Browsing by Author "Schunemann, Holger J."

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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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    American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism
    (2020) Ortel, Thomas L.; Neumann, Ignacio; Ageno, Walter; Beyth, Rebecca; Clark, Nathan P.; Cuker, Adam; Hutten, Barbara A.; Jaff, Michael R.; Manja, Veena; Schulman, Sam; Thurston, Caitlin; Vedantham, Suresh; Verhamme, Peter; Witt, Daniel M.; Florez, Ivan D.; Izcovich, Ariel; Nieuwlaat, Robby; Ross, Stephanie; Schunemann, Holger J.; Wiercioch, Wojtek; Zhang, Yuan; Zhang, Yuqing
    Background: Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), occurs in; 1 to 2 individuals per 1000 each year, corresponding to;300 000 to 600 000 events in the United States annually.
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    American Society of Hematology living guidelines on the use of anticoagulation for thromboprophylaxis in patients with COVID-19: July 2021 update on postdischarge thromboprophylaxis
    (2022) Cuker, Adam; Tseng, Eric K.; Nieuwlaat, Robby; Angchaisuksiri, Pantep; Blair, Clifton; Dane, Kathryn; Davila, Jennifer; DeSancho, Maria T.; Diuguid, David; Griffin, Daniel O.; Kahn, Susan R.; Klok, Frederikus A.; Lee, Alfred Ian; Neumann, Ignacio; Pai, Ashok; Righini, Marc; Sanfilippo, Kristen M.; Siegal, Deborah; Skara, Mike; Terrell, Deirdra R.; Touri, Kamshad; Akl, Elie A.; Al Jabiri, Reyad Nayif; Al Jabiri, Yazan Nayif; Barbara, Angela M.; Bognanni, Antonio; Akl, Imad Bou; Boulos, Mary; Brignardello-Petersen, Romina; Charide, Rana; Chan, Matthew; Colunga-Lozano, Luis E.; Dearness, Karin; Darzi, Andrea J.; Hussein, Heba; Karam, Samer G.; Kolb, Philipp; Mansour, Razan; Morgano, Gian Paolo; Morsi, Rami Z.; Muti-Schunemann, Giovanna; Nadim, Menatalla K.; Noori, Atefeh; Philip, Binu A.; Piggott, Thomas; Qiu, Yuan; Benitez, Yetiani Roldan; Schunemann, Finn; Stevens, Adrienne; Solo, Karla; Wiercioch, Wojtek; Mustafa, Reem A.; Schunemann, Holger J.
    Background: COVID-19-related acute illness is associated with an increased risk of venous thromboembolism (VTE).
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    American Society of Hematology, ABHH, ACHO, Grupo CAHT, Grupo CLAHT, SAH, SBHH, SHU, SOCHIHEM, SOMETH, Sociedad Panamena de Hematologia, Sociedad Peruana de Hematologia, and SVH 2022 guidelines for prevention of venous thromboembolism in surgical and medical patients and long-distance travelers in Latin America
    (2022) Neumann, Ignacio; Izcovich, Ariel; Aguilar, Ricardo; Leon Basantes, Guillermo; Casais, Patricia; Colorio, Cecilia C.; Guillermo Esposito, Maria Cecilia; Garcia Lazaro, Pedro P.; Pereira, Jaime; Meillon-Garcia, Luis A.; Meireles Rezende, Suely; Carlos Serrano, Juan; Tejerina Valle, Mario L.; Vera, Felipe; Karzulovic, Lorena; Rada, Gabriel; Schunemann, Holger J.
    Background: Venous thromboembolism (VTE) is a common disease in Latin American settings. Implementation of international guidelines in Latin American settings requires additional considerations.
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    American Society of Hematology, ABHH, ACHO, Grupo CAHT, Grupo CLAHT, SAH, SBHH, SHU, SOCHIHEM, SOMETH, Sociedad Panamena de Hematologia, Sociedad Peruana de Hematologia, and SVH 2023 guidelines for diagnosis of venous thromboembolism and for its management in special populations in Latin America
    (2023) Neumann, Ignacio; Izcovich, Ariel; Aguilar, Ricardo; Basantes, Guillermo Leon; Casais, Patricia; Colorio, Cecilia C.; Esposito, Maria Cecilia Guillermo; Lazaro, Pedro P. Garcia; Pereira, Jaime; Garcia, Luis A. Meillon; Rezende, Suely Meireles; Serrano, Juan Carlos; Valle, Mario L. Tejerina; Altuna, Diana; Zuniga, Pamela; Vera, Felipe; Karzulovic, Lorena; Schunemann, Holger J.
    Background: Implementation of international guidelines in Latin American settings requires additional considerations (ie, values and preferences, resources, accessibility, feasibility, and impact on health equity).Objective: The purpose of this guideline is to provide evidence-based recommendations about the diagnosis of venous thromboembolism (VTE) and its management in children and during pregnancy. Methods: We used the GRADE ADOLOPMENT method to adapt recommendations from 3 American Society of Hematology (ASH) VTE guidelines (diagnosis of VTE, VTE in pregnancy, and VTE in the pediatric population). ASH and 12 local hematology societies formed a guideline panel comprising medical professionals from 10 countries in Latin America. Panelists prioritized 10 questions about the diagnosis of VTE and 18 questions about its management in special populations that were relevant for the Latin American context. A knowledge synthesis team updated evidence reviews of health effects conducted for the original ASH guidelines and summarized information about factors specific to the Latin American context. Results: In comparison with the original guideline, there were significant changes in 2 of 10 diagnostic recommendations (changes in the diagnostic algorithms) and in 9 of 18 management recommendations (4 changed direction and 5 changed strength). Conclusions: This guideline ADOLOPMENT project highlighted the importance of contextualizing recommendations in other settings based on differences in values, resources, feasibility, and health equity impact.
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    GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction
    (2016) Alonso-Coello, Pablo; Schunemann, Holger J.; Moberg, Jenny; Brignardello-Petersen, Romina; Akl, Elie A.; Davoli, Marina; Treweek, Shaun; Mustafa, Reem A.; Rada, Gabriel; Rosenbaum, Sarah; Morelli, Angela; Guyatt, Gordon H.; Oxman, Andrew D.
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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.
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    Using explicit thresholds for benefits and harms in partially contextualized GRADE guidelines. Pilot experience from a living COVID-19 guideline
    (2022) Neumann, Ignacio; Quinelen, Eduardo; Nahuelhual, Paula; Burdiles, Pamela; Celedon, Natalia; Cerda, Katherine; Herrera-Omegna, Paloma; Kraemer, Patricia; Cancino, Karen Dominguez; Valenzuela, Juan Pablo; Sepulveda, Dino; Morgano, Gian Paolo; Akl, Elie A.; Schunemann, Holger J.
    Objectives: Guideline panels must assess the magnitude of health benefits and harms to develop sensible recommendations. However, they rarely use explicit thresholds. In this paper we report on the piloting and the use thresholds for benefits and harms.Study Design and Setting: We piloted the use of thresholds in a Chilean COVID-19 living guideline. For each of the critical outcomes, we asked panelists to suggest values of the thresholds for large, moderate, small, or trivial or no effect. We collected this information through a survey and an on-line discussion.Results: Twelve panelists decided on thresholds for three critical outcomes (mortality, need for mechanical ventilation and serious adverse events). For all outcomes, an absolute risk reduction was considered larger with more than 50 events, moderate with less than 50 events, small with less than 25 events, and trivial with less than 10 events. Having these a priori thresholds in place significantly impacted on the development of recommendations. Conclusion: Explicit thresholds were a valuable addition to the judgment of the certainty in the evidence, to decide the direction and strength of the recommendation and to evaluate the need for update. We believe this is a line of research worth perusing.(c) 2022 Elsevier Inc. All rights reserved.