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1. Protocol for a systematic review and network meta-analysis of the management of new onset atrial fibrillation in critically unwell adult patients

Author

Brian W. Johnston, Ruaraidh Hill, Rui Duarte, Chung Shen Chean, Danny F. McAuley, Bronagh Blackwood, Nathan Pace, and Ingeborg D. Welters

Subjects
Atrial fibrillation, Intensive care, Systematic review, Network meta-analysis, Medicine
Abstract

Abstract Background New onset atrial fibrillation is the most commonly encountered arrhythmia in critically unwell patients with a reported incidence of 4% to 29%. The occurrence of new onset atrial fibrillation may precipitate acute heart failure and lead to thromboembolic complications as well as being associated with increased in-hospital and in intensive care unit (ICU) mortality. Despite being common, much of our current knowledge regarding the treatment of new onset atrial fibrillation comes from patients with chronic atrial fibrillation or post cardiac surgery. It is unclear if management strategies in these patient cohorts can be applied to new onset atrial fibrillation in the general ICU. This protocol for a systematic review and network meta-analysis aims to address this uncertainty and define what is the most effective management strategy for the treatment of new onset atrial fibrillation (NOAF) in acutely unwell adult patients. Methods In this systematic review and network meta-analysis, we plan to search electronic databases (Cochrane Central Register of Controlled Trials [CENTRAL], MEDLINE, EMBASE, Science Citation Index Expanded on Web of Science and relevant trial registries) for relevant randomised and non-randomised trials. Citations will be reviewed by title, abstract and full text by two independent reviewers and disagreement resolved by discussion and a third independent reviewer, if necessary. The Cochrane Risk of Bias tool will be used to assess risk of bias in randomised trials and the Risk of Bias in Nonrandomised Studies of Interventions (ROBINS-I) tool will be used for non-randomised studies. Statistical analysis will be carried out using R package meta and netmeta. We will first conduct a pairwise meta-analysis. If conditions for indirect comparison are satisfied and suitable data are available, we will conduct network meta-analysis using frequentist methodology. Treatments will be ranked according to efficacy with associated P-scores. We will assess the quality of the evidence in the pairwise using GRADE methodology and network meta-analysis comparisons in the CINeMA module in R package meta. Discussion Our review will be the first to assess direct and indirect evidence to assess the efficacy and rank the treatments available for new onset atrial fibrillation in critically unwell patients. Our review findings will be applicable to the care of people in a range of acute settings including, ICU, the emergency department and acute medical units. Systematic review registration PROSPERO registry number: CRD42019121739.

Published
2019
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4. Systematic reviews and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: mortality, morbidity, and organ failure

Author

Alexander I.R. Jackson, Oliver Boney, Rupert M. Pearse, Andrea Kurz, D. James Cooper, Wilton A. van Klei, Luca Cabrini, Timothy E. Miller, S. Ramani Moonesinghe, Paul S. Myles, Michael P.W. Grocott, 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, 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, Hilary Grocott, Rod Eckenhoff, Lars Rasmussen, Lars Eriksson, Scott Beattie, Duminda Wijeysundera, Giovanni Landoni, Kate Leslie, Bruce Biccard, Simon Howell, Peter Nagele, Toby Richards, Andre Lamy, Manoj Lalu, Rupert Pearse, Monty Mythen, Jaume Canet, Ann Moller, Tony Gin, Marcus Schultz, Paolo Pelosi, Marcelo Gabreu, Emmanuel Futier, Ben Creagh-Brown, Tom Abbot, 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, Wilton van Klei, Tim Miller, Sandy Jackson, Donal Buggy, Tim Short, Bernhard Riedel, Vijay Gottumukkala, Nathan Pace, Bilal Alkhaffaf, Mark Johnson, Intensive Care Medicine, ACS - Pulmonary hypertension & thrombosis, and AII - Inflammatory diseases

Subjects
surgery, Anesthesiology and Pain Medicine, consensus, morbidity, organ failure, anaesthesia, postoperative morbidity, perioperative outcomes, mortality
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.

Published
2023
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5. 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

6. Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative : infection and sepsis

Author

Jonathan Barnes, Jennifer Hunter, Steve Harris, Manu Shankar-Hari, Elisabeth Diouf, Ib Jammer, Cor Kalkman, Andrew A. Klein, Tomas Corcoran, Stefan Dieleman, Michael P.W. Grocott, Michael G. Mythen, Paul Myles, Tang Joon Gan, Andrea Kurz, 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, Matthew Chan, Hilary Grocott, Rod Eckenhoff, Lars Rasmussen, Lars Eriksson, Scott Beattie, Duminda Wijeysundera, Giovanni Landoni, Kate Leslie, Bruce Biccard, Simon Howell, Peter Nagele, Toby Richards, Andre Lamy, Manoj Lalu, Rupert Pearse, Monty Mythen, Jaume Canet, Ann Moller, Tony Gin, Marcus Schultz, Paolo Pelosi, Marcelo Gabreu, Emmanuel Futier, Ben Creagh-Brown, Alexander Fowler, Tom Abbott, Andy Klein, David James Cooper, 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, Intensive Care Medicine, AII - Infectious diseases, ACS - Diabetes & metabolism, ACS - Pulmonary hypertension & thrombosis, ACS - Microcirculation, Tramer, Martin, and Haller, Guy Serge Antoine

Subjects
medicine.medical_specialty, Consensus, Delphi Technique, Endpoint Determination, Delphi method, perioperative medicine, Perioperative Care/standards, postoperative outcome, Surgical Wound Infection/therapy, Postoperative outcome, Perioperative Care, Sepsis, Perioperative medicine, sepsis, Core outcome measures, Respiratory Tract Infections/therapy, core outcome measures, infection, standardised endpoints, surgical site infection, Humans, Infection, Respiratory Tract Infections, Surgical Wound Infection, Anesthesiology and Pain Medicine, Anesthesiology, Outcome Assessment, Health Care, Endpoint Determination/standards, medicine, Attention, Standardised endpoints, Intensive care medicine, Infections/therapy, ddc:617, business.industry, Sepsis/therapy, Perioperative, anaesthesia, medicine.disease, Clinical trial, Clinical research, Quality and Patient Safety, business, Surgical site infection
Abstract

Background: Perioperative infection and sepsis are of fundamental concern to perioperative clinicians. However, standardised endpoints are either poorly defined or not routinely implemented. The Standardised Endpoints in Perioperative Medicine (StEP) 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 infection and sepsis used in the perioperative literature. A multi-round Delphi consensus process that included more than 60 clinician researchers was then used to refine a recommended list of outcome measures.Results: A literature search yielded 1857 titles of which 255 met inclusion criteria for endpoint extraction. A long list of endpoints, with definitions and timescales, was generated and those potentially relevant to infection and sepsis circulated to the theme subgroup and then the wider StEP-COMPAC working group, undergoing a three-stage Delphi process. The response rates for Delphi rounds 1, 3, and 3 were 89% (n=8), 67% (n=62), and 80% (n=8), respectively. A set of 13 endpoints including fever, surgical site, and organ-specific infections as defined by the US Centres for Disease Control and Sepsis-3 are proposed for future use.Conclusions: We defined a consensus list of standardised endpoints related to infection and sepsis for perioperative trials using an established and rigorous approach. Each endpoint was evaluated with respect to validity, reliability, feasibility, and patient centredness. One or more of these should be considered for inclusion in future perioperative clinical trials assessing infection, sepsis, or both, thereby permitting synthesis and comparison of future results.

Published
2019

8. Advances in and Limitations of Up-and-down Methodology: A Précis of Clinical Use, Study Design, and Dose Estimation in Anesthesia Research.

Author

Nathan Pace

Subjects
*ANESTHESIA, *STATISTICS, *DRUG dosage, *PHARMACEUTICAL research, *LABOR (Obstetrics)
Abstract

Sequential design methods for binary response variables exist for determination of the concentration or dose associated with the 50% point along the dose–response curve; the up-and-down method of Dixon and Mood is now commonly used in anesthesia research. There have been important developments in statistical methods that (1) allow the design of experiments for the measurement of the response at any point (quantile) along the dose–response curve, (2) demonstrate the risk of certain statistical methods commonly used in literature reports, (3) allow the estimation of the concentration or dose—the target dose—associated with the chosen quantile without the assumption of the symmetry of the tolerance distribution, and (4) set bounds on the probability of response at this target dose. This article details these developments, briefly surveys current use of the up-and-down method in anesthesia research, reanalyzes published reports using the up-and-down method for the study of the epidural relief of pain during labor, and discusses appropriate inferences from up-and-down method studies. [ABSTRACT FROM AUTHOR]

Published
2007
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