checklist items in CONSORT 2010 STATEMENT

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Dear members, Today we will start the discussion on latest version of consort i.e. CONSORT statement 2010.There are number of changes in this updated statement. The CONSORT website (http://www.consort-statement.org.) contains a side by side comparison of the 2001and 2010 versions along with summary of the noteworthy general changes. CONSORT 2010STATEMENTCONSORT 2010 is developed to assist:Ø Authors in writing reports of randomized controlled trials,Ø Editors and Peer reviewers in reviewing manuscripts for publication, andØ Readers in critically appraising published articles.The CONSORT 2010 statement is also published along with explanation and elaboration. This document is intended to enhance the use,understanding and dissemination of the CONSORT Statement. Through examples and explanations, the meaning and rationale for each checklist item are presented.The CONSORT Statement comprises a 25-item checklist and a flow diagram, along with some brief descriptive text. The checklist items focus on reporting how the trial was designed, analyzed, and interpreted; the flow diagram displays the progress of all participants through the trial.The ChecklistThe checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, Discussion, and Other information. The checklist includes the 25 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect, or because the information is essential to judge the reliability or relevance of the findings.Templates of the CONSORT 2010 checklist are available to download in MS Word and in PDFTheFlow DiagramThe flow diagram is intended to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrollment,intervention allocation, follow-up, and analysis).The diagram shows the number of participants, for each intervention group, included in the primary data analysis.Templates of the CONSORT 2010 flow diagram are available to download in MS Word and in PDF.CONSORT 2010 focuses predominantly on the two groups, parallel randomized controlled trial, which accounts for over half of trials in the literature. Most of the items from the CONSORT 2010 Statement, however, pertain to all types of randomized trials.The format of articles should abide by journal style, editorial directions, the traditions of the research field addressed,and, where possible, author preferences. There is no standardised structure of reporting. Authors should simply address checklist items somewhere in the article, with ample detail and lucidity. Checklist items along with explanation and elaboration in consort 2010Title and AbstractItem 1a - Identification as a randomized trial in the title.To help ensure that a study is appropriately indexed and easily identified, authors should use the word "randomized" in the title to indicate that the participants were randomly assigned to their comparison groups.Item 1b (title and abstract) -Providing a structured summary of trial design, methods, results, and conclusions and referenced. It should be clear, transparent, and sufficiently detailed. IntroductionItem 2a - Scientific background and explanation of rationale.The introduction should mainly consist of explanation about the scientific background and rationale for their trial and its general outline.The rationale could be explanatory (for example, to assess the possible influence of a drug on renal function) or pragmatic (for example, to guide practice by comparing the benefits and harms of two treatments.Authors should report any evidence of the benefits and harms of active interventions and should suggest a plausible explanation for how the interventions might work.Thus, the need for a new trial should be justified in the introduction.Ideally, it should include a reference to a systematic review of previous similar trials or a note of the absence of such trials. Item 2b - Specific objectives or hypothesesIn practice,objectives and hypotheses are not always easily differentiated.Objectives are the questions that the trial was designed to answer. They often relate to the efficacy of a particular therapeutic or preventive intervention.Hypotheses are pre-specified questions being tested to help meet the objectives. Hypotheses are more specific than objectives and are amenable to explicit statistical evaluation.contd........