Systematic data quality assessment of electronic health record data to evaluate study-specific fitness: Report from the PRESERVE research study.

Study-specific data quality testing is an essential part of minimizing analytic errors, particularly for studies making secondary use of clinical data. We applied a systematic and reproducible approach for study-specific data quality testing to the analysis plan for PRESERVE, a 15-site, EHR-based observational study of chronic kidney disease in children. This approach integrated widely adopted data quality concepts with healthcare-specific evaluation methods. We implemented two rounds of data quality assessment. The first produced high-level evaluation using aggregate results from a distributed query, focused on cohort identification and main analytic requirements. The second focused on extended testing of row-level data centralized for analysis. We systematized reporting and cataloguing of data quality issues, providing institutional teams with prioritized issues for resolution. We tracked improvements and documented anomalous data for consideration during analyses. The checks we developed identified 115 and 157 data quality issues in the two rounds, involving completeness, data model conformance, cross-variable concordance, consistency, and plausibility, extending traditional data quality approaches to address more complex stratification and temporal patterns. Resolution efforts focused on higher priority issues, given finite study resources. In many cases, institutional teams were able to correct data extraction errors or obtain additional data, avoiding exclusion of 2 institutions entirely and resolving 123 other gaps. Other results identified complexities in measures of kidney function, bearing on the study's outcome definition. Where limitations such as these are intrinsic to clinical data, the study team must account for them in conducting analyses. This study rigorously evaluated fitness of data for intended use. The framework is reusable and built on a strong theoretical underpinning. Significant data quality issues that would have otherwise delayed analyses or made data unusable were addressed. This study highlights the need for teams combining subject-matter and informatics expertise to address data quality when working with real world data.

Using electronic health records to enhance surveillance of diabetes in children, adolescents and young adults: a study protocol for the DiCAYA Network.

INTRODUCTION: Traditional survey-based surveillance is costly, limited in its ability to distinguish diabetes types and time-consuming, resulting in reporting delays. The Diabetes in Children, Adolescents and Young Adults (DiCAYA) Network seeks to advance diabetes surveillance efforts in youth and young adults through the use of large-volume electronic health record (EHR) data. The network has two primary aims, namely: (1) to refine and validate EHR-based computable phenotype algorithms for accurate identification of type 1 and type 2 diabetes among youth and young adults and (2) to estimate the incidence and prevalence of type 1 and type 2 diabetes among youth and young adults and trends therein. The network aims to augment diabetes surveillance capacity in the USA and assess performance of EHR-based surveillance. This paper describes the DiCAYA Network and how these aims will be achieved. METHODS AND ANALYSIS: The DiCAYA Network is spread across eight geographically diverse US-based centres and a coordinating centre. Three centres conduct diabetes surveillance in youth aged 0-17 years only (component A), three centres conduct surveillance in young adults aged 18-44 years only (component B) and two centres conduct surveillance in components A and B. The network will assess the validity of computable phenotype definitions to determine diabetes status and type based on sensitivity, specificity, positive predictive value and negative predictive value of the phenotypes against the gold standard of manually abstracted medical charts. Prevalence and incidence rates will be presented as unadjusted estimates and as race/ethnicity, sex and age-adjusted estimates using Poisson regression. ETHICS AND DISSEMINATION: The DiCAYA Network is well positioned to advance diabetes surveillance methods. The network will disseminate EHR-based surveillance methodology that can be broadly adopted and will report diabetes prevalence and incidence for key demographic subgroups of youth and young adults in a large set of regions across the USA.

Trends in Neonatal Opioid Withdrawal Syndrome and Opioid Exposure Diagnoses Among Infants With Private Health Insurance, 2016-2021: Introduction of the P04.14 ICD-10-CM Code.

OBJECTIVE: The opioid epidemic has led to a surge in diagnoses of neonatal opioid withdrawal syndrome (NOWS). Many states track the incidence of NOWS by using the P96.1 International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code for "neonatal withdrawal symptoms from maternal use of drugs of addiction." In October 2018, an ICD-10-CM code for neonatal opioid exposure (P04.14) was introduced. This code can be used when an infant is exposed to opioids in utero but does not have clinically significant withdrawal symptoms. We analyzed the effect of the P04.14 code on the incidence rate of NOWS (P96.1) and "other" neonatal drug exposure diagnoses (P04.49). METHODS: We used private health insurance data collected for infants in the United States from the first quarter of 2016 through the third quarter of 2021 to describe incidence rates for each code over time and examine absolute and percentage changes before and after the introduction of code P04.14. RESULTS: The exclusive use of code P96.1 declined from an incidence rate per 1000 births of 1.08 in 2016-2018 to 0.70 in 2019-2021, a -35.7% (95% CI, -47.6% to -23.8%) reduction. Use of code P04.49 only declined from an incidence rate of 2.34 in 2016-2018 to 1.64 in 2019-2021, a -30.0% (95% CI, -36.4% to -23.7%) reduction. Use of multiple codes during the course of treatment increased from an average incidence per 1000 births of 0.56 in 2016-2018 to 0.79 in 2019-2021, a 45.5% (95% CI, 24.8%-66.1%) increase. CONCLUSION: The introduction of ICD-10-CM code P04.14 altered the use of other neonatal opioid exposure codes. The use of multiple codes increased, indicating that some ambiguity may exist about which ICD-10-CM code is most appropriate for a given set of symptoms.

HIV Care Continuum Among People Living With HIV and History of Arrest and Mental Health Diagnosis.

OBJECTIVE: Justice involvement and psychiatric comorbidities contribute to excess HIV morbidity, yet their interaction is poorly understood. We examined associations of this overlap with HIV outcomes among people living with HIV (PLWH). METHODS: We conducted a retrospective cohort study of PLWH aged 13 years and older residing in Marion County (Indianapolis), IN, during 2018 (n = 5730) using linked HIV surveillance, arrest, and clinical data. We used univariable and multivariable regression to evaluate main and interaction effects of 2010-2017 arrest and mental health diagnosis on 2018 linkage to care (LTC), retention in care (RIC), and undetectable viral load (UVL). RESULTS: LTC decreased among those with, versus without, an arrest (P = 0.02), although mental health diagnoses had no significant effect on LTC. When controlling for demographics and substance use disorder, analyses indicated a protective effect of arrest history on odds of RIC (adjusted odds ratio [aOR] = 1.54) and UVL (aOR = 1.26). Mental health diagnosis also increased odds of RIC (aOR = 2.02) and UVL (aOR = 1.95). Post hoc tests demonstrated that these results were mediated by outpatient care utilization, although an arrest or mental health diagnosis did increase odds of RIC among PLWH and a history of low outpatient utilization. CONCLUSIONS: Outpatient care utilization improves HIV outcomes, even among those with justice involvement and psychiatric comorbidities. Holistic approaches to care can increase utilization. Implementation of "no wrong door" approaches, such as integration of mental health care in the primary care setting, simplifies health care navigation and improves access. Among those arrested, access to a Behavioral Court program can improve, rather than disrupt, HIV care.

Patient family engagement and partnership: Pilot survey results in assessing behavior, communication, and quality of life in children with Lennox-Gastaut syndrome and other drug-resistant epilepsy.

OBJECTIVES: Lennox-Gastaut Syndrome (LGS) and other drug-resistant epilepsy (DRE) can impact behavior, communication, and quality of life (QoL). In collaboration with community engagement efforts with the Lennox-Gastaut Syndrome Foundation (LGSF), we aimed to gain an initial snapshot of patient and family perspectives and experiences with evaluation of behavior, communication, and QoL. METHODS: A cross-sectional survey was conducted to collect self-reported information from caregivers of children with LGS and other DRE regarding their perspectives and experiences with healthcare providers' evaluation of behavior, communication, and QoL. The survey tool was developed by the study investigators in partnership with the LGS Foundation and had diffused to caregivers online by epilepsy advocacy groups including the Pediatric Epilepsy Surgery Alliance (PESA). Responses were analyzed. Descriptive statistics were calculated. The survey asked for caregiver perspectives and assessed which instruments the caregivers had previously been given for measuring these domains. RESULTS: Responses from 245 caregivers were included, with 132 (54%) caregivers of an individual with LGS and 113 (46%) caregivers of an individual with non-LGS related DRE. Respondents reported that 66% of their loved ones had undergone epilepsy-related surgery. Over 90% agreed that measuring behavior, communication, and QoL was important, but fewer than half felt that their healthcare providers evaluated these domains well. LGS caregivers largely shared non-LGS caregivers' perspectives; however, they reported more frequently that communication was not evaluated enough. Barriers to measuring these domains included a lack of good surveys (developmentally appropriate and specific to the type of epilepsy) or not receiving any survey instruments for these domains during clinic appointments. Caregivers play a crucial role for individuals with DRE, and their input is essential in identifying challenges and needs. Caregivers believe that measuring behavior, communication, and quality of life is important, and most of them feel that their loved ones are not adequately evaluated during their healthcare encounters. There is a need for appropriately scaled survey instruments to measure areas of importance for patients and caregivers, as well as incorporation of these outcomes in the healthcare discussion.

The INGENIOUS trial: Impact of pharmacogenetic testing on adverse events in a pragmatic clinical trial.

Adverse drug events (ADEs) account for a significant mortality, morbidity, and cost burden. Pharmacogenetic testing has the potential to reduce ADEs and inefficacy. The objective of this INGENIOUS trial (NCT02297126) analysis was to determine whether conducting and reporting pharmacogenetic panel testing impacts ADE frequency. The trial was a pragmatic, randomized controlled clinical trial, adapted as a propensity matched analysis in individuals (N = 2612) receiving a new prescription for one or more of 26 pharmacogenetic-actionable drugs across a community safety-net and academic health system. The intervention was a pharmacogenetic testing panel for 26 drugs with dosage and selection recommendations returned to the health record. The primary outcome was occurrence of ADEs within 1 year, according to modified Common Terminology Criteria for Adverse Events (CTCAE). In the propensity-matched analysis, 16.1% of individuals experienced any ADE within 1-year. Serious ADEs (CTCAE level ≥ 3) occurred in 3.2% of individuals. When combining all 26 drugs, no significant difference was observed between the pharmacogenetic testing and control arms for any ADE (Odds ratio 0.96, 95% CI: 0.78-1.18), serious ADEs (OR: 0.91, 95% CI: 0.58-1.40), or mortality (OR: 0.60, 95% CI: 0.28-1.21). However, sub-group analyses revealed a reduction in serious ADEs and death in individuals who underwent pharmacogenotyping for aripiprazole and serotonin or serotonin-norepinephrine reuptake inhibitors (OR 0.34, 95% CI: 0.12-0.85). In conclusion, no change in overall ADEs was observed after pharmacogenetic testing. However, limitations incurred during INGENIOUS likely affected the results. Future studies may consider preemptive, rather than reactive, pharmacogenetic panel testing.

Cardiovascular health trajectories from age 2-12: a pediatric electronic health record study.

PURPOSE: Many children have non-ideal cardiovascular health (CVH), but little is known about the course of CVH in early childhood. We identified CVH trajectories in children and assess the generalizability of these trajectories in an external sample. METHODS: We used data spanning 2010-2018 from children aged 2-12 years within the Chicago Area Patient-Centered Outcomes Research Network-an electronic health record network. Four clinical systems comprised the derivation sample and a fifth the validation sample. Body mass index, blood pressure, cholesterol, and blood glucose were categorized as ideal, intermediate, and poor using clinical measurements, laboratory readings, and International Classification of Diseases diagnosis codes and summed for an overall CVH score. Group-based trajectory modeling was used to create CVH score trajectories which were assessed for classification accuracy in the validation sample. RESULTS: Using data from 122,363 children (47% female, 47% non-Hispanic White) three trajectories were identified: 59.5% maintained high levels of clinical CVH, 23.4% had high levels of CVH that declined, and 17.1% had intermediate levels of CVH that further declined with age. A similar classification emerged when the trajectories were fitted in the validation sample. CONCLUSIONS: Stratification of CVH was present by age 2, implicating the need for early life and preconception prevention strategies.

Evolving availability and standardization of patient attributes for matching.

Variation in availability, format, and standardization of patient attributes across health care organizations impacts patient-matching performance. We report on the changing nature of patient-matching features available from 2010-2020 across diverse care settings. We asked 38 health care provider organizations about their current patient attribute data-collection practices. All sites collected name, date of birth (DOB), address, and phone number. Name, DOB, current address, social security number (SSN), sex, and phone number were most commonly used for cross-provider patient matching. Electronic health record queries for a subset of 20 participating sites revealed that DOB, first name, last name, city, and postal codes were highly available (>90%) across health care organizations and time. SSN declined slightly in the last years of the study period. Birth sex, gender identity, language, country full name, country abbreviation, health insurance number, ethnicity, cell phone number, email address, and weight increased over 50% from 2010 to 2020. Understanding the wide variation in available patient attributes across care settings in the United States can guide selection and standardization efforts for improved patient matching in the United States.

Informatics in Undergraduate Medical Education: Analysis of Competency Frameworks and Practices Across North America.

BACKGROUND: With the advent of competency-based medical education, as well as Canadian efforts to include clinical informatics within undergraduate medical education, competency frameworks in the United States have not emphasized the skills associated with clinical informatics pertinent to the broader practice of medicine. OBJECTIVE: By examining the competency frameworks with which undergraduate medical education in clinical informatics has been developed in Canada and the United States, we hypothesized that there is a gap: the lack of a unified competency set and frame for clinical informatics education across North America. METHODS: We performed directional competency mapping between Canadian and American graduate clinical informatics competencies and general graduate medical education competencies. Directional competency mapping was performed between Canadian roles and American common program requirements using keyword matching at the subcompetency and enabling competency levels. In addition, for general graduate medical education competencies, the Physician Competency Reference Set developed for the Liaison Committee on Medical Education was used as a direct means of computing the ontological overlap between competency frameworks. RESULTS: Upon mapping Canadian roles to American competencies via both undergraduate and graduate medical education competency frameworks, the difference in focus between the 2 countries can be thematically described as a difference between the concepts of clinical and management reasoning. CONCLUSIONS: We suggest that the development or deployment of informatics competencies in undergraduate medical education should focus on 3 items: the teaching of diagnostic reasoning, such that the information tasks that comprise both clinical and management reasoning can be discussed; precision medical education, where informatics can provide for more fine-grained evaluation; and assessment methods to support traditional pedagogical efforts (both at the bedside and beyond). Assessment using cases or structured assessments (eg, Objective Structured Clinical Examinations) would help students draw parallels between clinical informatics and fundamental clinical subjects and would better emphasize the cognitive techniques taught through informatics.

Implementing a pragmatic clinical trial to tailor opioids for acute pain on behalf of the IGNITE ADOPT PGx investigators.

Opioid prescribing for postoperative pain management is challenging because of inter-patient variability in opioid response and concern about opioid addiction. Tramadol, hydrocodone, and codeine depend on the cytochrome P450 2D6 (CYP2D6) enzyme for formation of highly potent metabolites. Individuals with reduced or absent CYP2D6 activity (i.e., intermediate metabolizers [IMs] or poor metabolizers [PMs], respectively) have lower concentrations of potent opioid metabolites and potentially inadequate pain control. The primary objective of this prospective, multicenter, randomized pragmatic trial is to determine the effect of postoperative CYP2D6-guided opioid prescribing on pain control and opioid usage. Up to 2020 participants, age ≥8 years, scheduled to undergo a surgical procedure will be enrolled and randomized to immediate pharmacogenetic testing with clinical decision support (CDS) for CYP2D6 phenotype-guided postoperative pain management (intervention arm) or delayed testing without CDS (control arm). CDS is provided through medical record alerts and/or a pharmacist consult note. For IMs and PM in the intervention arm, CDS includes recommendations to avoid hydrocodone, tramadol, and codeine. Patient-reported pain-related outcomes are collected 10 days and 1, 3, and 6 months after surgery. The primary outcome, a composite of pain intensity and opioid usage at 10 days postsurgery, will be compared in the subgroup of IMs and PMs in the intervention (n = 152) versus the control (n = 152) arm. Secondary end points include prescription pain medication misuse scores and opioid persistence at 6 months. This trial will provide data on the clinical utility of CYP2D6 phenotype-guided opioid selection for improving postoperative pain control and reducing opioid-related risks.

Mental Health Emergency Department Visits by Children Before and During the COVID-19 Pandemic.

OBJECTIVES: To describe pediatric mental health emergency department (ED) visit rates and visit characteristics before and during the COVID-19 pandemic. METHODS: We conducted a cross-sectional study of ED visits by children 5-17 years old with a primary mental health diagnosis from March 2018 to February 2021 at a 10-hospital health system and a children's hospital in the Chicago area. We compared demographic and clinical characteristics of children with mental health ED visits before and during the pandemic. We conducted an interrupted time series analysis to determine changes in visit rates. RESULTS: We identified 8,127 pediatric mental health ED visits (58.5% female, 54.3% White, Not Hispanic/Latino and 42.4% age 13-15). During the pandemic, visits for suicide or self-injury increased 6.69% (95% CI 4.73, 8.65), and visits for disruptive, impulse control, conduct disorders increased 1.94% (95% CI 0.85, 3.03). Mental health ED visits by children with existing mental health diagnoses increased 2.29% (95% CI 0.34, 4.25). Mental health ED visits that resulted in medical admission increased 4.32% (95% CI 3.11, 5.53). The proportion of mental health ED visits at community hospitals increased by 5.49% (95% CI 3.31, 7.67). Mental health ED visit rates increased at the onset of the pandemic (adjusted incidence rate ratio [aIRR] 1.27, 95% CI 1.06, 1.50), followed by a monthly increase thereafter (aIRR 1.04, 95% CI 1.02, 1.06). CONCLUSION: Mental health ED visit rates by children increased during the COVID-19 pandemic. Changes in mental health ED visit characteristics during the pandemic may inform interventions to improve children's mental health.

Design and rationale of GUARDD-US: A pragmatic, randomized trial of genetic testing for APOL1 and pharmacogenomic predictors of antihypertensive efficacy in patients with hypertension.

RATIONALE AND OBJECTIVE: APOL1 risk alleles are associated with increased cardiovascular and chronic kidney disease (CKD) risk. It is unknown whether knowledge of APOL1 risk status motivates patients and providers to attain recommended blood pressure (BP) targets to reduce cardiovascular disease. STUDY DESIGN: Multicenter, pragmatic, randomized controlled clinical trial. SETTING AND PARTICIPANTS: 6650 individuals with African ancestry and hypertension from 13 health systems. INTERVENTION: APOL1 genotyping with clinical decision support (CDS) results are returned to participants and providers immediately (intervention) or at 6 months (control). A subset of participants are re-randomized to pharmacogenomic testing for relevant antihypertensive medications (pharmacogenomic sub-study). CDS alerts encourage appropriate CKD screening and antihypertensive agent use. OUTCOMES: Blood pressure and surveys are assessed at baseline, 3 and 6 months. The primary outcome is change in systolic BP from enrollment to 3 months in individuals with two APOL1 risk alleles. Secondary outcomes include new diagnoses of CKD, systolic blood pressure at 6 months, diastolic BP, and survey results. The pharmacogenomic sub-study will evaluate the relationship of pharmacogenomic genotype and change in systolic BP between baseline and 3 months. RESULTS: To date, the trial has enrolled 3423 participants. CONCLUSIONS: The effect of patient and provider knowledge of APOL1 genotype on systolic blood pressure has not been well-studied. GUARDD-US addresses whether blood pressure improves when patients and providers have this information. GUARDD-US provides a CDS framework for primary care and specialty clinics to incorporate APOL1 genetic risk and pharmacogenomic prescribing in the electronic health record. TRIAL REGISTRATION: ClinicalTrials.govNCT04191824.

Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases.

The literature thoroughly describes the challenges of pediatric drug development for rare diseases. This includes (1) generating interest from sponsors, (2) small numbers of children affected by a particular disease, (3) difficulties with study design, (4) lack of definitive outcome measures and assessment tools, (5) the need for additional safeguards for children as a vulnerable population, and (6) logistical hurdles to completing trials, especially with the need for longer term follow-up to establish safety and efficacy. There has also been an increasing awareness of the need to engage patients and their families in drug development processes and to address inequities in access to pediatric clinical trials. The year 2020 ushered in yet another challenge-the COVID-19 pandemic. The pediatric drug development ecosystem continues to evolve to meet these challenges. This article will focus on several key factors including recent regulatory approaches and public health policies to facilitate pediatric rare disease drug development, emerging trends in product development (biologics, molecularly targeted therapies), innovations in trial design/endpoints and data collection, and current efforts to increase patient engagement and promote equity. Finally, lessons learned from COVID-19 about building adaptable pediatric rare disease drug development processes will be discussed.

Clinical Opportunities for Germline Pharmacogenetics and Management of Drug-Drug Interactions in Patients With Advanced Solid Cancers.

PURPOSE: Precision medicine approaches, including germline pharmacogenetics (PGx) and management of drug-drug interactions (DDIs), are likely to benefit patients with advanced cancer who are frequently prescribed multiple concomitant medications to treat cancer and associated conditions. Our objective was to assess the potential opportunities for PGx and DDI management within a cohort of adults with advanced cancer. METHODS: Medication data were collected from the electronic health records for 481 subjects since their first cancer diagnosis. All subjects were genotyped for variants with clinically actionable recommendations in Clinical Pharmacogenetics Implementation Consortium guidelines for 13 pharmacogenes. DDIs were defined as concomitant prescription of strong inhibitors or inducers with sensitive substrates of the same drug-metabolizing enzyme and were assessed for six major cytochrome P450 (CYP) enzymes. RESULTS: Approximately 60% of subjects were prescribed at least one medication with Clinical Pharmacogenetics Implementation Consortium recommendations, and approximately 14% of subjects had an instance for actionable PGx, defined as a prescription for a drug in a subject with an actionable genotype. The overall subject-level prevalence of DDIs and serious DDIs were 50.3% and 34.8%, respectively. Serious DDIs were most common for CYP3A, CYP2D6, and CYP2C19, occurring in 24.9%, 16.8%, and 11.7% of subjects, respectively. When assessing PGx and DDIs together, approximately 40% of subjects had at least one opportunity for a precision medicine-based intervention and approximately 98% of subjects had an actionable phenotype for at least one CYP enzyme. CONCLUSION: Our findings demonstrate numerous clinical opportunities for germline PGx and DDI management in adults with advanced cancer.

Antibiotics prior to age 2 years have limited association with preschool growth trajectory.

BACKGROUND: Prior studies of early antibiotic use and growth have shown mixed results, primarily on cross-sectional outcomes. This study examined the effect of oral antibiotics before age 24 months on growth trajectory at age 2-5 years. METHODS: We captured oral antibiotic prescriptions and anthropometrics from electronic health records through PCORnet, for children with ≥1 height and weight at 0-12 months of age, ≥1 at 12-30 months, and ≥2 between 25 and 72 months. Prescriptions were grouped into episodes by time and by antimicrobial spectrum. Longitudinal rate regression was used to assess differences in growth rate from 25 to 72 months of age. Models were adjusted for sex, race/ethnicity, steroid use, diagnosed asthma, complex chronic conditions, and infections. RESULTS: 430,376 children from 29 health U.S. systems were included, with 58% receiving antibiotics before 24 months. Exposure to any antibiotic was associated with an average 0.7% (95% CI 0.5, 0.9, p < 0.0001) greater rate of weight gain, corresponding to 0.05 kg additional weight. The estimated effect was slightly greater for narrow-spectrum (0.8% [0.6, 1.1]) than broad-spectrum (0.6% [0.3, 0.8], p < 0.0001) drugs. There was a small dose response relationship between the number of antibiotic episodes and weight gain. CONCLUSION: Oral antibiotic use prior to 24 months of age was associated with very small changes in average growth rate at ages 2-5 years. The small effect size is unlikely to affect individual prescribing decisions, though it may reflect a biologic effect that can combine with others.

Association of QT interval-prolonging drugs with clinical trial eligibility in patients with advanced cancer.

Introduction: Drug-induced prolongation of the heart rate-corrected QT interval (QTc) is associated with increased risk for the potentially fatal arrhythmia torsades de pointes. Due to arrhythmia risk, clinical trials with cancer therapeutics often exclude patients based on thresholds for QTc prolongation. Our objective was to assess associations between prescriptions for QT-prolonging drugs and the odds of meeting cancer trial exclusionary QTc thresholds in a cohort of adults with advanced cancer. Methods: Electronic health records were retrospectively reviewed for 271 patients seen at our institutional molecular solid tumor clinic. Collected data included demographics, QTc measurements, ventricular arrhythmia-related diagnoses, and all inpatient and outpatient prescriptions. Potential associations were assessed between demographic and clinical variables, including prescriptions for QT-prolonging drugs, and QTc measurements. Results: Women had longer median QTc measurements than men (p = 0.030) and were prescribed more QT-prolonging drugs during the study (p = 0.010). In all patients, prescriptions for QT-prolonging drugs were associated with longer median and maximum QTc measurements at multiple assessed time points (i.e., for QT-prolonging drugs prescribed within 10, 30, 60, and 90 days of QTc measurements). Similarly, the number of QT-prolonging drugs prescribed was correlated with longer median and maximum QTc measurements at multiple time points. Common QTc-related exclusionary criteria were collected from a review of ClinicalTrials.gov for recent cancer clinical trials. Based on common exclusion criteria, prescriptions for QT-prolonging drugs increased the odds of trial exclusion. Conclusion: This study demonstrates that prescriptions for QT-prolonging drugs were associated with longer QTc measurements and increased odds of being excluded from cancer clinical trials.

Electronic Health Record Network Research in Infectious Diseases.

With the marked increases in electronic health record (EHR) use for providing clinical care, there have been parallel efforts to leverage EHR data for research. EHR repositories offer the promise of vast amounts of clinical data not easily captured with traditional research methods and facilitate clinical epidemiology and comparative effectiveness research, including analyses to identify patients at higher risk for complications or who are better candidates for treatment. These types of studies have been relatively slow to penetrate the field of infectious diseases, but the need for rapid turnaround during the COVID-19 global pandemic has accelerated the uptake. This review discusses the rationale for her network projects, opportunities and challenges that such networks present, and some prior studies within the field of infectious diseases.

Identifying nonfatal firearm assault incidents through linking police data and clinical records: Cohort study in Indianapolis, Indiana, 2007-2016.

Nonfatal firearm assault incidents are more prevalent than gun homicides, however, little is understood about nonfatal firearm assault incidents due to a lack of accurate data in the United States. This is a descriptive study of all nonfatal firearm assault incidents identified through police and clinical records from 2007 to 2016 in Indianapolis, Indiana. Records were linked at the incident level to demonstrate the overlap and non-overlap of nonfatal firearm assault incidents in police and clinical records and describe differences in demographic characteristics of the victims. Incidents were matched within a 24-h time window of the recorded date of the police incident. Data were analyzed in fall 2020. There were 3797 nonfatal firearm assault incidents identified in police reports and 3131 clinical encounters with an ICD 9/10 diagnosis-based nonfatal firearm-related injury. 62% (n = 2366) of nonfatal firearm assault incidents matched within 24 h to a clinical encounter, 81% (n = 1905) had a firearm related ICD code: 40% (n = 947) were coded as a firearm-related assault, 32% (n = 754) were coded as a firearm-related accident; and 8.6% (n = 198) were coded as undetermined, self-inflicted or law enforcement firearm-related. The other 20% (n = 461) did not have an ICD firearm related diagnosis code. Results indicate most nonfatal firearm assault incidents overlap between police and clinical records systems, however, discrepancies between the systems exist. These findings also demonstrate an undercounting of nonfatal firearm assault incidents when relying on clinical data systems alone and more efforts are needed to link administrative police and clinical data in the study of nonfatal firearm assaults.

Two-year prevalence rates of mental health and substance use disorder diagnoses among repeat arrestees.

BACKGROUND: Individuals with mental illness and co-occurring substance use disorders often rapidly cycle through the justice system with multiple arrests. Therefore, is it imperative to examine the prevalence of mental health and substance use diagnoses among arrestees and repeat arrestees to identify opportunities for intervention. METHODS: We linked police arrest and clinical care data at the individual level to conduct a retrospective cohort study of all individuals arrested in 2016 in Indianapolis, Indiana. We classified arrestees into three levels: 1 arrest, 2 arrests, or 3 or more arrests. We included data on clinical diagnoses between January 1, 2014 and December 31, 2015 and classified mental health diagnoses and substance use disorder (SUD) based on DSM categories using ICD9/10 diagnoses codes. RESULTS: Of those arrested in 2016, 18,236 (79.5%) were arrested once, 3167 (13.8%) were arrested twice, and 1536 (6.7%) were arrested three or more times. In the 2 years before the arrest, nearly one-third (31.3%) of arrestees had a mental health diagnosis, and over a quarter (27.7%) of arrestees had an SUD diagnosis. Most of those with a mental health or SUD diagnosis had both (22.5% of all arrestees). Arrestees with multiple mental health (OR 2.68, 95% CI 2.23, 3.23), SUD diagnoses (OR 1.59, 95% CI 1.38, 1,82), or co-occurring conditions (1.72, 95% CI 1.48, 2.01) in the preceding 2 years had higher odds of repeat arrest. CONCLUSIONS: Our findings show that linked clinical and criminal justice data systems identify individuals at risk of repeat arrest and inform opportunities for interventions aimed at low-level offenders with behavioral health needs.

Opportunity for Genotype-Guided Prescribing Among Adult Patients in 11 US Health Systems.

The value of utilizing a multigene pharmacogenetic panel to tailor pharmacotherapy is contingent on the prevalence of prescribed medications with an actionable pharmacogenetic association. The Clinical Pharmacogenetics Implementation Consortium (CPIC) has categorized over 35 gene-drug pairs as "level A," for which there is sufficiently strong evidence to recommend that genetic information be used to guide drug prescribing. The opportunity to use genetic information to tailor pharmacotherapy among adult patients was determined by elucidating the exposure to CPIC level A drugs among 11 Implementing Genomics In Practice Network (IGNITE)-affiliated health systems across the US. Inpatient and/or outpatient electronic-prescribing data were collected between January 1, 2011 and December 31, 2016 for patients ≥ 18 years of age who had at least one medical encounter that was eligible for drug prescribing in a calendar year. A median of ~ 7.2 million adult patients was available for assessment of drug prescribing per year. From 2011 to 2016, the annual estimated prevalence of exposure to at least one CPIC level A drug prescribed to unique patients ranged between 15,719 (95% confidence interval (CI): 15,658-15,781) in 2011 to 17,335 (CI: 17,283-17,386) in 2016 per 100,000 patients. The estimated annual exposure to at least 2 drugs was above 7,200 per 100,000 patients in most years of the study, reaching an apex of 7,660 (CI: 7,632-7,687) per 100,000 patients in 2014. An estimated 4,748 per 100,000 prescribing events were potentially eligible for a genotype-guided intervention. Results from this study show that a significant portion of adults treated at medical institutions across the United States is exposed to medications for which genetic information, if available, should be used to guide prescribing.