Lewis 1998.
Methods | Study design: RCT Location: USA Setting: hospital and over telephone Recruitment: from inpatients admitted to the University of Wisconsin Hospital and clinics who expressed an interest in quitting smoking |
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Participants | Defining eligibility criteria?: hospital inpatient smokers interested in quitting Participant characteristics: 185 adult smokers; 85/185 (46.0%) female; mean age: control: 43, intervention: 44.7; mean cpd: control: 22.5, intervention: 24.9; nicotine dependence: mean FTND = control: 6.6, intervention: 6.9 Motivation to quit?: motivated |
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Interventions | Control: minimal care: brief (2–3 min) motivational message to quit smoking and a copy of the National Cancer Institute’s Clearing the Air self‐help smoking cessation pamphlet Intervention: counselling and placebo patch: as control, plus a placebo nicotine replacement patch, and a study nurse provided brief (10 to 15 minute) phone counselling at 1, 3, 6, and 24 weeks after the initiation of patch treatment. Phone counselling incorporated basic techniques of cognitive‐behavioural therapy and motivational interviewing. The nurse also frequently reminded participants of the Clearing the Air pamphlets and encouraged them to look over the pamphlet between sessions. Provider: nurse Intensity: five 10 to 15‐minute sessions over 24 weeks Was MI fidelity monitored?: no |
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Outcomes | Definition of cessation used: 7‐day point prevalence Length of longest follow‐up: 24 weeks Validation: expired carbon monoxide <= 10 ppm Was mental health and/or well‐being measured at follow‐up?: no Was quality of life measured at follow‐up?: no |
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Funding source | "This research was supported by a research grant provided by the Elan Pharmaceutical Research Corporation, Gainsville, Georgia, and Athlone, Ireland." | |
Author conflicts of interest | Not specified | |
Notes | This study also included an additional intervention arm, which was the same as the intervention arm reported above but included active rather than placebo nicotine patch. This study arm was not eligible for this review and was not included in analyses as the use of pharmacotherapy was not matched to the control arm. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The patient was randomized to either the MC condition or a patch condition using a predetermined computer‐generated randomization code." |
Allocation concealment (selection bias) | Unclear risk | Quote: "The patient was randomized to either the MC condition or a patch condition using a predetermined computer‐generated randomization code." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Cessation was biochemically verified. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Dropout rates not reported |