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
AU - Abbott, T. E.F.
AU - Patel, A.
AU - Ahmed, Tahania
AU - Pearse, Rupert M.
AU - Greaves, K. E.
AU - Haddow, James
AU - Futier, Emmanuel
AU - Biais, Matthieu
AU - Slim, Karem
AU - Beattie, Scott
AU - Clavien, Pierre Alain
AU - Demartines, Nicolas
AU - Fleisher, Lee A.
AU - Grocott, Mike
AU - Hoeft, Andreas
AU - Holt, Peter
AU - Moreno, Rui
AU - Pritchard, Naomi
AU - Rhodes, Andrew
AU - Wijeysundera, Duminda
AU - Wilson, Matt
AU - Everingham, Kirsty
AU - Hewson, Russell
AU - Januszewska, Marta
AU - Phull, Mandeep Kaur
AU - Halliwell, Richard
AU - Cope, Jennifer
AU - Shulman, Mark
AU - Myles, Paul
AU - Ferguson, Marissa
AU - MacMahon, Michael
AU - Schmid, Werner
AU - Hiesmayr, Michael
AU - Wouters, Patrick
AU - de Hert, Stefan
AU - Lobo, Suzana M.
AU - Fang, Xiangming
AU - Rasmussen, Lars
AU - Venara, Aurélien
AU - Sander, Michael
AU - Koulenti, Despoina
AU - Arvaniti, Kostoula
AU - Chan, Mathew
AU - Kulkarni, Atul
AU - Chandra, Susilo
AU - Tantri, Aida
AU - Geddoa, Emad
AU - Abbas, Muntadhar
AU - della Rocca, Giorgio
AU - Sivasakthi, Datin
AU - Mansor, Marzida
AU - Luna, Pastor
AU - Bouwman, Arthur
AU - Buhre, Wolfgang
AU - Beavis, Vanessa
AU - Campbell, Douglas
AU - Short, Tim
AU - Osinaike, Tunde
AU - Matos, Ricardo
AU - Grigoras, Ioana
AU - Kirov, Mikhail
AU - Protsenko, Denis
AU - Biccard, Bruce M.
AU - Aldecoa, Cesar
AU - Chew, Michelle
AU - Hofer, Christoph
AU - Hubner, Martin
AU - Ditai, James
AU - Szakmany, Tamas
AU - Fleisher, Lee
AU - Cherian, Ritchie
AU - Currow, Helen
AU - Kanathiban, Kathirgamanathan
AU - Gillespie, David
AU - Pathmanathan, Edward
AU - Phillips, Katherine
AU - Reynolds, Jenifer
AU - Rowley, Joanne
AU - Douglas, Jeanene
AU - Kerridge, Ross
AU - Currow, Helen
AU - Garg, Sameer
AU - Bennett, Michael
AU - Jain, Megha
AU - Alcock, David
AU - Terblanche, Nico
AU - Cotter, Rochelle
AU - Leslie, Kate
AU - Stewart, Marcelle
AU - Zingerle, Nicolette
AU - Clyde, Antony
AU - Hambidge, Oliver
AU - Rehak, Adam
AU - Cotterell, Sharon
AU - Huynh, Wilson Binh Quan
AU - McCulloch, Timothy
AU - Ben-Menachem, Erez
AU - Egan, Thomas
AU - Fellinger, Paul
AU - O'Connor, Laura
N1 - Publisher Copyright:
© 2019 BJS Society Ltd.
PY - 2019/1/1
Y1 - 2019/1/1
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.
UR - https://www.scopus.com/pages/publications/85059928177
U2 - 10.1002/bjs.11025
DO - 10.1002/bjs.11025
M3 - Article
C2 - 30620066
AN - SCOPUS:85059928177
SN - 0007-1323
VL - 106
SP - e73-e80
JO - British Journal of Surgery
JF - British Journal of Surgery
IS - 2
ER -