Cummings (Priv) 1989.
Methods |
Country: USA Design: Randomized controlled trial; Nested; Clustered Objective: To test if physicians who are trained to use the 'Quit for Life' (QFL) program are more effective in helping patients to quit smoking Methods of analysis: Chi² test for proportions and t‐tests for means; Multiple logistic regression (for proportions) and ordinary least‐squares (for means) and calculated adjustment rates from the partial slopes associated with a dummy variable; Individual patients were the unit of analysis Clustering adjustment made: No adjustment to presented data but separate analyses tested clustering effects Significance of cluster adjustment: Clustering effects were tested in separate analyses; These adjustments had no discernible effect on significance levels and did not alter the conclusion |
|
Participants |
Therapist description: Primary care physicians in private practice Eligible for study: n= 844 Randomized: Intervention n= 31; Control n= 28 Completed: Intervention n= 20; Control n= 18 Age: Not reported Gender: Intervention females n= 4; Control females n= 2 Patient description: n= 916 smoking patients not selected by motivation to quit Eligible for study: Not reported Randomized: Intervention n= 470; Control n= 446 Completed: Intervention n= 360; Control n= 364 Age: Intervention mean = 43 years; Control mean = 45 years Gender: Intervention mean = 53%; Control mean = 61% |
|
Interventions |
Setting: Private primary care internal medicine and family practice (primary care) in San Francisco, USA; Local hospitals at times that fit with the schedules of the participating physicians; Four who were unable to attend the second sessions received the training privately in their office Training of those delivering the intervention to the health professional: Not described Intervention description: Training (personalised advice, quit date, one follow‐up visit, self help materials and nicotine gum) Control description: Normal care (no training) Duration of intervention: Three, one hour seminars Intervention delivered by: Internist or psychologist Intensity: Three, one hour seminars, second seminar one or two weeks after the first, third seminar four to twelve weeks later |
|
Outcomes |
Pre‐specified outcome data: Demographic characteristics; Smoking history; How much do you want to quit smoking; How confident are you that you will not be smoking one year from now; Pressure to quit from family and friends; Was smoking discussed; Did you receive a self‐help booklet; Did you receive a follow‐up appointment about smoking Follow‐up period: Twelve months |
|
Notes |
Process measures: None reported Validation: Expired carbon monoxide and serum cotinine Manual adjustment for potential clustering effects performed in the meta‐analyses for primary outcome data |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Authors state patients were randomly assigned however methods not described |
Allocation concealment (selection bias) | Unclear risk | Methods not described |
Blinding (performance bias and detection bias) of participants | High risk | Due to the nature of the intervention blinding of participants was not possible for this study |
Blinding (performance bias and detection bias) of outcome assessors | Low risk | Authors state outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Participants assumed smokers if lost to follow‐up or abstinence unable to be biochemically verified; Missing outcome data accounted for in analyses |
Selective reporting (reporting bias) | Low risk | All expected outcomes, including those that were pre‐specified were reported |
Other bias | Low risk | No other biases identified |
Imbalance of outcome measures at baseline | Low risk | Imbalances adjusted for using logistic regression |
Comparability of intervention and control group characteristics at baseline | Low risk | Imbalances adjusted for using logistic regression |
Protection against contamination | Low risk | Members of the same group practice were assigned to the same condition to minimise cross‐over |
Selective recruitment of participants | Unclear risk | More control participants were recruited by practice staff than intervention subjects; Methods of recruitment not clearly described |