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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.

was the CONSORT statement (Consolidated Standards of Reporting Trials).38 The CONSORT statement (or simply CONSORT) comprises a checklist of essential items that should be included in reports of RCTs and a diagram for documenting the flow of participants through a trial. It is aimed at primary reports of RCTs with two group, parallel designs.

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