Feasibility of a clinic-based, multicomponent hydroxyurea adherence intervention for adolescents and young adults with sickle cell disease.

Despite the effectiveness of hydroxyurea, adherence remains low for adolescents and young adults (AYA) living with sickle cell disease (SCD). This study evaluated the feasibility, acceptability, and initial efficacy of a clinic-based, multicomponent (e.g., storytelling, problem solving) intervention with 20 AYA living with SCD. Results found that adherence significantly improved from intervention to follow-up 1 [t(19) = -2.213, p = .039]. AYA also were generally satisfied with the intervention. These findings, although promising, should be replicated on a larger scale.

Preventable harm because of outpatient medication errors among children with leukemia and lymphoma: A multisite longitudinal assessment.

BACKGROUND: There is little longitudinal information about the type and frequency of harm resulting from medication errors among outpatient children with cancer. We aimed to characterize rates and types of medication errors and harm to outpatient children with leukemia and lymphoma over 7 months of treatment. METHODS: We recruited children taking medications at home for leukemia or lymphoma from three pediatric cancer centers. Errors were identified by chart review, in-home medication review, observation of administration, and interviews. Physician reviewers confirmed error (Fleiss' κ = 0.95), harm (Fleiss' κ = 0.82), and suggested interventions. Generalized linear mixed models with random effects were used to account for clustering by site. RESULTS: Among 131 children taking 1669 medications with 367 home visits, 408 errors were identified, including 242 with potential for harm and 39 with harm (1.0 harm per 1000 patient-days [95% CI, 0.1-9.8]). Ten percent of children were injured by errors and 42% had errors with potential for harm. Twenty-six percent of caregivers reported that miscommunication led to missed doses or overdoses at home. Children on >13 medications had significantly more serious medication errors than those on fewer medications (77% vs 61%; p = .05). Physician reviewers judged that improved communication among caregivers and between caregivers and clinicians may have prevented the most harm (66%). CONCLUSIONS: In this longitudinal study, 10% children with leukemia or lymphoma experienced adverse drug events because of outpatient medication errors. Improvements addressing communication with and among caregivers should be codeveloped with families and based on human-factors engineering. PLAIN LANGUAGE SUMMARY: In this longitudinal study, medication errors in the clinic, pharmacy, or at home among children with leukemia or lymphoma over a 7-month period were common, and 10% suffered harm because of errors. Children on >13 medications had significantly more serious medication errors than those on fewer medications (77% vs 61%; p = .05). Physician reviewers judged that improved communication among caregivers and between caregivers and clinicians may have prevented the most harm (66%). Improvements addressing communication with and among caregivers should be codeveloped with families and based on human-factors engineering.

Professional stakeholders' perceptions of barriers to behavioral health care following pediatric traumatic brain injury.

OBJECTIVE: To examine professional stakeholders' perspectives of barriers to behavioral health care (BHC) follow-up and telepsychology after pediatric traumatic brain injury (TBI). METHODS: Twenty-nine professionals participated in a focus group (FG) or key informant interview (KII) between January and March 2020. Professionals answered questions about facilitators and barriers to BHC follow-up and telepsychology. Given widespread telepsychology implementation since COVID-19, a follow-up survey assessing telehealth perceptions since the pandemic was sent out in December 2020. Nineteen professionals completed the survey. RESULTS: Professionals identified individual (e.g., family factors, insurance coverage/finances, transportation/distance, availability, planning follow-up care) and system-level (e.g., lack of access to BHC providers) barriers to BHC post-injury. Possible solutions, like collaborative follow-up care, were also identified. Generally, clinical professionals have favorable impressions of telepsychology and utilized services as a delivery modality for clinical care. Though telepsychology could reduce barriers to care, professionals also expressed concerns (e.g., technology issues, security/safety) and challenges (e.g., funding, accessibility, training/licensure for clinicians) with implementing telepsychology. CONCLUSION: Barriers identified highlight the need for context-specific solutions to increase BHC access, with telepsychology generally recognized as a beneficial modality for BHC. Future work should continue to focus on understanding barriers to BHC and potential solutions after pediatric TBI.

Development and validation of a predictive model algorithm to identify anaphylaxis in adults with type 2 diabetes in U.S. administrative claims data.

PURPOSE: To use medical record adjudication and predictive modeling methods to develop and validate an algorithm to identify anaphylaxis among adults with type 2 diabetes (T2D) in administrative claims. METHODS: A conventional screening algorithm that prioritized sensitivity to identify potential anaphylaxis cases was developed and consisted of diagnosis codes for anaphylaxis or relevant signs and symptoms. This algorithm was applied to adults with T2D in the HealthCore Integrated Research Database (HIRD) from 2016 to 2018. Clinical experts adjudicated anaphylaxis case status from redacted medical records. We used confirmed case status as an outcome for predictive models developed using lasso regression with 10-fold cross-validation to identify predictors and estimate the probability of confirmed anaphylaxis. RESULTS: Clinical adjudicators reviewed medical records with sufficient information from 272 adults identified by the anaphylaxis screening algorithm, which had an estimated Positive Predictive Value (PPV) of 65% (95% confidence interval [CI]: 60%-71%). The predictive model algorithm had a c-statistic of 0.95. The model's probability threshold of 0.60 excluded 89% (84/94) of false positives identified by the screening algorithm, with a PPV of 94% (95% CI: 91%-98%). The model excluded very few true positives (15 of 178), and identified 92% (95% CI: 87%-96%) of the cases selected by the screening algorithm. CONCLUSIONS: Predictive modeling techniques yielded an accurate algorithm with high PPV and sensitivity for identifying anaphylaxis in administrative claims. This algorithm could be considered in future safety studies using similar claims data to reduce potential outcome misclassification.

Factors associated with adolescent and caregiver reported problems in using asthma medications.

OBJECTIVES: The purpose of this study was to: (a) describe the types of medication problems/concerns youth with asthma and their caregivers reported and (b) examine the association between sociodemographic characteristics and youth and caregiver reported medication problems/concerns. METHODS: English- and Spanish-speaking youth ages 11-17 with persistent asthma were recruited at four pediatric clinics. Youth were interviewed and caregivers completed questionnaires about reported asthma medication concerns/problems. Multiple logistic regression was used to analyze the data. RESULTS: Three hundred and fifty-nine youth were recruited. Eighty percent of youth and 70% of caregivers reported one or more problems in using asthma medications. The most commonly reported problems by youth were: (a) hard to remember when to take the asthma medication (54%) and (b) hard to use asthma medication at school (34%). Younger children were significantly more likely to report difficulty in understanding their asthma medication's directions and difficulty reading the print on the medication's package. Caregivers' top-reported problem was that it is hard for their child to remember to take their asthma medications (49%). Caregivers without Medicaid were significantly more likely to express difficulty paying for their child's asthma medications. CONCLUSIONS: Difficulty remembering to take asthma medication was a significant problem for youth and their caregivers. Providers should work with youth and their caregivers to identify asthma medication problems and discuss strategies to address those problems.

Smart pumps improve medication safety but increase alert burden in neonatal care.

BACKGROUND: Smart pumps have been widely adopted but there is limited evidence to understand and support their use in pediatric populations. Our objective was to assess whether smart pumps are effective at reducing medication errors in the neonatal population and determine whether they are a source of alert burden and alert fatigue in an intensive care environment. METHODS: Using smart pump records, over 370,000 infusion starts for continuously infused medications used in neonates and infants hospitalized in a level IV NICU from 2014 to 2016 were evaluated. Attempts to exceed preset soft and hard maximum limits, percent variance from those limits, and pump alert frequency, patterns and salience were evaluated. RESULTS: Smart pumps prevented 160 attempts to exceed the hard maximum limit for doses that were as high as 7-29 times the maximum dose and resulted in the reprogramming or cancellation of 2093 infusions after soft maximum alerts. While the overall alert burden from smart pumps for continuous infusions was not high, alerts clustered around specific patients and medications, and a small portion (17%) of infusions generated the majority of alerts. Soft maximum alerts were often overridden (79%), consistent with low alert salience. CONCLUSIONS: Smart pumps have the ability to improve neonatal medication safety when compliance with dose error reducing software is high. Numerous attempts to administer high doses were intercepted by dosing alerts. Clustered alerts may generate a high alert burden and limit safety benefit by desensitizing providers to alerts. Future efforts should address ways to improve alert salience.

Psychogenic pseudosyncope: Not always a diagnosis of exclusion.

BACKGROUND: Psychogenic pseudosyncope (PPS) frequently mimics syncope. The aim of this study was to assess the prevalence and clinical features of PPS and its relationship to vasovagal syncope (VVS). METHODS: We examined retrospectively the medical records of 1,401 consecutive patients referred to a syncope unit. We identified patients who had the final diagnosis of PPS. In these patients, we retrieved the initial diagnosis made during their first visit and the subsequent tests performed leading to the final diagnosis. RESULTS: Fourteen (1.0%) patients (mean age 35 ± 14; 11 females) were diagnosed as having PPS: seven had a diagnosis of PPS alone and seven had both VVS and PPS. High frequency of attacks (53 ± 35 attacks during the previous year), prolonged loss of consciousness (minutes to > 1 hour), and a history of psychiatric disorders characterized PPS patients. Tilt test reproduced a PPS attack in the presence of normal blood pressure and heart rate in seven patients (50%), and induced VVS in another three patients who had the final diagnosis of both PPS and VVS. In two patients, one or more events occurred during the clinic visits and were directly witnessed by the clinic personnel. CONCLUSIONS: We have shown that 1% of referrals to a syncope unit have the final diagnosis of PPS and that up to 50% of cases presented with a different initial diagnosis, namely VVS. Our findings suggest that causality between syncope and psychiatric disorders is likely bidirectional. The presence of a multidisciplinary team is important to address this often unrecognized relationship.

Measuring Harm in Health Care: Optimizing Adverse Event Review.

OBJECTIVE: The objective of this study was to identify modifiable factors that improve the reliability of ratings of severity of health care-associated harm in clinical practice improvement and research. METHODS: A diverse group of clinicians rated 8 types of adverse events: blood product, device or medical/surgical supply, fall, health care-associated infection, medication, perinatal, pressure ulcer, surgery. We used a generalizability theory framework to estimate the impact of number of raters, rater experience, and rater provider type on reliability. RESULTS: Pharmacists were slightly more precise and consistent in their ratings than either physicians or nurses. For example, to achieve high reliability of 0.83, 3 physicians could be replaced by 2 pharmacists without loss in precision of measurement. If only 1 rater was available for rating, ∼5% of the reviews for severe harm would have been incorrectly categorized. Reliability was greatly improved with 2 reviewers. CONCLUSIONS: We identified factors that influence the reliability of clinician reviews of health care-associated harm. Our novel use of generalizability analyses improved our understanding of how differences affect reliability. This approach was useful in optimizing resource utilization when selecting raters to assess harm and may have similar applications in other settings in health care.

Clinical Characteristics and Outcome of Patients with Situational Syncope Compared to Patients with Vasovagal Syncope.

BACKGROUNDS: The purpose of the study was to assess the clinical outcome of patients with situational syncope (SS) compared to patients with vasovagal syncope (VVS). METHODS: We assessed the prevalence, patients' characteristics, and outcome of consecutive patients with SS and VVS who presented to the Faint and Fall Clinic (University of Wisconsin) between January 2013 and December 2015. RESULTS: SS was found in 55/1,401 (4.0%) syncope patients with follow-up data available in 47 patients: defecation (n = 16), micturition (n = 15), cough (n = 10), swallow (n = 3), laughter (n = 1), sneeze (n = 1), and cough plus laughter (n = 1). Over the same time period, 252/1,401 patients (18%) were diagnosed with VVS with follow-up data available in 171 patients. Compared with VVS patients, SS patients were older, more likely to be male, had a higher prevalence of hypertension, had an absence of prodromes, and experienced more injuries at the time of syncope (P = 0.01 for all). During a mean follow-up duration of 15.4 ± 9.1 months, syncope recurred in 5/47 (10.6%) patients with SS and 16/171 (9.4%) patients with VVS. The recurrence rates at 1 year and 2 years were 20% (95% SE ± 13) and 40% (95% SE ± 20) for the SS group, and 23% (95% SE ± 13) and 43% (95% SE ± 20) for the VVS group (P = 0.6). No patient died. CONCLUSIONS: We have shown in a large cohort of consecutive patients with syncope that SS is a relatively infrequent form of reflex syncope with different clinical characteristics but similar recurrence rate to VVS.

Assessing the Revised Safer Dx Instrument® in the understanding of ambulatory system design changes for type 1 diabetes and autism spectrum disorder in pediatrics.

OBJECTIVES: We sought within an ambulatory safety study to understand if the Revised Safer Dx instrument may be helpful in identification of diagnostic missed opportunities in care of children with type 1 diabetes (T1D) and autism spectrum disorder (ASD). METHODS: We reviewed two months of emergency department (ED) encounters for all patients at our tertiary care site with T1D and a sample of such encounters for patients with ASD over a 15-month period, and their pre-visit communication methods to better understand opportunities to improve diagnosis. We applied the Revised Safer Dx instrument to each diagnostic journey. We chose potentially preventable ED visits for hyperglycemia, diabetic ketoacidosis, and behavioral crises, and reviewed electronic health record data over the prior three months related to the illness that resulted in the ED visit. RESULTS: We identified 63 T1D and 27 ASD ED visits. Using the Revised Safer Dx instrument, we did not identify any potentially missed opportunities to improve diagnosis in T1D. We found two potential missed opportunities (Safer Dx overall score of 5) in ASD, related to potential for ambulatory medical management to be improved. Over this period, 40 % of T1D and 52 % of ASD patients used communication prior to the ED visit. CONCLUSIONS: Using the Revised Safer Dx instrument, we uncommonly identified missed opportunities to improve diagnosis in patients who presented to the ED with potentially preventable complications of their chronic diseases. Future researchers should consider prospectively collected data as well as development or adaptation of tools like the Safer Dx.

Factors Associated With HIV Testing in Adolescent and Young Adult Females With a History of STI.

To determine the percentage of female adolescent patients (13-26 years old) who had HIV testing ordered within 90 days of incident sexually transmitted infection (STI) diagnosis during an outpatient clinic visit. This was a retrospective chart review study evaluating 830 visits among 589 female patients 13 to 26 years who had an incident STI diagnosed in outpatient Adolescent Medicine or Pediatric Practices in an urban, nonprofit, academic, free-standing children's hospital at the main campus and a community site in the Northeast United States. Odds of HIV screening was greater at the community-based adolescent medicine practice (odds ratio [OR] = 3.17; 95% confidence interval [CI]: [1.92, 5.24]) and when seen by an adolescent medicine provider (OR = 1.44; 95% CI: [1.02, 2.03]). Only 33.5% (n = 283) of 844 clinical encounters had HIV screening obtained within 90 days of incident STI diagnosis. Overall, HIV screening rates within 90 days of STI diagnosis was low, and there is much room for improvement.

Risk of Anaphylaxis Among New Users of GLP-1 Receptor Agonists: A Cohort Study.

OBJECTIVE: To assess risk of anaphylaxis among patients with type 2 diabetes mellitus who are initiating therapy with a glucagon-like peptide 1 receptor agonist (GLP-1 RA), with a focus on those starting lixisenatide therapy. RESEARCH DESIGN AND METHODS: A cohort study was conducted in three large, U.S. claims databases (2017-2021). Adult (aged ≥18 years) new users of a GLP-1 RA who had type 2 diabetes mellitus and ≥6 months enrollment in the database before GLP-1 RA initiation (start of follow-up) were included. GLP-1 RAs evaluated were lixisenatide, an insulin glargine/lixisenatide fixed-ratio combination (FRC), exenatide, liraglutide or insulin degludec/liraglutide FRC, dulaglutide, and semaglutide (injectable and oral). The first anaphylaxis event during follow-up was identified using a validated algorithm. Incidence rates (IRs) and 95% CIs were calculated within each medication cohort. The unadjusted IR ratio (IRR) comparing anaphylaxis rates in the lixisenatide cohort with all other GLP-1 RAs combined was analyzed post hoc. RESULTS: There were 696,089 new users with 456,612 person-years of exposure to GLP-1 RAs. Baseline demographics, comorbidities, and use of other prescription medications in the 6 months before the index date were similar across medication cohorts. IRs (95% CIs) per 10,000 person-years were 1.0 (0.0-5.6) for lixisenatide, 6.0 (3.6-9.4) for exenatide, 5.1 (3.7-7.0) for liraglutide, 3.9 (3.1-4.8) for dulaglutide, and 3.6 (2.6-4.9) for semaglutide. The IRR (95% CI) for the anaphylaxis rate for the lixisenatide cohort compared with the pooled other GLP-1 RA cohort was 0.24 (0.01-1.35). CONCLUSIONS: Anaphylaxis is rare with GLP-1 RAs. Lixisenatide is unlikely to confer higher risk of anaphylaxis than other GLP-1 RAs.

Clinician Perspectives on Continuous Monitor Use in a Children's Hospital: A Qualitative Study.

BACKGROUND AND OBJECTIVES: Variation in continuous cardiopulmonary monitor (cCPM) use across children's hospitals suggests preference-based use. We sought to understand how clinical providers make decisions to use cCPMs. METHODS: We conducted a qualitative study using semi-structed interviews with clinicians (nurses, respiratory therapists [RTs], and resident and attending physicians) from 2 hospital medicine units at a children's hospital. The interview guide employed patient cases and open-ended prompts to elicit information about workflows and decision-making related to cCPM, and we collected basic demographic information about participants. We used an inductive approach following thematic analysis to code transcripts and create themes. RESULTS: We interviewed 5 nurses, 5 RTs, 7 residents, and 7 attending physicians. We discovered that clinicians perceive a low threshold for starting cCPM, and this often occurred as a default action at admission. Clinicians thought of cCPMs as helping them cope with uncertainty. Despite acknowledging considerable flaws in how cCPMs were used, they were perceived as a low-risk intervention. Although RNs and RTs were most aware of the patient's current condition and number of alarms, physicians decided when to discontinue monitors. No structured process for identifying when to discontinue monitors existed. CONCLUSIONS: We concluded that nurses, physicians, and RTs often default to cCPM use and lack a standardized process for identifying when cCPM should be discontinued. Interventions aiming to reduce monitor use will need to account for or target these factors.

Prospective Study of the Multisite Spread of a Medication Safety Intervention: Factors Common to Hospitals With Improved Outcomes.

Context and implementation approaches can impede the spread of patient safety interventions. The objective of this article is to characterize factors associated with improved outcomes among 9 hospitals implementing a medication safety intervention. Nephrotoxic Injury Negated by Just-in-Time Action (NINJA) is a pharmacist-driven intervention that led to a sustained reduction in nephrotoxic medication-associated acute kidney injury (NTMx-AKI) at 1 hospital. Using qualitative comparative analysis, the team prospectively assessed the association between context and implementation factors and NTMx-AKI reduction during NINJA spread to 9 hospitals. Five hospitals reduced NTMx-AKI. These 5 had either (1) a pharmacist champion and >2 pharmacists working on NINJA (Scon 1.0, Scov 0.8) or (2) a nephrologist-implementing NINJA with minimal competing organizational priorities (Scon 1.0, Scov 0.2). Interviews identified ways NINJA team leaders obtained pharmacist support or successfully implemented without that support. In conclusion, these findings have implications for future spread of NINJA and suggest an approach to study spread of safety interventions more broadly.

Validation of anaphylaxis in the Food and Drug Administration's Mini-Sentinel.

PURPOSE: We aim to develop and validate the positive predictive value (PPV) of an algorithm to identify anaphylaxis using health plan administrative and claims data. Previously published PPVs for anaphylaxis using International Classification of Diseases, ninth revision, Clinical Modification (ICD-9-CM) codes range from 52% to 57%. METHODS: We conducted a retrospective study using administrative and claims data from eight health plans. Using diagnosis and procedure codes, we developed an algorithm to identify potential cases of anaphylaxis from the Mini-Sentinel Distributed Database between January 2009 and December 2010. A random sample of medical charts (n = 150) was identified for chart abstraction. Two physician adjudicators reviewed each potential case. Using physician adjudicator judgments on whether the case met diagnostic criteria for anaphylaxis, we calculated a PPV for the algorithm. RESULTS: Of the 122 patients for whom complete charts were received, 77 were judged by physician adjudicators to have anaphylaxis. The PPV for the algorithm was 63.1% (95%CI: 53.9-71.7%), using the clinical criteria by Sampson as the gold standard. The PPV was highest for inpatient encounters with ICD-9-CM codes of 995.0 or 999.4. By combining only the top performing ICD-9-CM codes, we identified an algorithm with a PPV of 75.0%, but only 66% of cases of anaphylaxis were identified using this modified algorithm. CONCLUSIONS: The PPV for the ICD-9-CM-based algorithm for anaphylaxis was slightly higher than PPV estimates reported in prior studies, but remained low. We were able to identify an algorithm that optimized the PPV but demonstrated lower sensitivity for anaphylactic events.

Measurement of Ambulatory Medication Errors in Children: A Scoping Review.

BACKGROUND AND OBJECTIVES: Children use most medications in the ambulatory setting where errors are infrequently intercepted. There is currently no established measure set for ambulatory pediatric medication errors. We have sought to identify the range of existing measures of ambulatory pediatric medication errors, describe the data sources for error measurement, and describe their reliability. METHODS: We performed a scoping review of the literature published since 1986 using PubMed, CINAHL, PsycINFO, Web of Science, Embase, and Cochrane and of grey literature. Studies were included if they measured ambulatory, including home, medication errors in children 0 to 26 years. Measures were grouped by phase of the medication use pathway and thematically by measure type. RESULTS: We included 138 published studies and 4 studies from the grey literature and identified 21 measures of medication errors along the medication use pathway. Most measures addressed errors in medication prescribing (n = 6), and administration at home (n = 4), often using prescription-level data and observation, respectively. Measures assessing errors at multiple phases of the medication use pathway (n = 3) frequently used error reporting databases and prospective measurement through direct in-home observation. We identified few measures of dispensing and monitoring errors. Only 31 studies used measurement methods that included an assessment of reliability. CONCLUSIONS: Although most available, reliable measures are too resource and time-intensive to assess errors at the health system or population level, we were able to identify some measures that may be adopted for continuous measurement and quality improvement.

Safer Type 1 Diabetes Care at Home: SEIPS-based Process Mapping with Parents and Clinicians.

Introduction: The limited data indicate that pediatric medical errors in the outpatient setting, including at home, are common. This study is the first step of our Ambulatory Pediatric Patient Safety Learning Lab to address medication errors and treatment delays among children with T1D in the outpatient setting. We aimed to identify failures and potential solutions associated with medication errors and treatment delays among outpatient children with T1D. Methods: A transdisciplinary team of parents, safety researchers, and clinicians used Systems Engineering Initiative for Patient Safety (SEIPS) based process mapping of data we collected through in-home medication review, observation of administration, chart reviews, parent surveys, and failure modes and effects analysis (FMEA). Results: Eight (57%) of the 14 children who had home visits experienced 18 errors (31 per 100 medications). Four errors in two children resulted in harm, and 13 had the potential for harm. Two injuries occurred when parents failed to treat severe hypoglycemia and lethargy, and two were due to repeated failures to administer insulin at home properly. In SEIPS-based process maps, high-risk errors occurred during communication between the clinic and home or in management at home. Two FMEAs identified interventions to better communicate with families and support home care, especially during evolving illness. Conclusion: Using SEIPS-based process maps informed by multimodal methods to identify medication errors and treatment delays, we found errors were common. Better support for managing acute illness at home and improved communication between the clinic and home are potentially high-yield interventions.