Table 1.

Risk of bias assessment for additional study

Santaularia et al 29
Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A randomisation list in blocks of 10 was created by a computer random number generator. The randomisation list and the allocation of patients to each group were independently controlled by the Clinical Trials Unit.
Allocation concealment (selection bias)	Low risk	A randomisation list in blocks of 10 was created by a computer random number generator. The randomisation list and the allocation of patients to each group were independently controlled by the Clinical Trials Unit.
Blinding of outcome assessment (detection bias): all outcomes	Low risk	An independent committee that was blind to the patients’ treatment group assessed the main outcomes. This committee comprised a cardiologist, a rehabilitation cardiologist and a health information manager, all from different centres.
Incomplete outcome data (attrition bias): all outcomes	Low risk	There was no loss to follow-up.
Selective reporting (reporting bias)	Low risk	All outcomes described in the methods were reported in the results. Results regarding quality of life are presented in supplementary data but were not required for the current review.
Groups balanced at baseline	Low risk	No significant differences between groups were observed, with the exception of gender: 23% of the control group were women compared with 7% in the intervention group (P=0.049).
Intention-to-treat analysis conducted	High risk	No analysis was conducted.
Groups received same treatment (apart from the intervention)	Low risk	Patients assigned to the control group received standard care given at the hospital. In addition to standard care, patients randomised to the intervention group.