ABSTRACT
The study aimed to determine how frequently the adverse events of the COVISHIELD vaccine occur among the Bangladeshi population. This cross-sectional study was conducted at Sheikh Russel Gastroliver Institute and Hospital, Mohakhali, Dhaka, Bangladesh, in May 2021. The inclusion criteria were the adult populations who received the 2nd dose of the COVISHELD vaccine and had passed 28 days following the completion of the 2nd dose. Three hundred and five persons fulfilling the inclusion criteria were asked over the telephone-based on a predesigned questionnaire. The rates of adverse events were 54.1% and 41.3% after the 1st and 2nd dose of vaccine, respectively, and the difference was statistically significant (p < 0.001). Pain at the injection site was the most common adverse event (32.5% following the 1st dose and 27.9% following the 2nd dose). All of the symptoms were mild and lasted for about 2 days. Age and comorbidities were significantly associated with the adverse events (p < 0.001). Neither doses had any vaccine-related life-threatening adverse event nor had any symptoms related to vaccine-related blood clotting. Nineteen persons (6.2%) had been diagnosed with COVID-19 after the 1st dose of vaccination, and three (1%) persons had been diagnosed with COVID-19 after the 2nd dose of vaccination. As no significant life-threatening adverse event was observed, this study might help reduce the hesitancy for vaccination among the population and thus help reduce transmission of this highly contagious virus.
ABSTRACT
BACKGROUND: Although protocol registration of systematic reviews/meta-analysis (SR/MA) is still not mandatory, it is highly recommended that authors publish their SR/MA protocols prior to submitting their manuscripts for publication as recommended by the Cochrane guidelines for conducting SR/MAs. our aim was to assess the awareness, obstacles, and opinions of SR/MA authors about the protocol registration process. METHODS: A cross-sectional survey study included the authors who published SR/MAs during the period from 2010 to 2016, and they were contacted for participation in our survey study. They were identified through the literature search of SR/MAs in Scopus database. An online questionnaire was sent to each participant via e-mail after receiving their approval to join the study. We have sent 6650 emails and received 275 responses. RESULTS: A total of 270 authors responses were complete and included in the final analysis. Our results has shown that PROSPERO was the most common database used for protocol registration (71.3%). The registration-to-acceptance time interval in PROSPERO was less than 1 month (99.1%). Almost half of the authors (44.2%) did not register their protocols prior to publishing their SR/MAs and according to their opinion that the other authors lack knowledge of protocol importance and mandance to be registered, was the most commonly reported reason (44.9%). A significant percenatge of respondents (37.4%) believed that people would steal their ideas from protocol databases, while only 5.3% reported that their SR/MA had been stolen. However, the majority (72.9%) of participants have agreed that protocol registries play a role in preventing unnecessary duplication of reviews. Finally, 37.4% of participants agree that SR/MA protocol registration should be mandatory. CONCLUSION: About half of the participants believes that the main reason for not registering protocols, is that the other authors lack knowledge concerning obligation and importance to register the SR/MA protocols in advance. Therefore, tools should be available to mandate protocol registration of any SRs beforehand and increasing awareness about the benefits of protocol registration among researchers.