bluuebunny/crossref_metadata_2025_split huggingface dataset:
Preference-weighted quality of life: Findings from the Selenium and Vitamin E Cancer Prevention Trial (SELECT).
Authors: Rock Matthew , Vaidya Riha , Till Cathee , Unger Joseph M. , Hershman Dawn L. , Maeng Daniel , Krouse Robert S. 
Published: September 2021

144 Background: The differences in preference-weighted health-related quality of life (HRQOL) among racial and ethnic groups have been previously reported. The Selenium and Vitamin E Cancer Prevention Trial (SELECT) enrolled 35,533 men aged 50 years and older, among whom 20% were minorities. HRQOL, using the SF-36V, was examined for a subset of participants. Using these survey data, we examined the preference-weighted HRQOL differences across the racial/ethnic categories included in SELECT. Methods: SELECT participants who completed the SF-36V at baseline, and subsequently in at least one of years 1, 3, and 5 were included. We used the SF-6D to calculate an HRQOL score ranging between 0 (worst possible) and 1 (best possible) for every participant using data from the SF-36V. We modeled the association of race/ethnicity with SF-6D scores using a linear mixed model adjusting for demographic and clinical characteristics. Results: At baseline, 9,691 men were eligible for analysis. Hispanic and non-Hispanic white participants had higher unadjusted mean SF-6D scores than non-Hispanic Black participants at baseline and every subsequent time point (p<0.05; Table). Non-Hispanic white participants had lower mean scores than Hispanic participants at every time point after baseline. After adjusting for demographic and clinical characteristics there are statistically significant differences in HRQOL among all three groups. In particular, Hispanic participants had higher scores than white participants by.074 (p<.001),.076 (p<.001), and.039 (p<.001) in years 1, 3, and 5 after baseline. Conversely, compared to non-Hispanic White participants, non-Hispanic Black participants had lower scores by.009 (p=.004) and.008 (p=.02) in years 1 and 3 after baseline. Conclusions: In this sample of men enrolled in a prostate cancer chemoprevention trial, preference-weighted HRQOL using the SF-6D was higher for Hispanic men than for white and Black men, and lower for Black men than for white men. Understanding how individuals belonging to different racial and/or ethnic categories view their own HRQOL is necessary not only for delivering culturally competent care but also for conducting accurate cost effectiveness analyses of new interventions and programs. Further research that includes a sample with women, reports on more categories of race/ethnicity, and explores underlying potential cultural and social differences is necessary. [Table: see text]
Mobile app and wearable sensor-based patient and caregiver physical function and reported outcomes: A survey on oncologists’ current practices and preferences on data delivery.
Authors: Neeman Elad , Kubo Ai , Kurtovich Elaine , Aghaee Sara , Ramsey Maya , Yunis Reem , Kolevska Tatjana , Liu Raymond , Oakley-Girvan Ingrid 
Published: September 2021

174 Background: Patient-reported outcomes and wearable sensor measures of physical function can predict important outcomes in oncology. However, mobile and wearable-sensor apps collect vast information from patients and caregivers; indiscriminate reporting may increase provider burden and reduce data reliance. This study aimed to assess medical oncologists’ current practices in utilizing such information, and their data delivery preferences. Methods: Cross-sectional survey delivered by email to all Kaiser Permanente Northern California medical oncologists, February-March 2021. Results: Thirty-eight oncologists (30% of 127) responded to the survey. Most agreed that to reduce adverse events (AEs) it is important for the oncologist to know about the following measures: 1) patient/caregiver-reported physical symptoms (92% responded either very important or essential); 2) patient/caregiver-reported physical function (87%); and 3) objective measures of gait/balance (55%) and physical activity (50%) obtained from wearable sensors. Similarly, most respondents strongly consider these data when making decisions related to treatment intent, dosage, or visit frequency. All respondents routinely rely on information from caregivers, and in case of a discrepancy, more rely on the caregiver’s report (45%) than the patient’s report (8%), and some seek additional objective information (26%). Most respondents indicated that they prefer to receive electronic information on physical function and symptoms only for “critical values” and/or to have the information accessible “as needed” in the electronic chart, but not actively delivered to them (Table). Conclusions: Oncologists believe that patient/caregiver reports of symptoms and physical function can predict AEs, and strongly rely on them in clinical decision making. The majority of respondents would like to have access to physical function/symptoms data from mobile/wearable apps, with more providers wishing to receive information prior to a visit and/or in case of “critical values”. These findings may inform future implementations of mobile/wearable technologies to track symptoms and function of cancer patients.[Table: see text]
“The waiting is the worst”: Development of a next day access (NDA) program for patients with cancer.
Authors: Mougalian Sarah Schellhorn , Shomsky Lisa , Major Campos Maureen , Chiang Anne C. 
Published: September 2021

205 Background: Delays in access to treatment can cause anxiety and distress in patients with cancer. Time to treatment is increasing nationally, with retrospective analyses showing worse outcomes in patients with longer times to treatment initiation. It is critical to implement interventions that enhance navigation, improve access to cancer care, and eliminate operational and cultural barriers to prompt establishment of care and subsequent treatment initiation. We piloted a program for oncologic consultation within 1 business day in two subspecialty clinics and two network sites within our NCI designated comprehensive cancer center. Methods: Each pilot team created an implementation plan, with algorithms defining patients “eligible” for NDA. Generally, patients with a diagnosis or findings suggestive of cancer were eligible; full records were not required prior to the NDA visit. Interventions included adjusting physician templates and use of specific scripting to set expectations for patients prior to NDA visit. An institutional dashboard was created to display metrics--including new patient volume, % NDA visits, and reasons for non-utilization. Plan-Do-Study-Act cycles were completed every 2 weeks to assess data input/validity and address challenges. Patients seen via NDA completed a brief anonymous survey regarding their experience. Results: In 7 months, a total of 3107 new patients were seen across the 4 pilot sites, 900 (29.8%) of whom met “next day appropriate” criteria, and 370 (12%) of whom were seen via NDA. Uptake of NDA appointments was higher in patients with breast cancer. NDA patient satisfaction was extremely high, with 96% indicating that expectations were met or exceeded. Over half (56%) responded that a timely appointment was important when choosing a cancer center. The most common reasons patients were not seen via NDA included: specific provider requested (41%), specific date requested (23%), unavailable next day appointment (6%). Cultural barriers, particularly from treating physicians, included feeling that NDA appointments were inefficient with incomplete data, less time for clinical review, and increased burden due to last minute new patients; operational challenges included insufficient staffing and ensuring complete/accurate data collection. During 12/2019 – 2/2020, median time to first visit ranged from 17 to 36 days; median time to first visit decreased in 3 of the 4 pilot sites to 6-20 days 1 year later. Conclusions: Overall, 12% of patients were seen via NDA Success of this pilot required extensive effort to address change management and perceived barriers. Deployment in other disease teams and community sites is underway.[Table: see text]
Health-system specialty pharmacy impact on oral chemotherapy outcomes.
Authors: Sheikh Tehsinabanu , Wu Cindy , Kalfayan Niree , Sakamoto Leanne , Shane Rita 
Published: September 2021

240 Background: Oral chemotherapy usage has grown significantly over the years as it provides a more convenient and less invasive administrative option for patients.In 2019, 89% of large hospitals owned and operated their own Health System Specialty Pharmacies (HSSP)1.Pharmacist-led medication therapy management services are crucial to provide patient education, monitoring of medication adherence and adverse effect management. With the current vertical integration of health plans and pharmacy benefit managers (PBMs) increasing their dominance over specialty dispensing channels, HSSP are often excluded from specialty networks. The objective of this study is to compare outcomes of oncology patients filling their oral chemotherapy at Cedars Sinai Medical Center (CSMC) Specialty Pharmacy versus those who are filling their medications at outside specialty pharmacies (OSP). Methods: Electronic health records were used to conduct a retrospective chart review of patients started on oral chemotherapy at CSMC between January 2019 to January 2021. Primary endpoints included time to treatment (TTT) and proportion of days covered (PDC). Secondary endpoints included drug-related problems (DRPs) and treatment-related ED visits and hospitalizations. DRPs were categorized by severity and type of intervention. Results: There were 100 patients included in the study: CSMC group (n = 50) and OSP group (n = 50). Patients in the CMSC group had significantly shorter TTT compared to OSP group (4 days vs. 9.5 days, respectively [P < 0.0026]), as well as a higher PDC (99.5% vs 91%, respectively [P < 0.0005]). Pharmacists identified and resolved 31 DRPs in CSMC arm with 19 DRPs categorized as serious and 1 DRP categorized as life-threatening. For the OSP group, 23 preventable DRPs were identified with 12 DRPs categorized as serious and 1 DRP categorized as life-threatening. There were no treatment-related ED visits or hospitalizations in either group. Conclusions: Patients filling their oral chemotherapy at CSMC Specialty Pharmacy had significantly quicker TTT and higher adherence rates as measured by PDC. Numerous DRPs were identified for OSP patients; potential pharmacist-interventions could have led to optimized and safer medication therapy if filled at a HSSP. Continued research comparing treatment outcomes and interventions made between HSSP and OSP can create a strong argument for health plans and PBMs to consider inclusion of HSSPs into their specialty networks. References: Pedersen CA, Schneider PJ, Ganio MC, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: Prescribing and transcribing—2019. American Journal of Health-System Pharmacy. 2020;77(13):1026-1050. doi:10.1093/ajhp/zxaa104
Health-related quality of life outcomes in adults with nonmuscle-invasive bladder cancer receiving a mitomycin-containing reverse thermal gel as a primary treatment (Optima II: Phase 2b, single-arm, open-label trial).
Authors: Stover Angela M. , Basak Ramsankar , Mueller Dana , Smith Angela B. 
Published: September 2021

270 Background: The standard of care for low-grade non‐muscle‐invasive bladder cancer (LG NMIBC) is transurethral resection of the bladder tumor, which can worsen health‐related quality of life (HRQOL). The “OPTimized Instillation of Mitomycin for Bladder Cancer Treatment” (Optima II, clinicaltrials.gov: NCT03558503) is a Phase 2b, open label, single arm, multicenter trial evaluating a nonsurgical alternative as a primary treatment. Patients receive six weekly instillations of UGN-102, a mitomycin-containing reverse thermal gel with a sustained release time of up to 8 hours. We report on HRQOL changes between baseline and the primary endpoint of 3 months. Methods: A total of 63 patients enrolled in the Optima II trial at 20 sites in the U.S. and 2 sites in Israel between October 2018 and October 2020. Of the 63 patients enrolled, 44 were in the HRQOL cohort and completed a quarterly questionnaire. The QLQ-NMIBC24 has six subscales (urinary symptoms, malaise, future health worries, bloating and flatulence, sexual functioning, and male sexual problems) and five single items (intravesical treatment issues, sexual intimacy, worry about contaminating partner, sexual enjoyment, and female sexual problems) assessed with 24 items. Items were rescaled to 0-100 and reverse-coded so that higher scores indicate worse symptom burden. Longitudinal score changes were evaluated using the Sign test. We examined demographic and clinical characteristics associated with HRQOL change scores with regression modeling. A p-value of ≤0.01 was used. Results: The HRQOL cohort was 61% men, 57% age 65+, and 89% non-Hispanic White. Clinically, most LG NMIBC patients had multiple tumors (88%) with prior NMIBC episodes (77%), and two or more prior transurethral resection of bladder procedures (TURBT) (85%). Approximately half (55%) had their most recent TURBT surgery within 12 months of trial enrollment. No patients had missing HRQOL data at baseline or the primary end point of 3 months. The chemoablative reverse thermal gel used as a primary treatment did not cause decrements in patient-reported urinary symptoms, bloating/ flatulence, malaise, fever, general health, or future health worries. Sexual function mildly worsened between baseline and 3 months, and abated by 6 months. Demographic and clinical characteristics were not correlated with HRQOL change scores. By 3 months, 31/44 (70%) LG NMIBC patients achieved a complete response (negative endoscopic examination, cytology, and for-cause biopsy) and 0 experienced a recurrence. By 12 months, 8/44 (18%) patients had a recurrence. Conclusions: Adults with LG NMIBC in a Phase 2b trial who received a mitomycin-containing reverse thermal gel with sustained release maintained their HRQOL through 3 months. A Phase 3 trial is warranted. Clinical trial information: NCT03558503.
Assessing oncology patient and provider telehealth experience.
Authors: Eng Kelly , Donohue Caitlin C. , Wagner Andrew J. , Dougherty David W. , Salehi Elahi , Lowenstein Carol , Gundersen Daniel A. , Lederman Ruth , Kadish Sarah 
Published: September 2021

284 Background: Due to COVID-19, telehealth volume at our comprehensive cancer center rose from less than 5% of exam visits to over 25% in April 2020. We sought to understand the experience of telehealth and compare it to in-person experiences for patients and providers (physicians, nurse practitioners, and physician assistants) to identify areas for improvement. Methods: A multidisciplinary team adapted our existing patient satisfaction survey to incorporate telehealth, defined as phone and video exam visits. A technology section was created to assess aspects unique to telehealth. Questions about the patient-provider experience were the same for telehealth and in-person visits. A provider experience survey was conducted during a two-week period in May and June 2020. The provider survey aligned questions with the patient survey to compare the perceptions of the provider-patient interaction. Results: Patient experience scores for in-person and telehealth visits were comparable, with a slightly higher mean score for in-person visits. The mean scores for patient perception of care given at our cancer center was 97.5 (n=11,969) and 96.9 (n=4670) and the likelihood to recommend was 97.8 (n=12,072) and 97.4 (n=4,398) for in-person and telehealth, respectively, between June and December 2020. Patient feedback prioritized addressing technical barriers. We implemented several interventions and increased the telehealth technology section mean scores from 93.2 (n=1,095) to 95.2 (n=700) between June and December 2020. When comparing the percent of respondents scoring good or very good, provider scores showed sizable gaps between in-person and telehealth experiences on all questions (see table). The question “degree to which the care team was well coordinated” had the largest difference between in-person and telehealth scores for both patients and providers. Several interventions to adapt staffing and workflows have been implemented to improve care telehealth coordination. Conclusions: While patients reported similar satisfaction between in-person and telehealth visits, increasing coordination remains vital to improving the experience for both patients and providers. Furthermore, understanding the gap in the provider experience between in-person and telehealth is critical for successful adoption of telehealth as a long-term strategy for healthcare delivery.[Table: see text]
Durvalumab consolidation therapy following chemoradiotherapy among patients with unresectable stage III non-small cell lung cancer (NSCLC) treated in a U.S. community oncology network.
Authors: Waterhouse David Michael , Yong Candice , Robert Nicholas J. , Aguilar Kathleen M. , Ndukum Juliet , Xie Yiqiong , Seal Brian S. , Cotarla Ion 
Published: September 2021

295 Background: While the introduction of durvalumab consolidation therapy shifted the treatment paradigm for unresectable stage III NSCLC, few studies have examined real-world use of durvalumab in this patient population. Methods: This was a retrospective study of adult patients diagnosed with unresectable Stage III NSCLC between 8/1/2017-2/29/2020 who received chemoradiotherapy (CRT) followed by durvalumab consolidation therapy in The US Oncology Network. Structured electronic health record (EHR) data was used to screen for potentially eligible patients who received durvalumab consolidation. Through a targeted chart review, patients’ eligibility was verified. Study variables on patient demographics, clinical characteristics, CRT and durvalumab treatment patterns were sourced from structured and unstructured EHR data. Results: Among 1,626 patients who received CRT during the study observation period and were screened through structured records, 851 (52.3%) of these patients received durvalumab. Through chart review, 528 patients were verified to be eligible for this analysis (median age 70 years, 51.5% male, 18% Eastern Cooperative Oncology Group performance status [ECOG PS] score of 0, 59% with an ECOG PS score of 1). Across the study population, 73.9% received a total radiation dose between 54 and 66 Gy, with the rest receiving higher doses (6.5%), lower doses (3.2%) or doses not documented (15.8%). The mean and median time from end of radiation to post-CRT scan were 41 and 36 days, respectively; the mean and median time from end of radiation to durvalumab initiation were 58 and 47 days, respectively, with 57% of patients initiating durvalumab > 42 days. At the end of study observation period (median follow-up duration of 46.9 weeks), 173 of 528 patients (32.7%) were still actively receiving durvalumab treatment, 98 (18.6%) had completed planned treatment and 257 (48.7%) had discontinued treatment due to progression (18.2%), adverse events (17.2%), death (5.3%) or other reasons (8%). Conclusions: These results provide insights into real-world use of the PACIFIC regimen in a community setting with an older and more fragile population. Radiation therapy doses administered during CRT were largely consistent with the PACIFIC trial. There were delays in time to post-CRT scan and durvalumab initiation, with more than half of patients starting durvalumab > 42 days after CRT. These findings highlight opportunities for quality improvement measures in this population.
Real-world EGFR testing patterns among U.S. patients with advanced NSCLC.
Authors: Vanderpoel Julie , Pericone Chris , He Jinghua 
Published: September 2021

298 Background: Guidelines recommend mutation testing prior to initiating first-line therapy (L1) for patients with advanced non-small cell lung cancer (aNSCLC), including testing for epidermal growth factor receptor (EGFR) mutations. Guidelines also recommend further testing after patients progress on targeted therapy to identify possible resistance mutations and inform selection of subsequent treatment. The present study characterized real-world (RW) EGFR testing patterns in aNSCLC patients. Methods: This retrospective observational cohort study evaluated an aNSCLC cohort (stage IIIB or higher) from the Flatiron Health database. Eligible patients were newly diagnosed, ≥18 years old, and received at least one line of therapy (LOT) during 2015-2020. Patients were followed to last activity, death, or end of the study period, whichever came first. Results: The final study cohort included a total of 22,726 patients. Of these, 17,165 (75.5%) had ≥1 EGFR test and 2,611 (15.2% of the tested study population) tested positive for EGFR mutations at any time during the study. The proportion of aNSCLC patients receiving EGFR testing prior to L1 initiation increased from 45.2% in 2015 to 56.6% in 2020. Among 11,791 patients who had an EGFR test prior to initiation of L1, 1,944 (16.5%) had positive results. Of these, the cumulative proportion of patients receiving a second EGFR test prior to L2, L3, and L4 (contingent on receiving the following LOT) was 36.3% (322 out of 888), 55.4% (241 out of 435), and 67.0% (146 out of 218), respectively. From 2015-2020, the median time from sample collection to EGFR test results decreased from 26 to 16 days for next generation sequencing (NGS) tests and from 17.5 to 12 days for polymerase chain reaction (PCR) tests. During this same period, the proportion of NGS EGFR tests increased from 27.6% to 75.0%. In addition, use of plasma samples for EGFR tests increased substantially (6.3% to 36.5%). Conclusions: The proportion of aNSCLC patients tested for EGFR mutations has increased over time (2015-2020). Median time to available EGFR test result has decreased for both NGS and PCR tests. NGS testing has become increasingly more common as has use of plasma samples. However, opportunities for improvement exist, including further increasing the proportion of patients tested prior to initiation of L1 therapy, as well as testing prior to the selection of subsequent therapy when indicated. As more targeted therapies emerge and resistance mutations to current therapies are further characterized, continued refinement of RW testing practices is required to optimize patient care.