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  1. Fulltext Real-world effectiveness of BNT162b2 mRNA vaccine: a meta-analysis of large observational studies
    Kow CS, Hasan SS
    Inflammopharmacology, 2021 Aug;29(4):1075-1090.
    PMID: 34241782 DOI: 10.1007/s10787-021-00839-2
    This paper aims to summarize through meta-analyses the overall vaccine effectiveness of the BNT162b2 mRNA vaccine from observational studies. A systematic literature search with no language restriction was performed in electronic databases to identify eligible observational studies which reported the adjusted effectiveness of the BNT162b2 mRNA vaccine to prevent RT-PCR confirmed COVID-19. Meta-analyses with the random-effects model were used to calculate the pooled hazard ratio (HR) and pooled incidence rate ratio (IRR) at 95% confidence intervals, and the vaccine effectiveness was indicated as (pooled HR - 1)/HR or (pooled IRR - 1)/IRR. Nineteen studies were included for this meta-analysis. The meta-analysis revealed significant protective effect against RT-PCR confirmed COVID-19 ≥ 14 days after the first dose, with vaccine effectiveness of 53% (95% confidence interval 32-68%), and ≥ 7 days after the second dose, with vaccine effectiveness of 95% (95% confidence interval: 96-97%). Despite its effectiveness, reporting vaccine safety data by relevant stakeholders should be encouraged as BNT162b2 mRNA is a new vaccine that has not gained full approval. There have been limited data about vaccine effectiveness among immunocompromised patients; thus, the vaccine should be used cautiously in this patient population.
    Matched MeSH terms: Pragmatic Clinical Trials as Topic/methods*
  2. Effectiveness of intensive perioperative nutrition therapy among adults undergoing gastrointestinal and oncological surgery in a public hospital: study protocol for a pragmatic randomized control trial
    A'zim AZA, Zaid ZA, Yusof BNM, Jabar MF, Shahar ASM
    Trials, 2022 Nov 26;23(1):961.
    PMID: 36435838 DOI: 10.1186/s13063-022-06898-2
    BACKGROUND: Perioperative malnutrition is common in patients undergoing gastrointestinal-oncology surgery and is associated with longer hospital stays, increased postoperative complications, poorer quality of life, and lower survival rates. Current practice emphasizes the role of early perioperative nutrition therapy as an early intervention to combat the postoperative complications of patients and the implementation is now widely adopted. However, there is still a lack of research on determining the effectiveness of intensive nutrition therapy and providing ONS perioperative locally. This becomes the significance of this study and serves as a basis for management and guideline in the local hospital settings.

    METHODS: This is a pragmatic randomized control trial study where elective admitted patients will be randomly divided into the intervention (SS) or control (NN) group. All data will be collected during a face-to-face interview, anthropometric measurement, blood sampling (albumin, white blood count, hemoglobin, and c-reactive protein), handgrip strength, and postoperative complications. Group SS will be receiving a tailored lifestyle and intensively supplemented with oral nutrition support as compared to Group NN that will receive standard medical care. The primary outcome for this study is the length of stay in the hospital. Additional outcome measures are changes in biochemical profile and nutritional and functional status. The effects of intervention between groups on the outcome parameters will be analyzed by using the SPSS General Linear Model (GLM) for the repeated measure procedure.

    DISCUSSION: The intervention implemented in this study will serve as baseline data in providing appropriate nutritional management in patients undergoing gastrointestinal and oncological surgery.

    TRIAL REGISTRATION: ClinicalTrials.gov Protocol Registration and Results System (PRS) NCT04347772 . Registered on 20 November 2019.

    Matched MeSH terms: Pragmatic Clinical Trials as Topic
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