McFarlane 2001.
| Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: 38 Length of follow‐up: No follow‐up Analysis: Per‐protocol (27 completers, 6 drop‐outs in the treatment group, 5 drop‐outs in the control group) |
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| Participants | Location: Canada Number of study centres and setting: Patients admitted to 1 coronary care unit CAD diagnosis: Acute myocardial infarction; assessment method and time to randomisation not specified Depression diagnosis: Score > 15 on the Inventory to Diagnose Depression (IDD) questionnaire on two occasions (just before hospital discharge and two weeks later) Other entry criteria: None stated Exclusion criteria: Predischarge 24‐hour Holter recordings showing either atrial fibrillation or ventricular etopic beats greater than 100 per hour, congestive heart failure, any life‐threatening comorbid condition, inability to complete the questionnaire, and taking antidepressant medication Treatment N: 12 (33% female, mean age: 56 (SD: 11)) Control N: 15 (47% female, mean age: 56 (SD: 12)) Comparability of groups: No significant baseline differences |
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| Interventions | Treatment: Sertraline (50 mg/d) Control: Placebo Duration of treatment: 22 weeks |
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| Outcomes | Review outcomes: IDD depression score Other outcomes: Time dependent changes in both time and frequency domain parameters of Heart Rate Variability (HRV) (heart rate, SD of all 24‐hour N‐N intervals (SDNN), root mean square of the SD of successive N‐N intervals (rMSSD), LF/HF ratio, LF power nu) |
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| Funding | Heart and Stroke Foundation of Ontario, Canada | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: No details reported |
| Allocation concealment (selection bias) | Unclear risk | Comment: No details reported |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Comment: No details reported |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: 11 drop‐outs (3 had side‐effects, 7 non‐compliant, 1 with ectopy) |
| Selective reporting (reporting bias) | Unclear risk | Comment: No protocol or design paper available Comment: Outcomes reported according to methods section |
| Other bias | High risk | Comment: Inconsistent description of results (p. 619 and p. 620) |