The Quality Improvement Review Board: An Innovative Approach to Oversight of Projects That Do Not Meet Criteria of Human Subject Research.

This article describes the development of an institutional quality improvement review board (QIRB) as an effective and efficient method for reviewing and overseeing institutional quality improvement (QI) initiatives. QI projects involve the systematic collection and analysis of data and the implementation of interventions designed to improve the quality of clinical care and/or educational programs for a distinct population in a specific setting. QI projects are fundamentally distinct from human subjects research (HuSR); however, the differences between them are subtle and highly nuanced.

Monitoring polysorbate 80 degradation in protein solutions using Total Holographic Characterization.

The degradation of polysorbate surfactants can limit the shelf life of biologic pharmaceutical products. Polysorbate is susceptible to degradation via either oxidation or hydrolysis pathways which releases free fatty acids (FFA) and other complex polymers. Degradants from Polysorbate 80 (PS80) can form particles and impact drug product quality.

Racial and Ethnic Disparities in Physical and Mental Health Care and Clinical Trials.

Historically, in the United States, scientific racism has been used to justify differential treatment of Black, Indigenous, People of Color (BIPOC) populations compared with the White population. Discrimination toward BIPOC populations by the medical community has contributed to racial and ethnic disparities in health care that persist to this day. At the 2022 American Society of Clinical Psychopharmacology Annual Meeting, a panel of 5 experts from the areas of academia, advocacy, and clinical research discussed racial and ethnic disparities in mental health care.

Efficacy of Müller's Muscle-conjunctival Resection With or Without Suturing for the Correction of Ptosis.

Purpose: The purpose of this study was to compare the efficacy of Müller muscle-conjunctival resection (MMCR) with or without suturing for the correction of ptosis.

Methods: A retrospective chart review was performed of 30 patients (56 eyelids) undergoing sutureless (sMMCR) (34 eyelids) or conventional MMCR (cMMCR) (22 eyelids). Primary outcome measures were the change in MRD1 and vertical eyelid height (VLH).

Label-free viability assay using in-line holographic video microscopy.

Total holographic characterization (THC) is presented here as an efficient, automated, label-free method of accurately identifying cell viability. THC is a single-particle characterization technology that determines the size and index of refraction of individual particles using the Lorenz-Mie theory of light scattering. Although assessment of cell viability is a challenge in many applications, including biologics manufacturing, traditional approaches often include unreliable labeling with dyes and/or time consuming methods of manually counting cells.

Dietary Protein Sources, Mediating Biomarkers, and Incidence of Type 2 Diabetes: Findings From the Women's Health Initiative and the UK Biobank.

Objective: Whether and how dietary protein intake is linked to type 2 diabetes (T2D) remains unclear. The aim of this study was to investigate the associations of protein intake with development of T2D and the potential mediating roles of T2D biomarkers.

Research Design And Methods: We included 108,681 postmenopausal women without T2D at baseline from the Women's Health Initiative (WHI) (primary cohort) and 34,616 adults without T2D from the U.

Distribution of Average Aggregate Density from Stir-Stressed NISTmAb Protein.

Quantifying the heterogeneous nature of protein aggregates is important to understanding the impact aggregates may have on the performance of antibody therapeutics. The spatially averaged density ρ of aggregates, defined as the total mass, including water, divided by the volume, is a parameter that can be used to relate size distributions measured by orthogonal methods, to characterize protein particles, and perhaps to estimate the amount of aggregated protein in a sample. We report measurements by two methods on the distribution of density values for different aggregate sizes, where the aggregates were produced by stir-stressing fluorescently labeled monoclonal antibody (NISTmAb).

The impact of a multidisciplinary care package for vaccination in needle phobic children: An observational study.

Aims: Children with severe needle phobia find vaccination extremely distressing and can remain unvaccinated, which puts them at an increased risk of contracting and transmitting vaccine preventable disease. Referral to a specialist or hospital service may occur when they cannot be safely vaccinated in the community, but engagement of allied health services can be inconsistent. The aim of the study was to assess the impact of a multidisciplinary, consumer-oriented model of care on vaccinations for needle phobic children.

An Interlaboratory Comparison on the Characterization of a Sub-micrometer Polydisperse Particle Dispersion.

The measurement of polydisperse protein aggregates and particles in biotherapeutics remains a challenge, especially for particles with diameters of ≈ 1 µm and below (sub-micrometer). This paper describes an interlaboratory comparison with the goal of assessing the measurement variability for the characterization of a sub-micrometer polydisperse particle dispersion composed of five sub-populations of poly(methyl methacrylate) (PMMA) and silica beads. The study included 20 participating laboratories from industry, academia, and government, and a variety of state-of-the-art particle-counting instruments.

Young people's journeys of recovery from trauma: A qualitative study of narratives from Internet forums.

Objectives: The present study aimed to address to the dearth of research into the phenomenology of recovery among young people exposed to trauma.

Method: Using an interpretative phenomenological approach, we analyzed Internet forum data to consider how young people experience recovery from trauma.

Results: Five domains of recovery were identified: meaningful shifts in the sense of self, gaining control and autonomy, establishing hope and commitment, making meaning out of tragedy, and engaging in normative activities and connecting with others.

Quantitative Differentiation of Protein Aggregates From Other Subvisible Particles in Viscous Mixtures Through Holographic Characterization.

We demonstrate the use of holographic video microscopy to detect individual subvisible particles dispersed in biopharmaceutical formulations and to differentiate them based on material characteristics measured from their holograms. The result of holographic analysis is a precise and accurate measurement of the concentrations and size distributions of multiple classes of subvisible contaminants dispersed in the same product simultaneously. We demonstrate this analytical technique through measurements on model systems consisting of human IgG aggregates in the presence of common contaminants such as silicone oil emulsion droplets and fatty acids.

Clinical experience of intramuscular immunoglobulin for measles prophylaxis in children: Is it practical?

Measles continues to be a public health concern world-wide. Vulnerable individuals including those in which vaccinations is contraindicated, may be reliant on normal human immunoglobulin (NHIG) prophylaxis in an aim to prevent disease. This paper will summarise and discuss a tertiary paediatric hospital's clinical experience and the practicalities of administering intramuscular (IM) NHIG to paediatric patients as per the current measles prophylaxis guidelines in Australia.

The role of the medium in the effective-sphere interpretation of holographic particle characterization data.

The in-line hologram of a micrometer-scale colloidal sphere can be analyzed with the Lorenz-Mie theory of light scattering to obtain precise measurements of the sphere's diameter and refractive index. The same technique also can be used to characterize porous and irregularly shaped colloidal particles provided that the extracted parameters are interpreted with effective-medium theory to represent the properties of an equivalent effective sphere. Here, we demonstrate that the effective-sphere model consistently accounts for changes in the refractive index of the medium as it fills the pores of porous particles and therefore yields quantitative information about such particles' structure and composition.

Liquid mycobacterial culture outcomes after different sputum collection techniques before and during treatment.

Setting: Mycobacterial sputum culture is a key diagnostic and research tool.

Objective: To compare mycobacterial culture outcomes of three sputum collection methods.

Design: We compared culture results within sets of three sputum samples collected from 18 HIV-infected adult tuberculosis patients at regular intervals up to 84 days after treatment initiation.

Opportunistic immunising in the paediatric emergency department: Are patients due vaccines?

Background: The aim of this study was to identify if patients presenting to a paediatric emergency department were due National Immunisation Program recommended vaccines in order to determine missed opportunities for vaccination or vaccination referral.

Method: A hospital chart audit assessed the documentation of an immunisation history, in comparison to the immunisation histories available from national and state immunisation databases to determine accuracy; to identify if patients were due vaccines as determined by the National Immunisation Program; and to identify factors associated with those due vaccines.

Results: Potential opportunities to vaccinate children due vaccines were missed (10/114, 8.

Holographic Characterization of Protein Aggregates in the Presence of Silicone Oil and Surfactants.

Characterizing protein aggregates in the presence of silicone oil is a long standing challenge for the pharmaceutical industry. Silicone oil is often used as a lubricant in devices that deliver and store therapeutic protein products and has been linked to protein aggregation, which can compromise a drug's effectiveness or cause autoimmune responses in patients. Most traditional technologies cannot quantitatively distinguish protein aggregates and silicone oil in their native formulations for sizes less than 5 μm.

Assessment of transport stress on cattle travelling a long distance (≈648 km), from Jessore (Indian border) to Chittagong, Bangladesh.

The effect of long-distance transport on cattle health has not frequently been studied in Bangladesh. The current study investigated the health conditions, and the extent and pattern of cattle injuries, along with haemato-biochemical and hormonal changes, before and after long-distance transportation (≈648 km) from the market of origin to the market of destination. A total of 100 adult cattle were selected at the Benapole live cattle market, Bangladesh, for physical examination before and after transportation.

Lifting degeneracy in holographic characterization of colloidal particles using multi-color imaging.

Micrometer sized particles can be accurately characterized using holographic video microscopy and Lorenz-Mie fitting. In this work, we explore some of the limitations in holographic microscopy and introduce methods for increasing the accuracy of this technique with the use of multiple wavelengths of laser illumination. Large high index particle holograms have near degenerate solutions that can confuse standard fitting algorithms.

The association between tuberculosis and the development of insulin resistance in adults with pulmonary tuberculosis in the Western sub-district of the Cape Metropole region, South Africa: a combined cross-sectional, cohort study.

Background: The existence of a bi-directional relationship between tuberculosis (TB) and insulin resistance (IR)/diabetes has been alluded to in literature. Although diabetes has been linked to increased tuberculosis risk, the relationship between tuberculosis as a causative factor for IR remains unclear. The study aimed to determine if an association existed between tuberculosis and IR development in adults with newly diagnosed pulmonary tuberculosis at baseline.

Holographic characterization of contaminants in water: Differentiation of suspended particles in heterogeneous dispersions.

Determining the size distribution and composition of particles suspended in water can be challenging in heterogeneous multicomponent samples. Light scattering techniques can measure the distribution of particle sizes, but provide no basis for distinguishing different types of particles. Direct imaging techniques can categorize particles by shape, but offer few insights into their composition.

Holographic Characterization of Protein Aggregates.

We demonstrate how holographic video microscopy can be used to detect, count, and characterize individual micrometer-scale protein aggregates as they flow down a microfluidic channel in their native buffer. Holographic characterization directly measures the radius and refractive index of subvisible protein aggregates and offers insights into their morphologies. The measurement proceeds fast enough to build up population averages for time-resolved studies and lends itself to tracking trends in protein aggregation arising from changing environmental factors.

Opportunistic immunisation in the emergency department: a survey of staff knowledge, opinion and practices.

Objective: The aim of this study was to identify (a) emergency department staff knowledge, opinion and practices in relation to childhood vaccines and opportunistic immunisation in the emergency department and (b) differences between nursing and medical staff knowledge, opinion and self reported practices.

Methods: A self-administered, cross-sectional survey was offered to a convenience sample of medical and nursing staff (n=86) working in a tertiary paediatric emergency department. Variables of interest were described using frequencies and odds ratios to report differences between medical and nursing staff responses.

Differentiating first episode substance induced and primary psychotic disorders with concurrent substance use in young people.

Objective: Substance use is common in first-episode psychosis, and complicates the accurate diagnosis and treatment of the disorder. The differentiation of substance-induced psychotic disorders (SIPD) from primary psychotic disorders (PPD) is particularly challenging. This cross-sectional study compares the clinical, substance use and functional characteristics of substance using first episode psychosis patients diagnosed with a SIPD and PPD.

Cross-cultural analysis of cognitive attributions of smoking in thai and South Korean adolescents.

Background: Understanding the cognitive attributions of smoking has the potential to advance youth smoking prevention efforts; however, research on this subject is limited in Asian countries. We attempted to determine the degree to which cognitive attributions of smoking differ among adolescents in 2 Asian countries, Thailand and South Korea.

Methods: We surveyed 10th- to 12th-grade students in Chiang Mai, Thailand (N = 2516) and Seoul, South Korea (N = 1166).