Haas 2015.
Study characteristics | ||
Methods | Design: Randomized controlled trial Setting: General practices in greater Boston, USA Recruitment: Eligible patients identified through electronic medical record and received a mailed invitation letter |
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Participants | 707 adults who smoked, living in a low or moderate household income census tract. (399 intervention, 308 control) av.age 50, 68% F, 15 cpd | |
Interventions | Intervention: participants received up to 4 counseling calls, a 6‐week supply of NRT patch, access to community‐based referrals to address sociocontextual mediators of tobacco use, and integration of all components into their normal health care through the electronic health records system Control: participants received usual care. No further details on the usual care reported |
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Outcomes | 7d PPA at 9m Validation: None |
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Funding Source | Lung Cancer Disparities Center at the Harvard School of Public Health (funded by National Cancer Institute grant P50 CA148596) and the Harvard Catalyst and from the Harvard Clinicaland Translational Science Center (funded by National Institutes of Health [NIH] grant 1 UL1 RR025758‐01 and financial contributions from participating institutions) | |
Author's declarations of interest | Authors declared that they had no conflict of interest | |
Notes | Strategy: Adjunctive counseling + cost‐free medications Level: Patient Comparison type: Multicomponent vs. standard care |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Sequence Generation | High risk | QUOTE: "Randomisation was performed in batches based on the date of the clinic visit..." |
Allocation concealment | High risk | QUOTE: "...The first patient randomised in each batch was randomised to intervention status; batches with an odd number of participants therefore resulted in an imbalance in the size of the intervention and control groups" |
Blinding of outcome assessors All outcomes | High risk | Smoking status was self‐report and there was variable contact between groups |
Incomplete outcome data All outcomes | Low risk | The overall loss to follow‐up was 34.2% (n = 242/707); 36.1% (n = 144/399) in the intervention group and 31.8% (n = 98/308) in the control group were lost to follow‐up at 9 months |