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AHRQ Research Studies Date
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- Adverse Events (1)
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- (-) Medical Devices (13)
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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 13 of 13 Research Studies DisplayedSteinberg 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
Bilchick KC, Stukenborg GJ
Comparative effectiveness of cardiac resynchronization therapy in combination with implantable defibrillator in patients with heart failure and wide QRS duration.
The researchers examined the long-term outcomes among Medicare patients with cardiac resynchronization therapy defibrillators (CRT-D) compared with those receiving standard implantable cardioverter defibrillators. They found that the greatest benefit of CRT-D was in patients with guideline-based class I recommendations for CRT-D. For these patients, there was a 17 percent reduction in risk of death.
AHRQ-funded; HS017693
Citation: Bilchick KC, Stukenborg GJ .
Comparative effectiveness of cardiac resynchronization therapy in combination with implantable defibrillator in patients with heart failure and wide QRS duration.
Am J Cardiol. 2014 Nov 15;114(10):1537-42. doi: 10.1016/j.amjcard.2014.08.017..
Keywords: Comparative Effectiveness, Medicare, Outcomes, Cardiovascular Conditions, Medical Devices
Berliner E
AHRQ Author: Berliner E
Adopting medical technology.
This editorial described a study by Gold and colleagues within this issue concerning the treatment accelerated partial breast irradiation (APBI), which was incorporated into clinical practice with few data on its benefits and risks. Berliner recommends a coordinated approach to evidence generation.
AHRQ-authored.
Citation: Berliner E .
Adopting medical technology.
Med Decis Making 2014 Nov;34(8):948-50. doi: 10.1177/0272989x14546378.
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Keywords: Evidence-Based Practice, Medical Devices
Khazanie P, Hammill BG, Qualls LG
Clinical effectiveness of cardiac resynchronization therapy versus medical therapy alone among patients with heart failure: analysis of the ICD Registry and ADHERE.
The researchers examined associations between cardiac resynchronization therapy with defibrillator (CRT-D) and mortality and readmission among patients with heart failure who received CRT-D in clinical practice, compared with those who received medical therapy alone. They found that CRT-D was associated with lower risks of mortality and readmission than medical therapy alone.
AHRQ-funded; HS021092
Citation: Khazanie P, Hammill BG, Qualls LG .
Clinical effectiveness of cardiac resynchronization therapy versus medical therapy alone among patients with heart failure: analysis of the ICD Registry and ADHERE.
Circ Heart Fail. 2014 Nov;7(6):926-34. doi: 10.1161/circheartfailure.113.000838..
Keywords: Comparative Effectiveness, Heart Disease and Health, Medical Devices, Hospital Readmissions, Outcomes
Yeh JS, Austad KE, Franklin JM
Association of medical students' reports of interactions with the pharmaceutical and medical device industries and medical school policies and characteristics: a cross-sectional study.
The study’s goal was to determine which medical school characteristics and which conflict of interest policy dimensions were most predictive of students’ reported behaviors. It found that students at schools with the highest ranked interaction policies based on the American Medical Student Association (AMSA) score were 63 percent less likely to accept gifts as students at the lowest ranked schools.
AHRQ-funded; HS018465.
Citation: Yeh JS, Austad KE, Franklin JM .
Association of medical students' reports of interactions with the pharmaceutical and medical device industries and medical school policies and characteristics: a cross-sectional study.
PLoS Med 2014 Oct;11(10):e1001743. doi: 10.1371/journal.pmed.1001743..
Keywords: Medical Devices, Medication, Policy, Practice Patterns
Borne RT, Peterson PN, Greenlee R
Temporal trends in patient characteristics and outcomes among Medicare beneficiaries undergoing primary prevention implantable cardioverter-defibrillator placement in the United States, 2006-2010.
Results from the National Cardiovascular Data Registry's Implantable Cardioverter-Defibrillator Registry. This study characterizing trends in clinical profiles and outcomes among Medicare patients undergoing primary implantable cardioverter-defibrillator implantation found only modest changes in clinical characteristics between 2006 and 2010. However, 6-month mortality and rehospitalization improved significantly over time, suggesting that there were meaningful improvements.
AHRQ-funded; HS019814
Citation: Borne RT, Peterson PN, Greenlee R .
Temporal trends in patient characteristics and outcomes among Medicare beneficiaries undergoing primary prevention implantable cardioverter-defibrillator placement in the United States, 2006-2010.
Circulation. 2014 Sep 2;130(10):845-53. doi: 10.1161/CIRCULATIONAHA.114.008653..
Keywords: Medical Devices, Outcomes, Medicare, Registries, Quality of Care
Setoguchi SR, Warner Stevenson L, Stewart GC
Influence of healthy candidate bias in assessing clinical effectiveness for implantable cardioverter-defibrillators: cohort study of older patients with heart failure.
This study assessed the potential contribution of unmeasured general health status to patient selection in assessments of implantable cardioverter-defibrillator (ICD) therapy. In a group of heart failure patients, those who received ICD therapy were younger and had lower ejection fraction and more cardiac admissions to hospital but fewer non-cardiac admissions. The lower risks of measured outcomes likely reflect unmeasured differences in comorbidity and frailty.
AHRQ-funded; 29020050016I; HS017731
Citation: Setoguchi SR, Warner Stevenson L, Stewart GC .
Influence of healthy candidate bias in assessing clinical effectiveness for implantable cardioverter-defibrillators: cohort study of older patients with heart failure.
BMJ. 2014 May 8;348:g2866. doi: 10.1136/bmj.g2866..
Keywords: Medical Devices, Outcomes, Registries, Heart Disease and Health, Medicare
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
Setoguchi S, Zhu Y, Jalbert JJ
Validity of deterministic record linkage using multiple indirect personal identifiers: linking a large registry to claims data.
The researchers compared the validity of several deterministic record linkage methods with multiple indirect identifiers by using data from the Centers for Medicare and Medicaid Services (CMS) implantable cardioverter-defibrillator (ICD) registry and administrative Medicare inpatient claims data. Linkage rules using 2 or 3 indirect, patient-level identifiers and hospital ID produced linkages with sensitivity of 95% and specificity of 98% compared with a gold standard linkage rule.
AHRQ-funded; 29020050016I; HS017731.
Citation: Setoguchi S, Zhu Y, Jalbert JJ .
Validity of deterministic record linkage using multiple indirect personal identifiers: linking a large registry to claims data.
Circ Cardiovasc Qual Outcomes 2014 May;7(3):475-80. doi: 10.1161/circoutcomes.113.000294..
Keywords: Medical Devices, Medicare, Registries, Data, Inpatient Care
Al-Khatib SM, Han JY, Edwards R
Do patients with a left ventricular ejection fraction between 30% and 35% benefit from a primary prevention implantable cardioverter defibrillator?
The researchers used data from randomized clinical trials involving patients with systolic heart failure who had received implantable cardioverter-defibrillators and compared outcomes for those whose left ventricular ejection fractions (LVEFs) was between 30 percent and 35 percent with those whose LVEF was less than 30 percent. The sample size was too small to permit any important conclusions.
AHRQ-funded; HS018505
Citation: Al-Khatib SM, Han JY, Edwards R .
Do patients with a left ventricular ejection fraction between 30% and 35% benefit from a primary prevention implantable cardioverter defibrillator?
Int J Cardiol. 2014 Mar 1;172(1):253-4. doi: 10.1016/j.ijcard.2013.12.278..
Keywords: Comparative Effectiveness, Outcomes, Medical Devices, Heart Disease and Health, Chronic Conditions
Kesselheim AS, Xu S
Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation.
In order to better understand medical device innovation, the researchers conducted interviews with the innovators whose work contributed to the development of coronary artery stents. They found that individual physician-inventors saw the need for coronary artery stents in their clinical practice and then developed prototypes with the support of academic medical centers, followed by early validation studies.
AHRQ-funded; HS018465
Citation: Kesselheim AS, Xu S .
Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation.
PLoS One. 2014 Feb 12;9(2):e88664. doi: 10.1371/journal.pone.0088664..
Keywords: Heart Disease and Health, Cardiovascular Conditions, Medical Devices
Earley A, Persson R, Garlitski AC
Effectiveness of implantable cardioverter defibrillators for primary prevention of sudden cardiac death in subgroups a systematic review.
The purpose of this review was to examine ICD effectiveness for primary prevention of SCD across subgroups by sex, age, QRS interval, time since myocardial infarction, blood urea nitrogen level, and diabetes. It concluded that there was weak evidence showing differences for all-cause mortality in subgroups of sex, age, and QRS interval. Also, evidence was indeterminate for all-cause mortality in the other subgroups and for SCD.
AHRQ-funded; 290200710055I.
Citation: Earley A, Persson R, Garlitski AC .
Effectiveness of implantable cardioverter defibrillators for primary prevention of sudden cardiac death in subgroups a systematic review.
Ann Intern Med 2014 Jan 21;160(2):111-21. doi: 10.7326/m13-1787..
Keywords: Medical Devices, Comparative Effectiveness, Prevention, Mortality
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