bluuebunny/crossref_metadata_2025_split huggingface dataset:
QLTI-15. MEDICAL MALPRACTICE AND GLIOMA
Authors: Fluss Rose , Crisman Celina 
Published: November 2024

Abstract

BACKGROUND
Medical malpractice affects the practice of medicine in every field and specialty. It is a particular concern in high risk specialties including neurological surgery, which has the greatest risk of malpractice litigation. Treatment of glioma patients is complex and requires diagnosis based on presentation and imaging, followed by the decision of resection versus biopsy to confirm diagnosis and potentially improve prognosis. The possibility of a complication accompanies every procedure and patients generally also go on to receive chemotherapy and radiation. Interdisciplinary care is a hallmark. We explored medical malpractice litigation pertaining to gliomas with a focus on outcomes and the role of the defendants as well as the liabilities prompting litigation.

METHODS
WestLaw Precision, an established legal database, was queried for all cases relevant to “glioma” occurring since 2000. Cases and settlements, in particular, were considered. Keywords included “glioma” and “medical malpractice” with the date range including all cases after January 1, 2000. Cases were identified and analyzed for variables of interest.

RESULTS
Fourteen relevant cases were identified and reviewed. There were three plaintiff verdicts, one settlement and ten defense verdicts in favor of the defense. Two cases involved minors, while all others concerned adults. Both cases pertaining to the care of minors with gliomas resulted in findings for the defense. The majority of cases centered on failure to diagnose occurring before surgery or treatment. Defendants included neurosurgeons, pathologists, radiologists, nurses and hospital systems. Although the number of cases considered here is small, jury verdicts in favor of plaintiffs resulted in far higher payouts compared with settlements.

CONCLUSIONS
Medical malpractice allegations relating to glioma treatment are shown to be rare and infrequent. The majority of cases alleged a failure to appropriately diagnose, before surgery or treatment took place. The great majority of cases reported within WestLaw Precision resulted in jury verdicts for the defense.
QLTI-16. QUALITY IMPROVEMENT PROJECT (QIPR) FOR IMPLEMENTATION OF PSYCHOSOCIAL ASSESSMENTS FOR ONCOLOGY CLINICAL CARE
Authors: Body Anjelica , Johnson Hannah , Patel Drashti , Pereira Deidre , Ghiaseddin Ashley 
Published: November 2024

Abstract

BACKGROUND
Patient-reported outcomes (PROs) have been used to assess individuals’ quality of life (QoL) throughout cancer treatment. Individuals with cancer often experience physical, psychological, and social challenges. It is crucial to evaluate their QoL to provide supportive care services to improve survival and treatment outcomes in real-world cancer clinical settings. Patients’ ability to engage with completing PROs is critical to ensuring PRO implementation efficacy. This QIPR (UF: 2216) examined these completion rates in coordinated medical-behavioral cancer care.

METHODS
Questionnaires delivered to neuro-oncology and psycho-oncology patients through the electronic health record (EHR) prior to scheduled office visits were: PROMIS – Anxiety, Depression, Pain Interference, Ability to Participate in Social Roles, and Cognitive and Physical Function. Data collection occurred from July 2023-January 2024. Descriptive statistics were calculated to assess battery completion rates. Information from the first 3 encounters following initiation of the battery into clinical practice were analyzed.

RESULTS
Of 906 scheduled encounters, 491 (54.2%) were attended by 280 unique patients. The battery was completed at least once by 106 (37.9%) patients. 72.6% (N=77) of these patients completed the battery at the first scheduled visit at which it was assigned. Of patients with 2 scheduled visits (N=25, 23.6%); 24.0% (N=6) completed the battery at both visits. Of patients that had 3 scheduled visits (N=12, 11.3%); 16.7% (N=2) completed it at all 3 visits.

CONCLUSION
Only approximately 38% of patients completed the battery at least once across 3 consecutive visits. The highest battery completion rate was at the first visit at which it was assigned. Completion rates were lower across additional visits. Future work will seek to understand barriers and facilitators of these completion rates to optimize implementation of PROs in coordinated medical-behavioral oncology care.
QLTI-21. STREAMLINING THE STUDY INTAKE PROCESS AT THE CANCER CLINICAL AND TRANSLATIONAL RESEARCH OFFICE (CCTRO)
Authors: Faddah Raid , Walbert Tobias , Snyder James , Gadgeel Shirish , Philip Philip , Lange Lisa 
Published: November 2024

Abstract
Challenges in the Protocol Intake/Activation process at the Henry Ford Cancer Center, particularly during the budget negotiation and coverage analysis (CA) phases, hamper operational efficiency and financial prospects. This study aimed to improve budget time and process efficiency. Process flow mapping, Value Stream Mapping (VSM), and cause-effect analysis using a fishbone diagram were used to identify and analyze key bottlenecks, focusing on the budget negotiation and CA phases. Budget negotiation took an average of 121.5 days in 2023 due to multiple procedures and a lack of standardized practices. Delays ranged from 127.75 days in August to a low of 69.84 days in November of 2023. The budget build process averaged 13.31 days, with an additional 7.57 days for approval, totaling 20.89 days. The CA phase had an average cycle time of 10.82 days (range 2-10 days). To improve approval times, it was recommended to implement an Electronic Document Management System to automate routing, signing, and tracking of budget and CA-related documents, standardized budget templates to streamline negotiations, a detailed electronic checklist to streamline task lists for document collection and budget negotiation, automated reminders for internal and external stakeholders to ensure timely submission of necessary documents, and timely submission policies enforced by a dedicated finance member on committees. Newly developed Key Performance Indicators (KPIs) such as ‘time to collect documents,’ ‘time between committees,’ and ‘time for budget negotiation process,’ along with a dual tracking system in Excel, were proposed to monitor and improve these metrics. The recommendations are expected to significantly enhance the efficiency of the Protocol Intake/Activation process. By reducing the budget negotiation phase to less than 60 days and optimizing the CA process, faster study initiation, better resource utilization, and improved responsiveness to research opportunities will be achieved. This study underscores the critical need to address operational challenges in clinical trial management to enhance CCTRO’s capability to conduct timely and effective research.
QLTI-22. TEMOZOLOMIDE CHEMOTHERAPY EFFECTS ON GLIOMA PATIENT FERTILITY AND THEIR OFFSPRING: A RETROSPECTIVE REVIEW
Authors: Lu Austin , Vu Mia , Schuman Eva , Ware Cornelius , Hsu Sigmund , Zhu Jay-Jiguang 
Published: November 2024

Abstract
Gliomas represent ~30% of primary brain tumors. Temozolomide (TMZ) chemotherapy with concurrent radiation or following radiation is the main course of treatment. Avoidance of pregnancy in female patients and partner of male patients is strongly encouraged due to unknown teratogenic and long-term effects to the health and development of fetus. Patients of childbearing age must wrestle with receiving TMZ treatment, potentially impacting fertility, and the desire for biological children in the future. Gamete preservation prior to TMZ induction is the current solution, which is often financially prohibitive, leaving patients to consider natural conception after completion of TMZ. We intend to identify potential difficulties in conception, pregnancy complications, birth abnormalities, and childhood developmental deficiencies that may be correlated to TMZ exposure prior to conception. Included patients conceived and delivered one or two children after completing treatment with TMZ. All patients received antiepileptic drugs (range = 1-4) which have variable known teratogenic effects during pregnancy. We identified 13 patients (7 male, 6 female; median age of 29) with diagnoses of astrocytoma (n=5), oligodendroglioma (n=5), oligoastrocytoma (n=2; diagnosed prior to 2021 WHO classification), and glioblastoma (n=1). Two reported issues with conceiving (1 male and 1 female) and 17 children were born. One child had developmental abnormalities (6%), and all other 16 children were healthy per parental assessment. Complete results of pregnancy complication and childhood development data will be updated at the meeting. Information on teratogenic and developmental effects of TMZ in humans is largely unknown. Animal studies have shown an increase in fetal malformations when exposed to TMZ during pregnancy. Despite the limitations of a retrospective study, our findings suggest that natural conception after the conclusion of TMZ treatment may be safer than suspected. Given the limited sample size, future comprehensive studies are warranted to corroborate these observations.
QOL-05. COMPARING DISEASE-SPECIFIC QUALITY-OF-LIFE OUTCOMES OF MICROSURGERY, RADIOTHERAPY, AND OBSERVATION IN VESTIBULAR SCHWANNOMA PATIENTS: A SYSTEMATIC REVIEW AND META-ANALYSIS
Authors: Salman Afia , Ghazanfar Shamas , Naeem Unaiza , Kumar Kanwal Ashok , Javaid Aaisha , Rafi Hania Mansoor , Naeem Komal , Lucky Hassan , Farhan Rida 
Published: November 2024

Abstract

BACKGROUND
Vestibular schwannoma (VS), also known as acoustic neuromas, are common tumors arising from the vestibulocochlear nerve and are located in the cerebellopontine angle. The benign tumor has a substantial impact on the patient-perceived quality of life (QoL) outcomes, which contribute to the decision regarding the ideal management plan. In this systematic review and meta-analysis, we aimed to compare the impact of microsurgery, radiotherapy, and observation on the QoL outcomes of VS patients.

METHODS
This study was conducted in accordance with the PRISMA guidelines and a total of four research databases were searched for eligible studies from inception to May 2024. The primary outcome of the study was the Penn Acoustic Neuroma Scale (PANQOL) total score and the secondary outcomes included the PANQOL subdomain scores. Data was pooled using the random-effects model and analyzed as OR (odds ratio) with 95% CI (confidence interval).

RESULTS
Compared to observation, radiotherapy was associated with superior QoL outcomes only in the face domain [MD (mean difference) = -4.59 [-7.29,-1.88]; I2= 85%; p = 0.0001], with observation being associated with superior outcomes across all others [PANQOL - total: MD = 4.94 [2.51,7.38]; I2= 85%; p = 0.0001]. Microsurgery, compared to radiotherapy, was associated with better outcomes only in the general domain [MD = -4.38 [-6.60,-2.16]; I2= 0%; p = 0.0001], with RT being associated with superior outcomes across all other domains [PANQOL - total: MD = 3.61 [1.29,5.93]; I2= 63%; p = 0.002]. Compared to microsurgery, observation was associated with superior QoL outcomes across all domains [PANQOL - total: MD = 9.22 [7.30,11.13]; I2= 64%; p = 0.0001].

CONCLUSION
The findings indicate that, broadly, observation is associated with better QoL outcomes relative to both radiotherapy and microsurgery; with radiotherapy superseding microsurgery. However, the association with QoL improvement was not uniform across all domains.
QOL-07. LONG-TERM FOLLOW-UP OF PHYSICAL FUNCTION AND SOCIAL CONDITIONS IN CENTRAL NERVOUS SYSTEM GERM CELL TUMORS
Authors: Takami Hirokazu , Nishikawa Ryo , Matsutani Masao 
Published: November 2024

Abstract

BACKGROUND
This paper presents an analysis of iving and social conditions from a long-term follow-up of Phase II clinical trial for central nervous system germ cell tumors conducted between 1995 and 2003.

METHODS
A retrospective analysis was performed on 228 cases, including 161 germinomas, 66 non-germinomas, and 1 mature teratoma, over a median follow-up of 222 months. There were 56 recurrences and 39 deaths recorded. The analysis at the final follow-up included final educational level, employment status, activities of daily living (ADLs), marital and parental status, and hormone replacement therapy. The study targeted 157 cases with more than 10 years of follow-up data.

RESULTS
At 20 years post-treatment, survival rates were 91% for germinomas and 65% for non-germinomas. At the last follow-up, ages ranged from 19 to 58 years (median 36 years). The Karnofsky Performance Status (KPS) was 80 or higher in 118 cases, 70 in 7 cases, and 60 or lower in 32 cases. Educational achievements were: elementary school in 1 case, middle school in 8, high school in 52, university in 45, and graduate school in 2. Employment status showed 37 unemployed, 4 in school, 23 part-time, 80 full-time, and 2 homemakers. Childbirth was reported in 16 men (18%) and 4 women (16%). The frequency of a KPS≧80 at the final follow-up was higher in initial germinoma cases than in non-germinoma cases (80 vs 62%, p=0.04), and was also higher in cases without recurrence (83 vs 47%, p&lt;0.0001). Only the proportion of growth hormone supplementation showed a significant correlation with KPS (≧80: 19% vs &lt;80: 3%, p=0.03).

CONCLUSION
Long-term social outcomes are favorable for germinoma patients without recurrence, while non-germinoma patients who have recurred and survived face tougher conditions, indicating significant treatment impacts. Managing treatment intensity and ensuring comprehensive long-term follow-up are crucial.
QOL-08. HEALTH-RELATED QUALITY-OF-LIFE (HRQOL) IN ADULTS AND CHILDREN WITH NEUROFIBROMATOSIS TYPE 1-ASSOCIATED PLEXIFORM NEUROFIBROMA (NF1-PN) TREATED WITH MIRDAMETINIB: PIVOTAL, PHASE 2B RENEU TRIAL
Authors: Babovic-Vuksanovic Dusica , Hirbe Angela , Moertel Christopher , Shuhaiber Hans , Sidhu Alpa , Bielamowicz Kevin , Viskochil David , Bell Timothy , Weber Michael , Langseth Abraham , Lokku Armend , Weintraub Lauren , Hajjar Fouad , Foreman Nick , Gershon Timothy , McNall-Knapp Rene 
Published: November 2024

Abstract
Patients with NF1-PN experience pain and other symptoms that negatively impact functioning and quality-of-life. We present patient- and parent proxy-reported HRQoL outcomes from ReNeu (NCT03962543), a pivotal, phase 2b trial of mirdametinib, an investigational MEK1/2 inhibitor, in adults and children (≥2 y) with NF1-PN causing morbidities. Fifty-eight adults and 56 children received mirdametinib (2 mg/m2 BID; 3-weeks-on/1-week-off, 28-d cycles). Change in HRQoL was assessed by Pediatric QoL Inventory (PedsQL) 4.0 Generic Core Scales from baseline across the 24-cycle treatment phase; change from baseline at Cycle 13 (C13) was a prespecified secondary endpoint. PedsQL is a HRQoL measure for adults and children with a Total Score (TS) and 4 subscales: physical, emotional, social, and school/work. Items are reported on a 0-100 scale (higher scores=better HRQoL). Clinically meaningful improvement was defined as change from baseline &gt;9.7 points for adults, &gt;8.5 points for child self-report, and &gt;9.0 points for parent proxy-report. PedsQL-TS improvement (least-squares mean, LSM [SE] change) from baseline at C13 was 3.9 (1.6; P=.018; n=34) for adults, 4.0 (2.4; P=.096; n=38) for children by self-report, and 5.6 (1.9; P=.005; n=43) by parent proxy-report. PedsQL-TS improvements for adults and children by parent proxy-report (not by children self-report) were observed early (at C5 and C3, respectively) and sustained through C24. Clinically meaningful improvement in PedsQL-TS from baseline at C13 was achieved by 37% (10/27) adults, 45% (13/29) children by self-report, and 47% (15/32) children by parent proxy-report (among patients who could have achieved a clinically meaningful change from baseline). Significant (P&lt;.05) improvement from baseline to C13 was reported for physical (adults, children, and parent proxy-report), school/work (adults), and emotional and social (parent proxy-report) subscales. Adults and children (by parent proxy-report) with NF1-PN had clinically meaningful, early, and sustained improvement in HRQoL over the course of mirdametinib treatment.
QOL-09. “I’VE DEFINITELY CHANGED WHO I AM”: A THEMATIC ANALYSIS OF CHALLENGES FACED BY PATIENTS WITH IDH-MUTANT GLIOMAS
Authors: Chiu Daniel , Whitman Jessica , Strander Sumita , Willis Kelcie , Temel Jennifer , Traeger Lara , Forst Deborah 
Published: November 2024

Abstract

BACKGROUND
Despite their more favorable prognosis, patients with isocitrate dehydrogenase (IDH)-mutant gliomas experience significant psychological distress across their disease trajectory. The specific drivers of distress in this population are poorly understood, and interventions to support these patients are lacking. We sought to better characterize drivers of distress and ways to enhance support for patients with IDH-mutant gliomas as they confront potentially prolonged but ultimately unpredictable survival with an incurable, progressive brain tumor.

METHODS
Eligible individuals were English-speaking adults ages 65 and younger diagnosed with an IDH-mutant glioma at a single academic medical center. We conducted semi-structured interviews (N=20) to better understand the distress patients experience as they progress along their illness trajectories. We audio-recorded and transcribed interviews and analyzed interview content using reflexive thematic analysis.

RESULTS
Distress among participating patients (female = 7/20; age &lt;40 years = 10/20) was linked to their struggles to maintain a coherent sense of identity while adapting to 1) neurocognitive changes and 2) altered life plans amidst prognostic uncertainty. Patients described feeling self-conscious and distrustful of their cognitive capacities, frequently comparing their current performance to their premorbid functioning (e.g. by checking their symptoms and indexing perceived deficits against scan results). Patients felt overwhelmed by the need to make decisions and set priorities (e.g., regarding family planning, retirement) due to the uncertain timing of their tumor’s progression and its unclear impact on their future functioning. Patients identified the transition from treatment to surveillance as a time of heightened worry, as they shifted their focus from the logistics of cancer care to the task of planning – financially, occupationally, socially – for an uncertain future.

CONCLUSION
These findings highlight the need for tailored supportive care to help patients with IDH-mutant gliomas cope with the distress caused by significant changes to identity and ongoing uncertainties regarding their future.
QOL-22. VACILLATING EMOTIONS AND SHIFTING INFORMATION PREFERENCES: A QUALITATIVE ANALYSIS OF CAREGIVER DISTRESS IN FACING A MALIGNANT GLIOMA DIAGNOSIS
Authors: Patnaik Pooja , Chiu Daniel , Whitman Jessica , Strander Sumita , Hauswirth Anna , Willis Kelcie , Temel Jennifer , Traeger Lara , Forst Deborah 
Published: November 2024

Abstract

BACKGROUND
Caregivers of patients with malignant gliomas (MG) experience considerable psychological distress as they contend with the implications of their loved one’s terminal illness. However, caregivers’ specific reactions to the patient’s diagnosis/prognosis and optimal ways to support caregivers in the months following diagnosis remain poorly understood.

METHODS
At a single academic medical center, we enrolled English-speaking adults identified by patients with newly diagnosed MG as their primary caregiver. Using a semi-structured interview guide, we conducted in-depth interviews with caregivers at the conclusion of concurrent chemoradiation exploring their experiences learning about the patient’s diagnosis and their prognostic information preferences. We used rapid qualitative analysis to analyze interview data.

RESULTS
We interviewed 7 caregivers (female: 5/7; spouse/partner: 6/7, sibling: 1/7) of MG patients (glioblastoma: 5/7). Caregivers described the time following diagnosis as tumultuous and difficult as they struggled to cope with their distress related to navigating the practical burdens of cancer treatment while also managing the emotional burden (e.g. fear, sadness) of living amidst uncertainty. Caregivers vacillated between feeling devastated by the patient’s poor prognosis and wanting to remain hopeful (e.g., by seeking out inspiring survivorship stories). Caregivers also reported varying and often evolving preferences regarding the manner, timing, and context in which they received information about the patient’s MG. Many caregivers desired more prognostic information (e.g., to facilitate planning for their future and for the patient’s eventual demise) while some chose to focus on the present (e.g., to avoid “dwelling” on potential negative outcomes), in light of inherent uncertainty about the patient’s trajectory.

CONCLUSIONS
Caregivers experience significant distress in the context of vacillating emotions and shifting information needs as they adapt to life in the aftermath of a MG diagnosis. These results highlight the need for tailored prognostic information and support for caregivers during this stressful, emotionally fraught time.
RBIO-01. CHARACTERIZING THE TEMPORAL EVOLUTION OF BRAIN ARCHITECTURE DURING RADIOTHERAPY FOR GLIOBLASTOMA USING NONLINEAR IMAGE REGISTRATION
Authors: DeWalt Nicholas , Xu Yuanguang , Wang Tony , Grinband Jack 
Published: November 2024

Abstract

BACKGROUND
Previous serial MRI studies following glioblastoma (GBM) resection reveal dynamic changes in the tumor cavity and surrounding tissue. However, the time course of these dynamics is unclear, especially in the immediate postoperative period.

METHODS
GBM patients (n=8) received three MRIs: within 72 hours post-resection, immediately preceding RT (RTstart), and at the RT midpoint (RTmid). The radiation field (RF) was based on the resection cavity (RC) and surrounding T2-FLAIR hyperintensities at the 72 hour MRI. Nonlinear image registration was performed across the two time intervals, allowing comparison between the intended radiation targets and the actual irradiated tissue. Dice coefficients (DRF and DRC), the relative volume of the RC (RCvol), and the volume of unintended iatrogenic radiation (IRvol) were measured at each timepoint, and IRvol was fitted to an exponential decay.

RESULTS
DRF showed modest reduction, with mean±SD of 0.97±0.02 at both RTstart and RTmid. In contrast, the RC showed more change, with mean DRC 0.63±0.13 and 0.60±0.12, and mean RCvol of 0.74±0.27 and 0.72±0.25 at RTstart and RTmid, respectively. DRF, DRC, and RCvol showed greater change during the first interval than the second (p=3.5x10-4, 4.1x10-4, and 0.1, respectively). The mean IRvol was 16.7±12.6 at RTstart and 21.7±12.8 at RTmid, with a time constant of -0.031 (95% CI=[-0.017, -0.060]), indicating that 80% of all voxels that receive unintended iatrogenic radiation moved into the radiation field by postoperative day 57, and 95% will have moved in by day 125.

CONCLUSIONS
Nonlinear registration demonstrated significant postoperative architectural changes, with most occurring in the first two months after surgery near the RC. This potentially suggests a role for adaptive planning during RT, particularly for protocols that focus on the RC rather than T2-FLAIR hyperintensities. Future prospective studies are needed to assess the role of adaptive radiotherapy for GBM.