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

T. E.F. Abbott; A. Patel; Tahania Ahmed; Rupert M. Pearse; K. E. Greaves; James Haddow; Emmanuel Futier; Matthieu Biais; Karem Slim; Scott Beattie; Pierre Alain Clavien; Nicolas Demartines; Lee A. Fleisher; Mike Grocott; Andreas Hoeft; Peter Holt; Rui Moreno; Naomi Pritchard; Andrew Rhodes; Duminda Wijeysundera; Matt Wilson; Kirsty Everingham; Russell Hewson; Marta Januszewska; Mandeep Kaur Phull; Richard Halliwell; Jennifer Cope; Mark Shulman; Paul Myles; Marissa Ferguson; Michael MacMahon; Werner Schmid; Michael Hiesmayr; Patrick Wouters; Stefan de Hert; Suzana M. Lobo; Xiangming Fang; Lars Rasmussen; Aurélien Venara; Michael Sander; Despoina Koulenti; Kostoula Arvaniti; Mathew Chan; Atul Kulkarni; Susilo Chandra; Aida Tantri; Emad Geddoa; Muntadhar Abbas; Giorgio della Rocca; Wolfgang Buhre; International Surgical Outcomes Study (ISOS) Group

doi:10.1002/bjs.11025

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

T. E.F. Abbott^*, A. Patel, Tahania Ahmed, Rupert M. Pearse^*, K. E. Greaves, James Haddow, Emmanuel Futier, Matthieu Biais, Karem Slim, Scott Beattie, Pierre Alain Clavien, Nicolas Demartines, Lee A. Fleisher, Mike Grocott, Andreas Hoeft, Peter Holt, Rui Moreno, Naomi Pritchard, Andrew Rhodes, Duminda WijeysunderaMatt Wilson, Kirsty Everingham, Russell Hewson, Marta Januszewska, Mandeep Kaur Phull, Richard Halliwell, Jennifer Cope, Mark Shulman, Paul Myles, Marissa Ferguson, Michael MacMahon, Werner Schmid, Michael Hiesmayr, Patrick Wouters, Stefan de Hert, Suzana M. Lobo, Xiangming Fang, Lars Rasmussen, Aurélien Venara, Michael Sander, Despoina Koulenti, Kostoula Arvaniti, Mathew Chan, Atul Kulkarni, Susilo Chandra, Aida Tantri, Emad Geddoa, Muntadhar Abbas, Giorgio della Rocca, Wolfgang Buhre, International Surgical Outcomes Study (ISOS) Group

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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.

Original language	English
Pages (from-to)	E73-E80
Number of pages	8
Journal	British Journal of Surgery
Volume	106
Issue number	2
DOIs	https://doi.org/10.1002/bjs.11025
Publication status	Published - 1 Jan 2019

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10.1002/bjs.11025

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Abbott, T. E. F., Patel, A., Ahmed, T., Pearse, R. M., Greaves, K. E., Haddow, J., Futier, E., Biais, M., Slim, K., Beattie, S., Clavien, P. A., Demartines, N., Fleisher, L. A., Grocott, M., Hoeft, A., Holt, P., Moreno, R., Pritchard, N., Rhodes, A., ... International Surgical Outcomes Study (ISOS) Group (2019). Prospective observational cohort study on grading the severity of postoperative complications in global surgery research. British Journal of Surgery, 106(2), E73-E80. https://doi.org/10.1002/bjs.11025

@article{e7c086644b894a0db2fcdbeb3f7436f9,

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.",

author = "Abbott, {T. E.F.} and A. Patel and Tahania Ahmed and Pearse, {Rupert M.} and Greaves, {K. E.} and James Haddow and Emmanuel Futier and Matthieu Biais and Karem Slim and Scott Beattie and Clavien, {Pierre Alain} and Nicolas Demartines and Fleisher, {Lee A.} and Mike Grocott and Andreas Hoeft and Peter Holt and Rui Moreno and Naomi Pritchard and Andrew Rhodes and Duminda Wijeysundera and Matt Wilson and Kirsty Everingham and Russell Hewson and Marta Januszewska and Phull, {Mandeep Kaur} and Richard Halliwell and Jennifer Cope and Mark Shulman and Paul Myles and Marissa Ferguson and Michael MacMahon and Werner Schmid and Michael Hiesmayr and Patrick Wouters and {de Hert}, Stefan and Lobo, {Suzana M.} and Xiangming Fang and Lars Rasmussen and Aur{\'e}lien Venara and Michael Sander and Despoina Koulenti and Kostoula Arvaniti and Mathew Chan and Atul Kulkarni and Susilo Chandra and Aida Tantri and Emad Geddoa and Muntadhar Abbas and {della Rocca}, Giorgio and Wolfgang Buhre and {International Surgical Outcomes Study (ISOS) Group}",

note = "Funding Information: The ISOS was funded through an unrestricted research grant from Nestl{\'e} Health Sciences. The writing committee comprised T. E. F. Abbott, K. E. Greaves, A. Patel, T. Ahmad, J. Haddow, E. Futier, M. Biais, K. Slim and R. M. Pearse. T.E.F.A. and K.E.G. are joint first authors of this paper. Patient recruitment and data collection were performed by members of the ISOS group (see Appendix S1, supporting information). R.M.P. is a UK National Institute for Health Research Professor. Funding Information: K.S. has given lectures for Sanofi, B. Braun, and Myers Squibb and Dohm. E.F. declares consulting fees from Edwards Lifesciences and Drager, lecture fees from GE Healthcare, Fresenius Kabi and Fisher Paykel. M.B. has received lecture fees from Edwards Lifesciences and Maquet Critical Care. R.M.P. holds research grants and has given lectures and/or performed consultancy work for Nestl? Health Sciences, B. Braun, Medtronic, Glaxo-SmithKline and Edwards Lifesciences, and is a member of the associate editorial board of the British Journal of Anaesthesia. Publisher Copyright: {\textcopyright} 2019 BJS Society Ltd.",

year = "2019",

month = jan,

day = "1",

doi = "10.1002/bjs.11025",

language = "English",

volume = "106",

pages = "E73--E80",

journal = "British Journal of Surgery",

issn = "0007-1323",

publisher = "Wiley",

number = "2",

}

Abbott, TEF, Patel, A, Ahmed, T, Pearse, RM, Greaves, KE, Haddow, J, Futier, E, Biais, M, Slim, K, Beattie, S, Clavien, PA, Demartines, N, Fleisher, LA, Grocott, M, Hoeft, A, Holt, P, Moreno, R, Pritchard, N, Rhodes, A, Wijeysundera, D, Wilson, M, Everingham, K, Hewson, R, Januszewska, M, Phull, MK, Halliwell, R, Cope, J, Shulman, M, Myles, P, Ferguson, M, MacMahon, M, Schmid, W, Hiesmayr, M, Wouters, P, de Hert, S, Lobo, SM, Fang, X, Rasmussen, L, Venara, A, Sander, M, Koulenti, D, Arvaniti, K, Chan, M, Kulkarni, A, Chandra, S, Tantri, A, Geddoa, E, Abbas, M, della Rocca, G, Buhre, W & International Surgical Outcomes Study (ISOS) Group 2019, 'Prospective observational cohort study on grading the severity of postoperative complications in global surgery research', British Journal of Surgery, vol. 106, no. 2, pp. E73-E80. https://doi.org/10.1002/bjs.11025

TY - JOUR

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

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 - Buhre, Wolfgang

AU - International Surgical Outcomes Study (ISOS) Group

N1 - Funding Information: The ISOS was funded through an unrestricted research grant from Nestlé Health Sciences. The writing committee comprised T. E. F. Abbott, K. E. Greaves, A. Patel, T. Ahmad, J. Haddow, E. Futier, M. Biais, K. Slim and R. M. Pearse. T.E.F.A. and K.E.G. are joint first authors of this paper. Patient recruitment and data collection were performed by members of the ISOS group (see Appendix S1, supporting information). R.M.P. is a UK National Institute for Health Research Professor. Funding Information: K.S. has given lectures for Sanofi, B. Braun, and Myers Squibb and Dohm. E.F. declares consulting fees from Edwards Lifesciences and Drager, lecture fees from GE Healthcare, Fresenius Kabi and Fisher Paykel. M.B. has received lecture fees from Edwards Lifesciences and Maquet Critical Care. R.M.P. holds research grants and has given lectures and/or performed consultancy work for Nestl? Health Sciences, B. Braun, Medtronic, Glaxo-SmithKline and Edwards Lifesciences, and is a member of the associate editorial board of the British Journal of Anaesthesia. 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.

U2 - 10.1002/bjs.11025

DO - 10.1002/bjs.11025

M3 - Article

SN - 0007-1323

VL - 106

SP - E73-E80

JO - British Journal of Surgery

JF - British Journal of Surgery

IS - 2

ER -