BMJ · 2015 · 154 citations · 70 references
Clinical EndpointConsort 2010Reporting TrialsConsort ExtensionClinical TrialsPatient-reported OutcomeRandomized Controlled TrialHealth SciencesMeta-analysisHealth PolicyClinical Trial ManagementOutcomes ResearchEpidemiologyCent 2015Clinical EffectivenessPatient SafetyDrug TrialN-of-1 TrialsMedicineClinical Trial EvaluationClinical Trial Design
N-of-1 trials are a useful tool for clinicians who want to determine the effectiveness of a treatment in a particular individual. The reporting of N-of-1 trials has been variable and incomplete, hindering their usefulness in clinical decision making and by future researchers. This document presents the CONSORT (Consolidated Standards of Reporting Trials) extension for N-of-1 trials (CENT 2015). CENT 2015 extends the CONSORT 2010 guidance to facilitate the preparation and appraisal of reports of an individual N-of-1 trial or a series of prospectively planned, multiple, crossover N-of-1 trials. CENT 2015 elaborates on 14 items of the CONSORT 2010 checklist, totalling 25 checklist items (44 sub-items), and recommends diagrams to help authors document the progress of one participant through a trial or more than one participant through a trial or series of trials, as applicable. Examples of good reporting and evidence based rationale for CENT 2015 checklist items are provided.
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Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement
David Moher, A. Liberati, Jennifer Tetzlaff et al. · BMJ · 2009 · 82.3K citations · Full text