Medical Record Abstraction Research Articles

Agreement of medical record abstraction and self‐report of breast cancer treatment with an extended recall window

AbstractBackgroundMedical record abstraction (MRA) and self‐report questionnaires are two methods frequently used to ascertain cancer treatment information. Prior studies have shown excellent agreement between MRA and self‐report, but it is unknown how a recall window longer than 3 years may affect this agreement.MethodsThe Women’s Environmental Cancer and Radiation Epidemiology (WECARE) Study is a multicenter, population‐based case‐control study of controls with unilateral breast cancer individually matched to cases with contralateral breast cancer. Participants who were diagnosed with a first primary breast cancer from 1985 to 2008 before the age of 55 years completed a questionnaire that included questions on treatment. First primary breast cancer treatment information was abstracted from the medical record from radiation oncology clinic notes for radiation treatment and from systemic adjuvant treatment reports for hormone therapy and chemotherapy. Agreement between MRA and self‐reported treatment was assessed with the kappa statistic and corresponding 95% confidence intervals (CIs).ResultsA total of 2808 participants with MRA and self‐reported chemotherapy treatment information, 2733 participants with MRA and self‐reported hormone therapy information, and 2905 participants with MRA and self‐reported radiation treatment information were identified. The median recall window was 12.5 years (range, 2.8–22.2 years). MRA and self‐reported treatment agreement was excellent across treatment modalities (kappachemo, 98.5; 95% CI, 97.9–99.2; kappahorm, 87.7; 95% CI, 85.9–89.5; kapparad, 97.9; 95% CI, 97.0–98.7). There was no heterogeneity across recall windows (pchemo = .46; phorm = .40; prad = .61).ConclusionsAgreement between self‐reported and MRA primary breast cancer treatment modality information was excellent for young women diagnosed with breast cancer and was maintained even among women whose recall window was more than 20 years after diagnosis.

Routine Vaccination During Pregnancy Among People Living With HIV in the United States

Pregnancy represents a window of opportunity for vaccination due to established maternal and fetal benefits of vaccination. Little is known about receipt of routinely recommended vaccines in pregnancy, specifically tetanus, diphtheria, plus acellular pertussis (Tdap) and influenza, among pregnant people living with HIV (PLHIV). To estimate prevalence of vaccination receipt among pregnant people with HIV (PLHIV) and identify demographic and clinical characteristics associated with vaccination. This multicenter cohort study included women participating in Women's Health Study (WHS) of the Surveillance Monitoring for ART Toxicities (SMARTT) Study of the Pediatric HIV/AIDS Cohort Study. The network has been enrolling pregnant PLHIV at 22 US sites since 2007. Participants for this study enrolled between December 2017 and July 2019. Data analysis was conducted from October 2021 to March 2022. Data on vaccination in pregnancy were collected through medical record abstraction. Vaccination receipt was defined as Tdap vaccination received at less than 36 weeks' gestation and influenza vaccination at any gestational age, based on current guidelines. Log-binomial and modified Poisson regression models with generalized estimating equations were fit to identify factors associated with successful receipt of (1) Tdap, (2) influenza, and (3) both vaccinations. A total of 310 pregnancies among 278 people participating in the WHS were included (mean [SD] age, 29.5 [6.1] years; 220 [71%] Black, 77 [25%] Hispanic, and 77 [25%] race and ethnicity other than Black; 64 [21%] with perinatally acquired HIV). Less than one-third of pregnancies were vaccinated as recommended (Tdap, 32.6% [95% CI, 27.4%-38.1%]; influenza, 31.6% [95% CI, 26.5%-37.1%]; both, 22.6% [95% CI, 18.0%-27.6%]). People living with perinatally acquired HIV, those who did not identify as Black, or those who were multiparous had adjusted risk ratios (aRRs) less than 1, while older PLHIV had aRRs greater than 1, but these differences did not reach statistical significance (perinatally acquired HIV: adjusted risk ratio [aRR], 0.46; 95% CI, 0.21-1.02; race other than Black: aRR, 0.53; 95% CI, 0.26-1.08; multiparous: aRR, 0.59; 95% CI, 0.35-1.00; age 24-29 years: aRR, 2.03; 95% CI, 0.92-4.48). In this diverse, multicenter cohort of pregnant PLHIV, receipt of recommended vaccinations was low. Identifying and addressing barriers to vaccination receipt is urgently needed for pregnant people with HIV.

Acute Cardiac Events in Hospitalized Older Adults With Respiratory Syncytial Virus Infection

Respiratory syncytial virus (RSV) infection can cause severe respiratory illness in older adults. Less is known about the cardiac complications of RSV disease compared with those of influenza and SARS-CoV-2 infection. To describe the prevalence and severity of acute cardiac events during hospitalizations among adults aged 50 years or older with RSV infection. This cross-sectional study analyzed surveillance data from the RSV Hospitalization Surveillance Network, which conducts detailed medical record abstraction among hospitalized patients with RSV infection detected through clinician-directed laboratory testing. Cases of RSV infection in adults aged 50 years or older within 12 states over 5 RSV seasons (annually from 2014-2015 through 2017-2018 and 2022-2023) were examined to estimate the weighted period prevalence and 95% CIs of acute cardiac events. Acute cardiac events, identified by International Classification of Diseases, 9th Revision, Clinical Modification or International Statistical Classification of Diseases, Tenth Revision, Clinical Modification discharge codes, and discharge summary review. Severe disease outcomes, including intensive care unit (ICU) admission, receipt of invasive mechanical ventilation, or in-hospital death. Adjusted risk ratios (ARR) were calculated to compare severe outcomes among patients with and without acute cardiac events. The study included 6248 hospitalized adults (median [IQR] age, 72.7 [63.0-82.3] years; 59.6% female; 56.4% with underlying cardiovascular disease) with laboratory-confirmed RSV infection. The weighted estimated prevalence of experiencing a cardiac event was 22.4% (95% CI, 21.0%-23.7%). The weighted estimated prevalence was 15.8% (95% CI, 14.6%-17.0%) for acute heart failure, 7.5% (95% CI, 6.8%-8.3%) for acute ischemic heart disease, 1.3% (95% CI, 1.0%-1.7%) for hypertensive crisis, 1.1% (95% CI, 0.8%-1.4%) for ventricular tachycardia, and 0.6% (95% CI, 0.4%-0.8%) for cardiogenic shock. Adults with underlying cardiovascular disease had a greater risk of experiencing an acute cardiac event relative to those who did not (33.0% vs 8.5%; ARR, 3.51; 95% CI, 2.85-4.32). Among all hospitalized adults with RSV infection, 18.6% required ICU admission and 4.9% died during hospitalization. Compared with patients without an acute cardiac event, those who experienced an acute cardiac event had a greater risk of ICU admission (25.8% vs 16.5%; ARR, 1.54; 95% CI, 1.23-1.93) and in-hospital death (8.1% vs 4.0%; ARR, 1.77; 95% CI, 1.36-2.31). In this cross-sectional study over 5 RSV seasons, nearly one-quarter of hospitalized adults aged 50 years or older with RSV infection experienced an acute cardiac event (most frequently acute heart failure), including 1 in 12 adults (8.5%) with no documented underlying cardiovascular disease. The risk of severe outcomes was nearly twice as high in patients with acute cardiac events compared with patients who did not experience an acute cardiac event. These findings clarify the baseline epidemiology of potential cardiac complications of RSV infection prior to RSV vaccine availability.

Sexual and Reproductive Health Among Cisgender Women With HIV Aged 18–44 Years

The sexual and reproductive health of cisgender women with HIV is essential for overall health and well-being. Nationally representative estimates of sexual and reproductive health outcomes among women with HIV were assessed in this study. Data from the Centers for Disease Control and Prevention's Medical Monitoring Project-including data on sexual and reproductive health-were collected during June 2018-May 2021 through interviews and medical record abstraction among women with HIV and analyzed in 2023. Among women with HIV aged 18-44 years (n=855), weighted percentages were reported, and absolute differences were assessed between groups, highlighting differences ≥|5%| with CIs that did not cross the null. Overall, 86.4% of women with HIV reported receiving a cervical Pap smear in the past 3 years; 38.5% of sexually active women with HIV had documented gonorrhea, chlamydia, and syphilis testing in the past year; 88.9% of women with HIV who had vaginal sex used ≥1 form of contraception in the past year; and 53.4% had ≥1 pregnancy since their HIV diagnosis-of whom 81.5% had ≥1 unintended pregnancy, 24.6% had ≥1 miscarriage or stillbirth, and 9.8% had ≥1 induced abortion. Some sexual and reproductive health outcomes were worse among women with certain social determinants of health, including women with HIV living in households <100% of the federal poverty level compared with women with HIV in households ≥139% of the federal poverty level. Many women with HIV did not receive important sexual and reproductive health services, and many experienced unintended pregnancies, miscarriages/stillbirths, or induced abortions. Disparities in some sexual and reproductive health outcomes were observed by certain social determinants of health. Improving sexual and reproductive health outcomes and reducing disparities among women with HIV could be addressed through a multipronged approach that includes expansion of safety net programs that provide sexual and reproductive health service coverage.

The Role of Patient-Reported Social Factors in Promoting Buprenorphine Consistency.

While medications for opioid use disorder (MOUD) reduce overdose risk, inconsistent use can lead to substance use recurrence and compromise achieving optimal opioid use disorder (OUD) treatment outcomes. Research is limited on patient-reported perspectives on consistency of MOUD self-administration at home and its related social factors. The primary aim was to report on rates of patient-reported buprenorphine consistency among a sample receiving outpatient OUD treatment. The secondary aim was to explore differences in social determinants of health (SDOH) between patients reporting and not reporting lapses in buprenorphine dosing. This is a secondary analysis from a cross-sectional survey and medical record abstraction study (N=96). The primary outcome was patient-reported buprenorphine consistency, as defined as no lapses in buprenorphine dosing in a preceding 28-day period. SDOH survey items were adapted from the Healthy People 2030 framework. Participants (n= 96) were three quarters female (74.0%); most identified as white (54.2%) or Black (38.9%). Most reported not missing any buprenorphine doses over the preceding 28-days (88.5%). Demographic and clinical variables were similar between buprenorphine consistency groups. Participants reporting no missed doses reported few negative social determinants of health (examples: 90% not needing help reading hospital materials and not being afraid that they would be hurt in their apartment building or house). These findings reinforce the known role of SDOH as strong predictors of treatment outcomes for chronic diseases (like substance use disorders), beyond contributions by demographic or clinical variables alone. Future MOUD research should incorporate patient perspectives with the goal of informing patient-centered interventions. Promoting consistency in buprenorphine dosing using strategies grounded in patient experience could be an avenue to promote positive OUD treatment outcomes.

Cannabis Exposure and Adverse Pregnancy Outcomes Related to Placental Function

Cannabis use is increasing among reproductive-age individuals and the risks associated with cannabis exposure during pregnancy remain uncertain. To evaluate the association between maternal cannabis use and adverse pregnancy outcomes known to be related to placental function. Ancillary analysis of nulliparous individuals treated at 8 US medical centers with stored urine samples and abstracted pregnancy outcome data available. Participants in the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be cohort were recruited from 2010 through 2013; the drug assays and analyses for this ancillary project were completed from June 2020 through April 2023. Cannabis exposure was ascertained by urine immunoassay for 11-nor-9-carboxy-Δ9-tetrahydrocannabinol using frozen stored urine samples from study visits during the pregnancy gestational age windows of 6 weeks and 0 days to 13 weeks and 6 days (visit 1); 16 weeks and 0 days to 21 weeks and 6 days (visit 2); and 22 weeks and 0 days to 29 weeks and 6 days (visit 3). Positive results were confirmed with liquid chromatography tandem mass spectrometry. The timing of cannabis exposure was defined as only during the first trimester or ongoing exposure beyond the first trimester. The dichotomous primary composite outcome included small-for-gestational-age birth, medically indicated preterm birth, stillbirth, or hypertensive disorders of pregnancy ascertained by medical record abstraction by trained perinatal research staff with adjudication of outcomes by site investigators. Of 10 038 participants, 9257 were eligible for this analysis. Of the 610 participants (6.6%) with cannabis use, 32.4% (n = 197) had cannabis exposure only during the first trimester and 67.6% (n = 413) had ongoing exposure beyond the first trimester. Cannabis exposure was associated with the primary composite outcome (25.9% in the cannabis exposure group vs 17.4% in the no exposure group; adjusted relative risk, 1.27 [95% CI, 1.07-1.49]) in the propensity score-weighted analyses after adjustment for sociodemographic characteristics, body mass index, medical comorbidities, and active nicotine use ascertained via urine cotinine assays. In a 3-category cannabis exposure model (no exposure, exposure only during the first trimester, or ongoing exposure), cannabis use during the first trimester only was not associated with the primary composite outcome; however, ongoing cannabis use was associated with the primary composite outcome (adjusted relative risk, 1.32 [95% CI, 1.09-1.60]). In this multicenter cohort, maternal cannabis use ascertained by biological sampling was associated with adverse pregnancy outcomes related to placental dysfunction.

Abstract A039: Translating research into practice: Results of a community-engaged, city-wide breast cancer patient navigation implementation study to reduce disparities

Abstract Introduction: Delays in accessing breast cancer care contribute to poor outcomes among women of color and those underinsured. Patient navigation is one of few proven interventions that overcome inequity in cancer care delivery, yet there is a need to address barriers to widespread implementation. Methods: Led by a city-wide coalition of multi-sector stakeholders, we conducted a Type 1 hybrid clinical effectiveness-implementation trial across five hospitals in Boston to test the impact of navigation on timely initiation of breast cancer treatment, while also exploring implementation outcomes including acceptability of and fidelity to an evidence-informed 11-step navigation protocol. A randomized cluster stepped wedge study design allowed for rolling out a multi-level navigation protocol iteratively in real life practices from 2019 through 2022. Hospital cancer registries sourced eligible cancer cases, while electronic medical record abstraction documented timely treatment, defined as within 60 or 90 days depending on the diagnosis. Odds ratios adjusted for time by calendar quarter and accounted for clustering by study site. Fidelity to protocol was measured using navigator documentation of interactions with patients and conducting social needs screenings. Key informant interviews and field observations were conducted to assess acceptability. Results: A total of 1,732 women with newly diagnosed breast cancer were included in the intent to treat analysis (553 historical control period, 1,179 intervention period). By study design, the majority of women were nonwhite (80%) and more than half were non-English speaking and on public health insurance. During the intervention period, 50% (n=587) had no documented evidence of receiving any contact from a navigator, 15% (n=181) had only one documented interaction with the navigator while 35% (n=407) were navigated and received social needs screens in accordance with study protocol. Compared with historical controls, navigated patients who received a social needs screen had twice the odds of receiving timely treatment (aOR 2.06, 95% CI 1.39, 3.06), those who had only one documented interaction with the navigator had 1.4 greater odds of timely treatment (aOR 1.44, 95% CI 1.08, 1.93) and those with no documented evidence of navigation were no more likely to receive timely treatment (aOR 1.42, 95% CI 0.81, 2.48. We found variability in how navigators identified patients, with significant disruption during the COVID pandemic. Navigators found navigation protocols and social needs screening acceptable, and patients reported feeling supported when asked about social needs. The study protocol formalized the navigation process within and across hospitals, yet tension for change in existing workflows and complexity in documentation served as barriers to adoption. Conclusions: Receipt of navigation is associated with more timely care among a diverse group of women at risk for poor outcomes. Despite stakeholder engagement, implementation of evidence-based breast cancer patient navigation remains suboptimal. Citation Format: Tracy A. Battaglia, Karen M. Freund, Jennifer S. Haas, Stephenie C. Lemon, Translating Research Into Practice (TRIP) Consortium. Translating research into practice: Results of a community-engaged, city-wide breast cancer patient navigation implementation study to reduce disparities [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 A039.

Mosaic Chromosomal Alterations and Monoclonal B-Cell Lymphocytosis: Relationship and Risk of Hematologic Malignancies

Background: Monoclonal B-cell lymphocytosis (MBL) is a precursor condition to chronic lymphocytic leukemia (CLL) characterized by the presence of circulating monoclonal B-cell populations in the peripheral blood of otherwise healthy individuals. MBL increases risk of several adverse clinical outcomes, including development of hematological malignancies. Mosaic chromosomal alterations (mCAs) are a form of clonal hematopoiesis which affect large segments of DNA and include gains, losses, and copy number neutral loss of heterozygosity events. mCAs can be detected from SNP-array genotyping. Prior work has suggested mCAs as a potent risk factor for hematological malignancies. However, the nature of the relationship between mCAs and MBL is unknown. We sought to determine 1) the association between mCAs and MBL and 2) their combined effect on risk of hematological malignancies, in a large, prospectively collected, and well-annotated cohort of individuals with known MBL, mCA, and clinical outcomes. Methods: We examined the prevalence of mCA in a cohort of individuals from the Mayo Clinic Biobank who were screened for MBL using a sensitive eight-color flow cytometry assay. We classified MBL by the size of the clone relative to total B-cells, with high count (HC) defined as those individuals who had a percent clonal B-cell count ≥85% out of total B-cell count and low-count (LC) otherwise. Autosomal mCAs were detected from whole blood DNA collected at the time of MBL screening using a SNP-array-based assay. The MoChA pipeline was used to identify mCA events. Logistic regression was used to estimate odds ratios (OR) and 95% confidence intervals (CIs). To examine incident hematological cancers, we identified and validated all hematological cancers through medical record abstraction using the International Statistical Classification of Diseases codes. Cox regression was used to calculate hazard ratios (HR) and 95% CIs, stratified by MBL status or autosomal mCA status. All models were adjusted for age and sex. Results: We evaluated the prevalence of autosomal mCA in 3,764 individuals (792 individuals with MBL of whom 64 had HC-MBL and 2,972 without MBL). The prevalence of autosomal mCA was 7.7% ( n=288) with a median mCA cell fraction of 0.09 (range 0.01-1). Among those with and without MBL overall, the prevalence of mCA was 15.5% ( n=123) and 5.6% ( n=165), respectively (Figure 1). Compared to those without an autosomal mCA, individuals with an autosomal mCA were 2.4-fold more likely to have MBL (95% CI 1.9-3.2; P =2.0x10 -11; Figure 1). CLL-associated mCA (i.e., those commonly altered in CLL including trisomy 12 and deletion of 6q, 11q, 13q, and 17p) were present in 42 individuals, of whom 38 (90.5%) had MBL overall and 30 (71.4%) individuals had HC-MBL. Compared to those without a CLL-associated mCA, individuals with a CLL-associated mCA were 539.39-fold more likely to have HC-MBL (95% CI 190.3-1975.9; P &amp;lt;2.0x10 -16) and 6.7-fold more likely to have LC-MBL (95% CI 2.0-26.5; P =0.0031; Figure 1). Next, we evaluated the relationship between MBL and mCA with risk of developing a hematologic malignancy in 3,009 individuals with follow-up data (median 10 years). Forty-one individuals developed an incident hematological malignancy (68.3% lymphoid). When we evaluated the effect of autosomal mCA stratified by MBL status we observed elevated but non-significant risk of hematological malignancies (Figure 2). When we evaluated the effect of MBL stratified by autosomal mCA status we observed elevated and significant increased risk of developing a hematological malignancy (Figure 2). Conclusions: We found that the presence of an autosomal mCA is highly associated with having MBL. In particular, &amp;gt;90% of CLL-associated mCA carriers had MBL with ~7- and ~540-fold increased association for LC- and HC-MBL, respectively. These results suggest that almost all individuals in large biobanks with CLL-associated mCAs have undiagnosed MBL. However, not all individuals with MBL have an mCA. When evaluating risk of hematological malignancies, we found autosomal mCAs had &amp;gt;2-fold elevated but non-significant effects when stratified by MBL status while MBL remained a significant risk factor regardless of autosomal mCA status. Collectively these results support that MBL remains an important risk factor and suggests that mCAs hold potential to identify a subgroup of individuals at greater risk of developing a hematological malignancy.

892. Epidemiology, clinical features, and outcomes of Rhinovirus/Enterovirus in older adults hospitalized with acute respiratory infections and those with CHF and COPD exacerbations

Abstract Background While Rhinovirus/Enterovirus (RV/EV) infections are common, the clinical characteristics of infections in hospitalized adults are not fully understood. Methods Adults ≥ 50 years of age hospitalized for Acute Respiratory Infections (ARI) or exacerbations of CHF or COPD in two hospitals in Atlanta, GA during the 2018-2019 and 2019-2020 respiratory seasons were offered enrollment. Following informed consent, participants were tested via BioFire® FilmArray® respiratory panels of nasopharyngeal and oropharyngeal swabs (combined), and standard-of-care molecular testing results were also recorded. Subjects were considered positive for RV/EV if any method of testing resulted positive. Baseline characteristics and clinical features were gathered via subject interviews and medical record abstractions. Variables were compared between subjects with RV/EV and two control groups: those negative for all pathogens and those negative for only RV/EV. Participants with RV/EV who had co-infections were excluded from the analysis. Descriptive statistics were performed using SAS v9.4. Results Of 1429 enrolled participants, 123 (8.6%) were positive for RV/EV, of whom 111 had RV/EV alone. When compared to those negative for all tested pathogens (n=1034), participants with RV/EV more commonly had underlying COPD (45.0% vs. 35.5%, P=0.047) and less commonly had CHF (36.0% vs. 48.3%, P=0.014) or experienced acute myocardial dysfunction (29.7% vs. 41.2%, P=0.019). Participants with RV/EV also more commonly experienced fever (39.6% vs. 27.7%, P=0.008), cough (90.1% vs. 69.0%, P&amp;lt; 0.001), sore throat (54.1% vs. 39.5%, P=0.003), chest pain (48.6% vs. 37.8%, P=0.026), and dyspnea/respiratory distress (25.2% vs. 13.1%, P&amp;lt; 0.001) than those negative for all pathogens. Differences between RV/EV positive and negative groups were similar to the all pathogen negative group, with the exception of no significant differences in acute myocardial dysfunction, fever, and COPD in the RV/EV negative group. Conclusion Among older adults hospitalized with ARIs, CHF, and/or COPD exacerbations, RV/EV was associated with symptoms of both upper and lower respiratory tract infection and was more frequent identified among those with COPD. Disclosures Elizabeth Begier, M.D., M.P.H., Pfizer: EB is an employee of Pfizer, the sponsor of this study|Pfizer: Stocks/Bonds Robin Hubler, MS, Pfizer, Inc.: Employee|Pfizer, Inc.: Stocks/Bonds Qing Liu, M.S., Pfizer Inc.: Stocks/Bonds Bradford D. Gessner, M.D., M.P.H., Pfizer: I am an employee of Pfizer|Pfizer: Stocks/Bonds Benjamin Lopman, PhD, Epidemiological Research and Methods, LLC: Advisor/Consultant|Hillevax, Inc: Advisor/Consultant Satoshi Kamidani, MD, CDC: Grant/Research Support|Emergent BioSolutions: Grant/Research Support|NIH: Grant/Research Support|Pfizer Inc: Grant/Research Support Nadine Rouphael, MD, Icon, EMMES, Sanofi, Seqirus, Moderna: Advisor/Consultant Evan J. Anderson, MD, GSK: Advisor/Consultant|GSK: Grant/Research Support|Janssen: Advisor/Consultant|Janssen: Grant/Research Support|Kentucky Bioprocessing, Inc.: Safety Monitoring Board|Moderna: Advisor/Consultant|Moderna: Grant/Research Support|Moderna: Currently an employee|Moderna: Stocks/Bonds|Pfizer: Advisor/Consultant|Pfizer: Grant/Research Support|Sanofi Pasteur: Advisor/Consultant|Sanofi Pasteur: Grant/Research Support|Sanofi Pasteur: Safety Monitoring Board|WCG/ACI Clinical: Data Adjudication Board Christina A. Rostad, MD, BioFire Inc.: Grant/Research Support|GlaxoSmithKline Biologicals: Grant/Research Support|Janssen: Grant/Research Support|MedImmune LLC: Grant/Research Support|Meissa Vaccines, Inc.: RSV vaccine technology|Merck &amp; Co., Inc.: Grant/Research Support|Micron Technology, Inc.: Grant/Research Support|Moderna, Inc.: Grant/Research Support|Novavax: Grant/Research Support|PaxVax: Grant/Research Support|Pfizer, Inc.: Grant/Research Support|Regeneron: Grant/Research Support|Sanofi Pasteur: Grant/Research Support

1933. Characteristics of Community-Associated Extended-Spectrum β-Lactamase Producing Enterobacterales Infections in Monroe County, NY, 2020-2021

Abstract Background Extended-spectrum β-lactamase–producing Enterobacterales (ESBL) have emerged as a serious multidrug resistant threat to the community. Epidemiologic data for community-associated (CA) ESBL infections are limited compared to that for healthcare-associated (HA) infections. We examined characteristics of CA ESBL cases over a two-year period and compared them to those of HA cases to guide prevention. Methods CA ESBL cases from 1/2020-12/2021 were identified via laboratory and population-based surveillance in Monroe County as part of the CDC Emerging Infections Program. Cases were defined as the first instance of positive culture in a county resident from a normally sterile site or urine of Escherichia coli, Klebsiella pneumoniae, or K. oxytoca resistant to ≥ 1 3rd-generation cephalosporin and nonresistant to carbapenems. Epidemiologic data were collected through medical record abstraction. Cases were classified as HA if they had prior healthcare exposures (e.g. hospitalization, surgery, chronic dialysis, indwelling devices, or external catheters) and CA if they did not. Case addresses were geocoded to the census tract level to obtain Social Vulnerability Index (SVI) percentiles. Chi-square analyses were conducted to quantify the difference in distribution of these characteristics between CA and HA cases. Results From 2020-2021, 1729 incident cases were identified; 854 (49%) were classified as CA. Compared to HA cases, CA cases were younger (median 59 vs. 70 years), more likely to be female (89.8% vs 65.3%), less likely to have a urinary tract abnormality (27.0% vs 56.8%) or underlying comorbidities (73.2 % vs 95.8%), and less likely to have received prior antibiotics (24.0% vs 55.1%). Interestingly, CA cases were more widely spread across SVI quartiles compared to HA cases; a higher proportion of HA cases resided in census tracts in the 3rd or 4th SVI quartiles (Table 1). Conclusion Patient-specific risk factors classically associated with HA ESBL are less commonly associated with CA ESBL in Monroe County. Community-based preventions may need to target different populations than hospital-based strategies. As ESBL incidence increases, continued surveillance to identify at-risk groups and explore the association of specific social determinants of health is necessary. Disclosures Rebecca Tsay, MPH, CDC: Grant/Research Support Ghinwa Dumyati, MD, Pfizer: Grant/Research Support

1479. Analysis of Depression in People Living with Human Immunodeficiency Virus (HIV) During the Coronavirus Disease 2019 Pandemic in 4 African Countries

Abstract Background We previously demonstrated higher odds of depression in PLWH during COVID-19 pandemic in our African Cohort Study (AFRICOS) between 07May2020 and 01Dec2021.1 This analysis updates the previous and estimates odds of depressive symptoms through 01Dec2022. Hypothesis: If the pandemic was truly associated with depressive symptoms in PLWH then odds of depressive symptoms will continue the downward trend identified in later timepoints of our first analysis. Methods AFRICOS: Ongoing prospective cohort study enrolling PLWH at 12 clinics in Kenya, Uganda, Tanzania, Nigeria.2 Longitudinal evaluations every 6 months include physical evaluation, medical record abstraction, extensive questionnaires including CES-D; depression defined by score &amp;gt;16.3 We compared odds of depression in preCOVID-19 period (1 Jan 2019 to 19 Mar 2020) with five timepoints in COVID-19 era (7 May 2020 to 1 Dec 2022). Logistic regression with generalized estimating equations for OR and 95% CI comparing depression before and during pandemic. Models a priori adjusted for sex, age, and site. Results 2,038 AFRICOS participants with complete cases and visits before and during COVID-19 periods included. Median age at first visit included: 43 years (IQR 36-51) 1,181 (57.9%) were female Depression varied significantly by: sex, participants by site, marital status, ART adherence at first timepoint included (Table 1). 60 (2.9%) participants had CES-D score suggestive of depression at first visit included. Compared with pre-pandemic: PLWH had higher odds of reporting depressive symptoms throughout pandemic. After adjusting for age, sex, and site, PLWH had higher odds of reporting depressive symptoms only in second, third, fourth parts of pandemic period, aORs: 1.62 (95% CI 1.13 – 2.31), 1.72 (95% CI 1.27-2.31), 1.41 (1.01 – 1.96) respectively (Table 2, Figure). Conclusion COVID-19 pandemic is associated with higher odds of depressive symptoms in PLWH in AFRICOS. Odds of depression increased as pandemic progressed, peaking in third period and decreasing sequentially in fourth, fifth periods to confirm our hypothesis. Given the strong association between depression and HIV outcomes, aggressive public health mental health response to pandemics may improve HIV clinical outcomes. Disclosures All Authors: No reported disclosures

Association between YouTube® videos and health literacy with postoperative healthcare utilization following pediatric urologic surgery: A randomized trial

Limited caregiver health literacy has been associated with poorer health outcomes in pediatric patients and may limit caregiver understanding of printed education resources. Postoperative healthcare utilization may be related to confusion about instructions or complications. To correlate caregiver health literacy and educational video intervention with postoperative healthcare utilization following ambulatory pediatric urologic surgery. From July through December 2021, a randomized double-blinded trial assessed postoperative healthcare utilization following pediatric urologic surgery. Caregivers were randomized to receive standardized postoperative counseling and printed instructions (control) or access to English-language educational YouTube® videos with standardized postoperative counseling and printed instructions (intervention). Medical record abstraction was completed 30 days following surgery to identify postoperative healthcare utilization with calls, messages, add-on clinic visits, or presentation for urgent or emergent care, and postoperative complications. Target enrollment was achieved with 400 caregivers with 204 in the intervention and 196 in the control groups. There was a 32.5% overall rate of postoperative healthcare utilization. Health literacy was inversely associated with total postoperative healthcare utilization (p<0.001). There was no difference in the incidence of postoperative healthcare utilization between the control and intervention groups (p=0.623). However, on sub-analysis of caregivers with postoperative healthcare utilization (Summary Figure), there were fewer total occurrences in the intervention group (intervention median 1, IQR 1,2.3; control median 2, IQR 1,3; p<0.001). For caregivers with limited health literacy, there was a greater associated reduction in median calls from 2 (IQR 0,2) to 0 (IQR 0,0.5) with video intervention (p=0.016). On multivariate analysis, total postoperative healthcare utilization was significantly associated with limited caregiver health literacy (OR 1.08; p=0.004), English as preferred language (OR 0.68; p=0.018), and older patient age (OR 0.95; p=0.001). Current resources for postoperative education are limited as resources can be written above recommended reading levels and families can have difficulty recalling information discussed during postoperative counseling. Video intervention is an underutilized resource that can provide an additional resource to families with visual and auditory aids and be accessed as needed. Caregiver health literacy was inversely associated with postoperative healthcare utilization. There was no difference in the incidence of postoperative healthcare utilization with video intervention. However, on subgroup analysis, supplemental videos were associated with fewer occurrences of postoperative healthcare utilization, especially in caregivers with limited health literacy. On multivariate regression, health literacy, preferred language, and patient age were significantly associated with total postoperative healthcare utilization.

Long-Term Outcomes with Single-Agent BRAF-Inhibitor Therapy in Erdheim-Chester Disease

Introduction The treatment of Erdheim-Chester disease (ECD) has been revolutionized by the discovery of MAPK/ERK pathway mutations, most common being BRAF-V600E (50%). The US-FDA approved single-agent vemurafenib for BRAF-V600-mutated ECD in 2017 based on a phase II trial that included 22 patients with ECD and 4 with Langerhans cell histiocytosis (LCH), resulting in 100% overall response rate (ORR) by FDG-PET criteria (Diamond et al. JAMA Onc 2018). However, adverse events (AEs) to vemurafenib led to treatment interruption and/or dose modification in all patients, and drug discontinuation in 8 (31%) patients. Long-term outcomes and tolerability of BRAF-inhibitor (BRAFi) monotherapy in real world setting are unknown. In this study, we aimed to address these questions utilizing a large cohort of patients with ECD. Methods Registry-based ( NCT03329274) study of patients with ECD who received BRAFi (vemurafenib or dabrafenib) as any line of treatment. The registry captures detailed longitudinal clinical, treatment, and outcomes data through medical record abstraction. For this study, we focused on the events of discontinuation, dose reductions, and AEs to BRAFi therapy. Time-to-event analyses were conducted using Kaplan-Meier method from the date of initiation of BRAFi. Primary endpoint of the study was event-free survival (EFS), defined as time to progression of disease, discontinuation or alteration of therapy due to any cause (including addition of a MEK inhibitor), or death. Secondary endpoints included progression-free survival (PFS), defined as time to progression of disease or death, and overall survival (OS). Results We included 64 patients with ECD (including 7 with mixed ECD/LCH) in this study. Median age at diagnosis was 56y (range, 26-77) and at initiation of BRAFi was 57y (range, 26-77). Of these, 59 (92%) were BRAF-V600E, 2 (3.1%) were BRAF-wildtype, 1 had BRAF-V471F, 1 had BRAF-PICALM fusion, and 1 had unknown BRAF status. The distribution of organ involvement was bone (91%), neurologic (78%), brain parenchyma (62%), cardiovascular (58%), retroperitoneum (58%), skin (25%), and pulmonary (19%). BRAFi therapy was used as first-line in 38 (59.3%) and as subsequent line in the rest (median 1, range 1-7). The most common initial BRAFi used was vemurafenib (80%) followed by dabrafenib (20%). The median starting dose of vemurafenib was 720 mg bid (range 480-960) and end dose was 480mg bid (range, 240-480). The median start dose of dabrafenib was 100mg bid (range 50-150) and end dose was 50mg bid (range 50-100). Initial dose reduction of BRAFi was required due to AEs in 28 of 52 cases (54%) with final dose data available, encompassing cutaneous (43%), generalized symptoms or fatigue (18%), &amp;gt;1 system affected (14%), lab abnormalities (11%), musculoskeletal (7%), and other (7%) toxicities. Of 60 patients with response data, a response was seen in 51 patients or 85% (42 partial response, 9 complete response, 8 stable disease, and 1 progressive disease). The median follow-up duration was 3.9 years (range 0.2-8.8). Single-agent BRAFi therapy was discontinued in 38 (59%) patients who received it initially (vemurafenib 63% vs. dabrafenib 46%, p=0.28). Reasons for discontinuation included AEs (n=20, 53%), addition of MEK-inhibitor (18%) for reducing cutaneous toxicities (n=5) or augment CNS response (n=2), disease progression (n=4, 11%), death (n=3, 8%), or others (n=4, 11%). 17 patients were rechallenged with a BRAFi after initial discontinuation, and 6 (35%) discontinued it again. The median EFS for the entire cohort from first BRAFi treatment was 2.99y (95% CI 1.6-4.8) and from second BRAFi was 2.82y (95% CI 1.19- not reached). The median PFS and OS were not reached, and 4 patients died at last follow-up (3 from ECD). Conclusions Almost 5 years after the FDA approval of vemurafenib for ECD, our real-world study from long-term follow-up of a large cohort of patients highlights high response rates, but at the cost of adverse events leading to dose reductions and treatment discontinuation in a large subset. Our results also highlight the entity of disease progression on BRAFi therapy. Our results underscore the importance of developing therapies that are efficacious and well-tolerated in this incurable disease.

Cost minimization analysis of subcutaneous trastuzumab versus intravenous biosimilar trastuzumab: policy recommendations for breast cancer treatment in Malaysia.

Current clinical practice recommends switching innovator intravenous trastuzumab (IV-TZMi) to subcutaneous trastuzumab (SC-TZM) to save healthcare resources. However, with the availability of biosimilar intravenous trastuzumab (IV-TZMb), there is a need to re-evaluate the recommendation. Hence, this study aims to compare the cost and resource use of SC-TZM and IV-TZMb in a Malaysian public healthcare facility. This activity-based costing study consists of (1) a retrospective medical record abstraction to determine patient details to estimate drug costs and (2) a time-motion study to quantify personnel time, patient time, and consumables used. The total cost of both SC-TZM and IV-TZMb were then compared using a cost-minimization approach, while differences were explored using an independent t-test. A sensitivity analysis was also conducted to determine the impact of uncertainties in the analysis. The mean total cost of SC-TZM and IV-TZMb was USD 13,693 and USD 5,624 per patient respectively. The cost difference was primarily contributed by savings in drug cost of IV-TZMb, a reduction of USD 8,546 (SD = 134), p < 0.001 compared to SC-TZM. Interestingly, SC-TZM had a significantly lower cost than IV-TZMb for both the consumable and personnel cost, a reduction by USD 300 (SD = 17.6); p < 0.001 and USD 176 (SD = 7.3); p < 0.001 respectively. The sensitivity analysis demonstrated that the total cost difference between the formulation was mainly driven by drug costs. The study evidenced that IV-TZMb was a more economically viable option in Malaysian public healthcare currently compared to SC-TZM.

Long-term effects of premenopausal bilateral oophorectomy with or without hysterectomy on physical aging and chronic medical conditions.

We examined the long-term effects of premenopausal bilateral oophorectomy (PBO) with or without concurrent or preceding hysterectomy on physical and cognitive function and on odds of chronic conditions. We enrolled 274 women with PBO with or without concurrent or preceding hysterectomy and 240 referents aged 55 years and older who were residents of Olmsted County, MN as of the PBO or index date. Chronic conditions were assessed via medical record abstraction. Cognitive diagnoses were based on neurocognitive testing. A physical function assessment included measures of strength and mobility. Multivariable regression models compared characteristics for women with PBO <46 years, PBO 46-49 years, and referent women with adjustments for age and other confounders. The clinical visits (median age, 67 years) were a median of 22 years after the PBO or index date. Of 274 women with PBO, 161 (59%) were <46 years at PBO and 113 (41%) were 46-49 years. Compared with referents, women with a history of PBO <46 years had increased odds of arthritis (odds ratio [OR], 1.64; 95% confidence interval [CI], 1.06-2.55), asthma (OR, 1.74; 95% CI, 1.03-2.93), obstructive sleep apnea (OR, 2.00; 95% CI, 1.23-3.26), and bone fractures (OR, 2.86; 95% CI, 1.17-6.98), and walked a shorter mean distance on a 6-minute walk test (b = -18.43; P = 0.034). Compared with referents, women with a history of PBO at age 46-49 years had increased odds of arthritis (OR, 1.92; 95% CI, 1.16-3.18) and obstructive sleep apnea (OR, 2.21; 95% CI, 1.33-3.66). There were no significant differences in cognitive status in women with PBO compared with referents. Women with a history of PBO with or without concurrent or preceding hysterectomy, especially at age <46 years, have more chronic conditions in late mid-life compared with referents.

Insurance Status is Associated With Recurrence in Cutaneous Head and Neck Squamous Cell Carcinoma.

To identify socioeconomic factors influencing the presentation and outcomes of cutaneous head and neck squamous cell carcinoma (cHNSCC). Retrospective cohort study. Tertiary academic medical center with comprehensive cancer center. Patients treated for cHNSCC at a single institution between 2008 and 2022 were included. Demographic, socioeconomic data and disease characteristics were obtained from medical record abstraction. Outcome measures included tumor stage, number of distinct primaries, recurrence, and disease-related death. χ2 and Mann-Whitney tests were implemented to evaluate clinicopathologic distributions across disease stages. Survival analyses were performed using Cox regression and Kaplan-Meier analysis. A total of 346 patients met the inclusion criteria. The median age at presentation and length of follow-up was 70.8 and 3.1 years, respectively. The majority of the cohort was white, male, and English-speaking. 13.3% of patients were underinsured and 27.5% were immunosuppressed. Patients who presented with advanced disease were more likely to be underinsured (21.7% vs 9.6%, P = .006) and have a history of homelessness (8.5% vs 2.1%, P = .014). Immunosuppressed patients were more likely to be underinsured (P = .009). Insurance status (1.97 [1.06-3.66],P = .032) and immune status (2.35 [1.30-4.26],P = .005) were independently associated with worse recurrence-free survival. Socioeconomic factors that influence access to care, such as insurance status, are associated with cHNSCC disease stage and disease recurrence. These factors may impose barriers that delay diagnosis and treatment. This may result in worse disease-related outcomes and greater treatment-associated morbidity for certain patients.

Silicosis Among Immigrant Engineered Stone (Quartz) Countertop Fabrication Workers in California

Silicosis associated with inhalation of respirable crystalline silica among engineered stone countertop fabrication workers is an emerging health concern. To describe clinical, socioeconomic, and occupational characteristics of patients diagnosed with silicosis associated with engineered stone in California. This case series included reported cases of silicosis associated with fabrication of engineered stone countertops, as identified by statewide surveillance by the California Department of Public Health (2019-2022). Data analysis was performed from October 2022 to March 2023. Patient interviews and medical record abstractions were used to assess occupational exposure to respirable crystalline silica, including duration of work tenure and preventive measures undertaken. Demographics, clinical characteristics, health care utilization, and clinical outcomes were obtained, including vital status, hypoxia, and lung transplant. This case series identified 52 male patients meeting inclusion criteria; median (IQR) age was 45 (40-49) years, and 51 were Latino immigrants. Ten (19%) were uninsured, and 20 (39%) had restricted-scope Medi-Cal; 25 (48%) presented initially to an emergency department. A delay in diagnosis occurred in 30 (58%) patients, most commonly due to alternative initial diagnoses of bacterial pneumonia (9 [30%]) or tuberculosis (8 [27%]). At diagnosis, 20 (38%) patients had advanced disease (progressive massive fibrosis) with severely or very severely reduced forced expiratory volume in 1 second in 8 (18%) and 5 (11%), respectively. Of the cases, 10 (19%) were fatal; median (IQR) age at death was 46 (38-51) years, and 6 patients (12%) were alive with chronic resting hypoxia. Eleven were referred for lung transplant: 3 underwent transplant with 1 fatality; 7 were declined transplant, with 6 fatalities; and 1 died prior to listing. Median (IQR) work tenure was 15 (10-20) years; 23 (45%) reported use of water suppression for dust mitigation, and 25 (48%) continued to fabricate stone after being diagnosed with silicosis. In this case series performed in California, silicosis associated with occupational exposure to dust from engineered stone primarily occurred among young Latino immigrant men. Many patients presented with severe disease, and some cases were fatal.

Predicting primary cesarean delivery in pregnancies complicated by gestational diabetes mellitus

Prediction models have shown promise in helping clinicians and patients engage in shared decision-making by providing quantitative estimates of individual risk of important clinical outcomes. Gestational diabetes mellitus is a common complication of pregnancy, which places patients at higher risk of primary CD. Suspected fetal macrosomia diagnosed on prenatal ultrasound is a well-known risk factor for primary CD in patients with gestational diabetes mellitus, but tools incorporating multiple risk factors to provide more accurate CD risk are lacking. Such tools could help facilitate shared decision-making and risk reduction by identifying patients with both high and low chances of intrapartum primary CD. This study aimed to develop and internally validate a multivariable model to estimate the risk of intrapartum primary CD in pregnancies complicated by gestational diabetes mellitus undergoing a trial of labor. This study identified a cohort of patients with gestational diabetes mellitus derived from a large, National Institutes of Health-funded medical record abstraction study who delivered singleton live-born infants at ≥34 weeks of gestation at a large tertiary care center between January 2002 and March 2013. The exclusion criteria included previous CD, contraindications to vaginal delivery, scheduled primary CD, and known fetal anomalies. Candidate predictors were clinical variables routinely available to a practitioner in the third trimester of pregnancy found to be associated with an increased risk of CD in gestational diabetes mellitus. Stepwise backward elimination was used to build the logistic regression model. The Hosmer-Lemeshow test was used to demonstrate goodness of fit. Model discrimination was evaluated via the concordance index and displayed as the area under the receiver operating characteristic curve. Internal model validation was performed with bootstrapping of the original dataset. Random resampling with replacement was performed for 1000 replications to assess predictive ability. An additional analysis was performed in which the population was stratified by parity to evaluate the model's predictive ability among nulliparous and multiparous individuals. Of the 3570 pregnancies meeting the study criteria, 987 (28%) had a primary CD. Of note, 8 variables were included in the final model, all significantly associated with CD. They included large for gestational age, polyhydramnios, older maternal age, early pregnancy body mass index, first hemoglobin A1C recorded in pregnancy, nulliparity, insulin treatment, and preeclampsia. Model calibration and discrimination were satisfactory with the Hosmer-Lemeshow test (P=.862) and an area under the receiver operating characteristic curve of 0.75 (95% confidence interval, 0.74-0.77). Internal validation demonstrated similar discriminatory ability. Stratification by parity demonstrated that the model worked well among both nulliparous and multiparous patients. Using information routinely available in the third trimester of pregnancy, a clinically pragmatic model can predict intrapartum primary CD risk with reasonable reliability in pregnancies complicated by gestational diabetes mellitus and may provide quantitative data to guide patients in understanding their individual primary CD risk based on preexisting and acquired risk factors.

Patterns of Pediatric Palliative and End-of-Life Care in Neonatal Intensive Care Patients in the Southern U.S.

Despite high rates of mortality among infants in the Southern U.S., little is known about the timing of pediatric palliative care (PPC), the intensity of end-of-life care, and whether there are differences among sociodemographic characteristics. To describe PPC patterns and treatment intensity during the last 48 hours of life among neonatal intensive care unit (NICU) patients in the Southern U.S. who received specialized PPC. Medical record abstraction of infant decedents who received PPC consultation in two NICUs (in Alabama and Mississippi) from 2009 to 2017 (n = 195) including clinical characteristics, palliative and end-of-life care characteristics, patterns of PPC, and intensive medical treatments in the last 48 hours of life. The sample was racially (48.2% Black) and geographically (35.4% rural) diverse. Most infants died after withdrawal of life-sustaining interventions (58%) and had do not attempt resuscitation orders documented (75.9%); very few infants enrolled in hospice (6.2%). Initial PPC consult occurred a median of 13 days after admission and a median of 17 days before death. Infants with a primary diagnosis of genetic or congenital anomaly received earlier PPC consultation (P = 0.02) compared to other diagnoses. In the last 48 hours of life, NICU patients received intensive interventions including mechanical ventilation (81.5%), CPR (27.7%) and surgeries or invasive procedures (25.1%). Black infants were more likely to receive CPR compared to White infants (P = 0.04). Overall, PPC consultation occurred late in NICU hospitalizations, infants received high-intensity medical interventions in the last 48 hours of life, and there are disparities in intensity of treatment interventions at end of life. Further research is needed to explore if these patterns of care reflect parent preferences and goal concordance.

Association of Traumatic Brain Injury with Late Life Neuropathological Outcomes in a Community-Based Cohort.

Prior studies into the association of head trauma with neuropathology have been limited by incomplete lifetime neurotrauma exposure characterization. To investigate the neuropathological sequelae of traumatic brain injury (TBI) in an autopsy sample using three sources of TBI ascertainment, weighting findings to reflect associations in the larger, community-based cohort. Self-reported head trauma with loss of consciousness (LOC) exposure was collected in biennial clinic visits from 780 older adults from the Adult Changes in Thought study who later died and donated their brain for research. Self-report data were supplemented with medical record abstraction, and, for 244 people, structured interviews on lifetime head trauma. Neuropathology outcomes included Braak stage, CERAD neuritic plaque density, Lewy body distribution, vascular pathology, hippocampal sclerosis, and cerebral/cortical atrophy. Exposures were TBI with or without LOC. Modified Poisson regressions adjusting for age, sex, education, and APOE ɛ4 genotype were weighted back to the full cohort of 5,546 participants. TBI with LOC was associated with the presence of cerebral cortical atrophy (Relative Risk 1.22, 95% CI 1.02, 1.42). None of the other outcomes was associated with TBI with or without LOC. TBI with LOC was associated with increased risk of cerebral cortical atrophy. Despite our enhanced TBI ascertainment, we found no association with the Alzheimer's disease-related neuropathologic outcomes among people who survived to at least age 65 without dementia. This suggests the pathophysiological processes underlying post-traumatic neurodegeneration are distinct from the hallmark pathologies of Alzheimer's disease.