Sana M Al-Khatib1, Jennifer M Gierisch1,2,3, Matthew J Crowley1,2,3, Remy R Coeytaux2,4, Evan R Myers2,5, Amy Kendrick2, Gillian D Sanders6,7. 1. Department of Medicine, Duke University School of Medicine, Durham, NC, USA. 2. Duke Evidence Synthesis Group, Duke Clinical Research Institute, 2400 Pratt Street, Durham, NC, 27705, USA. 3. Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC, USA. 4. Department of Community and Family Medicine, Duke University School of Medicine, Durham, NC, USA. 5. Department of Obstetrics and Gynecology, Duke University School of Medicine, Durham, NC, USA. 6. Department of Medicine, Duke University School of Medicine, Durham, NC, USA. gillian.sanders@dm.duke.edu. 7. Duke Evidence Synthesis Group, Duke Clinical Research Institute, 2400 Pratt Street, Durham, NC, 27705, USA. gillian.sanders@dm.duke.edu.
Abstract
BACKGROUND: Although the implantable cardioverter-defibrillator (ICD) is highly effective therapy for preventing sudden cardiac death, there is considerable uncertainty about its benefits and harms in older patients, especially in the presence of factors, other than old age, that increase the risk of death. OBJECTIVE: To develop a prioritized research agenda for the Patient-Centered Outcomes Research Institute as informed by a diverse group of stakeholders on the use and outcomes of the ICD in older patients. DESIGN: The existing literature was reviewed to identify evidence gaps, which were then refined by engaged stakeholders. Using a forced-ranking prioritization method, the stakeholders ranked evidence gaps by importance. For the highest-ranked evidence gaps, relevant recent studies were identified using PubMed, and relevant ongoing trials were identified using ClinicalTrials.gov. PARTICIPANTS: Eighteen stakeholders, including clinical experts and researchers in the prevention of sudden cardiac death and ICD therapy, representatives from federal and non-governmental funding agencies, representatives from relevant professional societies, health care decision-makers and policymakers, and representatives from related consumer and patient advocacy groups KEY RESULTS: The top 12 evidence gaps prioritized by stakeholders were related to the safety and effectiveness of ICDs in older patient subgroups not well represented in clinical trials, predictors of SCD, the impact of the ICD on quality of life, the use of shared decision-making, disparities in ICD use, risk stratification strategies, patient preferences, and distribution of modes of death in older patients. CONCLUSIONS: In this paper, we identify evidence gaps of high priority for current and future investigations of ICD therapy. Addressing these gaps will likely resolve many of the uncertainties surrounding the use and outcomes of the ICD in older patients seen in clinical practice.
BACKGROUND: Although the implantable cardioverter-defibrillator (ICD) is highly effective therapy for preventing sudden cardiac death, there is considerable uncertainty about its benefits and harms in older patients, especially in the presence of factors, other than old age, that increase the risk of death. OBJECTIVE: To develop a prioritized research agenda for the Patient-Centered Outcomes Research Institute as informed by a diverse group of stakeholders on the use and outcomes of the ICD in older patients. DESIGN: The existing literature was reviewed to identify evidence gaps, which were then refined by engaged stakeholders. Using a forced-ranking prioritization method, the stakeholders ranked evidence gaps by importance. For the highest-ranked evidence gaps, relevant recent studies were identified using PubMed, and relevant ongoing trials were identified using ClinicalTrials.gov. PARTICIPANTS: Eighteen stakeholders, including clinical experts and researchers in the prevention of sudden cardiac death and ICD therapy, representatives from federal and non-governmental funding agencies, representatives from relevant professional societies, health care decision-makers and policymakers, and representatives from related consumer and patient advocacy groups KEY RESULTS: The top 12 evidence gaps prioritized by stakeholders were related to the safety and effectiveness of ICDs in older patient subgroups not well represented in clinical trials, predictors of SCD, the impact of the ICD on quality of life, the use of shared decision-making, disparities in ICD use, risk stratification strategies, patient preferences, and distribution of modes of death in older patients. CONCLUSIONS: In this paper, we identify evidence gaps of high priority for current and future investigations of ICD therapy. Addressing these gaps will likely resolve many of the uncertainties surrounding the use and outcomes of the ICD in older patients seen in clinical practice.
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