bluuebunny/crossref_metadata_2025_split huggingface dataset:
Development and validation of a novel web application for patient-reported outcome measures monitoring.
Authors: Jones Rachel , Santoki Aditya , Peter Manas , Varma Sharan M. , Mathew Aju 
Published: June 2024

e23173 Background: Patient Reported Outcome Measures (PROM) and its role in managing cancer treatment associated symptoms can not only improve the quality of life but also often prevent complication related mortality. PROM can be defined as a self-reported status of a patient's health condition without physician interpretation. One key limitation of using an app based PROM monitoring is a digital divide, (unequal distribution and knowledge regarding modern information and communication technology). Integrating PROM with technology allows for an efficient and effective method to communicate disease management. Methods: We developed a web application called Meeval consisting of two tools - PROM monitoring and medication reconciliation. Patients are able to track the severity of their symptoms on a ten point likert scale and add the medication details to their profile. We conducted a pilot study of patients with cancer who were handed a pamphlet, invited to download the app and assess its usability. We aimed to find the proportion of patients who would download and use the app following a simple introduction by the doctor using a pamphlet. We postulated that greater than fifty percent of downloads would happen, thereby negating a possible digital divide when it comes to app based PROM monitoring. Results: We recruited 95 patients with cancer. It was determined that 60% of the study population had downloaded the app without much prompt. Of this population of users, it was found that 36.8% downloaded after a seven day follow up call and 63.2% required no follow up call for app installation. When looking at app usage it was found that 53.1% of patients are tracking symptoms, 15.6% are tracking medications and 31.3% are tracking both symptoms and medication. Conclusions: The Meeval application allows for a ‘Measure, Track and Respond’ model to be implemented in a clinical setting and further enforce patient-centric healthcare. Furthermore, this app allows for seamless interaction between the patient and the physician. Patients who log their symptoms daily allow for the physician to have a more comprehensive understanding of the disease profile and any adverse effects associated with the treatment plan. Patient Reported Outcome Measures can significantly improve the quality of life and prevent any medical oversight. Through PROM tools, early detection and intervention is possible. The goal of the novel Meeval application is to improve both patient and physician experience when it comes to a chronic diagnosis and disease management. We found that the Meeval application will bridge the digital divide and provide a platform for wider use in the field of oncology.
With eyes on the future: Prospective evaluation of immune-related adverse events in patients with lung cancer.
Authors: Florez Narjust , Kiel Lauren , Kaufman Rebekah , Horiguchi Miki , Haradon Danielle , Sanchez Michelle , Lederman Ruth , Amaral Duarte Flavia , Meza Kelly , Mantz Courtney , Nguyen Tom , McDonald Stephanie , Sharon Elad 
Published: June 2024

e23177 Background: Immune checkpoint inhibitors (ICIs) bear unique, time-dependent immune-related adverse events (irAEs). However, limited data exist regarding tolerability in real-world populations. We report interim, non-sex stratified results of the first study prospectively evaluating ICI tolerability in patients with lung cancer (LC) in a real-world setting. Methods: Recruitment began in July 2023 and is ongoing. The electronic Patient-Reported Outcomes version of the Common Terminology Criteria (PRO-CTCAE) was utilized to assess patients’ irAEs. Patients (pts) complete up to 6 questionnaires throughout their treatment plus an end of treatment evaluation. Inclusion criteria includes pts ≥18 years, with LC stage I to IV, receiving single-agent ICI at Dana-Farber Cancer Institute. Descriptive statistics summarized patients' demographics, clinical characteristics, and symptoms. Results: 36 pts were enrolled in the study as of January 23, 2024. 35 pts have completed their first PRO-CTCAE questionnaire; the median number of completed questionnaires was 2 (range: 1-6). Due to the current sample size, results reported reference pts’ first PRO-CTCAE assessment. 53% of pts identified as female, 92% identified as White, and 6% as Black (Table 1). 56% of pts (19/34) reported having shortness of breath (SOB), most of whom (63%; 12/19) reported having moderate to severe SOB that often (somewhat to very much; 42%; 8/19) interfered with daily activities; 21% of them (4/19) stated that the SOB had worsened since starting ICIs. Similarly, of the 54% (19/35) with a cough, 42% (8/19) reported a moderate to very severe cough and 16% (3/19) reported its worsening since ICI initiation. 14 pts reported anorexia secondary to treatment, with most of them (57%; 8/14) reporting that it interfered with daily activities. Most pts (79%; 27/34) noted some degree of lack of energy. Rates of skin toxicity were low, with only 6% (2/35) experiencing a rash after beginning ICIs. Many pts did not experience nausea, abdominal pain, or unexpected sweating (80%; 28/35, 83%; 29/35, 77%; 27/35). However, of the pts reporting nausea and abdominal pain, high severity of these symptoms was noted (43%; 3/7, 50%; 3/6). Other low frequency irAEs included diarrhea, dry mouth, and dysgeusia. Conclusions: SOB and cough were the most common symptoms experienced with high severity in this ongoing prospective evaluation of irAEs in pts with LC. Though nausea and abdominal pain were less common, when present, these symptoms were reported with high severity. Future data from this study will elucidate patient experiences with irAEs throughout their treatment course. [Table: see text]
Patient-centered perspectives: Examining quality-of-life integration in phase III lung cancer trials (2019-2023).
Authors: Kalantri Shreyas , Sainatham Chiranjeevi , Tallapalli Jayanth Reddy , Singh Rishabh , Kloecker Goetz Hans 
Published: June 2024

e23181 Background: In the dynamic landscape of lung cancer treatment, marked by precision medicine advancements, addressing the persistent global health challenge of lung cancer requires nuanced evaluations beyond traditional endpoints like Overall Survival (OS). Aligned with the emphasis on patient-centered care, both the US FDA and ASCO advocate for consistent integration of Quality of Life (QoL) and Patient-Reported Outcomes (PRO). The FDA's 2021 guidance underscores standardized assessment strategies, and ASCO's conceptual framework highlights the pivotal role of QoL and PRO data in elucidating the genuine value of cancer treatment options. This investigation aims to illuminate the extent to which recent trials consider patients' subjective experiences without presupposing an impact on QoL. Methods: This systematic review analyzed PubMed for Phase III lung cancer clinical trials involving anticancer drugs conducted between 2019 and 2023 to assess if QoL was included as an endpoint. Subgroup analyses categorized trials by cancer subtype (e.g., non-small cell lung cancer [NSCLC], small cell lung cancer [SCLC]). Analyses were also stratified by publication year to explore potential temporal trends. The total prevalence of QoL as an endpoint was calculated across all lung cancer subtypes for the entire 5-year period. Subanalyses included impact factor categories (≥ 10 and < 10) and differentiation between superiority and noninferiority trials. Results: The systematic analysis identified 191 Phase III lung cancer clinical trials published between 2019 and 2023, meeting the criteria. QoL was included in 31.93% of trials across all subtypes. Subgroup analyses showed that 33.72% of NSCLC trials incorporated QoL, with variations observed in early-stage resectable disease (26.31%) and unresectable advanced and metastatic cases (34.66%). For SCLC, 19.04% of trials included QoL, with none in the limited stage and 22.22% in the extensive stage. Stratified by publication year, 2019 had 33.33%, 2020 had 39.02%, 2021 had 33.33%, 2022 had 23.33%, and 2023 had 28.94% trials with QoL assessments. Stratification based on impact factor (IF) and trial type revealed 29.4% in Journals ≥10 IF, 35.6% in Journals < 10 IF, 35.5% in superiority trials, and 21.6% in non-inferiority trials. Conclusions: Our analysis reveals a significant shortfall in incorporating QoL as an endpoint. Across all subtypes and stages, a limited percentage of trials included PRO, highlighting a crucial gap in evaluating the comprehensive impact of interventions. The underrepresentation of QoL assessments signals a need for greater attention to the holistic patient experience in lung cancer research. Moving forward, a more standardized and comprehensive integration of QoL assessments in Phase III trials is essential to enhance our understanding of treatment impact and inform more patient-centered care decisions.
Association between perceived quality of care and social isolation among cancer survivors in the US.
Authors: Jackson Inimfon , Dosunmu Gideon T. , Olafimihan Ayobami Gbenga , Ntukidem Olanipekun Lanny 
Published: June 2024

e23182 Background: Though social isolation has been linked to poorer survival outcomes among cancer survivors, studies assessing its association with perceived quality of care have not been explored in this population. We examined the association between perceived quality of care and self-reported social isolation among cancer survivors. Methods: Cross-sectional analyses were conducted using the Health Information National Trends Survey (HINTS) data collected from a nationally representative population of US adults from March to November 2022. Social isolation was assessed with the self-reported Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation Short Form. Multiple linear regression models were used to examine the association between perceived quality of care and self-reported social isolation among cancer survivors. Other factors associated with social isolation in this population were also assessed. Results: In the adjusted analyses, social isolation scores were 6.3 points (95% CI: 2.30–10.28) higher among cancer survivors who reported fair/poor quality health care relative to those that reported excellent/very good/good quality of care. When compared to Non-Hispanic White cancer survivors, Non-Hispanic Blacks (β: –2.96; 95% CI: –5.35– –0.57) and Hispanic survivors (β: –4.06; 95% CI: –7.71– –0.40) had lower social isolation scores. Cancer survivors who were married or cohabiting had 3.3 points (95% CI: –6.01– –0.55) lower social isolation scores relative to single cancer survivors. Cancer survivors with high school or less education had lower isolation scores (β: –2.03; 95% CI: –4.00– –0.07) than those with some college education or more and those with an income of $50,000 or higher reported lower isolation scores (β: –2.19; 95% CI: –4.17– –0.21) than their counterparts earning less than $50,000. Furthermore, those with a diagnosis of depression or anxiety had 5.2 points (95%: 3.23–7.21) higher social isolation scores than cancer survivors without depression/anxiety. Conclusions: Fair or poor quality of care was associated with higher social isolation among cancer survivors. Additionally, race/ethnicity, marital status, level of education, income, and depression/anxiety were correlated with social isolation. To reduce the impact of social isolation and improve the health outcomes of cancer survivors, healthcare providers need to prioritize delivering holistic care, promote social connectivity and incorporate mental health screening and referrals into standard care practices.
Patient Reported Outcome Measurement Information System (PROMIS) in routine oncological care: A literature review and survey of users.
Authors: Nolla Kyle , Langer Michelle M. , Greene George J. , Sparling Amy , Rothrock Nan E. , Franklin Patricia D. 
Published: June 2024

e23192 Background: Patient-reported outcome measures (PROMs) are critical for patient-centered care in oncology, as they allow patients to communicate with their care team about a range of symptoms using well-validated tools. However, successful use of PROMs in routine care depends on the clinical user experience: the opinions and experiences of the clinicians and staff who administer and make treatment decisions using PROMs. This study characterizes the use of the NIH-sponsored Patient Reported Outcomes Measurement Information System (PROMIS) in routine oncological care through a literature review and user survey. Methods: First, we conducted a narrative review of papers published from 2010 to June 2023 to identify breadth of PROMIS use in routine care. We screened 262 abstracts and identified 10 articles describing routine care in patients with cancer. We coded for institution type, PROM administration methods, and types of PROMIS measures. Next, we conducted a survey to solicit the opinions and experiences of diverse stakeholders implementing PROMIS in routine care. We contacted 209 known users of PROMIS (published authors, PROMIS API clients, and respondent referrals). Item frequencies were used to characterize survey responses. Chi-square tests were used to test differences between users in oncology and other fields. Results: Review. Nine of the 10 institutions using PROMIS in routine cancer care were academic medical centers. Articles reported on data from 2011-2021. The most popular PROMIS measure was PROMIS Global Health which provides summary scores of physical and mental health. Other popular domains included fatigue (4), physical function (3), depression (3), and anxiety (3), all measured by PROMIS computerized adaptive tests (CATs). They were most often administered in the clinic waiting room (7) or online before appointments (6). Most institutions (6) had PROMIS results automatically integrated into the electronic health record. Survey. We had 89 respondents (6 from oncology). PROMIS users in oncology were more likely to have structured training on the use of PROMIS than other users (χ2 (1,79) = 6.0, p = 0.01) and less likely to give patients direct access to their results (χ2 (1,72) = 6.0, p = 0.01). Users in oncology did not differ from the whole sample in opinions of PROMIS (% agree): users viewed PROMIS as worthwhile (86%), clinically relevant (85%), easy to administer (76%), statistically reliable (73%), and beneficial to treatment monitoring (68%), but were less confident that PROMIS improves doctor-patient communication (57%), treatment decision-making (54%), or patient satisfaction (35%). Conclusions: Conclusions PROMIS has been successfully integrated into routine oncological care in several academic medical centers. While adoption is not widespread, these initial results suggest that PROMIS is a useful tool for symptom monitoring in cancer care.
Impact of early phase study enrollment for pediatric oncology patients on symptom burden and quality of life (QOL): Early report of trial-in-progress results.
Authors: Rodden Kendra , Rodden Isabelle LaForest , Deyell Rebecca , Tomlinson Deborah , Sung Lillian , Lewis Victor Anthony , Stapleton Cielle , Portwine Carol , Zorzi Alexandra Patricia , Marzouki Monia , Goudie Catherine , Barrowman Nick , Hayawi Lamia , Berman Jason N. , Palmer Antonia , Johnston Donna , Thacker Nirav , Abbott Lesleigh S. 
Published: June 2024

e23195 Background: Pediatric patients with relapsed or refractory malignancy have few options. The quality of life (QoL) impact for enrolling in a phase I or II trial compared to those not participating is unknown. This information is invaluable to the consenting process as well as to clinical trial design. The primary aim was to determine if those enrolled on a phase I or II trial had lower scores on the Symptom Screening in Pediatrics Tool (SSPedi) total score compared to those not enrolled on a trial. Methods: This Canadian multi-site study had nine sites open for accrual. SSPedi was calculated based on patient reports for 8-18 years and parent-proxy reports for all children. The total score is the sum of 15 items’ 4 Likert scale scores, score ranges from 0 to 60 (worst possible). Scores from baseline, 4 weeks and 8 weeks of those enrolled on an early phase trial were compared to those who did not enroll in such trials. Results: Of the 54 49 patients, 21 (43%) patients were enrolled on an early phase trial and 28 (57%) patients were not enrolled in a study. For those enrolled on the study at enrollment time, 4 weeks and 8 weeks time points, the total SSPedi score for the participant mean was 11.1 (SD 8.1), 9.2 (SD 6.3) and 10.1 (8.3) respectively compared to those not enrolled on a study with mean scores at the same time points of 13.8 (SD 8.6), 13.5 (SD 9.4), and 15.4 (SD 12.6). Conclusions: These results suggest that it is feasible to evaluate patients enrolled and not enrolled on early phase trials, and to compare their symptom experience. Further efforts will focus on more recruitment and using the PedsQL 3.0 Acute Cancer Module to further define differences in QoL. The results suggest that those enrolled in an early phase trial had an improved quality of life compared to those non-enrolled. This research is supported through granting from the C17 Council and Kindred Foundation. [Table: see text]
Utilizing large language models (LLMs) to pre-label candidate concepts from in conceptual development landscape reviews in oncology.
Authors: Thorlund Kristian , Nourizade Milad , Jafar Reza , Hudgens Stacie 
Published: June 2024

e23198 Background: Labeling and identifying concepts from qualitative studies and patient interviews in oncology can be challenging and time consuming, often requiring several iterations. Large language models (LLMs) may be tailored to serve as a ‘co-pilot’, thus reducing errors and time to completion. We therefore aimed to examine whether utilizing LLMs to pre-label concepts (i.e., how patient’s feel or function) from medical oncology literature text can be done at comparable accuracy as human. To examine whether such LLM pre-labelling can dramatically reduce the time required for manual labor in conceptual development landscape reviews in oncology. Methods: We developed GPT-4 (OpenAI) prompts to pre-label concepts reported in abstracts of qualitative study references. We further developed GPT-4 prompts to categorize each pre-labeled concept into one of the following relevant high-level category: clinician reported symptoms, cognitive impacts, symptoms due to treatment, symptoms due to diagnosis, emotional impacts, impact on caregiver, other impacts, physical appearance, physical function, and social impacts. The prompts were extended to also capture diagnosis, treatments, patient reported outcomes, as well as generic terms or irrelevant terms that would otherwise erroneously be captured under the concept category in the early iterations of the prompt-engineering. The prompts were tested on 48, 37, and 38 (total of 123) eligible references from three conceptual development reviews covering colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and acute myeloid leukemia (AML), respectively. Results: The LLM pre-labelled a total of 153, 131, and 159 candidate concepts across the CRC, NSCLC, and AML reviews, respectively. In all three reviews, clinical reported symptoms, emotional impacts, and social impacts all accounted for 18-25% each of the pre-labelled concepts, whereas physical function and social impact accounted for 5-9% each. A total of 2 (1.3%), 3 (2.3%) and 4 (2.5%) pre-labels were predicted to belong to the wrong high-level category. Incorrectly categorized labels were dispersed across most categories and should have been categorized as ‘other impacts’. In the NSCLC review, one pre-label categorized as impact on caregiver and two as other impacts were erroneously extracted concepts. Conclusions: LLMs are effective at capturing and pre-labelling concepts for further review, evident by the high number of concept labels extracted. Further high-level categorization with LLMs to guide manual reviewers also appears highly accurate.
Reducing the time to chemotherapy start for planned admissions.
Authors: Sadagopan Narayanan , Haber Jamie Kayla , Desai Aalisha , Weah-Konuwa Zoe S. , Latif Hira , Whitaker Kristen Danielle 
Published: June 2024

e23201 Background: Planned hospital admissions for chemotherapy should be initiated shortly after arrival. Between January 2022 and May 2023, 25.7% of sarcoma patients at Medstar Washington Hospital Center admitted for chemotherapy experienced initiation of chemotherapy delays of more than 6 hours. Delays in chemotherapy initiation can lead to prolonged hospitalization with associated higher costs, increased risk of hospital acquired conditions, and decreased patient satisfaction. Methods: Discussions with team members involved in the initiation of inpatient chemotherapy process identified the following issues contributing to delay: absence of recent lab results, challenges with IV access, missing chemotherapy consent forms, absence of chemotherapy orders, failure to notify team members of patient arrival, lack of dose adjustments based on lab work, and insufficient pharmacy staffing. As our chemotherapy floor policy is to start pre-medications once the chemotherapy is on the unit, we defined the time to chemotherapy start as the time of the first pre-medication minus the time the patient checked in to the hospital’s admissions office. Patients with unforeseen issues such as a new fever on arrival were excluded. We obtained baseline data for sarcoma admissions between January 2022 to May 2023. Two Plan-Do-Study-Act (PDSA) cycles were implemented. The first cycle involved the introduction of a chemotherapy calendar. The second cycle implemented a group email system to finalize all arrangements for the admission. We collected about 3 months of data for each PDSA cycle. Results: Pre-intervention, there were 101 sarcoma admissions with 14.9% of patients starting chemotherapy in < 3 hours while 25.7% took > 6 hours. In the post-intervention data combining both PDSA cycles, 6.8% of patients started chemotherapy in < 3 hours while 43.2% took > 6 hours. As such, the average time to chemotherapy start was increased in post-intervention groups (table 1) despite improvements in many of the common issues. The median time to chemotherapy start based on the number of agents the patient was receiving was 4.98, 6.4, and 7.18 hours respectively for 1, 2, and 3 agents in the post-intervention group. Conclusions: Despite multiple attempts, the median time to chemotherapy start increased in the post-intervention groups. Our interventions targeted many of the barriers except insufficient pharmacy staff. With the median start time increasing based on the number of agents the patient was receiving, it appears that pharmacy mixing and delivery chemotherapy is likely one of the main causes of the delays. Subsequent discussions with the pharmacy team revealed plans to increase staffing as a proactive measure to address this issue. [Table: see text]