Browsing by Author "Alonso-Coello, Pablo"

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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 methodological survey of the analysis, reporting and interpretation of Absolute Risk ReductiOn in systematic revieWs (ARROW): a study protocol
    (2013) Alonso-Coello, Pablo; Carrasco-Labra, Alonso; Brignardello-Petersen, Romina; Neumann Burotto, Gonzalo Ignacio; Akl, Elie A; Sun, Xin; Johnston, Bradley C; Briel, Matthias; Busse, Jason W; Glujovsky, Demián; Granados, Carlos E; Iorio, Alfonso; Irfan, Affan; García, Laura M; Mustafa, Reem A; Ramirez-Morera, Anggie; Solà, Iván; Tikkinen, Kari A O; Ebrahim, Shanil; Vandvik, Per O; Zhang, Yuqing; Selva, Anna; Sanabria, Andrea J; Zazueta, Oscar E; Vernooij, Robin W M; Schünemann, Holger J; Guyatt, Gordon H
    Abstract Background Clinicians, providers and guideline panels use absolute effects to weigh the advantages and downsides of treatment alternatives. Relative measures have the potential to mislead readers. However, little is known about the reporting of absolute measures in systematic reviews. The objectives of our study are to determine the proportion of systematic reviews that report absolute measures of effect for the most important outcomes, and ascertain how they are analyzed, reported and interpreted. Methods/design We will conduct a methodological survey of systematic reviews published in 2010. We will conduct a 1:1 stratified random sampling of Cochrane vs. non-Cochrane systematic reviews. We will calculate the proportion of systematic reviews reporting at least one absolute estimate of effect for the most patient-important outcome for the comparison of interest. We will conduct multivariable logistic regression analyses with the reporting of an absolute estimate of effect as the dependent variable and pre-specified study characteristics as the independent variables. For systematic reviews reporting an absolute estimate of effect, we will document the methods used for the analysis, reporting and interpretation of the absolute estimate. Discussion Our methodological survey will inform current practices regarding reporting of absolute estimates in systematic reviews. Our findings may influence recommendations on reporting, conduct and interpretation of absolute estimates. Our results are likely to be of interest to systematic review authors, funding agencies, clinicians, guideline developers and journal editors.
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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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    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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    The GRADE Evidence to Decision (EtD) framework for health system and public health decisions
    (2018) Moberg, Jenny; Oxman, Andrew D.; Rosenbaum, Sarah; Schünemann, Holger J.; Guyatt, Gordon; Flottorp, Signe; Glenton, Claire; Lewin, Simon; Morelli, Angela; Rada G., Gabriel; Alonso-Coello, Pablo
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    Users’ experiences with an interactive Evidence to Decision (iEtD) framework: a qualitative analysis
    (2021) Meneses-Echavez, José Francisco; Rosenbaum, Sarah; Rada G., Gabriel; Flottorp, Signe; Moberg, Jenny; Alonso-Coello, Pablo
    Abstract: Background: Evidence to Decision (EtD) frameworks bring clarity, structure and transparency to health care decision making. The interactive Evidence to Decision (iEtD) tool, developed in the context of the DECIDE project and published by Epistemonikos, is a stand-alone online solution for producing and using EtD frameworks. Since its development, little is known about how organizations have been using the iEtD tool and what characterizes users’ experiences with it. This missing information is necessary for any teams planning future developments of the iEtD tool. Methods: This study aimed to describe users’ experiences with the iEtD and identify main barriers and facilitators related to use. We contacted all users registered in the iEtD via email and invited people who identified themselves as having used the solution to a semi-structured interview. Audio recordings were transcribed, and one researcher conducted a directed content analysis of the interviews guided by a user experience framework. Two researchers checked the content independently for accuracy. Results: Out of 860 people contacted, 81 people replied to our introductory email (response rate 9.4%). Twenty of these had used the tool in a real scenario and were invited to an interview. We interviewed all eight users that accepted this invitation (from six countries, four continents). ‘Guideline development’ was the iEtD use scenario they most commonly identified. Most participants reported an overall positive experience, without major difficulties navigating or using the different sections. They reported having used most of the EtD framework criteria. Participants reported tailoring their frameworks, for instance by adding or deleting criteria, translating to another language, or rewording headings. Several people preferred to produce a Word version rather than working online, due to the burden of completing the framework, or lack of experience with the tool. Some reported difficulties working with the exportable formats, as they needed considerable editing. Conclusion: A very limited number of guideline developers have used the iEtD tool published by Epistemonikos since its development. Although users’ general experiences are positive, our work has identified some aspects of the tool that need improvement. Our findings could be also applied to development or improvement of other solutions for producing or using EtD frameworks.
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    Women’s Values and Preferences for Thromboprophylaxis during Pregnancy : A Comparison of Direct-choice and Decision Analysis using Patient Specific Utilities
    (2015) Eckman, Mark H.; Alonso-Coello, Pablo; Guyatt, Gordon H.; Ebrahim, Shanil; Tikkinen, Kari A.O.; Lopes, Luciane Cruz; Neumann Burotto, Gonzalo Ignacio; Mcdonald, Sarah D.; Zhang, Yuqing; Zhou, Qi; Akl, Elie A.; Jacobsen, Ann Flem; Santamaría, Amparo; Annichino-Bizzacchi, Joyce Maria; Bitar, Wael; Sandset, Per Morten; Bates, Shannon M.