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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 25 of 725 Research Studies DisplayedGómez-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
Dekeyser GJ, Martin BI, Marchand LS
Geriatric distal femur fractures treated with distal femoral replacement are associated with higher rates of readmissions and complications.
The objective of this study was to compare mortality and complications of distal femur fracture repair among elderly patients who received operative fixation versus distal femur replacement (DFR). Participants were Medicare beneficiaries aged 65 and older with distal femur fracture who were identified using Center for Medicare & Medicaid Services data. Most of the patients received operative fixation surgery. Results indicated that DFR was associated with significantly greater rates of infection, device-related complication, pulmonary embolism, deep vein thrombosis, costs, and readmission.
AHRQ-funded; HS024714.
Citation: Dekeyser GJ, Martin BI, Marchand LS .
Geriatric distal femur fractures treated with distal femoral replacement are associated with higher rates of readmissions and complications.
J Orthop Trauma 2023 Oct; 37(10):485-91. doi: 10.1097/bot.0000000000002638..
Keywords: Elderly, Injuries and Wounds, Hospital Readmissions, Adverse Events
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
Kalenderian E, Bangar S, Yansane A
Identifying contributing factors associated with dental adverse events through a pragmatic electronic health record-based root cause analysis.
This study’s objective was to analyze harmful dental adverse events (AEs) to assess potential contributing factors. Harmful AEs were defined as those that resulted in temporary moderate to severe harm, required hospitalization, or resulted in permanent moderate to severe harm. The authors classified potential contributing factors according to (1) who was involved (person), (2) what were they doing (tasks), (3) what tools/technologies were they using (tools/technologies), (4) where did the event take place (environment), (5) what organizational conditions contributed to the event? (organization), (6) patient (including parents), and (7) professional-professional collaboration. A second review was conducted by a blinded panel of dental experts to confirm the presence of an AE. A total of 59 cases at 2 dental institutions had 1 or more harmful AEs. The most common harmful AE was pain (27.1%) followed by nerve injury (16.9%), hard tissue injury (15.2%), and soft tissue injury (15.2%). The most common contribution factor was the care provider (training, supervision, and fatigue at 31.5%) followed by patient ((noncompliance, unsafe practices at home, low health literacy, 17.1%), and professional-professional collaboration (15.3%).
AHRQ-funded; HS027268.
Citation: Kalenderian E, Bangar S, Yansane A .
Identifying contributing factors associated with dental adverse events through a pragmatic electronic health record-based root cause analysis.
J Patient Saf 2023 Aug 1; 19(5):305-12. doi: 10.1097/pts.0000000000001122..
Keywords: Dental and Oral Health, Adverse Events, Electronic Health Records (EHRs), Health Information Technology (HIT), Medical Errors, Patient Safety
Liberman AL, Wang Z, Zhu Y
Optimizing measurement of misdiagnosis-related harms using Symptom-Disease Pair Analysis of Diagnostic Error (SPADE): comparison groups to maximize SPADE validity.
The purpose of this paper was to clarify features of the Symptom-Disease Pair Analysis of Diagnostic Error (SPADE) approach to accurately measure diagnostic errors to assure that researchers utilize this method to yield valid results, as well as improve the validity of SPADE and related approaches to quantify diagnostic error in medicine. The researchers describe four types of comparators (intra-group and inter-group), detailing the reason for selecting one over the other and conclusions that can be drawn from these comparative analyses.
AHRQ-funded; HS027614.
Citation: Liberman AL, Wang Z, Zhu Y .
Optimizing measurement of misdiagnosis-related harms using Symptom-Disease Pair Analysis of Diagnostic Error (SPADE): comparison groups to maximize SPADE validity.
Diagnosis 2023 Aug 1; 10(3):225-34. doi: 10.1515/dx-2022-0130..
Keywords: Diagnostic Safety and Quality, Medical Errors, Adverse Events, Electronic Health Records (EHRs), Health Information Technology (HIT), Patient Safety
Giuliano J, Krishna A, Napolitano N
Implementation of video laryngoscope-assisted coaching reduces adverse tracheal intubation-associated events in the PICU.
The purpose of this study was to assess the implementation of a video laryngoscope (VL) as a coaching device to decrease adverse tracheal intubation associated events (TIAEs). Between 2016 and 2020 the researchers implemented VLs as coaching devices with standardized coaching language. Laryngoscopists were encouraged to perform direct laryngoscopy with video images only available in real-time for experienced supervising clinician-coaches. The study found that a VL was used in 71% of 5,060 tracheal intubations. VL utilization increased from a baseline of 29.7% to an implementation phase level of 89.4%. VL utilization was related with lower TIAEs compared with standard laryngoscope (SL). VL utilization was related with lower severe TIAE rate, but not related with a reduction in severe hypoxemia. VL utilization was related with greater first attempt success. In the primary analysis after adjusting for site clustering, VL utilization was related with lower adverse TIAEs. In secondary analyses, VL utilization was not significantly related with severe TIAEs, severe hypoxemia, or first attempt success. After additional controlling for patient and provider characteristics, VL utilization was independently related with a lower TIAE rate.
AHRQ-funded; HS024511.
Citation: Giuliano J, Krishna A, Napolitano N .
Implementation of video laryngoscope-assisted coaching reduces adverse tracheal intubation-associated events in the PICU.
Crit Care Med 2023 Jul; 51(7):936-47. doi: 10.1097/ccm.0000000000005847..
Keywords: Children/Adolescents, Intensive Care Unit (ICU), Adverse Events, Patient Safety
Lenz KB, Nishisaki A, Lindell RB
Peri-intubation adverse events in the critically ill child after hematopoietic cell transplant.
The goal of this study was to investigate whether adverse peri-intubation associated events occur at increased frequency in pediatric patients with hematopoietic cell transplant (HCT) compared with non-HCT oncologic or other pediatric ICU (PICU) patients and therefore might contribute to increased mortality. This retrospective cohort study of critically ill children who underwent tracheal intubation (TI) was conducted between 2014 and 2019. Data was merged from local airway management quality databases and Virtual Pediatric Systems. Data was supplemented with a retrospective chart review for HCT-related data, including HCT indication, transplant-related comorbidity status, and patient condition at the time of TI procedure. There was a total of 1,931 children identified who underwent TI, of which 92 (4.8%) were post-HCT, while 319 (16.5%) had history of malignancy without HCT, and 1,520 (78.7%) had neither HCT nor malignancy. Children post-HCT were older, more often had respiratory failure, use of catecholamine infusions peri-intubation, and use of noninvasive ventilation prior to intubation. There was no difference in hemodynamic tracheal intubation-associated adverse events (TIAEs) or peri-intubation hypoxemia across three groups (HCT 16%, non-HCT with malignancy 10%, other 15%). The authors did not find an association between HCT status and the adverse TI outcome after adjusting for age, difficulty airway feature, provider type, device, apneic oxygenation use, and indication for intubation.
AHRQ-funded; HS024511.
Citation: Lenz KB, Nishisaki A, Lindell RB .
Peri-intubation adverse events in the critically ill child after hematopoietic cell transplant.
Pediatr Crit Care Med 2023 Jul; 24(7):584-93. doi: 10.1097/pcc.0000000000003243..
Keywords: Children/Adolescents, Intensive Care Unit (ICU), Critical Care, Adverse Events
Wang Y, Eldridge N, Metersky ML
Relationship between in-hospital adverse events and hospital performance on 30-day all-cause mortality and readmission for patients with heart failure.
Researchers sought to evaluate the association between hospital performance on mortality and readmission with hospital performance on safety adverse event rates. Their cross-sectional study linked patient-level adverse events data from the Medicare Patient Safety Monitoring System to hospital-level, heart failure (HF)-specific, 30-day, all-cause mortality and readmissions data from CMS. The study included data on over 39,000 patients with HF from over 3000 hospitals. Patients admitted with HF to hospitals with high 30-day, all-cause mortality and readmission rates had a higher risk of in-hospital adverse events. The researchers concluded that there might be common quality issues among the measure concepts in these hospitals that produce poor performance for patients with HF.
AHRQ-funded; AHRQ-authored; 290201800005C.
Citation: Wang Y, Eldridge N, Metersky ML .
Relationship between in-hospital adverse events and hospital performance on 30-day all-cause mortality and readmission for patients with heart failure.
Circ Cardiovasc Qual Outcomes 2023 Jul; 16(7):e009573. doi: 10.1161/circoutcomes.122.009573..
Keywords: Hospitals, Hospital Readmissions, Heart Disease and Health, Cardiovascular Conditions, Adverse Events, Provider Performance
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
Karlic KJ, Valley TS, Cagino LM
Identification of patient safety threats in a post-intensive care clinic.
This observational cohort study examined patient safety threats at a post-ICU clinic in an academic, tertiary care medical center and whether post-ICU clinics improve patient safety. The study identified 83 patients, of which 60 patients had 96 separate safety threats. The threats were categorized into 7 themes: medication errors (27%); inadequate medical follow-up (25%); inadequate patient support (16%); high-risk behaviors (5%); medical complications (5%); equipment/supplies failures (4%); and other (18%). They were also categorized as 41% preventable, 27% ameliorable, and 32% were neither preventable nor ameliorable.
AHRQ-funded; HS028038.
Citation: Karlic KJ, Valley TS, Cagino LM .
Identification of patient safety threats in a post-intensive care clinic.
Am J Med Qual 2023 May-Jun; 38(3):117-21. doi: 10.1097/jmq.0000000000000118..
Keywords: Patient Safety, Transitions of Care, Adverse Events
Zhang J, Kummerfield E, Hultman G
Application of causal discovery algorithms in studying the nephrotoxicity of remdesivir using longitudinal data from the EHR.
Researchers analyzed the role of remdesivir in the mechanism and optimal treatment of the development of acute kidney injury (AKI) in the setting of COVID. Applying causal discovery machine learning techniques, they built multifactorial causal models of COVID-AKI; risk factors and renal function measures were represented in a temporal sequence using longitudinal data from Electronic Health Records. Their results indicated a need for assessment of renal function on second- and third-day use of remdesivir, and also showed that remdesivir may pose less risk to AKI than existing conditions of chronic kidney disease.
AHRQ-funded; HS024532.
Citation: Zhang J, Kummerfield E, Hultman G .
Application of causal discovery algorithms in studying the nephrotoxicity of remdesivir using longitudinal data from the EHR.
AMIA Annu Symp Proc 2023 Apr 29; 2022:1227-36..
Keywords: COVID-19, Electronic Health Records (EHRs), Health Information Technology (HIT), Medication, Adverse Drug Events (ADE), Adverse Events
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
Kuzma N, Khan A, Rickey L
Effect of Patient and Family Centered I-PASS on adverse event rates in hospitalized children with complex chronic conditions.
This study’s objective was to compare the effect of the intervention Patient and Family Centered (PFC)I-PASS on adverse events (AE) rates in children with and without complex chronic conditions (CCCs). A cohort of 3106 hospitalized children from seven North American pediatric hospitals between December 2014 and January 2017 were included. An effect modification analysis did not show difference in the intervention on children with and without CCCs. There was no statistically significant change in AEs for children with or without CCCs.
AHRQ-funded; HS022986.
Citation: Kuzma N, Khan A, Rickey L .
Effect of Patient and Family Centered I-PASS on adverse event rates in hospitalized children with complex chronic conditions.
J Hosp Med 2023 Apr;18(4):316-20. doi: 10.1002/jhm.13065.
Keywords: Children/Adolescents, Patient-Centered Healthcare, Chronic Conditions, Adverse Events, Inpatient Care, Transitions of Care
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
Gamyroulas EM, Jones AE, Saunders JA
Trends in antiplatelet strategies 12-months following coronary stent placement in anticoagulated patients.
The guidelines for antithrombotic management in individuals undergoing percutaneous coronary interventions (PCIs) who also necessitate anticoagulant treatment are continually developing. The purpose of this study is to examine adjustments to antithrombotic regimens and correlated outcomes within a year following PCI in patients needing continued anticoagulation therapy. Data from patients discovered through electronic medical record searches were manually assessed to validate alterations in antithrombotic treatment from discharge up to one year post-PCI, as well as episodes of significant bleeding, clinically relevant non-major bleeding (CRNMB), major adverse cardiovascular or neurological events (MACNE), and all-cause mortality outcomes during an extra six-month follow-up period. The study found that one year after PCI, patients (n = 120) undergoing anticoagulation treatment were categorized based on their antiplatelet therapy status: no antiplatelet therapy (n = 16), single antiplatelet therapy (SAPT) (n = 85), or dual antiplatelet therapy (DAPT) (n = 19). Between 12 and 18 months post-PCI, there were two significant bleeds, seven CRNMB events, six MACNE incidents, two venous thromboembolisms, and five fatalities. All but one bleeding occurrence transpired in the SAPT group. The likelihood of maintaining DAPT at 12 months was elevated in patients who underwent PCI for acute coronary syndrome and those who experienced MACNE within one year post-PCI; however, these associations did not reach statistical significance.
AHRQ-funded; HS027960
Citation: Gamyroulas EM, Jones AE, Saunders JA .
Trends in antiplatelet strategies 12-months following coronary stent placement in anticoagulated patients.
BMC Cardiovasc Disord 2023 Mar 8;23(1):117. doi: 10.1186/s12872-023-03161-7.
Keywords: Blood Thinners, Medication, Heart Disease and Health, Cardiovascular Conditions, Adverse Drug Events (ADE), Adverse Events
Bamdad MC, Vitous CA, Rivard SJ
"You remember those days"-a qualitative study of resident surgeon responses to complications and deaths.
This qualitative study examined the impact of complications and deaths on surgery residents to facilitate development of improved support systems. Twenty-eight mid-level and senior residents (PGY3 and above) from 14 different training programs across the US were given semi-structured interviews. The interviewees described an initial emotional response of sadness, frustration, or grief. Simultaneously or soon after went through an examination period where they looked at how and why the outcome occurred with the goal of learning from it. The last phase was having a feeling of ownership, which was strengthened by involved in patient care and length of rotation.
AHRQ-funded; HS026772.
Citation: Bamdad MC, Vitous CA, Rivard SJ .
"You remember those days"-a qualitative study of resident surgeon responses to complications and deaths.
J Surg Educ 2022 Mar-Apr; 79(2):452-62. doi: 10.1016/j.jsurg.2021.09.011..
Keywords: Surgery, Provider: Physician, Adverse Events, Mortality
Hansten PD, Tan MS, Horn JR
Colchicine drug interaction errors and misunderstandings: recommendations for improved evidence-based management.
Colchicine serves as an effective therapy for the management and prevention of gout and various other medical conditions. As a substrate for CYP3A4 and P-glycoprotein (P-gp), its simultaneous use with CYP3A4/P-gp inhibitors can lead to critical drug-drug interactions (DDIs) that may result in pancytopenia, multiorgan dysfunction, and cardiac irregularities. Additionally, colchicine's potential for myotoxicity could elevate the risk of myopathy and rhabdomyolysis when combined with other myotoxic medications. Numerous sources of DDI information, encompassing journal articles, product labels, and online resources, contain inaccuracies or vague statements regarding colchicine's interactions with other drugs and subpar guidance on managing DDIs to minimize patient harm. Moreover, assessments of the clinical significance of specific colchicine DDIs can differ substantially between sources. The purpose of this study was to present an evidence-based analysis of drugs that are likely to interact with colchicine, as well as those that have been cited to interact but are improbable to do so. Based on these assessments, the researchers proposes strategies to mitigate the risk of severe adverse consequences from colchicine DDIs. The frequent recommendation to decrease colchicine dosage when administered with CYP3A4/P-gp inhibitors may, in some cases, lead to colchicine toxicity or therapeutic failure. An exhaustive evaluation of nearly 100 documented instances of colchicine DDIs is provided in a table within the electronic supplementary material. While colchicine is a beneficial medication, enhancements to the available information on colchicine DDIs are necessary to reduce the risk of serious adverse events.
AHRQ-funded; HS025984
Citation: Hansten PD, Tan MS, Horn JR .
Colchicine drug interaction errors and misunderstandings: recommendations for improved evidence-based management.
Drug Saf 2023 Mar;46(3):223-42. doi: 10.1007/s40264-022-01265-1.
Keywords: Medication, Adverse Drug Events (ADE), Adverse Events, Medical Errors, Evidence-Based Practice
Griffey RT, Schneider RM, Todorov AA
Near-miss events detected using the emergency department trigger tool.
The purpose of this study was to explore near misses and their significance for quality and safety in the emergency department (ED). This study presents a secondary analysis of data from a retrospective investigation of the ED Trigger Tool (EDTT) at an urban, academic ED. The EDTT, a computerized query for triggers, was applied to 13 months of ED visit data, and 5582 selected records were reviewed using a two-tiered approach. Events were categorized by occurrence (ED vs. present on arrival [POA]), severity, omission/commission, and type, employing a taxonomy featuring categories, subcategories, and cross-cutting modifiers. The researchers identified 1458 ED near misses in 1269 of the 5582 records and 80 near misses that were POA. Patient care events constituted the majority of ED near misses, including diagnostic delays, treatment delays, and monitoring failures, primarily influenced by ED boarding and overcrowding. Medication events ranked second in frequency (17%), with 80 medication administration errors identified. Among the 80 POA events, 42% were linked to overanticoagulation. It was estimated that 19.3% of all ED visits involved a near miss.
AHRQ-funded; HS027811; HS025052.
Citation: Griffey RT, Schneider RM, Todorov AA .
Near-miss events detected using the emergency department trigger tool.
J Patient Saf 2023 Mar 1; 19(2):59-66. doi: 10.1097/pts.0000000000001092..
Keywords: Emergency Department, Patient Safety, Adverse Events, Medical Errors
Stone CA, Jr., Robinson LB, Li L
Clinical phenotypes of immediate first-dose reactions to mRNA COVID-19: a multicenter latent class analysis.
The objectives of this retrospective study were to define distinct clinical phenotypes of immediate reactions after dose 1 of mRNA COVID-19 vaccination, and to assess the relation of clinical phenotype to mRNA COVID-19 vaccine second dose tolerance. Researchers identified 265 patients who experienced dose-1 immediate reactions with 3 phenotype clusters: limited or predominantly cutaneous, sensory, or systemic. Of these, 223 patients received a second dose and 200 tolerated the second dose; sensory cluster (numbness or tingling) was associated with a higher likelihood of second dose intolerance, but this finding did not persist when accounting for objective signs.
AHRQ-funded; HS026395.
Citation: Stone CA, Jr., Robinson LB, Li L .
Clinical phenotypes of immediate first-dose reactions to mRNA COVID-19: a multicenter latent class analysis.
J Allergy Clin Immunol Pract 2023 Feb;11(2):458-65.e1. doi: 10.1016/j.jaip.2022.08.048.
Keywords: COVID-19, Medication, Adverse Drug Events (ADE), Adverse Events, Infectious Diseases, Vaccination
Difazio RL, Shore BJ, Melvin P
Pneumonia after hip surgery in children with neurological complex chronic conditions.
The purpose of this retrospective cohort study was to estimate rates of postoperative pneumonia in children with neurological complex chronic conditions (CCC) undergoing hip surgery, to determine the effect of pneumonia on postoperative hospital resource use, and to identify predictors. Researchers used data from the Pediatric Health Information System for children 4 years and older with a neurological CCC who had undergone hip surgery from 2016 to 2018 in U.S. children's hospitals. Findings indicate that postoperative pneumonia in children with a neurological CCC was associated with longer length-of-stay, readmissions, and higher costs. Children who had undergone pelvic osteotomies and who had multimorbidity needed additional clinical support to prevent postoperative pneumonia and to decrease resource utilization.
AHRQ-funded; HS024453.
Citation: Difazio RL, Shore BJ, Melvin P .
Pneumonia after hip surgery in children with neurological complex chronic conditions.
Dev Med Child Neurol 2023 Feb; 65(2):232-42. doi: 10.1111/dmcn.15339..
Keywords: Children/Adolescents, Surgery, Neurological Disorders, Pneumonia, Respiratory Conditions, Hospital Readmissions, Adverse Events
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.
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
Ervin JN, Vitous CA, Wells EE
Rescue Improvement Conference: a novel tool for addressing failure to rescue.
The objective of this study was to understand the effectiveness of the Rescue Improvement Conference, a forum that addresses failure to rescue (FTR). FTR is the phenomenon where delayed recognition or response to surgical complications leads to a progressive cascade of adverse events culminating in patient death. The authors used 5 indicators of effectiveness: educational value, conference takeaways, discussion time, changes to surgical practice, and opportunities for improvement and conducted semi-structured interviews. The results showed that conference felt that the Rescue Improvement Conference was effective in all five indicators. The authors concluded that the conference has the potential to support other surgical departments in developing system-level strategies to recognize and manage postoperative complications that contribute to FTR.
AHRQ-funded; HS024403; HS023621.
Citation: Ervin JN, Vitous CA, Wells EE .
Rescue Improvement Conference: a novel tool for addressing failure to rescue.
Ann Surg 2023 Feb; 277(2):233-37. doi: 10.1097/sla.0000000000004832..
Keywords: Surgery, Adverse Events, Patient Safety, Quality of Care, Quality Improvement
Napolitano N, Polikoff L, Edwards L
Effect of apneic oxygenation with intubation to reduce severe desaturation and adverse tracheal intubation-associated events in critically ill children.
This study’s goal was to determine if apneic oxygenation (AO) delivered via nasal cannula during the apneic phase of tracheal intubation (TI) reduces adverse TI-associated events (TIAEs) in children. AO was implemented at 14 pediatric intensive care units as a quality improvement intervention from 2016 through 2020. Implementation consisted of an intubation safety checklist, leadership endorsement, use of a local champion, and data feedback to frontline clinicians. Of 6549 TIs during the study period, 2554 occurred during the pre-implementation phase and 3995 during post-implementation phase. AO utilization increased from 23 to 68%. It was utilized less often when intubating infants, those with a primary cardiac diagnosis or difficult airway features, and patients intubated due to respiratory or neurological failure or shock. Conversely, it was used more often in TIs done for procedures or those associated by video laryngoscopy. AO utilization was associated with a lower incidence of adverse TIAEs (AO 10.5% vs. without AO 13.5%). However, after further adjusting for patient and provider characteristics (secondary analysis), AO utilization was not independently associated with the occurrence of adverse TIAEs, and the occurrence of hypoxemia was not different (AO 14.2% versus without AO 15.2%).
AHRQ-funded; HS024511.
Citation: Napolitano N, Polikoff L, Edwards L .
Effect of apneic oxygenation with intubation to reduce severe desaturation and adverse tracheal intubation-associated events in critically ill children.
Crit Care 2023 Jan 17; 27(1):26. doi: 10.1186/s13054-023-04304-0..
Keywords: Children/Adolescents, Critical Care, Adverse Events, Respiratory Conditions
Encinosa W, Moon K, Figueroa J
Complications, adverse drug events, high costs, and disparities in multisystem inflammatory syndrome in children vs COVID-19.
This cross-sectional study’s goal was to determine outcomes from multisystem inflammatory syndrome in children (MIS-C) after COVID-19. Outcomes examined were 50 complications, adverse medication events, costs, and the Social Vulnerability Index. An analysis was conducted using data from the 2021 HCUP in individuals younger than 21 years from 31 states. There were 4107 individuals hospitalized with MIS-C (median age 9 years, 59.5% male, 38.1% White) and 23,686 hospitalizations for COVID-19 without MIS-C (median age 15 years, 54.5% female, 44.1% White). Hospitalization rate for MIS-C was 1.48 per 100,000 children, ranging from 0.97 hospitalizations per 100 for White and 1.99 hospitalizations per 100 for Black children. Outcomes were worse when organ dysfunction increased from 2 to 8 organs, with deaths increasing from less than 1% to 5.8% for MIS-C, and 1% to 17.2% for COVID-19. Median length of stay increased from 4 to 8 days for MIS-C, and 3 to 16 days for COVID-19. Median costs for MIS-C increased from $16,225 to $53 359 and from $6474 to $98,643 for COVID-19. The percentage of MIS-C cases in Black children doubled from 16.2% to 31.7% as organ dysfunction increased, remaining unchanged with COVID-19.
AHRQ-authored.
Citation: Encinosa W, Moon K, Figueroa J .
Complications, adverse drug events, high costs, and disparities in multisystem inflammatory syndrome in children vs COVID-19.
JAMA Netw Open 2023 Jan;6(1):e2244975. doi: 10.1001/jamanetworkopen.2022.44975..
Keywords: Healthcare Cost and Utilization Project (HCUP), Children/Adolescents, COVID-19, Medication, Adverse Drug Events (ADE), Adverse Events, Healthcare Costs, Disparities, Racial and Ethnic Minorities
