Research Staff COVID-19 Pandemic Survey-Results from the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network

Round 1

Reviewer 1 Report

1. Do not make abbreviation in abstract section.

2. Write paper in general text. Avoid We, our etc.

2. It possible to predict covid like situation in the future with their time and effect?

3.  Some lines are lengthy up to 4 lines like 84 to 87. They must be shorten.

4. Line no 86-87, patients who have acute respiratory distress syndrome, the precise condition seen in the most severe forms of COVID-19. It requires a proper citation of literature like- (i) Automated Deep Transfer Learning-Based Approach for Detection of COVID-19 Infection in Chest X-rays. (ii) Automatic Diagnosis of Covid-19 Related Pneumonia from CXR and CT-Scan Images.

5. Line no 158- why  lower age peoples like children’s are not considered in COVID-19 Impact on Research.

6. Line 341- Authors are talking about additional efforts should be made to develop a research contingency. I just suggest to use some example here.  

7. Conclusion must be revise and expended including the summary of what is presented in the paper.

8. Future work must also be present.

9. Further some reference and citation must be of 2023.  

Author Response

Please see the attachment

Author Response File: Author Response.pdf

Reviewer 2 Report

Comments to the articles: Research staff COVID-19 pandemic survey-results from the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network

The authors undertook a study that delved into the repercussions of the pandemic on scientific medical research, a realm of inquiry that holds pivotal significance. While their findings offer intriguing insights, it is crucial to deliberate thoughtfully on several matters embedded within the methodology and results sections. Notably, the study garnered a response rate of 37.7%, a statistic that merits further commentary for context. Discrepancies have emerged concerning the reported count of survey participants, which was specified as 277 in both the materials and methods as well as the results sections. However, upon closer examination, a misalignment becomes apparent between these figures and the numerical values depicted in the accompanying tables. To illustrate, the data tabulated in Table 2, elucidating participants' responses to the initial survey query, appears to aggregate to 293. Similarly, within the section dedicated to documenting pandemic-related experiences within departments, the sum of responses for each individual item converges to 284. It is worth highlighting that the cumulative tally for the topmost row of Table 3, pertaining to "Investigators, Research staff, and Others," ultimately tallies up to 293. The presence of these incongruities demands earnest attention and resolution within the forthcoming revision of the manuscript.

Furthermore, the inclusion of "Other additional support" seems to contribute minimal informational value and could potentially be omitted to enhance the article's clarity. Additionally, to enrich the reader's understanding, it would be beneficial to incorporate a footnote in Table 3 that elucidates the scale used for questions wherein participants evaluated their experiences or the clinical response of their organization to COVID-19. This addition would provide a valuable context for interpreting the responses.

Bias is a significant consideration in this study's limitations. While the discussion touches upon the external validity of the results, which is appropriate given the study sample's characteristics, there is a need for a more comprehensive examination of internal inter-validity. Notably, a substantial portion of the sample is drawn from Research Coordinators. It is important to elucidate how the authors account for this outcome. This prompts the question of whether the perspectives of this group might be disproportionately represented, potentially skewing the study's findings.

Regrettably, no information is furnished regarding the composition of PETAL Network collaborators. The absence of such data prevents a comprehensive understanding of potential biases originating from the collaboration's makeup. Likewise, most participants hailed from teaching university hospitals, but no information is disclosed regarding the types of hospitals within the PETAL Network.

The authors indicate that the questionnaire was administered by the PETAL Network’s Clinical Coordination Center. This raises concerns about the potential influence of this administering entity on participants' responses. The nature of the administrator-participant relationship could potentially impact participants' candor or responses, which warrants consideration in evaluating the study's internal validity.

In summary, while the study acknowledges external validity limitations, the study would greatly benefit from an in-depth exploration of internal inter-validity, addressing the potential biases stemming from the overrepresentation of Research Coordinators, the composition of PETAL Network collaborators, the hospital types within the PETAL Network, and the influence of the administering entity on participant responses. Such an analysis would enhance the study's overall rigor and contribute to a more nuanced interpretation of the results.

Finally, referring to Table 3, it appears that a correction is necessary for the p-value mentioned in the discussion section on page 11, at line 280.

 

 

 

 

 

 

Author Response

Please see the attachment:

 

Comments to the articles: Research staff COVID-19 pandemic survey-results from the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network

1)The authors undertook a study that delved into the repercussions of the pandemic on scientific medical research, a realm of inquiry that holds pivotal significance. While their findings offer intriguing insights, it is crucial to deliberate thoughtfully on several matters embedded within the methodology and results sections. Notably, the study garnered a response rate of 37.7%, a statistic that merits further commentary for context. Discrepancies have emerged concerning the reported count of survey participants, which was specified as 277 in both the materials and methods as well as the results sections. However, upon closer examination, a misalignment becomes apparent between these figures and the numerical values depicted in the accompanying tables. To illustrate, the data tabulated in Table 2, elucidating participants' responses to the initial survey query, appears to aggregate to 293. Similarly, within the section dedicated to documenting pandemic-related experiences within departments, the sum of responses for each individual item converges to 284. It is worth highlighting that the cumulative tally for the topmost row of Table 3, pertaining to "Investigators, Research staff, and Others," ultimately tallies up to 293. The presence of these incongruities demands earnest attention and resolution within the forthcoming revision of the manuscript.

Thank you for your helpful comments. We provided additional information regarding inclusion criteria and enrollment and how survey responses were counted in hopes to provide additional information how these numbers are counted from the responses.

The final survey included 37 questions (Supplement 1) and was distributed via email with individualized REDCap links from September 29, 2020, through December 12, 2020, by the PETAL Network’s Clinical Coordinating Center. Included were all research personnel that were listed as active within the PETAL network. To be listed active members of the network, regulatory documentation regarding research training, resume and familiarity with the network studies needed to be provided. An active PETAL network member would have an e-mail address stored within the network. Members of the PETAL network include but are not limited to research staff (i.e., research coordinators, research assistants and research associates), investigators (i.e., principal investigators, sub-principal investigators, and co-principal investigators), and other ancillary staff (pharmacists, regulatory coordinators, and statisticians) with a target population of N = 740.

3.1. Demographics

A total of 740 emails with survey links were sent out to the PETAL members (Figure 2). While 14 e-mails were returned, local sites identified 8 additional possible participants that were added to the survey leading to a survey audience reached of 734. Three-hundred-five PETAL members opened the survey link, and 277 members completed the survey, yielding a survey completion response rate of 37.7% (Figure 2).

Table 1 total N contact has been corrected to 734 to align with the text and the flow diagram (Figure 2.)

Additionally, the response rate of 37.7 % may have been related to the fact that the members of the research network (PETAL) work closely together and research on each level of participation is fostered and encouraged. The response rate may appear high, however other articles cited for the project looking at the impact on medical residents gained similar response rates when applied to a close peer group of survey takers:

            Abati, E.; Nelva Stellio, L.; Manini, A.; Moroni, F.; Azzalini, L.; Vilca, L.M. A cross-sectional survey study of the impact of COVID-19 pandemic on the training and quality of life of Italian medical residents in the Lombardy region. Ann Med 2022, 54, 2326-2339, doi:10.1080/07853890.2022.2105392.

Cross sectional survey distributed 01 June 2020 to 31 July 2020: 1564 residents enrolled at 4 Univesrities in Northern Italy, Completed survey by 498 residents, response rate of 30.3 %.

 

Khan, R.; Tandon, P.; Scaffidi, M.A.; Bishay, K.; Pawlak, K.M.; Kral, J.; Amin, S.; Bilal, M.; Lui, R.N.; Sandhu, D.S.; et al. COVID-19 and Canadian Gastroenterology Trainees. J Can Assoc Gastroenterol 2021, 4, 156-162, doi:10.1093/jcag/gwaa034.

Thirty-four Canadian trainees completed the survey. With approximately 87 fourth- and fifth-year gastroenterology trainees in Canada, based on the 2018 to 2019 Canadian Postgraduate MD Education Registry Specialty Report (8), the response rate was 39%.

 

 

Goldman, C.; Pradere, B.; Mete, M.; Talso, M.; Bernardino, R.; Campi, R.; Marchalik, D. A Multinational Study of The Impact of Covid-19 On Urologic Surgery Residency and Wellbeing. Urology 2022, 166, 87-94, doi:10.1016/j.urology.2022.01.069.

This survey had a broader multinational audience of urology residents in Italy, France, Portugal, and the United States had lower response rates US 41 of 243 (16.9%), France 85 of 420 (14.4%), Italy 83 of 589 (14.1%), Portugal 14 of 85 (16.5%) with an overall response rate of 16.7%. One could specultate that the response rate may be lower as the interest of the survey administraters may have not been clear to the survey audience.

            All these cited surveys were conducted during a similar time during 2020-2021.

Furthermore, the inclusion of "Other additional support" seems to contribute minimal informational value and could potentially be omitted to enhance the articles . Additionally, to enrich the reader's understanding, it would be beneficial to incorporate a footnote in Table 3 that elucidates the scale used for questions wherein participants evaluated their experiences or the clinical response of their organization to COVID-19. This addition would provide a valuable context for interpreting the responses.

See the response to the 1^st item.

We clarified enrollment and created a Supplemental table to explain the terms and the roles of these research team members. Based on the Petal network composition the group called “Others” is equally important as it includes important section of the research group comprising of pharmacist, administrative staff whose workflow was also impacted by ongoing Pandemic which have to address some of the logistical challenges faced by the research team members interacting with patients and clinical staff.

Page 6 line 176-179 and 186-189 does state the scale of responses, but we agree to quote that in the table footer as well.

Add: Under Table 3: Survey takers were asked to

Bias is a significant consideration in this study's limitations. While the discussion touches upon the external validity of the results, which is appropriate given the study sample's characteristics, there is a need for a more comprehensive examination of internal inter-validity. Notably, a substantial portion of the sample is drawn from Research Coordinators. It is important to elucidate how the authors account for this outcome. This prompts the question of whether the perspectives of this group might be disproportionately represented, potentially skewing the study's findings.

Regrettably, no information is furnished regarding the composition of PETAL Network collaborators. The absence of such data prevents a comprehensive understanding of potential biases originating from the collaboration's makeup. Likewise, most participants hailed from teaching university hospitals, but no information is disclosed regarding the types of hospitals within the PETAL Network.

Thank you for highlighting this issue. We added information regarding the PETAL network within the text. An additional supplemental table describes the responsibilities of study team members Supplemental Table 3.

“This research network funded by the National Heart, Lung, and Blood Institute (NHLBI) is called “Prevention and Early Treatment of Acute Lung Injury” or short PETAL network. The focus of this network is to develop and conduct randomized controlled clinical trials to prevent, treat and improve the outcomes of patients with or at risk for the development of acute lung injury and acute respiratory distress syndrome. [19] Prior to the start of the COVID-19 pandemic this network successfully had enrolled more than 8,000 patients into clinical trials often patients with critical illness in need for critical care unit admissions with respiratory illness such as the ROSE [20] and VIOLET studies [21]. This network responded quickly to address research questions related to the COVID-19 pandemic with initiation of trials such as ORCHID[22,23] and CORAL[24], but also aligned itself with other international networks to participate in the worldwide research response efforts with the ACTIV[25-29] research projects while continuing some one of the ongoing research projects with the CLOVERS study[30,31].

Added table for supplement as follows to explain the terms and the responsibilities.

Role in the PETAL network	Assigned Responsibilities
Research Staff: Research Coordinator Research Assistant Research Associate	Overlapping responsibilities for o   Screening of possible patients for enrollment o   Coordination of enrollment between research and clinical teams o   Consent documentation o   Biological sample collection and processing o   Documentation of research activities o   Data collection o   Assurance of Research Compliance
Investigators: Study Principal Investigator Study Sub/ Co Investigator	Overlapping responsibilities for o   Study planning and scientific oversight o   Procurement of funding o   Screening of possible patients for enrollment o   Coordination of enrollment between research and clinical teams o   Consent documentation o   Assurance of research compliance for all study team members/ study oversight
Ancillary Research Staff: Pharmacists Regulatory Coordinators Study Statistician	Pharmacists : Study drug related oversight and dispensing. Regulatory Coordinators : Regulatory documentation and research compliance oversight. Involved in coordinator level feedback on research activities for study design purposes. Management of study funding. Statistician: Oversight of research data.

The results section highlights some changes in responsibility with new study assignments.

 

The authors indicate that the questionnaire was administered by the PETAL Network’s Clinical Coordination Center. This raises concerns about the potential influence of this administering entity on participants' responses. The nature of the administrator-participant relationship could potentially impact participants' candor or responses, which warrants consideration in evaluating the study's internal validity.

Thank you for this comment, very important concern. We agree that our study manuscript cannot explain internal validity . However, Investigators have used due diligence in sending survey link to all the eligible PETAL network members. All survey takers could only take the survey once. To increase the response rate genuine reminders were send out to complete the survey as mentioned in material and method section.

In summary, while the study acknowledges external validity limitations, the study would greatly benefit from an in-depth exploration of internal inter-validity, addressing the potential biases stemming from the overrepresentation of Research Coordinators, the composition of PETAL Network collaborators, the hospital types within the PETAL Network, and the influence of the administering entity on participant responses. Such an analysis would enhance the study's overall rigor and contribute to a more nuanced interpretation of the results.

 

Finally, referring to Table 3, it appears that a correction is necessary for the p-value mentioned in the discussion section on page 11, at line 280.

Thank you for the in-depth review, we will correct the typo error in the body of the manuscript to reflect the correct p value of 0.017 instead of 0.17.

 

 

Thank you for your time helping us improve the manuscript by reviewing and providing valuable feedback. We sincerely appreciate it.

Author Response File: Author Response.pdf

Reviewer 3 Report

Dear authors, first of all I would like to congratulate you on this work. I think that the topic is really interesting, that it is original and so far the aspect of COVID and its impact on researchers, research staff and on non-COVID research as a whole has not been examined much.

The choice of theme is excellent. Moreover, as for the quality of the work itself, methodology, presentation, scientific style, I think that the work is on a  high level.

However, there are a few things that I did not understand very well and I need your interpretation and where I feel correction is needed in order for the paper to be of sufficient quality to be accepted for publication.

Introduction.

1. I believe that the introduction is short and that it should be enriched with a few more references from the literature that would be more significantly connected and from which the examined problem of self-employment would stand out more clearly.

2. I believe that hypotheses must be stated in the introduction, and they are missing in this paper. I consider the text between Lines 75-78 to be superfluous in the context of the introduction. The possible benefits of the work and its impact on scientific knowledge are usually given within the conclusion section.

Material and Methods.

1. I have a question about the methodology of forming the research group. The criteria for inclusion/exclusion from the study are not clear. In Line 133, and in Figure 2 it is shown that 740/734 email requests for participation in the PETAL study were sent to PETAL members. Does PETAL include only 740/734 members? How exactly were they chosen? Do they represent only a sample or is it the entire population? I believe that this is the main objection because it is not specified in the paper who and in what way enters the framework of the examined group. Also, it is not explained in the text who exactly is research staff, what is the role of "investigators (i.e., principal investigators, sub-principal investigators, and co-principal investigators), and other ancillary staff" - Line 113-115. A non-Western audience may not understand how the research system works in your country. I think it's especially important because later you compare the results of the impact of COVID on what I understand very well the poor researchers and the lower staff. Explain to us the scope of work of both so that we can have a clearer picture of how their pre-COVID work was affected by COVID, which I believe is the main topic of the paper.

Results.

The results are presented in a transparent, efficient and economical way. I consider this part of the work to be faultless.

 

Another significant objection is that the 4th section, which is Discussion, is nowhere to be seen in the text. There is no subtitle. Also, the content is problematic too.

If 227 lines are considered to start the discussion, I also think it is too short. There are not enough references and comparisons with similar results and similar aspects in relation to other similar researches. I believe that in that text the statements from the results are repeated quite often, and they are not connected adequately and are not adequately commented on in relation to other results from other similar studies. This paragraph changes in my opinion, because the hypotheses are not clearly formulated in the introduction and then in the discussion it is not clear what is proven and what is disproved. Expanding the discussion and directing it in relation to the researcher's hypotheses is necessary, in my opinion.

Conclusion.

If you follow some of my advice, then the Conclusion section itself will have to be changed, expanded and the conclusions will be more clearly derived from the results.

Literature.

I also think that it is necessary to expand the introduction and discussion sections a little more by enriching them with more literature references that would either support the hypotheses or confront them. The literature must be enriched with research from other parts of the world outside the USA.

 

Regarding the quality and level of the English language used in the text, I have no objection according to my competence.

 

Dear authors, once again I wish you the best of luck and that you will eventually publish this very good work.

Author Response

Please see the attachment.

Author Response File: Author Response.pdf