Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative: clinical indicators

Guy Haller; Sohail Bampoe; Tim Cook; L. A. Fleisher; Michael P.W. Grocott; Mark Neuman; D. Story; Paul S. Myles; B. Biccard; J. Blazeby; O. Boney; M. Chan; E. Diouf; C. Kalkman; A. Kurz; R. Moonesinghe; D. Wijeysundera; T. J. Gan; P. Peyton; D. Sessler; M. Tramèr; A. Cyna; G. S. De Oliveira; C. Wu; M. Jensen; H. Kehlet; M. Botti; G. Haller; R. Gruen; L. Evered; D. Scott; B. Silbert; D. van Dijk; H. Grocott; H. Grocott; R. Eckenhoff; L. Rasmussen; L. Eriksson; S. Beattie; G. Landoni; K. Leslie; S. Howell; P. Nagele; T. Richards; A. Lamy; M. Lalu; R. Pearse; M. Mythen; J. Canet; A. Moller; T. Gin; M. Schultz; P. Pelosi; M. Gabreu; E. Futier; B. Creagh-Brown; T. Abbott; A. Klein; T. Corcoran; D. Jamie Cooper; S. Dieleman; D. McIlroy; R. Bellomo; A. Shaw; J. Prowle; K. Karkouti; J. Billings; D. Mazer; M. Jayarajah; M. Murphy; J. Bartoszko; R. Sneyd; S. Morris; R. George; M. Shulman; M. Lane-Fall; U. Nilsson; N. Stevenson; J. D.J. Cooper; W. van Klei; L. Cabrini; T. Miller; N. Pace; N. Pace; S. Jackson; D. Buggy; T. Short; B. Riedel; V. Gottumukkala; B. Alkhaffaf; M. Johnson

doi:10.1016/j.bja.2019.04.041

Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative: clinical indicators

Guy Haller, Sohail Bampoe, Tim Cook, L. A. Fleisher, Michael P.W. Grocott, Mark Neuman, D. Story, Paul S. Myles, B. Biccard, J. Blazeby, O. Boney, M. Chan, E. Diouf, C. Kalkman, A. Kurz, R. Moonesinghe, D. Wijeysundera, T. J. Gan, P. Peyton, D. SesslerM. Tramèr, A. Cyna, G. S. De Oliveira, C. Wu, M. Jensen, H. Kehlet, M. Botti, G. Haller, R. Gruen, L. Evered, D. Scott, B. Silbert, D. van Dijk, H. Grocott, H. Grocott, R. Eckenhoff, L. Rasmussen, L. Eriksson, S. Beattie, G. Landoni, K. Leslie, S. Howell, P. Nagele, T. Richards, A. Lamy, M. Lalu, R. Pearse, M. Mythen, J. Canet, A. Moller, T. Gin, M. Schultz, P. Pelosi, M. Gabreu, E. Futier, B. Creagh-Brown, T. Abbott, A. Klein, T. Corcoran, D. Jamie Cooper, S. Dieleman, D. McIlroy, R. Bellomo, A. Shaw, J. Prowle, K. Karkouti, J. Billings, D. Mazer, M. Jayarajah, M. Murphy, J. Bartoszko, R. Sneyd, S. Morris, R. George, M. Shulman, M. Lane-Fall, U. Nilsson, N. Stevenson, J. D.J. Cooper, W. van Klei, L. Cabrini, T. Miller, N. Pace, N. Pace, S. Jackson, D. Buggy, T. Short, B. Riedel, V. Gottumukkala, B. Alkhaffaf, M. Johnson

Anesthesiology & PeriOperative Medicine

Research output: Contribution to journal › Review article › peer-review

46 Scopus citations

Abstract

Background: Clinical indicators are powerful tools to quantify the safety and quality of patient care. Their validity is often unclear and definitions extremely heterogeneous. As part of the International Standardised Endpoints in Perioperative Medicine (StEP) initiative, this study aimed to derive a set of standardised and valid clinical outcome indicators for use in perioperative clinical trials. Methods: We identified clinical indicators via a systematic review of the anaesthesia and perioperative medicine literature (PubMed/OVID, EMBASE, and Cochrane Library). We performed a three-stage Delphi consensus-gaining process that involved 54 clinician–researchers worldwide. Indicators were first shortlisted and the most suitable definitions for evaluation of quality and safety interventions determined. Indicators were then assessed for validity, reliability, feasibility, and clarity. Results: We identified 167 clinical outcome indicators. Participation in the three Delphi rounds was 100% (n=13), 68% (n=54), and 85% (n= 6), respectively. A final list of eight outcome indicators was generated: surgical site infection at 30 days, stroke within 30 days of surgery, death within 30 days of coronary artery bypass grafting, death within 30 days of surgery, admission to the intensive care unit within 14 days of surgery, readmission to hospital within 30 days of surgery, and length of hospital stay (with or without in-hospital mortality). They were rated by the majority of experts as valid, reliable, easy to use, and clearly defined. Conclusions: These clinical indicators can be confidently used as endpoints in clinical trials measuring quality, safety, and improvement in perioperative care. Registration: PROSPERO 2016 CRD42016042102 (http://www.crd.york.ac.uk/PROSPERO/display_record.php? ID=CRD42016042102).

Original language	English (US)
Pages (from-to)	228-237
Number of pages	10
Journal	British journal of anaesthesia
Volume	123
Issue number	2
DOIs	https://doi.org/10.1016/j.bja.2019.04.041
State	Published - Aug 1 2019

Keywords

clinical indicators
clinical trials
outcome measures
patient safety
perioperative medicine
quality improvement
standardised endpoint

ASJC Scopus subject areas

Anesthesiology and Pain Medicine

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10.1016/j.bja.2019.04.041

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Haller, G., Bampoe, S., Cook, T., Fleisher, L. A., Grocott, M. P. W., Neuman, M., Story, D., Myles, P. S., Biccard, B., Blazeby, J., Boney, O., Chan, M., Diouf, E., Kalkman, C., Kurz, A., Moonesinghe, R., Wijeysundera, D., Gan, T. J., Peyton, P., ... Johnson, M. (2019). Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative: clinical indicators. British journal of anaesthesia, 123(2), 228-237. https://doi.org/10.1016/j.bja.2019.04.041

Haller, G, Bampoe, S, Cook, T, Fleisher, LA, Grocott, MPW, Neuman, M, Story, D, Myles, PS, Biccard, B, Blazeby, J, Boney, O, Chan, M, Diouf, E, Kalkman, C, Kurz, A, Moonesinghe, R, Wijeysundera, D, Gan, TJ, Peyton, P, Sessler, D, Tramèr, M, Cyna, A, De Oliveira, GS, Wu, C, Jensen, M, Kehlet, H, Botti, M, Haller, G, Gruen, R, Evered, L, Scott, D, Silbert, B, van Dijk, D, Grocott, H, Grocott, H, Eckenhoff, R, Rasmussen, L, Eriksson, L, Beattie, S, Landoni, G, Leslie, K, Howell, S, Nagele, P, Richards, T, Lamy, A, Lalu, M, Pearse, R, Mythen, M, Canet, J, Moller, A, Gin, T, Schultz, M, Pelosi, P, Gabreu, M, Futier, E, Creagh-Brown, B, Abbott, T, Klein, A, Corcoran, T, Jamie Cooper, D, Dieleman, S, McIlroy, D, Bellomo, R, Shaw, A, Prowle, J, Karkouti, K, Billings, J, Mazer, D, Jayarajah, M, Murphy, M, Bartoszko, J, Sneyd, R, Morris, S, George, R, Shulman, M, Lane-Fall, M, Nilsson, U, Stevenson, N, Cooper, JDJ, van Klei, W, Cabrini, L, Miller, T, Pace, N, Pace, N, Jackson, S, Buggy, D, Short, T, Riedel, B, Gottumukkala, V, Alkhaffaf, B & Johnson, M 2019, 'Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative: clinical indicators', British journal of anaesthesia, vol. 123, no. 2, pp. 228-237. https://doi.org/10.1016/j.bja.2019.04.041

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abstract = "Background: Clinical indicators are powerful tools to quantify the safety and quality of patient care. Their validity is often unclear and definitions extremely heterogeneous. As part of the International Standardised Endpoints in Perioperative Medicine (StEP) initiative, this study aimed to derive a set of standardised and valid clinical outcome indicators for use in perioperative clinical trials. Methods: We identified clinical indicators via a systematic review of the anaesthesia and perioperative medicine literature (PubMed/OVID, EMBASE, and Cochrane Library). We performed a three-stage Delphi consensus-gaining process that involved 54 clinician–researchers worldwide. Indicators were first shortlisted and the most suitable definitions for evaluation of quality and safety interventions determined. Indicators were then assessed for validity, reliability, feasibility, and clarity. Results: We identified 167 clinical outcome indicators. Participation in the three Delphi rounds was 100% (n=13), 68% (n=54), and 85% (n= 6), respectively. A final list of eight outcome indicators was generated: surgical site infection at 30 days, stroke within 30 days of surgery, death within 30 days of coronary artery bypass grafting, death within 30 days of surgery, admission to the intensive care unit within 14 days of surgery, readmission to hospital within 30 days of surgery, and length of hospital stay (with or without in-hospital mortality). They were rated by the majority of experts as valid, reliable, easy to use, and clearly defined. Conclusions: These clinical indicators can be confidently used as endpoints in clinical trials measuring quality, safety, and improvement in perioperative care. Registration: PROSPERO 2016 CRD42016042102 (http://www.crd.york.ac.uk/PROSPERO/display_record.php? ID=CRD42016042102).",

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author = "Guy Haller and Sohail Bampoe and Tim Cook and Fleisher, {L. A.} and Grocott, {Michael P.W.} and Mark Neuman and D. Story and Myles, {Paul S.} and B. Biccard and J. Blazeby and O. Boney and M. Chan and E. Diouf and C. Kalkman and A. Kurz and R. Moonesinghe and D. Wijeysundera and Gan, {T. J.} and P. Peyton and D. Sessler and M. Tram{\`e}r and A. Cyna and {De Oliveira}, {G. S.} and C. Wu and M. Jensen and H. Kehlet and M. Botti and G. Haller and R. Gruen and L. Evered and D. Scott and B. Silbert and {van Dijk}, D. and H. Grocott and H. Grocott and R. Eckenhoff and L. Rasmussen and L. Eriksson and S. Beattie and G. Landoni and K. Leslie and S. Howell and P. Nagele and T. Richards and A. Lamy and M. Lalu and R. Pearse and M. Mythen and J. Canet and A. Moller and T. Gin and M. Schultz and P. Pelosi and M. Gabreu and E. Futier and B. Creagh-Brown and T. Abbott and A. Klein and T. Corcoran and {Jamie Cooper}, D. and S. Dieleman and D. McIlroy and R. Bellomo and A. Shaw and J. Prowle and K. Karkouti and J. Billings and D. Mazer and M. Jayarajah and M. Murphy and J. Bartoszko and R. Sneyd and S. Morris and R. George and M. Shulman and M. Lane-Fall and U. Nilsson and N. Stevenson and Cooper, {J. D.J.} and {van Klei}, W. and L. Cabrini and T. Miller and N. Pace and N. Pace and S. Jackson and D. Buggy and T. Short and B. Riedel and V. Gottumukkala and B. Alkhaffaf and M. Johnson",

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doi = "10.1016/j.bja.2019.04.041",

language = "English (US)",

volume = "123",

pages = "228--237",

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TY - JOUR

T1 - Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative

T2 - clinical indicators

AU - Haller, Guy

AU - Bampoe, Sohail

AU - Cook, Tim

AU - Fleisher, L. A.

AU - Grocott, Michael P.W.

AU - Neuman, Mark

AU - Story, D.

AU - Myles, Paul S.

AU - Biccard, B.

AU - Blazeby, J.

AU - Boney, O.

AU - Chan, M.

AU - Diouf, E.

AU - Kalkman, C.

AU - Kurz, A.

AU - Moonesinghe, R.

AU - Wijeysundera, D.

AU - Gan, T. J.

AU - Peyton, P.

AU - Sessler, D.

AU - Tramèr, M.

AU - Cyna, A.

AU - De Oliveira, G. S.

AU - Wu, C.

AU - Jensen, M.

AU - Kehlet, H.

AU - Botti, M.

AU - Haller, G.

AU - Gruen, R.

AU - Evered, L.

AU - Scott, D.

AU - Silbert, B.

AU - van Dijk, D.

AU - Grocott, H.

AU - Eckenhoff, R.

AU - Rasmussen, L.

AU - Eriksson, L.

AU - Beattie, S.

AU - Landoni, G.

AU - Leslie, K.

AU - Howell, S.

AU - Nagele, P.

AU - Richards, T.

AU - Lamy, A.

AU - Lalu, M.

AU - Pearse, R.

AU - Mythen, M.

AU - Canet, J.

AU - Moller, A.

AU - Gin, T.

AU - Schultz, M.

AU - Pelosi, P.

AU - Gabreu, M.

AU - Futier, E.

AU - Creagh-Brown, B.

AU - Abbott, T.

AU - Klein, A.

AU - Corcoran, T.

AU - Jamie Cooper, D.

AU - Dieleman, S.

AU - McIlroy, D.

AU - Bellomo, R.

AU - Shaw, A.

AU - Prowle, J.

AU - Karkouti, K.

AU - Billings, J.

AU - Mazer, D.

AU - Jayarajah, M.

AU - Murphy, M.

AU - Bartoszko, J.

AU - Sneyd, R.

AU - Morris, S.

AU - George, R.

AU - Shulman, M.

AU - Lane-Fall, M.

AU - Nilsson, U.

AU - Stevenson, N.

AU - Cooper, J. D.J.

AU - van Klei, W.

AU - Cabrini, L.

AU - Miller, T.

AU - Pace, N.

AU - Jackson, S.

AU - Buggy, D.

AU - Short, T.

AU - Riedel, B.

AU - Gottumukkala, V.

AU - Alkhaffaf, B.

AU - Johnson, M.

PY - 2019/8/1

Y1 - 2019/8/1

N2 - Background: Clinical indicators are powerful tools to quantify the safety and quality of patient care. Their validity is often unclear and definitions extremely heterogeneous. As part of the International Standardised Endpoints in Perioperative Medicine (StEP) initiative, this study aimed to derive a set of standardised and valid clinical outcome indicators for use in perioperative clinical trials. Methods: We identified clinical indicators via a systematic review of the anaesthesia and perioperative medicine literature (PubMed/OVID, EMBASE, and Cochrane Library). We performed a three-stage Delphi consensus-gaining process that involved 54 clinician–researchers worldwide. Indicators were first shortlisted and the most suitable definitions for evaluation of quality and safety interventions determined. Indicators were then assessed for validity, reliability, feasibility, and clarity. Results: We identified 167 clinical outcome indicators. Participation in the three Delphi rounds was 100% (n=13), 68% (n=54), and 85% (n= 6), respectively. A final list of eight outcome indicators was generated: surgical site infection at 30 days, stroke within 30 days of surgery, death within 30 days of coronary artery bypass grafting, death within 30 days of surgery, admission to the intensive care unit within 14 days of surgery, readmission to hospital within 30 days of surgery, and length of hospital stay (with or without in-hospital mortality). They were rated by the majority of experts as valid, reliable, easy to use, and clearly defined. Conclusions: These clinical indicators can be confidently used as endpoints in clinical trials measuring quality, safety, and improvement in perioperative care. Registration: PROSPERO 2016 CRD42016042102 (http://www.crd.york.ac.uk/PROSPERO/display_record.php? ID=CRD42016042102).

AB - Background: Clinical indicators are powerful tools to quantify the safety and quality of patient care. Their validity is often unclear and definitions extremely heterogeneous. As part of the International Standardised Endpoints in Perioperative Medicine (StEP) initiative, this study aimed to derive a set of standardised and valid clinical outcome indicators for use in perioperative clinical trials. Methods: We identified clinical indicators via a systematic review of the anaesthesia and perioperative medicine literature (PubMed/OVID, EMBASE, and Cochrane Library). We performed a three-stage Delphi consensus-gaining process that involved 54 clinician–researchers worldwide. Indicators were first shortlisted and the most suitable definitions for evaluation of quality and safety interventions determined. Indicators were then assessed for validity, reliability, feasibility, and clarity. Results: We identified 167 clinical outcome indicators. Participation in the three Delphi rounds was 100% (n=13), 68% (n=54), and 85% (n= 6), respectively. A final list of eight outcome indicators was generated: surgical site infection at 30 days, stroke within 30 days of surgery, death within 30 days of coronary artery bypass grafting, death within 30 days of surgery, admission to the intensive care unit within 14 days of surgery, readmission to hospital within 30 days of surgery, and length of hospital stay (with or without in-hospital mortality). They were rated by the majority of experts as valid, reliable, easy to use, and clearly defined. Conclusions: These clinical indicators can be confidently used as endpoints in clinical trials measuring quality, safety, and improvement in perioperative care. Registration: PROSPERO 2016 CRD42016042102 (http://www.crd.york.ac.uk/PROSPERO/display_record.php? ID=CRD42016042102).

KW - clinical indicators

KW - clinical trials

KW - outcome measures

KW - patient safety

KW - perioperative medicine

KW - quality improvement

KW - standardised endpoint

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Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative: clinical indicators

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