1. A single dose of BNT162b2 vaccine did not elicit a humoral immune response in most people receiving hemodialysis who had no history of previous SARS-CoV-2 infection.
Evidence Rating Level: 2 (Good)
One of the several groups of people at increased risk of SARS-CoV-2 exposure, infection, and death is comprised of those receiving hemodialysis. The BNT162b2 vaccine has demonstrated efficacy after one dose in the general population, but it is unclear if a single dose is equally efficacious among this vulnerable group. This prospective cohort study of 154 patients receiving hemodialysis (19 with and 135 without previous SARS-CoV-2 infection) and 40 healthcare-worker controls (20 with and without previous SARS-CoV-2 infection) investigated the efficacy of 1 dose of BNT162b2 stratified by previous infection status. Participants were recruited from 54 hemodialysis clinics in Quebec. Mean (SD) ages were calculated by group: hemodialysis without previous infection (median [range] age = 70  years) and receiving hemodialysis with previous infection (76  years). Serial plasma was obtained from all participants before and after one dose of the BNT162b2 vaccine. Further, convalescent plasma was collected from patients receiving hemodialysis who were previously infected. Anti-receptor binding domain (RBD) immunoglobin G (IgG) levels were also measured. Among the group without previous infection, anti-RBD IgG was undetectable after four weeks in most people receiving hemodialysis (57%, 95% CI 47 to 65%), compared to only 5% of controls (95% CI 1 to 23%, p<.001). All participants with undetectable levels of anti-RBD IgG at four weeks still had undetectable levels at eight weeks post-injection, with similar results across younger patients and those non-immunosuppressed. A total of three participants receiving hemodialysis developed severe COVID-19 following one dose of vaccine. Those who had a previous infection while receiving hemodialysis demonstrated median anti-RBD IgG levels at eight weeks similar to controls at three weeks (p = .03). Overall, this study demonstrated that a single dose of BNT162b2 vaccine did not elicit a humoral immune response in majority of participants receiving hemodialysis without previous SARS-CoV-2 infection. Antibody response was delayed in those with previous SARS-CoV-2 infection, such that those receiving hemodialysis be prioritized for a second dose of vaccine.
1. Most injured children and adolescents return to baseline functional status by discharge.
2. Pediatric populations with extremity injuries or severe head injuries were at greatest risk of functional impairment at discharge.
Evidence Rating Level: 2 (Good)
Pediatric injuries often result in short- and long-term functional impairments, negatively impacting quality of life to a degree that cannot be ascertained by mortality statistics. Quality of care may be better assessed by investigating these impairments and the characteristics of children and adolescents at highest risk. This prospective cohort study of the Assessment of Functional Outcomes and Health-Related Quality of Life After Pediatric Injury evaluated injury categories associated with increased prevalence of functional impairment in pediatric populations receiving treatment at one of seven pediatric trauma centers from March 2018 to February 2020. Participants were all >15 years and hospitalized with ≥1 serious injury (Abbreviated Injury Scale score ≥3, or Glasgow Coma Scale score <9, or Glasgow Coma Scale motor score <5). The Functional Status Scale (FSS) was used to assess changes in morbidity in mental status, sensory, communication, motor function, feeding, and respiratory domains. The study included 427 injured children and adolescents (median [IQR] age = 7.2 [2.5 to 11.7] years, 36.5% female). Of these, 17.3% had a new FSS domain morbidity at discharge. Increases in new FSS domain morbidities was greatest among those with several injured body regions and severe head trauma (83.3%). The lowest increases in new morbidities were found among those with isolated head injuries of mild-to-moderate severity (1.2%). Adjusting for oversampling of specific injury types, 14.4% of seriously injured children and adolescents had functional impairment at discharge, with the largest proportions attributable to extremity injuries (40.3%) and severe traumatic brain injuries (34.4%). Overall, this study found that most children and adolescents with injuries returned to baseline status by hospital discharge. However, more significant extremity and head injuries suggest a greater risk of functional impairment at discharge.
1. Cognitive behavioral therapy (CBT)-based counseling significantly improved perceived stress, anxiety, and quality of life among women with primary infertility.
2. Measures of depression suggested minimal effects of CBT-based counseling on these symptoms, based on this sample.
Evidence Rating Level: 1 (Excellent)
It is estimated that infertility impacts 11 to 51 million people worldwide. Infertility has a negative effect on quality of life, increasing stress, anxiety, and depressive symptoms both during pregnancy and after birth. This randomized, controlled clinical trial investigated the effect of group cognitive behavioral therapy (CBT)-based counseling on perceived stress, depression, anxiety, and quality of life among women with primary infertility. A total of 56 pregnant women with a history of primary infertility at a teaching hospital in Tabriz were randomly assigned to intervention (n = 28) and control (n = 28) groups. The CBT intervention included counseling after the 14th week of pregnancy, with six in-person sessions and two phone sessions weekly. Routine care was provided to the control group. Several measures were administered four weeks before and after the initiation of intervention: Perceived Stress Scale (PSS), Edinburgh Postnatal Depression Scale (EPDS), Van den Bergh’s Pregnancy-Related Anxiety Questionnaire (PRAQ), and Quality of Life in Pregnancy (Gravidarum; QOL-GRAV). Groups differed only in gestational age and husband educational attainment (ps>.05). Following CBT-based counseling, mean scores of the intervention group were significantly lower than the control group in perceived stress (M difference = -7.3, 95% CI -5.6 to -0.9, p<.001) and anxiety (M difference = -14.7, 95% CI -20.6 to -8.8, p<.001). Though depression levels were lower among the intervention group, this difference was not significant (p = .052). Lastly, quality of life was significantly higher among those in the intervention group, compared to controls (M difference = -5.4, 95% CI 3.4 to 7.4, p<.001). Overall, this clinical trial demonstrated that CBT-based counseling is effective for improving perceived stress, anxiety, and quality of life in pregnant women with a history of primary infertility. Effects on depression are relatively minimal, based on the current sample.
1. Nearly 20% of participants with unexplained sudden cardiac death carried pathogenic or likely pathogenic variants of cardiomyopathies and arrhythmia syndromes.
Evidence Rating Level: 2 (Good)
Genetic testing allows for diagnosing inheritable cardiac diseases in unexplained sudden cardiac death (SCD). However, it is currently unknown the degree to which pathogenic or likely pathogenic (P/LP) variants of inherited cardiomyopathies (CMs) and arrhythmia syndromes contribute to SCD in White and Black adults in the U.S. This genetic association study of 683 White and Black adults who passed away due to unexplained SCD were initially reviewed. A total of 413 participants had acceptable DNA data for genetic sequencing between January 1995 and December 2015 (median [IQR] age at death = 41 [29 to 48] years, 62.7% male, 50.4% Black). A total of 38 arrythmia genes and 30 CM genes were sequenced and curated as P/LP. A total of 18.4% of those with unexplained SCD had variants considered P/LP for arrhythmia and CM genes. Approximately 12.6% had 49 P/LP CM variants, 5.3% had 23 P/LP arrhythmia variants, and 0.5% had P/LP variants for both arrhythmia and CM. More specifically, 45 patients (10.9%) had 41 P/LP variants for hypertrophic CM, 11 patients (2.7%) had 9 P/LP variants for dilated CM, and 11 patients (2.7%) had 10 P/LP variants for long QT syndromes. White individuals were as likely to have P/LP variants as Black individuals and no significant difference was found in heart and clinical characteristics between those with and without P/LP variants. Overall, this study suggests that up to 20% of participants with unexplained SCD carried P/LP variants, such that genetics may contribute to many of these cases.
1. Among obese and overweight pregnant women, risk of early childhood obesity was not reduced by maternal dietary and lifestyle interventions during pregnancy.
Evidence Rating Level: 3 (Average)
It is well-known that maternal obesity increases the risk of childhood obesity and that dietary interventions during pregnancy can reduce gestational weight gain. However, less is known about maternal obesity and its association with long-term childhood obesity-related outcomes. This meta-analysis located seven randomized clinical trials with appropriate follow-up, six of which provided individual participant data. Participants were women with a singleton, live gestation between 10+0 and 20+0 weeks and body mass index (BMI) ≥25kg/m2. Participants were randomly assigned to diet and/or lifestyle interventions or standard care with child follow-up between 3 and 5 years of age. In total, 2,529 children and 2,383 women were included across the six trials. Roughly 30% of child participants had a BMI z-score at or above 90th percentile, with no significant difference between intervention group and controls (adjusted RR = 0.97, 95% CI 0.87 to 1.08, p = .610). Secondary measures, such as body circumference, blood pressure, neurodevelopment, dietary and physical activity patterns, and skinfold thickness, were not significantly different across groups. Overall, this study found that maternal diet and lifestyle interventions during pregnancy do not modify childhood obesity risk. However, further research needs to be conducted on the preconception period in women.
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