20.1 The Manuscript: Presenting Study Design, Rationale, and Statistical Analysis.

The structured abstract should enable the reader to assess the study hypothesis and methods quickly and easily. The context for the study question and the hypothesis (objective) should be clearly stated (eg, “To determine whether enalapril reduces left ventricular mass …”), the study design and and setting from which the sample was drawn described, and the main outcome measures explained. The results should include some explanation of effect size, if appropriate, with and used to describe the results. The conclusions should follow from the results without overinterpreting the data. Abstract format is too brief to permit detailed explanation of statistical ...Less

Whether the hypothesis was supported or refuted by the results should be addressed. The study result should be placed in context of published literature. The limitations of the study should be discussed, especially possible sources of bias and how these problems might affect conclusions and generalizability. Evidence to support or refute the problems introduced by the limitations should be provided. The implications for clinical practice, if any, and specific directions for future research may be offered. The conclusions should not go beyond the data and should be based on the study results and limited to the specific population represented by ...Less

Each portion of the manuscript should contribute to the reader’s understanding of why and how the study was done and should help persuade the reader that (1) the hypothesis or study question is clearly stated, carefully considered, and important, (2) the methods are designed to answer the question and the analysis is appropriate, (3) the results are credible, and (4) the implications are placed in context and the limitations do not preclude interpretation of the results.Words used herein that are defined in the glossary (see , Glossary of Statistical Terms) are given in a different font.The structured abstract should enable ...Less

The “Methods” section should include enough information to enable a knowledgeable reader to replicate the study and, given the original data, verify the reported results. Components should include as many of the following as are applicable to the study design: ▪ Study design (see sections ).▪ Year(s) (and exact dates if appropriate) when the study was conducted.▪ Disease or condition to be studied how was it defined?▪ Setting in which participants were studied (eg, community based, referral population, primary care clinic), as well as geographic location and, if applicable, name of institution.▪ Individuals or other data studied who or what ...Less

The “Results” section should include the number of individuals or other data units initially eligible for study, the number at its inception, and the number who were excluded, dropped out, or were lost to follow-up at each point in the study. For example, JAMA requires a figure showing the flow of participants through controlled trials (see , Randomized Controlled Trials). Authors should provide descriptive statistics about the sample and, if appropriate, the individual subgroups. Primary outcome measures should be discussed after the study population is described, followed by secondary outcome measures. Post hoc analyses may be presented, but they should ...Less