bluuebunny/crossref_metadata_2025_split huggingface dataset:
Standardization of toxicity related dose modification in oncology electronic health record (EHR).
Authors: Sanyal Amit , Wellner Daniel , Thomas James , Mattila Matthew 
Published: June 2022

e18616 Background: Inappropriate antineoplastic drug dosing can cause excessive toxicities or impaired efficacy. Chemotherapy dose delays and reduced dose intensity are common in community oncology practices[1]. Electronic tools can improve quality and safety of chemotherapy. Methods: A quality improvement project to standardize toxicity related dose modifications was initiated in January 2021. A dose modification section was created in BEACON (Epic Systems, Verona, WI) chemotherapy protocols. Dose modifications used in primary source studies were added to the protocols (Table, illustrative). An embedded link to relevant section of the study protocol allowed detailed review. Similarly, a link to the relevant CTCAE grading was embedded for reference. A user experience survey was conducted in August 2021 to evaluate adoption and perceived utility. Results: Dose modifications recommendations have been introduced in 104 protocols to date. Of the 70 survey respondents, there were 18 physicians and 5 advance practice providers, remainder being oncology nurses and pharmacists. Pre-implementation, 29% (8/27) of respondents whose role required performing dose modifications indicated using personal clinical judgement for hematological toxicity related dose modifications. 34% (9/26) did the same for non-hematological toxicities. Post-implementation, 87% respondents indicated awareness of the recommendations. 47% indicated that recommendations saved timed and 60% found these useful. 7.2% felt recommendations were impractical for clinical use. Conclusions: Embedding evidence-based dose modification recommendations into EHR based treatment protocols is feasible with widespread user adoption. References Denduluri, N., et al., Dose Delays, Dose Reductions, and Relative Dose Intensity in Patients With Cancer Who Received Adjuvant or Neoadjuvant Chemotherapy in Community Oncology Practices. J Natl Compr Canc Netw, 2015. 13(11): p. 1383-93. Illustrative Dose Modification Table. Reference Links 1. Grothey et al. Dose Modifications 2. CTCAE Grading. Refer to Reference Link for Detailed Instructions. Decrease Oxaliplatin and 5 FU one dose level for ANC<1000, platelets <50,000, Grade 4 diarrhea Decrease 5 FU one dose level for Grade 3 diarrhea, Grade 3 or 4 mucositis Decrease Oxaliplatin one dose level for Grade 2 neurotoxicity persisting between treatments, Grade 3 neurotoxicity resolving to </= Grade 2 between treatments Discontinue Oxaliplatin for Grade 3 neurotoxicity persisting between treatments, Grade 4 neurotoxicity.[Table: see text]
Altered cancer care delivery during COVID-19: Evaluating the impact of virtual clinics and treatment changes on oncology patient outcomes, quality of life, and satisfaction.
Authors: Kachura Jacob , Hrycyshyn Adriyan , Abbruzzino Alexandria , Deruchie Tan Adam , Smith Janet , Brezden Christine 
Published: June 2022

e18618 Background: The coronavirus disease (COVID-19) pandemic has created unprecedented strain on healthcare systems across the world. COVID-19 has thought to have significant impacts on the oncology patient population and has affected their care. Additional research is needed to ascertain the impact of the COVID-19 pandemic at the patient level. We sought to evaluate whether the delivery of cancer care, quality of life (QoL) and treatment outcomes of oncology patients at Mount Sinai Hospital (MSH), Toronto, Canada was impacted by the COVID-19 pandemic. Methods: A 3-part longitudinal questionnaire study including 138 oncology patients receiving active treatment or in active follow-up at MSH was conducted between June 15, 2020 and August 25, 2021. The questionnaire consisted of the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer QoL Questionnaire Version 3) and satisfaction with virtual healthcare questionnaire. The questionnaire was completed at baseline (Jun 15-Sep 8, 2020), 1 month follow-up (Jul 15-Oct 8, 2020), and 12 months follow-up (Aug 4-Aug 25, 2021). Repeated measures analysis of variance tests were performed to evaluate EORTC QLQ-C30 subscale score changes and satisfaction with virtual care question scores over time. Results: Overall, the mean EORTC QLQ-C30 QoL scores were seen to improve in oncology patients from 65.1 (SD±22.3) at baseline to 69.1 (SD±16.9) at 12 months follow-up (p = 0.2). Within the EORTC QLQ-C30 functional scales, mean role functioning and mean social functioning scores were observed to increase over 12 months of follow-up, 66.4 to 79.2 (p < 0.05) and 67.7 to 76.4 (p = 0.17), respectively. Little change was observed within other EORTC QLQ-C30 functional scales and individual symptom scales during follow-up. Over 12 months of follow-up, mean agreement (0 = strongly disagree to 6 = strongly agree) to the questionnaire statement regarding avoiding going to the hospital during COVID-19 pandemic had declined, from 4.6 (SD±2.0) at baseline to 3.9 (SD±2.2) at 12 months follow-up (p = 0.09). Although not significant, virtual care satisfaction generally decreased over the follow-up time period. 97% of 48 patients who completed the survey at 12 months of follow-up reported feeling more safe coming into the hospital when considering the current increased vaccination rates in Ontario. Conclusions: As the COVID-19 pandemic has evolved, there has been increased knowledge of disease transmission, along with the introduction of health care measures such as vaccination and treatment. During this time, cancer outpatients at MSH became more comfortable as demonstrated by improvements in both QoL and virtual care scores. Prospective studies should still be considered to assess the efficacy of different methods of improving oncology patient care and QoL during the COVID-19 pandemic.
Impact of personalized care discussions on advance care planning.
Authors: Hannan Emma , Collins Elizabeth , Wilde Lindsay , Worster Brooke , Hanson Molly , Csik Valerie Pracilio , Handley Nathan , VanSciver Jillian 
Published: June 2022

e18619 Background: Advanced Care Planning (ACP) involves learning about decisions that may need to be made during care so they are known to family and providers. ACP has been associated with less aggressive medical care near death and improved quality of life.However, despite evidence for their benefit, ACP is inconsistent among patients with advanced cancer. At our institution, only 52% of patients with cancer undergoing palliative intent treatment had an ACP at the time of death. We sought to increase ACP through a quality improvement project intended to proactively identify and introduce patients to Personalized Care Discussions (PCDs). PCDs engage oncology patients and palliative care providers in ACP to articulate goals of care. Methods: A team of palliative care providers, medical oncologists, and administrative staff designed each phase of the intervention. Inclusion criteria to proactively identify patients eligible for a PCD were created along with a workflow to introduce PCDs and schedule a PCD appointment. A plan-do-study-act (PDSA) model was used to test impact of change to the PCD referral workflow and patient inclusion criteria. Each PDSA cycle lasted between 4 and 9 weeks between 6/1/2021 and 1/31/2022. PDSA 1: Oncologist referral to PCD for new patients. PDSA 2: Oncologist referral to PCD for Stage IV patients. PDSA 3: Automatic referral to PCD of Stage IV patients. PDSA 4: Pancreatic patients, any stage, added to PDSA 3 criteria. Results: During the measurement period, 68 patients completed a PCD. While changes to the inclusion criteria throughout PDSA cycles resulted in more total unique patients completing PCDs, the completion rate of eligible patients did not vary significantly across cycles. However, the proportion of patients completing PCDs for oncologists engaged in the project increased during the eight-month QI period (92%) from the previous eight-month period (86%). Conclusions: This project sought to identify and introduce patients to PCDs to improve ACP. We found that access to PCDs was not sufficient to increase completion of PCDs, since fewer than half completed the appointment. However, 68 patients who otherwise may not have completed a PCD did so because of this intervention. Misperceptions of palliative care may contribute to high cancellation rates of PCD appointments. This pattern is seen in the overall low completion rate of palliative care appointments (56% in same timeframe). Informal patient feedback often indicated a preference for care discussions to be with the primary oncologist, whereas our intervention introduced a new provider. These results demonstrate that a trigger to identify patients for PCDs without primary oncologist engagement falls short. Continued focus is needed to determine a proactive approach to identify patients who will benefit most from PCDs to complete ACP proactively.[Table: see text]
Screening for anxiety and depression in cancer patients using PHQ4.
Authors: Bhakta Pooja N. , Hunzeker Zachary E. , Gudipally Sindusha R , Willis Maurice , Venkatesan Rohit 
Published: June 2022

e18629 Background: The prevalence of anxiety and depression disorder in patients with cancer is about 10% and 22%, respectively. Cancer patients were seven times more likely to have a psychiatric disorder than the normal population. Prior studies have used multiple questionnaires like GAD7, HADS, PHQ2 and PHQ9 which have been approved by national guidelines to assess severity of anxiety and depression in the cancer population. Patient Health Questionnaire-4 (PHQ4) questionnaire is a validated screening tool for anxiety and depression disorders. This study aimed to implement a concise screening tool, PHQ4, to identify the mental health status of cancer patients early and intervene with counseling, medications, and referral to PCP/Palliative care for symptoms control. Methods: Patients completed the 4-item PHQ4 during their clinic visits at University of Texas Medical Branch between December 1, 2021, and February 1, 2022. The patient was provided with a PHQ4 questionnaire at the beginning of their visit. The PHQ4 implements two screening questions for anxiety and depression each, with the frequency of symptoms determining the score on a scale of 0 (not at all) to 3 (nearly every day) for each item. When the total score was > or = 3, a presumptive diagnosis of anxiety, depression, or both was made. These patients were given information regarding support groups, resources for interventions, and provided with medications/referrals to primary care/palliative care/psychiatry for further management. Demographic factors (i.e., age, sex, race/ethnicity), type of cancer, and stage of cancer were other variables that were collected and analyzed as well. Results: Out of 70 total patients, 12 (17.1%) screened positive for anxiety, 14 (20%) screened positive for depression, and 9 (12.9%) screened positive for both depression and anxiety. 10 (14.3%) patients were diagnosed with mild symptoms (score 3-5), 10 (14.3%) with moderate symptoms (6-8), and 4 (5.7%) with severe symptoms. Median age of study population was 60, median age for positive screening was 54.5 years. While there were 35 males and females included in the study, 10 males (14.3%) and 7 females (10%) screened positive. Caucasian ethnicity (76.5%) and Colorectal cancer (24.3%) had the highest prevalence of patients who screened positive. All patients who screened positive were either stage 3 or 4 cancer patients. All patients (100%) who screened positive, received intervention. Conclusions: Based on our results, PHQ4 almost met the national average for depression screening. It possibly over diagnosed patients with anxiety and depression which may have been also contributed by other social/financial/personal stressors, warranting further attention with social worker support. PHQ4, is a quick, validated, effective screening tool that can regularly monitor cancer patients’ psychological health and enable timely intervention.
A lean-sprint approach to protocol development.
Authors: Paul Varun , Ferranti Lori , Dilts David M. 
Published: June 2022

e18639 Background: With the ever-increasing complexity of protocols and their required approvals, there is a need to improve the time and reduce the effort required to create a Phase III protocol. The objective of this research was to reduce from months to weeks the time to create a Phase III protocol at a large global pharmaceutical organization, while maintaining or improving the quality and scientific merit of the protocol. Methods: The method required two phases: process redesign and process execution/performance. For the first phase, a continuous improvement methodology (Lean), was utilized. In a multi-team-based approach, the first stage (process-prep) focused on the development of the initial draft protocol. The second stage used the concept of a Sprint, a process to complete all protocol changes and approvals within a rapid time span, while simultaneously guaranteeing protocol quality. A set of policies, procedures, and information technology tools were developed to facilitate both efforts. The Process-prep stage was team-based, where a streamlined Clinical Study Team and a sub-group, the Protocol Working Group, identified all the key tasks, activities and their associated completion dates, and created an 80% complete draft protocol. The Sprint was a one-week, intensive effort by all those responsible for creation of the protocol, and for its final approval. Working virtually and internationally allowed for a continuous 24-hour effort during the Sprint. One key element of success was the use of a visualization tool for the creation, adaptation, and finalization of the protocol’s schedule of assessments (SOA) which both assured that all assessments were required by the protocol and that there was concordance between the protocol and the SOA. Results: Quantitative results were significant: a completed protocol was created with a 50% reduction of time compared to the last protocol written by the molecule group, reduction of avoidable amendments, reducing missed errors and potentially decreasing the number of protocol amendments and the near elimination of process loops and email-chains. Qualitatively, team members were trained on useful process tools and methods, while also increasing their comfort level in active participation in remote meetings. This resulted in faster time to create any amendments that may be required in the future for the protocol. Conclusions: It is possible to employ efficiency and effectiveness methods, such as Lean and Sprint, that have been used successfully in other industries in the pharmaceutical research & development process. While using such concepts requires a great deal of initial planning, the rewards of using them are significant. Likewise, the extensive use of interdisciplinary remote teams will be of increasing importance in a post-COVID environment of clinical research.
Beneficial role of customized intraoral stents in radiotherapy for nasopharyngeal carcinoma.
Authors: Yang Mi , Xie Huanhuan , Hou Zhen , Jiang Yuya , Wang Kongcheng , Sun Fangfang , Wang Juan , Li Shuangshuang , Liu Juan , Gao Shanbao , Yan Jing 
Published: June 2022

e18642 Background: The intraoral stent is a mouth-opening device which may be used in nasopharyngeal carcinoma (NPC) patients during radiotherapy with the intention of preventing unnecessary irradiation in normal adjacent tissue. The purpose of this study was to investigate the effects of individualized intraoral stent on the intensity modulated radiation therapy(IMRT) by evaluation dose distribution and consequent radiobiological derived outcomes for NPC patients. Methods: Sixteen patients with NPC who used intraoral stent and 17 patients without intraoral stent were enrolled in this study. All patients underwent Helical Tomotherapy (HT) in our center. For the planning target volume (PTV), the conformity index (CI) and homogeneity index (HI) were used to compare two groups of HT plans (with or without intraoral stent). The mean dose of normal tissues were recorded for the two groups. Oral mucositis, gustatory sense, mouth opening and salivary function of each patients were weekly assessed at the beginning, during and after radiotherapy by clinical examination. Results: The mean dose metrics of oral cavity, mandible, left and right parotid gland in patients with intraoral stent was significantly decreased by 11.6%, 12.2%, 15.4%, and 8.7% on average, respectively (P < 0.05), while the conformity index (CI, P = 0.056) and homogeneity index (HI, P = 0.676) of the tumor target showed no statistically different. The rates of grade I，II, III of oral mucositis of patients with intraoral stent were 43.15%, 43.75%, 12.50% when radiotherapy was just over. While the rates of patients with intraoral stent were 23.53%, 17.65%, 58.82%. There were significantly different in two groups (p = 0.022). There was no significant difference in the decline of taste function among each groups. But the symptoms of xerostomia and mouth opening restriction in the group with intraoral stent had been relieved significantly compared the group without intraoral stent at 1 month and 6 months after radiation. Conclusions: The custom-made intraoral stents showed promising value at sparing normal tissue during radiotherapy for NPC without affecting target dose coverage or tumor control. Clinical trial information: No. NJSH-2021NL-041.
The clinical applicability of inpatient readmissions for cancer patients.
Authors: Garcia Sandra , Halm Ethan A , Lee Simon Craddock , Sweetenham John W. , Courtney D. Mark , Hong Arthur 
Published: June 2022

e18661 Background: The 30-day rate of readmission, a standard metric for many common acute medical conditions, has also been proposed as a quality measure in cancer. However, hospitalizations for cancer patients are more heterogeneous than traditional groups (pneumonia, heart failure patients). We analyzed the pattern and timing of inpatient readmissions for a population-based sample of adults newly diagnosed with cancer. Methods: We identifiably linked adults diagnosed with cancer (2008-2018) from the UT Southwestern tumor registry to comprehensive hospital visits from a regional all-payer health exchange covering a 100-mile radius of Dallas, TX. Our primary outcome was first inpatient readmission within 30 days of discharge among patients hospitalized within 1 year of cancer diagnosis. Subsequent index periods began > 30 days from index discharge to create non-overlapping readmission windows. We grouped primary diagnosis codes into 15 clinically relevant conditions, noting concordance between index and readmission diagnosis. We separately grouped hospital diagnoses deemed preventable by Medicare’s systemic therapy (chemo or immunotherapy) quality measure. We defined early readmission as occurring on days 0-7 and late as days 8-30. Results: Our cohort of 19,608 patients (49.5% female, 71.0% commercial/Medicare insurance) were most diagnosed with gastrointestinal (14.7%), breast (13.9%), and lung cancer (13.6%), with 28.9% advanced stage at diagnosis. Of those, 53.3% had received systemic therapy for their initial treatment. Patients generated 15,066 index admissions and 1,783 readmissions (11.8% 30-day readmission rate). The reason for readmission was the same as index hospitalization in 22.9% of early readmissions and 15.3% of late readmissions. Neoplasm and infection were the most common conditions; their frequencies were similar in early readmissions (12.7% and 12.8% respectively), but infections were higher in late admissions (12.0% and 15.7%). The next most common were gastrointestinal symptoms - modestly more frequent in systemic therapy patients vs. non-systemic therapy (11.4% and 9.3%); and complications of medical care, modestly more frequent in early readmissions vs. late (9.8% and 7.5%). The proportion of early readmissions for preventable diagnoses was 21.7% following receipt of systemic therapy vs 18.0% not receiving systemic therapy, and 29.2% vs. 22.5% respectively for late readmissions. Conclusions: The 30-day readmission rate in patients with cancer was 11.8% (lower than many inpatient conditions) and was usually due to reasons different than the index admission. More work is needed to validate/refine the concept of readmissions to cancer patients as an indicator of quality of care due heterogeneity of patients with cancer, the reasons they are hospitalized and rehospitalized, and relatively low rates of potential preventability.
Assessment of early and late symptom toxicity in a real-world cancer treatment population using the PRO-CTCAE.
Authors: Galaznik Aaron , Trask Peter , Dudley William 
Published: June 2022

e18663 Background: The FDA’s Draft Guidance for Core Patient-Reported Outcomes (PROs) in Cancer Clinical Trials, recommends assessment of disease-related symptoms, symptomatic adverse events, overall side effect impact, physical function, and role function. This guidance also recommends that core PROs be assessed more frequently within the first few treatment cycles. The NCI’s PRO Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a system to evaluate symptomatic toxicity. The objective of this study is to assess the utility of frequent assessment early in treatment, using PRO-CTCAE measures for symptom monitoring. Methods: The patient cohort (n = 248) was derived from users of PROmpt®, an application for remote patient reporting and provider symptom management, employed in routine care in 30+ integrated cancer treatment centers. Patients were enrolled (9/20-10/21) at treatment initiation. Baseline characteristics were assessed by survey and review of patient EMR records. PRO-CTCAE derived surveys of 14 core symptoms (pain, shortness-of-breath, nausea, diarrhea, sadness, anxiety, constipation, fever, neuropathy, insomnia, urinary problems, decreased appetite, fatigue and mouth sores) were administered weekly. Patients who completed surveys in weeks 1 – 3 AND weeks 9 – 11 were selected for analysis (n = 75), with weekly incidences calculated for these windows. Differences were tested using dependent measures T-test. Exploratory analysis of differences by gender, frailty status, and tumor type were also performed. Results: Overall cohort was predominantly female (86.7%), with mean age 59.6 yrs. Subjects with baseline multi-dimensional geriatric assessments (MGA), were 73% fit, 24.3% intermediate and 2.7% frail. The majority of symptoms (11 of 14) showed directional decline over time, with 6 trending towards significance (p < / = 0.10). Increases, however, were statistically significant for neuropathy(p = 0.01) and directional for shortness-of-breath (p = 0.10) and mouth sores (p = 0.32). Conclusions: Findings support recommendations for frequent, early assessment, with weekly surveys showing higher symptom incidence for most items compared with later assessment. Observation of late symptom increases support continued, regular monitoring for timely management of emerging symptoms with continued treatment.