bluuebunny/crossref_metadata_2025 huggingface dataset:
Creating the real-world medical record: Using digital patient-generated data to create an updated picture of patients outcomes.
Authors: Bivas-Benita Maytal , Deutsch Irad , Malki Eliran , Hasid Lior
Published: May 2019

e18092

Background: Value-based healthcare requires integration of real-world data (RWD) generated by patients in parallel to clinical documentation. This gives a holistic perspective of the patients’ health and care and could lead to reduced costs and better patient care and safety. Belong digital patient-powered network (PPN) is a social network for cancer patients and caregivers providing them access to other patients, healthcare professionals and disease management tools. In this study we compared the clinical data generated by Belong users with classical clinical documentation. Furthermore we explored the additional information generated in the PPN and its value. Methods: RWD collected from users of the Belong PPN was retrospectively analyzed. We evaluated patient-reported outcomes in parallel to medical records provided voluntarily and anonymously. Data of patient journeys was extracted and mapped from medical records and social engagement in our platform using artificial intelligence (AI) engines. Data was further validated manually by the research team to assure accuracy. Results: We compared 40 treatment journeys reported by patients in Belong to their doctor summary. The data showed that patients can accurately describe their cancer diagnosis and treatment, mentioning 85% and 90% of their diagnosis and treatment, respectively. In 38% of the cases, patients’ engagement data provided additional insights in the categories of OTC drugs, supplements, diet, alternative treatments, lifestyle changes and emotional health. Complementary information from patients with possible clinical consequences (changes in sugar levels, blood pressure, body minerals levels etc.) was also reported and could affect patients’ treatment and well-being. Conclusions: RWD collected in the Belong PPN recreated a comparable clinical description of standard medical documents and provided additional insights that created a more comprehensive picture of patients’ health. Superimposing the social data layer onto the clinical one could provide significant advancement of how we treat patients and result in better cost-efficiency, improved healthcare services and patients’ outcomes.
Harmonization of clinical data across Gen3 data commons.
Authors: Hughes LaRon , Grossman Robert L. , Flamig Zachary , Prokhorenkov Andrew , Lukowski Michael , Fitzsimons Michael , Lichtenberg Tara , Tang Yajing
Published: May 2019

e18094

Background: Gen3 is an open source software platform for developing and operating data commons. Gen3 systems are now used by a variety of institutions and agencies to share and analyze large biomedical datasets including clinical and genomic data. One of the challenges of working with these datasets is disparate clinical data standards used by researchers across different studies and fields. We have worked to address these hurdles in a variety of ways. Methods: Gen3 is an open source software platform for developing and operating data commons. Detailed specification and features can be found at https://gen3.org/ with code located on GitHub ( https://github.com/UC-cdis ). Results: The Gen3 data model is a graphical representation of the different nodes or classes of data that have been collected. Examples include diagnosis, demographic, exposure, and family history. The properties and values on each node are controlled by the data dictionary specified by the data commons creator. While each commons may have a unique data model and dictionary, specifying external standards allows for easier submission of new data and assists data consumers with interpretation of results. A variety of external references can be supported, but here we demonstrate the use of the National Cancer Institute Thesaurus (NCIt). NCIt provides reference terminologies and biomedical standards that contain a rich set of terms, codes, definitions, and concepts. Using the same reference standards across commons allows for the export of clinical data between commons. The Portable Format for Biomedical Data (PFB) was created to facilitate data export and to allow the data dictionary schema as well as the raw data to be compressed and exported. This new file format, which utilizes an Avro serialization, is small, fast, easy to modify, and enables simple data export and import. PFB also has the ability to house entire external reference ontologies and it is easy to update the PFB references as changes are introduced. Conclusions: We have shown here how the Gen3 data model, use of external reference standards for clinical data, and the export/import format of PFB enable the harmonization of clinical data across different data commons.
An algorithmic approach to deriving line of therapy in a real-world data set for non-small cell lung cancer (NSCLC).
Authors: Shadra Chhaya , Chen James Lin , Cho-Phan Cheryl D. , Ghosh Aradhana , Hirsch Jonathan
Published: May 2019

e18099

Background: Real World Data (RWD) is being used for outcomes research and regulatory submissions. A key variable needed to understand treatment outcomes is Line of Therapy (LoT). However, LoT is generally not captured in RWD sources such as electronic health records (EHR) or claims data, and is typically derived using manual abstraction. To determine whether an automated approach to LoT derivation is possible, we created an algorithm and applied it to patients (pts) in the Syapse Learning Health Network. Methods: We selected confirmed NSCLC pts from 4 health systems in the RWD set, verifying diagnosis using ICD-9/10/O3 topography and morphology codes. We analyzed the EHR-derived medication list using a regimen-independent algorithm that classified antineoplastic drugs (AD), as defined by ATC L01, into LoT. Within each LoT, we compared the top 80% of AD prescribed (by volume of pts) to the LoT as indicated on each drug’s FDA label. We then used descriptive statistical summaries to outline the alignment between automated algorithmic results and indicated usage within that LoT. Results: In a set of 10,842 NSCLC pts, a total of 106 unique AD were prescribed in the first line as identified by our algorithm, and 13 drugs were prescribed as first line for 80% of the pts. Of those, 9 (69%) of those are indicated for first line, 3 are not indicated for NSCLC, and 1 is indicated for a subsequent NSCLC line, per FDA labels. 82 unique AD were prescribed in the second line as identified by our algorithm, and 15 drugs were prescribed as second line for 80% of the pts. Of those, 11 (73%) are indicated for treatment/continuation therapy for recurrent, advanced or metastatic disease, 3 are not indicated for NSCLC, and 1 is indicated for first line NSCLC per FDA labels. 36 unique AD were prescribed in subsequent line as identified by our algorithm, and 18 drugs were prescribed as subsequent line for 80% of the pts. Of those, 12 (67%) are indicated for treatment of recurrent, advanced or metastatic disease or subsequent systemic therapy, 5 are not indicated for NSCLC and 1 is indicated for first line per FDA labels. Conclusions: An automated algorithmic approach for deriving lines of therapy may be a viable solution to scalably calculate LoT in RWD sets. A deeper analysis using statistical sensitivity and specificity assessment of such algorithms is needed to validate the potential of an algorithmic approach.
Rates and patterns of uninsured cancer survivors before and after implementation of the Affordable Care Act, 2000-2017.
Authors: Sanford Nina Niu , Lam Miranda , Sher David J. , Butler Santino , Ahn Chul , Aizer Ayal Aaron , Mahal Brandon Arvin Virgil
Published: May 2019

e18105

Background: Cancer survivors experience difficulties in maintaining healthcare coverage, however the reasons and risk factors for lack of insurance are poorly defined. We sought to assess self-reported reasons for not having insurance and to assess demographic and socioeconomic factors associated with non-insurance among cancer survivors, before and after implementation of the Affordable Care Act (ACA) in 2014. Methods: We used the National Health Interview Survey to identify adult participants (18-64 years) reporting a cancer diagnosis between 2000-2017. Multivariable logistic regression was used to define the association between demographic and socioeconomic variables and odds being uninsured. The prevalence of the most common self-reported reasons for not having insurance (unemployment, employment-related reason, family-related) were estimated, with AORs for each of the reasons defined by multivariable logistic regression. Results: Among 17,806 survey participants, 10.3% reported not having health insurance. Individuals surveyed in 2000-2013 had higher odds of not having insurance as compared to those surveyed in 2014-2017 (10.6% vs. 6.2%, AOR 1.75, 95% CI 1.49-2.08). Variables associated with higher odds of non-insurance throughout the entire study interval included younger age, annual family income below the poverty threshold, black race, Hispanic ethnicity, non-citizen status and current smoking (p < 0.001 for all). After implementation of the ACA, increasing interval from cancer diagnosis and black race were no longer associated with not having insurance. The most commonly cited reason for not having insurance were cost followed by unemployment, both of which decreased after ACA implementation (cost: 49.6% vs. 37.6%, AOR 0.62, 95% CI 0.46-0.85; unemployment: 37.1% vs. 28.5%, AOR 0.62, 95% CI 0.45-0.87). Conclusions: The proportion of uninsured cancer survivors decreased after implementation of the ACA, however certain subgroups remain at greater risk of being uninsured. Cost remains the primary barrier to obtaining insurance, although more than half of cancer survivors reported other barriers to coverage. Given the growing number of cancer survivors in conjunction with rising health costs, efforts addressing barriers to insurance coverage are needed for this population.
Acceptability of mobile health technology among cancer patients.
Authors: Potdar Rashmika , Thomas Arun , DiMeglio Matthew , Mohiuddin Kamran , Djibo Djeneba Audrey , Laudanski Krzysztof , Dourado Claudia M. , Leighton John Charles , Ford Jean G
Published: May 2019

e18139

Background: Advances in wireless technology have led to the increasing use of mobile health platforms. This approach, tele-medicine, enables healthcare providers to communicate remotely with patients, thereby enhancing timeliness and quality of care, and patient engagement. However, few studies address barriers to its implementation, especially in medically under served populations. Methods: A cross-sectional survey of 151 cancer patients was conducted at an academic medical center in North Philadelphia, PA. A trained interviewer performed structured interviews regarding the barriers and facilitators of patients’ current and desired utilization of technology for healthcare services. Statistical significance was defined as p < 0.05 on a two-tailed distribution. Chi-Square test was used for categorical variables. Odds ratios from logistic regression analysis were used to identify the relationship between demographic factors and willingness to utilize a mobile application for health surveillance. Results: Of the 151 patients who completed the survey, 35.8% were male; ages ranged from 21-104 years. Forty-two percent were married, 49.0% were single, and 9% were divorced at the time of the survey. No significant associations existed between the willingness to utilize a mobile health application and gender ( p = 0.73) or marital status ( p = 0.97). After controlling for other demographic variables, patients older than 70 were significantly less likely to utilize a mobile application. Conversely, patients with a college-level education or more were significantly more likely to utilize a mobile application [OR = 2.78, p = 0.01]. Conclusions: Age and education level represent potential barriers to mobile health applications for cancer patients in socioeconomically diverse community. Health networks should consider these factors when launching patient engagement platforms. [Table: see text]
Racial and insurance disparities in multiple myeloma management in a referral center.
Authors: Renteria Anne , Jagannath Sundar , Fei Kezhen , Lin Sylvia , Yagnik Radhi , La Lisa , Lin Jenny J. , Bickell Nina A.
Published: May 2019

e18140

Background: Multiple Myeloma (MM) management has significantly improved disease-free and overall (OS) survival but disparities among racial groups still exist. After the Affordable Care Act, the extent to which induction, autologous stem cell transplant (ASCT), and maintenance therapies are used are uncertain. We sought to describe underuse of induction, ASCT and maintenance in a large referral center. Methods: Between 2010 and 2014, 3101 patients were diagnosed with MM via ICD-9 code from the Data Warehouse and certified hospital tumor registry. NCCN 2014 and CMS guidelines were used to define the categories of treatment underuse, and define transplant eligibility. Demographics including insurance, Charlson Comorbidity Index and treatments received were determined via chart abstraction. To date, 393 confirmed MM from 697 charts were abstracted. Comparison by groups used Chi-square for categorical variables, t-test and ANOVA for continuous variables. Multivariate logistic regression models were applied to predict underuse of induction, harvest, ASCT, and maintenance. Results: Patients were 62 ±11.3 years-old, with no racial differences in age and insurance coverage. More minorities had Medicaid (Black [B] 13%, White [W] 7%, Hispanic [H] 25%; p = 0.001). Almost all patients (97%) received induction (B 99%, W 96%, H 100%; p = 0.3), with no difference by insurance. Among transplant eligible patients, 93% underwent harvest, 87% underwent ASCT, with no racial differences. Patients with Medicare or self-pay were less likely to undergo harvest compared to patients with Medicaid or private insurance (p = 0.01). No difference in ASCT rates by insurance were noted. B patients were less likely to receive maintenance than non-B (73% vs 86%; p = 0.03), with no difference by insurance. OS was 73%, with no racial differences. In multivariate model, older age predicted induction underuse (aOR = 1.15, 95% CI: 1.06-1.25) (c = 0.9, p = 0.005), and B patients experienced more maintenance underuse (aOR = 2.22, 95% CI: 1.09-4.54) (c = 0.61, p = 0.1), controlling for age and comorbidity. Conclusions: While there were no racial or insurance differences in access to induction therapy, fewer Black patients received maintenance therapy. Interviews are underway to understand reasons for observed differences.
Racial disparities in setting of care in women with breast cancer in South Carolina.
Authors: Sorrell McKenzie , Wickersham Karen , Adams Swann Arp , Heiney Sue P.
Published: May 2019

e18146

Background: African American (AA) women with breast cancer (BrCa) suffer a 40% higher mortality burden than White women despite having about equal incidence nationally and lower incidence in South Carolina. Our aim was to describe inpatient and emergency department visits by race and geographic location among BrCa survivors. Methods: We analyzed data from a study (1R15CA179355-01A1; Adams, PI) that combined administrative claims data from South Carolina’s Medicaid Program and a state-based, private-payor health plan to matching BrCA cases from the SC Central Cancer Registry. Race was determined by patient self-report. Geographic location was assigned using designations from the Rural-Urban Commuting Area Codes (RUCA). We used descriptive statistics to characterize the study sample and Chi-square test of independence to compare the descriptive statistics by race and rural/urban continuum. Results: The sample (N = 2723) was 33.6% AA, 91.8% non-Hispanic, primarily married 48.8%, and ranged in age from 14 to 64 years. Most women in the sample lived in an urban area (74.9 %). Most women had Stage I (16.9%), IIA (13.9%), or IIB (7.5%) disease. Women were primarily treated in an outpatient setting; 1.3% (n = 36) were seen in an emergency room and 1.2% (n = 34) were hospitalized. When comparing women living in a rural versus urban area, there were significant differences in TNM stage of disease (by pathology), marital status, race, and setting of care (all p’s ≤ 0.001). When comparing women by race, there were significant differences in age, ethnicity, marital status, stage of disease, and setting of care (all p’s ≤ 0.001). Conclusions: Women with BrCA in SC continue to experience disparities with regard to stage of disease at diagnosis and setting of care. Future research should focus on specific predictors of hospitalization and the relationship of rurality and race with setting of care.
Timeliness of treatment for patients referred urgently with a high suspicion of cancer in New Zealand.
Authors: McNeill Rob
Published: May 2019

e18147

Background: Delays in diagnosis and treatment have the potential to impact negatively on clinical outcomes for cancer patients. Guidelines for timeliness have been established for many cancer types and national targets have been established in some countries. At the end of 2014 New Zealand introduced a target for patients referred urgently with a high suspicion of cancer, aiming to have 90% of patients from referral to first treatment within 62 days. Methods: Timeliness data from 13,865 patients who were referred for their first specialist appointment in the years 2015-7 were obtained from the Ministry of Health. Z-tests for proportions were used to compare target performance across the time period. Cox regression was used to establish whether age, gender, and ethnicity were associated with timeliness. Results: The proportion of patients meeting the 62 day target increased significantly from 2015 (72.7%, 95%CI: 71.3-74.0; Median: 46 days) to 2016 (80.2%, 95%CI: 79.0-81.3; Median 43 days), but was not significantly higher in 2017 (80.7%, 95%CI: 79.6-81.8; Median 41 days). The Cox regression found that males (HR 0.965; 95% CI, 0.9330.999) and older people (HR 0.996; 95% CI, 0.9950.998) at a small but significantly higher risk of longer times to treatment. Much larger differences in risk of delay were found for Maori (HR 0.789; 95% CI, 0.7480.832), Pacific (HR 0.754; 95% CI, 0.6920.822) and Asian (HR 0.885; 95% CI, 0.8160.960), compared to European/Other ethnic group patients. Conclusions: This research has produced evidence that the introduction of the 62 day target was associated with a significant improvement in timeliness of treatment for this subgroup of patients. The results also highlight the large ethnic disparities in timeliness that exist both in New Zealand and in other countries. These are also reflected in ethnic disparities in outcomes across many cancer types. Further policy, system and practice changes are necessary to try to reduce these.
Comparable survival of African-Americans and Caucasian patients with multiple myeloma: A hospital-based study including 117,926 patients.
Authors: Malek Ehsan , Chamoun Kamal , Caimi Paolo Fabrizio , Gerson Stanton L. , Tomlinson Ben Kent , Patel Seema , De Lima Marcos J.G. , Fu Pingfu
Published: May 2019

e18170

Background: Multiple Myeloma (MM) counts the most common hematologic malignance among African-Americans with twice the incidence of whites. The outcomes have greatly improved during the last 15 years, however with changing demographics there is an increasing focus on how various subgroups, based on race and ethnicity may be benefiting from survival improvement in MM. Previous studies showed that if access to care is assured, racial disparity-driven differences in outcome may be mitigated. Here, we conducted a study using the National Cancer Data Base (NCDB), which covers more than 70% of cancer pts in the USA, to evaluate survival patterns by race. Methods: MM patients (pts) diagnosed between years 2005 and 2014 and reported to the NCDB were analyzed (n = 117926). Pts were divided in three groups based on the year (y) of diagnosis (2005-07, 2008-10 and 2011-14). Kaplan-Meier method and log-rank test were used for overall survival analysis (OS). The effect size, hazard ratio (HR), of race on OS was estimated by Cox model adjusted by confounders. Results: Median age at diagnosis was 67 y (19 - 90); 55% were males. Median follow up was 30 months (m) (0 - 145). Median OS for white and black pts was 46 m (95% CI: 45.4 - 46.6) and 50.6 m (95% CI: 49.1 - 52.3), respectively (p < 0.0001). Black had longer OS compared to white pts by univariable analysis in all three study periods, noticeably with a trend toward higher survival benefit in most recent years. After adjusting for a variety of factors there was no statistically significant difference between the two racial groups (Table). Conclusions: This large study confirmed that after adjusting for confounding factors survival is similar for white and black MM pts. [Table: see text]
Evaluation of Electronic Activity Monitors (EAMs) during phase I clinical trials.
Authors: Scaranti Mariana , Sundar Raghav , Daly Robert , Collins Dearbhaile Catherine , Dolling David , Gennatas Spyridon , Rao Baikady Bindumalini , Kaye Stan B , Banerji Udai , Lopez Juanita Suzanne , De Bono Johann S. , Minchom Anna Rachel
Published: May 2019

e18175

Background: EAMs are wearable devices that record aspects of activity, including heart rate and step count. Medical oncologists use performance status (PS) (such as ECOG and Karnofsky) to assess patient’s physical function and to aid treatment decisions. These are subject to patient and physician bias. Our study evaluated the use of EAMs (Fitbit ®) during phase I trials, correlating EAM indices with PS and patient outcomes. Methods: We recruited patients in an academic hospital Drug Development Unit. Patients participating in a phase I trial consented to wear an EAM prior to starting and during the first treatment cycle. Physicians assessed PS at 4 timepoints. Outcomes (progression free survival (PFS), overall survival (OS), adverse events) were recorded. Results: Twenty-five patients were enrolled. At the time of data analysis results were available for 16 patients. Patients wore the EAM for an average of 70.3% (standard deviation 21%) of their time on study, defined as time with recordable heart rate. Mean step count per day varied with ECOG PS although the correlation did not reach statistical significance (co-efficient -1611.1 steps for each change in ECOG PS, p = 0.07, mixed effect regression model). A higher mean step count/day correlated with longer OS (HR0.67, p = 0.01, Cox proportional hazard model). Physician-assessed PS did not correlate with OS (HR2.65, p = 0.37, Cox proportional hazard model). There was no correlation between mean step count and PFS (HR1.7, p = 0.39, Cox proportional hazard model). Conclusions: The use of EAMs is feasible in this patient group. A higher step count correlated with longer OS whereas physician-assessed PS did not. Further research into the potential of EAMs as a means of predicting patient survival to guide decisions on eligibility for phase I trials and the potential for devising a revised Royal Marsden prognostic score incorporating EAM indices is warranted. Clinical trial information: SE536. [Table: see text]
Impact of timing of palliative care team consults in patients with advanced cancer.
Authors: Bemis Thomas , Baratam Praneeth , Seiders Dawn , Ward Kristine Marie , Styler Michael
Published: May 2019

e18182

Background: The 2018 ASCO palliative care guidelines recommend palliative care team (PCT) involvement within 8 weeks for patients with an advanced cancer diagnosis. However, the optimal timing of PCT consults in the inpatient setting has not been established. We investigated whether early PCT involvement for in-patients with an advanced cancer diagnosis affected discharge outcomes. Methods: We queried the Hahnemann University Hospital’s Palliative Care In-patient database between 2015 and 2018 for patients with advanced cancer and an estimated life expectancy of < 6 months. Dates of admission, initial PCT consult and discharge were examined. PCT consults within 7 days of admission were defined as early consults and those > 7 days as late consults. Chi square analysis was used to determine differences in LOS and time from PCT consult to discharge between the two groups. Cost-savings estimates were based on the Kaiser State Health Facts, which list an average cost per inpatient day in US hospitals of $2,289 in nonprofit and $1,791 in for-profit hospitals. Results: The majority of cases (69.7%) had PCT involvement < 7 days from admission and were associated with an overall shorter LOS of 12 days compared to 30 days with consults called > 7 days (p = < 0.001). Furthermore, early PCT involvement led to a 2-day shorter time to discharge (p = < 0.02) for an average cost-savings of at least $4,578 at a non-profit hospital and $3,582 at a for-profit hospital. Conclusions: Our findings show that the majority of patients at our institution with advanced cancer had early PCT involvement, which was associated with reduced hospital length of stay. These findings suggest that PCT involvement may expedite hospital discharge and by extension lead to increased cost-savings and patient quality of life. Future studies will aim to investigate the impact of early PCT involvement on hospital readmission rates and discharge to hospice care among other indicators of improved patient well-being.[Table: see text]
Venous thromboembolism in breast cancer patients receiving cyclin-dependent kinase inhibitors.
Authors: Gervaso Lorenzo , Montero Alberto J. , Jia Xuefei , Khorana Alok A.
Published: May 2019

e18184

Background: Venous thromboembolism (VTE) complicates several anti-cancer regimens including chemotherapy and anti-angiogenic agents. Cyclin-dependent kinase 4/6 inhibitors (CDKIs) are a new approach for hormone receptor positive (HR+) metastatic breast cancer (mBC). Reported VTE rates in randomized trials range from 0.6% for ribociclib (MONALEESA-2) to 2% for palbociclib (PALOMA-3) and 5% for abemaciclib (MONARCH-3) but these may underestimate actual rates compared to patients in clinical practice who are generally older and have greater comorbidities. Little is known about real world incidence or prevalence of VTE with CDKIs in mBC. The aim of this study was to evaluate rates of VTE in clinical practice and association with outcomes in mBC patients on CDKIs. Methods: We conducted a retrospective cohort study at Cleveland Clinic Taussig Cancer Institute, approved by the institutional review board. We identified consecutive mBC patients who received any of three FDA-approved CDKIs (palbociclib, ribociclib, abemaciclib) from 1/2015 through 12/2017. VTE including deep venous thrombosis (DVT) and pulmonary embolism (PE) were identified by electronic medical record review. Overall survival (OS), progression free survival (PFS) and time to VTE were estimated by the Kaplan-Meier method and evaluated for association with VTE using Cox proportional hazard regression. Results: The study population included 424 patients, with a median age at diagnosis of 54.76 yrs, (range 27 -85). Palbociclib was the most commonly used CDKI (n = 390, 91.8%); 27 patients (6.3%) received more than one drug. VTE during CDKI therapy occurred in 9% of patients (n = 38), including DVT in 52.6% (n = 20), PE in 18.5% (n = 7) and visceral vein thrombosis (VVT) in 15.8% (n = 6). Median time to VTE was 314 days, and 6-months rate was 4.1%. VTE was associated with numerically worse PFS and OS, but this was not statistically significant (PFS [HR 1.25, 95% CI 0.73 – 2.14, p = 0.42], OS [HR 1.60, 95% CI 0.89 – 2.87, p = 0.12]). Conclusions: VTE affected nearly 10% of breast cancer patients receiving CDKIs, 2- to 5-fold greater than reported in registration trials. Further work is necessary to identify pathophysiology, risk factors and benefit of thromboprophylaxis.
Does adding claims to EMR data improve comorbidity burden capture? A Concerto Health AI Definitive Oncology Dataset and Symphony Linkage Study.
Authors: Wong William Bruce , Pal Navdeep , Wu Ning , Chen Li , Sheinson Daniel , Chu Laura Kay
Published: May 2019

e18186

Background: Current commercially available oncology electronic medical record (EMR) databases typically have limited data on patient comorbidities which may limit the ability to accurately include/exclude these patients or adjust for these factors in health outcomes research. The objective of this study was to investigate the impact of identifying comorbidities using both EMR and claims data. Methods: The Concerto Health AI Definitive Oncology Dataset is a deeply curated cohort of patients (pts) derived from a wide range of oncology practices throughout the United States. Concerto Health AI has a co-exclusive partnership with ASCO CancerLinQ and collects data from multiple other sources. These data were deterministically linked to US Symphony Health’s (SH) Integrated Dataverse, an anonymized, HIPAA-compliant data set. Advanced (stage IIIb/IV) non-small cell lung cancer (aNSCLC) pts with data curated via manual review by nurse practitioners and diagnosed after 2011 were included. Comorbidities within 1 year prior to advanced diagnosis were categorized using the Charlson Comorbidity Index (CCI). The impact of the claims linkage on inclusion/exclusion (I/E) criteria was assessed by applying criteria from the IMpower150 clinical study and exploring changes to survival estimates, as calculated using Kaplan-Meier method. Results: A total of 11,373 aNSCLC pts were identified, of which 7,887 pts were linked to SH. Using only Concerto, 278 pts (3.5%) had a CCI score ≥1, whereas 3,033 pts (38.4%) had a CCI score ≥1 using linked Concerto and SH. After applying I/E criteria from IMpower150 using available data elements from Concerto only, 88 pts were identified matching the trial criteria, with a median survival of 15.8 mths (95% CI: 14.4, 21.0). When leveraging Concerto and SH, 8 (9.1%) more patients were excluded (n = 80) based on comorbidities (6 pts) and oral medications (2 pts), with a median survival of 16.6 mths (95% CI: 14.6, 23.4). Conclusions: The addition of claims to EMR enhanced the ability to identify patient comorbidities given the longer history and broader physician specialty of claims data. Future real-world studies should explore linkages across datasets to better capture comorbidities for patient selection and adjustment.
Effect of right censoring bias on survival analysis.
Authors: Barrajon Enrique , Barrajon Laura
Published: May 2019

e18188

Background: Survival Kaplan-Meier analysis represents the most objective measure of treatment efficacy in oncology, though subjected to potential bias which is worrisome in an era of precision medicine. Independent of the bias inherent to the design of clinical trials, bias may be the result of patient censoring, or incomplete observation. Unlike disease/progression free survival, overall survival is based on a well defined time point and thus avoids interval censoring, but it is our claim that right censoring, due to incomplete follow-up, may still be a source of bias. Methods: The R version 3.5.1 language and the integrated development environment RStudio were used for simulations and survival analysis with the survival package and their available datasets . Survival time was simulated according to a Weibull model with 2 parameters, shape and scale, that determine the event time for every case. Three types of right censoring mechanisms are considered and analyzed independently: 1) case censoring, in which a random number of cases are censored, and the resulting survival time is shortened by a random amount, 2) time censoring, in which a random censoring time variable is applied if and only if it is shorter than the event time, and 3) interim censoring, where a random time variable determines the case inclusion time since the start of trial, and a fixed cutt-off time determines if every case is censored (if the cutt-off time is shorter the the inclusion time plus the event time) or not. For every censoring mechanism, 100 trials was simulated with a 1000 uncensored cases arm and 1000 censored cases arm, in such a way that a censoring Cox hazard ratio (cHR) may be estimated for every trial. An interactive app showing the right censoring effect is presented. Results: A bias index (BI) was buit based on the survival time of event and censored cases. Case censoring was associated with higher BI (mean = 1.75, SD = 0.29) than time censoring (mean = 1.15, SD = 0.19, p = 2.02e-30) and interim censoring (mean = 0.72, SD = 0.21, p = 3.46e-34). It was found an inverse relationship between the censoring proportion and the cHR in case censoring (r = -0.86). Of all the available datasets, the Veterans' Administration Lung Cancer study showed a bias of 1.83, suggesting case censoring bias in both treatment arms. Conclusions: Based in the results of this study it is suggested that: 1) Final results should include all the events in the defined period of interest, 2) a bias index may help in detecting potential bias and correct estimated survival. Censoring bias analysis is planned in recent clinical trials.
Molecular and clinical features of hospital admissions and immunotherapy related adverse events of immune checkpoint inhibitors in thoracic malignancies.
Authors: Zhao Dan , Mambetsariev Isa , Chen Chen , Li Haiqing , Fricke Jeremy , Hewelt Blake , Fann Patricia , Kulkarni Prakash , Xing Yan , Koczywas Marianna , Massarelli Erminia , Reckamp Karen L. , Salgia Ravi
Published: May 2019

e18192

Background: Immunotherapy related adverse events (irAEs) and hospital admissions with Immune Checkpoint Inhibitors (ICIs) in thoracic malignancies remain poorly characterized. Methods: Admissions after ICIs in all thoracic malignancies patients received ICIs at City of Hope (total 384) were identified as of 11/8/2018. IrAEs, outcomes, pathology and next-generation sequencing (NGS) data were collected, including Tumor mutation burden (TMB) and PD-L1 (22C3). Length of stay (LOS) and overall survival (OS) was calculated. Unpaired T-tests if data passed normality test, Chi-square and Fisher’s exact test, Gehan-Breslow-Wilcoxon test were used for comparison between 2 groups (irAEs VS no irAEs) for LOS, demographics and genetics, and survival respectively. Results: 100 patients had hospital admissions after ICIs therapy and 90 patients (41 women, 49 men) had stage IV disease (63 lung adenocarcinomas, 14 squamous cell lung cancer, 5 small cell lung cancer, 8 others). 28 out of 90 patients had irAEs (10 pneumonitis/pneumonia, 4 adrenal insufficiencies, 4 colitis, 3 liver toxicities, 2 nephritis, 1 heart failure, 1 pancreatitis, 1 diabetic ketone acidosis, and others including multiple irAEs). There was no difference between the patients who had irAEs VS no irAEs in LOS (median 7 days VS 6 days, P = 0.57). Patients with irAEs had more invasive diagnostic procedures than no irAEs (53.6% VS 25.8%, P = 0.02). There was a trend of longer OS in irAEs patients (median 16.4 months VS 6.8 months, P = 0.13) than no irAEs. Male gender (71.4% (20/28) VS 46.8% (29/62), OR = 2.85, P = 0.04) and smoking exposure (89.3% (25/28) VS 58.1% (36/62), OR = 6.0, P < 0.01) were associated with irAEs patients. Genetic alterations of LRP1B gene (83.3% (5/6) VS 26.9% (7/26), OR = 13.6, P = 0.02) and MLL3 gene (66.7% (4/6) VS 19.2% (5/26), OR = 8.4, P = 0.04) were associated with patients who had irAES. No difference was found in age, lines of therapy, TP53, KRAS, EGFR, STK11, PIK3CA, TMB, PD-L1 between the irAEs and no irAEs patients. Conclusions: Hospitalized patients who had irAEs had similar LOS compared with patients without irAEs but potentially longer OS. Gender, smoking status and genes associated with irAEs and ICIs outcomes were explored. Larger dataset for molecular and clinical features was planned.
Publication rate of registered clinical trials in lung cancer.
Authors: Al-shbool Ghassan , Latif Hira , Farid Saira , Yin Anqi , Ahn Jaeil , Giaccone Giuseppe , Kim Chul
Published: May 2019

e18211

Background: Clinical trials play a crucial role in shaping oncology practice. Publishing results of clinical trials is key to reducing publication bias. Lung cancer is the leading cause of cancer-related mortality in the U.S. We assessed the publication rate of registered lung cancer clinical trials. Methods: ClinicalTrials.gov was searched to identify registered lung cancer clinical trials with study completion date between 1/1/2000 and 8/7/2016. Interventional phase II and III clinical trials involving patients ³ 18 years old with a recruitment status of completed or terminated were included. Using National Clinical Trial identifier and keywords including the clinical trial name, three databases (PubMed, Google Scholar, EMBASE) were queried to assess the publication status of each trial. We analyzed the publication rate among the identified clinical trials and predictors of publication. Results: A total of 1293 clinical trials were identified. Among 1037 completed clinical trials, 690 (66.5%; 193,587 patients) were published in peer-reviewed journal, while 347 (33.5%; 51,505 patients) were unpublished. Industry sponsored, non-randomized, and single-center studies were less likely to be published with odds ratio 0.52 (95% CI: 0.28-0.97), 0.67 (0.45-1.00), and 0.36 (0.25-0.51), respectively. Among the 347 unpublished completed trials, 75 (21.6%) trials reported the results as meeting presentation and 63 (18.2%) trials posted the results only on ClinicalTrials.gov. Among 256 terminated clinical trials, 72 (28.1%; 19,858 patients) were published in peer-reviewed journal, while 184 (71.9%; 10,259 patients) were unpublished. Among the 184 unpublished terminated trials, 19 (10.3%) trials reported the results as meeting presentation and 70 (38.0%) trials posted the study results only on ClinicalTrials.gov; reporting of primary outcome was incomplete in 50 (71.4%) of 70 studies whose results were only available on ClinicalTrials.gov. Conclusions: A significant proportion of registered lung cancer clinical trials remain unpublished, raising the concern of publication bias in the field of thoracic oncology.
Factors associated with metastatic presentation in HPV-related squamous cell carcinoma of the head and neck (SCCHN): A National Cancer Database (NCDB) analysis.
Authors: Bean Marta Brygida , Switchenko Jeffrey M. , Steuer Conor Ernst , Patel Mihir , El-Deiry Mark , Higgins Kristin Ann , McDonald Mark William , Chen Zhuo Georgia , Beitler Jonathan Jay , Shin Dong Moon , Gillespie Theresa Wicklin , Saba Nabil F.
Published: May 2019

e18213

Background: Metastasis is an ominous sign in SCCHN. Human papillomavirus (HPV) infection-associated SCCHN cancers tend to have a distinct prognosis. Factors that are associated with metastatic disease at the time of presentation and diagnosis in patients with HPV-related SCCHN tumors were examined. Methods: NCDB was queried to assess 12,857 patients with HPV-related oropharyngeal carcinomas (HPVOPCA) and 952 patients with HPV related non-oropharyngeal carcinomas (HPVNOPCA) diagnosed between between 2010-2014 with non-missing survival or M stage. Rate of metastases at presentation was analyzed using clinical M stage. Multivariable analysis was performed evaluating race, ethnicity, sex, age, facility location, facility type, insurance status, income, education, urban/rural location, surgery, radiation, and chemotherapy using logistic regression. Results: In both HPVOPCA and HPVNOPCA, over 90% of patients were white. Private insurance was carried by 64% and 47% of patients with HPVOPCA and HPVNOPCA, respectively. HPVOPCA cancer was located in the tonsil in 47% of cases. Patients with HPVOPCA were more likely to present with advanced nodal disease than patients with HPVNOPCA. For both HPVOPCA and HPVNOPCA, there was no meaningful difference in the rate of distant metastasis at presentation in facility type or location, sex, race, Hispanic ethnicity, or urban rural location. For HPVOPCA, there were significantly lower odds of metastasis in privately insured patients vs. uninsured patients (HR: 0.35, 95% CI: 0.21-0.59, p < 0.001), and higher odds of metastasis for those living in census tracts with the lowest rates of high school graduates vs. those living in census tracts with the highest rates of high school graduates (HR: 1.82, 95% CI: 1.07-3.09, p = 0.026). For HPVNOPCA, patients living in census tracts with the lowest rates of high school graduates were less likely to develop metastasis compared to those living in census tracts with the highest rates of high school graduates (p = 0.031). Conclusions: This large retrospective analysis identifies likely modifiable risk factors for metastatic presentation in HPV-related SCCHN. Health policies and educational interventions may result in modifications of these patterns.
Depressive symptoms, mental health-related quality of life, and survival among older patients with multiple myeloma.
Authors: Alobaidi Ali , Nabulsi Nadia Azmi , Talon Brian , Asfaw Alemseged Ayele , Zhou Jifang , Sharp Lisa K. , Sweiss Karen , Patel Pritesh Rajni , Chiu Brian C-H , Ko Naomi , Calip Gregory Sampang
Published: May 2019

e18232

Background: Few studies have evaluated the impacts of depressive symptoms and mental health on patients diagnosed with multiple myeloma (MM). The aim of this study was to examine associations between depressive symptoms and poor mental health-related quality of life in relation to survival in a cohort of older MM patients. Methods: We conducted an analysis using a prospective cohort from the Surveillance, Epidemiology, and End Results (SEER)-Medicare Health Outcomes Survey (MHOS) of patients aged 65 years and older diagnosed with first primary MM between 1998 and 2014. Subjects were required to have completed at least 1 pre-diagnosis survey and depressive symptoms were determined based on positive responses to at least 1 of 3 depression screening questions. Veterans-RAND-12 mental component scores (MCS) were also analyzed to evaluate mental health-related quality of life. We used multivariable Cox proportional hazards models to estimate hazard ratios (HR) and 95% confidence intervals (CI) for the association between pre-diagnosis depressive symptoms and risks of all-cause and cancer-specific mortality. Secondary analyses examined mortality risks in relation to pre-diagnosis MCS. Results: Of 522 multiple myeloma patients, the mean (SD) age at diagnosis was 76.9 (6.1) years and 158 (30%) self-reported positive depressive symptoms. Patients with depressive symptoms had a higher number of comorbid conditions and nearly all (84%) scored below the median MCS. Pre-diagnosis depressive symptoms were not associated with all-cause (HR 1.01, 95% CI: 0.79-1.29) or cancer-specific mortality (HR 0.94, 95% CI: 0.69-1.28). Myeloma patients scoring in the second MCS tertile (versus the highest tertile) had a modestly increased risk of all-cause (HR 1.19, 95% CI 0.91-1.55) and cancer-specific mortality (HR 1.17, 95% CI 0.86-1.60), but these estimates were not statistically significant. Conclusions: Pre-diagnosis depressive symptoms and lower mental health-related quality of life are not associated with survival for MM. Nevertheless, the considerably high prevalence of depressive symptoms and poor mental health status among older patients with multiple myeloma deserves clinical attention.
Trends in the incidence and outcomes of Clostridioides difficile infection in hematological cancers: A nationwide analysis.
Authors: Furqan Fateeha , Tariq Raseen , Goldstein Nicolas , Kashinath Sanjana , Jamshed Saad , Khanna Sahil
Published: May 2019

e18244

Background: Clostridioides difficile infection (CDI) has higher incidence in cancer patients. To characterize the extent of CDI burden among hematologic cancer patients, we used the National Hospital Discharge Survey (NHDS) to report the incidence and outcomes of CDI. Methods: NHDS data from 2001-2010 were analyzed using diagnosis codes to identify patients with hematologic cancers and CDI. Demographics and discharge information were compared amongst hematologic cancer patients with and without CDI. Logistic regression models were runto estimate the impact of CDI on hematologic cancer patient outcomes, using STATA 12.0. Results: During the years 2001-2010, about 3.7 million patients (weighted data) were discharged with hematologic cancer. Among them, the incidence of CDI was 2.3%. Hematologic cancer patients with CDI were younger (mean age 66 vs 68 years), more likely to be men (66% vs 64.5%), to be of white race (68.1% vs 67.7%) and to have emergent admissions (73% vs 69%), all p values < 0.001. CDI incidence in these patients showed a steeper increase than non-cancer patients, with highest incidence in 2008-2009. Hematologic cancer patients with CDI had a longer mean Length of stay (16.9 vs 7.1 days; adjusted odds ratio (aOR) 9.5, 95% CI 9.4-9.6), all cause hospital mortality (11.3% vs 6.3%; aOR 1.92, 95% CI 1.88-1.97) and discharge to a care facility (28.4% vs 18.8%; aOR 2.06, 95% CI 2.02-2.10) compared to non-CDI cancer patients. Conclusions: CDI incidence is higher in patients with hematologic malignancy. They also have worse outcomes including overall mortality, longer hospitalizations and discharge to healthcare facility. These patients warrant closer screening and prompt treatment of CDI as they are at greater risk of unfavorable outcomes. [Table: see text]
Trends in mortality due to hypercalcemia in breast cancer.
Authors: Perimbeti Stuthi , Shrivastav Rishi , Stanchina Michele Dana , Pathak Priyadarshini , Rainone Michael Raphael , Jain Maneesh Rajiv , Ward Kristine Marie , Styler Michael
Published: May 2019

e18252

Background: Hypercalcemia (HC) in metastatic breast cancers results from various mechanisms including increased bone turnover and secretion of Parathyroid hormone-related peptide. The presence of HC has traditionally been associated with poor prognosis but recent advances in the treatment of both HC with bisphosphonates and RANK-L inhibitors, and metastatic breast cancers with chemotherapy and immunotherapy, have improved symptoms and progression free survival. It has yet to be determined whether HC remains a poor prognostic indicator. Methods: Adult admissions ( > 18 years) between 1999 and 2014 with a primary diagnosis of breast cancer (BC) were extracted from the Nationwide Inpatient Sample using ICD-9 code 174.9. They were stratified for the presence of HC (ICD-9 code: 275.42), and further according to the year of admission. Chi-Square test and cox proportional hazard regression were used to determine in-hospital mortality and hazard of death based on the presence of HC. Results: A total of 484,859 (N = 98,631, weighted N = 484,859) admissions with a primary diagnosis of BC were obtained. The prevalence of HC increased from 0.52% in 1999 to 1.32% in 2014, yet inpatient mortality and adjusted Hazard Ratios (HR) of mortality declined over time as shown in Table. Despite this, patients with HC continued to have a significant increase in hospital mortality and HR (p < .001). Conclusions: Due to advances in medical therapy, in hospital mortality for patients with metastatic breast cancer has been declining over the last 15 years, however, the presence of HC continues to carry an independent risk for mortality. More research is needed to elucidate why HC continues to confer worse prognosis despite new calcium-lowering treatment modalities.[Table: see text]