Borland 2008.
| Study characteristics | ||
| Methods | Design: Cluster‐randomized controlled trial with 2 active comparators Setting: Primary care practices, Australia Recruitment: Conducted in clinic, by GP or practice staff |
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| Participants | 1039 adults who smoked, 55.4% female, 17 cpd 45 providers |
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| Interventions | Common components in both groups: GPs were instructed to adhere to the National Guidelines, including a brief assessment of readiness to quit and if relevant, to deal with use of pharmacotherapy Intervention 1: in‐practice management GPs were encouraged to provide people who smoked with additional information and help to stop smoking. GPs were not precluded from recommending external assistance or from referring participants to the quitline if this was their clinical practice Intervention 2: referral GPs were encouraged to offer people who smoked with any interest in quitting referral to the quitline and were provided with a brochure on quitline services. Participants received an introductory call/letter from quitline, followed by up to 2 pre‐quitting and 4 post‐quitting telephone counseling sessions |
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| Outcomes | ≥10m sustained abstinence at 12m Validation: None Quit attempts Measures of provider implementation: Assist, Arrange |
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| Funding Source | National Health and Medical Research Council (284346) | |
| Author's declarations of interest | QUOTE: "RB, JB and NB are employees of The Cancer Council Victoria that runs the quitline service used in this study. None are involved in day to day operations of the service" | |
| Notes | Strategy: Adjunctive counseling Level: Patient Comparison type: Single component vs. standard care |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Sequence Generation | Low risk | QUOTE: "GPs were randomised by computer prior to their attendance at an education session" |
| Allocation concealment | Low risk | Computerised system |
| Blinding of outcome assessors All outcomes | High risk | Smoking status was self‐reported and not validated biochemically. The amount of contact differed between trial arms |
| Incomplete outcome data All outcomes | Low risk | Attrition rates were under 50% and similar across the groups. The overall loss to follow‐up was 33.6% (n = 349/1039); 32.0% (n = 233/728) in the referral group and 37.3% (n = 116/311) in the in‐practice group were lost to follow up at 12 months |
| Recruitment bias (cluster RCTs only) | Low risk | Participants were affiliated with the practice before randomization. QUOTE: "Patients who presented for any reason who were current smokers...were eligible for recruitment"; "Method of patient recruitment did not differ by condition (P=0.79)" |
| Balanced baseline characteristics? (cluster RCTs only) | Low risk | No significant differences between groups |
| Adjustment for clustering in analysis? (cluster RCTs only) | Low risk | Statistical analyses were performed with Stata, controlling for practice as a clustering variable QUOTE: "In order to take into account the correlated nature of the data and repeated measures over time, generalized estimating equations were used for a final analysis of outcomes" |