Small Sample Size Research Articles

Diagnostic Strategy Using Color Doppler Ultrasound of Temporal Arteries in Patients With High Clinical Suspicion of Giant Cell Arteritis : A Prospective Cohort Study.

Giant cell arteritis (GCA) is the most prevalent systemic vasculitis in people older than 50 years. Any delay in diagnosis impairs patients' quality of life and can lead to permanent damage, particularly vision loss. To evaluate a diagnostic strategy for GCA using color Doppler ultrasound of the temporal artery as a first-line diagnostic test, temporal artery biopsy (TAB) as a secondary test, and physician expertise as the reference method. Prospective multicenter study with a 2-year follow-up. (ClinicalTrials.gov: NCT02703922). Patients were referred by their general practitioner or ophthalmologist to a physician with extensive experience in GCA diagnosis and management in one of the participating centers: 4 general and 2 university hospitals. 165 patients with high clinical suspicion of GCA, aged 79 years (IQR, 73 to 85 years). The diagnostic procedure was ultrasound, performed less than 7 days after initiation of corticosteroid therapy. Only ultrasound-negative patients underwent TAB. Bilateral temporal halo signs seen on ultrasound were considered positive. Ultrasound and TAB results were compared with physician-diagnosed GCA based on clinical findings and other imaging. Diagnosis of GCA was confirmed in 44%, 17%, and 21% of patients by ultrasound, TAB, and clinical expertise and/or other imaging tests, respectively. Their diagnosis remained unchanged at 1 month, and 2 years for those with available follow-up data. An alternative diagnosis was made in 18% of patients. The proportion of ultrasound-positive patients among patients with a clinical GCA diagnosis was 54% (95% CI, 45% to 62%). Small sample size, no blinding of ultrasound and TAB results, lack of an objective gold-standard comparator, and single diagnostic strategy. By using ultrasound of the temporal arteries as a first-line diagnostic tool in patients with high clinical suspicion of GCA, further diagnostic tests for patients with positive ultrasound were avoided. Tender "Recherche CH-CHU Poitou-Charentes 2014."

Identifying Current Barriers in Patient Educational Content Surrounding Rectal Prolapse and Rectocele: Using Animation to Bridge the Gaps.

Patient-centered educational resources surrounding rectal prolapse and rectocele can be difficult to locate and understand. Findings of video animation as patient-specific material for these conditions can help guide creation of effective educational tools for patients. To identify female patient preferences for learning about rectal prolapse and rectocele and to obtain feedback on an animation developed to aid patient education on these conditions. This was a multiple methods study. Participants received a 20-question survey about educational preferences and a 100-second video animation on rectal prolapse and rectocele. Respondents were invited for a semi-structured interview to further express their thoughts regarding health education. This study was conducted from 2022 - 2023, surveys were administered via e-mail and interviews were held virtually. Female patients in the institutional review board-approved Stanford Rectal Prolapse Registry were included. Assess and describe the ability of short video animations to supplement patient education on rectal prolapse and rectocele. 46 female participants responded and 10 were interviewed. About 97% of participants indicated the video animation explained the condition clearly, and 66% felt comfortable explaining the condition. Feedback suggested showing the animation during the first appointment and creating similar content for surgery preparation. Patient challenges while researching rectal prolapse and rectocele online included difficulty finding content (41.5%), complex language (18.8%) and uncertainty about source reliability (16.9%). Small sample size with little socioeconomic diversity and highly educated participants. Patient-centered resources surrounding specific pelvic floor disorder(s) are not always readily accessible online. This study demonstrated the value of a short video animation to enhance patients' understanding of rectal prolapse and rectocele. See Video.

Association between COVID-19 severity and tobacco smoking status: a retrospective cohort study using propensity score matching weights analysis

IntroductionThe COVID-19 pandemic continues to be a global threat to public health, with over 766 million confirmed cases and more than 6 million reported deaths. Patients with a smoking history...

Relation of Mandibular Canal Discontinuity and IAN Paresthesia in Operated Cases of Mandibular Fracture.

Mandibular fractures are common in maxillofacial trauma, often requiring surgical intervention for optimal recovery. One critical concern during such procedures is the potential for nerve damage, specifically involving the mandibular canal. This study aims to investigate whether the presence of postoperative mandibular canal discontinuity is associated with an increased risk of nerve damage. A retrospective analysis was conducted on a cohort of 72 postoperative mandibular fracture patients. In total, 58 patients had entire mandibular canal continuity, while 14 showed discontinuity. Clinical records and follow-up data were examined to assess the occurrence of nerve injury. Statistical analysis was performed to determine the significance of any correlation. Of the 14 patients with mandibular canal discontinuity, 9 (64.28%) exhibited paresthesia. In patients where mandibular canal continuity was maintained, 5 (8.62%) patients reported paresthesia. These results suggest a higher incidence of paresthesia in patients with mandibular canal discontinuity, albeit with a small sample size. Notably, only 3 patients in the discontinuity group did not show any sign of improvement, while the remaining patients in both groups demonstrated complete recovery in 6 months of follow-up period. The findings suggest a potential link between mandibular canal discontinuity and an increased risk of paresthesia in postoperative mandibular fracture patients. It is hypothesized that discontinuity may lead to nerve compression, irritation, or direct damage during healing. The observed complete recovery in most patients, including those with paresthesia, highlights the potential for the nervous system to repair itself over a period of time. However, further studies with larger sample sizes are warranted to establish a more definitive correlation. This study provides preliminary evidence that mandibular canal discontinuity may contribute to a higher incidence of paresthesia in postoperative mandibular fracture patients. Clinicians should be cautious when addressing mandibular fractures to minimize the risk of nerve damage, particularly in cases involving canal discontinuity. The encouraging trend of complete recovery among the majority of patients suggests a positive prognosis for nerve healing.

Sex-Dependent Differences in the Neural Correlates of Cocaine and Emotional Cue-Reactivity in Regular Cocaine Users and Non-Drug-Using Controls: Understanding the Role of Duration and Severity of Use.

The development of cocaine use disorder in females is suggested to be more strongly related to neural mechanisms underlying stress-reactivity, whereas in males it is suggested to be more strongly related to neural mechanisms underlying drug cue-reactivity. Existing evidence, however, is based on neuroimaging studies that either lack a control group and/or have very small sample sizes that do not allow to investigate sex differences. The main objective of the current study was to investigate sex differences in the neural correlates of cocaine and negative emotional cue-reactivity within high-risk intranasal cocaine users (CUs: 31 males and 26 females) and non-cocaine-using controls (non-CUs: 28 males and 26 females). A region of interest (ROI) analysis was applied to test for the main and interaction effects of group, sex, and stimulus type (cocaine cues vs. neutral cocaine cues and negative emotional cues vs. neutral emotional cues) on activity in the dorsal striatum, ventral striatum (VS), amygdala, and dorsal anterior cingulate cortex (dACC). There were no significant sex or group differences in cocaine cue-reactivity in any of the ROIs. Results did reveal significant emotional cue-reactivity in the amygdala and VS, but these effects were not moderated by group or sex. Exploratory analyses demonstrated that emotional cue-induced activation of the dACC and VS was negatively associated with years of regular cocaine use in female CUs, while this relationship was absent in male CUs. While speculative, the sex-specific associations between years of regular use and emotional cue-reactivity in the dACC and VS suggest that, with longer years of use, female CUs become less sensitive to aversive stimuli, including the negative consequences of cocaine use, which could account for the observed "telescoping effect" in female CUs.

The use of shear-wave elastography for the assessment of muscle spasticity in patients with cerebral palsy, a systematic review.

We explore the use of shear wave elastography (SWE) for assessing muscle stiffness and treatment response in cerebral palsy (CP) children by way of a systematic review. SWE offers real-time muscle stiffness measurements, showing significant differences between CP patients and controls. Studies suggest that SWE can be used to follow muscle stiffness post-botulinum toxin treatment, correlating with clinical improvement. However, methodological variations and small sample sizes prevent comparison between different studies. Standardized protocols could enhance SWE's clinical utility. In conclusion, SWE holds promise for CP management, though standardized methodologies and larger studies are needed to validate its efficacy and integration into clinical practice.

The learning curve in endoscopic transsphenoidal skull-base surgery: a systematic review

BackgroundThe endoscopic endonasal transsphenoidal approach (EETA) has revolutionized skull-base surgery; however, it is associated with a steep learning curve (LC), necessitating additional attention from surgeons to ensure patient safety and surgical efficacy. The current literature is constrained by the small sample sizes of studies and their observational nature. This systematic review aims to evaluate the literature and identify strengths and weaknesses related to the assessment of EETA-LC.MethodsA systematic review was conducted following the PRISMA guidelines. PubMed and Google Scholar were searched for clinical studies on EETA-LC using detailed search strategies, including pertinent keywords and Medical Subject Headings. The selection criteria included studies comparing the outcomes of skull-base surgeries involving pure EETA in the early and late stages of surgeons’ experience, studies that assessed the learning curve of at least one surgical parameter, and articles published in English.ResultsThe systematic review identified 34 studies encompassing 5,648 patients published between 2002 and 2022, focusing on the EETA learning curve. Most studies were retrospective cohort designs (88%). Various patient assortment methods were noted, including group-based and case-based analyses. Statistical analyses included descriptive and comparative methods, along with regression analyses and curve modeling techniques. Pituitary adenoma (PA) being the most studied pathology (82%). Among the evaluated variables, improvements in outcomes across variables like EC, OT, postoperative CSF leak, and GTR. Overcoming the initial EETA learning curve was associated with sustained outcome improvements, with a median estimated case requirement of 32, ranging from 9 to 120 cases. These findings underscore the complexity of EETA-LC assessment and the importance of sustained outcome improvement as a marker of proficiency.ConclusionsThe review highlights the complexity of assessing the learning curve in EETA and underscores the need for standardized reporting and prospective studies to enhance the reliability of findings and guide clinical practice effectively.

Large scale investigation of the effect of gender on mu rhythm suppression in motor imagery brain-computer interfaces

ABSTRACT The utmost issue in Motor Imagery Brain-Computer Interfaces (MI-BCI) is the BCI poor performance known as ‘BCI inefficiency’. Although past research has attempted to find a solution by investigating factors influencing users’ MI-BCI performance, the issue persists. One of the factors that has been studied in relation to MI-BCI performance is gender. Research regarding the influence of gender on a user’s ability to control MI-BCIs remains inconclusive, mainly due to the small sample size and unbalanced gender distribution in past studies. To address these issues and obtain reliable results, this study combined four MI-BCI datasets into one large dataset with 248 subjects and equal gender distribution. The datasets included EEG signals from healthy subjects from both gender groups who had executed a right- vs. left-hand motor imagery task following the Graz protocol. The analysis consisted of extracting the Mu Suppression Index from C3 and C4 electrodes and comparing the values between female and male participants. Unlike some of the previous findings which reported an advantage for female BCI users in modulating mu rhythm activity, our results did not show any significant difference between the Mu Suppression Index of both groups, indicating that gender may not be a predictive factor for BCI performance.

Beak and feather disease virus detected in the endangered Red Goshawk (Erythrotriorchis radiatus)

We report the first detection and prevalence of Beak and feather disease virus (BFDV) in Australia’s Red Goshawk (Erythrotriorchis radiatus). This is a new host for this pervasive pathogen amongst a growing list of non-psittacine species including birds of prey from the orders Accipitriformes (hawks, eagles, kites), Falconiformes (falcons and caracas), and Strigiformes (owls). The Red Goshawk is the first non-psittacine species listed as Endangered to be diagnosed with BFDV. We report an initial case of infection discovered post-mortem in a dead nestling and subsequent surveillance of birds from across northern Australia. We reveal BFDV prevalence rates in a wild raptor population for the first time, with detections in 25% (n = 7/28) of Red Goshawks sampled. Prevalence appears higher in juveniles compared to adults, although not statistically significant, but is consistent with studies of wild psittacines. BFDV genotypes were associated with the Loriinae (lorikeets, budgerigar, and fig parrots), Cacatuini (Cockatoos), and Polytelini (long-tailed parrots) tribes; species which are preyed upon by Red Goshawks. A positive BFDV status may be associated with lower body mass but small sample sizes precluded robust statistical analysis. We postulate the possible impacts of the virus on Red Goshawks and discuss future research priorities given these preliminary observations.

PSIV-A-10 Pilot study: Acute changes in mare milk composition in response to concentrate feeding

Abstract Evaluating dietary effects on mare milk composition is important for optimizing nutrition programs for broodmares. Additionally, accurately measuring milk composition is important for many research studies. Different techniques have been used to collect milk samples, however, the effect time of collection after feeding has not been investigated. The objective of this study was to evaluate the short-term changes in mare milk composition after a concentrate meal. We hypothesized that milk composition, specifically lactose, follows a similar pattern as blood glucose after a high starch meal. Milk samples were collected from four mares at 6 to 7 d postpartum. Baseline blood samples and milk samples were collected, then mares were fed a concentrate meal containing 0.697 g starch/kg body weight (BW). Blood samples were collected via jugular venipuncture at 60, 120, 240, 360, and 480 min postprandial. Blood glucose was measured using a glucometer (OneTouch Ultra 2, LifeScan, USA). Milk samples were collected every 60 min for 480 min postprandial. Foals were muzzled for 60 min intervals and allowed to nurse at each time point to induce milk ejection. Milk samples (> 50 mL) were collected by hand while foals nursed. Milk lactose was measured using an infrared-based milk analyzer (MilkoScan FT+, Foss, Denmark). Area under the curve for lactose and glucose were calculated using the trapezoid method. Changes over time in milk lactose and blood glucose were evaluated using mixed model ANOVA with repeated measures. Pearson’s correlation coefficient was used to evaluate relationships between variables (SAS 9.4). Results were considered significant when P < 0.05. There was a change over time in milk lactose after the concentrate meal (P < 0.0001). Milk lactose was the least pre-feeding (59.0 ± 0.50 g/L) and greatest between 240 to 360 min postprandial (61.6 ± 0.47 g/L; P < 0.05). Blood glucose changed over time after the concentrate meal (P = 0.0365). Pre-feeding glucose was 88.25 ± 2.10 mg/dL which increased to 126.75 ± 10.82 mg/dL by 60 min postprandial (P < 0.05). By 240 min blood glucose was similar to pre-feeding (91.25 ± 6.90 mg/dL; P >0.05). Mean blood glucose AUC was 663 and mean milk lactose AUC was 834. Time to peak glucose was 82.5 min whereas time to peak milk lactose was 225 min. There was no relationship between peak blood glucose and peak milk lactose (P = 0.7311) or AUC for blood glucose or milk lactose (P = 0.8256). The lack of significant relationships may be due to the small sample size. The results from this pilot study demonstrated short term changes in milk lactose after a concentrate meal. Collecting milk samples between 240 to 360 min may be suitable to evaluate dietary effects on milk lactose. However, additional research is needed to evaluate other milk components.

Preliminary study of proton magnetic resonance spectroscopy to assess bone marrow adiposity in the third metacarpus or metatarsus in Thoroughbred racehorses.

Magnetic resonance spectroscopy (MRS) has been used to investigate metabolic changes within human bone. It may be possible to use MRS to investigate bone metabolism and fracture risk in the distal third metacarpal/tarsal bone (MC/MTIII) in racehorses. To determine the feasibility of using MRS as a quantitative imaging technique in equine bone by using the 1H spectra for the MC/MTIII to calculate fat content (FC). Observational cross-sectional study. Limbs from Thoroughbred racehorses were collected from horses that died or were subjected to euthanasia on racecourses. Each limb underwent magnetic resonance imaging (MRI) at 3 T followed by single-voxel MRS at three regions of interest (ROI) within MC/MTIII (lateral condyle, medial condyle, proximal bone marrow [PBM]). Percentage FC was calculated at each ROI. Each limb underwent computed tomography (CT) and bone mineral density (BMD) was calculated for the same ROIs. All MR and CT images were graded for sclerosis. Histology slides were graded for sclerosis and proximal marrow space was calculated. Pearson or Spearman correlations were used to assess the relationship between BMD, FC and marrow space. Kruskal-Wallis tests were used to check for differences between sclerosis groups for BMD or FC. Eighteen limbs from 10 horses were included. A negative correlation was identified for mean BMD and FC for the lateral condyle (correlation coefficient = -0.60, p = 0.01) and PBM (correlation coefficient = -0.5, p = 0.04). There was a significant difference between median BMD for different sclerosis grades in the condyles on both MRI and CT. A significant difference in FC was identified between sclerosis groups in the lateral condyle on MRI and CT. Small sample size. 1H Proton MRS is feasible in the equine MC/MTIII. Further work is required to evaluate the use of this technique to predict fracture risk in racehorses.

Primary school teachers' classroom‐based e‐assessment practices: Insights from the theory of planned behaviour

AbstractThere is a global trend in the increased adoption of e‐assessment in school classrooms to enhance learning. Teachers, as classroom‐based assessment designers and implementers, play a vital role in such assessment change. However, little is known about school teachers' classroom‐based e‐assessment practices and the underlying reasons. To address this research gap, this study identified the factors influencing Hong Kong primary school teachers' e‐assessment practices underpinned by the theory of planned behaviour (TPB). A large‐scale survey was issued to 878 teachers via Qualtrics. Structural equation modelling (SEM) analysis shows that primary school teachers' intentions of using e‐assessment and perceived behavioural control of it were the two strongest factors predicting their e‐assessment practices in a general way. Specifically, teachers' intentions outweighed perceived behavioural control in determining their use of alternative e‐assessment tasks and e‐feedback, but this reversed for e‐tests/exercises. The impact of perceived behavioural control was consistent across the three types of e‐assessment practices. Furthermore, teachers' attitudes significantly influenced their intentions to use alternative e‐assessment tasks, while subject norms primarily predicted their intentions to use e‐feedback. The findings have implications for primary schools to take countermeasures to facilitate the successful implementation of e‐assessment at the classroom level.Practitioner notesWhat is already known about this topic E‐assessment has the potential to influence learning. E‐assessment has often been used in a controlled environment with a relatively small sample size. The past 3 years have seen a surge in discussions and research around using e‐assessment in classroom settings, mostly in higher education. What this paper adds Primary school teachers used more e‐tests or exercises than alternative e‐assessment tasks and e‐feedback in their daily teaching. Teachers' intentions outweighed perceived behavioural control in determining their use of alternative e‐assessment tasks and e‐feedback, but this reversed for e‐tests/exercises. Teachers' attitudes significantly influenced their intentions to use alternative e‐assessment tasks, while subject norms primarily predicted their intentions to use e‐feedback. Implications for practice and/or policy Teachers' intentions of using alternative e‐assessment and e‐feedback should be increased to enhance their usage in the classroom. Teachers' e‐assessment literacy should be developed to enable them to integrate e‐assessment into their daily instruction.

Nerve transfer for upper extremity reanimation in people with spinal cord injury: A 2-year follow-up case series

Objective To describe the 2-year functional outcomes of nerve transfer (NT) for upper extremity reanimation. Study Design A prospective case series. Setting A highly specialized rehabilitation hospital for spinal cord injury (SCI) in Italy. Intervention Upper limb nerve transfer (32 NTs, 15 upper limbs). Participants Twelve male individuals with traumatic SCI (AIS A or B, neurological level from C4 to C7) were enrolled; 24-month follow-up data were available for 11. Outcome measures We evaluated the strength recovery of recipient muscles through the Medical Research Council (MRC) Scale for Muscle Strength. Upper limb function and independence were assessed with the Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP) test version 1 and the Spinal Cord Independent Measure III (SCIM III). Patient satisfaction was also evaluated. Results After 24 months, median MRC scores (range) were: triceps 2 (1–2); extensor digitorum communis 3 (1–4); extensor pollicis longus 2.5 (1–4); flexor digitorum profundus 2 (0–4); flexor pollicis longus 2 (0–4). No complication occurred. GRASSP prehension ability and prehension performance total scores significantly improved at 24 months from 1 (0–4) to 2 (0–7) and from 1 (0–8) to 5 (0–-22), respectively. The SCIM III self-care sub-scale score improved at 24-month follow-up (p = 0.009). This study has important limitations, including a limited generalizability of the results and a small sample size that does not allow definitive conclusions to be drawn. A large multicenter prospective study is needed to confirm our findings. Conclusions NT represents a functional surgery option with few complications for the resuscitation of upper limbs in persons with tetraplegia.

Evaluation of a Pilot Wellness Elective for Master of Public Health Students during the COVID-19 Pandemic

Background: Graduate student wellbeing is a public health issue in the United States. The COVID-19 outbreak exacerbated the mental health burden on graduate students worldwide. Culture of Wellness (PH 104) is a 2-week wellbeing elective course that teaches evidence-based wellbeing strategies for graduate students at a university in the United States. Our study aimed to evaluate the impact of this pilot wellbeing elective on Master of Public Health students’ mental health and wellness during the COVID-19 pandemic. Methods: Participants included 22 Master of Public Health students from the class of 2021 at a university in the United States. We provided a pre-course survey to students that assessed their perception of their own personal wellbeing, their knowledge about various wellbeing strategies, and their confidence in applying 13 wellbeing strategies before taking the course. Post-course students completed the same survey following course completion, as well as a matching evaluation and a five-month follow up survey. Results: Of the 13 strategies taught, students reported significant improvements in their ability to apply 10 strategies. There was a significant increase in self-reported emotional and physical wellbeing, as well as a significant decrease in burnout. Five months post-course, more than three quarters of respondents used strategies taught in the course on a weekly basis or more. Limitations: This pilot study is limited by its small sample size, which may restrict the generalizability of the findings. Conclusions: The PH 104 Culture of Wellness course was effective in improving graduate students’ wellbeing and confidence in applying wellbeing strategies

Efficacy of montelukast for adenoid hypertrophy in paediatrics: A systematic review and meta-analysis.

Leukotrienes play a significant role in the pathogenesis of adenoid hypertrophy (A.H.). Therefore, we aimed to analyse the role of montelukast, a leukotriene receptor antagonist, alone or in combination with mometasone, a potent local intranasal steroid, for the treatment of A.H. Participants were children with A.H. were treated with montelukast alone or montelukast and mometasone furoate. The main outcome measures were effect of montelukast on clinical symptoms of A.H. A literature review was conducted using online search engines, Cochrane Library, PubMed, Web of Science and Scopus, for randomized clinical trials assessing children with A.H. treated with montelukast alone or montelukast and mometasone furoate. Seven randomized clinical trials (RCTs) were included with 742 children. Our study reveals that montelukast alone or in combination with intranasal mometasone furoate significantly improves clinical symptoms of adenoid hypertrophy such as snoring, sleeping disturbance, mouth breathing and A/N ratio. Montelukast was superior to placebo in decreasing snoring (SMD = -1.00, 95% CI [-1.52, -0.49]), sleep discomfort (SMD = -1.26, 95% CI [-1.60, -0.93]), A/N ratio (MD = -0.11, 95% CI [-0.14, -0.09]) and mouth breathing (SMD = -1.36, 95% CI [-1.70, -1.02]). No difference was detected between montelukast and mometasone versus mometasone alone in snoring (SMD = -0.21, 95%CI [-0.69, 0.27]); however, the combination group was superior to the mometasone alone in mouth breathing (SMD = -0.46, 95% CI [-0.73, -0.19]). The limitation of studies included a small sample size, with an overall low to medium quality. Thus, further larger, higher-quality RCTs are recommended to provide more substantial evidence.

Efficacy of Interventions to Improve Cognitive Function in Adults with Spinal Cord Injury: A Systematic Review.

Cognitive impairment is a common complication following spinal cord injury (SCI) and imposes a significant negative impact on adjustment, functional independence, physical and mental health, and quality of life. It is unclear whether interventions for cognitive impairment following SCI are effective. A systematic review of controlled trials was performed to evaluate the effect of interventions on cognitive functions in adults with SCI using search engines: Embase, The Cochrane Library, MEDLINE, Scopus, CINAHL, and Web of Science up to December 2023. Two reviewers independently screened the articles, and study findings were synthesized and summarized. The risk of bias was evaluated using the Cochrane Risk of Bias 2.0 tool. Eight moderate-quality studies were found that investigated the effects of physical exercise/activity-based therapy plus cognitive training or intermittent hypoxia, diet modification and dietary supplements, tibial nerve or cortical stimulation, and drug therapy on cognitive function in SCI. Physical exercise/activity-based therapy plus cognitive training showed most promise for improving cognitive functions, while drug therapy, diet modification, and dietary supplements showed potential for improving cognitive function. However, about half of the participants experienced heightened instability in blood pressure following the administration of midodrine, and one participant reported gastrointestinal side effects after taking omega-3 fatty acids. There was no evidence of improvement in cognitive function for stimulation techniques. The current review highlights the scarcity of research investigating the effectiveness of interventions that target cognitive function after SCI. Further, the effects of these eight studies are uncertain due to concerns about the quality of designs and small sample sizes utilized in the trials, as well as the employment of insensitive neurocognitive tests when applied to adults with SCI. This review highlights a significant gap in knowledge related to SCI cognitive rehabilitation.

Abstract PO3-10-02: Cardiovascular Risk Factors and Outcomes in Native Americans who have Received Chemotherapy and/or Radiation: A Retrospective Single-center Study

Abstract Introduction: There is scarce literature regarding cardiovascular risk factors and cardiovascular outcomes in Native American patients with breast cancer. Cardiovascular complications are known to be associated with cancer treatment. Certain medications, such as anthracyclines and HER-2 agents are directly cardiotoxic, while other modalities of treatment may lead to accelerated atherosclerosis. We have conducted a single-center retrospective study assessing cardiovascular risk factors and outcomes in Native American patients with breast cancer. Methods: Data was extracted from the UNM Comprehensive Cancer Center tumor registry and PowerChart. Charts were selected based on if the patient was registered as a Native American with a breast cancer diagnosis from 2010-2020. Inclusion criteria were age 18 or older, identified as Native American, received a diagnosis of breast cancer between 2010-2020, received at least one chemotherapeutic agent, endocrine therapy, or radiation therapy. Results: The study included 89 participants. The median age at the time of diagnosis of breast cancer was 55 years. All were female. Cardiovascular risk factors prior to undergoing treatment were reported as follows: Hypertension (55.3%); diabetes (46.1%); hyperlipidemia (35.3%); smoking (25%); obesity (52.6%). Before initiating treatment, 3.5% of Native American breast cancer patients in our study population had coronary artery disease. Cardiovascular disease incidence before and after undergoing treatment was as follows: myocardial infarction (1.2% vs 2.4%), stroke (4.7% vs 1.2%), heart failure with reduced ejection fraction (HFrEF) (2.3% vs 4.8%), heart failure with preserved ejection fraction (HFpEF) (1.2% vs 1.2%), peripheral arterial disease (1.2% vs 1.2%), atrial fibrillation or another arrhythmia (4.7% vs 5.9%). We also noted new diagnoses of hypertension and arrhythmia in 3.6% and 1.2% of our study patient population respectively after starting chemotherapy. 43% of all included patients had a transthoracic echocardiogram (TTE) or multigated acquisition scan (MUGA) recorded in the chart before chemotherapy and 45% had one afterward. Of those, when comparing ejection fraction between pre- and post-chemotherapy, a change in mean EF (61.9% vs 57.8%) was seen. 37 patients (41.6%) received treatment with an anthracycline or a Her-2 agent. Mean EF prior to treatment was 65.0%, and mean EF after treatment was 59.1%. Pre- and post-treatment rates of HFrEF were 0% and 5.7%, respectively. Discussion: Hypertension, diabetes, hyperlipidemia, smoking, and obesity are highly prevalent in the Native American patient population who are treated for a diagnosis of breast cancer. Our study showed a change in mean EF after treatment (61.9% vs. 57.8%) in our Native American breast cancer patient population. For those receiving an anthracycline or Her-2 agent, EF changed from 65.0% to 59.1% after treatment. High rates of HFrEF, new onset hypertension, and arrhythmias post-treatment were also noted. These findings suggest that a thorough cardiovascular risk assessment prior to starting a treatment regimen for breast cancer may be important. Multidisciplinary management with cardiology may be critical in the care for these patients. Further investigation of cardiovascular risk factors and outcomes after cancer treatment is warranted in this population. There are several limitations of our study, one being that this was a single-center study which does not represent the Native American population throughout the United States and Canada. The small sample size also limits the power of the study. Many patients after initial evaluation at our facility received care at outside facilities, which limits data on treatments received, studies performed (e.g. TTE and MUGA), or cardiovascular events. Citation Format: Conor Kirby, Jewel Meyer-Hagen, Paul Andre, Umair Khan, Nicholas Harris, Eduardo Davila, Mark Garcia, Jacklyn Nemunaitis. Cardiovascular Risk Factors and Outcomes in Native Americans who have Received Chemotherapy and/or Radiation: A Retrospective Single-center Study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-10-02.

Abstract PO5-01-02: A retrospective review of pathological complete response and toxicity rates to a modified version of TCHP (Paclitaxel, Trastuzumab, Pertuzumab, Carboplatin) for HER2 positive breast cancer stage II and III

Abstract Background In 2018 the TRAIN-2 clinical trial demonstrated that in stage II–III HER2-positive breast cancer, the use of a neoadjuvant non-anthracycline chemotherapy regimen of 9 cycles of TCHP [paclitaxel and carboplatin (AUC 6 mg/mL/min) with trastuzumab and pertuzumab resulted in lower toxicity and comparable pathological complete responses to an anthracycline based regimen. A pathological complete response was recorded in 141 (67%) of 212 patients in the anthracycline group and in 140 (68%) of 206 in the non-anthracycline group. Our primary aim was to identify rates of pathological complete response and rates of toxicity with a less intensive regimen of 6 cycles of TCHP where carboplatin was dose adjusted to AUC5. Methods In this single center cohort study, we reviewed patients with stage II-III Her2-positive breast cancer who received a modified chemotherapy regimen of 6 cycles of neoadjuvant paclitaxel (80 mg/m2 days 1 and 8) and reduced dose of carboplatin (AUC= 5 mg/mL/min) with trastuzumab (6 mg/kg; loading dose 8 mg/kg) and pertuzumab (420 mg intravenously; loading dose 840 mg) every 3 weeks from 2021- June 2023. Clinicopathologic data, the number and length of treatment delays, treatment related toxicities of all grades, and pCR rate were extracted from the electronic medical record. Results 32 patients were included in the analysis. The median age of the cohort was 51 years (30-65). No patient had a BRCA mutation. 20 (62.5%) had T1-2 disease and 12 (37.5%) had T3-4 disease. 14(43.75%) patients had N0 disease and 20 (62.5%) had N1-3 disease. ECOG Performance status was 0, 1 and 2 in 26 patients (81.25%), 4 (12.5%) patients and 2(6.25%) patients respectively. At the time of analysis, 2 patients (6.25%) were continuing active treatment, while 30 (93.75%) had completed planned neoadjuvant therapy and underwent surgery. Of patients who completed planned neoadjuvant therapy, 6 patients (18.75%) had 1 or more hospitalisations due to toxicity. 10 patients (31.25%) required dose reductions and 3(9.38%) had early treatment discontinuation. Rates of adverse events will be presented. pCR rate was 60 % (N=18/30). 19 (63%) of 30 patients underwent mastectomy and 11 (36.7%) underwent breast-conserving surgery. Updated analysis will be included at time of presentation. Conclusion In this single-center retrospective study of patients receiving a modified version of TCHP we found a 60% pCR rate. The rate of dose reductions and treatment discontinuations appears favorable with use of this modified regimen. This was in a heterogeneous population of patients treated in routine clinical practice where there was a high rate of patients with locally advanced disease. Limitations of our study include immaturity of data and small sample size; however, these data warrant further exploration through longer-term follow-up and multi-center validation. Citation Format: Carolyn Moloney, Maggie Louise O'Connor, Caroline O'Leary, Aislinn Reilly, Simon Barry, David O'Reilly, Philip Bredin, Hadia Paryani, David Solaligue, Bryan Hennessy, Megan Greally, Patrick G. Morris. A retrospective review of pathological complete response and toxicity rates to a modified version of TCHP (Paclitaxel, Trastuzumab, Pertuzumab, Carboplatin) for HER2 positive breast cancer stage II and III [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-01-02.

Abstract PO2-09-05: Building genomic and transcriptomic data among African American and Black patients with triple-negative inflammatory breast cancer

Abstract Background: Inflammatory breast cancer (IBC) is an aggressive breast cancer associated with poor response and early metastases. It represents a health disparity, with higher incidence and worse outcomes in Black compared to White patients. Further, IBC is enriched for the more aggressive triple-negative receptor subtype, TN-IBC, and this subtype is more prevalent among Black IBC patients. It is critical to identify genetic and molecular features that may guide better treatments for these aggressive cancers across races, and thus imperative to identify and increase racial representation among bioinformatics datasets. We previously performed comprehensive genomic and transcriptomic analyses for TN-IBC patient samples and here examine the differences among self-identified African American or Black (AA/B) and other races among IBC patients. Methods: As previously described, we collected matched blood and baseline tumor samples before treatment from 19 patients with primary TN-IBC. We performed whole exome and RNA sequencing (RNA-Seq) on these samples and compared mutations and differentially expressed genes (DEGs). Results were compared between 3 AA/B patient tissues vs the remaining 16 (Other) cases. Results: Mutations shared by all AA/B patients included amplification of the five most commonly mutated hallmark genes in the complete cohort, ARNT, BCL9, DDR2, FCGR2B and LMNA (all 100% in AA/B patients versus all 50% in the Other cohort). All AA/B patients had a Notch1 mutation (two deletions and one missense mutation, 100% AA/B vs 6% Other (one deletion)). Comparing differentially expressed genes and gene set enrichment analyses of the Broad molecular signatures database (MSigDB) demonstrates the majority of DEGs are downregulated in these AA/B patients. Six of the top 20 downregulated gene sets from the MSigDB C2 group relate to breast cancer subtype and among this TNIBC cohort AA/B tumor expression was downregulated for luminal and normal subtype related genes in multiple gene sets and enriched in the Lien metaplastic related genes. In the MSigDB C5 sets, over half of the top 20 enriched gene ontology sets among AA/B patients related to chromosomes, chromatin, spindle assembly or histone binding, while 16 of the top 20 downregulated enriched sets related to immune function. Multiple KEGG pathways enriched in AA/B cases related to RNA processing and expression and DNA replication and repair. Lastly, hallmark gene sets enriched in AA/B patients were cell cycle related, and targets of Myc, Hedgehog, B-catenin, TGFb, and TNFa via NFKb, while top significantly downregulated sets related to metabolism and immune response. Conclusion: While findings from a small sample size can only be considered hypothesis generating, some patterns emerge from the data among this rare cohort of AA/B TN IBC patients. These tumors appear to be devoid of luminal signals, characterized by cell cycle and chromatin remodeling signals, enriched for signaling typical of stem cell self-renewal, and perhaps more immune-deprived than other TN-IBC. Additional work to build racially diverse IBC transcriptomic data are needed to develop strategies to understand and improve outcomes for these patients. Citation Format: Wencai Ma, Li Zhao, Gayathri Devi, Savitri Krishnamurthy, Larry Coffer, Angela Alexander, Megumi Kai, Xiaoping Wang, Huong Le-Petross, Miral Patel, Bisrat Debeb, Chandra Bartholomeusz, Jianhua Zhang, Xingzhi Song, Andrew Futreal, Naoto Ueno, Rachel Layman, Anthony Lucci, Jing Wang, Wendy Woodward. Building genomic and transcriptomic data among African American and Black patients with triple-negative inflammatory breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-09-05.

Abstract PO5-06-03: Impact of curative-intent treatment on survival for metastatic breast cancer limited to distant lymph nodes

Abstract BACKGROUND: Metastatic breast cancer limited to distant lymph nodes is classified as stage IV but potentially represents an anatomically distinct entity amenable to curative treatment. Its optimal management is unclear, with existing studies limited by small sample sizes and short follow-up durations. We sought to investigate the impact of curative-intent treatment on breast cancer-specific survival (BCSS) and overall survival (OS) for patients with this diagnosis. METHODS: Three cohorts of patients diagnosed with breast cancer from 2010 to 2019 were identified from the Surveillance, Epidemiology, and End Results 17 registries database. The curative cohort consisted of patients with metastatic breast cancer involving only distant lymph nodes who received a combination of chemotherapy, surgery to the primary site, and radiotherapy (curative-intent treatment). The palliative cohort included patients who underwent chemotherapy but not curative-intent treatment. The N3c cohort was comprised of patients with ipsilateral supraclavicular lymph node metastases but no distant metastases who received curative-intent treatment. Weighting based on covariate balancing propensity scores was performed to balance age, sex, race, median household income, year of diagnosis, T stage, histology, pathological grade, and ER/PR/HER2 status between the cohorts. Weight-adjusted multivariable Cox regression models with the same covariates were then used to compare the BCSS and OS of the three cohorts. RESULTS: A total of 2,089 patients with a median follow-up of 37 months were eligible for analysis, of whom 577 (27.6%) were in the curative cohort, 905 (43.3%) were in the palliative cohort, and 607 (29.1%) were in the N3c cohort. After propensity score weighting, the maximal standardized mean difference for all covariates was less than 0.1. Five-year BCSS for patients in the weight-adjusted curative, palliative, and N3c cohorts were 63.0% (95% CI 58.1-68.3), 46.7% (42.4-51.4), and 66.4% (61.4-71.8), respectively; and five-year OS were 57.9% (53.0-63.2), 41.2% (37.2-45.7), and 62.2% (57.3-67.6), respectively. Compared to the palliative cohort, the curative cohort exhibited better BCSS (HR 0.47, 95% CI 0.38-0.57; P< 0.001) and OS (HR 0.48, 95% CI 0.40-0.58; P< 0.001). In contrast, the N3c cohort had similar BCSS (HR 0.93, 95% CI 0.73-1.17; P=0.53) and OS (HR 0.96, 95% CI 0.77-1.19; P=0.68) to the curative cohort. CONCLUSIONS: Patients treated curatively for metastatic breast cancer limited to distant lymph nodes had higher BCSS and OS than those receiving palliative chemotherapy and similar BCSS and OS to patients receiving curative-intent treatment for ipsilateral supraclavicular lymph node metastases. These results support the use of aggressive multimodal therapy for select stage IV breast cancer patients with only distant nodal metastases and, if confirmed, suggest that a substantial portion of such patients may be undertreated. Citation Format: Yang Xu. Impact of curative-intent treatment on survival for metastatic breast cancer limited to distant lymph nodes [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-06-03.