De Azevedo 2010.
| Methods | Study design: RCT Location: Brazil Setting: public university hospital Recruitment: patients admitted to a public university hospital approached by research team to take part ‐ screening interview took place at patients’ bedside within 72 hours of admission |
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| Participants | Defining eligibility criteria?: hospital inpatients for variety of reasons Participant characteristics: 273 adult smokers randomised to intervention (141) and control (132), 63.6% M; mean age 47; cpd (range = 11 to 20) Motivation to quit?: not selected on motivation |
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| Interventions | 1. Control: 15‐min session of individual counselling where participants were advised to stop smoking. Counsellor reviewed the dangers of smoking and benefits of quitting. The counsellor suggested that, after discharge, the participant should seek help to stop smoking. 2. Intervention: 30‐min session of individual counselling consisting of a motivational interview, after hospital discharge. Participants were given 7 follow‐up telephone calls over 6 m (at 1, 2 and 3 weeks, and at 1, 2, 3 and 4 m). Each call lasted 10 mins. It was an opportunity to reinforce motivation for stopping smoking (or maintaining abstinence). Style of interview was in line with MI performed during hospitalisation. Intervention provider: smoking cessation advisor Intensity: 1 x 30‐minute session with 7 x 15‐minute follow‐up calls over 4 months Was MI fidelity monitored?: "Counselors and main researchers met fortnightly along the study period for clarification of any doubt that might have arisen." |
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| Outcomes | Definition of cessation used: 7‐day point prevalence Length of longest follow‐up: 6 months Validation: none Was mental health and/or well‐being measured at follow‐up?: no Was quality of life measured at follow‐up?: no |
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| Funding source | A grant from the Research Foundation of the State of São Paulo (grant no. 06/61885‐6) | |
| Author conflicts of interest | Not reported | |
| Notes | There were 3 arms in the study; however, the usual‐care arm was not randomised, so was not eligible for the review. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "An allocation sequence based on a random‐number table was used to randomly assign all enrolled subjects to either LII or HII." |
| Allocation concealment (selection bias) | Low risk | QUOTE: "The allocation was maintained in a serially numbered, opaque envelope, which was opened at the Phase 2 interview to prevent counselor bias." |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Abstinence was obtained via self‐report and the amount of researcher‐participant contact varied between trial arms. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 34/141 (24%) participants in the MI intervention group and 24/132 (18%) in the control group were lost to follow‐up. Less than 50% lost overall and similar between groups |