Categories
Nevin Manimala Statistics

Improving Micronutrient Status of Children and Women in Rural Communities in India Using Crystal Salt Enriched with Multiple Micronutrients

J Nutr Sci Vitaminol (Tokyo). 2021;67(2):111-117. doi: 10.3177/jnsv.67.111.

ABSTRACT

To demonstrate that fortified crystal salt enriched with iron, iodine, vitamin B12, folic acid and zinc can combat multi-micronutrient deficiencies. A randomized controlled study was conducted in 6 villages in Tiruvallur district, in Tamilnadu, South India. All the women and children aged 5-17 y in households in the experimental villages (n=117) were provided the fortified salt for 8 mo. Similar demographic group in the control villages (n=95) used regular non-fortified salts for the same time period. Blood from study subjects were analysed for hemoglobin, serum ferritin, serum transferrin receptor, AGP, CRP, and serum zinc, at the beginning and end of the study. Urine was analyzed for iodine at the same times. The experimental group showed a statistically significant increase in hemoglobin (>1.05 g/dL), serum zinc (>12.23 μg/dL), ferritin (>6.97 μg/L) and body iron stores (>0.73 mg/kg body weight), compared to the control group. A significant decrease in the prevalence of anaemia from 67.5% to 29.1% and zinc deficiency from 32.7% to 12.4% was observed in the experimental group relative to control group, using Binary logistic regression. There was no change in urinary iodine in the experimental group while it decreased significantly in the control. The fortified crystal salt was effective in decreasing multi-micronutrient deficiencies.

PMID:33952731 | DOI:10.3177/jnsv.67.111

Categories
Nevin Manimala Statistics

New atypical manifestations and prognostic factors of Vibrio vulnificus infection: A 10-year retrospective study

Jpn J Infect Dis. 2021 Apr 30. doi: 10.7883/yoken.JJID.2020.843. Online ahead of print.

ABSTRACT

Vibrio vulnificus (V. vulnificus) infection is rare but potentially fatal. This study explored the new atypical manifestations and prognostic factors of V. vulnificus-infected patients throughout hospitalization. we retrospectively reviewed 33 patients diagnosed as having V. vulnificus infection in Guangdong Province, China between 2010 and 2020. Medical records were analyzed. Multiple logistic regression and receiver operating characteristic (ROC) curve analyses were performed. New atypical manifestations were found, including cholangitis, urinary tract infection, and suppurative otitis media. Eleven of thirty-three (33.3%) V. vulnificus-infected patients died eventually. By univariate analysis, patients with cardio-cerebro-vascular diseases, lower platelet counts, higher levels of C-reactive protein and procalcitonin (PCT) had a statistically higher mortality. However, multivariate analysis showed that only PCT (P = 0.036) reached statistical significance. Also, the area under the ROC value estimate for PCT was 0.8816 (95% CI, 0.759-1.000; P = 0.0009). More than half of patients with V. vulnificus infection would die when PCT >20 ng/ml, while no patient dies when PCT ≤ 20 ng/ml. This study found new atypical manifestations of V. vulnificus infection. Also, PCT is an effective and independent predictor of mortality of V. vulnificus infection, and is suitable for clinicians to make early risk stratification and best therapeutic strategies.

PMID:33952769 | DOI:10.7883/yoken.JJID.2020.843

Categories
Nevin Manimala Statistics

Comparing PET and MRI Biomarkers Predicting Cognitive Decline in Preclinical Alzheimer Disease

Neurology. 2021 May 5:10.1212/WNL.0000000000012108. doi: 10.1212/WNL.0000000000012108. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare how structural MRI, Fluorodeoxyglucose (FDG), and Flortaucipir (FTP) PET signal predict cognitive decline in high-amyloid versus low-amyloid participants with the goal of determining which biomarker combination would result in the highest increase of statistical power for prevention trials.

METHODS: In this prospective cohort study, we analyzed data from clinically-normal adults from the Harvard Aging Brain Study with MRI, FDG, FTP, and PiB-PET acquired within a year, and prospective cognitive evaluations over a mean three-year follow-up. We focused analyses on pre-defined regions-of-interest: inferior temporal, isthmus cingulate, hippocampus, and entorhinal cortex. Cognition was assessed using the Preclinical Alzheimer’s Cognitive Composite (PACC5). We evaluated the association between biomarkers and cognitive decline using linear-mixed-effect models with random intercepts and slopes, adjusting for demographics. We generated power curves simulating prevention trials.

RESULTS: Data from 131 participants [52 females, 73.98±8.29 years old] were analyzed in the study. In separate models, most biomarkers had a closer association with cognitive decline in the high-PiB compared to the low-PiB participants. A backward stepwise regression including all biomarkers demonstrated that only neocortical PiB, entorhinal FTP, and entorhinal FDG were independent predictors of subsequent cognitive decline. Power analyses revealed that using both high-PiB and low entorhinal FDG as inclusion criteria reduced 3-fold the number of participants needed in a hypothetical trial compared to using only high-PiB.

DISCUSSION: In preclinical Alzheimer’s disease, entorhinal hypometabolism is a strong and independent predictor of subsequent cognitive decline, making FDG a potentially useful biomarker to increase power in clinical trials.

CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that in people with preclinical Alzheimer’s disease, entorhinal hypometabolism identified by FDG-PET is predictive of subsequent cognitive decline.

PMID:33952655 | DOI:10.1212/WNL.0000000000012108

Categories
Nevin Manimala Statistics

Characterizing the need for multiple epidural blood patches in the treatment of postdural puncture headache: an observational study

Reg Anesth Pain Med. 2021 May 5:rapm-2021-102692. doi: 10.1136/rapm-2021-102692. Online ahead of print.

NO ABSTRACT

PMID:33952685 | DOI:10.1136/rapm-2021-102692

Categories
Nevin Manimala Statistics

Test-Retest Reliability of a Functional Reaction Time Assessment Battery

J Sport Rehabil. 2021 May 5:1-5. doi: 10.1123/jsr.2021-0021. Online ahead of print.

ABSTRACT

CONTEXT: Reaction time is commonly assessed postconcussion through a computerized neurocognitive battery. Although this measure is sensitive to postconcussion deficits, it is not clear if computerized reaction time reflects the dynamic reaction time necessary to compete effectively and safely during sporting activities. Functional reaction time assessments may be useful postconcussion, but reliability must be determined before clinical implementation.

OBJECTIVE: To determine the test-retest reliability of a functional reaction time assessment battery and to determine if reaction time improved between sessions.

DESIGN: Cohort.

SETTING: Laboratory.

PARTICIPANTS: Forty-one participants (21 men and 20 women) completed 2 time points. Participants, on average, were 22.5 (2.1) years old, 72.5 (11.9) cm tall, had a mass of 71.0 (13.7) kg, and were mostly right leg and hand dominant (92.7%).

INTERVENTIONS: Participants completed 2 clinical reaction time tests (computerized Stroop and drop stick) and 5 functional reaction time tests (gait, jump landing, single-leg hop, anticipated cut, and unanticipated cut) across 2 sessions. Drop stick and functional reaction time assessments were performed in single (motor task only) and dual task (motor task with cognitive task).

MAIN OUTCOME MEASURES: Reaction time (in seconds) was calculated during all assessments. Test-retest reliability was determined using 2-way mixed-effects intraclass correlation coefficients (3, k). Paired samples t tests compared mean reaction time between sessions.

RESULTS: Test-retest reliability was moderate to excellent for all reaction time outcomes (intraclass correlation coefficients [3, k] range = .766-.925). Several statistically significant between-session mean differences were observed, but effect sizes were negligible to small (d range = 0.05-0.44).

CONCLUSIONS: The functional reaction time assessment battery displayed similar reliability to the standard computerized reaction time assessment battery and may provide important postinjury information, but more research is needed to determine clinical utility.

PMID:33952713 | DOI:10.1123/jsr.2021-0021

Categories
Nevin Manimala Statistics

Administration of parenteral nutrition during therapeutic hypothermia: a population level observational study using routinely collected data held in the National Neonatal Research Database

Arch Dis Child Fetal Neonatal Ed. 2021 May 5:fetalneonatal-2020-321299. doi: 10.1136/archdischild-2020-321299. Online ahead of print.

ABSTRACT

BACKGROUND: Parenteral nutrition is commonly administered during therapeutic hypothermia. Randomised trials in critically ill children indicate that parenteral nutrition may be harmful.

OBJECTIVE: To examine the association between parenteral nutrition during therapeutic hypothermia and clinically important outcomes.

DESIGN: Retrospective, population-based cohort study using the National Neonatal Research Database; propensity scores were used to create matched groups for comparison.

SETTING: National Health Service neonatal units in England, Scotland and Wales.

PARTICIPANTS: 6030 term and near-term babies, born 1/1/2010 and 31/12/2017, who received therapeutic hypothermia; 2480 babies in the matched analysis.

EXPOSURE: We compared babies that received any parenteral nutrition during therapeutic hypothermia with babies that did not.

MAIN OUTCOME MEASURES: Primary outcome: blood culture confirmed late-onset infection; secondary outcomes: treatment for late onset infection, necrotising enterocolitis, survival, length of stay, measures of breast feeding, hypoglycaemia, central line days, time to full enteral feeds, discharge weight.

RESULTS: 1475/6030 babies (25%) received parenteral nutrition. In comparative matched analyses, the rate of culture positive late onset infection was higher in babies that received parenteral nutrition (0.3% vs 0.9%; difference 0.6; 95% CI 0.1, 1.2; p=0.03), but treatment for presumed infection was not (difference 0.8%, 95% CI -2.1 to 3.6, p=0.61). Survival was higher in babies that received parenteral nutrition (93.1% vs 90.0%; rate difference 3.1, 95% CI 1.5, 4.7; p<0.001).

CONCLUSIONS: Receipt of parenteral nutrition during therapeutic hypothermia is associated with higher late-onset infection but lower mortality. This finding may be explained by residual confounding. Research should address the risks and benefits of parenteral nutrition in this population.

PMID:33952628 | DOI:10.1136/archdischild-2020-321299

Categories
Nevin Manimala Statistics

Study recruitment factors in advanced cancer: the Prognosis in Palliative care Study II (PiPS2) – a multicentre, prospective, observational cohort project

BMJ Support Palliat Care. 2021 May 5:bmjspcare-2020-002670. doi: 10.1136/bmjspcare-2020-002670. Online ahead of print.

ABSTRACT

OBJECTIVES: The Prognosis in Palliative care Study II (PiPS2) was a large multicentre observational study validating prognostic tools in patients with advanced cancer. Many palliative care studies fail to reach their recruitment target. To inform future studies, PiPS2 rigorously monitored and identified any potential recruitment barriers.

METHODS: Key recruitment stages (ie, whether patients were eligible for the study, approached by the researchers and whether consent was obtained for enrolment) were monitored via comprehensive screening logs at participating sites (inpatient hospices, hospitals and community palliative care teams). The reasons for patients’ ineligibility, inaccessibility or decision not to consent were documented.

RESULTS: 17 014 patients were screened across 27 participating sites over a 20-month recruitment period. Of those, 4642 (27%) were ineligible for participation in the study primarily due to non-cancer diagnoses. Of 12 372 eligible patients, 9073 (73%) were not approached, the most common reason being a clinical decision not to do so. Other reasons included patients’ death or discharge before they were approached by the researchers. Of the 3299 approached patients, 1458 (44%) declined participation mainly because of feeling too unwell, experiencing severe distress or having other competing priorities. 11% (n=1841/17 014) of patients screened were enrolled in the study, representing 15% (n=1841/12 372) of eligible patients. Different recruitment patterns were observed across inpatient hospice, hospital and community palliative care teams.

CONCLUSIONS: The main barrier to recruitment was ‘accessing’ potentially eligible patients. Monitoring key recruitment stages may help to identify barriers and facilitators to enrolment and allow results to be put into better context.

TRIAL REGISTRATION NUMBER: ISRCTN13688211.

PMID:33952580 | DOI:10.1136/bmjspcare-2020-002670

Categories
Nevin Manimala Statistics

Quality of life and healthcare utilisation improvements after atrial fibrillation ablation

Heart. 2021 May 5:heartjnl-2020-318676. doi: 10.1136/heartjnl-2020-318676. Online ahead of print.

ABSTRACT

OBJECTIVE: Pulmonary vein isolation (PVI) guided by a standardised CLOSE (contiguous optimised lesions) protocol has been shown to increase clinical success after catheter ablation for paroxysmal atrial fibrillation (PAF). This study analysed healthcare utilisation and quality of life (QOL) outcomes from a large multicentre prospective study, measured association between QOL and atrial fibrillation (AF) burden and identified factors associated with lack of QOL improvement.

METHODS: CLOSE-guided ablation was performed in 329 consecutive patients (age 61.4 years, 60.8% male) with drug-refractory PAF in 17 European centres. QOL was measured at baseline and 12 months post-ablation via Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT) and EuroQoL EQ-5D-5L questionnaires. All-cause and cardiovascular hospitalisations and cardioversions over 12 months pre-ablation and post-ablation were recorded. Rhythm monitoring included weekly and symptom-driven trans-telephonic monitoring, plus ECG and Holter monitoring at 3, 6 and 12 months. AF burden was defined as the percentage of postblanking tracings with an atrial tachyarrhythmia ≥30 s. Continuous measures across multiple time points were analysed using paired t-tests, and associations between various continuous measures were analysed using independent sample t-tests. Each statistical test used two-sided p values with a significance level of 0.05.

RESULTS: Both QOL instruments showed significant 12-month improvements across all domains: AFEQT score increased 25.1-37.5 points and 33.3%-50.8% fewer patients reporting any problem across EuroQoL EQ-5D-5L domains. Overall, AFEQT improvement was highly associated with AF burden (p=0.009 for <10% vs ≥10% burden, p<0.001 for <20% vs ≥20% burden). Cardiovascular hospitalisations were significantly decreased after ablation (42%, p=0.001). Patients without substantial improvement in AFEQT (55/301, 18.2%) had higher AFEQT and CHA2DS2-VASc scores at baseline, and higher AF burden following PVI.

CONCLUSIONS: QOL improved and healthcare utilisation decreased significantly after ablation with a standardised CLOSE protocol. QOL improvement was significantly associated with impairment at baseline and AF burden after ablation.

TRIAL REGISTRATION NUMBER: NCT03062046.

PMID:33952593 | DOI:10.1136/heartjnl-2020-318676

Categories
Nevin Manimala Statistics

Cardiovascular complications of systemic lupus erythematosus: impact of risk factors and therapeutic efficacy-a tertiary centre experience in an Appalachian state

Lupus Sci Med. 2021 May;8(1):e000467. doi: 10.1136/lupus-2020-000467.

ABSTRACT

OBJECTIVES: Cardiovascular complications became a notable cause of morbidity and mortality in patients with lupus as therapeutic advancements became more efficient at managing other complications. The Appalachian community in Kentucky has a higher prevalence of traditional cardiovascular risk factors, predisposing them to cardiovascular events. Namely, the mean body mass index of the members of the Kentucky Appalachian community was reported at 33 kg/m2 and 94.3% of male members of this community use tobacco. We sought to identify risk factors that predispose patients with lupus to cardiovascular morbidities and examine the effect of immunomodulatory drugs.

METHODS: We identified 20 UKHS patients having both a lupus diagnosis and experienced at least one cardiovascular event. We chose three controls matched for birth-year ±5 years to each case. In a case-control design, we analysed lupus manifestations, cardiovascular risk factors and immunosuppressive therapies. We collected Systemic Lupus Erythematosus Disease Activity Index 2000 disease activity index during the cardiovascular event.

RESULTS: We identified 308 patients with lupus from among all University of Kentucky Health System patients. 20 (6.5%) of such patients with lupus were confirmed to cardiovascular complication. Of those 20, 7 (35%) had experienced myocardial infarction, 10 (50%) had experienced stroke and 4 (20%) had peripheral ischaemia. Tobacco use and male gender were the only traditional cardiovascular risk factors higher in the cases group. Hydroxychloroquine and steroids were less utilised in the cases than in the controls (70% vs 100% in hydroxychloroquine, 30% vs 82% in steroids). Venous thrombosis was found to be significantly higher in the cases. On multivariate analysis, venous thrombosis remained significant.

CONCLUSION: Despite tobacco use partially explaining the increased risk of cardiovascular disease among the cases group, the higher prevalence of venous thrombosis in the cases group suggests lupus as a potential additional risk factor of cardiovascular morbidity among patients with lupus in this Appalachian community.

PMID:33952624 | DOI:10.1136/lupus-2020-000467

Categories
Nevin Manimala Statistics

Improving outcomes for primary school children at risk of cerebral visual impairments (the CVI project): study protocol for the process evaluation of a feasibility cluster-randomised controlled trial

BMJ Open. 2021 May 5;11(5):e044856. doi: 10.1136/bmjopen-2020-044856.

ABSTRACT

INTRODUCTION: Brain-related visual impairments, also known as cerebral visual impairment (CVI), are related to damage or poor function in the vision-related areas of the brain. There is broad agreement that CVI is an appropriate term to describe visual impairments that are not accounted by disorders of the eye or optic nerve, but differences remain as to which impairments can be included in this term. The CVI project is a programme of work that includes the development of a complex intervention to share knowledge with teachers, so that they can make both targeted and universal changes to support children with CVI. A feasibility study for a cluster-randomised controlled trial to evaluate this intervention is underway. This paper describes the protocol for an accompanying process evaluation to explore how the intervention is implemented and provide context for the interpretation of the feasibility trial outcomes.

METHODS AND ANALYSIS: A logic model has been developed to guide data collection. Both qualitative and quantitative data will be collected to assess the feasibility and acceptability of the intervention, the study design and explore how any changes that occur are brought about. Interviews with key primary school staff and parents will investigate responses to the intervention and trial processes. Surveys will collect data on intervention implementation and knowledge of CVI. Photographs of classroom walls will document any changes to visual clutter and document analysis will look for changes to school special educational needs and disability (SEND) policies.

ETHICS AND DISSEMINATION: Ethical approval was granted by the University of Bristol Faculty of Health Sciences Ethics Committee. Findings will contribute to the development of a full-scale cluster-randomised controlled trial to assess the effectiveness of the intervention with adequate statistical power. The results will also support the refinement of the intervention and its underlying theory.

PMID:33952549 | DOI:10.1136/bmjopen-2020-044856