bluuebunny/crossref_metadata_2025 huggingface dataset:
Impact of wallet cards compared to conventional chemotherapy education in patients with newly-diagnosed cancer.
Authors: Bhargava Anika , Jain Nikita , Rojan Adam , Ngo Phuong , Dong Brian
Published: September 2022

363

Background: According to American Cancer Society, 1.9 million new cases of cancer were diagnosed in year 2021, majority of who will undergo chemotherapy (1). With these treatments, there is often an overwhelming amount of information given to patients. We will first assess the percentage of new cancer patients that can recall their cancer treatments with the current patient education format. We then aim to improve patient understanding of their treatment with the introduction of a chemotherapy wallet card. Methods: This is a single center prospective cohort study at the University of Louisville, Brown Cancer Center. In phase one 50 new patients will be recruited from various oncology clinics who will receive conventional verbal chemotherapy education. On cycle two of their treatment, we will administer a survey (figure 1) to assess their understanding of their regimen. In phase two we will recruit 50 new patients and introduce a chemotherapy wallet card filled by the pharmacist to be given during their chemotherapy education and administer the survey on cycle two. We will then compare these two populations to evaluate the impact of the chemotherapy wallet cards. Results: Preliminary results from the first phase have been obtained of 15 newly diagnosed cancer patients. Surveys obtained on cycle two revealed 100% patients correctly identified their cancer diagnosis and 60% were able to correctly name their chemotherapy regimen. 53% of patients were able to identify three correct treatment side effects. Conclusions: Preliminary results show 60% of patients have suboptimal identification of their chemotherapy regimens. Previous studies have shown many patients will visit the emergency department in their first year of treatment. This is of concern as patients may not be able to provide accurate information of their current treatment to these providers resulting in suboptimal care. Our goal will be to see if chemotherapy wallet cards will help to increase patient knowledge and improve patient quality of care.[Table: see text]
Analysis of increased paclitaxel hypersensitivity at a single institution in setting of COVID 19 vaccination.
Authors: Jain Nikita , Bhargava Anika , Weaver Kelly , Volz Lesley , Conliffe Brette , Ingles Lauren , Dong Brian
Published: September 2022

364

Background: Paclitaxel is a commonly used chemotherapy agent effective in various malignancies. It is known to cause serious and potentially life-threatening hypersensitivity reactions (HRs). Pre-medication protocols have been employed, however approximately 10% of patients will still experience these reactions (1). On an internal review at the University of Louisville, Brown Cancer Center (UofL, BCC) there has been a considerable increase in the incidence of paclitaxel HRs from 4.2% in March 2020 - March 2021 to 14.8% in March 2021 - April 2022. Identifying risk factors that may predispose patients to these reactions is an area of interest in an effort to reduce these events. In this study we investigated clinical characteristics between patients that tolerated paclitaxel versus those who had a HR within the last year with a particular focus on the COVID-19 vaccine given the recent pandemic. Methods: This is a single center retrospective case-control study done at the UofL, BCC. Data was collected on patients who received cycle one day one paclitaxel from March 2021 to April 2022 (n = 135), and patients who developed a reaction were identified. Patient characteristics including demographics, COVID vaccination status, and prior allergies were also collected (table). A T-test analysis was performed between the two groups – those who had a HR and those who did not. Results: Of the 135 patients, 20 were found to have a HR. Absolute lymphocyte count (ALC) was found to be significantly higher with an average of 1125 in the HR group versus 853 in the no reaction group (p = 0.0357). Patients in the HR group also had fewer lines of chemotherapy with an average of 1.15 versus the no reaction group of 1.4 (p = 0.039). There was no significant difference between patients who received the COVID-19 vaccine and those who did not (table). Conclusions: Patients who experienced paclitaxel HRs were found to have higher levels of ALC and tend to be earlier in their treatment course with having undergone fewer lines of chemotherapy. Of note COVID-19 vaccination status appears to have no association with those experiencing paclitaxel HRs. The clinical implications of this requires further exploration in future studies[Table: see text]
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]
Rates of procedures among those with incidentally detected pulmonary nodules: A real-world data assessment.
Authors: Thompson Jeffrey C. , DaCosta Byfield Stacey , Hansen Pamela , Tucker Jamie , Vachani Anil
Published: September 2022

405

Background: With the increased utilization of chest computed tomography, incidental pulmonary nodules (PN) are frequently encountered in clinical practice. While several professional guidelines exist on PN management, limited evidence exists regarding the evaluation of PN in clinical practice. We examined the incidence of lung cancer (LC) and utilization of invasive procedures in patients with PNs using real-world data. Methods: We conducted a retrospective cohort study using longitudinal, real-world data with de-identified administrative claims and electronic health records (EHR). The cohort included adults (>18 years) with evidence of newly diagnosed PN (ICD9 793.11, 793.19; ICD10 R91.1*, R91.8*) from 1/2014 to 12/2020 in claims (the first claim identified was considered the index date) and ≥1 lung nodule measurement in the EHR with a note date +/- 30 days from the index date. Continuous enrollment in a commercial or Medicare Advantage plan for 12 months pre- and 12 months post-index was required. Exposure categories were created based on lung nodule size; < 6mm, 6-8mm, > 8mm-15mm, > 15-30mm. During the 12-month follow-up, we identified a diagnosis of invasive lung cancer (≥1 claims for ICD9 162.xx; ICD10 C34.xx) or carcinoma in situ of the lung (ICD9 231.xx; ICD10 D02.xx). Rates of repeat imaging, biopsy, and surgery were examined among patients with (LC cohort) and without lung cancer (benign PN cohort) during the 12-month follow-up period. Results: Among 4,304 patients with a nodule measurement, 4.7% (n = 201) were diagnosed with LC during the follow-up period; 2.1%, 4.2%, 8.2%, and 28.3% among those with lung nodules < 6mm, 6-8mm, > 8-15mm, and > 15-30mm, respectively. As expected, the proportion of patients receiving procedures during the follow-up period was significantly higher in patients with LC compared to those with benign PNs (p < 0.01), regardless of lung nodule size (see column percentages in Table). However, the majority (53%) of all procedures were performed in the benign PN cohort. Among all patients that underwent a procedure during the study period, 63% of bronchoscopy, 49% of TTNB, and 38% of thoracic surgery occurred in patients with benign PNs (see row percentages in Table). Conclusions: Although several professional guidelines exist for the management of incidental PN, there continues to be wide variation in the management of PNs with invasive procedures frequently performed in patients ultimately identified to have benign disease. Methods to improve risk stratification of pulmonary nodules would be of significant clinical utility.[Table: see text]
Real-world treatment patterns among men with metastatic castration-resistant prostate cancer (mCRPC) in the U.S. Medicare population.
Authors: Freedland Stephen J. , Davis Matthew , Epstein Andrew J. , Arondekar Bhakti , Ivanova Jasmina I.
Published: September 2022

406

Background: Multiple life-prolonging therapies have been approved for mCRPC, for example novel hormonal therapies (NHT; abiraterone [abi], enzalutamide [enza]), docetaxel (doc), cabazitaxel, sipuleucel-T, and radium-223. This study describes real-world treatment patterns with life-prolonging therapies and sequencing among men with mCRPC in the US Medicare population. Methods: Men newly diagnosed with mCRPC were identified in Medicare fee-for-service claims during 1/1/2014–6/30/2019. Adult men were required to have a diagnosis of prostate cancer, metastasis diagnosis, castration-resistance using a published claims-based algorithm, and continuous insurance coverage for ≥1 year before and ≥6 months after index mCRPC diagnosis unless patients died. Treatment patterns of life-prolonging therapies after mCRPC diagnosis and sequencing were described. Results: Among 14,780 men with mCRPC, median age was 75 years, 10% used NHT in the year prior to mCRPC, and 3% had prior taxane therapy. Median follow-up after mCRPC diagnosis was 17 months. 22% of men received no life-prolonging therapy after mCRPC diagnosis, 78% received ≥1 line of therapy with life-prolonging treatment after mCRPC diagnosis, 42% had ≥2, and 20% had ≥3. The most common first-line (1L) therapies were abi (36%), enza (28%), and doc (16%). The most common second-line (2L) therapies were enza (33%), abi (28%), and doc (15%). The most common third-line (3L) therapies were doc (24%), enza (19%), and abi (17%). Median time from start of 1L to next line of therapy or end of follow-up was 13.7 months, 10.9 months from the start of 2L, and 8.9 months from the start of 3L. The most common 1L to 2L treatment sequences among men with ≥2 lines were NHT followed by a different NHT (33%), chemotherapy followed by NHT (14%), and NHT followed by chemotherapy (13%). There were 5,630 men with ≥2 lines of therapy and ≥1 NHT, of whom 53% had ≥2 NHTs. Conclusions: Substantial proportions of men with mCRPC did not receive a life-prolonging therapy or had only 1L therapy after mCRPC diagnosis, with a 50% fall-off rate after each line of therapy. NHTs were the most common 1L and 2L therapies, and NHT followed by a different NHT was the most common treatment sequence. Further research is needed to understand how treatment patterns change as NHTs and doc are used earlier in the disease continuum and new therapies are introduced and ultimately to identify optimal treatment sequencing.
Clinical surveillance and PSA outcomes among patients with non-metastatic castration resistant prostate cancer (nmCRPC) treated with a next-generation androgen receptor inhibitor (ARI) in urology clinics with or without in-office dispensing (IOD).
Authors: Burbage Sabree , Waters Dexter , Rossi Carmine , Kinkead Frederic , Pilon Dominic , Muser Erik , Ellis Lorie
Published: September 2022

410

Background: As use of oral therapies in prostate cancer treatment increases, IOD of oral medication has become more common. The objective of this study was to describe clinical surveillance practices and PSA outcomes in nmCRPC patients (pts) treated in clinics with or without IOD. Methods: nmCRPC pts with ≥1 ARI prescription (Rx) were identified in data from 95 US urology practices between 2018-2021. Pts were categorized into 3 groups: (1) Treated in IOD clinic and received ARI onsite within 14 days of Rx (IOD+), (2) Treated in IOD clinic but no onsite ARI receipt within 14 days of Rx (IOD-), and (3) Treated in a clinic without IOD (non-IOD). Descriptive analyses were conducted on pt characteristics, PSA and imaging data. PSA response, reported using Kaplan-Meier rates, was defined as ≥50% reduction in post-index (PI; index date = 14 days after 1st ARI Rx) PSA compared to baseline PSA (measured within 13 weeks before 1st ARI prescription). PSA progression was defined as ≥25% increase in PI PSA above baseline PSA. Results: 3,300 nmCRPC pts were identified (N = 615 IOD+; 2,474 IOD-; 211 non-IOD). Baseline characteristics differed for race, use of bone resorption agents and 1st generation anti-androgens, and PSA doubling time (PSADT; table). By 6 months PI, PSA screening was observed in similar proportions of pts in IOD and non-IOD, while PSA response was observed in a higher proportion of IOD+ (80%) than IOD- (64%) or non-IOD (63%). PSA progression was observed in fewer IOD+ pts (10%) than IOD- (16%) or non-IOD (17%). PI imaging was conducted in similar proportions of pts in IOD and non-IOD clinics; however, non-IOD performed more imaging per pt and time to imaging was shorter than in IOD+ clinics. Conclusions: Differences were noted in patient characteristics and prior medication use in ARI-treated patients within IOD and non-IOD clinics. IOD+ was observed to have higher rates of PSA response, fewer patients with PSA progression, and use fewer imaging tests after ARI initiation than non-IOD or IOD-. Additional studies controlling for differences in baseline characteristics and examining longer term outcomes are needed to understand how IOD services impact quality of patient care.[Table: see text]
Identifying sources of burnout among clinicians at a cancer center: A qualitative analysis.
Authors: Nguyen Oliver , Alishahi Amir , Moore Colin Evan , Perkins Randa , Bickel Young Jennifer , Heimbeck Dorte , Turner Kea
Published: September 2022

429

Background: Clinician burnout leads to increased job turnover and workforce shortages, and reduced patient satisfaction and quality of care. Despite its importance, there has been limited study of burnout among the cancer care workforce including sources of burnout. This information can be used to inform intervention design for use in the cancer care setting specifically. To address this gap, we analyzed open-ended responses to a well-being survey administered to clinicians (physicians and advanced practice providers) at a Cancer Center. Methods: In February 2022, we electronically administered the American Medical Association’s clinician well-being survey to all practicing clinicians at a National Cancer Institute-designated Comprehensive Cancer Center in Florida. Of 700 clinicians, 405 (58%) responded. Of the respondents, 259 (64.0%) answered the free-text question “Tell us more about your stressors and what we can do to minimize them.” We used in-vivo coding to develop qualitative themes across responses. If a given response incorporated multiple themes, we coded the response under all pertinent themes. Results: A majority (76/259) of respondents commented on staffing issues, such as their clinics being understaffed or the quality of current staff. Another frequent theme (64/259) was the electronic health records (EHR) system, such as lack of integration between modules, inbox fatigue, alert fatigue, and inefficient documentation review processes. Respondents also reported scheduling issues as a pain point (56/259), such as having schedules that do not reflect actual clinical practice, being overbooked, and scheduling errors. Documentation burden was also highlighted as an issue across respondents (34/259). Documentation was considered tedious and some respondents reported a mismatch between available documentation tools in the EHR and actual documentation needs. Less common themes reported across respondents included design issues of facility space (e.g., no dedicated workspace to complete work without interruptions) and insufficient time to complete administrative, research, and documentation requirements. Conclusions: Our findings suggest that interventions that optimize staffing models, EHR processes (e.g., documentation), and scheduling practices may reduce burnout for a considerable number of cancer care clinicians.
Implementation of EHR medication-adherence screening tool in breast cancer clinic.
Authors: Desanti de Oliveira Beatriz , DeStephano David , Beauchemin Melissa Parsons , Law Cynthia , Howard Kristina ` , Wright Jason Dennis , Kronish Ian , Hershman Dawn L. , Accordino Melissa Kate
Published: September 2022

438

Background: Nonadherence to prescribed medications occurs frequently in patient with breast cancer (BC) and can affect BC outcomes as well as outcomes for comorbid conditions. We implemented a process to screen for medication adherence in the electronic health record (EHR) in an urban outpatient BC clinic. Methods: Plan-Do-Study-Act (PDSA) methodology was used to implement a screening process for medication adherence for all patients seen in the outpatient breast oncology clinic. At check-in (via the patient portal or clinic based kiosks), patients were asked to complete an EHR adherence screener. Two PDSA cycles were completed. During cycle one (2/16/22-5/17/22), patients were asked if they received ≥1 prescribed medication; if yes they were asked to complete the questionnaire (y/n); if yes a 3-item questionnaire was used to screen for adherence to all medications over the prior 7 days. Adherence was defined as 3 of 3 responses “none of the time” to “I have missed my medicine;” “I have skipped a dose of my medicine;” and “I did not take a dose of my medicine.” During cycle two (5/17/22-6/5/22) the screener was simplified. Patients were no longer asked to complete the survey; and the survey was modified to 1-item “I did not take a dose of my medicine”, adherence was defined as response of “none of the time”. We evaluated response rate and self-reported non-adherence rate. Results: During PDSA cycle 1 (2/16/22-5/17/22), 2840 visits occurred and 722 (25%) responses were received; 80% noted prescription of ≥1 medication, 38% agreed to complete the survey; and 87% reported adherence to all prescribed medications while 13% reported non-adherence. During PDSA cycle 2 (5/17/22-6/5/22), 512 visits occurred and 172 (33%) responses were received. Of those, 73% reported prescription of ≥1 medication; of those 66%-reported adherence to all prescribed medications, 21% reported non-adherence, and 17% preferred not to answer. Conclusions: This EHR screener is a simple and scalable tool to rapidly screen for medication adherence. Up to a quarter of patients who completed screening reported non-adherence. Further tools are needed to assess adherence among patients who lack access to the patient portal or clinic kiosk, or are uncomfortable checking in with these mechanisms. Future interventions are necessary to further screen potentially non-adherent patients and for interventions to improve adherence once vulnerable patients are identified.
Evaluating clinician emotion regulation during a serious illness conversation in oncology using multimodal assessment: A pilot study.
Authors: Wasp Garrett Thomas , Kaur Satveer , Andersen Eric , Vergo Maxwell Thomas , Chelen Julia , Tosteson Tor , Barr Paul J. , Barnato Amber E
Published: September 2022

439

Background: Clinician emotion regulation (ER), self and the patient’s, likely moderates successful prognostic discussions with patients, yet challenges around its evaluation limit its investigation. We performed a pilot study to develop and assess an experimental framework that uses multimodal assessment (self-report, observer, and biometric data) to measure clinician ER during a simulated, serious illness conversation (SIC). Methods: We developed our experimental framework in four steps: 1) drafted a patient case and assessment framework; 2) refined the data collection strategy using a multidisciplinary research team; 3) trained our actor; and 4) iteratively piloted the case to optimize data collection. For the assessment, we conducted a cross-sectional, case series pilot study with physicians trained in SIC to assess its feasibility and acceptability, defined a priori as an enrollment rate >60% of approached clinicians, > 90% completion rate of survey items, < 20% missing data from wearable heart rate variability (HRV) sensors. To characterize clinician ER strategies, we analyzed the visit dialogue, physician interviews performed while watching the visit back, and physician SIC documentation generated post visit. We used a hybrid approach of inductive and deductive coding and theme development based on preexisting ER theory. Results: The development phase yielded two major modifications: 1) abandoned use of AppleWatch since it did not provide continuous HRV measurement; and 2) used telehealth with video given context of COVID-19 pandemic. We approached 12 physicians and 11 enrolled, of which 5 were female and 10 white, 5 were medical oncologists, and 6 specialty palliative care physicians. All participants completed all study survey items. The results of our three HRV sensors were as follows: Empatica E4 and Polar H10 met our pre-specified HRV collection in all 11 resting tasks and SIC encounters, and the Scoche R24 the benchmark in 7/11 resting tasks and 4/11 of simulated encounters. Preliminary qualitative analysis suggests investigators can characterize clinician use of intrapersonal and interpersonal ER strategies. Conclusions: The use of multimodal assessment of clinician ER in a simulated, telehealth SIC visit was acceptable and feasible.
Genetic Dissection of Primary Aldosteronism in a Patient With MEN1 and Ipsilateral Adrenocortical Carcinoma and Adenoma
Authors: Parisien-La Salle Stéfanie , Corbeil Gilles , El-Haffaf Zaki , Duranceau Caroline , Latour Mathieu , Karakiewicz Pierre I , Lacroix André , Bourdeau Isabelle
Published: September 2022

Background

Adrenal tumors are found in up to 40% of patients with multiple endocrine neoplasia type 1 (MEN1). However, adrenocortical carcinomas (ACC) and primary aldosteronism (PA) are rare in MEN1.

Case

A 48-year-old woman known to have primary hyperparathyroidism and hypertension with hypokalemia was referred for a right complex 8-cm adrenal mass with a 38.1 SUVmax uptake on 18F-FDG PET/CT. PA was confirmed by saline suppression test (aldosterone 1948 pmol/L-1675 pmol/L; normal range [N]: <165 post saline infusion) and suppressed renin levels (<5 ng/L; N: 5-20). Catecholamines, androgens, 24-hour urinary cortisol, and pituitary panel were normal. A right open adrenalectomy revealed a concomitant 4-cm oncocytic ACC and a 2.3-cm adrenocortical adenoma. Immunohistochemistry showed high expression of aldosterone synthase protein in the adenoma but not in the ACC, supporting excess aldosterone production by the adenoma.

Genetic analysis

After genetic counseling, the patient underwent genetic analysis of leucocyte and tumoral DNA. Sequencing of MEN1 revealed a heterozygous germline pathogenic variant in MEN1 (c.1556delC, p.Pro519Leufs*40). The wild-type MEN1 allele was lost in the tumoral DNA of both the resected adenoma and carcinoma. Sequencing analysis of driver genes in PA revealed a somatic pathogenic variant in exon 2 of the KCNJ5 gene (c.451G>A, p.Gly151Arg) only in the aldosteronoma.

Conclusion

To our knowledge, we describe the first case of adrenal collision tumors in a patient carrying a germline pathogenic variant of the MEN1 gene associated with MEN1 loss of heterozygosity in both oncocytic ACC and adenoma and a somatic KCNJ5 pathogenic variant leading to aldosterone-producing adenoma. This case gives new insights on adrenal tumorigenesis in MEN1 patients.
Stendhal’s Definition of Beauty, in and as Philosophy
Authors: Weintraub Alex
Published: September 2022

In On the Genealogy of Morals (1887), Friedrich Nietzsche misquotes Stendhal’s definition of beauty. Beauty is not, as the German philosopher claims, “a promise of happiness” (72). Rather, Stendhal proposes in a footnote to his book De l’amour (1822)—in a chapter entitled “La Beauté détrônée par l’amour”—that “la beauté n’est que la promesse du bonheur” (40). Nevertheless, Nietzsche’s misquotation of Stendhal and his subsequent interpretation of the French author’s aesthetics have held sway in later philosophy, such that Stendhal is regularly recruited to endorse views about beauty quite dissimilar from his own. This article approaches Stendhal as a philosopher in order to develop a clearer sense of what the author really meant by characterizing beauty as “only a promise of happiness.” Through close readings of De l’amour and Rome, Naples, et Florence, it is proposed that Stendhal’s restrictive only allows for and even recommends so-called mere judgments of beauty, or the experience of beauty as a completed pleasure in reflective contemplation, as opposed to the Nietzschean reading of Stendhal, which would define judgments of beauty as forepleasures to future satisfactions. More importantly, this article aims to recover what Stendhal still has to teach present-day philosophers and critics about judgments of taste.
Should Shipwrecks Be Sweet?
Authors: Truglio Maria Rosa
Published: September 2022

Demand for books about current events in Italy has yielded scores of children’s books in the past three decades that treat the topic of immigration. The goals of eliciting empathy in children and explaining to them complex historical and contemporary events can be challenged by the perceived need to shield children from traumatizing scenes. This essay examines four recent children’s books published in Italy that dramatize immigration from Africa. Authors Maria Attanasio, Erminia Dell’Oro, Dino Ticli, and Francesco D’Adamo allude to canonical Western literature (such as Pinocchio and Cuore) as a way to sweeten these often bitterly disquieting narratives for their young readers. This essay probes the potentials and limits of intertextuality and ultimately argues that several texts go beyond leveraging the image of capsized ships in the Mediterranean, an image that has become a media fetish, to engage readers in ways that facilitate both empathy and critical self-reflection.
Electric Love Therapy
Authors: Modern John Lardas
Published: September 2022

In the early 1970s, as the industrial economy crumbled around Detroit and its suburbs, Dr. H. C. Tien, an independent electroconvulsive therapist who ran the Michigan Institute of Psychosynthesis in Lansing, MI, advocated a “cybernetic” approach to family psychiatry. In Tien’s practice, one can learn how the liberatory kernel of religion and the truth of sexual difference—key components of moral treatment in nineteenth-century asylum reform—became amplified by emerging paradigms of neural nets and information processing. In Tien’s practice—what he called Electric Love Therapy—electric shock treatment became a technology of conversion and, more precisely, of sexual differentiation and spiritual cultivation. Tien’s is a disturbing example of how the regulation of sexuality and gender as private matters serves as resource and spur to secular demands to proprietize religion as an interior matter.