Search

Background: A team approach is one of the most effective ways to lower blood pressure (BP) in uncontrolled hypertension, but different models for organizing team-based care have not been compared directly. Methods: A pragmatic, cluster-randomized trial compared 2 interventions in adult patients with moderately severe hypertension (BP≥150/95 mm Hg): (1) clinic-based care using best practices and face-to-face visits with physicians and medical assistants; and (2) telehealth care using best practices and adding home BP telemonitoring with home-based care coordinated by a clinical pharmacist or nurse practitioner. The primary outcome was change in systolic BP over 12 months. Secondary outcomes were change in patient-reported outcomes over 6 months. Results: Participants (N=3071 in 21 primary care clinics) were on average 60 years old, 47% male, and 19% Black. Protocol-specified follow-up within 6 weeks was 32% in clinic-based care and 27% in telehealth care. BP decreased significantly during 12 months of follow-up in both groups, from 157/92 to 139/82 mm Hg in clinic-based care patients (adjusted mean difference −18/−10 mm Hg) and 157/91 to 139/81 mm Hg in telehealth care patients (adjusted mean difference −19/−10 mm Hg), with no significant difference in systolic BP change between groups (−0.8 mm Hg [95% CI, −2.84 to 1.32]). Telehealth care patients were significantly more likely than clinic-based care patients to report frequent home BP measurement, rate their BP care highly, and report that BP care visits were convenient. Conclusions: Telehealth care that includes extended team care is an effective and safe alternative to clinic-based care for improving patient-centered care for hypertension. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02996565.

Objective Participant willingness to share electronic health record (EHR) information is central to success of the National Institutes of Health All of Us Research Program (AoURP). We describe the demographic characteristics of participants who decline access to their EHR data. Materials and Methods We included participants enrolling in AoURP between June 6, 2017 and December 31, 2019 through the Trans-American Consortium for the Health Care Systems Research Network (TACH). TACH is a consortium of health care systems spanning 6 states, and an AoURP research partner. Results We analyzed data for 25 852 participants (89.3% of those enrolled). Mean age = 52.0 years (SD 16.8), with 66.5% White, 18.7% Black/African American, 7.7% Hispanic, 32.5% female, and 76% with >a high school diploma. Overall, 2.3% of participants declined to share access to their EHR data (range across TACH sites = 1.3% to 3.5%). Younger age, female sex, and education >high school were significantly associated with decline to share EHR data, odds ratio (95% confidence interval) = 1.26 (1.19–1.33), 1.74 (1.42–2.14), and 2.44 (1.86–3.21), respectively. Results were similar when several sensitivity analyses were performed. Discussion AoURP seeks a dataset reflecting our nation’s diversity in all aspects of participation. Those under-represented in biomedical research may be reluctant to share access to their EHR data. Conclusion In our data, race and ethnicity were not independently related to participant decision to decline access to their EHR information. Results suggest that the value of the AoURP dataset is unlikely to be constrained by the size or the racial/ethnic composition of this subgroup.

Health plan claims may provide complete longitudinal data for timely, real-world population-level COVID-19 assessment. However, these data often lack laboratory results, the standard for COVID-19 diagnosis.We assessed the validity of ICD-10-CM diagnosis codes for identifying patients hospitalized with COVID-19 in U.S. claims databases, compared to linked laboratory results, among six Food and Drug Administration Sentinel System data partners (two large national insurers, four integrated delivery systems) from February 20-October 17, 2020. We identified patients hospitalized with COVID-19 according to five ICD-10-CM diagnosis code-based algorithms, which included combinations of codes U07.1, B97.29, general coronavirus codes, and diagnosis codes for severe symptoms. We calculated the positive predictive value (PPV) and sensitivity of each algorithm relative to laboratory test results. We stratified results by data source type and across three time periods: February 20-March 31 (Time A), April 1-30 (Time B), May 1-October 17 (Time C).The five algorithms identified between 34 806 and 47 293 patients across the study periods; 23% with known laboratory results contributed to PPV calculations. PPVs were high and similar across algorithms. PPV of U07.1 alone was stable around 93% for integrated delivery systems, but declined over time from 93% to 70% among national insurers. Overall PPV of U07.1 across all data partners was 94.1% (95% CI, 92.3%-95.5%) in Time A and 81.2% (95% CI, 80.1%-82.2%) in Time C. Sensitivity was consistent across algorithms and over time, at 94.9% (95% CI, 94.2%-95.5%).Our results support the use of code U07.1 to identify hospitalized COVID-19 patients in U.S. claims data.

To evaluate whether limited participation in life activities is associated with quality of life (QOL) in rectal cancer survivors, and if so, whether this association is independent of bowel function difficulties. We surveyed rectal cancer survivors from four healthcare systems about their QOL, bowel function, and participation in life activities. Additional demographic and clinical variables were extracted from the electronic health record. We examined independent associations between bowel function, participation in life activities, and QOL, controlling for potential confounders. We also identified factors, including ostomy status, that correlate with participation in life activities. Of the 527 respondents, 52% were male, 80% were non-Hispanic white, and the mean age was 63. In fully adjusted models for all rectal cancer survivors, participation in life activities was positively associated with QOL, while bowel function was not. Bowel function retained an independent association with QOL for those who previously had an ostomy and were therefore more likely to have a low rectal anastomosis. Lower participation in life activities was correlated with lower self-reported physical and cognitive function, younger age, financial difficulty, and being non-Hispanic white. Rectal cancer survivors’ participation in life activities was strongly associated with QOL, even when controlling for numerous confounders, including bowel function. Identifying ways to improve participation in life activities may be critical to developing rehabilitative and other supportive interventions that optimize QOL among rectal cancer survivors.

Several healthcare organizations across Minnesota have developed formal pharmacogenomic (PGx) clinical programs to increase drug safety and effectiveness. Healthcare professional and student education is strong and there are multiple opportunities in the state for learners to gain workforce skills and develop advanced competency in PGx. Implementation planning is occurring at several organizations and others have incorporated structured utilization of PGx into routine workflows. Laboratory-based and translational PGx research in Minnesota has driven important discoveries in several therapeutic areas. This article reviews the state of PGx activities in Minnesota including educational programs, research, national consortia involvement, technology, clinical implementation and utilization and reimbursement, and outlines the challenges and opportunities in equitable implementation of these advances.

The prevalence of medical cannabis (MC) use in patients with cancer is growing, but questions about safety, efficacy, and dosing remain. Conducting randomized, controlled trials (RCTs) using state-sponsored MC programs is novel and could provide data needed to guide patients and providers. A pilot RCT of patients with stage IV cancer requiring opioids was conducted. Thirty patients were randomized 1:1 to early cannabis (EC, n = 15) versus delayed start cannabis (DC, n = 15). The EC group obtained 3 months (3 M) of MC through a state program at no charge, while the DC group received standard oncology care without MC for the first 3 M. Patients met with licensed pharmacists at one of two MC dispensaries to determine a suggested MC dosing, formulation, and route. Patients completed surveys on pain levels, opioid/MC use, side effects, and overall satisfaction with the study. Interest in the study was high as 36% of patients who met eligibility criteria ultimately enrolled. The estimated mean daily THC and CBD allotments at 3 M were 34 mg and 17 mg, respectively. A higher proportion of EC patients achieved a reduction in opioid use and improved pain control. No serious safety issues were reported, and patients reported high satisfaction. Conducting RCTs using a state cannabis program is feasible. The addition of MC to standard oncology care was well-tolerated and may lead to improved pain control and lower opioid requirements. Conducting larger RCTs with MC in state-sponsored programs may guide oncology providers on how to safely and effectively incorporate MC for interested patients.

A Population-based Analysis of Prophylactic G-CSF Biosimilar and Originator Administration over time among Patients Diagnosed with Breast Cancer Pawloski PA1, McDermott CL2, Vazquez Benitez G1, DeFor T1, Mendelsohn A3, Marshall J3, Moyneur E4, Lockhart CM2; on behalf of the G-CSF Comparative Effectiveness Research Team. 1HealthPartners Institute, Bloomington MN USA 2Biologics and Biosimilars Collective Intelligence Consortium, Alexandria VA USA 3Harvard Pilgrim Healthcare Institute, Boston MA USA 4StatLog, Montreal QC Canada Objectives: To characterize G-CSF product use, including product switching, among patients diagnosed with breast cancer in the Biologics and Biosimilars Collective Intelligence Consortium’s (BBCIC) Distributed Research Network (DRN). Methods: A retrospective analysis of electronically extracted insurance claims from 2015-2019 at 4 Research Partner Sites was conducted. Patients aged >=20 years with a diagnosis of breast cancer who received chemotherapy associated with a risk of febrile neutropenia (FN) risk per National Comprehensive Cancer Network guidelines and any prophylactic granulocyte-colony stimulating factor (G-CSF), defined as before day 2 of the first cycle of chemotherapy were included. Results: A total of 11,788 patients were included; 89 (0.8%) were male sex per insurance records. The age distribution was 5,743 (49%) 50-64 years; 4,296 (36%) 20-49 years, and 1749 (15%) 65+ years. Chemotherapy regimens included cyclophosphamide/doxorubicin (n=7,377), carboplatin/docetaxel/trastuzumab/pertuzumab (n=1,862), cyclophosphamide/docetaxel (n=1,383), carboplatin/docetaxel/trastuzumab (n=430), cyclophosphamide/docetaxel/doxorubicin (n=147), and docetaxel/trastuzumab/pertuzumab (n=128). Overall, 218 patients (1.8%) developed FN during the first chemotherapy cycle. G-CSF utilization was pegfilgrastim 10,895 (92%), pegfilgrastim-cbqv 315 (3%), pegfilgrastim-jmdb 225 (2%), filgrastim 156 (1%), filgrastim-sndz 118 (1%), tbo-filgrastim 46 (< 1%), a combination of pegfilgrastim+filgrastim 26 (< 1%), and a combination of filgrastim+biosimilar 7 (< 1%) received. A total of 10,953 (93%) patients received high-risk chemotherapy and G-CSF utilization was 10,162 (93%) pegfilgrastim, 288 (3%) pegfilgrastim-cbqv, 200 (2%) pegfilgrastim-jmdb, 132 (1%) filgrastim, 101 (< 1%) filgrastim-sndz, 40 (< 1%) tbo-filgrastim, and 30 (< 1%) combination of products. Eight hundred fifteen (7%) patients received intermediate-risk chemotherapy and G-CSF utilization was, 716 (88%) pegfilgrastim, 27 (3%) pegfilgrastim-cbqv, 25 (3%) pegfilgrastim-jmdb, 23 (3%) filgrastim, 16 (2%) filgrastim-sndz, 5 (< 1%) tbo-filgrastim, and 3 (< 1%) combination. Twenty patients received low risk chemotherapy and of those 17 (85%) received pegfilgrastim. In 2019, the first full year of pegfilgrastim biosimilar availability, pegfilgrastim use was 76% pegfilgrastim, 13% pegfilgrastim-cbqv, and 9% pegfilgrastim-jmdb. Most patients who received a second cycle of chemotherapy received the same G-CSF product in the second cycle, specifically 67% received filgrastim, 71% tbo-filgrastim, 73% filgrastim-sndz, 96% pegfilgrastim, 84% pegfilgrastim-cbqv, and 81% pegfilgrastim-jmdb. Conclusions: The most common chemotherapy agents included cyclophosphamide, carboplatin, doxorubicin, docetaxel, or pertuzumab. Pegfilgrastim biosimilar uptake occurred following market availability. Within each G-CSF product, most patients received the same product during the second cycle of chemotherapy rather than switching products. Citation Format: Pamala A. Pawloski, Cara L McDermott, Gabriela Vazquez Benitez, Terese DeFor, Aaron B. Mendelsohn, James Marshall, Erick Moyneur, Catherine Lockhart. A Population-based Analysis of Prophylactic G-CSF Biosimilar and Originator Administration over time among Patients Diagnosed with Breast Cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-03-33.

Background Data on short-acting recombinant granulocyte colony-stimulating factor (G-CSF) biosimilar utilization from claims data in the USA are limited. Objective To evaluate patient baseline characteristics and utilization patterns for short-acting G-CSF products with particular focus on the assessment of filgrastim biosimilar usage relative to the originator product. Patients and methods We examined filgrastim, filgrastim-sndz, and tbo-filgrastim use among adult patients between January 2012 and March 2019 across the five health-plan research partners in the BBCIC Distributed Research Network. The publicly available Sentinel System analytic toolkit was used to perform the distributed analyses. Results We evaluated over 38 million eligible health-plan members representing more than 88 million person-years of data. We identified 45,204 incident treatment episodes, including 33,118 episodes with filgrastim, 6525 episodes with filgrastim-sndz, and 5,561 episodes with tbo-filgrastim. We observed that the demographic and clinical characteristics of users were comparable across products. While total use of all filgrastim products remained consistent, the proportion of incident episodes of the originator filgrastim steadily decreased since 2014, with filgrastim-sndz and tbo-filgrastim making up the difference. Utilization for the G-CSF biosimilar, filgrastim-sndz, increased from 40 (1%) of 6823 total filgrastim product episodes in 2015, to 2486 (44%) of a total 5668 episodes of filgrastim products in 2018 (partial data for 2018). Conclusion New episodes of short-acting biosimilar filgrastim products have increased over time while the overall number of new users remained flat. Although barriers to biosimilar use in oncology have been noted, uptake has begun and continues to grow.

IntroductionThis study aimed to assess data relevancy and data quality of the Innovation in Medical Evidence Development and Surveillance System Distributed Database (IMEDS-DD) for diabetes research and to evaluate comparability of its type 2 diabetes cohort to the general type 2 diabetes population.Research design and methodsA retrospective study was conducted using the IMEDS-DD. Eligible members were adults with a medical encounter between April 1, 2018 and March 31, 2019 (index period). Type 2 diabetes and co-existing conditions were determined using all data available from April 1, 2016 to the most recent encounter within the index period. Type 2 diabetes patient characteristics, comorbidities and hemoglobin A1c(HbA1c) values were summarized and compared with those reported in national benchmarks and literature.ResultsType 2 diabetes prevalence was 12.6% in the IMEDS-DD. Of 4 14 672 patients with type 2 diabetes, 52.8% were male, and the mean age was 65.0 (SD 13.3) years. Common comorbidities included hypertension (84.5%), hyperlipidemia (82.8%), obesity (45.3%), and cardiovascular disease (44.7%). Moderate-to-severe chronic kidney disease was observed in 20.2% patients. The most commonly used antihyperglycemic agents included metformin (35.7%), sulfonylureas (14.8%), and insulin (9.9%). Less than one-half (48.9%) had an HbA1cvalue recorded. These findings demonstrated the notable similarity in patient characteristics between type 2 diabetes populations identified within the IMEDS-DD and other large databases.ConclusionsDespite the limitations related to HbA1cdata, our findings indicate that the IMEDS-DD contains robust information on key data elements to conduct pharmacoepidemiological studies in diabetes, including member demographic and clinical characteristics and health services utilization.

400 Background: Bevacizumab (Avastin), an anti-angiogenic agent, was approved for various oncologic indications in 2004 in the US. Two biosimilars, bevacizumab-awwb (Mvasi) and bevacizumab-bvzr (Zirabev), were on the market 2017 and 2019, respectively. Real-world data on adverse events for bevacizumab biosimilars is limited. Methods: We conducted a retrospective cohort study using the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) distributed database to evaluate utilization patterns, patient characteristics, and prespecified adverse events of interest for the originator bevacizumab relative to its biosimilars in oncology among users 21 years of age and older between January 1, 2010, to December 31, 2020. Oncology indications included colon, lung, and gynecologic (cervical, uterine, and ovarian) cancers. Adverse events (AEs) of interest were arterial thromboembolism (ATE), congestive heart failure (CHF), gastrointestinal perforation, stroke and acute myocardial infarction (AMI), and venous thromboembolism (VTE). The study analyzed biosimilars collectively, which include bevacizumab-awwb and bevacizumab-bvzr. Results: Both bevacizumab originator and biosimilar users for colon cancer were mostly male (55%), had a mean age of 61 years, and a mean Charlson/Elixhauser combined comorbidity score from 7.0 to 8.0. Among patients with lung cancer users, 53% were female with an overall mean age of 64 years and comorbidity scores from 6.4 to 7.5. Patients with gynecologic cancers had mean age of 63 years, and comorbidity scores from 6.1 to 6.7. Overall, oncologic bevacizumab use increased by 19% over time. Of the 24,044 total episodes from 2010 to 2020, AEs included ATE (2,560 events, 11%), CHF (2,092 events, 9%), gastrointestinal perforation (2,858 events, 12%), stroke/AMI (399 events, 2%), and VTE (4,447 events, 19%). AE rates were comparable between the originator and biosimilars: 7% and 8% for ATE, 5% and 4% for CHF, 9% and 8% for gastrointestinal perforation, 0.6% and 1% for stroke and AMI, and 10% and 8% for VTE, respectively. From 2019 to 2020, biosimilar use increased from 6% to 49% of total bevacizumab utilization for patients with colon cancer, from 2% to 36% for patients with lung cancer, and from 2% to 38% for patients with gynecologic cancers. Conclusions: Bevacizumab utilization increased across all oncology indications evaluated during the study period. From 2019 to 2020, utilization for biosimilars relative to the originator increased. As there are limited data available on bevacizumab biosimilar use in real world settings, future research should be conducted to see if utilization for biosimilar products continues to rise as well as safety over time.

Radiation-induced sarcomas in the brain are extremely rare, usually occur with an average latency of 9 years, and are associated with poor outcomes. Latency periods shorter than 1 year may indicate a genetic predisposition such as Li-Fraumeni syndrome. A 34-year-old man underwent initial tumor resection and radiation therapy for a World Health Organization (WHO) Grade II Astrocytoma. Within 6 months, the tumor recurred as WHO Grade III and was treated with temozolomide and then bevacizumab. Despite the patient’s apparent improving condition, MRI revealed new dural-based lesions 10 months after radiation therapy and identified as high-grade sarcoma. The patient resumed bevacizumab, began NovoTTF treatment for progressing glioma, and ifosfamide/doxorubicin for the sarcoma. Genetic testing revealed no pathogenic mutation in the TP53 gene. Ultimately, treatment was unsuccessful and the patient succumbed to glioma and sarcoma within 2 years of initial diagnosis. This case was unique due to the rapidly progressing glioma and sudden appearance of a high-grade sarcoma. It is unusual to have two separate intracranial primary cancers with each requiring a different chemotherapy regimen. We discuss the difficulty of simultaneously treating with separate chemotherapy regimens. It remains unclear whether the sarcoma was induced by the radiation treatment or a genetic predisposition.

As clinical trials test efficacy rather than effectiveness of medications, real-world effectiveness data often vary from clinical trial data. Given the recent market entry of multiple biologics and biosimilars, a dedicated assessment of these diverse agents is needed to build the evidence base regarding efficacy and safety of innovator biologics and biosimilars.The Academy of Managed Care Pharmacy's Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) was convened to address the lack of real-world, postmarket outcome evidence generation for innovator biologics and corresponding biosimilars. The BBCIC is a multistakeholder scientific research consortium whose participants prioritize topics and collaboratively conduct research studies. The BBCIC conducts a wide range of analyses, including population characterization, epidemiologic studies, and active observational studies, and develops best practices for conducting large-scale studies to provide real-world evidence.Over the past 3 years, we undertook multiple descriptive analyses with the goal of characterizing data availability and demonstrating the feasibility and efficacy of using the BBCIC distributed research network (DRN), which includes commercial claims data from 2008-2018 covering approximately 100 million lives, with approximately 20 million active members in 2017 from 2 major U.S. health plans and 3 regional integrated delivery networks. We analyzed 4 medication classes of particular interest to biologics and biosimilars development: insulins, granulocyte colony-stimulating factors, erythropoietic-stimulating agents, and anti-inflammatories. We were able to identify exposures and user characteristics in all 4 categories. Herein we describe the successes and challenges of conducting some of our analyses, specifically among insulin users with type 1 diabetes mellitus.Our results demonstrate the BBCIC DRN's ability to identify and characterize exposures, cohorts, and outcomes that can contribute to more sophisticated comparative surveillance of biosimilars and innovator biologics in the future. Additional linkages to laboratory data and a wider range of insurance carriers will further strengthen the BBCIC DRN.This study was coordinated and funded by the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) and represents the independent findings of the BBCIC Insulins Principal Investigator and the BBCIC Insulins Research Team. Lockhart is employed by the BBCIC; Eichelberger was employed by the BBCIC at the time of this study. McMahill-Walraven is employed by Aetna, a CVS Health business. Panozzo, Marshall, and Brown are employed by Harvard Pilgrim Healthcare Institute. Aetna receives external funding through research grants and subcontracts with Harvard Pilgrim Healthcare Institute, which are funded by the FDA, NIH, PCORI, BBCIC, Pfizer, and GSK; the Reagan-Udall Foundation for IMEDS; and PCORI for the ADAPTABLE Study. Aetna was reimbursed for data and analytic support from Harvard Pilgrim Healthcare Institute and the Reagan Udall Foundation for the U.S. Food and Drug Administration. This work was presented as a poster at AMCP Nexus 2018; October 22-25, 2018; in Orlando, FL.

Background: Oral tyrosine kinase inhibitors (TKIs) have been the standard of care for chronic myeloid leukemia (CML) since 2001. However, few studies have evaluated changes in the treatment landscape of CML over time. This study assessed the long-term treatment patterns of oral anticancer therapies among patients with CML. Methods: This retrospective cohort study included patients newly diagnosed with CML between January 1, 2000, and December 31, 2016, from 10 integrated healthcare systems. The proportion of patients treated with 5 FDA-approved oral TKI agents—bosutinib, dasatinib, imatinib, nilotinib, and ponatinib—in the 12 months after diagnosis were measured, overall and by year, between 2000 and 2017. We assessed the use of each oral agent through the fourth-line setting. Multivariable logistic regression estimated the odds of receiving any oral agent, adjusting for sociodemographic and clinical characteristics. Results: Among 853 patients with CML, 81% received an oral agent between 2000 and 2017. Use of non-oral therapies decreased from 100% in 2000 to 5% in 2005, coinciding with imatinib uptake from 65% in 2001 to 98% in 2005. Approximately 28% of patients switched to a second-line agent, 9% switched to a third-line agent, and 2% switched to a fourth-line agent. Adjusted analysis showed that age at diagnosis, year of diagnosis, and comorbidity burden were statistically significantly associated with odds of receiving an oral agent. Conclusions: A dramatic shift was seen in CML treatments away from traditional, nonoral chemotherapy toward use of novel oral TKIs between 2000 and 2017. As the costs of oral anticancer agents reach new highs, studies assessing the long-term health and financial outcomes among patients with CML are warranted.

Background: Relatively little is known about factors associated with long-term survival (LTS) following a diagnosis of ovarian cancer. Methods: We conducted a retrospective study of high-grade serous ovarian cancer (HGSOC) to explore predictors of LTS (defined as ≥7 years of survival) using electronic medical record data from a network of integrated health care systems. Multivariable logistic regression with forward selection was used to compare characteristics of women who survived ≥7 years after diagnosis (n = 148) to those who died within 7 years of diagnosis (n = 494). Results: Our final model included study site, age, stage at diagnosis, CA-125, comorbidity score, receipt of chemotherapy, BMI, and four separate comorbid conditions: weight loss, depression, hypothyroidism, and liver disease. Of these, only younger age, lower stage, and depression were statistically significantly associated with LTS. Conclusions: We did not identify any new characteristics associated with HGSOC survival. Impact: Prognosis of ovarian cancer generally remains poor. Large, pooled studies of ovarian cancer are needed to identify characteristics that may improve survival.

Background: Electronic health records are central to cancer care delivery. Electronic clinical decision support (CDS) systems can potentially improve cancer care quality and safety. However, little is known regarding the use of CDS systems in clinical oncology and their impact on patient outcomes. Methods: A systematic review of peer-reviewed studies was performed to evaluate clinically relevant outcomes related to the use of CDS tools for the diagnosis, treatment, and supportive care of patients with cancer. Peer-reviewed studies published from 1995 through 2016 were included if they assessed clinical outcomes, patient-reported outcomes (PROs), costs, or care delivery process measures. Results: Electronic database searches yielded 2,439 potentially eligible papers, with 24 studies included after final review. Most studies used an uncontrolled, pre-post intervention design. A total of 23 studies reported improvement in key study outcomes with use of oncology CDS systems, and 12 studies assessing the systems for computerized chemotherapy order entry demonstrated reductions in prescribing error rates, medication-related safety events, and workflow interruptions. The remaining studies examined oncology clinical pathways, guideline adherence, systems for collection and communication of PROs, and prescriber alerts. Conclusions: There is a paucity of data evaluating clinically relevant outcomes of CDS system implementation in oncology care. Currently available data suggest that these systems can have a positive impact on the quality of cancer care delivery. However, there is a critical need to rigorously evaluate CDS systems in oncology to better understand how they can be implemented to improve patient outcomes.

Objectives We estimated prevalence of complementary and alternative medicine (CAM) use by reason for use (treatment, wellness, or both) among non-institutionalized adults with cancer in the United States. We also examined health-related quality of life (HRQOL) outcomes among adults with cancer who used CAM. Methods We used data from the 2012 National Health Interview Survey (NHIS), which represents non-institutionalized adults with cancer (n = 2967 unweighted). Using a cross-sectional design with survey sampling techniques, we estimated past year prevalence of CAM use. We ran multivariable logistic regression analyses to investigate the odds of perceived benefits of CAM. Results In the past 12 months, 35.1% of adults with cancer reported using some form of CAM. Among CAM users, 56.0% used CAM for both treatment and wellness, and 32.4% used CAM for wellness only. Only 11.6% used CAM for treatment only. Regardless of reason for use, the most commonly used CAM types in the past year were herbal therapies (56.8%), chiropractic (27.1%), and massage (24.9%). Among CAM users, those using CAM for wellness only and for a combination of treatment and wellness reported significantly higher odds of "a better sense of controlling health" and "improved overall health and feeling better" compared with treatment only users. Similar patterns were found in other HRQOL outcomes, but they were not statistically different. Conclusions CAM is widely used among adults with cancer for wellness only or a combination of treatment and wellness. Given improved HRQOL outcomes, CAM may be a promising approach for enhancing health promotion and well-being among adults with cancer.

Background: Older patients diagnosed with colorectal cancer are not routinely included in clinical trials and are frequently treated with less aggressive chemotherapy. To identify factors associated with treatment initiation in older adults, we conducted an observational study of patients diagnosed with stage I–IV colon or rectal cancer at 65 years and older between 2010 and 2014 across 6 integrated health care systems. Methods: Data were obtained from cancer registries based on chart abstraction and medical records. Time from diagnosis to surgery, chemotherapy, and radiation was measured in weeks and censored when disenrollment, death, or the end of the study period occurred. We assessed patient factors associated with time to chemotherapy initiation using survival analysis methods. Results: Among 8,088 patients diagnosed after the age of 65 with colon cancer, the mean age at diagnosis was 76 years (SD 7.7), 4,150 (51%) were female, and 34% were stage 3 or greater. More than half, 55% (n=4,434) of colon cancers were right-sided (RCC), 23% (n=1833) were left-sided (LCC), and 19% (n=1,559) were rectal cancers. Two-thirds (n=5,201) had moderately differentiated disease. Most (57%) received surgery within 4 weeks and 89% within 6 months of diagnosis (median, 3.4 weeks). At 6 months following diagnosis, 33% of patients had received chemotherapy, and only 4% received radiation. Factors associated with the receipt of chemotherapy were assessed in a multivariable survival model that included age, gender, stage, and site. Patients of older age were less likely to receive chemotherapy (HR, 0.49; 95%CI, 0.45–.53 for 75–79 vs 65–69 years), and more likely for advanced stage, and rectal site. No difference was observed between men and women. Refusal of chemotherapy was reported for only 6% of patients and was associated with age, stage, and site. Six month mortality was 13.3%. Conclusions: Factors associated with the receipt of treatment among older cancer survivors are similar to those in the general population.

Background: The incidence of pregnancy-associated cancer (PAC) is expected to increase as more women delay childbearing until later ages. However, information on frequency and incidence of PAC is scarce in the United States. Methods: We identified pregnancies among women aged 10–54 years during 2001–2013 from five U.S. health plans participating in the Cancer Research Network (CRN) and the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP). We extracted information from the health plans' administrative claims and electronic health record databases, tumor registries, and infants' birth certificate files to estimate the frequency and incidence of PAC, defined as cancer diagnosed during pregnancy and up to 1 year postpartum. Results: We identified 846 PAC events among 775,709 pregnancies from 2001 to 2013. The overall incidence estimate was 109.1 (95% confidence interval [CI] = 101.8–116.7) per 100,000 pregnancies. There was an increase in the incidence between 2002 and 2012 (the period during which complete data were available), from 75.0 (95% CI = 54.9–100.0) per 100,000 pregnancies in 2002 to 138.5 (95% CI = 109.1–173.3) per 100,000 pregnancies in 2012. The most common invasive cancers diagnosed were breast (n = 208, 24.6%), thyroid (n = 168, 19.9%), melanoma (n = 93, 11.0%), hematologic (n = 87, 10.3%), and cervix/uterus (n = 74, 8.7%). Conclusions: Our study provides contemporary incidence estimates of PAC from a population-based cohort of U.S. women. These estimates provide the data needed to help develop clinical and public health policies aimed at diagnosing PAC at an early stage and initiating appropriate therapeutic interventions in a timely manner.

ImportanceThe incidence of arterial thromboembolism and venous thromboembolism in persons with COVID-19 remains unclear.ObjectiveTo measure the 90-day risk of arterial thromboembolism and venous thromboembolism in patients hospitalized with COVID-19 before or during COVID-19 vaccine availability vs patients hospitalized with influenza.Design, Setting, and ParticipantsRetrospective cohort study of 41 443 patients hospitalized with COVID-19 before vaccine availability (April-November 2020), 44 194 patients hospitalized with COVID-19 during vaccine availability (December 2020-May 2021), and 8269 patients hospitalized with influenza (October 2018-April 2019) in the US Food and Drug Administration Sentinel System (data from 2 national health insurers and 4 regional integrated health systems).ExposuresCOVID-19 or influenza (identified by hospital diagnosis or nucleic acid test).Main Outcomes and MeasuresHospital diagnosis of arterial thromboembolism (acute myocardial infarction or ischemic stroke) and venous thromboembolism (deep vein thrombosis or pulmonary embolism) within 90 days. Outcomes were ascertained through July 2019 for patients with influenza and through August 2021 for patients with COVID-19. Propensity scores with fine stratification were developed to account for differences between the influenza and COVID-19 cohorts. Weighted Cox regression was used to estimate the adjusted hazard ratios (HRs) for outcomes during each COVID-19 vaccine availability period vs the influenza period.ResultsA total of 85 637 patients with COVID-19 (mean age, 72 [SD, 13.0] years; 50.5% were male) and 8269 with influenza (mean age, 72 [SD, 13.3] years; 45.0% were male) were included. The 90-day absolute risk of arterial thromboembolism was 14.4% (95% CI, 13.6%-15.2%) in patients with influenza vs 15.8% (95% CI, 15.5%-16.2%) in patients with COVID-19 before vaccine availability (risk difference, 1.4% [95% CI, 1.0%-2.3%]) and 16.3% (95% CI, 16.0%-16.6%) in patients with COVID-19 during vaccine availability (risk difference, 1.9% [95% CI, 1.1%-2.7%]). Compared with patients with influenza, the risk of arterial thromboembolism was not significantly higher among patients with COVID-19 before vaccine availability (adjusted HR, 1.04 [95% CI, 0.97-1.11]) or during vaccine availability (adjusted HR, 1.07 [95% CI, 1.00-1.14]). The 90-day absolute risk of venous thromboembolism was 5.3% (95% CI, 4.9%-5.8%) in patients with influenza vs 9.5% (95% CI, 9.2%-9.7%) in patients with COVID-19 before vaccine availability (risk difference, 4.1% [95% CI, 3.6%-4.7%]) and 10.9% (95% CI, 10.6%-11.1%) in patients with COVID-19 during vaccine availability (risk difference, 5.5% [95% CI, 5.0%-6.1%]). Compared with patients with influenza, the risk of venous thromboembolism was significantly higher among patients with COVID-19 before vaccine availability (adjusted HR, 1.60 [95% CI, 1.43-1.79]) and during vaccine availability (adjusted HR, 1.89 [95% CI, 1.68-2.12]).Conclusions and RelevanceBased on data from a US public health surveillance system, hospitalization with COVID-19 before and during vaccine availability, vs hospitalization with influenza in 2018-2019, was significantly associated with a higher risk of venous thromboembolism within 90 days, but there was no significant difference in the risk of arterial thromboembolism within 90 days.

e12535 Background: Bisphenol A (BPA), a widely used chemical in plastics production, has been shown to have estrogenic activity, although it is unclear whether BPA exposure alters effectiveness of aromatase inhibitor (AI) treatment among women with breast cancer. In vitro studies have indicated that at higher concentrations (≥10-4 μM), BPA inhibits aromatase expression and activity, whereas at environmentally relevant concentrations (≤10-8 μM), BPA increases aromatase expression and activity. Few in vivo studies have investigated the association between BPA exposure and estrogen concentrations among non-pregnant women. This pilot study among post-menopausal women receiving AI therapy evaluated whether BPA is detectable in participants’ urine, and the association between BPA and hormone concentrations. Methods: This study was ancillary to a larger intervention study (ClinicalTrials.gov NCT01509079), and participants provided informed consent for this ancillary study under a protocol approved by the institutional review boards of Park Nicollet Institute/HealthPartners and the University of Minnesota. AI adherence during the 4 weeks prior to the baseline visit was monitored through weekly diaries. Participants were instructed to collect spot urine collections in sterile, BPA-free polypropylene containers in the 24 hours prior to the baseline study visit. Serum hormone concentrations were measured using serum collected at the baseline study visit. The Breast Cancer Prevention Trial - Musculoskeletal Symptom (BCPT-MS) scale was used to assess AI-associated musculoskeletal syndrome symptoms at the baseline study visit. Results: Fourteen women agreed to participate in the pilot study, however one participant’s data was excluded due to substances interfering with BPA measurement. BPA was detected in urine from all 13 remaining participants. Geometric mean urinary BPA concentration (1.55 mcg/g creatinine, 95% confidence interval (CI): 0.98-2.45) was higher than concentrations reported for females (1.36 mcg/g creatinine, 95% CI: 1.23-1.51) in the 2013-14 National Health and Nutrition Examination Survey biomonitoring data. Age, body mass index, and percent body fat did not differ between women above or below the study median urinary BPA concentrations (1.49 ng/mL). Women with BPA concentrations >1.49 ng/mL had consistently lower serum estrone (5.0 vs. 7.0 pg/mL, p=0.15), estradiol (2.8 vs. 3.6 pg/mL, p=0.04), and testosterone (21.5 vs 23.8 ng/dL, p=0.28) concentrations compared to women with lower BPA concentrations. No statistically significant differences in BCPT-MS scores were observed between women with higher vs. lower urinary BPA concentrations. Conclusions: These preliminary findings suggest that BPA exposures may work in concert with AIs to lower serum estrogen levels. However, further research is needed to confirm these findings.

Introduction: Patient ratings of their experience of care are part of the “Triple Aim”. Improvements are highly valued by health care organizations, but are hard to achieve. Hypothesis: We tested the effect of a telehealth intervention on satisfaction with hypertension care. Methods: Hyperlink 3 is an ongoing pragmatic cluster-randomized trial in 3072 patients with uncontrolled hypertension in 21 primary care clinics in HealthPartners, an integrated health system in Minnesota and Wisconsin. Clinics were randomized to Clinic-based Care (CC, 9 clinics, 1648 patients) or Telehealth Care (TC, 12 clinics, 1424 patients). CC patients received guideline-based hypertension care in face-to-face visits. TC patients were additionally offered home blood pressure (BP) telemonitoring with pharmacist care management. Patients were surveyed at baseline and after 6 months of study enrollment and asked to rate their hypertension care in the previous 6 months on a scale of 0-10. We compared change in the proportion of patients rating their care at the highest level (9 or 10). Results: In the TC group, about 37% of patients attended an intake pharmacist visit and 434 (30%) participated in home BP telemonitoring. Baseline surveys were completed by 1719 (56%) of patients at baseline (goal 50% completion) and 1301 (76%) of those completing the baseline survey completed the 6 month survey (goal 75% completion). Baseline survey respondents’ mean age was 62 y (non-respondents 58 y), 46% were men (non-respondents 48%), 19% were black (non-respondents 20%), and mean BP was 164/93 mm Hg (non-respondents 164/95 mm Hg.) Nearly all patients (over 90%) took antihypertensive medications (median 2). Hypertension care ratings of 9 or 10 were 27.9% at baseline and 30.2% at 6 months in CC, compared with 29.0% at baseline and 39.5% at 6 months in TC. The odds ratio (OR) for change over time in 9 or 10 ratings was 1.11 (95% CI 0.87 - 1.42) in CC, and 1.61 (95% CI 1.26 - 2.07) in TC. The OR for change in 9 or 10 ratings over time in TC vs CC was 1.45 (95% CI 1.03 - 2.06). Conclusions: Home BP telemonitoring with pharmacist care management increased the proportion of patients who highly rated their experience of hypertension care, even though only a minority of the TC patients received the intervention.

Background Certain medications may increase the risk of death or death from specific causes (eg, sudden cardiac death), but these risks may not be identified in premarket randomized trials. Having the capacity to examine death in postmarket safety surveillance activities is important to the US Food and Drug Administration’s (FDA) mission to protect public health. Distributed networks of electronic health plan databases used by the FDA to conduct multicenter research or medical product safety surveillance studies often do not systematically include death or cause-of-death information. Objective This study aims to develop reusable, generalizable methods for linking multiple health plan databases with the Centers for Disease Control and Prevention’s National Death Index Plus (NDI+) data. Methods We will develop efficient administrative workflows to facilitate multicenter institutional review board (IRB) review and approval within a distributed network of 6 health plans. The study will create a distributed NDI+ linkage process that avoids sharing of identifiable patient information between health plans or with a central coordinating center. We will develop standardized criteria for selecting and retaining NDI+ matches and methods for harmonizing linked information across multiple health plans. We will test our processes within a use case comprising users and nonusers of antiarrhythmic medications. Results We will use the linked health plan and NDI+ data sets to estimate the incidences and incidence rates of mortality and specific causes of death within the study use case and compare the results with reported estimates. These comparisons provide an opportunity to assess the performance of the developed NDI+ linkage approach and lessons for future studies requiring NDI+ linkage in distributed database settings. This study is approved by the IRB at Harvard Pilgrim Health Care in Boston, MA. Results will be presented to the FDA at academic conferences and published in peer-reviewed journals. Conclusions This study will develop and test a reusable distributed NDI+ linkage approach with the goal of providing tested NDI+ linkage methods for use in future studies within distributed data networks. Having standardized and reusable methods for systematically obtaining death and cause-of-death information from NDI+ would enhance the FDA’s ability to assess mortality-related safety questions in the postmarket, real-world setting. International Registered Report Identifier (IRRID) DERR1-10.2196/21811

Introduction: Telehealth and remote monitoring have become critical to patient access to care during the COVID-19 pandemic. We measured the effect of a telehealth care intervention on frequency, sharing methods, and clinical usage of home blood pressure (BP) measurements. Methods: Hyperlink 3 is an ongoing pragmatic cluster-randomized trial in 3072 patients with uncontrolled hypertension in 21 primary care clinics in an integrated health system. Clinics were randomized to Clinic-based Care (CC, 9 clinics, 1648 patients) or Telehealth Care (TC, 12 clinics, 1424 patients). TC patients were offered home BP telemonitoring with pharmacist care management. Patients were surveyed at baseline (Nov 2017 - Apr 2019) and after 6 mo of study enrollment. Results: In the TC group, about 37% of patients attended an intake pharmacist visit and 434 (30%) participated in home BP telemonitoring. Baseline surveys were completed by 1719 (56%) of patients at baseline (goal 50%) and 1301 (76%) of those completing the baseline survey completed the 6 mo survey (goal 75%). Baseline survey respondents' mean age was 62, 46% were men, 19% were black, and mean BP was 164/93 mm Hg. Nearly all patients (>90%) took antihypertensive medications (median 2). The odds ratio (OR) for change in measuring BP > 2 times/week vs. less often was 0.97 (95% CI 0.87 - 1.42) in CC, and 2.01 (95% CI 1.56 - 2.59) in TC. The OR for change in frequent measurement in TC vs CC was 2.08 (95% CI 1.45 - 2.97). Conclusions: A telehealth care intervention markedly increased the frequency of home BP self- monitoring, electronic data sharing, and data-driven BP medication changes, even though only a minority of TC patients received the intervention.

Uncontrolled hypertension is a leading contributor to cardiovascular disease. A cluster-randomized trial in 16 primary care clinics showed that 12 months of home blood pressure telemonitoring and pharmacist management lowered blood pressure more than usual care (UC) for 24 months. We report cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, hospitalized heart failure, coronary revascularization, and cardiovascular death) and costs over 5 years of follow-up. In the telemonitoring intervention (TI group, n=228), there were 15 cardiovascular events (5 myocardial infarction, 4 stroke, 5 heart failure, 1 cardiovascular death) among 10 patients. In UC group (n=222), there were 26 events (11 myocardial infarction, 12 stroke, 3 heart failure) among 19 patients. The cardiovascular composite end point incidence was 4.4% in the TI group versus 8.6% in the UC group (odds ratio, 0.49 [95% CI, 0.21–1.13], P =0.09). Including 2 coronary revascularizations in the TI group and 10 in the UC group, the secondary cardiovascular composite end point incidence was 5.3% in the TI group versus 10.4% in the UC group (odds ratio, 0.48 [95% CI, 0.22–1.08], P =0.08). Microsimulation modeling showed the difference in events far exceeded predictions based on observed blood pressure. Intervention costs (in 2017 US dollars) were $1511 per patient. Over 5 years, estimated event costs were $758 000 in the TI group and $1 538 000 in the UC group for a return on investment of 126% and a net cost savings of about $1900 per patient. Telemonitoring with pharmacist management lowered blood pressure and may have reduced costs by avoiding cardiovascular events over 5 years. Registration— URL: https://www.clinicaltrials.gov ; Unique identifier: NCT00781365.

BACKGROUND Certain medications may increase the risk of death or death from specific causes (eg, sudden cardiac death), but these risks may not be identified in premarket randomized trials. Having the capacity to examine death in postmarket safety surveillance activities is important to the US Food and Drug Administration’s (FDA) mission to protect public health. Distributed networks of electronic health plan databases used by the FDA to conduct multicenter research or medical product safety surveillance studies often do not systematically include death or cause-of-death information. OBJECTIVE This study aims to develop reusable, generalizable methods for linking multiple health plan databases with the Centers for Disease Control and Prevention’s National Death Index Plus (NDI+) data. METHODS We will develop efficient administrative workflows to facilitate multicenter institutional review board (IRB) review and approval within a distributed network of 6 health plans. The study will create a distributed NDI+ linkage process that avoids sharing of identifiable patient information between health plans or with a central coordinating center. We will develop standardized criteria for selecting and retaining NDI+ matches and methods for harmonizing linked information across multiple health plans. We will test our processes within a use case comprising users and nonusers of antiarrhythmic medications. RESULTS We will use the linked health plan and NDI+ data sets to estimate the incidences and incidence rates of mortality and specific causes of death within the study use case and compare the results with reported estimates. These comparisons provide an opportunity to assess the performance of the developed NDI+ linkage approach and lessons for future studies requiring NDI+ linkage in distributed database settings. This study is approved by the IRB at Harvard Pilgrim Health Care in Boston, MA. Results will be presented to the FDA at academic conferences and published in peer-reviewed journals. CONCLUSIONS This study will develop and test a reusable distributed NDI+ linkage approach with the goal of providing tested NDI+ linkage methods for use in future studies within distributed data networks. Having standardized and reusable methods for systematically obtaining death and cause-of-death information from NDI+ would enhance the FDA’s ability to assess mortality-related safety questions in the postmarket, real-world setting. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/21811

Background: Chemotherapy-induced febrile neutropenia (FN) is prevented or minimized with granulocyte colony-stimulating factors (G-CSFs). Several G-CSF biosimilars are approved in the United States. The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) is a nonprofit initiative whose objective is to provide scientific evidence on real-world use and comparative safety and effectiveness of biologics and biosimilars using the BBCIC distributed research network (DRN). Patients and Methods: We describe real-world G-CSF use in patients with breast or lung cancer receiving first-cycle chemotherapy associated with high FN risk. We assessed hospitalizations for FN, availability of absolute neutrophil counts, and G-CSF–induced adverse events to inform future observational comparative effectiveness studies of G-CSF reference products and their biosimilars. A descriptive analysis of 5 participating national health insurance plans was conducted within the BBCIC DRN. Results: A total of 57,725 patients who received at least one G-CSF dose were included. Most (92.5%) patients received pegfilgrastim. FN hospitalization rates were evaluated by narrow (Conclusions: Readily available BBCIC DRN data can be used to assess G-CSF use with the incidence of FN hospitalizations. Insufficient laboratory result data were available to report absolute neutrophil counts; however, other safety data are available for assessment that provide valuable baseline data regarding the effectiveness and safety of G-CSFs in preparation for comparative effectiveness studies of reference G-CSFs and their biosimilars.

Purpose The use of validated criteria to identify birth defects in electronic healthcare databases can avoid the cost and time-intensive efforts required to conduct chart reviews to confirm outcomes. This study evaluated the validity of various case-finding methodologies to identify neural tube defects (NTDs) in infants using an electronic healthcare database. Methods This analysis used data generated from a study whose primary aim was to evaluate the association between first-trimester maternal prescription opioid use and NTDs. The study was conducted within the Medication Exposure in Pregnancy Risk Evaluation Program. A broad approach was used to identify potential NTDs including diagnosis and procedure codes from inpatient and outpatient settings, death certificates and birth defect flags in birth certificates. Potential NTD cases were chart abstracted and confirmed by clinical experts. Positive predictive values (PPVs) and 95% confidence intervals (95% CI) are reported. Results The cohort included 113 168 singleton live-born infants: 55 960 infants with opioid exposure in pregnancy and 57 208 infants unexposed in pregnancy. Seventy-three potential NTD cases were available for the validation analysis. The overall PPV was 41% using all diagnosis and procedure codes plus birth certificates. Restricting approaches to codes recorded in the infants' medical record or to birth certificate flags increased the PPVs (72% and 80%, respectively) but missed a substantial proportion of confirmed NTDs. Conclusions Codes in electronic healthcare data did not accurately identify confirmed NTDs. These results indicate that chart review with adjudication of outcomes is important when conducting observational studies of NTDs using electronic healthcare data.

PURPOSE: Reports suggest that up to 50% of women with hormone receptor positive (HR+) breast cancer (BC) do not complete the recommended 5 years of adjuvant endocrine therapy (AET). We examined the impact of an outreach program at Kaiser Permanente Northern California (KPNC) on adherence and discontinuation of AET among patients who initiated AET. METHODS: We assembled a retrospective cohort of all KPNC patients diagnosed with HR+, stage I-III BC initiating AET before (n=4,287) and after (n=3,580) implementation of the outreach program. We compared adherence proportions and discontinuation rates before and after program implementation, both crude and adjusted for age, race/ethnicity, education, income and stage. We conducted a pooled analysis of data from six Cancer Research Network (CRN) sites that had not implemented programs for improving AET adherence, using identical methods and time periods, to assess possible secular trends. RESULTS: In the pre-outreach period, estimated adherence in years 1, 2 and 3 following AET initiation were 75.2%, 71.0% and 67.3%; following the outreach program, the estimates were 79.4%, 75.6% and 72.2% (p-values

To determine the prevalence of opioid use before, during, and after pregnancy and describe its use based on patient-specific characteristics. Determine secular trend of opioid use 2006 to 2014.Retrospective cohort study. A large Upper Midwest integrated health care system and insurer. Female individuals age 10 to 50 years with a delivery diagnosis from July 1, 2006 through June 30, 2014.prevalence of opioid use before, during, and after pregnancy; description of opioid use during these time periods.From 11,565 deliveries among 9690 unique women, 862 (7.5%) deliveries were associated with significant opioid use. Significant opioid use was associated with single marital status, Cesarean section, Medicaid coverage, tobacco use, depression, anxiety, bipolar disorder, substance use disorder, nonopioid analgesic use, and referral to physical therapy, psychotherapy, or pain specialists. From 2006 to 2014 opioid use decreased from 9% to 6% before, during, and after pregnancy with a rate of change per year of -0.2%.Known risk factors including tobacco and alcohol use, mental health diagnoses, substance use disorder, or Medicaid enrollment may enable enhanced assessments and targeted interventions to reduce unnecessary prescribing and use of opioids among pregnant women and those who might become pregnant. Strategies to decrease opioid use during pregnancy should be considered by health care systems and health plans to reduce opioid prescribing in this patient population.

Background Pharmacist-managed (team-based) care for hypertension with home blood pressure monitoring support interventions have been widely studied and shown to be effective in improving rates of hypertension control and lowering blood pressure; however, few studies have evaluated the economic considerations related to bringing these programs into usual practice. Objective To analyze the economic outcomes of the Blood Pressure Telemonitoring and Pharmacist Management on Blood Pressure (Hyperlink) study, a cluster randomized controlled trial which used home blood pressure telemonitoring and pharmacist case management to achieve better blood pressure control in patients with uncontrolled hypertension. Methods A prospective analysis compared differences in medical costs and encounters in the Hyperlink telemonitoring intervention and usual care groups in the 12 months pre- and post-enrollment using medical and pharmacy insurance claims from a health care sector perspective. Generalized estimating equation models were used to estimate differences between groups over time. These results, combined with previously published prospective study results on intervention costs and blood pressure outcomes, were used to estimate cost-effectiveness measures for blood pressure control and reduction. Findings Total medical costs in the intervention group were lower compared with the usual care group by an average of $281 per person, but this difference was not statistically significant. Clinic-based office visit, radiology, pharmacy, and hospital costs were also non-significantly lower in the intervention group. Statistically significant differences were found in lipid-related laboratory costs (higher) and in hypertension- (higher) and lipid-related (lower) pharmacy costs. Patterns in medical costs were similar for medical encounters. On average, the intervention cost $7337 per person achieving hypertension control and $139 or $265 per mm Hg reduction in systolic or diastolic blood pressure, respectively. Conclusions Home blood pressure monitoring and pharmacist case management to improve hypertension care can be implemented without increasing, and potentially reducing, overall medical care costs.

The purpose of this pilot study was to assess Chronic Myeloid Leukemia (CML) patients’ adherence to, beliefs about, and barriers to oral anticancer agents (OAC) using brief self-report measures in community-based cancer clinics. Patients completed a structured interview including a health literacy assessment, a Brief Medication Questionnaire, two single-item self-report adherence questions, and the Medications Adherence Reasons Scale. Of the 86 participants, 88.4% were white, 55.8% male, mean age, 58.7 years, and 22.1% had limited health literacy. Nonadherence (missing at least one dose in the last week) was reported by 18.6% of participants and associated (p &lt, 0.003) with less-than-excellent perceived ability to take CML medications (16.3%). Black participants reported more difficulty taking CML medications than white participants (28.6% vs. 8.3%, p = 0.053). Among all participants, 43.0% reported their CML medicine was ineffective and 24.4% that taking CML pills was somewhat to very hard. The most common reasons for missing a dose were simply missed it (24.4%) and side effects (18.6%). Most patients perceived their ability to take CML medication was good to excellent, yet nearly one in five reported missing at least one dose in the last week. Brief, no-cost self-report assessments to screen CML patients’ OAC adherence, barriers, and beliefs could facilitate counseling in busy community cancer clinics.

308 Background: Biosimilars for trastuzumab, a HER2 inhibitor (HER2I), have been available for use in the US since in 2019, yet information on their utilization and patient characteristics is limited. We assessed utilization and patient characteristics for the trastuzumab originator, biosimilars, and other HER2Is in the US. Methods: We analyzed healthcare claims for 10/1/2016-up to 2/29/2020 (end date varied across health plans) from the Biologics and Biosimilars Collective Intelligence Consortium’s Distributed Research Network ( > 95 million persons) using the FDA’s Sentinel distributed analysis tools. We conducted descriptive analyses on the number of incident users and patients’ characteristics for each HER2I. Adults continuously enrolled in their health plan with medical and drug coverage ≥365 days (baseline period) prior to their incident HER2I use were eligible for analysis. Results: Of the incident users (incident to any HER2Is), we identified 6,631 originator trastuzumab users, 122 trastuzumab-anns, 116 ado-trastuzumab emtansine, 54 neratinib, and 54 lapatinib users. Trastuzumab-dkst and trastuzumab/hyaluronidase-oysk had < 11 users each. Mean age was the highest for trastuzumab/hyaluronidase-oysk (73.7 years; SD, 18.6) and similar between the trastuzumab originator and biosimilars (52.5-59.0). The number of incident users/100,000 person-years decreased for the trastuzumab originator from 13.5 in 2016 to 9.4 in 2020 and increased for trastuzumab-anns from 0.4 in 2019 to 4.9 in 2020. Of the baseline clinical characteristics examined, Charlson/Elixhauser comorbidity score was the highest for lapatinib (2.0), lowest for trastuzumab-dkst and neratinib (0.5), and similar between the trastuzumab originator (1.1) and trastuzumab-anns (1.3). The proportion of patients who received any chemotherapy during the baseline period was 38.9% for lapatinib, 18.5% for the trastuzumab originator, and 14.8% for trastuzumab-anns. The proportion of endocrine therapy users was the highest for neratinib (63.0%) and similar between the trastuzumab originator (11.1%) and trastuzumab-anns (10.7%). Among incident users with metastatic breast cancer, endocrine therapy receivers during the baseline period accounted for 19.3% for the trastuzumab originator and 69.6% for lapatinib. Conclusions: Though full data were not available for 2019-2020 for all health plans, these preliminary findings suggest that utilization of biosimilar trastuzumab-anns increased whereas the trastuzumab originator use decreased over time and that there is a variation in patient characteristics between HER2Is and by metastatic status while the characteristics were generally similar between the trastuzumab originator and trastuzumab-anns. We plan to conduct ongoing assessment of HER2I utilization as more data become available to help inform clinical practices and health policies.

Purpose: Cancer-related pain is common, negatively affects quality of life and survival, and often requires treatment with opioid analgesics. Patient-reported data that describe the incidence and severity of pain, medication use, and patient satisfaction with care are lacking. Methods: We analyzed 18 months of outpatient oncology clinic encounters from the electronic medical record to obtain data on pain levels and opioid and nonopioid treatments. In June 2014, we instituted a pain intervention by creating a pain management information handout for patients, educating clinicians on opioid cost-effectiveness, and implementing a nursing protocol to document personalized pain goals (PPGs). Results: Moderate to severe pain was reported in nearly 15% of patient encounters. We observed an increase in the percentage of encounters with a documented PPG of 16% to 71% ( P < .001). On average, PPG was achieved in 84% of patients. Rates of high-cost long-acting opioid prescriptions (oxycodone controlled release and fentanyl patches), as a total of all long-acting opioids, declined from 45% preintervention to 33% postintervention ( P = .005). Conclusion: Our intervention improved rates of PPG documentation and decreased the number of prescriptions for high-cost long-acting opioids. Oncology clinics can implement simple quality improvement methods, such as asking patients about their PPG and educating clinicians about opioid costs, to improve outcomes and lower treatment costs.