outcomes of the treated individuals. Moreover, additional assessment is necessary of courses impact on the long term ability of providers to manage patients on ECMO and the overall healthcare system or the ability to manage increasing number of patients on ECMO and the impact on patient outcomes. Discussion - Conclusions are not fully justified by the results but - limitations of the study were discussed well. Response: The Conclusion part was improved: The dedicated R&D Innovation Ecosystem established in the “ECMO for Greater Poland” program, with developed National Education Center can play a crucial role in the knowledge and know-how transfer. More research is needed to assess the sustainability of training and its impact on the quality of health care. The short-term results of developed concept in “Center of Artificial Life Support and Patient Safety” with ELSO cooperation are very promising. Our course confirmed the simulation as an educational approach is valuable not only in training and testing of novel or commonly used procedures, skills upgrading, but also in practicing very rare cases. The implementation of the education program during COVID-19 pandemic may be helpful in founding specialized ECMO centers and teams including mobile ones. Reviewer #2: This manuscript provided information on the utility of simulation as an educational approach in this pandemic era. Overall, this paper is well written. However following issues should be resolved to make it scientifically sound: 1. Use abbreviation with the first use of the word. Like the words Chest decompression appeared first in line 129, but abbreviated form was used from line 275. Similar use is applicable for abstract too. Response: Thank you for that suggestion, it was corrected in manuscript. 2. As it was a before and after study (Quasi-experimental trial) it should be mentioned in the methodology and methodology section should be re-organized accordingly. Response: We thank the reviewer for the comments. We would like to clarify that this was not a quasi-experimental study. We wanted to assess the impact of ECMO education on the various aspects of participant’s development of technical and non-technical skills. The courses were not developed for the study. The study developed comprehensive assessments for the cognitive, behavioral and technical impacts of the course in addition to the impact of the simulation portions on the participants performance in managing ECMO emergencies. There were no study specific interventions to qualify for an experimental aspect. 3. In methodology section you have mentioned Mann-Whitney U test was used in the study. But, your study design is not appropriate for this test. Response: We agree, it was incorrect. That part was changed: The categorical variables were expressed as the frequency (n) and percentages (%). The quantitative variables were checked for normality distribution with the use of the Shapiro-Wilk W test. Due to the non-normal distribution among the variables, nonparametric Wilcoxon pairwise rank test was used and data were presented as median [interquartile range]. For normal distribution paired t-test for was used and data were presented as mean±SD. A value of p<0.05 was considered as statistically significant. Statistical analysis was performed in R Application (1.4.1106 © 2009-2021 RStudio, PBC). 4. Box and whisker plots were used in Figure 1-5. But in the results sectioned mean values were presented (But the data were not normally distributed). Use only the median (IQR) values for the presentation and analysis of data which were not normally distributed. Response: We agree with reviewer comment. All data with not normal distribution were presented as median. Only for normal distribution date mean and SD were presented. Part of knowledge assessment was improved. Additionaly the Table 4 was delated and we create new one for congenital, behavioral and technical assessment with knowledge assessment including mean, SD, median, min, max. 5. Rewrite the discussion chapter. Sections 4.3 to 4.8 are not relevant with the study, especially in the discussion part. Response: That part was changed, we removed non relevant part. We left part of importance of knowledge transfer with simulation-based training. That part can be some indication in developing Artificial Life Support centers. Reviewer #3: Interesting paper However, please revise based on the following comments: A. Statistical analysis: Please revise some analysis and presentation for clarity 1. In method section, Revised according and include all analyses conducted. Descriptive analysis: Categorical data using frequency (n) and percentage (%). Continuous data using mean with standard deviation (SD) or median with interquartile range (IQR). Categorical data was not included and check the spelling for "interquartile" Pre-post test: Paired t test for normally distributed data. What is the role of Mann-Whitney U test here? Response: We agree, that part was incorrect. That part was changed: The categorical variables were expressed as the frequency (n) and percentages (%). The quantitative variables were checked for normality distribution with the use of the Shapiro-Wilk W test. Due to the non-normal distribution among the variables, nonparametric Wilcoxon pairwise rank test was used and data were presented as median [interquartile range]. For normal distribution paired t-test for was used and data were presented as mean±SD.. A value of p<0.05 was considered as statistically significant. Statistical analysis was performed in R Application (1.4.1106 © 2009-2021 RStudio, PBC). 2. In result section Table 2: please revise to frequency (n) instead if count Rearrange again all categorical ordinal data accordingly to show the order. Example clinical practice duration, ECMO practice. Revise the range of each category. Example for clinical practice duration , there are 5-10 years, 10-15 years and 15-20 years categories. Where do participants with practice of 10 years and 15 years belong to?? Was it? <5 5-10 >10-15 >15-20 >20 Please check all variables i.e ECMO experience, Hospital ECMO experience, Annual ECMO volume etc Response: Thank you for valuable suggestions. Count was changed into frequency. All categorical data were organized in order. Data frames were checked and corrected in table 2. Table 3 Add the SD for all variables mean accordingly Response: According to suggestions SD for all variables mean were added and additionally in Table 4. Suggest omit Table 4 as knowledge has been presented graphically Response: Table 4 was removed according to suggestions. New table with all assessments were added. Figure 1, 2 and 3 Omit the "mean" box-whisker in each section A since this box-whisker is repeated in Section B. Furthermore, each item of cognitive, behaviour and technical was described with median (IQR). Having the "mean" box-whisker here is confusing. Please revise the test for Section A (median: Wilcoxon signed rank test) and Section B (mean: paired t test) Response: The data in section B for each figure is the mean of all the variables in each category (cognitive, behavioral and technical) compared before and after the course. We believe presenting the data in this fashion provides easier to follow presentation than a figure with comparison of the pre and post data for each variable in each category. All the data, for each variable and for the mean of all variables for each category, were not normally distributed so could only be compared using Wilcoson rank sum test and not paired t test. Figure 4: Revise test (mean knowledge: paired t test) Response: For figures 1, 2 & 3 Section B compares the mean of ALL the assessed variables before and after the course. This is different data than that presented in section A. We believed comparing the before and after for each variable in each figure would be too much information and confusing for the reader so we decided to compare the Mean of each category (cognitive, technical and behavioral) before and after. For all the compared data, including the means for each category, the data were not normally distributed so was compared using Wilcoxon test instead of t test. Similarly for figure 4, the data were not normally distributed so could not be compared by paired t test. Please provide detail values [ie. mean (SD), median (IQR) etc] for cognitive, behaviour and technical (total and each item). This can be as supplementary table and include detail values of knowledge as well (Table 4). This values are important for other researchers' reference in the future. Response: The new table 4 was deleted and we create new one for cognitive, behavioral and technical assessment with knowledge assessment including mean, SD, median, min, max. Figure 6. not available in the manuscript Response: Figure 6 file was uploaded successfully. B. Discussion The discussion is acceptable and related to the objective and findings of the study up to 4.3 only. Starting from 4.4 onwards till 4.8, it is more of a narrative review. This should be written and submitted separately. Response: That part of discussion was changed, we removed non relevant part. We left part of importance of knowledge transfer with simulation-based training. That part can be some indication in developing Artificial Life Support centers. Reviewer #4: The study meets the aims set out to evaluate the results of training. The study design does this to some extent. I have 3 main comments: 1. are about about what 'results' of training are expected to be - you would expect enhancement in knowledge (and cannot as the limitations note - evaluate on practice and impact until the medium or long term) - but it would be useful to know what is the comparator? Response: Use of ECMO as advanced life support was not a routine procedure in Poland in intensive care units, even of the highest reference before COVID pandemic. Apart from places in Poland where such treatment was carried out as part of bottom-up initiatives, there was no systemic solution. The overarching goal of the proposed program is: Development of knowledge and skills and consolidation of Polish doctors' awareness in the area of availability and safe use of medical technologies, which guarantee the survival of patients in the life-threatening states, in the course of acute either respiratory or circulatory failure, after exhaustion of conventional therapy as a standard of medical treatment resulting from evidence-based knowledge. We expect that new ECMO centers will be created, new ECMO teams, or Mobile ECMO Team and total number of ECMO application will increase. We plan to evaluate these results in the survey in the future - in the period of 1 and 2 years - to assess whether new centers have been established or in centers where they were not used or are now being used. The long-term effect is not easy to predict. Our courses have gained importance in connection with the COVID epidemic. Total number of participants in our project is 264 physicians (it will be upgraded to 312 in 2022). The comparator of implementation of extracorporeal techniques can be: number of ECMO centers, number of ECMO applications. Evaluation of medium- and long-term impact of the courses if very important and is the next step. We believe that the first step is to evaluate the short-term impact of the simulation courses as these are newly implemented nationwide and to our knowledge, no one has previously published the short-term impact of ECMO simulation courses. 2. What was the 'input' or resource use for this training? This is important for an international readership Response: Sentences includes in Methods and Limitation 1. As knowledge background ELSO recommend for every participant Books – Red Book and ECMO Specialist Manual – it is included in Methods section. 2. The ELSO recommend that the course hours at least 50% should be performed in the simulated conditions. 3. The necessary minimum space is 3 rooms equipped with high-fidelity simulation mannequin rooms, cannulation room and ultrasound imaging room. 4. Because simulations are high fidelity we work with expensive clinical equipment, disposable equipment is also expensive. 5. Human resources - ELSO recommends 1-2 instructors for 4 participants during practical classes. In our case, 8-10 people are involved in the simulation workshops. The entire organization of one course for 12 people requires the activity of 16 staff people: Including 4 simulation technicians, 2 ecmo specialists, 2 nurses, 4 simulation trainers and 4 doctors - instructors. 6. The cost-consumption of the courses is their main limitation. Lack of funding in the form of a grant or a diluted government financing means that such highly sophisticated education centers are only few in the world. 7. Every program and center needs ELSO accreditation – usually 1-2 control visits od ELSO Education Committee. 8. Additional cost of accommodation, hotel, meals, and recommended by ELSO books. 3. How can this be scaled up? Response: It was indicated in poin 2. Additionally: 1. ELSO sets a rigorous and clear time and program framework for endorsed courses and centers. 2. Our center to 2022 will perform total number of 26 courses with number 312 physicians. 3. COVID19 pandemic accelerated global interesting in artificial life support and it is not easy to estimate how it will be after pandemic time. 4. Our center is prepared to be referral education center for Central and east Europe. The development of the offer can be conducted in English and German language. 5. The development of the network of ELSO-endorsed training centers is the responsibility of ELSO. Although our initiative can be repeated anywhere, it only requires financing and development of the proposed HUB center for knowledge transfer. Minor comments: 1. I found some of the sentences hard to understand - I have highlighted some instances in the enclosed. Response: According to suggestions we rephrased some sentences. 2. There is an excessive amount of descriptive content which can be better summarized leaving more space for analytic discussion. Response: That part of discussion was changed, we removed not relevant part. We leaved part of importance of knowledge transfer with simulation based training. That part can be some indication in developing Artificial Life Support centers. Thank you for the opportunity to revise this work. Mateusz Puslecki and co-authors Attachments Attachment Submitted filename: Response to reviewers29.07.2021.docx https://doi.org/10.1371/journal.pone.0257162.r002
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Formally Accepted
24 Sep 2021 Acceptance Letter - Marcel Pikhart, Editor PONE-D-21-14816R1 Comprehensive assessment of a nationwidesimulation-based course for artificial life support Dear Dr. Puślecki: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. 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. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Marcel Pikhart Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0257162.r004

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