title: Use and misuse of p-values in designed and observational studies: guide for researchers and reviewers.
abstract: Analysis of scientific data involves many components, one of which is often statistical testing with the calculation of p-values. However, researchers too often pepper their papers with p-values in the absence of critical thinking about their results. In fact, statistical tests in their various forms address just one question: does an observed difference exceed that which might reasonably be expected solely as a result of sampling error and/or random allocation of experimental material? Such tests are best applied to the results of designed studies with reasonable control of experimental error and sampling error, as well as acquisition of a sufficient sample size. Nevertheless, attributing an observed difference to a specific treatment effect requires critical thinking on the part of the scientist. Observational studies involve data sets whose size is usually a matter of convenience with results that reflect a number of potentially confounding factors. In this situation, statistical testing is not appropriate and p-values may be misleading; other more modern statistical tools should be used instead, including graphic analysis, computer-intensive methods, regression trees, and other procedures broadly classified as bioinformatics, data mining, and exploratory data analysis. In this review, the utility of p-values calculated from designed experiments and observational studies are discussed, leading to the formation of a decision tree to aid researchers and reviewers in understanding both the benefits and limitations of statistical testing.
authors: Dept. of Pediatrics, Medical College of Georgia, Georgia Prevention Institute, Augusta, GA 30912-3710, USA. dludwig@mcg.edu
authors: David A
authors: DA
authors: Ludwig
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D003627:Data Interpretation, Statistical; D006801:Humans; D012107:Research Design; D012108:Research Personnel