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Prospective observational cohort study on grading the severity of postoperative complications in global surgery research

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@article{f8c3af92c35742ea8a32115fe5bf8a7c,
title = "Prospective observational cohort study on grading the severity of postoperative complications in global surgery research",
abstract = "BACKGROUND: The 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).METHODS: This 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, comparing HICs with LMICs.RESULTS: A total of 44 814 patients were recruited from 474 hospitals in 27 countries (19 HICs and 8 LMICs). Some 7508 patients (16·8 per cent) experienced at least one postoperative complication, equivalent to 11 664 complications in total. Using the ISOS classification, 5504 of 11 664 complications (47·2 per cent) were graded as mild, 4244 (36·4 per cent) as moderate and 1916 (16·4 per cent) as severe. Using Clavien-Dindo, 6781 of 11 664 complications (58·1 per cent) were graded as I or II, 1740 (14·9 per cent) as III, 2408 (20·6 per cent) as IV and 735 (6·3 per cent) as V. Agreement between classification systems was poor overall (ICC 0·41, 95 per cent c.i. 0·20 to 0·55), and in LMICs (ICC 0·23, 0·05 to 0·38) and HICs (ICC 0·46, 0·25 to 0·59).CONCLUSION: Caution is recommended when using a treatment approach to grade complications in global surgery studies, as this may introduce bias unintentionally.",
keywords = "Adult, Aged, Cohort Studies, Elective Surgical Procedures/adverse effects, Female, Global Health, Humans, Male, Middle Aged, Outcome Assessment, Health Care, Postoperative Complications/diagnosis, Prospective Studies, Severity of Illness Index",
author = "{International Surgical Outcomes Study (ISOS) group} and Kim Ekelund and Arash Afshari and Rasmussen, {Lars Simon}",
note = "{\circledC} 2019 BJS Society Ltd Published by John Wiley & Sons Ltd.",
year = "2019",
month = "1",
doi = "10.1002/bjs.11025",
language = "English",
volume = "106",
pages = "e73--e80",
journal = "Netherlands Journal of Surgery",
issn = "0007-1323",
publisher = "John/Wiley & Sons Ltd",
number = "2",

}

RIS

TY - JOUR

T1 - Prospective observational cohort study on grading the severity of postoperative complications in global surgery research

AU - International Surgical Outcomes Study (ISOS) group

A2 - Ekelund, Kim

A2 - Afshari, Arash

A2 - Rasmussen, Lars Simon

N1 - © 2019 BJS Society Ltd Published by John Wiley & Sons Ltd.

PY - 2019/1

Y1 - 2019/1

N2 - BACKGROUND: The 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).METHODS: This 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, comparing HICs with LMICs.RESULTS: A total of 44 814 patients were recruited from 474 hospitals in 27 countries (19 HICs and 8 LMICs). Some 7508 patients (16·8 per cent) experienced at least one postoperative complication, equivalent to 11 664 complications in total. Using the ISOS classification, 5504 of 11 664 complications (47·2 per cent) were graded as mild, 4244 (36·4 per cent) as moderate and 1916 (16·4 per cent) as severe. Using Clavien-Dindo, 6781 of 11 664 complications (58·1 per cent) were graded as I or II, 1740 (14·9 per cent) as III, 2408 (20·6 per cent) as IV and 735 (6·3 per cent) as V. Agreement between classification systems was poor overall (ICC 0·41, 95 per cent c.i. 0·20 to 0·55), and in LMICs (ICC 0·23, 0·05 to 0·38) and HICs (ICC 0·46, 0·25 to 0·59).CONCLUSION: Caution is recommended when using a treatment approach to grade complications in global surgery studies, as this may introduce bias unintentionally.

AB - BACKGROUND: The 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).METHODS: This 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, comparing HICs with LMICs.RESULTS: A total of 44 814 patients were recruited from 474 hospitals in 27 countries (19 HICs and 8 LMICs). Some 7508 patients (16·8 per cent) experienced at least one postoperative complication, equivalent to 11 664 complications in total. Using the ISOS classification, 5504 of 11 664 complications (47·2 per cent) were graded as mild, 4244 (36·4 per cent) as moderate and 1916 (16·4 per cent) as severe. Using Clavien-Dindo, 6781 of 11 664 complications (58·1 per cent) were graded as I or II, 1740 (14·9 per cent) as III, 2408 (20·6 per cent) as IV and 735 (6·3 per cent) as V. Agreement between classification systems was poor overall (ICC 0·41, 95 per cent c.i. 0·20 to 0·55), and in LMICs (ICC 0·23, 0·05 to 0·38) and HICs (ICC 0·46, 0·25 to 0·59).CONCLUSION: Caution is recommended when using a treatment approach to grade complications in global surgery studies, as this may introduce bias unintentionally.

KW - Adult

KW - Aged

KW - Cohort Studies

KW - Elective Surgical Procedures/adverse effects

KW - Female

KW - Global Health

KW - Humans

KW - Male

KW - Middle Aged

KW - Outcome Assessment, Health Care

KW - Postoperative Complications/diagnosis

KW - Prospective Studies

KW - Severity of Illness Index

U2 - 10.1002/bjs.11025

DO - 10.1002/bjs.11025

M3 - Journal article

VL - 106

SP - e73-e80

JO - Netherlands Journal of Surgery

JF - Netherlands Journal of Surgery

SN - 0007-1323

IS - 2

ER -

ID: 58926143