National Healthcare Quality and Disparities Report
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- (-) Adverse Drug Events (ADE) (111)
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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 25 of 111 Research Studies DisplayedCohen TN, Berdahl CT, Coleman BL
Medication safety event reporting: Factors that contribute to safety events during times of organizational stress.
This study’s objective was to understand the insights conveyed in hospital incident reports about how work system factors affected medication safety during a coronavirus disease-2019 (COVID-19) surge. The authors randomly selected 100 medication safety incident reports from an academic medical center (December 2020 to January 2021), identified near misses and errors, and classified contributing work system factors using the Human Factors Analysis and Classification System-Healthcare. Results showed that among 35 near misses/errors, incident reports described contributing factors (mean 1.3/report) involving skill-based errors (n = 20), communication (n = 8), and tools/technology (n = 4). Seven of these events were linked to COVID-19.
AHRQ-funded; HS027455.
Citation: Cohen TN, Berdahl CT, Coleman BL .
Medication safety event reporting: Factors that contribute to safety events during times of organizational stress.
J Nurs Care Qual 2024 Jan-Mar; 39(1):51-57. doi: 10.1097/ncq.0000000000000720..
Keywords: Medication: Safety, Medication, Patient Safety, COVID-19, Adverse Drug Events (ADE), Adverse Events, Medical Errors
Kaufman BG, Holland DE, Vanderboom CE
Multicomponent pharmacist intervention did not reduce clinically important medication errors for ambulatory patients initiating direct oral anticoagulants.
The aim of this randomized controlled trial study was to evaluate the effectiveness of a multicomponent intervention for decreasing clinically important medication errors (CIMEs). The researchers included ambulatory patients beginning a DOAC or resuming one after a complication. The intervention included pharmacist evaluation and monitoring based on the implementation of a recently published checklist. The primary measure was anticoagulant-related CIMEs and non-anticoagulant-related CIMEs over 90 days from DOAC initiation. Primary variables included evaluation of the appropriateness of DOAC, need for DOAC affordability assistance, three pharmacist-initiated telephone consultations, access to a DOAC hotline, documented hand-off to the patient's continuity provider, and monitoring of follow-up laboratory tests. A total of 561 patients contributed 479 anticoagulant-CIMEs including 31 preventable and ameliorable ADEs and 448 significant anticoagulant medication errors without subsequent documented ADEs. The most common anticoagulant-related CIMEs were failure to perform required blood tests and concurrent, inappropriate usage of a DOAC with aspirin or NSAIDs despite pharmacist documentation systematically identifying these issues when present. There was no reduction in anticoagulant-related CIMEs among intervention patients or non-anticoagulant-related CIMEs.
AHRQ-funded; HS02592401.
Citation: Kaufman BG, Holland DE, Vanderboom CE .
Multicomponent pharmacist intervention did not reduce clinically important medication errors for ambulatory patients initiating direct oral anticoagulants.
J Gen Intern Med 2023 Dec; 38(16):3526-34. doi: 10.1007/s11606-023-08315-z..
Keywords: Provider: Pharmacist, Medication, Adverse Drug Events (ADE), Adverse Events, Medical Errors, Blood Thinners, Medication: Safety, Patient Safety
Boxley C, Fujimoto M, Ratwani RM
A text mining approach to categorize patient safety event reports by medication error type.
This study examined whether natural language processing can be used to better categorize medication related patient safety event reports. A total of 3,861 medication related patient safety event reports that were previously annotated using a consolidated medication error taxonomy were used to develop three models using the following algorithms: (1) logistic regression, (2) elastic net, and (3) XGBoost. The models were tested and performance was analyzed. The authors found the XGBoost model performed best across all medication error categories. 'Wrong Drug', 'Wrong Dosage Form or Technique or Route', and 'Improper Dose/Dose Omission' categories performed best across the three models. In addition, they identified five words most closely associated with each medication error category and which medication error categories were most likely to co-occur.
AHRQ-funded; HS026481.
Citation: Boxley C, Fujimoto M, Ratwani RM .
A text mining approach to categorize patient safety event reports by medication error type.
Sci Rep 2023 Oct 26; 13(1):18354. doi: 10.1038/s41598-023-45152-w..
Keywords: Health Information Technology (HIT), Patient Safety, Medication, Medication: Safety, Adverse Drug Events (ADE), Adverse Events
Gómez-Lumbreras A, Boyce RD, Villa-Zapata L
Drugs that interact with colchicine via inhibition of cytochrome P450 3A4 and P-glycoprotein: a signal detection analysis using a database of spontaneously reported adverse events (FAERS).
The objective of this study was to examine clinical outcomes associated with colchicine drug interactions. Researchers conducted a disproportionality analysis using the spontaneous reports of the FDA Adverse Event Reporting System (FAERS). The study’s results identified numerous safety signals for colchicine and CYP3A4/P-gp inhibitor drugs. The authors concluded that avoiding interactions or monitoring for toxicity in patients when co-prescribing colchicine and these agents is highly recommended.
AHRQ-funded; HS025984.
Citation: Gómez-Lumbreras A, Boyce RD, Villa-Zapata L .
Drugs that interact with colchicine via inhibition of cytochrome P450 3A4 and P-glycoprotein: a signal detection analysis using a database of spontaneously reported adverse events (FAERS).
Ann Pharmacother 2023 Oct; 57(10):1137-46. doi: 10.1177/10600280221148031..
Keywords: Medication, Adverse Drug Events (ADE), Adverse Events, Patient Safety
Herzig SJ, Anderson TS, Urman RD
Risk factors for opioid-related adverse drug events among older adults after hospitalization for major orthopedic procedures.
The purpose of this retrospective cohort study was to identify risk factors for opioid-related adverse drug events (ORADEs) after hospital discharge following orthopedic procedures. The participants of this study included a national sample of Medicare beneficiaries who underwent major orthopedic surgery during hospitalization in 2016 and had an opioid prescription filled within 2 days of discharge. The study found that among 30,514 hospitalizations with a major orthopedic procedure and an opioid claim, a potential ORADE requiring hospital revisit occurred in 2.5%. After adjustment for patient characteristics, prior opioid use, co-prescribed sedating medications, and opioid prescription characteristics were not related with ORADEs. Independent risk factors did include age of 80 years or older, female sex, and clinical conditions, including heart failure, respiratory illness, kidney disease, dementia/delirium, anxiety disorder, and musculoskeletal/nervous system injuries.
AHRQ-funded; HS026215.
Citation: Herzig SJ, Anderson TS, Urman RD .
Risk factors for opioid-related adverse drug events among older adults after hospitalization for major orthopedic procedures.
J Patient Saf 2023 Oct 1; 19(6):379-85. doi: 10.1097/pts.0000000000001144..
Keywords: Elderly, Opioids, Adverse Drug Events (ADE), Adverse Events, Hospitalization, Orthopedics, Surgery, Medication, Risk, Medication: Safety, Patient Safety
Langlieb ME, Sharma P, Hocevar M
The additional cost of perioperative medication errors.
The aim of this study was to calculate the additional annual cost to the U.S. healthcare system attributable to preventable medication errors (MEs) in the operating room. The ME types were grouped into 13 categories by their related harm (or potential harm), and researchers calculated the incidence of operations involving each ME category: 1) delayed or missed required perioperative antibiotic; 2) prolonged hemodynamic swings; 3) untreated postoperative pain; 4) residual neuromuscular blockade; 5) oxygen saturation <90% due to ME; 6) delayed emergence; 7) untreated new onset intraoperative cardiac arrhythmia; 8) medication documentation errors; 9) syringe swaps; 10) presumed hypotension with inability to obtain a blood pressure reading; 11) potential for bacterial contamination due to expired medication syringes; 12) untreated bradycardia <40 beats/min; and 13) other. Through a PubMed search, the researchers established the possibility that the ME category would cause downstream patient harm such as surgical site infection or acute kidney injury, and the additional fully allocated cost of care for each potential downstream patient harm event. The cost of the MEs across the U.S. healthcare system was then calculated by scaling the number of MEs to the total number of annual operations in the United States. The total additional fully allocated annual cost of care due to perioperative MEs was estimated to be $5.33 billion U.S. dollars.
AHRQ-funded; HS024764.
Citation: Langlieb ME, Sharma P, Hocevar M .
The additional cost of perioperative medication errors.
J Patient Saf 2023 Oct 1; 19(6):375-78. doi: 10.1097/pts.0000000000001136..
Keywords: Medication: Safety, Medication, Medical Errors, Adverse Drug Events (ADE), Adverse Events, Surgery, Patient Safety
Marcaccio CL, Patel PB, Rastogi V
Efficacy and safety of single versus dual antiplatelet therapy in carotid artery stenting.
This study’s objective was to examine the efficacy and safety of preoperative single antiplatelet therapy (AP) therapy vs double antiplatelet therapy (DAPT) in patients who had undergone transfemoral CAS (tfCAS) or transcarotid artery revascularization (TCAR). The authors identified all patients who had undergone tfCAS or TCAR in the Vascular Quality Initiative database from 2016 to 2021. A total of 18,570 tfCAS patients were included, of which 70% had received DAPT, 5.6% no AP therapy, 10% ASA only, 8.0% ASA + AP loading dose, 4.6% P2Y12 inhibitor (P2Yi) only, and 2.9% P2Yi + AP loading dose. After adjustment, compared with DAPT, the incidence of stroke/death was higher with no AP therapy, ASA only, and ASA + AP loading dose, but was similar with P2Yi only, and P2Yi + AP loading dose. No differences were found in the incidence of bleeding rates between the treatment groups after tfCAS or TCAR. These findings support the current guidelines recommending DAPT before CAS but also suggest that P2Yi monotherapy might confer thromboembolic benefits similar to those with DAPT.
AHRQ-funded; HS027285.
Citation: Marcaccio CL, Patel PB, Rastogi V .
Efficacy and safety of single versus dual antiplatelet therapy in carotid artery stenting.
J Vasc Surg 2023 May; 77(5):1434-46.e11. doi: 10.1016/j.jvs.2022.12.034..
Keywords: Blood Thinners, Medication, Medication: Safety, Cardiovascular Conditions, Stroke, Adverse Drug Events (ADE), Adverse Events, Patient Safety
Grauer A, Rosen A, Applebaum JR
Examining medication ordering errors using AHRQ network of patient safety databases.
Research on the impact of Computerized Physician Order Entry (CPOE) systems on drug order inaccuracies has shown inconsistent results, with CPOE not reliably preventing such mistakes. The study utilized the Network of Patient Safety Databases (NPSD) from the Agency for Healthcare Research and Quality (AHRQ) to explore the frequency and degree of harm associated with reported events during the ordering stage, and to classify them by error type.
The researchers conducted a retrospective analysis of reported safety incidents provided by healthcare systems associated with patient safety organizations from June 2010 to December 2020. All errors related to medication and other substance orders reported to the NPSD using the common format v1.2 during this period were assessed. The researchers grouped and categorized the prevalence of reported medication order errors by error type, harm levels, and demographic data. The study found that during the study period, 12,830 mistakes were reported. Incorrect dosage accounted for 3,812 errors (29.7%), followed by incorrect medicine 2,086 (16.3%), and incorrect duration 765 (6.0%). Out of 5,282 incidents that affected the patient and had a known severity level, 12 resulted in fatalities, 4 led to severe harm, 45 caused moderate harm, 341 led to minor harm, and 4,880 resulted in no harm. The study concluded that the most frequently reported and damaging types of medication order errors were incorrect dose and incorrect medication orders.
The researchers conducted a retrospective analysis of reported safety incidents provided by healthcare systems associated with patient safety organizations from June 2010 to December 2020. All errors related to medication and other substance orders reported to the NPSD using the common format v1.2 during this period were assessed. The researchers grouped and categorized the prevalence of reported medication order errors by error type, harm levels, and demographic data. The study found that during the study period, 12,830 mistakes were reported. Incorrect dosage accounted for 3,812 errors (29.7%), followed by incorrect medicine 2,086 (16.3%), and incorrect duration 765 (6.0%). Out of 5,282 incidents that affected the patient and had a known severity level, 12 resulted in fatalities, 4 led to severe harm, 45 caused moderate harm, 341 led to minor harm, and 4,880 resulted in no harm. The study concluded that the most frequently reported and damaging types of medication order errors were incorrect dose and incorrect medication orders.
AHRQ-funded; HS026121.
Citation: Grauer A, Rosen A, Applebaum JR .
Examining medication ordering errors using AHRQ network of patient safety databases.
J Am Med Inform Assoc 2023 Apr 19; 30(5):838-45. doi: 10.1093/jamia/ocad007..
Keywords: Medication, Adverse Drug Events (ADE), Adverse Events, Medical Errors, Patient Safety, Electronic Prescribing (E-Prescribing), Health Information Technology (HIT), Medication: Safety
Wong CI, Vannatta K, Gilleland Marchak J
Preventable harm because of outpatient medication errors among children with leukemia and lymphoma: a multisite longitudinal assessment.
The goal of this longitudinal study was to characterize rates and types of medication errors and harm to outpatient children with leukemia and lymphoma over seven months of treatment. The study included children taking medications at home for leukemia or lymphoma from three pediatric cancer centers. Ten percent experienced adverse drug events because of outpatient medication errors. Twenty-six percent of caregivers reported miscommunication leading to missed doses or overdoses. The authors concluded that improvements addressing communication with and among caregivers should be based on human-factors engineering and codeveloped with families.
AHRQ-funded; HS024390.
Citation: Wong CI, Vannatta K, Gilleland Marchak J .
Preventable harm because of outpatient medication errors among children with leukemia and lymphoma: a multisite longitudinal assessment.
Cancer 2023 Apr 1;129(7):1064-74. doi: 10.1002/cncr.34651.
Keywords: Children/Adolescents, Cancer, Adverse Drug Events (ADE), Adverse Events, Medical Errors, Ambulatory Care and Surgery, Medication: Safety, Patient Safety
Kravchenko OV, Boyce RD, Gomez-Lumbreras A
Drug-drug interaction between dexamethasone and direct-acting oral anticoagulants: a nested case-control study in the national COVID cohort collaborative (N3C).
This study examined whether there is an association between thromboembolotic events (TEEs) and concomitant use of dexamethasone with either apixaban or rivaroxaban (both direct oral anticoagulants or DOACs) during treatment for COVID-19. The authors used data from the National COVID Cohort Collaborative (N3C) to conduct a nested case-control study. Eligible participants were adults over 18 years who were exposed to a DOAC for 10 or more consecutive days and exposure to dexamethasone at least 5 or more consecutive days. The study did not find a discernible association of TEE in patients concomitantly exposed to dexamethasone and a DOAC.
AHRQ-funded; HS025984.
Citation: Kravchenko OV, Boyce RD, Gomez-Lumbreras A .
Drug-drug interaction between dexamethasone and direct-acting oral anticoagulants: a nested case-control study in the national COVID cohort collaborative (N3C).
BMJ Open 2022 Dec 29; 12(12):e066846. doi: 10.1136/bmjopen-2022-066846..
Keywords: COVID-19, Blood Thinners, Medication, Adverse Drug Events (ADE), Adverse Events, Cardiovascular Conditions, Medication: Safety, Patient Safety
Tan MS, Gomez-Lumbreras A, Villa-Zapata L
Colchicine and macrolides: a cohort study of the risk of adverse outcomes associated with concomitant exposure.
The authors conducted a cohort study using electronic health records comparing encounters with colchicine plus a macrolide and colchicine with an antibiotic non-macrolide, then assessed the relationship between the two groups. They found that heart failure was more frequent in the colchicine plus a macrolide cohort and that there was also a higher mortality rate. As there is a significant increase in the risk of hepatic failure and mortality when colchicine is concomitantly administered with a macrolide, they concluded that colchicine should not be used concomitantly with these antibiotics or should be temporarily discontinued to avoid toxic levels of colchicine.
AHRQ-funded; HS025984.
Citation: Tan MS, Gomez-Lumbreras A, Villa-Zapata L .
Colchicine and macrolides: a cohort study of the risk of adverse outcomes associated with concomitant exposure.
Rheumatol Int 2022 Dec;42(12):2253-59. doi: 10.1007/s00296-022-05201-5..
Keywords: Adverse Drug Events (ADE), Adverse Events, Medication, Risk, Antibiotics, Medication: Safety, Patient Safety
Lusk C, Catchpole K, Neyens DM
Improving safety in the operating room: medication icon labels increase visibility and discrimination.
The purpose of this study was to assess whether the addition of icons to medication labels in an operating room setting would improve visibility and reduce medication administration errors. The multi-disciplinary team of researchers added icons to medication labels applied to vasoactive medication infusions, and the study found that participants were 1.12 times more likely to correctly identify medications with icons from farther away. In addition, when icons were present on the labels, participants were 2.16 times more likely to be more confident in their identifications.
AHRQ-funded; HS026625.
Citation: Lusk C, Catchpole K, Neyens DM .
Improving safety in the operating room: medication icon labels increase visibility and discrimination.
Appl Ergon 2022 Oct;104:103831. doi: 10.1016/j.apergo.2022.103831..
Keywords: Medication: Safety, Medication, Patient Safety, Medical Errors, Adverse Drug Events (ADE), Adverse Events
Villa-Zapata L, Gómez-Lumbreras A, Horn J
A disproportionality analysis of drug-drug interactions of tizanidine and CYP1A2 inhibitors from the FDA Adverse Event Reporting System (FAERS).
This study’s aim was to examine the occurrence of adverse events reported in the FDA Adverse Event Reporting System (FAERS) involving the combination of tizanidine and drugs that inhibit the metabolic activity of CYP1A2. Tizanidine is used to help control muscle spasticity. From 2004 quarter 1 through 2020 quarter 3 a total of 89 reports were identified mentioning tizanidine, at least one CYP1A2 inhibitor, and one of the adverse events of interest including: hypotension, bradycardia, syncope, shock, cardiorespiratory arrest, and fall or fracture. More than half the reports identified tizanidine as having a suspect or interacting role, and the reports more frequently involved women (65.1%). The median age was 56.1 years. Hypotension had the highest odds for adverse event reports involving tizanidine and a CYP1A2 inhibitor which can lead to falls and fractures.
AHRQ-funded; HS025984.
Citation: Villa-Zapata L, Gómez-Lumbreras A, Horn J .
A disproportionality analysis of drug-drug interactions of tizanidine and CYP1A2 inhibitors from the FDA Adverse Event Reporting System (FAERS).
Drug Saf 2022 Aug;45(8):863-71. doi: 10.1007/s40264-022-01200-4..
Keywords: Health Information Technology (HIT), Medication, Adverse Drug Events (ADE), Adverse Events, Medication: Safety, Patient Safety
Lai LY, Oerline MK, Caram MEV
Risk of metabolic and cardiovascular adverse events with abiraterone or enzalutamide among men with advanced prostate cancer.
Investigators examined the association between the use of abiraterone or enzalutamide and the risk of metabolic or cardiovascular adverse events while on treatment for advanced prostate cancer. They found that, compared with men not receiving abiraterone, men receiving abiraterone were at increased risk of both a major composite adverse event and a minor composite adverse event. Compared with men not receiving enzalutamide, men receiving enzalutamide were at an increased risk of a major composite adverse event but not a minor composite adverse event. They recommended careful monitoring and management of men on abiraterone or enzalutamide through team-based approaches.
AHRQ-funded; HS027507.
Citation: Lai LY, Oerline MK, Caram MEV .
Risk of metabolic and cardiovascular adverse events with abiraterone or enzalutamide among men with advanced prostate cancer.
J Natl Cancer Inst 2022 Aug 8;114(8):1127-34. doi: 10.1093/jnci/djac081..
Keywords: Cardiovascular Conditions, Cancer: Prostate Cancer, Cancer, Risk, Adverse Events, Medication, Adverse Drug Events (ADE), Medication: Safety, Patient Safety
Yerneni S, Shah S, Blackley SV
Heterogeneity of drug allergies and reaction lists in two U.S. healthcare systems' electronic health records.
This study compared adverse drug reaction (ADRs) picklists for clinicians in the electronic health record (EHR) allergy list for two different healthcare institutions. The authors used data from the EHRs of patients who visited the emergency department or outpatient clinics at Brigham and Women's Hospital (BWH) and University of Colorado Hospital (UCH) from 2013-2018. They investigated the reactions on each picklist and compared the top 40 reactions at each institution, as well as the top 10 reactions within each drug class. Out of 2,160,116 patients sampled, 30% reported active drug allergies. The most commonly reported drug class allergens were similar between the two institutions, however BWH’s picklist had 48 reactions while UCH’s had 160. Twenty-nine reactions were shared by both picklists. There was a lot more granularity with UCH’s picklist so that body locality, swelling and edema were described in much greater detail than for BWH. These picklists may partially explain variations in reported ADRs across healthcare systems.
AHRQ-funded; HS025375.
Citation: Yerneni S, Shah S, Blackley SV .
Heterogeneity of drug allergies and reaction lists in two U.S. healthcare systems' electronic health records.
Appl Clin Inform 2022 May 26;13(3):741-51. doi: 10.1055/a-1862-9425..
Keywords: Electronic Health Records (EHRs), Health Information Technology (HIT), Medication, Adverse Drug Events (ADE), Adverse Events, Medication: Safety, Patient Safety
Marcaccio CL, Patel PB, Wang S
Effect of postoperative antithrombotic therapy on lower extremity outcomes after infrapopliteal bypass for chronic limb-threatening ischemia.
This study’s goal was to examine the effects of different postoperative antithrombotic regimens on 3-year clinical outcomes after infrapopliteal bypass for chronic limb-threatening ischemia (CLTI). The authors identified patients who had undergone infrapopliteal bypass for CLTI in the Vascular Quality Initiative (VQI) registry from 2003 to 2017 with linkage to Medicare claims for long-term outcomes. They divided the patients into three cohorts according to the discharge antithrombotic regimen: single-antiplatelet therapy (SAPT; aspirin or clopidogrel), dual antiplatelet therapy (DAPT; aspirin and clopidogrel), or anticoagulation (AC) plus any antiplatelet (AP) agent. To reduce selection bias, they restricted the analysis cohorts to patients treated by providers who discharged >50% of patients with each antithrombotic regimen. Their primary outcome was 3-year major adverse limb events (MALE; major amputation or reintervention). Among 1812 patients with a median follow-up time of >2 years, 693 (38%) were discharged with SAPT, 544 (30%) with DAPT, and 575 (32%) with AC+AP. At 3 years, MALE rates were 75% with DAPT, 74% with AC+AP, and 68% with SAPT. In adjusted analyses with SAPT as the reference group, no differences were found in 3-year MALE with DAPT or AC+AP. Across the treatment groups, we also found no differences in the individual end points of 3-year major amputation (DAPT: aHR, 0.98; AC+AP: aHR, 1.3), reintervention (DAPT: aHR, 1.0; AC+AP: aHR, 1.1), or mortality (DAPT: aHR, 1.1; AC+AP: aHR, 0.95).
AHRQ-funded; HS027285.
Citation: Marcaccio CL, Patel PB, Wang S .
Effect of postoperative antithrombotic therapy on lower extremity outcomes after infrapopliteal bypass for chronic limb-threatening ischemia.
J Vasc Surg 2022 May; 75(5):1696-706.e4. doi: 10.1016/j.jvs.2022.01.011..
Keywords: Cardiovascular Conditions, Medication, Adverse Drug Events (ADE), Adverse Events, Patient Safety, Surgery, Medication: Safety
Marcaccio CL, Patel PB, Liang P
Efficacy and safety of perioperative dual antiplatelet therapy with ticagrelor versus clopidogrel in carotid artery stenting.
This study’s objective was to compare the efficacy and safety of perioperative dual antiplatelet therapy with aspirin/ticagrelor vs aspirin/clopidogrel in patients undergoing transfemoral carotid artery stenting (tfCAS) or transcarotid artery revascularization (TCAR). The authors identified all patients who underwent tfCAS or TCAR in the Vascular Quality Initiative registry from January 2016 to March 2021. They stratified patients by procedure and assessed outcomes using 1:3 propensity score-matched cohorts of patients who received perioperative aspirin/ticagrelor vs aspirin/clopidogrel. Among the cohort of 17,731 tfCAS patients, 593 (3.3%) received aspirin/ticagrelor and 11,404 (64%) received aspirin/clopidogrel. For the 2065 matched patients, no significant differences were found in the composite endpoint of stroke/death (aspirin/ticagrelor, 4.1%; vs aspirin/clopidogrel, 2.6%) or in the individual endpoints of stroke (2.9% vs 1.8%) or death (1.7% vs 1.1%). However, aspirin/ticagrelor was associated with a higher risk of bleeding (5.8% vs 2.8%). In a subgroup analysis of 297 tfCAS patients (14%) who received intraoperative protamine, no differences remained in stroke/death (1.5% vs 3.9%), and there was no longer a difference in bleeding (3.0% vs 2.6%). Among 17,946 TCAR patients, 453 (2.5%) received aspirin/ticagrelor and 13,696 (76%) received aspirin/clopidogrel. With the 1618 matched patients, no differences were found in stroke/death (0.7% vs 1.4%), stroke (0.2% vs 1.2%), death (0.5% vs 0.2%), or bleeding (1.2% vs 1.6%). For the 1429 TCAR patients (88%) who received protamine, no differences were found in stroke/death (0.8% vs 1.2%) or bleeding (0.6% vs 1.4%).
AHRQ-funded; HS027285.
Citation: Marcaccio CL, Patel PB, Liang P .
Efficacy and safety of perioperative dual antiplatelet therapy with ticagrelor versus clopidogrel in carotid artery stenting.
J Vasc Surg 2022 Apr; 75(4):1293-303.e8. doi: 10.1016/j.jvs.2021.09.045..
Keywords: Cardiovascular Conditions, Medication, Stroke, Adverse Drug Events (ADE), Adverse Events, Patient Safety, Surgery
Chen C, Winterstein AG, Lo-Ciganic WH
Concurrent use of prescription gabapentinoids with opioids and risk for fall-related injury among older US Medicare beneficiaries with chronic noncancer pain: a population-based cohort study.
This study compared the risk of fall-related injury in two cohorts who used gabapentinoids concurrently with opioid use and those who used opioids only. The authors created 2 cohorts based on whether concurrent users initiated gabapentinoids on the day of opioid initiation (Cohort 1) or after opioid initiation (Cohort 2). Both cohorts were identified from a sample of older Medicare beneficiaries with chronic non-cancer pain (CNCP). Four concurrent users were matched up with 1 opioid-only user. They identified 6,733 concurrent users and 27,092 matched opioid-only users in Cohort 1 and 5,709 concurrent users and 22,388 matched opioid-only users in Cohort 2. Cohort 1’s incidence rate of fall-related injury was 24.5 per 100 person-users during follow-up and was 18.0 per 100-person-years during follow-up for Cohort 2. Concurrent users had had similar risk of fall-related injury as opioid-only users in Cohort 1 but had higher risk for fall-related injury than opioid-only users in Cohort 2.
AHRQ-funded; HS027230.
Citation: Chen C, Winterstein AG, Lo-Ciganic WH .
Concurrent use of prescription gabapentinoids with opioids and risk for fall-related injury among older US Medicare beneficiaries with chronic noncancer pain: a population-based cohort study.
PLoS Med 2022 Mar;19(3):e1003921. doi: 10.1371/journal.pmed.1003921..
Keywords: Elderly, Opioids, Medication, Medication: Safety, Adverse Drug Events (ADE), Adverse Events, Falls, Patient Safety, Injuries and Wounds, Pain, Chronic Conditions
Wei YJ, Chen C, Lewis MO
Trajectories of prescription opioid dose and risk of opioid-related adverse events among older Medicare beneficiaries in the United States: a nested case-control study.
This study used a sample of older patients who are Medicare beneficiaries who were newly prescribed opioids to determine rates of 4 prescription opioid dose trajectories and the risk of opioid-related adverse events (ORAEs). A 5% random sample of Medicare beneficiaries from 2011 to 2018 was used to conduct a nested case-control study of patients age 65 and older who were newly diagnosed with chronic noncancer pain (CNCP). Among the cases and controls, 2,192 (70.6%) were women and mean age was 77.1 years. Four prescribed opioid trajectories before the incident ORAE diagnosis or matched date emerged: gradual dose discontinuation (from ≤3 to 0 daily morphine milligram equivalent (MME), 1,456 [23.5%]), gradual dose increase (from 0 to >3 daily MME, 1,878 [30.3%]), consistent low dose (between 3 and 5 daily MME, 1,510 [24.3%]), and consistent moderate dose (>20 daily MME, 1,362 [22.0%]). Less than 5% were prescribed a mean daily dose of ≥90 daily MME during 6 months before diagnosis or matched date. Patients with gradual dose discontinuation versus those with a consistent low or moderate dose, and increase dose were more likely to be 65 to 74 years, Midwest US residents, and receiving no low-income subsidy. Those with gradual dose increase and consistent moderate dose had a higher risk of ORAE, after adjustment for covariates.
AHRQ-funded; HS027230.
Citation: Wei YJ, Chen C, Lewis MO .
Trajectories of prescription opioid dose and risk of opioid-related adverse events among older Medicare beneficiaries in the United States: a nested case-control study.
PLoS Med 2022 Mar;19(3):e1003947. doi: 10.1371/journal.pmed.1003947..
Keywords: Elderly, Opioids, Medication, Adverse Drug Events (ADE), Adverse Events, Risk, Chronic Conditions, Pain, Substance Abuse, Behavioral Health, Medication: Safety, Patient Safety
Martin BA, Breslow RM, Sims A
Identifying over-the-counter information to prioritize for the purpose of reducing adverse drug reactions in older adults: a national survey of pharmacists.
This study’s objective was to determine which information on over-the-counter (OTC) Drug Facts Labels (DFS) is most critical in reducing adverse drug reactions (ADRs) among older adults and should be placed in front of the label. A national survey of practicing pharmacists knowledgeable about OTC medication use by older adults asked respondents to rank order the importance of the DFL sections to reduce ADRs. A total of 318 responses were analyzed. There was high consensus that uses and purposes, active ingredient, warnings, and directions for use were the most important sections on the label. Two specific warnings “Do not use” and “Ask a doctor or pharmacist” were deemed most important in the warnings section.
AHRQ-funded; HS025386.
Citation: Martin BA, Breslow RM, Sims A .
Identifying over-the-counter information to prioritize for the purpose of reducing adverse drug reactions in older adults: a national survey of pharmacists.
J Am Pharm Assoc 2022 Jan-Feb;62(1):167-75.e1. doi: 10.1016/j.japh.2021.08.019..
Keywords: Elderly, Medication: Safety, Medication, Adverse Drug Events (ADE), Adverse Events, Patient Safety, Health Literacy, Education: Patient and Caregiver
Adams KT, Pruitt Z, Kazi S
Identifying health information technology usability issues contributing to medication errors across medication process stages.
Researchers sought to identify the types of medication errors associated with health IT use, whether they reached the patient, where in the medication process those errors occurred, and the specific usability issues contributing to those errors. They found that health IT usability issues were a prevalent contributing factor to medication errors, many of which reach the patient. They recommended that data entry, workflow support, and alerting be prioritized during usability and safety optimization efforts.
AHRQ-funded; HS025136.
Citation: Adams KT, Pruitt Z, Kazi S .
Identifying health information technology usability issues contributing to medication errors across medication process stages.
J Patient Saf 2021 Dec 1;17(8):e988-e94. doi: 10.1097/pts.0000000000000868..
Keywords: Medication, Health Information Technology (HIT), Medical Errors, Adverse Drug Events (ADE), Adverse Events, Patient Safety
McGrath SP, McGovern KM, Perreard IM
Inpatient respiratory arrest associated with sedative and analgesic medications: impact of continuous monitoring on patient mortality and severe morbidity.
Inpatient respiratory arrest associated with sedative and analgesic medications: impact of continuous monitoring on patient mortality and severe morbidity.
The purpose of this study was to investigate the impact of surveillance monitoring on mortality and severe morbidity associated with administration of sedative/analgesic medications in the general care setting. A review of available rescue event and patient safety data from a tertiary care hospital in a rural setting was conducted. Findings showed that, for a 10-year period, the rescue system with continuous surveillance monitoring had a profound effect on prevention of death due to sedative/analgesic administration in the general care setting.
The purpose of this study was to investigate the impact of surveillance monitoring on mortality and severe morbidity associated with administration of sedative/analgesic medications in the general care setting. A review of available rescue event and patient safety data from a tertiary care hospital in a rural setting was conducted. Findings showed that, for a 10-year period, the rescue system with continuous surveillance monitoring had a profound effect on prevention of death due to sedative/analgesic administration in the general care setting.
AHRQ-funded; HS024403.
Citation: McGrath SP, McGovern KM, Perreard IM .
Inpatient respiratory arrest associated with sedative and analgesic medications: impact of continuous monitoring on patient mortality and severe morbidity.
J Patient Saf 2021 Dec 1;17(8):557-61. doi: 10.1097/pts.0000000000000696..
Keywords: Respiratory Conditions, Medication, Adverse Drug Events (ADE), Adverse Events, Patient Safety
Reese TJ, Del Fiol G, Morgan K
A shared decision-making tool for drug interactions between warfarin and nonsteroidal anti-inflammatory drugs: design and usability study.
Exposure to life-threatening drug-drug interactions (DDIs) occurs despite the widespread use of clinical decision support. The DDI between warfarin and nonsteroidal anti-inflammatory drugs is common and potentially life-threatening. Patients can play a substantial role in preventing harm from DDIs; however, the current model for DDI decision-making is clinician centric. This study aimed to design and examine the usability of DDInteract, a tool to support shared decision-making (SDM) between a patient and provider for the DDI between warfarin and nonsteroidal anti-inflammatory drugs.
AHRQ-funded; HS026198.
Citation: Reese TJ, Del Fiol G, Morgan K .
A shared decision-making tool for drug interactions between warfarin and nonsteroidal anti-inflammatory drugs: design and usability study.
JMIR Hum Factors 2021 Oct 26;8(4):e28618. doi: 10.2196/28618..
Keywords: Blood Thinners, Medication: Safety, Medication, Clinical Decision Support (CDS), Decision Making, Electronic Health Records (EHRs), Health Information Technology (HIT), Adverse Drug Events (ADE), Adverse Events, Patient Safety
Herzig SJ, Anderson TS, Jung Y
Relative risks of adverse events among older adults receiving opioids versus NSAIDs after hospital discharge: a nationwide cohort study.
This retrospective cohort study’s objective was to determine the incidence and risk of post-discharge adverse events among opioid claims in the week after hospital discharge, compared to those with nonsteroidal anti-inflammatory drugs (NSAIDs) claims alone. A national sample of Medicare beneficiaries age 65 and older who were hospitalized in the United States in 2016 was used. Beneficiaries who were admitted from or discharged to a facility were excluded. The authors used 3:1 propensity matching to match beneficiaries with an opioid claim in the week after discharge (13,385) with beneficiaries with NSAID claim alone (4,677). Beneficiaries receiving opioids had a higher incidence of death, healthcare utilization, and any potential adverse effect compared to those with an NSAID claim only. Specific adverse effects included higher relative risk of fall/fracture, nausea/vomiting, and slowed colonic motility.
AHRQ-funded; HS026215.
Citation: Herzig SJ, Anderson TS, Jung Y .
Relative risks of adverse events among older adults receiving opioids versus NSAIDs after hospital discharge: a nationwide cohort study.
PLoS Med 2021 Sep 27;18(9):e1003804. doi: 10.1371/journal.pmed.1003804..
Keywords: Elderly, Opioids, Medication, Medication: Safety, Adverse Drug Events (ADE), Adverse Events, Patient Safety, Risk, Hospital Discharge
De Oliveira GS, Castro-Alves LJ, Kendall MC
Effectiveness of pharmacist intervention to reduce medication errors and health-care resources utilization after transitions of care: a meta-analysis of randomized controlled trials.
The main objective of the current investigation was to examine the effectiveness of pharmacist-based transition-of-care interventions on the reduction of medication errors after hospital discharge. Findings showed that pharmacist transition-of-care intervention is an effective strategy to reduce medication errors after hospital discharge and also reduces subsequent emergency room visits.
AHRQ-funded; HS024158.
Citation: De Oliveira GS, Castro-Alves LJ, Kendall MC .
Effectiveness of pharmacist intervention to reduce medication errors and health-care resources utilization after transitions of care: a meta-analysis of randomized controlled trials.
J Patient Saf 2021 Aug 1;17(5):375-80. doi: 10.1097/pts.0000000000000283..
Keywords: Medication: Safety, Medication, Adverse Drug Events (ADE), Adverse Events, Medical Errors, Patient Safety, Provider: Pharmacist, Transitions of Care