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

Author

Myles, P., Grocott, M., Biccard, B., Blazeby, J., Boney, O., Chan, M., Diouf, E., Fleisher, L., Kalkman, C., Kurz, A., Moonesinghe, R., Wijeysundera, D., Gan, T.J., Peyton, P., Sessler, D., Tramèr, M., Cyna, A., De Oliveira, G.S., Jr., Wu, C., Jensen, M., Kehlet, H., Botti, M., Haller, G., Cook, T., Neuman, M., Story, D., Gruen, R., Bampoe, S., Evered, L., Scott, D., Silbert, B., van Dijk, D., 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, J.D.J., van Klei, W., Cabrini, L., Miller, T., Pace, N., Jackson, S., Buggy, D., Short, T., Riedel, B., Gottumukkala, V., Alkhaffaf, B., Johnson, M., Haller, Guy, Bampoe, Sohail, Cook, Tim, Fleisher, Lee A., Grocott, Michael P.W., Neuman, Mark, Story, David, and Myles, Paul S.

Published
2019
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3. Systematic review and consensus definitions for standardised endpoints in perioperative medicine: postoperative cancer outcomes

Author

Gan, T.J., Peyton, P., Tramèr, M., Cyna, A., De Oliveira, G.S., Jr., 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, Lis, 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., Alkhaffaf, B., Buggy, D.J., Freeman, J., Johnson, M.Z., Leslie, K., Riedel, B., Sessler, D.I., Kurz, A., Gottumukkala, V., Short, T., Pace, N., and Myles, P.S.

Published
2018
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4. A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications

Author

Myles, P., Gan, T.J., Kurz, A., Peyton, P., Sessler, D., Tramèr, M., Cyna, A., De Oliveira, G.S., Jr., 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, Lis, 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., Leslie, K., Biccard, B., Howell, S., Nagele, P., Richards, T., Lamy, A., Gabreu, M., 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., Pace, N., Jackson, S., Buggy, D., Short, T., Riedel, B., Gottumukkala, V., Alkhaffaf, B., Johnson, M., Abbott, T.E.F., Fowler, A.J., Pelosi, P., Gama de Abreu, M., Møller, A.M., Canet, J., Creagh-Brown, B., Mythen, M., Gin, T., Lalu, M.M., Futier, E., Grocott, M.P., Schultz, M.J., and Pearse, R.M.

Published
2018
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5. Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: patient comfort

Author

Myles, P.S., Boney, O., Botti, M., Cyna, A.M., Gan, T.J., Jensen, M.P., Kehlet, H., Kurz, A., De Oliveira, G.S., Jr., Peyton, P., Sessler, D.I., Tramèr, M.R., Wu, C.L., Myles, Paul, Grocott, Michael, Biccard, Bruce, Blazeby, Jane, Boney, Oliver, Chan, Matthew, Diouf, Elisabeth, Fleisher, Lee, Kalkman, Cor, Kurz, Andrea, Moonesinghe, Ramani, and Wijeysundera, Duminda

Published
2018
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7. Standardizing end points in perioperative trials: towards a core and extended outcome set

Author

Myles, P. S., Grocott, M. P. W., Boney, O., Moonesinghe, S. R., Myles, Paul, Grocott, Michael, Biccard, Bruce, Boney, Oliver, Chan, Matthew, Fleisher, Lee, Kalkman, Cor, Kurz, Andrea, Moonesinghe, Ramani, Wijeysundera, Duminda, Bartoszko, J., Beattie, W. S., Bellomo, R., Buggy, D., Cabrini, L., Canet, J., Cook, T., Cooper, D. J., Corcoran, T., Devereaux, P. J., Eckenhoff, R., Evered, L., Gan, T. J., Gin, T., Grocott, H., Haller, G., Howell, S., Jayarajah, M., Kalkman, C., Karkouti, K., Kavanagh, B., Klein, A., Landoni, G., Leslie, K., McIlroy, D. R., Mazer, D., Moller, A., Mythen, M., Neuman, M., Neuman, M., Pearse, R., Peyton, P., Prowle, J., Richards, T., Scott, D. A., Sessler, D., Shaw, A., Short, T., Shulman, M., Silbert, B., Singer, M., Sneyd, J. R., Story, D., van Dijk, D., and van Klei, W.

Published
2016
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8. Systematic review and consensus definitions for the Standardized Endpoints in Perioperative Medicine (StEP) initiative: cardiovascular outcomes

Author

Beattie, WS, Lalu, M, Bocock, M, Feng, S, Wijeysundera, DN, Nagele, P, Fleisher, LA, Kurz, A, Biccard, B, Leslie, K, Howell, S, Landoni, G, Grocott, H, Lamy, A, Richards, T, Myles, P, Cooper, DJ, Gan, TJ, Peyton, P, Sessler, D, Tramèr, M, Cyna, A, De Oliveira, GS, Wu, C, Jensen, M, Kehlet, H, Botti, Mari, 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, Eckenhoff, R, Rasmussen, L, Eriksson, L, Beattie, S, Wijeysundera, D, Bartlett, RJ, McMonnies, R, Gerstl, J, Jay, M, Kishlyansky, D, Machina, M, Bobcock, 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, 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, Cooper, J, van Klei, W, Cabrini, L, Miller, T, Pace, N, Jackson, S, Buggy, D, Short, T, Riedel, B, Gottumukkala, V, Alkhaffaf, B, Beattie, WS, Lalu, M, Bocock, M, Feng, S, Wijeysundera, DN, Nagele, P, Fleisher, LA, Kurz, A, Biccard, B, Leslie, K, Howell, S, Landoni, G, Grocott, H, Lamy, A, Richards, T, Myles, P, Cooper, DJ, Gan, TJ, Peyton, P, Sessler, D, Tramèr, M, Cyna, A, De Oliveira, GS, Wu, C, Jensen, M, Kehlet, H, Botti, Mari, 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, Eckenhoff, R, Rasmussen, L, Eriksson, L, Beattie, S, Wijeysundera, D, Bartlett, RJ, McMonnies, R, Gerstl, J, Jay, M, Kishlyansky, D, Machina, M, Bobcock, 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, 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, Cooper, J, van Klei, W, Cabrini, L, Miller, T, Pace, N, Jackson, S, Buggy, D, Short, T, Riedel, B, Gottumukkala, V, and Alkhaffaf, B

Published
2021

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

Author

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, Lis, 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., Dieleman, S., van Klei, W., and The StEP-COMPAC Group

Subjects
Anesthesiology and Pain Medicine, clinical trials, endpoints, cancer, surgery, cancer, recurrence, surgery, postoperative 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.

Published
2018

10. A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications

Author

Abbott, T.E.F., Fowler, A.J., Pelosi, P., Gama de Abreu, M., Møller, A.M., Canet, J., Creagh-Brown, B., Mythen, M., Gin, T., Lalu, M.M., Futier, E., Grocott, M.P., Schultz, M.J., Pearse, R.M., Myles, P., Gan, T. J., Kurz, A., Peyton, P., Sessler, D., Tramèr, M., Cyna, A., De Oliveira, G. S., Wu, C., Jensen, M., Kehlet, H., Botti, M., Boney, O., Haller, G., Cook, T., Fleisher, L., Neuman, M., Story, D., Gruen, R., Bampoe, S., Evered, Lis, 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., Leslie, K., Biccard, B., and Howell, S.

Abstract

Background: There is a need for robust, clearly defined, patient-relevant outcome measures for use in randomised trials in perioperative medicine. Our objective was to establish standard outcome measures for postoperative pulmonary complications research. Methods: A systematic literature search was conducted using MEDLINE, Web of Science, SciELO, and the Korean Journal Database. Definitions were extracted from included manuscripts. We then conducted a three-stage Delphi consensus process to select the optimal outcome measures in terms of methodological quality and overall suitability for perioperative trials. Results: From 2358 records, the full texts of 81 manuscripts were retrieved, of which 45 met the inclusion criteria. We identified three main categories of outcome measure specific to perioperative pulmonary outcomes: (i) composite outcome measures of multiple pulmonary outcomes (27 definitions); (ii) pneumonia (12 definitions); and (iii) respiratory failure (six definitions). These were rated by the group according to suitability for routine use. The majority of definitions were given a low score, and many were imprecise, difficult to apply consistently, or both, in large patient populations. A small number of highly rated definitions were identified as appropriate for widespread use. The group then recommended four outcome measures for future use, including one new definition. Conclusions: A large number of postoperative pulmonary outcome measures have been used, but most are poorly defined. Our four recommended outcome measures include a new definition of postoperative pulmonary complications, incorporating an assessment of severity. These definitions will meet the needs of most clinical effectiveness trials of treatments to improve postoperative pulmonary outcomes.

Published
2018

11. A systematic review and consensus definitions for standardised end-points in perioperative medicine : pulmonary complications

Author

Abbott, T. E.F., Fowler, A. J., Pelosi, P., Gama de Abreu, M., Møller, A. M., Canet, J., Creagh-Brown, B., Mythen, M., Gin, T., Lalu, M. M., Futier, E., Grocott, M. P., Schultz, M. J., Pearse, R. M., Myles, P., Gan, T. J., Kurz, A., Peyton, P., Sessler, D., 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, Lis, 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., Dieleman, S., van Klei, W., and the StEP-COMPAC Group

Subjects
Anesthesiology and Pain Medicine, perioperative care/methods, outcome assessment (healthcare)/standards
Abstract

Background: There is a need for robust, clearly defined, patient-relevant outcome measures for use in randomised trials in perioperative medicine. Our objective was to establish standard outcome measures for postoperative pulmonary complications research. Methods: A systematic literature search was conducted using MEDLINE, Web of Science, SciELO, and the Korean Journal Database. Definitions were extracted from included manuscripts. We then conducted a three-stage Delphi consensus process to select the optimal outcome measures in terms of methodological quality and overall suitability for perioperative trials. Results: From 2358 records, the full texts of 81 manuscripts were retrieved, of which 45 met the inclusion criteria. We identified three main categories of outcome measure specific to perioperative pulmonary outcomes: (i) composite outcome measures of multiple pulmonary outcomes (27 definitions); (ii) pneumonia (12 definitions); and (iii) respiratory failure (six definitions). These were rated by the group according to suitability for routine use. The majority of definitions were given a low score, and many were imprecise, difficult to apply consistently, or both, in large patient populations. A small number of highly rated definitions were identified as appropriate for widespread use. The group then recommended four outcome measures for future use, including one new definition. Conclusions: A large number of postoperative pulmonary outcome measures have been used, but most are poorly defined. Our four recommended outcome measures include a new definition of postoperative pulmonary complications, incorporating an assessment of severity. These definitions will meet the needs of most clinical effectiveness trials of treatments to improve postoperative pulmonary outcomes.

Published
2018

12. Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative : patient comfort

Author

Myles, P S, Boney, O, Botti, M, Cyna, A M, Gan, T J, Jensen, M P, Kehlet, H, Kurz, Andrea, De Oliveira, G S, Peyton, P, Sessler, D I, Tramèr, M R, Wu, C L, StEP–COMPAC Group, Myles, Paul, Grocott, Michael, Biccard, Bruce, Blazeby, Jane, Boney, Oliver, Chan, Matthew, Diouf, Elisabeth, Fleisher, Lee, Kalkman, Cor, Moonesinghe, Ramani, and Wijeysundera, Duminda

Subjects
surgery, clinical trials, patient-reported outcomes, Journal Article, anaesthesia, Review
Abstract

BACKGROUND: Maximising patient comfort during and after surgery is a primary concern of anaesthetists and other perioperative clinicians, but objective measures of what constitutes patient comfort in the perioperative period remain poorly defined. The Standardised Endpoints in Perioperative Medicine initiative was established to derive a set of standardised endpoints for use in perioperative clinical trials. METHODS: We undertook a systematic review to identify measures of patient comfort used in the anaesthetic, surgical, and other perioperative literature. A multi-round Delphi consensus process that included up to 89 clinician researchers was then used to refine a recommended list of outcome measures. RESULTS: We identified 122 studies in a literature search, which were the basis for a preliminary list of 24 outcome measures and their definitions. The response rates for Delphi Rounds 1, 2, and 3 were 100% (n=22), 90% (n=79), and 100% (n=13), respectively. A final list of six defined endpoints was identified: pain intensity (at rest and during movement) at 24 h postoperatively, nausea and vomiting (0-6 h, 6-24 h, and overall), one of two quality-of-recovery (QoR) scales (QoR score or QoR-15), time to gastrointestinal recovery, time to mobilisation, and sleep quality. CONCLUSIONS: As standardised outcomes will support benchmarking and pooling (meta-analysis) of trials, one or more of these recommended endpoints should be considered for inclusion in clinical trials assessing patient comfort and pain after surgery.

Published
2018

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

Author

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

Published
2019
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14. Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative : clinical indicators

Author

Haller, Guy, Bampoe, Sohail, Cook, Tim, Fleisher, L. A., Grocott, Michael P.W., Neuman, Mark, Story, D., Myles, Paul S., Myles, P., Grocott, M., Biccard, B., Blazeby, J., Boney, O., Chan, M., Diouf, E., Fleisher, L., Kalkman, C., Kurz, A., Moonesinghe, R., Wijeysundera, D., Gan, T. J., Peyton, P., Sessler, D., Tramèr, M., Cyna, A., De Oliveira, G. S., Wu, C., Jensen, M., Kehlet, H., Botti, M., Haller, G., Cook, T., Neuman, M., Gruen, R., Bampoe, S., Evered, L., Scott, D., Silbert, B., van Dijk, D., Grocott, H., Eckenhoff, R., Rasmussen, L., Eriksson, L., Beattie, S., Landoni, G., Leslie, K., Dieleman, S., van Klei, W., Jackson, S., Haller, Guy, Bampoe, Sohail, Cook, Tim, Fleisher, L. A., Grocott, Michael P.W., Neuman, Mark, Story, D., Myles, Paul S., Myles, P., Grocott, M., Biccard, B., Blazeby, J., Boney, O., Chan, M., Diouf, E., Fleisher, L., Kalkman, C., Kurz, A., Moonesinghe, R., Wijeysundera, D., Gan, T. J., Peyton, P., Sessler, D., Tramèr, M., Cyna, A., De Oliveira, G. S., Wu, C., Jensen, M., Kehlet, H., Botti, M., Haller, G., Cook, T., Neuman, M., Gruen, R., Bampoe, S., Evered, L., Scott, D., Silbert, B., van Dijk, D., Grocott, H., Eckenhoff, R., Rasmussen, L., Eriksson, L., Beattie, S., Landoni, G., Leslie, K., Dieleman, S., van Klei, W., and Jackson, S.

Published
2019

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

Author

Medische staf Anesthesiologie, Brain, Circulatory Health, Medische Staf Intensive Care, Management Vitale Functies, Onderzoek Radiotherapie, Haller, Guy, Bampoe, Sohail, Cook, Tim, Fleisher, L. A., Grocott, Michael P.W., Neuman, Mark, Story, D., Myles, Paul S., Myles, P., Grocott, M., Biccard, B., Blazeby, J., Boney, O., Chan, M., Diouf, E., Fleisher, L., Kalkman, C., Kurz, A., Moonesinghe, R., Wijeysundera, D., Gan, T. J., Peyton, P., Sessler, D., Tramèr, M., Cyna, A., De Oliveira, G. S., Wu, C., Jensen, M., Kehlet, H., Botti, M., Haller, G., Cook, T., Neuman, M., Gruen, R., Bampoe, S., Evered, L., Scott, D., Silbert, B., van Dijk, D., Grocott, H., Eckenhoff, R., Rasmussen, L., Eriksson, L., Beattie, S., Landoni, G., Leslie, K., Dieleman, S., van Klei, W., Jackson, S., Medische staf Anesthesiologie, Brain, Circulatory Health, Medische Staf Intensive Care, Management Vitale Functies, Onderzoek Radiotherapie, Haller, Guy, Bampoe, Sohail, Cook, Tim, Fleisher, L. A., Grocott, Michael P.W., Neuman, Mark, Story, D., Myles, Paul S., Myles, P., Grocott, M., Biccard, B., Blazeby, J., Boney, O., Chan, M., Diouf, E., Fleisher, L., Kalkman, C., Kurz, A., Moonesinghe, R., Wijeysundera, D., Gan, T. J., Peyton, P., Sessler, D., Tramèr, M., Cyna, A., De Oliveira, G. S., Wu, C., Jensen, M., Kehlet, H., Botti, M., Haller, G., Cook, T., Neuman, M., Gruen, R., Bampoe, S., Evered, L., Scott, D., Silbert, B., van Dijk, D., Grocott, H., Eckenhoff, R., Rasmussen, L., Eriksson, L., Beattie, S., Landoni, G., Leslie, K., Dieleman, S., van Klei, W., and Jackson, S.

Published
2019

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

Author

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

Published
2018
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17. A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications

Author

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

Published
2018
Full Text
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18. Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: patient comfort

Author

Myles, P. S., Boney, O., Botti, M., Cyna, A. M., Gan, T. J., Jensen, M. P., Kehlet, H., Kurz, A., De Oliveira, G. S., Peyton, P., Sessler, D. I., Tramèr, M. R., Wu, C. L., StEP–COMPAC Group, Myles, P., Grocott, M., Biccard, B., Blazeby, J., Chan, M., Diouf, E., Fleisher, L., Kalkman, C., Moonesinghe, R., Wijeysundera, D., Myles, P. S., Boney, O., Botti, M., Cyna, A. M., Gan, T. J., Jensen, M. P., Kehlet, H., Kurz, A., De Oliveira, G. S., Peyton, P., Sessler, D. I., Tramèr, M. R., Wu, C. L., StEP–COMPAC Group, Myles, P., Grocott, M., Biccard, B., Blazeby, J., Chan, M., Diouf, E., Fleisher, L., Kalkman, C., Moonesinghe, R., and Wijeysundera, D.

Published
2018

19. A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications

Author

Abbott, TEF, Fowler, AJ, Pelosi, P, Gama de Abreu, M, Møller, AM, Canet, J, Creagh-Brown, B, Mythen, M, Gin, T, Lalu, MM, Futier, E, Grocott, MP, Schultz, MJ, Pearse, RM, Myles, P, Gan, TJ, Kurz, A, Peyton, P, Sessler, D, Tramèr, M, Cyna, A, De Oliveira, GS, Wu, C, Jensen, M, Kehlet, H, Botti, Mari, 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, Leslie, K, Biccard, B, Howell, S, Nagele, P, Richards, T, Lamy, A, Gabreu, M, 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, Pace, N, Jackson, S, Buggy, D, Short, T, Riedel, B, Gottumukkala, V, Alkhaffaf, B, Johnson, M, Abbott, TEF, Fowler, AJ, Pelosi, P, Gama de Abreu, M, Møller, AM, Canet, J, Creagh-Brown, B, Mythen, M, Gin, T, Lalu, MM, Futier, E, Grocott, MP, Schultz, MJ, Pearse, RM, Myles, P, Gan, TJ, Kurz, A, Peyton, P, Sessler, D, Tramèr, M, Cyna, A, De Oliveira, GS, Wu, C, Jensen, M, Kehlet, H, Botti, Mari, 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, Leslie, K, Biccard, B, Howell, S, Nagele, P, Richards, T, Lamy, A, Gabreu, M, 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, Pace, N, Jackson, S, Buggy, D, Short, T, Riedel, B, Gottumukkala, V, Alkhaffaf, B, and Johnson, M

Published
2018

20. Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: patient comfort.

Author

Myles, PS, Peyton, PJ, Cyna, AM, Boney, O, Botti, M, Gan, TJ, Jensen, MP, Kehlet, H, Kurz, A, De Oliveira, GS Jr, Peyton, P, Sessler, DI, Tramèr, MR, Wu, CL, StEP–COMPAC Group, Myles, P, Grocott, M, Biccard, B, Blazeby, J, Chan, M, Diouf, E, Fleisher, L, Kalkman, C, Moonesinghe, R, Wijeysundera, D, Myles, PS, Peyton, PJ, Cyna, AM, Boney, O, Botti, M, Gan, TJ, Jensen, MP, Kehlet, H, Kurz, A, De Oliveira, GS Jr, Peyton, P, Sessler, DI, Tramèr, MR, Wu, CL, StEP–COMPAC Group, Myles, P, Grocott, M, Biccard, B, Blazeby, J, Chan, M, Diouf, E, Fleisher, L, Kalkman, C, Moonesinghe, R, and Wijeysundera, D

Abstract

BACKGROUND: Maximising patient comfort during and after surgery is a primary concern of anaesthetists and other perioperative clinicians, but objective measures of what constitutes patient comfort in the perioperative period remain poorly defined. The Standardised Endpoints in Perioperative Medicine initiative was established to derive a set of standardised endpoints for use in perioperative clinical trials. METHODS: We undertook a systematic review to identify measures of patient comfort used in the anaesthetic, surgical, and other perioperative literature. A multi-round Delphi consensus process that included up to 89 clinician researchers was then used to refine a recommended list of outcome measures. RESULTS: We identified 122 studies in a literature search, which were the basis for a preliminary list of 24 outcome measures and their definitions. The response rates for Delphi Rounds 1, 2, and 3 were 100% (n=22), 90% (n=79), and 100% (n=13), respectively. A final list of six defined endpoints was identified: pain intensity (at rest and during movement) at 24 h postoperatively, nausea and vomiting (0-6 h, 6-24 h, and overall), one of two quality-of-recovery (QoR) scales (QoR score or QoR-15), time to gastrointestinal recovery, time to mobilisation, and sleep quality. CONCLUSIONS: As standardised outcomes will support benchmarking and pooling (meta-analysis) of trials, one or more of these recommended endpoints should be considered for inclusion in clinical trials assessing patient comfort and pain after surgery

Published
2018

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

Author

Medische Staf Intensive Care, Brain, Circulatory Health, Epi Methoden Team 1, Medische staf Anesthesiologie, Management Vitale Functies, 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, Lis, 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., Dieleman, S., van Klei, W., The StEP-COMPAC Group, Medische Staf Intensive Care, Brain, Circulatory Health, Epi Methoden Team 1, Medische staf Anesthesiologie, Management Vitale Functies, 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, Lis, 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., Dieleman, S., van Klei, W., and The StEP-COMPAC Group

Published
2018

22. Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: patient comfort

Author

Epi Methoden Team 1, Medische staf Anesthesiologie, Brain, Circulatory Health, Myles, P S, Boney, O, Botti, M, Cyna, A M, Gan, T J, Jensen, M P, Kehlet, H, Kurz, Andrea, De Oliveira, G S, Peyton, P, Sessler, D I, Tramèr, M R, Wu, C L, StEP–COMPAC Group, Myles, Paul, Grocott, Michael, Biccard, Bruce, Blazeby, Jane, Boney, Oliver, Chan, Matthew, Diouf, Elisabeth, Fleisher, Lee, Kalkman, Cor, Moonesinghe, Ramani, Wijeysundera, Duminda, Epi Methoden Team 1, Medische staf Anesthesiologie, Brain, Circulatory Health, Myles, P S, Boney, O, Botti, M, Cyna, A M, Gan, T J, Jensen, M P, Kehlet, H, Kurz, Andrea, De Oliveira, G S, Peyton, P, Sessler, D I, Tramèr, M R, Wu, C L, StEP–COMPAC Group, Myles, Paul, Grocott, Michael, Biccard, Bruce, Blazeby, Jane, Boney, Oliver, Chan, Matthew, Diouf, Elisabeth, Fleisher, Lee, Kalkman, Cor, Moonesinghe, Ramani, and Wijeysundera, Duminda

Published
2018

23. A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications

Author

Medische Staf Intensive Care, Brain, Circulatory Health, Epi Methoden Team 1, Medische staf Anesthesiologie, Management Vitale Functies, Abbott, T. E.F., Fowler, A. J., Pelosi, P., Gama de Abreu, M., Møller, A. M., Canet, J., Creagh-Brown, B., Mythen, M., Gin, T., Lalu, M. M., Futier, E., Grocott, M. P., Schultz, M. J., Pearse, R. M., Myles, P., Gan, T. J., Kurz, A., Peyton, P., Sessler, D., 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, Lis, 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., Dieleman, S., van Klei, W., The StEP-COMPAC Group, Medische Staf Intensive Care, Brain, Circulatory Health, Epi Methoden Team 1, Medische staf Anesthesiologie, Management Vitale Functies, Abbott, T. E.F., Fowler, A. J., Pelosi, P., Gama de Abreu, M., Møller, A. M., Canet, J., Creagh-Brown, B., Mythen, M., Gin, T., Lalu, M. M., Futier, E., Grocott, M. P., Schultz, M. J., Pearse, R. M., Myles, P., Gan, T. J., Kurz, A., Peyton, P., Sessler, D., 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, Lis, 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., Dieleman, S., van Klei, W., and The StEP-COMPAC Group

Published
2018

24. A systematic review and consensus definitions for standardised end-points in perioperative medicine:pulmonary complications

Author

Abbott, T. E.F., Fowler, A. J., Pelosi, P., Gama de Abreu, M., Møller, A. M., Canet, J., Creagh-Brown, B., Mythen, M., Gin, T., Lalu, M. M., Futier, E., Grocott, M. P., Schultz, M. J., Pearse, R. M., Myles, P., Gan, T. J., Kurz, A., Peyton, P., Sessler, D., Tramèr, M., Cyna, A., De Oliveira, G. S., Wu, C., Jensen, M., Kehlet, H., Botti, M., Boney, O., Haller, G., Cook, T., Fleisher, L., Neuman, M., Story, D., Gruen, R., Bampoe, S., Evered, Lis, 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., Leslie, K., Biccard, B., Howell, S., Nagele, P., Richards, T., Lamy, A., Gabreu, M., 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., Pace, N., Jackson, S., Buggy, D., Short, T., Riedel, B., Gottumukkala, V., Alkhaffaf, B., Johnson, M., Abbott, T. E.F., Fowler, A. J., Pelosi, P., Gama de Abreu, M., Møller, A. M., Canet, J., Creagh-Brown, B., Mythen, M., Gin, T., Lalu, M. M., Futier, E., Grocott, M. P., Schultz, M. J., Pearse, R. M., Myles, P., Gan, T. J., Kurz, A., Peyton, P., Sessler, D., Tramèr, M., Cyna, A., De Oliveira, G. S., Wu, C., Jensen, M., Kehlet, H., Botti, M., Boney, O., Haller, G., Cook, T., Fleisher, L., Neuman, M., Story, D., Gruen, R., Bampoe, S., Evered, Lis, 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., Leslie, K., Biccard, B., Howell, S., Nagele, P., Richards, T., Lamy, A., Gabreu, M., 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., Pace, N., Jackson, S., Buggy, D., Short, T., Riedel, B., Gottumukkala, V., Alkhaffaf, B., and Johnson, M.

Abstract

Background: There is a need for robust, clearly defined, patient-relevant outcome measures for use in randomised trials in perioperative medicine. Our objective was to establish standard outcome measures for postoperative pulmonary complications research. Methods: A systematic literature search was conducted using MEDLINE, Web of Science, SciELO, and the Korean Journal Database. Definitions were extracted from included manuscripts. We then conducted a three-stage Delphi consensus process to select the optimal outcome measures in terms of methodological quality and overall suitability for perioperative trials. Results: From 2358 records, the full texts of 81 manuscripts were retrieved, of which 45 met the inclusion criteria. We identified three main categories of outcome measure specific to perioperative pulmonary outcomes: (i) composite outcome measures of multiple pulmonary outcomes (27 definitions); (ii) pneumonia (12 definitions); and (iii) respiratory failure (six definitions). These were rated by the group according to suitability for routine use. The majority of definitions were given a low score, and many were imprecise, difficult to apply consistently, or both, in large patient populations. A small number of highly rated definitions were identified as appropriate for widespread use. The group then recommended four outcome measures for future use, including one new definition. Conclusions: A large number of postoperative pulmonary outcome measures have been used, but most are poorly defined. Our four recommended outcome measures include a new definition of postoperative pulmonary complications, incorporating an assessment of severity. These definitions will meet the needs of most clinical effectiveness trials of treatments to improve postoperative pulmonary outcomes.

Published
2018

25. Standardizing end points in perioperative trials: Towards a core and extended outcome set

Author

Epi Methoden Team 1, Medische staf Anesthesiologie, Circulatory Health, Brain, Myles, P. S., Grocott, M. P W, Boney, O., Moonesinghe, S. R., Myles, Paul, Grocott, Michael, Biccard, Bruce, Boney, Oliver, Chan, Matthew, Fleisher, Lee, Kalkman, Cor, Kurz, Andrea, Moonesinghe, Ramani, Wijeysundera, Duminda, Epi Methoden Team 1, Medische staf Anesthesiologie, Circulatory Health, Brain, Myles, P. S., Grocott, M. P W, Boney, O., Moonesinghe, S. R., Myles, Paul, Grocott, Michael, Biccard, Bruce, Boney, Oliver, Chan, Matthew, Fleisher, Lee, Kalkman, Cor, Kurz, Andrea, Moonesinghe, Ramani, and Wijeysundera, Duminda

Published
2016

27. Systematic review and consensus definitions for the Standardized Endpoints in Perioperative Medicine (StEP) initiative: cardiovascular outcomes

Author

W. Scott Beattie, Manoj Lalu, Matthew Bocock, Simon Feng, Duminda N. Wijeysundera, Peter Nagele, Lee A. Fleisher, Andrea Kurz, Bruce Biccard, Kate Leslie, Simon Howell, Giovanni Landoni, Hilary Grocott, Andre Lamy, Toby Richards, 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, Oliver Boney, 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, Rod Eckenhoff, Lars Rasmussen, Lars Eriksson, Scott Beattie, Duminda Wijeysundera, Richard J. Bartlett, Robert McMonnies, Jacob Gerstl, Mohammad Jay, David Kishlyansky, Matthew Machina, Matthew Bobcock, Rupert Pearse, Monty Mythen, Jaume Canet, Ann Moller, Tony Gin, Marcus Schultz, Paolo Pelosi, Marcelo Gabreu, Emmanuel Futier, Ben Creagh-Brown, Tom Abbott, 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, Jamie (DJ) Cooper, Wilton van Klei, Luca Cabrini, Tim Miller, Nathan Pace, Sandy Jackson, Donal Buggy, Tim Short, Bernhard Riedel, Vijay Gottumukkala, Bilal Alkhaffaf, Mark Johnson, Beattie, W. S., Lalu, M., Bocock, M., Feng, S., Wijeysundera, D. N., Nagele, P., Fleisher, L. A., Kurz, A., Biccard, B., Leslie, K., Howell, S., Landoni, G., Grocott, H., Lamy, A., Richards, T., Myles, P., Cooper, D. J., Gan, T. J., Peyton, P., Sessler, D., Tramer, 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., Eckenhoff, R., Rasmussen, L., Eriksson, L., Beattie, S., Wijeysundera, D., Bartlett, R. J., Mcmonnies, R., Gerstl, J., Jay, M., Kishlyansky, D., Machina, M., Bobcock, 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., 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., Cooper, J. D., van Klei, W., Cabrini, L., Miller, T., Pace, N., Jackson, S., Buggy, D., Short, T., Riedel, B., Gottumukkala, V., Alkhaffaf, B., Johnson, M., Tramer, Martin, and Haller, Guy Serge Antoine

Subjects
medicine.medical_specialty, Consensus, Heart disease, Delphi Technique, Endpoint Determination, perioperative medicine, MACE, Cochrane Library, Perioperative Care, 03 medical and health sciences, Patient safety, cardiovascular events, outcome measures, 0302 clinical medicine, Postoperative Complications, 030202 anesthesiology, Anesthesiology, medicine, Humans, clinical trials, myocardial infarction, standardised endpoint, Intensive care medicine, Adverse effect, Clinical Trials as Topic, Perioperative medicine, ddc:617, business.industry, Cardiovascular Diseases, Perioperative Medicine, Research Design, Perioperative, medicine.disease, Clinical trial, Anesthesiology and Pain Medicine, business
Abstract

Background: Adverse cardiovascular events are a leading cause of perioperative morbidity and mortality. The definitions of perioperative cardiovascular adverse events are heterogeneous. As part of the international Standardized Endpoints in Perioperative Medicine initiative, this study aimed to find consensus amongst clinical trialists on a set of standardised and valid cardiovascular outcomes for use in future perioperative clinical trials.Methods: We identified currently used perioperative cardiovascular outcomes by 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 55 clinician researchers worldwide. Cardiovascular outcomes were first shortlisted and the most suitable definitions determined. These cardiovascular outcomes were then assessed for validity, reliability, feasibility, and clarity.Results: We identified 18 cardiovascular outcomes. Participation in the three Delphi rounds was 100% (n=19), 71% (n=55), and 89% (n=17), respectively. A final list of nine cardiovascular outcomes was elicited from the consensus: myocardial infarction, myocardial injury, cardiovascular death, non-fatal cardiac arrest, coronary revascularisation, major adverse cardiac events, pulmonary embolism, deep vein thrombosis, and atrial fibrillation. These nine cardiovascular outcomes were rated by the majority of experts as valid, reliable, feasible, and clearly defined.Conclusions: These nine consensus cardiovascular outcomes can be confidently used as endpoints in clinical trials designed to evaluate perioperative interventions with the goal of improving perioperative outcomes.

Published
2021

28. Standardizing end points in perioperative trials: towards a core and extended outcome set

Author

Guy Haller, Matthew Chan, Tony GIN, Mervyn Singer, Andrea Kurz, Keyvan Karkouti, Paul Myles, Simon Howell, John Sneyd, David Story, John Prowle, Giovanni LANDONI, Suneetha Ramani Moonesinghe, Michael Grocott, Haller, Guy Serge Antoine, Myles, P, Grocott, Mp, Boney, O, Moonesinghe, Sr, on behalf of the COMPAC-StEP, Group, and Landoni, G

Subjects
medicine.medical_specialty, Endpoint Determination, Outcome assessment, Outcome (game theory), Perioperative Care, 03 medical and health sciences, Postoperative Complications, 0302 clinical medicine, 030202 anesthesiology, Anesthesiology, Outcome Assessment, Health Care, medicine, Humans, Medical physics, 030212 general & internal medicine, Set (psychology), Clinical Trials as Topic, Postoperative Complications / diagnosis, ddc:617, business.industry, Perioperative Care / standards, Perioperative, Clinical Trials as Topic / methods, Clinical trial, Patient Outcome Assessment, Core (game theory), Clinical Trials as Topic / standards, Anesthesiology and Pain Medicine, Editorial, Outcome Assessment, Health Care / methods, Perioperative care, Endpoint Determination / methods, Outcome Assessment, Health Care / standards, business, Endpoint Determination / standards
Published
2016

29. Systematic reviews and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: mortality, morbidity, and organ failure.

Author

Jackson AIR, Boney O, Pearse RM, Kurz A, Cooper DJ, van Klei WA, Cabrini L, Miller TE, Moonesinghe SR, Myles PS, and Grocott MPW

Subjects
Humans, Consensus, Reproducibility of Results, Morbidity, Delphi Technique, Perioperative Care methods, Perioperative Medicine
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., (Copyright © 2023 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.)

Published
2023
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30. Core Outcome Measures for Perioperative and Anaesthetic Care (COMPAC): a modified Delphi process to develop a core outcome set for trials in perioperative care and anaesthesia.

Author

Boney O, Moonesinghe SR, Myles PS, and Grocott MPW

Subjects
Adolescent, Adult, Aged, Anesthetics administration & dosage, Consensus, Delphi Technique, Female, Humans, Male, Middle Aged, Postoperative Complications epidemiology, Quality of Life, Randomized Controlled Trials as Topic methods, Young Adult, Anesthesia methods, Outcome Assessment, Health Care methods, Perioperative Care methods
Abstract

Background: Outcome selection underpins clinical trial interpretation. Inconsistency in outcome selection and reporting hinders comparison of different trials' results, reducing the utility of research findings., Methods: We conducted an iterative consensus process to develop a set of Core Outcome Measures for Perioperative and Anaesthetic Care (COMPAC), following the established Core Outcome Measures for Effectiveness Trials (COMET) methodology. First, we undertook a systematic review of RCTs in high-impact journals to describe current outcome reporting trends. We then surveyed patients, carers, researchers, and perioperative clinicians about important outcomes after surgery. Finally, a purposive stakeholder sample participated in a modified Delphi process to develop a core outcome set for perioperative and anaesthesia trials., Results: Our systematic review revealed widespread inconsistency in outcome reporting, with variable or absent definitions, levels of detail, and temporal criteria. In the survey, almost all patients, carers, and clinicians rated clinical outcome measures critically important, but clinicians rated patient-centred outcomes less highly than patients and carers. The final core outcome set was: (i) mortality/survival (postoperative mortality, long-term survival); (ii) perioperative complications (major postoperative complications/adverse events; complications/adverse events causing permanent harm); (iii) resource use (length of hospital stay, unplanned readmission within 30 days); (iv) short-term recovery (discharge destination, level of dependence, or both); and (v) longer-term recovery (overall health-related quality of life)., Conclusions: This core set, incorporating important outcomes for both clinicians and patients, should guide outcome selection in future perioperative medicine or anaesthesia trials. Mapping these alongside standardised endpoint definitions will yield a comprehensive perioperative outcome framework., (Copyright © 2021 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.)

Published
2022
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32. Standardizing endpoints in perioperative research.

Author

Boney O, Moonesinghe SR, Myles PS, and Grocott MP

Subjects
Biomedical Research standards, Cooperative Behavior, Decision Making, Endpoint Determination methods, Endpoint Determination standards, Humans, Perioperative Care methods, Quality of Health Care, Surgical Procedures, Operative adverse effects, Biomedical Research methods, Outcome Assessment, Health Care methods, Surgical Procedures, Operative methods
Abstract

Measuring patient-relevant, clinically important, and valid outcomes is fundamental to the delivery of high-quality clinical care and to the innovation and development of such care through research. As surgical innovations become more complex and the burden of age and comorbidities in the surgical patient population continues to increase, understanding the benefits and harms of surgical interventions becomes ever more important. Nevertheless, we can understand only what we can adequately describe. Truly collaborative decision-making, delivery of safe effective care, and on-going quality improvement are also critically dependent on reliable valid measurement of patient-relevant and clinically important data. Attempts to describe the full spectrum of outcomes following surgery necessarily entail moving beyond the traditional endpoints of mortality and resource use towards more complex measures of morbidity, patient-reported outcomes, and functional status. Without standardization and consensus to guide the use of increasingly complex and nuanced endpoints, there is a real risk that perioperative research will become embroiled in a mire of inconsistent heterogeneous outcome measures that cannot be meaningfully compared and contrasted between trials or combined within meta-analyses. This would result in limiting the value of the research effort and depriving patients and clinicians of definitive answers. Collaboration in perioperative medicine-whether between institutions or across continents-has enormous potential to improve the value of research output. Standardizing endpoints for outcome measurement is fundamental to maximizing the quality of such collaboration and ensuring the impact of future perioperative research.

Published
2016
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33. Identifying research priorities in anaesthesia and perioperative care: final report of the joint National Institute of Academic Anaesthesia/James Lind Alliance Research Priority Setting Partnership.

Author

Boney O, Bell M, Bell N, Conquest A, Cumbers M, Drake S, Galsworthy M, Gath J, Grocott MP, Harris E, Howell S, Ingold A, Nathanson MH, Pinkney T, and Metcalf L

Subjects
Anesthesia adverse effects, Humans, Interprofessional Relations, Patient Care Team organization & administration, Perioperative Care adverse effects, Postoperative Complications prevention & control, Surveys and Questionnaires, United Kingdom, Anesthesia methods, Biomedical Research, Perioperative Care methods
Abstract

Objective: To identify research priorities for Anaesthesia and Perioperative Medicine., Design: Prospective surveys and consensus meetings guided by an independent adviser., Setting: UK., Participants: 45 stakeholder organisations (25 professional, 20 patient/carer) affiliated as James Lind Alliance partners., Outcomes: First 'ideas-gathering' survey: Free text research ideas and suggestions. Second 'prioritisation' survey: Shortlist of 'summary' research questions (derived from the first survey) ranked by respondents in order of priority. Final 'top ten': Agreed by consensus at a final prioritisation workshop., Results: First survey: 1420 suggestions received from 623 respondents (49% patients/public) were refined into a shortlist of 92 'summary' questions. Second survey: 1718 respondents each nominated up to 10 questions as research priorities. Top ten: The 25 highest-ranked questions advanced to the final workshop, where 23 stakeholders (13 professional, 10 patient/carer) agreed the 10 most important questions: ▸ What can we do to stop patients developing chronic pain after surgery? ▸ How can patient care around the time of emergency surgery be improved? ▸ What long-term harm may result from anaesthesia, particularly following repeated anaesthetics?▸ What outcomes should we use to measure the 'success' of anaesthesia and perioperative care? ▸ How can we improve recovery from surgery for elderly patients? ▸ For which patients does regional anaesthesia give better outcomes than general anaesthesia? ▸ What are the effects of anaesthesia on the developing brain? ▸ Do enhanced recovery programmes improve short and long-term outcomes? ▸ How can preoperative exercise or fitness training, including physiotherapy, improve outcomes after surgery? ▸ How can we improve communication between the teams looking after patients throughout their surgical journey?, Conclusions: Almost 2000 stakeholders contributed their views regarding anaesthetic and perioperative research priorities. This is the largest example of patient and public involvement in shaping anaesthetic and perioperative research to date., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Published
2015
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