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Ann Clin Transl Neurol ; 7(7): 1148-1157, 2020 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-32515889


OBJECTIVE: To determine the potential for improving amyotrophic lateral sclerosis (ALS) clinical trials by having patients or caregivers perform frequent self-assessments at home. METHODS AND PARTICIPANTS: We enrolled ALS patients into a nonblinded, longitudinal 9-month study in which patients and caregivers obtained daily data using several different instruments, including a slow-vital capacity device, a hand grip dynamometer, an electrical impedance myography-based fitness device, an activity tracker, a speech app, and the ALS functional rating scale-revised. Questions as to acceptability were asked at two time points. RESULTS: A total of 113 individuals enrolled, with 61 (43 men, 18 women, mean age 60.1 ± 9.9 years) collecting a minimum of 7 days data and being included in the analysis. Daily measurements resulted in more accurate assessments of the slope of progression of the disease, resulting in smaller sample size estimates for a hypothetical clinical trial. For example, by performing daily slow-vital capacity measurements, calculated sample size was reduced to 182 subjects/study arm from 882/arm for monthly measurements. Similarly, performing the ALS functional rating scale weekly rather than monthly led to a calculated sample size of 73/arm as compared to 274/arm. Participants generally found the procedures acceptable and, for many, improved their sense of control of their disease. INTERPRETATION: Frequent at-home measurements using standard tools holds the prospect of tracking progression and reducing sample size requirements for clinical trials in ALS while also being acceptable to the patients. Future studies in this and other neurological disorders should consider adopting this approach to data collection.

Int J Biostat ; 14(2)2018 11 22.
Artículo en Inglés | MEDLINE | ID: mdl-30465718


Background Many researchers have studied the relationship between diet and health. Specifically, there are papers showing an association between the consumption of sugar sweetened beverages and Type 2 diabetes. Many meta-analyses use individual studies that do not attempt to adjust for multiple testing or multiple modeling. Hence the claims reported in a meta-analysis paper may be unreliable as the base papers do not ensure unbiased statistics. Objective Determine (i) the statistical reliability of 10 papers and (ii) indirectly the reliability of the meta-analysis study. Method We obtained copies of each of the 10 papers used in a metaanalysis paper and counted the numbers of outcomes, predictors, and covariates. We estimate the size of the potential analysis search space available to the authors of these papers; i. e. the number of comparisons and models available. The potential analysis search space is the number of outcomes times the number of predictors times 2 c , where c is the number of covariates. This formula was applied to information found in the abstracts (Space A) as well as the text (Space T) of each base paper. Results The median and range of the number of comparisons possible across the base papers are 6.5 and (2 12,288), respectively for Space A, and 196,608 and (3072-117,117,952), respectively for Space T. It is noted that the median of 6.5 for Space A may be misleading as each study has 60-165 foods that could be predictors. Conclusion Given that testing is at the 5% level and the number of comparisons is very large, nominal statistical significance is very weak support for a claim. The claims in these papers are not statistically supported and hence are unreliable so the meta-analysis paper is also unreliable.

Interpretación Estadística de Datos , Epidemiología/normas , Metaanálisis como Asunto , Fenómenos Fisiológicos de la Nutrición , Evaluación de Resultado en la Atención de Salud/normas , Humanos
US Army Med Dep J ; (1-17): 23-33, 2017.
Artículo en Inglés | MEDLINE | ID: mdl-28511271


Zika virus (ZIKV) was declared an international public health emergency by the World Health Organization on February 1, 2016. Due to the known and estimated range of the ZIKV mosquito vectors, southern and central US states faced increased risk of ZIKV transmission. With the state of Georgia hosting the world's busiest international airport, a climate that supports the ZIKV vectors, and limited surveillance (13 counties) and response capacity, the Department of Public Health (DPH) was challenged to respond and prevent ZIKV transmission. This case study describes and evaluates the state's surveillance capacity before and after the declaration of ZIKV as a public health emergency. METHOD: We analyzed surveillance data from the DPH to compare the geographical distribution of counties conducting surveillance, total number, and overall percentage of mosquito species trapped in 2015 to 2016. Counties conducting surveillance before and after the identification of the ZIKV risk were mapped using ArcMap 10.4.1. Using SAS (version 9.2) (SAS Institute, Inc, Cary, NC), we performed the independent 2 sample t test to test for differences in prevalence in both years, and a χ² analysis to test for differences between numbers of species across the 13 counties. In addition, weighted frequency counts of mosquitoes were used to test (χ²) an association between major mosquito vector species and 7 urban counties. Lastly, using data from 2012-2016, a time-trend analysis was conducted to evaluate temporal trends in species prevalence. RESULTS: From 2015 to 2016, surveillance increased from 13 to 57 (338% increase) counties geographically dispersed across Georgia. A total of 76,052 mosquitoes were trapped and identified in 2015 compared to 144,731 (90.3% increase) in 2016. Significant differences between species (P<.001) and significant associations (P<.0001) between 7 urban counties and major mosquito vectors were found. Significant differences in prevalence were found between several species and year highlighting species-year temporal trends. CONCLUSIONS: The DPH collaborative response to ZIKV allowed a rapid increase in its surveillance footprint. Existing and new partnerships were developed with the military and local health departments to expand and share data. This additional surveillance data allowed DPH to make sound public health decisions regarding mosquito-borne disease risks and close gaps in data related to vector distribution.

Culicidae , Monitoreo Epidemiológico , Control de Mosquitos/métodos , Mosquitos Vectores , Distribución Animal , Animales , Georgia , Humanos , Virus Zika