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research methods & reporting - CONSORT Statement

BMJ | online FiRST | 1 of 28research methods & reporting The whole of medicine depends on the transparent report ing of clinical trials. 1 Well designed and properly executed randomised con trolled trials (RCTs) provide the most reliable evidence on the efficacy of healthcare interventions, but trials with inadequate methods are associated with bias, especially exaggerated treatment 5 Biased results from poorly designed and reported trials can mislead decision making in health care at all levels, from treatment decisions for a patient to formulation of national public health appraisal of the quality of clinical trials is possible only if the design, conduct, and analysis of RCTs are thor oughly and accurately described in the report.

guidelines for reporting parallel group randomised trials ... checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included. ... We have made several substantive and some cosmetic

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