Open access Research Effect of the comprehensive smoke-free law on time trends in smoking behaviour in primary healthcare patients in Spain: a longitudinal observational study Mariona Pons-Vigués, 1,2,3 Yolanda Rando-Matos,1,4 Teresa Rodriguez-Blanco,1,2 Josep Lluís Ballvé-Moreno,1,4 Joana Ripoll,5,6 Joan Llobera,5,6 Julio Morán,7 Tomàs López-Jiménez,1,2 Concepción Violán-Fors,1,2 Bonaventura Bolibar 1,2 To cite: Pons-Vigués M, Abstract Rando-Matos Y, Rodriguez- Strengths and limitations of this study Objective This study aimed to analyse the impact of Blanco T, et al. Effect of the comprehensive smoke-free legislation (SFL) on the comprehensive smoke-free ►► To our knowledge, no studies have been pub- prevalence and incidence of adult smoking in primary law on time trends in smoking lished on the impact of the Spanish comprehensive healthcare (PHC) patients from three Spanish regions, behaviour in primary healthcare smoke-free legislation in all adult primary health- patients in Spain: a longitudinal overall and stratified by sex. care patients. observational study. BMJ Open Design Longitudinal observational study conducted ►► Used as a research tool, electronic health records 2019;9:e020120. doi:10.1136/ between 2008 and 2013. portray real life conditions and provide comprehen- bmjopen-2017-020120 Setting 66 PHC teams in Catalonia, Navarre and the sive, long-term health histories from a large popu- Balearic Islands (Spain). ►► Prepublication history and lation sample. Participants Population over 15 years of age assigned to additional material for this paper ►► The results of quarterly data by Joinpoint analysis are available online. To view PHC teams. provides more precise information than an analysis please visit the journal online Primary and secondary outcomes measures Quarterly before-after the implementation of the law. (http://​dx.​doi.​org/​10.​1136/​ age-standardised prevalence of non-smoker, smoker ►► This study only considered age and sex since oth- bmjopen-​2017-​020120). and ex-smoker and incidence of new smoker, new ex- er variables were not available for the adjusted smoker and ex-smoker relapse rates were estimated Received 16 October 2017 analysis. with data retrieved from PHC electronic health records. Revised 18 October 2018 ►► The study period started later (shorter follow-up) in Joinpoint analysis was used to analyse the trends of age- Accepted 11 December 2018 the Balearic Islands to ensure reliability of data. standardised prevalence and incidence rates. Trends were expressed as annual percentage change and average annual percent change. Results The overall standardised smoker prevalence rate is estimated that at least 30 million people showed a significant downward trend (higher in men than may die prematurely from tobacco-re- women) and the overall standardised ex-smoker prevalence lated diseases.2 Legislative measures have rate showed a significant increased trend (higher in women been adopted to protect people’s health in than men) in the three regions. Standardised smoker and public areas and workplaces. These include ex-smoker prevalence rates were higher for men than women increasing the price of cigarettes, banning in all regions. With regard to overall trends of incidence rates, new smokers decreased significantly in Catalonia and Navarre advertising, sponsorship and smoking in and similarly in men and women, new ex-smokers decreased workplaces and public spaces, displaying significantly and more in men in Catalonia and the Balearic warnings on tobacco packets and imple- Islands, and ex-smoker relapse increased in Catalonia menting prevention programmes.3 © Author(s) (or their (particularly in women) and decreased in Navarre. Some studies show a decrease in smoking employer(s)) 2019. Re-use Conclusions Trends in smoking behaviour in PHC patients prevalence since the introduction of smoke- permitted under CC BY-NC. No commercial re-use. See rights remain unchanged after the implementation of comprehensive free legislation (SFL).4–9 A meta-analysis of and permissions. Published by SFL. The impact of the comprehensive SFL might have been 26 studies on the effect of the smoke-free BMJ. lessened by the effect of the preceding partial SFL. workplace in various countries concluded For numbered affiliations see in 2002 that smoke-­free workplaces protect end of article. non-smokers from the dangers of passive Correspondence to Introduction smoking, and they encourage smokers to Dr Mariona Pons-Vigués; Smoking is the leading worldwide cause of reduce tobacco consumption. The authors ​mponsv@​idiapjgol.​info preventable death.1 According to WHO, it concluded that SFL is associated with a Pons-Vigués M, et al. BMJ Open 2019;9:e020120. doi:10.1136/bmjopen-2017-020120 1 Open access 3%–4% reduction in tobacco consumption.10 In contrast, smoking in PHC patients in three regions (Catalonia, a Cochrane review published in 2016, which included 24 Navarre and Balearic Islands), during the 2008–2013 studies on smoking behaviour, showed inconsistencies period, overall and stratified by sex. regarding the impact of smoking bans on smoking preva- lence and tobacco consumption.11 On 1 January 2006, the Spanish government intro- Methods duced a partial SFL (Law 28/2005),12 which included Design, study participants and information source regulations on the sale, supply, consumption and adver- Longitudinal observational study of the adult popula- tising of tobacco products. Smoking was banned at all tion assigned to 66 PHC teams (PHCTs) in three Spanish indoor public and private workplaces with the exception regions: Catalonia, Navarre and the Balearic Islands (22 of the hospitality sector, where partial restrictions were PHCTs per region). Inclusion criteria of the PHCTs were: established depending on the size of the establishment, (1) Computerisation of electronic health records (EHRs) that is, in bars or restaurants smaller than 100 m2 the by 1 January 2005 in Catalonia and Navarre, and 2008 managers could decide whether to allow smoking in the in the Balearic Islands. (2) Agreement to participate in premises (Law 28/2005). The mean concentration of the study by over 80% healthcare professionals working nicotine subsequently decreased by 60% in public admin- in each PHCT. Random cluster sampling was stratified istration offices and by 97.4% in private workplaces, but by region, with PHCT as randomisation unit.26 In each in areas where smoking was permitted, including bars and PHCT, general practitioners (GPs) with a patient list nightclubs, no changes were found.13–15 This prompted between 400 and 3000 were selected. GPs with shorter the enactment of comprehensive SFL (Law 42/2010),16 patient lists were accepted if it was their first year in the which came into force in January 2011. This comprehen- PHCT. sive law expanded smoking restriction to all hospitality The study period included from the first quarter of 2008 venues of any size and, as a result, smoking was forbidden to the fourth quarter of 2013 in Catalonia and Navarre; in all enclosed public places, including bars, restaurants and from the second quarter of 2010 to the fourth quarter and nightclubs, and in some open-air public places such of 2013 in the Balearic Islands. The study started in 2008 as playgrounds. to obtain data from the 2 years prior analysis, a require- Some studies have analysed the impact of these two ment to adequately construct the variable ex-smoker. In Spanish laws on smoking prevalence. However, most the case of the Balearic Islands, the study started later to have been based on health surveys13 17–20 and surveys of ensure reliability of data. hospitality workers.21 22 Moreover, some studies evaluate Inclusion criteria for patients were: (1) Population only the partial law,13 17 18 whereas others analyse the allocated to the selected PHCT for the whole 2007–2013 compound impact of both laws.19 20 23 24 The results of period in Catalonia and Navarre; in the Balearic Islands, these studies are often conflicting; while some conclude patients allocated to the selected PHCT in 2013 and eval- that the partial SFL does not have any effect on the down- uated retrospectively (no historical annual comprehen- ward trend in the prevalence of smokers,13 19 23 other sive register of allocation of patients was available). (2) studies show a reduction in smoking prevalence,24 an Age ≥16 years and ≤100 years in 2007 in Catalonia and increase of the smoking quit ratio in the short term18 and Navarre, and 2010 in the Balearic Islands. (3) In order to minor increases in the prevalence of active smoking.20 have data in the EHR collected during the study period, Only one study conducted in PHC patients evaluates a minimum of one visit to their PHCT during the 2007– the impact of the Spanish partial SFL, including smoking 2013 period in Catalonia and Navarre and 2010–2013 in prevalence in active smoker workers that attended PHC the Balearic Islands. (4) Information on smoking habit visits; 1 month after the implementation of the law, a 9.5% recorded in the EHR for the quarter prior to the onset of decline of smokers was observed.25 To our knowledge, no the study: last quarter of 2007 in Catalonia and Navarre studies have been published on the impact of the Spanish and first quarter of 2010 in the Balearic Islands, to enable comprehensive SFL in all adult PHC patients. In view of the adequate construction of the various variables. Since the pivotal role of PHC services in smoking habits, we smoking is not an acute condition, this information was consider that the information registered in PHC records considered valid until new information was entered. Thus, is a good proxy to generate up-to-date evidence and to closed cohorts (with fixed membership, where nobody is evaluate the impact of comprehensive SFL in the general added nor excluded after the study begins) were consti- population. tuted in the three regions. Figure 1 shows the flow chart We hypothesised that Law 42/2010 does reduce expo- of the study. sure to environmental cigarette smoke and its harmful Data were retrieved from the Registry of Preventive effects and crucially, it promotes smoking denormali- Services in Primary Care (REGIPREV) database,26 which sation in society, thus encouraging smokers to quit or contains encrypted and anonymised clinical information reduce consumption and discouraging non-smokers from recorded in the EHR by these 66 PHCTs. An algorithm initiating this habit. Accordingly, the aim of this study was was applied to extract equivalent data from the health to examine the impact of the Spanish comprehensive SFL records software used in each region: ‘ECAP’ in Catalonia, (Law 42/2010) on the prevalence and incidence of adult ‘Atenea’ in Navarre and ‘e-siap’ in the Balearic Islands. 2 Pons-Vigués M, et al. BMJ Open 2019;9:e020120. doi:10.1136/bmjopen-2017-020120 Open access Figure 1 Flow chart of patients included in the study, by region. Codes of the International Classification of Diseases, smoking cessation). This information is stored with the ninth revision in the Balearic Islands (ICD-9) and tenth entry date (online supplementary file table S1). With the in Catalonia (ICD tenth revision)27 and the International information on smoking status and entry date we created Classification of Primary Care, second edition, in Navarre the following dependent variables at the end of each (ICPC-2)28 were used. quarter of the study period: Variables Smoking status (three categories): (1) Non-smoker: Information on smoking is registered in the EHRs using patient that has never been a tobacco consumer. (2) diagnostic codes to classify diseases (codes F17.0 to F17.9 Smoker: tobacco consumer or patient that has quit and Z72.0 of the ICD-10, 305.1 of the ICD-9 and P17 of smoking for less than 12 months. (3) Ex-smoker: pa- the ICPC-2), and also clinical variables (number of ciga- tient who used to smoke but has quit smoking for at rettes per day, history of smoking, history of advice for least 12 continuous months. When the EHR did not Pons-Vigués M, et al. BMJ Open 2019;9:e020120. doi:10.1136/bmjopen-2017-020120 3 Open access contain a new entry related to smoking status (diag- non-smoker prevalence rates was not calculated because nostic codes or clinical variables), we considered that the study consisted of a closed cohort where no new no changes in smoking status had taken place and thus participants are recruited, and thus the prevalence of the last observation was still valid. non-smokers can either remain the same or decrease, but New smoker: patient non-smoker for the 12 months never increase. prior to the considered quarter that has started smok- Analyses were performed using Stata/SE V.14.2 for ing during the said quarter. Windows (Stata Corp, College Station, Texas, USA). New ex-smoker: the patient was a smoker 2 years before The Joinpoint regression analysis was carried out using the considered quarter and has continuously abstained the Joinpoint software from the Surveillance Research from tobacco for at least 12 months. Programme of the US National Cancer Institute (ref. Ex-smoker relapse: patient ex-smoker during the 12 Joinpoint Regression Program, V.4.6.0. April, 2018; Statis- months prior to the considered quarter that has start- tical Research and Applications Branch, National Cancer ed smoking again during the said quarter. Institute) (https://​surveillance.​cancer.​gov/​branches/​ For higher accuracy in prevalence and incidence srab/). changes, quarterly estimates were calculated. The following variables of each patient were collected Patient and public involvement at baseline (2008 in Catalonia and Navarre; 2010 in Study participants were not involved in the development the Balearic Islands): age, sex (male/female), annual of the research question or the outcome measures, nor number of health problems and annual number of PHC in the design of the study. The results will be presented visits. The number of health problems was used as a to citizens through informative activities and the media. morbidity indicator; it was calculated as the sum of the number of different active health problems (chronic and acute, coded by ICPC-2). Results The study population was 392 966 patients: 141 071 in Data analyses Catalonia, 73 644 in Navarre and 178 251 in the Balearic Descriptive statistics were used to summarise overall Islands (figure 1). At the onset of the study, the mean age information. Categorical variables were expressed as was 50.4 years in Catalonia, 54.0 years in Navarre and 47.7 percentage, and continuous variables as mean (SD) or years in the Balearic Islands. In the three cohorts more median (IQR). than half were women (>51%). Catalonia presented Because the three regions used different EHR systems the highest median number of visits (9, IQR: 3–16) and (different standards and computer programs), have the Balearic Islands presented the highest number of different socioeconomic characteristics, different recorded active health problems per patient (median 10, complementary measures to the SFL and also due to IQR: 6–16) (table 1). the shorter study period in the Balearic Islands, we The overall standardised smoker prevalence rates per 10 000 performed a stratified analysis per region, overall and inhabitants were of similar magnitude in the three regions by sex. Age-standardised prevalence (non-smokers, (ranges of 3579.2–4138.9 in Catalonia, 3719.8–4034.2 smokers and ex-smokers) and incidence (new smokers, in Navarre and 3787.4–4029.7 in the Balearic Islands). new ex-smokers and ex-smoker relapse) rates were calcu- The prevalence rate decreased in Navarre during the lated for each quarter using the direct method, and based whole study period, decreased in the Balearic Islands in on the European standard population (rates per 10 000 most quarters and also in Catalonia except for the last inhabitants). year. These rates were higher for men than for women Joinpoint analysis was used to analyse the trends of in all regions (online supplementary file table S2–S7). age-standardised prevalence (smokers and ex-smokers) A significant downward overall trend of smoker prevalence and incidence rates (new smokers, new ex-smokers rates was found in Catalonia (AAPC=−2.18), Navarre and ex-smoker relapse) and to identify the best-fitting (AAPC=−1.44) and the Balearic Islands (AAPC=−1.75); points (the ‘joinpoints’, in calendar quarters) where this downward trend was higher for men than for women the rate changes significantly in the linear slope of the in the three regions. In Catalonia, the most significant temporal trend. Significant changes include changes in reduction occurred during the period 2010.3–2011.4 direction or in the rate of increase or decrease.29 Join- (APC=−6.75), similarly to the Balearic Islands (2010.2– point analysis estimates the magnitude of the increase 2012.4; APC=−2.19), whereas in Navarre it occurred or the decrease observed in each specified time interval between 2008.1 and 2013.4 (APC=−1.44) (tables 2, 3 and by estimating the annual percentage change (APC). In 4, online supplementary file figure S1). addition, temporal trends were expressed as the average For the whole period, the overall standardised ex-smoker annual percent change (AAPC), computed to summarise prevalence rates per 10 000 inhabitants increased in Navarre, and compare these trends over the entire time period. in the Balearic Islands and in Catalonia except for the Because the outcomes originate from repeated measure- last year. The rates in Catalonia were higher (ranges of: ments, control for the autocorrelation errors was used; 1168.5–1781.2 in Catalonia; 313.3–764.1 in Navarre; and 95% CIs of APC and AAPC were calculated. The trend of 559.3–914.1 in the Balearic Islands). The standardised 4 Pons-Vigués M, et al. BMJ Open 2019;9:e020120. doi:10.1136/bmjopen-2017-020120 Open access Table 1 Characteristics of the cohort study population by region at the onset of the study (2008 in Catalonia and Navarre, 2010 in the Balearic Islands) Catalonia Navarre Balearic Islands n = 1 41 071 n = 73 644 n = 1 78 251 Age (years), SD 50.37 (17.23) 54.04 (18.26) 47.65 (17.56) Sex (female), number (%) 72 340 (51.28) 37 898 (51.46) 94 164 (52.83) Number of visits, mean (SD); median (IQR) 11.69 (12.19); 8.93 (9.30); 11.01 (13.25); 9.00 (3.00–16.00) 7.00 (3.00–12.00) 7.00 (3.00–15.00) Number of health problems, mean (SD); median (IQR) 6.23 (4.58); 9.95 (5.39); 11.85 (7.74); 5.00 (3.00–8.00) 9.00 (6.00–13.00) 10.00 (6.00–16.00) Patients belonged to 22 primary healthcare teams in each region. Abbreviations: SD, standard deviation; IQR, interquartile range. ex-smoker prevalence rates were higher for men than for increases in Catalonia (AAPC=18.60), particularly in women in all regions (online supplementary file table S2– women (AAPC=14.56), although a decrease from 2008.1 S7). The overall trend of ex-smoker prevalence rates increased to 2012.3 was observed (APC=−8.40). In contrast, Navarre significantly in the three regions throughout the study showed significant decreases (AAPC=−11.42)(tables 2, 3 period but was higher in Navarre (Navarre AAPC=16.67; and 4, online supplementary file figure S2). Catalonia AAPC=7.19; Balearic Islands AAPC=14.96). The increase in the prevalence rate of ex-smokers was higher for the 2008.1–2008.2 period in Catalonia, 2008.1–2008.4 Discussion in Navarre and for 2010.2–2012.2 in the Balearic Islands, The previous implementation of the partial Spanish SFL and higher in women in the three regions (women: Cata- could account for the low effectiveness of the comprehen- lonia AAPC=10.87; Navarre AAPC=17.30 and Balearic sive SFL observed in this study. A significant downward Islands AAPC=19.51) (tables 2, 3 and 4, online supple- trend of smoker prevalence rates, higher in men than in mentary file figure S1). women, was found in the three regions throughout the The overall new smoker standardised incidence rates per study period. Correspondingly, the trend of ex-smoker 10 000 inhabitants showed low values in the three regions prevalence rates increased in the three regions, partic- (ranges of 7.9–26.8 in Catalonia; 9.5–30.9 in Navarre; ularly in Navarre and during the period 2008.1–2008.2 1.6–17.5 in the Balearic Islands) and higher for men than in Catalonia, 2008.1–2008.4 in Navarre, and 2010.2– for women in Catalonia and Navarre (online supplemen- 2012.2 in the Balearic Islands. Even though the stan- tary file table S2–S7). The overall trend of new smoker incidence dardised ex-smoker prevalence rate was higher for men, rates decreased significantly in Catalonia (AAPC=−10.39) the increase in the trend of ex-smoker prevalence rate and Navarre (AAPC=−9.49); additionally, the decline was was higher in women in the three regions. The overall similar for men and women. In contrast, the overall trend trends of new smoker incidence rates decreased signifi- remained stable in the Balearic Islands despite a decrease cantly in Catalonia and Navarre and were similar for men until 2012.4 (APC=−46.20) and a considerable increase and women. Also, the overall trends of new ex-smokers from 2012.4 to 2013.4 (APC=1054.2) (tables 2, 3 and 4, decreased significantly in Catalonia and the Balearic online supplementary file figure S2). Islands, particularly for men. In addition, the overall The overall standardised new ex-smoker incidence rates per trends of ex-smoker relapse increased in Catalonia and 10 000 inhabitants showed higher values in Catalonia decreased in Navarre, more for women than for men in (range: 110.7–317.6) than in Navarre (range: 48.6–181.0) both cases. and the Balearic Islands (range: 93.7–188.1) (online The trends of smoker prevalence declined throughout supplementary file table S2–S7). The overall trend of new the study and no changes were observed after the imple- ex-smoker incidence rates showed a significant decrease in mentation of the comprehensive SFL. Indeed, the most Catalonia (AAPC=−7.27) and especially in the Balearic significant decrease begins in 2010 in Catalonia (third Islands (AAPC=−11.24). This downward trend was higher quarter) and the Balearic Islands and in 2008 in Navarre, for men than for women in Catalonia and the Balearic prior to the implementation of the comprehensive SFL Islands (tables 2, 3 and 4, online supplementary file (1 January 2011). However, the trend in Catalonia shows figure S2). a drop in the prevalence rate of smokers around the time The overall standardised ex-smoker relapse incidence rates of the implementation of the law. In contrast, trends in per 10 000 inhabitants presented higher values in the Navarre and the Balearic Islands show a more progres- Balearic Islands (range: 103.9–576.6) than in Catalonia sive decline. Comparisons are difficult due to the lack (range: 70.7–334.5) and Navarre (range: 58.6–230.3) of studies on smoking prevalence and incidence from a (online supplementary file table S2–S7). The overall PHC perspective and because some studies evaluate the trend of ex-smoker relapse incidence rates showed significant impact of SFL on smoking prevalence with surveys that Pons-Vigués M, et al. BMJ Open 2019;9:e020120. doi:10.1136/bmjopen-2017-020120 5 6 Table 2 Trends in prevalence of smoking status and incidence of new smokers, ex-smokers and ex-smoker relapse for age-standardised rates. Joinpoints overall and by sex in Catalonia; n=141 071 (2008–2013) Trend 1 Trend 2 Trend 3 Trend 4 Trend 5 AAPC (95% CI) Time APC (95% CI) Time APC (95% CI) Time APC(95% CI) Time APC (95% CI) Time APC (95% CI) 2008.1–2013.4 Smoker prevalence Open access F 2008.1– −0.72* 2010.3– −9.85† 2011.2– −0.53* −1.88‡ 2010.3 (−1.51 to 0.09) 2011.2 (−16.24 to −2.98) 2013.4 (−1.29 to 0.24) (−2.85 to −0.90) M 2008.1– −2.12‡ 2010.3– −8.17‡ 2011.2– −2.93‡ 2012.4– 2.81‡ −2.31‡ 2010.3 (−2.52 to −1.71) 2011.2 (−11.24 to −4.99) 2012.4 (−3.88 to −1.98) 2013.4 (1.47 to 4.17) (−2.83 to −1.79) G 2008.1– −1.71† 2010.3– −6.75† 2011.4– 0.19* −2.18‡ 2010.3 (−2.88 to −0.53) 2011.4 (−10.46 to −2.89) 2013.4 (−1.37 to 1.78) (−3.22 to −1.13) Ex-smoker prevalence F 2008.1– 17.54‡ 2008.4– 11.25‡ 2011.2– 15.73‡ 2012.1– 9.55‡ 2013.1– 0.65* 10.87‡ 2008.4 (12.88 to 22.40) 2011.2 (10.17 to 12.34) 2012.1 (9.03 to 22.85) 2013.1 (5.91 to 13.31) 2013.4 (−2.49 to 3.89) (9.68 to 12.07) M 2008.1– 6.64‡ 2012.4– 4.45§ 4.63‡ 2012.4 (6.01 to 7.30) 2013.4 (−8.23 to −0.51) (3.79 to 5.48) G 2008.1– 16.70† 2008.2– 7.63‡ 2011.1– 9.68‡ 2012.4– −2.34§ 7.19‡ 2008.2 (7.23 to 27.01) 2011.1 (6.96 to 8.30) 2012.4 (8.50 to 10.86) 2013.4 (−4.21 to −0.42) (6.31 to 8.07) New smokers incidence F 2008.1– −10.82§ −10.82§ 2013.4 (−19.17 to −1.59) (−19.17 to −1.59) M 2008.1– −10.53† −10.53† 2013.4 (−16.03 to −4.68) (−16.03 to −4.68) G 2008.1– −10.39† −10.39† 2013.4 (−16.06 to −4.33) (−16.06 to −4.33) New ex-smokers incidence F 2008.1– −4.55* −4.55* 2013.4 (−11.06 to 2.45) (−11.06 to 2.45) M 2008.1– −7.80§ −7.80§ 2013.4 (−13.44 to −1.79) (−13.44 to −1.79) G 2008.1– −7.27§ −7.27§ 2013.4 (−12.89 to −1.29) (−12.89 to −1.29) Ex-smokers relapse incidence F 2008.1– −9.20* 2012.3– 162.73‡ 14.56§ 2012.3 (−18.05 to 1.03) 2013.4 (67.31 to 312.56) (1.65 to 29.11) M 2008.1– −47.47* 2009.3– 115.64* 2010.2– −27.20* 2012.3– 515.1* 2013.2– 77.79* 9.97* 2009.3 (−81.34 to 47.84) 2013.4 (−100 to 1930603) 2012.3 (−44.70 to 1.35) 2013.2 (−80.2 to 18963.4) 2013.4 (−72.27 to 1040) (−64.32 to 238.91) G 2008.1– −8.40§ 2012.3– 200.54‡ 18.60‡ 2012.3 (−15.98 to −0.13) 2013.4 (120.8 to 309.0) (8.50 to 29.64) Note: 2008.1 represents the first trimester of the year 2008 *p>0.05; †p≤0.01; ‡p≤0.001; §p≤0.05. APC, annual percentage change; AAPC, average annual percent change estimated by Joinpoint regression analysis; CI, confidence interval; F, female; G, global; M, male. Pons-Vigués M, et al. BMJ Open 2019;9:e020120. doi:10.1136/bmjopen-2017-020120 Table 3 Trends in prevalence of smoking status and incidence of new smokers, ex-smokers and ex-smoker relapse for age-standardised rates. Joinpoints overall and by sex in Navarre; n=73 644 (2008–2013) Trend 1 Trend 2 Trend 3 Time APC (95% CI) Time APC (95% CI) Time APC (95% CI) AAPC (95 % CI) Smoker prevalence F 2008.1–2013.4 −0.93* (−1.11 to −0.75) −0.93* (−1.11 to −0.75) M 2008.1–2013.4 −1.95* (−2.09 to −1.81) −1.95* (−2.09 to −1.81) G 2008.1–2013.4 −1.44* (−1.59 to −1.28) −1.44* (−1.59 to −1.28) Ex-smoker prevalence F 2008.1–2008.4 35.81* (25.56 to 46.90) 2008.4–2012.2 16.50* (15.45 to 17.56) 2012.2–2013.4 10.66* (8.31 to 13.06) 17.30* (15.88 to 18.67) M 2008.1–2009.2 25.93* (20.68 to 31.41) 2009.2–2012.4 13.90* (12.85 to 14.97) 2012.4–2013.4 9.32* (5.21 to 13.59) 15.59* (14.24 to 16.95) G 2008.1–2008.4 34.30* (24.61 to 44.74) 2008.4–2012.2 15.80* (14.78 to 16.83) 2012.2–2013.4 10.68* (8.41 to 12.99) 16.67* (15.35 to 18.01) New smokers incidence Pons-Vigués M, et al. BMJ Open 2019;9:e020120. doi:10.1136/bmjopen-2017-020120 F 2008.1–2013.4 −9.43† (−15.95 to −2.75) −9.43† (−15.95 to −2.75) M 2008.1–2013.4 −9.40‡ (−14.96 to −3.48) −9.40‡ (−14.96 to −3.48) G 2008.1–2013.4 −9.49* (−14.31 to −4.40) −9.49* (−14.31 to −4.40) New ex-smokers incidence F 2008.1–2013.4 −9.67‡ (−15.05 to −3.96) −9.67‡ (−15.05 to −3.96) M 2008.1–2013.4 −2.83§ (−8.94 to 3.70) −2.83§ (−8.94 to 3.70) G 2008.1–2013.4 −5.01§ (−10.74 to 1.09) −5.01§ (−10.74 to 1.09) Ex-smoker relapse incidence F 2008.1–2013.4 −13.85‡ (−20.68 to −6.42) −13.85‡ (−20.68 to −6.42) M 2008.1–2013.4 −11.77† (−18.33 to −4.69) −11.77† (−18.33 to −4.69) G 2008.1–2013.4 −11.42* (−16.95 to −5.51) −11.42* (−16.95 to −5.51) *p≤0.001; †p≤0.05; ‡p≤0.01; §p>0.05 Note, 2008.1 represents the first trimester of the year 2008. APC, annual percentage change; AAPC, average annual percent change estimated by Joinpoint regression analysis; CI, confidence interval; F, female; G, global; M, male. Open access 7 8 Open access Table 4 Trends in prevalence of smoking status and incidence of new smokers, ex-smokers and ex-smoker relapse for age-standardised rates. Joinpoints overall and by sex in the Balearic Islands; n=178 251 (2010–2013) Trend 1 Trend 2 Trend 3 Time APC (95% CI) Time APC (95% CI) Time APC (95% CI) AAPC (95 % CI) Smoker prevalence F 2010.2–2013.4 −1.20* (−1.40 to −1.01) −1.20* (−1.40 to −1.01) M 2010.2–2012.4 −2.73* (−2.93 to −2.54) 2012.4–2013.4 −1.39† (−2.16 to −0.65) −2.35.* (−2.58 to −2.12) G 2010.2–2012.4 −2.19* (−2.33 to −1.89) 2012.4–2013.4 −0.86 ‡ (−1.90 to 0.18) −1.75* (−2.05 to −1.46) Ex-smoker prevalence F 2010.2–2012.1 26.19* (25.24 to 27.15) 2012.1–2013.4 13.18* (12.46 to 13.91) 19.51* (18.99 to 20.03) M 2010.2–2012.1 15.82* (14.04 to 17.62) 2012.1–2013.4 7.44* (5.37 to 9.56) 12.15* (10.96 to 13.36) G 2010.2–2012.2 19.29* (18.34 to 20.24) 2012.2–2013.4 9.43* (8.37 to 10.50) 14.96* (14.34 to 15.59) New smokers incidence F 2010.2–2012.4 −46.09† (−60.51 to −26.40) 2012.4–2013.4 1370.6† (169.9 to 7913.0) 38.65‡ (−13.24 to 121.58) M 2010.2–2012.4 −44.29§ (−64.78 to −11.87) 2012.4–2013.4 610.8† (98.1 to 2530.4) 15.32‡ (−25.52 to 78.56) G 2010.2–2012.4 −46.20† (−60.28 to −27.12) 2012.4–2013.4 1054.2† (222.2 to 4034.8) 29.19‡ (−11.04 to 87.61) New ex-smokers incidence F 2010.2–2013.4 −11.68§ (−19.32 to −3.31) −11.68§ (−19.32 to −3.31) M 2010.2–2013.4 −10.94§ (−20.39 to −0.38) −10.94§ (−20.39 to −0.38) G 2010.2–2013.4 −11.24† (−18.61 to −3.21) −11.24† (−18.61 to −3.21) Ex-smokers relapse incidence F 2010.2–2012.1 −33.75† (−47.83 to −15.88) 2012.1–2013.1 47.37‡ (−75.08 to 771.40) 2013.1–2013.4 −89.71‡ (−99.7 to 313) −44.15‡ (−74.54 to 22.53) M 2010.2–2013.4 −36.30* (−44.63 to −26.72) −36.30* (−44.63 to −26.72) G 2010.2–2013.2 −18.19* (−23.60 to −12.40) 2013.2–2013.4 −95.73‡ (−99.99 to 1380.5) −46.35‡ (−74.32 to 12.09) *p≤0.001; †p≤0.01; ‡p>0.05; §p≤0.05. Note, 2010.1 represents the first trimester of the year 2010. APC, annual percentage change; AAPC, average annual percent change estimated by Joinpoint regression analysis; CI, confidence interval; F, female; G, global; M, male. Pons-Vigués M, et al. BMJ Open 2019;9:e020120. doi:10.1136/bmjopen-2017-020120 Open access use different methodologies. Two studies that analysed SFL on the incidence of new smokers. However, our data data from surveys of the general population19 20 did not show a continuation in the trend observed in Pinilla’s find a significant decrease in the prevalence of smokers study35 on the impact of the partial law. after the Spanish comprehensive law. In contrast, Lidón The incidence trend in new ex-smokers declined grad- et al24 showed that after the implementation of both ually throughout the study period in Catalonia and the Spanish SFLs, a significant decrease was observed in the Balearic Islands. While the literature to date lacks data on smoking prevalence (from 34.5% to 26.1%, prevalence the effect of the SFL on the incidence of new ex-smokers, ratio=0.76, p<0.001) of people 16 years of age and older it provides some information on prevalence. In this living in Barcelona surveyed in 2004–2005 and followed up respect, one study on the Spanish partial SFL observed in 2013–2014. In addition, National Health Survey data an increase of 8% between 2006 and 2011 in the rate of from the 1987–2005 period revealed an annual average cessation among adult smokers (age 21 years and older) absolute decline of 1.0% in the prevalence of male according to data from the National Health Survey.35 In smokers, whereas women showed an annual average Luxembourg, smoking cessation attributed to the SFL absolute increase in prevalence of 0.2%. Between 2006 was higher among daily smokers with a higher socio- and 2014, the prevalence of smokers declined annually by economic status.8 In our cohort, we observed apparent 0.7% in men and 0.5% in women.23 Although the values random increases and declines in the adjusted rates in of the current study are higher, the steeper decline in the the three regions throughout the study. prevalence of smokers in men agree with these data.23 The incidence trend in ex-smoker relapses increased in Also, one study that estimated the effect of the Spanish Catalonia and declined in Navarre constantly throughout SFL for the 2012–2025 period predicted a decrease in the whole period, particularly for women, but the overall smoking prevalence in all age groups and for both sexes, trend remained stable in the Balearic islands (most likely except for women aged 40–64 years.30 because of the shorter study period). However, the liter- Concomitantly with the decline in the prevalence ature presents conflicting results regarding smoking trends in smokers, a constant increase of prevalence relapse. One study on the partial Spanish SFL observed trends in ex-smokers was observed in the three regions. that most people who had succeeded in giving up smoking Other studies failed to note a significant change in the in 2006 had not relapsed by 2009.34 On the other hand, prevalence of ex-smokers after the comprehensive SFL: a quasi-experimental study conducted in USA observed a difference of only 0.3% between 2007 and 2 011,20 and that relapse was similar between employees in workplaces a non-significant increase of 3.3% between 2006 and with SFL and employees where smoking was permitted.36 2011.19 In agreement with a recent evidence review,23 we In contrast, Shang found that comprehensive SFL in bars observed a higher increase in the trend of ex-smokers significantly deters smoking relapse among people aged prevalence in women. This review showed that the rate 21 years and older.37 According to Buczkowski et al,38 the of smoking cessation in men increased 0.9% annually main reasons for relapse are stress, missing the pleasure during the 1987–2014 period, and 1.5% in women after obtained from smoking and the smoking environment. the partial SFL came into force. The later incorpora- Other factors not analysed in our study that might influ- tion of women to smoking might explain these gender ence relapse rates could explain the variations between differences. We should underscore that other studies regions, for instance living with other smokers, being that use health surveys as an information source have a enrolled in work or clinics cessation programmes,39 or higher prevalence of ex-smokers than the prevalence we the region-specific complementary measures to the SFL obtained in this study, especially for Navarre and the Bale- (for instance, Foral Law 6/2003,40 of smoking preven- aric Islands.31 This discrepancy could be explained by the tion, protection from secondhand tobacco smoke and misclassification of long-term ex-smokers as non-smokers promotion of health with regard to smoking in Navarre). during the process of computerisation of medical records In addition, we should consider the impact of the finan- in the cases where the smoking habit was not sufficiently cial crisis during the study period and the subsequent investigated.32 increase of anxiety and depression in the population.41 In We observed a gradual decline in the new smoker inci- this respect, Navarre was the region with the lowest unem- dence trends in Catalonia and Navarre throughout the ployment rate in Spain according to the 2010 Economi- study period, whereas incidence trends remained stable cally Active Population Survey (unemployment of 11.6% in the Balearic Islands (possibly due to the shorter study in Navarre, versus 18.0% in Catalonia and 22.2% in the period or lower rates). A review by Wilson et al33 of two Balearic Islands). According to the 2009 European Health studies that evaluated smoking initiation reported mixed Survey in Spain, these unemployment figures correlate results, while Guerrero et al34 concluded that the Spanish with the prevalence of chronic depression, which was of partial SFL had no effect on new smokers in 2009. In 3.4% in Navarre versus 5.4% in Catalonia and 7.0% in the contrast, Pinilla and Abásolo35 observed a 6% decrease in Balearic Islands. the rate of smoking initiation among young people after The SFL is a keystone of the WHO Framework Conven- the implementation of the same law, with a more positive tion on Tobacco Control and the MPOWER policy impact in higher socioeconomic strata. We have not found package (M=Monitor; P=Protect; O=Offer; W=Warm; studies that evaluate the impact of the comprehensive E=Enforce; R=Raise).42 The enforcement of Laws 28/2005 Pons-Vigués M, et al. BMJ Open 2019;9:e020120. doi:10.1136/bmjopen-2017-020120 9 Open access and 42/2010 have significantly advanced smoking control knowledge, this study is among the first to show quarterly in Spain, in particular the ‘Protect people from tobacco’ data from EHRs. strategy. However, the remaining MPOWER strategies have been patchily implemented and require further development.23 On balance, a combination of specific, Conclusions feasible, pragmatic, sufficiently funded policies and inter- The introduction of the Spanish comprehensive SFL (Law ventions aimed at populations and individuals is essential 42/2010) does not significantly modify incidence and to achieve progress regarding smoking behaviour. prevalence trends of smoking behaviour in PHC adult patients in Catalonia, Navarre and the Balearic Islands. Limitations and strengths of the study The impact of the comprehensive SFL might have been It is important to take into account that other than the lessened by the effect of the previous implementation law, the pattern of tobacco consumption is influenced by of the partial SFL (Law 28/2005). The current article factors such as health interventions, level of education, provides baseline data for future research into the effec- age, civil status, having children and being unemployed.43 tiveness of this law. In addition to specific factors associ- However, this study only considered age, sex, number of ated with smoking behaviour (such as the price of a pack health problems and number of PHC visits since other of cigarettes or funding of smoking cessation services), variables were not available. In addition, many patients future studies should consider socioeconomic status and were excluded from the study because of lack of baseline age groups. data on smoking (missing data are a common problem in studies based on EHR). In order to prevent bias caused Author affiliations by improved smoking records, we excluded the cases 1 Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi with no information at the beginning of the study. The Gol i Gurina (IDIAPJGol), Barcelona, Spain 2 selection criteria and the longitudinal design aimed to Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Spain 3 Departament d'Infermeria, Universitat de Girona, Girona, Spain maximise the internal validity of the study. Moreover, 4 Centre d'Atenció Primària (CAP) Florida Nord, Institut Català de la Salut (ICS), young people might be under-represented due to their Hospitalet de Llobregat, Barcelona, Spain lower use of PHC services. On the other hand, 70% of the 5 Primary Care Research Unit of Mallorca, Baleares Health services-IbSalut, Palma, population attends PHC services at least once a year and Spain 6 smokers attend more frequently than no smokers.44 In 7 Balearic Islands Health Research Institute (IdISBa), Palma, Spain Equipo de Atención Primaria de Tafalla, Servicio Navarro de Salud, Barasoain, view of the limited length of the study period, particularly Spain in the Balearic Islands, we consider these results a first approximation to be succeeded by follow-up research. Acknowledgements The authors thank all professionals of the 66 PHC teams We should underscore that rather than just comparing who volunteered to participate in the study. The authors also thank Josep M Elorza- two different periods, Joinpoint analysis evaluates longitu- Ricart, Magdalena Rosell-Murphy, Lluís Martínez, Javier Baquedano, Javier Arranz, dinal trends, thus producing a more accurate assessment. Mª Ángeles Nuin and Carlos Martín-Cantera for their collaboration, and Eulàlia Farré for the English translation. This article forms part of the doctoral dissertation The following characteristics of the study were taken into of Yolanda Rando-Matos at the Universitat Autònoma de Barcelona (Department of consideration: scarcity of data prior to the implementa- Medicine of the Autonomous University of Barcelona). tion of the SFL; delayed changes in smoking status; possi- Contributors BB, TR-B, MP-V, JLlB-M and CV-F designed the study and wrote bility of detecting more than one change in smoking the protocol. YR-M, MP-V and JLlB-M conducted literature searches and provided trends; and influence of unanticipated factors. While summaries of previous research studies. BB, JLl, JM, JR and MP-V obtained the data. TR-B and TL-J conducted the statistical analysis. All authors contributed to the other statistical models could have been used, we believe interpretation of the results. YR-M and MP-V wrote the first draft of the manuscript. that Joinpoint is a suitable method to achieve the study All authors read, contributed and approved the final version of the manuscript. objectives, as shown in previous studies.45–47 Funding This project has been funded by the Carlos III Health Institute (Ministry of This study provides useful data on the impact of the Economy and Competitiveness, Spain) with a grant for research projects on health Spanish comprehensive SFL on adult smoking behaviour (PI11/01413) through the Network for Prevention and Health Promotion in Primary in PHC patients. It is crucial to analyse the consequences Care (redIAPP, RD12/0005/0001; RD16/0007/0001), and by European Union ERDF funds. of a public health law on PHC users. PHC has a pivotal role in smoking cessation because it is the gatekeeper of Competing interests None declared. the health services; it is accessible and provides continuity Patient consent for publication Not required. of care to smokers.48 We should also highlight that this Ethics approval This study follows the tenets of the Helsinki Declaration and of study includes the evaluation of novel variables such as Good Clinical Research Practice and has been approved by the Ethical and Clinical Research Committee of the IDIAP Jordi Gol. Confidentiality was guaranteed through incidence of new smokers, new ex-smokers and ex-smoker data encryption and anonymisation in agreement with the data confidentiality Law relapse, which we consider of great relevance in relation 15/1999. to PHC interventions for smoking cessation. Used as Provenance and peer review Not commissioned; externally peer reviewed. a research tool, EHRs portray real life conditions and Data sharing statement No additional data are available. provide comprehensive, long-term health histories from a Open access This is an open access article distributed in accordance with the large population sample, ensure high representativeness Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which and external validity, and minimise potential recall bias. permits others to distribute, remix, adapt, build upon this work non-commercially, The results are only generalisable to PHC users. To our and license their derivative works on different terms, provided the original work is 10 Pons-Vigués M, et al. BMJ Open 2019;9:e020120. doi:10.1136/bmjopen-2017-020120 Open access properly cited, appropriate credit is given, any changes made indicated, and the use the law 28/2005, health measures against smoking]. 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