Marat Fudim1, Frederik Dalgaard2, Sana M Al-Khatib3, Daniel J Friedman1, Kathryn Lallinger4, William T Abraham5, John G F Cleland6, Anne B Curtis7, Michael R Gold8, Valentina Kutyifa9, Cecilia Linde10, Daniel E Schaber11, Anthony Tang12, Fatima Ali-Ahmed13, Sarah A Goldstein13, Brystana Kaufman14, Robyn Fortman4, J Kelly Davis14, Lurdes Y T Inoue15, Gillian D Sanders16. 1. Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC; Division of Cardiology, Duke University School of Medicine, Durham, NC. 2. Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC; Department of Cardiology, Herlev and Gentofte hospital, Copenhagen, Denmark. 3. Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC; Division of Cardiology, Duke University School of Medicine, Durham, NC; Department of Medicine, Duke University School of Medicine, Durham, NC. 4. Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC; Duke-Margolis Center for Health Policy, Duke University, Durham, NC; Evidence Synthesis Group, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. 5. Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH. 6. National Heart and Lung Institute, Royal Brompton & Harefield Hospitals, Imperial College, London, United Kingdom. 7. Department of Medicine, University at Buffalo, Buffalo, NY. 8. Medical University of South Carolina, Charleston, SC. 9. Division of Cardiology, Department of Medicine, University of Rochester Medical Center, Rochester, NY. 10. Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden. 11. Medtronic, Inc, Minneapolis, MN. 12. Department of Medicine, Western University, London, Ontario, Canada. 13. Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. 14. Duke-Margolis Center for Health Policy, Duke University, Durham, NC. 15. Department of Biostatistics, University of Washington, Seattle, WA. 16. Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC; Department of Medicine, Duke University School of Medicine, Durham, NC; Duke-Margolis Center for Health Policy, Duke University, Durham, NC; Evidence Synthesis Group, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC. Electronic address: gillian.sanders@duke.edugillian.sanders@duke.edu.
Abstract
BACKGROUND: Although cardiac resynchronization therapy (CRT) is effective for some patients with heart failure and a reduced left ventricular ejection fraction (HFrEF), evidence gaps remain for key clinical and policy areas. The objective of the study was to review the data on the effects of CRT for patients with HFrEF receiving pharmacological therapy alone or pharmacological therapy and an implantable cardioverter-defibrillator (ICD) and then, informed by a diverse group of stakeholders, to identify evidence gaps, prioritize them, and develop a research plan. METHODS: Relevant studies were identified using PubMed and EMBASE and ongoing trials using clinicaltrials.gov. Forced-ranking prioritization method was applied by stakeholders to reach a consensus on the most important questions. Twenty-six stakeholders contributed to the expanded list of evidence gaps, including key investigators from existing randomized controlled trials and others representing different perspectives, including patients, the public, device manufacturers, and policymakers. RESULTS: Of the 18 top-tier evidence gaps, 8 were related to specific populations or subgroups of interest. Seven were related to the comparative effectiveness and safety of CRT interventions or comparators, and 3 were related to the association of CRT treatment with specific outcomes. The association of comorbidities with CRT effectiveness ranked highest, followed by questions about the effectiveness of CRT among patients with atrial fibrillation and the relationship between gender, QRS morphology and duration, and outcomes for patients either with CRT plus ICD or with ICD. CONCLUSIONS: Evidence gaps presented in this article highlight numerous, important clinical and policy questions for which there is inconclusive evidence on the role of CRT and provide a framework for future collaborative research.
BACKGROUND: Although cardiac resynchronization therapy (CRT) is effective for some patients with heart failure and a reduced left ventricular ejection fraction (HFrEF), evidence gaps remain for key clinical and policy areas. The objective of the study was to review the data on the effects of CRT for patients with HFrEF receiving pharmacological therapy alone or pharmacological therapy and an implantable cardioverter-defibrillator (ICD) and then, informed by a diverse group of stakeholders, to identify evidence gaps, prioritize them, and develop a research plan. METHODS: Relevant studies were identified using PubMed and EMBASE and ongoing trials using clinicaltrials.gov. Forced-ranking prioritization method was applied by stakeholders to reach a consensus on the most important questions. Twenty-six stakeholders contributed to the expanded list of evidence gaps, including key investigators from existing randomized controlled trials and others representing different perspectives, including patients, the public, device manufacturers, and policymakers. RESULTS: Of the 18 top-tier evidence gaps, 8 were related to specific populations or subgroups of interest. Seven were related to the comparative effectiveness and safety of CRT interventions or comparators, and 3 were related to the association of CRT treatment with specific outcomes. The association of comorbidities with CRT effectiveness ranked highest, followed by questions about the effectiveness of CRT among patients with atrial fibrillation and the relationship between gender, QRS morphology and duration, and outcomes for patients either with CRT plus ICD or with ICD. CONCLUSIONS: Evidence gaps presented in this article highlight numerous, important clinical and policy questions for which there is inconclusive evidence on the role of CRT and provide a framework for future collaborative research.
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