Subsidized pharmacological treatment for smoking cessation by the Spanish public health system: A randomized, pragmatic, clinical trial by clusters
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Perales del Río Health Center, Dirección Asistencial Centro, Servicio Madrileño de Salud, Madrid, Spain
Los Castillos Health Center, Dirección Asistencial Oeste, Servicio Madrileño de Salud, Madrid, Spain
Area Medicina Preventiva y Salud Pública, Universidad Rey Juan Carlos, Madrid, Spain
Unidad de Apoyo a la Investigación, Gerencia Asistencial de Atención Primaria, Servicio Madrileño de Salud, Madrid, Spain
Red de Investigación Servicios de Salud en enfermedades crónicas, REDISSEC, Madrid, Spain
Fuentelarreina Health Center, Dirección Asistencial Norte, Servicio Madrileño de Salud, Madrid, Spain
Infanta Mercedes Health Center, Dirección Asistencial Norte, Servicio Madrileño de Salud, Madrid, Spain
Guayaba Health Center, Dirección Asistencial Centro, Servicio Madrileño de Salud, Madrid, Spain
Doctor Castroviejo Health Center, Dirección Asistencial Norte, Servicio Madrileño de Salud, Madrid, Spain
Majadahonda Valle de la Oliva Health Center, Dirección Asistencial Noroeste, Servicio Madrileño de Salud, Madrid, Spain
Los Fresnos Health Center, Dirección Asistencial Este, Servicio Madrileño de Salud, Madrid, Spain
César Minué-Lorenzo   

Perales del Río Health Center, Dirección Asistencial Centro, Servicio Madrileño de Salud, Juan de Mairena s/n. 28909 Getafe, Madrid, Spain
Publish date: 2019-09-05
Tob. Induc. Dis. 2019;17(September):64
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.

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 mixedeffect logistic regression.

A total of 1154 patients were included from 23 healthcare centers. In the intention-to-treat analysis, selfreported 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)

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.

We thank each of the many personnel, of the 24 participating health centers, whose names are listed in the Supplementary file – Acknowledgements.
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.
This trial was funded by the Fondo de Investigaciones Sanitarias (FIS) del Instituto de Salud Carlos III (ISCIII), the European Regional Development Fund (ERDF) under registration number 07528, as well as the 2016 and 2017 calls for grants for translations and publishing by the Fundación para la Investigación e Innovación Biomédica en Atención Primaria (FIIBAP).
The idea for the study was conceived by C.M.L. and E.O.E.; J.M.V.S, F.C.G., J.A.G.G. and M.R.P. also participated in the design of the study. All coordinated the field work, together with M.I.G.C. and F.J.M.S; I.C.G. carried out the data analysis and interpretation, and wrote the first draft of the paper jointly with C.M.L. and E.O.E. The other authors and E.S.S. contributed ideas, interpreted the findings, critically reviewed the draft and approved the final version.
Not commissioned; externally peer reviewed.
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