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. 2019 Sep 5:17:64.
doi: 10.18332/tid/111368. eCollection 2019.

Subsidized pharmacological treatment for smoking cessation by the Spanish public health system: A randomized, pragmatic, clinical trial by clusters

César Minué-Lorenzo  1 , Eduardo Olano-Espinosa  2   3 , Isabel Del Cura-González  3   4   5 , Jose M Vizcaíno-Sánchez  6 , Francisco Camarelles-Guillem  7 , José A Granados-Garrido  8 , Margarita Ruiz-Pacheco  9 , M Isabel Gámez-Cabero  10 , F Javier Martínez-Suberviola  8 , Encarnación Serrano-Serrano  11
Affiliations

Subsidized pharmacological treatment for smoking cessation by the Spanish public health system: A randomized, pragmatic, clinical trial by clusters

César Minué-Lorenzo et al. Tob Induc Dis. .

Abstract

Introduction: Research has shown that financing drug therapy increases smoking abstinence rates, although most of these studies have been carried out in the private healthcare setting. The aim of this work is to assess the effect of subsidized pharmacological treatment on smoking cessation rates by the Spanish public healthcare system.

Methods: A pragmatic, randomized, clinical trial was performed by clusters. Randomization unit was the primary healthcare center and the analysis unit was the patient. Smokers consuming ≥10 cigarettes/day were randomly assigned to an intervention group that received financed pharmacological treatment or to a control group that followed usual care. The main outcome was self-reported or CO-confirmed continuous abstinence at 12 months. The main outcome, continuous abstinence rates (%), were compared between groups at 12 months post-intervention. A model was adjusted using mixed-effect logistic regression.

Results: A total of 1154 patients were included from 23 healthcare centers. In the intention-to-treat analysis, self-reported abstinence after 12 months in the control and intervention groups, respectively, was 9.6% (37/387) and 15.4% (118/767) (gender-adjusted OR=1.75; 95% CI: 1.1-2.8); for CO-confirmed abstinence the corresponding values were 3.1% (12/387) and 6.4% (49/767) (gender-adjusted OR=1.72; 95% CI: 0.7-4.0). Pharmacological treatment use was 35.1% (136/387) in the control group, and 58.3% (447/767) in the intervention group (adjusted OR=4.25; 95% CI: 1.8-9.9).

Conclusions: Subsidizing pharmacological treatment for smoking cessation increases self-reported or CO-confirmed abstinence rates under realistic conditions in the primary care setting of the Spanish public health system.

Keywords: Spain; drug therapy; healthcare financing; primary health care; smoking cessation.

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Conflict of interest statement

The authors declare that they have no competing interests, financial or otherwise, related to the current work. C. Minué-Lorenzo reports grants from Fondo de Investigaciones Sanitarias (FIS) del Instituto de Salud Carlos III (ISCIII), European Regional Development Fund (ERDF), grants from Fundación para la Investigación e Innovación Biosanitaria en Atención 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.

Figures

Figure 1
Figure 1
Flow chart of participants
See this image and copyright information in PMC

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