National Healthcare Quality and Disparities Report
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Topics
- (-) Adverse Drug Events (ADE) (16)
- Adverse Events (9)
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- Comparative Effectiveness (1)
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- (-) Kidney Disease and Health (16)
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- Patient Adherence/Compliance (1)
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- Quality of Care (1)
- Risk (3)
- Transplantation (2)
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 16 of 16 Research Studies DisplayedEhmann MR, Mitchell J, Levin S
Renal outcomes following intravenous contrast administration in patients with acute kidney injury: a multi-site retrospective propensity-adjusted analysis.
The purpose of this retrospective study was to investigate the relationship between intravenous contrast media (CM) administration and persistent acute kidney injury (AKI) in patients with pre-existing AKI. The researchers used propensity-weighted and entropy-balanced observational cohort analysis of consecutive hospitalized patients aged 18 years or older who met the Kidney Disease Improving Global Outcomes (KDIGO) creatinine-based criteria for AKI upon arrival at one of three emergency departments between 7/ 2017 and 6/2021. Patients either received or did not receive intravenous CM. The analysis included 14,449 patient encounters, with 12.8% admitted to the intensive care unit (ICU). The study found that CM was administered in 18.4% of all encounters. AKI resolved before hospital discharge in 69.1% of cases. No association between intravenous CM administration and persistent AKI was found after unadjusted multivariable logistic regression modeling, propensity weighting, and entropy balancing. Similar results were obtained from sub-group analysis of patients admitted to the ICU. Initiation of dialysis within 180 days occurred in 5.4% of the cohort, with no observed association between CM administration and increased risk of dialysis within this timeframe.
AHRQ-funded; HS027793; HS02664002.
Citation: Ehmann MR, Mitchell J, Levin S .
Renal outcomes following intravenous contrast administration in patients with acute kidney injury: a multi-site retrospective propensity-adjusted analysis.
Intensive Care Med 2023 Feb; 49(2):205-15. doi: 10.1007/s00134-022-06966-w..
Keywords: Kidney Disease and Health, Adverse Drug Events (ADE), Adverse Events, Outcomes
Miano TA, Hennessy S, Yang W
Association of vancomycin plus piperacillin-tazobactam with early changes in creatinine versus cystatin C in critically ill adults: a prospective cohort study.
The purpose of this study was to test the hypothesis that the association between vancomycin + piperacillin-tazobactam and increased acute kidney injury (AKI) risk by contrasting changes in creatinine concentration after antibiotic initiation with changes in cystatin C concentration. The researchers included patients enrolled in the Molecular Epidemiology of SepsiS in the ICU (MESSI) prospective cohort who were treated for greater than or equal to 48 h with vancomycin + piperacillin-tazobactam or vancomycin + cefepime. The kidney function biomarkers of blood urea nitrogen (BUN), creatinine, and cystatin C were measured before antibiotic treatment and again on day two after initiation. Creatinine-defined AKI and dialysis were evaluated through day14, and mortality was assessed through day 30. The study found that in the 739 patients vancomycin + piperacillin-tazobactam was associated with a higher percentage increase of creatinine at day-two and a higher incidence of creatinine-defined AKI: rate ratio. Vancomycin + piperacillin-tazobactam was not associated with change in alternative biomarkers. The researchers concluded that the study supports the hypothesis that vancomycin + piperacillin-tazobactam effects on creatinine represent pseudotoxicity.
AHRQ-funded; HS027626.
Citation: Miano TA, Hennessy S, Yang W .
Association of vancomycin plus piperacillin-tazobactam with early changes in creatinine versus cystatin C in critically ill adults: a prospective cohort study.
Intensive Care Med 2022 Sep;48(9):1144-55. doi: 10.1007/s00134-022-06811-0..
Keywords: Critical Care, Medication, Kidney Disease and Health, Adverse Drug Events (ADE), Adverse Events
Gonzales HM, Fleming JN, Gebregziabher M
A critical analysis of the specific pharmacist interventions and risk assessments during the 12-month TRANSAFE Rx randomized controlled trial.
The objective of this study was to describe frequency and types of interventions made during a pharmacist-led, mobile health-based intervention of high-risk kidney transplant (KTX) recipients and to assess impact on patient risk levels. Primary pharmacist intervention types were medication reconciliation, patient education, and medication changes. The authors concluded that pharmacist-led mHealth may enhance opportunities for interventions and mitigate risk levels in KTX recipients.
AHRQ-funded; HS023754.
Citation: Gonzales HM, Fleming JN, Gebregziabher M .
A critical analysis of the specific pharmacist interventions and risk assessments during the 12-month TRANSAFE Rx randomized controlled trial.
Ann Pharmacother 2022 Jun; 56(6):685-90. doi: 10.1177/10600280211044792..
Keywords: Provider: Pharmacist, Medication: Safety, Medication, Risk, Transplantation, Kidney Disease and Health, Adverse Drug Events (ADE), Medical Errors, Patient Safety
Mian HS, Fiala MA, Sanchez L
Renal failure among multiple myeloma patients utilizing carfilzomib and associated factors in the "real world."
Researchers investigated the rate of renal failure and associated risk factors in real-world populations of patients with multiple myeloma taking carfilzomib. Using Surveillance, Epidemiology, and End Results (SEER)-Medicare linked data, they found that renal failure developed in 22% of patients during the study period. The median time to development of renal failure from first carfilzomib administration was 1.6 months. Increasing age, pre-existing heart failure, and pre-existing chronic kidney disease were associated with a higher risk of developing renal failure. As their study could not determine the exact cause and mechanism of renal failure, they recommended future studies to further understand this cause among patients on carfilzomib and to devise strategies to mitigate the risk.
AHRQ-funded; HS019455.
Citation: Mian HS, Fiala MA, Sanchez L .
Renal failure among multiple myeloma patients utilizing carfilzomib and associated factors in the "real world."
Ann Hematol 2021 May;100(5):1261-66. doi: 10.1007/s00277-021-04420-3..
Keywords: Cancer, Kidney Disease and Health, Medication, Adverse Drug Events (ADE), Adverse Events, Risk
Assimon MM, Wang L, Pun PH
Use of QT prolonging medications by hemodialysis patients and individuals without end-stage kidney disease.
Investigators characterized the extent and patterns of QT-interval prolonging medication use by adult hemodialysis patients and individuals without end-stage kidney disease annually from 2012 to 2016. They found that hemodialysis patients used QT prolonging medications with known torsades de pointes risk more extensively than individuals without end-stage kidney disease. They recommended future studies evaluating the cardiac safety of these drugs in the hemodialysis population.
AHRQ-funded; HS026801.
Citation: Assimon MM, Wang L, Pun PH .
Use of QT prolonging medications by hemodialysis patients and individuals without end-stage kidney disease.
J Am Heart Assoc 2020 Jul 7;9(13):e015969. doi: 10.1161/jaha.120.015969..
Keywords: Medication, Medication: Safety, Adverse Drug Events (ADE), Adverse Events, Kidney Disease and Health, Risk
Kurani S, Jeffery MM, Thorsteinsdottir B
Use of potentially nephrotoxic medications by U.S. adults with chronic kidney disease: NHANES, 2011-2016.
This study looked at the prevalence of potentially inappropriate medication (PIM) use by US adults by chronic kidney disease (CKD) stage and self-reported CKD awareness. A cross-sectional analysis of National Health and Nutrition Examination Surveys, 2011-2016 was conducted using a cohort of non-pregnant CKD adults with stages 3a, 3b, or 4-5 CKD. Analyses were adjusted for sex, age, race/ethnicity, education, comorbidities, and insurance type. More than 50% of US adults were taking PIM(s) for all CKD stages and awareness categories, but rates were highest among CKD-unaware patients with stages 4-5 CKD. Proton pump inhibitors, opioids, metformin, sulfonylureas, and NSAIDS were used frequently in all CKD stages. NSAIDS were used less frequently when the patient was CKD-aware.
AHRQ-funded; HS025164; HS025402; HS025517.
Citation: Kurani S, Jeffery MM, Thorsteinsdottir B .
Use of potentially nephrotoxic medications by U.S. adults with chronic kidney disease: NHANES, 2011-2016.
J Gen Intern Med 2020 Apr;35(4):1092-101. doi: 10.1007/s11606-019-05557-8..
Keywords: Medication: Safety, Medication, Adverse Drug Events (ADE), Adverse Events, Kidney Disease and Health, Chronic Conditions, Patient Safety
Flory JH, Hennessy S, Bailey CJ
Reports of lactic acidosis attributed to metformin, 2015-2018.
This study examined the effects of allowing patients with mild-moderate chronic kidney disease to use metformin. The researchers examined rates of reports of metformin-associated lactic acidosis (MALA) to FDA’s Adverse Event Reporting System (FAERS). Publicly available data from 2015 to 2018 was analyzed. Reports from the US increased from 111 in 2015 to 243 in 2018. However due to a lack of a denominator or control group they could not conclude US MALA rates have increased. The authors also concluded that while the increased reports deserve attention, further study is needed.
AHRQ-funded; HS023898.
Citation: Flory JH, Hennessy S, Bailey CJ .
Reports of lactic acidosis attributed to metformin, 2015-2018.
Diabetes Care 2020 Jan;43(1):244-46. doi: 10.2337/dc19-0923.
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Keywords: Kidney Disease and Health, Medication, Medication: Safety, Patient Safety, Adverse Drug Events (ADE), Adverse Events
Stoops C, Stone S, Evans E
Baby NINJA (Nephrotoxic Injury Negated by Just-in-Time Action): reduction of nephrotoxic medication-associated acute kidney injury in the neonatal intensive care unit.
The purpose of this study was to test if acute kidney injury (AKI) is preventable in patients in the neonatal intensive care unit and if infants at high-risk of nephrotoxic medication-induced AKI can be identified using a systematic surveillance program previously used in the pediatric non-intensive care unit setting. The authors concluded that a systematic surveillance program to identify high-risk infants can prevent nephrotoxic-induced AKI and has the potential to prevent short and long-term consequences of AKI in critically ill infants.
AHRQ-funded; HS023763.
Citation: Stoops C, Stone S, Evans E .
Baby NINJA (Nephrotoxic Injury Negated by Just-in-Time Action): reduction of nephrotoxic medication-associated acute kidney injury in the neonatal intensive care unit.
J Pediatr 2019 Dec;215:223-28.e6. doi: 10.1016/j.jpeds.2019.08.046..
Keywords: Newborns/Infants, Medication, Medication: Safety, Patient Safety, Kidney Disease and Health, Intensive Care Unit (ICU), Critical Care, Quality Improvement, Quality of Care, Prevention, Adverse Drug Events (ADE), Adverse Events
Assimon MM, Brookhart MA, Flythe JE
Comparative cardiac safety of selective serotonin reuptake inhibitors among individuals receiving maintenance hemodialysis.
This retrospective cohort study compared cardiac safety of selective serotonin reuptake inhibitors (SSRIs) among individuals receiving maintenance hemodialysis. These individuals may be particularly susceptible to lethal cardiac consequences of drug-induced QT prolongation due to a substantial cardiovascular disease burden and their use of many medications. Data from a cohort of Medicare beneficiaries receiving hemodialysis included in the US Renal Data system registry from 2007-2014 was used. Researchers compared the 1-year risk of death among hemodialysis patients taking different SSRIs. Use of higher QT-prolonging potential SSRIs (citalopram, escitalopram) was associated with a higher risk of sudden cardiac death than patients taking lower risk SSRIs (fluoxetine, fluvoxamine, paroxetine, sertraline). The association was higher among elderly individuals, females, patients with conduction disorders, and those treated with other non-SSRI QT-prolonging medications.
AHRQ-funded; HS026801.
Citation: Assimon MM, Brookhart MA, Flythe JE .
Comparative cardiac safety of selective serotonin reuptake inhibitors among individuals receiving maintenance hemodialysis.
J Am Soc Nephrol 2019 Apr;30(4):611-23. doi: 10.1681/asn.2018101032..
Keywords: Medication, Medication: Safety, Patient Safety, Adverse Drug Events (ADE), Adverse Events, Kidney Disease and Health, Cardiovascular Conditions, Chronic Conditions
Shetterly Shetterly, S Flory, J
Diagnosis-based cohort augmentation using laboratory results data: the case of chronic kidney disease.
This study used data from FDA’s Sentinel System to determine if augmenting a diagnosis-based chronic kidney disease cohort with patients identified through laboratory results impacted cohort characteristics and outcomes. They divided the cohort into three different groups to compare demographic, clinical, and health care utilization characteristics. They observed mortality rates between the different groups.
AHRQ-funded; HS023898.
Citation: Shetterly Shetterly, S Flory, J .
Diagnosis-based cohort augmentation using laboratory results data: the case of chronic kidney disease.
Pharmacoepidemiol Drug Saf 2018 Aug;27(8):872-77. doi: 10.1002/pds.4583..
Keywords: Diagnostic Safety and Quality, Kidney Disease and Health, Chronic Conditions, Adverse Drug Events (ADE), Medication, Adverse Events
Snyder GM, McCoy C, D'Agata EM
Quantifying antimicrobial exposure: hazards in populations with end-stage renal disease.
Using a rigorously collected data set of antimicrobial use among patients receiving chronic hemodialysis, antimicrobial use was calculated using 3 different methodologies: daily defined dose, days of therapy, and start-stop days. Estimates of antimicrobial use varied by as much as 10-fold, depending on the type of antimicrobial.
AHRQ-funded; HS021666.
Citation: Snyder GM, McCoy C, D'Agata EM .
Quantifying antimicrobial exposure: hazards in populations with end-stage renal disease.
Infect Control Hosp Epidemiol 2017 Mar;38(3):360-63. doi: 10.1017/ice.2016.290.
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Keywords: Adverse Drug Events (ADE), Antimicrobial Stewardship, Dialysis, Kidney Disease and Health, Patient Safety
Cooper LB, Hammill BG, Peterson ED
Characterization of mineralocorticoid receptor antagonist therapy initiation in high-risk patients with heart failure.
Heart failure guidelines recommend routine monitoring of serum potassium, and renal function in patients treated with a mineralocorticoid receptor antagonist (MRA). This study found that patients initiated on MRA therapy as an outpatient had extremely poor rates of guideline indicated follow-up laboratory monitoring after drug initiation. In particular, patients with chronic kidney disease were at high risk for adverse events after MRA initiation.
AHRQ-funded; HS021092.
Citation: Cooper LB, Hammill BG, Peterson ED .
Characterization of mineralocorticoid receptor antagonist therapy initiation in high-risk patients with heart failure.
Circ Cardiovasc Qual Outcomes 2017 Jan;10(1):pii: e002946. doi: 10.1161/circoutcomes.116.002946.
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Keywords: Care Management, Heart Disease and Health, Kidney Disease and Health, Adverse Drug Events (ADE), Patient Adherence/Compliance
Lipska KJ, Flory JH, Hennessy S
Citizen petition to the US Food and Drug Administration to change prescribing guidelines: The metformin experience.
Although healthcare professionals rarely submit citizen petitions, they can exert a powerful impact on the labeling requirements for drugs. Metformin is one such example. The authors filed 2 petitions to the FDA, asking the FDA to change the label and to relax the renal contraindications. In 2016, the FDA issued a safety communication that partially granted our requests by requiring the manufacturers of metformin to change the labeling of metformin in several ways.
AHRQ-funded; HS023898.
Citation: Lipska KJ, Flory JH, Hennessy S .
Citizen petition to the US Food and Drug Administration to change prescribing guidelines: The metformin experience.
Circulation 2016 Nov 1;134(18):1405-08. doi: 10.1161/circulationaha.116.023041.
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Keywords: Medication, Medication: Safety, Adverse Drug Events (ADE), Kidney Disease and Health, Diabetes
Santos CA, Brennan DC, Saeed MJ
Pharmacoepidemiology of cytomegalovirus prophylaxis in a large retrospective cohort of kidney transplant recipients with Medicare Part D coverage.
The researchers sought to determine real-world use of cytomegalovirus (CMV) prophylaxis. They found that variability in usage of prophylaxis among transplant centers was greater than variability within transplant centers. They concluded that limiting unnecessary use of CMV prophylaxis may decrease healthcare costs and drug-related harms.
AHRQ-funded; HS019455.
Citation: Santos CA, Brennan DC, Saeed MJ .
Pharmacoepidemiology of cytomegalovirus prophylaxis in a large retrospective cohort of kidney transplant recipients with Medicare Part D coverage.
Clin Transplant 2016 Apr;30(4):435-44. doi: 10.1111/ctr.12706.
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Keywords: Adverse Drug Events (ADE), Kidney Disease and Health, Medication, Prevention, Transplantation
Lo Re V, 3rd, Carbonari DM, Lewis JD
Oral azole antifungal medications and risk of acute liver injury, overall and by chronic liver disease status.
The researchers evaluated incidence rates of acute liver injury associated with oral azole antifungals. They concluded that rates of acute liver injury were similarly low for fluconazole, ketoconazole, and itraconazole. Events were more common among voriconazole and posaconazole users but were comparable. Pre-existing chronic liver disease increased risk of azole-induced liver injury.
AHRQ-funded; HS018372.
Citation: Lo Re V, 3rd, Carbonari DM, Lewis JD .
Oral azole antifungal medications and risk of acute liver injury, overall and by chronic liver disease status.
Am J Med 2016 Mar;129(3):283-91.e5. doi: 10.1016/j.amjmed.2015.10.029.
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Keywords: Antimicrobial Stewardship, Medication, Kidney Disease and Health, Chronic Conditions, Adverse Drug Events (ADE)
Brookhart MA, Freburger JK, Ellis AR
Comparative short-term safety of sodium ferric gluconate versus iron sucrose in hemodialysis patients.
Despite different pharmacologic properties, little is known about the comparative safety of sodium ferric gluconate versus iron sucrose in hemodialysis patients. This study found that, overall, the 2 iron formulations studied exhibited similar safety profiles; however, ferric gluconate was associated with a slightly decreased risk for infection-related outcomes compared to iron sucrose among patients with a hemodialysis catheter.
AHRQ-funded; 290200500401.
Citation: Brookhart MA, Freburger JK, Ellis AR .
Comparative short-term safety of sodium ferric gluconate versus iron sucrose in hemodialysis patients.
Am J Kidney Dis 2016 Jan;67(1):119-27. doi: 10.1053/j.ajkd.2015.07.026.
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Keywords: Comparative Effectiveness, Kidney Disease and Health, Medication: Safety, Outcomes, Adverse Drug Events (ADE)