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Systematic Reviews
Published in: Systematic Reviews 1/2017

Open Access 01-12-2017 | Protocol

N of 1 trials and the optimal individualisation of drug treatments: a systematic review protocol

Authors: Weyinmi A. Demeyin, Julia Frost, Obioha C. Ukoumunne, Simon Briscoe, Nicky Britten

Published in: Systematic Reviews | Issue 1/2017

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Abstract

Background

Guidelines and evidence-based drug treatment recommendations are usually based on the results of clinical trials, which have limited generalisability in routine clinical settings due to their restrictive eligibility criteria. These trials are also conducted in ideal and rigorously controlled settings. N of 1 trials, which are single patient multiple crossover studies, offer a means of increasing the evidence base and individualising care for individuals in clinical practice. This systematic review of the N of 1 drug treatment trial aims to investigate its usefulness for achieving optimal individualised patient care.

Methods

The following databases will be searched for relevant articles: MEDLINE, EMBASE, PsycINFO (all via Ovid), AMED, CINAHAL (via EBSCO), The Cochrane Library (including CENTRAL, NHS EED, and DARE), and Web of Science (Thomson Reuters). Supplementary searches will include ongoing trial databases and organisational websites. All N of 1 trials in which patients have been treated with a drug will be considered. Outcomes will include information on the clinical usefulness of N of 1 trials—i.e. achievement of optimal individualised care, health-care utilisation of patients, frequently used practices, experiences of clinical care or participation in N of 1 trials, adherence to treatment plan, and unwanted effects of the treatment. Screening of included papers will be undertaken independently by two reviewers, while data extraction and the quality of reporting will be conducted by one reviewer and checked by another. Both quantitative and qualitative summaries will be reported using appropriate methods.

Discussion

This review will provide new insights into the clinical utility of N of 1 drug trials in helping participants find the most acceptable treatment as defined by patients and clinicians based on the selected outcome measures and the perspectives of participants involved in such trials. Findings from this review will inform the development of a stakeholder workshop and guidance to help physicians find the optimum therapy for their patients and will help guide future research on N of 1 trials.

Systematic review registration

PROSPERO CRD42016032452
Appendix
Available only for authorised users
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Metadata
Title
N of 1 trials and the optimal individualisation of drug treatments: a systematic review protocol
Authors
Weyinmi A. Demeyin
Julia Frost
Obioha C. Ukoumunne
Simon Briscoe
Nicky Britten
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Systematic Reviews / Issue 1/2017
Electronic ISSN: 2046-4053
DOI
https://doi.org/10.1186/s13643-017-0479-6

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