Pilot Validation Study Research Articles

Development of an Interprofessional Education Project in Dentistry Based on the Positive Behavior Support Theory: Pilot Curriculum Development and Validation Study

Background Effective interprofessional education (IPE) can facilitate teamwork between dentists and dental technicians, thereby enabling the efficient provision of high-quality dental care. Objective This study aimed to design and assess an IPE module named Project 35, which was offered to dental and dental technology students early in their undergraduate training as a precursor to a more comprehensive IPE curriculum in dentistry and dental technology. Methods Leveraging positive behavior support (PBS) theory, Project 35 was devised as an innovation and entrepreneurship educational training framework. It used project-based learning to cultivate teamwork skills and to promote the professional development of dental and dental technology students. The pilot study was designed to present the IPE module and preliminarily assess its validity. In survey 1, which was conducted immediately after the course, the dental and dental technology students’ self-reported skill acquisition and attitudes were assessed and compared. Survey 2, conducted 1 year after the course, focused on the comparative benefits of Project 35 training for dental technology students versus an untrained group. Results A total of 66 students, including 36 dental students and 30 dental technology students who had undertaken the training, were recruited. Project 35 training improved teamwork skills for students in both disciplines comparably, and the students recognized the training as highly valuable and effective. The mean values for all items indicating skills improvement of students ranged from 4.13 (SD 0.797) to 4.63 (SD 0.495) for dental students and from 4.13 (SD 0.869) to 4.74 (SD 0.619) for dental technology students. Among the dental technology students, the trained group showed greater independent and innovative approaches and was more optimistic about the future of the profession than the nontrained group (P<.05). Conclusions Despite the small sample size, the validity of the Project 35 training system was evident, and the success of our pilot study provides a sound basis for the future development of IPE in clinical dental and dental technology education programs.

Comparison of Analgesia Methods Through a Web Platform in Patients Undergoing Thoracic Surgery: Pilot Design, Implementation, and Validation Study.

Pain management is a vital and essential part of postoperative pectus excavatum (PE) care. Given the lack of an international consensus on guidelines for postoperative handling and evaluation, further research is necessary to compare the efficacy of existing pain management methods regarding pain relief, side effects, and long-term outcomes. In this context, the use of eHealth solutions for data mining can enhance data collection efficiency, reduce errors, and improve patient engagement. However, these digital health care frameworks are currently underused in the context of pain management for PE. This research is part of the broader Cryoanalgesia for Pain Management After Pectus Excavatum Repair (COPPER) study conducted by Giannina Gaslini Children's Hospital to address postoperative pain and recovery in PE patients treated with either standard thoracic epidural analgesia or cryoanalgesia, which is considered its innovative alternative approach. Specifically, this work is aimed at introducing a valuable tool for a comprehensive and quantitative comparison of the 2 analgesia strategies. The tool is a web and mobile app designed to facilitate data collection, management, and analysis of clinical data for pain assessment. The adopted approach involves a careful design based on clinician input, resulting in an intuitive app structure with 3 main screens. Digital surveys are borrowed from paper surveys, including medical history and preoperative, postoperative, and follow-up evaluations. XTENS 2.0 was used to manage the data, and Ionic facilitated cross-platform app development, ensuring secure and adaptable data handling. Preliminary analysis on a pilot cohort of 72 patients (36 treated with standard therapy and 36 treated with cryoanalgesia) indicated successful patient enrollment and balanced representation across treatment groups and genders. Notably, hospital stay was significantly shorter with cryoanalgesia than with standard therapy (Mann-Whitney-Wilcoxon 2-sided test with Bonferroni correction; P<.001; U statistic=287.5), validating its treatment efficacy. This work is a step toward modernizing health care through digital transformation and patient-centered models. The app shows promise in streamlined data collection and patient engagement, although improvements in multilingual support, data validation, and incentivization of questionnaire completion are warranted. Overall, this study highlights the potential of digital health solutions in revolutionizing health care practices, fostering patient involvement, and improving care quality.

The Knowledge, Attitudes, and Practices of Healthy Eating Questionnaire: a pilot validation study in Chinese families.

Identifying the knowledge, attitudes, and practices (KAP) gaps of healthy eating can inform the design of effective interventions. This study aimed to test the validity and psychometric properties of a KAP of Healthy Eating Questionnaire (KAP-HEQ) tailored to the Chinese culture. The dimensions and potential items of each KAP scale were identified from published KAP and health literacy questionnaires, which were supplemented by the findings of a previous qualitative healthy eating study. Content validity of the KAP-HEQ was evaluated by eight experts and eight Chinese parent-adolescent dyads in Hong Kong through content validity ratio (CVR), content validity index (CVI), and qualitative feedback. The feasibility, construct validity, reliability, and sensitivity of the KAP-HEQ were evaluated in this pilot study among 60 adolescent-parent dyads (120 persons) through an online survey. The first 30 dyads who completed the KAP-HEQ were invited to repeat the KAP-HEQ 2 weeks later to assess the test-retest reliability. The final 44-item KAP-HEQ was completed in 10-15 min by both adolescents and their adult parents. The CVR ranged from -0.38 to 1, and the CVI ranged from 0.56 to 1. Over 80% of the items achieved convergent validity (a significantly positive correlation with its hypothesized scale) and discriminant validity (a higher correlation with its hypothesized scale than with the other two scales). Cronbach's alpha for the internal consistency of the Overall, Attitude, and Practice scales was >0.7, while that of the Knowledge scale was 0.54. The intraclass correlation coefficient (ICC) on test-retest reliability of the Overall and individual scales were all >0.75 except that of the Knowledge scale (ICC = 0.58). The significant differences in KAP scale scores with small to large effect sizes were found between known groups as hypothesized, except the Attitude score between groups by household income, which supported the sensitivity of the KAP-HEQ. The KAP-HEQ has shown good validity, reliability, and sensitivity among Chinese adolescents and adults, which can be applied to evaluate KAP status and gaps to inform the design and assess the effectiveness of healthy eating interventions.

Development and Pilot Validation of the DuMAND Checklist to Screen for Duchenne Muscular Dystrophy-Associated Neurobehavioral Difficulties (DuMAND).

Patients with Duchenne muscular dystrophy (DMD) face a higher risk of neurobehavioral problems, yet an international consensus on screening, assessing, and managing these difficulties is lacking. This report introduces the term Duchenne Muscular Dystrophy-Associated Neurobehavioral Difficulties (DuMAND) to comprehensively cover the spectrum of neurobehavioral issues in DMD patients, including behavior, psychiatric disorders, and various cognitive, academic, and psychosocial deficits. To facilitate screening, the DuMAND Checklist, a 43-item tool with five subscales, was developed. DuMAND categories were derived through literature review, parent (48 mothers and 37 fathers), and expert (n = 28) input and feedback. The DuMAND Checklist subscales were developed iteratively, incorporating item selection, expert panel (n = 10) assessment for face validity, comprehensiveness, and a pilot validation study in a DMD sample (n = 20). DuMAND encompasses five categories: cognition and learning, social responsiveness, emotion regulation, externalizing behavior, and eating and sleeping. Preliminary validation of the DuMAND Checklist indicates acceptable-to-excellent internal consistency and construct validity. By introducing the DuMAND concept, this study seeks to inspire a consensus approach for screening, assessing, and managing neurobehavioral issues in DMD. Incorporating screening, using the DuMAND Checklist, in addition to medical follow-up will facilitate early intervention, addressing a critical gap in identification of neurobehavioral disorders in DMD. Future research is needed to further evaluate psychometric properties of the DuMAND Checklist and investigate the natural course of DuMAND.

Development of a questionnaire for assessing the functions informal subgroups perform in relation to the work group

The paper presents the results of assessing validity and reliability of a questionnaire designed to measure three key functions of informal subgroups in relation to a small work group, namely: (1) implementing group tasks; (2) within group positioning and influence; and (3) organizing group activity. The questionnaire contains three subscales to assess the corresponding functions of informal subgroups. Three experienced psychologists assessed content validity of the questionnaire. In addition, 290 employees from 49 working groups (departments, sectors, production units, etc.) of various organizations took part in the pilot testing and validation study of the developed questionnaire and of the associated tool for identifying informal subgroups — within the software package “Group Profile — Universal. Descriptive statistics (means and standard deviations) and Cronbach’s alpha α were calculated, and confirmatory factor analysis was performed. The questionnaire evaluation procedure was carried out separately for the data obtained: (a) among those sample participants who were included in informal subgroups and (b) for the entire sample. The study shows that in both cases the questionnaire has adequate content validity and confirms a three-factor structure of the questionnaire with every subscale being internally consistent. The questionnaire can be used to solve research and applied problem alike. Its application will allow researchers to expand their understanding of the role of informal subgroups in the life and functioning of work groups. Practitioners (psychologists and human resource professionals) will be able to assess the prevalence of the functions of each subgroup or of a set of subgroups and, based on outcomes of such assessment, purposefully build their work with subgroups in order to improve joint activities and increase performance effectiveness of work groups.

The Quebec Semantic Memory Battery: Development, Standardization, and Psychometric Assessment of a Semantic Memory Battery in French.

People with aphasia often experience semantic memory (SM) impairment. To improve diagnostic outcomes, SM tasks should recruit various sensory input channels (oral, written, and pictographic), permitting accessible, complete evaluation. There is a need for SM batteries for French-speaking Quebecers that use multiple input channels. The present study, therefore, describes the development of a novel French-language semantic battery: la Batterie québécoise de la mémoire sémantique (BQMS), the assessment of the BQMS's psychometric properties, and the establishment of normative data for the BQMS. We first developed eight SM tasks. Following a pilot validation study, we determined the BQMS's reliability and validity, to ensure consistent, accurate detection of SM impairment. Among French-speaking Quebecers with cerebrovascular aphasia (n = 10), people with the semantic variant of Primary Progressive Aphasia (n = 4), and healthy controls (n = 14), we examined its convergent validity, concurrent validity, test-retest reliability, and internal consistency. Finally, we established normative data for the BQMS by calculating cut-off scores per task that indicate SM impairment (in 93 cognitively healthy French-speaking Quebecers), stratified by sociodemographic variables associated with performance. The BQMS shows high concurrent, discriminant, and convergent validity, as well as good test-retest reliability and internal consistency. The cut-off score indicating SM impairment ranged from the 2nd to 25th percentiles (stratified by task, age, and sex). The BQMS's psychometric properties indicate that it could be a valuable clinical tool for detecting SM impairment. Our normative data will help clinicians detect such impairments.

Recognizing Traumatization in Children Aged 4 to 8: A Pilot Validation Study of the Odense Child Trauma Screening (OCTS) Measure in Lithuania

ABSTRACT Early identification of children at risk of posttraumatic stress symptomatology or other emotional and behavioral problems is highly needed for the prevention of long-term consequences of traumatic events and abuse. However, the assessment of the traumatization of very young children is challenging because they cannot fully verbalize their psychological experiences. The purpose of this pilot study was to test the internal consistency, interrater reliability, and validity of the Odense Child Trauma Screening (OCTS) measure, a structured play test for signs of traumatization in young children. The total sample was comprised of 26 (50%) children from the community and 26 from risk groups in Lithuania. The mean age of the participants was 6.44 (SD = 1.63; range 3–9); 62% were girls. The OCTS interviews were conducted with all children. The Child and Adolescent Trauma Screen (CATS) and the Strengths and Difficulties Questionnaire (SDQ) were used to collect data about the child from the caregivers. Caregivers of the risk sample group reported significantly more potentially traumatic events experienced by the children (M = 2.73) than in the community sample (M = 1.00). The OCTS results indicated acceptable internal consistency and good inter-rater reliability. However, only one of the four OCTS stories scores was significantly higher in the risk group. We found no sex effects on the OCTS scores. This pilot study of the psychometric properties of the OCTS supports the reliability of the OCTS and indicates that the OCTS administration and coding procedures can be consistently applied in various settings.

Health-related quality of life instrument with 8 items to measure health-related quality of life among family caregivers of people with dementia: A pilot validation study.

The health-related quality of life instrument with 8 items (HINT-8) was developed to measure health-related quality of life (HRQoL) in Korea. However, the HINT-8 has not yet been validated among the family caregivers of people with dementia (PwD). A cross-sectional pilot study. The study aimed to examine the convergent and discriminant validity of the HINT-8 among family caregivers of individuals with dementia. Forty-seven family caregivers of PwD. HINT-8 was compared with the 5-level EQ-5D (EQ-5D-5L) to assess its convergent and discriminant validity. Additionally, the association between the two instruments assessing HRQoL was examined using the short-form Bédard-Zarit Burden Interview (SZBI). The HINT-8 was a promising and valid HRQoL instrument for family caregivers of PwD. There was a significantly high correlation between the overall HINT-8 and EQ-5D-5L indices (r=0.85, p<.001). The HINT-8 had acceptable psychometric properties compared to the commonly used EQ-5D-5L, as indicated by the subdomains associated with family caregivers' burden measured by the SZBI. Future studies should compare the HINT-8 with existing dementia carer-specific QoL instruments among a larger study sample to enhance its statistical power and confirm its reliability and structural validity.

The Psychological Immune Competence Inventory: A Pilot Validation Study in Slovakia

Introduction: Psychological immunity refers to an individual’s potential to cope with psychological risk factors, as well as to promote and maintain mental health and well-being. The method of its measurement is the Psychological Immune Competence Inventory (PICI), which appears to have good psychometric parameters. Despite the use of translated versions in various foreign studies, the authors have found no studies verifying its factor structure or reliability. Aims: In this article, our objective is to present the results of the PICI pilot validation in Slovakia. The Slovak version of PICI was expected to have psychometric properties comparable to those of the original version. Methods: We collected data from a research sample of 213 healthcare students (162 women and 51 men) aged 19 to 35 years (M = 21.18; SD = 2.81), and validated the internal structure of the inventory using Structural Equation Modeling (SEM) via employing the DWLS estimation method. The convergent validity of individual factors was further verified by correlation with personality traits, psychopathological symptoms, preferred coping strategies and trait emotional intelligence. Results: The results of the second-order confirmatory analysis indicate an acceptable fit of the original model to our data. The convergent validity of the observed individual psychological immunity factors was also supported. Conclusions: The Slovak version of PICI showed promising psychometric properties. The research serves as a reference to Slovak standardization. Nevertheless, further validation is recommended in a representative sample.

Validation of an instrumented mouthguard in rugby union-a pilot study comparing impact sensor technology to video analysis.

To better understand the biomechanical profile of direct head impacts and the game scenarios in which they occur in Rugby Union, there is a need for an on-field validation of a new instrumented mouthguard (IMG) against the reference standard. This study considers the potential of a combined biomechanical (IMG) and video analysis approach to direct head impact recognition, both of which in isolation have limitations. The aim of this study is to assess the relationship between an instrumented mouthguard and video analysis in detection of direct head impacts in rugby union. Pilot Study - Observational Cohort design. The instrumented mouthguard was worn by ten (3 backs, 7 forwards) professional Rugby Union players during the 2020-21 Gallagher Premiership (UK) season. Game-day video was synchronized with timestamped head acceleration events captured from the instrumented mouthguard. Direct Head Impacts were recorded in a 2 × 2 contingency table to determine sensitivity. Impact characteristics were also collected for all verified head impacts to further the understanding of head biomechanics during the game. There were 2018 contact events that were reviewed using video analysis. Of those 655 were categorized as direct head impacts which also correlated with a head acceleration event captured by the IMG. Sensitivity analysis showed an overall sensitivity of 93.6% and a positive predictive value (PPV of 92.4%). When false positives were excluded due to ball out of play, mouthguard removal or handling after a scoring situation or stoppage, PPV was improved (98.3%). Most verified head impacts occurred in and around the ruck contest (31.2%) followed by impacts to the primary tackler (28.4%). This pilot validation study demonstrates that this IMG provides a highly accurate measurement device that could be used to complement video verification in the recognition of on-field direct head impacts. The frequency and magnitude of direct head impacts derived from specific game scenarios has been described and allows for greater recognition of high-risk situations. Further studies with larger sample sizes and in different populations of Rugby Union players are required to develop our understanding of head impact and enable strategies for injury mitigation.

Development and validation of the Chinese oral anticoagulants knowledge tool (C-OAKT): A pilot study

ObjectiveTo develop and validate an oral anticoagulant knowledge tool for Chinese-speaking patients treated with warfarin or direct oral anticoagulants (DOACs) in Hong Kong. MethodThis pilot validation study consisted of the following three phases: (1) the development of a knowledge tool and content validity assessment; (2) a pilot study of 200 participants, consisting of 100 patients taking warfarin or DOACs, 50 pharmacists, and 50 members of the general public; and (3) known-group validity and reliability assessments. ResultsA 19-item “Chinese Oral Anticoagulants Knowledge Tool (C-OAKT)” was developed with a scale content validity index of 0.95. The mean score for known-group validity was significantly higher in the pharmacist group than the patient groups, and the patient groups scored significantly higher than the general public (mean ± standard deviation [SD] = 90.00 ± 7.11 vs. 51.55 ± 17.49 vs. 19.0 ± 15.42, respectively; p < 0.001). The mean score was higher for patients who attended a pharmacist-managed anticoagulant therapy management clinic (PAC) than for non-PAC patients (mean ± SD = 56.80 ± 13.60 vs. 46.30 ± 9.43; p = 0.004). An analysis of internal consistency showed a Cronbach's alpha value of 0.86. ConclusionThe results of the pilot validation study suggested that the C-OAKT is a valid and reliable instrument for assessing patients' knowledge of oral anticoagulants in ambulatory care settings. InnovationsThis is the first validated Chinese version of an anticoagulant knowledge assessment tool. This tool will be utilized in public hospitals in Hong Kong, and will facilitate future research exploring the relationship between anticoagulant knowledge and patient-related outcomes.

Deep learning based ultrasonic visualization of distal humeral cartilage for image-guided therapy: a pilot validation study.

Ultrasound is widely used for image-guided therapy (IGT) in many surgical fields, thanks to its various advantages, such as portability, lack of radiation and real-time imaging. This article presents the first attempt to utilize multiple deep learning algorithms in distal humeral cartilage segmentation for dynamic, volumetric ultrasound images employed in minimally invasive surgery. The dataset, consisting 5,321 ultrasound images were collected from 12 healthy volunteers. These images were randomly split into training and validation sets in an 8:2 ratio. Based on deep learning algorithms, 9 semantic segmentation networks were developed and trained using our dataset at Southern University of Science and Technology Hospital in September 2022. The performance of the networks was evaluated based on their segmenting accuracy and processing efficiency. Furthermore, these networks were implemented in an IGT system to assess their feasibility in 3-dimentional imaging precision. In 2D segmentation, Medical Transformer (MedT) showed the highest accuracy result with a Dice score of 89.4%, however, the efficiency in processing images was relatively lower at 2.6 frames per second (FPS). In 3D imaging, the average root mean square (RMS) between ultrasound (US)-generated models based on the networks and magnetic resonance imaging (MRI)-generated models was no more than 1.12 mm. The findings of this study indicate the technological feasibility of a novel method for real-time visualization of distal humeral cartilage. The increased precision of ultrasound calibration and segmentation are both important approaches to improve the accuracy of 3D imaging.

#5228 ASSESSING ACCURACY OF POINT-OF-CARE CREATININE AND POTASSIUM TESTING IN A MULTI-ETHNIC SOUTH LONDON POPULATION

Abstract Background and Aims Point-of-care (POC) testing allows rapid analysis of blood samples without delay of laboratory testing. For patients with chronic kidney disease (CKD), this allows for instant identification of changes in kidney function, such as acute kidney injury or hyperkalaemia, and assists in timely decision-making in outpatient or community settings (e.g. commencing or up-titrating medications dependent on renal function). It also provides an opportunity for early recognition of CKD in high-risk populations by providing screening in more convenient and trusted settings. To achieve these aims, it essential to confirm that POC systems can produce accurate results in real world settings with diverse patient populations. This pilot validation study assessed accuracy of the Siemens Epoc Blood Analysis System venous creatinine and potassium compared with laboratory assays in a diverse UK renal patient population. Method Venous blood samples from 57 patients, aged ≥ 18 years old and receiving care at a London teaching hospital, were analysed using the Siemens Epoc Blood Analysis System. POC-Creatinine (POC-Cr) and Potassium (POC-K) measurements were compared with laboratory (IDMS-traceable Siemens enzymatic and Roche) assays. Demographics (age, ethnicity and sex) were recorded for each patient. Passing-Bablock regression analysis were used to compare the results using both methods. Comparison between testing methods was assessed using a Bland-Altman plot. Limits of agreement were compared with CLIA criteria for acceptable performance for creatinine and potassium. Results The mean age was 55.6 ± 15.3 years old and 64.9% were male (n = 37). The majority of patients were of White (N = 23; 40.4%), Black (N = 21; 36.8%) or South Asian (N = 9; 15.8%) ethnicity respectively. Median POC-Cr was 216 μmol/L (interquartile range (IQR) 111, 396 μmol/L) versus median venous creatinine 212 μmol/L (IQR 114, 380 μmol/L). The median bias for creatinine was +1.0 (IQR -3.0, +8.0). Limits of agreement on Bland-Altman plot were +36.5μmol/L and – 34.4μmol/L (Figure 1). Overall, there remained a strong positive correlation between POC-Cr and IDMS-traceable enzymatic creatinine assays (R = 0.997; P&amp;lt;0.0001) (Figure 2). Median POC-K was 4.3 mmol/L, IQR 4.0, 4.8 mmol/L versus median venous potassium 5.0, IQR 4.3, 5.3 mmol/L. The median bias for potassium was +0.4 (IQR +0.2, +0.5). Limits of agreement on Bland-Altman plot were +0.16mmol/L and – 0.91mmol/L (Figure 3). A strong positive correlation between POC-K and laboratory potassium assays was also confimed (R = 0.937; P&amp;lt;0.0001) (Figure 4). Conclusion There was strong positive correlation between POC and laboratory analysis of venous creatinine, comparable to product literature (R = 0.997 vs 0.998). Limits of agreement were outside the CLIA criteria for acceptable performance (+/- 27μmol/L). POC and laboratory potassium levels were also strongly correlated and comparable to product literature (R = 0.937 vs 0.997). Limits of agreement were outside the CLIA criteria for acceptable performance (+/- 0.5mmol/L). This discrepancy is likely due to haemolysis in some blood samples and small sample size. Overall, this pilot study demonstrated a strong correlation between POC and laboratory testing. Larger scale evaluation is still required in a multi-ethnic population, prior to assessing feasibility in community-led protocolized pathways.

A Pilot Validation Study Comparing Fluorescence-Imitating Brightfield Imaging, A Slide-Free Imaging Method, With Standard Formalin-Fixed, Paraffin-Embedded Hematoxylin-Eosin-Stained Tissue Section Histology for Primary Surgical Pathology Diagnosis.

Digital pathology using whole slide images has been recently approved to support primary diagnosis in clinical surgical pathology practices. Here we describe a novel imaging method, fluorescence-imitating brightfield imaging, that can capture the surface of fresh tissue without requiring prior fixation, paraffin embedding, tissue sectioning, or staining. To compare the ability of pathologists to evaluate direct-to-digital images with standard pathology preparations. One hundred surgical pathology samples were obtained. Samples were first digitally imaged, then processed for standard histologic examination on 4-μm hematoxylin-eosin-stained sections and digitally scanned. The resulting digital images from both digital and standard scan sets were viewed by each of 4 reading pathologists. The data set consisted of 100 reference diagnoses and 800 study pathologist reads. Each study read was compared to the reference diagnosis, and also compared to that reader's diagnosis across both modalities. The overall agreement rate, across 800 reads, was 97.9%. This consisted of 400 digital reads at 97.0% versus reference and 400 standard reads versus reference at 98.8%. Minor discordances (defined as alternative diagnoses without clinical treatment or outcome implications) were 6.1% overall, 7.2% for digital, and 5.0% for standard. Pathologists can provide accurate diagnoses from fluorescence-imitating brightfield imaging slide-free images. Concordance and discordance rates are similar to published rates for comparisons of whole slide imaging to standard light microscopy of glass slides for primary diagnosis. It may be possible, therefore, to develop a slide-free, nondestructive approach for primary pathology diagnosis.

383 A Pilot Study of Tear Cytokine Profiling in a Patient with Ocular Graft versus Host Disease

OBJECTIVES/GOALS: Ocular graft versus host disease (oGVHD) affects ~50% of individuals after an allogeneic hematopoietic stem cell transplant for treating blood cancers. OGVHD results in severe dry eye disease and decreased vision. Quantifying specific cytokine changes in tears may reveal biomarkers and future treatment targets for patients with oGVHD. METHODS/STUDY POPULATION: The goal of this study is to determine if cytokines can be measured in tears with the Isoplexis platform. This pilot validation study evaluates the tears of a patient with oGVHD utilizing the Isoplexis platform. The Isoplexis has specific advantages for tear samples including high-throughput analysis, and small sample requirements, but has yet to be validated in tears. A sample from normal and oGVHD patient tears were collected for comparison. Samples were analyzed on two separate backgrounds–standard Bovine Serum Albumin (BSA) background and artificial tears (ATs). The negative control was ATs and positive control was a concentrated cytokine solution. Analysis of 22 cytokines was performed. RESULTS/ANTICIPATED RESULTS: Analysis of 22 cytokines was performed. As expected, the cytokine levels of the ATs alone were below the limit of detection (LOD). The oGVHD patient tears showed elevated TNF-alpha, TNF-beta, perforin, MIP-1a, MIP-1β, MCP-1, IL2, IL4, IL5, IL-7A, IL9, IL-13, IL-15, IFN-γ, granzyme B, and GM-CSF with ATS background, but no cytokines above the LOD in the BSA background plate. The control tears had elevated IP-10. The elevated cytokines for the oGVHD patient corresponded to symptom severity and clinical findings. DISCUSSION/SIGNIFICANCE: These results suggest that using ATs as the background with the Isoplexis platform improves the sensitivity to detect tear cytokines. Findings of elevated IL-7A and GM-CSF in tears parallels literature findings for oGVHD. Further evaluation of samples will continue to validate the Isoplexis multiplex assay for tear cytokine analyses.

Two novel models evaluating the determinants of resting metabolic rate in Indian children

Background: Resting metabolic rate (RMR) quantifies the minimal energy required to sustain vital body functions and is a crucial component of childhood development. Mean RMR per unit body mass (RMR/BM) has very accurately been modelled in references for Caucasian adolescents.Objectives: Here we address the extent to which such a model can be adapted to explain RMR/BM in Indian children.Subjects and Methods: The multicenter study (MCS) is a cross-sectional dataset on 495 children (235 girls and 260 boys) aged 9 to 19 years with anthropometric, body composition, and RMR measurements. The RMR-ultrasonography study (RMR-USG) consists of anthropometric data, RMR, and liver and kidney volume measured through ultrasonography in nine girls and nine boys aged 6 to 8 years.Results: The mean RMR/BM in Indian children is significantly lower compared to their Caucasian counterparts, except in boys in the age group 9–13 years. We present two novel phenomenological models that describe the mean RMR/BM stratified by age in Indian children and adolescents. The first is a modified Wang model in which the relative masses of four major organs are assumed to be uniformly lowered for Indian children. Theoretical predictions of liver size are not uniformly borne out in a pilot validation study; however, the relative mass of the kidney is found to be significantly lower. The second model demonstrates that changes in body composition alone can also explain the Indian data.Conclusion: A modified Wang model in which the relative masses of four major organs are assumed to be uniformly lower in Indian children and differences in body composition can be used to estimate mean RMR/BM by age in Indian children; however, understanding the mechanistic basis of variation in RMR/BM remains an open problem.

Validation of a Useful Tool for Screening for Overweight and Obesity in Pre-Adolescents

The purpose of this observational study with a convenience sample is to validate a simple measurement of the mid-upper arm circumference to establish the screening points using the mid-upper arm circumference tape (MUAC) for childhood overweight and obesity between 9 and 12 years of age, or from 4th grade to 6th grade. Prior to the screening study, a pilot validation study of the MUAC tape measure versus anthropometric standard tape was carried out. The total sample for the screening cut-offs was 360 school students. The results obtained had a predictive value according to the evaluation of the area under the curve of 0.96 and overweight detection cut-off points were established at 23.3 and 22.4 cm for 4th grade, 23.6 and 22.7 cm for 5th grade and 24.6 and 23.8 cm for 6th grade for boys and girls, respectively. The cut-off points for the detection of obesity were established at 25.2 and 23.9 cm for 4th grade, 26.4 and 25.1 cm for 5th grade, and 27.7 and 26.4 cm for 6th grade boys and girls, respectively. The cut-off values of the MUAC are different not only between the sexes, but also increase as age or the specific course increases.

IsiXhosa translation of the Patient Health Questionnaire (PHQ-9) shows satisfactory psychometric properties for the measurement of depressive symptoms [Stage 2

Depression is a debilitating illness, and stigma associated with it often prevents people from seeking support. Easy-to-administer and culturally- inclusive tools can allow for early screening for depressive symptoms in primary care clinics, especially in resource-limited settings. In this pre-registered pilot study (Stage 1 Report available at DOI: 10.3389/fpsyt.2022.840912), we produced an open-access isiXhosa-language version of the nine-item Patient Health Questionnaire (PHQ-9), a well-validated measure of depression incidence and severity, using a transcultural translation framework. We validated this isiXhosa PHQ-9 in a sample of N = 47 adolescents living with and without HIV in Cape Town, South Africa who speak isiXhosa at home. Reliability, convergent validity, and criterion validity were assessed, with T scores on the Achenbach System of Empirically Based Assessment Youth Self Report (YSR) form completed previously as reference standard. Our isiXhosa PHQ-9 exhibited satisfactory reliability, with Cronbach's , inter-item correlations ranging from 0.229 to 0.730, and mean item-total correlation of 0.69. PHQ-9 score and Withdrawn/Depressed component T scores on the Youth Self Report were moderately associated (Spearman's , indicating acceptable convergent validity. The isiXhosa PHQ-9 showed satisfactory criterion validity (area under the receiver operating characteristic curve, AUC = 0.706), but these analyses were under-powered. Principal component analysis revealed a one-factor solution, with 45.8% of variance explained by the first principal component and all factor loadings above conventional thresholds. Our isiXhosa translation of the PHQ-9 thus exhibited satisfactory psychometric properties in this pilot validation study and performed comparably to other PHQ-9 versions validated in different languages in African and global contexts. This questionnaire may serve as an invaluable culturally-inclusive screening tool for measuring depressive symptoms among isiXhosa speakers. Caution must be exercised as screening tools including the PHQ-9 may over- or under-estimate prevalence of depression. Further validation in larger, independent cohorts may enable wider use of our isiXhosa PHQ-9 as a screening tool in clinics, research studies, and mental health non-profits who serve amaXhosa.

Polish version of the TOSCA-3 questionnaire (The Test of Self-Conscious Affect, J. P. Tangney, R. Dearing, P. E. Wagner, &amp; R. Gramzow) – a pilot study

Objective The operationalization of the concepts of shame and guilt poses a challenge not only for research participants attempting to analyze these emotions, but also for psychologists themselves. Scenario-based questionnaires offer a solution to this problem. This article describes the process of adapting the TOSCA-3 questionnaire to the Polish language. Method The TOSCA-3 questionnaire was adapted to Polish based on the international recommendations for the cultural adaptation of psychometric questionnaires. A pilot study was conducted using the newly adapted TOSCA-3 questionnaire, the SWLS questionnaire, the MCSDS self-report questionnaire, and the EPQ-R(S) questionnaire. The study was conducted on a random sample of 148 people. Results The obtained results (means, standard deviations, and Cronbach’s α) were satisfactory, which points to the psychometric validity of the adapted questionnaire. The validation process revealed lower life satisfaction among people who are more prone to experience shame (r = ‒.177; p &lt; .05), whereas the scores of subjects who are more prone to experience guilt confirmed a positive correlation with the results obtained on the social approval-seeking scale (MCSDS; r = .38; p &lt; .05). Furthermore, the scores on extraversion and neuroticism scales were correlated with shame proneness (r = ‒.25; p &lt; .05 and r = .40; p &lt; .05, respectively). Conclusions The statistical analysis confirmed that the TOSCA-3 questionnaire was reliably translated and adapted to the Polish language. The results of the pilot study suggest that the adaptation process was successful. The tool can be used in research. However, the collected data do not support analyses of factor relevance or the development of standards for individual diagnoses. The results of the pilot validation study make a valuable contribution to the scientific debate on shame and guilt proneness which are rarely discussed in the Polish literature.

The development of a Self-Rated ICF-based questionnaire (HEAR-COMMAND Tool) to evaluate Hearing, Communication, and Conversation disability: Multinational experts' and patients' perspectives.

An instrument that facilitates the advancement of hearing healthcare delivery from a biomedical model to a biopsychosocial one that underpins the International Classification of Functioning, Disability, and Health framework (ICF) brief and comprehensive Core Sets for Hearing Loss (CSHL) is currently unavailable. The objective is to describe the process of developing and validating a new questionnaire named the HEAR-COMMAND Tool created by transferring the ICF CSHL into a theory-supported, practically manageable concept. A team from Germany, the USA, the Netherlands, and Egypt collaborated on development. The following ICF domains were considered; "Body Functions" (BF), "Activities and Participation" (AP), and "Environmental Factors" (EF). The development yielded English, German, and Arabic versions. A pilot validation study with a total of 109 respondents across three countries, Germany, Egypt, and the USA was conducted to revise the item terminology according to the feedback provided by the respondents. The questionnaire included a total of 120 items. Ninety items were designed to collect information on the functioning and 30 items inquiring about demographic information, hearing status, and Personal Factors. Except for the "Body Structures" (BS) domain, all the categories of the brief ICF CSHL were covered (a total of 85% of the categories). Moreover, the items covered 44% of the comprehensive ICF CSHL categories including 73% of BF, 55% of AP, and 27% of EF domains. Overall, the terminology of 24 ICF-based items was revised based on the qualitative analysis of the respondents' feedback to further clarify the items that were found tod be unclear or misleading. The tool highlighted the broad connection of HL with bodily health and contextual factors. The HEAR-COMMAND Tool was developed based on the ICF CSHL and from multinational experts' and patients' perspectives with the aim to improve the execution of audiological services, treatment, and rehabilitation for adult patients with HL. Additional validation of the tool is ongoing. The next step would be to pair the tool with BS categories since it was excluded from the tool and determine its effectiveness in guiding hearing health care practitioners to holistically classify categories influencing hearing, communication, and conversation disability.