Browsing by Author "Rochwerg, Bram"

Now showing 1 - 5 of 5
  • No Thumbnail Available
    Item
    Development and application of health outcome descriptors facilitated decision-making in the production of practice guidelines
    (2021) Wiercioch, Wojtek; Nieuwlaat, Robby; Dahm, Philipp; Iorio, Alfonso; Mustafa, Reem A.; Neumann, Ignacio; Rochwerg, Bram; Manja, Veena; Alonso-Coello, Pablo; Ortel, Thomas L.; Santesso, Nancy; Vesely, Sara K.; Akl, Elie A.; Schuenemann, Holger J.; Zakai, Neil; Cuker, Adam; Lim, Wendy; Monagle, Paul; Kunkle, Robert; Witt, Daniel M.; Kahn, Susan R.; McLintock, Claire; Rezende, Suely M.; Zakai, Neil A.
    Objective: Stakeholders involved in developing recommendations need to have a common understanding of health outcomes and the perspective of affected individuals. In this paper we report on the development and application of health outcome descriptors (HODs) to inform decision-making by panels developing guideline recommendations.
  • No Thumbnail Available
    Item
    Doppler identified venous congestion in septic shock: protocol for an international, multi-centre prospective cohort study (Andromeda-VEXUS)
    (2023) Prager, Ross; Argaiz, Eduardo; Pratte, Michael; Rola, Philippe; Arntfield, Robert; Beaubien-Souligny, William; Denault, Andre Y.; Haycock, Korbin; Aguiar, Francisco Miralles; Bakker, Jan; Ospina-Tascon, Gustavo; Orozco, Nicolas; Rochwerg, Bram; Lewis, Kimberley; Quazi, Ibrahim; Kattan, Eduardo; Hernandez, Glenn; Basmaji, John
    Introduction Venous congestion is a pathophysiological state where high venous pressures cause organ oedema and dysfunction. Venous congestion is associated with worse outcomes, particularly acute kidney injury (AKI), for critically ill patients. Venous congestion can be measured by Doppler ultrasound at the bedside through interrogation of the inferior vena cava (IVC), hepatic vein (HV), portal vein (PV) and intrarenal veins (IRV). The objective of this study is to quantify the association between Doppler identified venous congestion and the need for renal replacement therapy (RRT) or death for patients with septic shock.Methods and analysis This study is a prespecified substudy of the ANDROMEDA-SHOCK 2 (AS-2) randomised control trial (RCT) assessing haemodynamic resuscitation in septic shock and will enrol at least 350 patients across multiple sites. We will include adult patients within 4 hours of fulfilling septic shock definition according to Sepsis-3 consensus conference. Using Doppler ultrasound, physicians will interrogate the IVC, HV, PV and IRV 6-12 hours after randomisation. Study investigators will provide web-based educational sessions to ultrasound operators and adjudicate image acquisition and interpretation. The primary outcome will be RRT or death within 28 days of septic shock. We will assess the hazard of RRT or death as a function of venous congestion using a Cox proportional hazards model. Sub-distribution HRs will describe the hazard of RRT given the competing risk of death.Ethics and dissemination We obtained ethics approval for the AS-2 RCT, including this observational substudy, from local ethics boards at all participating sites. We will report the findings of this study through open-access publication, presentation at international conferences, a coordinated dissemination strategy by investigators through social media, and an open-access workshop series in multiple languages.Trial registration number NCT05057611.
  • No Thumbnail Available
    Item
    How to write a guideline: a proposal for a manuscript template that supports the creation of trustworthy guidelines
    (2021) Nieuwlaat, Robby; Wiercioch, Wojtek; Brozek, Jan L.; Santesso, Nancy; Kunkle, Robert; Alonso-Coello, Pablo; Anderson, David R.; Bates, Shannon M.; Dahm, Philipp; Iorio, Alfonso; Lim, Wendy; Lyman, Gary H.; Middeldorp, Saskia; Monagle, Paul; Mustafa, Reem A.; Neumann, Ignacio; Ortel, Thomas L.; Rochwerg, Bram; Vesely, Sara K.; Witt, Daniel M.; Cuker, Adam; Schunemann, Holger J.
    Trustworthy health guidelines should provide recommendations, document the development process, and highlight implementation information. Our objective was to develop a guideline manuscript template to help authors write a complete and useful report. The McMaster Grading of Recommendations Assessment, Development and Evaluation Centre collaborated with the American Society of Hematology (ASH) to develop guidelines for the management of venous thromboembolism. A template for reporting the guidelines was developed based on prior approaches and refined using input from other key stakeholders. The proposed guideline manuscript template includes: (1) title for guideline identification, (2) abstract, including a summary of key recommendations, (3) overview of all recommendations (executive summary), and (4) the main text, providing sufficient detail about the entire process, including objectives, background, and methodological decisions from panel selection and conflict-of-interest management to criteria for updating, as well as supporting information, such as links to online (interactive) tables. The template further allows for tailoring to the specific topic, using examples. Initial experience with the ASH guideline manuscript template was positive, and challenges included drafting descriptions of recommendations involving multiple management pathways, tailoring the template for a specific guideline, and choosing key recommendations to highlight. Feedback from a larger group of guideline authors and users will be needed to evaluate its usefulness and refine. The proposed guideline manuscript template is the first detailed template for transparent and complete reporting of guidelines. Consistent application of the template may simplify the preparation of an evidence-based guideline manuscript and facilitate its use.
  • No Thumbnail Available
    Item
    Methodology for the American Society of Hematology VTE guidelines: current best practice, innovations, and experiences
    (2020) Wiercioch, Wojtek; Nieuwlaat, Robby; Akl, Elie A.; Kunkle, Robert; Alexander, Kendall E.; Cuker, Adam; Rajasekhar, Anita; Alonso-Coello, Pablo; Anderson, David R.; Bates, Shannon M.; Cushman, Mary; Dahm, Philipp; Guyatt, Gordon; Iorio, Alfonso; Lim, Wendy; Lyman, Gary H.; Middeldorp, Saskia; Monagle, Paul; Mustafa, Reem A.; Neumann, Ignacio; Ortel, Thomas L.; Rochwerg, Bram; Santesso, Nancy; Vesely, Sara K.; Witt, Daniel M.; Schunemann, Holger J.
    Background: Methods for the development of clinical guidelines have advanced dramatically over the past 2 decades to strive for trustworthiness, transparency, user-friendliness, and rigor. The American Society of Hematology (ASH) guidelines on venous thromboembolism (VTE) have followed these advances, together with application of methodological innovations.
  • No Thumbnail Available
    Item
    New methods facilitated the process of prioritizing questions and health outcomes in guideline development
    (2022) Wiercioch, Wojtek; Nieuwlaat, Robby; Zhang, Yuan; Alonso-Coello, Pablo; Dahm, Philipp; Iorio, Alfonso; Manja, Veena; Mustafa, Reem A.; Neumann, Ignacio; Ortel, Thomas L.; Rochwerg, Bram; Santesso, Nancy; Vesely, Sara K.; Akl, Elie A.; Schunemann, Holger J.
    Background: Health guideline development requires sequential prioritization of the guideline topic, questions, and health outcomes. In this paper we report on new approaches for prioritizing questions and outcomes in guidelines. Methods: Ten guideline panels on venous thromboembolism rated potential guideline questions on a 9-point scale according to their overall importance and 6 criteria: common in practice, uncertainty in practice, variation in practice, new evidence available, cost consequences, not previously addressed. We randomized panelists to rate one potential question with and without the 6 criteria. Panelists rated importance of outcomes, defined with health outcome descriptors (HODs), using a 9-point scale, and health utility of outcomes on a visual analogue scale. Results: Of 469 potential questions identified, 72.5% were rated as important but not of high priority, and 25.4% as high priority. Each criterion was significantly associated with the overall importance rating. The overall importance rating means were 5.96 (SD 2.38) and 6.53 (SD 2.45) ( P = 0.25) for those randomized to rate questions with and without the criteria, respectively. The mean importance rating for 121 outcomes was 6.01 (SD 1.25), with 35.5% rated as critical for decision-making. Panelists provided health utility ratings for 127 outcomes, with a minimum mean rating of 0.12 (SD 0.10) and maximum of 0.91 (SD 0.15). Conclusion: Our structured process provided information to help explain perspectives of question importance, to facilitate panels' outcome prioritization, and to facilitate decision-making in guideline development. (c) 2021 Published by Elsevier Inc.