Electronic Medical Record Database Research Articles

Clinical and molecular characteristics of hemophilia A affected individuals and carriers: A 24 years experience from three centers.

Hemophilia A is a rare bleeding disorder with variable expressivity and allelic heterogeneity. Despite the advancement of prenatal diagnostics and molecular studies, the number of studies reviewing the reproductive choices of hemophilia A carriers and affected individuals remains limited. Through this retrospective review, we hope to gain a deeper understanding of hemophilia A-affected individuals' clinical and molecular characteristics, as well as the reproductive choices of the at-risk couples. A total of 122 individuals harboring likely causative F8 gene alterations from 64 apparently unrelated families attending three centers between 3/2000 and 3/2023 were included in this study. Their clinical and molecular findings as well as reproductive choices were gathered in a clinical setting and verified through the electronic medical record database of the public health system. Forty-seven affected males and 75 female heterozygous carriers were included in the analysis. Among 64 apparently unrelated families, 36 distinct pathogenic/likely pathogenic variants were identified, of which 30.6% (11/36) of variants were novel. While the majority of clinical findings and genotype-phenotype correlations appear to be in accordance with existing literature, female carriers who had no fertility intention were significantly more likely to have affected sons than those who had fertility intention (5/19 vs. 4/5; p = 0.047). Through this retrospective review, we summarized the clinical and molecular characteristics of 122 individuals harboring pathogenic/likely pathogenic F8 variants, as well as their fertility intentions and reproductive outcomes. Further studies are required to look into the considerations involved in reproductive decision-making.

Fumarate Hydratase-Deficient Renal Cell Carcinoma—A Clinicopathological Study of a Series of 11 Cases

Abstract Introduction Fumarate hydratase (FH)-deficient renal cell carcinoma (RCC) is a rare, molecularly defined renal tumor with aggressive behavior. The diagnosis of these tumors is challenging because of varied morphology and limited access to molecular testing and immunohistochemistry (IHC) for FH and 2-succinocysteine. We aim to elucidate the histomorphology, clinical presentation, and follow-up of this tumor in this first series of cases of FH-deficient RCCs from India. Objectives This article aims to understand and elucidate the clinical presentation, pathologic findings, treatment options, and outcomes of FH-deficient RCC. Materials and Methods Diagnosed cases of FH-deficient RCC between January 2021 and January 2023 including clinical details were retrieved from the electronic medical record database. Histopathological and immunohistochemical slides were reviewed. Results Out of 11 cases of FH-deficient RCC, 36% had been referred with a diagnosis of type 2 papillary RCC. One patient presented with metastatic disease. All had mixed histologic patterns with the predominant pattern being papillary and showed FH loss on IHC. The classically described inclusion like nucleoli was present only focally in most cases. A subset of tumors had low-grade solid-nested morphology and these patients presented at an earlier stage (T2a). Two patients on multikinase inhibitors are alive with disease at 14 months' follow-up. Conclusion FH-deficient RCCs can have varied histologic patterns within the same tumor and show loss of FH expression by IHC. A subset has low grade morphology and tends to have a more indolent course. It is important to have a high index of suspicion for this diagnosis due to its varied histological appearance and aggressive behavior.

Abstract PS04-06: Breast cancer recurrence among women with pre-diagnostic major depression and co-existing substance abuse disorder: A retrospective study in the United States Veterans Health Administration Cohort

Abstract Background: Our prior study observed a 34% higher risk of breast cancer (BC) recurrence among women with major depressive disorder (MDD) at the time of their BC diagnosis compared to women without MDD after adjusting for sociodemographic, clinical, and prognostic factors. Given the high prevalence of substance abuse disorders among individuals with MDD and the positive association between alcohol use and mortality among BC survivors, we were interested to examine whether the risk of BC recurrence was compounded for women with both conditions. Objective: To investigate whether pre-diagnostic substance abuse disorders modify the association between MDD and BC recurrence. Methods: We established a retrospective cohort of women (age ≥ 18 years) with incident, early-stage BC diagnosed from 2010 through 2019 using the VHA’s electronic medical record database. A two-year window was used to identify women with MDD and co-existing substance abuse disorders prior to their BC diagnosis. We examined potential interactions between MDD and alcohol abuse and MDD and other substance abuse using multivariable proportional hazards regression, accounting for competing risk of death. Our outcome of interest was BC recurrence. The reference group for all analyses was women with BC alone. The models were adjusted for patient characteristics including age, race, ethnicity, marital status, rurality of primary residence, priority group rating (proxy for socioeconomic status), any homelessness or economic problems, comorbidity burden, body mass index, smoking status, receipt of a screening mammography, year of BC diagnosis, cancer stage, cancer subtype, and cancer treatment. Subgroup analyses were conducted by cancer subtype. Results: Our cohort comprised 6,045 women with BC, of whom 1,754 (29%) had a pre-diagnostic MDD diagnosis and 1,509 (25%) had a substance abuse disorder. Among women with MDD, 386 (22%) abused alcohol and 336 (19%) abused other substances. The median length of follow-up from BC diagnosis was 4.5 years (IQR=4.8 years). The average age at BC diagnosis was 57 years (SD=11 years) overall, 56 years (SD=10 years) among women with MDD, and 57 years (SD=9 years) among women with substance abuse disorders. On multivariable analysis, MDD (HR=1.33; 95% CI: 1.14, 1.53), alcohol abuse disorder (HR=1.37; 95% CI: 1.12, 1.68), and other substance abuse disorders (HR=1.33; 95% CI: 1.13, 1.56) were independent risk factors for BC recurrence. Further, there was a statistically significant interaction between pre-diagnostic MDD and alcohol abuse disorder (p-interaction=0.003). Women with BC who had both pre-diagnostic MDD and alcohol abuse disorder were at a 65% (HR=1.65; 95% CI: 1.29, 2.11) higher risk of BC recurrence compared to women with BC alone. A statistically significant interaction was also observed between pre-diagnostic MDD and other substance abuse disorders (p-interaction < 0.001). Women with BC who had both pre-diagnostic MDD and other substance abuse disorders were at a 90% (HR=1.90; 95% CI: 1.50, 2.42) higher risk of BC recurrence compared to women with BC alone. In subgroup analyses, the interaction between MDD and alcohol abuse disorders (p-interaction=0.001) and MDD and other substance abuse disorders (p-interaction < 0.001) was limited to women with estrogen receptor positive cancer but not estrogen receptor negative cancer. Conclusion: Women with incident BC who have prior diagnoses of both MDD and substance abuse disorder are at higher risk of recurrence than women with either exposure independently. Further research is needed to examine the etiology of our findings and to evaluate whether this newly defined risk group would benefit from closer monitoring and more tailored treatment options. Citation Format: Maya Aboumrad, Kala Visvanathan. Breast cancer recurrence among women with pre-diagnostic major depression and co-existing substance abuse disorder: A retrospective study in the United States Veterans Health Administration Cohort [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PS04-06.

Healthcare resource utilization and costs among patients with alpha-1 antitrypsin deficiency with liver and/or lung disease: a longitudinal retrospective study in the USA.

Aim: To evaluate all-cause and liver-associated healthcare resource utilization (HCRU) and costs among patients with alpha-1 antitrypsin deficiency (AATD) with liver disease (LD) and/or lung disease (LgD). Materials & methods: This was a retrospective analysis of linked administrative claims data from the IQVIA PharMetrics® Plus and the IQVIA Ambulatory Electronic Medical Records (AEMR) databases from 1July2021 to 31January 2022. Patients with AATD in the IQVIA PharMetrics Plus database were included with ≥1 inpatient or ≥2 outpatient medical claims ≥90days apart with a diagnosis of AATD, or with records indicating a protease inhibitor (Pi)*ZZ/Pi*MZ genotype in the IQVIA AEMR database with linkage to IQVIA PharMetrics Plus. For a patient's identified continuous enrollment period, patient time was assigned to health states based on the initial encounter with an LD/LgD diagnosis. A unique index date was defined for each health state, and HCRU and costs were calculated per person-year (PPY). Results: Overall, 5136 adult and pediatric patients from the IQVIA PharMetrics Plus and IQVIA AEMR databases were analyzed. All-cause and liver-associated HCRU and costs were substantially higher following onset of LD/LgD. All-cause cost PPY ranged from US $11,877 in the absence of either LD/LgD to US $74,015 in the presence of both LD and LgD. Among liver transplant recipients in the AATD with LD health state, liver-associated total costs PPY were US $87,329 1-year pre-transplantation and US $461,752 1-year post-transplantation. In the AATD with LgD and AATD with LD and LgD health states, patients who received augmentation therapy were associated with higher all-cause total costs PPY and lower liver-associated total costs PPY than their counterparts who did not receive augmentation therapy. Conclusion: Patients with AATD had increased HCRU and healthcare costs in the presence of LD and/or LgD. HCRU and healthcare costs were highest in the AATD with LD and LgD health state.

Endoscopic Endonasal Anterior Skull Base Meningoencephalocele and Cerebrospinal Fluid Leak Repair: Our Intraoperative and Postoperative Protocol and Long-term Outcomes

Abstract Objective We evaluated the long-term outcomes from a single neurosurgeon and otolaryngologist team using a specific operative protocol for repair and postoperative evaluation. Design The charts of patients undergoing endoscopic endonasal repair of meningoencephaloceles (MECs) and cerebrospinal fluid (CSF) leaks were retrospectively reviewed from 2015 to 2023. Intraoperative steps of the repair and reconstruction were analyzed. Patients' postoperative assessments and complications were analyzed. Setting Loyola University Medical Center's electronic medical record database. Participants Forty-three patients (32 female) aged between 11 and 81 years. Main Outcome Measures Long-term outcomes of patients who underwent endoscopic endonasal repair of MECs and CSF leaks by a single team and protocol. We hypothesized that there would be minimal complications and no recurrences, requiring secondary operation. Results The most common site for MECs was the cribriform plate. Lumbar drain opening pressures ranged from 10 to 35 cm H2O with 18 out of 34 patients having the lumbar drain removed immediately postoperatively. The median hospital stay was 3 days. The average length of follow-up was 3.8 years. No recurrences or secondary operations were noted in all patients. One patient had a sinonasal infection that was successfully treated. Eight patients were noted to have venous stenosis and underwent further evaluation. Conclusion This study represents one of the largest long-term analyses of outcomes by a single team. Our specific protocol for the endoscopic endonasal repair of anterior skull base MECs and CSF leaks is safe and effective. These patients should be evaluated and treated for elevated intracranial pressure following the repair.

Neuropsychiatric complications of coronavirus disease 2019: Mount Sinai Health System cohort study.

To describe the frequency of neuropsychiatric complications among hospitalized patients with coronavirus disease 2019 (COVID-19) and their association with pre-existing comorbidities and clinical outcomes. We retrospectively identified all patients hospitalized with COVID-19 within a large multicenter New York City health system between March 15, 2020 and May 17, 2021 and randomly selected a representative cohort for detailed chart review. Clinical data, including the occurrence of neuropsychiatric complications (categorized as either altered mental status [AMS] or other neuropsychiatric complications) and in-hospital mortality, were extracted using an electronic medical record database and individual chart review. Associations between neuropsychiatric complications, comorbidities, laboratory findings, and in-hospital mortality were assessed using multivariate logistic regression. Our study cohort consisted of 974 patients, the majority were admitted during the first wave of the pandemic. Patients were treated with anticoagulation (88.4%), glucocorticoids (24.8%), and remdesivir (10.5%); 18.6% experienced severe COVID-19 pneumonia (evidenced by ventilator requirement). Neuropsychiatric complications occurred in 58.8% of patients; 39.8% experienced AMS; and 19.0% experienced at least one other complication (seizures in 1.4%, ischemic stroke in 1.6%, hemorrhagic stroke in 1.0%) or symptom (headache in 11.4%, anxiety in 6.8%, ataxia in 6.3%). Higher odds of mortality, which occurred in 22.0%, were associated with AMS, ventilator support, increasing age, and higher serum inflammatory marker levels. Anticoagulant therapy was associated with lower odds of mortality and AMS. Neuropsychiatric complications of COVID-19, especially AMS, were common, varied, and associated with in-hospital mortality in a diverse multicenter cohort at an epicenter of the COVID-19 pandemic.

Missed diagnosis-a major barrier to patient access to obesity healthcare in the primary care setting.

To investigate whether individuals with an elevated BMI measurement, for whom a diagnosis of overweight or obesity (OW/OB) is not recorded, are less likely to be offered clinical care for obesity compared to those with a recorded diagnosis. A retrospective cohort study using the electronic medical record database of Maccabi Healthcare Services (MHS) in Israel. Included were 200,000 adults with BMI ≥ 25 kg/m2 measurement recorded during a primary care visit between 2014 and 2020, and no prior diagnosis of OW/OB or related co-morbidities. The relationships between a recorded diagnosis of OW/OB and two composite outcomes: 1. A composite of referrals to screening tests for metabolic complications; 2. A composite of weight loss intervention and follow up, were analyzed using multivariate logistic regression models. In only 18% of individuals, a diagnosis of OW/OB was recorded. After adjusting for multiple potential confounding factors, individuals who received a recorded diagnosis were 18% more likely to be offered an evaluation for obesity-related metabolic complication, (OR 1.18, 95% CI 1.15-1.21, p < 0.001), and almost twice as likely to be offered intervention and follow up for their excess body weight (OR 1.84, 95% CI 1.76-1.94, p < 0.001) compared to individuals with missed diagnosis. These results persisted after adjusting for inter-physician variability. In addition, male sex, older age, and Arab sector were all associated with lower rates of weight loss intervention and follow up, while young individuals were less likely to be screened for metabolic complications. Beyond BMI measurement, a recorded diagnosis of OW/OB is associated with statistically and clinically significant higher rates of performance of obesity care and intervention. Undiagnosed OW/OB presents a significant clinical opportunity, as recording a diagnosis of OW/OB would predict improved patient access to obesity healthcare and improved clinical outcomes.

Validation of an Inhaled Therapy Beliefs Questionnaire in Patients with Chronic Obstructive Pulmonary Disease.

Background: To carry out a validation questionnaire that assesses beliefs about inhaled treatments in patients with chronic obstructive pulmonary disease (COPD), as knowing patients' beliefs could help to improve medication adherence and health outcomes. Methods: We evaluated data from 260 COPD patients from electronic medical record databases from five primary healthcare centers, in a descriptive, cross-sectional study with a sample size calculated for a 10-item questionnaire, with an estimated Cronbach's alpha of 0.70 and a 95% confidence level. Study participants were selected via systematic random sampling. Variables: Ten-item Inhaled Therapy Beliefs Questionnaire, CCTI-Questionnaire v.2.0, time for completion, age, sex, educational level, spirometry severity (GOLD criteria), exacerbations (previous year), characteristics of inhaled treatment, and smoking habit. A two-year follow-up in a subsample of 77 patients from one health center was utilized. The Morisky-Green test, pharmacy dispensing data, test-retest (kappa coefficient), and an exploratory analysis of the adherence-belief relationship (ji-squared) were measured. Results: The 10-item questionnaire showed good viability (3 min completion time) when performed face-to-face or telephonically; its psychometric properties were acceptable, with an internal consistency (Cronbach's alpha) score of 0.613. Three factors explained 47.58% of the total variance (p < 0.0001): use (factor 1), effects (factor 2), and objectives (factor 3) of inhalers. The two-year follow-up ultimately considered 58 out of the 77 patients (10 deceased, 4 unlocated, 2 mistakes, 2 no inhaled treatment, and 1 withdrawal). Non-adherence was 48.3% in terms of the Morisky-Green test; 31% in terms of pharmacy dispensing data; and 40.4% considering both methods. There was low test-retest reliability, indicated by items 4, 8, and 9 of the CCTI-Questionnaire (Kappa = 0.4, 0.26, and 0.34; p-value < 0.0001, 0.008, and 0.001, respectively). There was mild correlation between beliefs and adherence. Conclusions: The ten-item CCTI-Questionnaire v.2.0 demonstrated acceptable psychometric properties regarding feasibility, reliability, and content validity.

Prevalence, T2 Biomarkers, and Cost of Severe Asthma in the Era of Biologics: The BRAVO-1 Study.

Background: The last decade has seen new classifications of the pathophysiology of asthma that have changed the treatment options available. Objectives: To update data on the prevalence of T2 asthma, comorbidities, biomarker characterization, and costs of severe asthma in patients aged ≥12 years, taking into account new classifications and treatment options. Retrospective, observational, nationwide study using a top-down approach. Data were obtained from BIG-PAC®, an electronic medical record database of 1.7 million patients in Spain. The study population comprised patients aged ≥12 years who had received medical care during the period 2016-2017 and been diagnosed with asthma at least 1 year prior to the index date. Patients were followed for 1 year. The prevalence of asthma was 5.5%. Asthma was severe in 3031 of these patients (7.7%), 81.2% of whom presented T2 asthma. Among patients with severe asthma, 64.1% had uncontrolled disease, 31.2% were oral corticosteroid-dependent (37% in the uncontrolled severe asthma group), and only 3.8% were receiving biologics. The most common T2 comorbidities were allergic rhinitis (66.1%), atopic dermatitis (29.1%), and chronic rhinosinusitis with nasal polyps (14.6%). Mortality rates in the total population and uncontrolled severe asthma groups were 4.2% and 5.5%, respectively. The total annual costs per patient with severe asthma were €5890 (uncontrolled) and €2841 (controlled). In the era of biologics, most severe asthma patients present T2 asthma. Despite the availability of new treatments, rates of oral corticosteroid-dependent patients with uncontrolled severe asthma remain high, although biologics continue to be underused. The costs of uncontrolled severe asthma are twice as high as those of controlled severe asthma.

Characterization of the Epidemiologic Profile and Non-pharmacologic Therapy Utilization Profile of Functional Neurologic Disorder in Patients with Migraine from a Multicenter Electronic Medical Record Database (P1-12.008)

Characterization of the Epidemiologic Profile and Non-pharmacologic Therapy Utilization Profile of Functional Neurologic Disorder in Patients with Migraine from a Multicenter Electronic Medical Record Database (P1-12.008)

Abstract 6464: Real-world evidence (RWE) presented at AACR annual meetings: A 10-year trend analysis

Abstract Introduction: RWE is increasingly used in the oncology community, particularly following the 2016 21st Century Cures Act. A recent analysis of RWE presented at ASCO reported a significant increase in relative frequency of RWE abstracts from 2011-2021[1]. We conducted a similar trend analysis of RWE presented at AACR and predictive factors associated with publication. Methods: EMBASE was queried for abstracts presented at AACR 2013-2022, using terms related to study designs and methodologies that employ use of RWE. Details on study design, location, data source, patient number, cancer site, analytical approach, endpoints, and presentation type (oral vs. poster) were extracted and analyzed. Searches in Google Scholar identified published manuscripts associated with each abstract. The Cochran-Armitage trend test and Monte-Carlo estimation of the exact test were used to detect trends over time; p-values are provided for descriptive purposes. Relative risk ratios were calculated to determine statistically significant predictors of publication. Results: Of 56,920 total abstracts presented at AACR from 2013-2022, 611 (1.1%) RWE abstracts were identified. The proportion of presented abstracts with RWE increased from 0.6% in 2013 to 2.0% in 2022 (p&amp;lt;0.001). Among the RWE abstracts, use of electronic medical record (2013: 0% vs. 2022: 9.3%; p=0.002) and genomics databases (i.e., GENIE) (2013: 0% vs. 2022: 8.3%; p=0.006) increased over time. While majority of RWE abstracts were presented as posters (95.9%), the proportion of oral presentations increased in the last decade (2013: 0.0% vs. 2022: 3.7%; p=0.005). Abstracts with sample sizes &amp;lt;500 decreased significantly over time (p=0.002); those with sample sizes 5,000-&amp;lt;50,000 increased significantly over time (p=0.001). The proportion of abstracts including multiple cancer sites (vs. single-site) increased from 5.1% in 2013 to 20.4% in 2022 (p&amp;lt;0.001). The most common cancer sites were lung, breast, and colorectal. Statistically significant factors associated with publishing an abstract into a manuscript included study sample size 500-&amp;lt;5,000 or ≥100,000, inferential statistics (vs. descriptive), propensity score matching, and effectiveness or disease burden endpoints.Conclusion: RWE studies presented at AACR increased in the recent decade, with more robust study designs, incorporation of novel clinico-genomic databases such as GENIE, and advanced analytical approaches. These findings suggest the value of RWE has been increasingly recognized by the oncology research community and that RWE is being used to provide critical insights and inform patient care. Given FDA’s recent guidance on RWE to support regulatory decision-making, this trend will likely continue. [1] Azad Fet al. Longitudinal trends of real-world evidence (RWE) reporting in oncology conferences: An 11-year ASCO Annual Meeting analysis. Citation Format: Jihong Zong, Lauren C. Bylsma, Orsolya Lunacsek, Jon Fryzek. Real-world evidence (RWE) presented at AACR annual meetings: A 10-year trend analysis [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 6464.

The correlation between serum total bile acid and adverse perinatal outcomes in pregnant women with intrahepatic cholestasis of pregnancy (ICP) and non-ICP hypercholanemia of pregnancy.

The association between excessive serum total bile acid (TBA) and adverse perinatal outcomes in individuals with non-intrahepatic cholestasis of pregnancy (non-ICP) hypercholanemia has not been determined, and it is unclear if this link is similar to that observed in patients with ICP. To examine the adverse perinatal outcomes in two specific subcategories: those with ICP and those with non-ICP, including individuals with liver disease and asymptomatic hypercholanemia of pregnancy (AHP), at different levels of TBA. Investigate the correlation between TBA levels and adverse perinatal outcomes of ICP, liver disease, and AHP. From 2013 to 2021, pregnant women with excessive TBA levels were taken from the electronic medical record database of our hospital and categorized into three groups: ICP (n = 160), liver disease (n = 164), and AHP (n = 650). This was done as part of a retrospective cohort research project. Multivariable regression and subgroup analyses were performed to examine the association between TBA levels and adverse perinatal outcomes in each group. The study found no significant differences in adverse perinatal outcomes between the ICP and liver disease groups at different TBA levels. However, at moderate TBA levels, both groups had a higher risk of adverse perinatal outcomes than the AHP group (p < 0.017). Among liver disease cases with TBA ≥ 100µmol/L, three cases of perinatal deaths (6.67%) associated with moderate-to-severe acute hepatitis occurred between 27 and 33 weeks of gestation. A 59% higher chance of perinatal death was found for every 10 µmol/L rise in TBA, even after significant variables and confounders were taken into account (adjusted odds ratio (aOR) = 1.59; 95% confidence interval (CI): 1.06-2.40; p = 0.03). If a pregnant woman has moderate-to-severe liver disease and TBA ≥ 100µmol/L, preterm termination of pregnancy (before 34 weeks) may be considered.

Use of a machine learning algorithm with a focus on spinopelvic parameters to predict development of symptomatic tethered cord after initial untethering surgery.

Among patients with a history of prior lipomyelomeningocele repair, an association between increased lumbosacral angle (LSA) and cord retethering has been described. The authors sought to build a predictive algorithm to determine which complex tethered cord patients will develop the symptoms of spinal cord retethering after initial surgical repair with a focus on spinopelvic parameters. An electronic medical record database was reviewed to identify patients with complex tethered cord (e.g., lipomyelomeningocele, lipomyeloschisis, myelocystocele) who underwent detethering before 12 months of age between January 1, 2008, and June 30, 2022. Descriptive statistics were used to characterize the patient population. The Caret package in R was used to develop a machine learning model that predicted symptom development by using spinopelvic parameters. A total of 72 patients were identified (28/72 [38.9%] were male). The most commonly observed dysraphism was lipomyelomeningocele (41/72 [56.9%]). The mean ± SD age at index MRI was 2.1 ± 2.2 months, at which time 87.5% of patients (63/72) were asymptomatic. The mean ± SD lumbar lordosis at the time of index MRI was 23.8° ± 11.1°, LSA was 36.5° ± 12.3°, sacral inclination was 30.4° ± 11.3°, and sacral slope was 23.0° ± 10.5°. Overall, 39.6% (25/63) of previously asymptomatic patients developed new symptoms during the mean ± SD follow-up period of 44.9 ± 47.2 months. In the recursive partitioning model, patients whose LSA increased at a rate ≥ 5.84°/year remained asymptomatic, whereas those with slower rates of LSA change experienced neurological decline (sensitivity 77.5%, specificity 84.9%, positive predictive value 88.9%, and negative predictive value 70.9%). This is the first study to build a machine learning algorithm to predict symptom development of spinal cord retethering after initial surgical repair. The authors found that, after initial surgery, patients who demonstrate a slower rate of LSA change per year may be at risk of developing neurological symptoms.

A single-center real-world review of 10 kHz high-frequency spinal cord stimulation outcomes for treatment of chronic pain

ObjectiveTo compare pragmatic real-world 10-kHz high-frequency spinal cord stimulation (HF-SCS) outcomes at a single academic center to the industry-sponsored SENZA-RCT and Stauss et al. study. MethodsThis single-center retrospective study included patients with refractory back or limb pain trialed and/or permanently implanted with the Nevro HF-SCS system from 2016 to 2021. Demographic and outcome data were obtained from the electronic medical record (EMR) and real-world global database maintained by Nevro Corp. Data obtained from the global database were confirmed using the EMR. Main outcome measures included positive responder status (≥50% patient-reported percentage pain reduction (PRPPR)), improvement in function, improvement in sleep, and reduction in pain medication usage. Comparison groups included patient outcomes from the SENZA-RCT and Stauss et al. study. ResultsPatients (N = 147) trialed with HF-SCS were reviewed, with data available for 137. Positive trialed patient responder rate (≥50% PRPPR) was 77% (106/137, 95CI 70–84%) vs. 87% (1393/1607, 95CI 85–89%) Stauss et al. vs. 93% (90/97, 95CI 88–98%) SENZA-RCT HF-SCS. At the last available follow-up, positive implanted patient responder rate was 73% (58/80, 95CI 63–82%) vs. 78% (254/326, 95CI 73–82%) Stauss et al. vs. 79% (71/90, 95CI 70–87%) SENZA-RCT HF-SCS. Sixty-seven percent (59/88, 95CI 57–77%) reported improved function vs. 72% (787/1088, 95CI 70–75%) Stauss et al.; 45% (31/69, 95CI 33–57%) reported improved sleep vs. 68% (693/1020, 95CI 65–71%) Stauss et al. and 16% (9/56, 95CI 6–26%) reported decrease in medication use vs. 32% (342/1070, 95CI 29–35%) Stauss et al. ConclusionPatient responder rates in this retrospective pragmatic real-world study of HF-SCS are consistent with previous industry-sponsored studies. However, improvements in quality-of-life measures and reduction in medication usage were not as robust as reported in industry-sponsored studies. The findings of this non-industry-sponsored, independent study of HF-SCS complement those of previously published studies by reporting patient outcomes collected in the absence of industry sponsorship.

Safety risks of interstitial lung disease upon real-world usage of Janus kinase inhibitors and biologics for patients with autoimmune diseases: epidemiological study using nationwide electronic medical record database in Japan

Although Janus kinase inhibitor (JAKi) therapy is used for patients with autoimmune diseases (AD), one safety concern, interstitial lung disease (ILD), is life-threatening. We evaluated actual usage of JAKi and safety upon JAKi treatment, in an epidemiological retrospective cohort study utilizing the electronic medical record database in Japan. Among 391,565 AD patients, we analyzed data of new-users receiving JAKi or tumor necrosis factor alpha inhibitor (TNFi)/biologics during the period July 2013–May 2022. ILD (ICD10: J70.2, J70.3, J70.4 and J84) criteria were defined: new-ILD (1) and new-ILD (2) which differed in the latter’s prompter therapeutics cessation upon ILD development. We analyzed ILD occurrence and death, ILD cumulative incidence by the Kaplan–Meier method, and hazard ratio (HR) by the Cox model, for 957 JAKi and 3931 TNFi users. JAKi use has become widespread amidst additional drug-development. Among JAKi users, two-year new-ILD (2) incidence, at 1.4%, was higher than for TNFi users (risk ratio: new-ILD (2) 1.75, death 2.31). Cumulative incidence (2.9% in 20.48 days) was also significantly higher (log-rank test p = .013, HR 2.23 (95% CI 1.16–4.27)); risk factors estimated by HR included JAKi (2.14), rheumatoid arthritis (4.94), diabetes mellitus (2.67) and cerebrovascular disease (2.86). ILD screening is essential.

Clinical and Economic Burden of Antibiotic Use Among Pediatric Patients With Varicella Infection in the Outpatient Setting: A Retrospective Cohort Analysis of Real-world Data in France.

Varicella infects 90% of children before age 9. Though varicella is self-limiting, its complications may require antibiotics, though how antibiotics are utilized for varicella in France is not well known. This study assessed antibiotic use and costs associated with varicella and its complications in pediatric patients managed in the outpatient setting in France. A retrospective cohort study using the Cegedim Strategic Data-Longitudinal Patient Database, an electronic medical record database from general practitioners and office-based specialists in France, was conducted. Children <18 years old diagnosed with varicella between January 2014 and December 2018 with 3-month follow-up available were included. We used descriptive analysis to assess varicella-related complications, medication use, healthcare resource utilization and costs. Overall, 48,027 patients were diagnosed with varicella; 15.3% (n = 7369) had ≥1 varicella-related complication. Antibiotics were prescribed in up to 25.1% (n = 12,045/48,027) of cases with greater use in patients with complications (68.1%, n = 5018/7369) compared with those without (17.3%, n = 7027/40,658). Mean medication and outpatient varicella-related costs were €32.82 per patient with medications costing a mean of €5.84 per patient; antibiotics contributed ~23% to total costs annually. This study showed high antibiotic use for the management of varicella and its complications. A universal varicella vaccination program could be considered to alleviate complications and associated costs in France.

Temporal Trends in Practice Patterns After Introduction of Pediatric Hypertension Guidelines in Canada

In 2016 and 2017, respectively, new Canadian and US guidelines for diagnosis and management of pediatric hypertension (HTN) were published. Six years after their publication, it is unknown whether the recommendations have led to changes in primary care practice patterns. To determine whether HTN guidelines are associated with changes in practice patterns among primary care clinicians. This retrospective, multicenter, population-based cohort study was conducted across 3 phases: January 1, 2011, to December 31, 2015 (era 1), January 1, 2016, to December 31, 2017 (washout period), and January 1, 2018, to December 31, 2019 (era 2). Data were collected from 7 Canadian provinces using the Canadian Primary Care Sentinel Surveillance Network Electronic Medical Record database. Eligible participants included children and adolescents (aged ≥3 to <18 years) with 1 or more encounters in the database. Data analysis was conducted from February 2022 to February 2023. Implementation of the 2016 Hypertension Canada and 2017 American Academy of Pediatrics guidelines. The primary outcomes were annual BP screening documentation, high BP follow-up documentation at 6 months and 1-year, HTN prevalence, laboratory testing rates, and medication prescription rates. Interrupted time series analysis was used to assess the association of the introduction of the Canadian and US guidelines with outcomes. The study included 343 191 children and adolescents (mean [SD] age at first encounter, 6.7 (4.6) years; 173 290 female [50.5%]; 169 901 male [49.5%]), including 235 094 patients in era 1 and 193 473 patients in era 2. In era 1, 55 550 patients (23.6%) had at least 1 BP measurement, and in era 2, 45 006 patients (23.3%) had at least 1 BP measurement. There was a significant increase in BP screening in era 2 from 26 876 of 148 554 screenings (18.1%) to 28 556 of 141 192 screenings (20.2%; β = 0.202; 95% CI, 0.009 to 0.390; P = .04), and the increasing trend was sustained. There was a significant decrease in the trend of follow-up of high BP measurement at 6 months (1265 of 4941 patients with BP measurements [25.6%] to 1718 of 7321 patients with BP measurements [23.5%]; β = -0.490; 95% CI, -0.758 to -0.223; P = .001) and 1 year (1974 of 4941 measurements [40.0%] to 2314 of 7321 measurements [31.6%]; β = -1.392; 95% CI, -1.573 to -1.212; P < .001) in era 2. The proportion of patients meeting HTN criteria significantly increased from 2540 of 55 550 patients (4.6%) in era 1 to 5690 of 45 006 patients (12.6%) in era 2 (β = 0.0210; 95% CI, 0.0021 to 0.0410; P = .03). There was no significant change in the trend of laboratory testing rates in era 2 (949 of 4941 patients tested [19.2%] to 1149 of 7321 patients tested [15.7%]; β = -0.159; 95% CI, -0.364 to 0.046; P = .12). The trend in prescribing of medications to patients with HTN also decreased in era 2 (1305 of 4941 patients prescribed medication [26.4%] to 1415 of 7321 patients prescribed medication [19.3%]; β = -0.605; 95% CI, -0.830 to -0.358; P < .001). The findings of this cohort study within the Canadian primary care setting suggest that there was a significant increase in BP screening and HTN prevalence after the publication of national and international HTN guidelines; however, the follow-up of high BP was still suboptimal. Increasing rates of pediatric HTN emphasize the need for better adherence to pediatric HTN guidelines to improve care and outcomes.

Transmastoid Approach to Repair Iatrogenic Cerebrospinal Fluid Otorhinorrhea After Cerebellopontine Angle Tumor Resection.

The precise treatment of iatrogenic cerebrospinal fluid (CSF) otorhinorrhea has been poorly studied. The purpose of the study was to investigate the clinical manifestation, surgical results, and management of CSF leak. Electronic medical record database of iatrogenic CSF leaks after erebellopontine angle(CPA) surgery from 2019 to 2022 was retrospectively analyzed. Three patients returned to the hospital with the complication of CSF leak. After failed attempts of conservative strategies or reverse surgical repair, adipose tissue was applied to the mastoid cracks repair. With the techniques described above, the CSF leaks were successfully settled. The identified patients were observed for at least 10 months. and there was no recurrence or other complications. Conservative treatment and initial surgical methods for occult postoperative CSF leaks are prone to delay effective results, particularly in patients with well-evaporated temporal bone. This complication can be minimized with transmastoid closure utilizing autologous fat.

Predicting preterm birth using auto-ML frameworks: a large observational study using electronic inpatient discharge data.

To develop and compare different AutoML frameworks and machine learning models to predict premature birth. The study used a large electronic medical record database to include 715,962 participants who had the principal diagnosis code of childbirth. Three Automatic Machine Learning (AutoML) were used to construct machine learning models including tree-based models, ensembled models, and deep neural networks on the training sample (N = 536,971). The area under the curve (AUC) and training times were used to assess the performance of the prediction models, and feature importance was computed via permutation-shuffling. The H2O AutoML framework had the highest median AUC of 0.846, followed by AutoGluon (median AUC: 0.840) and Auto-sklearn (median AUC: 0.820), and the median training time was the lowest for H2O AutoML (0.14 min), followed by AutoGluon (0.16 min) and Auto-sklearn (4.33 min). Among different types of machine learning models, the Gradient Boosting Machines (GBM) or Extreme Gradient Boosting (XGBoost), stacked ensemble, and random forrest models had better predictive performance, with median AUC scores being 0.846, 0.846, and 0.842, respectively. Important features related to preterm birth included premature rupture of membrane (PROM), incompetent cervix, occupation, and preeclampsia. Our study highlights the potential of machine learning models in predicting the risk of preterm birth using readily available electronic medical record data, which have significant implications for improving prenatal care and outcomes.

Real-world prescription of anti-COVID-19 drugs in hospitalized patients with COVID-19 in Japan.

Prescription trends and patterns of anti-COVID-19 drugs in hospitalized patients were examined based on real world data to understand the use of anti-COVID-19 drugs in clinical practice in Japan. The longitudinal and cross-sectional study was conducted utilizing data from January 1, 2019 to December 31, 2021 of the MID-NET® medical information database, which stored the electronic medical records, administrative claim data, and diagnosis procedure combination data of patients in Japan. Hospitalized patients with a COVID-19-related diagnosis who received at least one anti-COVID-19 drug between April 1, 2020 and December 31, 2021. The following 14 drugs were included in this study: remdesivir, baricitinib, combination product of casirivimab and imdevimab, favipiravir, dexamethasone, ivermectin, azithromycin, nafamostat mesylate, camostat mesylate, ciclesonide, tocilizumab, sarilumab, combination product of lopinavir and ritonavir, and hydroxychloroquine. We identified 5,717 patients hospitalized with COVID-19 and prescribed at least one anti-COVID-19 drug. The entire cohort generally included patients over 41-50 years and more males. The most common prescription pattern was dexamethasone monotherapy (22.9%), followed by the concomitant use of remdesivir and dexamethasone (15.0%), azithromycin monotherapy (15.0%), remdesivir monotherapy (10.2%), and nafamostat mesylate monotherapy (8.5%). However, an often prescribed anti-COVID-19 drug differed depending on the period. This study revealed the real-world situation of anti-COVID-19 drug prescriptions in hospitalized COVID-19 patients in Japan. A prescribed drug would depend on the latest scientific evidence, such as efficacy, safety, and approval status, at the time of prescription. Understanding the prescription of anti-COVID-19 drugs will be important for providing the most up-to-date treatments to patients and evaluating the benefit and/or risk of anti-COVID-19 drugs based on the utilization of an electronic medical record database.