期刊
BMJ-BRITISH MEDICAL JOURNAL
卷 350, 期 -, 页码 -出版社
BMJ PUBLISHING GROUP
DOI: 10.1136/bmj.h1738
关键词
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资金
- Alberta Innovates - Health Solutions (AHIS)
- Afexa Life Sciences
- Hecht Foundation
- HEEL
- Pfizer USA
- Schwabe Pharma
- Canadian Institutes for Health Research [86766]
- AHIS as a health scholar
- MRC [MR/J004871/1] Funding Source: UKRI
- Cancer Research UK [16895] Funding Source: researchfish
- Medical Research Council [MR/J004871/1] Funding Source: researchfish
N-of-1 trials provide a mechanism for making evidence based treatment decisions for an individual patient. They use key methodological elements of group clinical trials to evaluate treatment effectiveness in a single patient, for situations that cannot always accommodate large scale trials: rare diseases, comorbid conditions, or in patients using concurrent therapies. Improvement in the reporting and clarity of methods and findings in N-of-1 trials is essential for reader to gauge the validity of trials and to replicate successful findings. A CONSORT extension for N-of-1 trials (CENT 2015) provides guidance on the reporting of individual and series of N-of-1 trials. CENT provides additional guidance for 14 of the 25 items of the CONSORT 2010 checklist and recommends a diagram for depicting an individual N-of-1 trial and modifies the CONSORT flow diagram to address the flow of a series of N-of-1 trials. The rationale, development process, and CENT 2015 checklist and diagrams are reported in this document.
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