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Published in: Systematic Reviews 1/2017

Open Access 01-12-2017 | Protocol

Digoxin versus placebo, no intervention, or other medical interventions for atrial fibrillation and atrial flutter: a protocol for a systematic review with meta-analysis and Trial Sequential Analysis

Authors: Naqash J. Sethi, Sanam Safi, Joshua Feinberg, Emil E. Nielsen, Christian Gluud, Janus C. Jakobsen

Published in: Systematic Reviews | Issue 1/2017

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Abstract

Background

Atrial fibrillation is the most common arrhythmia of the heart with a prevalence of approximately 2% in the western world. Atrial flutter, another arrhythmia, occurs less often with an incidence of approximately 200,000 new patients per year in the USA. Patients with atrial fibrillation and atrial flutter have an increased risk of death and morbidities. In the management of atrial fibrillation and atrial flutter, it is often necessary to use medical interventions to lower the heart rate. Lowering the heart rate may theoretically prevent the development of heart failure and tachycardia-mediated cardiomyopathy. The evidence on the benefits and harms of digoxin compared with placebo or with other medical interventions is unclear. This protocol for a systematic review aims at identifying the beneficial and harmful effects of digoxin compared with placebo, no intervention, or with other medical interventions for atrial fibrillation and atrial flutter.

Methods

This protocol for a systematic review was conducted following the recommendations of Cochrane and the eight-step assessment procedure suggested by Jakobsen and colleagues. We plan to include all relevant randomised clinical trials comparing digoxin with placebo, no intervention, or with other medical interventions. We plan to search the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, LILACS, Science Citation Index Expanded on Web of Science, and BIOSIS to identify relevant trials. Any eligible trial will be assessed and classified as either at high risk of bias or low risk of bias, and our primary conclusions will be based on trials with low risk of bias. We will perform our meta-analyses of the extracted data using Review Manager 5.3 and Trial Sequential Analysis ver. 0.9.5.5 beta. For both our primary and secondary outcomes, we will create a ‘Summary of Findings’ table based on GRADE assessments of the quality of the evidence.

Discussion

The results of this systematic review have the potential to benefit millions of patients worldwide as well as healthcare economy.

Systematic review registration

PROSPERO CRD42016052935
Appendix
Available only for authorised users
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Metadata
Title
Digoxin versus placebo, no intervention, or other medical interventions for atrial fibrillation and atrial flutter: a protocol for a systematic review with meta-analysis and Trial Sequential Analysis
Authors
Naqash J. Sethi
Sanam Safi
Joshua Feinberg
Emil E. Nielsen
Christian Gluud
Janus C. Jakobsen
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/s13643-017-0470-2

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