Pérez Tortosa 2015.
| Study characteristics | ||
| Methods | Design: Cluster‐randomized controlled trial Setting: Primary care teams from Barcelona, Spain Recruitment: Opportunistically in practice |
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| Participants | 948 people with diabetes who smoked, aged 14 or older, that receive routine diabetes care in the participating practice (456 intervention, 492 control). 73% M, av.age 58, 17cpd. | |
| Interventions | Intervention: • Doctors and nurses received a full‐day specific training workshop on motivational interview and pharmacological treatment. Workshops were focused on people with diabetes who smoked and were taught by trained experts. They also were trained in the dynamics of the follow‐up visits according to the stages of change and in how to use the electronic data collection systems • Participants received adjunctive counseling. Control: providers attended a practical training session that covered the methodology of the study and the electronic data collection system |
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| Outcomes | 6m continuous abstinence at 12m Validation: Expired CO < 6 ppm |
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| Funding Source | Financial help from an Evaluation of SanitaryTechnologies and Health Services grant (Evaluación de Tecnologías Sanitariasy Servicios de Salud), given by the Carlos III Health Institute (PI08/90345) in 2008 | |
| Author's declarations of interest | QUOTE: "the authors declare that they have no conflicts of interest in relation to this study" | |
| Notes | Strategy: Provider training + Adjunctive counseling Level: Provider + Patient Comparison type: Multicomponent vs. standard care |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Sequence Generation | Low risk | QUOTE: "...using a centralized, computerized randomisation system" |
| Allocation concealment | Low risk | QUOTE: "...using a centralized, computerized randomisation system" |
| Blinding of outcome assessors All outcomes | Low risk | Smoking status biochemically validated |
| Incomplete outcome data All outcomes | Low risk | At participant level, the overall loss to follow‐up was 23.8% (n = 226/948); 24.3% (n = 111/456) in the intervention group and 23.4% (n = 115/492) in the control group at 12 months |
| Recruitment bias (cluster RCTs only) | Low risk | Participants were affiliated with the practice before randomization |
| Balanced baseline characteristics? (cluster RCTs only) | Low risk | QUOTE: "Patients in the intervention arm as compared with controls showed significantly higher scores in the Richmond test". Statistically significant differences in baseline TTM stages, with a lower percentage of participants in the pre‐contemplation stage (27.8% vs. 49.6%) and a higher percentage in the preparation/action stage in the intervention group than in controls. Adjusted for differences. |
| Adjustment for clustering in analysis? (cluster RCTs only) | Low risk | QUOTE: "A multilevel mixed‐effects logistic regression with random effect estimates for primary care team clusters was performed to assess the effect of intervention on smoking abstinence adjusted by TTM stage at inclusion in the study" |