Hughes 1991.
Study characteristics | ||
Methods | Study design: parallel RCT Country: USA Recruitment: primary care patients |
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Participants | 106 smokers, motivation to quit not required 48% men, average age 38, average cigarettes per day 26 | |
Interventions | 1) Free prescription for nicotine gum for up to 6 months 2) Nicotine gum at cost of USD 6/box (96 pieces 2 mg) 3) Nicotine gum at USD 20/box All participants received brief physician advice with 1 follow‐up | |
Outcomes | Abstinence at 6 months
Validation: observer verification of all 6‐month quitters Adverse events: not measured |
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Notes | Tested effect of price on gum use and efficacy. We combined groups 2 and 3 to make 1 purchasing arm in meta‐analysis. Similar quit rates in the 2 combined arms
This study was supported by a grant (DA‐04066) and Research Scientist Development Award (DA‐00109) from the National Institute on Drug Abuse. Merrell‐Dow Research Institute provided nicotine gum. Conflicts of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Low risk | Quote: "Physician opened a sealed envelope" which assigned participants to a price group |
Blinding (performance bias and detection bias) All outcomes | High risk | Double‐blind, as described above. But physicians knew how much each participant paid, and therefore which group they were in, so could have managed them differently (Quote: "no anecdotal evidence that this occurred") |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Losses at 6 months reported; all were counted as failures, but distribution across the groups not reported |