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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., Gan, T.J., Peyton, P., Tramèr, M., Cyna, A., De Oliveira, G.S., Wu, C., Jensen, M., Kehlet, H., Botti, M., Boney, O., Haller, G., Grocott, M., Cook, T., Fleisher, L., Neuman, M., Story, D., Gruen, R., Bampoe, S., Evered, L., Scott, D., Silbert, B., van Dijk, D., Kalkman, C., Chan, M., Grocott, H., Eckenhoff, R., Rasmussen, L., Eriksson, L., Beattie, S., Wijeysundera, D., Landoni, G., Biccard, B., 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., Diouf, E., 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., Moonesinghe, R., Shulman, M., Lane-Fall, M., Nilsson, U., Stevenson, N., van Klei, W., Cabrini, L., Miller, T., Jackson, S. and Alkhaffaf, B. (2018) Systematic review and consensus definitions for standardised endpoints in perioperative medicine: postoperative cancer outcomes British Journal of Anaesthesia, 121 (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.

Item Type: Article
Divisions : Faculty of Health and Medical Sciences > School of Biosciences and Medicine
Authors :
NameEmailORCID
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.
Gan, T.J.
Peyton, P.
Tramèr, M.
Cyna, A.
De Oliveira, G.S.
Wu, C.
Jensen, M.
Kehlet, H.
Botti, M.
Boney, O.
Haller, G.
Grocott, M.
Cook, T.
Fleisher, L.
Neuman, M.
Story, D.
Gruen, R.
Bampoe, S.
Evered, L.
Scott, D.
Silbert, B.
van Dijk, D.
Kalkman, C.
Chan, M.
Grocott, H.
Eckenhoff, R.
Rasmussen, L.
Eriksson, L.
Beattie, S.
Wijeysundera, D.
Landoni, G.
Biccard, B.
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.b.creagh-brown@surrey.ac.uk
Abbott, T.
Klein, A.
Corcoran, T.
Jamie Cooper, D.
Dieleman, S.
Diouf, E.
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.
Moonesinghe, R.
Shulman, M.
Lane-Fall, M.
Nilsson, U.
Stevenson, N.
van Klei, W.
Cabrini, L.
Miller, T.
Jackson, S.
Alkhaffaf, B.
Date : 1 May 2018
DOI : 10.1016/j.bja.2018.03.020
Uncontrolled Keywords : Clinical trials, endpoints; Cancer, surgery; Surgery, postoperative outcomes; Cancer, recurrence
Depositing User : Clive Harris
Date Deposited : 18 Mar 2019 10:49
Last Modified : 18 Mar 2019 10:49
URI: http://epubs.surrey.ac.uk/id/eprint/850750

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