Health Record Data Of Patients Research Articles

Treatment characteristics of patients with hereditary transthyretin amyloidosis: a cohort study

BackgroundThere are novel medications approved for the treatment of hereditary transthyretin amyloidosis (ATTRv), classified as transthyretin (TTR) stabilizers or gene silencers. While many patients may be on both classes of medications, there is no data available on the safety and efficacy of combination therapy.ObjectivesTo describe ATTRv patient and TTR-targeted therapy characteristics in a US cohort, and compare outcomes with combination therapy versus monotherapy.MethodsWe performed a retrospective cohort study with electronic health record data of patients with ATTRv seen at a single institution between January 2018 and December 2022. We collected data on symptomatology, gene mutation, disease severity, ATTRv treatment, hospitalizations, and mortality.ResultsOne hundred sixty-two patients with ATTRv were identified. The average age at diagnosis was 65 years. 86 patients (53%) had the V122I variant. 119 patients were symptomatic, of whom 103 were started on ATTRv-specific treatment. 41 patients (40%) had cardiomyopathy only, and 53 (51%) had a mixed phenotype of cardiomyopathy and neuropathy. 38 patients (37%) received therapy with both a gene silencer and protein stabilizer. 9 patients (15%) in the monotherapy group had two or more cardiac hospitalizations after starting treatment, compared to 3 patients (9%) on combination therapy (p=0.26). The adjusted hazard ratio of all-cause mortality for the patients on combination therapy compared to monotherapy was 0.37 (0.08-1.8, p=0.21).ConclusionsWhile the efficacy is unproven, over one-third of patients with ATTRv are on both a stabilizer and a silencer. There were no safety issues for combination therapy. There was a trend towards improved hospitalizations and survival in patients in the combination group but this was not statistically significant. Larger studies with longer follow-up are necessary to determine benefit of combination therapy.

Screening for Unhealthy Alcohol Use Among Patients With Multiple Chronic Conditions in Primary Care

IntroductionUnhealthy alcohol use (UAU) increases risk for and exacerbation of chronic health conditions. As such, screening, prevention, and management of UAU is especially critical to improving health outcomes for patients with multiple physical or mental chronic health conditions (MCC). It is unclear to what extent multiple chronic condition (MCC) status is a barrier to screening for UAU in the primary care setting. We hypothesized that patients with MCC would be at lower odds of being screened for UAU compared with patients with no MCC. MethodsWe performed a secondary analysis of electronic health record data for patients from 67 primary care practices in Virginia (2020-2023). Using the Center for Medicare and Medicaid Services’ chronic disease framework, we classified patients by MCC status: no MCC, physical MCC (P-MCC), mental health MCC (MH-MCC), and physical & mental health MCC (P&MH-MCC). We used multiple logistic regressions with an added practice-level random effect to analyze the relationship between MCC status and odds of receiving an alcohol-related assessment, of being screened for UAU with a U.S. Preventive Services Task Force (USPSTF)-recommended instrument, and of screening positive for UAU within the past 2 years. ResultsWithin a final cohort of n= 11,789, a total of 6796 patients (58%) had MCC (29% P-MCC, 4% MH-MCC, and 25% P&MH-MCC). In all, 69% of patients were screened for UAU, while 16% were screened with a USPSTF-recommended instrument and 7% screened positive for UAU. Relative to those with no MCC, patients with P&MH-MCC had 0.9 times lower odds of receiving any screening for UAU [95% CI: (0.8, 1.0), p = 0.0240], while patients with only P-MCC or only MH-MCC had similar odds. There was no difference in odds of being screened with a USPSTF-recommended instrument based on MCC status. Patients with MH-MCC and P&MH-MCC had 1.8 and 1.5 times greater odds, respectively, of screening positive for UAU [95% CI: (1.3, 2.7), p= 0.0014) and 95% CI: (1.2, 1.8), p=0.0003)]. ConclusionAlthough patients with chronic mental health conditions were more likely to screen positive for UAU than patients without MCC, Virginia primary care patients with P&MH MCC were less likely to receive an alcohol-related assessment during the past 2 years. Given the overall modest rate of screening with a USPSTF-recommended instrument, further efforts are needed to create the conditions for high quality alcohol-related preventive service delivery in primary care, particularly for patients with high complexity and/or mental health conditions.

An Algorithm to Assess Guideline Concordance of Antibiotic Choice in Community-Acquired Pneumonia.

This study aimed to develop and evaluate an algorithm to reduce the chart review burden of improvement efforts by automatically labeling antibiotic selection as either guideline-concordant or -discordant based on electronic health record data for patients with community-acquired pneumonia (CAP). We developed a 3-part algorithm using structured and unstructured data to assess adherence to an institutional CAP clinical practice guideline. The algorithm was applied to retrospective data for patients seen with CAP from 2017 to 2019 at a tertiary children's hospital. Performance metrics included positive predictive value (precision), sensitivity (recall), and F1 score (harmonized mean), with macro-weighted averages. Two physician reviewers independently assigned "actual" labels based on manual chart review. Of 1345 patients with CAP, 893 were included in the training cohort and 452 in the validation cohort. Overall, the model correctly labeled 435 of 452 (96%) patients. Of the 286 patients who met guideline inclusion criteria, 193 (68%) were labeled as having received guideline-concordant antibiotics, 48 (17%) were labeled as likely in a scenario in which deviation from the clinical practice guideline was appropriate, and 45 (16%) were given the final label of "possibly discordant, needs review." The sensitivity was 0.96, the positive predictive value was 0.97, and the F1 was 0.96. An automated algorithm that uses structured and unstructured electronic health record data can accurately assess the guideline concordance of antibiotic selection for CAP. This tool has the potential to improve the efficiency of improvement efforts by reducing the manual chart review needed for quality measurement.

Abstract A131: Clinical characteristics and outcomes of Black patients with multiple myeloma compared with other races

Abstract Introduction: Black patients with multiple myeloma (MM) in the US have a greater incidence rate, inferior survival, and younger onset of MM vs other races. This analysis evaluated differences in clinical characteristics between Black patients compared with other races with MM to determine the impact on survival outcomes. Methods: Data were retrospectively collected from the ConcertAI Patient360 database containing aggregated electronic health record data of patients treated in US-based oncology centers. Adult patients diagnosed with MM (2011–2022) who received ≥1 line of systemic therapy and had ≥3-month follow up were included. Patients were stratified by race (Black vs other [American Indian/Alaska Native, Asian, Native Hawaiian/other Pacific Islander, White, and other/unknown]). Baseline characteristics were compared between races using Chi-squared tests. Outcomes included first-line (1L), overall survival (OS), and progression-free survival (PFS), estimated by Kaplan-Meier. The impact of race and characteristics on outcomes was evaluated with Cox proportional hazards models. Results: Black patients (n=806) vs other races (n=3164), were younger (63.3 vs 67.4 years, p<0.001) with greater prevalence of concurrent cancer (13.3% vs 10.6%, p=0.027) at time of diagnosis, and higher baseline mean Charlson Comorbidity Index (CCI) score (0.48 vs 0.39, p=0.047). Black patients vs other races more frequently had diabetes without complications (14.8% vs 10.3%, p<0.001), renal disease (3.7% vs 1.7%, p<0.001), and AIDS/HIV (1.4% vs 0.1%, p<0.001), and 1L therapy regimen use (p=0.56) did not differ between races. The proportion progressing to 3L was 20.5% vs 19.2% among Black vs other races. Among overall patients, median (95% CI) 1L OS and PFS in months was similar between Black patients and other races (OS: 129 [109, 167] vs 133 [122, 157]; PFS: 39.5 [35.0, 45.3] vs 38.1 [36.2, 40.5]). Survival outcomes did not differ between races before (Hazard ratio [HR] [95% CI]; OS: 0.97 [0.84, 1.11]; PFS: 0.91 [0.82, 1.01]) or after adjusting for patient characteristics (OS: 1.13 [0.97, 1.31]; PFS: 1.0 [0.89, 1.12]). Characteristics impacting outcomes regardless of race included age (50–64 vs <50 years; OS: 1.48 [1.13, 1.95]); PFS: 1.32 (1.11, 1.57), CCI score (OS: 1.15 [1.10, 1.20]; PFS: 1.06 [1.02, 1.10]), and ECOG score 2–4 vs 0–1 (OS: 1.76 [1.08, 1.37]; PFS: 1.52 [1.35, 1.71]; p<0.01). Conclusions: Although 1L survival outcomes were similar between races, Black patients were younger at diagnosis with more comorbidities. Since improved survival outcomes were associated with younger age, fewer comorbidities and lower ECOG score, prompt diagnosis and care are needed. Funding: Financial support for the study was provided by AbbVie. AbbVie and Genentech participated in interpretation of data, review, and approval of the abstract. All authors contributed to development of the abstract and maintained control over final content. No honoraria or payments were made for authorship. Citation Format: Shelli Spence, Junhua Yu, Allicia Girvan, Sophia Ng, Sophia Li, Faiza Zafar, Archibong Yellow-Duke, R. Frank Cornell. Clinical characteristics and outcomes of Black patients with multiple myeloma compared with other races [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A131.

Real-World Progression-Free Survival and Treatment Patterns for t(11;14) Positive Patients with Multiple Myeloma with at Least 2 Prior Lines of Treatment

Background : Multiple myeloma (MM) is a subclonal disease characterized by large heterogeneity with a complex treatment landscape. Patients with MM have a myriad of available treatment options, prescribed based on several factors, including genetic testing, comorbidities, risk status, age, patient preference, and/or prior treatment failures. Cytogenetic abnormalities determines risk stratification and prognosis. The prognostic significance of t(11;14)-positivity has been debated and it is currently considered a standard-risk abnormality; however, testing for t(11;14) may be of potential therapeutic significance. Despite recent advances in treatment that have improved response rates and survival, MM remains incurable. This results in a continuous treat-to-failure approach that eventually leads to a lack of effective therapeutic options. Treatment patterns and outcomes for patients by lines of therapy (LOT) in real-world settings provide important benchmarks for assessments of future targeted therapies. Methods : Data were retrospectively collected from the ConcertAI Patient360 database containing aggregated electronic health record data of patients treated in primarily community-based oncology centers in the US. Adults diagnosed with MM (2011-2022) who received a National Comprehensive Cancer Network-guideline recommended treatment and had ≥2-months follow up were included; this analysis focused on patients with relapsed or refractory (RR) MM who are t(11;14)-positive and received ≥2 prior lines of systemic therapy. Baseline characteristics were determined for the third-line plus (3L+) subgroup of patients with t(11;14) RRMM. Real-world progression-free survival (PFS) and overall survival (OS) were estimated by the Kaplan-Meier method. Results were stratified by the use of doublet or triplet regimens, in which patients were treated with 2 or 3 classes of treatments among 6 options (ie, proteasome inhibitors [PI], immunomodulatory imide drugs [IMID], anti-CD38 monoclonal antibodies, chemotherapy, BCL-2 inhibitors, exportin-1 inhibitors, or steroid therapy), respectively, at any time during the LOT. Results : Eighty-four patients with t(11;14) RRMM received 3L+ of therapy. Of patients, 43% were female, 20% were Black, and 75% were White. The median (range) age at diagnosis was 64 (37-84), and the median (range) follow-up since diagnosis was 76 (10-209) months. At 24 months since the initiation of treatment, the median (range) PFS for all t(11;14)-positive patients that received 3L+ of therapy was 7.5 (5.9-9.4) months, and the median (range) PFS rate was 14.8% (9.7%-22.5%) (Figure); the median (range) OS for all t(11;14)-positive patients that received 3L+ of therapy was 32.1 (25.4-48.0) months, and the median (range) OS rate was 58.3% (51.0%-66.6%). The most common treatment regimens used in 3L+ included Daratumumab + Pomalidomide ± Dexamethasone (12%), Venetoclax monotherapy (9%), Pomalidomide ± Dexamethasone (7%), and Bortezomib ± Dexamethasone (7%). Of doublet regimens used in 3L+ (n = 69 LOT), 18 (26%) were IMID + steroid, 14 (20%) were PI + steroid, and 11 (16%) monoclonal antibody (MA)+ steroid. For triplet regimens used at 3L+ (n = 97 LOT), 28 (29%) were IMID + MA + steroid, 23 (24%) were IMID + PI + steroid, and 12 (12%) were MA + PI + steroid. Triplet regimen use increased from 52% in 3L to 61% in 4L and was associated with slightly longer PFS in 3L, relative to doublet regimen use. For patients that received 3L+ therapies, the median (95% CI) PFS was 6.7 (5.4-11.1) months for patients receiving doublet regimens, and 7.7 (5.9-11.3) months for patients receiving triplet regimens. Conclusions: Triplet regimens were more commonly used than doublet regimens as 3L+ therapy. Triplets were also associated with slightly longer PFS in 3L; however, PFS rates were low and did not translate into longer OS, suggesting an unmet need for novel therapeutic options for patients with t(11;14) RRMM.

Temporal Generalizability of Machine Learning Models for Predicting Postoperative Delirium Using Electronic Health Record Data: Model Development and Validation Study.

Although machine learning models demonstrate significant potential in predicting postoperative delirium, the advantages of their implementation in real-world settings remain unclear and require a comparison with conventional models in practical applications. The objective of this study was to validate the temporal generalizability of decision tree ensemble and sparse linear regression models for predicting delirium after surgery compared with that of the traditional logistic regression model. The health record data of patients hospitalized at an advanced emergency and critical care medical center in Kumamoto, Japan, were collected electronically. We developed a decision tree ensemble model using extreme gradient boosting (XGBoost) and a sparse linear regression model using least absolute shrinkage and selection operator (LASSO) regression. To evaluate the predictive performance of the model, we used the area under the receiver operating characteristic curve (AUROC) and the Matthews correlation coefficient (MCC) to measure discrimination and the slope and intercept of the regression between predicted and observed probabilities to measure calibration. The Brier score was evaluated as an overall performance metric. We included 11,863 consecutive patients who underwent surgery with general anesthesia between December 2017 and February 2022. The patients were divided into a derivation cohort before the COVID-19 pandemic and a validation cohort during the COVID-19 pandemic. Postoperative delirium was diagnosed according to the confusion assessment method. A total of 6497 patients (68.5, SD 14.4 years, women n=2627, 40.4%) were included in the derivation cohort, and 5366 patients (67.8, SD 14.6 years, women n=2105, 39.2%) were included in the validation cohort. Regarding discrimination, the XGBoost model (AUROC 0.87-0.90 and MCC 0.34-0.44) did not significantly outperform the LASSO model (AUROC 0.86-0.89 and MCC 0.34-0.41). The logistic regression model (AUROC 0.84-0.88, MCC 0.33-0.40, slope 1.01-1.19, intercept -0.16 to 0.06, and Brier score 0.06-0.07), with 8 predictors (age, intensive care unit, neurosurgery, emergency admission, anesthesia time, BMI, blood loss during surgery, and use of an ambulance) achieved good predictive performance. The XGBoost model did not significantly outperform the LASSO model in predicting postoperative delirium. Furthermore, a parsimonious logistic model with a few important predictors achieved comparable performance to machine learning models in predicting postoperative delirium.

Using Electronic Health Record Data to Measure the Latent Tuberculosis Infection Care Cascade in Safety-Net Primary Care Clinics

Prevention of tuberculosis disease through diagnosis and treatment of latent tuberculosis infection is critical for achieving tuberculosis elimination in the U.S. Diagnosis and treatment of latent tuberculosis infection in safety-net primary care settings that serve patients at risk for tuberculosis may increase uptake of this prevention effort and accelerate progress toward elimination. Optimizing tuberculosis prevention in these settings requires measuring the latent tuberculosis infection care cascade (testing, diagnosis, and treatment) and identifying gaps to develop solutions to overcome barriers. We used electronic health record data to describe the latent tuberculosis infection care cascade and identify gaps among a network of safety-net primary care clinics. Electronic health record data for patients seen in the OCHIN Clinical Network, the largest network of safety-net clinics in the U.S., between 2012 and 2019 were extracted. electronic health record data were used to measure the latent tuberculosis infection care cascade: patients who met tuberculosis screening criteria on the basis of current recommendations were tested for tuberculosis infection, diagnosed with latent tuberculosis infection, and prescribed treatment for latent tuberculosis infection. Outcomes were stratified by diagnostic test and treatment regimen. Among 1.9 million patients in the analytic cohort, 43.5% met tuberculosis screening criteria, but only 21.4% were tested for latent tuberculosis infection; less than half (40.4%) were tested using an interferon-gamma release assay. Among those with a valid result, 10.5% were diagnosed with latent tuberculosis infection, 29.1% of those were prescribed latent tuberculosis infection treatment, and only 33.6% were prescribed a recommended rifamycin-based regimen. Electronic health record data can be used to measure the latent tuberculosis infection care cascade. A large proportion of patients in this safety-net clinical network are at high risk for tuberculosis infection. Addressing identified gaps in latent tuberculosis infection testing and treatment may have a direct impact on improving tuberculosis prevention in primary care clinics and accelerate progress toward elimination.

Impact of an intervention to implement provision of opioid use disorder medication among patients with and without co-occurring substance use disorders

IntroductionCo-occurring substance use disorders (SUDs) are common among people with opioid use disorder (OUD) and known to hinder receipt of medications for OUD (MOUD). It is important to understand how MOUD care implemented outside of SUD specialty settings impacts access for patients with co-occurring SUDs. The Veterans Health Administration's (VA) Stepped Care for Opioid Use Disorder Train the Trainer (SCOUTT) initiative was implemented in primary care, mental health, and pain clinics in 18 VA facilities, and was found to increase MOUD receipt. This study assessed the SCOUTT initiative's impact among patients with and without co-occurring SUDs. MethodsThis study used a controlled interrupted time series design. We extracted electronic health record data for patients with OUD with visits in SCOUTT intervention or matched comparison clinics during the post-implementation year (9/1/2018–8/31/2019). We examined the monthly proportion of patients who received MOUD in SCOUTT intervention or comparison clinics (primary care, mental health, and pain clinics), or in a VA SUD specialty clinic (where patients may have been referred), during the pre- and post-implementation years. Segmented logistic regression models estimated pre-post changes in outcomes (immediate level change from the final month of the pre-implementation period to the first month of the post-implementation period, change in trend/slope) in intervention vs. comparison facilities, adjusting for patient characteristics and pre-implementation trends. We stratified analyses by the presence of co-occurring SUDs. ResultsAmong patients without co-occurring SUDs, the pre-post trend/slope change in MOUD received in SCOUTT intervention or comparison clinics was greater in intervention vs. comparison facilities (adjusted odds ratio [aOR]: 1.06, 95% confidence interval [CI]: 1.02–1.10), and the immediate increase in MOUD received in SUD clinics was greater in intervention vs. comparison facilities (aOR: 1.12, 95% CI: 1.02–1.22). These changes did not significantly differ in intervention vs. comparison facilities among patients with co-occurring SUDs. ConclusionsThe SCOUTT initiative may have increased MOUD receipt primarily among patients without co-occurring SUDs. Focusing on increasing MOUD receipt for patients with co-occurring SUDs may improve the overall effectiveness of MOUD implementation efforts.

National population-based survival estimates after definitive radiation therapy for prostate cancer.

395 Background: Understanding contemporary radiation therapy outcomes for prostate cancer (i.e., metastasis, death) is important for shared decision-making and setting expectations for patients and providers. Unfortunately, long-term outcome estimates are often derived from meta-analyses of outdated prospective clinical trials or population-based data lacking reliable clinical details (e.g., incident metastatic disease). For these reasons, we used a recently validated, natural language processing algorithm to identify incident metastatic prostate cancer within the electronic medical records of men treated with radiation therapy for localized prostate cancer in order to conduct an innovative and contemporary population-based survival outcomes study. Methods: We used national administrative, cancer registry, and electronic health record data for patients undergoing definitive radiation therapy with or without concurrent androgen deprivation therapy (ADT) within the Veterans Health Administration from 2005 to 2015. We used National Death Index data through 2019 for overall and prostate cancer-specific survival, and identified the date of incident metastatic prostate cancer using a validated natural language processing algorithm. We estimated metastasis-free, prostate cancer-specific, and overall survival using Kaplan-Meier methods. Results: We identified 41,876 patients treated with definitive radiation therapy for prostate cancer from 2005 through 2015, and followed them for over 8 years (follow up, median, 8.7 years, age at diagnosis, median, 65 years). Most patients had intermediate (42%) and high risk (33%) disease, with nearly half treated with ADT as part of initial therapy (44%). Unadjusted 10-year metastasis-free survival was 96%, 92%, and 80% for low, intermediate, and high risk disease. Similarly, unadjusted 10-year prostate cancer-specific survival was 98%, 97%, and 90% for low, intermediate, and high risk disease. Unadjusted overall survival was lower across disease risk categories at 77%, 71%, and 62% for low, intermediate, and high risk disease. Conclusions: These data provide population-based benchmarks for clinically relevant endpoints, including metastasis-free survival, among patients with low, intermediate, and high risk prostate cancer undergoing radiation therapy using contemporary techniques. The survival rates for high risk disease, in particular, compare favorably with historical outcomes.

MEASURING SPECIALTY CARE UTILIZATION AMONG MEDICALLY FRAGILE, LOW-INCOME OLDER OR DISABLED ADULTS

Abstract The purpose of this research was to quantify the rates of specialty care referral completion and identify variables associated with successful completion among a population of low-income, elderly and/or disabled homebound patients with barriers to accessing office-based care. This was a cross-sectional study using descriptive and multivariate predictive analysis of specialty care referral completion, operationalized as attending an appointment of the same specialty care type within 6 months of being referred. Independent variables include patient age, sex, race, marital status, health insurance, blood pressure, and body mass index. Patient characteristics, referral information, and appointment information from July 1, 2014 to July 1, 2019 were extracted from electronic health record data of patients enrolled in the Just for Us primary care home visiting program in Durham, NC. Specialty care referrals were restricted to those for office-based consultations for chronic disease co-management originating from an outpatient primary care provider. Of 443 total referrals identified from 162 patients, 36% were successfully completed. Being married and female gender were found to be associated with successful referral completion. Of the 217 total patients in the study sample, 25% were identified as not having any referrals. No included patient characteristics were found to be significantly associated with being referred to specialty care. This study demonstrates that the specialty care needs of a medically and socially vulnerable population of homebound patients are not being adequately met.

Medication use and hospital-acquired acute kidney injury: an electronic health record-based study.

Medications remain an important contributor to the development of acute kidney injury (AKI). This study aimed to examine associations between (i) administration of medications known to reduce glomerular filtration rate (GFR), that is, GFR modifiers and subsequent hospital-acquired AKI; and (ii) potentially medication-related AKI and patient adverse outcomes. A retrospective cohort study utilising electronic health record data of patients admitted to a tertiary hospital in Australia in 2015. Timing of medication administration was compared with timing of AKI development. AKI cases were identified using an algorithm based on serum creatinine level changes. Multilevel regression models were applied with adjustment for relevant demographic and clinical factors. Among 11 503 admissions, AKI was identified in 955 patients (8.3%) and 637 (66.7% of 955) were preceded by administration of a GFR modifier. Patients without prior AKI were 17% more likely to develop AKI after administration of these medications (adjusted odds ratio 1.17, 95% confidence interval (CI) 1.003-1.37). Older age and comorbidity with diabetes, acute myocardial infarction, peripheral vascular disease, liver cirrhosis and multiple myeloma were also significant predictors. Patients with potentially medication-related AKI were 11.69 times more likely to die in hospital (95% CI 7.84-17.43) and stayed 3.49 times longer in hospital (95% CI 3.26-3.73), compared with those without AKI. Administration of medications contributing to the reduction of GFR is associated with an increased risk of hospital-acquired AKI and worse patient outcomes. Caution is required when prescribing these medications to patients at risk of developing AKI, and monitoring patients for deterioration is needed if administered.

Rapid infusion of infliximab biosimilars and the incidence and severity of infusion-related reactions in patients with inflammatory bowel disease.

Infliximab is an anti-tumour necrosis factor agent used in the treatment of inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis. While the use of infliximab is well established in the treatment of IBD, there are now four recently FDA-approved infliximab biosimilars that are increasingly used due to their cost-benefit for patients, institutions and payors. In addition, shortening the length of infliximab infusions from 120 min (standard infusion) to 60 min or less (rapid infusion) has been shown to safely provide further cost-benefit while also improving patient convenience. The safety of rapid infusions has been well-established for the infliximab reference product, however, there are limited data available regarding the safety of rapid infusions for infliximab biosimilars. The purpose of this study was to compare the incidence and severity of infusion reactions among patients with IBD receiving rapid infusion of infliximab reference product compared with infliximab biosimilar. This was a retrospective analysis of electronic health record data of patients with a diagnosis of IBD receiving an infliximab reference product or infliximab biosimilar infusion between December 2020 and December 2021. Patient-level variables included demographics, immunomodulator use, IBD-related hospitalization and infliximab trough concentration and antibody levels. Infusion-related variables of interest included total number of infusions, drug, dose, dosing interval, infusion time and use of pre-medications. Infusion-related reactions were defined as safety concerns documented by the administering nurse (anaphylaxis, shortness of breath, hypotension, swelling, rash, pruritus, hives, flushing, chest pain, muscle pain, joint pain, fevers, chills, headache or hypertension) or administration of emergency medications. Fisher's exact test was used to compare reaction rates. A total of 188 patients met inclusion criteria for analysis, and a total of 1124 infusions were administered during the study period. There were no statistically significant differences among any of the pre-specified outcomes. There were no differences in the incidence of infusion reactions among rapid infusion (60 min) infliximab and infliximab biosimilars (p=0.863). Additionally, there were no differences in the incidence of infusion reactions among standard infusion (120 min) infliximab and infliximab biosimilars (p=0.993). Finally, there were no differences among the rate of infusion reactions between rapid infusion of infliximab biosimilars and standard infusion of infliximab biosimilars (p=0.536). Eight patients experienced safety issues, with three patients requiring emergency medications (1.6% of 188 patients). Rapid infusions of infliximab biosimilars were not associated with an increase in the incidence of infusion reactions compared with: rapid infusion of infliximab reference product, standard infusion of infliximab biosimilars, or standard infusion of infliximab reference product. This should reassure clinicians that rapid infusions of infliximab biosimilars are safe in clinical practice.

Complications rate of surgically assisted endoscopic retrograde cholangiopancreatography

• Bariatric surgery is becoming more prevalent throughout the population. • Surgically assisted ERCP is the standard way to access the biliary tree in the majority of post bariatric surgery patients. • Surgical assisted ERCP carries a significant risk of complications. • Further studies are warranted to determine if patients would benefit from alternate methods to access the biliary tree following bariatric surgery. With the rise in obesity and gastric bypass procedures, the normal anatomy and approach for endoscopic retrograde cholangiopancreatography (ERCP) is eliminated. Surgically assisted ERCP is the standard technique to access the biliary system and perform ERCP in these patients. These patients are at increased risk for cholelithiasis. As such, the need for surgically assisted ERCP has increased in patients when transoral access to the biliary tree is not possible. To date, there are little data reporting complications and outcomes of this procedure. We aimed to perform a retrospective cohort study to identify demographic, clinical and outcomes data to ascertain significant complications and complications rates of surgically assisted ERCP. We conducted a retrospective review of electronic health record data of patients who underwent surgically assisted ERCP at three hospitals over a 10-year period, between April 2010 and July 2020, and identified 53 patient encounters for 50 unique patients. Fifty patients who underwent 53 surgically assisted ERCP were identified during the study period. Twenty-two (41.5%) of those patients had a complication. Conversion from laparoscopic to open procedure occurred in 10 cases. The overall complication rate was 44% with most complications (91%) related to surgical access as opposed to ERCP (9%). Surgically assisted ERCP is associated with significant risks for complications primarily due to surgical access. Further studies need to be conducted to compare the risks of surgically assisted ERCP to other approaches for biliary access in the post-bariatric surgery population.

Continuity and Completeness of Electronic Health Record Data for Patients Treated With Oral Hypoglycemic Agents: Findings From Healthcare Delivery Systems in Taiwan.

Objective: To evaluate the continuity and completeness of electronic health record (EHR) data, and the concordance of select clinical outcomes and baseline comorbidities between EHR and linked claims data, from three healthcare delivery systems in Taiwan. Methods: We identified oral hypoglycemic agent (OHA) users from the Integrated Medical Database of National Taiwan University Hospital (NTUH-iMD), which was linked to the National Health Insurance Research Database (NHIRD), from June 2011 to December 2016. A secondary evaluation involved two additional EHR databases. We created consecutive 90-day periods before and after the first recorded OHA prescription and defined patients as having continuous EHR data if there was at least one encounter or prescription in a 90-day interval. EHR data completeness was measured by dividing the number of encounters in the NTUH-iMD by the number of encounters in the NHIRD. We assessed the concordance between EHR and claims data on three clinical outcomes (cardiovascular events, nephropathy-related events, and heart failure admission). We used individual comorbidities that comprised the Charlson comorbidity index to examine the concordance of select baseline comorbidities between EHRs and claims. Results: We identified 39,268 OHA users in the NTUH-iMD. Thirty-one percent (n = 12,296) of these users contributed to the analysis that examined data continuity during the 6-month baseline and 24-month follow-up period; 31% (n = 3,845) of the 12,296 users had continuous data during this 30-month period and EHR data completeness was 52%. The concordance of major cardiovascular events, nephropathy-related events, and heart failure admission was moderate, with the NTU-iMD capturing 49–55% of the outcome events recorded in the NHIRD. The concordance of comorbidities was considerably different between the NTUH-iMD and NHIRD, with an absolute standardized difference >0.1 for most comorbidities examined. Across the three EHR databases studied, 29–55% of the OHA users had continuous records during the 6-month baseline and 24-month follow-up period. Conclusion: EHR data continuity and data completeness may be suboptimal. A thorough evaluation of data continuity and completeness is recommended before conducting clinical and translational research using EHR data in Taiwan.

Prescription smoking-cessation medication pharmacy claims after stroke and transient ischemic attack

Smoking cessation is critical in secondary prevention after stroke and transient ischemic attack. Data regarding use of smoking-cessation interventions after stroke and transient ischemic attack are sparse. We examined the use of prescription smoking-cessation medications in these patients. This is a retrospective cohort study using 2013–2016 data from the INSIGHT Clinical Research Network, comprised of Medicare prescription claims data merged with electronic health record data for patients receiving care across five New York City health care institutions. Active smoking was ascertained based on a validated ICD-9-CM diagnosis code or the presence of an electronic health record active smoking indicator, reflecting clinician-entered data in the health record. The primary outcome was a claim for any prescription smoking-cessation medication (varenicline or bupropion) within 12 months of hospital discharge. We evaluated claims for any statin medication as a comparator because statins are a standard component of stroke secondary prevention. We identified 3,153 patients with stroke or transient ischemic attack who were active smokers at the time of their event. Among these patients, 3.1% (95% CI, 2.5–3.9) had a pharmacy claim for a prescription smoking-cessation medication at 6 months, and 4.7% (95% CI, 3.9–5.6) did at 12 months hospital discharge. In contrast, cumulative statin medication claims rates were 67.5% (95% CI, 65.5–69.5%) at 6 months and 74.6% (95% CI, 72.7–76.6%) at 12 months. Prescription smoking-cessation medications were infrequently used after stroke and transient ischemic attack.

Harnessing Innovative Technologies to Train Nurses in Suicide Safety Planning With Hospitalized Patients: Protocol for Formative and Pilot Feasibility Research.

BackgroundSuicide is the 10th leading cause of death in the United States, with >47,000 deaths in 2019. Most people who died by suicide had contact with the health care system in the year before their death. Health care provider training is a top research priority identified by the National Action Alliance for Suicide Prevention; however, evidence-based approaches that target skill-building are resource intensive and difficult to implement. Advances in artificial intelligence technology hold promise for improving the scalability and sustainability of training methods, as it is now possible for computers to assess the intervention delivery skills of trainees and provide feedback to guide skill improvements. Much remains to be known about how best to integrate these novel technologies into continuing education for health care providers.ObjectiveIn Project WISE (Workplace Integrated Support and Education), we aim to develop e-learning training in suicide safety planning, enhanced with novel skill-building technologies that can be integrated into the routine workflow of nurses serving patients hospitalized for medical or surgical reasons or traumatic injury. The research aims include identifying strategies for the implementation and workflow integration of both the training and safety planning with patients, adapting 2 existing technologies to enhance general counseling skills for use in suicide safety planning (a conversational agent and an artificial intelligence–based feedback system), observing training acceptability and nurse engagement with the training components, and assessing the feasibility of recruitment, retention, and collection of longitudinal self-report and electronic health record data for patients identified as at risk of suicide.MethodsOur developmental research includes qualitative and observational methods to explore the implementation context and technology usability, formative evaluation of the training paradigm, and pilot research to assess the feasibility of conducting a future cluster randomized pragmatic trial. The trial will examine whether patients hospitalized for medical or surgical reasons or traumatic injury who are at risk of suicide have better suicide-related postdischarge outcomes when admitted to a unit with nurses trained using the skill-building technology than those admitted to a unit with untrained nurses. The research takes place at a level 1 trauma center, which is also a safety-net hospital and academic medical center.ResultsProject WISE was funded in July 2019. As of September 2021, we have completed focus groups and usability testing with 27 acute care and 3 acute and intensive care nurses. We began data collection for research aims 3 and 4 in November 2021. All research has been approved by the University of Washington institutional review board.ConclusionsProject WISE aims to further the national agenda to improve suicide prevention in health care settings by training nurses in suicide prevention with medically hospitalized patients using novel e-learning technologies.International Registered Report Identifier (IRRID)DERR1-10.2196/33695

Gaps and Disparities in Primary Prevention Statin Prescription During Outpatient Care

The 2018 American College of Cardiology/American Heart Association Guideline on the Management of Blood Cholesterol recommends statin therapy for eligible patients to reduce the risk of atherosclerotic cardiovascular disease (ASCVD). We extracted electronic health record data for patients with at least one primary care or cardiology visit between October 2018 and January 2020 at an urban, academic medical center in New York City. Clinical and demographic data were used to identify patients eligible for primary prevention statin therapy. Statin prescription status was extracted from the electronic health record, and multivariate logistic regression was used to assess the association between statin prescription and age, gender, race, ethnicity, and other clinical and demographic covariables. In 7,550 patients eligible for primary prevention statin therapy, 3,994 (52.9%) were prescribed statins on at least 1 visit. Statin prescription was highest in patients with diabetes mellitus (73.6%) and with a 10-year ASCVD risk ≥20% (60.6%) and was lowest for those with a 10-year ASCVD risk between 5% and 7.5% (18.7%). Compared with those never prescribed statins, patients prescribed statins were less likely to be women, mainly driven by lower statin prescription rates for women with diabetes. In a fully adjusted model, women remained less likely to be prescribed statin therapy (adjusted odds ratios 0.79, 95% confidence interval 0.71 to 0.88). In conclusion, primary prevention statin therapy remains underutilized.

Evaluation of Quality of Care for US Veterans With Recent-Onset Heart Failure With Reduced Ejection Fraction

Multiple guideline-recommended therapies for heart failure with reduced ejection fraction (HFrEF) are available and promoted by performance measures. However, contemporary data on the use of these therapies are limited. To evaluate trends in guideline-directed medical therapy, implantable cardioverter-defibrillator (ICD) use, and risk-adjusted mortality among patients with recent-onset HFrEF. This cohort study analyzed claims and electronic health record data of patients with recent-onset HFrEF diagnosed at US Department of Veterans Affairs (VA) health care system facilities from July 1, 2013, through June 30, 2019. Veterans who had a history of heart transplant or used a ventricular assist device were among the patients who were excluded. Guideline-directed medical therapy (any β-blocker, guideline-recommended β-blocker [bisoprolol, carvedilol, or metoprolol succinate], angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, angiotensin receptor-neprilysin inhibitor, mineralocorticoid receptor antagonist, and hydralazine plus nitrate) and ICD. Treatment rates for guideline-directed medical therapies and ICDs were calculated within 6 months of the index HFrEF date using medication fills, procedural codes for implantation and monitoring, and diagnosis codes. Risk-adjusted mortality was calculated after adjusting for baseline patient characteristics. For both treatment rates and risk-adjusted mortality, we evaluated the change over 3 periods (period 1: July 1, 2013, to June 30, 2015; period 2: July 1, 2015, to June 30, 2017; and period 3: July 1, 2017, to June 30, 2019) and variation across VA facilities. The final cohort comprised 144 074 eligible patients with incident HFrEF that was diagnosed between July 1, 2013, and June 30, 2019. The cohort had a mean (SD) age of 71.0 (11.4) years and was mostly composed of men (140 765 [97.7%]). Overall, changes in medical therapy rates were minimal over time, with the use of a guideline-recommended β-blocker increasing from 64.2% in 2013 to 72.0% in 2019. Rates for mineralocorticoid receptor antagonist therapy increased from 23.9% in 2013 to 26.9% in 2019, and rates for hydralazine plus nitrate therapy remained stable at 24.2% over the study period. Rates for angiotensin receptor-neprilysin inhibitor therapy increased since its introduction in 2015 but only to 22.6% in 2019. Among patients with an ICD indication, early use rates decreased over time. Substantial variation in medical therapy rates persisted across VA facilities. Risk-adjusted mortality decreased over the study period from 19.9% (95% CI, 19.6%-20.2%) in July 1, 2013, to June 30, 2015, to 18.4% (95% CI, 18.0%-18.7%) in July 1, 2017, to June 30, 2019 (OR, 0.96 per additional year; 95% CI, 0.96-0.97). This study found only marginal improvement between 2013 and 2019 in the guideline-recommended therapy and mortality rates among patients with recent-onset HFrEF. New approaches to increase the uptake of evidence-based HFrEF treatment are urgently needed and could lead to larger reductions in mortality.

Electronic health record-derived outcomes in obstructive sleep apnea managed with positive airway pressure tracking systems.

To assess the effectiveness of continuous positive airway pressure (CPAP) management guided by CPAP machine downloads in newly diagnosed patients with obstructive sleep apnea (OSA) using electronic health record-derived health care utilization, biometric variables, and laboratory data. Electronic health record data of patients seen at the University of Utah Sleep Program from 2012-2015 were reviewed to identify patients with new diagnosis of OSA in whom CPAP adherence and residual apnea-hypopnea index as measured by a positive airway pressure adherence tracking device data for ≥ 1 year were available. Biometric data, laboratory data, and system-wide charges were compared in the 1 year before and after CPAP therapy. Subgroups were divided by whether patients met tracking criteria, mean nightly usage, and OSA severity. 976 consecutive, newly diagnosed participants with OSA (median age 55 years, 56.6% male) met inclusion criteria. There was a mean decrease of systolic blood pressure (BP) of 1.2 mm Hg and diastolic BP of 1.0 mm Hg within a year of initiation of CPAP therapy. BP improvements in the subgroup meeting CPAP tracking targets were 1.36 mmHg (systolic) and 1.37 mmHg (diastolic). No significant change was noted in body mass index, glycated hemoglobin, or serum creatinine values within a year of starting CPAP therapy, and health care utilization increased (mean acute care visits 0.22 per year to 0.53 per year; mean charges of $3,997 per year to $8,986 per year). An improvement in BP was noted within a year of CPAP therapy in newly diagnosed patients with OSA, with no difference in the magnitude of improvement between those meeting tracking system adherence targets. Locke BW, Neill SE, Howe HE, Crotty MC, Kim J, Sundar KM. Electronic health record-derived outcomes in obstructive sleep apnea managed with positive airway pressure tracking systems. J Clin Sleep Med. 2022;18(3):885-894.

Effect modification by age of the association between obstructive lung diseases, smoking, and COVID-19 severity

IntroductionObstructive lung diseases (asthma and chronic obstructive pulmonary disease (COPD)) and smoking are associated with greater risk of respiratory infections and hospitalisations, but conflicting data exist regarding their association with...