Laboratory-based Measures Research Articles

A sound insulation prediction tool and LCA: A comparative study considering different wooden assemblies

This paper aims to develop an acoustic design methodology for CLT floor assemblies using artificial neural networks approach by integration of life cycle assessment (LCA). 72 Lab-based measurements are used to develop the acoustic prediction tool. They are related to 29 different CLT-based floor assemblies. The weighted sound reduction index (Rw), and the weighted normalized impact sound pressure level (Ln,w) are estimated with an accuracy of 2 dB. Then a LCA study is conducted on assemblies that are used to test the network model. The acoustic performance and their environmental impacts are compared to highlight trends that may guide decision-makers in the design phase. This paper initially found that CLT-based floor assemblies generally increase the environmental impacts to achieve better acoustic insulation. However, a good sound attenuation can be reached by selecting suitable acoustic solutions.

Prospective memory functions in traumatic brain injury: The role of neuropsychological deficits, metamemory and impaired self-awareness.

A large body of evidence suggests that individuals with traumatic brain injury (TBI) have significant difficulties with prospective memory (PM), the memory for future intentions. However, the processes underlying this cognitive deficit remain unclear. This study aimed to gather further evidence regarding PM functions in TBI and clarify the role of neuropsychological deficits, metamemory, and mood disorders. We used a laboratory-based clinical measure, the Virtual Week, to examine PM function in 18 patients with TBI and 18 healthy control subjects. Measures of attention, processing speed, executive functions, episodic memory, and self-report questionnaires were also administered. In line with prior literature, our findings indicate that individuals with TBI had a consistent deficit compared to controls across all PM tasks. In previous studies, TBI patients had more severe impairment on time-based tasks; nevertheless, our results show that across all participants event-based tasks were easier to perform compared to time-based only when the retrospective memory demand was high. The patients were not only impaired on the prospective component of PM but also failed to recognise the content of their task (the retrospective component). Interestingly, the TBI group did not report higher levels of everyday memory problems, anxiety and depression compared to the control group. These measures also failed to correlate with PM and recognition memory performance. This study found that besides the neuropsychological deficits, a global impairment in PM functioning is present in individuals with TBI across various task types, tasks low and high in retrospective demands, and event versus time-based.

Autonomic assessment at the intersection of psychosocial and gastrointestinal health.

Wearable technology is increasingly used in clinical practice and research to monitor functional gastrointestinal symptoms and mental health. This article explores the potential of wearable sensors to enhance the understanding of the autonomic nervous system (ANS), particularly its role in linking psychological and gastrointestinal function. The ANS, facilitates brain-gut communication and is responsive to psychosocial conditions. It is implicated in disorders related to psychological stress and gut-brain interaction. Wearable technology enables tracking of the ANS in daily life, offering complementary and alternative methods from traditional lab-based measures. This review places focus on autonomic metrics such as respiratory sinus arrhythmia, vagal efficiency, and electrodermal activity as well as self-reports of autonomic symptoms. Potential applications include use of wearable sensors for tracking autonomic activity in disorder of gut-brain interaction such as cyclic vomiting syndrome, in which ANS dysregulation may be triggered by psychosocial factors. Considerations for data interpretation and contextualization are addressed, acknowledging challenges such as situational confounders of ANS activity and accuracy of wearable devices.

Laboratory-based measures of executive function and daily living skills in young children with Down syndrome: informing future interventions.

Adaptive behaviour refers to the practical skills necessary for independence and is considered a high-priority intervention target for children with neurogenetic conditions associated with intellectual disability, like Down syndrome (DS). Daily living skills (DLS) are a critical aspect of adaptive behaviour, but they have received little intervention attention, possibly because they involve a wide variety of skills across many settings. The present study aimed to advance DLS intervention science by examining the concurrent and longitudinal association between DLS performances and a cognitive skillset hypothesised to support DLS skill acquisition, executive function (EF). Participants were 71 children with DS between the ages of 2.5 and 8.7years (M=5.23years; standard deviation=1.65) who completed a battery of adapted EF tasks and a primary caregiver who completed the Vineland Adaptive Behavior Scales 3rd Edition Parent/Caregiver Comprehensive Report Form. A subset of caregivers also provided 6- and 12-month follow-up adaptive behaviour information. Results demonstrated a positive association between EF task performance and DLS standard scores and v-scores both concurrently and longitudinally. The findings have implications for potential future intervention approaches that aim to strengthen DLS performances by advancing EF skills in this population.

Interoceptive attention and mood in daily life: an experience-sampling study.

Theories of emotion ascribe a fundamental role to the processing of bodily signals (interoception) in emotional experience. Despite evidence consistent with this, current knowledge is limited by a focus on interoceptive accuracy and laboratory-based interoception measures. This experience-sampling study examines how state interoceptive attention and state emotional experience are related in everyday life, providing the first data to our knowledge examining: (1) within-subject fluctuations in interoceptive attention across domains, and (2) the relationship between trait and state interoception. Compared with rates of exteroceptive attention (auditory attention: engaged 83% of the time), interoceptive signals captured attention approximately 20% of the time, with substantial within- and between-person variability across domains. There were relationships between interoceptive attention and emotion in daily life (greater attention being associated with more negative valence and fatigue) that were specific to interoceptive attention (different patterns were observed with exteroceptive attention). State measures of interoceptive (but not exteroceptive) attention were correlated with the trait interoceptive attention, but not accuracy. Results underscore the relationship between interoceptive attention and emotion, providing new insights into interoceptive attention and the structure of interoceptive ability. Future research should examine the source(s) of within- and between-person variability in interoceptive and exteroceptive attention and its relationship with emotional experience. This article is part of the theme issue 'Sensing and feeling: an integrative approach to sensory processing and emotional experience'.

Measurement ofenergy availability in highly trained male endurance athletes and examination of its associations with bone health and endocrine function.

Despite the introduction of Relative Energy Deficiency in Sport (RED-s) in 2014, there is evidence to suggest that male endurance athletes still present with a high prevalence of low energy availability (LEA). Previous findings suggest that energy availability (EA) status is strongly correlated with impairments in endocrine function such as reduced leptin, triiodothyronine (T3), and insulin, and elevated bone loss. This study aimed to report the current EA status, endocrine function and bone health of highly trained Irish male endurance athletes. In this cross-sectional study, participants (n = 3 triathletes; n = 10 runners) completed a 7-day testing period during the competition season using lab-based measures, to ascertain EA status, hormone level and rates of bone metabolism. Serum blood samples were obtained to assess hormone levels and markers of bone metabolism. Mean EA was < 30kcal/kg lean body mass (LBM)/day in 76.9% of athletes. There was a strong association between LEA and low carbohydrate intake, and lower LBM. Mean levels of insulin, IGF-1 and leptin were significantly lower than their reference ranges. Elevated mean concentrations of β-CTX and a mean P1NP: β-CTX ratio < 100, indicated a state of bone resorption. The EA level, carbohydrate intake, hormone status and bone metabolism status of highly trained male endurance athletes are a concern. Based on the findings of this study, more frequent assessment of EA across a season is recommended to monitor the status of male endurance athletes, in conjunction with nutritional education specific to EA and the associated risks.

Nutritional parameters following first episode of pediatric acute pancreatitis

Acute pancreatitis (AP) carries the risk of subsequent nutritional deficiencies. The prevalence of these deficiencies following a single episode of AP in children is unknown. We aimed to determine prevalence of anthropometric and laboratory-based measures of nutritional status in children following their first (index) admission for AP. Prospective observational cohort study of patients ≤21 years of age with first episode of confirmed AP. Anthropometric and laboratory values were obtained at time of AP onset and at follow up time points of 3 and 12 months (m) post AP. AP attack was classified as either: mild, moderately severe or severe (which were combined in one group (SAP)). 181 patients met criteria and were followed prospectively with 52% male, a median age of 13.7 years (IQR 9.4-16.0) and median Body Mass Index (BMI) Z-score of 0.6 (IQR -0.5, 1.6). Most patients had mild AP (140, 77%), with 23% meeting criteria for moderate or severe (41/181). 6 (3%) had diabetes mellitus (DM) predating AP and were excluded from further analysis. BMI Z-score remained stable during the follow up period. 13% of patients developed pre-DM or DM at 3m or 12m. Nearly one third of patients had low ferritin at 3m (29%) or 12m (29%). At 12m, 8% of patients had Vitamin A deficiency. 6% of patients had low Vitamin E levels at 3m and 5% at 12m. Over half of patients at both 3m and 12m had 25 OH Vitamin D insufficiency or deficiency (56% and 56%). Prolonged International Normalized Ratio (INR) (>1.3) was seen in 9% of patients at 12m. Very low albumin (<3.5g/dL) was found in 24% of patients at 3m and 18% at 12m (Table1). Patients with very low albumin at 3m were younger (median 10.7 vs. 14.2 years, p=0.04), however sex, BMI Z-score and AP severity were not associated with albumin level. Although BMI Z-score did not differ between the groups, those with SAP had a significant decrease in BMI Z-score from first attack compared to mild AP at 3m (-0.4 vs. 0.0, p=0.0002, Figure2). At 3m, Vitamin E deficiency in SAP versus mild AP was found in 20% vs 2% (p=0.04) and SAP had a lower median hematocrit (35.8 vs. 37.6, p=0.046). There were no other laboratory significant differences at 3m in mild versus SAP groups. At 12m, those with SAP were more likely to have pre-DM or DM compared to mild AP (31% vs. 7%, p=0.002). No other significant laboratory differences occurred at 12m. After the first AP attack patients experience nutritional deficiencies, including ferritin, all fat-soluble vitamins, and low albumin. SAP is associated with a decrease in BMI Z-score, increased prevalence of vitamin E deficiency at 3m, and an increase in pre-diabetes and diabetes at 12m. Serial monitoring of vitamin and mineral values post AP is warranted and further prospective studies are needed.

Variation in Divergent Thinking, Executive-Control Abilities, and Mind-Wandering Measured in and Out of the Laboratory

ABSTRACT Individual differences in executive functions (or executive control abilities) predict variation in creative thinking ability. Relatedly, propensity for mind-wandering – or task unrelated thought – has been gaining attention among creativity scholars, but its effects on creativity remain unclear. The present study conceptually replicates and extends recent laboratory and experience-sampling work to assess the links between individual differences in divergent thinking, executive control abilities (working memory capacity and attention control), and measures of mind-wandering collected in both contexts. SEM analyses indicated that executive control factors weakly predicted divergent thinking scores, mainly due to their role in filtering out uncreative ideas rather than generating highly novel ones. Lab-based measures of mind-wandering didn’t significantly correlate with overall creative thinking, challenging the idea that mind-wandering uniformly enhances creativity, but they were positively linked to highly creative divergent thinking scores. Daily-life measures of mind-wandering, meanwhile, did not provide stronger predictive insights into creative thinking than lab measures. Finally, exploratory analyses found that divergent thinking scores based on highly creative responses were positively associated with episodes of more fantastical, unrealistic mind-wandering, or “daydreaming.” We end our investigation with a call for greater theoretical precision and some hypotheses to guide future work. [Data, scripts, and preprint: https://osf.io/at5gx/]

Development of a Self-Report Measure of Prediction in Daily Life: The Prediction-Related Experiences Questionnaire.

Predictions are complex, multisensory, and dynamic processes involving real-time adjustments based on environmental inputs. Disruptions to prediction abilities have been proposed to underlie characteristics associated with autism. While there is substantial empirical literature related to prediction, the field lacks a self-assessment measure of prediction skills related to daily tasks. Such a measure would be useful to better understand the nature of day-to-day prediction-related activities and characterize these abilities in individuals who struggle with prediction. An interdisciplinary mixed-methods approach was utilized to develop and validate a self-report questionnaire of prediction skills for adults, the Prediction-Related Experiences Questionnaire (PRE-Q). Two rounds of online field testing were completed in samples of autistic and neurotypical (NT) adults. Qualitative feedback from a subset of these participants regarding question content and quality was integrated and Rasch modeling of the item responses was applied. The final PRE-Q includes 19 items across 3 domains (Sensory, Motor, Social), with evidence supporting the validity of the measure's 4-point response categories, internal structure, and relationship to other outcome measures associated with prediction. Consistent with models of prediction challenges in autism, autistic participants indicated more prediction-related difficulties than the NT group. This study provides evidence for the validity of a novel self-report questionnaire designed to measure the day-to-day prediction skills of autistic and non-autistic adults. Future research should focus on characterizing the relationship between the PRE-Q and lab-based measures of prediction, and understanding how the PRE-Q may be used to identify potential areas for clinical supports for individuals with prediction-related challenges.

Hotter deserts and the impending challenges for the Spiny-tailed Lizard in India.

Ectotherms are particularly vulnerable to climate change, especially those living in extreme areas, such as deserts, where species are already thermally constrained. Using the vulnerable herbivorous lizard Saara hardwickii as a model system, we used a multi-pronged approach to understand the thermal ecology of a desert agamid and potential impacts of rising temperatures. Our data included field-based measures of operative temperatures, body temperatures, and activity, as well as lab-based measures of thermal limits, preferences, and sprint speed. As expected, the temperature dependence of locomotor performance and foraging activity were different, and in the worst-case global warming scenario (SSP5-8.5), potential sprint speed may decrease by up to 14.5% and foraging activity may decrease by up to 43.5% by 2099. Burrows are essential thermal refuges, and global warming projections suggest that S. hardwickii may be restricted to burrows for up to 9 h per day by 2099, which would greatly limit critical activities, like foraging and seeking mating opportunities. Overall, we show that key information on thermal ecology, including temperature-sensitive behaviours in the wild, is necessary to understand the multiple ways in which increasing temperatures may influence ectothermic vertebrates, especially for species like S. hardwickii that are already vulnerable to environmental change.

Validity and Responsiveness of a Modified Balance Error Scoring System Assessment Using a Mobile Device Application in Patients Recovering from Ankle Sprain.

Static balance is often impaired in patients after ankle sprains. The ability to identify static balance impairments is dependent on an effective balance assessment tool. The Sway Balance Mobile Application (SWAY App) (Sway Medical, Tulsa, OK) uses a smart phone or tablet to assess postural sway during a modified Balance Error Scoring System (mBESS) assessment and shows promise as an accessible method to quantify changes in static balance after injury. The primary purposes of this study were to determine the ability to differentiate between those with ankle sprain versus controls (construct validity) and ability to detect change over time (responsiveness) of a mBESS assessment using a mobile device application to evaluate static balance after an acute ankle sprain. Case-control study. Twenty-two military academy Cadets with an acute ankle sprain and 20 healthy Cadets were enrolled in the study. All participants completed an assessment measuring self-reported function, ankle dorsiflexion range of motion (via the weightbearing lunge), dynamic balance, and static balance. Static balance measured with the mBESS using the SWAY App was validated against laboratory-based measures. Cadets with ankle sprains completed their assessment twice: once within two weeks of injury (baseline) and again after four weeks of rehabilitation that included balance training. Independent and paired t-tests were utilized to analyze differences over time and between groups. Effect sizes were calculated and relationships explored using Pearson's correlation coefficients. The mBESS scores measured by the SWAY App were lower in participants with acute ankle sprains than healthy Cadets (t = 3.15, p = 0.004). Injured participants improved their mBESS score measured by SWAY at four weeks following their initial assessments (t = 3.31, p = 0.004; Baseline: 74.2 +/- 16.1, 4-weeks: 82.7 +/- 9.5). The mBESS measured by the SWAY App demonstrated moderate to good correlation with a laboratory measure of static balance (r = -0.59, p \< 0.001). The mBESS assessed with a mobile device application is a valid and responsive clinical tool for evaluating static balance. The tool demonstrated construct (known groups) validity detecting balance differences between a healthy and injured group, concurrent validity demonstrating moderate to good correlation with established laboratory measures, and responsiveness to changes in static balance in military Cadets during recovery from an acute ankle sprain. Level 3.

Can Competitiveness Predict Education and Labor Market Outcomes? Evidence from Incentivized Choice and Survey Measures

Abstract We assess the predictive power of two measures of competitiveness for education and labor market outcomes using a large, representative survey panel. The first is incentivized and is an online adaptation of the laboratory-based Niederle-Vesterlund measure. The second is an unincentivized survey question eliciting general competitiveness. Both measures are strong predictors of income, occupation, level of education and field of study. The predictive power of the new unincentivized measure is robust to controlling for other traits, including risk attitudes, confidence and the Big Five personality traits. For most outcomes, the predictive power of competitiveness exceeds that of the other traits.

The neurobiological effects of childhood maltreatment on brain structure, function, and attachment.

Childhood maltreatment is a risk factor for psychopathologies, and influences brain development at specific periods, particularly during early childhood and adolescence. This narrative review addresses phenotypic alterations in sensory systems associated with specific types of childhood maltreatment exposure, periods of vulnerability to the neurobiological effects of maltreatment, and the relationships between childhood maltreatment and brain structure, function, connectivity, and network architecture; psychopathology; and resilience. It also addresses neurobiological alterations associated with maternal communication and attachment disturbances, and uses laboratory-based measures during infancy and case-control studies to elucidate neurobiological alterations in reactive attachment disorders in children with maltreatment histories. Moreover, we review studies on the acute effects of oxytocin on reactive attachment disorder and maltreatment and methylation of oxytocin regulatory genes. Epigenetic changes may play a critical role in initiating or producing the atypical structural and functional brain alterations associated with childhood maltreatment. However, these changes could be reversed through psychological and pharmacological interventions, and by anticipating or preventing the emergence of brain alterations and subsequent psychopathological risks.

Development of a new acoustic prediction tool by integration of life cycle assessment

Recently, environmental awareness has been the key driver for using renewable materials that have low environmental impact and fulfill constructional requirements, such as timber. Despite the advantages of wood as a building material, it has a lower subjective quality of sound insulation. To fulfill the sound insulation requirements, it is, therefore, unavoidable to complement based-wooden assemblies with additional element(s). However, identifying the acoustic performance is costly and time-consuming. Therefore, developing an accurate prediction tool is vital. Since wood-based structures have been developed to consider the environmental aspects, the environmental performance of buildings should be integrated into the acoustic design. This paper aims to develop an acoustic design methodology for wooden structures using artificial neural network approach by integration of life cycle assessment (LCA). Various Lab-based measurements are used to develop the acoustic prediction tool. Then, a LCA study is conducted on the test assemblies. This paper initially found that wooded assemblies generally increase the environmental impacts to achieve better acoustic insulation. Moreover, different assemblies can meet the sound insulation requirements. Therefore, designers should cognize of environmental and acoustic trade-off by selecting assemblies that consider both aspects.

Real-World Balance Assessment While Standing for Fall Prediction in Older Adults.

Postural control naturally declines with age, leading to an increased risk of falling. Within clinical settings, the deployment of balance assessments has become commonplace, facilitating the identification of postural instability and targeted interventions to forestall falls among older adults. Some studies have ventured beyond the controlled laboratory, leaving, however, a gap in our understanding of balance in real-world scenarios. Previously reported algorithms were used to build a finite-state machine (FSM) with four states: walking, turning, sitting, and standing. The FSM was validated against video annotations (gold standard) in an independent dataset with data collected on 20 older adults. Later, the FSM was applied to data from 168 community-dwelling older people in the InCHIANTI cohort who were evaluated both in the laboratory and then remotely in real-world conditions for a week. A 70/30 data split with recursive feature selection and resampling techniques was used to train and test four machine-learning models. In identifying fallers, duration, distance, and mean frequency computed during standing in real-world settings revealed significant relationships with fall risk. Also, the best-performing model (Lasso Regression) built on real-world balance features had a higher area under the curve (AUC, 0.76) than one built on lab-based assessments (0.57). Real-world balance features differ considerably from laboratory balance assessments (Romberg test) and have a higher predictive capacity for identifying patients at high risk of falling. These findings highlight the need to move beyond traditional laboratory-based balance measures and develop more sensitive and accurate methods for predicting falls.

Predicting self-reported hearing problems using suprathreshold auditory processing and cognitive measures

Measures typically included in standard audiometric test batteries often fail to correlate with self-reported auditory complaints. This is especially common for patients with normal- or near-normal-hearing sensitivity, like those who are aging or have a history of traumatic brain injury (TBI). This discrepancy likely stems from the use of measures that are not sensitive to auditory or cognitive processing deficits underlying patient complaints, which limits effective clinical assessment and management. Recent work has focused on making common laboratory-based measures more clinically accessible using a tablet-based app called PART. The goal of the current study was to identify PART measures that better reflect patient complaints. Data was collected from adults with (n = 37) or without (n = 36) a history of TBI that were matched in age and hearing sensitivity. Regression modeling was used to determine relationships between self-reported auditory difficulties and measures of auditory processing and cognition, including spectrotemporal modulation detection, frequency modulation detection, spatial release from masking, and the Auditory Visual Divided Attention Task (AVDAT). Items from the Concussion Symptom Subtype Inventory were used to measure self-reported auditory complaints. Results contribute to a better understanding of processing difficulties that underly auditory complaints in those with and without TBI.

MiniMovers: An Initial Pilot and Feasibility Study to Investigate the Impact of a Mobile Application on Children's Motor Skills and Parent Support for Physical Development.

The MiniMovers (MM) APP combines motor development theory with creativity expertise and has been designed to provide parents with developmentally appropriate activities to support children's motor skills. This study investigates how MiniMovers activities enabled parents to support their children's physical development. Families participated in an 8-week MM programme of activities from the MM APP (Mini, Mighty and Mega levels), with pre- and post-intervention data collected using multiple tools (e.g., motion capture system, force plate, eye-tracking glasses, and videos). Mixed research methods were applied among children (N = 8; aged 21-79 months) and their parents, providing quantitative analysis on children's performance (running, throwing, jumping, kicking, balancing and catching), as well as qualitative analysis on parents' attitude and behaviour (two-weekly feedback surveys and interviews). Lab-based measures showed significant improvements in run time, underarm throwing distance, and horizontal jump distance. Test of Gross Motor Development-3 showed a significant gain in running, underarm and overarm throwing, horizontal jump and kicking. Further, developmental stages indicated significant improvements in running, kicking and catching. Parents reported increased enjoyment and knowledge, children's enjoyment, independence and confidence. This pilot study provides support for the research and development of the MM App and suggests more research into the use of APPs to support home activities among families with young children.

Assessing Free-Living Postural Sway in Persons With Multiple Sclerosis.

Postural instability is associated with disease status and fall risk in Persons with Multiple Sclerosis (PwMS). However, assessments of postural instability, known as postural sway, leverage force platforms or wearable accelerometers, and are most often conducted in laboratory environments and are thus not broadly accessible. Remote measures of postural sway captured during daily life may provide a more accessible alterative, but their ability to capture disease status and fall risk has not yet been established. We explored the utility of remote measures of postural sway in a sample of 33 PwMS. Remote measures of sway differed significantly from lab-based measures, but still demonstrated moderately strong associations with patient-reported measures of balance and mobility impairment. Machine learning models for predicting fall risk trained on lab data provided an Area Under Curve (AUC) of 0.79, while remote data only achieved an AUC of 0.51. Remote model performance improved to an AUC of 0.74 after a new, subject-specific k-means clustering approach was applied for identifying the remote data most appropriate for modelling. This cluster-based approach for analyzing remote data also strengthened associations with patient-reported measures, increasing their strength above those observed in the lab. This work introduces a new framework for analyzing data from remote patient monitoring technologies and demonstrates the promise of remote postural sway assessment for assessing fall risk and characterizing balance impairment in PwMS.

Utility of Vizient Clinical Data Base as a benchmarking tool for laboratory stewardship programs

Abstract Establishing an effective laboratory stewardship program across healthcare systems to improve patient care has been of growing interest. Despite general guidelines from various organizations, clear definitions for these laboratory-based quality measures, and associated benchmarks, are still lacking. Hence, we utilized Vizient® Clinical Data Base (CDB) as a tool to benchmark our institution against U.S. News and World Reports’ Honor Roll (USNW) healthcare organizations 2021-2022. We focused on inpatient laboratory testing with specific targets including mean laboratory resource units used per patient per day to obtain an overview of our institution’s overall performance, daily basic metabolic panel and CBC test ordering patterns across various service lines, and C-reactive protein (CRP) to erythrocyte sedimentation rate (ESR) order ratios compared to USNW hospitals. As one of the five institutions with the highest mean laboratory resource units used per case per day (12.7) from January 1, 2021-January 31, 2022, we investigated this further to identify tests driving this result. Of all the laboratory tests ordered, blood gas was identified at the 99th percentile compared to peers. Stratifying by service, we found cardiac surgery (17%), general medicine (15%), pulmonary/critical care (11%), neonatology (10%) and transplant (9%) services at our institution were the major contributors to blood gas orders. Investigating daily laboratory test orders (BMP, CBC) showed that our institution was at the 46th and 71st percentile overall, respectively. Further CBC analysis showed that general medicine (28%) and oncology (11%) services were the major contributors for the test volume and highest total resource units used per quarter in 2021. Assessing CRP to ESR ratio depicted that our institution’s ratio of 2.2 was lower compared to USNW hospitals’ average of 2.9, meaning ESR is likely overutilized. In conclusion, Vizient CDB can be used as a resource for benchmarking laboratory utilization patterns. It can be helpful in developing road maps and prioritizing interventions for lab stewardship programs. This study identified a general overuse of laboratory resources at the hospital compared to peers, and identified some intervention targets including blood gas testing and ESR.

Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon, in Patients with Relapsed or Refractory Multiple Myeloma, Lymphomas, or Histiocytic/Dendritic Cell Neoplasms

Background: Oncolytic virotherapy, an innovative immunomodulatory therapeutic approach, is currently being investigated for its potential in treating relapsed refractory (R/R) hematologic malignancies. This study focuses on the use of an engineered Vesicular Stomatitis Virus called VSV-IFNβ-NIS, a bullet-shaped rhabdovirus which encodes both interferon beta (IFNβ) and sodium iodine symporter (NIS) with particular tumor cell tropism. Viral IFNβ serves as an indicator of viral proliferation and boosts the host's anti-tumor immune response. This is a phase 1 clinical trial with the identifier NCT03017820, wherein patients (pts) with R/R multiple myeloma (MM), and non-Hodgkin lymphoma (NHL) are treated with a single systemic administration of VSV-IFNβ-NIS. Study Design and Methods: Patient Eligibility Criteria: The Mayo Clinic Institutional Review Board approved the protocol. The study includes adult patients with relapsed or refractory multiple myeloma (MM), or T-cell lymphoma (TCL). For MM or plasmacytoma, patients should have &amp;lt;15% plasma cells and a largest diameter of &amp;lt;5 cm. TCL patients should have a mass &amp;lt;5 cm. Study Design: This is a single-center phase 1 trial aiming to determine the maximum tolerated dose of VSV-IFNβ-NIS in patients with R/R MM, and TCL. Secondary objectives included assessing the safety profile and estimating the clinical response rate of VSV-IFNβ-NIS. Correlative objectives involved monitoring viral replication through plasma IFN-β transgene levels and using SPECT/CT imaging with the NIS gene. Viral genomes were measured through quantitative reverse transcription (qRT) polymerase chain reaction (PCR) of VSV RNA, and any virus shedding was examined in body fluids. The tested doses were 5 × 109 TCID50, 1.7 × 1010, 5 × 1010, and 1.7 × 1011 TCID50. The virus was administered via IV infusion over 30 minutes, and patients received 650 mg acetaminophen and 50 mg diphenhydramine hydrochloride before infusion and every 6 hours for 24 hours to manage fever and hypotension. Two expansion cohorts at DL4 have been added (20 additional PTCL, 10 B-cell lymphoma and histiocytic neoplasms) to obtain additional data on tolerability and efficacy and biomarkers of response in these histologies. Safety and Response Assessments: All patients undergo toxicity evaluation, and adverse events (AEs) assessment using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria, except for cytokine release syndrome (CRS) grading, which follows the 2014 Lee criteria. Dose escalation and tolerability are based on the standard 3+3 phase 1 trial design. Ruxolitinib is added from days 2-5 or day -1 to day 9 depending on the arm to mitigate IFNβ toxicity. Response assessment followed the International Myeloma Working Group criteria for MM and the Lugano Classification for NHL and histiocytic neoplasms. Pharmacodynamic and Pharmacokinetic Analyses: For viremia and viral shedding assessment, RNA is isolated from whole blood, mouth rinse, buccal swabs, and urine samples. Quantitative RT-PCR determined VSV-nucleocapsid (N) RNA copy number, and virus shedding is assessed through coculturing samples on Vero cells. Anti-VSV antibodies are evaluated using the standard plaque reduction neutralization assay. Plasma cytokine levels are measured with a 30-plex human cytokine kit, and human IFN-β levels is quantified using an enzyme-linked immunosorbent assay (ELISA) kit. Statistical Analysis: Incidence of dose-limiting toxicities and AEs are tabulated by dose level (DL). AEs are summarized by type, maximum grade, and duration across patients in each DL. Spearman rank correlation tests are used evaluated correlations between laboratory-based measures, and Wilcoxon rank sum tests compared continuous measures between response groups. Response rates will be summarized by DL and disease group, with estimated response rates and corresponding 95% binomial confidence intervals calculated.