CONSORT extension for reporting N-of-1 trials (CENT) 2015: explanation and elaboration.

作者: Larissa Shamseer , Margaret Sampson , Cecilia Bukutu , Christopher H. Schmid , Jane Nikles

DOI: 10.1016/J.JCLINEPI.2015.05.018

关键词: Family medicineMEDLINEEvidence-based practiceEvidence-based medicineRandomized controlled trialConsolidated Standards of Reporting TrialsN of 1 trialMedicineChecklistClinical trialData mining

摘要: N-of-1 trials are a useful tool for clinicians who want to determine the effectiveness of treatment in particular individual. The reporting has been variable and incomplete, hindering their usefulness clinical decision making by future researchers. This document presents CONSORT (Consolidated Standards Reporting Trials) extension (CENT 2015). CENT 2015 extends 2010 guidance facilitate preparation appraisal reports an individual trial or series prospectively planned, multiple, crossover trials. elaborates on 14 items checklist, totalling 25 checklist (44 sub-items), recommends diagrams help authors progress one participant through more than trials, as applicable. Examples good evidence based rationale provided.

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