Systematic review and consensus definitions for standardised endpoints in perioperative medicine: postoperative cancer outcomes

The StEP-COMPAC Group

Research output: Contribution to journalReview article

8 Citations (Scopus)

Abstract

Background: The Standardising Endpoints for Perioperative Medicine group was established to derive an appropriate set of endpoints for use in clinical trials related to anaesthesia and perioperative medicine. Anaesthetic or analgesic technique during cancer surgery with curative intent may influence the risk of recurrence or metastasis. However, given the current equipoise in the existing literature, prospective, randomised, controlled trials are necessary to test this hypothesis. As such, a cancer subgroup was formed to derive endpoints related to research in onco-anaesthesia based on a current evidence base, international consensus and expert guidance. Methods: We undertook a systematic review to identify measures of oncological outcome used in the oncological, surgical, and wider literature. A multiround Delphi consensus process that included up to 89 clinician–researchers was then used to refine a recommended list of endpoints. Results: We identified 90 studies in a literature search, which were the basis for a preliminary list of nine outcome measures and their definitions. A further two were added during the Delphi process. Response rates for Delphi rounds one, two, and three were 88% (n=9), 82% (n=73), and 100% (n=10), respectively. A final list of 10 defined endpoints was refined and developed, of which six secured approval by ≥70% of the group: cancer health related quality of life, days alive and out of hospital at 90 days, time to tumour progression, disease-free survival, cancer-specific survival, and overall survival (and 5-yr overall survival). Conclusion: Standardised endpoints in clinical outcomes studies will support benchmarking and pooling (meta-analysis) of trials. It is therefore recommended that one or more of these consensus-derived endpoints should be considered for inclusion in clinical trials evaluating a causal effect of anaesthesia–analgesia technique on oncological outcomes.

Original languageEnglish
Pages (from-to)38-44
Number of pages7
JournalBritish Journal of Anaesthesia
Volume121
Issue number1
DOIs
Publication statusPublished - 1 Jul 2018
Externally publishedYes

Fingerprint

Medicine
Outcome Assessment (Health Care)
Neoplasms
Disease-Free Survival
Anesthesia
Clinical Trials
Benchmarking
Analgesics
Anesthetics
Meta-Analysis
Randomized Controlled Trials
Quality of Life
Neoplasm Metastasis
Recurrence
Research

Cite this

@article{64cc39ef34f74c2088c1546f797c0b35,
title = "Systematic review and consensus definitions for standardised endpoints in perioperative medicine: postoperative cancer outcomes",
abstract = "Background: The Standardising Endpoints for Perioperative Medicine group was established to derive an appropriate set of endpoints for use in clinical trials related to anaesthesia and perioperative medicine. Anaesthetic or analgesic technique during cancer surgery with curative intent may influence the risk of recurrence or metastasis. However, given the current equipoise in the existing literature, prospective, randomised, controlled trials are necessary to test this hypothesis. As such, a cancer subgroup was formed to derive endpoints related to research in onco-anaesthesia based on a current evidence base, international consensus and expert guidance. Methods: We undertook a systematic review to identify measures of oncological outcome used in the oncological, surgical, and wider literature. A multiround Delphi consensus process that included up to 89 clinician–researchers was then used to refine a recommended list of endpoints. Results: We identified 90 studies in a literature search, which were the basis for a preliminary list of nine outcome measures and their definitions. A further two were added during the Delphi process. Response rates for Delphi rounds one, two, and three were 88{\%} (n=9), 82{\%} (n=73), and 100{\%} (n=10), respectively. A final list of 10 defined endpoints was refined and developed, of which six secured approval by ≥70{\%} of the group: cancer health related quality of life, days alive and out of hospital at 90 days, time to tumour progression, disease-free survival, cancer-specific survival, and overall survival (and 5-yr overall survival). Conclusion: Standardised endpoints in clinical outcomes studies will support benchmarking and pooling (meta-analysis) of trials. It is therefore recommended that one or more of these consensus-derived endpoints should be considered for inclusion in clinical trials evaluating a causal effect of anaesthesia–analgesia technique on oncological outcomes.",
keywords = "cancer, recurrence, cancer, surgery, clinical trials, endpoints, surgery, postoperative outcomes",
author = "{The StEP-COMPAC Group} and Buggy, {D. J.} and J. Freeman and Johnson, {M. Z.} and K. Leslie and B. Riedel and Sessler, {D. I.} and A. Kurz and V. Gottumukkala and T. Short and N. Pace and Myles, {P. M.} and Gan, {T. J.} and P. Peyton 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 O. Boney and G. Haller and M. Grocott and T. Cook and L. Fleisher and M. Neuman and D. Story and R. Gruen and S. Bampoe and Lis Evered and D. Scott and B. Silbert and {van Dijk}, D. and C. Kalkman and M. Chan and H. Grocott and R. Eckenhoff and L. Rasmussen and L. Eriksson and S. Beattie and D. Wijeysundera and G. Landoni and B. Biccard 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 E. Diouf 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 R. Moonesinghe and M. Shulman and M. Lane-Fall and U. Nilsson and N. Stevenson and {van Klei}, W. and L. Cabrini and T. Miller and S. Jackson and B. Alkhaffaf",
year = "2018",
month = "7",
day = "1",
doi = "10.1016/j.bja.2018.03.020",
language = "English",
volume = "121",
pages = "38--44",
journal = "British Journal of Anaesthesia",
issn = "0007-0912",
publisher = "Oxford University Press",
number = "1",

}

Systematic review and consensus definitions for standardised endpoints in perioperative medicine : postoperative cancer outcomes. / The StEP-COMPAC Group.

In: British Journal of Anaesthesia, Vol. 121, No. 1, 01.07.2018, p. 38-44.

Research output: Contribution to journalReview article

TY - JOUR

T1 - Systematic review and consensus definitions for standardised endpoints in perioperative medicine

T2 - postoperative cancer outcomes

AU - The StEP-COMPAC Group

AU - Buggy, D. J.

AU - Freeman, J.

AU - Johnson, M. Z.

AU - Leslie, K.

AU - Riedel, B.

AU - Sessler, D. I.

AU - Kurz, A.

AU - Gottumukkala, V.

AU - Short, T.

AU - Pace, N.

AU - Myles, P. M.

AU - Gan, T. J.

AU - Peyton, P.

AU - Tramèr, M.

AU - Cyna, A.

AU - De Oliveira, G. S.

AU - Wu, C.

AU - Jensen, M.

AU - Kehlet, H.

AU - Botti, M.

AU - Boney, O.

AU - Haller, G.

AU - Grocott, M.

AU - Cook, T.

AU - Fleisher, L.

AU - Neuman, M.

AU - Story, D.

AU - Gruen, R.

AU - Bampoe, S.

AU - Evered, Lis

AU - Scott, D.

AU - Silbert, B.

AU - van Dijk, D.

AU - Kalkman, C.

AU - Chan, M.

AU - Grocott, H.

AU - Eckenhoff, R.

AU - Rasmussen, L.

AU - Eriksson, L.

AU - Beattie, S.

AU - Wijeysundera, D.

AU - Landoni, G.

AU - Biccard, B.

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 - Diouf, E.

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 - Moonesinghe, R.

AU - Shulman, M.

AU - Lane-Fall, M.

AU - Nilsson, U.

AU - Stevenson, N.

AU - van Klei, W.

AU - Cabrini, L.

AU - Miller, T.

AU - Jackson, S.

AU - Alkhaffaf, B.

PY - 2018/7/1

Y1 - 2018/7/1

N2 - Background: The Standardising Endpoints for Perioperative Medicine group was established to derive an appropriate set of endpoints for use in clinical trials related to anaesthesia and perioperative medicine. Anaesthetic or analgesic technique during cancer surgery with curative intent may influence the risk of recurrence or metastasis. However, given the current equipoise in the existing literature, prospective, randomised, controlled trials are necessary to test this hypothesis. As such, a cancer subgroup was formed to derive endpoints related to research in onco-anaesthesia based on a current evidence base, international consensus and expert guidance. Methods: We undertook a systematic review to identify measures of oncological outcome used in the oncological, surgical, and wider literature. A multiround Delphi consensus process that included up to 89 clinician–researchers was then used to refine a recommended list of endpoints. Results: We identified 90 studies in a literature search, which were the basis for a preliminary list of nine outcome measures and their definitions. A further two were added during the Delphi process. Response rates for Delphi rounds one, two, and three were 88% (n=9), 82% (n=73), and 100% (n=10), respectively. A final list of 10 defined endpoints was refined and developed, of which six secured approval by ≥70% of the group: cancer health related quality of life, days alive and out of hospital at 90 days, time to tumour progression, disease-free survival, cancer-specific survival, and overall survival (and 5-yr overall survival). Conclusion: Standardised endpoints in clinical outcomes studies will support benchmarking and pooling (meta-analysis) of trials. It is therefore recommended that one or more of these consensus-derived endpoints should be considered for inclusion in clinical trials evaluating a causal effect of anaesthesia–analgesia technique on oncological outcomes.

AB - Background: The Standardising Endpoints for Perioperative Medicine group was established to derive an appropriate set of endpoints for use in clinical trials related to anaesthesia and perioperative medicine. Anaesthetic or analgesic technique during cancer surgery with curative intent may influence the risk of recurrence or metastasis. However, given the current equipoise in the existing literature, prospective, randomised, controlled trials are necessary to test this hypothesis. As such, a cancer subgroup was formed to derive endpoints related to research in onco-anaesthesia based on a current evidence base, international consensus and expert guidance. Methods: We undertook a systematic review to identify measures of oncological outcome used in the oncological, surgical, and wider literature. A multiround Delphi consensus process that included up to 89 clinician–researchers was then used to refine a recommended list of endpoints. Results: We identified 90 studies in a literature search, which were the basis for a preliminary list of nine outcome measures and their definitions. A further two were added during the Delphi process. Response rates for Delphi rounds one, two, and three were 88% (n=9), 82% (n=73), and 100% (n=10), respectively. A final list of 10 defined endpoints was refined and developed, of which six secured approval by ≥70% of the group: cancer health related quality of life, days alive and out of hospital at 90 days, time to tumour progression, disease-free survival, cancer-specific survival, and overall survival (and 5-yr overall survival). Conclusion: Standardised endpoints in clinical outcomes studies will support benchmarking and pooling (meta-analysis) of trials. It is therefore recommended that one or more of these consensus-derived endpoints should be considered for inclusion in clinical trials evaluating a causal effect of anaesthesia–analgesia technique on oncological outcomes.

KW - cancer, recurrence

KW - cancer, surgery

KW - clinical trials, endpoints

KW - surgery, postoperative outcomes

UR - http://www.scopus.com/inward/record.url?scp=85046366529&partnerID=8YFLogxK

U2 - 10.1016/j.bja.2018.03.020

DO - 10.1016/j.bja.2018.03.020

M3 - Review article

VL - 121

SP - 38

EP - 44

JO - British Journal of Anaesthesia

JF - British Journal of Anaesthesia

SN - 0007-0912

IS - 1

ER -