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- (-) Adverse Events (14)
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- Healthcare-Associated Infections (HAIs) (2)
- Healthcare Cost and Utilization Project (HCUP) (1)
- Health Information Technology (HIT) (3)
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- (-) Medical Devices (14)
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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 14 of 14 Research Studies DisplayedMovahedi F, Kanwar MK, Antaki JF
Timelines of adverse event journeys of LVAD patients.
The objective of this study was to investigate the timelines of adverse events (AEs) in the INTERMACS database to obtain insights into the "AE journeys" of left ventricular assist device (LVAD) patients. The characteristics of the timelines were investigated via six descriptive research questions. The analysis revealed time-related characteristics and patterns of the AE journey after LVAD, including the most common time of occurrences, duration, and time intervals between AEs. The authors concluded that the INTERMACS Event dataset is a valuable resource for research about the timeline of AE journeys of LVAD patients and noted that future studies should consider the time-related characteristics of the dataset to choose an appropriate scope of time and time granularity.
AHRQ-funded; HS027784.
Citation: Movahedi F, Kanwar MK, Antaki JF .
Timelines of adverse event journeys of LVAD patients.
Artif Organs 2023 Oct; 47(10):1604-12. doi: 10.1111/aor.14596..
Keywords: Heart Disease and Health, Cardiovascular Conditions, Adverse Events, Medical Devices
Mao J, Sedrakyan A, Sun T
Assessing adverse event reports of hysteroscopic sterilization device removal using natural language processing.
This study’s objective was to develop an annotation model to develop natural language processing (NLP) to device adverse event reports and to implement the model to evaluate the most frequently experienced events among women reporting a sterilization device removal. Adverse event reports from the Manufacturer and User Facility Device Experience database from January 2005 to June 2018 were included. The authors used an iterative process to develop an annotation model that extracts six categories of desired information and applied the annotation model to train an NLP algorithm. A total of 16,535 reports of device removal were analyzed with the most frequently reported patient and device events being abdominal/pelvic/genital pain (79.6%) and device dislocation/migration (19.2%), respectively. A total of 7,932 patients reported an additional sterilization procedure of a hysterectomy or salpingectomy. One-fifth of the cases that had device removal timing specified reported a removal 7 years after original insertion.
AHRQ-funded; HS026291.
Citation: Mao J, Sedrakyan A, Sun T .
Assessing adverse event reports of hysteroscopic sterilization device removal using natural language processing.
Pharmacoepidemiol Drug Saf 2022 Apr;31(4):442-51. doi: 10.1002/pds.5402..
Keywords: Adverse Events, Surgery, Medical Devices, Patient Safety
Mentias A, Briasoulis A, Vaughan Sarrazin MS
Trends, perioperative adverse events, and survival of patients with left ventricular assist devices undergoing noncardiac surgery.
This longitudinal cohort study examined outcomes of noncardiac surgery (NCS) in patients with left ventricular assist devices (LVADs). This study examined patients enrolled in Medicare who had undergone durable LVAD implantation from January 2012 to November 2017 with follow-up through December 2017. Primary outcome after NCS was major adverse cardiovascular events (MACEs), defined as in-hospital or 30-day all-cause mortality, ischemic stroke, or intracerebral hemorrhage. Of the 8118 patients with LVAD, 1326 underwent NCS with 75.4% emergent or urgent, and 24.6% elective. Both elective and urgent or emergent NCS was associated with higher mortality early and late compared with patients with LVAD who did not undergo NCS.
AHRQ-funded; HS023104.
Citation: Mentias A, Briasoulis A, Vaughan Sarrazin MS .
Trends, perioperative adverse events, and survival of patients with left ventricular assist devices undergoing noncardiac surgery.
JAMA Netw Open 2020 Nov 2;3(11):e2025118. doi: 10.1001/jamanetworkopen.2020.25118..
Keywords: Heart Disease and Health, Cardiovascular Conditions, Surgery, Medical Devices, Chronic Conditions, Outcomes, Adverse Events
Dhruva SS, Ross JS, Mortazavi BJ
Association of use of an intravascular microaxial left ventricular assist device vs intra-aortic balloon pump with in-hospital mortality and major bleeding among patients with acute myocardial infarction complicated by cardiogenic shock.
This study examines outcomes among patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) complicated by cardiogenic shock. Two interventions are compared: intravascular microaxial left ventricular assist devices (LVADs) versus intra-aortic balloon pumps (IABPs). The American College of Cardiology’s National Cardiovascular Data Registry was used to identify patients with AMI complicated by cardiogenic shock from hospitals participating in the CathPCI and Chest Pain-MI registries and identified 28,304 patients. Over the study period (2015 to 2017), LVAD was used in 6.2% of patients and IABP in 29.9%. LVAD was shown to have higher rates of in-hospital death and major bleeding complications compared to IABP.
AHRQ-funded; HS022882; HS025402; HS025517; HS026379.
Citation: Dhruva SS, Ross JS, Mortazavi BJ .
Association of use of an intravascular microaxial left ventricular assist device vs intra-aortic balloon pump with in-hospital mortality and major bleeding among patients with acute myocardial infarction complicated by cardiogenic shock.
JAMA 2020 Feb 25;323(8):734-45. doi: 10.1001/jama.2020.0254..
Keywords: Medical Devices, Heart Disease and Health, Cardiovascular Conditions, Mortality, Adverse Events, Registries, Patient Safety, Patient-Centered Outcomes Research, Evidence-Based Practice
Chandanabhumma PP, Fetters MD, Pagani FD
Understanding and addressing variation in health care-associated infections after durable ventricular assist device therapy: protocol for a mixed methods study.
This paper discusses an ongoing AHRQ-funded study to understand and address variation in health care-associated infections (HAIs) after durable ventricular assist device (VAD) implantation surgery. This procedure is used only on patients with advanced heart failure who have a poor 1-year estimated survival rate. This is a sequential mixed methods study which is conducting a systematic review of HAI prevention studies, and an in-depth quantitative analyses using administration claims, in-depth clinical data, and organizational surveys of VAD centers. The last aim is to develop and disseminate a best practices toolkit for HAI prevention. Data analysis is currently underway.
AHRQ-funded; HS026003.
Citation: Chandanabhumma PP, Fetters MD, Pagani FD .
Understanding and addressing variation in health care-associated infections after durable ventricular assist device therapy: protocol for a mixed methods study.
JMIR Res Protoc 2020 Jan 7;9(1):e14701. doi: 10.2196/14701..
Keywords: Healthcare-Associated Infections (HAIs), Surgery, Medical Devices, Prevention, Heart Disease and Health, Cardiovascular Conditions, Adverse Events
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.
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
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
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
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
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
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
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
Steinberg BA, Al-Khatib SM, Edwards R
Outcomes of implantable cardioverter-defibrillator use in patients with comorbidities: results from a combined analysis of 4 randomized clinical trials.
The researchers aimed to determine if the benefit of implantable cardioverter-defibrillators (ICDs) is modulated by medical comorbidity. They concluded that patients with extensive comorbid medical illnesses may experience less benefit from primary prevention ICDs than those with less comorbidity, and that implantation should be carefully considered in sick patients. They recommended further study of ICDs in medically complex patients.
AHRQ-funded; HS018505.
Citation: Steinberg BA, Al-Khatib SM, Edwards R .
Outcomes of implantable cardioverter-defibrillator use in patients with comorbidities: results from a combined analysis of 4 randomized clinical trials.
JACC Heart Fail 2014 Dec;2(6):623-9. doi: 10.1016/j.jchf.2014.06.007.
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Keywords: Adverse Events, Heart Disease and Health, Medical Devices, Patient-Centered Outcomes Research