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. 2017 Mar 14;2017(3):CD006887. doi: 10.1002/14651858.CD006887.pub4

Williams 2006.

Study characteristics
Methods Randomised controlled trial, parallel group (7:3)
Participants Inclusion criteria: adult smokers who smoked > 5 cigarettes/day
Exclusion criteria: history of psychotic illness, unable to read/speak English, minimum life expectancy of 18 months
Total randomised: 1006 participants (n = 714 intervention group, n = 292 comparison group)
Mean age: 46 years, 64% women, 82% white
Interventions Intervention group: multifaceted intervention
  • Encouraged to meet at least 4 times with a counsellor (in‐person or by phone)

  • Encouraged to meet twice with a dietician if LDL cholesterol was elevated

  • Provided with a choice of a study physician or 1 of their own to prescribe medications


Counselors were trained to support participants in making clear and autonomous choices and goal‐setting.
Comparison group: received booklets on smoking cessation and healthy diet; also encouraged to enrol in a smoking cessation programme and to meet with their physician
Outcomes Primary outcome: 12‐month prolonged tobacco abstinence
Secondary outcomes: change in percent calories from fat, LDL‐C from baseline to 18 months
Total analysed: same as above (ITT analysis)
Follow‐up: 18 months
Study funding sources National Institute of Mental Health, USA; National Cancer Institute, USA
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of random sequence generation not reported
Allocation concealment (selection bias) Low risk "The results of a stratified permutated blocked randomization were placed in numbered double‐sealed security envelopes."
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants and personnel not blinded to treatment assignment
Blinding of outcome assessment (detection bias)
All outcomes High risk Self‐reported outcomes
Incomplete outcome data (attrition bias)
All outcomes High risk 28% loss to follow‐up at 18 months; ITT analysis reported by authors but analyses appear to be completers analysis for LDL
Selective reporting (reporting bias) Low risk Prespecified outcomes all reported
Other bias Unclear risk Received funding from pharmaceutical industry