bluuebunny/crossref_metadata_2025_split huggingface dataset:
Translation and cultural adaption of the control preference scale across various care settings in a Danish hospital
Authors: Knudsen Bettina Mølri , Steffensen Karina Dahl 
Published: August 2024

Abstract
Background
In recent decades, there has been a growing emphasis on involving patients in healthcare decision-making, driven by political, ethical, and research considerations. Although patient involvement is associated with improved health outcomes, understanding patient preferences regarding their role in decision-making is crucial for effective interventions. The Control Preferences Scale (CPS) measures patient preferences along a continuum from passive to active participation. However, its application in Denmark necessitates translation and cultural adaptation.

Methodology
This study aimed to translate and culturally adapt the CPS for Danish use across diverse healthcare settings: acute care, cancer care, elective surgery, chronic medical treatment, and parental involvement in pediatric care. Following a cross-sectional design, the translation process was systematically planned and executed using Beaton’s guidelines, including the five stages: forward and back translation, synthesis, expert review, and pre-testing.

Results
The translation and adaption process was carried out successfully. Few linguistic challenges were identified and resolved by the expert review. The findings of the pre-testing indicated high acceptability and usability of the adapted CPS among 152 Danish patients and parents. The collaborative role emerged as the most preferred across settings (69.8%), with passive roles more prevalent among cancer patients (30%) and parents waiting with their child to see a pediatrician (23.3%). Notable, more women preferred collaborative or active roles (83.9%) than men (73.9%). The content validity assessment yielded positive feedback, affirming the relevance and comprehensiveness of the CPS.

Conclusions
In summary, the adaptation and validation of the CPS for Danish use proved successful, providing a valuable tool for assessing patient’s role preferences in healthcare decision-making. However, future studies are recommended to ensure construct validity and reliability through psychometric testing.
Combined treatment with vitamin C, hydrocortisone and thiamine does not attenuate morbidity and mortality of septic sheep
Authors: Baljinnyam Tuvshintugs , Fukuda Satoshi , Niimi Yosuke , Prough Donald , Enkhbaatar Perenlei 
Published: August 2024

Abstract
Background
Sepsis is associated with a highest mortality rate in the ICU. Present study tests the efficacy of combined therapy with vitamin C, hydrocortisone and thiamine (combined therapy) in the ovine model of sepsis induced by Pseudomonas aeruginosa. In this study, sepsis was induced in sheep by instillation of Pseudomonas aeruginosa (1 × 1011 CFU) into the lungs via bronchoscope, under anesthesia. Nine hours after injury, intravenous infusion of vitamin C (0.75 g every 6 h), hydrocortisone (25 mg every 6 h), and thiamine (100 mg every 12 h) or saline was given to the treatment and control groups. Cardiopulmonary variables were recorded.

Results
The survival rate was 16.7% in control and 33.3% in treatment groups. In the control group, mean arterial pressure dropped from 93.6 ± 8.6 to 75.5 ± 9.7 mmHg by 9 h, which was not affected by the combined therapy. Pulmonary dysfunction was not attenuated by the combined therapy either. The combined therapy had no effect on increased extravascular lung water content and fluid effusion into thoracic cavity. The bacterial number in the bronchoalveolar lavage fluid was significantly increased in the treatment group than the control group. The blood bacterial number remained comparable between groups.

Conclusions
Combined vitamin C, hydrocortisone, and thiamine did not attenuate severity of ovine sepsis.
Changes in the treatment landscape of metastatic hormone-sensitive prostate cancer: A multicenter study.
Authors: Urabe Fumihiko , Kimura Takahiro 
Published: August 2024

118 Background: A multicenter database was utilized to examine the current treatment landscape and clinical outcomes among patients with metastatic hormone-sensitive prostate cancer (mHSPC) following approval of upfront androgen receptor signaling inhibitors (ARSIs). Methods: We retrospectively analyzed patients with mHSPC who commenced treatment between February 2018 and June 2023. The Kaplan–Meier method was used to assess oncological outcomes, including time to castration-resistant prostate cancer (CRPC), progression-free survival 2 (PFS2, duration from initial treatment to tumor progression during second-line treatment), cancer-specific survival (CSS), and overall survival (OS). Cox regression analyses were performed to determine the impact of treatment choices on oncological outcomes. In addition, the incidence rate of adverse events was assessed. Results: In total, 829 patients were analyzed; 42.5% received ARSIs with androgen deprivation therapy (ADT), 44.0% received combined androgen blockade (CAB), and 13.5% received ADT alone. Analysis of annual treatment choice trends revealed an increasing preference for ARSIs with ADT. Kaplan–Meier curves and multivariate Cox regression analyses indicated higher rates of CRPC and shorter PFS2 in patients treated with CAB versus ARSIs with ADT. By contrast, CSS and OS were not significantly different between the ARSI with ADT group and the CAB group. Grade 3–4 adverse events occurred in 1.9% of patients receiving CAB and 6.0% of those receiving ARSIs with ADT. Conclusions: For patients with mHSPC, initial treatment with ARSIs in combination with ADT resulted in a longer time to CRPC and longer PFS2 compared to CAB. Although CAB and ADT alone were associated with fewer adverse events, ARSIs with ADT should be considered a first-line treatment option given its superior oncological outcomes.
Single centre real world data on disease profile and outcome of 700 patients with penile cancer treated with curative intent at an Indian cancer centre.
Authors: Prakash Gagan , Arora Amandeep , Pal Mahendra , Menon Santosh , Murthy Vedang , Misra Ankit , Maitre Priyamvada , Gujela Ajit , Tummala Manoj , Chandankhede Uday , Mohan Anand , Bonkar Dethe Shraddha , Ringe-Katdare Aparna , Agrawal Archi , Joshi Amit , Prabhash Kumar , Noronha Vanita , Bakshi Ganesh 
Published: August 2024

121 Background: Globocan 2022 reported that there are close to 10000 newly diagnosed penile cancer (PeCa) patients annually in India, which contributes to around 27% of the world’s burden of this disease. With the rarity of this male genitourinary cancer globally and absence of level I evidence on most aspects of the disease, real world data from a single Centre assumes importance and this retrospective study highlights the clinico-demographic profile, oncological outcome and surgical complications in patients treated with a curative intent. Methods: We retrospectively reviewed our prospectively maintained institutional database for patients with PeCa treated with curative intent from 2013 to 2021. Data was collected for demographic variables, clinico-pathological characteristics, post-operative complications and oncological outcomes. Descriptive data were expressed as mean / median / proportions. The Kaplan Meier method was used to calculate the cancer specific survival (CSS) of the patients, stratified by pN status. Results: From 2013 to 2021, 700 patients were treated for PeCa at our centre with curative intent, with a median age of 54 years (IQR 44-62) and a mean BMI of 24.1 kg/m2. Around 40% of the patients had history of tobacco use. The clinico-pathological features and Clavian Dindo complication rates are summarized in the table. With a median follow-up of 42 months, the CSS for cN0 patients under observation for their groins was 97.3%.CSS for patients with pN0, pN1, pN2 and pN3 was 90.6%, 79.4%, 71.4% and 55%. Amongst pN3, 24.3% received adjuvant chemo alone, 23.7% received adjuvant RT/CTRT alone while 33.7% received both adjuvant chemo and RT.CSS of pelvic nodal pN3 patients was 35% compared to 71% of inguinal perinodal extension pN3. Conclusions: Our series, one of the largest reported from a single centre, highlights the real world oncological outcome of PeCa patients. We reemphasize the importance of addressing inguinal nodes early and adequately and the worser outcome of pN3 due to pelvic node involvement compared to pN3 due to extra nodal extension of inguinal nodes. [Table: see text]
PD-1 blockade with camrelizumab after chemoradiotherapy in nasopharyngeal carcinoma.
Authors: Ma Jun , Sun Ying , Liang Ye-Lin , Liu Xu , Shen Liangfang , Hu Guangyuan , Zou Guorong , Zhang Ning , Chen Chuanben , Chen Xiaozhong , Zhu Xiao-Dong , Yuan Yawei , Yang Kunyu , Jin Feng , Hong Shu-Bin , Zhao Hongyun , Li Ji-Bin 
Published: August 2024

129 Background: Approximately 30% of locoregionally advanced nasopharyngeal carcinoma (NPC) experience disease relapse despite definitive chemoradiotherapy. The programmed death-1 (PD-1) blockade camrelizumab has demonstrated considerable value in recurrent/metastatic NPC, while its role in locoregionally advanced NPC is worth exploring. Methods: We conducted a randomized, open-label, phase 3 trial to evaluate adjuvant camrelizumab in locoregionally advanced NPC after definitive chemoradiotherapy. Patients with T4N1M0 or T1-4N2-3M0 NPC who have undergone induction chemotherapy and concurrent chemoradiotherapy were randomized in a 1:1 ratio to receive adjuvant camrelizumab (200mg intravenously once every 3 weeks for up to 12 cycles; Camrelizumab group) or observation ( Standard-therapy group). The primary endpoint was event-free survival (freedom from randomization to locoregional recurrence, distant metastasis, or death from any cause). The secondary endpoint included locoregional recurrence-free survival, distant metastasis-free survival, overall survival, safety, and quality of life. Results: A total of 226 patients were randomized to the Camrelizumab group and 224 to Standard-therapy group. At a median follow-up of 37 months, the 3-year event-free survival was 86.9% in the Camrelizumab group and 77.4% in the Standard-therapy groups (stratified hazard ratio, 0.61; 95% confidence interval [CI], 0.38 to 0.96; P = 0.03). Grade 3 or 4 adverse events were reported in 11.2% patients in the Camrelizumab group and 3.2% of those in the Standard-therapy group. The most common adverse event of grade 3 or 4 was leukopenia (4.9% and 1.4%, respectively). There was no meaningful deterioration in quality of life associated with the use of adjuvant camrelizumab. Conclusions: Adjuvant PD-1 blockade with camrelizumab significantly improved event-free survival, with mild toxicity, highlighting its compelling role in the management of locoregionally advanced NPC. (DIPPER,ClinicalTrials.gov numberNCT03427827). Clinical trial information: NCT03427827 . [Table: see text]
Health disparity viewed from public historic cancer mortality data in the US: Advocacy for gastrointestinal cancers, for tailored prevention measures, and for inter-agency population data harmonization.
Authors: Zhang Tingting , Hung Tony 
Published: August 2024

152 Background: We searched public datasets released by CDC to answer the question ”Can we have a bird’s-eye view of health disparity in cancer care in the US?” By looking into historic data, we hope to identify not only health disparity reflected by the different cancer mortality rates for major cancer types, but also signs of missing data. Methods: We analyzed 2016-2020 US Cancer Statistics (USCS) cancer burden data to assess cancer disparity as reflected by rates of death in different races or ethnicities. Since the 2022 AACR report on cancer in Asian Americans raised concerns, we then looked into the “Single Race 15” grouping for the underlying cause-of-death data in WONDER@CDC to count liver cancer deaths (ICD10: C22) 2018-2021 among 6 Asian minority groups with population data from 2021 Census ACS data. 2020 GLOBOCAN estimated liver cancer mortality data were also compared. With anecdotal stories suggesting immigrants may seek end-of-life care in the birth country to access culture-concordant services, we looked into how cancer deaths abroad was reported. Results: Gastrointestinal (GI) cancers emerged as an area of cancer health disparity from USCS data. 5 GI cancers (colon and rectum, pancreas, liver and bile duct, stomach, and esophagus) contributed to 1/4 of US cancer deaths, and cancers in the pancreas, liver and bile duct, and esophagus still have poor outcomes. Black non-hispanic Americans are more likely to die from cancers of colon/rectum or pancreas. All minority races or ethnicities are more likely to die from cancers in liver and bile duct, or stomach than white non-Hispanic Americans. Cancers in colon and rectum, liver and bile duct, or stomach also cause high numbers of death in US under-50 population. Liver cancer mortality of US East Asian alone groups shown in the table were lower than GLOBOCAN estimated ASR of 16.1, with the greatest discrepancy in the Chinese (9.1 vs 17.2). Difference between the Vietnamese and Asian Indians may reflect that liver cancer is #1 cause of death in Vietnam, or HepB infection is low in India. Census data excluded expat US citizens, and consulate reports of death abroad have neither cause of death nor race/ethnicity data. Conclusions: We identified gastrointestinal cancers as a focus for cancer health disparity advocacy. Divergent risks for liver cancer in Asian Americans call for tailored prevention measures. Cross-agency death abroad data harmonisation to include race/ethnicity information will complete views of cancer mortality data in US. [Table: see text]
Retrieval-augmented large language models for clinical trial screening.
Authors: He Jianqiao , Gai Shanglei , Ho Si Xian , Chua Shi Ling , Oo Viviana , Zaw Ma Wai Wai , Tan Daniel Shao-Weng , Tan Ryan 
Published: August 2024

157 Background: Clinical trial screening is currently manual and laborious. We tested several large language models enhanced with retrieval-augmented generation (RAG-LLM) to assess their performance on this task. Methods: We extracted eligibility criteria of 184 oncology trials with FDA approval notifications between 8 January 2020 and 18 January 2024, as well as information on cancer staging and performance status scoring for the RAG-LLM vector database. A medical oncologist and 2 senior clinical trial coordinators developed a test set of 975 synthetic patient profiles which included primary site, stage, prior therapy, tumor mutations and one additional clinical feature. Each profile was paired with one of the 184 trials and annotated for ground-truth eligibility and the reason for it. This process was repeated for another validation set of 240 longer and more challenging profiles paired with 8 ongoing trials. We developed RAG-LLMs with 4 leading LLMs (Zephyr-7B, Med42, GPT 3.5, GPT4) and evaluated their accuracy in determining trial eligibility as well as retrieval-augmented generation assessment (RAGAs) metrics. A response was deemed accurate only if it correctly assigned both trial eligibility and the reason for assignment. Results: GPT4 performed best and achieved an accuracy of 95.18% and 80.00% on the test and validation set respectively with a mean inference time of 10.95 seconds. It also demonstrated the highest answer relevancy, context relevancy and faithfulness (Table). Conclusions: Our results demonstrate potential for RAG-LLMs to assist with trial screening at scale. Further evaluation in real-world cohorts utilizing electronic records and full protocol data with tracking of impact on trial enrolment can be explored within secure firewalls. [Table: see text]
Collaborative data sharing: The International Acute Myeloid Leukemia Consortium (INTERACT).
Authors: Tomizawa Daisuke , Wyatt Kirk D. , Kolb E. Anders , Reinhardt Dirk , Tasian Sarah K , Rubnitz Jeffrey E , Zwaan C Michel , Hindi Enal , Alonzo Todd Allen , Tanaka Shiro , Furner Brian , Birz Suzi , Petit Arnaud , Watkins Michael , Gerbing Robert B , Tanoshima Reo , Pounds Stanley B. , Achen Bhavya , Volchenboum Samuel Louis , Cooper Todd Michael 
Published: August 2024

169 Background: Outcomes for children and adolescents/young adults (AYAs) with acute myeloid leukemia (AML) remain suboptimal and are decidedly poor for patients with subtypes defined by high-risk features, including canonical genetic alterations and relapsed/refractory presentation. Due to their rarity, these subtypes are difficult to study within the existing clinical trials paradigm. Data sharing efforts aim to increase our understanding of rare cancer subtypes by pooling data from multiple sources. The INTERnational Acute myeloid leukemia ConsorTium (INTERACT) was established to pool and share data on pediatric and AYA patients with AML. Methods: In 2019, a data dictionary was created through an iterative, consensus-driven process that analyzed pre-existing clinical trials case report forms as the initial basis. By developing this standardized representation for data on patients with AML, data could be harmonized and integrated. A memorandum of understanding was signed in 2021, formally establishing INTERACT. An executive committee was convened to establish scientific priorities, facilitate ongoing data dictionary work, usher agreements with data contributors and review data requests submitted by investigators. In January 2024, the initial set of AML data was released on the Pediatric Cancer Data Commons (PCDC) data portal. Results: As of April 2024, the data dictionary includes 157 standardized data elements that were used to harmonize clinical data on 3,413 patients who participated in seven clinical trials conducted by four pediatric oncology cooperative groups across the United States, Europe, and Asia. Elements in the data dictionary include demographics, initial disease characteristics, genetic alterations, and survival status. Aggregate data can be freely explored using the publicly-available PCDC data portal (portal.pedscommons.org) and investigators seeking line-level access to data may submit a project request to the INTERACT executive committee for consideration. Conclusions: International collaborative data-sharing efforts will advance our understanding of pediatric and AYA AML by reducing barriers that constrain our study of AML to smaller cohorts of data. We hope that an early outcome of data sharing will be to increase our understanding of optimal treatments for patients with relapsed/refractory disease. Future goals of INTERACT include identifying data from additional studies to include, establishing relationships with new data contributors, and establishing working groups to advance the consortium’s scientific and clinical trials goals.
Unveiling the impact: Exploring malnutrition rates in patients with cancer and its association with anticancer treatments.
Authors: Pradeep Roshini , Deora Kunal , Danca Emily , Young Tarra , Mott Kelly , Chezik Ashley , Rocca Neychelle , Kudelka Andrzej Piotr 
Published: August 2024

189 Background: Malnutrition is a common cause of morbidity and mortality in patients with cancer. Malnutrition is seen in 40 to 80% of patients with cancer. Recent literature has shown loss of lean body mass in cancer population can be an independent factor for poorer outcomes. Anorexia, the loss of appetite has been either secondary to the disease itself or as a side effect of treatment. The mechanism of anorexia development is due to physiologic alteration in metabolism during carcinogenesis. Hence, it becomes important to screen for malnutrition in all patients with diagnosis of cancer. Methods: This single-center cohort study, conducted between January 15, 2024, and February 9, 2024, involved 106 patients receiving outpatient oncology care. Patients aged 18 to 90 years who consented to participate were administered the Mini Nutritional Assessment (MNA) questionnaire at the oncology registration desk. Exclusion criteria included patients with a dietician and those with pure nonmalignant hematological diagnoses. Data analysis comprised identifying patients at risk of malnutrition (8-11 points) or malnourished (0-7 points) using the MNA scale, followed by retrospective chart review. Primary outcomes focused on identifying prevalent cancer types among malnourished or at-risk patients, while secondary outcomes included comparing malnutrition proportions among different treatment groups and assessing gastrointestinal tract metastases and common causes of malnutrition. Results: The data encompassed 106 patients, among whom 29 (27.3%) were identified as at risk of malnutrition, while 9 (8.4%) were malnourished. Notably, a majority of at-risk or malnourished patients (60.5%) were classified as overweight or obese. The most prevalent cancers among these patients were breast cancer (26.3%), genitourinary cancer (23.6%), and gastrointestinal cancer (18.4%). Chemotherapy use was noted in 16 (42.1%) patients, immune checkpoint inhibitor treatment in 12 (31.5%), and a combination of both in 7 (18.4%). Gastrointestinal metastasis was observed in 5 (13.1%) patients. Among those at risk of malnutrition, the primary contributing factors identified were tumor impact and location (63.1%), diarrhea (18.4%), and fatigue (18.4%). Conclusions: The study underscores the significant prevalence of malnutrition risk among cancer patients, emphasizing the importance of systematic screening during outpatient oncology follow-ups.
Real-world outcomes with lurbinectedin in second-line and beyond for small cell lung cancer in Korea.
Authors: Shim Joosung Gabriel , Lim Sun Min , Cho Byoung Chul , Hong Min Hee , Lee Jii Bum 
Published: August 2024

211 Background: Small-cell lung cancer (SCLC) accounts for approximately 10~15% of all lung cancers and is characterized by a strong tendency for early metastasis, and a poor prognosis. Most patients are diagnosed with extensive disease, with only one-third presenting with earlier-stage disease amenable to potentially curative multimodality therapy. Before the advent of lurbinectedin in 2020, only few options existed for treating patients with SCLC that had progressed after first-line therapy. The sole available second-line option for metastatic SCLC was topotecan, which is associated with hematological toxicities and only modest efficacy. Although lurbinectedin has been added to the arsenal against metastatic SCLC, real-world data on its efficacy has been scarce due to its recent implementation. In this study, we investigated the demographics and clinical outcomes of metastatic SCLC patients treated with lurbinectedin in Korea. Methods: Patients with metastatic SCLC who had failed first-line therapy were identified (n=51) at Yonsei Cancer Center, Seoul, Republic of Korea, and received lurbinectedin at a starting dose of 3.2mg/kg. Efficacy data, including investigator-assessed tumor response, progression data, survival, and demographic information, were recorded. Results: A total of 51 patients were treated with lurbinectedin at a single center in Korea. Thirty-four patients were eligible for assessment. The median age of diagnosis was 68. The overall objective response rate and disease control rate were 20% and 47%, respectively. For patients treated with lurbinectedin in the second-line therapy, the ORR and DCR were 12% and 15% respectively, while the ORR was 18% and DCR was 29% for patients in beyond third-line of therapy. The median progression-free survival was 1.8 months (95% CI 0.38 to 2.08), and the median overall survival was 2.8 months (95% CI 0.55 to 2.70). A patient group with a history of smoking showed prolonged overall survival and disease control rate. The most common adverse effects related to lurbinectedin were anemia (55%), leukopenia (53%), nausea (35%), loss of appetite (25%), general weakness (19%), neutropenia (12%), dizziness (6%), alopecia (6%), phlebitis (3%), thrombocytopenia (3%), pneumonia (3%). Conclusions: The real-world data of lurbinectedin in SCLC patients suggests that it is still a viable option in this disease area with dismal prognosis. [Table: see text]