Yang 2019.
| Study characteristics | ||
| Methods | RCT design: 2‐arm parallel group Total N randomised: 224 Length of follow‐up: 12 months Analysis: ITT with last‐observation‐carried‐forward |
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| Participants | Location: China Number of study centres and settings: 1 hospital CAD criteria: at least 1 coronary artery having a stenosis greater than the cutoff point of 50% by coronary angiography Depression entry criteria: HADS Depression > 8 and SDS score > 50 Other entry criteria: > 18 years of age; life expectancy > 1 year; available to be followed up regularly Exclusion criteria: treated with antidepressants within 3 months before enrolment; history of other mental disorders (e.g. dementia, schizophrenia, schizotypal affective disorder, delusional disorder, bipolar affective disorder, alienation, schizoid personality disorders, etc.); imminent risk of suicide and risk of suicide attempts; uncontrolled hypertension, cardiac arrhythmia, or unstable angina pectoris; history of severe pulmonary and renal comorbidities, heart failure, tumours, or other life‐threatening diseases; pregnancy or lactation Treatment: 112 (27.7% female, mean age: 61.25 (SD: 8.6)) Control: 112 (28.6% female, mean age: 60.85 (SD: 10.8)) Comparability of groups: no significant baseline differences |
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| Interventions | Treatment: patients’ intensive telephone‐based care program Control: usual care Duration of treatment: 12 months |
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| Outcomes | Review outcomes: depression symptoms (HADS Depression), depression remission (HADS Depression), all‐cause mortality | |
| Funding | Unclear | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: Block‐randomization generated in SAS Comment: Randomization was performed by an independent analyzer who was not involved in other parts of the study |
| Allocation concealment (selection bias) | Unclear risk | Comment: Allocation was done by a randomized module by a medical and statistical service company (Shanghai Qeejen Bio‐tech Co) Comment: Randomization was performed by an independent analyzer who was not involved in other parts of the study |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: Participants unblinded to allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: Nurses who were in charge of the primary depression outcome (HADS‐D) were blinded to allocation Comment: Unclear whether outcome assessor for death and cardiac events were blinded to allocation |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: Reasons for drop‐out described for both groups during treatment phase and longer‐term follow‐up Comment: Analyses were ITT with last observation carried forward |
| Selective reporting (reporting bias) | Unclear risk | Comment: Results of all main outcomes reported as described in the methods. No protocol available. Comment: there is a discrepancy between the all‐cause mortality reported in the CONSORT flow chart and the survival analyses reported in the results section. No numbers at risk were reported with the Kaplan‐Meier survival plot |
| Other bias | Unclear risk | Comment: no monitoring of intervention quality was reported for study‐trained counsellors |