|Year : 2017 | Volume
| Issue : 5 | Page : 47-53
Effect of a brief smoking cessation intervention on adult tobacco smokers with pulmonary tuberculosis: A cluster randomized controlled trial from North India
Sonu Goel1, Jeyashree Kathiresan2, Preeti Singh3, Rana J Singh4
1 Additional Professor of Health Management, School of Public Health, Postgraduate Institute of Medical Education and Research, Chandigarh, India
2 Assistant Professor, Department of Community Medicine, Velammal Medical College, Madurai, Tamil Nadu, India
3 Project Officer, School of Public Health, Postgraduate Institute of Medical Education and Research, Chandigarh, India
4 Deputy Director, Department of Noncommunicable Diseases, International Union Against Tuberculosis and Lung Diseases, New Delhi, India
|Date of Web Publication||15-Sep-2017|
School of Public Health, Postgraduate Institute of Medical Education and Research, Chandigarh
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: An association between smoking and poor tuberculosis (TB) treatment outcomes has been globally established. Various smoking cessation interventions (SCIs) have been proven worldwide to curb smoking behavior. There is a need for evidence to assess if SCI increases the chance of successful treatment outcome among TB patients. Objectives: To assess the effectiveness of a brief SCI; The Ask, Brief, Cessation support (ABC) package, on treatment outcomes and smoking cessation in smear-positive adult pulmonary TB patients. Methods: A cluster, randomized controlled trial was conducted wherein 17 designated microscopic centers of Chandigarh, India were randomly assigned using a computer-generated randomization sequence to receive SCI within directly observed treatment, short (DOTS) services, or existing standard of care. Eligible and consenting smokers (15 + years) registered as smear-positive pulmonary TB for DOTS (n = 156) between January and June 2013 were enrolled. Smoking cessation (self-reported) was assessed at intervals till the end of treatment. End TB treatment outcomes were extracted from patient records. Results: Treatment success was lower in intervention arm (83.6%) as compared control arm (88.2%), but the difference was statistically insignificant (P = 0.427). Smoking cessation was higher in intervention arm (80.2%) compared to comparison arm (57.5%) (adjusted incidence risk ratio = 1.56; 95% confidence interval = 1.24–1.93; P < 0.0001). Conclusions: SCI is effective in inducing smoking cessation among TB patients. No association of SCI with TB treatment outcomes could be detected.
Keywords: Advice, India, smoking cessation, tobacco control, tuberculosis
|How to cite this article:|
Goel S, Kathiresan J, Singh P, Singh RJ. Effect of a brief smoking cessation intervention on adult tobacco smokers with pulmonary tuberculosis: A cluster randomized controlled trial from North India. Indian J Public Health 2017;61, Suppl S1:47-53
|How to cite this URL:|
Goel S, Kathiresan J, Singh P, Singh RJ. Effect of a brief smoking cessation intervention on adult tobacco smokers with pulmonary tuberculosis: A cluster randomized controlled trial from North India. Indian J Public Health [serial online] 2017 [cited 2019 May 19];61, Suppl S1:47-53. Available from: http://www.ijph.in/text.asp?2017/61/5/47/214909
| Introduction|| |
Tuberculosis (TB) is a leading cause of death worldwide, alongside HIV and was responsible for 1.4 million deaths in 2015. India accounts for more than a quarter of the global TB load. As an established risk factor of TB, tobacco smoking has increased substantially over the past three decades, especially in developing countries. The WHO has strongly recommended coordination between national TB and tobacco control programs. Observational studies have shown association between smoking and poor TB treatment outcomes such as increased loss to follow-up rate, increased severity of disease.,,,,,,, So logically drawing from it, smoking cessation efforts should lead to quitting and thus reduce the incidence of unfavorable TB treatment outcomes.
However, Jeyashree et al. in their systematic review had identified no randomized controlled trials to support the effect of smoking cessation on TB treatment outcomes and had stressed the need for the same. The authors hypothesized that smoking cessation intervention (SCI) would be associated with favorable TB treatment outcomes. Hence, among smear-positive pulmonary TB patients in Chandigarh city, India, the present study aims to assess the effect of SCI on smoking cessation and TB treatment outcomes.
| Materials and Methods|| |
This was a two-arm parallel cluster randomized controlled trial.
The study was carried out in all the seventeen Designated Microscopy Centre (DMC) under three TB units (TUs) of Chandigarh. DMC is a health facility with TB diagnostic facility through sputum smear examination, catering to a population of 50,000–100,000 which is routinely staffed with a medical officer, TB health visitor (TBHV), and a laboratory technician. Cluster randomization technique was used in the study, and the clusters were defined at the DMC level so as to reduce contamination between clinics. DMCs were randomized based on computer-generated block randomization sequence (block size 4) ensuring equal allocation in both arms.
All sputum smear-positive pulmonary TB patients, males and females, aged 15 years and above, registered for treatment under Revised National TB Control Program (RNTCP) in two-quarters (January till June 2013) in various DMCs of Chandigarh were the target population in the study. Among those registered, consenting current and occasional smokers (n = 152) were enrolled into the study. They were followed up till completion of the study period (i.e., December 2013).
TBHV of the intervention DMCs were trained by the investigators to deliver ABC package while those in the control arm continued to provide the existing standards of care for the smokers in their area. Data were collected by two field investigators who were blinded to the allocation of DMCs.
Enrolling tuberculosis patients and classification into smokers and nonsmokers
The smoking history among TB patients was obtained from all smear-positive pulmonary TB patients using a structured questionnaire, and the smokers were thereafter enrolled in the study. Their basic sociodemographic characteristics, prevalence, and smoking history were also obtained.
Follow-up of smokers in two arms
The participants from both arms were followed till the end of 6 months follow-up period. The outcomes for the two arms were analyzed and compared for assessing the effectiveness of the SCI on TB treatment outcomes.
ABC intervention: Ask, brief advice, and cessation support
The intervention by the International Union against TB and Lung Disease (The Union) “Smoking Cessation and Smoke-free Environments for TB Patients 2010” was used in the study. “ABC for TB” is an intervention that guides the health-care provider to Ask about smoking habit, give brief advice on smoking cessation and provide cessation support. It can be delivered by any health-care worker. The intervention is delivered systematically within the existing program activities and can be done within as little as 2–5 min. These services are delivered at the time of registration of the patients and during his/her sputum reexamination visits (2 months, 5 months, end) [Figure 1].
Treatment outcome (as per WHO 2013 revised guidelines)
Treatment outcomes were recorded as treatment success or treatment failed.
Treatment success was a sum of cured (a pulmonary TB patient with bacteriologically confirmed TB at the beginning of treatment who was smear- or culture-negative in the last month of treatment and on at least one previous occasion) and treatment completed (a TB patient who completed treatment without evidence of failure but with no record to show that sputum smear or culture results in the last month of treatment either because tests were not done or because results are unavailable and on at least one previous occasion were negative). Treatment failed was a TB patient whose sputum smear or culture is positive at month 5 or later during treatment.
Smoking cessation was recorded as positive and negative. Smoking cessation was recorded as positive if patient had not smoked at all in the last 2 weeks and negative if patient smoked in the last 2 weeks and did not attempt to quit smoking since their last sputum examination visit (quit attempt was defined patient who tried to quit and succeeded for at least 24 h).
Two key statistical approaches used for the analyses of trial results were “clusterlevel” parametric analysis of summary measures estimated for each cluster and “individual-level” parametric analysis adjusted for clustering at TU level. The intraclass correlation coefficient (ICC) of baseline smoking habit was calculated using Stata (loneway command). At individual-level univariate analysis, Chi-square test was used. Multivariate analyses of incidence risk ratios (IRRs) or simply relative risks for quit of smoking at follow-up in the 2 study arms adjusted for TU-level clustering as well as important covariates were carried out by generalized estimating equations (GEE; using log Poisson as well as binomial regression models with exchangeable correlation and robust variance estimates). The linear mixed model was also used to predict follow-up treatment outcome in the two-study arms adjusted for covariates. Analyses were both per protocol (PP) and intention-to-treat (ITT; latter included all randomized participants). Missing smoking status data on follow-up were imputed by the “last observation carried forward” method. Using two-tailed statistical tests, P < 0.05 was taken as statistically significant. Stata version 11.0 (Lakeway Drive, College Station, TX 77845, USA) was used for analyses.
Appropriate permissions were taken from the State TB cell Chandigarh to access the data of the TB patients. The data were kept confidential with access restricted only to the principal investigator. The trial was ethically approved by the Institute Ethics Committee, PGIMER (Histopath/NK/EC/46-102 DATED 8/1/2013).
| Results|| |
There were a total of 17 clusters (DMCs) with 685 smear-positive pulmonary TB patients enrolled from January to June 2013. Of 685, 152 (22.7%) smokers (current daily and occasional smokers) were enrolled to the study. The smokers were assigned in the intervention (n = 78) and control arm (n = 74). Postintervention status of smoking could not be done in 13.8% (21/152) subjects–16.6% (13/78) in intervention arm and 10.8% (8/74) in comparison arm [Figure 2]. Nonetheless, baseline characteristics did not differ statistically between subjects with and without missing follow-up data (P > 0.05) when analyzed by Chi-square test of significance for each variable separately. The ICC was estimated from a one-way random effects model using the analysis of variance method. The mean sum of squares between TU clusters was 0.304, and mean sum of squares within the centers was 0.170, which resulted in an ICC of 0.019 (95% confidence interval (CI) = 0.00–0.050). The majority of participants were males (96.7%), in the age bracket of 30–44 years (37.9%), educated (70.5%), and having some occupation (97.3%). The baseline characteristics of smokers in intervention and control arm did not differ significantly except for the age [Table 1]. Factors determining nicotine dependence in both arms were found to be statistically insignificant, reflecting similar smoking habits in both arms.
|Table 1: Baseline characteristics of smokers among new smear positive tuberculosis patients registered in tuberculosis units of Chandigarh from January to June 2013|
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Smoking cessation and treatment outcome
Treatment outcome was defined as cured (n = 113), treatment completed (n = 6), treatment failed (failure/on treatment/MDR) (n = 12), died (n = 6), loss to follow-up (n = 7), and not evaluated (n = 8). The intervention group reported 83.6% successful outcomes compared to the control group that reported 88.2% successful outcomes. More adverse outcomes were noted in the intervention (11, 16.4%) as compared to the control group (8, 11.8%), but the difference was not statistically significant (P = 0.427).
To measure the association between quitting and treatment outcomes, regression model was run between the last status of smoking (noted on month 7 or end sputum examination day) and treatment outcome between the two arms. The association between smoking and treatment outcome was done adjusting for age and nicotine dependence variables to exclude the possibility of confounding by these variables. The treatment success was found higher among quitters (74.7%) as compared to smokers (25.2%), the difference was found to be significant (IRR = 1.31; 95% CI = 1.30–1.32; P ≤ 0.0001).
Smoking cessation and intervention
At the end of the treatment, 57 (80.2%) patients in the intervention arm had quit smoking as against 42 (57.5%) in the control arm. After adjusting for confounders such as age, socioeconomic, and nicotine dependence variables [Table 1], the relative risk of quitting on follow-up was significantly higher in the intervention arm as compared to the comparison arm for both PP analysis (adjusted IRR = 1.56; 95% CI = 1.24–1.93; P < 0.0001) and ITT analysis (adjusted IRR = 1.52; 95% CI = 1.19–1.87; P < 0.0001) by GEE analysis with log Poisson regression [Table 2].
|Table 2: Smoking cessation status among intervention and comparison arm using regression model adjusted for clustering and covariates at individual level|
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It was also found that the percentage of quitters were significantly higher in intervention arm (as compared to comparison arm); after first counseling session (P < 0.0001), after second counseling session (P < 0.0001), and after third counseling session and (P = 0.008). Overall, 69.2% (n = 54) of smokers had quit and the quit rate increased progressively from the first follow-up to the end of anti-TB treatment.
| Discussion|| |
This is the first randomized controlled trial conducted in India that investigated the effect of a SCI on tobacco smoking behavior and on the treatment outcomes of new smear-positive pulmonary TB patients. The intervention did not affect the treatment outcome of the patient difference in treatment outcome was found to be insignificant between intervention and control arm. This finding could be due to the fact that for an intervention to bring positive treatment outcome, the total time spent for each session should be relatively more. This idea can be verified with the finding from a study done in Rio de Janeiro, Brazil, which stated that a dose–response relationship exists between the length of a session by person-to-person contact and successful treatment outcomes. Repeated brief cessation advice has been shown to be a feasible and inexpensive addition to routine TB case management in this study and others. Basu et al. had also concluded that in spite of evidence that tobacco control may be highly relevant to the future control of TB; such control has not been integrated into most TB control programs.
We also found that the smokers who received SCI were more likely to quit smoking as compared to those who received standard advice on smoking in TB case management under RNTCP. The findings observed in our study with respect to smoking cessation are consistent with other studies conducted in Bangladesh (82%), Indonesia (66.8%), Sudan (67%), and Malaysia (78%) which has also showed increase in quit percent in TB patients by simplified SCI.,,, A study conducted on TB patients in Kerala, India observed that almost one-third patients relapsed among the quitters during the first 4–8 weeks of treatment, unlike our study which had zero relapse during intervention. The high quit rate and absence of relapse during the entire course of treatment in our study may have occurred due to many reasons. First, standardized cessation intervention supplemented with adequate training support to existing health force may have led to positive outcomes in our study. Second, person-to-person delivery of intervention for four or more sessions appeared to be especially effective in increasing abstinence rates. A study in Brazil has also documented that minimal interventions lasting <3 min increases overall tobacco abstinence rates.
A study by Kaur et al. conducted in India found that by offering “brief advice” for tobacco cessation based on five A's approach advocated by the WHO and the Union, resulted in a quit percentage of 67.3% among smokers at the end of 6 months treatment period from baseline. A cohort of newly diagnosed TB cases was followed up from their discharge after completion of treatment, and it was found that smoking was associated with the relapse of TB with odds ratio = 2.53 (95% CI: 1.23–5.21), even after adjustment for the socioeconomic variables. Although there is lack of evidence on the direct effects of smoking cessation on TB treatment outcomes, available data suggest that smokers are less adherent to TB treatment, and thus at higher risk for default and persistent infectivity.,
We found that there was not much difference observed in the percentage of quitters from month 5 till the end of treatment in the intervention arm. This could be because of the fact that repeated reinforcements on quitting are most effective during the initial period of treatment. None of the sociodemographic factors contributed as a factor to quit smoking which is unlike the findings of many other studies where high socioeconomic status, high family income, literacy, and sex are potential determinates for quit attempts of tobacco.,,
The treatment success was found to be higher among quitters (74.7%) as compared to smokers (25.2%) in the present study; the difference was found to be significant. Merely, one study documented that advising patients with TB to stop smoking also help them to complete their TB treatment and to respond better to that treatment.
The study was conducted under routine program conditions, and the wide coverage with disaggregated data of patients registered in RNTCP of an entire Union Territory makes the study conditions representative of programmatic conditions in India. Second, the study used robust methodology, which included predefined operational definitions for the study population and variables, and also adhered to CONSORT guidelines for conducting and reporting on randomized controlled trials. Third, involvement of health workers throughout the treatment of patients helped in sustenance of smoking cessation care within RNTCP. The intervention is not time or resource intensive as it can be done by existing health-care staff in routine settings. All health centers were located in the community which made the informal visits of health workers to monitor progress easier.
In intervention arm, we approached family members to ascertain whether patient quit smoking or not, however in control arm we just relied on the response of the patient. This may be the reason of over reporting of quit percent in control arm. Smokeless tobacco users were excluded from the study. While the sample size was adequate to detect an association between SCIs and smoking cessation, the power of the study to detect an existing association between SCI and TB treatment outcome was small.
| Conclusions|| |
Interventions such as “ABC intervention” that are based on the principal of stepped approach of health education have proved to be useful in reducing smoking practices among smokers and should be recommended as a part of national TB control programs.
Financial support and sponsorship
The study was supported by North Zonal Task Force on Tuberculosis, India.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2]