Assessment of adaptive behavior in people with intellectual disabilities: Design and development of a new test battery.

Background: Adaptive behavior is an important characteristic of people with intellectual disabilities, and it has been associated with a person's performance in social and work contexts. Indeed, adaptive behavior denotes what a person does independently, without help, support, reminders, or prompts. In Peru, available measures of adaptive behavior are commercial; thus, there is a need for an open-access tool to assess the adaptive behavior of people with intellectual disabilities. For this reason, the aim of the study was to design and develop a new Adaptive Behavior Test Battery for people from 13 to 60 years old with intellectual disabilities who have an interest in being part of the economically active population. Methods: A cross-sectional design was defined, starting with a qualitative approach to designing and constructing the item pool for the test battery. Then, quantitative indexes Aiken's V for content validity and Krippendorff's alpha for inter-observer reliability were estimated, resulting in a first version of the three subscales that comprised the test battery. The initial versions were tested on a sample of 566 persons with intellectual disabilities from two regions of Peru: Lima (Coast) and San Martín (Jungle). The internal structure was analyzed under a factor analysis approach, along with internal consistency measures of reliability. Further analyses of invariance regarding gender, region, and age were carried out. Results: Three observer subscales were proposed: Daily living activities (11 items), Instrumental skills (4 items), and Communication (9 items). All subscales showed excellent psychometric properties denoted by the Aiken's V coefficient, Krippendorff's alpha, factor analysis, internal consistency analysis, and invariance analyses. Conclusion: The developed a new Adaptive Behavior Test Battery is a useful tool for the measurement of adaptive behavior and the monitoring of social and labor inclusion programs for people with intellectual disabilities.

Development and validation of a test instrument for the assessment of perceived basic motor competencies in first and second graders: the SEMOK-1-2 instrument.

Both actual motor competencies (AMC) and perceived motor competencies (PMC) play an important role in motor development research and children's physical and psychological development. PMC refer to children's perceptions of their motor competencies. To assess the PMC of first and second grade children (aged 6-9 years), the SEMOK-1-2 instrument was developed. The instrument is aligned to the validated MOBAK-1-2 instrument which assesses AMC in the competence areas "object movement" and "self-movement" Accounting for possible reading difficulties in younger children, the motor tasks and answer options were illustrated and explained verbally. The purpose of this study was to test and validate the SEMOK-1-2 instrument and investigate the associations between the constructs AMC, PMC and physical activity (PA), whereby PA was measured by the participation in team and individual sports. Data from N = 404 pupils in the German-speaking part of Switzerland from first and second grades (M = 7.8 years, SD = 0.69, 49% boys) were analyzed. Confirmatory factor analyses were conducted to test the factorial validity of the SEMOK-1-2 instrument. Structural equation models were used to investigate the association between the constructs. The analyses confirmed a two-factor structure with the factors PMC "object movement" and PMC "self-movement", corresponding to the factors existing in the MOBAK-1-2 instrument. Latent correlations between AMC factors and the corresponding PMC factors were r = 0.79 for "object movement" and r = 0.76 for "self-movement". Associations with external criteria and covariates, such as sex, were associated with both AMC and PMC. Analyses also revealed that children who participated more often in individual and team sports showed higher levels in both AMC and PMC. The confirmation of the two-factorial structure of the SEMOK-1-2 instrument and the associations between AMC and PMC as well as external criteria indicate construct and criterion validity. The SEMOK-1-2 instrument can be economically utilized for assessing PMC and is also suitable for the monitoring of PMC in the context of Physical Education.

When multidisciplinary clinical practice and research meet: Quality development in the Danish Children Centers.

BACKGROUND: Collaboration between clinical practice and research is often warranted. Extended periods of collaboration integrating research and practice is however rare. This article is about a series of joint research projects through the course of 8 years involving the Danish Center of Psychotraumatology and five regional centres dedicated to combating the sequelae of child abuse across Denmark. METHOD: We describe the development of a standardized assessment battery and how this work evolves, analyses of administrative data, what happens after the assessment, the impact of working with child abuse on employees, profiles of abuse that vary by gender, national conferences and training programs, and international collaboration. RESULT: The collaboration between research and practice against child abuse has been seminal and is still ongoing. We have learnt about new problem areas and have produced information that can be used to serve children, employees, and civil society in better ways. DISCUSSION: This work is inspired by and aligns with initiatives abroad pertaining the construction of Children Centers, of assessments tools and child abuse trauma research. CONCLUSION: Mutual respect, dedication, and patient persistence pave the way for significant results in a committed relationship.

This article describes and reflect upon a year-long collaboration between a multidisciplinary clinical organization, the Danish Children Centers, and a research centre, the Danish Center of Psychotraumatology who have joined forces to provide the best help for children exposed to physical, sexual, or psychological abuse. The article describes the collaboration on developing a trauma-focused, developmentally sensitive psychological assessment battery for children of all ages. The article thereafter describes and reflects upon other projects of the collaboration that benefit both research and practice, including the establishment of data base for studying the psychological state of children exposed to abuse and related studies on child abuse; evaluations of the Children Centers practices; examinations of care and treatment for abused and traumatized children, training of staff and other interested parties; and examination and prevention of secondary traumatization among the Children Centers staff. With mutual respect for all professions, dedication, and patient persistence a professional collaboration can evolve.

Development of the Arabic Inventory of Parent and Domestic Worker Attachment (A-IPDWA): A tool to assess adolescents' attachment to secondary figures.

INTRODUCTION: Adolescents' attachment security toward parental figures has been assessed in multiple cultures and languages. In some cultural contexts, the presence of a secondary parental figure is ubiquitous, though its effect on children's and adolescents' well-being has been understudied. The present study aimed to validate a culture-specific Arabic instrument of attachment security, in an adolescent sample of Qatar. Since foreign domestic workers (Khadama) play a key role as secondary caring figures in Middle Eastern countries, the new instrument included parents (i.e., mother and father) and domestic workers as providers of attachment security. METHODS: A sample of 387 adolescents (ages 12-17 years; 48.3% females) participated in the study in the 2020-2021 school term. While 286 students completed the version in modern Arabic, 101 counterparts attending international schools filled in the English version for comparison purposes. RESULTS: Confirmatory Factor Analysis for all three forms (i.e., mother, father, and domestic worker) showed the one-dimension of the Arabic tool. Optimal Tucker's Phi coefficient indicated a comparable one-factor structure of attachment security across linguistic versions. Moderate correlations (positive and negative, respectively) of attachment security towards father and mother (but not towards domestic workers) with family cohesion and family conflict dimensions of the Family Environment Scale provided evidence for the concurrent validity. DISCUSSION: Gender differences in the links between adolescents' attachment security and family conflict were observed; culturally relevant relationship family patterns are stressed. The practical implications of the Arabic Inventory of Parent and Domestic Worker Attachment (A-IPDWA) validation are discussed.

Is there an affective neuroscience of spirituality? The development and validation of the OCEANic feelings scale.

Background: Oceanic feelings represent a phenomenological structure of affective sensations that characteristically involve feelings of self-dissolution and feelings of unity and transcendence. This study presents the preliminary version of a self-report instrument to measure individual dispositions toward oceanic feelings in order to enable further research within the concept of primary emotions postulated by Jaak Panksepp. Methods: A first version of the questionnaire was applied to a total sample of 926 German-speaking adults of the general population. After performing item analysis and principal component analysis (PCA) in a first study (N = 300), the questionnaire was shortened. In a second study (N = 626), confirmatory factor analysis (CFA) was conducted and emerged scales were related to the already established instruments for the assessment of primary emotions (BANPS-GL) and Big Five personality traits (BFI-44). Results: The OCEANic scale exhibited reliabilities ranging from Cronbach's α = 0.82 (positive) to α = 0.88 (negative) and plausible correlations with behavioral traits related to the seven affective neurobiological systems (ANGER, FEAR, CARE, SEEK, PLAY, SADNESS, and LUST) as well as with personality factors measured by the Big Five Inventory. For CFA, a bifactorial model with an overall factor demonstrated good fit: RMSEA = 0.00 (90% CI:0.00, 0.03); TLI = 1.00; CFI = 1.00; NFI = 0.99. Discussion: The OCEANic scale enables the operationalization of oceanic feelings comprising two subscales and one total scale. The results indicate good reliability and acceptable factorial validity. Establishment and further validation of the OCEANic scale within future research will be needed to fully understand the role of oceanic feelings within the human affective life, especially the personality trait of spirituality.

Development and preliminary validation of a novel eating disorder screening tool for vegetarians and vegans: the V-EDS.

BACKGROUND: Eating disorders have one of the highest mortality of all mental illnesses but are associated with low rates of screening and early intervention. In addition, there remains considerable uncertainty regarding the use of current standardised screening tools in measuring eating pathology in vegetarians and vegans. With these groups presenting as potential at-risk groups for disordered eating development, the present study aimed to develop and preliminary validate a novel eating disorder screening tool, the Vegetarian Vegan Eating Disorder Screener (V-EDS). METHODS: We utilised a mixed-methods approach, comprising four phases. RESULTS: A conceptual framework was developed from 25 community, clinician, and lived experience interviews and used to derive a preliminary set of 163 items (Phase 1). Phase 2 piloted the items to establish face and content validity through cognitive debriefing interviews of 18 additional community, clinician, and lived experience participants, resulting in a reduced, revised questionnaire of 53 items. Phase 3 involved scale purification using Item Response Theory in analysis of 230 vegetarians and 230 vegans resulting in a further reduced 18-item questionnaire. Phase 4 validated the screening tool in a large community sample of 245 vegetarians and 405 vegans using traditional psychometric analysis, finding the V-EDS supports a unidimensional factor structure with excellent internal consistency (α = 0.95-0.96) and convergent validity (0.87-0.88), and moderate discriminate validity (0.45-0.55). CONCLUSIONS: This study provided strong initial support for the psychometric validity and theoretical assumptions of the novel V-EDS screening tool. The V-EDS has the potential to increase early intervention rates for vegetarians and vegans experiencing eating disorder symptoms, further supporting advocacy and treatment approaches for these expanding dietary groups.

The present study describes the development and preliminary validation of the first screening tool designed to uniquely assess eating disorder symptoms in individuals following a vegetarian or vegan diet. Following several development phases, the final version of the Vegetarian Vegan Eating Disorder Screener (V-EDS) comprises 18-items, with six dietary characteristic items and 12 eating disorder scored items. The current findings support excellent initial reliability and validity of the V-EDS. The V-EDS constitutes a promising tool that could potentially be integrated as a standalone measure for initial screening in clinical and research settings, but also for more comprehensive assessment when combined with other gold-standard eating disorder tools.

Intermediate-tier options in the environmental risk assessment of plant protection products for soil invertebrates-Synthesis of a workshop.

The European environmental risk assessment (ERA) of plant protection products follows a tiered approach. The approach for soil invertebrates currently consists of two steps, starting with a Tier 1 assessment based on reproduction toxicity tests with earthworms, springtails, and predatory mites. In case an unacceptable risk is identified at Tier 1, field studies can be conducted as a higher-tier option. For soil invertebrates, intermediate tiers are not implemented. Hence, there is limited possibility to include additional information for the ERA to address specific concerns when the Tier 1 fails, as an alternative to, for example, a field study. Calibrated intermediate-tier approaches could help to address risks for soil invertebrates with less time and resources but also with sufficient certainty. A multistakeholder workshop was held on 2-4 March 2022 to discuss potential intermediate-tier options, focusing on four possible areas: (1) natural soil testing, (2) single-species tests (other than standard species), (3) assessing recovery in laboratory tests, and (4) the use of assembled soil multispecies test systems. The participants acknowledged a large potential in the intermediate-tier options but concluded that some issues need to be clarified before routine application of these approaches in the ERA is possible, that is, sensitivity, reproducibility, reliability, and standardization of potential new test systems. The definition of suitable assessment factors needed to calibrate the approaches to the protection goals was acknowledged. The aims of the workshop were to foster scientific exchange and a data-driven dialog, to discuss how the different approaches could be used in the risk assessment, and to identify research priorities for future work to address uncertainties and strengthen the tiered approach in the ERA for soil invertebrates. This article outlines the background, proposed methods, technical challenges, difficulties and opportunities in the ERA, and conclusions of the workshop. Integr Environ Assess Manag 2024;20:780-793. © 2023 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Italian Adaptation of the Diagnostic Adaptive Behavior Scale: Application of the Best Practices for Translating and Adapting Tests.

BACKGROUND: The presence during the developmental period of significant limitations in adaptive behavior is an essential component along with deficits in intellectual functioning for diagnosing intellectual disability. Only the Diagnostic Adaptive Behavior Scale (DABS) specifically assesses the required significant limitations in adaptive behavior. The DABS allows measuring the three adaptive behavior domains of conceptual, practical, and social skills, in individuals aged 4 to 21. This paper aims to present the process of translation/adaptation of the DABS for the Italian culture/country and describes the best practices in adapting a test across cultures/countries. METHODS: A six-step procedure was followed: (1) translation/adaptation of the original DABS into Italian; (2) consolidation of the translation/adaptation and preparation of the Preliminary Translation; (3) validation of the Preliminary Translation; (4) revision/adjustment and preparation of the Pretest Translation; (5) field-testing of the Pretest Translation; and (6) revision/ adjustment and preparation of the Final Translation of the DABS Italian version. Two different committees were involved and were composed of members with competencies in the development/adaptation of psychological tests, in the target construct (i.e., adaptive behavior), in the administration of measures assessing the target construct, in the target populations/languages (i.e., American and Italian), and in the target individuals (i.e., with deficits in adaptive behavior). Furthermore, a field-test was conducted with potential test users. RESULTS: The results of the translation/adaptation process described herein present evidence that it resulted in a valid DABS Italian version. It can be said that the final item pool best represented the substantive meaning of the original DABS items in a linguistic style that was understandable and simple while capturing behaviors that can be observed/measured in the Italian cultural context. CONCLUSIONS: Following the best practices in translating/adapting tests, we developed the DABS Italian version with evidence of psychometric properties as excellent as those of the original DABS.

WORDS: A New Verbal Memory Test to Evaluate Cognitive Health in a Zambian School-aged Population.

Objective: The paucity of psychometric instruments is one of the challenges preventing the effective implementation of child cognitive health testing in Sub-Saharan countries. WORDS is a new memory assessment tool originally validated in a Zambian school-aged population. Design: WORDS involves the standardized administration of a multitrial, verbal, free recall task with acquisition and immediate recall of a structured list of 16 words, followed by a second acquisition and delayed recall after a five-minute interference. A field trial was carried out to evaluate test feasibility of use, reliability, and validity. A total of 448 children, aged 5 to 17 years, were recruited at multiple Zambian clinical sites and schools. Results: WORDS provides a summary score of recall productivity derived from the sum of items correctly retrieved at immediate and delayed recalls. Recall productivity showed a moderate/good reliability at test-retest with alternate forms (N=53, 95% confidence interval of the intraclass correlation [CI-IC]: 0.73, 0.54-0.85). Recall productivity was found to increase with age. Altered memory functioning, as indicated by lower recall productivity, was associated with poor health status resulting from chronic neurologic or medical disease or prolonged exposure to psychosocial stress and deprivation [recall productivity, range: 0-32, healthy mean (standard deviation [SD]): 15.36 (4.7) vs. poor health, mean (SD): 12.62 (4.8); F (1,446)=27.79, p=0.000, d=0.58]. Conclusion: WORDS addresses the need for new psychometric tools to evaluate memory in a school-aged Zambian population. WORDS has the potential for clinical utility to evaluate cognitive development, as well as the effect of different health conditions on memory. Study results warrant research to further validate its use in Sub-Saharan clinical and epidemiological research settings.

Using Automatic Item Generation to Create Multiple-Choice Questions for Pharmacy Assessment.

OBJECTIVE: Automatic item generation (AIG) is a new area of assessment research where a set of multiple-choice questions (MCQs) are created using models and computer technology. Although successfully demonstrated in medicine and dentistry, AIG has not been implemented in pharmacy. The objective was to implement AIG to create a set of MCQs appropriate for inclusion in a summative, high-stakes, pharmacy examination. METHODS: A 3-step process, well evidenced in AIG research, was employed to create the pharmacy MCQs. The first step was developing a cognitive model based on content within the examination blueprint. Second, an item model was developed based on the cognitive model. A process of systematic distractor generation was also incorporated to optimize distractor plausibility. Third, we used computer technology to assemble a set of test items based on the cognitive and item models. A sample of generated items was assessed for quality against Gierl and Lai's 8 guidelines of item quality. RESULTS: More than 15,000 MCQs were generated to measure knowledge and skill of patient assessment and treatment of nausea and/or vomiting within the scope of clinical pharmacy. A sample of generated items satisfies the requirements of content-related validity and quality after substantive review. CONCLUSION: This research demonstrates the AIG process is a viable strategy for creating a test item bank to provide MCQs appropriate for inclusion in a pharmacy licensing examination.

Development and validation of the Character Strengths Test 24 (CST24): a brief measure of 24 character strengths.

BACKGROUND: The present study aimed to develop and validate the Character Strengths Test 24 (CST24), a simple scale consisting of 24 character strengths represented by one concept word and one sentence each. Three studies were conducted to examine the validation and utility of the CST24 for future research. METHODS: Three internet-based surveys were conducted in Japan to investigate the psychometric properties of the CST24. Study 1 comprised 846 adults and focused on test development, including the evaluation of well-being and strengths scales, as well as retest reliability. Study 2 involved 1137 high school students and 1101 college undergraduates, aiming to investigate the factor structure of the CST24 and reaffirm its validity by utilizing happiness and meaning in life scales. In Study 3, 524 working adults participated to explore the scale's potential for future research. This study incorporated various psychological scales, such as value orientation, moral foundation, and work-related scales, to assess the utility of the CST24. RESULTS: In Study 1, the CST24 items exhibited a well-distributed response pattern, demonstrating favorable retest reliability and internal consistency. Significant positive correlations were found between the CST24 items and measures of subjective well-being, meaning in life, positive self-compassion, and knowledge or utilization of strengths. Study 2 confirmed the stability of the factor structure across diverse sample groups, consistent with prior studies utilizing larger-scale measures. Study 3 identified both core and peripheral strengths, highlighting specific strengths that made substantial contributions to well-being, value orientation, moral foundation, sense of mission, and work-related indices through multiple regression analysis. CONCLUSION: The findings support the reliability and validity of the CST24 as a concise assessment tool for measuring 24 character strengths. Its potential utility for screening and exploratory research warrants attention in future studies, enhancing our understanding of the role of character strengths in various domains.

Metabolic biomarkers significantly enhance the prediction of HBV-related ACLF occurrence and outcomes.

BACKGROUND & AIMS: Acute-on-chronic liver failure (ACLF) is a clinical syndrome associated with high short-term mortality in patients with chronic liver disease. Chronic hepatitis B is the main cause of ACLF (HBV-ACLF) in China and other Asian countries. To improve disease management and survival for patients with ACLF, we aimed to discover novel biomarkers to enhance HBV-ACLF diagnosis and prognostication. METHODS: We performed a metabolomics profiling of 1,024 plasma samples collected from patients with HBV-related chronic liver disease with acute exacerbation at hospital admission in a multi-year and multi-center prospective study (367 ACLF and 657 non-ACLF). The samples were randomly separated into equal halves as a discovery set and a validation set. We identified metabolites associated with 90-day mortality in the ACLF group and the progression to ACLF within 28 days in the non-ACLF group (pre-ACLF) using statistical analysis and machine learning. We developed diagnostic algorithms in the discovery set and used these to assess the findings in the validation set. RESULTS: ACLF significantly altered the plasma metabolome, particularly in membrane lipid metabolism, steroid hormones, oxidative stress pathways, and energy metabolism. Numerous metabolites were significantly associated with 90-day mortality in the ACLF group and/or pre-ACLF in the non-ACLF group. We developed algorithms for the prediction of 90-day mortality in patients with ACLF (area under the curve 0.87 and 0.83 for the discovery set and validation set, respectively) and the diagnosis of pre-ACLF (area under the curve 0.94 and 0.88 for the discovery set and validation set, respectively). To translate our discoveries into practical clinical tests, we developed targeted assays using liquid chromatography-mass spectrometry. CONCLUSIONS: Based on novel metabolite biomarkers, we established tests for HBV-related ACLF with higher accuracy than existing methods. CLINICAL TRIAL NUMBER: NCT02457637 and NCT03641872. IMPACT AND IMPLICATIONS: Acute-on-chronic liver failure (ACLF) is a clinical syndrome associated with high short-term mortality affecting 25% of patients hospitalized with cirrhosis. Chronic hepatitis B is the main etiology of ACLF in China and other Asian counties. There is currently no effective therapy. Early diagnosis and accurate prognostication are critical for improving clinical outcomes in patients with ACLF. Based on novel metabolite biomarkers, we developed liquid chromatography-mass spectrometry tests with improved accuracy for the early diagnosis and prognostication of HBV-related ACLF. The liquid chromatography-mass spectrometry tests can be implemented in clinical labs and used by physicians to triage patients with HBV-related ACLF to ensure optimized clinical management.

Development of Brief Alcohol and Cannabis Motives Measures: Psychometric Evaluation Using Expert Feedback and Longitudinal Methods.

Objective: Alcohol and cannabis use motives are often studied as contributors to risky substance use patterns. While various measures for capturing such motives exist, most contain 20+ items, which render their inclusion in certain research designs (e.g., daily diary) or with certain populations (e.g., polysubstance users) unfeasible. We sought to generate and validate six-item measures of cannabis and alcohol motives from existing measures, the Marijuana Motives Measure (MMM) and the Modified Drinking Motives Questionnaire-Revised (MDMQ-R). Methods: In Study 1, items were generated, feedback from 33 content- domain experts was obtained, and item revisions were made. In Study 2, the finalized brief cannabis and alcohol motives measures, along with the MMM, MDMQ-R, and substance-related measures, were administered to 176 emerging adult cannabis and alcohol users (71.6% female) at two timepoints, two months apart. Participants were recruited through a participant pool. Results: Study 1 experts indicated satisfactory ratings of face and content validity. Expert feedback was used to revise three items. Study 2 results suggest test-retest reliabilities for the single-item forms (r = .34 to .60) were similar to those obtained with full motives measures (r = .39 to .67). Validity was acceptable-to-excellent in that brief and full-length measures were significantly intercorrelated (r = .40 to .83). The brief and full-length measures had similar concurrent and predictive relationships for cannabis and alcohol quantity x frequency (coping- with-anxiety for cannabis and enhancement for alcohol) and problems (coping-with-depression), respectively. Conclusions: The brief measures represent psychometrically-sound measures of cannabis and alcohol use motives with substantially less participant burden than the MMM and MDMQ-R.

Defining aphasia: Content analysis of six aphasia diagnostic batteries.

Clear operational definitions of constructs are necessary to ensure that research findings are meaningful and interpretable. In the field of aphasiology, aphasia is often defined to the effect of "aphasia is an acquired language disorder often due to brain injury that affects expressive and receptive language." To contribute to our understanding of the construct of aphasia, we conducted a content analysis of six diagnostic aphasia tests: the Minnesota Test for the Differential Diagnosis of Aphasia, the Porch Index of Communicative Ability, the Boston Diagnostic Aphasia Examination, the Western Aphasia Battery, the Comprehensive Aphasia Test, and the Quick Aphasia Battery. These chosen tests have historical prominence, with several in regular clinical and research use today. We hypothesized that the content of the aphasia tests should be very similar since they all purport to identify and characterize (if present) aphasia, with recognition that there may be some subtle differences in test content stemming in large part to epistemological differences in the test makers' views of aphasia. Instead, we found predominantly weak Jaccard indices, a similarity correlation coefficient, between test targets. Only five test targets were found in all six aphasia tests: auditory comprehension of words and sentences, repetition of words, confrontation naming of nouns, and reading comprehension of words. The qualitative and quantitative results suggest that the content across aphasia tests may be more disparate than expected. We conclude by discussing the implication of our results for the field, including the importance of updating, if necessary, the operational definition of aphasia through conversation with a broad audience of interested and affected people.

WAVES: A Novel Test to Evaluate Visuospatial Construction Ability in a School-aged Population.

Objective: The paucity of valid diagnostic tools is one of the challenges preventing the effective implementation of child cognitive health testing in Sub-Saharan developing countries. WAVES addresses the need for new psychometric tests to evaluate visuospatial construction ability in a school-aged population. WAVES involves the standardized administration of a copy design task that is sequentially repeated by four distinct reproduction modalities: copy design with open eyes (CDO), immediate reproduction from memory with open eyes (IRMO), immediate reproduction from memory with closed eyes (IRMC), and delayed reproduction from memory with closed eyes (DRMC). Design: WAVES reliability and validity were assessed in a field trial using Classical Test Theory or Item Response Theory (IRT) methods. A total of 445 children, aged 5 to 17 years old, were recruited at multiple Zambian clinical sites and schools. Results: WAVES provides a visuographomotor construction processing (VGCP) index and three subscale inaccuracy of reproduction scores: perseveration, decreased spacing, and changing direction difficulty (CDD). WAVES scores depended on age and showed an age-related increase of reproduction accuracy. Altered visuospatial construction, as indicated by higher scores, was associated with poor health status (i.e., chronic neurologic or medical disease or prolonged exposure to psychosocial stress and deprivation). Reliability estimates, expressed as an intraclass correlation coefficient (ICC; 95% confidence interval [CI]), at test-retest (n=86) were: VGCP Index: 0.94 (0.91, 0.96); perseveration: 0.76 (0.62, 0.84); decreased spacing: 0.86 (0.79, 0.91); and CDD: 0.93 (0.89, 0.95). Conclusion: WAVES has potential for clinical utility in evaluating the effect of different health conditions on visuospatial construction ability. Study results warrant further research to validate its use in healthcare and clinical research settings.

Development of a Symbol Cancellation Test to Evaluate Attention in a School-aged Zambian Population.

Objective: The assessment of child cognitive health in Sub-Saharan developing countries poses significant challenges, including the paucity of valid diagnostic tools. We report the development and the initial validation of the Zambia Symbol Cancellation Test (ZSCT), a psychometric test to evaluate selective attention in a pediatric, school-aged population. Design: ZSCT reliability and validity were assessed in a field trial. A total of 409 children, aged 5 to 17 years, were recruited at multiple Zambian clinical sites and schools. The ZSCT provides a visuomotor processing index (VMPI), a measure of effortful processing to deliver accurate task response. Results: The VMPI reliability estimate at test-retest was found to be adequate for a clinical use (intraclass correlation coefficient [ICC]: 0.79, ICC-95% confidence interval [CI]: 0.69-0.86). Age showed a large effect on VMPI (n=323, r=-0.62, p=0.000). Impaired visuo-perceptual-motor processing, as measured by VMPI, was associated with poor health status (i.e., chronic neurologic or medical disease or prolonged exposure to psychosocial stress and deprivation). A two-way ANOVA found significant and small health status and age group effects [F (7, 408): 33.24, p=0.0000, η2=0.367]; the main effect of health status [F (1, 408): 37.79, p=0.000, η2=0.09], age group [F (3, 408): 35.06, p=0.000, η2=0.21], and their interaction was not significant (p=0.364). Conclusion: Study findings indicate that the ZSCT has satisfactory reliability, validity, and clinical utility to evaluate cognitive development and the effect of health conditions on attention. Study results warrant further research to validate its use in healthcare and clinical research settings.

Impact of VALID Act implementation on mass spectrometry-based clinical proteomic laboratory developed tests.

Mass spectrometry (MS)-based clinical proteomic Laboratory Developed Tests (LDTs) for the measurement of protein biomarkers related to endocrinology, cardiovascular disease, cancer, and Alzheimer's disease are gaining traction in clinical laboratories due to their value in supporting diagnostic and treatment decisions for patients. Under the current regulatory landscape, MS-based clinical proteomic LDTs are regulated by Clinical Laboratory Improvement Amendments (CLIA) under the auspices of the Centers for Medicaid and Medicare Services (CMS). However, should the Verifying Accurate Leading-Edge In Vitro Clinical Test Development (VALID) Act pass, it will grant the FDA greater authority to oversee diagnostic tests, including LDTs. This could impede clinical laboratories' ability to develop new MS-based proteomic LDTs to support existing and emerging patient care needs. Therefore, this review discusses the currently available MS-based proteomic LDTs and their current regulatory landscape in the context of the potential impacts imposed by the passage of the VALID Act.