Dr. S. Manikandan Assistant Professor of Pharmacology JIPMER, Pondicherry. Standard Reporting guidelines: CONSORT and Others

1.Why do we need reporting guidelines? 2.What is a reporting guideline? 3.What are the various reporting guidelines? 4.What are their applications?

The Problem  Information on the method used in the trial to assign participants to comparison groups was reported only in 34% of 616 studies in 2006 (BMJ 2010;340:c723. ).  Only 53% of trial reports in 2006 defined a primary end point.  Only 45%of the trials explained sample size calculation.

The Implications  Trials with inadequate methods are associated with bias especially exaggerated treatment effects.  Biased results from poorly designed and reported trials can mislead decision making in healthcare at all levels. (treating patients to national policies).  Hence the whole of medicine depends on the transparent reporting of clinical trials and other research.

The Solution Standard reporting guidelines What are standard reporting guidelines? Guidelines that help in the proper reporting of research in journals

What are the various reporting guidelines?  CONSORT – Consolidated Standards of Reporting Trials.  PRISMA – Preferred Reporting Items for Systematic reviews and Meta-analysis.  STROBE – Strengthening the Reporting of Observational Studies in Epidemiology.  CHEERS – Consolidated Health Economic Evaluation Reporting Standards (CHEERS)  CARE – Consensus based Clinical Case Reporting

Applications of Reporting Guidelines  As a tool for reporting (many journals have adopted this format).  Critical appraisal of published articles.  Can be used as a tool for writing protocol and helps in the initial planning of research.