Inclusive measure development: amplifying the voices of adolescents and young adults with spina bifida in a new measure of benefit-finding and growth.

OBJECTIVE: Benefit-finding and growth is an important process across a range of medical populations. However, it has been understudied in the context of lifelong chronic conditions, such as spina bifida (SB). This study aimed to develop a new measure of benefit-finding and growth for youth with SB, confirm its factor structure, and examine its psychometric properties. METHOD: To generate items for the new measure, 20 adolescents and young adults with SB completed qualitative interviews regarding their experience of living with SB. Interviews were coded for benefits. Questionnaire items were generated from these benefits, and an expert panel refined the wording of these items. The resultant 31-item measure was shared with six of the 20 participants for feedback and then piloted among 251 youth with SB. The factor structure of the measure was confirmed and reliability and convergent validity were assessed. RESULTS: Both a one- and four-factor structure were supported. The four factors include: Life Perspectives and Priorities, Personal Characteristics and Traits, Connections and Opportunities, and Problem Solving. Higher total and factor scores represent greater benefit-finding and growth. The measure demonstrated excellent internal consistency (α = 0.95). The new measure also showed significant positive correlations with optimism, positive affect, and life satisfaction. CONCLUSIONS: This study produced a measure of benefit-finding and growth for youth with SB. Clinically, information about what youth with SB perceive to be their areas of strength and growth from their condition provides crucial insight into which factors to enhance in this population.

Differential item functioning of the revised Multigroup Ethnic Identity Measure (MEIM-R) in racially and income diverse youth with type 1 diabetes.

OBJECTIVE: Racially minoritized youth with T1D are made vulnerable to disproportionately adverse health outcomes compared to White peers due to enduring systems of oppression. Thus, understanding modifiable psychosocial factors associated with diabetes-related outcomes in racially minoritized youth may help to buffer deleterious effects of racism. One factor meriting exploration is racial-ethnic identity. There is currently limited research on measures fit to assess ethnic identity in youth with chronic illnesses. This study's purpose is to examine the factor structure, reliability, and validity of the revised Multigroup Ethnic Identity Measure (MEIM-R) in a racially- and income-diverse sample of youth with T1D across sociodemographic and illness-related proxies for one's positionality in oppressive systems. METHOD: As part of a larger study examining resilience, 142 youth with T1D ages 12-18 (Mage = 14.66, SDage = 1.62, 55.6% Black/African-American, 44.4% White) completed the MEIM-R and various psychosocial measures. HbA1c levels and illness duration were extracted from medical records and caregivers reported income information. Confirmatory factor analyses compared the structural validity of competing MEIM-R models, and uniform and non-uniform differential item functioning (DIF) was explored across sociodemographic and illness-related factors. RESULTS: While a bifactor structure was supported, the MEIM-R was found to exhibit DIF by race and gender on multiple MEIM-R items and did not demonstrate linear bivariate relations with other psychosocial factors. CONCLUSIONS: Since different MEIM-R item response patterns were observed across racial/ethnic and gender groups, caution is warranted in using this measure in racially and gender diverse youth with T1D.

Examining the psychometric properties of the CEFIS-AYA using item response theory.

OBJECTIVE: The COVID-19 Exposure and Family Impact Scale, Adolescent and Young Adult Version (CEFIS-AYA; Schwartz, L. A., Lewis, A. M., Alderfer, M. A., Vega, G., Barakat, L. P., King-Dowling, S., Psihogios, A. M., Canter, K. S., Crosby, L., Arasteh, K., Enlow, P., Hildenbrand, A. K., Kassam-Adams, N., Pai, A., Phan, T. L., Price, J., Schultz, C. L., Sood, E., Wood, J., & Kazak, A. (2022). COVID-19 exposure and family impact scales for adolescents and young adults. Journal of Pediatric Psychology, 47, 631-640. https://doi.org/10.1093/jpepsy/jsac036) was developed to assess the pandemic's effects on adolescents and young adults (AYA). Via principal component analysis, measure developers examined the structure and reliability of the CEFIS-AYA and identified seven exposure and five impact components. This study built upon prior work through use of item response theory (IRT) models to characterize the dimensionality of the CEFIS-AYA, determine the strength of relations between items and underlying trait(s), and examine associations between trait scores and pandemic-related distress. METHODS: This was a secondary analysis of data collected between July 2020 and July 2021 from three studies of emerging adults (ages 18-29; N = 834). RESULTS: The CEFIS-AYA structure was multidimensional, with the strongest support for five traits. Trait 1 represented pandemic impact on social/emotional functioning and self-care. Trait 2 reflected other pandemic disruptions. Trait 3 represented pandemic disruptions to education and/or other milestones. Trait 4 represented pandemic impact on physical well-being. Trait 5 assessed pandemic disruptions to work/financial circumstances. Item loadings and parameters indicated variability in how consistently trait level was associated with item endorsement. Trait scores did not predict distress, except that increases in Trait 3 were associated with lower distress. CONCLUSIONS: The present study examined the psychometric properties of the CEFIS-AYA among emerging adults using a statistical framework better suited for modeling categorical data. The identified dimensional structure was relatively consistent with the initial psychometric evaluation of the CEFIS-AYA, albeit more parsimonious. However, replication is critical in light of sample demographic characteristics.

An ultrahigh-performance liquid chromatography-tandem mass spectrometry method for quantification of methotrexate and 7-hydroxy-methotrexate and application for therapeutic drug monitoring in patients with central nervous system lymphoma.

A method using ultrahigh-performance liquid chromatography-tandem mass spectrometry was developed, validated, and applied to simultaneously determine plasma methotrexate (MTX) and 7-hydroxy-methotrexate (7-OH-MTX) in 117 patients with central nervous system (CNS) lymphoma. The ion transitions utilized were m/z 455.2 > 308.2 for MTX and m/z 471.2 > 324.1 for 7-OH-MTX. Samples were prepared through protein precipitation using methanol. Chromatographic separation was achieved within 3.0 min on a CMS9030 column (Ruixi, 2.1 × 50 mm, 3 µm) through a gradient elution of methanol and a 10% ammonium acetate solution at a flow rate of 0.4 mL/min. The method demonstrated linearity in the concentration range of 0.05-10 µM for MTX and 0.25-50 µM for 7-OH-MTX. The intra- and inter-day inaccuracy ranged from -7.38% to 7.83%, and the imprecision was less than 6.00% for both analytes. The recovery and matrix effect normalized by the internal standard (MTX-D3 ) remained consistent. Both analytes remained stable under nine different storage conditions. In patients with CNS lymphoma, MTX levels at 12 h and 7-OH-MTX levels at 12, 36, and 60 h after dosing in individuals with impaired renal function were significantly higher compared with those with normal renal function. 7-OH-MTX could potentially serve as a superior indicator for nephrotoxicity compared with MTX.

Development and Validation of USM-Insulin Adherence Module for Patients with Type 2 Diabetes Mellitus.

Background: Many patients with type 2 diabetes mellitus (T2DM) do not achieve the desired glycaemic control despite being treated with insulin. Studies found this due to an improper understanding of insulin function, its intensification process and patients' negative perspective on insulin. We developed an education module to enhance adherence to insulin therapy. Methods: This study applied a mixed design. It was conducted in three phases: i) Phase I: literature search and focus group discussions (FGDs), ii) Phase II: module development and iii) Phase III: content and face validation of Universiti Sains Malaysia-Insulin Adherence Module (USM-IAM). FGDs were used to gather patients' opinions. All researchers repeatedly discussed about the module content and arrangement, the words and images used, and the grammar in producing the final draft. Specialists and target audience performed content and face validation of the module. Results: Thirty-six participants were involved in the FGDs. Data saturation was achieved at the 4th FGD. Three themes emerged from qualitative data analysis and were incorporated into the module. USM-IAM was finalised with five units. The content validity index (CVI) was 0.92, while face validity agreements were between 86% and 97%. Conclusion: The CVI and face agreement for USM-IAM exceed the cut-off point for a sound module. It has good potential to be used as a resource for educating patients in enhancing insulin adherence.

Preclinical pharmacokinetic and in vitro metabolic stability study of lysosomotropic autophagy inhibitor, IITZ-01 in mice by using UPLC-MS/MS.

The present study evaluates the pharmacokinetics and metabolic stability of a novel lysosomotropic autophagy inhibitor, IITZ-01 using an ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS-MS). It is required as this lead molecule awaits pre-clinical studies for development because of significant therapeutic outcomes in triple-negative breast cancer and renal cancer. A bioanalytical method for the quantitative determination of IITZ-01 in the plasma of mice was developed using the UPLC-MS/MS technique. The UPLC-MS/MS method was validated according to US-FDA bioanalytical guidance and successfully applied to study the pharmacokinetics and metabolic stability. Separation of IITZ- 01 and ZSTK474 (IS) from endogenous components with high selectivity and sensitivity (0.5 ng/mL) was achieved using Waters Acquity BEH C-18 column (50 mm × 2.1 mm, 1.7 µm). A gradient mobile phase consisting of 0.1 % formic acid in water and 0.1 % formic acid in acetonitrile was applied at a flow rate of 0.2 mL/min. Electrospray ionization was employed in positive ion mode for detection, while quantification utilized the multiple reaction monitoring (MRM) mode. This involved using [M+H]+fragment ions at m/z 483.19 â†’ 235.09 for IITZ-01 and m/z 418 â†’ 138 for the internal standard (IS). The method was validated over the calibration range of 0.5-800 ng/mL. The LLOQ of IITZ-01 was 0.5 ng/mL in mice plasma. The method demonstrated good in terms of intra- and inter-day precision and accuracy. The matrix effect was found to be negligible, and the stability data were within acceptable limits. The validated technique supports suitability, reliability, reproducibility, and sensitivity for the pre-clinical investigation of IITZ-01 pharmacokinetics in mice and metabolic stability in human liver microsomes.

A multi-residue method for trace analysis of pesticides in soils with special emphasis on rigorous quality control.

A multi-residue trace analytical method is presented to accurately quantify 146 currently used pesticides in (agricultural) soils with varying soil properties. Pesticides were extracted using an optimized quick, easy, cheap, effective, rugged, and safe (QuEChERS) approach and chemical analysis was carried out by liquid chromatography coupled to tandem mass spectrometry (triple quadrupole). Quantification was based on matrix-matched internal standards calibration, using 95 isotopically labeled analyte analogues. In contrast to the common approach of method validation using soils freshly spiked with analytes shortly before the extraction, our method is additionally validated via an in-house prepared partly aged soil, which contains all target pesticides and via agricultural field soils with native pesticide residues. The developed method is highly sensitive (median method limit of quantification: 0.2 ng/g), precise (e.g., median intra-day and inter-day method precision both ~ 4% based on field soils), and true ((i) quantified pesticide concentrations of the partly aged soil remained stable during 6 months, were close to the initially spiked nominal concentration of 10 ng/g, and thus can be used to review trueness in the future; (ii) median freshly spiked relative recovery: 103%; and (iii) participation in a ring trial: median z-scores close to one (good to satisfactory result)). Its application to selected Swiss (agricultural) soils revealed the presence of in total 77 different pesticides with sum concentrations up to 500 ng/g. The method is now in use for routine soil monitoring as part of the Swiss Action Plan for Risk Reduction and Sustainable Use of Plant Protection Products.

Stability-indicating method development and validation for quantitative estimation of organic impurities of the antidiabetic drug glipizide in drug substance and pharmaceutical dosage form using HPLC.

Glipizide is an antidiabetic drug used for the treatment of type 2 diabetes. A simple, reliable and robust reverse-phase liquid chromatographic method (RP-HPLC) was developed and validated as per International Conference on Harmonization Q2(R1) for estimating the impurities of glipizide in pharmaceutical formulations. The chromatographic separation was carried out on a Phenomenex Luna C18 (2), 250 × 4.6 mm, 5 µm with a binary solvent delivery system [MP-A, a homogenous mixture of water and acetonitrile in a ratio of 90:10 (v/v) and 1 ml of orthophosphoric acid; and MP-B, a homogenous mixture of water and acetonitrile in a ratio of 10:90 (v/v) and 1 ml of orthophosphoric acid] with a detection wavelength of 225 nm, a column temperature of 30°C, a flow rate of 1.5 ml/min, and an injection volume of 20 µl. All process, degradant and unknown impurities were separated well with a resolution >2.2 and were estimated accurately without any interference. The recovered values and regression values were 98.7-100.5% and R2 > 0.9999, respectively. The recovery and linearity studies covered the quantitation limit to 150% of the specification limit. The stability-indicating properties of the developed RP-HPLC method was assessed from the forced degradation studies. The developed method was successfully applied for real-time sample analysis of the glipizide dosage form.

Stability-indicating method development and validation for quantitative estimation of assay and organic impurities of antiviral drug baloxavir marboxil in drug substance and pharmaceutical dosage form using HPLC and LC-MS methods.

Baloxavir marboxil (BXM) is a polymerase acidic endonuclease inhibitor used as an antiviral drug. A simple, reliable, and robust liquid chromatographic method was developed and validated per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q2(R1) for estimating the assay and impurities of BXM in drug substance and pharmaceutical formulations. The chromatographic separation was carried out on C18 (100 × 4.6 mm, 5 µm) with binary solvent delivery system (A:0.1% trifluoroacetic acid in water; B:0.1% trifluoroacetic-acid in acetonitrile) along with detection wavelength of 260 nm, column temperature of 57°C, flow of 1.2 mL/min and injection volume of 10 µL. All five known impurities and unknown impurities were separated well with resolution >1.7 and were estimated accurately without any interference. Recovered values and regression value were 99.5%-101.2% and R2  > 0.999, respectively. The recovery and linearity studies covered from 50% to 150% for assay, and quantitation limit, 120% for five BXM impurities. Stability-indicating property of the HPLC developed method was assessed from the forced degradation studies. The mass spectral data of unknown impurity formed under oxidation stress condition were discussed. The developed method was also successfully utilized for stability sample analysis of drug substance and tablet dosage form.

Development and psychometric validation of the hospitalized older adults' dignity scale for measuring dignity during acute hospitalization.

AIM: To develop and validate a culturally appropriate patient-reported outcome measure for measuring dignity for older adults during acute hospitalization. DESIGN: A three-phased exploratory sequential mixed-method design was used. METHODS: Domains were identified and items were generated from findings of a recent qualitative study, two systematic reviews and grey literature. Content validity evaluation and pre-testing were undertaken using standard instrument development techniques. Two-hundred and seventy hospitalized older adults were surveyed to test construct and convergent validity, internal consistency reliability and test-retest reliability of the measure. Analysis was performed using Statistical Package for the Social Sciences, version 25. The STROBE checklist was used to document reporting of the study. RESULTS: We established the 15-item Hospitalized Older Adults' Dignity Scale (HOADS) that has a 5-factor structure: shared decision-making (3 items); healthcare professional-patient communication (3 items); patient autonomy (4 items); patient privacy (2 items); respectful care (3 items). Excellent content validity, adequate construct and convergent validity, acceptable internal consistency reliability and good test-retest reliability were demonstrated. CONCLUSION: We established the HOADS is a valid and reliable scale to measure dignity for older adults during acute hospitalization. Future studies using confirmatory factor analysis are needed to corroborate the dimensionality of the factor structure and external validity of the scale. Routine use of the scale may inform the development of strategies to improve dignity-related care in the future. IMPACT: The development and validation of the HOADS will provide nurses and other healthcare professionals with a feasible and reliable scale for measuring older adults' dignity during acute hospitalization. The HOADS advances the conceptual understanding of dignity in hospitalized older adults by including additional constructs that have not been captured in previous dignity-related measures for older adults (i.e. shared decision-making and respectful care). The factor structure of the HOADS, therefore, includes five domains of dignity and offers a new opportunity for nurses and other healthcare professionals to better understand the nuances of dignity for older adults during acute hospitalization. For example, the HOADS enables nurses to identify differences in levels of dignity based on contextual factors and to use this information to guide the implementation of strategies that promote dignified care. PATIENT OR PUBLIC CONTRIBUTION: Patients were involved in the generation of items for the scale. Their perspectives and the perspectives of experts were sought in determining the relevance of each item of the scale to patients' dignity.

Measuring midwives' perceptions of their practice climate across racial-ethnic identities: An invariance analysis of the Midwifery Practice Climate Scale.

Diversification of the midwifery workforce is key to addressing disparities in maternal health in the United States. Midwives who feel supported in their practice environments report less burnout and turnover; therefore, creating positive practice environments for midwives of color is an essential component of growing and retaining midwives of color in the workforce. The Midwifery Practice Climate Scale (MPCS) is a 10-item instrument developed through multiphase empirical analysis to measure midwives' practice environments, yet the MPCS had not been independently tested with midwives of color. We conducted invariance analyses to test whether latent means can be compared between midwives of color and non-Hispanic White samples. A step-up approach applied a series of increasingly stringent constraints to model estimations with multiple group confirmatory factor analyses with two pooled samples. A configural model was estimated as the basis of multiple group comparisons where all parameters were allowed to freely vary. Metric invariance was estimated by constraining item factor loadings to be equal. Scalar invariance was estimated by constraining intercepts of indicators to be equal. Each model was compared to the baseline model. The findings supported scalar invariance of MPCS across midwives of color and non-Hispanic White midwives, indicating that the MPCS is measuring the same intended construct across groups, and that differences in scores between these two groups reflect true group differences and are not related to measurement error. Additionally, in this sample, there was no statistically significant difference in perceptions of the practice environments across midwives of color and non-Hispanic White midwives (p > 0.05).

A unified modelling framework for type I (discrete) settling and rising of microplastics in primary sedimentation tanks.

Sewage treatment plants (STPs) are considered as a significant source of microplastic pollution into the terrestrial and aquatic environment. Existing observations suggest that primary treatment accounts for major microplastics removal in STPs, though with high variability due to the complex nature of the polymer compositions, abundance, and sizes in the incoming sewage. Here, we develop a unified modelling framework to simulate the Type I (or discrete) settling or rising behaviour of microplastics to predict their eventual fate in Primary Sedimentation Tank (PST). The model was developed as per the conventional design protocol for PST involving Stokes equation and modifications as per flow regime for settling of nylon and polystyrene microplastics. It was subsequently validated with independent column experiments for both settling (nylon and polystyrene) and rising (low-density polyethylene and polypropylene) microplastics in different size ranges. The validated model was then applied for multiple realistic scenarios of polymer compositions, relative abundance, and size distributions in the incoming sewage. The model predicts removals ranging from 12% to 94% for a mixture of microplastics in the size fraction 0-500 µm. Model simulations also suggest better microplastics removal with the integration of skimming in PST, and optimization of surface overflow velocity.

An analytical quality by design approach towards a simple and novel HPLC-UV method for quantification of the antifibrotic peptide N-acetyl-seryl-aspartyl-lysyl-proline.

N-acetyl-seryl-aspartyl-lysyl proline (Ac-SDKP) is a tetrapeptide possessing anti-fibrotic, angiogenic, anti-inflammatory, anti-apoptotic, and immunomodulatory properties. Currently, the main method to quantify the peptide is liquid chromatography-tandem mass spectrometry (LC-MS/MS) and enzyme-linked immunosorbent assay (ELISA), both of which are labour intensive and require expensive equipment and consumables. Furthermore, these techniques are generally utilised to detect very low or trace concentrations, such as in biological samples. The use of high concentrations of analyte might overload the extraction column or the separation column in LC-MS/MS or the ELISA plates, so the response could be a non-linear relationship at high analyte concentrations. Thus, they are not ideal for formulation development where detection of dose-equivalent concentrations is typically required. Therefore, a cost-effective, simple, and accurate quantification method for the peptide at a higher concentration needs to be developed. In this study, a simple and novel HPLC-UV method is proposed and validated using an Analytical Quality by Design (AQbD) approach. The method is first screened and optimised using chromatographic responses including capacity factor, resolution, tailing factor, and theoretical plate counts, fulfilling the International Council for Harmonisation (ICH) Q2 (R1) guidelines. The resultant optimised chromatography conditions utilised 10 mM phosphate buffer at pH 2.5 and acetonitrile as mobile phases, starting at 3% (v/v) acetonitrile and 97% (v/v) buffer and increasing to 9.7% (v/v) acetonitrile and 90.3% (v/v) buffer over 15 min at a flow rate of 1 mL/min at the column temperature of 25 °C. The injection volume is set at 10 µL and the VWD detector wavelength is 220 nm. The method established is suitable for detecting the peptide at a relatively high concentration, with a quantifiable range from 7.8 µg/mL to 2.0 mg/mL. In addition, the use of a relatively simple HPLC-UV approach could significantly reduce costs and allow easier access to quantify the peptide concentration. A limitation of this method is lower sensitivity compared with using LC-MS/MS and ELISA methods but running costs are lower and the methodology is simpler. The method is capable to quantify the peptide in various tested matrix solutions, with successful quantitation of the peptide in samples obtained from in vitro drug release study in PBS and from a chitosan-TPP nanogels formulation. Therefore, the method developed here offers a complementary approach to the existing quantification methods, quantifying this peptide at increased concentrations in simple to intermediately complex matrix solutions, such as HBSS, DMEM and FluoroBrite cell culture media.

Development and validation of a novel 26-plex system for prenatal diagnosis with forensic markers.

Short tandem repeat (STR) loci are commonly used in forensic casework, such as personal identification and paternity testing. In recent years, STR has also been widely used for rapid, accurate and automated prenatal diagnosis, known as quantitative fluorescent PCR (QF-PCR). Despite their usefulness, the current systems often lack the power to detect mosaicism for Turner syndrome. In this study, we developed a novel 26-plex system that combined the 22 STRs in chromosome 21/18/13/X, 3 sex loci and 1 quality control marker (TAF9L). The system was generated to achieve greater diagnostic power of trisomy 21/18/13 and sex chromosome abnormalities. Studies of the sensitivity, specificity, stability and accuracy were performed according to the Scientific Working Group on DNA Analysis Methods (SWGDAM) guidelines. Compared with the results of the chromosomal microarray analysis (CMA)/copy number variation sequencing (CNV-seq), the detection ratio of non-mosaic chromosome abnormalities of this system in the identification of chromosome 21/18/13/X/Y aneuploidies reached 100%, and the rate of negative results was consistently 100% based on 203 prenatal diagnosis sample analyses. In addition, our results suggested that this panel was a useful tool for mosaicism for Turner syndrome cases. Interestingly, we found one case with large segment loss of chromosome X, which indicated that we should be alert to this situation when the STR genotype of the parent-child is inconsistent in forensic genetics. In summary, this study demonstrated that our system is an accurate, cost-effective and rapid approach for the detection of chromosome numerical abnormalities in prenatal diagnosis.

Development of novel models for predicting mismatch repair protein deficiency and relevant disease-free survival in colorectal cancer patients.

PURPOSE: DNA mismatch repair (MMR) protein deficiency has attached more attention for its potential to be a biomarker of immunotherapy for colorectal cancer (CRC) patients. However, clinical models involving the expression status of MMR protein are rare. Herein, we sought to develop two clinical models (a diagnostic model for the prediction of MMR status and a prognostic model for the prediction of disease-free survival) for CRC patients. METHODS: A total of 582 CRC patients were finally included. There were 53 patients with deficient expression of MMR protein. The differences between the deficient MMR (dMMR) group and the proficient MMR (pMMR) group were analyzed. RESULTS: Compared to pMMR patients, those with dMMR status were younger and had better pathological features (depth of invasion, lymph node metastasis, distant metastasis, pathological stage, perineuronal invasion, and PLT level) and disease-free survival (DFS). The tumor location of the left colon, adenocarcinoma, and abnormal PLT level were identified as the independent predictors for pMMR. Based on these data, we developed the diagnostic model using Logistic regression analysis. It showed a satisfactory accuracy (AUC = 82.3% in the derivate set; AUC = 73.6% in the validation set). Furthermore, pMMR, poorer differentiation, perineuronal invasion, distant metastasis, lower hemoglobin level, and abnormal CEA level were established as the independent prognostic factors of poorer DFS. Based on them, a prognostic model with valuable performance (1-year AUC = 75.5%/3-year AUC = 76.9% in the derivate set; 1-year AUC = 72.3%/3-year AUC = 73.8% in the validation set) was developed. CONCLUSIONS: Our diagnostic and prognostic models could identify CRC patients at risk for pMMR protein expression and disease recurrence. It may contribute to improving the diagnosis and treatment of CRC patients at an individual level.

Development and validation of the food availability and related eating behaviors questionnaire: A stage 1 registered report.

OBJECTIVE: Historically, eating disorder research has excluded marginalized and underserved populations, such as those with food insecurity (which also impacts higher numbers of Black/African American and Latinx communities). However, burgeoning research suggests an association between food insecurity and the development of eating disorder pathology. Examining patterns of food availability and related eating behaviors may elucidate the association between food insecurity and eating disorder pathology. However, to date, there are no comprehensive measures that accurately capture food availability patterns and related eating behaviors. METHOD: In Study 1, 40 participants (20 adolescents, 20 adults) will respond to and provide qualitative feedback on the Food Availability and Related Eating Behaviors Questionnaire (FAREB-Q). In study 2, 50 participants (approximately 25 with and without food insecurity) will complete the FAREB-Q at two time-points, and respond to questions about food insecurity, disordered eating, and every day stress to assess the FAREB-Q's reliability and validity. RESULTS: Results will clarify whether the FAREB-Q is a reliable and valid instrument that measures food availability and related eating behavior patterns. DISCUSSION: The present study aims to develop, pilot, and examine the psychometric properties of the FAREB-Q, a self-report measure examining food availability and related eating behaviors in community populations. PUBLIC SIGNIFICANCE: The novel FAREB-Q assesses food availability and related eating patterns in the general community. The FAREB-Q will be reviewed by experts in disordered eating, food insecurity, psychometric statisticians and piloted in the general public before being psychometrically evaluated in a larger sample. The FAREB-Q is anticipated to help elucidate the mechanisms linking food availability, food (in)security, disordered eating behaviors, and eating pathology.

Delirium detection using GAMMA wave and machine learning: A pilot study.

Delirium occurs in as many as 80% of critically ill older adults and is associated with increased long-term cognitive impairment, institutionalization, and mortality. Less than half of delirium cases are identified using currently available subjective assessment tools. Electroencephalogram (EEG) has been identified as a reliable objective measure but has not been feasible. This study was a prospective pilot proof-of-concept study, to examine the use of machine learning methods evaluating the use of gamma band to predict delirium from EEG data derived from a limited lead rapid response handheld device. Data from 13 critically ill participants aged 50 or older requiring mechanical ventilation for more than 12 h were enrolled. Across the three models, accuracy of predicting delirium was 70 or greater. Stepwise discriminant analysis provided the best overall method. While additional research is needed to determine the best cut points and efficacy, use of a handheld limited lead rapid response EEG device capable of monitoring all five cerebral lobes of the brain for predicting delirium hold promise.

Measuring moral distress in nurses during a pandemic: Development and validation of the COVID-MDS.

The COVID-19 pandemic created novel patient care circumstances that may have increased nurses' moral distress, including COVID-19 transmission risk and end-of-life care without family present. Well-established moral distress instruments do not capture these novel aspects of pandemic nursing care. The purpose of this study was to develop and evaluate the psychometric properties of the COVID-19 Moral Distress Scale (COVID-MDS), which was designed to provide a short MDS that includes both general and COVID-19-specific content. Researcher-developed COVID-19 items were evaluated for content validity by six nurse ethicist experts. This study comprised a pilot phase and a validation phase. The pilot sample comprised 329 respondents from inpatient practice settings and the emergency department in two academic medical centers. Exploratory factor analysis (EFA) was conducted with the pilot data. The EFA results were tested in a confirmatory factor analysis (CFA) using the validation data. The validation sample comprised 5042 nurses in 107 hospitals throughout the United States. Construct validity was evaluated through CFA and known groups comparisons. Reliability was assessed by the omega coefficient from the CFA and Cronbach's alpha. A two-factor CFA model had good model fit and strong loadings, providing evidence of a COVID-19-specific dimension of moral distress. Reliability for both the general and COVID-19-specific moral distress subscales was satisfactory. Known groups comparisons identified statistically significant correlations as theorized. The COVID-MDS is a valid and reliable short tool for measuring moral distress in nurses including both broad systemic sources and COVID-19 specific sources.

Quantification of Low Amounts of Zoledronic Acid by HPLC-ESI-MS Analysis: Method Development and Validation.

Zoledronic acid (ZA) is used in the treatment of various bone pathologies, but it forms complexes with calcium ions present in body fluids, decreasing ZA bioavailability. Thereby, the study first describes the identification of ZA-calcium complexes that form in calcium-rich environments, in order to establish the bioavailable ZA concentration. Then, a new method for quantification of low ZA amounts in milieus that mimics in vivo conditions by using simulated body fluid and calcium sulfate hemihydrate was described. Almost all analytical methods of ZA quantification described in the literature require compound derivatization. At very low concentrations, derivatization is prone to analyte loss, therefore compromising the analytical results. In our study, we avoided ZA derivatization by using a high-performance liquid chromatography and electrospray ionization mass spectrometry (HPLC-ESI-MS) system, conducting the investigation based on the fragmentation mass extracted ion chromatograms specific to the ZA protonated form. The method was validated by selectivity, precision, accuracy, linearity, signal to noise ratio, and limit of detection and limit of quantification calculation. Experimentally, this method can detect ranges of 0.1-0.5 ng/mL and precisely quantify ZA concentrations as low as 0.1 ng/mL. This method could provide the basis for quantifying low amounts of ZA in the blood during long-term administration.

Development and Validation of HPLC Method for Efinaconazole: Application to Human Nail Permeation Studies.

Efinaconazole is the first azole derivative approved by FDA for the topical treatment of onychomycosis. The objective of present study was to develop and validate HPLC method for estimation of efinaconazole in ex vivo human nail permeation study samples. The chromatographic analysis was performed on a HPLC system equipped with diode array detector. The efinaconazole and internal standard (IS) were extracted from the human nail samples by using the protein precipitation method. The samples were injected on to 5 µm Polar C18 100Å, 4.6 mm × 150 mm column. The mobile phase consisted of 0.01 M potassium dihydrogen phosphate: acetonitrile (36:64) and eluent was monitored at 205 nm. The chromatographic separation of drug and analyte was achieved using isocratic elution at flow rate of 1 mL/min with a total run time of 15 min. The efinaconazole and IS were eluted at 6.4 ± 0.5 and 8.3 ± 0.5 min, respectively. The developed method was validated as per FDA guidelines, and the results met with acceptance criteria. The method developed was specific, and the analyte concentrations were linear at range of 50 to 10000 ng/mL (R2 ≥ 0.9981). The validated HPLC method was applied for quantifying efinaconazole in human nail permeation study samples. The permeation of efinaconazole was increased by twofolds with Labarfac CC (15135.4 ± 2233.9 ng/cm2) compared to formulations containing Transcutol P (6892.0 ± 557.6 ng/cm2) and Labrasol (7266.1 ± 790.6 ng/cm2). The study results demonstrate that developed efinaconazole HPLC method can be employed for formulation evaluation and clinical studies.