Murray 2008.
| Study characteristics | ||
| Methods | Design: Cluster‐randomized controlled trial Setting: 3 Nottingham Primary Care Trust areas, UK Recruitment: Proactive identification of people who smoked via a letter offering smoking cessation support through the National Health Smoking Cessation Service |
|
| Participants | 6856 adults who smoked, av.age 45, 51% M, av. cpd not reported | |
| Interventions | Intervention: participants received brief advice on smoking cessation and information about their local NHS Stop Smoking Service by the research team via telephone • If participants wished, an initial consultation with the NHS stop smoking service was booked. Paarticipants who attended this were offered the option of one‐to‐one or group behavioral support lasting an average of 8 weeks, and NRT or bupropion therapy, and set a quit date • If participants declined an appointment or were uncontactable, an information pack was sent. The pack included an information leaflet from the service, encouragement to use the service, and contact details for the research team and the local service Control: QUOTE: "for six months from baseline, smokers in the control practices received no further intervention other than that provided by usual care. Previous studies suggest that, in most cases, little or no advice or support would have been given". No further details reported |
|
| Outcomes | 7‐day PPA at 6m Validation: Salivary cotinine < 15 ng/ml or exhaled CO < 10 ppm |
|
| Funding Source | Funded by the British Heart Foundation. The study was designed, conducted, analyzed and interpreted independently of all funding sources | |
| Author's declarations of interest | Not reported | |
| Notes | Strategy: Adjunctive counseling Level: Patient Comparison type: Single component vs. standard care |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Sequence Generation | Unclear risk | No details reported |
| Allocation concealment | Unclear risk | No details reported |
| Blinding of outcome assessors All outcomes | Low risk | Smoking status biochemically validated |
| Incomplete outcome data All outcomes | Low risk | At participant level, the overall loss to follow‐up was 48.8% (n = 3344/6856). The mean response was 47.9% (range 28.8 ‐ 55.6) in the intervention group and 53.7% (range 39.6 ‐ 63.3) in the control group at 6 months |
| Recruitment bias (cluster RCTs only) | Low risk | Participants were affiliated with the practice before randomization |
| Balanced baseline characteristics? (cluster RCTs only) | Low risk | QUOTE: "The distribution of gender and age was similar for participants in intervention and control practices" |
| Adjustment for clustering in analysis? (cluster RCTs only) | Low risk | QUOTE: "We used a two‐level hierarchical model with subjects nested within practices, a random effect of practice, intervention fitted at the practice level, and age, sex, Townsend score and amount smoked per day at the subject level"; "...assuming an intracluster correlation coefficient of not more than 0.007..." |