Wojtek Wiercioch1,2,3, Robby Nieuwlaat1,2,3, Elie A Akl3,4, Robert Kunkle5, Kendall E Alexander5, Adam Cuker6,7, Anita Rajasekhar8, Pablo Alonso-Coello9, David R Anderson10, Shannon M Bates11, Mary Cushman6,12, Philipp Dahm13,14, Gordon Guyatt3, Alfonso Iorio3,11, Wendy Lim11, Gary H Lyman15,16, Saskia Middeldorp17, Paul Monagle18,19,20, Reem A Mustafa3,21, Ignacio Neumann22, Thomas L Ortel6,23, Bram Rochwerg3,11, Nancy Santesso1,2,3, Sara K Vesely24, Daniel M Witt25, Holger J Schünemann1,2,3,11. 1. Michael G. DeGroote Cochrane Canada Centre. 2. McMaster GRADE Centre, and. 3. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. 4. Department of Internal Medicine, American University of Beirut, Beirut, Lebanon. 5. American Society of Hematology, Washington, DC. 6. Department of Medicine and. 7. Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. 8. Department of Medicine, University of Florida, Gainesville, FL. 9. Iberoamerican Cochrane Center, Biomedical Research Institute Sant Pau (IIB Sant Pau-Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública), Barcelona, Spain. 10. Department of Medicine, Dalhousie University, Halifax, NS, Canada. 11. Department of Medicine, McMaster University, Hamilton, ON, Canada. 12. Department of Pathology and Laboratory Medicine, Larner College of Medicine, University of Vermont, Burlington, VT. 13. Urology Section, Minneapolis Veterans Affairs Health Care System, Minneapolis, MN. 14. Department of Urology, University of Minnesota, Minneapolis, MN. 15. Fred Hutchinson Cancer Research Center, Seattle, WA. 16. Department of Medicine, School of Medicine, University of Washington, Seattle, WA. 17. Department of Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands. 18. Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia. 19. Department of Haematology, Royal Children's Hospital, Melbourne, VIC, Australia. 20. Haematology Research, Murdoch Children's Research Institute, Melbourne, VIC, Australia. 21. Division of Nephrology and Hypertension, Department of Medicine, University of Kansas Medical Center, Kansas City, KS. 22. Department of Internal Medicine, Pontificia Universidad Catolica de Chile, Santiago, Chile. 23. Department of Pathology, Duke University Medical Center, Durham, NC. 24. Department of Biostatistics and Epidemiology, Hudson College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK; and. 25. Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake City, UT.
Abstract
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. OBJECTIVE: In this article, we describe methods and methodological innovations as a model to inform future guideline enterprises by ASH and others to achieve guideline standards. Methodological innovations introduced in the development of the guidelines aim to address current challenges in guideline development. METHODS: We followed ASH policy for guideline development, which is based on the Guideline International Network (GIN)-McMaster Guideline Development Checklist and current best practices. Central coordination, specialist working groups, and expert panels were established for the development of 10 VTE guidelines. Methodological guidance resources were developed to guide the process across guidelines panels. A methods advisory group guided the development and implementation of methodological innovations to address emerging challenges and needs. RESULTS: The complete set of VTE guidelines will include >250 recommendations. Methodological innovations include the use of health-outcome descriptors, online voting with guideline development software, modeling of pathways for diagnostic questions, application of expert evidence, and a template manuscript for publication of ASH guidelines. These methods advance guideline development standards and have already informed other ASH guideline projects. CONCLUSIONS: The development of the ASH VTE guidelines followed rigorous methods and introduced methodological innovations during guideline development, striving for the highest possible level of trustworthiness, transparency, user-friendliness, and rigor.
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. OBJECTIVE: In this article, we describe methods and methodological innovations as a model to inform future guideline enterprises by ASH and others to achieve guideline standards. Methodological innovations introduced in the development of the guidelines aim to address current challenges in guideline development. METHODS: We followed ASH policy for guideline development, which is based on the Guideline International Network (GIN)-McMaster Guideline Development Checklist and current best practices. Central coordination, specialist working groups, and expert panels were established for the development of 10 VTE guidelines. Methodological guidance resources were developed to guide the process across guidelines panels. A methods advisory group guided the development and implementation of methodological innovations to address emerging challenges and needs. RESULTS: The complete set of VTE guidelines will include >250 recommendations. Methodological innovations include the use of health-outcome descriptors, online voting with guideline development software, modeling of pathways for diagnostic questions, application of expert evidence, and a template manuscript for publication of ASH guidelines. These methods advance guideline development standards and have already informed other ASH guideline projects. CONCLUSIONS: The development of the ASH VTE guidelines followed rigorous methods and introduced methodological innovations during guideline development, striving for the highest possible level of trustworthiness, transparency, user-friendliness, and rigor.
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Authors: Gary H Lyman; Marc Carrier; Cihan Ay; Marcello Di Nisio; Lisa K Hicks; Alok A Khorana; Andrew D Leavitt; Agnes Y Y Lee; Fergus Macbeth; Rebecca L Morgan; Simon Noble; Elizabeth A Sexton; David Stenehjem; Wojtek Wiercioch; Lara A Kahale; Pablo Alonso-Coello Journal: Blood Adv Date: 2021-02-23
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Authors: Adam Cuker; Eric K Tseng; Robby Nieuwlaat; Pantep Angchaisuksiri; Clifton Blair; Kathryn Dane; Jennifer Davila; Maria T DeSancho; David Diuguid; Daniel O Griffin; Susan R Kahn; Frederikus A Klok; Alfred Ian Lee; Ignacio Neumann; Ashok Pai; Menaka Pai; Marc Righini; Kristen M Sanfilippo; Deborah Siegal; Mike Skara; Kamshad Touri; Elie A Akl; Imad Bou Akl; Mary Boulos; Romina Brignardello-Petersen; Rana Charide; Matthew Chan; Karin Dearness; Andrea J Darzi; Philipp Kolb; Luis E Colunga-Lozano; Razan Mansour; Gian Paolo Morgano; Rami Z Morsi; Atefeh Noori; Thomas Piggott; Yuan Qiu; Yetiani Roldan; Finn Schünemann; Adrienne Stevens; Karla Solo; Matthew Ventresca; Wojtek Wiercioch; Reem A Mustafa; Holger J Schünemann Journal: Blood Adv Date: 2021-02-09