European Journal of Surgical Oncology (EJSO), 2017
on behalf the International Surgical Outcomes Study (ISOS) group* *members of study group listed ... more on behalf the International Surgical Outcomes Study (ISOS) group* *members of study group listed in the Supplementary Appendix
BackgroundThe Clavien–Dindo classification is perhaps the most widely used approach for reporting... more BackgroundThe Clavien–Dindo classification is perhaps the most widely used approach for reporting postoperative complications in clinical trials. This system classifies complication severity by the treatment provided. However, it is unclear whether the Clavien–Dindo system can be used internationally in studies across differing healthcare systems in high- (HICs) and low- and middle-income countries (LMICs).MethodsThis was a secondary analysis of the International Surgical Outcomes Study (ISOS), a prospective observational cohort study of elective surgery in adults. Data collection occurred over a 7-day period. Severity of complications was graded using Clavien–Dindo and the simpler ISOS grading (mild, moderate or severe, based on guided investigator judgement). Severity grading was compared using the intraclass correlation coefficient (ICC). Data are presented as frequencies and ICC values (with 95 per cent c.i.). The analysis was stratified by income status of the country, comparin...
Supplemental material, sj-docx-1-cjk-10.1177_20543581211069225 for Effect of a Perioperative Hypo... more Supplemental material, sj-docx-1-cjk-10.1177_20543581211069225 for Effect of a Perioperative Hypotension-Avoidance Strategy Versus a Hypertension-Avoidance Strategy on the Risk of Acute Kidney Injury: A Clinical Research Protocol for a Substudy of the POISE-3 Randomized Clinical Trial by Amit X. Garg, Meaghan Cuerden, Hector Aguado, Mohammed Amir, Emilie P. Belley-Cote, Keyur Bhatt, Bruce M. Biccard, Flavia K. Borges, Matthew Chan, David Conen, Emmanuelle Duceppe, Sergey Efremov, John Eikelboom, Edith Fleischmann, Landoni Giovanni, Peter Gross, Raja Jayaram, Mikhail Kirov, Ydo Kleinlugtenbelt, Andrea Kurz, Andre Lamy, Kate Leslie, Valery Likhvantsev, Vladimir Lomivorotov, Maura Marcucci, Maria José Martínez-Zapata, Michael McGillion, William McIntyre, Christian Meyhoff, Sandra Ofori, Thomas Painter, Pilar Paniagua, Chirag Parikh, Joel Parlow, Ameen Patel, Carisi Polanczyk, Toby Richards, Pavel Roshanov, Denis Schmartz, Daniel Sessler, Tim Short, Jessica M. Sontrop, Jessica Spence, S...
Canadian Journal of Kidney Health and Disease, 2022
Background: Most patients who take antihypertensive medications continue taking them on the morni... more Background: Most patients who take antihypertensive medications continue taking them on the morning of surgery and during the perioperative period. However, growing evidence suggests this practice may contribute to perioperative hypotension and a higher risk of complications. This protocol describes an acute kidney injury substudy of the Perioperative Ischemic Evaluation-3 (POISE-3) trial, which is testing the effect of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy in patients undergoing noncardiac surgery. Objective: To conduct a substudy of POISE-3 to determine whether a perioperative hypotension-avoidance strategy reduces the risk of acute kidney injury compared with a hypertension-avoidance strategy. Design: Randomized clinical trial with 1:1 randomization to the intervention (a perioperative hypotension-avoidance strategy) or control (a hypertension-avoidance strategy). Intervention: If the presurgery systolic blood pressure (SBP) is &l...
Background For patients undergoing noncardiac surgery, bleeding and hypotension are frequent and ... more Background For patients undergoing noncardiac surgery, bleeding and hypotension are frequent and associated with increased mortality and cardiovascular complications. Tranexamic acid (TXA) is an antifibrinolytic agent with the potential to reduce surgical bleeding; however, there is uncertainty about its efficacy and safety in noncardiac surgery. Although usual perioperative care is commonly consistent with a hypertension-avoidance strategy (i.e., most patients continue their antihypertensive medications throughout the perioperative period and intraoperative mean arterial pressures of 60 mmHg are commonly accepted), a hypotension-avoidance strategy may improve perioperative outcomes. Methods The PeriOperative Ischemic Evaluation (POISE)-3 Trial is a large international randomized controlled trial designed to determine if TXA is superior to placebo for the composite outcome of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of majo...
Background Preoperative SARS-CoV-2 vaccination could support safer elective surgery. Vaccine numb... more Background Preoperative SARS-CoV-2 vaccination could support safer elective surgery. Vaccine numbers are limited so this study aimed to inform their prioritization by modelling. Methods The primary outcome was the number needed to vaccinate (NNV) to prevent one COVID-19-related death in 1 year. NNVs were based on postoperative SARS-CoV-2 rates and mortality in an international cohort study (surgical patients), and community SARS-CoV-2 incidence and case fatality data (general population). NNV estimates were stratified by age (18–49, 50–69, 70 or more years) and type of surgery. Best- and worst-case scenarios were used to describe uncertainty. Results NNVs were more favourable in surgical patients than the general population. The most favourable NNVs were in patients aged 70 years or more needing cancer surgery (351; best case 196, worst case 816) or non-cancer surgery (733; best case 407, worst case 1664). Both exceeded the NNV in the general population (1840; best case 1196, worst ...
European Journal of Surgical Oncology (EJSO), 2017
on behalf the International Surgical Outcomes Study (ISOS) group* *members of study group listed ... more on behalf the International Surgical Outcomes Study (ISOS) group* *members of study group listed in the Supplementary Appendix
BackgroundThe Clavien–Dindo classification is perhaps the most widely used approach for reporting... more BackgroundThe Clavien–Dindo classification is perhaps the most widely used approach for reporting postoperative complications in clinical trials. This system classifies complication severity by the treatment provided. However, it is unclear whether the Clavien–Dindo system can be used internationally in studies across differing healthcare systems in high- (HICs) and low- and middle-income countries (LMICs).MethodsThis was a secondary analysis of the International Surgical Outcomes Study (ISOS), a prospective observational cohort study of elective surgery in adults. Data collection occurred over a 7-day period. Severity of complications was graded using Clavien–Dindo and the simpler ISOS grading (mild, moderate or severe, based on guided investigator judgement). Severity grading was compared using the intraclass correlation coefficient (ICC). Data are presented as frequencies and ICC values (with 95 per cent c.i.). The analysis was stratified by income status of the country, comparin...
Supplemental material, sj-docx-1-cjk-10.1177_20543581211069225 for Effect of a Perioperative Hypo... more Supplemental material, sj-docx-1-cjk-10.1177_20543581211069225 for Effect of a Perioperative Hypotension-Avoidance Strategy Versus a Hypertension-Avoidance Strategy on the Risk of Acute Kidney Injury: A Clinical Research Protocol for a Substudy of the POISE-3 Randomized Clinical Trial by Amit X. Garg, Meaghan Cuerden, Hector Aguado, Mohammed Amir, Emilie P. Belley-Cote, Keyur Bhatt, Bruce M. Biccard, Flavia K. Borges, Matthew Chan, David Conen, Emmanuelle Duceppe, Sergey Efremov, John Eikelboom, Edith Fleischmann, Landoni Giovanni, Peter Gross, Raja Jayaram, Mikhail Kirov, Ydo Kleinlugtenbelt, Andrea Kurz, Andre Lamy, Kate Leslie, Valery Likhvantsev, Vladimir Lomivorotov, Maura Marcucci, Maria José Martínez-Zapata, Michael McGillion, William McIntyre, Christian Meyhoff, Sandra Ofori, Thomas Painter, Pilar Paniagua, Chirag Parikh, Joel Parlow, Ameen Patel, Carisi Polanczyk, Toby Richards, Pavel Roshanov, Denis Schmartz, Daniel Sessler, Tim Short, Jessica M. Sontrop, Jessica Spence, S...
Canadian Journal of Kidney Health and Disease, 2022
Background: Most patients who take antihypertensive medications continue taking them on the morni... more Background: Most patients who take antihypertensive medications continue taking them on the morning of surgery and during the perioperative period. However, growing evidence suggests this practice may contribute to perioperative hypotension and a higher risk of complications. This protocol describes an acute kidney injury substudy of the Perioperative Ischemic Evaluation-3 (POISE-3) trial, which is testing the effect of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy in patients undergoing noncardiac surgery. Objective: To conduct a substudy of POISE-3 to determine whether a perioperative hypotension-avoidance strategy reduces the risk of acute kidney injury compared with a hypertension-avoidance strategy. Design: Randomized clinical trial with 1:1 randomization to the intervention (a perioperative hypotension-avoidance strategy) or control (a hypertension-avoidance strategy). Intervention: If the presurgery systolic blood pressure (SBP) is &l...
Background For patients undergoing noncardiac surgery, bleeding and hypotension are frequent and ... more Background For patients undergoing noncardiac surgery, bleeding and hypotension are frequent and associated with increased mortality and cardiovascular complications. Tranexamic acid (TXA) is an antifibrinolytic agent with the potential to reduce surgical bleeding; however, there is uncertainty about its efficacy and safety in noncardiac surgery. Although usual perioperative care is commonly consistent with a hypertension-avoidance strategy (i.e., most patients continue their antihypertensive medications throughout the perioperative period and intraoperative mean arterial pressures of 60 mmHg are commonly accepted), a hypotension-avoidance strategy may improve perioperative outcomes. Methods The PeriOperative Ischemic Evaluation (POISE)-3 Trial is a large international randomized controlled trial designed to determine if TXA is superior to placebo for the composite outcome of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of majo...
Background Preoperative SARS-CoV-2 vaccination could support safer elective surgery. Vaccine numb... more Background Preoperative SARS-CoV-2 vaccination could support safer elective surgery. Vaccine numbers are limited so this study aimed to inform their prioritization by modelling. Methods The primary outcome was the number needed to vaccinate (NNV) to prevent one COVID-19-related death in 1 year. NNVs were based on postoperative SARS-CoV-2 rates and mortality in an international cohort study (surgical patients), and community SARS-CoV-2 incidence and case fatality data (general population). NNV estimates were stratified by age (18–49, 50–69, 70 or more years) and type of surgery. Best- and worst-case scenarios were used to describe uncertainty. Results NNVs were more favourable in surgical patients than the general population. The most favourable NNVs were in patients aged 70 years or more needing cancer surgery (351; best case 196, worst case 816) or non-cancer surgery (733; best case 407, worst case 1664). Both exceeded the NNV in the general population (1840; best case 1196, worst ...
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