Browsing by Author "Neumann, Ignacio"

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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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    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 2021 guidelines on the use of anticoagulation for thromboprophylaxis in patients with COVID-19
    (2021) 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; Pai, Menaka; Righini, Marc; Sanfilippo, Kristen M.; Siegal, Deborah; Skara, Mike; Touri, Kamshad; Akl, Elie A.; Akl, Imad Bou; Boulos, Mary; Brignardello-Petersen, Romina; Charide, Rana; Chan, Matthew; Dearness, Karin; Darzi, Andrea J.; Kolb, Philipp; Colunga-Lozano, Luis E.; Mansour, Razan; Morgano, Gian Paolo; Morsi, Rami Z.; Noori, Atefeh; Piggott, Thomas; Qiu, Yuan; Roldan, Yetiani; Schuenemann, Finn; Stevens, Adrienne; Solo, Karla; Ventresca, Matthew; Wiercioch, Wojtek; Mustafa, Reem A.; Schuenemann, Holger J.
    Background: Coronavirus disease 2019 (COVID-19)-related critical illness and acute illness are associated with a risk of venous thromboembolism (VTE).
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    American Society of Hematology living guidelines on the use of anticoagulation for thromboprophylaxis in patients with COVID-19: January 2022 update on the use of therapeutic-intensity anticoagulation in acutely ill patients
    (2022) Cuker, Adam; Tseng, Eric K.; Nieuwlaat, Robby; Angchaisuksiri, Pantep; Blair, Clifton; Dane, Kathryn; 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 M.; Skara, Mike; Terrell, Deirdra R.; Touri, Kamshad; Akl, Elie A.; Al Jabiri, Reyad; Al Jabiri, Yazan; Barbara, Angela M.; Bognanni, Antonio; Boulos, Mary; Brignardello-Petersen, Romina; Charide, Rana; Colunga-Lozano, Luis E.; Dearness, Karin; Darzi, Andrea J.; Hussein, Heba; Karam, Samer G.; Mansour, Razan; Morgano, Gian Paolo; Morsi, Rami Z.; Muti-Schunemann, Giovanna; Nadim, Menatalla K.; Philip, Binu A.; Qiu, Yuan; Benitez, Yetiani Roldan; Stevens, Adrienne; Solo, Karla; Wiercioch, Wojtek; Mustafa, Reem A.; Schuenemann, 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 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 living guidelines on the use of anticoagulation for thromboprophylaxis in patients with COVID-19: May 2021 update on the use of intermediate-intensity anticoagulation in critically ill patients
    (2021) 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.; Akl, Imad Bou; Bognanni, Antonio; Boulos, Mary; Brignardello-Petersen, Romina; Charide, Rana; Chan, Matthew; Dearness, Karin; Darzi, Andrea J.; Kolb, Philipp; Colunga-Lozano, Luis E.; Mansour, Razan; Morgano, Gian Paolo; Morsi, Rami Z.; Muti-Schunemann, Giovanna; Noori, Atefeh; Philip, Binu A.; Piggott, Thomas; Qiu, Yuan; Roldan, Yetiani; Schuenemann, Finn; Stevens, Adrienne; Solo, Karla; Wiercioch, Wojtek; Mustafa, Reem A.; Schuenemann, Holger J.
    Background: COVID-19-related critical illness is associated with an increased risk of venous thromboembolism (VTE). Objective: These evidence-based guidelines of the American Society of Hematology (ASH) are intended to support patients, clinicians, and other health care professionals in making decisions about the use of anticoagulation for thromboprophylaxis in patients with COVID-19-related critical illness who do not have confirmed or suspected 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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    ASH, ABHH, ACHO, Grupo CAHT, Grupo CLAHT, SAH, SBHH, SHU, SOCHIHEM, SOMETH, Sociedad Panamena de Hematologia, SPH, and SVH 2021 guidelines for management of venous thromboembolism in Latin America
    (ELSEVIER, 2021) Neumann, Ignacio; Izcovich, Ariel; Aguilar, Ricardo; Leon Basantes, Guillermo; Casais, Patricia; Colorio, Cecilia C.; Guillermo Esposito, Maria Cecilia; Garcia Lazaro, Pedro P.; Meillon Garcia, Luis A.; Pereira, Jaime; Rezende, Suely Meireles; Carlos Serrano, Juan; Tejerina Valle, Mario L.; Vera, Felipe; Karzulovic, Lorena; Rada, Gabriel; Schuenemann, Holger
    Background: Venous thromboembolism (VTE) is a common disease in Latin American settings. Implementing international guidelines in Latin American settings requires additional considerations.
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    Clinical guidelines using the GRADE system (Grading of Recommendations Assessment, Development and Evaluation)
    (SOC MEDICA SANTIAGO, 2017) Mendoza, Carolina; Kraemer, Patricia; Herrera, Paloma; Burdiles, Pamela; Sepulveda, Dino; Nunez, Eliozka; Munoz, Cecilia; Neumann, Ignacio
    The Ministry of Health of Chile, aiming to improve the quality of clinical practice guidelines, gradually incorporated the GRADE system (Grading of Recommendations, Assessment, Development and Evaluation) to develop evidence based recommendations. This system summarizes and evaluates the certainty of the available evidence. It moves from evidence to decision in a systematic and transparent manner, based on four main dimensions: balance between benefits and harms, certainty of evidence, patient's values and preferences and use of resources. The GRADE system produces strong and conditional recommendations. Strong recommendations provide confidence that the favorable consequences of an intervention clearly outweigh the adverse consequences, or vice versa. These recommendations apply to a broad range of patients and circumstances. Conditional recommendations, however, indicate that there is a close balance between favorable and unfavorable consequences of the intervention, there is uncertainty in the magnitude of benefits or adverse effects, there is uncertainty or variability in values and preferences of individuals or costs are not justified. These recommendations apply to many patients, but not all of them: ideally they should be discussed with each person. To achieve a better implementation of the recommendations made with GRADE methodology, health professionals should know the meaning of strong and conditional recommendations and they should be able to critically assess of them.
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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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    Equity issues rarely addressed in the development of COVID-19 formal recommendations and good practice statements: a cross-sectional study
    (2023) Dewidar, Omar; Bondok, Mostafa; Abdelrazeq, Leenah; Aliyeva, Khadija; Solo, Karla; Welch, Vivian; Brignardello-Petersen, Romina; Mathew, Joseph L.; Hazlewood, Glen; Pottie, Kevin; Hartling, Lisa; Khalifa, Dina Sami; Duda, Stephanie; Falavigna, Maicon; Khabsa, Joanne; Lotfi, Tamara; Petkovic, Jennifer; Elliot, Sarah; Chi, Yuan; Parker, Roses; Kristjansson, Elizabeth; Riddle, Alison; Darzi, Andrea J.; Magwood, Olivia; Saad, Ammar; Radav, Gabriel; Neumann, Ignacio; Loeb, Mark; Reveiz, Ludovic; Mertz, Dominik; Piggott, Thomas; Turgeon, Alexis F.; Schunemann, Holger; Tugwell, Peter
    Background and Objective: To identify COVID-19 actionable statements (e.g., recommendations) focused on specific disadvantaged populations in the living map of COVID-19 recommendations (eCOVIDRecMap) and describe how health equity was assessed in the development of the formal recommendations. Methods: We employed the place of residence, race or ethnicity or culture, occupation, gender or sex, religion, education, socio-economic status, and social capital-Plus framework to identify statements focused on specific disadvantaged populations. We assessed health equity considerations in the evidence to decision frameworks (EtD) of formal recommendations for certainty of evidence and impact on health equity criteria according to the Grading of Recommendations, Assessment, Development, and Evaluations criteria.Results: We identified 16% (124/758) formal recommendations and 24% (186/819) good practice statements (GPS) that were focused on specific disadvantaged populations. Formal recommendations (40%, 50/124) and GPS (25%, 47/186) most frequently focused on children. Seventy-six percent (94/124) of the recommendations were accompanied with EtDs. Over half (55%, 52/94) of those considered indirectness of the evidence for disadvantaged populations. Considerations in impact on health equity criterion most frequently involved implementation of the recommendation for disadvantaged populations (17%, 16/94). Conclusion: Equity issues were rarely explicitly considered in the development COVID-19 formal recommendations focused on specific disadvantaged populations. Guidance is needed to support the consideration of health equity in guideline development during health emergencies.& COPY; 2023 Elsevier Inc. All rights reserved.
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    Global access to affordable direct oral anticoagulants
    (2021) Neumann, Ignacio; Schunemann, Holger; Bero, Lisa; Cooke, Graham; Magrini, Nicola; Moja, Lorenzo
    Poor control of cardiovascular disease accounts for a substantial proportion of the disease burden in developing countries, but often essential anticoagulant medicines for preventing strokes and embolisms are not widely available. In 2019, direct oral anticoagulants were added to the World Health Organization's WHO Model list of essential medicines. The aims of this paper are to summarize the benefits of direct oral anticoagulants for patients with cardiovascular disease and to discuss ways of increasing their usage internationally. Although the cost of direct oral anticoagulants has provoked debate, the affordability of introducing these drugs into clinical practice could be increased by: price negotiation; pooled procurement; competitive tendering; the use of patent pools; and expanded use of generics. In 2017, only 14 of 137 countries that had adopted national essential medicines lists included a direct oral anticoagulant on their lists. This number could increase rapidly if problems with availability and affordability can be tackled. Once the types of patient likely to benefit from direct oral anticoagulants have been clearly defined in clinical practice guidelines, coverage can be more accurately determined and associated costs can be better managed. Government action is required to ensure that direct oral anticoagulants are covered by national budgets because the absence of reimbursement remains an impediment to achieving universal coverage. Tackling cardiovascular disease with the aid of direct oral anticoagulants is an essential component of efforts to achieve the World Health Organization's target of reducing premature deaths due to noncommunicable disease by 25% by 2025.
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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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    Low Anonymous Voting Compliance With the Novel Policy for Managing Conflicts of Interest Implemented in the 9th Version of the American College of Chest Physicians Antithrombotic Guidelines
    (2013) Neumann, Ignacio; Akl, Elie A.; Valdes, Macarena; Bravo, Stephanie; Araos, Silvana; Kairouz, Victor; Schuenemann, Holger; Guyatt, Gordon H.
    Background: The executive committee of the Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (AT9) developed a strategy to limit the impact of conflict of interest (COI) on recommendations. This policy excluded conflicted panelists from voting on recommendations with which they had conflicts. The objective of the study is to explore the compliance of the attendees of the AT9 final conference.
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    Methodology for adaptation of the ASH Guidelines for Management of Venous Thromboembolism for the Latin American context
    (2021) Neumann, Ignacio; Izcovich, Ariel; Alexander, Kendall E.; Castano, Jenny; Plovnick, Robert; Kunkle, Robert; Zhang, Yuan; Aguilar, Ricardo; Leon Basantes, Guillermo; Casais, Patricia; Colorio, Cecilia C.; Guillermo Esposito, Maria Cecilia; Garcia Lazaro, Pedro P.; Pereira, Jaime; Meillon-Garcia, Luis A.; Rezende, Suely Meireles; Carlos Serrano, Juan; Tejerina Valle, Mario L.; Schuenemann, Holger
    Background: From 2017 to 2020, the American Society of Hematology (ASH) collaborated with 12 hematology societies in Latin America to adapt the ASH guidelines on venous thromboembolism (VTE).
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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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    Outcomes intermedios
    (SOC MEDICA SANTIAGO, 2012) Neumann, Ignacio; Claro G-A., Juan Carlos