Carpenter 2020.
| Study characteristics | ||
| Methods | Design: Cluster‐randomized trial Setting: 22 primary care clinics in South Carolina, USA Recruitment: patients identified at routine visits |
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| Participants | 1245 adults who smoked, 61% female, average age 50.7, average cpd 15 | |
| Interventions | Intervention: cessation advice and brochure with information on quitline, plus a 2‐week supply of both nicotine patch and lozenge, with minimal instructions on use
Control: cessation advice and brochure with information on quitline Training given to providers was based on study procedures and standard care |
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| Outcomes | 7‐day PPA at 6m Validation: none Quit attempts |
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| Funding Source | National Institute on Drug Abuse (R01 DA 021619), with additional research support through NIH UL1 TR001450 and K23 DA 045766 | |
| Author's declarations of interest | Some authors have received consulting honoraria from Pfizer (does not produce NRT) | |
| Notes | Strategy: Cost‐free medication 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 | Stratified randomization lists created at the outset of the study |
| Allocation concealment | Low risk | Accessible only to the study statistician |
| Blinding of outcome assessors All outcomes | Low risk | Smoking status was not validated, but both groups had minimal contact, with no difference in the face‐to‐face contact between the arms |
| Incomplete outcome data All outcomes | Low risk | At patient level, the number of participants lost was 41.1% (512/1245); 40.3% (263/652) in the standard care group and 42.0% (249/593) in the intervention group, no significant differences between groups, intention‐to‐ treat used to analyze data |
| Recruitment bias (cluster RCTs only) | Low risk | 22/24 clinics approached agreed to participants. Patient participants were affiliated with the practice before randomization. 6 eligible patients did not enrol |
| Balanced baseline characteristics? (cluster RCTs only) | High risk | Quote: "several baseline variables differed significantly between groups…" and adjusted for in the analysis |
| Adjustment for clustering in analysis? (cluster RCTs only) | Low risk | adjustment for clustering was conducted |