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JMIR Public Health and Surveillance Jun 2024The potential association between bivalent COVID-19 vaccination and ischemic stroke remains uncertain, despite several studies conducted thus far.
BACKGROUND
The potential association between bivalent COVID-19 vaccination and ischemic stroke remains uncertain, despite several studies conducted thus far.
OBJECTIVE
This study aimed to evaluate the risk of ischemic stroke following bivalent COVID-19 vaccination during the 2022-2023 season.
METHODS
A self-controlled case series study was conducted among members aged 12 years and older who experienced ischemic stroke between September 1, 2022, and March 31, 2023, in a large health care system. Ischemic strokes were identified using International Classification of Diseases, Tenth Revision codes in emergency departments and inpatient settings. Exposures were Pfizer-BioNTech or Moderna bivalent COVID-19 vaccination. Risk intervals were prespecified as 1-21 days and 1-42 days after bivalent vaccination; all non-risk-interval person-time served as the control interval. The incidence of ischemic stroke was compared in the risk interval and control interval using conditional Poisson regression. We conducted overall and subgroup analyses by age, history of SARS-CoV-2 infection, and coadministration of influenza vaccine. When an elevated risk was detected, we performed a chart review of ischemic strokes and analyzed the risk of chart-confirmed ischemic stroke.
RESULTS
With 4933 ischemic stroke events, we found no increased risk within the 21-day risk interval for the 2 vaccines and by subgroups. However, risk of ischemic stroke was elevated within the 42-day risk interval among individuals aged younger than 65 years with coadministration of Pfizer-BioNTech bivalent and influenza vaccines on the same day; the relative incidence (RI) was 2.13 (95% CI 1.01-4.46). Among those who also had a history of SARS-CoV-2 infection, the RI was 3.94 (95% CI 1.10-14.16). After chart review, the RIs were 2.34 (95% CI 0.97-5.65) and 4.27 (95% CI 0.97-18.85), respectively. Among individuals aged younger than 65 years who received Moderna bivalent vaccine and had a history of SARS-CoV-2 infection, the RI was 2.62 (95% CI 1.13-6.03) before chart review and 2.24 (95% CI 0.78-6.47) after chart review. Stratified analyses by sex did not show a significantly increased risk of ischemic stroke after bivalent vaccination.
CONCLUSIONS
While the point estimate for the risk of chart-confirmed ischemic stroke was elevated in a risk interval of 1-42 days among individuals younger than 65 years with coadministration of Pfizer-BioNTech bivalent and influenza vaccines on the same day and among individuals younger than 65 years who received Moderna bivalent vaccine and had a history of SARS-CoV-2 infection, the risk was not statistically significant. The potential association between bivalent vaccination and ischemic stroke in the 1-42-day analysis warrants further investigation among individuals younger than 65 years with influenza vaccine coadministration and prior SARS-CoV-2 infection. Furthermore, the findings on ischemic stroke risk after bivalent COVID-19 vaccination underscore the need to evaluate monovalent COVID-19 vaccine safety during the 2023-2024 season.
Topics: Humans; Ischemic Stroke; Middle Aged; Male; Female; Adult; Aged; COVID-19 Vaccines; Young Adult; Adolescent; COVID-19; Child; Aged, 80 and over; Incidence
PubMed: 38916940
DOI: 10.2196/53807 -
JAMA Network Open Jun 2024The ELEKT-D: Electroconvulsive Therapy (ECT) vs Ketamine in Patients With Treatment Resistant Depression (TRD) (ELEKT-D) trial demonstrated noninferiority of intravenous... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
The ELEKT-D: Electroconvulsive Therapy (ECT) vs Ketamine in Patients With Treatment Resistant Depression (TRD) (ELEKT-D) trial demonstrated noninferiority of intravenous ketamine vs ECT for nonpsychotic TRD. Clinical features that can guide selection of ketamine vs ECT may inform shared decision-making for patients with TRD.
OBJECTIVE
To evaluate whether selected clinical features were associated with differential improvement with ketamine vs ECT.
DESIGN, SETTING, AND PARTICIPANTS
This secondary analysis of an open-label noninferiority randomized clinical trial was a multicenter study conducted at 5 US academic medical centers from April 7, 2017, to November 11, 2022. Analyses for this study, which were not prespecified in the trial protocol, were conducted from May 10 to Oct 31, 2023. The study cohort included patients with TRD, aged 21 to 75 years, who were in a current nonpsychotic depressive episode of at least moderate severity and were referred for ECT by their clinicians.
EXPOSURES
Eligible participants were randomized 1:1 to receive either 6 infusions of ketamine or 9 treatments with ECT over 3 weeks.
MAIN OUTCOMES AND MEASURES
Association between baseline factors (including 16-item Quick Inventory of Depressive Symptomatology Self-Report [QIDS-SR16], Montgomery-Asberg Depression Rating Scale [MADRS], premorbid intelligence, cognitive function, history of attempted suicide, and inpatient vs outpatient status) and treatment response were assessed with repeated measures mixed-effects model analyses.
RESULTS
Among the 365 participants included in this study (mean [SD] age, 46.0 [14.5] years; 191 [52.3%] female), 195 were randomized to the ketamine group and 170 to the ECT group. In repeated measures mixed-effects models using depression levels over 3 weeks and after false discovery rate adjustment, participants with a baseline QIDS-SR16 score of 20 or less (-7.7 vs -5.6 points) and those starting treatment as outpatients (-8.4 vs -6.2 points) reported greater reduction in the QIDS-SR16 with ketamine vs ECT. Conversely, those with a baseline QIDS-SR16 score of more than 20 (ie, very severe depression) and starting treatment as inpatients reported greater reduction in the QIDS-SR16 earlier in course of treatment (-8.4 vs -6.7 points) with ECT, but scores were similar in both groups at the end-of-treatment visit (-9.0 vs -9.9 points). In the ECT group only, participants with higher scores on measures of premorbid intelligence (-14.0 vs -11.2 points) and with a comorbid posttraumatic stress disorder diagnosis (-16.6 vs -12.0 points) reported greater reduction in the MADRS score. Those with impaired memory recall had greater reduction in MADRS during the second week of treatment (-13.4 vs -9.6 points), but the levels of MADRS were similar to those with unimpaired recall at the end-of-treatment visit (-14.3 vs -12.2 points). Other results were not significant after false discovery rate adjustment.
CONCLUSIONS AND RELEVANCE
In this secondary analysis of the ELEKT-D randomized clinical trial of ECT vs ketamine, greater improvement in depression was observed with intravenous ketamine among outpatients with nonpsychotic TRD who had moderately severe or severe depression, suggesting that these patients may consider ketamine over ECT for TRD.
Topics: Humans; Ketamine; Electroconvulsive Therapy; Female; Male; Middle Aged; Depressive Disorder, Treatment-Resistant; Adult; Aged; Treatment Outcome
PubMed: 38916891
DOI: 10.1001/jamanetworkopen.2024.17786 -
JAMA Network Open Jun 2024Spinal cord injury (SCI) causes drastic changes to an individual's physical health that may be associated with the ability to work.
IMPORTANCE
Spinal cord injury (SCI) causes drastic changes to an individual's physical health that may be associated with the ability to work.
OBJECTIVE
To estimate the association of SCI with individual earnings and employment status using national administrative health databases linked to income tax data.
DESIGN, SETTING, AND PARTICIPANTS
This was a retrospective, national, population-based cohort study of adults who were hospitalized with cervical SCI in Canada between January 2005 and December 2017. All acute care hospitalizations for SCI of adults ages 18 to 64 years were included. A comparison group was constructed by sampling from individuals in the injured cohort. Fiscal information from their preinjury years was used for comparison. The injured cohort was matched with the comparison group based on age, sex, marital status, province of residence, self-employment status, earnings, and employment status in the year prior to injury. Data were analyzed from August 2022 to January 2023.
MAIN OUTCOMES AND MEASURES
The first outcome was the change in individual annual earnings up to 5 years after injury. The change in mean yearly earnings was assessed using a linear mixed-effects differences-in-differences regression. Income values are reported in 2022 Canadian dollars (CAD $1.00 = US $0.73). The second outcome was the change in employment status up to 5 years after injury. A multivariable probit regression model was used to compare proportions of individuals employed among those who had experienced SCI and the paired comparison group of participants.
RESULTS
A total of 1630 patients with SCI (mean [SD] age, 47 [13] years; 1304 male [80.0%]) were matched to patients in a preinjury comparison group (resampled from the same 1630 patients in the SCI group). The mean (SD) of preinjury wage earnings was CAD $46 000 ($48 252). The annual decline in individual earnings was CAD $20 275 (95% CI, -$24 455 to -$16 095) in the first year after injury and CAD $20 348 (95% CI, -$24 710 to -$15 985) in the fifth year after injury. At 5 years after injury, 52% of individuals who had an injury were working compared with 79% individuals in the preinjury comparison group. SCI survivors had a decrease in employment of 17.1 percentage points (95% CI, 14.5 to 19.7 percentage points) in the first year after injury and 17.8 percentage points (14.5 to 21.1 percentage points) in the fifth year after injury.
CONCLUSIONS AND RELEVANCE
In this study, SCI was associated with a decline in earnings and employment up to 5 years after injury for adults aged 18 to 64 years in Canada.
Topics: Humans; Spinal Cord Injuries; Male; Female; Adult; Employment; Middle Aged; Income; Retrospective Studies; Canada; Young Adult; Adolescent; Cervical Cord
PubMed: 38916890
DOI: 10.1001/jamanetworkopen.2024.18468 -
JAMA Network Open Jun 2024Prostate cancer is a prevalent disease among men worldwide, exhibiting substantial heterogeneity in presentation and outcomes influenced by various factors, including... (Observational Study)
Observational Study
IMPORTANCE
Prostate cancer is a prevalent disease among men worldwide, exhibiting substantial heterogeneity in presentation and outcomes influenced by various factors, including race and ethnicity. Disparities in incidence, stage at diagnosis, and survival rates have been observed between Black men and those of other races and ethnicities.
OBJECTIVE
To compare prostate cancer outcomes between Black men and men with other race (Asian, Hispanic, Indigenous, Middle Eastern, White, Multiracial, and Other) in a universal health care system, with race and ethnicity self-reported.
DESIGN, SETTING, AND PARTICIPANTS
This was a prospective, observational cohort study of men diagnosed with prostate cancer between June 1, 2014, and August 28, 2023, who self-identified race and ethnicity. Participants included men who had been prospectively enrolled in the Alberta Prostate Cancer Research Initiative from the 2 major urology referral centers in Alberta (University of Alberta and University of Calgary). All men with prostate cancer enrolled in the initiative were included.
EXPOSURE
Race and ethnicity.
MAIN OUTCOMES AND MEASURES
The primary outcome was the stage and grade of prostate cancer at diagnosis. Further outcomes included age and prostate-specific antigen level at diagnosis, initial treatment modality, time from diagnosis to initial treatment, and prostate cancer-specific, metastasis-free, and overall survivals.
RESULTS
A total of 6534 men were included; 177 (2.7%) were Black, and 6357 (97.3%) had another race or ethnicity. Men who identified as Black were diagnosed with prostate cancer at an earlier age (mean [SD], 62.0 [8.2] compared with 64.6 [7.7] years; P < .001) and had a lower Charlson Comorbidity Index rating (14% compared with 7% ≤ 1; P < .001) compared with men of other races. Men who identified as Black had similar prostate-specific antigen levels at diagnosis, TNM category (74% vs 74% with T1-T2; P = .83) and Gleason Grade Group (34% compared with 35% Gleason Grade Group 1; P = .63). Black men had similar rates of prostate cancer-specific (hazard ratio [HR], 1.10; 95% CI, 0.41-2.97; P = .85), metastasis-free (HR, 0.88; 95% CI, 0.42-1.46; P = .44), and overall (HR, 0.55; 95% CI, 0.25-1.24; P = .15) survival.
CONCLUSIONS AND RELEVANCE
The findings of this cohort study suggest that Black men, despite being diagnosed at a younger age, experience comparable prostate cancer outcomes compared with men of other races.
Topics: Male; Humans; Prostatic Neoplasms; Aged; Middle Aged; Prospective Studies; Alberta; Canada; Black or African American; Neoplasm Grading; Black People; Neoplasm Staging; Prostate-Specific Antigen
PubMed: 38916889
DOI: 10.1001/jamanetworkopen.2024.18475 -
Prevalence of and Risk Factors for Post-COVID-19 Condition during Omicron BA.5-Dominant Wave, Japan.Emerging Infectious Diseases Jul 2024The increased risk for post-COVID-19 condition after the Omicron-dominant wave remains unclear. This population-based study included 25,911 persons in Japan 20-69 years...
The increased risk for post-COVID-19 condition after the Omicron-dominant wave remains unclear. This population-based study included 25,911 persons in Japan 20-69 years of age with confirmed SARS-CoV-2 infection enrolled in the established registry system during July-August 2022 and 25,911 age- and sex-matched noninfected controls who used a self-reported questionnaire in January-February 2023. We compared prevalence and age- and sex-adjusted odds ratios of persistent COVID-19 symptoms (lasting ≥2 months). We evaluated factors associated with post-COVID-19 condition by comparing cases with and without post-COVID-19 condition. We analyzed 14,710 (8,392 cases and 6,318 controls) of 18,183 respondents. Post-COVID-19 condition proportion among cases was 11.8%, higher by 6.3% than 5.5% persistent symptoms among controls. Female sex, underlying medical conditions, mild to moderate acute COVID-19, and vaccination were associated with post-COVID-19 condition. Approximately 12% had post-COVID-19 condition during the Omicron-dominant wave, indicating the need for longer follow-up.
Topics: Humans; COVID-19; Middle Aged; Female; Male; Japan; Adult; Risk Factors; Aged; SARS-CoV-2; Prevalence; Young Adult; Post-Acute COVID-19 Syndrome; Case-Control Studies
PubMed: 38916571
DOI: 10.3201/eid3007.231723 -
MBio Jun 2024Pathogenic bacteria of the genus pose a severe threat to human health worldwide due to their strong adaptability, tolerance, and antibiotic resistance. Most isolates of...
Pathogenic bacteria of the genus pose a severe threat to human health worldwide due to their strong adaptability, tolerance, and antibiotic resistance. Most isolates of these bacteria harbor a type VI secretion system (T6SS) that allows them to outcompete co-residing microorganisms, but whether this system is involved in acquiring nutrients from preys remains less studied. In this study, we found that Ab25, a clinical isolate of utilizes a T6SS to kill taxonomically diverse microorganisms, including bacteria and fungi. The T6SS of Ab25 is constitutively expressed, and among the three predicted effectors, T6e1, a member of the RHS effector family, contributes the most for its antimicrobial activity. T6e1 undergoes self-cleavage, and a short carboxyl fragment with nuclease activity is sufficient to kill target cells via T6SS injection. Interestingly, strain Ab25 encodes an orphan VgrG protein, which when overexpressed blocks the firing of its T6SS. In niches such as dry plastic surfaces, the T6SS promotes prey microorganism-dependent survival of Ab25. These results reveal that employs T6SSs that are highly diverse in their regulation and effector composition to gain a competitive advantage in environments with scarce nutrient supply and competing microbes.IMPORTANCEThe type VI secretion system (T6SS) plays an important role in bacterial adaptation to environmental challenges. Members of the genus, particularly and are notorious for their multidrug resistance and their ability to survive in harsh environments. In contrast to , whose T6SS has been well-studied, few research works have focused on . In this study, we found that an strain utilizes a contitutively active T6SS to kill diverse microorganisms, including bacteria and fungi. Although T6SS structural proteins of are similar to those of , the effector repertoire differs greatly. Interestingly, the T6SS of the strain codes for an ophan VgrG protein, which blocks the firing of the system when overexpressed, suggesting the existence of a new regulatory mechanism for the T6SS. Importantly, although the T6SS does not provide an advantage when the bacterium is grown in nutrient-rich medium, it allows to survive better in dry surfaces that contain co-existing bacteria. Our results suggest that killing of co-residing microorganisms may increase the effectiveness of strategies designed to reduce the fitness of bacteria by targeting their T6SS.
PubMed: 38916378
DOI: 10.1128/mbio.01468-24 -
Reumatismo Jun 2024Chronic diseases, which caused 36 million deaths in 2008, are the most common cause of death worldwide. Exercise is one of the non-pharmacological treatment methods....
OBJECTIVE
Chronic diseases, which caused 36 million deaths in 2008, are the most common cause of death worldwide. Exercise is one of the non-pharmacological treatment methods. Although exercise benefits are well known, more than half of the population does not exercise due to the burden of exercise. The objectives of the current study were to evaluate the Turkish version of the Exercise Therapy Burden Questionnaire (ETBQ-T) and to investigate its reliability and validity.
METHODS
A total of 100 participants (female: 69, male: 31) who were diagnosed with at least one chronic disease participated in the translation validity and reliability analysis of the study. Cross-cultural adaptation of the ETBQ-T was performed according to Beaton's guidelines. The ETBQ-T, the European Quality of Life 5 Dimensions (EQ-5D), pain, satisfaction, and self-efficacy were applied for convergent validity. The ETBQ-T was retested to examine its reliability after 7 days.
RESULTS
The internal consistency and reliability were excellent (intraclass correlation coefficient=0.959; Cronbach's α=0.919). The standard error of measurement was reported as 5.35. The minimum detectable difference was also demonstrated at 1.35. The ETBQ-T had a good correlation with pain (r=0.545, p<0.001), satisfaction (r=-501, p<0.001), and self-efficacy (r=-0.579, p<0.001). However, the correlation of the ETBQ-T with EQ-5D (r=0.340, p=0.001) was weak. A factor was extracted, accounting for 58.289% of the total variation. There were no floor or ceiling effects.
CONCLUSIONS
The ETBQ-T is a reliable and valid tool to evaluate the exercise burden in the Turkish population with chronic disease.
Topics: Humans; Male; Female; Reproducibility of Results; Turkey; Chronic Disease; Middle Aged; Surveys and Questionnaires; Exercise Therapy; Adult; Translations; Quality of Life; Cross-Cultural Comparison; Aged; Cost of Illness
PubMed: 38916165
DOI: 10.4081/reumatismo.2024.1684 -
Journal of Primary Care & Community... 2024Lifestyle interventions can prevent type 2 diabetes (T2D) by successfully inducing behavioral changes (eg, avoiding physical inactivity and sedentariness, increasing...
Hybrid Evaluation of a Lifestyle Change Program to Prevent the Development of Type 2 Diabetes Among Individuals With Prediabetes: Intended and Observed Changes in Intervening Mechanisms.
BACKGROUND
Lifestyle interventions can prevent type 2 diabetes (T2D) by successfully inducing behavioral changes (eg, avoiding physical inactivity and sedentariness, increasing physical activity and/or healthy eating) that reduce body weight and normalize metabolic levels (eg, HbA1c). For interventions to be successful, it is important to influence "behavioral mechanisms" such as self-efficacy, which motivate behavioral changes. Theory-based expectations of how self-efficacy, chronic stress, and mood changed over time were investigated through a group-based behavior change intervention (PREMIT). At 8 intervention sites, PREMIT was offered by trained primary care providers in 18 group-sessions over a period of 36 months, divided into 4 intervention phases. Adherence to the intervention protocol was assessed.
METHOD
Participants (n = 962) with overweight and prediabetes who had achieved ≥8% weight loss during a diet reduction period and completed the intervention were categorized into 3 groups: infrequent, frequent, or very frequent group sessions attendance. The interactions between participation in the group sessions and changes in self-efficacy, stress, and mood were multivariate tested. Intervention sites were regularly asked where and how they deviated from the intervention protocol.
RESULTS
There was no increase in the participants' self-efficacy in any group. However, the level of self-efficacy was maintained among those who attended the group sessions frequently, while it decreased in the other groups. For all participants, chronic stress and the frequency of attending group sessions were inversely related. Significant differences in mood were found for all groups. All intervention centers reported specific activities, additional to intervention protocol, to promote participation in the group sessions.
CONCLUSIONS
The results suggest that the behavioral changes sought by trained primary care providers are related to attendance frequency and follow complex trajectories. The findings also suggest that group-based interventions in naturalistic primary care settings aimed at preventing T2D require formats and strategies that encourage participants to attend group sessions regularly.
Topics: Humans; Diabetes Mellitus, Type 2; Prediabetic State; Male; Female; Middle Aged; Self Efficacy; Life Style; Aged; Adult; Stress, Psychological; Exercise; Program Evaluation; Affect; Risk Reduction Behavior; Primary Health Care; Overweight
PubMed: 38916158
DOI: 10.1177/21501319241248223 -
ELife Jun 2024Few national-level studies have evaluated the impact of 'hybrid' immunity (vaccination coupled with recovery from infection) from the Omicron variants of SARS-CoV-2....
Few national-level studies have evaluated the impact of 'hybrid' immunity (vaccination coupled with recovery from infection) from the Omicron variants of SARS-CoV-2. From May 2020 to December 2022, we conducted serial assessments (each of ~4000-9000 adults) examining SARS-CoV-2 antibodies within a mostly representative Canadian cohort drawn from a national online polling platform. Adults, most of whom were vaccinated, reported viral test-confirmed infections and mailed self-collected dried blood spots to a central lab. Samples underwent highly sensitive and specific antibody assays to spike and nucleocapsid protein antigens, the latter triggered only by infection. We estimated cumulative SARS-CoV-2 incidence prior to the Omicron period and during the BA.1/1.1 and BA.2/5 waves. We assessed changes in antibody levels and in age-specific active immunity levels. Spike levels were higher in infected than in uninfected adults, regardless of vaccination doses. Among adults vaccinated at least thrice and infected more than six months earlier, spike levels fell notably and continuously for the nine months post-vaccination. By contrast, among adults infected within six months, spike levels declined gradually. Declines were similar by sex, age group, and ethnicity. Recent vaccination attenuated declines in spike levels from older infections. In a convenience sample, spike antibody and cellular responses were correlated. Near the end of 2022, about 35% of adults above age 60 had their last vaccine dose more than six months ago, and about 25% remained uninfected. The cumulative incidence of SARS-CoV-2 infection rose from 13% (95% CI 11-14%) before omicron to 78% (76-80%) by December 2022, equating to 25 million infected adults cumulatively. However, the COVID-19 weekly death rate during the BA.2/5 waves was less than half of that during the BA.1/1.1 wave, implying a protective role for hybrid immunity. Strategies to maintain population-level hybrid immunity require up-to-date vaccination coverage, including among those recovering from infection. Population-based, self-collected dried blood spots are a practicable biological surveillance platform. Funding was provided by the COVID-19 Immunity Task Force, Canadian Institutes of Health Research, Pfizer Global Medical Grants, and St. Michael's Hospital Foundation. PJ and ACG are funded by the Canada Research Chairs Program.
PubMed: 38916134
DOI: 10.7554/eLife.89961 -
Clinical, Cosmetic and Investigational... 2024This in vitro study investigated the effects of dietary solvents on the microhardness and color stability of CAD/CAM provisional restorations compared to conventional...
PURPOSE
This in vitro study investigated the effects of dietary solvents on the microhardness and color stability of CAD/CAM provisional restorations compared to conventional materials.
METHODS
Disc-shaped specimens (n=200) were fabricated from self-cured acrylic resin, two 3D-printing resins (FormLabs, NextDent), and a milled material (TelioCAD). Randomization assigned specimens (n=10/group) to immersion solutions: artificial saliva, citric acid, heptane, coffee, and tea. Microhardness and color stability were evaluated. One-way and three-way ANOVA with Tukey's post hoc test analyzed the data.
RESULTS
Dietary solvents significantly reduced the surface microhardness of all tested materials (p<0.05). Unpolished surfaces exhibited greater color changes compared to polished ones (p<0.05) across all materials. Coffee and tea induced the most substantial reductions in hardness and the most significant color alterations (p<0.05), whereas saliva and citric acid had minimal effects.
CONCLUSION
Milled provisional restorations exhibited superior hardness and color stability. Dietary solvents significantly affected material properties over time, highlighting the importance of material selection for clinical applications.
PubMed: 38915917
DOI: 10.2147/CCIDE.S462107