Title |
Protocol for a systematic review of N-of-1 trial protocol guidelines and protocol reporting guidelines
|
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Published in |
Systematic Reviews, July 2017
|
DOI | 10.1186/s13643-017-0525-4 |
Pubmed ID | |
Authors |
Antony J. Porcino, Salima Punja, An-Wen Chan, Richard Kravitz, Aaron Orkin, Philippe Ravaud, Christopher H. Schmid, Sunita Vohra |
Abstract |
N-of-1 trials are multiple cross-over trials done in individual participants, generating individual treatment effect information. While reporting guidelines for the CONSORT Extension for N-of-1 trials (CENT) and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) already exist, there is no standardized recommendation for the reporting of N-of-1 trial protocols. The objective of this study is to evaluate current literature on N-of-1 design and reporting to identify key elements of rigorous N-of-1 protocol design. We will conduct a systematic search for all N-of-1 trial guidelines and protocol-reporting guidelines published in peer-reviewed literature. We will search Medline, Embase, PsycINFO, CINAHL, the Cochrane Methodology Register, CENTRAL, and the NHS Economic Evaluation Database. Eligible articles will contain explicit guidance on N-of-1 protocol construction or reporting. Two reviewers will independently screen all titles and abstracts and then undertake full-text reviews of potential articles to determine eligibility. One reviewer will perform data extraction of selected articles, checked by the second reviewer. Data analysis will ascertain common features of N-of-1 trial protocols and compare them to the SPIRIT and CENT items. This systematic review assesses recommendations on the design and reporting of N-of-1 trial protocols. These findings will inform an international Delphi development process for an N-of-1 trial protocol reporting guideline. The development of this guideline is critical for improving the quality of N-of-1 protocols, leading to improvements in the quality of published N-of-1 trial research. |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 40 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Master | 6 | 15% |
Other | 5 | 13% |
Researcher | 5 | 13% |
Student > Ph. D. Student | 4 | 10% |
Professor | 3 | 8% |
Other | 9 | 23% |
Unknown | 8 | 20% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 14 | 35% |
Neuroscience | 3 | 8% |
Nursing and Health Professions | 3 | 8% |
Biochemistry, Genetics and Molecular Biology | 2 | 5% |
Business, Management and Accounting | 1 | 3% |
Other | 5 | 13% |
Unknown | 12 | 30% |