Leppänen 2019.
| Study characteristics | ||
| Methods | Design: Cluster‐randomized controlled trial Setting: Primary healthcare centres, Sweden Recruitment: QUOTE: "Eligibility was assessed using a short screening questionnaire before patients were invited to participate. The patients were recruited by one to three appointed PHC providers at each PHC centre that were responsible for the treatment of patients in the study" |
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| Participants | 250 adults who smoked from 18 primary healthcare centres in Sweden. Participants had a mean age of 54.4 years, av. cpd not reported, most had chronic disease (70%) | |
| Interventions | Intervention: Tobacco Cessation on Prescription (TCP) consisting of 1) person‐centered tobacco cessation counseling from a qualified healthcare professional for at least 10 minutes; 2) an individualized prescription of tobacco cessation treatment; 3) follow‐up on at least 1 occasion; 4) providers received 3 hours of training. Healthcare providers could use the prescription form as a basis for tobacco cessation counseling with the patient, discussing available treatment options and deciding together what option(s) would suit the participant best Control: participants received standard treatment (brief advice consisting of < 5 minutes of tobacco cessation counseling, but providers were free to offer whatever treatment they wanted as long as this was documented). Providers also received a written manual and 3 hours of training in tobacco cessation treatment |
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| Outcomes | 7‐day PPA at 6m and 12m Validation: none Quit attempts (however, result only reported narratively and unable to extract data for analysis) |
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| Funding Source | The study is funded by grants from the Stockholm County Council (grant no: HSN 1309‐1029), The Public Health Agency of Sweden (grant no: 03074‐2015‐6.2) and Livförsäkringsbolaget Skandia. | |
| Author's declarations of interest | None | |
| Notes | Strategy: Adjunctive counseling, provider training Level: Patient & provider Comparison type: Active vs. active (isolates adjunctive counseling) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Sequence Generation | Low risk | Computer‐generated |
| Allocation concealment | Low risk | Quote: "A computer generated random allocation sequence will be applied to randomize the PHC centers to either intervention or control conditions" |
| Blinding of outcome assessors All outcomes | High risk | Self‐reported outcomes and more contact in the intervention group |
| Incomplete outcome data All outcomes | High risk | 56% participants responded to 6‐month follow‐up questionnaire. Imputation used for missing data |
| Recruitment bias (cluster RCTs only) | Unclear risk | 77 PHC centers invited and 17 agreed |
| Balanced baseline characteristics? (cluster RCTs only) | Low risk | Quote: "The patients were similar in the treatment groups but patients in the intervention group were more often female, born in Sweden, had more previous quit attempts, experience of pharmacotherapy and lower prevalence of chronic disease compared to the control group." |
| Adjustment for clustering in analysis? (cluster RCTs only) | Low risk | Adjustment for clustering conducted |