RESEARCH PAPER
Subsidized pharmacological treatment for smoking cessation by the Spanish public health system: A randomized, pragmatic, clinical trial by clusters
 
More details
Hide details
1
Perales del Río Health Center, Dirección Asistencial Centro, Servicio Madrileño de Salud, Madrid, Spain
2
Los Castillos Health Center, Dirección Asistencial Oeste, Servicio Madrileño de Salud, Madrid, Spain
3
Area Medicina Preventiva y Salud Pública, Universidad Rey Juan Carlos, Madrid, Spain
4
Unidad de Apoyo a la Investigación, Gerencia Asistencial de Atención Primaria, Servicio Madrileño de Salud, Madrid, Spain
5
Red de Investigación Servicios de Salud en enfermedades crónicas, REDISSEC, Madrid, Spain
6
Fuentelarreina Health Center, Dirección Asistencial Norte, Servicio Madrileño de Salud, Madrid, Spain
7
Infanta Mercedes Health Center, Dirección Asistencial Norte, Servicio Madrileño de Salud, Madrid, Spain
8
Guayaba Health Center, Dirección Asistencial Centro, Servicio Madrileño de Salud, Madrid, Spain
9
Doctor Castroviejo Health Center, Dirección Asistencial Norte, Servicio Madrileño de Salud, Madrid, Spain
10
Majadahonda Valle de la Oliva Health Center, Dirección Asistencial Noroeste, Servicio Madrileño de Salud, Madrid, Spain
11
Los Fresnos Health Center, Dirección Asistencial Este, Servicio Madrileño de Salud, Madrid, Spain
CORRESPONDING AUTHOR
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
KEYWORDS
TOPICS
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 mixedeffect logistic regression.

Results:
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)

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.

ACKNOWLEDGEMENTS
We thank each of the many personnel, of the 24 participating health centers, whose names are listed in the Supplementary file – Acknowledgements.
CONFLICTS OF INTEREST
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.
FUNDING
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).
AUTHORS' CONTRIBUTIONS
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.
PROVENANCE AND PEER REVIEW
Not commissioned; externally peer reviewed.
 
REFERENCES (31)
1.
US Department of Health and Human Services. Treating Tobacco Use and Dependence: 2008 Update. Rockville, MD: US Department of Health and Human Services; 2008. http://www.ncbi.nlm.nih.gov/bo.... Accessed September 28, 2012.
 
2.
Cahill K, Stevens S, Perera R, Lancaster T. Pharmacological interventions for smoking cessation: an overview and network meta-analysis. Cochrane Database Syst Rev. 2013;(5):CD009329. doi:10.1002/14651858.CD009329.pub2
 
3.
Edwards SA, Bondy SJ, Callaghan RC, Mann RE. Prevalence of unassisted quit attempts in population-based studies: a systematic review of the literature. Addict Behav. 2014;39(3):512-519. doi:10.1016/j.addbeh.2013.10.036
 
4.
Bartsch A-L, Härter M, Niedrich J, Brütt AL, Buchholz A. A Systematic Literature Review of Self-Reported Smoking Cessation Counseling by Primary Care Physicians. PloS One. 2016;11(12):e0168482. doi:10.1371/journal.pone.0168482
 
5.
Kruger J, O’Halloran A, Rosenthal AC, Babb SD, Fiore MC. Receipt of evidence-based brief cessation interventions by health professionals and use of cessation assisted treatments among current adult cigarette-only smokers: National Adult Tobacco Survey, 2009-2010. BMC Public Health. 2016;16(1):141. doi:10.1186/s12889-016-2798-2
 
6.
Bernstein SL, Yu S, Post LA, Dziura J, Rigotti NA. Undertreatment of tobacco use relative to other chronic conditions. Am J Public Health. 2013;103(8):e59-65. doi:10.2105/AJPH.2012.301112
 
7.
Jarlenski M, Hyon Baik S, Zhang Y. Trends in Use of Medications for Smoking Cessation in Medicare, 2007-2012. Am J Prev Med. 2016;51(3):301-308. doi:10.1016/j.amepre.2016.02.018
 
8.
Gross B, Brose L, Schumann A, et al. Reasons for not using smoking cessation aids. BMC Public Health. 2008;8:129. doi:10.1186/1471-2458-8-129
 
9.
van den Brand FA, Nagelhout GE, Reda AA, et al. Healthcare financing systems for increasing the use of tobacco dependence treatment. Cochrane Database Syst Rev. 2017;9:CD004305. doi:10.1002/14651858.CD004305.pub5
 
10.
Verbiest MEA, Chavannes NH, Crone MR, et al. An increase in primary care prescriptions of stop‐smoking medication as a result of health insurance coverage in the Netherlands: population based study. Addiction. 2013;108(12):2183-2192. doi:10.1111/add.12289
 
11.
Willemsen MC, Segaar D, van Schayck OCP. Population impact of reimbursement for smoking cessation: a natural experiment in The Netherlands. Addict Abingdon Engl. 2013;108(3):602-604. doi:10.1111/j.1360-0443.2012.04089.x
 
12.
Land T, Warner D, Paskowsky M, et al. Medicaid coverage for tobacco dependence treatments in Massachusetts and associated decreases in smoking prevalence. PloS One. 2010;5(3):e9770. doi:10.1371/journal.pone.0009770
 
13.
World Health Organization. WHO Report on the global tobacco epidemic, 2008: the MPOWER package. 2008. https://www.who.int/tobacco/mp.... Accessed April 27, 2019.
 
14.
Ferguson J, Docherty G, Bauld L, et al. Effect of offering different levels of support and free nicotine replacement therapy via an English national telephone quitline: randomised controlled trial. BMJ. 2012;344:e1696. doi:10.1136/bmj.e1696
 
15.
Sheffer CE, Stitzer M, Landes R, Brackman SL, Munn T, Moore P. Socioeconomic disparities in community-based treatment of tobacco dependence. Am J Public Health. 2012;102(3):e8-e16. doi:10.2105/AJPH.2011.300519
 
16.
Hiscock R, Dobbie F, Bauld L. Smoking Cessation and Socioeconomic Status: An Update of Existing Evidence from a National Evaluation of English Stop Smoking Services. BioMed Res Int. 2015;2015:274056. doi:10.1155/2015/274056
 
17.
Land T, Rigotti NA, Levy DE, et al. A longitudinal study of medicaid coverage for tobacco dependence treatments in Massachusetts and associated decreases in hospitalizations for cardiovascular disease. PLoS Med. 2010;7(12):e1000375. doi:10.1371/journal.pmed.1000375
 
18.
Dey P, Foy R, Woodman M, Fullard B, Gibbs A. Should smoking cessation cost a packet? A pilot randomized controlled trial of the cost-effectiveness of distributing nicotine therapy free of charge. Br J Gen Pract. 1999;49(439):127. PMID:10326267.
 
19.
Selby P, Brosky G, Oh P, Raymond V, Arteaga C, Ranger S. A pragmatic, randomized, controlled study evaluating the impact of access to smoking cessation pharmacotherapy coverage on the proportion of successful quitters in a Canadian population of smokers motivated to quit (ACCESSATION). BMC Public Health. 2014;14(1):433. doi:10.1186/1471-2458-14-433
 
20.
Parrott S, Godfrey C, Raw M, West R, McNeill A. Guidance for commissioners on the cost effectiveness of smoking cessation interventions. Health Educational Authority. Thorax. 1998;53 Suppl 5 Pt 2:S1-38. PMID:10226676.
 
21.
Olano-Espinosa E, Matilla-Pardo B, Minue C, Anton E, Gomez-Gascon T, Ayesta FJ. Effectiveness of a Health Professional Training Program for Treatment of Tobacco Addiction. Nicotine Tob Res. 2013;15(10):1682-1689. doi:10.1093/ntr/ntt040
 
22.
West R, Hajek P, Stead L, Stapleton J. Outcome criteria in smoking cessation trials: proposal for a common standard. Addict Abingdon Engl. 2005;100(3):299-303. doi:10.1111/j.1360-0443.2004.00995.x
 
23.
Kaper J, Wagena EJ, Willemsen MC, van Schayck CP. Reimbursement for smoking cessation treatment may double the abstinence rate: results of a randomized trial. Addict Abingdon Engl. 2005;100(7):1012-1020. doi:10.1111/j.1360-0443.2005.01097.x
 
24.
Twardella D, Brenner H. Effects of practitioner education, practitioner payment and reimbursement of patients’ drug costs on smoking cessation in primary care: a cluster randomised trial. Tob Control. 2007;16(1):15-21. doi:10.1136/tc.2006.016253
 
25.
Du J, Leigh JP. Effects of wages on smoking decisions of current and past smokers. Ann Epidemiol. 2015;25(8):575-582.e1. doi:10.1016/j.annepidem.2015.03.016
 
26.
Over EAB, Feenstra TL, Hoogenveen RT, Droomers M, Uiters E, van Gelder BM. Tobacco control policies specified according to socioeconomic status: health disparities and cost-effectiveness. Nicotine Tob Res. 2014;16(6):725-732. doi:10.1093/ntr/ntt218
 
27.
Cahill K, Lindson-Hawley N, Thomas KH, Fanshawe TR, Lancaster T. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2016;(5):CD006103. doi:10.1002/14651858.CD006103.pub7
 
28.
Aveyard P, Begh R, Parsons A, West R. Brief opportunistic smoking cessation interventions: a systematic review and meta-analysis to compare advice to quit and offer of assistance: Brief interventions for smoking cessation. Addiction. 2012;107(6):1066-1073. doi:10.1111/j.1360-0443.2011.03770.x
 
29.
West R, Sohal T. “Catastrophic” pathways to smoking cessation: findings from national survey. BMJ. 2006;332(7539):458-460. doi:10.1136/bmj.38723.573866.AE
 
30.
Jardin BF, Cropsey KL, Wahlquist AE, et al. Evaluating the effect of access to free medication to quit smoking: a clinical trial testing the role of motivation. Nicotine Tob Res Off J Soc Res Nicotine Tob. 2014;16(7):992-999. doi:10.1093/ntr/ntu025
 
31.
Thorpe KE, Zwarenstein M, Oxman AD, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol. 2009;62(5):464-475. doi:10.1016/j.jclinepi.2008.12.011
 
eISSN:1617-9625