A novel scoring system to predict the requirement for surgical intervention in victims of motor vehicle crashes: Development and validation using independent cohorts

Ryo Yamamoto; Tomohiro Kurihara; Junichi Sasaki

doi:10.1371/journal.pone.0226282

Peer Review History

Original SubmissionSeptember 2, 2019
14 Nov 2019 Decision Letter - Itamar Ashkenazi, Editor PONE-D-19-24717 A novel scoring system to predict the requirement for surgical intervention in victims of motor vehicle crashes: Development and validation using independent cohorts PLOS ONE Dear Dr. YAMAMOTO, 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 Dec 29 2019 11:59PM. 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 see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. Additional Editor Comments (if provided): Dear Author, Three very experienced and distinguished trauma physicians reviewed your manuscript. Their recommendations on whether to accept or not to accept this manuscript for publication were far from being homogenous. Attached to this letter below, you will find their comments that need to be addressed. Among the criticism raised, there is one major limitation I wish to discuss. The score significantly relies on data that was measured upon admission of the patients to the emergency department (3 of 6 variables accounting for 6 of 9 potential points). You were forced to make this decision since prehospital vital-signs were missing in many of your study subjects. This gravely affects the validity of your results. One cannot assume that the measurements upon admission to the hospital are similar to prehospital measurements made at the scene of injury. Since the score aims to guide the prehospital team as to where to transport the trauma victim, this deficiency is of utmost importance. Still, it does not rule out this study. This deficit, however, should be discussed thoroughly as a limitation at the appropriate place within the manuscript. Sincerely, Itamar Ashkenazi, Academic Editor [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 ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: I Don't Know ****** 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 ****** 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: the authors have attempted to create a prehospital score that will help predict who needs "emergency surgery" using data from a registry. I understand the need, and agree, however I have several significant concerns. 1. emergency surgery is broader than thoracotomy or laparotomy. For instance why isnt major vascular repair or craineotomy considered emergency surgery? 2. the use of 24 hours to define multiple time points in the paper is a major problem. It likely springs from using a registry, and times within 60 minutes of arrival may not be available. emergency surgery performed 18 hours after injury is likely not important to survival. These times after injury have been explored by multiple authors. 3. the lack of prehospital vital signs in a prehospital score is really an issue. Reviewer #2: Thanks for submitting you score derivation study. The methodology and sample size calculation are noted. The grammar is generally good - there are minor English errors that do not really detract from the message. The statistical analysis seems in order and the message is clear - the predicted and actual rates were clearly similar. This is a good study and results in a practical score that should now be externally validated. Reviewer #3: This is an interesting study which probably has some local relevance. The broader issue is whether this score will be helpful. Clearly at present trauma patients are taken to hospitals without surgical capabilities. This is hardly every appropriate and I presume this happens because the prehospital resources do not have the capability to take trauma patients to hospitals with surgical capabilities. In that context, will knowing that they are more likely to need surgery be helpful? Some specific comments are Language such as "trauma care should imbibe the philosophy of hemostasis" might be appropriate in a novel but is probably too flowery for a scientific paper The outcome measure used (which is a good one) is usually described as "days alive and out of hospital (DAOH) Why was 80yo chosen as the cut score for age Is it helpful to use vital signs on arrival when clearly it would be better if the patients did not arrive at hospitals without surgical capability. If poor or missing data is an issue in relation to prehospital vital signs would that not be an important issue to address? It looks like the likelihood of needing surgery is 5% with a score of 3, 7.5% with 4, 15% with 5, 20% with 6, 25% with 7 and 40% with 8. What is the cut point which the authors feel justifies transport to a surgical facility? ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). 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Revision 1
19 Nov 2019 Author Response Editor Author Response: Thank you and your reviewers for the insightful comments and the opportunity to resubmit our manuscript. We have revised the manuscript following your comments. Please see our specific responses below. 1. The score significantly relies on data that was measured upon admission of the patients to the emergency department (3 of 6 variables accounting for 6 of 9 potential points). You were forced to make this decision since prehospital vital-signs were missing in many of your study subjects. This gravely affects the validity of your results. One cannot assume that the measurements upon admission to the hospital are similar to prehospital measurements made at the scene of injury. Since the score aims to guide the prehospital team as to where to transport the trauma victim, this deficiency is of utmost importance. Still, it does not rule out this study. This deficit, however, should be discussed thoroughly as a limitation at the appropriate place within the manuscript. Author Response: Thank you for bringing this to our attention. We agree with your comments that not including prehospital vital signs would be a significant limitation. To clarify this limitation, the text in lines 334-340 in p.21 in Discussion have been revised to the following: “Another limitation is the fact that prehospital vital signs were not incorporated into the initial regression model as potential predictors due to high number of missing data. As the vital sings upon hospital arrival are not always similar to prehospital measurements made at the scene of injury, this might gravely affect the validity of the SIM score to use as a prehospital triage algorithm. Although the significant correlations between prehospital vital signs and those upon hospital arrival were identified, the SIM score would only holds promise for the effective determination of early transfer or activation of surgical subspecialties after hospital arrival until the score is externally validated with other data sets in future studies.” Reviewer 1 Author Response: Thank you for your attention to detail and requests for clarification. We are grateful for your insightful comments and the valuable suggestions on our manuscript. We have revised the manuscript following your comments. Please see our specific responses below. 1. Emergency surgery is broader than thoracotomy or laparotomy. For instance why isn’t major vascular repair or craniotomy considered emergency surgery? Author Response: Thank you for pointing this out to us. Our writing was unclear. We didn’t consider craniotomy and vascular repair as emergency surgical intervention because some anatomic and physiologic criteria, such as Glasgow Coma Scale (GCS) and massive bleeding and/or distal circulatory deficit in extremities have been reported to be able to predict the need for such surgical interventions in previous studies. We added the references and the text have been revised to the following: In line 66 in p.4 in Introduction, “Although several triage algorithms using mechanism of injury (MOI) and/or anatomic and physiologic criteria successfully identified patients who needed treatment at high-level trauma centres [11-13], they have not been validated to predict the need for emergency surgical intervention, particularly for laparotomy and thoracotomy.” In lines 106-110 in p.6 in Methods, “Craniotomy and vascular surgery in extremities were not included as the emergency surgical intervention in this study because some anatomic and physiologic criteria, such as Glasgow Coma Scale (GCS) and massive bleeding and/or distal circulatory deficit in extremities have been reported to be able to predict the need for such surgical interventions [16,17].” 2. The use of 24 hours to define multiple time points in the paper is a major problem. It likely springs from using a registry, and times within 60 minutes of arrival may not be available. emergency surgery performed 18 hours after injury is likely not important to survival. These times after injury have been explored by multiple authors Author Response: Thank you for this important feedback. We agree with your comments and understand that the SIM score would not exclusively predict immediate hemostatic intervention for exsanguinating injury and would not be associated with clinical outcomes. To clarify this limitation, we added a paragraph in lines 341-347 in pp.21-22 in Discussion as follows: “Furthermore, we defined several variables as emergency procedures when they were performed within 24 hours after hospital arrival. As patients who needed surgical intervention several hours after arrival might not have had fatal haemorrhage, the SIM score would not exclusively predict immediate hemostatic intervention for exsanguinating injury. Whether the SIM score would predict the need for resuscitative hemostatic procedure, as well as whether applying the score would introduce favorable clinical outcome, should be further examined.” 3. The lack of prehospital vital signs in a prehospital score is really an issue. Author Response: Thank you for bringing this to our attention. We agree with your comments that not including prehospital vital signs would be a significant limitation. To clarify this limitation, the text in lines 334-340 in p.21 in Discussion have been revised to the following: “Another limitation is the fact that prehospital vital signs were not incorporated into the initial regression model as potential predictors due to high number of missing data. As the vital sings upon hospital arrival are not always similar to prehospital measurements made at the scene of injury, this might gravely affect the validity of the SIM score to use as a prehospital triage algorithm. Although the significant correlations between prehospital vital signs and those upon hospital arrival were identified, the SIM score would only holds promise for the effective determination of early transfer or activation of surgical subspecialties after hospital arrival until the score is externally validated with other data sets in future studies.” Reviewer 2 Author Response: We are grateful for your comments on our manuscript. We will validate the SIM score externally using other dataset in a future study. Reviewer 3 Author Response: Thank you for your valuable comments on our manuscript and requests for clarification. We have revised the manuscript following your comments. Please see our specific responses below. 1. The broader issue is whether this score will be helpful. Clearly at present trauma patients are taken to hospitals without surgical capabilities. This is hardly every appropriate and I presume this happens because the prehospital resources do not have the capability to take trauma patients to hospitals with surgical capabilities. In that context, will knowing that they are more likely to need surgery be helpful? Author Response: Thank you for bringing this to our attention. We think the score needs to be externally validated to use as a prehospital triage algorithm, particularly outside the study setting. To clarify that the current study would only conclude the SIM score would help deciding to transfer patients to other hospitals with surgical capabilities, the text in Discussion have been revised to the following: In lines 316-317 in p.20, “the SIM score can be implemented even in non-designated trauma centres to where patients with less severe injuries are transported, and would help deciding to transfer patients to other hospitals with surgical capabilities.” In lines 337-340 in p.21, “the SIM score would only holds promise for the effective determination of early transfer or activation of surgical subspecialties after hospital arrival until the score is externally validated with other data sets in future studies.” 2. Language such as "trauma care should imbibe the philosophy of hemostasis" might be appropriate in a novel but is probably too flowery for a scientific paper. Author Response: Thank you, this has been corrected as follows. In line 60 in p.4 in Introduction, “Considering that timely surgical interventions improve outcomes for trauma victims following MVCs, the strategy for trauma care should include early hemostasis, decontamination of peritoneal infection, and early control of digestive fluid leakage, particularly outside the well-designed trauma system or designated trauma centres.” 3. The outcome measure used (which is a good one) is usually described as "days alive and out of hospital (DAOH). Author Response: Thank you for pointing this out to us. After discussing among authors, we decided to use “hospital-free days”. However, we added “days alive and out of hospital” to explain the hospital free days. The text was added in line 120 in p.7 in Methods as follows: “The primary outcome was the requirement of emergency surgery. Secondary outcomes included emergency hemostatic surgery, emergency hemostatic IVR, survival to discharge, and hospital-free days, also known as days alive and out of hospital, till day 90 after injury (combination of in-hospital death and length of hospital stay defined as the number of days alive and out of the hospital).” 4. Why was 80yo chosen as the cut score for age? Author Response: Thank you for the valuable comment. We used the cut-off to define “old-old” elderly population because some previous studies suggested old-old patients aged ≥80 years had different outcomes. We added a reference (#23) in line 145 in p.8 in Methods as follows: “Owing to clinical plausibility and practicality, age and vital signs were transformed to binary variables as follows: age (< 80 or ≥80 years) [23], GCS(≤13 or ≥14), systolic blood pressure (sBP; <110 or ≥110 mmHg) [22], heart rate (HR; <100 or ≥100 bpm), respiratory rate (RR; <22 or ≥22 /min).” 5. Is it helpful to use vital signs on arrival when clearly it would be better if the patients did not arrive at hospitals without surgical capability. If poor or missing data is an issue in relation to prehospital vital signs would that not be an important issue to address? Author Response: Thank you for bringing this to our attention. We agree with your comments that not including prehospital vital signs would be a significant limitation. To clarify this limitation, the text in lines 334-340 in p.21 in Discussion have been revised to the following: “Another limitation is the fact that prehospital vital signs were not incorporated into the initial regression model as potential predictors due to high number of missing data. As the vital sings upon hospital arrival are not always similar to prehospital measurements made at the scene of injury, this might gravely affect the validity of the SIM score to use as a prehospital triage algorithm. Although the significant correlations between prehospital vital signs and those upon hospital arrival were identified, the SIM score would only holds promise for the effective determination of early transfer or activation of surgical subspecialties after hospital arrival until the score is externally validated with other data sets in future studies.” 6. It looks like the likelihood of needing surgery is 5% with a score of 3, 7.5% with 4, 15% with 5, 20% with 6, 25% with 7 and 40% with 8. What is the cut point which the authors feel justifies transport to a surgical facility? Author Response: Thank you for your thoughts about this important component of our manuscript. Although an appropriate cut-off value for the SIM score would differ depending on the trauma system, we believe 3 would be low enough cut-off value because it suggests < 5% of possibility of the need for emergency surgical intervention. We added sentences in lines 300-302 in p.19 in Discussion as follows: “Although an appropriate cut-off value for the SIM score would differ depending on the trauma system, it should be noted that less than 3 of the SIM score suggests < 5% of possibility of the need for emergency surgical intervention.” Attachments Attachment Submitted filename: MVC_SIM_response_RY111619.docx https://doi.org/10.1371/journal.pone.0226282.r002
25 Nov 2019 Decision Letter - Itamar Ashkenazi, Editor A novel scoring system to predict the requirement for surgical intervention in victims of motor vehicle crashes: Development and validation using independent cohorts PONE-D-19-24717R1 Dear Dr. YAMAMOTO, Thank you for addressing the reviewers' comments. 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, Itamar Ashkenazi Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0226282.r003
Formally Accepted
2 Dec 2019 Acceptance Letter - Itamar Ashkenazi, Editor PONE-D-19-24717R1 A novel scoring system to predict the requirement for surgical intervention in victims of motor vehicle crashes: Development and validation using independent cohorts Dear Dr. YAMAMOTO: 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 Dr. Itamar Ashkenazi Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0226282.r004

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