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The Hidden Overlap Between Patient Group Means in Bariatric Randomized Controlled Trials
IF 1.8 3区 医学 Q2 SURGERY Pub Date : 2025-03-01 DOI: 10.1016/j.jss.2025.01.018
Sunny Kahlon BS , Jacob Parker BS , Joseph Sujka MD , Vic Velanovich MD

Introduction

Reliance on summary data such as averages may not fully represent the breadth of individual patient responses that occur within a randomized controlled trial. As a result, a large portion of reported patient outcomes may be reasonably expected regardless of the trial arm to which a study subject is assigned. This study aims to investigate the extent of results overlap that exists between interventions in bariatric randomized controlled trials, despite significant P values by analyzing differences in trial means and standard deviations (SDs).

Methods

A comprehensive literature review was conducted on bariatric RCTs from 2010 to 2023, sourced from PubMed, MEDLINE, Cochrane Library, and EMBASE. Bariatric surgery trials examining percent weight loss were selected due to the continuous nature of the data. The inclusion criteria for the data were outcomes reported as mean ± SD, and normally distributed. The data distributions for each study were visualized using histograms to assess overlaps in mean weight loss across different interventions. Using provided sample means and SDs from each selected randomized controlled trial, percentage of overlap between patient group distributions of each study was determined.

Results

Out of 27 initially identified RCTs, six were included. These showed significant overlap between means, based on P values, for different bariatric interventions. The mean percent overlap of patients across all interventions of the 6 studies was 84.58%, with a minimum of 68.42% and maximum of 98%. This indicates that across all studies, only an average of 15.42% of patients fell outside the overlapping distribution and could be considered to have a weight loss solely as a response to the specific treatment.

Conclusions

While means are essential for statistical analyses, it is crucial to examine deeper nuances in data to understand prior to assigning causation for an individual patient response. Such insights are pivotal in the era of evidence-based and precision medicine, ensuring that treatment decisions are tailored not just based on group averages but also considering the potential range of individual outcomes.
{"title":"The Hidden Overlap Between Patient Group Means in Bariatric Randomized Controlled Trials","authors":"Sunny Kahlon BS ,&nbsp;Jacob Parker BS ,&nbsp;Joseph Sujka MD ,&nbsp;Vic Velanovich MD","doi":"10.1016/j.jss.2025.01.018","DOIUrl":"10.1016/j.jss.2025.01.018","url":null,"abstract":"<div><h3>Introduction</h3><div>Reliance on summary data such as averages may not fully represent the breadth of individual patient responses that occur within a randomized controlled trial. As a result, a large portion of reported patient outcomes may be reasonably expected regardless of the trial arm to which a study subject is assigned. This study aims to investigate the extent of results overlap that exists between interventions in bariatric randomized controlled trials, despite significant <em>P</em> values by analyzing differences in trial means and standard deviations (SDs).</div></div><div><h3>Methods</h3><div>A comprehensive literature review was conducted on bariatric RCTs from 2010 to 2023, sourced from PubMed, MEDLINE, Cochrane Library, and EMBASE. Bariatric surgery trials examining percent weight loss were selected due to the continuous nature of the data. The inclusion criteria for the data were outcomes reported as mean ± SD, and normally distributed. The data distributions for each study were visualized using histograms to assess overlaps in mean weight loss across different interventions. Using provided sample means and SDs from each selected randomized controlled trial, percentage of overlap between patient group distributions of each study was determined.</div></div><div><h3>Results</h3><div>Out of 27 initially identified RCTs, six were included. These showed significant overlap between means, based on <em>P</em> values, for different bariatric interventions. The mean percent overlap of patients across all interventions of the 6 studies was 84.58%, with a minimum of 68.42% and maximum of 98%. This indicates that across all studies, only an average of 15.42% of patients fell outside the overlapping distribution and could be considered to have a weight loss solely as a response to the specific treatment.</div></div><div><h3>Conclusions</h3><div>While means are essential for statistical analyses, it is crucial to examine deeper nuances in data to understand prior to assigning causation for an individual patient response. Such insights are pivotal in the era of evidence-based and precision medicine, ensuring that treatment decisions are tailored not just based on group averages but also considering the potential range of individual outcomes.</div></div>","PeriodicalId":17030,"journal":{"name":"Journal of Surgical Research","volume":"307 ","pages":"Pages 139-147"},"PeriodicalIF":1.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143510158","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Short-Term Exposure to Ambient Particulate Matter Pollution and Surgical Outcomes
IF 1.8 3区 医学 Q2 SURGERY Pub Date : 2025-03-01 DOI: 10.1016/j.jss.2025.01.011
Wendelyn M. Oslock MD, MBA , Lauren Wood MSPH , Arundhati Sawant MBBS , Nathan C. English MBChB , Bayley A. Jones MD , Colin A. Martin MD , Ruzmyn Vilcassim PhD , Daniel I. Chu MD, MSPH

Introduction

Particulate matter less than 2.5 μm in diameter (PM2.5) can activate inflammatory cascades, cause oxidative damage, and induce cell death. Short-term exposures to PM2.5 have been associated with appendicitis and inflammatory bowel disease presentations, yet it is unclear if exposures may impact surgical recovery.

Methods

We conducted a retrospective cohort study of adult, colorectal surgery patients from 2006 to 2021. Institutional American College of Surgeons National Surgical Quality Improvement Program data were linked to Environmental Protection Agency PM2.5 concentrations on the day of admission stratified into low, moderately elevated, and high exposures. The environmental justice index chronic environmental burden and social vulnerability modules accounted for chronic stressors. The outcomes included length of stay (LOS), complications, and readmissions. After appropriate bivariate tests, multivariable regression models for the primary outcomes were constructed.

Results

1038 patients were included with the majority experiencing low PM2.5 (53.4%, n = 554). Patients were similar in terms of demographic, clinical, and procedural characteristics across pollution groups, with a median age of 59.6, 53.5% female, 38.3% Black, and 74.5% American Society of Anesthesiologists class 3. The unadjusted outcomes did not differ significantly across groups; however, on adjusted models, higher PM2.5 groups had longer LOS: incident rate ratio 1.12 [95% CI 1.05-1.19] and incident rate ratio 1.37 [95% CI 1.16-1.62] for moderately elevated and high PM2.5, respectively (P < 0.001).

Conclusions

This study found a novel association between surgical outcomes and short-term ambient air pollution, with higher PM2.5 on the day of admission associated with longer LOS. Notably, this is also the first surgical study to use the environmental justice index to control for social and environmental determinants of health.
{"title":"Short-Term Exposure to Ambient Particulate Matter Pollution and Surgical Outcomes","authors":"Wendelyn M. Oslock MD, MBA ,&nbsp;Lauren Wood MSPH ,&nbsp;Arundhati Sawant MBBS ,&nbsp;Nathan C. English MBChB ,&nbsp;Bayley A. Jones MD ,&nbsp;Colin A. Martin MD ,&nbsp;Ruzmyn Vilcassim PhD ,&nbsp;Daniel I. Chu MD, MSPH","doi":"10.1016/j.jss.2025.01.011","DOIUrl":"10.1016/j.jss.2025.01.011","url":null,"abstract":"<div><h3>Introduction</h3><div>Particulate matter less than 2.5 μm in diameter (PM<sub>2</sub><sub>.5</sub>) can activate inflammatory cascades, cause oxidative damage, and induce cell death. Short-term exposures to PM<sub>2.5</sub> have been associated with appendicitis and inflammatory bowel disease presentations, yet it is unclear if exposures may impact surgical recovery.</div></div><div><h3>Methods</h3><div>We conducted a retrospective cohort study of adult, colorectal surgery patients from 2006 to 2021. Institutional American College of Surgeons National Surgical Quality Improvement Program data were linked to Environmental Protection Agency PM<sub>2.5</sub> concentrations on the day of admission stratified into low, moderately elevated, and high exposures. The environmental justice index chronic environmental burden and social vulnerability modules accounted for chronic stressors. The outcomes included length of stay (LOS), complications, and readmissions. After appropriate bivariate tests, multivariable regression models for the primary outcomes were constructed.</div></div><div><h3>Results</h3><div>1038 patients were included with the majority experiencing low PM<sub>2.5</sub> (53.4%, <em>n</em> = 554). Patients were similar in terms of demographic, clinical, and procedural characteristics across pollution groups, with a median age of 59.6, 53.5% female, 38.3% Black, and 74.5% American Society of Anesthesiologists class 3. The unadjusted outcomes did not differ significantly across groups; however, on adjusted models, higher PM<sub>2.5</sub> groups had longer LOS: incident rate ratio 1.12 [95% CI 1.05-1.19] and incident rate ratio 1.37 [95% CI 1.16-1.62] for moderately elevated and high PM<sub>2.5,</sub> respectively (<em>P</em> &lt; 0.001).</div></div><div><h3>Conclusions</h3><div>This study found a novel association between surgical outcomes and short-term ambient air pollution, with higher PM<sub>2.5</sub> on the day of admission associated with longer LOS. Notably, this is also the first surgical study to use the environmental justice index to control for social and environmental determinants of health.</div></div>","PeriodicalId":17030,"journal":{"name":"Journal of Surgical Research","volume":"307 ","pages":"Pages 148-156"},"PeriodicalIF":1.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143511423","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Contemporary Management of Malignant Ascites
IF 1.8 3区 医学 Q2 SURGERY Pub Date : 2025-03-01 DOI: 10.1016/j.jss.2025.01.025
Mason A. Vierra MD , Ryan B. Morgan MD , Neal Bhutiani MD, PhD , Michael G. White MD , Oliver S. Eng MD

Introduction

Malignant ascites (MA) develops when malignant disease of the peritoneum causes excess fluid to accumulate in the abdominal cavity. It portends a poor prognosis and is associated with debilitating symptoms. While several palliative therapies exist, none have proven curative or free from side effects and complications. This review article describes experimental therapies on the horizon and the contemporary management of MA.

Materials and methods

A literature review was performed using MEDLINE/PubMed, in which studies of emerging or experimental therapies under investigation for the management of MA were reviewed. Current therapies were also reviewed to provide important context. Data, including study design, sample size, primary and secondary outcomes, and side effects were recorded and described. Studies were then categorized into distinct sections and subsections, with tables corresponding to each section.

Results

Five current therapies, including paracentesis, diuretics, peritoneovenous shunting, permanent catheters, and intraperitoneal chemotherapy, are described. Their limitations in effectively managing MA are highlighted. The “Experimental therapies” section is subsectioned into several categories, with the major studies corresponding to each section thoroughly described regarding methods, results, and validity. A final section describes treatments for mucinous ascites, which has distinct characteristics.

Conclusions

While each of the experimental therapies described offers unique benefits and has demonstrated some promise in managing MA, they all have limitations that have thus far prevented any one of them from being routinely used in practice. MA remains a challenging condition to treat, warranting further research into novel therapies.
{"title":"Contemporary Management of Malignant Ascites","authors":"Mason A. Vierra MD ,&nbsp;Ryan B. Morgan MD ,&nbsp;Neal Bhutiani MD, PhD ,&nbsp;Michael G. White MD ,&nbsp;Oliver S. Eng MD","doi":"10.1016/j.jss.2025.01.025","DOIUrl":"10.1016/j.jss.2025.01.025","url":null,"abstract":"<div><h3>Introduction</h3><div>Malignant ascites (MA) develops when malignant disease of the peritoneum causes excess fluid to accumulate in the abdominal cavity. It portends a poor prognosis and is associated with debilitating symptoms. While several palliative therapies exist, none have proven curative or free from side effects and complications. This review article describes experimental therapies on the horizon and the contemporary management of MA.</div></div><div><h3>Materials and methods</h3><div>A literature review was performed using MEDLINE/PubMed, in which studies of emerging or experimental therapies under investigation for the management of MA were reviewed. Current therapies were also reviewed to provide important context. Data, including study design, sample size, primary and secondary outcomes, and side effects were recorded and described. Studies were then categorized into distinct sections and subsections, with tables corresponding to each section.</div></div><div><h3>Results</h3><div>Five current therapies, including paracentesis, diuretics, peritoneovenous shunting, permanent catheters, and intraperitoneal chemotherapy, are described. Their limitations in effectively managing MA are highlighted. The “Experimental therapies” section is subsectioned into several categories, with the major studies corresponding to each section thoroughly described regarding methods, results, and validity. A final section describes treatments for mucinous ascites, which has distinct characteristics.</div></div><div><h3>Conclusions</h3><div>While each of the experimental therapies described offers unique benefits and has demonstrated some promise in managing MA, they all have limitations that have thus far prevented any one of them from being routinely used in practice. MA remains a challenging condition to treat, warranting further research into novel therapies.</div></div>","PeriodicalId":17030,"journal":{"name":"Journal of Surgical Research","volume":"307 ","pages":"Pages 157-175"},"PeriodicalIF":1.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143528651","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Role of Markedly Elevated Cyst Carcinoembryonic Antigen in Risk-Stratifying Pancreatic Cysts
IF 1.8 3区 医学 Q2 SURGERY Pub Date : 2025-03-01 DOI: 10.1016/j.jss.2025.01.027
Grace C. Bloomfield MS , George Yusin MD , Pejman Radkani MD , Jean Namgoong BS , Nadim G. Haddad MD , Walid Chalhoub MD , Thomas M. Fishbein MD , Emily R. Winslow MD

Introduction

Carcinoembryonic antigen (CEA) level is currently being used in algorithms of commercially available pancreatic cyst fluid analysis platforms. However, the evidence to date on its role in risk stratification for mucinous lesions is heterogenous. We therefore sought to examine the relationship between the magnitude of CEA elevation and the structural and molecular properties of pancreatic cysts.

Methods

All patients who underwent pancreatic cyst fluid analysis at a single institution from 2012 to 2019 were retrospectively examined. Structural features on endoscopic ultrasound were analyzed as a function of cyst fluid CEA. A subset of patients who underwent surgical resection was separately analyzed.

Results

A total of 634 pancreatic cyst fluid samples were obtained from 566 patients. Among all samples, 57% had normal cyst fluid CEA. Of those with elevated CEA, 22% had elevations <1000, 13% between 1000 and 10,000, and 8% > 10,000 ng/mL. The CEA >10,000 group had the highest rates of solid components (P = 0.039), mural nodules (P = 0.044), and mean number of DNA abnormalities (P < 0.001). The overall malignancy rate among all patients with cyst CEA >10,000 ng/mL was 14% (n = 7). Importantly, there was a strong association between the magnitude of the CEA elevation and the number of DNA abnormalities (P < 0.001) and the presence of oncogene mutations (P < 0.001).

Conclusions

In this large dataset of pancreatic cyst fluid aspirates, the magnitude of the CEA elevation was associated with worrisome features. Especially at its most extreme, elevated CEA should be further examined in the assessment of neoplastic risk for patients with an established diagnosis of a mucinous pancreatic cyst.
{"title":"The Role of Markedly Elevated Cyst Carcinoembryonic Antigen in Risk-Stratifying Pancreatic Cysts","authors":"Grace C. Bloomfield MS ,&nbsp;George Yusin MD ,&nbsp;Pejman Radkani MD ,&nbsp;Jean Namgoong BS ,&nbsp;Nadim G. Haddad MD ,&nbsp;Walid Chalhoub MD ,&nbsp;Thomas M. Fishbein MD ,&nbsp;Emily R. Winslow MD","doi":"10.1016/j.jss.2025.01.027","DOIUrl":"10.1016/j.jss.2025.01.027","url":null,"abstract":"<div><h3>Introduction</h3><div>Carcinoembryonic antigen (CEA) level is currently being used in algorithms of commercially available pancreatic cyst fluid analysis platforms. However, the evidence to date on its role in risk stratification for mucinous lesions is heterogenous. We therefore sought to examine the relationship between the magnitude of CEA elevation and the structural and molecular properties of pancreatic cysts.</div></div><div><h3>Methods</h3><div>All patients who underwent pancreatic cyst fluid analysis at a single institution from 2012 to 2019 were retrospectively examined. Structural features on endoscopic ultrasound were analyzed as a function of cyst fluid CEA. A subset of patients who underwent surgical resection was separately analyzed.</div></div><div><h3>Results</h3><div>A total of 634 pancreatic cyst fluid samples were obtained from 566 patients. Among all samples, 57% had normal cyst fluid CEA. Of those with elevated CEA, 22% had elevations &lt;1000, 13% between 1000 and 10,000, and 8% &gt; 10,000 ng/mL. The CEA &gt;10,000 group had the highest rates of solid components (<em>P</em> = 0.039), mural nodules (<em>P</em> = 0.044), and mean number of DNA abnormalities (<em>P</em> &lt; 0.001). The overall malignancy rate among all patients with cyst CEA &gt;10,000 ng/mL was 14% (<em>n</em> = 7). Importantly, there was a strong association between the magnitude of the CEA elevation and the number of DNA abnormalities (<em>P</em> &lt; 0.001) and the presence of oncogene mutations (<em>P</em> &lt; 0.001).</div></div><div><h3>Conclusions</h3><div>In this large dataset of pancreatic cyst fluid aspirates, the magnitude of the CEA elevation was associated with worrisome features. Especially at its most extreme, elevated CEA should be further examined in the assessment of neoplastic risk for patients with an established diagnosis of a mucinous pancreatic cyst.</div></div>","PeriodicalId":17030,"journal":{"name":"Journal of Surgical Research","volume":"307 ","pages":"Pages 189-196"},"PeriodicalIF":1.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143562480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Whole Blood Requirements in Civilian Trauma Resuscitation: Implications for Blood Inventory Program
IF 1.8 3区 医学 Q2 SURGERY Pub Date : 2025-03-01 DOI: 10.1016/j.jss.2024.12.060
Riley Goldsmith BS, Arshin Ghaedi MD, MPH, Audrey L. Spencer MD, Hamidreza Hosseinpour MD, Adam Nelson MD, FACS, Muhammad Haris Khurshid MD, Sai Krishna Bhogadi MD, Michael Ditillo DO, FACS, Louis J. Magnotti MD, MS, FACS, Bellal Joseph MD, FACS

Introduction

It is unclear what volume of whole blood (WB) a center may need to maintain an adequate inventory. This study aimed to determine the current WB requirements, using the military concept of WB equivalent (WBE), across different levels of trauma centers.

Methods

This is a retrospective analysis of the American College of Surgeons Trauma Quality Improvement Program database (2017-2018), including adult (≥16 ys) trauma patients who received massive transfusions. The primary outcome was WBE, which was calculated for each patient as units of WB plus equivalent component product units (1 red blood cell + 1 fresh frozen plasma + 0.2 platelet).

Results

A total of 9976 patients were identified. The mean (standard deviation) age was 41 (18), and 77.8% were male. The mean initial shock index was 1.2 (1.1), with the mean (standard deviation) systolic blood pressure of 104 (40) during resuscitation in the emergency department. The median (interquartile range) 24-h packed red blood cell, fresh frozen plasma, platelet, and WB were 12 (8-17), 8 (5-13), 2 (1-3), and 2 (1-3), respectively. The median 24-h WBE transfusion was 10 units, 75% of patients required 14 units or less, and 90% required 17 units or less. There was no difference in terms of median WBE transfusions across different levels of trauma centers (Level I: 10U, Level II: 10U, Level III and lower: 10U, P = 0.126).

Conclusions

On a nationwide scale, 75% of patients with massive transfusions received a maximum of 14 WBE units. These findings provide important insights to trauma centers on the volume of WB required to maintain adequate WB inventory to effectively support the successful implementation of future WB programs.
{"title":"Whole Blood Requirements in Civilian Trauma Resuscitation: Implications for Blood Inventory Program","authors":"Riley Goldsmith BS,&nbsp;Arshin Ghaedi MD, MPH,&nbsp;Audrey L. Spencer MD,&nbsp;Hamidreza Hosseinpour MD,&nbsp;Adam Nelson MD, FACS,&nbsp;Muhammad Haris Khurshid MD,&nbsp;Sai Krishna Bhogadi MD,&nbsp;Michael Ditillo DO, FACS,&nbsp;Louis J. Magnotti MD, MS, FACS,&nbsp;Bellal Joseph MD, FACS","doi":"10.1016/j.jss.2024.12.060","DOIUrl":"10.1016/j.jss.2024.12.060","url":null,"abstract":"<div><h3>Introduction</h3><div>It is unclear what volume of whole blood (WB) a center may need to maintain an adequate inventory. This study aimed to determine the current WB requirements, using the military concept of WB equivalent (WBE), across different levels of trauma centers.</div></div><div><h3>Methods</h3><div>This is a retrospective analysis of the American College of Surgeons Trauma Quality Improvement Program database (2017-2018), including adult (≥16 ys) trauma patients who received massive transfusions. The primary outcome was WBE, which was calculated for each patient as units of WB plus equivalent component product units (1 red blood cell + 1 fresh frozen plasma + 0.2 platelet).</div></div><div><h3>Results</h3><div>A total of 9976 patients were identified. The mean (standard deviation) age was 41 (18), and 77.8% were male. The mean initial shock index was 1.2 (1.1), with the mean (standard deviation) systolic blood pressure of 104 (40) during resuscitation in the emergency department. The median (interquartile range) 24-h packed red blood cell, fresh frozen plasma, platelet, and WB were 12 (8-17), 8 (5-13), 2 (1-3), and 2 (1-3), respectively. The median 24-h WBE transfusion was 10 units, 75% of patients required 14 units or less, and 90% required 17 units or less. There was no difference in terms of median WBE transfusions across different levels of trauma centers (Level I: 10U, Level II: 10U, Level III and lower: 10U, <em>P</em> = 0.126).</div></div><div><h3>Conclusions</h3><div>On a nationwide scale, 75% of patients with massive transfusions received a maximum of 14 WBE units. These findings provide important insights to trauma centers on the volume of WB required to maintain adequate WB inventory to effectively support the successful implementation of future WB programs.</div></div>","PeriodicalId":17030,"journal":{"name":"Journal of Surgical Research","volume":"307 ","pages":"Pages 122-128"},"PeriodicalIF":1.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143510157","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
High Priority Traumatic Brain Injury Science: Analysis of the National Trauma Research Action Plan
IF 1.8 3区 医学 Q2 SURGERY Pub Date : 2025-03-01 DOI: 10.1016/j.jss.2025.01.021
Shayan Rakhit MD, MPH , David Xiao MD, MPH , Francisco A. Alvarado BS , Erika L. Rivera MD , Deborah M. Stein MD, MPH , Mayur B. Patel MD, MPH , Amelia W. Maiga MD, MPH

Introduction

The National Trauma Research Action Plan convened 11 topic area panels to complete consensus-driven Delphi surveys to identify high priority trauma research questions. The Neurotrauma Panel identified questions relating to interventional and comparative effectiveness trials in severe traumatic brain injury (sTBI) critical care as highest priority. This qualitative secondary analysis aims to translate results across several Delphi panels into potential studies in sTBI critical care.

Methods

High priority consensus research questions related to sTBI in the critical phase of care (ranked >6.5 on a 1-9 Likert scale) were screened from the Neurotrauma, Critical Care, Geriatric, and Long-Term Outcomes Panels results. Using grounded theory, two reviewers inductively open-coded questions independently and then refined them for consensus. A similar approach was used to recategorize questions into codes. Each code was then characterized into research project(s) with an aim, design, exposure(s), and outcome(s).

Results

Among 376 high-priority questions reaching consensus, 55 related to sTBI critical care. Twelve projects emerged across eight consensus thematic codes: biomarkers (1 project, average priority score/range 6.92), imaging (1, 6.84), prognostication (1, 6.77), novel neuromonitoring (3, 6.61-6.77), intracranial pressure/cerebral perfusion pressure (2, 6.67-6.76), coagulopathy (2, 6.66-6.74), early rehabilitation (1, 6.67), and pharmacologic intervention (1, 6.66).

Conclusions

This National Trauma Research Action Plan secondary analysis identified several high-priority research projects in sTBI critical care. While some questions are being addressed in ongoing trials, investigators and funding agencies should consider using these consensus-driven Delphi panel results and subsequent analyses to prioritize future research proposals.
{"title":"High Priority Traumatic Brain Injury Science: Analysis of the National Trauma Research Action Plan","authors":"Shayan Rakhit MD, MPH ,&nbsp;David Xiao MD, MPH ,&nbsp;Francisco A. Alvarado BS ,&nbsp;Erika L. Rivera MD ,&nbsp;Deborah M. Stein MD, MPH ,&nbsp;Mayur B. Patel MD, MPH ,&nbsp;Amelia W. Maiga MD, MPH","doi":"10.1016/j.jss.2025.01.021","DOIUrl":"10.1016/j.jss.2025.01.021","url":null,"abstract":"<div><h3>Introduction</h3><div>The National Trauma Research Action Plan convened 11 topic area panels to complete consensus-driven Delphi surveys to identify high priority trauma research questions. The Neurotrauma Panel identified questions relating to interventional and comparative effectiveness trials in severe traumatic brain injury (sTBI) critical care as highest priority. This qualitative secondary analysis aims to translate results across several Delphi panels into potential studies in sTBI critical care.</div></div><div><h3>Methods</h3><div>High priority consensus research questions related to sTBI in the critical phase of care (ranked &gt;6.5 on a 1-9 Likert scale) were screened from the Neurotrauma, Critical Care, Geriatric, and Long-Term Outcomes Panels results. Using grounded theory, two reviewers inductively open-coded questions independently and then refined them for consensus. A similar approach was used to recategorize questions into codes. Each code was then characterized into research project(s) with an aim, design, exposure(s), and outcome(s).</div></div><div><h3>Results</h3><div>Among 376 high-priority questions reaching consensus, 55 related to sTBI critical care. Twelve projects emerged across eight consensus thematic codes: biomarkers (1 project, average priority score/range 6.92), imaging (1, 6.84), prognostication (1, 6.77), novel neuromonitoring (3, 6.61-6.77), intracranial pressure/cerebral perfusion pressure (2, 6.67-6.76), coagulopathy (2, 6.66-6.74), early rehabilitation (1, 6.67), and pharmacologic intervention (1, 6.66).</div></div><div><h3>Conclusions</h3><div>This National Trauma Research Action Plan secondary analysis identified several high-priority research projects in sTBI critical care. While some questions are being addressed in ongoing trials, investigators and funding agencies should consider using these consensus-driven Delphi panel results and subsequent analyses to prioritize future research proposals.</div></div>","PeriodicalId":17030,"journal":{"name":"Journal of Surgical Research","volume":"307 ","pages":"Pages 197-203"},"PeriodicalIF":1.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143562479","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Association of Antibiotic Use and Surgical Site Infection Following Pectus Bar Removal
IF 1.8 3区 医学 Q2 SURGERY Pub Date : 2025-03-01 DOI: 10.1016/j.jss.2025.01.013
Jack H. Scaife BA , Christopher E. Clinker BS , Marshall W. Wallace MD , R. Scott Eldredge MD , Justin Lee MD , Katie W. Russell MD

Introduction

Surgical site infection (SSI) following pectus bar removal (PBR) is one of the most common complications despite being a clean procedure. The effect of preoperative antibiotic use on SSI rates has not been well-studied. This study aimed to evaluate the association of preoperative antibiotic use on SSIs following PBR. We hypothesized that patients who received preoperative antibiotics would have lower SSI rates.

Methods

A retrospective review was conducted of pediatric patients who underwent PBR from January 2018 to July 2023 at a single center. Patient demographic data, preoperative antibiotic administration, and a 30-d postoperative clinical course were collected. SSI was defined as a documented infection adjacent to the surgical incision requiring antibiotics or operative intervention within 30 ds of surgery.

Results

There were 198 patients in the cohort. The majority were male (81%), with a median age of 18. Postpectus bar removal SSI was documented in 2% (4/198) of patients, with any complications occurring in 6% of the cohort. Despite being a clean case, 67% received preoperative antibiotics. There was no statistical difference between SSIs in patients who received preoperative antibiotics versus those who did not (0.8% versus 4.6%, P = 0.10).

Conclusions

Following PBR, close to 5% of patients had a documented SSI when antibiotics were not part of routine preoperative care. While we did not find a significant difference in SSI with antibiotic use, the incidence of SSI is higher than in other clean wound class procedures. Further efforts are needed to identify risk factors of SSI following PBR.
{"title":"Association of Antibiotic Use and Surgical Site Infection Following Pectus Bar Removal","authors":"Jack H. Scaife BA ,&nbsp;Christopher E. Clinker BS ,&nbsp;Marshall W. Wallace MD ,&nbsp;R. Scott Eldredge MD ,&nbsp;Justin Lee MD ,&nbsp;Katie W. Russell MD","doi":"10.1016/j.jss.2025.01.013","DOIUrl":"10.1016/j.jss.2025.01.013","url":null,"abstract":"<div><h3>Introduction</h3><div>Surgical site infection (SSI) following pectus bar removal (PBR) is one of the most common complications despite being a clean procedure. The effect of preoperative antibiotic use on SSI rates has not been well-studied. This study aimed to evaluate the association of preoperative antibiotic use on SSIs following PBR. We hypothesized that patients who received preoperative antibiotics would have lower SSI rates.</div></div><div><h3>Methods</h3><div>A retrospective review was conducted of pediatric patients who underwent PBR from January 2018 to July 2023 at a single center. Patient demographic data, preoperative antibiotic administration, and a 30-d postoperative clinical course were collected. SSI was defined as a documented infection adjacent to the surgical incision requiring antibiotics or operative intervention within 30 ds of surgery.</div></div><div><h3>Results</h3><div>There were 198 patients in the cohort. The majority were male (81%), with a median age of 18. Postpectus bar removal SSI was documented in 2% (4/198) of patients, with any complications occurring in 6% of the cohort. Despite being a clean case, 67% received preoperative antibiotics. There was no statistical difference between SSIs in patients who received preoperative antibiotics <em>versus</em> those who did not (0.8% <em>versus</em> 4.6%, <em>P</em> = 0.10).</div></div><div><h3>Conclusions</h3><div>Following PBR, close to 5% of patients had a documented SSI when antibiotics were not part of routine preoperative care. While we did not find a significant difference in SSI with antibiotic use, the incidence of SSI is higher than in other clean wound class procedures. Further efforts are needed to identify risk factors of SSI following PBR.</div></div>","PeriodicalId":17030,"journal":{"name":"Journal of Surgical Research","volume":"307 ","pages":"Pages 184-188"},"PeriodicalIF":1.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143549998","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Testing ChatGPT's Ability to Provide Patient and Physician Information on Aortic Aneurysm
IF 1.8 3区 医学 Q2 SURGERY Pub Date : 2025-03-01 DOI: 10.1016/j.jss.2025.01.015
Daniel J. Bertges MD , Adam W. Beck MD , Marc Schermerhorn MD , Mark K. Eskandari MD , Jens Eldrup-Jorgensen MD , Sean Liebscher MD , Robyn Guinto MD , Mead Ferris MD , Andy Stanley MD , Georg Steinthorsson MD , Matthew Alef MD , Salvatore T. Scali MD

Introduction

Our objective was to test the ability of ChatGPT 4.0 to provide accurate information for patients and physicians about abdominal aortic aneurysms (AAA) and to assess its alignment with Society for Vascular Surgery (SVS) clinical practice guidelines (CPG) for AAA care.

Material and methods

Fifteen patient-level questions, 37 questions selected to reflect 28 SVS CPGs and 4 questions regarding AAA rupture risk were posed to ChatGPT 4.0. Single responses were recorded and graded for accuracy and quality by ten board-certified vascular surgeons as well as two fellow trainees using a 5-point Likert scale; 1 = very poor, 2 = poor, 3 = fair, 4 = good, and 5 = excellent.

Results

The mean of the means (MoM) accuracy rating across all 15 patient-level questions was 4.4 (SD 0.4, quartile range (QR) 4.2-4.7). ChatGPT 4.0 demonstrated good alignment with SVS practice guidelines (MoM: 4.2, SD: 0.4, QR: 3.9-4.5). The accuracy of responses was consistent across guideline categories; screening or surveillance (4.2), indications for surgery (4.5), preoperative risk assessment (4.5), perioperative coronary revascularization (4.1), and perioperative management (4.2). The generative artificial intelligence bot demonstrated only fair performance in answering the annual AAA rupture risk (MoM: 3.4, SD: 1.2, QR: 2.3-4.3).

Conclusions

ChatGPT 4.0 provided accurate responses to a variety of patient-level questions regarding AAA. Responses were well-aligned with current SVS CPGs except for inaccuracies in the risk of AAA rupture at varying diameters. The emergence of generative artificial intelligence bots presents an opportunity for study of applications in patient education and to determine their ability to augment the vascular specialist's knowledge base.
{"title":"Testing ChatGPT's Ability to Provide Patient and Physician Information on Aortic Aneurysm","authors":"Daniel J. Bertges MD ,&nbsp;Adam W. Beck MD ,&nbsp;Marc Schermerhorn MD ,&nbsp;Mark K. Eskandari MD ,&nbsp;Jens Eldrup-Jorgensen MD ,&nbsp;Sean Liebscher MD ,&nbsp;Robyn Guinto MD ,&nbsp;Mead Ferris MD ,&nbsp;Andy Stanley MD ,&nbsp;Georg Steinthorsson MD ,&nbsp;Matthew Alef MD ,&nbsp;Salvatore T. Scali MD","doi":"10.1016/j.jss.2025.01.015","DOIUrl":"10.1016/j.jss.2025.01.015","url":null,"abstract":"<div><h3>Introduction</h3><div>Our objective was to test the ability of ChatGPT 4.0 to provide accurate information for patients and physicians about abdominal aortic aneurysms (AAA) and to assess its alignment with Society for Vascular Surgery (SVS) clinical practice guidelines (CPG) for AAA care.</div></div><div><h3>Material and methods</h3><div>Fifteen patient-level questions, 37 questions selected to reflect 28 SVS CPGs and 4 questions regarding AAA rupture risk were posed to ChatGPT 4.0. Single responses were recorded and graded for accuracy and quality by ten board-certified vascular surgeons as well as two fellow trainees using a 5-point Likert scale; 1 = very poor, 2 = poor, 3 = fair, 4 = good, and 5 = excellent.</div></div><div><h3>Results</h3><div>The mean of the means (MoM) accuracy rating across all 15 patient-level questions was 4.4 (SD 0.4, quartile range (QR) 4.2-4.7). ChatGPT 4.0 demonstrated good alignment with SVS practice guidelines (MoM: 4.2, SD: 0.4, QR: 3.9-4.5). The accuracy of responses was consistent across guideline categories; screening or surveillance (4.2), indications for surgery (4.5), preoperative risk assessment (4.5), perioperative coronary revascularization (4.1), and perioperative management (4.2). The generative artificial intelligence bot demonstrated only fair performance in answering the annual AAA rupture risk (MoM: 3.4, SD: 1.2, QR: 2.3-4.3).</div></div><div><h3>Conclusions</h3><div>ChatGPT 4.0 provided accurate responses to a variety of patient-level questions regarding AAA. Responses were well-aligned with current SVS CPGs except for inaccuracies in the risk of AAA rupture at varying diameters. The emergence of generative artificial intelligence bots presents an opportunity for study of applications in patient education and to determine their ability to augment the vascular specialist's knowledge base.</div></div>","PeriodicalId":17030,"journal":{"name":"Journal of Surgical Research","volume":"307 ","pages":"Pages 129-138"},"PeriodicalIF":1.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143510159","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Validating the Epic Deterioration Index (DI) for First Episode Rapid Response Team Activation in Sepsis Patients
IF 1.8 3区 医学 Q2 SURGERY Pub Date : 2025-03-01 DOI: 10.1016/j.jss.2025.01.024
Olivia K. Hoy BS , Allison R. Walker MD , Charles Sonday DNP , Aldo Carmona MD , Anna Ng Pellegrino MD

Introduction

The epic electronic medical records software's deterioration index (DI) is an artificial intelligence-driven algorithm, which quantifies the probability of patient deterioration. Our study aimed to assess the relationship between DI score and activation of a rapid response team (RRT) and to identify a cutoff score to screen for deterioration events.

Materials and methods

A retrospective case control study was performed on adult sepsis patients across a nonprofit regional health network composed of 15 hospitals between August 2021 and April 2022. Linear mixed regression modeling was used to evaluate the impact of RRT status on DI scores. We then quantified the performance of the DI score for predicting first-episode RRT events using a threshold of 40.

Results

A total of 138 patients were included in this study; sixty-five patients were in sepsis with RRT cohort, and 73 patients were in sepsis without RRT cohort. The average DI score was 50.8 (31,557 DI scores) for sepsis with RRT and 26.8 for sepsis without RRT (34,279 DI scores). Although the DI score changed significantly throughout hospitalization, linear mixed regression failed to distinguish between the two cohorts based on the RRT status (P = 0.33). Using DI > 40 as a screening tool was 100% specific and 73% sensitive for predicting RRT in sepsis patients.

Conclusions

Despite higher average DI scores in RRT patients, there was no difference in DI score changes over time based on the RRT status; however, the DI score has the potential to serve as an effective screening tool for predicting deterioration events in sepsis patients.
{"title":"Validating the Epic Deterioration Index (DI) for First Episode Rapid Response Team Activation in Sepsis Patients","authors":"Olivia K. Hoy BS ,&nbsp;Allison R. Walker MD ,&nbsp;Charles Sonday DNP ,&nbsp;Aldo Carmona MD ,&nbsp;Anna Ng Pellegrino MD","doi":"10.1016/j.jss.2025.01.024","DOIUrl":"10.1016/j.jss.2025.01.024","url":null,"abstract":"<div><h3>Introduction</h3><div>The epic electronic medical records software's deterioration index (DI) is an artificial intelligence-driven algorithm, which quantifies the probability of patient deterioration. Our study aimed to assess the relationship between DI score and activation of a rapid response team (RRT) and to identify a cutoff score to screen for deterioration events.</div></div><div><h3>Materials and methods</h3><div>A retrospective case control study was performed on adult sepsis patients across a nonprofit regional health network composed of 15 hospitals between August 2021 and April 2022. Linear mixed regression modeling was used to evaluate the impact of RRT status on DI scores. We then quantified the performance of the DI score for predicting first-episode RRT events using a threshold of 40.</div></div><div><h3>Results</h3><div>A total of 138 patients were included in this study; sixty-five patients were in sepsis with RRT cohort, and 73 patients were in sepsis without RRT cohort. The average DI score was 50.8 (31,557 DI scores) for sepsis with RRT and 26.8 for sepsis without RRT (34,279 DI scores). Although the DI score changed significantly throughout hospitalization, linear mixed regression failed to distinguish between the two cohorts based on the RRT status (<em>P</em> = 0.33). Using DI &gt; 40 as a screening tool was 100% specific and 73% sensitive for predicting RRT in sepsis patients.</div></div><div><h3>Conclusions</h3><div>Despite higher average DI scores in RRT patients, there was no difference in DI score changes over time based on the RRT status; however, the DI score has the potential to serve as an effective screening tool for predicting deterioration events in sepsis patients.</div></div>","PeriodicalId":17030,"journal":{"name":"Journal of Surgical Research","volume":"307 ","pages":"Pages 176-183"},"PeriodicalIF":1.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143549377","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Reducing Air Leak After Empyema Surgery: COPD’s Role and Patient Management 减少肺水肿手术后的漏气:慢性阻塞性肺病的作用和患者管理
IF 1.8 3区 医学 Q2 SURGERY Pub Date : 2025-02-26 DOI: 10.1016/j.jss.2025.01.020
Daniel Scheese MD , Devon C. Freudenberger MD , Elizabeth Mastoloni BS , Luke G. Wolfe MS , Bhavishya Ramamoorthy MD , Walker Julliard MD

Introduction

Despite medical advancements, the rise in pleural empyemas persists in the United States. Surgical decortication for pleural empyema subjects patients to the potential complication of a prolonged air leak (PAL). This study aims to uncover the incidence, predictors, and outcomes of PAL following surgical decortication for pleural empyemas within a single tertiary institution.

Materials and methods

Patients who underwent surgical decortication for plural empyema between 2011 and 2021 were identified in our single tertiary institution and divided into two groups: PAL and no PAL. Preoperative characteristics and postoperative outcomes were compared, and the results of the descriptive univariate analyses were reported.

Results

Among the 228 patients who met inclusion criteria, 7.5% undergoing surgical decortication for pleural empyema were diagnosed with PAL. While demographic differences were not significant between PAL and no PAL groups, PAL patients showed higher chronic obstructive pulmonary disease prevalence (82.4% versus 34.1%, P < 0.001) and lifetime tobacco use. PAL cases had increased rates of reoperation (29.4% versus 8.1%, P = 0.015) and remained intubated at the conclusion of the case.

Conclusions

Patients with chronic obstructive pulmonary disease were significantly more likely to develop PAL, which is associated with higher rates of reoperation and extended hospital stays. These findings underscore the importance of preoperative identification of high-risk patients and the implementation of targeted preventive measures to improve surgical and postoperative outcomes, thereby reducing morbidity and healthcare costs.
{"title":"Reducing Air Leak After Empyema Surgery: COPD’s Role and Patient Management","authors":"Daniel Scheese MD ,&nbsp;Devon C. Freudenberger MD ,&nbsp;Elizabeth Mastoloni BS ,&nbsp;Luke G. Wolfe MS ,&nbsp;Bhavishya Ramamoorthy MD ,&nbsp;Walker Julliard MD","doi":"10.1016/j.jss.2025.01.020","DOIUrl":"10.1016/j.jss.2025.01.020","url":null,"abstract":"<div><h3>Introduction</h3><div>Despite medical advancements, the rise in pleural empyemas persists in the United States. Surgical decortication for pleural empyema subjects patients to the potential complication of a prolonged air leak (PAL). This study aims to uncover the incidence, predictors, and outcomes of PAL following surgical decortication for pleural empyemas within a single tertiary institution.</div></div><div><h3>Materials and methods</h3><div>Patients who underwent surgical decortication for plural empyema between 2011 and 2021 were identified in our single tertiary institution and divided into two groups: PAL and no PAL. Preoperative characteristics and postoperative outcomes were compared, and the results of the descriptive univariate analyses were reported.</div></div><div><h3>Results</h3><div>Among the 228 patients who met inclusion criteria, 7.5% undergoing surgical decortication for pleural empyema were diagnosed with PAL. While demographic differences were not significant between PAL and no PAL groups, PAL patients showed higher chronic obstructive pulmonary disease prevalence (82.4% <em>versus</em> 34.1%, <em>P</em> &lt; 0.001) and lifetime tobacco use. PAL cases had increased rates of reoperation (29.4% <em>versus</em> 8.1%, <em>P</em> = 0.015) and remained intubated at the conclusion of the case.</div></div><div><h3>Conclusions</h3><div>Patients with chronic obstructive pulmonary disease were significantly more likely to develop PAL, which is associated with higher rates of reoperation and extended hospital stays. These findings underscore the importance of preoperative identification of high-risk patients and the implementation of targeted preventive measures to improve surgical and postoperative outcomes, thereby reducing morbidity and healthcare costs.</div></div>","PeriodicalId":17030,"journal":{"name":"Journal of Surgical Research","volume":"307 ","pages":"Pages 116-121"},"PeriodicalIF":1.8,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143488310","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Journal of Surgical Research
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