bluuebunny/crossref_metadata_2025_split huggingface dataset:
The Debriefing Assessment in Real Time (DART) tool for simulation-based medical education
Authors: Baliga Kaushik , Halamek Louis P. , Warburton Sandra , Mathias Divya , Yamada Nicole K. , Fuerch Janene H. , Coggins Andrew 
Published: March 2023

Abstract
Background
Debriefing is crucial for enhancing learning following healthcare simulation. Various validated tools have been shown to have contextual value for assessing debriefers. The Debriefing Assessment in Real Time (DART) tool may offer an alternative or additional assessment of conversational dynamics during debriefings.

Methods
This is a multi-method international study investigating reliability and validity. Enrolled raters (n = 12) were active simulation educators. Following tool training, the raters were asked to score a mixed sample of debriefings. Descriptive statistics are recorded, with coefficient of variation (CV%) and Cronbach’s α used to estimate reliability. Raters returned a detailed reflective survey following their contribution. Kane’s framework was used to construct validity arguments.

Results
The 8 debriefings (μ = 15.4 min (SD 2.7)) included 45 interdisciplinary learners at various levels of training. Reliability (mean CV%) for key components was as follows: instructor questions μ = 14.7%, instructor statements μ = 34.1%, and trainee responses μ = 29.0%. Cronbach α ranged from 0.852 to 0.978 across the debriefings. Post-experience responses suggested that DARTs can highlight suboptimal practices including unqualified lecturing by debriefers.

Conclusion
The DART demonstrated acceptable reliability and may have a limited role in assessment of healthcare simulation debriefing. Inherent complexity and emergent properties of debriefing practice should be accounted for when using this tool.
Early identification of treatment non-response in first-episode psychosis
Authors: Wold Kristin Fjelnseth , Ottesen Akiah , Camilla Bärthel Flaaten , Johnsen Erik , Lagerberg Trine Vik , Romm Kristin Lie , Simonsen Carmen , Ueland Torill , Widing Line , Åsbø Gina , Melle Ingrid 
Published: March 2023

Abstract

Background
Approximately one-third of patients with psychotic disorders does not respond to standard antipsychotic treatments. Consensus criteria for treatment resistance (TR) may aid the identification of non-response and subsequent tailoring of treatments. Since consensus criteria require stability of clinical status, they are challenging to apply in first-episode psychosis (FEP). This study aims to investigate (a) if an adaptation of consensus criteria can be used to identify FEP patients with early signs of TR (no early clinical recovery—no-ECR) after 1 year in treatment and (b) to what extent differences in antipsychotic treatments differentiate between outcome groups.

Methods
Participants with FEP DSM-IV schizophrenia spectrum disorders were recruited during their first treatment. A total of 207 participated in the 1-year follow-up. Remission and recovery definitions were based on adaptations of the “Remission in Schizophrenia Working Group” criteria and TR on adaptations of the “Treatment Response and Resistance in Psychosis” (TRRIP) working group criteria.

Results
97 participants (47%) could be classified as no-ECR, 61 (30%) as ECR, and 49 (23%) as with partial ECR (P-ECR). Statistically significant baseline predictors of no-ECR matched previously identified predictors of long-term TR. Only 35 no-ECR participants had two adequate treatment trials and met the full TRRIP criteria. 21 no-ECR participants were using the same medication over the follow-up year despite the lack of significant effects.

Conclusion
The difference in the percentage of FEP participants classified as no-ECR versus TR indicates that we may underestimate the prevalence of early TR when using consensus criteria.
Survival in Black and non-Black patients with metastatic prostate cancer.
Authors: Cheranda Nina , Luo Suhong , Sanfilippo Kristen Marie , Eisen Seth A , Schoen Martin W. 
Published: March 2023

101 Background: In the general population, Black men have greater incidence, lower five-year survival, and higher mortality due to prostate cancer when compared to white men. However, in clinical trials and studies of metastatic castrate resistant prostate cancer (mCRPC) in the Veterans Health Affairs (VHA) that excluded chemotherapy, Black men have longer overall survival (OS). We sought to analyze outcomes of Black men treated with androgen receptor targeting agents (ARTAs) abiraterone (AA) and enzalutamide (ENZ) in the VHA. Methods: Patients initially treated with AA or ENZ for mCRPC from May 2011 to June 2017 were identified within the VHA. Racial cohorts of Black and non-Black were determined from patient charts. ANOVA, Kaplan-Meier, and Cox proportional hazards modeling were used to assess the association between overall survival and covariates, including treatment, age, Charlson Comorbidity Index, body-mass index, PSA, year of treatment, prior docetaxel therapy, hemoglobin, creatinine clearance, bilirubin, and albumin at start of treatment. Results: Of 11,027 patients treated for mCRPC with ARTAs, 2550 (23.1%) were identified as Black. Black patients were significantly younger (72.6 vs. 75.8 years, p<0.001), had higher median PSA (60.3 vs. 37.0, p<0.001) and higher Charlson comorbidity index (4.5 vs. 3.9, p<0.001) with lower mean BMI (27.7 vs. 28.4, p<0.001) and higher rates of cardiovascular disease (62.0% vs. 59.8%, p=0.044) and diabetes (45.8% vs. 34.1%, p<0.001). Docetaxel was given more frequently to Black veterans both prior to ARTA (24.7% vs. 16.9%, p<0.001) and at any time (43.1% vs. 31.3%, p<0.001). Black men had a median 2.0 months longer OS than non-Black men (22.0 vs. 20.0, p<0.001) and decreased mortality in unadjusted models (HR 0.89, 95% CI 0.85-0.94) and multivariable models (aHR 0.76, 95% CI 0.72-0.80). Black veterans had longer OS with ENZ compared to AA (24.5 vs. 21.3 months, p<0.001) and decreased mortality (HR 0.83, 95% CI 0.75-0.92) in unadjusted models. However, there was no difference in OS between ENZ and AA in neither multivariable models in all Black men (aHR 0.95, 95% CI 0.85-1.05) nor Black men with cardiovascular disease or diabetes (n=1912, aHR 0.91, 95% CI 0.80-1.03). Conclusions: In the VHA, which provides more equitable access to care, Black men have longer OS with ARTAs compared to non-Black men and increased use of chemotherapy. Importantly, Black men are significantly younger (>3 years) when treated for mCRPC, with higher PSA, and higher rates of comorbid diseases.
Main reasons of choice of formulation and route of triptorelin treatment initiated in patients with prostate cancer (PCa): TALISMAN study.
Authors: Thiery-Vuillemin Antoine , Crehange Gilles , Lebret Thierry , Pello Leprince Ringuet Nathalie , Perrot Valérie , Rigaud Jerome 
Published: March 2023

104 Background: Modalities of use of androgen deprivation therapy (ADT), like triptorelin, in real life, at the era of new strategies in advanced stages, lack of recent data. Our purpose here was to describe main reasons of choice of formulation and route (F&R) of triptorelin treatment (Tt) declared by the physician. Patient comorbidities, cancer aggressiveness and physician habits may influence their choices. Methods: Initiated in 2020, a prospective, multicenter, non-interventional study is ongoing in France (TALISMAN, NCT04593420). Patients with histologically confirmed PCa, eligible for ≥ 12-month triptorelin Tt within its label were enrolled. Interim analysis of baseline data was planned when 50% of 786 planned patients were enrolled. Modalities of use, including F&R of triptorelin prescribed [monthly intramuscular (1mIM), every 3 months subcutaneous (3mSC) or intramuscular (3mIM), every 6 months intramuscular (6mIM)], were described. Results: 509 patients were included in the interim analysis. Overall population was presented at ASCO-GU22. Subgroups of F&R are presented here. Main F&R prescribed was 3mSC (70.7%). Main baseline parameters in F&R subgroups are presented (except for 1mIM, 4 patients (0.8%)). 31 patients had missing F&R data and were not included in subgroups. 62.1% of patients overall received at least one concomitant systemic Tt for comorbidity at baseline (58.2% in 3mIM, 61.7% in 3mSC and 6mIM). 18.6% and 13.0% of patients overall received, respectively, platelet aggregation inhibitor and anticoagulant; they were 20.9% and 13.8% in 3mSC, 7.3% and 5.5% in 3mIM, 18.5% and 11.1% in 6mIM. Conclusions: Main reason of choice of F&R of triptorelin was physician preferred F&R (47.7%); noticeable reasons included anticoagulants for the choice of 3mSC, planned total duration of Tt for 3mIM and 6mIM, and potential impact on compliance for 6mIM. As the covid pandemic may change the management of patients with prostate cancer, longer acting formulations may become more attractive. Clinical trial information: NCT04593420 . [Table: see text]
Patient perceptions regarding the process of obtaining oral prostate cancer medications.
Authors: Schwartz Eric B , Furgal Allison , Widmer Gina , Caram Megan Veresh , Veenstra Christine M 
Published: March 2023

120 Background: Various oral therapies exist and have improved outcomes for men with prostate cancer. These agents are expensive and put patients at risk for financial toxicity. Although assistance mechanisms exist to offset these costs, navigating through assistance can be complicated and places excess burdens on patients. We conducted a survey of men prescribed oral therapies for prostate cancer to assess financial toxicity and perceptions on the process of obtaining oral cancer medications for prostate cancer. Methods: Patients with prostate cancer who had been prescribed abiraterone, enzalutamide, apalutamide or darolutamide at our institution in the six months prior to survey distribution were identified. Those with an email address were eligible for inclusion and sent a survey. Financial toxicity was assessed using the FACIT-COST score. Perceptions of the process of obtaining medication were assessed with a novel measure, which included questions regarding affordability, delays in care and ease of obtaining medications. We assessed bivariate associations between financial variables and financial toxicity measures. Results: Of 238 patients identified, 188 had a listed email address. Response rate was 28% of eligible patients (n = 53). Among respondents, 53% reported household income < $100,000 and 32% > $100,000, 15% declined to answer. A total of 41% utilized commercial insurance, 23% Medicare D, 28% an alternative Medicare program, 2% Medicaid and 4% had no prescription coverage. Monthly costs were between $100 and $1000 for 15% of patients and > $1000 for 6%. A total of 25% of patients considered their medication somewhat or very unaffordable; 13% were somewhat or not at all confident about affording their medication in the future; 6% reported delays in starting; 15% found the initial process of obtaining their medication somewhat or very stressful; 9% reported ongoing stress about affording their medications. Those with monthly cost > $100 were less likely to consider their medication affordable (p = 0.001). Those with commercial insurance were least likely to perceive delays in care (p = 0.024). Primary insurance type but no other variable was associated with difference in COST score with those who had commercial insurance reporting less financial toxicity than those with Medicare. Conclusions: The costs of oral prostate cancer medications are a concern for many men with prostate cancer. In a survey at our institution, many patients have high costs, despite the availability of financial assistance. In addition, many reported distress and uncertainty related to the process of obtaining their prostate cancer medications. Our survey was limited by small sample size and low response rate utilizing email as primary contact. We expect that many patients without access to email would be those at higher risk of financial toxicity. Further studies will aim to recruit patients directly in clinics.
Effect of cerebral dopamine metabolism genetic polymorphism on patient-reported quality-of-life (QOL): An analysis of the E3805 CHAARTED trial.
Authors: Gupta Arjun , Chen Yu-Hui , Sweeney Christopher , Jarrard David Frazier , Plimack Elizabeth R. , Gartrell Benjamin Adam , Carducci Michael Anthony , Hussain Maha H. A. , Garcia Jorge A. , Cella David , DiPaola Robert S. , Morgans Alicia K. 
Published: March 2023

123 Background: QOL outcomes have been associated with specific genetic variants in neurotransmitter metabolism. One such variant associated with reduced symptoms in placebo studies is in the rs4680 SNP of Carboxy-O-Methyltransferase (COMT). This variant is associated with reduced COMT enzymatic activity, higher cerebral dopamine levels, and improved mood. The interaction between this germline variant and cancer-directed treatment on QOL is undefined. A priori, we hypothesized that the COMT rs4680 SNP would be associated with better pain and QOL patient reported outcomes (PROs), than wildtype (WT) COMT within the E3805 CHAARTED Trial. Methods: E3805 compared docetaxel + androgen deprivation therapy (ADT+D) vs ADT in patients with metastatic hormone sensitive prostate cancer (mHSPC). PROs were collected at baseline, 3, 6, 9, and 12 months. Blood samples were genotyped prior to treatment. We compared PROs between patients with COMT WT vs rs4680 SNP within treatment arms longitudinally. PROs include Brief Pain Inventory (BPI) classified as: no (0), minimal (1), or more (≥2) pain, and BPI interference (range 0-10, 0= no pain or interference), and the Functional Assessment of Cancer Therapy-Prostate (FACT-P, higher score= better QOL, clinically important difference (CID)= 6). Descriptive statistics were used to characterize QOL over time. Fisher’s exact test, Wilcoxon rank sum test and mixed effects models were used to evaluate the associations between SNP and QOL in each arm. Results: Of 790 participants, 550 with SNP data were included. In the ADT+D arm, SNPs were not associated with PROs at any time point. In contrast, in the ADT alone arm, when compared to WT, rs4680 was associated with less pain at 3 months, less interference at 3, 6 and 9 months, and better QOL at 6 months (met criteria for CID). Conclusions: The rs4680 SNP, often associated with higher cerebral dopamine levels and improved QOL, was associated with less pain and superior QOL among patients with mHSPC treated with ADT, but not chemohormonal therapy. This is the first hypothesis driven genotyping study to demonstrate that genetics are associated with QOL in patients with cancer, especially when treatment does not cause profound symptoms. Clinical trial information: NCT00309985 . [Table: see text]
Developing a novel patient-reported outcome measure for patients with prostate cancer receiving radionuclide therapy: The FACT-RNT.
Authors: Gudenkauf Lisa M. , Chavez Melody , Maconi Melinda , Geiss Carley , Seyedroudbari Ameen , Thin Pan , Hoogland Aasha , Nguyen Kathleen , Oswald Laura B. , Jim Heather S.L. , El-Haddad Ghassan , Fendler Wolfgang Peter , Herrmann Ken , Cella David , Czernin Johannes , Hofman Michael S , Dicker Adam P. , Calais Jeremie , Tagawa Scott T. , Gonzalez Brian D. 
Published: March 2023

130 Background: The field of targeted radionuclide therapy (RNT) for prostate cancer (PC) is growing rapidly with recent FDA approval of the first lutetium-177-PSMA-ligand. Commonly used patient-reported outcome (PRO) measures were originally designed to assess the impacts of traditional therapies (e.g., chemotherapy, surgery). We aimed to develop the first PRO measure for PC patients receiving RNT. Methods: We used a multi-step approach based on input from experts and patients. We identified symptoms and toxicities potentially relevant in the context of RNT for PC from a literature review of published trials and interviews with PC patients who had received RNT, caregivers of RNT recipients, and clinicians. We identified items to include in the measure from the Functional Assessment of Chronic Illness Therapy (FACIT) item library. Finally, we reviewed, refined, and finalized the new measure. Results: Potentially relevant symptoms/toxicities were identified by reviewing published trials (e.g., xerostomia, nausea). Interviews with PC patients who received RNT (n=29), caregivers (n=14), and clinicians (n=11) yielded additional symptoms/toxicities (e.g., fatigue, constipation). After selecting a broad and comprehensive list of items from the FACIT item library, we refined the list based on input from 9 experts in the field of RNTs and PROs from 5 institutions. Patients who received RNT for PC (n=11) reviewed the draft measure and confirmed items were relevant to RNT recipients and comprehensible. This resulted in a brief 15-item measure deemed by key stakeholders to be relevant and useful in the context of RNT for PC. Conclusions: The FACT-RNT (Functional Assessment of Cancer Therapy – Radionuclide Therapy) is a PRO new measure for RNT recipients developed through multi-step collaboration with patients, caregivers, clinicians, and international experts. The FACT-RNT can be used in RNT clinical trials and real-world settings.
Optimising bone health management in advanced prostate cancer: A comparative cohort study.
Authors: Waton Anthony , Prichard Rachel , Navarro Rodriquez Carolina , Hannaway Nicola , Azzabi Ashraf , Chandler Robert , Frew John A. , Jiang Xue Yan , Pearson Rachel , Pedley Ian 
Published: March 2023

133 Background: Survival in prostate cancer is increasing due to advances in hormonal therapy. The recommended duration of Androgen Deprivation Therapy (ADT) is 18 months or more for patients with Non-Metastatic (NM) high risk disease, and lifelong in Metastatic disease. ADT is, however, an independent risk factor for osteoporosis, a disease characterised by low Bone Mineral Density (BMD) and subsequent increased risk of fractures, which can lead to significant disability and early death. In patients with advanced prostate cancer, it is therefore recommended that BMD is assessed yet there remains no established national guidance on how bone health should be managed. Methods: In total, 515 case notes for patients with newly diagnosed advanced hormone sensitive prostate cancer were retrospectively reviewed for assessment of bone health management. Our data analysis included a comparison of outcomes between patient cohorts managed at a dedicated Cancer Bone Health Unit (CBHU) and the Northern centre for Cancer Care (Oncology Centre, OC). Results: 1) Baseline characteristics: The cohorts were well balanced in terms of age and cancer stage. Data was available for 410 patients in the CBHU and 105 in the OC. Median age was 75 (range 59-94) in the CBHU and 71 (range 46-86) in the OC. The majority of patients had metastatic disease and were therefore receiving lifelong ADT. 2) Fracture incidence: was consistently higher in the OC (p<0.001). The most common fractures were hip, spine and wrist. Median time to first fracture in the CBHU was 112 (range 2 to 240) vs 83 weeks (8 to 229) in the OC (p=0.252). 3) Survival: for all patients 2 years after ADT commenced was 96.7% in the CBHU vs 91.8% in the OC (HR 0.321, 95% CI 0.19-0.55, p<0.001). Median survival has not yet been reached. Conclusions: This comparative analysis suggests that a strategy of standardised bone health management within a CBHU is associated with reduced fracture incidence and may delay time to first fracture compared with clinician discretion in an OC. Additionally the data suggests that this strategy also improves survival at 2 years in patients with NM high risk disease. Bone health strategies for prostate cancer should be implemented within hospital trusts to provide standardised care across the region. This could reduce costs associated with fractures and improve quality of life for patients who avoid fractures through timely introduction of treatment. The Northern Cancer Alliance (NCA) has recently approved guidance on the management of bone health in prostate cancer, and implementation has since commenced.
Phase 1/2a study of PRL-02, a long-acting intramuscular (IM) depot injection of abiraterone decanoate in patients (pts) with advanced prostate cancer.
Authors: Avitia Jose W. , Tutrone Ronald F. , Shore Neal D. , Bailen James L. , Nordquist Luke T. , Richardson William , Peer Cody J. , Figg William Douglas , Walling Jacqueline M. , Eisner Joel Robert , Sharp Matthew , Schotzinger Robert , Moore William R. 
Published: March 2023

141 Background: PRL-02 (abiraterone decanoate) is a novel, long-acting IM depot prodrug of abiraterone. In non-clinical models, PRL-02 provided high and durable concentrations of prodrug and abiraterone to target tissues including adrenal glands, lymph nodes and bone. Single doses of PRL-02 suppressed testosterone (T) through 14 weeks in a castrate monkey model to concentrations comparable to oral abiraterone acetate (AA) with lower and less variable plasma abiraterone exposures. Clinically, PRL-02 blocks androgens with minimal increases in mineralocorticoids or depletion of glucocorticoids via inhibition of CYP17 lyase and minimal inhibition of CYP17 hydroxylase. PRL-02 has the potential for a superior therapeutic index and safety profile compared to oral AA. Methods: Phase 1 is a standard 3+3 design intended to identify a recommended phase 2 dose (RP2D). Pts with metastatic castrate resistant or sensitive prostate cancer (mCRPC/mCSPC) and a screening T of 2 - 50 ng/dL were administered IM PRL-02 every 12 weeks with daily oral dexamethasone. Results: As of 8Sep22, 17 pts (6 mCRPC, 11 mCSPC) were treated across 5 dose cohorts (180, 360, 720, 1260, 1800mg). Generally, there was a dose-proportional increase in abiraterone concentrations following a single dose of PRL-02 with a Tmax of 14 - 28 days and a plasma half-life of 18.3 days. The median baseline T level was 7.45ng/dL. Among pts dosed at 720mg and above, 9 of 11 had a 90% reduction in T or values ≤ 1ng/dL at day 28, including 2 pts with T≤LLOQ of 0.1 ng/dL, and PSA50 responses were observed in 8 of 10 with post-baseline results. There were no treatment related serious adverse events (AEs) or dose limiting toxicities. G3 AEs related to PRL-02 included hip and shoulder pain. G2 related AEs included fatigue, decreased appetite, insomnia and hot flush; symptoms of mineralocorticoid excess were not reported. Minimal and transient changes in ‘up-stream’ steroids (e.g., progesterone (P) and corticosterone (C)) were observed through the 1800mg dose. Although serial radiology was not prospectively required, there was radiographic improvement in 6 pts with data available. Conclusions: PRL-02 was well tolerated. Dose-dependent T suppression was associated with clinical benefit including PSA responses and radiographic improvement. Based on a historical comparison, the levels of P and C are significantly lower than seen with AA + prednisone which appear to be due to greater CYP17 lyase selectivity. The 1260mg or 1800mg dose will be the RP2D. Clinical trial information: NCT04729114 . [Table: see text]