1. In a cohort of adults from Israel, a booster vaccine of BNT162b2 was associated with decreased odds of testing positive for SARS-CoV-2
Evidence Rating Level: 3 (Average)
There have been many clinical trials that demonstrated the efficacy of the 2-dose regimen of the mRNA vaccine BNT162b2 (Pfizer- BioNTech) against SARS-CoV-2 (COVID-19). However, the long-term effectiveness remains unclear and there is evidence of waning immunity. Israel initiated a third-dose (booster) vaccination campaign in August, 2021, yet there are only a few studies examining its efficacy. Therefore, this retrospective case-control study aimed to evaluate whether there is additional protection gained through a booster dose of the Pfizer vaccine. During the study period, 500 232 COVID-19 PCR tests were performed amongst 306 710 patients 40 years or older without any prior documented COVID-19 infection. From the total number of tests, 227 380 were completed on patients with 2 doses and 272 852 were completed on patients with 3 doses of the vaccine. The study found that from those with 2 doses, 14 989 (6.6%) tests were positive results while tests done on patients with 3 doses had 4941 (1.8%) positive results. The marginal measure of effectiveness of the third dose compared with the second dose increased overtime following receipt of the booster. There was a small reduction in odds of testing positive in the first 7 days (12% reduction; 95% CI, 8%-17%), moderate reduction in days 7 through 13 (58% reduction; 95% CI, 56%-61%), and high reduction in days 14 through 20 and beyond (85% reduction; 95% CI, 83%-86%). The study also evaluated the odds of hospitalization amongst those who received the booster versus those with only 2 doses. After 14 days, the odds of hospitalization among those who received a booster dose were 92% to 97% lower than those who had received just 2 doses. Therefore, the study concluded that a third dose of the BNT162b2 vaccine was associated with lower odds of COVID-19 infection and hospitalization. However, there were significant methodological limitations to this study such as the retrospective design and potential for bias, and thus, more studies are needed to confirm its findings.
1. In a cohort of pediatric patients, use of intravenous lidocaine reduces requirements of propofol, provides better sedation, improves postprocedural pain management and reduces recovery time.
Evidence Rating Level: 1 (Excellent)
Colonoscopies are an important diagnostic tool for which pediatric patients usually require deep sedation. Propofol is the most commonly used sedatives during this procedure, however, it can cause cardiopulmonary adverse effects. Recent studies have demonstrated that intravenous lidocaine, used as an adjunct to propofol during adult colonoscopies, can aid with sedation and analgesia. However, there are no such studies in the pediatric population. Therefore, this randomized controlled trial aimed to evaluate the effects of lidocaine on propofol requirements, adverse effects, and postoperative recovery in pediatric patients undergoing colonoscopies. The study included 40 pediatric patients who were divided into two groups of 20 participants. There were no statistically significant differences in age, sex, height, weight, and American Society of Anesthesiologists (ASA) status between the two groups. The intervention group received 1.5 mg/kg of lidocaine intravenously before induction of anaesthesia and were maintained at 2 mg/kg/h until the end of the procedure. The control group received the same volume of normal saline instead of lidocaine. The study found that intravenous lidocaine reduced the dose of propofol used in the intervention group by 35.5% (p < 0.001; 95% CI, -100.60 – -41.02). Additionally, it was found that awakening (p < 0.001; 95% CI, -7.67 – -5.13) and recovery times (p < 0.001; 95% CI, -7.45 – -4.35) were significantly reduced in the lidocaine group compared to the control. There were no statistically significant differences in changes in heart rate and blood pressure between the two groups. Finally, pain was measured using a facial visual analogue scale (F-VAS) score. The intervention group had a significantly lower F-VAS score, thus less pain, than the control group after 30 minutes (0 [0–4] vs. 3 [0–5], p < 0.001) and 60 minutes (0 [0–2] vs. 1 [0–3], p = 0.001). Therefore, the study concluded that lidocaine significantly reduced the dose of propofol used during pediatric colonoscopies, improves post-operative pain and recovery, without causing any adverse events. Although the study was methodologically sound, more studies with greater sample sizes are needed to support these conclusions.
1. In children with type 1 diabetes, episodes of diabetic ketoacidosis are associated with an increased risk of developing microalbuminuria.
Evidence Rating Level: 2 (Good)
Diabetic ketoacidosis (DKA) occurs most commonly in children with type 1 diabetes (T1D), and acute kidney injuries (AKI) occur in about half of these episodes. Diabetes is also leading cause of kidney disease worldwide. There have been no studies examining whether episodes of AKI during DKA contribute to a future risk of diabetic kidney disease. Microalbuminuria is an early manifestation of diabetic kidney disease. Therefore, this study examined whether children with T1D who experience DKA have a greater risk of developing microalbuminuria and if so, whether it occurs during the episode of DKA. The study included 2345 patients with T1D with the mean (SD) age at diagnosis of 9.4 (4.4) years and the mean (SD) duration of follow-up 6.5 (3.5) years. 963 (41%) patients experienced at least 1 episode of DKA and an AKI occurred in 560 (47%) DKA episodes. The study found that the hazard rate for microalbuminuria was higher among patients after experiencing an episode of DKA and increased further with each subsequent DKA episode (hazard ratio, 1.73; 95% CI, 1.50 – 2.01). Additionally, the development of an AKI during a DKA episode also increased the hazard rate of microalbuminuria (hazard ratio for each episode, 1.87; 95% CI, 1.58 – 2.21). Even after adjusting for age at diagnosis of T1D and mean HbA1c, DKA with AKI continued to be significantly associated with an increased hazard rate for microalbuminuria (hazard ratio for each episode, 1.56; 95% CI, 1.30 – 1.87). However, DKA without AKI was not associated with an increased risk of microalbuminuria. Therefore, the study concluded that the occurrence of AKI during a DKA episode was associated with an increased risk of microalbuminuria which increased with the number of AKI episodes. This is an important conclusion that can be used to support clinical guidelines, however, more studies are needed to support the conclusions.
1. In a cohort of healthy middle-aged adults, cardiorespiratory fitness is associated with decreased risk of peripheral artery disease later in life.
Evidence Rating Level: 2 (Good)
Peripheral artery disease (PAD) is associated with significant morbidity and mortality world-wide. Supervised exercise programs are a first-line therapy for the symptomatic treatment of patients with PAD. Additionally, lower fitness in patients with PAD is associated with increased rates of mortality and mobility loss. However, there are no studies demonstrating the association between fitness and PAD longitudinally. Therefore, this cohort study aimed to evaluate the relationship between cardiorespiratory fitness in midlife and the development of severe PAD later in life. The study examined 19 023 participants with a mean (SD) interval of 17.5 (7.6) years between the baseline exam and entry into the Medicaire claims surveillance pool. The baseline characteristics of the participants included median age of 50 years, 21.1% women, 98.3% white, and 15.6% actively smoking at baseline. Cardiorespiratory fitness was measured using the modified Balke protocol, which evaluated time on a treadmill using different regression equations. Based on these results, participants were divided into 3 categories: low fit (n=3130), moderate fit (n=7644), and high fit (n=8249). The primary outcome was lower extremity PAD-related hospitalizations and/or lower extremity surgical or endovascular procedure. It was found that there was an association between lower levels of fitness at baseline and a higher long‐term incident PAD event rate in both men and women. The incidence in men was 11.4 per 1000 person-years in the low fit group compared to 5.4 per 1000 person-years in the high fit group. Similarly, the incidence in women declined from 5.1 per 1000 person-years in the low fit group to 3.2 per 1000 person-years in the high fit group. After adjusting for multiple variables, it was found that midlife fitness was associated with a lower risk for incident PAD compared with low midlife fitness (hazard ratio [HR], 0.71; 95% CI, 0.57–0.88; p = 0.002). Therefore, the study concluded that higher midlife cardiorespiratory fitness is associated with a lower incidence of lower extremity PAD‐related hospitalizations/procedures in men and women, independent of other predictors of PAD. However, this study population was not representative of a diverse community population, thus lowering the external validity.
1. In a cohort of infants, low socioeconomic status was associated with increased body mass index and accelerated growth during early infancy.
Evidence Rating Level: 2 (Good)
Childhood obesity is a growing public health concern as it is associated with poorer health outcomes later in life. Infancy body mass index (BMI) has been shown to be associated with increased later adiposity. Another risk factor for childhood obesity is found to be rapid and catch-up growth during infancy. Multiple studies have demonstrated that poverty and other social determinants of health can result in major adverse health outcomes. However, there are no studies examining the role of SES on infancy (0 – 12 months) BMI trajectory. Therefore, this study examined the differences of BMI trajectory between normal birth weight (NBW) and low birth weight (LBW) infants with socioeconomic disparities. The study included 387 participants with an average (SD) gestational age of 37.4 (2.9) weeks and average (SD) birth weight of 2.64 (0.69) kg. The study found that low SES was associated with higher BMI in the infants for LBW group at 6 months and 12 months [BMI difference at 6 months, 0.28; 95% CI, 0.03 – 0.53); BMI difference at 12 months, 0.21; 95% CI, 0.01 – 0.43). However, these significant differences were not observed in the NBW infants’ group. Overall, the study concluded that low SES is associated with higher BMI for LBW infants at 6 and 12 months when compared to high SES infants. This study answered an important clinical question, filling a gap in literature. However, future larger studies are needed that take into account confounding factors to further validate these results.
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