Challenges in the Ethical Review of Clinical and Biomedical Research in Malaysia: A Mixed Methods Study.

Empirical evidence of the ethical review of clinical and biomedical research in Malaysia is limited. We have conducted a convergent mixed methods research, which comprises an online survey and semistructured interviews to examine the challenges in the ethical review of clinical and biomedical research. Data collected reveal that the ethics review process is inconsistent, duplicate, and inadequate. The results indicate a strong need for a centralized ethical review mechanism and a national system for mutual recognition of ethics reviews to improve the effectiveness and efficiency of the ethics review system in Malaysia. A joint research ethics committee review between Malaysia and sponsoring countries for multinational research should also be encouraged as it could address the concerns of the lack of expertise and training.

Species distribution and clinical profiles of coagulase-negative staphylococci (CoNS) isolated from blood cultures among paediatric patients in Hospital Kuala Lumpur.

INTRODUCTION: Coagulase-negative staphylococci (CoNS) is often considered as a culture contaminants but it can potentially be pathogenic to patients with risk factors. A combination of species identification and clinical criteria has been suggested in determining true CoNS bacteraemia. OBJECTIVES: To identify the species distribution, antibiotic susceptibility patterns and clinical profiles of CoNS isolated from blood cultures among paediatric patients in Hospital Kuala Lumpur (HKL). METHODS: This study involved CoNS isolation from blood cultures of paediatric in-patients of the Paediatric Institute HKL. Isolates were identified to species level using Analytical Profile Index Staph identification strips and antimicrobial susceptibility pattern following Kirby-Bauer Disc Diffusion method. The clinical profiles of patients were obtained from their medical records. RESULTS: Eleven CoNS species were identified from 148 isolates. Staphylococcus epidermidis was the most frequent species isolated (67.6%). The majority of the isolates showed resistance to penicillin (85.8%); while 70.3% were methicillin-resistant (MR) CoNS, which demonstrated a significant association with true infection (p=0.021). Predictors for significant CoNS infection included thrombocytopaenia, presence of predisposing factors, nosocomial infection, blood collected from peripheral vein, and CoNS isolated from two consecutive blood cultures. The most common predisposing factors for the isolation of CoNS were the presence of peripheral (54.1%) and central venous catheters (35.1%). CONCLUSION: CoNS can cause significant bloodstream infections. The isolation of CoNS from blood cultures should be carefully interpreted by considering the predictive factors. Local data regarding predictive factors of patients with culture-positive CoNS, species distribution and antimicrobial susceptibility pattern are useful to determine the significance of blood culture results and care management of patients.

Bacteria, mould and yeast spore inactivation studies by scanning electron microscope observations.

Spores are the most resistant form of microbial cells, thus difficult to inactivate. The pathogenic or food spoilage effects of certain spore-forming microorganisms have been the primary basis of sterilization and pasteurization processes. Thermal sterilization is the most common method to inactivate spores present on medical equipment and foods. High pressure processing (HPP) is an emerging and commercial non-thermal food pasteurization technique. Although previous studies demonstrated the effectiveness of thermal and non-thermal spore inactivation, the in-depth mechanisms of spore inactivation are as yet unclear. Live and dead forms of two food spoilage bacteria, a mould and a yeast were examined using scanning electron microscopy before and after the inactivation treatment. Alicyclobacillus acidoterrestris and Geobacillus stearothermophilus bacteria are indicators of acidic foods pasteurization and sterilization processes, respectively. Neosartorya fischeri is a phyto-pathogenic mould attacking fruits. Saccharomyces cerevisiae is a yeast with various applications for winemaking, brewing, baking and the production of biofuel from crops (e.g. sugar cane). Spores of the four microbial species were thermally inactivated. Spores of S. cerevisiae were observed in the ascus and free form after thermal and HPP treatments. Different forms of damage and cell destruction were observed for each microbial spore. Thermal treatment inactivated bacterial spores of A. acidoterrestris and G. stearothermophilus by attacking the inner core of the spore. The heat first altered the membrane permeability allowing the release of intracellular components. Subsequently, hydration of spores, physicochemical modifications of proteins, flattening and formation of indentations occurred, with subsequent spore death. Regarding N. fischeri, thermal inactivation caused cell destruction and leakage of intracellular components. Both thermal and HPP treatments of S. cerevisiae free spores attacked the inner membrane, altering its permeability, and allowing in final stages the transfer of intracellular components to the outside. The spore destruction caused by thermal treatment was more severe than HPP, as HPP had less effect on the spore core. All injured spores have undergone irreversible volume and shape changes. While some of the leakage of spore contents is visible around the deformed but fully shaped spore, other spores exhibited large indentations and were completely deformed, apparently without any contents inside. This current study contributed to the understanding of spore inactivation by thermal and non-thermal processes.