Farid Foroutan1, Gordon Guyatt2, Victoria Zuk2, Per Olav Vandvik3, Ana Carolina Alba4, Reem Mustafa5, Robin Vernooij6, Ingrid Arevalo-Rodriguez7, Zachary Munn8, Pavel Roshanov9, Richard Riley10, Stefan Schandelmaier2, Ton Kuijpers11, Reed Siemieniuk2, Carlos Canelo-Aybar6, Holger Schunemann2, Alfonso Iorio2. 1. Department of Health Research Methods, Evidence, and Impact, McMaster University, Ontario, Canada; Ted Rogers Center for Heart Research, Toronto General Hospital, Ontario, Canada. Electronic address: foroutaf@mcmaster.ca. 2. Department of Health Research Methods, Evidence, and Impact, McMaster University, Ontario, Canada. 3. Division Gjøvik, Department of Medicine, Innlandet Hospital Trust, Gjøvik, Norway. 4. Ted Rogers Center for Heart Research, Toronto General Hospital, Ontario, Canada. 5. Department of Internal Medicine, The University of Kansas Medical Center, Kansas City, USA. 6. Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain. 7. Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, IRYCIS, CIBER of Epidemiology and Public Health, Madrid, Spain; Centro de investigación en Salud Pública y Epidemiología Clínica. Facultad de Ciencias de la Salud Eugenio Espejo, Universidad UTE, Quito, Ecuador. 8. Faculty of Health and Medical Sciences, Joanna Briggs Institute, The University of Adelaide, Adelaide, Australia. 9. Department of Medicine, McMaster University, Ontario, Canada. 10. School of Health and Population Sciences, University of Birmingham, Birmingham, UK. 11. Department of Guideline Development, Dutch College of General Practitioners, Utrecth, The Netherlands.
Abstract
OBJECTIVE: The objective of this study was to provide guidance on the use of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to determine certainty in estimates of association between prognostic factors and future outcomes. STUDY DESIGN AND SETTING: We developed our guidance through an iterative process that involved review of published systematic reviews and meta-analyses of prognostic factors, consultation with members, feedback, presentation, and discussion at the GRADE Working Group meetings. RESULTS: For questions of prognosis, a body of observational evidence (potentially including patients enrolled in randomized controlled trials) begins as high certainty in the evidence. The five domains of GRADE for rating down certainty in the evidence, that is, risk of bias, imprecision, inconsistency, indirectness, and publication bias, as well as the domains for rating up, also apply to estimates of associations between prognostic factors and outcomes. One should determine if their ratings do not consider (noncontextualized) or consider (contextualized) the clinical context as this will may result in variable judgments on certainty of the evidence. CONCLUSIONS: The same principles GRADE proposed for bodies of evidence addressing treatment and overall prognosis work well in assessing individual prognostic factors, both in noncontextualized and contextualized settings.
OBJECTIVE: The objective of this study was to provide guidance on the use of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to determine certainty in estimates of association between prognostic factors and future outcomes. STUDY DESIGN AND SETTING: We developed our guidance through an iterative process that involved review of published systematic reviews and meta-analyses of prognostic factors, consultation with members, feedback, presentation, and discussion at the GRADE Working Group meetings. RESULTS: For questions of prognosis, a body of observational evidence (potentially including patients enrolled in randomized controlled trials) begins as high certainty in the evidence. The five domains of GRADE for rating down certainty in the evidence, that is, risk of bias, imprecision, inconsistency, indirectness, and publication bias, as well as the domains for rating up, also apply to estimates of associations between prognostic factors and outcomes. One should determine if their ratings do not consider (noncontextualized) or consider (contextualized) the clinical context as this will may result in variable judgments on certainty of the evidence. CONCLUSIONS: The same principles GRADE proposed for bodies of evidence addressing treatment and overall prognosis work well in assessing individual prognostic factors, both in noncontextualized and contextualized settings.
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