National Healthcare Quality and Disparities Report
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Topics
- Adverse Events (6)
- Cardiovascular Conditions (3)
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- Data (1)
- Elderly (1)
- Emergency Medical Services (EMS) (1)
- Evidence-Based Practice (1)
- Health Information Technology (HIT) (3)
- Heart Disease and Health (2)
- Home Healthcare (1)
- (-) Medical Devices (12)
- Medical Errors (1)
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- Patient-Centered Outcomes Research (1)
- (-) Patient Safety (12)
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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 12 of 12 Research Studies DisplayedMao 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
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
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
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
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)
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
Hwang TJ, Kesselheim AS, Bourgeois FT
Postmarketing trials and pediatric device approvals.
The authors sought to describe the current state of trial evidence underpinning the approval of pediatric devices. They found that most high-risk pediatric devices are approved on the basis of trials in patients 18 years of age or older, with few pediatric patients exposed to the devices before market availability. Also, few postmarketing studies require additional study in pediatric patients.
AHRQ-funded; HS018465.
Citation: Hwang TJ, Kesselheim AS, Bourgeois FT .
Postmarketing trials and pediatric device approvals.
Pediatrics 2014 May;133(5):e1197-202. doi: 10.1542/peds.2013-3348.
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Keywords: Children/Adolescents, Medical Devices, Patient Safety, Children/Adolescents
Rome BN, Kramer DB, Kesselheim AS
Approval of high-risk medical devices in the US: implications for clinical cardiology.
The authors review the premarket approval (PMA) process to approve high-risk cardiovascular devices, as well as the five different types of PMA supplements used to approve alterations to device design. They summarize the types of data required to approve new high-risk cardiovascular devices and discuss implications of the PMA process for clinicians and patients.
AHRQ-funded; HS018465
Citation: Rome BN, Kramer DB, Kesselheim AS .
Approval of high-risk medical devices in the US: implications for clinical cardiology.
Curr Cardiol Rep. 2014;16(6):489. doi: 10.1007/s11886-014-0489-0..
Keywords: Medical Devices, Cardiovascular Conditions, Patient Safety