Chan 2012.
| Methods | Study design: Randomized controlled trial Country: Hong Kong Recruitment: Cardiac outpatient clinics at 10 major hospitals |
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| Participants | 1860 Chinese cardiac patients smoking ≥ 1 cig in past week. 91% men, av. age 58, av. cpd 12. Excluded from study if "too clinically ill." | |
| Interventions | Therapist: nurse counsellors 1. Intervention: At baseline, 30‐min individual face‐to‐face counselling matched to stage of readiness to quit. At 1 wk and 1 m: telephone calls from nurse counsellor, re‐assessment of stage and counselling to suit that stage, av. phone call length 15 mins 2. Control: 15‐min, individual face‐to‐face counselling on healthy diet from nurse counsellor at baseline Pharmacotherapy: No smoking cessation drugs provided, but stage‐matched medication counselling on NRT was discussed with intervention participants "if deemed appropriate". |
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| Outcomes | 7‐day PP at 12 m (30‐day PP at 12 m and 3 m and 6 m outcomes also reported) Validation: CO ≤ 8 ppm, urinary cotinine < 100 ng/ml |
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| Notes | New for 2016 update Validated rates used in MA; only about 25% of people self‐reporting abstinence were validated. Participants in intervention group had higher stage of readiness to quit smoking than in the control group. Adjusted OR provided in text (unadjusted OR 1.35, 95% CI 0.91 to 2.00; adjusted OR 1.26, 95% CI 0.85 to 1.87); numbers used in MA are unadjusted. 54% intervention received all counselling. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The allocation sequence was generated sequentially by the project co‐ordinator based on simple random sampling procedure using MS Excel." |
| Allocation concealment (selection bias) | Low risk | "serially numbered sealed and opaque envelope" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical validation of abstinence |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Similar rates of follow‐up in both groups at 12 m (85.5% intervention and 84.3% control) "No statistically significant difference was found between the two groups." ITT analysis conducted, 25 who died during study removed from denominators |