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
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 fibri...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2017-04-01
|
| Series: | Systematic Reviews |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13643-017-0470-2 |
| _version_ | 1811218664832106496 |
|---|---|
| author | Naqash J. Sethi Sanam Safi Joshua Feinberg Emil E. Nielsen Christian Gluud Janus C. Jakobsen |
| author_facet | Naqash J. Sethi Sanam Safi Joshua Feinberg Emil E. Nielsen Christian Gluud Janus C. Jakobsen |
| author_sort | Naqash J. Sethi |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-04-12T07:13:12Z |
| format | Article |
| id | doaj.art-d89940e9199b4cf4995c961bb5d1bebe |
| institution | Directory Open Access Journal |
| issn | 2046-4053 |
| language | English |
| last_indexed | 2024-04-12T07:13:12Z |
| publishDate | 2017-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Systematic Reviews |
| spelling | doaj.art-d89940e9199b4cf4995c961bb5d1bebe2022-12-22T03:42:35ZengBMCSystematic Reviews2046-40532017-04-016111410.1186/s13643-017-0470-2Digoxin 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 AnalysisNaqash J. Sethi0Sanam Safi1Joshua Feinberg2Emil E. Nielsen3Christian Gluud4Janus C. Jakobsen5Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University HospitalCopenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University HospitalCopenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University HospitalCopenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University HospitalCopenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University HospitalCopenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University HospitalAbstract 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 CRD42016052935http://link.springer.com/article/10.1186/s13643-017-0470-2Atrial fibrillationAtrial flutterDigoxinMedical therapySystematic reviewMeta-analysis |
| spellingShingle | Naqash J. Sethi Sanam Safi Joshua Feinberg Emil E. Nielsen Christian Gluud Janus C. Jakobsen 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 Systematic Reviews Atrial fibrillation Atrial flutter Digoxin Medical therapy Systematic review Meta-analysis |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Atrial fibrillation Atrial flutter Digoxin Medical therapy Systematic review Meta-analysis |
| url | http://link.springer.com/article/10.1186/s13643-017-0470-2 |
| work_keys_str_mv | AT naqashjsethi digoxinversusplacebonointerventionorothermedicalinterventionsforatrialfibrillationandatrialflutteraprotocolforasystematicreviewwithmetaanalysisandtrialsequentialanalysis AT sanamsafi digoxinversusplacebonointerventionorothermedicalinterventionsforatrialfibrillationandatrialflutteraprotocolforasystematicreviewwithmetaanalysisandtrialsequentialanalysis AT joshuafeinberg digoxinversusplacebonointerventionorothermedicalinterventionsforatrialfibrillationandatrialflutteraprotocolforasystematicreviewwithmetaanalysisandtrialsequentialanalysis AT emilenielsen digoxinversusplacebonointerventionorothermedicalinterventionsforatrialfibrillationandatrialflutteraprotocolforasystematicreviewwithmetaanalysisandtrialsequentialanalysis AT christiangluud digoxinversusplacebonointerventionorothermedicalinterventionsforatrialfibrillationandatrialflutteraprotocolforasystematicreviewwithmetaanalysisandtrialsequentialanalysis AT januscjakobsen digoxinversusplacebonointerventionorothermedicalinterventionsforatrialfibrillationandatrialflutteraprotocolforasystematicreviewwithmetaanalysisandtrialsequentialanalysis |