Glasgow 2009a.
| Methods | Study design: RCT Location: USA Setting: healthcare clinic and telephone Recruitment: "Members of the Kaiser Permanente ‐ Health Maintenance Organisation eligible for the programme were notified by letter and provided with an “opt out” postcard. Members who did not decline were contacted." |
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| Participants | N = 391 Specialist population?: no, although most had multiple chronic conditions Participant characteristics: 232/391 (73%) female; average age: 55.4 y; average cig/day: 21; nicotine dependence: not reported Preference for quitting abruptly versus gradually: not reported |
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| Interventions | Comparator: Enhanced usual care: participants took part in in a recruitment/baseline call. 3 quarterly, generic health‐education mailings were sent out Modality of support: newsletters Overall contact time: n/a Number of sessions: n/a Pharmacotherapy: none Quit date set?: no Intervention: Smoking reduction: telephone counselling calls aimed to increase participant self‐efficacy to achieve and sustain reduced smoking levels (using a graduated reduction approach). Participants were encouraged to set an initial goal of a ⅓ reduction in number of cigarettes smoked. Based upon progress and self‐efficacy, participants’ later reduction goals were individually tailored, although they were encouraged to attempt at least a 50% reduction. Participants who achieved a 50% or greater reduction were encouraged to quit. Newsletters were sent out including tailoring based upon data collected during the counselling calls Modality of support: telephone and newsletter Overall contact time: unclear Number of sessions: 4 Pharmacotherapy: none Quit date set?: no |
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| Outcomes | Definition of abstinence: point prevalence Longest follow‐up: 12 m Biochemical validation:expired CO |
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| Funding source | National Cancer Institute (RO1 CA 90974‐01) | |
| Author conflicts of interest | Not reported | |
| Notes | Relevant comparisons: 1) Reduction versus no treatment, but content of comparator arm is unclear ‐ described as 'generic health education mailings'; unclear whether this included any specific advice to stop smoking | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "randomly assigned to intervention conditions, using a computer algorithm developed by the project statistician." |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Abstinence was biochemically validated |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 97/200 (49%) and 63/191 (33%) were lost to follow‐up in the smoking‐reduction and usual‐care arms respectively |