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

D. J. Buggy, J. Freeman, M. Z. Johnson, K. Leslie, B. Riedel, D. I. Sessler, A. Kurz, V. Gottumukkala, T. Short, N. Pace, P. M. Myles, the StEP-COMPAC Group

Research output: Contribution to journalReview ArticleResearchpeer-review

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

Keywords

  • cancer, recurrence
  • cancer, surgery
  • clinical trials, endpoints
  • surgery, postoperative outcomes

Cite this

Buggy, D. J. ; Freeman, J. ; Johnson, M. Z. ; Leslie, K. ; Riedel, B. ; Sessler, D. I. ; Kurz, A. ; Gottumukkala, V. ; Short, T. ; Pace, N. ; Myles, P. M. ; the StEP-COMPAC Group. / Systematic review and consensus definitions for standardised endpoints in perioperative medicine : postoperative cancer outcomes. In: British Journal of Anaesthesia. 2018 ; Vol. 121, No. 1. pp. 38-44.
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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.",
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author = "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 {the StEP-COMPAC Group} and T. Corcoran",
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Buggy, DJ, Freeman, J, Johnson, MZ, Leslie, K, Riedel, B, Sessler, DI, Kurz, A, Gottumukkala, V, Short, T, Pace, N, Myles, PM & the StEP-COMPAC Group 2018, 'Systematic review and consensus definitions for standardised endpoints in perioperative medicine: postoperative cancer outcomes' British Journal of Anaesthesia, vol. 121, no. 1, pp. 38-44. https://doi.org/10.1016/j.bja.2018.03.020

Systematic review and consensus definitions for standardised endpoints in perioperative medicine : postoperative cancer outcomes. / Buggy, D. J.; Freeman, J.; Johnson, M. Z.; Leslie, K.; Riedel, B.; Sessler, D. I.; Kurz, A.; Gottumukkala, V.; Short, T.; Pace, N.; Myles, P. M.; the StEP-COMPAC Group.

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

Research output: Contribution to journalReview ArticleResearchpeer-review

TY - JOUR

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

T2 - postoperative cancer outcomes

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 - the StEP-COMPAC Group

AU - Corcoran, T.

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

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U2 - 10.1016/j.bja.2018.03.020

DO - 10.1016/j.bja.2018.03.020

M3 - Review Article

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JF - British Journal of Anaesthesia

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