bluuebunny/crossref_metadata_2025_split huggingface dataset:
Would patients benefit from a decision aid for surgical decision making for rectal cancer? A qualitative analysis.
Authors: Goldwag Jenaya , Saunders Catherine , Read Jackson , Durand Marie-Anne , Elwyn Glyn , Ivatury Srinivas J 
Published: May 2020

e19139 Background: Rectal cancer surgery drastically changes the lives of patients. Decision aids available to guide patients on this decision are limited and of poor quality. We aimed to identify the content and delivery preferences of rectal cancer survivors who have faced this surgical decision and colorectal surgeons to guide future decision aid creation. Methods: We performed semi-structured interviews of survivors and their caregivers, as well as colorectal surgeons from April through August 2019. We purposively sampled patients treated surgically for rectal cancer and colorectal surgeons to include different demographics, surgical experiences, and practice types. We achieved thematic saturation in both groups. We performed dual coding and inductive thematic analysis. Results: A total of 30 participants were interviewed, 15 patients with 5 caregivers, and 10 colorectal surgeons. Patient demographics demonstrated an equal distribution of sex, age categories, and operative type. Physician demographics demonstrated a mean of 10±7 years in practice with 70% academic and 30% private practice. Main themes for both groups stated that a massive patient educational need exists throughout the continuum of disease into survivorship. Participants emphasized the need for a comprehensive educational tool to address these needs rather than a decision aid. Both wanted a tool that was personalized, simple, understandable, visually appealing, interactive, and delivered in a combination of modalities to capture the broadest audience. Patients also desired specific features like care timelines and resources. Surgeons felt than an educational tool would enhance patient/provider interaction by reinforcing material covered in clinic. Conclusions: A surgical decision aid for rectal cancer is not enough. Patients and surgeons acknowledged the need for a comprehensive tool to address the educational gap that exists through the continuum of rectal cancer care.
Emerging trends and utilization of patient-reported outcomes (PROs) in clinical trials of chimeric antigen receptor (CAR) T-cell therapies.
Authors: Messina Anthony John , Andrianov Vasily , Mazzolenis Daniel , Vidal-Fisher Liat 
Published: May 2020

e19142 Background: Patient-reported outcomes (PROs) are an important tool to assess the impact of new therapies on health-related quality of life (HRQoL). This study aimed to describe if and what PRO instruments are currently being utilized in CAR-T cell therapy studies in solid and hematological malignancies while assessing the patterns of inclusion and trends of HRQoL data reporting. Methods: We used Citeline to search for clinical trials between Jan 2008 - Jan 2020, excluding planned or terminated studies, non-oncology, non-treatment, and duplicates. Reviewers extracted various parameters for included trials, then cross-matched data with EU Clinical Trials Register, Clinical trials.gov, trial protocols (when available), and Google. The reporting of PRO data was then assessed for those Closed/Completed trials that included a PRO via PubMed/MEDLINE, Sponsor, and Google. Results: A sample of 664 CAR-T trials was identified. PROs were included in only 6.17% (41/664) studies. Of the 41 trials that included a PRO, 63.41% (26/41) utilized more than one PRO, with the generic EORTC QLQ-C30 and the EQ-5D being used predominately. Median HRQoL follow-up was 5-years on most trials. No studies used PROs as primary endpoints. The majority of PROs were observed to be utilized in early phase trials (phase I, 12; Phase I/II, 17). PROs were first incorporated in CAR-T trials beginning in 2014, and the utilization rate has increased steadily, except for 2019. PROs were included in 3 first line trials, 22 second line, 5 third line, and 11 fourth line or greater. PRO utilization between solid tumor trials and hematologic malignancies was comparable (6.04% [9/149], and 6.26% [32/511]). Of the completed/closed trials, 28.57% (3/14) published PRO data and met at least eight of the CONSORT-PRO quality indicators. Conclusions: The utilization of PROs in CAR-T trials (6.17%) is under the industry average of 27%, despite the growing importance of HRQoL and its impact on value-based care. The findings from this review reflect the overall increased attention to CAR-T as a new therapeutic entity and the continued deficiency of including and reporting of PROs in trial designs.
NGS testing use and results: A survey of U.S. oncologists.
Authors: Smith Mary Lou , Railey Elda , White Carol B. , Dieterich Julianne S , Garrett-Mayer Elizabeth , Bruinooge Suanna S. , Freedman Andrew N. , De Moor Janet , Gray Stacy W. 
Published: May 2020

e19145 Background: Scientific advances in genomics have ushered in new cancer tests and therapies. Many researchers, clinicians and advocates wonder how breakthroughs are implemented in practice. Methods: We examined Next Generation Sequencing (NGS) use, results, actions and outcomes among US oncologists (oncs) in treatment of their patients (pts) with advanced cancer (AC). 178 physician members of ASCO who used NGS for AC pts in past 3 months completed an online survey (response rate=30%). Results: Table shows NGS use, outcomes, and perceptions of treatment response among oncs who treat AC pts. Results from questions that were NOT asked by cancer type: 19% of respondents reported that NGS results guided treatment recommendations to a great extent, and 37% to a moderate extent, 65% reported tests often provided no actionable information; among oncs reporting NGS results provided actionable information, 31% reported they sometimes/often tried but couldn’t obtain the FDA-approved drug; respondents used many approaches to “decide what to do” with results. 83% explored trials, 68% reviewed scientific literature, 64% explored feasibility of FDA-indicated drug, 52% used NGS report recommendations, 47% talked with colleague, and 23% accessed molecular tumor board most (>60%) of the time. Conclusions: Oncologists reported high use of NGS results to guide treatment decisions for pts with select ACs and an associated benefit in some pts. Two-thirds of oncs often experienced lack of actionable information across a broad range of tumor types. Even when NGS yielded actionable information, it was common for oncs to experience problems obtaining FDA-approved drugs. The large number of approaches oncs used to make treatment decisions may suggest an important opportunity to improve decision-making efficiency in healthcare delivery. [Table: see text]
Real-world adoption of PD-L1 testing in metastatic urothelial carcinoma.
Authors: Gupta Shilpa , Maculaitis Martine C , Bernstein Andrew , Boudoures Anna , Tesic-Schnell Marija , Seal Brian S. , Mulvihill Emily , Doleh Yunes 
Published: May 2020

e19184 Background: The role of PD-L1 testing in locally advanced (LA) or metastatic urothelial carcinoma (mUC) is not currently well-defined, except in cisplatin-ineligible patients (pts). IMVigor130 trial data are the first to suggest cisplatin-eligible PD-L1 positive pts may also benefit from immunotherapy (IO) (ESMO LBA14_PR, 2019). As clinical data accumulate on the influence of PD-L1 expression on LA/mUC pt outcomes with IO, we assessed medical oncologists’ (ONCs) PD-L1 testing perceptions and practices. Methods: ONCs completed a longitudinal, online self-report survey fielded from August 22 to September 23, 2019, prior to release of IMVigor130 data. Baseline results are reported. Descriptive statistics and bivariate comparisons by practice setting were conducted. Results: ONCs (N = 203) had a mean of 15 years in practice; a majority (64%) practice in the community. ONCs tested most LA/mUC pts, but initiated treatment for about a third before receiving results (Table). Half believe PD-L1 testing in LA/mUC will increase over time; this view was more common for ONCs who do not (n = 55) vs. do (n = 148) order PD-L1 testing as standard for LA/mUC pts (55% vs. 49%). Most ONCs reported that pts in an IO + chemotherapy trial arm should be stratified by PD-L1 status (74%), but not platinum agent (69%). Common barriers to more LA/mUC pts (n = 92) getting a PD-L1 test were limited biopsy sample (54%), lack of influence on treatment decisions (54%), and treatment initiation urgency (30%). ONCs varied little by practice setting. Conclusions: PD-L1 testing has been adopted by ONCs for most of their LA/mUC pts. However, ONCs report limited biopsy sample and lack of influence on treatment decisions as barriers to testing more LA/mUC pts, supporting their initiation of therapy prior to receipt of results and desire for trial data to be stratified by PD-L1 status. Results suggest PD-L1 expression is not yet a key driver in treatment decisions. Given the variability in self-reported responses, results should be interpreted with this limitation in mind. [Table: see text]
Implementing a genomic oncology program in an integrated health care network with large scale genomic Next Generation Sequencing (NGS) testing of advanced cancers in a community setting.
Authors: Suga Jennifer Marie , Thomas Sachdev P. , Truong Thach-Giao , Sundaresan Tilak Kumar , Pan Minggui , Kim Won , Hoodfar Elizabeth , Cheng Lirong , Chung Elaine , Tse Pamela , Achacoso Ninah , Jiang Chen , Goldstein Desiree , Habel Laurel A. 
Published: May 2020

e19185 Background: The importance of NGS testing to help guide oncologic therapy decisions has grown over time, presenting a unique challenge for community oncologists to properly translate the NGS test results to treatment (Tx) recommendations for patients. Kaiser Permanente Northern California (KPNC) is a large, integrated health care system providing comprehensive primary and specialty care to 4.4 million members, with over 4000 patients (pts) diagnosed with advanced cancer each year. NGS testing at KPNC is performed in a collaboration with Strata Oncology, that provides systematized comprehensive NGS testing (StrataNGS) paired with a portfolio of genomically guided clinical trials. Methods: KPNC has established workflows for upfront empiric review of all NGS results by our KPNC Genomic Oncology Committee (GOC), that includes representatives from medical oncology subspecialists, genetics, pathology, and clinical trials. KPNC GOC reviews all StrataNGS test results in our KPNC network to identify patients that might benefit from either a clinical trial, appropriate on or off-label drug options and/or genetic counseling. In addition, GOC conducts an in-depth case review per request of the treating oncologist. A study nurse pre-screens all pts whose results match to a trial for eligibility. Results: The numbers of pts tested with StrataNGS has increased over time with around 300 pts tested monthly and 4,977 NGS tests performed since Nov 2017. Median age was 65.2 (Range 18.5-96.0). About 42.4% of Pts were non-white. Approximately, 39% of Pts had an actionable mutation including 21.7% eligible for a promising in or out of network trial. 1.6% and 10.9% pts were potentially eligible for off- or on-label approved drugs, respectively. 4.9% were recommended to receive genetic counseling. The 3 most frequently sequenced cancers were: lung, colon and breast. Conclusions: KPNC is providing systematic subspecialty review and management of NGS results for pts in a community setting. Our approach has allowed for greater adoption of routine NGS testing, especially for rare cancer types with less effective standard Tx options available. This model also helps accrual to genomic-based drug trials that have been a challenge for the field. Workflows to streamline automated centralized acquisition of prior Tx history and analysis of response to therapy are in development.
Pharmacist assistance for patients on oral oncologic therapy: Impact on adherence and costs.
Authors: Murad Junior Munir , Pegnolato Suellen , Lodi Luiz Adelmo , Marcolino Milena , Fonseca Roberto Porto 
Published: May 2020

e19198 Background: Oral cancer treatment has becoming progressively more frequent and its costs are rising. To implement strategies that monitor adverse effects, adherence and manage financial resources is of utmost importance. Our goal is to develop an intervention based on pharmaceutical monitoring that promotes the correct use of medication through the early identification of adverse events, as well as to describe an economic analysis of this intervention. Methods: Quasi-experimental study, which included consecutive patients from a private oncologic clinic in Belo Horizonte, Southeast Brazil, who were taking oral medications for the treatment of cancer. Patients had regular consultations with pharmacists, at the beginning of each treatment cycle. The consultation consisted of the assessment of adherence (if they took at least 80% of the pills on a specific period of time) and adverse effects. The number of pills dispensed in the new cycle was adjusted by the number of pills remaining in the previous cycle. Prices were calculated using Brasindice and the dollar price of Feb/2020. Follow-up period was from Oct/2018 to Nov/2019. Results: Throughout the study, 1224 patients were included: 86% female, mean age 63 years, 37% had at least 7 years education. Breast cancer accounted for 77% and prostate cancer for 6% of the patients, and 23% of all patients were treating stage IV cancer. The most used treatments were tamoxifen (44%) anastrazole (34%) and capecitabine (3%). In total, 10.640 pharmacists consultations were performed, which corresponds, on average, 887 consultations per month and 8.7 per patient. On average, 88.6% were adherent to the medication. In 50% of those consultations, patients reported adverse effects (hot flashes 42%, musculoskeletal syndrome 22%, fatigue 14%, cramps 7%). In that scenario, pharmaceutical care has resulted in total savings of 4067 pills or $ 136,854.89 (Table). Conclusions: Pharmaceutical care was responsible for high rates of adherence, despite the high frequency of adverse effects, and also promoted cost savings. [Table: see text]
Barriers to goals of care discussion and early palliative care referral in patients with advanced cancer: A community oncology clinic survey.
Authors: Maradana Sandhya , Kate Yugandhara , Pandey Deepali , Syed Masood Pasha , Velamala Pruthvi Raj , Patil Shekhar , Siddiqui Ahmad Daniyal 
Published: May 2020

e19199 Background: Earlier discussion of end-of-life (EOL) preferences in patients with advanced cancer is associated with less aggressive EOL care. Most terminally-ill patients have not discussed their goals of care (GOC) with their healthcare providers before becoming acutely ill. Identifying various barriers in the outpatient setting might help improve GOC discussion and EOL experience for patients with advanced cancer. Methods: This cross sectional survey was designed after a thorough literature review and distributed to internal medicine residents, oncologists and oncology nurses involved in patient care in an outpatient cancer center at a community hospital. Barriers to GOC discussions and early palliative care (PC) referral were assessed on a 7-point Likert scale (1 = extremely unimportant; 7 = extremely important). Most important barrier was defined by people ranking it as very important or extremely important (6 or 7). A total of 33 health care providers were included in the final analysis. Trends were reported using descriptive statistics. Results: Patient/family related barriers were ranked the highest overall. 88% of respondents perceived patient’s difficulty in accepting prognosis as most important, followed by lack of agreement among family members (82%) and patient wanting to be 'aggressive' (82%). Among groups, 100% (6 of 6) oncologists perceived patient wanting to be ‘aggressive’ as the most important barrier, whereas disagreement among family members and patient’s difficulty in accepting poor prognosis was perceived as most important by 88% (7 of 8) nurses and 84% (16 of 19) residents respectively. Nurses also ranked patient's difficulty in understanding limitations of life sustaining treatments high. 67% of respondents, especially nurses and residents, perceived lack of training to have GOC conversations as the most important health care provider related barrier. Patient’s refusal for PC services was rated as the most important barrier for early PC referral by 61% of respondents, however, oncologists (100%) ranked lack of outpatient PC services the highest. Conclusions: These results emphasize the need for better resources to improve communication between health care providers and cancer patients in an outpatient setting. Initiatives such as formal training and targeted education in communication about GOC to health care providers can be instrumental in addressing these barriers. Integration of outpatient palliative care services into community-based oncology can be beneficial.
Evaluation of high-dose methotrexate serum concentration requirement for discharge.
Authors: Yellala Amulya , Dhakal Prajwal , Deason Brooke , Liewer Susanne , Kallam Avyakta , Lunning Matthew Alexander , Bierman Philip Jay , Vose Julie , Bociek Gregory 
Published: May 2020

e19204 Background: Methotrexate (MTX) is used in high doses for the treatment of ALL, lymphoma, and metastatic breast cancer with CNS involvement. To avoid drug accumulation and mitigate toxicities caused by delayed clearance, patients (pts) are usually admitted to the hospital and standard supportive care with IV hydration, urinary alkalization, and leucovorin is provided and adjusted based on daily levels. Historically, a serum methotrexate level ≤ 0.05 µmol/L has been used to declare clearance and an ideal level for discharge based on studies conducted in the 1970s. We conducted a retrospective review in 2018 to identify frequency of supportive dose escalations required with MTX levels > 0.05 µmol/L. In 69 pts, 4 patients demonstrated delayed renal clearance and required supportive care escalations but all occurred at MTX levels > 0.3 µmol/L. This led to a proposed pilot discharge process once MTX was < 0.3 µmol/L to confirm the safety of earlier discharge. Methods: A retrospective chart review of pts with baseline CrCl ≥60 who received HD MTX between 07/2018 – 08/2019. Data collection included diagnosis, MTX discharge level, supportive care at discharge including PO Leucovorin and PO sodium bicarbonate and number of days supply, post-discharge complications (AKI, mucositis, fever, others). Primary outcome was the number of patients who required inpatient or outpatient supportive care for acute complications after being discharged with a methotrexate level ≥ 0.1 µmol/L. Descriptive statistics were used. Results: A total of 41 pts were included. Median age was 55 yrs (32-78), 25% were male. 73% were treated for DLBCL, median dose of MTX was 3500 mg/m2. Median MTX level at the time of discharge was 0.16 µmol/L (0.1-0.3 µmol/L). 12 pts were discharged with PO Leucovorin and 15 pts were discharged with both Leucovorin and PO Sodium bicarbonate with an average of 2 day’s supply. 1 acute complication of neutropenic fever requiring admission for inpatient antibiotics occurred which was felt to be unrelated to MTX level at discharge. Conclusions: This pilot suggests that pts can be safely discharged with MTX levels upto 0.3 µmol/L without acute complications. Results of this study will be used to a develop a standardized protocol outlining criteria for early discharge in select pts with MTX levels < 0.3 µmol/L to reduce length of stay, cost of hospitalization and improve patient satisfaction. [Table: see text]
Selection of a set of quality indicators (QIs) for oncological clinical pathway with patient associations and healthcare professionals.
Authors: Di Palma Mario , Fourcade Aude , Ferrua Marie , Chirrane Mariem , Daouphars Mikaël , Berger Virginie , Clairaz-Mahiou Béatrice , Bezie Yvonnick , Garibbo Audrey , Giacchetti Sylvie , Tournigand Christophe , Minvielle Etienne 
Published: May 2020

e19221 Background: Clinical pathways in oncology are increasingly complex and involve many healthcare professionals inside and outside the hospital. The available QIs focus on hospital care, few of them describe the entire clinical pathway. Our objective is to select a set of QIs for oncological clinical pathway by involving hospital professionnals, patient associations and non-hospital professionals (GPs, pharmacists and private nurses). The step described concerns the research conducted with hospital professionals and 11 patient associations. Methods: A review of available QIs assessing the clinical pathway was conducted from the gray literature and literature reviews. Selection criteria were applied to extract oncological clinical pathway indicators. The list of identified QIs was submitted to two working groups: hospital professionals (26 oncologists, pharmacists and SRNs of various hospitals in France) and patient associations. Two meetings in each group were necessary. The first one to select by consensus (nominal group) the QIs on the basis of their rating on relevance and feasibility. The second, to describe precisely the QIs selected. Results: 5731 QIs were identified in the initiatives, 131 QIs related to oncological clinical pathway were presented. 10 QIs were selected by hospital professionals: outcome (2), process (3) and structure (5). 10 QIs were retained by patient associations: process (4), structure (2) and outcome (4). Both groups selected QIs on symptom assessment, adherence to treatment, access to palliative care and management of patients receiving oral therapy. They also emphasized the need to gather information directly from patients by selecting PREMS on patients’ experience and PROMS on quality of life, emotional state, symptoms and toxicity. Conclusions: The QIs selected responds to a real need for oncological clinical pathway in France. The next step will be to carry out the same work with non hospital professionals to have a representative set of all actors. The QIs will then be collected from the hospitals experts in France and in Europe to validate their metrological qualities.
Assessing patient satisfaction after comprehensive medication review including oral chemotherapy adherence with an oncology pharmacist at the Southcoast Centers for Cancer Care (SCCC).
Authors: Skeffington Patrick John , Haynes Laura , Raymond Donna , McCarthy Heather 
Published: May 2020

e19241 Background: Use of oral chemotherapy has increased dramatically over the past few years. Patient often are required to obtain their oral chemotherapy from a third party specialty pharmacy while continuing to receive their other medications from other pharmacies. Many community pharmacists lack knowledge about oral chemotherapy, safe practices, or effective counseling of these medications. Objective: To assess patient perception and satisfaction of a pharmacist 1 on 1 appointment when starting oral chemotherapy. Methods: A program was designed at SCCC whereby all patients starting oral chemotherapy are scheduled for an appointment with a clinical oncology pharmacist to update medication lists, evaluate adherence, and conduct a "brown bag" visit where patients are allowed to voice concerns and ask questions. After each appointment patients were asked to fill out a short survey, The Patient Satisfaction with Pharmacist Services Questionnaire (PSPSQ 2.0). Results: PSPSQ 2.0 uses a Likert scale ranging from 1 to 4. From October 2016 to June 2019, 174 patients had appointments and 55 returned their surveys yielding a 30% response rate. Average scores hovered around 1 (strongly agree) for each question except question 11 (the only negatively worded question). Question 11 averaged 3.1; Disagree. Conclusions: Patients who were seen by an oncology clinical pharmacist to evaluate adherence, participate in a "brown bag" clinic and open discussion, found the appointment worthy of their time.