An 2006.
Study characteristics | ||
Methods | Design: Randomized controlled trial Setting: Primary care clinics of Veterans Affairs Medical Centers, USA Recruitment: Invitation letter to primary care patients |
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Participants | 837 people who smoked daily, 26 cpd, av.age 57, 10% F | |
Interventions | Intervention: participants received behavioral counseling via telephone (7 calls over 2 months) with mailing of smoking cessation medications as clinically indicated. Additional calls were placed over a 12‐month period at the discretion of the counselor Control: participants were mailed self‐help materials and had continued access to clinical smoking cessation services through their Veterans Affairs Medical Center. All of these had referral‐based smoking cessation programs. Program structure varied by site (e.g., number of sessions and group or individual therapy). However, nicotine patches, nicotine gum, and slow‐release bupropion were available at all sites |
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Outcomes | 6m sustained abstinence at 12m Validation: None Measures of provider implementation: Assist‐Meds, Arrange |
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Funding Source | Department of Veterans Affairs Health Services Research and Development Service grant SUI 99101‐1 | |
Author's declarations of interest | Authors declared that they had no financial conflict of interest. | |
Notes | Strategy: Adjunctive counseling Level: Patient Comparison type: Single component vs. standard care |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Sequence Generation | Low risk | Computer‐generated randomization scheme stratified by primary care facility and blocked within sites |
Allocation concealment | Low risk | Computer‐generated |
Blinding of outcome assessors All outcomes | High risk | Smoking status was self‐reported. Intervention group had greater face‐to‐face contact. |
Incomplete outcome data All outcomes | Low risk | The overall loss to follow‐up was 14.6% (n = 122/838); 13.9% (n = 58/418) in the intervention group and 15.2% (n = 64/420) in the control group were lost to follow‐up at 12 months |