Wiggers 2006.
Methods | Study design: Randomized controlled trial Setting: Cardiovascular outpatient department, Netherlands Recruitment: People attending regular consultation; those consenting referred to nurse practitioner |
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Participants | 385 smokers (8 deaths excluded from outcomes) 37% women, av. age 59, av. cpd 21 | |
Interventions | Therapist: nurse practitioner In both groups, participants planning to quit received 8 wks nicotine patch with instruction from nurse. 1. Minimal Intervention Strategy for cardiology patients (C‐MIS). 15 ‐ 30 mins at baseline, 1 phone call at 2 wks, additional session on request. Assessment of dependency and motivation, barriers; TQD set for motivated participants 2. Usual care without motivational counselling. |
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Outcomes | Abstinence for 7 days at 12 m Validation: Urine or saliva nicotine/cotinine/thiocyanate. Self‐reported smokers also tested; validated rates include smokers with negative biochemical results, so self‐reported non‐smoking used in MA | |
Notes | Included on grounds that participants were referred to nurse practitioner for counselling; not part of usual care | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "A computerized balanced randomization programme taking prognostic factors (e.g. clinic attendance, age and gender) into account." |
Allocation concealment (selection bias) | Low risk | "While patients completed their baseline questionnaire (and signed a written informed consent) nurses randomly assigned ..." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical validation of abstinence |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 withdrawal due to cognitive problems and 8 deaths during follow‐up not included in analyses. At 12 m 45 not reached by mail or phone, included in ITT. More unmarried participants lost |