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A Five-Region Hypothesis Test for Exposure-Disease Associations.

ABSTRACT: Characterizing exposure-disease associations is a central issue in epidemiology, one which epidemiologists often approach by adopting the index of the odds ratio and presenting its point estimate, p-value and confidence interval. In this study, the parameter space of the odds ratio is partitioned into five mutually exclusive regions corresponding to 'strong protective factor', 'weak protective factor', 'no association', 'weak risk factor', and 'strong risk factor', respectively. The authors presented a suite of statistical methods tailored to such a five-region demarcation, including methods for hypothesis testing, confidence interval estimation and calculation of the sample size needed to obtain the desired level of statistical power. The authors show that the five-region methods can efficiently and informatively describe a putative exposure-disease association, including its presence or absence, as well as its direction and strength (if any association exists). Three published results were re-analyzed to demonstrate the methods. R code is provided for convenience as well. The five-region methods are recommended for routine use during the analysis of epidemiologic data.

SUBMITTER: Shih HY

PROVIDER: S-EPMC5506070 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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A Five-Region Hypothesis Test for Exposure-Disease Associations.

Shih Han-Yi HY Lee Wen-Chung WC

Scientific reports 20170711 1

Characterizing exposure-disease associations is a central issue in epidemiology, one which epidemiologists often approach by adopting the index of the odds ratio and presenting its point estimate, p-value and confidence interval. In this study, the parameter space of the odds ratio is partitioned into five mutually exclusive regions corresponding to 'strong protective factor', 'weak protective factor', 'no association', 'weak risk factor', and 'strong risk factor', respectively. The authors pres ...[more]

PMID: 28698548

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Project description:Alzheimer's disease (AD) is an age-related neurodegenerative disease that affects 50 million people worldwide, with 10 million new cases occurring each year. The emotional and economic impacts of AD on patients and families are devastating. Approved treatments confer modest improvement in symptoms, and recently one treatment obtained accelerated approval from the United States Food and Drug Administration (FDA) and may have modest disease modifying benefit. Research over the past three decades has established a clear causal linkage between AD and elevated brain levels of amyloid β (Aβ) peptide, and substantial evidence now implicates soluble, non-fibrillar Aβ oligomers (AβOs) as the molecular assemblies directly responsible for AD-associated memory and cognitive failure and accompanying progressive neurodegeneration. The widely recognized linkage of elevated Aβ and AD spawned a comprehensive 20-year therapeutic campaign that focused primarily on two strategies - inhibition of the secretase enzymes responsible for Aβ production and clearance of Aβ peptide or amyloid plaques with Aβ-directed immunotherapeutics. Unfortunately, all clinical trials of secretase inhibitors were unsuccessful. Of the completed phase 3 immunotherapy programs, bapineuzumab (targeting amyloid plaque) and solanezumab (targeting Aβ monomers) were negative, and the crenezumab program (targeting Aβ monomers and to a small extent oligomers) was stopped for futility. Aducanumab (targeting amyloid plaques), which recently received FDA accelerated approval, had one positive and one negative phase 3 trial. More than 25 negative randomized clinical trials (RCTs) have evaluated Aβ-targeting therapeutics, yet none has directly evaluated whether selective blockage of disease-relevant AβOs can stop or reverse AD-associated cognitive decline. Here, we briefly summarize studies that establish the AD therapeutic rationale to target AβOs selectively, and we describe ACU193, the first AβO-selective immunotherapeutic to enter human clinical trials and the first positioned to test the AβO hypothesis of AD.

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A Five-Region Hypothesis Test for Exposure-Disease Associations.

Publications

A Five-Region Hypothesis Test for Exposure-Disease Associations.

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