Solimene 1983.
Study characteristics | ||
Methods | Parallel design (2 arms) Country: Brazil Follow‐up period: 12 hours | |
Participants | Randomly assigned: N = 43
Age, years, mean (standard error or standard deviation: not stated)
Gender, male, % (n/N)
Inclusion criteria: based on clinic criteria and electrocardiogram (no additional details) Exclusion criteria: not stated |
|
Interventions | Lidocaine
Control group: no lidocaine Co‐intervention: cardioversion |
|
Outcomes | Ventricular extrasystoles Ventricular tachycardia Ventricular fibrillation | |
Notes | Sample size calculation a priori: not reported
Sponsor: not reported
Trial conduction dates: not stated E‐mail was sent to the main trial author |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "... os pacientes foram seleccionados, ao acaso,..." (page 377) Insufficient information about the sequence generation process to permit judgement of ‘low risk’ or ‘high risk’ |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement of ‘low risk’ or ‘high risk’ |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information to permit judgement of ‘low risk’ or ‘high risk’ |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to permit judgement of ‘low risk’ or ‘high risk’ |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The report gave the impression that no dropouts or withdrawals had occurred, but this was not specifically stated |
Selective reporting (reporting bias) | High risk | The study report fails to include results for a key outcome that would be expected to have been reported for such a study This study did not report mortality data |
Other bias | High risk | Design bias and bias in data presentation (Porta 2008). |