bluuebunny/crossref_metadata_2025_split huggingface dataset:
Creation of standard work for the management of outpatient oral antineoplastic therapy.
Authors: Naveed Ahmad Junid Naveed , Whalen Nicole , Hemeon Karen , Rosales Joseph Grant F 
Published: September 2022

369 Background: Recently, there has been a dramatic increase in the use of oral antineoplastics for the treatment of various malignancies. The development of these agents has been so rapid that the infrastructure needed for their appropriate supervision has trailed their availability. Previously at Virginia Mason, there was no standard work established for the management of patients starting these agents and consequently there were defects noted, including delays in the medications’ delivery to the patient, lack of appropriate teaching regarding potential medication toxicities and even delayed provider follow-up. The goal of this project was to create standard work around the treatment initiation and follow-up of all patients starting outpatient oral antineoplastic therapy. Methods: A multi-disciplinary team of providers, nurses, and pharmacists held a flow mapping session to identify defects and waste points in the process between the prescription being written until the first provider follow-up visit after medication delivery. The team focused on decreasing the amount of time between prescription initiation and first clinic follow up, as well as increasing the percentage of RN teaching sessions performed and documented. This involved the creation of a dedicated inbox in the Electronic Medical Record (EMR) to which pharmacy and care manager nurses had exclusive access to facilitate rapid communication between team members. The work also resulted in the creation of an antineoplastics teaching template which was used to document teaching on potential treatment toxicities. Results: Standard work was created for the outpatient oral antineoplastic administration process and teaching documentation. Using the new tools, lead time was improved by 21.7% and teaching documentation was improved by 185% at the 30-day mark. These metrics were monitored over a 3 month period, and at the end of 90 days the lead time improvement was maintained at 21.2% and teaching documentation improvement at 110% (Table). Conclusions: The rapid development of oral antineoplastic medications has required Oncology practices to develop more robust workflow infrastructure to administer these medications properly and safely. We created standard work for the proper initiation and follow-up of oral antineoplastic therapy. In doing so we identified specific defects and instances of waste and were able to improve the workflow process to address these issues, resulting in measurable quality improvements and overall better patient care.[Table: see text]
Evaluation of patient decision aid for opportunistic salpingectomy and salpingectomy as sterilization method to prevent ovarian cancer.
Authors: Gelderblom Malou , Piek Jurgen M.J. , Briet J , Bullens Lauren , Coppus Sjors , Ebisch Inge , van Ginkel Alexandra , van de Laar Rafli , de Lange Natascha , Ngo Huy , Maassen Marloes , Oei Angele , Pijlman Brenda , Slangen Brigitte , Smedts Dineke , Vos M.Caroline , De Hullu Joanne , Hermens Rosella 
Published: September 2022

379 Background: The fallopian tubes play an important role in the pathogenesis of epithelial ovarian cancer. This has led to recommendations for performing bilateral salpingectomy as primary prevention of ovarian cancer, the opportunistic salpingectomy (OS). OS has gained territory globally, however with unwanted practice variation. Since all women have the right to be informed on OS, a patient decision aid (PtDA) on OS and salpingectomy as sterilization method has been developed to provide uniform counseling and reduce this practice variation. The aim of this study was to evaluate the effect of the PtDA on the decision-making process. Methods: As part of the STOPOVCA-implementation-study we conducted a multicenter observational prospective study between July 2020 until now. Women who were eligible for OS were invited to use the PtDA while they considered whether or not to undergo OS during gynecological surgery. Evaluation was performed using digital questionnaires regarding their decision, the decision process, and the PtDA. Preliminary. Results: In total 84 women participated to the questionnaire of which 71 used the PtDA. The majority chose to undergo OS (90%). Main reasons for women choosing OS were the risk reducing effect of ovarian cancer and the unnecessary preservation of the fallopian tubes after childbearing. After using the PtDA, from patients perspective the extent to which they were involved in the decision-making process was high, and the decisional conflict low. Patients thought it is a usable aid and recommend other women who face the decision regarding OS to use it with an 8.4 out of 10. Conclusions: The PtDA supports the decision-making on whether or not to undergo OS among patients who have completed childbearing and undergo abdominal gynecological surgery.
EMR-based clinical decision support to address rising Clostridioides difficile rates in a pediatric hematology/oncology/BMT unit.
Authors: Stokes Claire , Cotter Jillian , Cost Carrye Rudolph , Dorris Kathleen McCarthy O'Toole , Lugo Virginia , Child Jason , Coughlin Rebecca , Cox Stephanie , Hazleton Keith , Dominguez Samuel 
Published: September 2022

383 Background: The transition from conventional microbe detection methods to multiplex polymerase chain reaction-based gastrointestinal pathogen panels (GIP) has contributed to increased detection of Clostridioides difficile. Children undergoing cancer therapy often experience changes in stool patterns that present similarly to infectious diarrhea and they have high rates of C. difficile colonization, potentially leading to excessive testing and attendant false positive detection of C. difficile. In response to rising rates of C. difficile detection in our pediatric inpatient hematology/oncology/BMT unit, we developed and implemented a decision support tool to address rising rates of C. difficile for our population. Methods: A multidisciplinary team was convened in 2018 to develop an evidence-based clinical pathway for stool testing and C. difficile. treatment. A clinical decision support tool was designed and integrated into the electronic medical record (EMR) to guide providers in whether to order C.difficile testing in the presence or absence of broader GIP. This tool incorporated stool quality as documented by the Bristol stool scale and stool frequency, recent laxative administration, age, length of stay, and recent stool testing in order to limit C. difficile testing to those patients with high likelihood of infection. In parallel, a team focused on implementation of appropriate hand hygiene, universal gloving, ultraviolet disinfection, and signage to reduce colonization among our patients. Monthly rates of hospital acquired C. difficile. infections were followed from February 2018 through June 2020. Results: After introduction of the pathway and implementation of the stool testing restrictions, the rate of hospital-acquired C. difficile infection rate decreased from 27.6 to 14.3 infections per 10,000 hospital days a, 48.1% reduction. Conclusions: After implementation of an EMR-based clinical decision support reinforcing evidence-based practice guidelines, we observed a meaningful reduction in C. difficile infections on a pediatric hematology/oncology/BMT unit. Continuous efforts towards environmental changes to reduce colonization in our population potentially contributed to our success.
Telehealth closing racial/ethnic disparities? Increased adherence with remote symptom monitoring using patient-reported outcomes (PROs) among Black and Hispanic patients with telemedicine compared to in-person visits.
Authors: Subbiah Ishwaria M 
Published: September 2022

392 Background: Adherence with remote PROs in the real-world, non-clinical trial setting remains varied in pts with cancer. The rapid widespread telehealth into routine healthcare delivery raises concern for disparate impact on race/ethnic minorities. In this study, we sought to understand the impact of telehealth via electronic health record (EHR) on pt adherence with PRO-based remote symptom monitoring implemented through that same EHR portal. Methods: We queried a prospective institutional database of all PROs remotely delivered to our pts bw 1/1/18 - 12/31/21. Pts were divided into 2 time cohorts (pre-pandemic 1/1/18 to 3/31/20, mid-pandemic 4/1/20 to 12/31/21), their self-identified race/ethnicity, and age cohorts (AYA 15-39y, midage 40-64y, older adults 65y+). Then, one representative global symptom burden PRO measure used across different clinics was analyzed for completion in a representative month over 4 years, 2 pre- (Oct ’18, ‘19) and 2 mid-pandemic (Oct ’20, ‘21). We calculated descriptive statistics and compared (t-test, ANOVA) between time, race/ethnicity and age cohorts and independent variables. Results: Over 4 years, 93,875 unique patients received 1+ EHR-based remote PROs within their routine cancer care. Remote EHR-based PRO response rate almost doubled from pre-pandemic (35%, 12011 responders of 34742 pts) to mid-pandemic time (67%, 39812 of 59200 pts, p < 0.00001). Analysis of one global symptom burden PRO widely used at our institution pre- and during pandemic showed the response rates rising (56.7% pre-pandemic vs 84.9% mid-pandemic, p 0.0004) with the sharp rise traced to 2nd and 3rd quarters of 2020 (response rate, 42.4% vs 85%, p < 0.001), with the transition to telehealth. Within the representative 4m period, 2738 pts (1075 pts in 2 pre- & 1663 in 2 mid-pandemic months) were sent that PRO – median age 60y, range 17-94y; 290 AYA 15-39y, 1444 midage 40-64y, 1004 older adults 65y+. PRO response rate increased (52% pre- to 81% mid-pandemic) w more responding without reminders from clinic team (13% pre-pandemic to 79% mid, p < 0.001). Older adults saw the highest increases in PRO response rates up by 35% vs AYA up by 21% & midage up 27%, p 0.012). Response rate without clinic reminders increased significantly (AYA, by 71%, midage by 78%, senior by 61%, p < 0.00001). When further analyzing by visit type during pandemic, the increased PRO response rates are driven by telehealth where in-person PRO completion decreased by 19% (pre-pandemic 52%, during 33%) while pts who had an upcoming virtual visit had 94% PRO response rate (p < 0.00001). Conclusions: Pt adherence w PRO-based remote symptom monitoring increased during the pandemic due to telehealth with the greatest gains seen in racial/ethinic minorities, inc. Black and Hispanic patients with cancer.
One-year mortality and varying ascertainment windows for a Medicare claims-based proxy for frailty in women with stage I-III breast cancer.
Authors: Duchesneau Emilie Danielle , Sturmer Til , Kim Dae Hyun , Jonsson Funk Michele , Poole Charles , Kinlaw Alan C , Faurot Keturah R , Her Qoua L , Wang Tiansheng , Lund Jennifer Leigh 
Published: September 2022

396 Background: Frail cancer patients are more likely to die or experience treatment toxicity than non-frail patients. The Faurot frailty index (FFI) is a validated Medicare claims-based proxy that predicts frailty in individuals. Frailty is dynamic and can change over time. We assessed the distribution of the FFI and associations with 1-year mortality using varying durations of frailty ascertainment windows in breast cancer patients. Methods: We identified women (66+ yrs) with stage I-III breast cancer in the SEER-Medicare database who had ≥1 year of continuous enrollment in Medicare Parts A and B prior to diagnosis. The FFI-predicted probability of frailty was assessed using demographic and diagnostic and procedural billing information during varying pre-diagnosis ascertainment windows: 3, 6, 8, or 12 months or using all available pre-diagnosis claims. We described the distributions of the claims-based frailty measures using each of the five ascertainment windows and reported 1-year mortality for individuals with high (≥0.20), medium (0.05 - < 0.20), or low (< 0.05) claims-based frailty using Kaplan-Meier analysis. Follow-up began on the date of cancer diagnosis. Results: We identified 235,145 women with breast cancer. Using a 3-month ascertainment window, 76%, 20%, and 4% were classified as having low, medium, and high claims-based frailty. Although the distributions of claims-based frailty were similar using 3, 6, 8, and 12-month frailty ascertainment windows, the use of all available lookback led a wider interquartile range (IQR) for claims-based frailty (Table). Overall, 4% of women died within 1 year of diagnosis. Higher claims-based frailty was strongly associated with increased 1-year mortality risk, using each ascertainment window. Mortality associations were strongest with a 3-month ascertainment window: risk difference (RD) high vs. low frailty 20% (95% CI, 19-20%). Associations were weakest with an all available lookback window: RD high vs. low frailty 11% (95% CI, 11-12%). Conclusions: Varying frailty ascertainment window durations did not lead to substantial differences in the distribution of the FFI in women with stage I-III breast cancer. Associations between the FFI and 1-year mortality monotonically decreased with increasing ascertainment window durations. This may be due to claims in the distant past having less etiological relevance for predicting mortality during the year following cancer diagnosis.[Table: see text]
Treatment patterns, clinical outcomes, and costs following the approval of new systemic therapy medications for hepatocellular carcinoma.
Authors: Pham Timothy , Gordon Aliza , Debono David Joseph , Fisch Michael Jordan 
Published: September 2022

398 Background: Between March 2017 and May 2020, ten new systemic medication therapies for hepatocellular carcinoma (HCC) were approved for the US market. However, clinical trials for medications only showed marginal improvement in health outcomes compared to placebo or sorafenib, the only medication previously approved for HCC. The objective of this study was to examine the change in treatment patterns and outcomes of incident patients with HCC before and after multiple medication approvals. Methods: This observational cohort study used administrative medical and pharmacy claims data for adult commercially insured and Medicare Advantage patients with at least two diagnoses of HCC during July 2013 to December 2020. Patients were categorized into two groups: the pre-approval group (identified between July 2013 and March 2017) and the post-approval group (identified between April 2017 and December 2020). We compared systemic therapy treatment (e.g., sorafenib and lenvatinib) patterns, survival, hospitalization for serious infections, other treatments such as G-CSF use and liver transplants, and cost (e.g, total all-cause costs and anti-HCC systemic therapy). Generalized linear model and Cox proportional hazards regression were used to assess the effect of new approvals on outcomes while controlling for baseline characteristics. Results: We identified 2,730 patients in the pre-approval group and 2,290 patients in the post-approval group. After risk adjustment, the latter was more likely to use systemic therapy medications (20.4% vs. 13.7%, adjusted odds ratio [aOR] 1.41, 95% confidence interval [CI] 1.22-1.62). Overall survival remained similar between the two groups (adjusted hazard ratio [HR] 0.96, 95% CI 0.87-1.06) and among the subsets who used systemic therapy (aHR 1.10, 95% CI 0.91-1.32). Odds of liver transplant (aOR 1.03, 95% CI 0.80-1.34) and hospitalization for serious infections (aOR 0.95, 95% CI 0.87-1.09) were similar, while the post-approval group had lower odds of G-CSF use (aOR 0.59, 95% CI 0.48-0.73). No differences in total per-member-per-month (PMPM) costs were seen, but the post-approval group had lower PMPM pharmacy-related costs (adj cost diff -$1,188, 95% CI -$1,575 to -$755) and higher PMPM systemic therapy costs (adj cost diff $971, 95% CI $584 to $1446). Conclusions: As expected, use of newer systemic therapies in HCC patients increased following approval of new medications. However, there was no associated change in clinical outcomes such as survival or serious infections, providing additional real-world evidence of marginal improvement, if any. Pharmacy costs decreased in the post-approval group, which may reflect a shift from oral sorafenib to newer injectable systemic therapies.
Real-world utilization of liquid biopsy for epidermal growth factor receptor (EGFR) testing in patients with metastatic non-small cell lung cancer (mNSCLC).
Authors: Shah Anne , Apple Jon , Ryan Debra L. , de Silva Kevin , Cai Ling , Shenolikar Rahul 
Published: September 2022

402 Background: Tissue biopsy (TB) testing is the standard of care to guide the selection of targeted therapy in EGFRm patients with mNSCLC. However, liquid biopsy (LB) tests are increasingly important in assessing tumor genomics at mNSCLC diagnosis. This study assessed real-world utilization of LB for EGFR testing in 1L setting and its influence on 1L treatment decisions in mNSCLC patients. Methods: Adults newly diagnosed with mNSCLC from January 1, 2019 to May 31, 2021 and treated with 1L were identified from the Flatiron EMR database. LB utilization and patterns (either used alone or in combination with TB) were evaluated. “Concurrent” (TB & LB) testing was defined as patients with both test order dates prior to result dates for either test, while “sequential” (TB & LB) testing was defined as patients having one test’s result date before the other test’s order date. As patients could have multiple biomarker tests, the first two EGFR tests following diagnosis were evaluated. Results: Of 5,036 patients that met the study criteria, 89.2% (N = 4,494) had EGFR testing following diagnosis. Among those tested for EGFRm, 63.7% (N = 2,864) had TB only, while 36.3% (N = 1,630) had LB (LB only: 37.9%; concurrent: 36.1%; sequential: 26.0%). Around 90% of patients with LB had NGS testing (87.7% received LB testing within 90 days of diagnosis). Among patients who initiated 1L after EGFR testing, the median (IQR) time in days from testing to 1L initiation varied by testing patterns: LB only: 18 (12-30); concurrent: 29 (22-39); sequential: 28 (18-41). Disagreement in test results was 10.6% for patients who had conclusive test results for both TB and LB tests. Among concurrent EGFRm patients (N = 130), 21.5% initiated 1L after receiving LB results (and before TB results) and 60.0% after receiving both test results. Among patients with sequential LB followed by TB (N = 10), 80.0% of them initiated 1L after receiving LB results and before TB results (Table). Conclusions: In this real-world study among mNSCLC patients in a 1L setting, more than one-third used LB for EGFR testing, either alone or in combination with TB. Among LB patients, majority had NGS testing.[Table: see text]
Time trends of overall survival and other outcomes in patients with mHSPC: An observational study of U.S. EHR data (TIMES).
Authors: Shore Neal D. , McKay Rana R. , Preston Mark , Gregg Justin R. , Salami Simpa Samuel , Ross Ashley , Bruno Amanda , Srinivasan Shankar , Ortiz Jorge A. , Constantinovici Niculae 
Published: September 2022

403 Background: Metastatic hormone-sensitive prostate cancer (mHSPC) initially responds to androgen deprivation therapy (ADT), but unfortunately most patients (pts) develop metastatic castration-resistant prostate cancer (mCRPC) within 1–3 years. The CHAARTED trial showed a clear benefit of adding docetaxel (DTX) to ADT, improving median overall survival (OS) by 10.4 months (mo). ARASEC is a single-arm US study evaluating darolutamide + ADT in 200 pts with mHSPC, who will be matched using patient-level data to the ADT alone arm of CHAARTED. The TIMES study evaluated a potential time bias in treatment patterns and clinical outcomes in pts with mHSPC receiving therapy before or after the OS analysis of CHAARTED was reported. Methods: This retrospective study used Flatiron Metastatic Prostate Cancer Core Registry data from January 1, 2013, to June 30, 2020, divided into two cohorts: before and after June 30, 2016 (cohort 1 pre-CHAARTED; cohort 2 post-CHAARTED). Differences in OS and time to mCRPC were assessed using Cox proportional hazard models controlling for baseline characteristics, including age, initial mHSPC treatment, Gleason score, and time from prostate cancer diagnosis to mHSPC. The test for equivalence used hazard ratio (HR) confidence limits of 0.80 to 1.25 at a 2-sided 95% level. Results: Data from 9256 pts with mHSPC (cohort 1 4503; cohort 2 4753) were analyzed. Median age was 73 years in both cohorts. M1 status at initial diagnosis was 55% in cohort 1 and 60% in cohort 2. Other clinical characteristics and laboratory values were generally similar. mHSPC treatments are shown in the Table. Use of DTX or novel anti-hormonal agent (NAH) increased from cohort 1 to cohort 2. The percentage of pts receiving ADT alone or with other treatment (supportive care) remained essentially the same (25.7% and 26.5%, respectively), and no mHSPC treatment was identified for 32.9% and 21.7% of pts in cohorts 1 and 2, respectively. Median OS was 5.4 months longer for cohort 1 (43.7 mo) vs cohort 2 (38.3 mo). In multivariate analyses adjusting for baseline variables, cohort 2 had poorer survival, with an HR upper confidence limit outside the predefined limits for equivalence (HR 1.18; 95% CI 1.09, 1.28). The HR for time to mCRPC fell within the predefined limits (HR 1.16; 95% CI 1.09, 1.23). Conclusions: Changes in treatment patterns were observed following CHAARTED, but use of DTX or NAH increased only to 32%, despite level I evidence and guideline recommendations. Real-world mHSPC patient outcomes, which are influenced by multiple factors, have changed minimally during the past 5 years, suggesting that use of the CHAARTED ADT alone arm as a comparator for ARASEC has a low risk of historical time bias.[Table: see text]