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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.
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1 to 5 of 5 Research Studies DisplayedRao BR, Merchant FM, Abernethy ER
The impact of government-mandated shared decision-making for implantable defibrillators: a natural experiment.
This study examined the impact of the 2018 Centers for Medicare and Medicaid Services (CMS) mandate that patients considering implantation of an implantable cardioverter-defibrillator (ICD) for primary prevention of sudden cardiac death undergo shared decision-making (SDM) using a decision-aid. The authors surveyed patients who underwent implantation of a primary prevention ICD within the Emory Healthcare system between 2017-2019 (pre and post SDM mandate). Survey domains included decisional conflict, knowledge about the ICD, values-choice concordance, and engagement in decision-making. Of 101 patients who completed the survey, 45 had an ICD placed before the mandate and 56 placed after. No major differences were found between any of the survey domains. Patients with ICDs after the mandate were more likely to subjectively feel more informed about the benefits of the procedure but were less likely to be able to correctly identify the frequency of complications.
AHRQ-funded; HS028558.
Citation: Rao BR, Merchant FM, Abernethy ER .
The impact of government-mandated shared decision-making for implantable defibrillators: a natural experiment.
Pacing Clin Electrophysiol 2022 Feb; 45(2):274-80. doi: 10.1111/pace.14414..
Keywords: Decision Making, Medical Devices, Policy, Cardiovascular Conditions
Rao BR, Merchant FM, Howard DH
Shared decision-making for implantable cardioverter-defibrillators: policy goals, metrics, and challenges.
Researchers discussed shared decision-making for implantable cardioverter-defibrillators (ICDs), including the results from a case study implementing the shared decision-making mandate for ICDs, which involved providing patients with decision aids prior to or following the doctor consultation.
AHRQ-funded; HS028558.
Citation: Rao BR, Merchant FM, Howard DH .
Shared decision-making for implantable cardioverter-defibrillators: policy goals, metrics, and challenges.
J Law Med Ethics 2021 Win;49(4):622-29. doi: 10.1017/jme.2021.85..
Keywords: Decision Making, Medical Devices, Policy, Cardiovascular Conditions
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
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
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