Pub Date : 2024-11-06DOI: 10.1097/SLA.0000000000006586
Cody Lendon Mullens, Andrew M Ibrahim, Nina M Clark, Nicholas Kunnath, Joseph L Dieleman, Justin B Dimick, John W Scott
Objective: To quantify recent trends in access to timely, high-quality, affordable surgical care in the US.
Background: Insufficient access to surgical care remains an ongoing concern in the US. Previous attempts to understand and quantify barriers in access to surgical care in the US lack a comprehensive, policy-relevant lens.
Methods: This observational cross-sectional study evaluates multiple domains of access to surgical care across the US from 2011-2015 and 2016-2020. Our stepwise model included timeliness (<60-minute drive time), quality (surgically capable hospital with ≥3 CMS stars), and affordability (neither uninsured nor underinsured) of access to surgical care using a novel combination of data from the American Hospital Association, Medicare claims, CMS's Five-Star Quality Rating System, the American Community Survey, and the Medical Expenditure Panel Survey.
Results: The number of Americans lacking access to timely, high-quality, affordable surgical care increased from 97.7 million in 2010-2015 to 98.7 million in 2016-2020. Comparing these two periods, we found improvements in the number of Americans lacking access due to being uninsured (decrease from 38.5 to 26.5 million). However, these improvements were offset by increasing numbers of Americans for whom timeliness (increase from 9.5 to 14.1 million), quality (increase from 3.4 to 4.9 million), and underinsured status (increase from 46.3 to 53.1 million) increased as barriers to access. Multiple sensitivity analyses using alternative thresholds for each access domain demonstrated similar trends. Those with insufficient access to care tended to be more rural (6.7% vs. 2.0%, P<0.001), lower income (40.7% vs. 30.0%, P<0.001), and of Hispanic ethnicity (35.9% vs. 15.8%, P<0.001).
Conclusions: Nearly one-in-three Americans lack access to surgical care that is timely, high-quality, and affordable. This study identifies the multiple actionable drivers of access to surgical care that notably can each be addressed with specific policy interventions.
{"title":"Trends in Timely Access to High-Quality and Affordable Surgical Care in the United States.","authors":"Cody Lendon Mullens, Andrew M Ibrahim, Nina M Clark, Nicholas Kunnath, Joseph L Dieleman, Justin B Dimick, John W Scott","doi":"10.1097/SLA.0000000000006586","DOIUrl":"https://doi.org/10.1097/SLA.0000000000006586","url":null,"abstract":"<p><strong>Objective: </strong>To quantify recent trends in access to timely, high-quality, affordable surgical care in the US.</p><p><strong>Background: </strong>Insufficient access to surgical care remains an ongoing concern in the US. Previous attempts to understand and quantify barriers in access to surgical care in the US lack a comprehensive, policy-relevant lens.</p><p><strong>Methods: </strong>This observational cross-sectional study evaluates multiple domains of access to surgical care across the US from 2011-2015 and 2016-2020. Our stepwise model included timeliness (<60-minute drive time), quality (surgically capable hospital with ≥3 CMS stars), and affordability (neither uninsured nor underinsured) of access to surgical care using a novel combination of data from the American Hospital Association, Medicare claims, CMS's Five-Star Quality Rating System, the American Community Survey, and the Medical Expenditure Panel Survey.</p><p><strong>Results: </strong>The number of Americans lacking access to timely, high-quality, affordable surgical care increased from 97.7 million in 2010-2015 to 98.7 million in 2016-2020. Comparing these two periods, we found improvements in the number of Americans lacking access due to being uninsured (decrease from 38.5 to 26.5 million). However, these improvements were offset by increasing numbers of Americans for whom timeliness (increase from 9.5 to 14.1 million), quality (increase from 3.4 to 4.9 million), and underinsured status (increase from 46.3 to 53.1 million) increased as barriers to access. Multiple sensitivity analyses using alternative thresholds for each access domain demonstrated similar trends. Those with insufficient access to care tended to be more rural (6.7% vs. 2.0%, P<0.001), lower income (40.7% vs. 30.0%, P<0.001), and of Hispanic ethnicity (35.9% vs. 15.8%, P<0.001).</p><p><strong>Conclusions: </strong>Nearly one-in-three Americans lack access to surgical care that is timely, high-quality, and affordable. This study identifies the multiple actionable drivers of access to surgical care that notably can each be addressed with specific policy interventions.</p>","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":" ","pages":""},"PeriodicalIF":7.5,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142581968","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-06DOI: 10.1097/SLA.0000000000006583
Avery Brown, Karan R Chhabra
{"title":"Your Weight and Your Wallet: Comparing Out-of-Pocket Costs of Bariatric Surgery and GLP1 Agonists.","authors":"Avery Brown, Karan R Chhabra","doi":"10.1097/SLA.0000000000006583","DOIUrl":"https://doi.org/10.1097/SLA.0000000000006583","url":null,"abstract":"","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":" ","pages":""},"PeriodicalIF":7.5,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142581979","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-06DOI: 10.1097/SLA.0000000000006582
Alexis Mah, Fahad Alam, Jeremie Larouche, Marie-Antonette Dandal, Tara Cohen, Susan Hallbeck, Hamid Norasi, Csilla Kallocsai, Sapna Sriram, James D Helman, Julie Hallet
Objective: To examine perceived OR ergonomics facilitators and barriers, with a focus on the interdisciplinary team.
Summary background data: Poor ergonomics causes musculoskeletal injuries affecting all operating room (OR) staff with repercussions on patient care, outcomes, and sustainability. Lack of ergonomic awareness and education are risk factors.
Methods: We conducted a self-administered web-based survey of OR nurses, surgeons, and anesthesiologists at a single centre (n=238). We developed a questionnaire through items generation and reduction, followed by reliability and validity testing.
Results: Response rate was 53.8%. Respondents perceived that on average 80% of nurses, 70% of surgeons, and 40% anesthesiologists experienced MSK injuries, with no difference in professional groups' perceptions. Guideline ergonomics interventions were rarely used (<25%) except for specialized clothing (33%), equipment repositioning (59%), and seating (37%), though perceived beneficial by 80-90%. Reported barriers to optimal ergonomics were organizational/structural (lack of time, space, equipment, funding), whereas solutions were individual. Fear of unfavourable perception from others was a concern for 62%. Teams discussing, prioritizing, monitoring, or helping with ergonomics was indicated by <50%. Individual ergonomic adaptations were perceived as convenience by other staff.
Conclusions: While structural/organizational issues are reported as barriers to ergonomics, solutions appeared as individual responsibilities. Team dynamics did not prioritize nor support ergonomics. Education tools leveraging the interdisciplinary team are warranted. This work will be supplemented by interviews and live observations to build tailored educational tools for OR teams.
{"title":"Interdisciplinary Operating Room Ergonomics Needs and Priorities: A Survey of Operating Room Staff.","authors":"Alexis Mah, Fahad Alam, Jeremie Larouche, Marie-Antonette Dandal, Tara Cohen, Susan Hallbeck, Hamid Norasi, Csilla Kallocsai, Sapna Sriram, James D Helman, Julie Hallet","doi":"10.1097/SLA.0000000000006582","DOIUrl":"https://doi.org/10.1097/SLA.0000000000006582","url":null,"abstract":"<p><strong>Objective: </strong>To examine perceived OR ergonomics facilitators and barriers, with a focus on the interdisciplinary team.</p><p><strong>Summary background data: </strong>Poor ergonomics causes musculoskeletal injuries affecting all operating room (OR) staff with repercussions on patient care, outcomes, and sustainability. Lack of ergonomic awareness and education are risk factors.</p><p><strong>Methods: </strong>We conducted a self-administered web-based survey of OR nurses, surgeons, and anesthesiologists at a single centre (n=238). We developed a questionnaire through items generation and reduction, followed by reliability and validity testing.</p><p><strong>Results: </strong>Response rate was 53.8%. Respondents perceived that on average 80% of nurses, 70% of surgeons, and 40% anesthesiologists experienced MSK injuries, with no difference in professional groups' perceptions. Guideline ergonomics interventions were rarely used (<25%) except for specialized clothing (33%), equipment repositioning (59%), and seating (37%), though perceived beneficial by 80-90%. Reported barriers to optimal ergonomics were organizational/structural (lack of time, space, equipment, funding), whereas solutions were individual. Fear of unfavourable perception from others was a concern for 62%. Teams discussing, prioritizing, monitoring, or helping with ergonomics was indicated by <50%. Individual ergonomic adaptations were perceived as convenience by other staff.</p><p><strong>Conclusions: </strong>While structural/organizational issues are reported as barriers to ergonomics, solutions appeared as individual responsibilities. Team dynamics did not prioritize nor support ergonomics. Education tools leveraging the interdisciplinary team are warranted. This work will be supplemented by interviews and live observations to build tailored educational tools for OR teams.</p>","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":" ","pages":""},"PeriodicalIF":7.5,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142581954","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-05DOI: 10.1097/SLA.0000000000006579
Sara Villasante, Nair Fernandes, Marc Perez, Miguel Angel Cordobés, Gemma Piella, María Martinez, Concepción Gomez-Gavara, Laia Blanco, Piero Alberti, Ramón Charco, Elizabeth Pando
Objective: To evaluate machine learning models' performance in predicting acute pancreatitis severity using early-stage variables while excluding laboratory and imaging tests.
Summary background data: Severe acute pancreatitis (SAP) affects approximately 20% of acute pancreatitis (AP) patients and is associated with high mortality rates. Accurate early prediction of SAP and in-hospital mortality is crucial for effective management. Traditional scores such as APACHE-II and BISAP are complex and require laboratory tests, while early predictive models are lacking. Machine learning (ML) has shown promising results in predictive modelling, potentially outperforming traditional methods.
Methods: We analysed data from a prospective database of AP patients admitted to Vall d'Hebron Hospital from November 2015 to January 2022. Inclusion criteria were adults diagnosed with AP according to the 2012 Atlanta classification. Data included basal characteristics, current medication, and vital signs. We developed machine learning models to predict SAP, in-hospital mortality, and intensive care unit (ICU) admission. The modelling process included two stages: Stage 0, which used basal characteristics and medication, and Stage 1, which included data from Stage 0 and vital signs.
Results: Out of 634 cases, 594 were analysed. The Stage 0 model showed AUC values of 0.698 for mortality, 0.721 for ICU admission, and 0.707 for persistent organ failure. The Stage 1 model improved performance with AUC values of 0.849 for mortality, 0.786 for ICU admission, and 0.783 for persistent organ failure. The models demonstrated comparable or superior performance to APACHE-II and BISAP scores.
Conclusions: The ML models showed good predictive capacity for SAP, ICU admission, and mortality using early-stage data without laboratory or imaging tests. This approach could revolutionise AP patients' initial triage and management, providing a personalised prediction method based on early clinical data.
{"title":"Prediction of Severe Acute Pancreatitis at a Very Early Stage of the Disease Using Artificial Intelligence Techniques, Without Laboratory Data or Imaging Tests: The PANCREATIA Study.","authors":"Sara Villasante, Nair Fernandes, Marc Perez, Miguel Angel Cordobés, Gemma Piella, María Martinez, Concepción Gomez-Gavara, Laia Blanco, Piero Alberti, Ramón Charco, Elizabeth Pando","doi":"10.1097/SLA.0000000000006579","DOIUrl":"https://doi.org/10.1097/SLA.0000000000006579","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate machine learning models' performance in predicting acute pancreatitis severity using early-stage variables while excluding laboratory and imaging tests.</p><p><strong>Summary background data: </strong>Severe acute pancreatitis (SAP) affects approximately 20% of acute pancreatitis (AP) patients and is associated with high mortality rates. Accurate early prediction of SAP and in-hospital mortality is crucial for effective management. Traditional scores such as APACHE-II and BISAP are complex and require laboratory tests, while early predictive models are lacking. Machine learning (ML) has shown promising results in predictive modelling, potentially outperforming traditional methods.</p><p><strong>Methods: </strong>We analysed data from a prospective database of AP patients admitted to Vall d'Hebron Hospital from November 2015 to January 2022. Inclusion criteria were adults diagnosed with AP according to the 2012 Atlanta classification. Data included basal characteristics, current medication, and vital signs. We developed machine learning models to predict SAP, in-hospital mortality, and intensive care unit (ICU) admission. The modelling process included two stages: Stage 0, which used basal characteristics and medication, and Stage 1, which included data from Stage 0 and vital signs.</p><p><strong>Results: </strong>Out of 634 cases, 594 were analysed. The Stage 0 model showed AUC values of 0.698 for mortality, 0.721 for ICU admission, and 0.707 for persistent organ failure. The Stage 1 model improved performance with AUC values of 0.849 for mortality, 0.786 for ICU admission, and 0.783 for persistent organ failure. The models demonstrated comparable or superior performance to APACHE-II and BISAP scores.</p><p><strong>Conclusions: </strong>The ML models showed good predictive capacity for SAP, ICU admission, and mortality using early-stage data without laboratory or imaging tests. This approach could revolutionise AP patients' initial triage and management, providing a personalised prediction method based on early clinical data.</p>","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":" ","pages":""},"PeriodicalIF":7.5,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142574814","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01Epub Date: 2024-07-30DOI: 10.1097/SLA.0000000000006462
Zhihao Li, Matthias Pfister, Florian Huwyler, Waldemar Hoffmann, Mark W Tibbitt, Philipp Dutkowski, Pierre-Alain Clavien
Objective: To assess the impact of normothermic machine perfusion (NMP) on patients, medical teams, and costs by gathering global insights and exploring current limitations.
Background: NMP for ex situ liver graft perfusion is gaining increasing attention for its capability to extend graft preservation. It has the potential to transform liver transplantation (LT) from an urgent to a purely elective procedure, which could revolutionize LT logistics, reduce burden on patients and health care providers, and decrease costs.
Methods: A 31-item survey was sent to international transplant directors to gather their NMP experiences and vision. In addition, we performed a systematic review on cost-analysis in LT and assessed studies on cost-benefit in converting urgent-to-elective procedures. We compared the costs of available NMPs and conducted a sensitivity analysis of NMP's cost benefits.
Results: Of 120 transplant programs contacted, 64 (53%) responded, spanning North America (31%), Europe (42%), Asia (22%), and South America (5%). Of the total, 60% had adopted NMP, with larger centers (>100 transplants/year) in North America and Europe more likely to use it. The main NMP systems were OrganOx-metra (39%), XVIVO (36%), and TransMedics-OCS (15%). Despite NMP adoption, 41% of centers still perform >50% of LTs at nights/weekends. Centers recognized NMP's benefits, including improved work satisfaction and patient outcomes, but faced challenges like high costs and machine complexity. 16% would invest $100,000 to 500'000, 33% would invest $50,000 to 100'000, 38% would invest $10,000 to 50'000, and 14% would invest <$10,000 in NMP. These results were strengthened by a cost analysis for NMP in emergency-to-elective LT transition. Accordingly, while liver perfusions with disposables up to $10,000 resulted in overall positive net balances, this effect was lost when disposables' cost amounted to >$40,000/organ.
Conclusions: The adoption of NMP is hindered by high costs and operational complexity. Making LT elective through NMP could reduce costs and improve outcomes, but overcoming barriers requires national reimbursements and simplified, automated NMP systems for multiday preservation.
{"title":"Revolutionizing Liver Transplantation: Transitioning to an Elective Procedure Through Ex Situ Normothermic Machine Perfusion - A Benefit Analysis.","authors":"Zhihao Li, Matthias Pfister, Florian Huwyler, Waldemar Hoffmann, Mark W Tibbitt, Philipp Dutkowski, Pierre-Alain Clavien","doi":"10.1097/SLA.0000000000006462","DOIUrl":"10.1097/SLA.0000000000006462","url":null,"abstract":"<p><strong>Objective: </strong>To assess the impact of normothermic machine perfusion (NMP) on patients, medical teams, and costs by gathering global insights and exploring current limitations.</p><p><strong>Background: </strong>NMP for ex situ liver graft perfusion is gaining increasing attention for its capability to extend graft preservation. It has the potential to transform liver transplantation (LT) from an urgent to a purely elective procedure, which could revolutionize LT logistics, reduce burden on patients and health care providers, and decrease costs.</p><p><strong>Methods: </strong>A 31-item survey was sent to international transplant directors to gather their NMP experiences and vision. In addition, we performed a systematic review on cost-analysis in LT and assessed studies on cost-benefit in converting urgent-to-elective procedures. We compared the costs of available NMPs and conducted a sensitivity analysis of NMP's cost benefits.</p><p><strong>Results: </strong>Of 120 transplant programs contacted, 64 (53%) responded, spanning North America (31%), Europe (42%), Asia (22%), and South America (5%). Of the total, 60% had adopted NMP, with larger centers (>100 transplants/year) in North America and Europe more likely to use it. The main NMP systems were OrganOx-metra (39%), XVIVO (36%), and TransMedics-OCS (15%). Despite NMP adoption, 41% of centers still perform >50% of LTs at nights/weekends. Centers recognized NMP's benefits, including improved work satisfaction and patient outcomes, but faced challenges like high costs and machine complexity. 16% would invest $100,000 to 500'000, 33% would invest $50,000 to 100'000, 38% would invest $10,000 to 50'000, and 14% would invest <$10,000 in NMP. These results were strengthened by a cost analysis for NMP in emergency-to-elective LT transition. Accordingly, while liver perfusions with disposables up to $10,000 resulted in overall positive net balances, this effect was lost when disposables' cost amounted to >$40,000/organ.</p><p><strong>Conclusions: </strong>The adoption of NMP is hindered by high costs and operational complexity. Making LT elective through NMP could reduce costs and improve outcomes, but overcoming barriers requires national reimbursements and simplified, automated NMP systems for multiday preservation.</p>","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":" ","pages":"887-895"},"PeriodicalIF":7.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141791752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01Epub Date: 2024-08-06DOI: 10.1097/SLA.0000000000006493
Isabelle Holscher, Anton F Engelsman, Koen M A Dreijerink, Markus W Hollmann, Tijs J van den Berg, Els J M Nieveen van Dijkum
Objective: This study describes the effects of introducing a protocol omitting preoperative α-blockade dose-escalation (de-escalation) in a prospective patient group.
Background: The decline of mortality and morbidity associated with pheochromocytoma resection is frequently attributed to the introduction of preoperative α-blockade. Current protocols require preoperative α-blockade dose-escalation and multiple-day hospital admissions. However, correlating evidence is lacking. Moreover, recent data suggest equal perioperative safety regardless of preoperative α-blockade escalation.
Methods: Single-institution evaluation of protocol implementation, including patients who underwent adrenalectomy for pheochromocytoma between 2015 and 2023. Intraoperative hemodynamic control was regulated by active adjustment of blood pressure using vasoactive agents. The primary outcome was intraoperative hypertension, defined as the time-weighted average of systolic blood pressure (TWA-SBP) above 200 mm Hg. Secondary outcomes included perioperative hypotension, postoperative blood pressure support requirement, hospital stay duration, and complications.
Results: Of 102 pheochromocytoma patients, 82 were included; 44 in the de-escalated preoperative α-adrenergic protocol and 38 following the previous dose-escalation protocol. Median [IQR] TWA-SBP above 200 mm Hg was 0.01 [0.0-0.4] mm Hg in the de-escalated group versus 0.0 [0.0-0.1] mm Hg in the dose-escalated group ( P =0.073). The median duration of postoperative continuous norepinephrine administration was 0.3 hours [0.0-5.5] versus 5.1 hours [0.0-14.3], respectively ( P =0.003). Postoperative symptomatic hypotension occurred in 34.2% versus 9.1% of patients ( P =0.005). Median hospital stay was 2.5 days [1.9-3.6] versus 7.1 days [6.0-11.9] ( P <0.001). No significant differences in complication rates were observed.
Conclusion: Our data suggest that adrenalectomy for pheochromocytoma employing a de-escalated preoperative α-blockade protocol is safe and results in a shorter hospital stay.
{"title":"Omitting the Escalating Dosage of Alpha-adrenergic Blockade Before Pheochromocytoma Resection: Implementation of a Treatment Strategy in Discordance With Current Guidelines.","authors":"Isabelle Holscher, Anton F Engelsman, Koen M A Dreijerink, Markus W Hollmann, Tijs J van den Berg, Els J M Nieveen van Dijkum","doi":"10.1097/SLA.0000000000006493","DOIUrl":"10.1097/SLA.0000000000006493","url":null,"abstract":"<p><strong>Objective: </strong>This study describes the effects of introducing a protocol omitting preoperative α-blockade dose-escalation (de-escalation) in a prospective patient group.</p><p><strong>Background: </strong>The decline of mortality and morbidity associated with pheochromocytoma resection is frequently attributed to the introduction of preoperative α-blockade. Current protocols require preoperative α-blockade dose-escalation and multiple-day hospital admissions. However, correlating evidence is lacking. Moreover, recent data suggest equal perioperative safety regardless of preoperative α-blockade escalation.</p><p><strong>Methods: </strong>Single-institution evaluation of protocol implementation, including patients who underwent adrenalectomy for pheochromocytoma between 2015 and 2023. Intraoperative hemodynamic control was regulated by active adjustment of blood pressure using vasoactive agents. The primary outcome was intraoperative hypertension, defined as the time-weighted average of systolic blood pressure (TWA-SBP) above 200 mm Hg. Secondary outcomes included perioperative hypotension, postoperative blood pressure support requirement, hospital stay duration, and complications.</p><p><strong>Results: </strong>Of 102 pheochromocytoma patients, 82 were included; 44 in the de-escalated preoperative α-adrenergic protocol and 38 following the previous dose-escalation protocol. Median [IQR] TWA-SBP above 200 mm Hg was 0.01 [0.0-0.4] mm Hg in the de-escalated group versus 0.0 [0.0-0.1] mm Hg in the dose-escalated group ( P =0.073). The median duration of postoperative continuous norepinephrine administration was 0.3 hours [0.0-5.5] versus 5.1 hours [0.0-14.3], respectively ( P =0.003). Postoperative symptomatic hypotension occurred in 34.2% versus 9.1% of patients ( P =0.005). Median hospital stay was 2.5 days [1.9-3.6] versus 7.1 days [6.0-11.9] ( P <0.001). No significant differences in complication rates were observed.</p><p><strong>Conclusion: </strong>Our data suggest that adrenalectomy for pheochromocytoma employing a de-escalated preoperative α-blockade protocol is safe and results in a shorter hospital stay.</p>","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":" ","pages":"817-824"},"PeriodicalIF":7.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141892688","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01Epub Date: 2024-08-08DOI: 10.1097/SLA.0000000000006476
Jingpu Wang, Cas de Jongh, Zhouqiao Wu, Eline M de Groot, Alexandre Challine, Sheraz R Markar, Hylke J F Brenkman, Jelle P Ruurda, Richard van Hillegersberg
Objective: To clarify the impact of the preoperative time intervals on short-term postoperative and pathologic outcomes in patients with esophageal cancer who underwent neoadjuvant chemoradiotherapy (nCRT) followed by esophagectomy.
Background: The impact of preoperative intervals on patients with esophageal cancer who received multimodality treatment remains unknown.
Methods: Patients (cT1-4aN0-3M0) treated with nCRT plus esophagectomy were included using the Dutch national DUCA database. Multivariate logistic regression was used to determine the effect of different time intervals upon short-term postoperative and pathologic outcomes: diagnosis-to-nCRT intervals (≤5, 5-8, and 8-12 weeks), nCRT-to-surgery intervals (5-11, 11-17, and >17 weeks) and total preoperative intervals (≤16, 16-25, and >25 weeks).
Results: Between 2010 and 2021, a total of 5052 patients were included. Compared with diagnosis-to-nCRT interval ≤5 weeks, the interval of 8 to 12 weeks was associated with a higher risk of overall complications ( P =0.049). Compared with nCRT-to-surgery interval of 5 to 11 weeks, the longer intervals (11-17 and >17 weeks) were associated with a higher risk of overall complications ( P =0.016; P <0.001) and anastomotic leakage ( P =0.004; P =0.030), but the interval >17 weeks was associated with lower risk of ypN+ ( P =0.021). The longer total preoperative intervals were not associated with the risk of 30-day mortality and complications compared with the interval ≤16 weeks, but the longer total preoperative interval (>25 weeks) was associated with higher ypT stage ( P =0.010) and lower pathologic complete response rate ( P =0.013).
Conclusions: In patients with esophageal cancer undergoing nCRT and esophagectomy, prolonged preoperative time intervals may lead to higher morbidity and disease progression, and the causal relationship requires further confirmation.
{"title":"Impact of Preoperative Time Intervals for Neoadjuvant Chemoradiotherapy on Short-term Postoperative Outcomes of Esophageal Cancer Surgery: A Population-based Study Using the Dutch Upper Gastrointestinal Cancer Audit (DUCA) Data.","authors":"Jingpu Wang, Cas de Jongh, Zhouqiao Wu, Eline M de Groot, Alexandre Challine, Sheraz R Markar, Hylke J F Brenkman, Jelle P Ruurda, Richard van Hillegersberg","doi":"10.1097/SLA.0000000000006476","DOIUrl":"10.1097/SLA.0000000000006476","url":null,"abstract":"<p><strong>Objective: </strong>To clarify the impact of the preoperative time intervals on short-term postoperative and pathologic outcomes in patients with esophageal cancer who underwent neoadjuvant chemoradiotherapy (nCRT) followed by esophagectomy.</p><p><strong>Background: </strong>The impact of preoperative intervals on patients with esophageal cancer who received multimodality treatment remains unknown.</p><p><strong>Methods: </strong>Patients (cT1-4aN0-3M0) treated with nCRT plus esophagectomy were included using the Dutch national DUCA database. Multivariate logistic regression was used to determine the effect of different time intervals upon short-term postoperative and pathologic outcomes: diagnosis-to-nCRT intervals (≤5, 5-8, and 8-12 weeks), nCRT-to-surgery intervals (5-11, 11-17, and >17 weeks) and total preoperative intervals (≤16, 16-25, and >25 weeks).</p><p><strong>Results: </strong>Between 2010 and 2021, a total of 5052 patients were included. Compared with diagnosis-to-nCRT interval ≤5 weeks, the interval of 8 to 12 weeks was associated with a higher risk of overall complications ( P =0.049). Compared with nCRT-to-surgery interval of 5 to 11 weeks, the longer intervals (11-17 and >17 weeks) were associated with a higher risk of overall complications ( P =0.016; P <0.001) and anastomotic leakage ( P =0.004; P =0.030), but the interval >17 weeks was associated with lower risk of ypN+ ( P =0.021). The longer total preoperative intervals were not associated with the risk of 30-day mortality and complications compared with the interval ≤16 weeks, but the longer total preoperative interval (>25 weeks) was associated with higher ypT stage ( P =0.010) and lower pathologic complete response rate ( P =0.013).</p><p><strong>Conclusions: </strong>In patients with esophageal cancer undergoing nCRT and esophagectomy, prolonged preoperative time intervals may lead to higher morbidity and disease progression, and the causal relationship requires further confirmation.</p>","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":" ","pages":"808-816"},"PeriodicalIF":7.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11446532/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141900785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01Epub Date: 2024-08-26DOI: 10.1097/SLA.0000000000006492
Vegar Johansen Dagenborg, Kristoffer Watten Brudvik, Christin Lund-Andersen, Annette Torgunrud, Marius Lund-Iversen, Kjersti Flatmark, Stein Gunnar Larsen, Sheraz Yaqub
Objective: To study outcomes after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) in patients also treated for colorectal liver metastases (CLM).
Background: Colorectal cancer (CRC) frequently metastasizes to the liver and peritoneum and is associated with a poor prognosis. In selected patients, a benefit in overall survival (OS) was shown for both peritoneal metastases (PM-CRC) offered CRS-HIPEC, and CLM treated with surgical resection. However, the presence of CLM was considered a relative contraindication to CRS-HIPEC, causing a paucity of outcome data in this patient group.
Methods: Patients with PM-CRC having CRS-HIPEC at a single national center between 2007 and 2023, with additional intervention for CLM, were included (previous curative treatment for extraperitoneal and extrahepatic metastases was allowed). Three groups were defined: CLM before CRS-HIPEC (pre-CRS-HIPEC), CLM resected simultaneously with CRS-HIPEC (sim-CRS-HIPEC), and CLM after CRS-HIPEC (post-CRS-HIPEC), aiming to retrospectively analyze outcomes.
Results: Fifty-seven patients were included and classified as: pre-CRS-HIPEC (n = 11), sim-CRS-HIPEC (n = 29), and post-CRS-HIPEC (n = 17). Median Peritoneal Cancer Index (PCI) was 8; 13 patients had severe complications (Clavien-Dindo ≥3), and no 90-day mortality. Median OS was 48 months after CRS-HIPEC. PCI was a predictor of OS (hazard ratio: 1.11, P < 0.001). We observed no difference in short or long-term outcomes between intervention groups.
Discussion: This study demonstrated that patients with CLM having CRS-HIPEC had comparable OS to reports on CRS-HIPEC only, likely explained by a low PCI. Simultaneous CLM resection did not increase the risk of severe complications.
Conclusions: In this national cohort, CRS-HIPEC and CLM intervention offers long-term survival, suggesting that this treatment may be offered to selected patients with PM-CRC and CLM.
{"title":"Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy and Liver Resection is a Treatment Option for Patients With Peritoneal and Liver Metastases From Colorectal Cancer.","authors":"Vegar Johansen Dagenborg, Kristoffer Watten Brudvik, Christin Lund-Andersen, Annette Torgunrud, Marius Lund-Iversen, Kjersti Flatmark, Stein Gunnar Larsen, Sheraz Yaqub","doi":"10.1097/SLA.0000000000006492","DOIUrl":"10.1097/SLA.0000000000006492","url":null,"abstract":"<p><strong>Objective: </strong>To study outcomes after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) in patients also treated for colorectal liver metastases (CLM).</p><p><strong>Background: </strong>Colorectal cancer (CRC) frequently metastasizes to the liver and peritoneum and is associated with a poor prognosis. In selected patients, a benefit in overall survival (OS) was shown for both peritoneal metastases (PM-CRC) offered CRS-HIPEC, and CLM treated with surgical resection. However, the presence of CLM was considered a relative contraindication to CRS-HIPEC, causing a paucity of outcome data in this patient group.</p><p><strong>Methods: </strong>Patients with PM-CRC having CRS-HIPEC at a single national center between 2007 and 2023, with additional intervention for CLM, were included (previous curative treatment for extraperitoneal and extrahepatic metastases was allowed). Three groups were defined: CLM before CRS-HIPEC (pre-CRS-HIPEC), CLM resected simultaneously with CRS-HIPEC (sim-CRS-HIPEC), and CLM after CRS-HIPEC (post-CRS-HIPEC), aiming to retrospectively analyze outcomes.</p><p><strong>Results: </strong>Fifty-seven patients were included and classified as: pre-CRS-HIPEC (n = 11), sim-CRS-HIPEC (n = 29), and post-CRS-HIPEC (n = 17). Median Peritoneal Cancer Index (PCI) was 8; 13 patients had severe complications (Clavien-Dindo ≥3), and no 90-day mortality. Median OS was 48 months after CRS-HIPEC. PCI was a predictor of OS (hazard ratio: 1.11, P < 0.001). We observed no difference in short or long-term outcomes between intervention groups.</p><p><strong>Discussion: </strong>This study demonstrated that patients with CLM having CRS-HIPEC had comparable OS to reports on CRS-HIPEC only, likely explained by a low PCI. Simultaneous CLM resection did not increase the risk of severe complications.</p><p><strong>Conclusions: </strong>In this national cohort, CRS-HIPEC and CLM intervention offers long-term survival, suggesting that this treatment may be offered to selected patients with PM-CRC and CLM.</p>","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":" ","pages":"745-752"},"PeriodicalIF":7.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11446514/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142054731","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01Epub Date: 2024-08-05DOI: 10.1097/SLA.0000000000006468
Jean Pinson, Julie Henriques, Ludivine Beaussire, Nasrin Sarafan-Vasseur, Antonio Sa Cunha, Jean-Baptiste Bachet, Dewi Vernerey, Frederic Di Fiore, Lilian Schwarz
<p><strong>Objective: </strong>To investigate in patients treated for a resectable pancreatic ductal adenocarcinoma [pancreatic adenocarcinoma (PA)], the prognostic value of baseline carbohydrate antigen 19.9 (CA19-9) and circulating tumor DNA (ctDNA) for overall survival (OS), to improve death risk stratification, based on a planned ancillary study from PANACHE01-PRODIGE 48 trial.</p><p><strong>Background: </strong>Biological borderline situation that was first used by the MD Anderson, became a standard practice following the international consensus conference in 2016 to manage PA. Regarding the risk of systemic disease, especially in the setting of "markedly elevated" CA19-9, neoadjuvant therapy is advised to avoid unnecessary surgery, with a risk of early recurrence. To best define biological borderline situations, new biomarkers are needed.</p><p><strong>Methods: </strong>Characteristics at diagnosis and OS were compared between patients with or without ctDNA status available. OS was estimated with the Kaplan-Meier method and compared with a log-rank test. The restricted cubic spline approach was used to identify the optimal threshold for biological parameters for death risk stratification. Univariate and multivariate Cox proportional hazard models were estimated to assess the association of ctDNA status and other parameters with OS.</p><p><strong>Results: </strong>Among the 132 patients from the primary population for analysis in the PANACHE01 -PRODIGE 48 trial, 92(71%) were available for ctDNA status at diagnosis. No selection bias was identified between patients with or without ctDNA status. Fourteen patients (15%) were ctDNA+ and exhibited a higher risk for death [ P = 0.0188; hazard ratio (95% CI): 2.28 (1.12-4.63)]. In the 92 patients with ctDNA status available among the other parameters analyzed, only CA19-9 was statically associated with OS in univariate analysis. Patients with a log of CA19-9 equal or superior to 4.4 that corresponds to a CA19-9 of 80 UI/mL were identified at higher risk for death [ P = 0.0143; hazard ratio (95% CI): 2.2 (1.15-4.19)]. In multivariate analysis, CA19-19 remained independently associated with OS ( P = 0.0323). When combining the 2 biomarkers, the median OS was 19.4 [IC 95%: 3.8-not reached (NR)] months, 30.2 (IC 95%: 17.1-NR) months and NR (IC 95%: 39.3-NR) for "CA19-9 high and ctDNA+ group," "CA19-9 high or ctDNA+ group," and "CA19-9 low and ctDNA- group," respectively (log-rank P = 0.0069).</p><p><strong>Conclusions: </strong>Progress in the management of potentially operable PA remains limited, relying solely on strategies to optimize the sequence of complete treatment, based on modern multidrug chemotherapy (FOLFIRINOX, GemNabPaclitaxel) and surgical resection. The identification of risk criteria, such as the existence of systemic disease, is an important issue, currently referred to as "biological borderline disease." Few data, particularly from prospective studies, allow us to identify biomarkers
目的基于PANACHE01-PRODIGE 48试验的一项计划辅助研究,研究基线CA19-9和循环肿瘤DNA(ctDNA)对可切除胰腺导管腺癌(PA)患者总生存期(OS)的预后价值,以改善死亡风险分层:在 2016 年国际共识会议之后,MD Anderson 首次使用的生物边界情况成为管理 PA 的标准做法。考虑到全身性疾病的风险,尤其是在 CA19-9 "明显升高 "的情况下,建议进行新辅助治疗,以避免不必要的手术和早期复发的风险。为了更好地界定生物学边界情况,需要新的生物标志物:方法:比较有或没有ctDNA状态的患者的诊断特征和OS。OS 采用 Kaplan Meier 法估算,并用对数秩检验进行比较。采用限制立方样条法确定用于死亡风险分层的生物参数的最佳阈值。估算了单变量和多变量考克斯比例危险模型,以评估ctDNA状态和其他参数与OS的关系:在PANACHE01 -PRODIGE 48试验的主要分析人群132名患者中,有92人(71%)在诊断时可获得ctDNA状态。有无ctDNA状态的患者之间未发现选择偏差。14名患者(15%)为ctDNA+,死亡风险较高(P=0,0188;HR95% CI:2.28(1.12-4.63))。在 92 例可获得 ctDNA 状态的患者中,在分析的其他参数中,只有 CA19-9 在单变量分析中与 OS 有统计学相关性。CA19-9对数等于或大于4.4(相当于CA19-9为80 UI/mL)的患者死亡风险较高(P=0,0143;HR95% CI:2.2(1.15-4.19))。在多变量分析中,CA19-19 仍与 OS 独立相关(P 值=0.0323)。如果将两种生物标志物结合起来,"CA19-9高和ctDNA+组"、"CA19-9高或ctDNA+组 "和 "CA19-9低和ctDNA-组 "的中位OS分别为19.4个月(IC 95% 3.8-未达到)、30.2个月(IC 95% 17.1-NR)和未达到(IC 95% 39.3-NR)(logrank P=0,0069):讨论:潜在可手术 PA 的治疗进展仍然有限,仅依赖于基于现代多药化疗(FOLFIRINOX、GemNabPaclitaxel)和手术切除的完全治疗顺序优化策略。确定风险标准(如存在全身性疾病)是一个重要问题,目前被称为 "生物学边界疾病"。很少有数据,尤其是来自前瞻性研究的数据,能让我们确定 CA19-9 以外的生物标志物:结论:将ctDNA与CA19-9结合起来可能有助于更好地界定PA的生物学边界情况。
{"title":"New Biomarkers to Define a Biological Borderline Situation for Pancreatic Adenocarcinoma: Results of an Ancillary Study of the PANACHE01-PRODIGE48 Trial.","authors":"Jean Pinson, Julie Henriques, Ludivine Beaussire, Nasrin Sarafan-Vasseur, Antonio Sa Cunha, Jean-Baptiste Bachet, Dewi Vernerey, Frederic Di Fiore, Lilian Schwarz","doi":"10.1097/SLA.0000000000006468","DOIUrl":"10.1097/SLA.0000000000006468","url":null,"abstract":"<p><strong>Objective: </strong>To investigate in patients treated for a resectable pancreatic ductal adenocarcinoma [pancreatic adenocarcinoma (PA)], the prognostic value of baseline carbohydrate antigen 19.9 (CA19-9) and circulating tumor DNA (ctDNA) for overall survival (OS), to improve death risk stratification, based on a planned ancillary study from PANACHE01-PRODIGE 48 trial.</p><p><strong>Background: </strong>Biological borderline situation that was first used by the MD Anderson, became a standard practice following the international consensus conference in 2016 to manage PA. Regarding the risk of systemic disease, especially in the setting of \"markedly elevated\" CA19-9, neoadjuvant therapy is advised to avoid unnecessary surgery, with a risk of early recurrence. To best define biological borderline situations, new biomarkers are needed.</p><p><strong>Methods: </strong>Characteristics at diagnosis and OS were compared between patients with or without ctDNA status available. OS was estimated with the Kaplan-Meier method and compared with a log-rank test. The restricted cubic spline approach was used to identify the optimal threshold for biological parameters for death risk stratification. Univariate and multivariate Cox proportional hazard models were estimated to assess the association of ctDNA status and other parameters with OS.</p><p><strong>Results: </strong>Among the 132 patients from the primary population for analysis in the PANACHE01 -PRODIGE 48 trial, 92(71%) were available for ctDNA status at diagnosis. No selection bias was identified between patients with or without ctDNA status. Fourteen patients (15%) were ctDNA+ and exhibited a higher risk for death [ P = 0.0188; hazard ratio (95% CI): 2.28 (1.12-4.63)]. In the 92 patients with ctDNA status available among the other parameters analyzed, only CA19-9 was statically associated with OS in univariate analysis. Patients with a log of CA19-9 equal or superior to 4.4 that corresponds to a CA19-9 of 80 UI/mL were identified at higher risk for death [ P = 0.0143; hazard ratio (95% CI): 2.2 (1.15-4.19)]. In multivariate analysis, CA19-19 remained independently associated with OS ( P = 0.0323). When combining the 2 biomarkers, the median OS was 19.4 [IC 95%: 3.8-not reached (NR)] months, 30.2 (IC 95%: 17.1-NR) months and NR (IC 95%: 39.3-NR) for \"CA19-9 high and ctDNA+ group,\" \"CA19-9 high or ctDNA+ group,\" and \"CA19-9 low and ctDNA- group,\" respectively (log-rank P = 0.0069).</p><p><strong>Conclusions: </strong>Progress in the management of potentially operable PA remains limited, relying solely on strategies to optimize the sequence of complete treatment, based on modern multidrug chemotherapy (FOLFIRINOX, GemNabPaclitaxel) and surgical resection. The identification of risk criteria, such as the existence of systemic disease, is an important issue, currently referred to as \"biological borderline disease.\" Few data, particularly from prospective studies, allow us to identify biomarkers","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":" ","pages":"734-744"},"PeriodicalIF":7.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141888299","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01Epub Date: 2024-08-01DOI: 10.1097/SLA.0000000000006473
Tessa E Hendriks, Alberto Balduzzi, Susan van Dieren, J Annelie Suurmeijer, Roberto Salvia, Thomas F Stoop, Marco Del Chiaro, Sven D Mieog, Mark Nielen, Sabino Zani, Daniel Nussbaum, Thilo Hackert, Jakob R Izbicki, Ammar A Javed, D Brock Hewitt, Bas Groot Koerkamp, Roeland F de Wilde, Yi Miao, Kuirong Jiang, Kohei Nakata, Masafumi Nakamura, Jin-Young Jang, Mirang Lee, Cristina R Ferrone, Shailesh V Shrikhande, Vikram A Chaudhari, Olivier R Busch, Ajith K Siriwardena, Oliver Strobel, Jens Werner, Bert A Bonsing, Giovanni Marchegiani, Marc G Besselink
Objective: To determine the interobserver variability for complications of pancreatoduodenectomy as defined by the International Study Group for Pancreatic Surgery (ISGPS) and others.
Background: Good interobserver variability for the definitions of surgical complications is of major importance in comparing surgical outcomes between and within centers. However, data on interobserver variability for pancreatoduodenectomy-specific complications are lacking.
Methods: International cross-sectional multicenter study including 52 raters from 13 high-volume pancreatic centers in 8 countries on 3 continents. Per center, 4 experienced raters scored 30 randomly selected patients after pancreatoduodenectomy. In addition, all raters scored 6 standardized case vignettes. This variability and the "within centers" variability were calculated for 2-fold scoring (no complication/grade A vs grade B/C) and 3-fold scoring (no complication/grade A vs grade B vs grade C) of postoperative pancreatic fistula, postpancreatoduodenectomy hemorrhage, chyle leak, bile leak, and delayed gastric emptying. Interobserver variability is presented with Gwet AC-1 measure for agreement.
Results: Overall, 390 patients after pancreatoduodenectomy were included. The overall agreement rate for the standardized cases vignettes for 2-fold scoring was 68% (95% CI: 55%-81%, AC1 score: moderate agreement), and for 3-fold scoring 55% (49%-62%, AC1 score: fair agreement). The mean "within centers" agreement for 2-fold scoring was 84% (80%-87%, AC1 score; substantial agreement).
Conclusions: The interobserver variability for the ISGPS-defined complications of pancreatoduodenectomy was too high even though the "within centers" agreement was acceptable. Since these findings will decrease the quality and validity of clinical studies, ISGPS has started efforts aimed at reducing the interobserver variability.
{"title":"Interobserver Variability in the International Study Group for Pancreatic Surgery (ISGPS)-Defined Complications After Pancreatoduodenectomy: An International Cross-Sectional Multicenter Study.","authors":"Tessa E Hendriks, Alberto Balduzzi, Susan van Dieren, J Annelie Suurmeijer, Roberto Salvia, Thomas F Stoop, Marco Del Chiaro, Sven D Mieog, Mark Nielen, Sabino Zani, Daniel Nussbaum, Thilo Hackert, Jakob R Izbicki, Ammar A Javed, D Brock Hewitt, Bas Groot Koerkamp, Roeland F de Wilde, Yi Miao, Kuirong Jiang, Kohei Nakata, Masafumi Nakamura, Jin-Young Jang, Mirang Lee, Cristina R Ferrone, Shailesh V Shrikhande, Vikram A Chaudhari, Olivier R Busch, Ajith K Siriwardena, Oliver Strobel, Jens Werner, Bert A Bonsing, Giovanni Marchegiani, Marc G Besselink","doi":"10.1097/SLA.0000000000006473","DOIUrl":"10.1097/SLA.0000000000006473","url":null,"abstract":"<p><strong>Objective: </strong>To determine the interobserver variability for complications of pancreatoduodenectomy as defined by the International Study Group for Pancreatic Surgery (ISGPS) and others.</p><p><strong>Background: </strong>Good interobserver variability for the definitions of surgical complications is of major importance in comparing surgical outcomes between and within centers. However, data on interobserver variability for pancreatoduodenectomy-specific complications are lacking.</p><p><strong>Methods: </strong>International cross-sectional multicenter study including 52 raters from 13 high-volume pancreatic centers in 8 countries on 3 continents. Per center, 4 experienced raters scored 30 randomly selected patients after pancreatoduodenectomy. In addition, all raters scored 6 standardized case vignettes. This variability and the \"within centers\" variability were calculated for 2-fold scoring (no complication/grade A vs grade B/C) and 3-fold scoring (no complication/grade A vs grade B vs grade C) of postoperative pancreatic fistula, postpancreatoduodenectomy hemorrhage, chyle leak, bile leak, and delayed gastric emptying. Interobserver variability is presented with Gwet AC-1 measure for agreement.</p><p><strong>Results: </strong>Overall, 390 patients after pancreatoduodenectomy were included. The overall agreement rate for the standardized cases vignettes for 2-fold scoring was 68% (95% CI: 55%-81%, AC1 score: moderate agreement), and for 3-fold scoring 55% (49%-62%, AC1 score: fair agreement). The mean \"within centers\" agreement for 2-fold scoring was 84% (80%-87%, AC1 score; substantial agreement).</p><p><strong>Conclusions: </strong>The interobserver variability for the ISGPS-defined complications of pancreatoduodenectomy was too high even though the \"within centers\" agreement was acceptable. Since these findings will decrease the quality and validity of clinical studies, ISGPS has started efforts aimed at reducing the interobserver variability.</p>","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":" ","pages":"728-733"},"PeriodicalIF":7.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141858882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}