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      The null hypothesis significance test in health sciences research (1995-2006): statistical analysis and interpretation

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          Abstract

          Background

          The null hypothesis significance test (NHST) is the most frequently used statistical method, although its inferential validity has been widely criticized since its introduction. In 1988, the International Committee of Medical Journal Editors (ICMJE) warned against sole reliance on NHST to substantiate study conclusions and suggested supplementary use of confidence intervals (CI). Our objective was to evaluate the extent and quality in the use of NHST and CI, both in English and Spanish language biomedical publications between 1995 and 2006, taking into account the International Committee of Medical Journal Editors recommendations, with particular focus on the accuracy of the interpretation of statistical significance and the validity of conclusions.

          Methods

          Original articles published in three English and three Spanish biomedical journals in three fields (General Medicine, Clinical Specialties and Epidemiology - Public Health) were considered for this study. Papers published in 1995-1996, 2000-2001, and 2005-2006 were selected through a systematic sampling method. After excluding the purely descriptive and theoretical articles, analytic studies were evaluated for their use of NHST with P-values and/or CI for interpretation of statistical "significance" and "relevance" in study conclusions.

          Results

          Among 1,043 original papers, 874 were selected for detailed review. The exclusive use of P-values was less frequent in English language publications as well as in Public Health journals; overall such use decreased from 41% in 1995-1996 to 21% in 2005-2006. While the use of CI increased over time, the "significance fallacy" (to equate statistical and substantive significance) appeared very often, mainly in journals devoted to clinical specialties (81%). In papers originally written in English and Spanish, 15% and 10%, respectively, mentioned statistical significance in their conclusions.

          Conclusions

          Overall, results of our review show some improvements in statistical management of statistical results, but further efforts by scholars and journal editors are clearly required to move the communication toward ICMJE advices, especially in the clinical setting, which seems to be imperative among publications in Spanish.

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          Most cited references30

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          Effect size, confidence interval and statistical significance: a practical guide for biologists.

          Null hypothesis significance testing (NHST) is the dominant statistical approach in biology, although it has many, frequently unappreciated, problems. Most importantly, NHST does not provide us with two crucial pieces of information: (1) the magnitude of an effect of interest, and (2) the precision of the estimate of the magnitude of that effect. All biologists should be ultimately interested in biological importance, which may be assessed using the magnitude of an effect, but not its statistical significance. Therefore, we advocate presentation of measures of the magnitude of effects (i.e. effect size statistics) and their confidence intervals (CIs) in all biological journals. Combined use of an effect size and its CIs enables one to assess the relationships within data more effectively than the use of p values, regardless of statistical significance. In addition, routine presentation of effect sizes will encourage researchers to view their results in the context of previous research and facilitate the incorporation of results into future meta-analysis, which has been increasingly used as the standard method of quantitative review in biology. In this article, we extensively discuss two dimensionless (and thus standardised) classes of effect size statistics: d statistics (standardised mean difference) and r statistics (correlation coefficient), because these can be calculated from almost all study designs and also because their calculations are essential for meta-analysis. However, our focus on these standardised effect size statistics does not mean unstandardised effect size statistics (e.g. mean difference and regression coefficient) are less important. We provide potential solutions for four main technical problems researchers may encounter when calculating effect size and CIs: (1) when covariates exist, (2) when bias in estimating effect size is possible, (3) when data have non-normal error structure and/or variances, and (4) when data are non-independent. Although interpretations of effect sizes are often difficult, we provide some pointers to help researchers. This paper serves both as a beginner's instruction manual and a stimulus for changing statistical practice for the better in the biological sciences.
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            Toward evidence-based medical statistics. 1: The P value fallacy.

            An important problem exists in the interpretation of modern medical research data: Biological understanding and previous research play little formal role in the interpretation of quantitative results. This phenomenon is manifest in the discussion sections of research articles and ultimately can affect the reliability of conclusions. The standard statistical approach has created this situation by promoting the illusion that conclusions can be produced with certain "error rates," without consideration of information from outside the experiment. This statistical approach, the key components of which are P values and hypothesis tests, is widely perceived as a mathematically coherent approach to inference. There is little appreciation in the medical community that the methodology is an amalgam of incompatible elements, whose utility for scientific inference has been the subject of intense debate among statisticians for almost 70 years. This article introduces some of the key elements of that debate and traces the appeal and adverse impact of this methodology to the P value fallacy, the mistaken idea that a single number can capture both the long-run outcomes of an experiment and the evidential meaning of a single result. This argument is made as a prelude to the suggestion that another measure of evidence should be used--the Bayes factor, which properly separates issues of long-run behavior from evidential strength and allows the integration of background knowledge with statistical findings.
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              Null hypothesis significance testing: a review of an old and continuing controversy.

              Null hypothesis significance testing (NHST) is arguably the most widely used approach to hypothesis evaluation among behavioral and social scientists. It is also very controversial. A major concern expressed by critics is that such testing is misunderstood by many of those who use it. Several other objections to its use have also been raised. In this article the author reviews and comments on the claimed misunderstandings as well as on other criticisms of the approach, and he notes arguments that have been advanced in support of NHST. Alternatives and supplements to NHST are considered, as are several related recommendations regarding the interpretation of experimental data. The concluding opinion is that NHST is easily misunderstood and misused but that when applied with good judgment it can be an effective aid to the interpretation of experimental data.
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                Author and article information

                Journal
                BMC Med Res Methodol
                BMC Medical Research Methodology
                BioMed Central
                1471-2288
                2010
                19 May 2010
                : 10
                : 44
                Affiliations
                [1 ]Centro Nacional de Investigación de Ciencias Médicas, La Habana, Cuba
                [2 ]Unidad de Investigación. Hospital de Cabueñes, Servicio de Salud del Principado de Asturias (SESPA), Gijón, Spain
                [3 ]CIBER Epidemiología y Salud Pública (CIBERESP), Spain and Departamento de Medicina, Unidad de Epidemiología Molecular del Instituto Universitario de Oncología, Universidad de Oviedo, Spain
                Article
                1471-2288-10-44
                10.1186/1471-2288-10-44
                2886084
                20482841
                f2ba8131-84fd-47a1-a778-62b917234243
                Copyright ©2010 Silva-Ayçaguer et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 29 December 2009
                : 19 May 2010
                Categories
                Research Article

                Medicine
                Medicine

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