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BackgroundThe completeness of adverse event (AE) reports, crucial for assessing putative causal relationships, is measured using the vigiGrade completeness score in VigiBase, the World Health Organization global database of reported potential AEs. Malaysian reports have surpassed the global average score (approximately 0.44), achieving a 5-year average of 0.79 (SD 0.23) as of 2019 and approaching the benchmark for well-documented reports (0.80). However, the contributing factors to this relatively high report completeness score remain unexplored. ObjectiveThis study aims to explore the main drivers influencing the completeness of Malaysian AE reports in VigiBase over a 15-year period using vigiGrade. A secondary objective was to understand the strategic measures taken by the Malaysian authorities leading to enhanced report completeness across different time frames. MethodsWe analyzed 132,738 Malaysian reports (2005-2019) recorded in VigiBase up to February 2021 split into historical International Drug Information System (INTDIS; n=63,943, 48.17% in 2005-2016) and newer E2B (n=68,795, 51.83% in 2015-2019) format subsets. For machine learning analyses, we performed a 2-stage feature selection followed by a random forest classifier to identify the top features predicting well-documented reports. We subsequently applied tree Shapley additive explanations to examine the magnitude, prevalence, and direction of feature effects. In addition, we conducted time-series analyses to evaluate chronological trends and potential influences of key interventions on reporting quality. ResultsAmong the analyzed reports, 42.84% (56,877/132,738) were well documented, with an increase of 65.37% (53,929/82,497) since 2015. Over two-thirds (46,186/68,795, 67.14%) of the Malaysian E2B reports were well documented compared to INTDIS reports at 16.72% (10,691/63,943). For INTDIS reports, higher pharmacovigilance center staffing was the primary feature positively associated with being well documented. In recent E2B reports, the top positive features included reaction abated upon drug dechallenge, reaction onset or drug use duration of

Aims:Discontinuation from antiretroviral therapy (ART) lowers the immunological advantages of human immunodeficiency virus (HIV) treatment and increases the problems related to HIV. Therefore, this study determined the predictors of discontinuation among HIV-infected adults at Hospital Sungai Buloh.Methods:We carried out an institutional-based retrospective cohort study and reviewed the medical records of ART-naïve patients with HIV in Hospital Sungai Buloh, Selangor, Malaysia from January 2007 through December 2016. Discontinuation was defined as not attending the follow-up for 90 days or longer. Simple and multiple logistic regression was used to identify the predictors.Results:Out of 339 patients, 63 (18.6%) experienced discontinuation. Among them, 63.5% were younger than 39 years, 81.0% were male and 62.0% were of Malay ethnicity. Sexual transmission via homosexual and heterosexual routes was the commonest mode of HIV transmission (76.7%). Patients with Malay ethnicity [adjusted Odds ratio (AOR): 2.5, confidence interval (CI): 1.4-4.5, p=0.002], tuberculosis co-infection (AOR: 2.0, CI: 1.1-3.7, p=0.025) and a history of ART regimen switch (AOR: 5.3, CI: 2.2-13.1, p

Objective: To compare the reporting pattern of hearing loss and tinnitus across different vaccines brands used in Malaysia (BNT162b2, CoronaVac, ChAdOx1, Ad5.CoV2-S and BBIBP-CorV). Methods: This retrospective study included all reports of hearing loss and tinnitus occurring after COVID-19 vaccination that were received in the national pharmacovigilance database, QUEST, from February 24, 2021 through July 31, 2022. Reports given causality consistent or indeterminate were included. Results: There were 21 cases of hearing loss, with overall reporting rate of 0.29 cases per million doses. The rate was similar across BNT162b2, CoronaVac and ChAdOx1. For tinnitus, 35 cases were reported, with the overall reporting rate of 0.49 cases per million doses, and the highest rate was reported for ChAdOx1. For both events, most cases aged 30 to 49 years. No gender disparity was observed. Both events were mainly reported to have occurred after the primary doses, with a median time-to-onset of two days. There were no statistically significant differences in the reporting patterns for both events across BNT162b2, CoronaVac and ChAdOx1 by age group, gender, race, and dose number. Conclusions: Despite the low reporting rates and insufficient evidence to confirm its relationship, hearing loss and tinnitus following vaccinations should not be ignored due to its disabling potential and impact on one’s quality of life. Continual reporting is encouraged for better signal characterization in the future.

An eating disorder presenting simultaneously in identical twins remains a rarity in the literature. In this case report, we describe monozygotic twins who presented simultaneously with anorexia nervosa as a psychological effect of COVID-19 home quarantine. Both twins were previously well but developed food restriction, exercise, and mutual surveillance behaviours in competition with each other over three months in early 2020. There were no features of other mood, anxiety or psychotic disorders, and there was no organic disease. However, a strong family history of anxiety disorders and highly permeable familial boundaries were identified. Non-pharmacological management modalities including family therapy and psychotherapy were implemented, and tailored to the twins. We discuss the unique genetic and psychological interactions that conceivably explain the aetiology of this simultaneous presentation of an eating disorder in a pair of twins and examine a simple psychodynamic formulation of this simultaneous emergence. Lastly, we look at the sequelae of COVID-19 related quarantines and isolation as potentiators of eating disorders in adolescents whose education and potential employment were drastically curtailed by movement restrictions. [ABSTRACT FROM AUTHOR]