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. |