Swan 2010.
Methods | Setting: HMO (Group Health), Seattle, WA, USA Recruitment: Group Health members contacted by phone & mail from Free & Clear |
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Participants | 1202 smokers (≥ 10 cpd); 67% F, av age 47, av cpd 22 | |
Interventions | Pharmacotherapy: varenicline for 12 weeks (1 mg x 2/day, titrated 1st week). All received 5 to 10‐min orientation call, printed Quit Guides and access to a free support line for ad hoc calls. 1. Web‐based counselling: access to online programme, including quit plan, online library, quit calendar, cost calculator, progress tracker, email links to friends and family and discussion forums 2. Proactive telephone‐based counselling: Free & Clear Quit for Life programme. Up to 5 'brief' one‐to‐one phone sessions initiated by F&C counsellor. Timed for convenience and at relapse‐sensitive stages. Used MI techniques 3. Combination: proactive calls + web access; counsellor could view info entered online. Participants encouraged to use website for additional info and social support, and to track cpd. Counsellors could view quit status, last log‐in and last use of discussion forum. | |
Outcomes | Abstinence at 6 m (PP) Validation: none | |
Source of Funding/CoI | National Cancer Institute. "Varenicline and nominal support for recruiting participants was provided by Pfızer, Inc. Neither entity [NCI or Pfizer] had any role in the study design; the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication." Authors declared potential conflicts of interest. | |
Notes | 3 vs 1 in main analysis, 2 & 3 vs 1 had little effect on result. 60‐min contact on average for 3 64% were no longer taking varenicline at 3 months, but no between‐group differences in non‐compliance or reasons for stopping |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Group assignment was randomly allocated using an automated algorithm built into the study database". |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Self‐report only and differential levels of support |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Participants lost to follow‐up counted as smokers in ITT analysis; equal losses between groups (103 web, 107 phone, 100 web + phone) |