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Current practices in studies applying the target trial emulation framework: a protocol for a systematic review

Lookup NU author(s): Dr Theophile Bigirumurame, Shaun HiuORCiD, Professor Dawn Teare, Professor James WasonORCiD, Andrew Bryant, Dr Matthew Breckons

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).

Abstract

Introduction Observational studies represent an alternative to estimate real-world causal effects in the absence of available randomised controlled trials (RCTs). Target trial emulation is a framework for the application of RCT design principles to emulate a hypothetical open-label RCT (the hypothetical target trial) using existing observational data as the primary data source as opposed to the prospective recruitment and measurement of randomised units. The aim of this systematic review is to investigate the practices of studies applying the target trial emulation framework to evaluate the effectiveness of interventions.Methods and analysis We will systematically search in Medline (via Ovid), Embase (via Ovid, entries from medRxiv are included), PsycINFO (via Ovid), SCOPUS, Web of Science, Cochrane Library, the ISRCTN registry and ClinicalTrials.gov for all study reports and protocols which used the trial emulation framework (without time restriction). We will extract information concerning study design, data source, analysis, results, interpretation and dissemination. Two reviewers will perform study selection, data extraction and quality assessment. Disagreements between reviewers will be resolved by a third reviewer. A narrative approach will be used to synthesise and report qualitative and quantitative data. Reporting of the review will be informed by Preferred Reporting Items for Systematic Review and Meta-Analysis guidance (PRISMA).Ethics and dissemination Ethical approval is not required as it is a protocol for a systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations.

Publication metadata

Author(s): Bigirumurame T, Hiu SKW, Teare MD, Wason JMS, Bryant A, Breckons M

Publication type: Article

Publication status: Published

Journal: BMJ Open

Year: 2023

Volume: 13

Issue: 6

Online publication date: 27/06/2023

Acceptance date: 06/06/2023

Date deposited: 20/07/2023

ISSN (electronic): 2044-6055

Publisher: BMJ Group

URL: https://doi.org/10.1136/bmjopen-2022-070963

DOI: 10.1136/bmjopen-2022-070963

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