bluuebunny/crossref_metadata_2025 huggingface dataset:
Personal protective equipment and medical students in times of COVID-19: experiences and perspectives from the final clerkship year
Authors: Straub Janina , Franz Anne , Holzhausen Ylva , Schumann Marwa , Peters Harm
Published: October 2023

Background

The availability and correct use of personal protective equipment (PPE) to prevent and control infections plays a critical role in the safety of medical students in clinical placements. This study explored their experiences and perspectives in their final clerkship year with PPE during the COVID-19 pandemic.

Methods

This qualitative study was based on social constructivism and was conducted in 2021 at the Charité - Universitätsmedizin Berlin. In three online focus group discussions, 15 medical students in their final clerkship year reported their experiences with PPE training and use during the COVID-19 pandemic. Data were recorded, transcribed and analysed based on Kuckartz’s approach to content analysis. We drew upon the a priori dimensions of the capability, opportunity, motivation - behaviour (COM-B) model as main categories as well as emergent issues raised by the study participants (subcategories).

Results

In addition to the three main categories of the COM-B model, eleven subcategories were identified through inductive analysis. The study participants reported several factors that hindered the correct use of PPE. In the area of capabilities, these factors were related to learning experience with PPE in terms of both theoretical and practical learning together with later supervision in practice. In the area of opportunities, these factors included the limited availability of some PPE components, a lack of time for PPE instruction and supervision and inappropriate role modelling due to the inconsistent use of PPE by physicians and nursing staff. The area of motivation to use PPE was characterized by an ambivalent fear of infection by the SARS-CoV-2 virus and the prioritization of patient safety, i.e., the need to prevent the transmission of the virus to patients.

Conclusions

Our study revealed several limitations pertaining to the enabling factors associated with the trainable behaviour “correct use of PPE”. The concept of shared responsibility for student safety was used to derive recommendations for future improvement specifically for the medical school as an organization, the teachers and supervisors, and students themselves. This study may guide and stimulate other medical schools and faculties to explore and analyse components of student safety in clinical settings in times of infectious pandemics.
Inflammatory response-based prognostication and personalized therapy decisions in clear cell renal cell cancer to aid precision oncology
Authors: Zhong Weimin , Chen Huijing , Yang Jiayi , Huang Chaoqun , Lin Yao , Huang Jiyi
Published: October 2023

Objective

The impact of inflammatory response on tumor development and therapeutic response is of significant importance in clear cell renal cell carcinoma (ccRCC). The customization of specialized prognostication approaches and the exploration of supplementary treatment options hold critical clinical implications in relation to the inflammatory response.

Methods

In the present study, unsupervised clustering was implemented on TCGA-KIRC tumors using transcriptome profiles of inflammatory response genes, which was then validated in two ccRCC datasets (E-MATB-1980 and ICGC) and two immunotherapy datasets (IMvigor210 and Liu et al.) via SubMap and NTP algorithms. Combining co-expression and LASSO analyses, inflammatory response-based scoring system was defined, which was evaluated in pan-cancer.

Results

Three reproducible inflammatory response subtypes (named IR1, IR2 and IR3) were determined and independently verified, each exhibiting distinct molecular, clinical, and immunological characteristics. Among these subtypes, IR2 had the best OS outcomes, followed by IR3 and IR1. In terms of anti-angiogenic agents, sunitinib may be appropriate for IR1 patients, while axitinib and pazopanib may be suitable for IR2 patients, and sorafenib for IR3 patients. Additionally, IR1 patients might benefit from anti-CTLA4 therapy. A scoring system called IRscore was defined for individual ccRCC patients. Patients with high IRscore presented a lower response rate to anti-PD-L1 therapy and worse prognostic outcomes. Pan-cancer analysis demonstrated the immunological features and prognostic relevance of the IRscore.

Conclusion

Altogether, characterization of inflammatory response subtypes and IRscore provides a roadmap for patient risk stratification and personalized treatment decisions, not only in ccRCC, but also in pan-cancer.
Profiles of quality of life among patients using emergency departments for mental health reasons
Authors: Fleury Marie-Josée , Cao Zhirong , Grenier Guy , Ferland Francine
Published: October 2023

Background

This study identified profiles associated with quality of life (QoL) and sociodemographic and clinical characteristics of patients using emergency departments (ED) for mental health reasons and associated these profiles with patient service use.

Methods

Recruited in four Quebec (Canada) ED networks, 299 patients with mental disorders (MD) were surveyed from March 1st, 2021, to May 13th, 2022. Data from medical records were collected and merged with survey data. Cluster analysis was conducted to identify QoL profiles, and comparison analyses used to assess differences between them.

Results

Four QoL profiles were identified: (1) Unemployed or retired men with low QoL, education and household income, mostly having substance-related disorders and bad perceived mental/physical health conditions; (2) Men who are employed or students, have good QoL, high education and household income, the least personality disorders, and fair perceived mental/physical health conditions; (3) Women with low QoL, multiple mental health problems, and very bad perceived mental/physical health conditions; (4) Mostly women with very good QoL, serious MD, and very good perceived mental/physical health conditions.

Conclusion

The profiles with the highest QoL (4 and 2) had better overall social characteristics and perceived their health conditions as superior. Profile 4 reported the highest level of satisfaction with services used. To improve QoL programs like permanent supportive housing, individual placement and support might be better implemented, and satisfaction with care more routinely assessed in response to patient needs – especially for Profiles 1 and 3, that show complex health and social conditions.
Factors influencing practice choices of early-career family physicians in Canada: a qualitative interview study
Authors: Grudniewicz Agnes , Randall Ellen , Lavergne M. Ruth , Marshall Emily Gard , Jones Lori , Rudoler David , Horrey Kathleen , Mathews Maria , McKay Madeleine , Mitra Goldis , Scott Ian , Snadden David , Wong Sabrina T. , Goldsmith Laurie J.
Published: October 2023

Background

Comprehensiveness of primary care has been declining, and much of the blame has been placed on early-career family physicians and their practice choices. To better understand early-career family physicians’ practice choices in Canada, we sought to identify the factors that most influence their decisions about how to practice.

Methods

We conducted a qualitative study using framework analysis. Family physicians in their first 10 years of practice were recruited from three Canadian provinces: British Columbia, Ontario, and Nova Scotia. Interview data were coded inductively and then charted onto a matrix in which each participant’s data were summarized by code.

Results

Of the 63 participants that were interviewed, 24 worked solely in community-based practice, 7 worked solely in focused practice, and 32 worked in both settings. We identified four practice characteristics that were influenced (scope of practice, practice type and model, location of practice, and practice schedule and work volume) and three categories of influential factors (training, professional, and personal).

Conclusions

This study demonstrates the complex set of factors that influence practice choices by early-career physicians, some of which may be modifiable by policymakers (e.g., policies and regulations) while others are less so (e.g., family responsibilities). Participants described individual influences from family considerations to payment models to meeting community needs. These findings have implications for both educators and policymakers who seek to support and expand comprehensive care.
Stochastic cost-effectiveness analysis on population benefits
Authors: Chen Ermo
Published: October 2023

Dealing with randomness is a crucial aspect that cost-effectiveness analysis (CEA) tools need to address, but existing stochastic CEA tools have rarely examined risk and return from the perspective of population benefits, concerning the benefits of a group of individuals but not just a typical one. This paper proposes a stochastic CEA tool that supports medical decision-making from the perspective of population benefits of risk and return, the risk-adjusted incremental cost-effectiveness ratio (ICER). The tool has a traditional form of ICER but uses the cost under a risk-adjusted expectation. Theoretically, we prove that the tool can provide medical decisions trimming that promote the risk-return level on population benefits within any intervention structure and can also serve as a criterion for the optimal intervention structure. Numerical simulations within a framework of mean–variance support the conclusions in this paper.
Unilaterally extrapedicular versus transpedicular kyphoplasty in treating osteoporotic lumbar fractures: a randomized controlled study
Authors: Hong Hao , Li Jun , Ding Haoyang , Deng Yi , Deng Zhongliang , Jiang Qilong
Published: October 2023

Background

The unilaterally extrapedicular approach is adopted increasingly to perform balloon kyphoplasty in treating osteoporotic lumbar fractures, which is intended to improve radiological and clinical efficacy. We compared the efficacy and safety of this method with a unilaterally transpedicular approach.

Methods

We conducted a single-center, randomized controlled trial enrolling participants with a one-level osteoporotic lumbar fracture in less than 1 month. Patients were randomly assigned to undergo kyphoplasty via either a unilaterally extrapedicular approach (treatment group) or a unilaterally transpedicular approach (control group). The primary outcome was the difference in change from baseline to 1 month in visual analog scale (VAS) scores between the two groups. Secondary outcome measures included vertebral height ratio, operation time, fluoroscopic times, hemoglobin loss, and cement leakage between groups. Data were analyzed by intention to treat principle.

Results

A total of 80 participants were assigned to the treatment group (n = 40) and control group (n = 40), with three and two patients lost to follow-up during 12 months in the two groups, respectively. At 1 month postoperatively, the treatment group showed a greater reduction in VAS score from baseline, compared with the control group (mean difference between groups = 0.63, 95%CI 0.19–1.06). There were no significant between-group differences in restoration in anterior, middle, and posterior vertebral body (P > 0.05). No significant differences were found in the rate of cement leakage and perioperative hemoglobin loss (P > 0.05).

Conclusion

Compared with balloon kyphoplasty via the unilaterally transpedicular approach in treating lumbar OVCFs, the unilaterally extrapedicular approach appears to be promising in achieving effective pain relief, adequate cement infusion, short operation time, less fluoroscopy exposure, and comparable risk of cement leakage and vessel injury. It is an alternative approach for lumbar OVCFs treated with kyphoplasty.
Impact of NLRP3 gene polymorphisms (rs10754558 and rs10733113) on HPV infection and cervical cancer in southern Chinese population
Authors: Lu Qingchun , Lao Xiaoxia , Gan Jinghua , Du Ping , Zhou Yingpei , Nong Wenzheng , Yang Zhige
Published: October 2023

Objective

Mutations in the NLRP3gene have previously been linked to certain forms of cancer, but there have not been any specific studies examining the association between NLRP3 polymorphisms and cervical cancer (CC). This study was therefore designed to investigate the effect of NLRP3 gene polymorphisms on HPV infection and cervical cancer in southern Chinese population.

Methods

Multiplex PCR and next-generation sequencing approaches were used to assess the NLRP3 rs10754558 and rs10733113 polymorphisms in 404 cervical lesion patients, including 227 diagnosed with CC and 177 diagnosed with cervical intraepithelial neoplasia(CIN), with 419 healthy female controls being included for comparison. Correlations between the rs10754558 and rs10733113 genotypes and alleles in these patients and CC and CIN were then analyzed.

Results

No correlations were found between NLRP3 rs10754558 and rs10733113 and human papillomavirus(HPV) infection status. Relative to the healthy control group, the NLRP3 rs10754558 GG genotype, CG + GG genotype, and G allele frequencies were significantly increased among patients with cervical lesions (CC and CIN) (OR = 1.815,P = 0.013;OR = 1.383, P = 0.026; OR = 1.284, P = 0.014,respectively), whereas no such differences were observed for rs10733113. A higher cervical lesion risk was detected for patients over the age of 45 exhibiting the rs10754558 GG genotype (OR = 1.848, P = 0.040). Additionally, the risk of CC was elevated in patients with the rs10754558 GG genotype or the G allele relative to patients with the CC genotype or the C allele(OR = 1.830, P = 0.029; OR = 1.281, P = 0.039). The rs10733113 genotypes or alleles were not significantly associated with CC risk (P > 0.05). No association between rs10754558 and rs10733113 genotypes and CC patient clinicopathological features were observed (P > 0.05). Serum NLRP3, IL-1β, and IL-18 levels were significantly elevated in CC patients relative to healthy controls(P < 0.05). Relative to the CC genotype, CC patients harboring the rs10754558 GG genotype exhibited significantly elevated IL-1β and IL-18 levels(P < 0.05).

Conclusion

The rs10754558 polymorphism in the NLRP3 gene may contribute to an elevated risk of CC, although it is not significantly correlated with HPV infection and CC progression.
The Quartet Data Portal: integration of community-wide resources for multiomics quality control
Authors: Yang Jingcheng , Liu Yaqing , Shang Jun , Chen Qiaochu , Chen Qingwang , Ren Luyao , Zhang Naixin , Yu Ying , Li Zhihui , Song Yueqiang , Yang Shengpeng , Scherer Andreas , Tong Weida , Hong Huixiao , Xiao Wenming , Shi Leming , Zheng Yuanting
Published: October 2023

The Quartet Data Portal facilitates community access to well-characterized reference materials, reference datasets, and related resources established based on a family of four individuals with identical twins from the Quartet Project. Users can request DNA, RNA, protein, and metabolite reference materials, as well as datasets generated across omics, platforms, labs, protocols, and batches. Reproducible analysis tools allow for objective performance assessment of user-submitted data, while interactive visualization tools support rapid exploration of reference datasets. A closed-loop “distribution-collection-evaluation-integration” workflow enables updates and integration of community-contributed multiomics data. Ultimately, this portal helps promote the advancement of reference datasets and multiomics quality control.
The effect of postoperative intravenous iron in anaemic, older cardiac surgery patients on disability-free survival (AGE ANEMIA study): study protocol for a multi-centre, double-blind, randomized, placebo-controlled trial
Authors: Smoor R. M. , Rettig T. C. D. , Vernooij L. M. , Groenewegen E. M. , van Dongen H. P. A. , Noordzij P. G.
Published: October 2023

Background

Postoperative anaemia is common in older cardiac surgery patients and often caused by iron deficiency. Anaemia may negatively affect recovery after cardiac surgery. This study aims to determine the efficacy of treatment of postoperative iron deficiency anaemia (IDA) with intravenous iron (IVI) on disability 90 days after cardiac surgery in older patients.

Methods

This is a randomized placebo-controlled double-blind multi-centre trial. In total, 310 patients aged ≥ 70 years with moderate IDA on postoperative day 1 (haemoglobin 85–110 g/L and ferritin concentration < 100 μg/L or iron saturation < 20%) after uncomplicated elective cardiac surgery (aortic valve repair or coronary artery bypass graft surgery) will be included. Patients will be randomly allocated to receive either IVI (ferric derisomaltose) or placebo (sodium chloride 0.9%) on postoperative day 1 in a 1:1 ratio, stratified by centre and type of cardiac surgery. The primary outcome is disability measured by the 12-item World Health Organization Disability Assessment score 2.0 after 90 days. Secondary outcome measures are the number of postoperative red blood cell (RBC) transfusions, change in reticulocyte haemoglobin content (pg) from randomization to hospital discharge, Hb levels at discharge, hospital complications, dyspnoea (assessed with the Rose Dyspnoea Scale) and health-related quality of life (HRQL) (assessed with The Older Persons and Informal Caregivers-Short Form (TOPICS-SF) questionnaire) after 90 days and days alive and out of hospital after 90 days. Lastly, the functional outcomes (e.g. steep ramp or 6-min walk test) and Hb level after 90 days will be assessed as an exploratory endpoint.

Discussion

The results of this study will demonstrate whether early treatment of postoperative IDA with IVI improves disability at 90 days in older cardiac surgery patients.

Trial registration

ClinicalTrials.gov NCT04913649. Registered on June 4, 2021.
Identification of antigens in the Trichinella spiralis extracellular vesicles for serological detection of early stage infection in swine
Authors: Li Chengyao , Li Chen , Xu Fengyan , Wang Haolu , Jin Xuemin , Zhang Yuanyuan , Liu Xiaolei , Wang Ruizhe , You Xihuo , Liu Mingyuan , Bai Xue , Yang Yong
Published: October 2023

Background

Several studies have reported the roles of Trichinella spiralis extracellular vesicles in immune regulation and pathogen diagnosis. Currently, the T. spiralis muscle larvae excretory/secretory product (Ts-ML-ES) is the antigen recommended by the International Commission on Trichinellosis (ICT) for serological diagnosis of trichinellosis. However, it can only be used to detect middle and late stages of infections, and cross-reactions with other parasite detections occur. Therefore, there is a need to identify antigens for specific detection of early stage trichinellosis.

Methods

Extracellular vesicles of T. spiralis muscle larvae (Ts-ML-EVs) were isolated by ultracentrifugation and characterized by transmission electron microscopy, nanoparticle tracking analysis, flow cytometry and western blot. Ts-ML-EVs protein profiles were analyzed by LC-MS/MS proteomics for identification of potential antigens (Ts-TTPA). Ts-TTPA were cloned into pMAL-c5X vector and expressed as recombinant proteins for evaluation of potential as detected antigens by western blot and ELISA.

Results

Isolated Ts-ML-EVs were round or elliptic (with diameters between 110.1 and 307.6 nm), showing a bilayer membrane structure. The specific surface markers on the Ts-ML-EVs were CD81, CD63, enolase and the 14-3-3 protein. A total of 53 proteins were identified by LC-MS/MS, including a variety of molecules that have been reported as potential detection and vaccine candidates. The cDNA of Ts-TTPA selected in this study has a total length of 1152 bp, encoding 384 amino acids with a molecular weight of 44.19 kDa. It contains a trypsin domain and can be recognized by anti-His antibody. It reacted with swine sera infected with 10,000 T. spiralis at 15, 25, 35 and 60 days post-infection (dpi). At 10 μg/ml, this antigen could detect T. spiralis antibodies from the swine sera at 13 dpi. There were no cross-reactions with the swine sera infected with other parasites including Clonorchis sinensis, Toxoplasma gondii, Taenia suis, Ascaris suis and Trichuris suis.

Conclusions

This study identifies potential early stage detection antigens and more thoroughly characterizes a serine protease domain-containing protein. Extracellular vesicle proteins may be explored as effective antigens for the early stage detection of trichinellosis.

Graphical Abstract
ACSL4 inhibition prevents macrophage ferroptosis and alleviates fibrosis in bleomycin-induced systemic sclerosis model
Authors: Cao Dianyu , Zheng Jina , Li Zheng , Yu Yong , Chen Zengrui , Wang Qiang
Published: October 2023

Background

Systemic sclerosis (SSc), with unclear pathophysiology, is a paradigmatic rheumatic disease of immunity dysfunction-driven multi-organ inflammation and ultimate fibrosis. Pathogenesis breakthroughs are urgently needed for available treatments halting its unremitting stiffness. This study aims to investigate whether ferroptosis can regulate the progressive SSc fibrosis.

Methods

In vivo, bleomycin (BLM)-induced mice model was subjected to ferroptosis detection using western blotting, malondialdehyde (MDA), and glutathione (GSH) assays. Pharmacological inhibitor of the acyl-CoA synthetase long-chain family member 4 (ACSL4) was utilized to explore its potential therapeutic effects for fibrosis, from histological, biochemical, and molecular analyses. In vitro, bone marrow-derived macrophages (BMDM) were activated into inflammatory phenotype and then the relationship was evaluated between activation level and ferroptosis sensitivity in lipopolysaccharide (LPS) incubation with gradient concentrations. The potential calpain/ACSL4 axis was analyzed after calpain knockdown or over-expression in Raw264.7.

Results

Both skin and lung tissue ferroptosis were present in SSc mice with enhanced ACSL4 expression, while ACSL4 inhibition effectively halted fibrosis progressing and provides protection from inflammatory milieu. Meanwhile, a positive regulation relationship between LPS-induced macrophage activity and ferroptosis sensitivity can be observed. After calpain knockdown, both inflammatory macrophage ferroptosis sensitivity and ACSL4 expression decreased, while its over-expression renders ACSL4-envoking condition. Also, calpain pharmacological inhibition reduced both ferroptosis and fibrosis aptitude in mice.

Conclusions

ACSL4 induces inflammatory macrophage ferroptosis to aggravate fibrosis progressing. ACSL4 and its upregulators of calpains may be potential therapeutic targets for BLM model of SSc.
A study of grief experience interviews with family members of patients with advanced malignant tumors based on noninvasive death index monitoring
Authors: Ren Li , Shen Liang-liang , Lu Hong , Wen Xiao , Xu Chun-juan
Published: October 2023

Objective

To explore the grief experiences of family members of patients with advanced malignant tumors before and after death.

Methods

This study used both quantitative and qualitative research methods. A total of 10 people with family members with terminal malignant tumors were chosen and assessed five times according to a specific non-invasive mortality index and the Distress Thermometer scale. Additionally, the participants attended an in-depth interview.

Results

The grief experiences of the bereaved included their knowledge of and attitude towards death, the physical and mental conditions of the family members of patients in the terminal stage, the needs of family members, and the response to death and growth of those family members.

Conclusions

The grief experience interviews of family members of patients with advanced malignant tumors are universal. It is suggested that the nursing staff should pay attention to the emotional experience of the bereaved after the death of the patient throughout the whole nursing process, including the continuous follow-up during the home period. It is hoped that the implementation of grief counseling methods in the later stage can help the bereaved to successfully go through the grieving period, prevent grief disorders, and help them return to society.
Characterizing post-fire delayed tree mortality with remote sensing: sizing up the elephant in the room
Authors: Reilly Matthew J. , Zuspan Aaron , Yang Zhiqiang
Published: October 2023

Background

Despite recent advances in understanding the drivers of tree-level delayed mortality, we lack a method for mapping delayed mortality at landscape and regional scales. Consequently, the extent, magnitude, and effects of delayed mortality on post-fire landscape patterns of burn severity are unknown. We introduce a remote sensing approach for mapping delayed mortality based on post-fire decline in the normalized burn ratio (NBR). NBR decline is defined as the change in NBR between the first post-fire measurement and the minimum NBR value up to 5 years post-fire for each pixel. We validate the method with high-resolution aerial photography from six wildfires in California, Oregon, and Washington, USA, and then compare the extent, magnitude, and effects of delayed mortality on landscape patterns of burn severity among fires and forest types.

Results

NBR decline was significantly correlated with post-fire canopy mortality (r2 = 0.50) and predicted the presence of delayed mortality with 83% accuracy based on a threshold of 105 NBR decline. Plots with NBR decline greater than 105 were 23 times more likely to experience delayed mortality than those below the threshold (p < 0.001). Delayed mortality occurred across 6–38% of fire perimeters not affected by stand-replacing fire, generally affecting more areas in cold (22–41%) and wet (30%) forest types than in dry (1.7–19%) types. The total area initially mapped as unburned/very low-severity declined an average of 38.1% and generally persisted in smaller, more fragmented patches when considering delayed mortality. The total area initially mapped as high-severity increased an average of 16.2% and shifted towards larger, more contiguous patches.

Conclusions

Differences between 1- and 5-year post-fire burn severity maps depict dynamic post-fire mosaics resulting from delayed mortality, with variability among fires reflecting a range of potential drivers. We demonstrate that tree-level delayed mortality scales up to alter higher-level landscape patterns of burn severity with important implications for forest resilience and a range of fire-driven ecological outcomes. Our method can complement existing tree-level studies on drivers of delayed mortality, refine mapping of fire refugia, inform estimates of habitat and carbon losses, and provide a more comprehensive assessment of landscape and regional scale fire effects and trends.
Open-Label, Multicenter, Randomized, Biomarker-Integrated Umbrella Trial for Second-Line Treatment of Advanced Gastric Cancer: K-Umbrella Gastric Cancer Study
Authors: Lee Choong-kun , Kim Hyo Song , Jung Minkyu , Kim Hyunki , Bae Woo Kyun , Koo Dong-Hoe , Jeung Hei Cheul , Park Sook Ryun , Hwang In Gyu , Zang Dae Young , Lee Hyun Woo , Park Sejung , Nam Chung Mo , Chung Hyun Cheol , Rha Sun Young
Published: October 2023

PURPOSE

This study aimed to screen targeted agents as second-line treatment with a standard-of-care (SOC) controlled umbrella trial design in advanced gastric cancer (AGC).

PATIENTS AND METHODS

Patients with HER2-negative AGC from eight Korean cancer centers were screened for druggable targets using immunohistochemistry (IHC) and in situ hybridization, and randomly assigned to the biomarker versus control group at a 4:1 ratio. In the biomarker group, patients were treated with specific targeted agent plus paclitaxel: pan-ERBB inhibitor for epidermal growth factor receptor (EGFR) 2+/3+ patients (afatinib; EGFR cohort), PIK3Cβ inhibitor for phosphatase and tensin homolog (PTEN) loss/null patients (GSK2636771; PTEN cohort), and anti–PD-1 inhibitor for PD-L1+, deficient mismatch repair/microsatellite instability-high, or Epstein-Barr virus–related cases (nivolumab; NIVO cohort). NONE cohort in the biomarker group without predefined biomarkers and control group received SOC (paclitaxel with or without ramucirumab). The primary end point was progression-free survival (PFS), and the secondary end points were efficacy and safety.

RESULTS

A total of 318 patients were randomly assigned into the control (n = 64) and biomarker (n = 254; EGFR, n = 67; PTEN, n = 37; NIVO, n = 48; NONE, n = 102) groups. Median follow-up was 35 months. Median PFS and overall survival (OS) were 3.7 (95% CI, 3.1 to 4.1) and 8.6 (95% CI, 7.6 to 9.8) months in the biomarker group and 4.0 (95% CI, 3.0 to 4.6) and 8.7 (95% CI, 7.1 to 9.9) months in the control group. Afatinib addition led to marginal survival benefits to patients with EGFR 3+ compared with SOC (PFS, 4.0 v 2.2 months; P = .09), but GSK2636771 did not prolong the survival of patients with PTEN loss. Addition of nivolumab showed a durable survival benefit (median OS, 12.0 v 7.6 months; P = .08).

CONCLUSION

Although biomarker group did not show better survival than the control group, IHC-based screening and allocation of patients with AGC to the second-line treatment in an umbrella design were feasible for effective early screening of novel agents.
Healthcare costs associated with first-line (1L) treatment of patients with locally advanced or metastatic urothelial carcinoma (la/mUC) in the United States (US).
Authors: Ike Chiemeka , Kongnakorn Thitima , Tichy Eszter , Benedict Agnes , Sanchez Alvarez Javier , Kearney Mairead
Published: October 2023

11

Background: In 2023 in the US, 82,290 new cases of bladder cancer and 16,670 related deaths were estimated. Prior analyses assessing the economic burden of la/mUC in the current and evolving treatment landscape have been limited. This study aimed to estimate the direct medical costs of treating patients with la/mUC, from US Medicare and commercial perspectives. Methods: A cost model was developed to estimate annual direct medical care costs in patients with la/mUC eligible for 1L platinum-based chemotherapy (PBC) in 2023. Costs (2023 USD)—including drug acquisition and administration, disease management and adverse event (AE) management—were calculated, including subsequent therapy costs. Inputs included estimated number of treated patients per year, treatment duration, progression-free survival and overall survival with various therapies, AEs incidence, and market shares. Efficacy and safety data were sourced from product prescribing information, epidemiology data from Surveillance, Epidemiology, and End Results (SEER) database and published literature. Market share assumptions were based on market research data. Results: For a hypothetical health plan with 1,000,000 members, 108 and 22 patients with la/mUC from Medicare and commercial perspectives, respectively, were estimated to be eligible for 1L PBC in 2023. Estimated total annual costs per treated patient are shown in the Table below. With market share data comprising 1L PBC, with and without avelumab (AVE) 1L maintenance (61% and 25%) and enfortumab vedotin (EV) + pembrolizumab (PEM) (for cisplatin-ineligible patients, 14%), annual costs of $16,673,645 ($12,861 per treated member per month) and $4,637,226 ($17,852 per treated member per month) were estimated for Medicare and commercial perspectives, respectively. Drug acquisition costs in 1L represented most of the total costs (Medicare, 75%; commercial, 64%). Conclusions: Understanding the economic burden associated with la/mUC treatments may facilitate informed decision making on treatment choice and optimal sequencing. Further real-world studies are needed to assess the impact of these innovative treatments on disease and AE management costs of la/mUC. [Table: see text]
Factors that influence clinical trial participation for oncology patients in Australia: A scoping review.
Authors: You Kyung Ha , Lwin Zarnie , Ahern Elizabeth Stephanie , Roberts Natasha Anne , Wyld David
Published: October 2023

111

Background: Equity in clinical trials is a key priority for the health ecosystem and research community. Although participating in clinical trials has well documented benefits, enrolment rates remain a global challenge. Despite a modest population, Australia is competitive in the international clinical trial sphere, contributing 5% of industry-sponsored clinical trial activity globally. However, the factors that impact participation remains unknown in Australia. Our scoping review aims to assess factors that influence clinical trial participation by oncology patients in Australia. Methods: This scoping review was conducted in accordance with the Joanna Briggs Institute (JBI) methodology and followed the PRISMA-ScR reporting guidelines. Searches were undertaken of four electronic databases and grey literature platforms. Two independent reviewers screened articles based on abstract and title followed by full text using pre-defined inclusion criteria. Data was extracted from the included articles by two reviewers independently, utilising a preformed data extraction tool. Characteristics of included articles were summarized using descriptive statistics. Extracted data underwent qualitative analysis. Results: Of 1010 identified references, 649 underwent title and abstract screening. Forty-six articles were reviewed in full text and 36 articles were included in the final analysis. The number of studies significantly increased over time which reflects the growing interest in this field. Cross-sectional surveys of patients and or health care professionals (HCP) were the most popular study design. Four key themes were derived: (1) Factors relating to patients, (2) factors relating to health care professionals, (3) factors relating to clinical trials, and (4) factors relating to health services. While self-reported patient willingness was consistent across various sociodemographic backgrounds, this contrasted with studies reporting lower participation rates in minority groups. HCP were keen to be involved in clinical trials, but limited support in resources appeared to a barrier. Contrasting with international literature, finances were uncommonly reported as a barrier to participation. Furthermore, international literature highlights trial availability and study eligibility criteria as major barriers to participation, this has not been explored in the Australian context. Conclusions: Addressing disparities in cancer clinical trials requires foundational knowledge of the factors that influence cancer clinical trial participation. Along with the developing body of the international literature, this scoping review provides a unique perspective through the Australian lens. Together, we can use this understanding to tailor our strategies and only then, can we improve equity, diversity, and inclusion in cancer clinical trials.
Is financial toxicity associated with delays in diagnosis in gynecologic cancers?
Authors: Reyes Maria Fatima , Rivera Casul Giuliana , Noor Chelsea Nadiha , Gompers Annika , Hacker Michele R. , Esselen Katharine
Published: October 2023

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Background: Patients with gynecologic cancer and high financial toxicity (FT) are significantly more likely to report delaying care than patients with low FT. We compared time of symptoms onset to diagnosis and treatment stratified by FT in patients with gynecologic cancer. Methods: Patients with gynecologic cancer completed a cross-sectional survey at follow-up visits with gynecology oncology providers from 2017-2021. The survey included the Comprehensive Score for Financial Toxicity (COST) tool. Data were abstracted from medical records, including dates of symptom onset, initial biopsy, surgery and/or start of relevant treatment. FT was categorized as high (COST score ≤23) and low (COST score >23). Data are presented as n (%) and median (interquartile range). Results: There were 258 respondents, 54% with uterine cancer, 30% with ovarian and 16% with cervical. High FT was reported by 31% and low FT by 69%. Median age at diagnosis was 62 (53.8-69.9) years, 81% of respondents were Non-Latinx White, and 7% had a non-English primary language. Most cancers were stage I (59%), 10% stage II, and 31% stages III-IV. Most patients had surgery (91%), 50% had chemotherapy and 45% had radiation; 15% had recurrence. Median time of COST score since diagnosis was 13.6 months (5.7-41.1). Risk factors for high FT included age, race and ethnicity, education, employment, insurance status, income, and chemotherapy (all p<0.05). Median time from symptom onset to diagnosis in all gynecologic cancers was longer in the high FT [3.1 (1.1-5.8) months] compared to the low FT [1.8 (0.9-3.8) months] group (p=0.01). Time from biopsy to gynecologic oncology consult and time from consult to surgery did not differ based on FT (both p> 0.05). Among patients with cervical cancer, those with high FT had a longer median time from symptom onset to diagnosis [5.0 months (3.1–8.8)] compared to those with low FT [1.7 months (0.9–3.7); (p=0.04)]. Similarly, patients with uterine cancer and high FT had longer median time from symptoms onset to diagnosis [3.0 months (1.0–6.4)] than those with low FT [1.8 months (0.9–3.8); p=0.03]. In patients with ovarian cancer, time from symptom onset to diagnosis was not significantly different based on financial toxicity (p>0.05). Conclusions: Patients with uterine and cervical cancer who reported high FT had a longer time to diagnosis compared to patients with low FT. Delays in accessing care, initial evaluation and treatment may contribute to worse cancer outcomes and survival for patients with FT as reported in other studies. More work is needed to understand what financial and social factors lead to the longer time to diagnosis in patients with uterine and cervical cancer.
Spatial access to screening centers and late-stage lung cancer in Alabama.
Authors: Niranjan Soumya J. , Tipre Meghan , Opoku-Agyeman William , Allgood Ashleigh , Dransfield Mark , Baskin Monica L
Published: October 2023

130

Background: Cancer stage at diagnosis has a tremendous influence on type of treatment, recovery and survival. This study examined the impact of spatial access to healthcare services on late-stage lung cancer diagnosis in Alabama, taking into account access and travel time to the nearest Screening Center of Excellence (SCOE). Methods: A cross-sectional retrospective study of lung cancer incidence in the state of Alabama was employed, using zipcode as unit of analysis. Data on individual lung cancer diagnosis between 2013 and 2018 was obtained from Alabama State Cancer Registry. Geographic information system (GIS) network analysis was used to calculate distance to the nearest SCOE. Descriptive statistics were used to compare distribution of independent variables including residential status, age, race, gender and insurance across lung cancer diagnosis stage. Multi-variable logistic regression assessed odds ratio and 95% confidence intervals to evaluate the relationship between residential status and late-stage diagnosis. Results: 14,556 individuals were diagnosed with lung cancer in Alabama from 2013 - 2018. Late-stage diagnosis accounted for 72.7% of cases, predominantly among males (56.5%) and Whites (79.8%). Late-stage vs. early-stage cases differed significantly in sex (males: 59.2% vs. 50.9%) and race (Whites: 78.6% vs. 83.4%) (p < 0.0001). Multivariable logistic regression analyses found that Alabamians were more likely to be diagnosed with late stage lung cancer if they were Black (p < 0.0001); male (p < 0.0001); uninsured (p < 0.0001); and/or insured via Medicaid (p < 0.0001). Alabamians were less likely to be diagnosed with late stage lung cancer if they were within 60 miles of a SCOE (p < 0.0001). Living in a persistent poverty census tract was associated with a lower OR for late-stage lung cancer occurrence (adjusted OR = 0.88, 95% CI =0.78-0.99, p=0.0341). Neighborhood Deprivation Index did not significantly correlate with late-stage lung cancer (p = 0.8280). Conclusions: Proximity to screening centers within 60 miles is associated with a reduced likelihood of late-stage lung cancer. Additionally, race, sex, insurance status, and age are significant factors. These findings underscore the importance of access to screening centers and the influence of demographic and socioeconomic factors on lung cancer stage at diagnosis.
Efforts to increase the application of low-dose computed tomography (LDCT): A resident-led strategy to improve lung cancer screening in an urban primary care clinic.
Authors: Sugg Kyle Austin , Vyas Rahul , Shaik Asra , Bathla Jasdeep , Saini Astha , Yalavarthi Nagasai , Raheem Mariam , Devara Anupama
Published: October 2023

132

Background: Lung cancer carries the highest mortality rate of all malignancies, implicated in approximately 20% of cancer-related deaths in the United States. The 2011 National Lung Screening Trial (NLST) established a 20% reduction in lung cancer-associated mortality associated with annual LDCT screening in high-risk populations compared to screening chest radiography. In 2013 the United States Preventative Services Task Force (USPSTF) adopted this approach into their recommendations, with a subsequent update in 2021 establishing a recommended annual LDCT screening for those at high risk. There remains a concerning lack of access to PCP-initiated LDCT screening in medically underserved (e.g., urban, rural) areas, translating to relatively low rates of early lung cancer detection. Methods: Any patient meeting the 2021 USPSTF criteria (at least 20-pack-year history of tobacco use, who still smoke or have quit within the past 15 years) was deemed eligible. Excluded were those meeting these criteria and any patient who had received LDCT within the past 12 months. The pre-intervention stage of this study included a 15-week data collection of chart review to establish baseline rates. The intervention involved an educational flyer detailing the guidelines for lung cancer screening, placed in each clinic exam room to promote patient self-assessment of eligibility. Results: In the 15-week control group (i.e., pre-intervention), 177 patients were eligible for LDCT screening, with 65 successful LDCT orders and 112 not ordered (36.7% screened appropriately) and 27 (41.5%) LDCT orders completed. Through the 15 weeks of post-intervention data, 193 patients were eligible for LDCT screening, with 99 orders placed and 94 not (51.3% screened appropriately), and 42 (42.4%) of these LDCT orders were completed. Conclusions: The initial goal set for this project was a 50% lung cancer screening rate among eligible patients, with at least 50% of those LDCT orders performed by the patient. There was a remarkable improvement in LDCT ordering rates; however, the primary goal of these ordering improvement rates was to translate them into a higher percentage of patients completing these orders. Despite the increase in LDCT orders, the percentage completed stagnated (41.5% pre-intervention, 42.4% post-intervention). It was essential to our team that the interventions remain cost-effective. We did achieve this using printed flyers, allowing for patient-initiated involvement in the process. Using these interventions as a template, a clinic in any setting may benefit their LDCT ordering rates. However, these measures alone will not improve the percentage of patients completing the LDCT orders. As our project continues, we plan to modify the intervention to reflect constructive feedback from the resident physicians and patients involved.
Using crowdsourcing approach to obtain real-world insights to improve access to cancer medicine.
Authors: Jazieh Abdul-Rahman , Pyle Doug , Kerr Calum , Kerr David James
Published: October 2023

135

Background: Barriers of access to cancer medicines vary tremendously among practice settings. Our initiative is aimed at obtaining insights about the challenges and potential solutions to improve access to cancer medicine from a wide range of stakeholders and front-line practitioners across the world. Methods: We used a two-step approach. The first step is to convene a panel of distinguished international experts to identify key stakeholders and pertinent issues to cover during crowdsourcing process. The second step is to run a crowdsourcing (Hackathon) through a virtual platform (Within3, Lakewood, Ohio, USA). The platform was divided into four rooms, each moderated by one expert posing a series of questions related to the following themes: Access to affordable quality medicines; reliable, verifiable, and sustainable supply chain; guidelines and the rationale use of medicines; and measuring and validating quality standards. Results: Between June 8 and July 8, 2022, 78 participants from 33 countries joined the platform. Participants responded to questions by reporting local/ regional experiences and suggested solutions. Participants were able to comment on others’ posts or like a specific comment. The contributions revealed the disparities in access to medicines and highlighted the needs for cooperation across borders and among healthcare systems and stakeholder organizations and emphasized the needs to improve communications, education and accurate data generation and experience sharing. Questions that generated the most responses related to access to quality essential medicines (n=25) and the use of treatment guidelines based on essential cancer medicines (n=22). Solutions that generated the most “likes” related to actions that can be taken to make medicines more affordable and accessible and actions to engage diverse audiences in efforts to improve access to medicines. The importance of creating practical and relevant guidelines was clearly highlighted. Conclusions: Crowdsourcing is an innovative and practical approach to gain insights from stakeholders of different backgrounds professionally, geographically and practice settings. It creates an opportunity for interested individuals to participate in asynchronous ways in easily accessible platform at their convenience over extended period of time. A follow-up plan is underway to crystalize the most practical next steps to build on the complied information.
Classifying oncologist rurality by practice location and patient population.
Authors: Cornelius Sarah , Wong Sandra L. , Moen Erika L.
Published: October 2023

136

Background: Geographic variation in the oncology workforce has contributed to reduced access to cancer specialists in rural areas. Workforce studies most often classify provider rurality by their practice location. We hypothesized this approach, given its high specificity, would miss the true extent of providers involved in rural cancer care. In this study, we aim to identify a new method for classifying oncologist rurality. Methods: We created a cohort of Medicare beneficiaries diagnosed with breast, colorectal, or lung cancer in 2018. This informed a cohort of all medical, radiation, and surgical oncologists who treated these patients. Two methods were used to classify oncologists’ rurality using Rural Urban Commuting Area (RUCA) codes: 1) Based on the ZIP Code where they provided the plurality of their care; and 2) Based on the percentage of their patients who reside in a rural ZIP Code. We used sensitivity, specificity, and summary statistics to compare these methods and identify a threshold of rural patients to classify provider rurality. Results: We identified 815 rural oncologists by their practice location and 5,450 by their patient population. We found high concordance between these two definitions (AUC: 0.87), with providers practicing in a rural location treating the highest proportion of rural patients (n=658 [80.7%]). Oncologists practicing in a rural area had a lower patient volume (6.4 [SD: 7.8] vs. 12.2 [SD: 14.2]) and were more likely to be a surgeon (73.1% vs. 51.8%) than their metropolitan counterparts. By categorizing oncologist rurality by their patient panel, we have expanded who is considered a rural oncologist (n=5,450 vs. n=815) and created a continuous measure of oncologist rurality. Oncologists treating a high proportion of rural patients had a higher patient volume than those treating no rural patients (10.9 [SD: 11.6] vs. 8.7 [SD: 10.7]). Conclusions: Special consideration should be made when defining oncologists’ rurality status. Basing rurality on their patient panel results in a broader definition of a rural physician, and could be useful for interventions aiming to improve quality of rural cancer care.[Table: see text]