A simulation based difficult conversations intervention for neonatal intensive care unit nurse practitioners: A randomized controlled trial

Roberta Bowen; Kate M. Lally; Francine R. Pingitore; Richard Tucker; Elisabeth C. McGowan; Beatrice E. Lechner

doi:10.1371/journal.pone.0229895

Peer Review History

Original SubmissionDecember 6, 2019
20 Jan 2020 Decision Letter - Karen-Leigh Edward, Editor PONE-D-19-33859 A simulation based difficult conversations intervention for NICU nurse practitioners: A randomized controlled trial PLOS ONE Dear Dr Lechner 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. We would appreciate receiving your revised manuscript by 13/04/2020. When you are 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. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. 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Please note while forming your response, if your article is accepted, you may have the opportunity to make the peer review history publicly available. The record will include editor decision letters (with reviews) and your responses to reviewer comments. If eligible, we will contact you to opt in or out. We look forward to receiving your revised manuscript. Kind regards, Karen-Leigh Edward Academic Editor PLOS ONE 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 http://www.journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and http://www.journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf [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: Partly Reviewer #3: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No Reviewer #2: Yes Reviewer #3: 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: No Reviewer #3: 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 ****** 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: First of all, thanks for giving me the possibility to review this interesting article. The authors intend to evaluate whether a simulation based Difficult Conversations Workshop for neonatal nurse practitioners leads to improved skills in conducting difficult conversations. The topic is relevant and current for nursing practice in the context of NICU. The article is well written. However, in my opinion, there are some considerations that authors should consider so that the article can be published. On the one hand, the sample size is too small for results support the conclusions and to be able to make inference. Should Authors consider it as a pilot study? On the other hand, the study has another important limitation related to the design. Authors state that it is a randomized and controlled study with a control and intervention groups . However, test scenarios are only measured once in each group, and at different times. This does not allow to know and compare the baseline situation of both groups, nor if there are intragroup differences. I feel that authors did not evaluate the effectiveness of the Workshop through the evaluators, but the structure of the intervention ¿test scenario before or after ?. Regarding the evaluation tool, authors could explain how it was created or developed (Expert consensus?) Another aspect to consider is that I think the introduction is too concise. The authors can go a little deeper into other intervention studies with the same objective, as well as justify why they conduct the workshop in their context. In addition, I believe that they should present a little more about the context (USA) where the study is being carried out since nursing is not the same throughout the world and may not be well understood. Finally, I believe that the writing of the Results can improve. The authors section Results in many subsections and star each with a kind of conclusion. Some subsections only continue one line. I think it would be better to regroup the results in less subsections to facilitate reading. I hope these comments are helpful. I encourage you to continue your work. Best regards. Reviewer #2: The difficult workshop time period for the lecture and simulation is not well explained. The communication skill development needs adequate time but it is not clear. Please revise The workshop includes lecture and simulation but the discussion was focused on only simulation. Please review The conclusion is not clear and it doesn't go with the objective of the study.Please ammend Reviewer #3: Generally, the manuscript is well written with a good protocol. I will strongly recommend authors to look thoroughly comments and incorporate them. Describe abbreviation fully when you are using them for the first time. Overall comments Generally, the manuscrpit is well written with a good protocol. I will strongly recommend authors to look at the following comments and incorporate them. Describe abbreviation fully when you are using them for the first time. Introduction The introduction part doesn’t show gap. You need to show the gap between existing situation and what the situation should be. Also, show the severity of the problem on the parents and health care services. Materials and Methods Clearly state your measurements. Describe also reliablity and validity of your measurements. Conclusion Describe the limitations of your study under this part. ****** 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: No Reviewer #2: Yes: Mikiyas Amare Getu Reviewer #3: No [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 to be viewed.] 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 us at figures@plos.org. Please note that Supporting Information files do not need this step. Attachments Attachment Submitted filename: Reviwers comments.docx https://doi.org/10.1371/journal.pone.0229895.r001
Revision 1
12 Feb 2020 Author Response Dr. Joerg Heber Editor in Chief PLOS One January 30, 2020 Dear Dr. Heber, We are pleased that you have allowed us to resubmit a revised version of our manuscript “A simulation based difficult conversations intervention for NICU nurse practitioners: A randomized controlled trial” to PLOS One for consideration for publication. We thank the reviewers for their encouraging comments and their thorough and helpful critique. We have carefully considered their comments and have made changes based on them that we believe improve the overall manuscript. Most noteworthy is the expansion of the Introduction. Please find below a point-by-point response to the Reviewer’s critique. Reviewer 1 Critique 1: “…the sample size is too small for results support the conclusions and to be able to make inference. Should Authors consider it as a pilot study?” The description of this study as a pilot study would not be appropriate given the definition of a pilot study as a study that is performed to test the methods and other practical aspects of a study (van Teijlingen and Hundley 2001). While the sample size is smaller than we would have liked, it is large enough that appropriate statistical analysis could be performed. Additionally, studies such as this are very difficult to do given the significant time commitment that is demanded of each subject to take part in the study, especially as the subjects are professionals with a clinical workload. Thus, there is an understandable paucity of this type of literature, making this study and our findings especially valuable to the neonatal research community. Critique 2: “Authors state that it is a randomized and controlled study with a control and intervention groups. However, test scenarios are only measured once in each group, and at different times. This does not allow to know and compare the baseline situation of both groups, nor if there are intragroup differences. I feel that authors did not evaluate the effectiveness of the Workshop through the evaluators, but the structure of the intervention ¿test scenario before or after?” The Reviewer’s observation that the baseline situation in both groups and intragroup differences were not measured is correct. In an ideal experimental structure, one would have a Test Scenario for both the control and intervention group, in order to compare the baseline. Then, the control group would immediately participate in a second Test Scenario, and the intervention group would take part in the Difficult Conversations Workshop and then participate in the second Test Scenario. However, in a real world clinical setting, this is not a practicable structure for two reasons. First, the study volunteers were busy professionals who were donating their time to this research study. It would have been ethically inappropriate to not allow the control group to also benefit from the teaching opportunity provided by the workshop. Second, this structure would have taken up even more of the donated clinical time of the intervention group. The study team felt that the minimal additional benefit of having a baseline comparison as well as the lack of a research advantage to not allowing the control group to participate in the workshop after they had completed their role as controls didn’t warrant using this structure for the study. Evaluating for intragroup (individual) differences was not a stated objective of the study and would not have been helpful in answering the study question of whether the Difficult Conversations Workshop improves communication skills. As the Reviewer correctly states, we evaluated the difference between “test scenario before or after”, which means, in other words, “test scenario without completed Workshop and test scenario with completed Workshop”, thus evaluating the impact that having taken part in the Workshop had on test scenario performance, which was the stated objective of the study. We have explained this experimental structure in the Materials and Methods Study structure section (page 5, lines 101-113) as well as in Figure 1. Critique 3: “Regarding the evaluation tool, authors could explain how it was created or developed (Expert consensus?)” Thank you for pointing out that we had not adequately described the methods for the development of the tools used. We explained the steps taken in the manuscript (page 7, line 144-147). Critique 4: “Another aspect to consider is that I think the introduction is too concise. The authors can go a little deeper into other intervention studies with the same objective, as well as justify why they conduct the workshop in their context. In addition, I believe that they should present a little more about the context (USA) where the study is being carried out since nursing is not the same throughout the world and may not be well understood.” We thank the Reviewer for drawing our attention to our oversight regarding the context of nurse practitioners in the US. We have added this context to the Introduction as well as expanding on similar studies in the literature both in medicine in general and in neonatology in particular (page 4, lines 54-58 and 59-64). Critique 5: “Finally, I believe that the writing of the Results can improve. The authors section Results in many subsections and star each with a kind of conclusion. Some subsections only continue one line. I think it would be better to regroup the results in less subsections to facilitate reading.” We have reorganized the Results section into fewer subsections to facilitate the flow of the section. Reviewer 2 Critique 1: “The difficult workshop time period for the lecture and simulation is not well explained. The communication skill development needs adequate time but it is not clear.” Thank you for pointing out this oversight. We have explained the timeline of the lecture and simulation aspects of the workshop as well as the entire workshop timeline in the manuscript (page 6, lines 118-126). Critique 2: “The workshop includes lecture and simulation but the discussion was focused on only simulation. Please review.” We thank the Reviewer for pointing out that we did not mention the lecture portion of the workshop in our discussion. We have revised the Discussion to clarify that the workshop consisted of both components (page 5, line 77; pages 12-17, lines 231-325). Critique 3: “The conclusion is not clear and it doesn't go with the objective of the study. Please amend.” We have revised the conclusions both in the Abstract and in the Discussion to align with the stated hypothesis (page 3, lines 46-48; page 17, lines 325-328). Reviewer 3 Critique 1: “Describe abbreviation fully when you are using them for the first time.” We have clarified abbreviations when using them for the first time in the manuscript. Critique 2: “The introduction part doesn’t show gap. You need to show the gap between existing situation and what the situation should be. Also, show the severity of the problem on the parents and health care services.” We have added literature on what is known and what is not known about the subject and where the gap is, as well as discussing the importance of communication skills in the NICU given the significant mental health. Issues parents face given the difficulty of having an infant in the NICU (page 4, lines 59-64 and 72-74). Critique 3: “Clearly state your measurements. Describe also reliability and validity of your measurements.” We expanded on the explanation of the measurements under (page 7, line 141-147). The reliability was tested via interrater reliability testing and found to be appropriate (page 9, lines 165-167). Validity was determined as described under (page 7, lines 144-147). In brief, the instruments were internally developed specifically for this purpose and items chosen resulted from a literature search and expert consensus on their face validity. Critique 4: “Conclusion: Describe the limitations of your study under this part.” The limitations of the study are described between page 15, line 292 and page 16, line 314. We would like to thank the Reviewers again. We hope you will find the revised manuscript acceptable for publication in PLOS One. Sincerely, Beatrice Lechner MD Attachments Attachment Submitted filename: Response to Reviewers.doc https://doi.org/10.1371/journal.pone.0229895.r002
19 Feb 2020 Decision Letter - Karen-Leigh Edward, Editor A simulation based difficult conversations intervention for neonatal intensive care unit nurse practitioners: A randomized controlled trial PONE-D-19-33859R1 Dear Dr. Lechner, We are pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it complies with all outstanding technical requirements. Within one week, you will receive an e-mail containing information on the amendments required prior to publication. When all required modifications have been addressed, you will receive a formal acceptance letter and your manuscript will proceed to our production department and be scheduled for publication. Shortly after the formal acceptance letter is sent, an invoice for payment will follow. To ensure an efficient production and billing process, please log into Editorial Manager at https://www.editorialmanager.com/pone/, click the "Update My Information" link at the top of the page, and update your user information. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to enable them to help maximize its impact. If they will be preparing press materials for this manuscript, you must inform our press team as soon as possible and no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. With kind regards, Karen-Leigh Edward Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0229895.r003
Formally Accepted
25 Feb 2020 Acceptance Letter - Karen-Leigh Edward, Editor PONE-D-19-33859R1 A simulation based difficult conversations intervention for neonatal intensive care unit nurse practitioners: A randomized controlled trial Dear Dr. Lechner: I am 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 notify them about your upcoming paper at this point, to enable them to help maximize its impact. If they will be preparing press materials for this manuscript, 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. For any other questions or concerns, please email plosone@plos.org. Thank you for submitting your work to PLOS ONE. With kind regards, PLOS ONE Editorial Office Staff on behalf of Professor Karen-Leigh Edward Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0229895.r004

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