Shaikh, Asim

Coronavirus disease 2019 (COVID-19) vaccine side effects have an important role in the hesitancy of the general population toward vaccine administration. Another reason for vaccine hesitancy might be that healthcare professionals may not address their concerns regarding vaccines appropriately. Regardless, hesitancy in the form of delay, refusal, or acceptance with doubts about its usefulness can limit the downward trajectory of the COVID-19 pandemic. Therefore, the authors conducted a national cross-sectional study (n=306) to assess causes and concerns for vaccine hesitancy in caregivers in Pakistan toward getting their children vaccinated. The questions identified caregivers by socioeconomic demographics, perceived COVID-19 pandemic severity, and concerns toward the COVID-19 vaccine. The majority of the participants were 45–59 years of age (42.8%) with a mean age of 36.11 years (SD: 7.81). A total of 80% of these participants were willing to vaccinate their child with any COVID-19 vaccine. Present comorbidities had a frequency of 28.4% (n=87/306) and only 26.9% (n=66/245) participants were willing to vaccinate their child. Participants with high social standing were 15.4% (n=47/306) with the majority of them being willing to vaccinate their children (45/47). Socioeconomic status (OR:2.911 [0.999–8.483]), and the child’s vaccinations being up to date (OR:1.904 [1.078–3.365]) were found to be independent factors for caregivers to be willing to vaccinate their child. Around 62% (n=191/306) were not willing to vaccinate due to the concern for side effects, 67.6% (n=207/306) were not willing because they did not have ample information available, and 51% (n=156/306) were not willing as they were concerned about vaccine effectiveness. Further studies on vaccine safety in the pediatric population are required to improve caregivers’ perceptions.

Background: Efficacy of an intervention is commonly evaluated using P values, in addition to effect size measures such as absolute risk reduction, relative risk reduction, and numbers needed to treat. However, these measures are not always intuitive to clinicians. The fragility index (FI) is a more intuitive number that can facilitate interpretation but can only be used with binary outcomes. FI is the minimum number of patients who must be moved from the nonevent group to the event group to turn a significant result nonsignificant. In this retrospective analysis, we assessed the robustness of cardiovascular randomized controlled trials (RCTs), which report a positive (statistically significant) primary outcome by using the FI. Methods and Results: We searched Medline from 2007 to 2017 to identify cardiovascular RCTs published in 6 high impact journals ( The Lancet , New England Journal of Medicine , Journal of the American Medical Association , Circulation , Journal of the American College of Cardiology and European Heart Journal ). Only RCTs with sample sizes >500 and a 2-by-2 factorial design or dichotomous primary outcomes were selected. FI was calculated using a defined approach. Among the cohort of 123 RCTs that met inclusion criteria, median FI was 13 (interquartile range, 5–26). In 28 trials (22.8%), FI ranged between 1 and 4. In 37 trials (30.1%), number of patients lost to follow-up was higher than the FI. Pharmaceutical interventions had higher FI compared with other interventions, FI=19 (7–52; P =0.002). Median FI varied according to subspecialty (electrophysiology=2; heart failure=11; interventional cardiology=8; P =0.020) and multiregional RCTs had higher FI=22 (12–53.25; P =0.023). FI did not differ based on risk of bias indicators, funding, or publication year. Conclusions: Considerable variations in FI were observed among cardiovascular trials, suggesting the need for careful interpretation of results, particularly when number of patients lost to follow-up exceeds FI.

Background: In the busy world of cardiovascular medicine, abstracts may be the only part of a publication that clinicians read. Therefore, it is critical for abstracts to accurately reflect article content. The extended CONSORT (Consolidated Standards of Reporting Trials) Statement for Abstracts was developed to ensure high abstract quality. However, it is unknown how often adherence to CONSORT guidelines occurs among cardiovascular journals. Methods and Results: We searched MEDLINE for randomized controlled trials published in 3 major cardiovascular journals ( Circulation, Journal of the American College of Cardiology , and European Heart Journal ) from 2011 to 2017. Post hoc, interim, and cost-effective analyses of randomized controlled trials were excluded. Two independent investigators extracted the data using a prespecified data collection form and a third investigator adjudicated the data. The primary outcome was frequency of subcategory adherence to CONSORT guidelines. A total of 478 abstracts were included in the analysis. Approximately half of the abstracts (53%; 255/478; 95% CI, 49%–57%) identified the article as randomized in the title. All abstracts detailed the interventions for both study groups (100%) and 81% (95% CI, 78%–85%) reported trial registration. Methodological quality reporting was relatively low: 9% (45/478; 95% CI, 6%–12%) described participant eligibility criteria with settings for data collection, 43% (204/478; 95% CI, 39%–47%) reported details of blinding, and <1% (4/478; 95% CI, 0%–2%) reported allocation concealment. Approximately 60% (301/478; 95% CI, 59%–67%) of the included abstracts provided primary outcome results while 55% (262/478; 95% CI, 51%–60%) reported harms or adverse effects. Conclusions: There is a high prevalence of nonadherence to CONSORT guidelines among leading cardiovascular journals. Efforts by editors, authors, and reviewers should be made to increase adherence and promote transparent and unbiased presentation of study results.