bluuebunny/crossref_metadata_2025_split huggingface dataset:
Using customized PRO profiles to evaluate expected patient quality-of-life outcomes.
Authors: Iaconangelo Charles , McManus Shauna , Serrano Daniel 
Published: June 2022

e18607 Background: Patient Reported Outcomes (PROs) are routinely employed in patient-focused drug development programs. However, PRO data are often under-utilized. Better approaches could employ trial data to describe expected patient outcomes. The objective of this work was to present a method for leveraging PRO-based patient profiles to project and thereby anticipate expected patient outcomes. Methods: A model-based approach to analyzing PRO scores allows for a more tailored approach to evaluating outcomes of interest. To demonstrate this approach, we analyzed PRO data from a Phase 3 trial of patients with prostate cancer randomized to either Hypofractionated 3D-CRT/MRT (experimental arm) or Conventionally Fractionated 3D-CRT/MRT (comparator arm). The outcome of interest was the difference between treatment arms on the Expanded Prostate cancer Index Composite (EPIC) urinary domain scores, defined on the sum of responses to 12 items. A longitudinal regression model was fit to EPIC scores at 6, 12, 24, and 60 months post-baseline. Patient profile variables (baseline EPIC urinary scores, treatment arm, age, race, clinical T-stage, and Gleason score) were included as predictors. For a particular patient profile of interest, expected EPIC urinary score at 6 months was estimated, as well as associated 95% confidence intervals, which allowed for an understanding of the range of likely outcomes for that particular patient profile. Results: n = 550 patients in the experimental arm and n = 542 patients in the comparator were analyzed. The difference in EPIC urinary scores between treatment arms at 6 and 12 months were computed, with higher scores reflecting greater symptom severity. The model estimated a difference of 2.12 points (p = 0.009) at 6 months and 2.16 points (p = 0.013) at 12 months, favoring the experimental arm. To illustrate how customized patient profiles can be used to better understand patient outcomes, a single profile is presented. At baseline, a patient receiving the experimental treatment, EPIC urinary score 98.0, age 57, white, clinical T-stage T2, Gleason score 6, could be expected to report an EPIC urinary score of 94.3 (92.06, 96.00) at 6 months based on the statistical model. In the observed trial data, one patient with this profile reported an EPIC urinary score of 93.8 at 6 months. The expected EPIC urinary score overestimated the observed score by only 0.53%, indicating the accuracy of the expected EPIC urinary scores. This corresponds to approximately one category decrease on two of the 12 domain items (i.e., a decrease in symptom severity). Conclusions: Well-established statistical methods can lead to improved clinician understanding of expected outcomes specific to a given patient profile. This would facilitate communication between clinician and patient regarding anticipated oncology treatment outcomes. Recommendations to support the use of these methods should be considered.
Beyond biomarker testing: Aligning the needs of oncologist and diagnostic companies to improve biomarker results reports for accurate clinical treatment selection.
Authors: Lovly Christine M. , Martin Nikki A. , Basu Roy Upal Kunal 
Published: June 2022

e18611 Background: The benefits of precision medicine, including targeted therapies and immunotherapy, for lung cancer patients are well-documented. National clinical guidelines recommend broad multiplex molecular panels for advanced stage NSCLC. Increased understanding of the molecular heterogeneity of lung cancer has led to novel biomarkers being discovered, increasing the potential to match patients to new treatments. Pairing a patient to the correct biomarker-defined therapy is dependent on both biomarker test being ordered and accurate interpretation of test results. However, the increasing complexity of biomarker reports could contribute to inaccurate diagnoses and suboptimal therapeutic selections. Our objective was to understand the extent of the problem of report interpretation and identify opportunities for harmonizing key elements of the reports, in order to improve report interpretability and patient care. Methods: A multi-stakeholder group comprised of 40 leaders from thoracic medical oncology, professional societies, government agencies, and diagnostic companies was convened by LUNGevity Foundation. Participants responded to pre-and-post meeting surveys to capture insights on the main challenges of results report generation (diagnostic companies) and accurate interpretation for patient care (oncologists) as well as recommended solutions and areas to jointly address. Recommendations were informed by an audit of 12 biomarker reports from commercial/ governmental labs for similarities and differences regarding report structure, terminology, and content. Results: Pre-meeting survey results and discussion from diagnostic companies (N = 12) and academic and community cancer center oncologists (N = 8) revealed multiple challenges with report generation as well as interpretation. Diagnostic companies highlighted the need for superior, time-intensive attention to detail for accurate evidence curation and report generation. Oncologists highlighted challenges reviewing and interpreting results such as inconsistencies in nomenclature for genomic variants, alignment of genomic alterations with approved therapies, and lack of clarification of the level of evidence for therapeutic selection. In post-meeting surveys, participants proposed solutions to harmonize specific aspects of biomarker testing reports to improve patient care. Top areas for alignment included establishing consensus on harmonization of clinical nomenclature, refining report structure, and shortening report length. Conclusions: It is not enough to only promote biomarker testing for lung cancer patients. Attention is also needed to systematically unify and streamline clinical biomarker reports to best serve the oncology community. These efforts may also serve as a model for application in other cancers beyond lung cancer.
International approaches to head and neck cancer multidisciplinary tumor board.
Authors: Yao Christopher MKL , Beatty Sydney , Giri Anshu , Liu Jeffrey Chang-Jen , Bauman Jessica R , Sturgis Erich M. , Galloway Thomas James , Ridge John A. 
Published: June 2022

e18615 Background: Multidisciplinary tumor boards are widely accepted as vehicles for improving patient outcomes in Head and Neck Cancer (HNC). Little work describes their structure and practices. The purpose of this study is to better understand the international practice patterns of multidisciplinary HNC tumor boards. Methods: A cross-sectional survey on head and neck cancer multidisciplinary tumor board practice patterns was developed by a panel of six experts and distributed internationally to HNC providers. The survey interrogated the attendance, participation, operation, and perceptions of multidisciplinary tumor conferences, through a mix of Likert-based, tick box and open-ended questions. Results: One hundred and twenty-three responses (55%) were received from 88 surgical oncologists, 17 radiation oncologists, and 18 medical oncologists from nine different countries. Overall, most HNC tumor boards are led by a surgeon (77%), and most commonly 5-10 minutes (61%) was spent on each case. In 60% of responses, all HNC patients were discussed at their tumor boards, while select cases were presented in 40% of responses. Pathology was routinely reviewed in 75% of sites and imaging reviewed in 95% of sites. In 75% of responses, sufficient time was felt to be spent on each case. Majority (75%) of tumor boards documented their recommendation, with 92% reporting that inability to reach a consensus recommendation was rare. When this occurred, the most common recourse was involving patient decision making (53%), followed by offline discussion until an agreement is reached (38%). Most respondents felt that tumor boards rarely altered the treatment plan (68%), while 37% felt the treatment plan was sometimes altered. Involvement of radiation and medical oncology prior to surgery varied, with 53% sending patients routinely, 32% sometimes, and 15% deferring referral. Logistics was cited as a primary barrier. Surgeons and radiation oncologists agree that the top three reasons tumor boards assist in cancer care are: receiving additional opinion and perspective, coordinating care, and communication. Medical oncologist also found tumor boards enhance clinical trial enrollment. Conclusions: While there are variations in the structure and process of multidisciplinary tumor boards, the majority of management is agreed upon by the treatment team. Areas of improvement include verification of cancer stage, identifying logistics that prevent timely and documentation of recommendations. Identifying the variations from most-common practice should provide a mechanism for improvement.
Quality of cancer care in a low-resource setting: A single-center observational study.
Authors: Tolani Musliu Adetola , Gundu Isaac , Nwabuoku Emeka Stanley , Umar Shehu Salihu , Dansani Amina Ibrahim , Dauda Bashir Abubakar 
Published: June 2022

e18622 Background: There are challenges in access to healthcare in developing countries. The quality of care is however an important consideration in achieving sustainable positive outcomes during patient management. This study, therefore, aimed to assess this measure of cancer care in our setting. Methods: A cross-sectional study of sixty-three patients with malignancy, who had or were planned for cancer treatment, was performed. Information on their demographic and clinical characteristics were obtained. Quality of cancer care was measured using the Consumer Assessment of Healthcare Providers and Systems instrument. SPSS was used for data analysis and p-value < 0.05 was considered significant. Results: Their average age was 60.0 (43.8 – 69.3) years. Twenty (31.7%) had gastrointestinal malignancy while 17 (27.0%), 15 (23.8%) and 11 (17.5%) had prostate, breast and cervical cancer respectively. The median duration since cancer diagnosis was 4.0 (2.0 – 14.0) months. Regarding support provided by the care team to manage the cancer and the effects of its treatment; majority of the respondents, 30 (54.5%), answered in a negative tone. Similarly, the majority of the respondents did not select the maximum score on the scale in the aspects of receiving timely appointments, care, and information; communication between the cancer care team and patients; information use for care co-ordination; and the availability to give information when required (Table). Despite this, patient rating of their cancer care team and their overall experience was 8.0 ± 1.8 and 7.8 ± 2.0 respectively. There was however a significant difference in the latter between those who had cancer recurrence in comparison to those who did not experience this event (6.8 ± 2.2 versus 8.2 ± 1.7, p = 0.048). Conclusions: Even though the general rating of the experience of these patients was high; the gaps highlighted in the areas of patient support, communication and navigation and their sub-optimal experience during cancer recurrence could be further improved to enhance the delivery of cancer care in this limited resource setting.[Table: see text]
Breast cancer characteristics and time to chemotherapy initiation in Belize.
Authors: Wong Wayne , Dickerson James , Sood Rupali , Yacab Ramon Argenes , Valtis Yannis , Lattin John , Garrity Philip , Bhatt Ami Siddharth , Huang Franklin W. 
Published: June 2022

e18643 Background: Breast cancer is the most common cancer in low and middle-income countries. Belize, a middle-income country in the Caribbean with significant inequality, lacks a national screening program and has limited treatment capacity. There are no studies describing breast cancer characteristics in Belize in the available literature. We collected data from the sole public oncology clinic in the country, established in 2018 at Karl Heusner Memorial Hospital (KHMH), to describe the characteristics of breast cancer patients and establish baseline measurements of time to chemotherapy initiation for the curative intent treatment population; the aim being to identify potential areas for quality improvement. Methods: We performed a retrospective chart review of available patient data from December 2020 to December 2021. We examined the time from a patient’s initial visit at KHMH until chemotherapy initiation (TCI) in the neoadjuvant setting with patients stratified by stage. Significant outliers (predominantly patients with misclassified data or those with private access to physicians and therapeutics) were excluded. Results: The clinic provided care for 80 patients with biopsy-proven breast cancer between December 2020 to December 2021. Patients were 97% female with a median age of 55 (Range: 34-81). For stageable patients (n=75), 33% presented with clinically localized disease, 49% with locally advanced, and 17% with recurrent or metastatic disease. Of the 51 patients on chemotherapy, 57% were receiving preoperative treatment, 31% were on adjuvant therapy, and 12% on palliative therapy. Patients not on therapy (n=29) at KHMH were either in surveillance, referred to a private cancer center, or deceased. Neoadjuvant TCI was calculated for 21 patients after the removal of outliers (n=5). The majority of these patients arrived at their initial clinic visit with a biopsy-proven diagnosis. Mean TCI for early stage disease was 49 days (n=7, 95% CI [9, 89]) and locally advanced disease was 36 days (n=14, 95% CI [12, 61]). Aggregate mean TCI was 40 days (n=21, 95% CI [19, 62]). Conclusions: In Belize, breast cancer affects younger women and patients present with later stages of disease than in high-income countries; however, time to chemotherapy initiation in a small sample of neoadjuvant patients at the Belizean clinic was comparable. Given the inherent limitations of small samples of data, additional investigation is needed to support these findings, as well as to delineate patient barriers to access and potential for improvements in clinic follow-up. Nevertheless, indications of a robust TCI call for further characterization of this newly established cancer clinic and its practices.
The impact of patient-reported outcomes in cancer patients in Croatia.
Authors: Trivanovic Dragan , Kopic Boris , Budisavljevic Anuska , Hrstic Irena 
Published: June 2022

e18659 Background: Perception of symptoms is essential for optimal cancer care and improving the quality of life but an inappropriate interpretation may lead to treatment outcomes failure or may leave the patients undertreated. This variation in the perception of adverse events (AEs) can lead to wrong assumptions and potentially unnecessary hospitalizations (H) or emergency room visits (ERV). Methods: Patients considered for inclusion were 18 years of age or older receiving systemic therapy and were able to read and understand questionnaire via tablet computers. All patients had a verified diagnosis of malignant disease of breast (31%), lung (17%), colorectal (16%), hematological (8%) or other site cancers (28%). Patients were asked on the same day as physician assessment, to complete 10 PRO-CTCAE symptoms (including fatigue, pain, nausea, vomiting, diarrhea, dysgeusia, appetite, sleep disturbance, fever, and alopecia). Participants remained on study until discontinuation of cancer treatment, withdrawal, or death. Informed consent was obtained from all patients and the study was approved by the institutional review board of the General Hospital Pula, Croatia. Concordance of symptoms reporting between patients and health care providers at the individual level was compared, and intraclass correlation coefficients were computed by a two way mixed effect model and an absolute agreement definition. Univariate and multivariate COX proportional hazard models adjusted for covariates including age, gender, cancer type and performance status were constructed for unplanned H and ERV. Results: The median age of 308 included patients in this trial was 62 years. Cohen's coefficient of agreement that corrects for chance for AEs gr. 1-5 and AEs gr. 3-4 was 0.115 (95%, CI, 0.15 to 0.02), indicating only slight agreement and 0.320 (95%, CI, 0.428 to 0.448) indicating fair agreement, respectively. Physicians underestimated symptoms at the group level (p < 0.013) for all symptoms. The highest level of agreement was found for pain but fatigue and alopecia were most underestimated. The median times of follow-up were 13 months, and 8,1 % of patients had H or ERV. Female patients had worse PRO scores, with higher levels of pain, fatigue, and alopecia across disease groups. In multivariate analysis, patient symptoms was not predictive, but we noticed trend for higher patient reports of pain (p = 0.05) for unnecessary H or ERV. Conclusions: The failure of the physician to identify a substantial number and severity of symptoms identified by the PRO instrument is not surprising considering the published experience in clinical trials. To our knowledge, this is the first such analysis aimed specifically at examining the reliability of physician identification of AEs in a real world practice in Croatia. The incorporation of PRO measures into routine practice might help to avoid unnecessary hospitalizations and emergency room visits. Clinical trial information: 2019-000855-15.
Development of a risk stratification model to predict oncology patient emergency room and/or hospital utilization.
Authors: Laird Courtney C , McLarty Sarah , Reddy Shirisha , Thompson Edward , Cullum Robert , Cavers William , Friend Kayla E , Johnson Kathryn D , Johlie Melissa , Sawicki Christine , Johnson Kjel Andrew 
Published: June 2022

e18664 Background: Patients diagnosed with cancer require comprehensive care management during the complex cancer care journey to improve outcomes and control healthcare costs. A care team can use risk stratification to provide patient-specific interventions to improve outcomes and reduce unplanned admissions. The purpose of this study is to evaluate specific factors that may predict a cancer patient’s likelihood of requiring unplanned emergency room (ER) visits and/or hospitalizations, which can then ultimately be used to classify patients into risk categories and match cancer patients to the appropriate level of care management. Methods: Medical claims data from oncology patients included age, gender, cancer type and co-morbidities. Stepwise multiple regression was then used to determine the correlation between predictors and patient ER and/or hospital admissions during the study period, January 1, 2021, to December 31, 2021. Akaike’s Information Criterion (AIC) was used to limit the total number of variables included in the final model to those predictive of outcomes. A logistic regression model was to determine which predictors significantly correlated with unplanned outcomes; p < 0.05 was considered statistically significant. Results: 779 Medicare patients were evaluated. A total of 13 common comorbidities, patient age, gender and cancer type were explored. The final model included age, cancer type, and 6 comorbidities. Increasing age (p < 0.07) and certain cancer types (cervical, pancreatic and ovarian) increased the risk of emergency room and/or hospital utilization. Metastatic cancer (p < 0.007), sepsis (p < 0.0003), renal failure (p < 0.01), heart disease (p < 0.0002), hypertension (p < 0.002) and back pain (p < 0.003) were also significant predictors of an ER visit and/or hospitalization. In receiver operating characteristic (ROC) analysis, our model demonstrated strong discriminative power, with an area under the ROC (AuROC) of 0.762 and p < 0.05. Conclusions: This study developed and tested an algorithm to predict cancer patients for whom an ER visit and/or hospitalization outcome is more likely. The results can be used to prioritize and personalize care management resulting in improved outcomes, better allocation of care management resources, and improved overall value of care.
Clinical assessment of the Omicron outbreak in Europe and trends in morbidity and mortality from COVID-19 and cancer.
Authors: Cortellini Alessio , Aguilar-Company Juan , Sharkey Rachel , Sureda Balari Anna , Bertuzzi Alexia Francesca , Brunet Joan , Rizzo Gianpiero , Perachino Marta , Lee Alvin Jun Xing , Chowdhury Amani , Ruiz-Camps Isabel , Plaja Andrea , Hanbury Georgina Helen , Van Hemelrijck Mieke , Diamantis Nikolaos , Gaidano Gianluca , Grosso Federica , Gennari Alessandra , Tabernero Josep , Pinato David J. James 
Published: June 2022

e18673 Background: Whilst patients (pts) with cancer are at increased risk of adverse outcome from Coronavirus disease 2019 (COVID-19), no evidence exists as to the natural history of the SARS-CoV-2 B.1.1.529 (Omicron) variant in this population. Methods: Capitalizing on OnCovid study data (NCT04393974), a European registry that collects data on consecutive patients with cancer and COVID-19, we analysed COVID-19 morbidity and case fatality rates at 14 days (CFR14) across 3 phases defined following the evolution of the pandemic in Europe, according to date of COVID-19 diagnosis: “Pre-vaccination” phase (27/02/2020-30/11/2020), “Alpha-Delta variant” phase (01/12/2020-14/12/2021), “Omicron variant” phase (15/12/2020-31/01/2022). Results: By the data lock of 04/02/2022, 3820 consecutive pts were enrolled, 3473 of whom were eligible for this analysis. Among them, 2033 (58.6%), 1075 (30.9%) and 365 (10.5%) were diagnosed during the Pre-vaccination, Alpha-Delta and Omicron phases. Pts diagnosed in the Omicron phase were more likely aged < 65 years (48.6% vs 42.5%, 39.4% p = 0.01), had < 2 comorbidities (61.9% vs 55.6%, 52.1% p = 0.01). They had more advanced-stage tumours (62.1% vs 53.3%, 49.0%, p < 0.01) and were more likely receiving systemic anticancer therapy (SACT) at COVID-19 diagnosis (54.9% vs 43.9%, 39.6%, p < 0.01). Proportions of fully vaccinated/boosted pts were higher in the Omicron phase (33.9%-48.1%) compared to the Alpha-Delta phase (16.6%-2.3%, p < 0.01). Pts diagnosed in the Omicron phase had improved CFR14 (9.0% vs 13.9%, 23.1%, p < 0.01) lower hospitalization rates due to COVID-19 (24.4% vs 41.4%, 56.6%, p < 0.01), lower complications rates (15.3% vs 33.6%, 39.4%, p < 0.01) and reduced need for COVID-19 specific therapy (22.4% vs 43.0%, 65.7% p < 0.01) compared to the Alpha-Delta and pre-vaccinal phase. After adjusting for country of origin, sex, age, comorbidities, tumour stage, status and receipt of SACT at COVID-19, patients diagnosed in the Omicron phase displayed the lowest risk of death at 14 days compared to earlier phases. Similarly, rates of hospitalization and complicated COVID-19 were lowest for Omicron phase. Conclusions: This is the first study to portray the evolution of the SARS-CoV-2 Omicron outbreak in Europe, documenting an improvement in all COVID-19 outcomes compared to earlier phases of the pandemic. Enhanced healthcare capacity, improved disease management, immunization campaigns alongside differential virulence of viral strains are likely contributing to improved outcomes across phases.[Table: see text]