National Healthcare Quality and Disparities Report
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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
26 to 50 of 71 Research Studies DisplayedSong J, Tark A, Larson EL
The relationship between pocket hematoma and risk of wound infection among patients with a cardiovascular implantable electronic device: an integrative review.
Pocket hematoma is a common adverse event following the insertion of cardiovascular implantable electronic devices (CIEDs), but the risk of wound infections associated with a pocket hematoma is unclear. The objective of this integrative review was to examine the relationship between pocket hematoma and risk of wound infection in a CIED population.
AHRQ-funded; HS024915.
Citation: Song J, Tark A, Larson EL .
The relationship between pocket hematoma and risk of wound infection among patients with a cardiovascular implantable electronic device: an integrative review.
Heart Lung 2020 Jan-Feb;49(1):92-98. doi: 10.1016/j.hrtlng.2019.09.009..
Keywords: Medical Devices, Cardiovascular Conditions, Surgery, Adverse Events, Healthcare-Associated Infections (HAIs), Injuries and Wounds, Risk
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, Shared 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
Dhruva SS, Ross JS, Schulz WL
Fulfilling the promise of unique device identifiers.
This article discusses unique device identifiers (UDIs). Unique device identifiers must be applied to implanted devices, such as pacemakers and artificial hips, and most invasive devices, such as robotic surgical instruments. The authors indicate that the UDI has had limited effect because it is available in neither electronic health records (EHRs) nor administrative claims data. As such, medical devices cannot be easily identified, tracked, or associated with patients, preventing population-level analyses of their safety and effectiveness.
AHRQ-funded; HS022882; HS025164.
Citation: Dhruva SS, Ross JS, Schulz WL .
Fulfilling the promise of unique device identifiers.
Ann Intern Med 2018 Aug 7;169(3):183-85. doi: 10.7326/m18-0526..
Keywords: Medical Devices
Bates J, Parzynski CS, Dhruva SS
Quantifying the utilization of medical devices necessary to detect postmarket safety differences: a case study of implantable cardioverter defibrillators.
The purpose of this study was to estimate medical device utilization needed to detect safety differences among implantable cardioverter defibrillators (ICDs) generator models and compare these estimates to utilization in practice. The investigators concluded that small safety differences among ICD generator models are unlikely to be detected through routine surveillance given current ICD utilization in practice, but large safety differences can be detected for most patients at anticipated average adverse event rates.
AHRQ-funded; HS022882.
Citation: Bates J, Parzynski CS, Dhruva SS .
Quantifying the utilization of medical devices necessary to detect postmarket safety differences: a case study of implantable cardioverter defibrillators.
Pharmacoepidemiol Drug Saf 2018 Aug;27(8):848-56. doi: 10.1002/pds.4565..
Keywords: Cardiovascular Conditions, Heart Disease and Health, Medical Devices, Patient Safety, Registries, Surgery
Patel S, Poorjary P, Pawar S
National landscape of unplanned 30-day readmissions in patients with left ventricular assist device implantation.
This study tracked unplanned 30-day readmissions in patients who had undergone left ventricular assist device (LVAD) implantation during 2013. Data from the Healthcare Cost and Utilization Project (HCUP) National Readmission Database was used. Out of 2,235 patients who had an LVAD implantation, 29.7% had at least 1 unplanned readmission within 30 days. The top reasons for readmission were implant complications (14.9%), congestive heart failure (11.7%), and gastrointestinal bleeding (8.4%). Predictors of readmission included a prolonged length stay during the primary admission, Medicare insurance, and discharge to a short-term facility.
AHRQ-funded; HS023000.
Citation: Patel S, Poorjary P, Pawar S .
National landscape of unplanned 30-day readmissions in patients with left ventricular assist device implantation.
Am J Cardiol 2018 Jul 15;122(2):261-67. doi: 10.1016/j.amjcard.2018.03.363..
Keywords: Healthcare Cost and Utilization Project (HCUP), Heart Disease and Health, Cardiovascular Conditions, Surgery, Medical Devices, Adverse Events
Desai NR, Bourdillon PM, Parzynski CS
Association of the US Department of Justice Investigation of Implantable Cardioverter-Defibrillators and
The US Department of Justice (DOJ) conducted an investigation into implantable cardioverter-defibrillators (ICDs) not meeting the Centers for Medicare & Medicaid Services National Coverage Determination (NCD) criteria. To examine changes in the proportion of initial primary prevention ICDs that did not meet NCD criteria following the announcement of the DOJ investigation at hospitals that reached settlements (settlement hospitals) and those that did not (nonsettlement hospitals).
AHRQ-funded; HS023000.
Citation: Desai NR, Bourdillon PM, Parzynski CS .
Association of the US Department of Justice Investigation of Implantable Cardioverter-Defibrillators and
JAMA 2018 Jul 3;320(1):63-71. doi: 10.1001/jama.2018.8151..
Keywords: Cardiovascular Conditions, Medical Devices, Medical Devices, Medicare, Policy
Sharma A, Al-Khatib SM, Ezekowitz JA
Implantable cardioverter-defibrillators in heart failure patients with reduced ejection fraction and diabetes.
This study evaluates the effectiveness of a strategy that uses an implantable cardioverter-defibrillator (ICD) plus medical therapy versus medical therapy alone among patients with heart failure (HF) and diabetes. Researchers conducted a patient-level combined-analysis using a combined dataset that included four primary prevention ICD trials of patients with HF or severely reduced ejection fractions. The results indicate that primary prevention ICD in combination with medical therapy versus medical therapy alone was not significantly associated with a reduced risk of all-cause death. The authors conclude that further studies are needed to evaluate the effectiveness of ICDs among patients with diabetes.
AHRQ-funded; HS018505.
Citation: Sharma A, Al-Khatib SM, Ezekowitz JA .
Implantable cardioverter-defibrillators in heart failure patients with reduced ejection fraction and diabetes.
Eur J Heart Fail 2018 Jun;20(6):1031-38. doi: 10.1002/ejhf.1192..
Keywords: Cardiovascular Conditions, Comparative Effectiveness, Diabetes, Heart Disease and Health, Medical Devices, Prevention
Bachmann JM, Duncan MS, Shah AS
Association of cardiac rehabilitation with decreased hospitalizations and mortality after ventricular assist device implantation.
This study examined whether outcomes of cardiac patients who had received ventricular assist device (VAD) implementation had decreased hospitalization and mortality with cardiac rehabilitation (CR). Medicare beneficiaries enrolled for disability or aged 65 years and older in 2014 were included. The investigators identified VAD recipients by diagnosis codes. It was found that each 5-year increase in age was associated with attending an additional 1.6 CR sessions and there was a 23% lower 1-year hospitalization risk and a 47% lower 1-year mortality risk.
AHRQ-funded; HS022990.
Citation: Bachmann JM, Duncan MS, Shah AS .
Association of cardiac rehabilitation with decreased hospitalizations and mortality after ventricular assist device implantation.
JACC Heart Fail 2018 Feb;6(2):130-39. doi: 10.1016/j.jchf.2017.11.002..
Keywords: Cardiovascular Conditions, Rehabilitation, Heart Disease and Health, Medical Devices, Surgery, Patient-Centered Outcomes Research, Outcomes, Mortality, Evidence-Based Practice, Hospitalization
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
Chrisinger BW, Grossestreuer AV, Laguna MC
Characteristics of automated external defibrillator coverage in Philadelphia, PA, based on land use and estimated risk.
The authors investigated how well the likelihood of out-of-hospital cardiac arrest was met by the supply of automated external defibrillators (AED) in a dense urban environment. This article offers one method by which local officials can use spatial data to prioritize attention for AED placement and coverage.
AHRQ-funded; HS018362.
Citation: Chrisinger BW, Grossestreuer AV, Laguna MC .
Characteristics of automated external defibrillator coverage in Philadelphia, PA, based on land use and estimated risk.
Resuscitation 2016 Dec;109:9-15. doi: 10.1016/j.resuscitation.2016.09.021.
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Keywords: Medical Devices, Health Insurance, Urban Health, Cardiovascular Conditions
Krishnamurthy Y, Cooper LB, Parikh KS
Pulmonary hypertension in the era of mechanical circulatory support.
The researchers summarized the literature available to highlight the definition, pathogenesis, and prognosis of pulmonary hypertension (PH) due to left heart disease (LHD). Additionally, they discussed the use of mechanical circulatory support (MCS) in this population. Then, they provided recommendations regarding the management and reassessment of PH due to LHD in the specific context of MCS.
AHRQ-funded; HS021092.
Citation: Krishnamurthy Y, Cooper LB, Parikh KS .
Pulmonary hypertension in the era of mechanical circulatory support.
ASAIO J 2016 Sep-Oct;62(5):505-12. doi: 10.1097/mat.0000000000000408.
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Keywords: Comparative Effectiveness, Heart Disease and Health, Medical Devices, Respiratory Conditions
Khazanie P, Hammill BG, Patel CB
Use of heart failure medical therapies among patients with left ventricular assist devices: insights from INTERMACS.
The authors examined the use of heart failure medications before and after left ventricular assist devices (LVAD) implant in adult patients enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). They found that overall use of neurohormonal antagonists was low after LVAD implant, whereas use of loop diuretics and amiodarone remained high, and concluded that heart failure medication use is highly variable, but appears to generally increase after LVAD implantation.
AHRQ-funded; HS021092.
Citation: Khazanie P, Hammill BG, Patel CB .
Use of heart failure medical therapies among patients with left ventricular assist devices: insights from INTERMACS.
J Card Fail 2016 Sep;22(9):672-9. doi: 10.1016/j.cardfail.2016.02.004.
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Keywords: Comparative Effectiveness, Heart Disease and Health, Medical Devices, Medication, Patient-Centered Outcomes Research
Kostick KM, Minard CG, Wilhelms LA
Development and validation of a patient-centered knowledge scale for left ventricular assist device placement.
The authors presented a comprehensive and valid methodology for developing a clinically informed and patient-centered measure of knowledge about left ventricular assist device (LVAD) therapy to facilitate discussion and measure candidate understanding of treatment options. They concluded that the LVAD knowledge scale may be useful in clinical settings to identify gaps in knowledge among patient candidates considering LVAD treatment; to better tailor education and discussion with patients and their caregivers; and to enhance informed decision-making before treatment decisions are made.
AHRQ-funded; HS024849.
Citation: Kostick KM, Minard CG, Wilhelms LA .
Development and validation of a patient-centered knowledge scale for left ventricular assist device placement.
J Heart Lung Transplant 2016 Jun;35(6):768-76. doi: 10.1016/j.healun.2016.01.015.
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Keywords: Shared Decision Making, Heart Disease and Health, Medical Devices, Patient and Family Engagement, Patient-Centered Outcomes Research
Zhu Y, Chen CY, Matsuyama Y
Comparative validity of methods to select appropriate cutoff weight for probabilistic linkage without unique personal identifiers.
The researchers aimed to assess the validity of probabilistic linkage in the absence of unique personal identifiers (UPI) and the methods of cutoff weight selection. They found that probabilistic linkage without UPI generated valid linkages when an optimal cutoff was chosen and concluded that histogram inspection, the duplicate method, and the odds formula method can be used in conjunction when a gold standard is not available.
AHRQ-funded; 29020050016I.
Citation: Zhu Y, Chen CY, Matsuyama Y .
Comparative validity of methods to select appropriate cutoff weight for probabilistic linkage without unique personal identifiers.
Pharmacoepidemiol Drug Saf 2016 Apr;25(4):444-52. doi: 10.1002/pds.3832.
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Keywords: Data, Medical Devices, Registries