Safety, efficacy and immunogenicity of aerosolized Ad5-nCoV COVID-19 vaccine in a non-inferiority randomized controlled trial.

This phase 3, observer-blinded, non-inferiority randomized trial (ClinicalTrials.gov: NCT05517642), conducted from September 2022 to May 2023 at three Malaysian sites, involved 540 adults previously vaccinated with three COVID-19 doses. Participants were randomized 1:1 to receive either one dose of inhaled Recombinant COVID-19 Vaccine (Ad5-nCoV-IH) or intramuscular tozinameran (BNT-IM). The study assessed safety, vaccine efficacy (VE) and immunogenicity against SARS-CoV-2 variants. The primary outcome was the non-inferiority of anti-spike protein receptor-binding domain (S-RBD IgG) antibodies, with a 97.5% confidence interval lower limit for the geometric mean concentration (GMC) ratio >0.67. Ad5-nCoV-IH showed lower immunogenicity than BNT-IM, with a GMC ratio of 0.22 and a seroconversion rate difference of -71.91%. Adverse drug reactions (ADRs) were less frequent with Ad5-nCoV-IH (39.26%) compared to BNT-IM (64.68%). No serious vaccine-related adverse events were reported. Both vaccines had comparable efficacy against COVID-19 variants. This study was funded by Tianjin Biomedical Science and Technology Major Project.

Identifying factors in the provision of intravenous stroke thrombolysis in Malaysia: a multiple case study from the healthcare providers' perspective.

BACKGROUND: Translation into clinical practice for use of intravenous thrombolysis (IVT) for the management of ischemic stroke remains a challenge especially across low- and middle-income countries, with regional inconsistencies in its rate. This study aimed at identifying factors that influenced the provision of IVT and the variation in its rates in Malaysia. METHODS: A multiple case study underpinning the Tailored Implementation for Chronic Diseases framework was carried out in three public hospitals with differing rates of IVT using a multiple method design. Twenty-five in-depth interviews and 12 focus groups discussions were conducted among 89 healthcare providers, along with a survey on hospital resources and a medical records review to identify reasons for not receiving IVT. Qualitative data were analysed using reflective thematic method, before triangulated with quantitative findings. RESULTS: Of five factors identified, three factors that distinctively influenced the variation of IVT across the hospitals were: 1) leadership through quality stroke champions, 2) team cohesiveness which entailed team dynamics and its degree of alignment and, 3) facilitative work process which included workflow simplification and familiarity with IVT. Two other factors that were consistently identified as barriers in these hospitals included patient factors which largely encompassed delayed presentation, and resource constraints. About 50.0 - 67.6% of ischemic stroke patients missed the opportunity to receive IVT due to delayed presentation. CONCLUSIONS: In addition to the global effort to explore sustainable measures to improve patients' emergency response for stroke, attempts to improve the provision of IVT for stroke care should also consider the inclusion of interventions targeting on health systems perspectives such as promoting quality leadership, team cohesiveness and workflow optimisation.

The effects of enhanced primary healthcare interventions on primary care providers' job satisfaction.

BACKGROUND: In response to the rising burden of cardiovascular risk factors, the Malaysian government has implemented Enhanced Primary Healthcare (EnPHC) interventions in July 2017 at public clinic level to improve management and clinical outcomes of type 2 diabetes and hypertensive patients. Healthcare providers (HCPs) play crucial roles in healthcare service delivery and health system reform can influence HCPs' job satisfaction. However, studies evaluating HCPs' job satisfaction following primary care transformation remain scarce in low- and middle-income countries. This study aims to evaluate the effects of EnPHC interventions on HCPs' job satisfaction. METHODS: This is a quasi-experimental study conducted in 20 intervention and 20 matched control clinics. We surveyed all HCPs who were directly involved in patient management. A self-administered questionnaire which included six questions on job satisfaction were assessed on a scale of 1-4 at baseline (April and May 2017) and post-intervention phase (March and April 2019). Unadjusted intervention effect was calculated based on absolute differences in mean scores between intervention and control groups after implementation. Difference-in-differences analysis was used in the multivariable linear regression model and adjusted for providers and clinics characteristics to detect changes in job satisfaction following EnPHC interventions. A negative estimate indicates relative decrease in job satisfaction in the intervention group compared with control group. RESULTS: A total of 1042 and 1215 HCPs responded at baseline and post-intervention respectively. At post-intervention, the intervention group reported higher level of stress with adjusted differences of - 0.139 (95% CI -0.266,-0.012; p = 0.032). Nurses, being the largest workforce in public clinics were the only group experiencing dissatisfaction at post-intervention. In subgroup analysis, nurses from intervention group experienced increase in work stress following EnPHC interventions with adjusted differences of - 0.223 (95% CI -0.419,-0.026; p = 0.026). Additionally, the same group were less likely to perceive their profession as well-respected at post-intervention (ß = - 0.175; 95% CI -0.331,-0.019; p = 0.027). CONCLUSIONS: Our findings suggest that EnPHC interventions had resulted in some untoward effect on HCPs' job satisfaction. Job dissatisfaction can have detrimental effects on the organisation and healthcare system. Therefore, provider experience and well-being should be considered before introducing healthcare delivery reforms to avoid overburdening of HCPs.