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Protocol for a systematic review of N-of-1 trial protocol guidelines and protocol reporting guidelines

Authors :
Antony J. Porcino
Salima Punja
An-Wen Chan
Richard Kravitz
Aaron Orkin
Philippe Ravaud
Christopher H. Schmid
Sunita Vohra
Source :
Systematic Reviews, Vol 6, Iss 1, Pp 1-5 (2017)
Publication Year :
2017
Publisher :
BMC, 2017.

Abstract

Abstract Background 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. Objective 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. Methods 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. Discussion 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.

Details

Language :
English
ISSN :
20464053
Volume :
6
Issue :
1
Database :
Directory of Open Access Journals
Journal :
Systematic Reviews
Publication Type :
Academic Journal
Accession number :
edsdoj.796db30d5665411a8d239fc391759a45
Document Type :
article
Full Text :
https://doi.org/10.1186/s13643-017-0525-4