Crowley 1995.
Methods | Country: USA Setting: outpatient smokers at a Denver COPD clinic Design: 3‐arm randomized controlled trial |
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Participants | 49 smokers (18 experimental group, 16 cigarette self‐report group, 15 control group), age at least 35 with COPD, breath CO > 14 ppm and FEV < 70% of FVC. Exclusion criteria: absence from study region, job exposure to high CO, pregnancy, other serious health or dental conditions, elevated bilirubin or blood urea nitrogen. 12 (24%) female, average age 61.4, average FEV 49.5% of normal value. No baseline imbalances. |
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Interventions | All participants had daily CO monitoring performed by a study technician over 85 days, + brochure + nicotine gum. At start of study participants were given 3 Colorado Lottery tickets to quote: “throw cigarettes down the toilet”. All were given 1 lottery ticket per day for quote: “time and effort”. Experimental group: received lottery ticket reward for every CO test < 10 ppm. Cigarette self‐report group: received lottery ticket reward for each self‐reported abstinence since previous visit. Control group: each pt received (irrespective of their own abstinence) the same reward as an experimental participant with whom they had been paired. Measurement intervals and payment schedules were changed frequently. |
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Outcomes | Verified 24‐hour PPA, measured at 6 months (CO corrected for air pollution < 10 ppm, also verified using urinary cotinine and blood oxygen saturation). Corrected CO relative to number of cigarettes reported. |
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Notes | Also in ISC. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated. |
Allocation concealment (selection bias) | High risk | Participants stratified by sex and FEV and groups allocated randomly, such that within each stratum, a participant was always assigned to the experimental group before a participant could be assigned to the control group. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical validation used in addition to self‐report. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropout: experimental group 4/18; cigarette self‐report group 4/16; control group 1/15. 4/40 moved away or died. An ITT analysis was conducted. |
Other bias | High risk | Paper does not report 6‐month cessation outcome per group, but only figures for all groups combined after noting non‐significant differences. |