Minué‐Lorenzo 2019.
| Study characteristics | ||
| Methods | Design: Cluster‐randomized controlled trial Setting: Primary care practice, Spain Recruitment: Patients who attended the healthcare centre for any reason were approached by a general practitioner or a nurse |
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| Participants | 1154 adults who attended the primary healthcare centre for any reason between June and December 2009, smoking ≥ 10 cigarettes/day, at any stage of the smoking cessation process, av. age 46, av. cpd 22 | |
| Interventions | Intervention: participants received first‐line quit‐smoking medication (varenicline, bupropion or NRT) free of cost. Type of pharmacotherapy was chosen by the physician in accordance with participant preference. NRT provided for 8 weeks and dose based on CPD; Varenicline or bupropion standard doses for 12 weeks. Participants also received usual care as defined below Control: usual care described as behavioral treatment and recommendation for using pharmacological treatment in accordance with standard health services offered in primary care (prescribed pharmacological treatment but had to purchase it). No further details on the behavioral treatment reported |
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| Outcomes | CO‐confirmed continuous abstinence at 12m (self‐reported 12m rates also reported) Validation: CO |
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| Funding Source | Fondo de Investigaciones Sanitarias (FIS) del Instituto de Salud Carlos III (ISCIII), the European Regional Development Fund (ERDF) | |
| Author's declarations of interest | QUOTE: "The authors declare that they have no competing interests, financial or otherwise, related to the current work. C.Minue‐Lorenzo reports grants from Fondo de Investigaciones Sanitarias (FIS) del Instituto de Salud Carlos III (ISCIII), European Regional Development Fund (ERDF), grants from Fundacion para la Investigacion e Innovacion Biosanitaria en Atencion Primaria (FIIBAP), during the conduct of the study. The rest of the authors have also completed and submitted an ICMJE form for disclosure of potential conflicts of interest" | |
| Notes | Strategy: Cost‐free pharmacotherapy 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 | QUOTE: "computer‐generated random sequence" |
| Allocation concealment | Low risk | QUOTE: "Randomization was performed centrally by a researcher not involved in the study, and who was blind to the identity of the HCCs" |
| Blinding of outcome assessors All outcomes | Low risk | Abstinence was biochemically validated |
| Incomplete outcome data All outcomes | Low risk | 32/387 (8.3%) in the usual care arm and 53/767 (6.9%) in the intervention arm were lost to follow‐up |
| Recruitment bias (cluster RCTs only) | Low risk | Participants were members of the practices before they were randomized |
| Balanced baseline characteristics? (cluster RCTs only) | Unclear risk | QUOTE: "the intervention group comprised a larger percentage of men, smoked more cigarettes per day, and showed higher scores in the FTND (Table 1). Additionally, the rate of patients at the preparation and action stages of the cessation process was significantly higher in the intervention group" |
| Adjustment for clustering in analysis? (cluster RCTs only) | Low risk | A multilevel logistic regression model was built and significant variables tested as covariates, taking into consideration sampling by clusters |