1. Systematic reviews and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: mortality, morbidity, and organ failure
- Author
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Alexander I.R. Jackson, Oliver Boney, Rupert M. Pearse, Andrea Kurz, D. James Cooper, Wilton A. van Klei, Luca Cabrini, Timothy E. Miller, S. Ramani Moonesinghe, Paul S. Myles, Michael P.W. Grocott, Paul Myles, T.J. Gan, Phil Peyton, Dan Sessler, Martin Tramèr, Alan Cyna, Gildasio S. De Oliveira, Christopher Wu, Mark Jensen, Henrik Kehlet, Mari Botti, Guy Haller, Mike Grocott, Tim Cook, Lee Fleisher, Mark Neuman, David Story, Russell Gruen, Sam Bampoe, Lis Evered, David Scott, Brendan Silbert, Diederik van Dijk, Cor Kalkman, Matthew Chan, Hilary Grocott, Rod Eckenhoff, Lars Rasmussen, Lars Eriksson, Scott Beattie, Duminda Wijeysundera, Giovanni Landoni, Kate Leslie, Bruce Biccard, Simon Howell, Peter Nagele, Toby Richards, Andre Lamy, Manoj Lalu, Rupert Pearse, Monty Mythen, Jaume Canet, Ann Moller, Tony Gin, Marcus Schultz, Paolo Pelosi, Marcelo Gabreu, Emmanuel Futier, Ben Creagh-Brown, Tom Abbot, Andy Klein, Tomas Corcoran, D. Jamie Cooper, Stefan Dieleman, Elisabeth Diouf, David McIlroy, Rinaldo Bellomo, Andrew Shaw, John Prowle, Keyvan Karkouti, Josh Billings, David Mazer, Mohindas Jayarajah, Michael Murphy, Justyna Bartoszko, Rob Sneyd, Steve Morris, Ron George, Ramani Moonesinghe, Mark Shulman, Meghan Lane-Fall, Ulrica Nilsson, Nathalie Stevenson, Wilton van Klei, Tim Miller, Sandy Jackson, Donal Buggy, Tim Short, Bernhard Riedel, Vijay Gottumukkala, Nathan Pace, Bilal Alkhaffaf, Mark Johnson, Intensive Care Medicine, ACS - Pulmonary hypertension & thrombosis, and AII - Inflammatory diseases
- Subjects
surgery ,Anesthesiology and Pain Medicine ,consensus ,morbidity ,organ failure ,anaesthesia ,postoperative morbidity ,perioperative outcomes ,mortality - Abstract
Background: Mortality, morbidity, and organ failure are important and common serious harms after surgery. However, there are many candidate measures to describe these outcome domains. Definitions of these measures are highly variable, and validity is often unclear. As part of the International Standardised Endpoints in Perioperative Medicine (StEP) initiative, this study aimed to derive a set of standardised and valid measures of mortality, morbidity, and organ failure for use in perioperative clinical trials. Methods: Three domains of endpoints (mortality, morbidity, and organ failure) were explored through systematic literature review and a three-stage Delphi consensus process using methods consistently applied across the StEP initiative. Reliability, feasibility, and patient-centredness were assessed in round 3 of the consensus process. Results: A high level of consensus was achieved for two mortality time points, 30-day and 1-yr mortality, and these two measures are recommended. No organ failure endpoints achieved threshold criteria for consensus recommendation. The Clavien–Dindo classification of complications achieved threshold criteria for consensus in round 2 of the Delphi process but did not achieve the threshold criteria in round 3 where it scored equivalently to the Post Operative Morbidity Survey. Clavien–Dindo therefore received conditional endorsement as the most widely used measure. No composite measures of organ failure achieved an acceptable level of consensus. Conclusions: Both 30-day and 1-yr mortality measures are recommended. No measure is recommended for organ failure. One measure (Clavien–Dindo) is conditionally endorsed for postoperative morbidity, but our findings suggest that no single endpoint offers a reliable and valid measure to describe perioperative morbidity that is not dependent on the quality of deli-vered care. Further refinement of current measures, or development of novel measures, of postoperative morbidity might improve consensus in this area.
- Published
- 2023