National Healthcare Quality and Disparities Report
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- Adverse Events (1)
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AHRQ Research Studies
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Research Studies is a compilation of published research articles funded by AHRQ or authored by AHRQ researchers.
Results
1 to 7 of 7 Research Studies DisplayedRao BR, Merchant FM, Howard DH
Shared decision-making for implantable cardioverter-defibrillators: policy goals, metrics, and challenges.
Researchers discussed shared decision-making for implantable cardioverter-defibrillators (ICDs), including the results from a case study implementing the shared decision-making mandate for ICDs, which involved providing patients with decision aids prior to or following the doctor consultation.
AHRQ-funded; HS028558.
Citation: Rao BR, Merchant FM, Howard DH .
Shared decision-making for implantable cardioverter-defibrillators: policy goals, metrics, and challenges.
J Law Med Ethics 2021 Win;49(4):622-29. doi: 10.1017/jme.2021.85..
Keywords: Decision Making, Medical Devices, Policy, Cardiovascular Conditions
Brescia AA, Watt TMF, Pagani FD
Assessment of mortality among durable left ventricular assist device recipients ineligible for clinical trials.
This study compared the mortality of heart patients undergoing durable left ventricular assist device (LVAD) implantation who were enrolled in a clinical trial called Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Therapy With HeartMate 3 (MOMENTUM 3) to general population LVAD recipients from 181 North American centers from January 1, 2012, to June 30, 2017, identified in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). Among 14,679 recipients, a total of 6429 recipients (43.8%) would have been ineligible for enrollment in the MOMENTUM 3 study. Estimated mortality for recipients who were trial-ineligible was higher than for recipients who were trial-eligible (25.3% versus 16.2% for 1-year mortality, 42.8% versus 36.4% for 3-year mortality). The authors concluded that a better representation of the patient population would reflect real-world experience better than the trial eligibility criteria that was used.
AHRQ-funded; HS026003.
Citation: Brescia AA, Watt TMF, Pagani FD .
Assessment of mortality among durable left ventricular assist device recipients ineligible for clinical trials.
JAMA Netw Open 2021 Jan 4;4(1):e2032865. doi: 10.1001/jamanetworkopen.2020.32865..
Keywords: Heart Disease and Health, Cardiovascular Conditions, Mortality, Medical Devices
Sobotka SA, Lynch E, Quinn MT
Unmet respite needs of children with medical technology dependence.
Children with medical technology dependency (MTD) require a medical device to compensate for a vital body function and substantial nursing care. As such, they require constant high-level supervision. Respite care provides caregivers with a temporary break, and is associated with reduced stress; however, there are often barriers. The study utilizes mixed methodology with the National Survey of Children with Special Health Care Needs (NS-CSHCN) and semistructured interviews with state-wide care coordinators to understand the gap for respite care services.
AHRQ-funded; HS023007.
Citation: Sobotka SA, Lynch E, Quinn MT .
Unmet respite needs of children with medical technology dependence.
Clin Pediatr 2019 Oct;58(11-12):1175-86. doi: 10.1177/0009922819870251..
Keywords: Children/Adolescents, Medical Devices, Disabilities, Caregiving, Home Healthcare, Care Coordination
Zhang AD, Schwartz JL, Ross JS
Association between Food and Drug Administration Advisory Committee recommendations and agency actions, 2008-2015.
In this paper, the authors examined the association between Food and Drug Administration Advisory Committee Recommendations and agency actions for a time period of 2008-2015. The investigators concluded that the FDA disagrees with the recommendations of its advisory committees a minority of the time, and in these cases it tends to be less likely to approve new products or supplemental indications and take safety actions.
AHRQ-funded; HS022882.
Citation: Zhang AD, Schwartz JL, Ross JS .
Association between Food and Drug Administration Advisory Committee recommendations and agency actions, 2008-2015.
Milbank Q 2019 Sep;97(3):796-819. doi: 10.1111/1468-0009.12403..
Keywords: Medical Devices, Policy, Patient Safety
Wang E, Kang H, Gong Y
Generating a health information technology event database from FDA MAUDE reports.
This study examined using a health information technology (HIT) event database to identify patient safety events (PSEs) or medical errors. The study used the FDA Manufacturer and User Facility Device Experience (MAUDE) database to extract HIT events. Classic and CNN models were utilized on a test set. The model was capable of identifying HIT event with about a 90% accuracy.
AHRQ-funded; HS022895.
Citation: Wang E, Kang H, Gong Y .
Generating a health information technology event database from FDA MAUDE reports.
Stud Health Technol Inform 2019 Aug 21;264:883-87. doi: 10.3233/shti190350..
Keywords: Health Information Technology (HIT), Medical Devices, Adverse Events, Data, Medical Errors, Patient Safety
Reeder HT, Shen C, Buxton AE
Joint shock/death risk prediction model for patients considering implantable cardioverter-defibrillators.
This study’s goal was to develop a joint shock/death risk prediction tool for patients who received implantable cardioverter-defibrillators (ICDs). Secondary analysis of patients was conducted as part of the SCD-HeFT trial (Sudden Cardiac Death in Heart Failure Trial). An illness-death regression model was applied for both ICD shocks and deaths. Among 803 ICD recipients, 430 (53.5%) did not receive an ICD shock or die, 206 (25.7%) received at least 1 shock but did not die, 113 (14.1%) died before receiving a shock, and 54 (6.7%) received at least 1 shock but still died. This predictive performance can be used as a tool for individualized counseling for patients contemplating an ICD.
AHRQ-funded; HS024520.
Citation: Reeder HT, Shen C, Buxton AE .
Joint shock/death risk prediction model for patients considering implantable cardioverter-defibrillators.
Circ Cardiovasc Qual Outcomes 2019 Aug;12(8):e005675. doi: 10.1161/circoutcomes.119.005675..
Keywords: Heart Disease and Health, Cardiovascular Conditions, Medical Devices, Risk, Decision Making, Mortality
Hajduk AM, Gurwitz JH, Tabada G
Influence of multimorbidity on burden and appropriateness of implantable cardioverter-defibrillator therapies.
Researchers sought to determine whether burden of multiple chronic conditions (MCCs) influences the risk of receiving inappropriate vs appropriate device therapies. They studied adults with left ventricular systolic dysfunction receiving an implantable cardioverter-defibrillator (ICD) for primary prevention. In these patients, they found that MCC burden was independently associated with an increased risk of inappropriate but not appropriate device therapies. They recommended considering comorbidity burden when engaging patients in shared decision making about ICD implantation.
AHRQ-funded; 290050033.
Citation: Hajduk AM, Gurwitz JH, Tabada G .
Influence of multimorbidity on burden and appropriateness of implantable cardioverter-defibrillator therapies.
J Am Geriatr Soc 2019 Jul;67(7):1370-78. doi: 10.1111/jgs.15839..
Keywords: Cardiovascular Conditions, Heart Disease and Health, Chronic Conditions, Medical Devices, Prevention, Elderly, Risk, Patient-Centered Outcomes Research