Browsing by Author "Santesso, Nancy"

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    A guide for health professionals to interpret and use recommendations in guidelines developed with the GRADE approach
    (2016) Neumann, Ignacio; Santesso, Nancy; Akl, Elie A.; Rind, David M.; Vandvik, Per Olav; Alonso-Coello, Pablo; Agoritsas, Thomas; Mustafa, Reem A.; Alexander, Paul Elias; Schuenemann, Holger; Guyatt, Gordon H.
    An increasing number of organizations worldwide are using new and improved standards for developing trustworthy clinical guidelines. One of such approaches, developed by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) working group, offers systematic and transparent guidance in moving from evidence to recommendations. The GRADE strategy concentrates on four factors: the balance between benefits and harms, the certainty of the evidence, values and preferences, and resource considerations. However, it also considers issues around feasibility, equity, and acceptability of recommendations. GRADE distinguishes two types of recommendations: strong and weak. Strong recommendations reflect a clear preference for one alternative and should apply to all or almost all patients, obviating the need for a careful review of the evidence with each patient. Weak recommendations are appropriate when there is a close balance between desirable and undesirable consequences of alternative management strategies, uncertainty regarding the effects of the alternatives, uncertainty or variability in patients' values and preferences, or questionable cost-effectiveness. Weak recommendations usually require accessing the underlying evidence and a shared decision-making approach. Clinicians using GRADE recommendations should understand the meaning of the strength of the recommendation, be able to critically appraise the recommendation, and apply trustworthy recommendations according to their strength. (C) 2016 Elsevier Inc. All rights reserved.
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    A taxonomy and framework for identifying and developing actionable statements in guidelines suggests avoiding informal recommendations
    (2022) Lotfi, Tamara; Hajizadeh, Anisa; Moja, Lorenzo; Akl, Elie A.; Piggott, Thomas; Kredo, Tamara; Langendam, Miranda W.; Iorio, Alfonso; Klugar, Miloslav; Klugarova, Jitka; Neumann, Ignacio; Wiercioch, Wojtek; Leontiadis, Grigorios, I; Mbuagbaw, Lawrence; Turgeon, Alexis F.; Meerpohl, Joerg; Stevens, Adrienne; Brozek, Jan; Santesso, Nancy; Pottie, Kevin; Dewidar, Omar; Flottorp, Signe A.; Karpusheff, Justine; Saz-Parkinson, Zuleika; Rojas, Maria X.; Parmelli, Elena; Chu, Derek K.; Tugwell, Peter; Welch, Vivian; Avey, Marc T.; Brignardello-Petersen, Romina; Mathew, Joseph L.; Munn, Zachary; Nieuwlaat, Robby; Ford, Nathan; Qaseem, Amir; Askie, Lisa M.; Schunemann, Holger J.
    Objective: To propose a taxonomy and framework that identifies and presents actionable statements in guidelines.
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    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.
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    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.
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    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.
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    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.