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Paul S Myles - One of the best experts on this subject based on the ideXlab platform.

  • systematic review and consensus definitions for the standardised endpoints in Perioperative Medicine initiative clinical indicators
    BJA: British Journal of Anaesthesia, 2019
    Co-Authors: Paul S Myles, Lee A. Fleisher, Michael P W Grocott, Guy Haller, Sohail Bampoe, T M Cook, Mark D Neuman, David A Story
    Abstract:

    BACKGROUND: Clinical indicators are powerful tools to quantify the safety and quality of patient care. Their validity is often unclear and definitions extremely heterogeneous. As part of the International Standardised Endpoints in Perioperative Medicine (StEP) initiative, this study aimed to derive a set of standardised and valid clinical outcome indicators for use in Perioperative clinical trials. METHODS: We identified clinical indicators via 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 54 clinician-researchers worldwide. Indicators were first shortlisted and the most suitable definitions for evaluation of quality and safety interventions determined. Indicators were then assessed for validity, reliability, feasibility, and clarity. RESULTS: We identified 167 clinical outcome indicators. Participation in the three Delphi rounds was 100% (n=13), 68% (n=54), and 85% (n= 6), respectively. A final list of eight outcome indicators was generated: surgical site infection at 30 days, stroke within 30 days of surgery, death within 30 days of coronary artery bypass grafting, death within 30 days of surgery, admission to the intensive care unit within 14 days of surgery, readmission to hospital within 30 days of surgery, and length of hospital stay (with or without in-hospital mortality). They were rated by the majority of experts as valid, reliable, easy to use, and clearly defined. CONCLUSIONS: These clinical indicators can be confidently used as endpoints in clinical trials measuring quality, safety, and improvement in Perioperative care. REGISTRATION: PROSPERO 2016 CRD42016042102 (http://www.crd.york.ac.uk/PROSPERO/display_record.php? ID=CRD42016042102).

  • clinical indicators for reporting the effectiveness of patient quality and safety related interventions a protocol of a systematic review and delphi consensus process as part of the international standardised endpoints for Perioperative Medicine init
    BMJ Open, 2018
    Co-Authors: Sohail Bampoe, Paul S Myles, Lee A. Fleisher, Michael P W Grocott, T M Cook, Mark D Neuman, David A Story, Guy Haller
    Abstract:

    Introduction Clinical indicators are used to measure and quantify the safety and quality of patient care. They are also often used as endpoints in clinical trials. Definitions of clinical indicators in common use are extremely heterogeneous, limiting their applicability. As part of the international Standardised Endpoints in Perioperative Medicine initiative, this study will identify clinical indicators by systematically reviewing the anaesthesia and Perioperative Medicine literature, and will provide consensus, clinically useful definitions for those indicators using a Delphi process. Methods and analysis An electronic database search will be conducted of Medline (PubMed/OVID), EMBASE and the Cochrane Library in order to meet this review’s objectives that are: (1) To identify clinical indicators and their definitions used in randomised controlled trials that assess patient-related quality and safety interventions in Perioperative Medicine; (2) To select a shortlist of recommended indicators and definitions that are the most suitable for evaluation of quality and safety interventions following an expert-based consensus-gaining process (Delphi method) and (3) To provide a classification scale for each indicator related to its clarity of definition, validity (strength), reliability, feasibility (ease of use) and frequency of use. This systematic review protocol is reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidance. Ethics and dissemination Ethical approval is not required for this systematic review and Delphi process. The results of this study will be disseminated to the anaesthesia and Perioperative Medicine clinical and academic community through national and international presentations and through publication in a peer reviewed journal. PROSPERO registration number CRD42016042102.

  • Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: renal endpoints.
    British journal of anaesthesia, 2018
    Co-Authors: D R Mcilroy, F T Billings, A D Shaw, Keyvan Karkouti, John R. Prowle, Rinaldo Bellomo, Paul S Myles
    Abstract:

    Renal injury is a common Perioperative complication. The adoption of renal endpoints, standardised and valid for use in Perioperative clinical trials, would enhance the quality of Perioperative clinical research. The Standardised Endpoints in Perioperative Medicine (StEP) initiative was established to derive standardised endpoints for use in Perioperative clinical trials. A systematic review was conducted to identify renal endpoints currently reported in Perioperative clinical trials. In parallel, an initial list of candidate endpoints was developed based on renal theme group expertise. A multi-round Delphi consensus process was used to refine this list and produce a suite of recommended Perioperative renal outcome measures. Based on our systematic review, 63 studies were included for analysis. Marked heterogeneity and imprecision of endpoint definitions were observed. Our initial list of candidate endpoints included 10 endpoints for consideration. The response rates for Delphi rounds 1, 2, and 3 were 89% (n=16), 90% (n=75), and 100% (n=6), respectively. A final list of four renal endpoints was identified: acute kidney injury defined by the Kidney Disease: Improving Global Outcomes (KDIGO) consensus criteria, acute kidney disease defined by ≥30% decline in estimated glomerular filtration rate from baseline at 30 days after operation in patients meeting the acute-kidney-injury criteria within 7 days of surgery, the composite of death or renal replacement therapy, and the Major Adverse Kidney Events (MAKE) composite. We identified four key renal outcome measures that should be considered for use in Perioperative clinical trials. Using standardised definitions to capture and report these endpoints will facilitate improved benchmarking and meta-analysis of future trials. Copyright © 2018 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

  • systematic review and consensus definitions for the standardised endpoints in Perioperative Medicine step initiative patient comfort
    BJA: British Journal of Anaesthesia, 2018
    Co-Authors: D R Mcilroy, F T Billings, Keyvan Karkouti, John R. Prowle, Rinaldo Bellomo, Andrew D Shaw, Paul S Myles
    Abstract:

    Abstract Background Renal injury is a common Perioperative complication. The adoption of renal endpoints, standardised and valid for use in Perioperative clinical trials, would enhance the quality of Perioperative clinical research. The Standardised Endpoints in Perioperative Medicine (StEP) initiative was established to derive standardised endpoints for use in Perioperative clinical trials. Methods A systematic review was conducted to identify renal endpoints currently reported in Perioperative clinical trials. In parallel, an initial list of candidate endpoints was developed based on renal theme group expertise. A multi-round Delphi consensus process was used to refine this list and produce a suite of recommended Perioperative renal outcome measures. Results Based on our systematic review, 63 studies were included for analysis. Marked heterogeneity and imprecision of endpoint definitions were observed. Our initial list of candidate endpoints included 10 endpoints for consideration. The response rates for Delphi rounds 1, 2, and 3 were 89% (n=16), 90% (n=75), and 100% (n=6), respectively. A final list of four renal endpoints was identified: acute kidney injury defined by the Kidney Disease: Improving Global Outcomes (KDIGO) consensus criteria, acute kidney disease defined by ≥30% decline in estimated glomerular filtration rate from baseline at 30 days after operation in patients meeting the acute-kidney-injury criteria within 7 days of surgery, the composite of death or renal replacement therapy, and the Major Adverse Kidney Events (MAKE) composite. Conclusions We identified four key renal outcome measures that should be considered for use in Perioperative clinical trials. Using standardised definitions to capture and report these endpoints will facilitate improved benchmarking and meta-analysis of future trials.

  • Standardized Renal Endpoints for Perioperative Clinical Trials: The Standardized Endpoints in Perioperative Medicine Initiative
    Nephron, 2017
    Co-Authors: D R Mcilroy, Andrew D Shaw, Paul S Myles
    Abstract:

    Perioperative acute kidney injury is a common problem. While clinical trials seek to evaluate the impact of interventions on a variety of primary and secondary endpoints with the aim of implementing this knowledge to improve Perioperative outcomes, the use of valid and relevant endpoints within clinical trials is of critical importance to achieving this goal. Suitable endpoints must be validated for the study population and in light of the clinical context under investigation while also considering regulatory requirements that govern the licensing of new therapeutic agents as well as the values of patients whose outcomes we seek to improve. Heterogeneity in Perioperative clinical trial endpoints and their definitions limits the ability to compare and interpret differences in outcomes across studies or to pool outcomes from different studies in meta-analysis. The Standardized Endpoints in Perioperative Medicine (StEP) initiative is an international collaboration whose goal is to identify and recommend a suite of clearly and precisely defined endpoints across multiple domains, specifically suited for use in Perioperative clinical trials. The current review describes the rationale, goals and the planned pathway of the StEP renal subgroup. Development of a set of standardized and core renal endpoints, valid and relevant for use in the Perioperative context, precisely defined and yet with sufficient flexibility to encourage broad uptake and application should facilitate high-quality and practice-changing Perioperative research into the future.

Michael P W Grocott - One of the best experts on this subject based on the ideXlab platform.

  • systematic review and consensus definitions for the standardised endpoints in Perioperative Medicine initiative clinical indicators
    BJA: British Journal of Anaesthesia, 2019
    Co-Authors: Paul S Myles, Lee A. Fleisher, Michael P W Grocott, Guy Haller, Sohail Bampoe, T M Cook, Mark D Neuman, David A Story
    Abstract:

    BACKGROUND: Clinical indicators are powerful tools to quantify the safety and quality of patient care. Their validity is often unclear and definitions extremely heterogeneous. As part of the International Standardised Endpoints in Perioperative Medicine (StEP) initiative, this study aimed to derive a set of standardised and valid clinical outcome indicators for use in Perioperative clinical trials. METHODS: We identified clinical indicators via 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 54 clinician-researchers worldwide. Indicators were first shortlisted and the most suitable definitions for evaluation of quality and safety interventions determined. Indicators were then assessed for validity, reliability, feasibility, and clarity. RESULTS: We identified 167 clinical outcome indicators. Participation in the three Delphi rounds was 100% (n=13), 68% (n=54), and 85% (n= 6), respectively. A final list of eight outcome indicators was generated: surgical site infection at 30 days, stroke within 30 days of surgery, death within 30 days of coronary artery bypass grafting, death within 30 days of surgery, admission to the intensive care unit within 14 days of surgery, readmission to hospital within 30 days of surgery, and length of hospital stay (with or without in-hospital mortality). They were rated by the majority of experts as valid, reliable, easy to use, and clearly defined. CONCLUSIONS: These clinical indicators can be confidently used as endpoints in clinical trials measuring quality, safety, and improvement in Perioperative care. REGISTRATION: PROSPERO 2016 CRD42016042102 (http://www.crd.york.ac.uk/PROSPERO/display_record.php? ID=CRD42016042102).

  • Perioperative quality initiative consensus statement on the physiology of arterial blood pressure control in Perioperative Medicine
    BJA: British Journal of Anaesthesia, 2019
    Co-Authors: Gareth L Ackland, Michael P W Grocott, Charles S Brudney, Maurizio Cecconi, Can Ince, Michael G Irwin, Jonathan Lacey, Michael R Pinsky
    Abstract:

    Abstract Background Perioperative arterial blood pressure management is a physiologically complex challenge influenced by multiple factors. Methods A multidisciplinary, international working subgroup of the Third Perioperative Quality Initiative (POQI) consensus meeting reviewed the (patho)physiology and measurement of arterial pressure as applied to Perioperative Medicine. We addressed predefined questions by undertaking a modified Delphi analysis, in which primary clinical research and review articles were identified using MEDLINE. Strength of recommendations, where applicable, were graded by National Institute for Health and Care Excellence (NICE) guidelines. Results Multiple physiological factors contribute to the Perioperative physiological importance of arterial pressure: (i) arterial pressure is the input pressure to organ blood flow, but is not the sole determinant of perfusion pressure; (ii) blood flow is often independent of changes in perfusion pressure because of autoregulatory changes in vascular resistance; (iii) microvascular dysfunction uncouples microvascular blood flow from arterial pressure (haemodynamic incoherence). From a practical clinical perspective, we identified that: (i) ambulatory measurement is the optimal method to establish baseline arterial pressure; (ii) automated and invasive arterial pressure measurements have inherent physiological and technical limitations; (iii) individualised arterial pressure targets may change over time, especially in the Perioperative period. There remains a need for research in non-invasive, continuous arterial pressure measurements, macro- and micro-circulatory control, regional perfusion pressure measurement, and the development of sensitive, specific, and continuous measures of cellular function to evaluate blood pressure management in a physiologically coherent manner. Conclusion The multivariable, complex physiology contributing to dynamic changes in Perioperative arterial pressure may be underappreciated clinically. The frequently unrecognised dissociation between arterial pressure, organ blood flow, and microvascular and cellular function requires further research to develop a more refined, contextualised clinical approach to this routine Perioperative measurement.

  • clinical indicators for reporting the effectiveness of patient quality and safety related interventions a protocol of a systematic review and delphi consensus process as part of the international standardised endpoints for Perioperative Medicine init
    BMJ Open, 2018
    Co-Authors: Sohail Bampoe, Paul S Myles, Lee A. Fleisher, Michael P W Grocott, T M Cook, Mark D Neuman, David A Story, Guy Haller
    Abstract:

    Introduction Clinical indicators are used to measure and quantify the safety and quality of patient care. They are also often used as endpoints in clinical trials. Definitions of clinical indicators in common use are extremely heterogeneous, limiting their applicability. As part of the international Standardised Endpoints in Perioperative Medicine initiative, this study will identify clinical indicators by systematically reviewing the anaesthesia and Perioperative Medicine literature, and will provide consensus, clinically useful definitions for those indicators using a Delphi process. Methods and analysis An electronic database search will be conducted of Medline (PubMed/OVID), EMBASE and the Cochrane Library in order to meet this review’s objectives that are: (1) To identify clinical indicators and their definitions used in randomised controlled trials that assess patient-related quality and safety interventions in Perioperative Medicine; (2) To select a shortlist of recommended indicators and definitions that are the most suitable for evaluation of quality and safety interventions following an expert-based consensus-gaining process (Delphi method) and (3) To provide a classification scale for each indicator related to its clarity of definition, validity (strength), reliability, feasibility (ease of use) and frequency of use. This systematic review protocol is reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidance. Ethics and dissemination Ethical approval is not required for this systematic review and Delphi process. The results of this study will be disseminated to the anaesthesia and Perioperative Medicine clinical and academic community through national and international presentations and through publication in a peer reviewed journal. PROSPERO registration number CRD42016042102.

  • Perioperative Medicine the value proposition for anesthesia a uk perspective on delivering value from anesthesiology
    Anesthesiology Clinics, 2015
    Co-Authors: Monty G. Mythen, Michael P W Grocott
    Abstract:

    : Perioperative Medicine describes the practice of patient centered, multidisciplinary, and integrated medical care of patients from the moment of contemplation of surgery until full recovery. The value proposition for Perioperative Medicine rests on defining benefits that outweigh the costs of change. This article discusses the concept of value in the context of healthcare and highlights a number of reasons for relative market failure. Five key opportunities for adding value in the Perioperative journey are suggested: collaborative decision-making, lifestyle modification before surgery, standardization of in-hospital Perioperative care, achieving full recovery after surgery, and the use of data for quality improvement.

Keyvan Karkouti - One of the best experts on this subject based on the ideXlab platform.

  • Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: renal endpoints.
    British journal of anaesthesia, 2018
    Co-Authors: D R Mcilroy, F T Billings, A D Shaw, Keyvan Karkouti, John R. Prowle, Rinaldo Bellomo, Paul S Myles
    Abstract:

    Renal injury is a common Perioperative complication. The adoption of renal endpoints, standardised and valid for use in Perioperative clinical trials, would enhance the quality of Perioperative clinical research. The Standardised Endpoints in Perioperative Medicine (StEP) initiative was established to derive standardised endpoints for use in Perioperative clinical trials. A systematic review was conducted to identify renal endpoints currently reported in Perioperative clinical trials. In parallel, an initial list of candidate endpoints was developed based on renal theme group expertise. A multi-round Delphi consensus process was used to refine this list and produce a suite of recommended Perioperative renal outcome measures. Based on our systematic review, 63 studies were included for analysis. Marked heterogeneity and imprecision of endpoint definitions were observed. Our initial list of candidate endpoints included 10 endpoints for consideration. The response rates for Delphi rounds 1, 2, and 3 were 89% (n=16), 90% (n=75), and 100% (n=6), respectively. A final list of four renal endpoints was identified: acute kidney injury defined by the Kidney Disease: Improving Global Outcomes (KDIGO) consensus criteria, acute kidney disease defined by ≥30% decline in estimated glomerular filtration rate from baseline at 30 days after operation in patients meeting the acute-kidney-injury criteria within 7 days of surgery, the composite of death or renal replacement therapy, and the Major Adverse Kidney Events (MAKE) composite. We identified four key renal outcome measures that should be considered for use in Perioperative clinical trials. Using standardised definitions to capture and report these endpoints will facilitate improved benchmarking and meta-analysis of future trials. Copyright © 2018 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

  • systematic review and consensus definitions for the standardised endpoints in Perioperative Medicine step initiative patient comfort
    BJA: British Journal of Anaesthesia, 2018
    Co-Authors: D R Mcilroy, F T Billings, Keyvan Karkouti, John R. Prowle, Rinaldo Bellomo, Andrew D Shaw, Paul S Myles
    Abstract:

    Abstract Background Renal injury is a common Perioperative complication. The adoption of renal endpoints, standardised and valid for use in Perioperative clinical trials, would enhance the quality of Perioperative clinical research. The Standardised Endpoints in Perioperative Medicine (StEP) initiative was established to derive standardised endpoints for use in Perioperative clinical trials. Methods A systematic review was conducted to identify renal endpoints currently reported in Perioperative clinical trials. In parallel, an initial list of candidate endpoints was developed based on renal theme group expertise. A multi-round Delphi consensus process was used to refine this list and produce a suite of recommended Perioperative renal outcome measures. Results Based on our systematic review, 63 studies were included for analysis. Marked heterogeneity and imprecision of endpoint definitions were observed. Our initial list of candidate endpoints included 10 endpoints for consideration. The response rates for Delphi rounds 1, 2, and 3 were 89% (n=16), 90% (n=75), and 100% (n=6), respectively. A final list of four renal endpoints was identified: acute kidney injury defined by the Kidney Disease: Improving Global Outcomes (KDIGO) consensus criteria, acute kidney disease defined by ≥30% decline in estimated glomerular filtration rate from baseline at 30 days after operation in patients meeting the acute-kidney-injury criteria within 7 days of surgery, the composite of death or renal replacement therapy, and the Major Adverse Kidney Events (MAKE) composite. Conclusions We identified four key renal outcome measures that should be considered for use in Perioperative clinical trials. Using standardised definitions to capture and report these endpoints will facilitate improved benchmarking and meta-analysis of future trials.

  • defining clinically important Perioperative blood loss and transfusion for the standardised endpoints for Perioperative Medicine step collaborative a protocol for a scoping review
    BMJ Open, 2017
    Co-Authors: Justyna Bartoszko, Keyvan Karkouti, Leon Vorobeichik, Mohandas Jayarajah, A A Klein, Andre Lamy, David C Mazer, Michael F Murphy
    Abstract:

    INTRODUCTION: 'Standardised Endpoints for Perioperative Medicine' (StEP) is an international collaboration undertaking development of consensus-based consistent definitions for endpoints in Perioperative clinical trials. Inconsistency in endpoint definitions can make interpretation of trial results more difficult, especially if conflicting evidence is present. Furthermore, this inconsistency impedes evidence synthesis and meta-analyses. The goals of StEP are to harmonise definitions for clinically meaningful endpoints and specify standards for endpoint reporting in clinical trials. To help inform this endeavour, we aim to conduct a scoping review to systematically characterise the definitions of clinically important endpoints in the existing published literature on Perioperative blood loss and transfusion. METHODS AND ANALYSIS: The scoping review will be conducted using the widely adopted framework developed by Arksey and O'Malley, with modifications from Levac. We refined our methods with guidance from research librarians as well as researchers and clinicians with content expertise. The electronic literature search will involve several databases including Medline, PubMed-not-Medline and Embase. Our review has three objectives, namely to (1) identify definitions of significant blood loss and transfusion used in previously published large Perioperative randomised trials; (2) identify previously developed consensus-based definitions for significant blood loss and transfusion in Perioperative Medicine and related fields; and (3) describe the association between different magnitudes of blood loss and transfusion with postoperative outcomes. The multistage review process for each question will involve two reviewers screening abstracts, reading full-text articles and performing data extraction. The abstracted data will be organised and subsequently analysed in an iterative process. ETHICS AND DISSEMINATION: This scoping review of the previously published literature does not require research ethics approval. The results will be used to inform a consensus-based process to develop definitions of clinically important Perioperative blood loss and transfusion. The results of the scoping review will be published in a peer-reviewed scientific journal.

Rinaldo Bellomo - One of the best experts on this subject based on the ideXlab platform.

  • Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: renal endpoints.
    British journal of anaesthesia, 2018
    Co-Authors: D R Mcilroy, F T Billings, A D Shaw, Keyvan Karkouti, John R. Prowle, Rinaldo Bellomo, Paul S Myles
    Abstract:

    Renal injury is a common Perioperative complication. The adoption of renal endpoints, standardised and valid for use in Perioperative clinical trials, would enhance the quality of Perioperative clinical research. The Standardised Endpoints in Perioperative Medicine (StEP) initiative was established to derive standardised endpoints for use in Perioperative clinical trials. A systematic review was conducted to identify renal endpoints currently reported in Perioperative clinical trials. In parallel, an initial list of candidate endpoints was developed based on renal theme group expertise. A multi-round Delphi consensus process was used to refine this list and produce a suite of recommended Perioperative renal outcome measures. Based on our systematic review, 63 studies were included for analysis. Marked heterogeneity and imprecision of endpoint definitions were observed. Our initial list of candidate endpoints included 10 endpoints for consideration. The response rates for Delphi rounds 1, 2, and 3 were 89% (n=16), 90% (n=75), and 100% (n=6), respectively. A final list of four renal endpoints was identified: acute kidney injury defined by the Kidney Disease: Improving Global Outcomes (KDIGO) consensus criteria, acute kidney disease defined by ≥30% decline in estimated glomerular filtration rate from baseline at 30 days after operation in patients meeting the acute-kidney-injury criteria within 7 days of surgery, the composite of death or renal replacement therapy, and the Major Adverse Kidney Events (MAKE) composite. We identified four key renal outcome measures that should be considered for use in Perioperative clinical trials. Using standardised definitions to capture and report these endpoints will facilitate improved benchmarking and meta-analysis of future trials. Copyright © 2018 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

  • systematic review and consensus definitions for the standardised endpoints in Perioperative Medicine step initiative patient comfort
    BJA: British Journal of Anaesthesia, 2018
    Co-Authors: D R Mcilroy, F T Billings, Keyvan Karkouti, John R. Prowle, Rinaldo Bellomo, Andrew D Shaw, Paul S Myles
    Abstract:

    Abstract Background Renal injury is a common Perioperative complication. The adoption of renal endpoints, standardised and valid for use in Perioperative clinical trials, would enhance the quality of Perioperative clinical research. The Standardised Endpoints in Perioperative Medicine (StEP) initiative was established to derive standardised endpoints for use in Perioperative clinical trials. Methods A systematic review was conducted to identify renal endpoints currently reported in Perioperative clinical trials. In parallel, an initial list of candidate endpoints was developed based on renal theme group expertise. A multi-round Delphi consensus process was used to refine this list and produce a suite of recommended Perioperative renal outcome measures. Results Based on our systematic review, 63 studies were included for analysis. Marked heterogeneity and imprecision of endpoint definitions were observed. Our initial list of candidate endpoints included 10 endpoints for consideration. The response rates for Delphi rounds 1, 2, and 3 were 89% (n=16), 90% (n=75), and 100% (n=6), respectively. A final list of four renal endpoints was identified: acute kidney injury defined by the Kidney Disease: Improving Global Outcomes (KDIGO) consensus criteria, acute kidney disease defined by ≥30% decline in estimated glomerular filtration rate from baseline at 30 days after operation in patients meeting the acute-kidney-injury criteria within 7 days of surgery, the composite of death or renal replacement therapy, and the Major Adverse Kidney Events (MAKE) composite. Conclusions We identified four key renal outcome measures that should be considered for use in Perioperative clinical trials. Using standardised definitions to capture and report these endpoints will facilitate improved benchmarking and meta-analysis of future trials.

Andrew D Shaw - One of the best experts on this subject based on the ideXlab platform.

  • systematic review and consensus definitions for the standardised endpoints in Perioperative Medicine step initiative patient comfort
    BJA: British Journal of Anaesthesia, 2018
    Co-Authors: D R Mcilroy, F T Billings, Keyvan Karkouti, John R. Prowle, Rinaldo Bellomo, Andrew D Shaw, Paul S Myles
    Abstract:

    Abstract Background Renal injury is a common Perioperative complication. The adoption of renal endpoints, standardised and valid for use in Perioperative clinical trials, would enhance the quality of Perioperative clinical research. The Standardised Endpoints in Perioperative Medicine (StEP) initiative was established to derive standardised endpoints for use in Perioperative clinical trials. Methods A systematic review was conducted to identify renal endpoints currently reported in Perioperative clinical trials. In parallel, an initial list of candidate endpoints was developed based on renal theme group expertise. A multi-round Delphi consensus process was used to refine this list and produce a suite of recommended Perioperative renal outcome measures. Results Based on our systematic review, 63 studies were included for analysis. Marked heterogeneity and imprecision of endpoint definitions were observed. Our initial list of candidate endpoints included 10 endpoints for consideration. The response rates for Delphi rounds 1, 2, and 3 were 89% (n=16), 90% (n=75), and 100% (n=6), respectively. A final list of four renal endpoints was identified: acute kidney injury defined by the Kidney Disease: Improving Global Outcomes (KDIGO) consensus criteria, acute kidney disease defined by ≥30% decline in estimated glomerular filtration rate from baseline at 30 days after operation in patients meeting the acute-kidney-injury criteria within 7 days of surgery, the composite of death or renal replacement therapy, and the Major Adverse Kidney Events (MAKE) composite. Conclusions We identified four key renal outcome measures that should be considered for use in Perioperative clinical trials. Using standardised definitions to capture and report these endpoints will facilitate improved benchmarking and meta-analysis of future trials.

  • Standardized Renal Endpoints for Perioperative Clinical Trials: The Standardized Endpoints in Perioperative Medicine Initiative
    Nephron, 2017
    Co-Authors: D R Mcilroy, Andrew D Shaw, Paul S Myles
    Abstract:

    Perioperative acute kidney injury is a common problem. While clinical trials seek to evaluate the impact of interventions on a variety of primary and secondary endpoints with the aim of implementing this knowledge to improve Perioperative outcomes, the use of valid and relevant endpoints within clinical trials is of critical importance to achieving this goal. Suitable endpoints must be validated for the study population and in light of the clinical context under investigation while also considering regulatory requirements that govern the licensing of new therapeutic agents as well as the values of patients whose outcomes we seek to improve. Heterogeneity in Perioperative clinical trial endpoints and their definitions limits the ability to compare and interpret differences in outcomes across studies or to pool outcomes from different studies in meta-analysis. The Standardized Endpoints in Perioperative Medicine (StEP) initiative is an international collaboration whose goal is to identify and recommend a suite of clearly and precisely defined endpoints across multiple domains, specifically suited for use in Perioperative clinical trials. The current review describes the rationale, goals and the planned pathway of the StEP renal subgroup. Development of a set of standardized and core renal endpoints, valid and relevant for use in the Perioperative context, precisely defined and yet with sufficient flexibility to encourage broad uptake and application should facilitate high-quality and practice-changing Perioperative research into the future.

  • evidence based Perioperative Medicine comes of age the Perioperative quality initiative poqi the 1st consensus conference of the Perioperative quality initiative poqi
    Perioperative medicine (London England), 2016
    Co-Authors: Timothy E Miller, Andrew D Shaw, Monty G. Mythen
    Abstract:

    The 1st POQI Consensus Conference occurred in Durham, NC, on March 4–5, 2016, and was supported by the American Society of Enhanced Recovery (ASER) and Evidence-Based Perioperative Medicine (EBPOM). The conference focused on enhanced recovery for colorectal surgery and discussed four topics—Perioperative analgesia, Perioperative fluid management, preventing nosocomial infection, and measurement and quality in enhanced recovery pathways.

  • genetics and epigenetics in Perioperative Medicine
    Current Opinion in Critical Care, 2012
    Co-Authors: Christopher Bain, Andrew D Shaw
    Abstract:

    PURPOSE OF REVIEW: To summarize is to review recent progress in 'genomic' science and how this may be applied to the Perioperative environment. Although investigations that relate genetic variation to Perioperative outcomes continue, it is increasingly apparent that epigenetic mechanisms may contribute to much of the observed variation in complex outcomes not otherwise explained by differences in genetic sequence. RECENT FINDINGS: Examples of recent findings relating to the role of epigenetic modifications in complex disease and outcomes are derived from research into type 1 diabetes, pain, and the hypoxic response. These studies provide models for future cohort study design, potential Perioperative drug targets, and hypothesis development. Genetic and epigenetic factors combine to alter both gene expression and drug responses at both pharmacokinetic and pharmacodynamic levels. These factors impact on the efficacy and safety of multiple drug classes used in Perioperative Medicine. SUMMARY: Enhancing our understanding of the way in which patients as genomic organisms interact with the Perioperative environment requires a more sophisticated appreciation of the factors governing gene expression than has been the case to date. Epigenetic mechanisms are sure to play a pivotal role in what is essentially an acquired phenotype.