bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cancer clinical trial consent forms: A readability analysis.
Authors: Roy Mohana , Schapira Lidia 
Published: May 2020

e19075 Background: The National Cancer Institute (NCI) provides a template for cancer clinical trial consent forms and recommends a reading grade level of eight grade or lower for such forms. This recommendation aligns with the goal of making clinical trials accessible to more patients. Methods: We surveyed clinical trial leaders at a large tertiary academic cancer center, to provide consent forms for active or recently closed, interventional cancer clinical trials (as of 2019). We requested forms that were preferably from multi-center trials and those perceived to have the highest accruals. We received 26 consent forms representing nine disease groups. Results: The average Flesh-Kincaid reading grade level was 11.2 (reflecting a 11th grade reading level), and no single form met the 8th grade reading level mark. The grade levels were assessed with three additional readability analyses (SMOG, FORCAST, and Raygor, see Table). The average Flesch reading ease was 50.7, rated as “fairly difficult”, with a scale of 0-100 (100 =“very easy” to read). The general HIPAA consent followed similar patterns, with a reading level of 10.9 and a reading ease of 49.2. There was an average of 18-20 words used per sentence. The reading levels and ease did not significantly vary with disease group or phase of trial. Conclusions: The overall readability level of cancer clinical trial forms, at our center, still require at least at least a 10th grade reading level. These forms may be difficult to understand for those with lower English proficiency and/or health literacy. We recommend a basic readability screen of such forms, and use of shorter sentences and simplified writing structure, to aid in comprehension. Flesh-Kincaid: uses word and sentence length; SMOG: used particularly for health messaging; FORCAST: used for functional literacy (number of single syllable words); Raygor: uses number of sentences and letters per hundred words [Table: see text]
Investigating potential disparities in clinical trial eligibility, offers and enrollment at an NCI-designated comprehensive cancer center.
Authors: Patel Monica Arun , Brinley F. John , Shah Jennifer Lobo , Abrahamse Paul , Veenstra Christine M , Schott Anne F. 
Published: May 2020

e19076 Background: Although many prior studies have demonstrated the existence of disparities in cancer clinical trial enrollment, few studies have explored clinical trial eligibility criteria and offers as potential drivers of disparities in enrollment. Methods: We identified patients age 18-96 with gastrointestinal (GI) cancers who were seen as new patients at the University of Michigan in 2016. Primary outcomes were: 1) Eligibility for; 2) Offer of; and 3) Enrollment in, a clinical trial. All 28 clinical trials available in 2016 for patients with GI cancers were considered. We assessed individual patient eligibility for any trial by exhaustive review of the electronic medical record (EMR). We determined trial offers and patient enrollment in a trial by EMR review, including notes by clinicians and research coordinators. Independent variables included clinical and non-clinical patient-related factors (such as age, race, and gender) as well as provider-related factors. We assessed associations between patient- and provider-related factors and our primary outcomes, using multivariable regression. Results: Of 827 patients, 40% were female, 18% were age ≥75, 7% were Black, and 2% were Asian. 155 (19%) patients were potentially eligible for an open clinical trial. Among patients potentially eligible for a trial, 83 (54%) had documentation of a trial being offered and 46 (30%) enrolled. After adjustment, age < 75, lower Charlson comorbidity index, not having a second primary cancer, hepatobiliary primary, and higher disease stage were associated with a higher odds of clinical trial eligibility (all P < 0.05). Having ≥1 child, lower Charlson comorbidity index, hepatobiliary primary, and higher disease stage were associated with a higher odds of being offered a clinical trial (all P < 0.05). Hepatobiliary primary and higher disease stage were associated with a higher odds of enrollment (all P < 0.05). Conclusions: We found that patients age 75 or over were less likely to be eligible for a clinical trial, but did not find significant disparities in eligibility by other non-clinical factors such as gender and race. Only 54% of patients potentially eligible for a trial had documentation of a trial being offered; this varied by number of children, but not by any other non-clinical factors. We found no significant associations between non-clinical factors and enrollment. Future work is needed to ensure that eligibility criteria for clinical trials reflect the overall patient population, and that trials are offered to eligible patients.
Changes in black-white disparity in receipt of guideline concordant treatment for women with early-stage breast tumors.
Authors: Nadeem Hasan , Romley John , Warren-Andersen Shaneda 
Published: May 2020

e19089 Background: Racial disparities are well documented in the treatment of women with breast cancer. Whereas clinical treatment guidelines are established for early stage breast tumors, disparities in guideline-concordant (GC) treatment may influence variation in breast cancer outcomes. As such, we investigated differences in the receipt of GC treatment for black and white women with early-stage breast cancer between 2008 and 2016. Methods: We evaluated the Surveillance, Epidemiology, and End Results Registry (SEER) Incidence database for black and white women aged 20-64 years with stage I / stage II breast tumors. Primary analyses investigated associations between race and receipt of GC treatment in three chronological periods. Potential driving factors for trends in receipt of guideline-concordant treatment were also assessed. Results: Among 145,561 women diagnosed with early stage breast tumors, overall receipt of GC care decreased from 84.58% in 2008 to 83.89% in 2016. In period 1 (2008-2010), there was a prominent disparity between black and white women (81.89% black vs 86.24% white; p < 0.001). By period 3 (2014-2016), GC care increased for black women (84.29%) but decreased for white women (84.82%), eliminating the disparity (p = 0.276). Multivariate logistic regression on changes in the black-white disparity across the study period showed increased receipt of GC treatment for black women relative to white women in period 2 (2011-2013, odds ratio [OR], 1.202; 95% confidence interval [CI], 1.075 – 1.344) and period 3 (OR, 1.376; 95% CI, 1.212 – 1.505). For black women undergoing breast conserving surgery, administration of radiation therapy increased from 44.01% in period 1 to 50.64% in period 3 (p < 0.001) and was a prominent driver for increased GC care. Conclusions: Overall receipt of guideline-concordant treatment decreased from 2008-2016. Black women experienced a substantial increase in receipt of guideline-concordant care in period 2 (2011-2013) and period 3 (2014-2016) relative to white women. Delivery and completion of radiation therapy with breast conserving surgery increased the likelihood of receipt of guideline-concordant treatment.
Addressing rural disparities in cancer care via telehealth.
Authors: Heifetz Laurence J. , Koppel Ahrin B. , Kaime Elaine M , Palmer Daphne , Semrad Thomas John , Lara Primo , Bold Richard J. 
Published: May 2020

e19090 Background: Patients in rural areas have reduced access to high-quality cancer care, which contributes to rural-urban disparities in cancer mortality. Telehealth technologies can connect providers across rural and urban communities. Methods: In 2006, one author (LH) established an oncology program in Truckee, CA, a rural community with a single critical access hospital without oncology services. The program joined with 4 other facilities comprising the UC Davis Cancer Care Network, a central element being daily participation in structured virtual tumor boards addressing the four sites (colorectal, prostate, lung, & breast) that compromise ~80% of all cancer diagnoses. Remote telemedicine clinics outside the primary catchment area were also established to serve the mountain communities of Quincy, Portola, Loyalton, and South Lake Tahoe, CA. We assessed the reach and quality of the cancer program through referrals, in-migration, clinical trial accruals and accreditations. Results: The combination of virtual tumor boards and telehealth clinics associated with growth of the program to 3 medical oncologists, 1 radiation oncologist and expansion into a 20,000 ft2 facility. Total new patient visits, the percent of patients coming from zip codes outside of the primary catchment area, clinical trial enrollments, and quality accreditations steadily increased (Table). The program is accredited by the Commission on Cancer with commendation, ASTRO’s APEX, ASCO’s QOPI and CancerLinq programs, and is a G02Foundation for Lung Cancer Community Center of Excellence. Conclusions: We termed the knowledge dissemination that occurs through a telehealth connected rural oncology program involving a Comprehensive Cancer Center partner and disseminated rural telemedicine nodes a “synaptic knowledge network.” In this implementation, it enhanced the reach and quality of care as measured by volume, in-migration, clinical trial activity, and national quality accreditations. Application of synaptic knowledge networks to other rural sites is a promising strategy to reduce rural-urban disparities in cancer care. [Table: see text]
Outcomes of Pneumocystis juroveci pneumonia complicating treatment of solid tumors.
Authors: Dean Andrew Peter , Rolston Amy , Kelly Geena , Seeley-Rogers Madeleine , Ong Shaun 
Published: May 2020

e19104 Background: Pneumocystis Juroveci Pneumonia (PJP) is a life threatening infection by an opportunistic pathogen historically affecting those with HIV and patients with immunosuppression from multiple lines of cytotoxic therapy, with mortality rates often > 50%. We previously reported data showing that PJP can affect patients early in the course of treatment, even during 1st line treatment. We analysed our outcomes from PJP occurring in these patients. Methods: Electronic database records were searched to identify PJP, chemotherapy, lines of therapy and survival. Results: 12 patients were identified who contracted PJP whilst undergoing chemotherapy for solid tumours, 4 during first line therapy and 5 during second line therapy. Age ranged from 33 to 84. 3 of 12 patients died within 1 week of diagnosis, one during first line therapy with erlotinib, 1 after 5 lines of chemotherapy and 1 after 7 lines of chemotherapy. 1 patient who survived had received 10 lines of therapy. Those who survived the initial infection had received between 1 and 10 lines of therapy and survival ranged from 2 to 25 months with a median survival of 11.5 months. Patients contracting PJP during 1-3 lines of therapy had the highest likelihood of survival with median survival of 11 months. Conclusions: PJP had a mortality rate in our series of 25% and was not exclusive to those with multiple lines of chemotherapy. Early recognition of infection resulted in good outcomes with ultimate prognosis being related to underlying malignancy rather than PJP.
Impact of oligometastatic disease on survival in ER positive breast cancer: A population-based analysis.
Authors: LeVasseur Nathalie , Willemsma Kaylie , Lohrisch Caroline A. , Lalani Nafisha , Chia Stephen K. L. , Liu Mitchell , Gelmon Karen A. 
Published: May 2020

e19109 Background: Estrogen positive (ER) advanced breast cancers (ABC) are associated with a longer survival compared to other subtypes. However, clinical equipoise remains for the management of oligometastatic disease. While recent phase I and II data support the use of metastasis-directed therapy, breast cancer patients remain underrepresented and real-world outcomes for breast cancer patients with directed treatment for oligometastases is lacking. Methods: The BC Cancer Breast Cancer Outcomes Unit (BCOU) database was utilized to identify patients with ER positive breast cancer referred to BC Cancer from 2005-2014 with documented metastases. Baseline clinical, pathological and treatment data were compiled. Overall survival (OS) was compared between the group with oligometastatic disease(OM) (defined as < = 5 foci of metastases) and the group with non-oligometastatic disease (defined as > = 6 foci of metastases) using Kaplan-Meier survival curves. Key secondary endpoints included metastasis-directed treatment impact, based on the site of metastasis, local control (LC) and distant failure (DF) rate. Results: A total of 938 patients met the inclusion criteria. Of these, 191 (20.4%) had OM and 747 (79.6%) had widespread disease at 1st diagnosis of ABC. The groups were well balanced for clinical characteristics (all p > 0.05), with a median age of 59yrs (23-99). 84% were ductal carcinomas, 14% were also HER2 positive. Sites of oligometastases were bone (66.5%), liver (12.0%), brain (8.4%) and lung (5.8%). Median follow-up was 7.4 yrs. Median OS was 24 mo (95% CI 20.2, 27.8) for patients with OM and 11 mo (9.5, 12.5) for those with widespread disease (p < 0.0001). In the OM group, 114 (59.7%) of patients received metastasis-directed treatment, whereas 77 (40.3%) did not. Treatment modalities included radiation in 53.4% of patients, surgery in 8.9% of patients and stereotactic body radiotherapy (SBRT) in 3.7%. Median OS was 24 mo (18.3, 29.7) for patients who received metastasis-directed treatment and 23 mo (17.5, 28.5) for those who did not (p = 0.954). Patients with bone-only metastases had a median OS of 27mo with directed treatment and 25mo without directed-treatment (p = 0.334). Conclusions: Oligometastatic state was associated with a significantly better OS. Metastasis-directed treatment was associated with a non-significant OS difference in patients with bone-only metastases in a real world cohort. However, the impact of modern systemic treatment and SBRT methods are evolving. Large prospective randomized studies of this approach merit further study.
Quality of life (QOL), financial burden, and perception of care in patients enrolled on clinical trials (CTs).
Authors: Sidana Surbhi , Allmer Cristine , Larson Melissa C. , Dueck Amylou C. , Yost Kathleen J. , Warsame Rahma M. , Thanarajasingam Gita , Cerhan James Robert , Paludo Jonas , Rajkumar S. Vincent , Habermann Thomas Matthew , Nowakowski Grzegorz S. , Lin Yi , Gertz Morie A. , Witzig Thomas E. , Dispenzieri Angela , Gonsalves Wilson I. , Ansell Stephen M. , Thompson Carrie A. , Kumar Shaji 
Published: May 2020

e19112 Background: We sought to study the longitudinal QOL, financial burden and perception of care (PoC) in patients with multiple myeloma (MM) or lymphoma (LYM) enrolled on CTs vs. those receiving standard care (Non-CT). Methods: QOL was evaluated using the FACT-G questionnaire (baseline, 1, 2, 3, 6 & 12 months). Financial burden was evaluated using 10 questions adapted from the MEPS survey and PoC was evaluated using 6 questions adapted from the CAHPS survey (baseline, 3, 6 & 12 months). Results: 35 (28%) of 123 enrolled patients were treated on CTs. Demographics, QOL and financial burden are shown in the Table. Baseline QOL scores were similar in CT vs non-CT groups. Age, gender and self-reported performance status were significantly associated with baseline QOL, while lines of therapy & cancer type were not. There were no significant differences in change in QOL vs. baseline in patients treated on CTs vs. non-CTs at 1, 2, 3, 6 and 12 months from baseline, including the total FACT-G score and the subdomains of functional, physical, emotional and social well-being. Within each group, there was a decline in QOL over the first 3 months, specifically physical WB, which gradually returned to baseline. Baseline answers to financial burden questions were similar, except patients on CTs reported less need for taking extended time-off from work (22% vs. 46%, p = 0.02). The only statistically significant difference in individual Qs over 1 year was ‘worry about having to pay large medical bills’ at the 6-month timepoint (CT: 0%, non-CT: 52%, p = 0.01). Using a composite score from 4 MEPS questions, financial burden over time was lower in the CT group, though the differences were not statistically significant. There were no significant differences in PoC at baseline, 3, 6 and 12 months in the two groups based on answers to each of the six questions adapted from the CAHPS survey. Conclusions: Over 1 year, patients on CTs experienced a similar QOL and perceived their care to be similar as non-CT patients. Financial burden was lower in the CT group, though differences were not statistically significant. [Table: see text]
The use of a chatbot based on artificial intelligence to collect patients reported outcomes in oncology practice. A pilot study with real-world data.
Authors: Murad Junior Munir , Nascimento Arthur , De Castro Alexandre Fonseca , Paiva Lilian , Fernandes Amandio S. , Lodi Luiz Adelmo 
Published: May 2020

e19119 Background: There is growing interest in enhancing symptoms monitoring during routine cancer care using patient-reported outcomes (PROs). The quality of evidence that demonstrates clinical benefits of this type of assistance is also increasing. However, the best method for this approach is evolving and there are many barriers to implement these tools in the real world scenario. We aim to describe a pilot study about a chatbot with artificial intelligence developed to collect PROs and to optimize adherence to systemic cancer treatment. Methods: This is a case series that reports the first patients in a private oncology clinic in Belo Horizonte, Southeast Brazil who consecutively underwent regular conversations with a chatbot based on artificial intelligence. Data was collected from February the 23th to December the 3rd 2019. The virtual assistant interacted with the patient in four different ways, being the first three of these an active search from the chatbot: a) search for adverse events, b) adherence to oral treatment c) screening for depression d) spontaneous patient demand (not an active search). Results: Interaction with the chatbot was offered to 193 patients. A total of 107 patients were included. Of these 74% were female, 55% older than 60 years and 22% had at least 7 years education.194 protocols of treatment were analysed, 66% of these being chemotherapy regimens and 23% hormone therapy. Oral drugs corresponded to 23% of the protocols. The main adverse events reported were fatigue 20%, nausea 13%, pain 11%, diarrhea 10%, lack of appetite 6%. Adverse effects were classified by patients as grade III or IV approximately 24% of the time. For patient safety the system runs a script twice a day to detect any adverse effect and send it to the service attended. A total of 3883 dialogues were initiated, the majority of which (3772) was carried out by the machine. Only 3% of the dialogues were spontaneously initiated by the patients. Once the conversation started, adherence was considerably satisfactory since engagement was 73% for questions about adherence to oral medications and 76% of people reported at least one adverse event. Conclusions: An initial barrier must be surpassed since the chatbot was offered to 193 patients and 86 (44%) did not register for use. Once the contact started, we understand that the use of AI is promising since the engagement rates were very good. It is important to highlight the potential capacity for early identification of symptoms since most dialogues were initiated by the virtual assistant.
Adoption patterns of an electronic patient-reported outcomes tool in oncology.
Authors: Polubriaginof Fernanda CG , Parekh Priti K , Akella Naga Ravi Shankar , Stetson Peter D. 
Published: May 2020

e19127 Background: Patient-reported outcomes (PROs) are critical for the delivery of patient-centric care. Previous research has shown that the use of PROs can impact clinical outcomes in Oncology. Despite these benefits, PROs have not been widely implemented as part of standard of care. Significant barriers exist for its adoption including lack of integration between PRO tools and electronic health record systems (EHRs). We developed MSK Engage, a home-grown PRO tool integrated with the EHR and embedded within MSK's patient portal (MyMSK). It was launched in late 2015 and it is currently used enterprise-wide for both standard of care and research purposes. The purpose of this study was to describe the usage patterns of PROs in a real-world setting. Methods: We conducted a retrospective analysis of patients that have been assigned at least one MSK Engage survey instrument between 2015 and 2019. Patient demographic information was extracted from the EHR system. Usage patterns including the number of survey instruments assigned and completed were extracted from MSK Engage. Survey completion rates were stratified by patient demographic information and number of assigned surveys. We performed univariate and multivariate analyses to identify factors associated with survey completion rates. Results: During the study period, 57 survey instruments were implemented, with the majority being used for standard of care (41 for standard of care only, 9 for research protocols, 6 for standard of care and research, and one for a quality improvement initiative). In total, 246,638 patients were assigned 557,559 surveys. Of those, 146,505 patients completed a total of 265,174 surveys, with a median completion time of 3 minutes. Among the patients that were assigned a survey, 73.7% were women. Women in our sample were older than men, with median age 52 and 47 years old, respectively. Men were more likely to complete the assigned surveys with 61.2% completion rate among men and 43.3% among women (p < 0.001). On multivariate analysis, men were less likely to miss surveys than women (odds ratio [OR], 0.49; 95% CI, 0.48-0.49). We also identified a significant correlation between the survey completion rate and number of assigned surveys, demonstrating that assigning a large number of surveys for each patient can lead to a reduced survey response. Conclusions: Providers have quickly adopted MSK Engage demonstrating that it is feasible to incorporate PROs as part of standard of care. Patients are willing to answer PROs; however, it is important to mindful when assigning surveys to avoid negative effects of survey burden.