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Effects of the COVID-19 pandemic on routine pediatric vaccination in Brazil

Expert Rev Vaccines. 2021 Oct 6. doi: 10.1080/14760584.2021.1990045. Online ahead of print.

ABSTRACT

BACKGROUND: COVID-19 pandemic has disrupted health services, including vaccination demand. We describe the impact of the COVID-19 pandemic on routine pediatric vaccination in Brazil.

METHODS: We conducted a retrospective analysis of all vaccine doses provided to children aged 0-6 years from January 2019 to December 2020. We obtained data stratified by age group (0 to 2 years and >2 to 6 years) and Brazilian region. Difference-in-difference (DiD) analyses were performed to compare vaccine uptake in the pre-pandemic (January-February), stay-at-home (March-June), and reopening (July-December) periods.

RESULTS: The number of vaccine doses administered declined in the stay-at-home period. For children aged 0 to 2 years, the highest reductions were recorded in the North (-25.3%), Northeast (-16.8%) and Central-West (-10.2%) regions. For children aged >2 to 6 years, the highest decline was observed in the North (DiD = -27.2%) and South (DiD = -14.0%) regions. The number of vaccine doses administered in the reopening period has slightly increased in all regions.

CONCLUSIONS: Vaccination decreased during the COVID-19 pandemic. Although the number of doses recovered in part during the reopening phase, additional strategies, such as increased public awareness and vaccination booster campaigns are required.

PMID:34612135 | DOI:10.1080/14760584.2021.1990045

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How to assess the risks associated with the usage of a medical device based on predictive modeling: the case of an anemia control model certified as medical device

Expert Rev Med Devices. 2021 Oct 6. doi: 10.1080/17434440.2021.1990037. Online ahead of print.

ABSTRACT

BACKGROUND: The successful application of Machine Learning (ML) to many clinical problems can lead to its implementation as medical devices (MD), being important to assess the associated risks.

METHODS: An anemia control model (ACM), certified as MD may face adverse events as the result of wrong predictions that are translated into suggestions of doses of erythropoietic stimulating agents to dialysis patients. Risks are assessed as the combination of severity and probability of a given hazard. While severities are typically assessed by clinicians, probabilities are tightly related to the performance of the predictive model.

RESULTS: A post-marketing dataset formed by all adult patients registered in French, Portuguese and Spanish clinics, belonging to an international network was considered; 3876 patients and 11508 suggestions were eventually included. The achieved results show that there are no statistical differences between the probabilities of adverse events that are estimated in the ACM test set (using only Spanish clinics) and those actually observed in the post-marketing cohort.

CONCLUSIONS: The risks of an ACM-MD can be accurately and robustly estimated, thus enhancing patients’ safety. The proposed methodology is applicable to other clinical decisions based on predictive models since our proposal does not depend on the particular predictive model.

PMID:34612120 | DOI:10.1080/17434440.2021.1990037

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Evaluation of cytokines in protective effect of docosahexaenoic acid in experimental achilles tendinopathy rat model induced with type-1 collagenase

Connect Tissue Res. 2021 Oct 6:1-13. doi: 10.1080/03008207.2021.1982915. Online ahead of print.

ABSTRACT

BACKGROUND: We aimed to investigate the effectiveness of docosahexaenoic acid (DHA) as a treatment for Achilles tendinopathy (AT) induced with type-I collagenase in rats and compare it with collagen.

METHODS: The AT model was induced with type I collagenase, and animals were randomly assigned to groups. Group 1:AT, Group 2: Collagen (7.2 mg/kg/day), Group 3:DHA (300 mg/kg/day), and Group 4:DHA (100 mg/kg/day). Right tendons of Group1 were used as a healthy control (HC). Oral treatments were applied for eight weeks. Serum tumor necrosis factor-alpha(TNF-α), matrix metalloproteinase-13 (MMP-13), and interleukin-1 beta(IL-1β) concentrations were determined by ELISA. Tendon samples were taken for histopathological evaluation and examined immunohistochemically with antibodies specific for Col1A1, TNF-α, MMP-13, IL-1β, and nitric oxide synthase-2(NOS-2). The ultimate tensile force (UTF) yield force(YF) and stiffness were measured by biomechanical assessments.

RESULTS: UTF,YF and stiffness values were increased in all treatment groups compared to the AT control, a significant increase was found in Group 2 (p < 0.05). There was severe degeneration of tendon cells in the AT control. The tendon cells in samples from Groups 2-3 were less degraded, and this was statistically significant (p < 0.05). TNF-α, MMP-13, IL-1β, and NOS-2 expressions were significantly higher in the AT control compared to the HC. In all treatment groups, their concentrations were lower than in the AT control. Serum TNF-α, MMP-13, and IL-1β levels were lower in all treatment groups (Especially in Group3 (p < 0.001)) compared to Group1.

CONCLUSION: The efficacy of high-dose DHA as a treatment for AT was investigated from biochemical, histopathological, and biomechanical perspectives. The results showed that DHA could be an alternative treatment compound to collagen.

PMID:34612118 | DOI:10.1080/03008207.2021.1982915

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Interpreting change on the Symbol Digit Modalities Test in people with relapsing multiple sclerosis using the reliable change methodology

Mult Scler. 2021 Oct 6:13524585211049397. doi: 10.1177/13524585211049397. Online ahead of print.

ABSTRACT

BACKGROUND: The Symbol Digit Modalities Test (SDMT) is increasingly utilized in clinical trials. A SDMT score change of 4 points is considered clinically important, based on association with employment anchors. Optimal thresholds for statistically reliable SDMT changes, accounting for test reliability and measurement error, are yet to be applied to individual cases.

OBJECTIVE: The aim of this study was to derive a statistically reliable marker of individual change on the SDMT.

METHODS: This prospective, case-control study enrolled 166 patients with multiple sclerosis (MS). SDMT scores at baseline, relapse, and 3-month follow-up were compared between relapsing and stable patient groups. Using data from the stable group and three previously published studies, candidate thresholds for reliable decline were calculated and validated against other tests and a clinically meaningful anchor-cognitive relapse.

RESULTS: Candidate thresholds for reliable decline at the 80% confidence level varied between 6 and 11 points. An SDMT change of 8 or more raw score points was deemed to offer the best balance of discriminatory power and external validity for estimating cognitive decline.

CONCLUSION: This study illustrates the feasibility and usefulness of reliable change methodology for identifying statistically meaningful cognitive decline that could be implemented to identify change in individual patients, for both clinical management and clinical trial outcomes.

PMID:34612114 | DOI:10.1177/13524585211049397

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Multiple sclerosis diagnosis: Knowledge gaps and opportunities for educational intervention in neurologists in the United States

Mult Scler. 2021 Oct 6:13524585211048401. doi: 10.1177/13524585211048401. Online ahead of print.

ABSTRACT

BACKGROUND: Few studies have addressed the results of educational efforts concerning proper use of McDonald criteria (MC) revisions outside multiple sclerosis (MS) subspecialty centers. Neurology residents and MS subspecialist neurologists demonstrated knowledge gaps for core elements of the MC in a recent prior study.

OBJECTIVE: To assess comprehension and application of MC core elements by non-MS specialist neurologists in the United States who routinely diagnose MS.

METHODS: Through a cross-sectional study design, a previously developed survey instrument was distributed online.

RESULTS: A total of 222 neurologists completed the study survey. Syndromes atypical for MS were frequently incorrectly considered “typical” MS presentations. Fourteen percent correctly identified definitions of both “periventricular” and “juxtacortical” lesions and 2% correctly applied these terms to 9/9 images. Twenty-four percent correctly identified all four central nervous system (CNS) regions for satisfaction of magnetic resonance imaging (MRI) dissemination in space. In two presented cases, 61% and 71% correctly identified dissemination in time (DIT) was not fulfilled, and 85% and 86% subsequently accepted nonspecific historical symptoms without objective evidence for DIT fulfillment.

CONCLUSION: The high rate of knowledge deficiencies and application errors of core elements of the MC demonstrated by participants in this study raise pressing questions concerning adequacy of dissemination and educational efforts upon publication of revisions to MC.

PMID:34612110 | DOI:10.1177/13524585211048401

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Using 360-degree video for teaching emergency medicine during and beyond the COVID-19 pandemic

Ann Med. 2021 Dec;53(1):1520-1530. doi: 10.1080/07853890.2021.1970219.

ABSTRACT

OBJECTIVE: During the COVID-19 pandemic, emergency medicine (EM) teachers had to employ innovative methods to ensure the continuity of the education process. The purpose of this study was to explore the adequacy of the 360-degree video (video 360) technology in EM education in the context of: (a) students’ attitudes towards the video 360; (b) students’ academic performance in their required examination at the end of the EM course compared to the assessment results of students from the previous academic year.

METHODS: A mixed-method research project enrolled the fourth-year medical students who attended the required EM course during the first semester of the academic year 2020-2021 when all activities with undergraduate students went online and teaching scenarios recorded in the video 360 format were employed. Data collection was two-fold: (a) anonymous questionnaires, complemented with basic YouTube analytics; (b) multiple-choice questionnaires (MCQ) and oral examination, contrasting the results with those in 2019-2020. Data analysis used descriptive statistics and non-parametric methods.

RESULTS: Seventy-nine students (53 females and 26 males) participated in the project and all completed the EM course. Students’ interest in and their acceptance of the video 360 technology were high (total scoring in the upper 20% of the respective scales), with consistently good performance in two parallel, independent, interview-based oral/practical evaluations (Spearman correlation coefficient R = 0.665, p < .001). The majority scored over 90% in the summative MCQ, with higher values compared to their colleagues’ during the previous academic year (with on-site teaching): scoring percentages with mean ± standard deviation of 92.52 ± 4.57 and 76.67 ± 18.77, respectively.

CONCLUSION: Our project showed that the video 360 scenarios were effective in teaching EM. In the long term, employing this accessible and inexpensive educational approach would add value to on-site training by enriching the exposure to a specific ED environment.KEY MESSAGESMedical students valued the 360-degree video scenarios as contributing substantially to their EM knowledge and preparedness.Examination results confirmed the 360-degree video scenarios as viable in EM teaching.The 360-degree video technology would be a sustainable solution for hybrid medical teaching in the long term.

PMID:34612105 | DOI:10.1080/07853890.2021.1970219

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Temporal trends in self-reported HIV stigma and association with adherence and viral suppression in the African Cohort Study

AIDS Care. 2021 Oct 6:1-8. doi: 10.1080/09540121.2021.1984380. Online ahead of print.

ABSTRACT

HIV stigma is a major barrier to HIV care and treatment among people living with HIV (PLWH). Evidence suggests that expansion in antiretroviral therapy (ART) may reduce stigma. However, there are limited longitudinal studies examining temporal trends in HIV stigma in sub-Saharan Africa in the Undetectable = Untransmittable (U = U) era. We longitudinally assessed temporal trends in self-reported experienced stigma and the association of experienced stigma with ART adherence and viral suppression among PLWH enrolled in the African Cohort Study (AFRICOS). AFRICOS is an ongoing cohort study enrolling PLWH in Uganda, Kenya, Tanzania, and Nigeria. As of 1 March 2020, 2937 PLWH enrolled in AFRICOS and had available data. In 2013, 22% of participants reported stigma at the enrollment visit and by 2018 the prevalence decreased to 1% overall and was below 2% for all countries. However, there was not a statistically significant change in stigma prevalence in our longitudinal models. In adjusted models, experiencing stigma was associated with a 0.67 decreased odds of ART Adherence (95% confidence interval (CI): 0.56-0.80) and a 0.64 decreased odds of viral suppression (95% CI: 0.73-0.99). HIV-associated stigma was associated with poor self-reported ART adherence and unsuppressed viral load.

PMID:34612100 | DOI:10.1080/09540121.2021.1984380

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Long-Term Exposure to Air Pollution, Road Traffic Noise, and Heart Failure Incidence: The Danish Nurse Cohort

J Am Heart Assoc. 2021 Oct 6:e021436. doi: 10.1161/JAHA.121.021436. Online ahead of print.

ABSTRACT

Background We examined the association of long-term exposure to air pollution and road traffic noise with incident heart failure (HF). Methods And Results Using data on female nurses from the Danish Nurse Cohort (aged >44 years), we investigated associations between 3-year mean exposures to air pollution and road traffic noise and incident HF using Cox regression models, adjusting for relevant confounders. Incidence of HF was defined as the first hospital contact (inpatient, outpatient, or emergency) between cohort baseline (1993 or 1999) and December 31, 2014, based on the Danish National Patient Register. Annual mean levels of particulate matter with a diameter <2.5 µm since 1990 and NO2 and road traffic noise since 1970 were estimated at participants’ residences. Of the 22 189 nurses, 484 developed HF. We detected associations with all 3 pollutants, with hazard ratios (HRs) of 1.17 (95% CI, 1.01-1.36), 1.10 (95% CI, 0.99-1.22), and 1.12 (95% CI, 0.99-1.26) per increase of 5.1 µg/m3 in particulate matter with a diameter <2.5 µm, 8.6 µg/m3 in NO2, and 9.3 dB in road traffic noise, respectively. We observed an enhanced risk of HF incidence for those exposed to high levels of the 3 pollutants; however, the effect modification of coexposure was not statistically significant. Former smokers and nurses with hypertension showed the strongest associations with particulate matter with a diameter <2.5 µm (Peffect modification<0.05). Conclusions We found that long-term exposures to air pollution and road traffic noise were independently associated with HF.

PMID:34612059 | DOI:10.1161/JAHA.121.021436

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Validation of the 4-Item PRECISE-DAPT Score: A SWEDEHEART Study

J Am Heart Assoc. 2021 Oct 6:e020974. doi: 10.1161/JAHA.121.020974. Online ahead of print.

ABSTRACT

Background The Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score has been shown to predict out-of-hospital major bleeding after myocardial infarction treated with percutaneous coronary intervention and dual antiplatelet therapy (DAPT). However, large validation studies have been scarce and the discriminative ability for patients with a preexisting bleeding risk factor (elderly, underweight, women, anemia, kidney dysfunction, or cancer) in a real-world setting is unknown. Methods and Results Patients undergoing percutaneous coronary intervention for myocardial infarction between 2008 and 2017 were included from the SWEDEHEART (Swedish Web System for Enhancement of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) registry (n=66 295). The predictive value of the PRECISE-DAPT score for rehospitalization with major bleeding during dual antiplatelet therapy was evaluated using receiver operating characteristic analyses. A high PRECISE-DAPT score (≥25; n=13 894) was associated with increased risk of major bleeding (3.9% versus 1.8%; hazard ratio [HR], 2.2; 95% CI, 2.0-2.5; P<0.001) compared with a non-high score (<25; n=52 401). The score demonstrated a c-statistic of 0.64 (95% CI, 0.63-0.66). The discriminative ability of the score to further stratify bleeding risk in patients with preexisting bleeding risk factors was poor, especially in patients who are elderly (c-statistic=0.57; 95% CI, 0.55-0.60) or underweight (c-statistic=0.56; 95% CI, 0.51-0.61), for whom a non-high PRECISE-DAPT score was associated with similar bleeding risk as a high PRECISE-DAPT score in the general myocardial infarction population. Conclusions In this nationwide population-based study, the PRECISE-DAPT score performed moderately in the general myocardial infarction population and poorly in patients with preexisting bleeding risk factors, where its usefulness seems limited.

PMID:34612051 | DOI:10.1161/JAHA.121.020974

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A randomized, feasibility trial of an exercise and nutrition-based rehabilitation programme (ENeRgy) in people with cancer

J Cachexia Sarcopenia Muscle. 2021 Oct 5. doi: 10.1002/jcsm.12806. Online ahead of print.

ABSTRACT

BACKGROUND: Despite rehabilitation being increasingly advocated for people living with incurable cancer, there is limited evidence supporting efficacy or component parts. The progressive decline in function and nutritional in this population would support an approach that targets these factors. This trial aimed to assess the feasibility of an exercise and nutrition based rehabilitation programme in people with incurable cancer.

METHODS: We randomized community dwelling adults with incurable cancer to either a personalized exercise and nutrition based programme (experimental arm) or standard care (control arm) for 8 weeks. Endpoints included feasibility, quality of life, physical activity (step count), and body weight. Qualitative and health economic analyses were also included.

RESULTS: Forty-five patients were recruited (23 experimental arm, 22 control arm). There were 26 men (58%), and the median age was 78 years (IQR 69-84). At baseline, the median BMI was 26 kg/m2 (IQR: 22-29), and median weight loss in the previous 6 months was 5% (IQR: -12% to 0%). Adherence to the experimental arm was >80% in 16/21 (76%) patients. There was no statistically significant difference in the following between trial arms: step count – median % change from baseline to endpoint, per trial arm (experimental -18.5% [IQR: -61 to 65], control 5% [IQR: -32 to 50], P = 0.548); weight – median % change from baseline to endpoint, per trial arm (experimental 1%[IQR: -3 to 3], control -0.5% [IQR: -3 to 1], P = 0.184); overall quality of life – median % change from baseline to endpoint, per trial arm (experimental 0% [IQR: -20 to 19], control 0% [IQR: -23 to 33], P = 0.846). Qualitative findings observed themes of capability, opportunity, and motivation amongst patients in the experimental arm. The mean incremental cost of the experimental arm versus control was £-319.51 [CI -7593.53 to 6581.91], suggesting the experimental arm was less costly.

CONCLUSIONS: An exercise and nutritional rehabilitation intervention is feasible and has potential benefits for people with incurable cancer. A larger trial is now warranted to test the efficacy of this approach.

PMID:34612012 | DOI:10.1002/jcsm.12806