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Action to Stop Smoking in Suspected Tuberculosis (ASSIST) in Pakistan: A Cluster Randomized, Controlled Trial

Kamran Siddiqi, PhD; Amir Khan, PhD; Maqsood Ahmad, MPhil; Omara Dogar, MPH; Mona Kanaan, PhD; James N. Newell, PhD; and Heather Thomson, BA
[+] Article and Author Information

From University of York and Hull York Medical School, York, United Kingdom; Association for Social Development, Islamabad, Pakistan; and University of Leeds and NHS Leeds, Leeds, United Kingdom.

Acknowledgment: The authors thank Donald Hedeker (Professor of Biostatistics, University of Illinois, Chicago, Illinois) for his help in statistical data analysis and Robert West (Professor of Health Psychology, University College, London, United Kingdom) and Najma Siddiqi (Consultant Psychiatrist, Bradford District Care Trust, Saltaire, United Kingdom) for reading and providing helpful edits to the manuscript.

Grant Support: By grant 104825-002 from the International Development Research Centre.

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-1351.

Reproducible Research Statement: Study protocol: Available at www.biomedcentral.com/1471-2458/10/160. Statistical code: Available from Dr. Siddiqi (e-mail, kamran.siddiqi@york.ac.uk). Data set: Available from Dr. Siddiqi (e-mail, kamran.siddiqi@york.ac.uk) after written agreements.

Requests for Single Reprints: Kamran Siddiqi, PhD, Hull York Medical School, University of York, Seebohm Rowntree Building, York YO10 5DD, United Kingdom; e-mail, kamran.siddiqi@york.ac.uk.

Current Author Addresses: Drs. Siddiqi, Dogar, and Kanaan: University of York, Seebohm Rowntree Building, York YO10 5DD, United Kingdom.

Drs. Khan and Ahmad: Association for Social Development, House 12, Street 48, F/7 4, Islamabad, Pakistan.

Dr. Newell: Nuffield Centre for International Health and Development, Leeds LS2 9LJ, United Kingdom.

Ms. Thomson: NHS Leeds, North West House, West Park Ring Road, Leeds, United Kingdom.

Author Contributions: Conception and design: K. Siddiqi, A. Khan, H. Thomson.

Analysis and interpretation of the data: K. Siddiqi, A. Khan, M. Ahmad, O. Dogar, M. Kanaan, J.N. Newell.

Drafting of the article: K. Siddiqi, A. Khan, M. Ahmad, O. Dogar, M. Kanaan, J.N. Newell, H. Thomson.

Critical revision of the article for important intellectual content: K. Siddiqi, A. Khan, M. Ahmad, O. Dogar, M. Kanaan, J.N. Newell.

Final approval of the article: K. Siddiqi, A. Khan, M. Ahmad, O. Dogar, M. Kanaan, J.N. Newell.

Provision of study materials or patients: K. Siddiqi, A. Khan, M. Ahmad, H. Thomson.

Statistical expertise: M. Kanaan, J.N. Newell.

Obtaining of funding: K. Siddiqi, A. Khan.

Administrative, technical, or logistic support: K. Siddiqi, A. Khan, H. Thomson.

Collection and assembly of data: A. Khan, M. Ahmad, O. Dogar.


Ann Intern Med. 2013;158(9):667-675. doi:10.7326/0003-4819-158-9-201305070-00006
Text Size: A A A

Background: Tobacco use is responsible for a large proportion of the total disease burden from tuberculosis. Pakistan is one of the 10 high-burden countries for both tuberculosis and tobacco use.

Objective: To assess the effectiveness of a behavioral support intervention and bupropion in achieving 6-month continuous abstinence in adult smokers with suspected pulmonary tuberculosis.

Design: Cluster randomized, controlled trial. (Current Controlled Trials: ISRCTN08829879)

Setting: Health centers in the Jhang and Sargodha districts in Pakistan.

Patients: 1955 adult smokers with suspected tuberculosis.

Intervention: Health centers were randomly assigned to provide 2 brief behavioral support sessions (BSS), BSS plus 7 weeks of bupropion therapy (BSS+), or usual care.

Measurements: The primary end point was continuous abstinence at 6 months after the quit date and was determined by carbon monoxide levels in patients. Secondary end points were point abstinence at 1 and 6 months.

Results: Both treatments led to statistically significant relative risks (RRs) for abstinence compared with usual care (RR for BSS+, 8.2 [95% CI, 3.7 to 18.2]; RR for BSS, 7.4 [CI, 3.4 to 16.4]). Equivalence between the treatments could not be established. In the BSS+ group, 275 of 606 patients (45.4% [CI, 41.4% to 49.4%]) achieved continuous abstinence compared with 254 of 620 (41.0% [CI, 37.1% to 45.0%]) in the BSS group and 52 of 615 (8.5% [CI, 6.4% to 10.9%]) in the usual care group. There was substantial heterogeneity of program effects across clusters.

Limitations: Imbalances in the urban and rural proportions and smoking habits among treatment groups, and inability to confirm adherence to bupropion treatment and validate longer-term abstinence or the effect of smoking cessation on tuberculosis outcomes.

Conclusion: Behavioral support alone or in combination with bupropion is effective in promoting cessation in smokers with suspected tuberculosis.

Primary Funding Source: International Development Research Centre.

Figures

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Figure 1.

Study flow diagram.

BSS = behavioral support sessions; BSS+ = behavioral support sessions plus 7 wk of bupropion therapy.

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Figure 2.

Empirical Bayes estimates (random-effects) for health centers.

Substantial heterogeneity was seen across centers in their relative rates (empirical Bayes estimates) of achieving the primary outcome. In general, centers assigned to the control group had lower-than-average success rates (relative risk 1). However, some control centers (HC 29 and HC 33) were able to achieve abstinence rates similar to those of the best BSS and BSS+ centers. Furthermore, some BSS (HC 12, HC 08, and HC 07) and BSS+ (HC 20 and HC 06) centers were not statistically better than the 5 worst control centers. BSS = behavioral support sessions; BSS+ = behavioral support sessions plus 7 wk of bupropion therapy; HC = health center.

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