ALIT 1985.

Study characteristics
Methods	Parallel design (2 arms) Duration of the study: 33 months Country: The Netherlands Follow‐up: unclear
Participants	Enrolled: 7026 Randomly assigned, N = 6024 Lidocaine group: 2987 Control group (not stated): 3037 Age, mean, years (standard deviation) Lidocaine group: 66.0 (12.6) Control group (not stated): 66.0 (12.32) Gender, male, % (n/N) Lidocaine group: 57.7 (1724/2987) Control group (not stated): 58.6 (1782/3037) Inclusion criteria: suspected to have acute myocardial infarction Exclusion criteria Severe congestive failure Pre‐treatment with lidocaine Heart rate < 45 bpm Technical failure (refusal, equipment failure, misunderstanding of study procedure and so forth)
Interventions	Lidocaine: 400 mg, intramuscular route Control group: not stated
Outcomes	Mortality Incidence of ventricular fibrillation Frequent termination of ventricular tachycardia
Notes	Sample size calculation a priori: not reported Sponsor: The Netherlands Heart Fundation Role of sponsor: not reported Trial conduction dates: 16 September 1986 and 17 June 1983
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"...was thus randomized... " (page 1106) Insufficient information about the sequence generation process to permit judgement of ‘low risk’ or ‘high risk’
Allocation concealment (selection bias)	Unclear risk	Insufficient information about the allocation concealment process to permit judgement of ‘low risk’ or ‘high risk’
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Insufficient information about the blinding level process to permit judgement of ´‘low risk’ or ‘high risk’
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"...observers who were blinded to randomization" (page 1106)
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)	Low risk	The study protocol is not available, but it is clear that published reports describe all expected outcomes, including those that were pre‐specified (convincing text of this nature may be uncommon)
Other bias	High risk	Design bias (Porta 2008)