Search results for: Yael Cohen Azaria

Authors: Alon Cohen, Jeffrey Kantor, Shalom Levy

Abstract:

The use of the audit risk model in auditing has faced limitations and difficulties, leading auditors to rely on a conceptual level of its application. The qualitative approach to assessing risks has resulted in different risk assessments, affecting the quality of audits and decision-making on the adoption of CAATTs. This study aims to investigate risk factors impacting the implementation of the audit risk model and propose a complementary risk-based instrument (KRIs) to form substance risk judgments and mitigate against heightened risk of material misstatement (RMM). The study addresses the question of how risk factors impact the implementation of the audit risk model, improve risk judgments, and aid in the adoption of CAATTs. The study uses a three-stage scale development procedure involving a pretest and subsequent study with two independent samples. The pretest involves an exploratory factor analysis, while the subsequent study employs confirmatory factor analysis for construct validation. Additionally, the authors test the ability of the KRIs to predict audit efforts needed to mitigate against heightened RMM. Data was collected through two independent samples involving 767 participants. The collected data was analyzed using exploratory factor analysis and confirmatory factor analysis to assess scale validity and construct validation. The suggested KRIs, comprising two risk components and seventeen risk items, are found to have high predictive power in determining audit efforts needed to reduce RMM. The study validates the suggested KRIs as an effective instrument for risk assessment and decision-making on the adoption of CAATTs. This study contributes to the existing literature by implementing a holistic approach to risk assessment and providing a quantitative expression of assessed risks. It bridges the gap between intuitive risk evaluation and the theoretical domain, clarifying the mechanism of risk assessments. It also helps improve the uniformity and quality of risk assessments, aiding audit standard-setters in issuing updated guidelines on CAATT adoption. A few limitations and recommendations for future research should be mentioned. First, the process of developing the scale was conducted in the Israeli auditing market, which follows the International Standards on Auditing (ISAs). Although ISAs are adopted in European countries, for greater generalization, future studies could focus on other countries that adopt additional or local auditing standards. Second, this study revealed risk factors that have a material impact on the assessed risk. However, there could be additional risk factors that influence the assessment of the RMM. Therefore, future research could investigate other risk segments, such as operational and financial risks, to bring a broader generalizability to our results. Third, although the sample size in this study fits acceptable scale development procedures and enables drawing conclusions from the body of research, future research may develop standardized measures based on larger samples to reduce the generation of equivocal results and suggest an extended risk model.

Keywords: audit risk model, audit efforts, CAATTs adoption, key risk indicators, sustainability

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Authors: Tamar Lin, Nufar Buchshtab, Yifat Elharar, Julian Nicenboim, Rotem Edgar, Iddo Weiner, Lior Zelcbuch, Ariel Cohen, Sharon Kredo-Russo, Inbar Gahali-Sass, Naomi Zak, Sailaja Puttagunta, Merav Bassan

Abstract:

Background: Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disorder that is characterized by dry skin and flares of eczematous lesions and intense pruritus. Multiple lines of evidence suggest that AD is associated with increased colonization by Staphylococcus aureus, which contributes to disease pathogenesis through the release of virulence factors that affect both keratinocytes and immune cells, leading to disruption of the skin barrier and immune cell dysfunction. The aim of the current study is to develop a bacteriophage-based product that specifically targets S. aureus. Methods: For the discovery of phage, environmental samples were screened on 118 S. aureus strains isolated from skin samples, followed by multiple enrichment steps. Natural phages were isolated, subjected to Next-generation Sequencing (NGS), and analyzed using proprietary bioinformatics tools for undesirable genes (toxins, antibiotic resistance genes, lysogeny potential), taxonomic classification, and purity. Phage host range was determined by an efficiency of plating (EOP) value above 0.1 and the ability of the cocktail to completely lyse liquid bacterial culture under different growth conditions (e.g., temperature, bacterial stage). Results: Sequencing analysis demonstrated that the 118 S. aureus clinical strains were distributed across the phylogenetic tree of all available Refseq S. aureus (~10,750 strains). Screening environmental samples on the S. aureus isolates resulted in the isolation of 50 lytic phages from different genera, including Silviavirus, Kayvirus, Podoviridae, and a novel unidentified phage. NGS sequencing confirmed the absence of toxic elements in the phages’ genomes. The host range of the individual phages, as measured by the efficiency of plating (EOP), ranged between 41% (48/118) to 79% (93/118). Host range studies in liquid culture revealed that a subset of the phages can infect a broad range of S. aureus strains in different metabolic states, including stationary state. Combining the single-phage EOP results of selected phages resulted in a broad host range cocktail which infected 92% (109/118) of the strains. When tested in vitro in a liquid infection assay, clearance was achieved in 87% (103/118) of the strains, with no evidence of phage resistance throughout the study (24 hours). A S. aureus host was identified that can be used for the production of all the phages in the cocktail at high titers suitable for large-scale manufacturing. This host was validated for the absence of contaminating prophages using advanced NGS methods combined with multiple production cycles. The phages are produced under optimized scale-up conditions and are being used for the development of a topical formulation (BX005) that may be administered to subjects with atopic dermatitis. Conclusions: A cocktail of natural phages targeting S. aureus was effective in reducing bacterial burden across multiple assays. Phage products may offer safe and effective steroid-sparing options for atopic dermatitis.

Keywords: atopic dermatitis, bacteriophage cocktail, host range, Staphylococcus aureus

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