National Healthcare Quality and Disparities Report
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- Adverse Events (6)
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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 19 of 19 Research Studies DisplayedSobotka 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
Goldstone AB, Chiu P, Baiocchi M
Mechanical or biologic prostheses for aortic-valve and mitral-valve replacement.
This study compared long-term mortality and rates of reoperation, stroke, and bleeding between cohorts of patients who underwent primary aortic-valve replacement or mitral-valve replacement with a mechanical or biologic prosthesis. The long-term mortality benefit associated with a mechanical prosthesis, as compared with a biologic prosthesis, persisted until 70 years of age among patients undergoing mitral-valve replacement and until 55 years of age among those undergoing aortic-valve replacement.
AHRQ-funded; HS022192.
Citation: Goldstone AB, Chiu P, Baiocchi M .
Mechanical or biologic prostheses for aortic-valve and mitral-valve replacement.
N Engl J Med 2017 Nov 9;377(19):1847-57. doi: 10.1056/NEJMoa1613792.
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Keywords: Adverse Events, Cardiovascular Conditions, Medical Devices, Patient-Centered Outcomes Research, Surgery
Zeitler EP, Al-Khatib SM, Friedman DJ
Predicting appropriate shocks in patients with heart failure: patient level meta-analysis from SCD-HeFT and MADIT II.
The study authors sought to identify characteristics predictive of appropriate shocks in patients with a primary prevention implantable cardioverter defibrillator (ICD). In this meta-analysis of patient level data from Multicenter Automatic Defibrillator Implantation Trial II and Sudden Cardiac Death in Heart Failure Trial, higher NYHA class, lower LVEF, no beta-blocker therapy, and single chamber ICD (vs. dual chamber) were significant predictors of appropriate shocks.
AHRQ-funded; HS018505.
Citation: Zeitler EP, Al-Khatib SM, Friedman DJ .
Predicting appropriate shocks in patients with heart failure: patient level meta-analysis from SCD-HeFT and MADIT II.
J Cardiovasc Electrophysiol 2017 Nov;28(11):1345-51. doi: 10.1111/jce.13307.
Keywords: Comparative Effectiveness, Heart Disease and Health, Medical Devices, Medical Devices, Risk
Branzetti JB, Adedipe AA, Gittinger MJ
Randomised controlled trial to assess the effect of a Just-in-Time training on procedural performance: a proof-of-concept study to address procedural skill decay.
The purpose of this study was to evaluate the impact of a novel Just-in-Time (JIT) intervention on transvenous pacemaker (TVP) placement during a simulated patient event. The authors concluded that a JIT intervention improved procedure performance, suggesting a role for JIT interventions in rarely performed procedures.
AHRQ-funded; HS020295
Citation: Branzetti JB, Adedipe AA, Gittinger MJ .
Randomised controlled trial to assess the effect of a Just-in-Time training on procedural performance: a proof-of-concept study to address procedural skill decay.
BMJ Qual Saf 2017 Nov;26(11):881-91. doi: 10.1136/bmjqs-2017-006656..
Keywords: Medical Devices, Patient Safety, Surgery, Training, Emergency Medical Services (EMS)
Sobotka SA, Agarwal RK, Msall ME
Prolonged hospital discharge for children with technology dependency: a source of health care disparities.
As the population of children who use medical technology such as long-term ventilation increases, it is important to critically evaluate the systems for preparing families for home life. The authors discuss the complication of hospital discharge and how it contributes to health and developmental disparities. They also describe a hospital-to-home transitional care model, which presents a home-like environment to provide developmental support while focusing on parental training, home nursing, and public-funding arrangements.
AHRQ-funded; HS023007.
Citation: Sobotka SA, Agarwal RK, Msall ME .
Prolonged hospital discharge for children with technology dependency: a source of health care disparities.
Pediatr Ann 2017 Oct;46(10):e365-e70. doi: 10.3928/19382359-20170919-01.
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Keywords: Children/Adolescents, Disparities, Home Healthcare, Hospital Discharge, Medical Devices
Ross JS, Bates J, Parzynski CS
Can machine learning complement traditional medical device surveillance? A case study of dual-chamber implantable cardioverter-defibrillators.
Using data from the National Cardiovascular Data Registry for implantable cardioverter-defibrillators (ICDs) linked to Medicare administrative claims for longitudinal follow-up, the researchers applied three statistical approaches to safety-signal detection for commonly used dual-chamber ICDs that used two propensity score (PS) models. The three approaches, including one machine learning method, identified important safety signals, but without exact agreement.
AHRQ-funded; HS023000.
Citation: Ross JS, Bates J, Parzynski CS .
Can machine learning complement traditional medical device surveillance? A case study of dual-chamber implantable cardioverter-defibrillators.
Med Devices 2017 Aug 16;10:165-88. doi: 10.2147/mder.s138158.
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Keywords: Medical Devices, Registries, Patient Safety, Adverse Events
Keller SC, Gurses AP, Werner N
Older adults and management of medical devices in the home: five requirements for appropriate use.
This study concerns a qualitative evaluation of barriers and facilitators of appropriate use, and outcomes of inappropriate use, among older adults at the transition from hospital to home with skilled home health care (SHHC). Five requirements for the appropriate use of home medical devices were identified. A systems approach integrating the hospital with the SHHC agency is needed to make the use of home medical devices safer.
AHRQ-funded; HS022916.
Citation: Keller SC, Gurses AP, Werner N .
Older adults and management of medical devices in the home: five requirements for appropriate use.
Popul Health Manag 2017 Aug;20(4):278-86. doi: 10.1089/pop.2016.0070.
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Keywords: Elderly, Caregiving, Home Healthcare, Medical Devices, Patient Safety
Kang H, Yu Z, Gong Y
Initializing and growing a database of health information technology (HIT) events by using TF-IDF and biterm topic modeling.
Health information technology (HIT) events were listed in the top 10 technology-related hazards since one in six patient safety events (PSE) is related to HIT. Aiming to retrieve HIT events from millions of event reports related to medical devices in FDA Manufacturer and User Facility Device Experience (MAUDE) database, the study authors proposed a novel identification strategy. Their strategy holds promise of initializing and growing an HIT database to meet the challenges of collecting, analyzing, sharing, and learning from HIT events at an aggregated level.
AHRQ-funded; HS022895.
Citation: Kang H, Yu Z, Gong Y .
Initializing and growing a database of health information technology (HIT) events by using TF-IDF and biterm topic modeling.
AMIA Annu Symp Proc 2017 Apr 16;2017:1024-33..
Keywords: Adverse Events, Health Information Technology (HIT), Medical Devices, Health Information Technology (HIT), Patient Safety
Kang H, Wang F, Zhou S
Identifying and synchronizing health information technology (HIT) events from FDA medical device reports.
Health information technology (HIT) events, a subtype of patient safety events, pose a major threat and barrier toward a safer healthcare system. The study authors proposed a strategy to identify and synchronize HIT events from the FDA Manufacturer and User Facility Device Experience (MAUDE) database by using a filter based on structured features and classifiers based on unstructured features. The strategy will help develop and grow an HIT event-exclusive database, keeping pace with updates to MAUDE toward shared learning.
AHRQ-funded; HS022895.
Citation: Kang H, Wang F, Zhou S .
Identifying and synchronizing health information technology (HIT) events from FDA medical device reports.
Stud Health Technol Inform 2017;245:1048-52.
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Keywords: Adverse Events, Health Information Technology (HIT), Medical Devices, Health Information Technology (HIT), Patient Safety
Blumenthal-Barby JS, Kostick KM, Delgado ED
Assessment of patients' and caregivers' informational and decisional needs for left ventricular assist device placement: implications for informed consent and shared decision-making.
The authors investigated the decision-making process and informational and decisional needs of patients and their caregivers regarding left ventricular assist device (LVAD) placement. They found that participants easily and clearly identified their values: life extension; family; and mobility. Participants reported the need to meet other patients and caregivers before device placement and to have an involved caregiver to synthesize information. They further found that some participants demonstrated a lack of clarity regarding transplant probability.
AHRQ-funded; HS024849.
Citation: Blumenthal-Barby JS, Kostick KM, Delgado ED .
Assessment of patients' and caregivers' informational and decisional needs for left ventricular assist device placement: implications for informed consent and shared decision-making.
J Heart Lung Transplant 2015 Sep;34(9):1182-9. doi: 10.1016/j.healun.2015.03.026.
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Keywords: Caregiving, Decision Making, Heart Disease and Health, Medical Devices, Patient and Family Engagement
Chen CY, Stevenson LW, Stewart GC
Real world effectiveness of primary implantable cardioverter defibrillators implanted during hospital admissions for exacerbation of heart failure or other acute co-morbidities: cohort study of older patients with heart failure.
The researchers examined the effectiveness of primary implantable cardioverter defibrillators (ICDs) in elderly patients receiving the device during a hospital admission for exacerbation of heart failure or other acute co-morbidities. They concluded that the benefits of primary ICD therapy seen in pivotal trials were not apparent in patients aged 66 or over who received ICDs during a hospital admission for exacerbation of heart failure or other acute co-morbidities.
AHRQ-funded; 290-2005-0016-I -TO3; HS017731.
Citation: Chen CY, Stevenson LW, Stewart GC .
Real world effectiveness of primary implantable cardioverter defibrillators implanted during hospital admissions for exacerbation of heart failure or other acute co-morbidities: cohort study of older patients with heart failure.
BMJ 2015 Jul 14;351:h3529. doi: 10.1136/bmj.h3529..
Keywords: Comparative Effectiveness, Elderly, Medical Devices, Heart Disease and Health, Outcomes
Pokorney SD, Miller AL, Chen AY
Implantable cardioverter-defibrillator use among Medicare patients with low ejection fraction after acute myocardial infarction.
This study examined Implantable Cardioverter-Defibrillator (ICD) implantation rates and associated mortality among older MI patients with low ejection fraction (EF). It found that fewer than 1 in 10 eligible patients with low EF received an ICD within 1 year after MI, although ICD implantation was associated with lower risk-adjusted mortality at 2 years.
AHRQ-funded; HS021092.
Citation: Pokorney SD, Miller AL, Chen AY .
Implantable cardioverter-defibrillator use among Medicare patients with low ejection fraction after acute myocardial infarction.
JAMA 2015 Jun 23-30;313(24):2433-40. doi: 10.1001/jama.2015.6409..
Keywords: Medical Devices, Heart Disease and Health, Medicare
Masoudi FA, Go AS, Magid DJ
Age and sex differences in long-term outcomes following implantable cardioverter-defibrillator placement in contemporary clinical practice: findings from the Cardiovascular Research Network.
The objectives of this study were to characterize the risks of adverse outcomes in women and older patients. following implantable cardioverter-defibrillator placement with a focus on death, hospitalization, and complications. It concluded that the burden of adverse outcomes is substantial and varies according to patient age and sex. These differences in outcome generally do not vary according to baseline heart failure characteristics.
AHRQ-funded; 290050033; HS019814.
Citation: Masoudi FA, Go AS, Magid DJ .
Age and sex differences in long-term outcomes following implantable cardioverter-defibrillator placement in contemporary clinical practice: findings from the Cardiovascular Research Network.
J Am Heart Assoc 2015 Jun 2;4(6):e002005. doi: 10.1161/jaha.115.002005..
Keywords: Medical Devices, Cardiovascular Conditions, Patient-Centered Outcomes Research, Elderly, Outcomes
Heidenreich PA, Tsai V, Bao H
Does age influence cardiac resynchronization therapy use and outcome?
This study sought to describe the use of cardiac resynchronization therapy with defibrillator (CRT-D) and its association with survival for older patients. It found that receipt of CRT-D was associated with better survival at 1 year (82.1 percent vs. 77.1 percent, respectively) and 4 years (54.0 percent vs. 46.2 percent , respectively) than in those receiving only an implantable cardiac defibrillator.
AHRQ-funded; HS019814.
Citation: Heidenreich PA, Tsai V, Bao H .
Does age influence cardiac resynchronization therapy use and outcome?
JACC Heart Fail 2015 Jun;3(6):497-504. doi: 10.1016/j.jchf.2015.01.012..
Keywords: Medical Devices, Cardiovascular Conditions, Heart Disease and Health, Elderly, Patient-Centered Outcomes Research
Walker J, Tucker LY, Goodney P
Adherence to endovascular aortic aneurysm repair device instructions for use guidelines has no impact on outcomes.
The authors reported on their long-term endovascular aortic aneurysm repair (EVAR) experience in a large multicenter registry with regard to adherence to instructions for use (IFU) guidelines. They found that overall mortality and aneurysm-related mortality were unaffected by IFU adherence, and that rates of endoleak and reintervention after initial EVAR were similar, suggesting that lack of IFU-based anatomic suitability was not a driver of outcomes.
AHRQ-funded; HS021581.
Citation: Walker J, Tucker LY, Goodney P .
Adherence to endovascular aortic aneurysm repair device instructions for use guidelines has no impact on outcomes.
J Vasc Surg 2015 May;61(5):1151-9. doi: 10.1016/j.jvs.2014.12.053.
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Keywords: Adverse Events, Guidelines, Medical Devices, Outcomes