INT J TUBERC LUNG DIS 19(2):237–243 Q 2015 The Union http://dx.doi.org/10.5588/ijtld.14.0615
Tuberculosis patients learning about second-hand smoke (TBLASS): results of a pilot randomised controlled trial N. Safdar,* R. Zahid,* S. Shah,† R. Fatima,‡ I. Cameron,§ K. Siddiqi† *Social and Health Inequalities Network (SHINe), Islamabad, Pakistan; †Department of Health Sciences, University of York, UK; ‡National TB Programme, Islamabad, Pakistan; §Leeds City Council, Leeds, UK SUMMARY B A C K G R O U N D : Passive smoking is associated with tuberculosis (TB). Measures are required to protect non-smoking TB patients from second-hand smoke (SHS). S E T T I N G : We developed a behavioural intervention to encourage TB patients to implement smoking restrictions at home in Pakistan. O B J E C T I V E S : To assess the likelihood of such an intervention being successful and to inform a definitive trial in future. D E S I G N : This was a pilot randomised controlled trial in which non-smoking TB patients were randomised to receive either individual-based support or individualbased support combined with family reminders. We recruited patients living with at least one smoker in their homes. Our primary outcome was urinary cotinine level
as a measure of SHS exposure 2 months post-randomisation. R E S U LT S : Of 273 patients assessed for eligibility, 150 (56%) patients were recruited and all but one were retained throughout the trial. A statistically significant absolute reduction was observed in non-smoking participants’ exposure to SHS based on urinary cotinine levels in both Arm 1 (71%, 95%CI 61–79) and Arm 2 (76%, 95%CI 67–83) between baseline and follow-up at 2 months. C O N C L U S I O N S : The recruitment and retention rates for trial participants make it feasible to conduct a definitive trial in future. The observed effect size makes it worthwhile to conduct such a trial. K E Y W O R D S : tuberculosis; passive smoking; tobacco; smoke-free homes
SMOKING INCREASES THE RISK of acquiring tuberculous infection and developing tuberculosis (TB) disease.1,2 In those with established TB, smoking leads to poor outcomes, death and recurrence.1,3–5 Furthermore, TB transmission is higher in smoking households than in those with smoking restrictions.6 For passive smoking, evidence based on a relatively small number of observational studies suggests that second-hand smoke (SHS) exposure is also likely to be associated with TB.7,8 In countries with high TB incidence and high smoking rates, the association between smoking (active and passive) and TB accounts for a substantial disease burden. It has been suggested that smoking will lead to an extra 18 million TB cases and 40 million TB deaths between 2010 and 2050.9 Unfortunately, these colliding epidemics have so far been addressed entirely independently through distinct programmes. Integrating tobacco control interventions within TB control offers a great opportunity to reduce their interactive disease burden. For active smoking, the World Health Organiza-
tion (WHO) and the International Union Against Tuberculosis and Lung Disease (The Union) suggest offering cessation support to those TB patients who smoke, as part of their TB treatment.10,11 This has been shown to be successful in achieving smoking abstinence when offered by TB programme health care workers.12 For passive smoking, most countries have introduced comprehensive smoking bans in enclosed public and work places. This has significantly reduced exposure to SHS and its associated mortality and morbidity in countries where these bans are strictly enforced.13 However, for most nonsmoking women and children, homes and cars remain likely places for SHS exposure. Moreover, in many low- and middle-income countries where TB is common, smoking bans are only partially implemented. Additional measures are therefore required to protect non-smokers, particularly women, children and other vulnerable groups (such as TB patients), from SHS. In this regard, The Union recommends smoke-free homes and expects TB health care workers to advise patients to negotiate smoking
Correspondence to: Kamran Siddiqi, Department of Health Sciences, University of York, UK. Tel: (þ44) 79 7054 4872. Fax: (þ44) 19 0432 1335. e-mail: [email protected] Article submitted 18 August 2014. Final version accepted 8 October 2014.
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restrictions at home with co-residing smokers.11 However, our literature search did not find any empirical studies on interventions that encourage TB patients to do so. Our eventual aim is to assess the effectiveness of behavioural interventions that encourage TB patients to implement smoking restrictions at homes and protect them from SHS. Pakistan is a suitable place for such a study, as it has one of the highest TB burdens worldwide, with approximately 400 000 incident cases annually,14 and tobacco use is also highly prevalent in Pakistan.15 Passive smoking is also common, with more than half of the population exposed to SHS.15,16 This happens because there are no restrictions on smoking indoors; 91.6% of pregnant women reported allowing smoking in their homes.17 We conducted a pilot trial of a behavioural intervention to encourage TB patients to implement smoking restrictions at home in Pakistan. Our intention was to assess the likelihood of such an intervention being successful and to inform the methods for a definitive trial in future.
METHODS A detailed trial protocol is published elsewhere.18 A summary is presented here. Study design This was a two-arm pilot individual randomised controlled trial. Settings The trial was conducted in two public sector hospitals in Rawalpindi and Sialkot Districts. Both had a designated TB out-patient facility and were endorsed by the National TB Programme as basic management units for TB control. Participants All non-smoking pulmonary TB cases living with one or more smokers were eligible. Pulmonary TB cases were defined as those with a new, definitive and firm diagnosis, either sputum-negative or -positive, and registered to receive anti-tuberculosis treatment. Patients aged ,10 years, with recurrent TB, residing outside the study districts and those who had received anti-smoking educational interventions in the past were excluded.
resource by a TB health care worker during a 20 min consultation with a TB patient at the time of diagnosis and another 10 min consultation after a month. The first consultation was aimed to provide information on the harms associated with SHS exposure for TB patients and to help them negotiate smoking restrictions at home with co-residing smokers. The second consultation was to address any barriers, including intrapersonal (nicotine addiction) and interpersonal barriers (smoker’s attitude) and those related to physical environment (lack of outside space) encountered in sustaining smoke-free homes. Based on the taxonomy of behavioural change techniques,19 the intervention was expected to improve knowledge, change attitude, enhance motivation, build confidence and negotiation skills, and increase intention to act with further reinforcement at follow-up (see Appendix Table*). The intervention acted at two levels: first at the interface between the health care worker and the non-smoking patient, and second between the patient and the co-residing smoker(s). All participants received an illustrative leaflet to stimulate conversation with the co-residing smoker(s) on making their homes smoke free. Family reminders While the onus of individual-based support is placed on TB patients to start the relevant conversations and bring about change, family reminders were designed to directly address the co-residing smokers. These consisted of eight short message service (SMS) messages (statements) sent to the co-residing smoker(s) on a weekly basis over 8 weeks. Mapped on behaviour change techniques, these messages were designed to enhance knowledge, change attitude and increase intention to act. Family reminders were expected to influence behaviour change directly, and were hypothesised to have an added effect when coadministered with individual-based support.
Interventions All eligible and consenting participants were randomised to receive either individual-based support or individual-based support plus family reminders.
Randomisation and allocation Participants were randomly assigned to one of the two treatment conditions using a computer-generated allocation sequence. The system generated a permuted simple randomisation list for each site. For every consenting participant, a research assistant based at the respective site first collected some baseline information and then phoned the research office to allocate a numeric trial code from the allocation sequence. All trial patients in Arms 1 and 2 received individual-based support at the hospital. In addition, those allocated to Arm 2 received ‘family reminders’. Both research assistants were blinded to the alloca-
Individual-based support Individual-based support was a behavioural intervention delivered face-to-face using an educational
* The appendix is available in the online version of this article, at http://www.ingentaconnect.com/content/iuatld/ijtld/2015/ 00000019/00000002/art00020
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Figure Trial flow chart.
tion and the primary outcome results until the trial database was locked at the end of the study.
ments were taken at baseline and at 1 and 2 months follow-up after randomisation.
Outcome measurements and follow-ups The primary outcome was participants’ exposure to SHS measured by urinary cotinine levels collected both at baseline and at 2-month follow-up after randomisation. Cotinine testing was carried out by a laboratory technician who received relevant training in conducting and interpreting the test. The test involved dipping an Accutestw NicAlertTM (Jant Pharmacal Corp, Encino, CA, USA) strip in a urine sample and reading the colour change in one of the zones (levels 0–6) on the strip. An absolute reduction in exposure would mean a change from level 1 or above down to level 0. The secondary outcomes included self-reported change in the number of homes where smoking restrictions resulted in smokers (residents and visitors) smoking: 1) only outside the home; 2) in one room only; 3) not in the presence of children; and 4) not in the presence of TB patients. TB clinical outcomes were also recorded from TB registers kept routinely within the designated TB facilities. These included a proportion of patients 1) who were cured, i.e., a smear-positive case becoming smear-negative in the last month of treatment and on at least one previous occasion; 2) who completed treatment; 3) who defaulted, i.e., whose treatment was interrupted for 72 consecutive months; 4) who died due to any cause; 5) who failed, i.e., who were initially smearpositive and who remained smear-positive at month 5 or later during treatment; and 6) who transferred out to another reporting unit and for whom the treatment outcome is not known. All self-reported measure-
Analysis All analyses were conducted using SAS v.9.3 statistical software (Statistical Analysis System, Cary, NC, USA) on an intention-to-treat basis, including all randomised participants. Summaries of the baseline characteristics of the participants are presented by trial arm. Although determining differences in the primary outcome between the two arms was not the primary purpose of this study, a comparison was undertaken to investigate the feasibility of studying this measurement and to calculate an estimate for the likely effect size. Ethical clearance for the trial was sought from the National Bioethics Committee of the Pakistan Medical and Research Council, Islamabad, Pakistan and the University of York, York, UK.
RESULTS Recruitment and retention The flow of the trial participants is presented in a CONSORT (Consolidated Standards Of Reporting Trials) diagram (Figure).20 Recruitment took place between November 2012 and May 2013. Of 2782 individuals presumed to have TB, 506 (18%) were diagnosed with pulmonary TB at the two sites. With one research assistant at each site, we could only assess 54% (273/506) of these patients for eligibility. Of those assessed for eligibility, 44% (122/273) were not recruited because they either did not live with a smoker or they smoked themselves. Of those eligible, we recruited 99% (150/151) of patients, with only one refusing to participate for personal reasons. The
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Table 1
Baseline characteristics of trial participants
Characteristic TB patient Total, n Mean age 6 SD, years
Arm 1: individual-based Arm 2: individual-based support only support þ family reminders n/N (%) n/N (%) P value 75 33 6 17
75 31 6 16
Sex Male Female
21/74 (28) 53/74 (72)
25/75 (33) 50/75 (67)
Education No formal schooling Formal education
29/74 (39) 45/74 (61)
25/75 (33) 50/75 (67)
Occupation Housewife Office worker Student Others‡
37/74 5/74 15/74 17/74
32/75 2/75 11/75 30/75
TB type§ Smear-positive Smear-negative
31/73 (42) 42/73 (58)
41/75 (55) 34/75 (45)
Co-habiting smoker(s) Total, n Mean age 6 SD
90 51 6 17
89 50 6 16
84/90 (92) 6/90 (8)
85/89 (96) 4/89 (4)
74/90 (82) 11/90 (12) 5/90 (6)
72/89 (82) 12/89 (13) 5/89 (5)
40/78 (51) 38/78 (49)
36/77 (47) 41/77 (53)
Number of rooms 1 .1
6/74 (8) 68/74 (92)
4/75 (5) 71/75 (95)
Number of smokers 1 .1
61/74 (82) 13/74 (18)
65/75 (87) 10/75 (13)
Sex Male Female Type of smoking Cigarettes only Hookah only Cigarette þ others (e.g., hookah) Number of cigarettes smoked/day ,10 .10
0.47* 0.59
0.5
0.12† (50) (7) (20) (23)
(43) (3) (15) (40) 0.14
0.74* 0.52
1
0.573
Household 0.53
0.5
* Paired t-test used to compare means. † Some cells have expected count less than 5. Fisher’s exact test was applied. ‡ Includes unemployed, self-employed, farmer, trader, labourer. § Data missing for two observations in Arm 1. TB ¼ tuberculosis; SD ¼ standard deviation.
non-smoking trial participants were predominantly females (68%) and younger (mean age 32.2 years), compared to mostly male (94%) and older (mean age 51 years) co-habiting smokers (Table 1). We retained all but one participant in each arm at 2 months follow-up. Four participants (1 in Arm 1 and 3 in Arm 2) subsequently died due to TB post follow-up but before the end of their 6-month anti-tuberculosis treatment. Allocation and treatment adherence Simple randomisation resulted in equal allocation, i.e., 75 participants in each arm. In Arm 1 (individualbased support only), 99% (74/75) of participants received the intervention, while in Arm 2, 100% (75/ 75) received individual-based support and family reminders. Both trial arms were balanced for all
confounders, including age and sex of non-smoking participants, and age, sex and smoking behaviour of co-habiting smokers (Table 1). Feasibility of measuring end points We measured (and interpreted) urinary cotinine levels among all participants at baseline and those we were able to follow up. However, among four participants at baseline, the cotinine levels were indicative of either active smoking or smokeless tobacco use. Given that we excluded those with high carbon monoxide measurements, this is likely to be due to smokeless tobacco use. TB outcome data were obtained in all but one patient in Arm 1. Likewise, information on smoking behaviour in the house, smoking in the presence of children and TB patients
TB and second-hand smoke
Table 2
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Outcomes and their effect sizes before and after the intervention Baseline
Outcome
Trial arms*
Follow-up
Total n/N
% (95%CI)
Total, n/N
% (95%CI)
Reduction in exposure % (95%CI)
74/75 75/75
99 (93–100) 100
21/75 18/75
28 (18–38) 24 (16–35)
71 (61–79) 76 (67–83)
17 (11–28) 9 (5–18)
69/74 69/75
93 (85–97) 92 (84–92)
76 (67–83) 83 (74–89)
82 (72–89) 83 (73–90)
0/74 6/75
0 8 (4–16)
82 (73–88) 75 (66–82)
55 (44–66) 49 (38–60)
1/74 3/75
1 (0.2–7) 4 (1–11)
54 (44–63) 45 (36–55)
55 (44–66) 49 (38–60)
1/74 3/75
1 (0.2–7) 4 (1–11)
55 (45–64) 45 (36–55)
Primary outcome Exposure to SHS† Arm 1 Arm 2
Secondary outcomes: smoking behaviour Smoking outside house Arm 1 13/74 Arm 2 7/75 Smoking in the presence of children Arm 1 61/74 Arm 2 62/75 Resident smoking in the presence of the patient Arm 1 41/74 Arm 2 37/75 Visitor smoking in the presence of the patient Arm 1 41/74 Arm 2 37/75
Secondary outcomes: tuberculosis‡ (assessed 6 months post-randomisation) Cured Arm 1 Arm 2 Treatment completed Arm 1 Arm 2 Defaulted Arm 1 Arm 2 Died Arm 1 Arm 2 Transferred out Arm 1 Arm 2
22/74 30/75
30 (19.3–40.1) 41 (28.9–51.1)
45/74 38/75
61 (49.7–71.9) 51 (39.3–61.9)
5/74 2/75
7 (1.03–12.5) 3 (0.3–9.3)
1/74 3/75
1 (0–3.9) 4 (0–8.4)
1/74 1/75
1 (0–3.9) 1 (0–3.9)
* Arm 1 ¼ individual-based support only; Arm 2 ¼ individual-based support þ family reminders. † Urinary cotinine level 0 ¼ no exposure; level 71 ¼ SHS exposure. ‡ One case in Arm 2 had no treatment outcome documented. CI ¼ confidence interval; SHS ¼ second-hand smoke.
was only missing for one participant at baseline and for three at follow-up. Effect sizes A statistically significant absolute reduction was observed in non-smoking participants’ exposure to SHS, both in Arm 1 (71%, 95%CI 61–79) and Arm 2 (76%, 95%CI 67–83) between baseline and on follow-up at 2 months (Table 2). Among secondary outcomes, post-intervention change was observed as the co-habiting smokers began to smoke outside the home (76% [95%CI 67–83] and 83% [95%CI 74– 89] absolute increase in Arm 1 and Arm 2, respectively) and not in the presence of children (82% [95%CI 73–88] and 75% [95%CI 66–82] absolute reduction in Arm 1 and Arm 2, respectively). There was also a modest but significant reduction in smoking in the presence of non-smoking participants with TB (Table 2). Most patients recovered (cured or completed treatment) from TB in both arms (91% in Arm 1 and 92% in Arm 2), and only a small
proportion died (1% in Arm 1 and 4% in Arm 2) or defaulted (7% in Arm 1 and 3% in Arm 2). Lack of support from other family members, strong nicotine addiction, mental illnesses and physical disability among smokers were reported as some of key barriers to sustaining smoking restrictions at home.
DISCUSSION The trial was successful in securing 1) high recruitment rates, as the majority of TB patients who attended the two typical TB out-patient’s facility were eligible, and all but one were willing to participate; 2) low attrition rates, as most trial participants completed the study to the last follow-up date; 3) high treatment adherence rates, as almost all participants in different treatment conditions received the intervention; and 4) high feasibility for measuring outcomes, including self-reported measures, urinary cotinine levels and those obtained from routine data collection. We did not specify any progression criteria
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for a definitive trial. However, our study met all recruitment and retention targets specified in the protocol18 and should be able to progress to a definitive trial. This was not unexpected, as a previously conducted trial of smoking cessation in TB out-patient’s facilities in Pakistan also achieved high recruitment and low attrition rates.18 We also found a big drop in SHS exposure among participants after the intervention in both treatment conditions, as measured by assessing urinary cotinine levels. It is possible that some of the reduction in SHS exposure was due to patients moving away from places where smoking took place. However, changes observed in the self-reported secondary outcomes (smoking restrictions at home, smoking in the presence of children and of the TB patient) correlates well with those observed in the primary outcome, indicating that the reduction in SHS exposure was largely due to a shift in the smoker’s behaviour. These findings were remarkable but not surprising, as in a previous study in Pakistan the majority of smokers changed their behaviour as a result of a community-based intervention designed to raise awareness about the harms of SHS, particularly to children’s health.16 We restricted recruitment to only those who resided in the catchment districts. As patients were expected to attend regular follow-up visits, the trial posed a minimal research burden on TB patients. The intervention was considered appropriate by the study participants, despite concerns over the power imbalance between smokers (mostly men) and nonsmokers (mostly women and children) within households in patriarchal societies. The magnitude of change observed in smoking behaviour in this study is also remarkable but possible in a low- to middleincome country such as Pakistan, where public awareness of the harms of active and passive smoking is very limited.21 Furthermore, TB patients concerned about their condition and its consequences, along with newly acquired knowledge about the association between TB and smoking, might have been more motivated to implement smoking restrictions in their homes compared to the general public. Likewise, their family members and visitors who would have otherwise continued their smoking habit might have felt obliged to change their behaviour as part of caring for the patient. Similar shifts in smoking behaviour have been observed among parents who smoke when confronted with a sick child due to an associated condition22 or with measurements indicating high levels of exposure to SHS in their newborns.23 One potential limitation of this trial could be the absence of a control condition in which no intervention was offered. We favoured a two intervention arm study for this pilot to obtain parameters required for a future definitive trial using the most efficient design. As a pilot study, the trial was only expected to report
descriptive statistics to inform sample size estimations for a definitive trial and not inferential statistics to test a hypothesis requiring a control arm with no treatment conditions.24 This trial was also not powered to show a statistically significant difference between the two intervention arms.
CONCLUSION The high participant recruitment and retention rates make it feasible to conduct a definitive trial to assess the effectiveness of behavioural approaches to reduce SHS exposure in TB patients. The effect size observed in the two trial arms makes it worthwhile to conduct such a trial. Acknowledgements The authors are grateful to O Dogar, University of York, York, and M Siddiqi, University of Newcastle, Newcastle, UK, for proofreading this paper and giving helpful advice. Trial Registration Number: ISRCTN83630841. The study was funded by the National Health Service Leeds. Conflicts of interest: none declared.
References 1 Lin H H, Ezzati M, Murray M. Tobacco smoke, indoor air pollution and tuberculosis: a systematic review and metaanalysis. PLOS MED 2007; 4: e20. 2 Slama K, Chiang C-Y, Enarson D A, et al. Tobacco and tuberculosis: a qualitative systematic review and meta-analysis [Review Article]. Int J Tuberc Lung Dis 2007; 11: 1049–1061. 3 Yen Y F, Yen M Y, Lin Y S, et al. Smoking increases risk of recurrence after successful anti-tuberculosis treatment: a population-based study. Int J Tuberc Lung Dis 2014; 18: 492– 498. 4 Batista J A L, de Albuquerque M F P, de Alencar Ximenes R A, Rodrigues L C. Smoking increases the risk of relapse after successful tuberculosis treatment. Int J Epidemiol 2008; 37: 841–851. 5 Santha T, Garg R, Frieden T R, et al. Risk factors associated with default, failure and death among tuberculosis patients treated in a DOTS programme in Tiruvallur District, South India, 2000. Int J Tuberc Lung Dis 2002; 6: 780–788. 6 Bates M N, Khalakdina A, Pai M, Chang L, Lessa F, Smith K R. Risk of tuberculosis from exposure to tobacco smoke: a systematic review and meta-analysis. Arch Intern Med 2007; 167: 335–342. 7 Leong C. Passive smoking and tuberculosis. Arch Intern Med 2010; 170: 287–292. 8 Lin H-H, Ezzati M, Murray M. Tobacco smoke, indoor air pollution and tuberculosis: a systematic review and metaanalysis. PLOS MED 2007; 4: e20 9 Basu S, Stuckler D, Bitton A, Glantz S A. Projected effects of tobacco smoking on worldwide tuberculosis control: mathematical modelling analysis. BMJ 2011; 343: d5506. 10 World Health Organization. A WHO/The Union monograph on TB and tobacco control: joining efforts to control two related global epidemics. Geneva, Switzerland: WHO, 2007. 11 Bissell K, Fraser T, Chen-Yuan C, Enarson D A. Tobacco cessation interventions for tuberculosis patients: a guide for low-income countries. Paris, France: International Union Against TB and Lung Disease, 2010. 12 Siddiqi K, Khan A, Ahmad M, et al. Action to stop smoking in suspected tuberculosis (ASSIST) in Pakistan: a cluster
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randomized, controlled trial. Ann Intern Med 2013; 158: 667– 675. Been J V, Nurmatov U B, Cox B, Nawrot T S, van Schayck C P, Sheikh A. Effect of smoke-free legislation on perinatal and child health: a systematic review and meta-analysis. Lancet 2014; 383: 1549–1560. World Health Organization. Global tuberculosis control 2011. WHO/HTM/TB/2011.16. Geneva, Switzerland: WHO, 2011. Alam A Y, Iqbal A, Mohamud K B, Laporte R E, Ahmed A, Nishtar S. Investigating socio-economic-demographic determinants of tobacco use in Rawalpindi, Pakistan. BMC Public Health 2008; 8: 50. Siddiqi K, Sarmad R, Usmani R A, Kanwal A, Thomson H, Cameron I. Smoke-free homes: an intervention to reduce second-hand smoke exposure in households. Int J Tuberc Lung Dis 2010; 14: 1336–1341. Bloch M, Althabe F, Onyamboko M, et al. Tobacco use and secondhand smoke exposure during pregnancy: an investigative survey of women in 9 developing nations. Am J Public Health 2008; 98: 1833. Safdar N, Zahid R, Shah S, et al. TB patients learning about
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second hand smoke (TBLASS): a pilot individual randomised controlled trial. [Study protocol] SpringerPlus 2013; 2: 556. Michie S, Hyder N, Walia A, West R. Development of a taxonomy of behaviour change techniques used in individual behavioural support for smoking cessation. Addict Behav 2011; 36: 315–319. Campbell M K, Piaggio G, Elbourne D R, Altman D G. Consort 2010 statement: extension to cluster randomised trials. BMJ 2012; 345: e5661. Lee A C K, Siddiqi K, Khan M A, Ahmed M, Shams N, Nazir A. Local determinants of tobacco use in Pakistan and the importance of context. J Smok Cessat 2010; 5: 145–150. Priest N, Roseby R, Waters E, et al. Family and carer smoking control programmes for reducing children’s exposure to environmental tobacco smoke. Cochrane Database Syst Rev 2008; (4): CD001746. Wilson I, Semple S, Mills L M, et al. REFRESH—reducing families’ exposure to secondhand smoke in the home: a feasibility study. Tob Control 2013; 22: e8. Arain M, Campbell M J, Cooper C L, Lancaster G A. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol 2010; 10: 67.
Knowledge, attitude, motivation
Motivation
Social influences, Motivation, Belief about capabilities
Explore information on consequences (discussion around consequence)
Provide information about others’ approval
Determinants of behaviour
Theory of reasoned action, theory of planned behaviour, information motivation, behavioural skills model
Theory of reasoned action; theory of planned behaviour; socialcognitive theory
Information motivation, behavioural skills model
Link to theoretical framework
Information about what others think about the person’s behaviour and whether others will approve or disapprove of any proposed behaviour change
Information about the benefits and costs of action or inaction, focusing on what will happen if the person does or does not perform the behaviour
Information about behavioural risks e.g., susceptibility to poor health outcomes in relation to the behaviour; information about the benefits of action, focusing on what will happen if the person performs the behaviour in question
Definitions of BCTs Provide information about SHS, why it is harmful and to whom, etc. Positive messages about benefits Flip chart (slides 1–3) Initiate conversation about SHS, why it is harmful and to whom and the benefits of SFH with the smoker(s) at home Audio cassette/pictorial pamphlet Identification of perceived cost-benefit balance in relation to the discussion on SFH with smoker(s) in the household Flip chart (slides 4–6) Identification of perceived cost-benefit balance in relation to successful anti-tuberculosis treatment. Benefits as in better health outcomes for infants and children in the household as well as for pregnant women, if any, in the household Audio cassette/pictorial pamphlet The RA will discuss best practices around smoking/taking care of a sick person with the TB patient. The RA will share with the TB patient that a person who selfrestricts in consideration of a sick person will be considered a responsible and good person by others
Activity/process/materials
Application of a taxonomy of behaviour change techniques used in a smoke-free home intervention*
Provide information about behaviour health link
BCTs
Appendix Table
TB patient
Smoker(s)
TB patient
RA
TB patient
Smoker(s)
TB patient
RA
TB patient
Recipient
RA
Agent
TB and second-hand smoke
i
Prompt barrier identification
Prompt intention formation
BCTs
Appendix Table
Motivation
Determinants of behaviour
(continued)
Social cognitive theory
Theory of reasoned action, theory of planned behaviour, social cognitive theory, information motivation, behavioural skills model
Link to theoretical framework
Identify barriers to performing the behaviour and plan ways of overcoming them
Encouraging the person to decide to act or set a specific goal, e.g., to make a behavioural resolution such as ‘I will take more exercise next week’
Definitions of BCTs Activity/process/materials Flip chart (slide 7) The TB patient will discuss best practices for smoking/ taking care of sick person, with smoker(s)and share that a person who selfrestricts in consideration of a sick person will be considered a responsible and good person by others. Audio cassette/pictorial pamphlet Prepare and send text message/letter templates for smokers at home, presenting information on social norms. Understand and take into account the social norms of most TB patients and their family (only for Arm 2) Have a discussion with the TB patient to set a goal that they are confident they can achieve, such as raising the issue with smoker/family Use flip chart (slides 8–9) Have a discussion with smoker(s) to set a goal that they are confident they can achieve, such as smoking away from TB patient or smoking in veranda or smoking outside the house, etc. Audio cassette/pictorial pamphlet Identify/explore barriers to having the discussion with smoker(s) at home Check list and/or pictorial cards. Flip chart (10–13) to suggest steps to address common barriers
TB patient
Smoker(s) at home
RA
TB patient
TB patient
Smoker at home
Co-investigator
RA
Smoker(s)
Recipient
TB patient
Agent
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Motivation; attitude
Skills; motivation; knowledge
Set graded tasks
Determinants of behaviour
(continued)
Provide general encouragement
BCTs
Appendix Table
Social cognitive theory
Social cognitive theory
Link to theoretical framework
Set easy tasks and increase difficulty until target behaviour is performed
Praising or rewarding the person for effort or performance without this being contingent on specified behaviours or standards of performance
Definitions of BCTs Activity/process/materials The RA will do this exercise three times, i.e., on first contact (Month 0), second contact (Month 1) and first follow-up (Month 2) The TB patient will discuss the barriers to change in behaviour with the smoker(s) and encourage them to suggest solutions The RA will praise the intention and provide positive encouragement— building rapport during intervention and also during follow-up Placing SFH logo on TB01 patient card will also have an encouraging message The TB patient will praise the intention of the smoker for SFH and provide positive encouragement— building family engagement and praising resolve to go smoke-free Encourage the TB patient to identify small steps towards the goal of having the discussion about SFHs (4-week challenge). May want to discuss some suggestions and encourage the TB patient to come up with his own Flip chart (slides 14–15) Introduce SFH steps and 4week challenge: smoke away from TB patient – smoke in one room only – totally SFH – stay smokefree for at least 4 weeks Audio cassette/pictorial pamphlet
Smoker(s)
TB patient
Smoker(s)
TB patient
Smoker(s)
RA
TB patient
RA
TB patient
Recipient
TB patient
Agent
TB and second-hand smoke
iii
Skills; social influences
Self-efficacy; skills; motivation
Model or demonstrate the behaviour/ rehearsal of relevant skills
Prompt specific goal setting
Determinants of behaviour
Motivation; memory
(continued)
Provide instruction
BCTs
Appendix Table
Control theory
Social cognitive theory
Social cognitive theory
Link to theoretical framework
Involves detailed planning of what the person will do, including a definition of the behaviour specifying timeframe, scope or duration and specification of at least one context, i.e., where, when, how or with whom
Telling the person how to perform a behaviour and/or preparatory behaviours (an expert shows the person how to correctly perform a behaviour, e.g., video/ role play)
Telling the person how to perform a behaviour and/or preparatory behaviours
Definitions of BCTs Verbally summarise the immediate steps to be taken by the TB patient, based on the strategy adopted by the TB patient to convince the smoker(s) at home to ensure a smokefree environment at home Flip chart (slide 16) The RA will write these tasks down on a specified place on the medicine box After discussion on SFH with the smoker(s) at home, the TB patient will verbally summarise the steps agreed to be taken by the smoker(s) Write down on a paper and place in a specific place provided on the medicine box The RA will perform a role play (or plan with the TB patient a scenario and dialogue between TB patient and smoker(s) at home, taking into account the expected barriers/ resistance (under consideration, feasibility of performing role play in hospital setting) The RA will add dates for completion of tasks written on the medicine box These dates will act as reminders to the TB patient to accomplish their task in time The TB patient will add dates as reminders against all steps agreed upon by the smoker(s) and written on medicine box
Activity/process/materials
TB patient
Smoker(s)
RA
TB patient
TB patient
Smoker(s)
TB patient
RA
TB patient
Recipient
RA
Agent
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Prompt selfmonitoring of behaviour
Prompt review of behavioural goals
BCTs
Appendix Table
Determinants of behaviour
Skills; attitude
(continued)
Control theory
Control theory
Link to theoretical framework
The person is asked to keep a record of specified behaviour(s) (e.g., in a diary)
Review and/or reconsideration of previously set goals or intentions
Definitions of BCTs When the patient comes for first follow-up at Month 2, the RA will prompt review of behavioural goals by reviewing the previously set goals pasted on the medicine box In case the goals could not be met, the RA will help the TB patient set new goals and place them on the medicine box The goals will be reviewed on subsequent visits Once the TB patient is successful in having a discussion with smoker(s) at home and setting goals for SFH, on subsequent discussion the TB patient will review the goals previously set by the smoker(s) and if not met, they will agree on new goals that will help move towards a SFH The RA will ask the TB patient to monitor his own behaviour by reviewing the tasks/goals written on the medicine box The TB patient will also teach the smoker(s) to monitor their own behaviour periodically to ensure SFH, for example, by using a calendar where they tick each day the home has been smoke-free
Activity/process/materials TB patient
Smoker(s) at home
TB patient
Smoker(s)
TB patient
RA
TB patient
Recipient
RA
Agent
TB and second-hand smoke
v
Memory, attention, decision process, action planning
Teach to use prompts or cues
Determinants of behaviour
Attitude; beliefs about consequences and capabilities
(continued)
Provide feedback on performance
BCTs
Appendix Table
Operant conditioning
Control theory
Link to theoretical framework
Teach the person to identify environmental cues that can be used to remind them to perform a behaviour, including times of day or elements of contexts
Providing data about recorded behaviour or evaluating performance in relation to a set standard or others’ performance, i.e., the person received feedback on their behaviour
Definitions of BCTs
On subsequent visits, the RA will review the goals mentioned on the medicine box If not achieved then ask what worked well/what did not work so well/ what could have been different Flip chart (slide 17) The TB patient will also review with the smoker(s) the goals written on the medicine box and discuss what worked well If we did not achieve what we could then suggest a change in strategy Append SFH logo and message to Patient TB01 card and record on appropriate place on patient card (TB02) This logo will also act as prompt to TB patient to initiate a conversation about SFH, for example, a reminder to initiate a conversation when the smoker next smokes inside the house in the presence of the TB patient The TB patient will place prompts/cues in the home to remind the smoker(s) to smoke outside the house. Prompts could be a calendar/no smoking signs, sticker on the mirror where the smoker brushes teeth in the morning
Activity/process/materials
TB patient
RA
TB patient
RA
Agent
Smoker(s)
TB patient
Smoker(s)
TB patient
Recipient
vi The International Journal of Tuberculosis and Lung Disease
Determinants of behaviour
Self-efficacy
Social influences
Plan social support or social change
Motivation; action planning
(continued)
Use follow-up prompts
Prompt practice
Agree on behavioural contracts
BCTs
Appendix Table
Social support theories
Operant conditioning
Operant conditioning
Link to theoretical framework
Prompt consideration of how others could change their behaviour to offer the person help or (instrumental) social support, including ‘buddy’ systems and/or providing social support
Contacting the person again after the main part of the intervention is complete
Prompt the person to rehearse and repeat the behaviour or preparatory behaviours
Agreement (i.e., signing) of a contract specifying behaviour to be performed so that there is a written record of the person’s resolution witnessed by another
Definitions of BCTs The RA will present an informal contract to the TB patient that reinforces the resolve to make their home smoke-free. The RA will read out the contract to the TB patient and obtain verbal agreement The TB patient will show the agreement to the smoker(s) at home, explain the agreement and obtain verbal agreement to make their home smoke-free Encourage the TB patient to rehearse discussion beforehand Flip chart (slide 18) Prepare the smoker(s) to think about dealing with specific situations such as when friends/relatives who are smokers visit Audio cassette/pictorial pamphlet The RA will follow up the TB patient twice after the intervention is completed: once in Month 2 and then in Month 6 and maintain record on the questionnaire (Under consideration, this is sensitive in our context, so we will try to find an alternative) The TB patient can involve an influential family member who can support the TB patient to influence smoker(s) Flip chart (slide)
Activity/process/materials
TB patient
Smoker(s)
TB patient
Smoker(s)
TB patient
RA
TB patient
RA
TB patient
Smoker(s) at home
TB patient
RA
TB patient
Recipient
RA
Agent
TB and second-hand smoke
vii
Activity/process/materials The RA will explain to the TB patient that a smoker who chooses to smoke outside the home will be a role model for others The TB patient will explain to the smoker(s) that they will become role models for family members and relatives The RA will help the TB patient to identify possible triggers that could result in a relapse (resuming smoking in the house) The TB patient will identify possible triggers that could result in a relapse (smoking in the house) and discuss with the smoker(s), strategies to address them
Smoker(s) Smoker(s)
TB patient
Smoker(s)
TB patient Text message
RA
TB patient
Recipient TB patient
Agent RA
* Behaviour to be changed: smoking inside the home of a TB patient (non-smoker). The activities listed will be in the following scenario: Research Assistant TB patient Smoker (s) at home. BCT ¼ behaviour change technique; RA ¼ Research Assistant; TB ¼ tuberculosis; SHS ¼ second-hand smoke; SFH ¼ smoke-free home.
Relapse prevention therapy
Definitions of BCTs
Following initial change, help identify situations likely to result in readopting risk behaviour or failure to maintain new behaviours and help person plan to avoid/manage these situations
Self-efficacy; skills; beliefs about capabilities
Link to theoretical framework
Relapse prevention
Determinants of behaviour Indicating how the person may be an example to others and influence their behaviour or provide an opportunity for the person to set a good example
(continued)
Prompt identification as a role model
BCTs
Appendix Table
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TB and second-hand smoke
ix
RESUME
Le tabagisme passif est associ´e a` la tuberculose (TB). Il est n´ecessaire de prendre des mesures de protection des patients non-fumeurs de la fume´ e passive (SHS). Nous avons e´ labore´ une intervention comportementale afin d’encourager les patients tuberculeux a` mettre en œuvre des restrictions du tabagisme a` leur domicile au Pakistan. O B J E C T I F S : Evaluer la probabilit´e de succ`es d’une telle intervention et de pr´eparer une e´ tude de plus grande ampleur a` l’avenir. S C H E´ M A : Essai pilote randomis´e et control´ ˆ e dans lequel les patients tuberculeux non-fumeurs ont e´ t´e s´electionn´es au hasard pour b´en´eficier soit d’un «soutien individuel», soit de ce mˆeme soutien combin´e a` des «rappels familiaux». Nous avons recrut´e des patients vivant avec au moins un fumeur a` leur domicile. Notre CONTEXTES :
r´esultat principal e´ tait le dosage urinaire de nicotine, comme mesure de l’exposition a` la SHS, 2 mois apr`es la s´election. R E´ S U LT A T S : Parmi les 273 patients e´ valu´es pour leur e´ ligibilit´e, 150 (56%) ont e´ t´e recrut´es et tous sauf un ont e´ t´e retenus pour toute l’´etude. Une r´eduction absolue, statistiquement significative, a e´ t´e observ´ee en termes d’exposition a` la SHS pour les non-fumeurs, objectiv´ee par la nicotine urinaire, a` la fois dans le Bras 1 (71% ; IC95% 61–79) et le Bras 2 (76% ; IC95% 67–83) entre la mesure de d´epart et le suivi a` 2 mois. C O N C L U S I O N S : Le taux de recrutement et de r´etention observ´es dans cette e´ tude attestent de la faisabilit´e d’une e´ tude plus importante a` l’avenir. L’ampleur observ´e de l’effet justifie d’entreprendre cette nouvelle e´ tude.
RESUMEN M A R C O D E R E F E R E N C I A S: El tabaquismo pasivo se asocia con la tuberculosis (TB). Se precisan medidas que protejan del humo ajeno a los pacientes tuberculosos no fumadores. Se elaboro´ una intervencion ´ conductual encaminada a estimular a los pacientes tuberculosos a introducir restricciones al tabaquismo en el hogar, en Pakista´n. O B J E T I V O S: Evaluar la probabilidad de e´ xito de una intervencion ´ conductual de este tipo con el proposito ´ de informar la planeacion ´ de un estudio definitivo en el futuro. M E´ T O D O: Fue este un estudio preliminar comparativo y aleatorizado en el cual los pacientes tuberculosos no fumadores se distribuyeron en dos grupos, uno recib´ıa ‘apoyo individual’ exclusivo y en el otro grupo se enviaron adema´s ‘mensajes recordatorios a los familiares’. Se escogieron para el estudio pacientes que conviv´ıan como m´ınimo con un fumador. El criterio primario de evaluacion ´ fue la determinacion ´ urinaria de
cotinina, como medida de la exposicion ´ al tabaquismo pasivo, dos meses despu´es de la aleatorizacion. ´ R E S U L T A D O S: De los 273 pacientes en quienes se evaluaron los criterios de seleccion, ´ se incluyo´ 150 (56%), y todos permanecieron en el estudio hasta el final del mismo, con la excepcion ´ de un paciente. Se puso en evidencia una disminucion ´ estad´ısticamente significativa de la exposici on ´ al tabaquismo pasivo en los participantes no fumadores, medida mediante la determinacion ´ de la cotinina urinaria al comienzo del estudio y a los 2 meses de seguimiento, en el grupo que recibio´ un respaldo individual (71%; IC95% 61–79) y en el grupo que recibio´ mensajes recordatorios (76%; IC95% 67–83). ´ N: Las tasas de inclusion CONCLUSIO ´ y fidelizacion ´ de los participantes en este estudio preliminar hacen posible la realizacion ´ de un estudio definitivo en el futuro. La magnitud del efecto observado justifica la realizacion ´ del nuevo estudio.
Tuberculosis patients learning about second-hand smoke (TBLASS): results of a pilot randomised controlled trial N. Safdar,* R. Zahid,* S. Shah,† R. Fatima,‡ I. Cameron,§ K. Siddiqi† *Social and Health Inequalities Network (SHINe), Islamabad, Pakistan; †Department of Health Sciences, University of York, UK; ‡National TB Programme, Islamabad, Pakistan; §Leeds City Council, Leeds, UK SUMMARY B A C K G R O U N D : Passive smoking is associated with tuberculosis (TB). Measures are required to protect non-smoking TB patients from second-hand smoke (SHS). S E T T I N G : We developed a behavioural intervention to encourage TB patients to implement smoking restrictions at home in Pakistan. O B J E C T I V E S : To assess the likelihood of such an intervention being successful and to inform a definitive trial in future. D E S I G N : This was a pilot randomised controlled trial in which non-smoking TB patients were randomised to receive either individual-based support or individualbased support combined with family reminders. We recruited patients living with at least one smoker in their homes. Our primary outcome was urinary cotinine level
as a measure of SHS exposure 2 months post-randomisation. R E S U LT S : Of 273 patients assessed for eligibility, 150 (56%) patients were recruited and all but one were retained throughout the trial. A statistically significant absolute reduction was observed in non-smoking participants’ exposure to SHS based on urinary cotinine levels in both Arm 1 (71%, 95%CI 61–79) and Arm 2 (76%, 95%CI 67–83) between baseline and follow-up at 2 months. C O N C L U S I O N S : The recruitment and retention rates for trial participants make it feasible to conduct a definitive trial in future. The observed effect size makes it worthwhile to conduct such a trial. K E Y W O R D S : tuberculosis; passive smoking; tobacco; smoke-free homes
SMOKING INCREASES THE RISK of acquiring tuberculous infection and developing tuberculosis (TB) disease.1,2 In those with established TB, smoking leads to poor outcomes, death and recurrence.1,3–5 Furthermore, TB transmission is higher in smoking households than in those with smoking restrictions.6 For passive smoking, evidence based on a relatively small number of observational studies suggests that second-hand smoke (SHS) exposure is also likely to be associated with TB.7,8 In countries with high TB incidence and high smoking rates, the association between smoking (active and passive) and TB accounts for a substantial disease burden. It has been suggested that smoking will lead to an extra 18 million TB cases and 40 million TB deaths between 2010 and 2050.9 Unfortunately, these colliding epidemics have so far been addressed entirely independently through distinct programmes. Integrating tobacco control interventions within TB control offers a great opportunity to reduce their interactive disease burden. For active smoking, the World Health Organiza-
tion (WHO) and the International Union Against Tuberculosis and Lung Disease (The Union) suggest offering cessation support to those TB patients who smoke, as part of their TB treatment.10,11 This has been shown to be successful in achieving smoking abstinence when offered by TB programme health care workers.12 For passive smoking, most countries have introduced comprehensive smoking bans in enclosed public and work places. This has significantly reduced exposure to SHS and its associated mortality and morbidity in countries where these bans are strictly enforced.13 However, for most nonsmoking women and children, homes and cars remain likely places for SHS exposure. Moreover, in many low- and middle-income countries where TB is common, smoking bans are only partially implemented. Additional measures are therefore required to protect non-smokers, particularly women, children and other vulnerable groups (such as TB patients), from SHS. In this regard, The Union recommends smoke-free homes and expects TB health care workers to advise patients to negotiate smoking
Correspondence to: Kamran Siddiqi, Department of Health Sciences, University of York, UK. Tel: (þ44) 79 7054 4872. Fax: (þ44) 19 0432 1335. e-mail: [email protected] Article submitted 18 August 2014. Final version accepted 8 October 2014.
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restrictions at home with co-residing smokers.11 However, our literature search did not find any empirical studies on interventions that encourage TB patients to do so. Our eventual aim is to assess the effectiveness of behavioural interventions that encourage TB patients to implement smoking restrictions at homes and protect them from SHS. Pakistan is a suitable place for such a study, as it has one of the highest TB burdens worldwide, with approximately 400 000 incident cases annually,14 and tobacco use is also highly prevalent in Pakistan.15 Passive smoking is also common, with more than half of the population exposed to SHS.15,16 This happens because there are no restrictions on smoking indoors; 91.6% of pregnant women reported allowing smoking in their homes.17 We conducted a pilot trial of a behavioural intervention to encourage TB patients to implement smoking restrictions at home in Pakistan. Our intention was to assess the likelihood of such an intervention being successful and to inform the methods for a definitive trial in future.
METHODS A detailed trial protocol is published elsewhere.18 A summary is presented here. Study design This was a two-arm pilot individual randomised controlled trial. Settings The trial was conducted in two public sector hospitals in Rawalpindi and Sialkot Districts. Both had a designated TB out-patient facility and were endorsed by the National TB Programme as basic management units for TB control. Participants All non-smoking pulmonary TB cases living with one or more smokers were eligible. Pulmonary TB cases were defined as those with a new, definitive and firm diagnosis, either sputum-negative or -positive, and registered to receive anti-tuberculosis treatment. Patients aged ,10 years, with recurrent TB, residing outside the study districts and those who had received anti-smoking educational interventions in the past were excluded.
resource by a TB health care worker during a 20 min consultation with a TB patient at the time of diagnosis and another 10 min consultation after a month. The first consultation was aimed to provide information on the harms associated with SHS exposure for TB patients and to help them negotiate smoking restrictions at home with co-residing smokers. The second consultation was to address any barriers, including intrapersonal (nicotine addiction) and interpersonal barriers (smoker’s attitude) and those related to physical environment (lack of outside space) encountered in sustaining smoke-free homes. Based on the taxonomy of behavioural change techniques,19 the intervention was expected to improve knowledge, change attitude, enhance motivation, build confidence and negotiation skills, and increase intention to act with further reinforcement at follow-up (see Appendix Table*). The intervention acted at two levels: first at the interface between the health care worker and the non-smoking patient, and second between the patient and the co-residing smoker(s). All participants received an illustrative leaflet to stimulate conversation with the co-residing smoker(s) on making their homes smoke free. Family reminders While the onus of individual-based support is placed on TB patients to start the relevant conversations and bring about change, family reminders were designed to directly address the co-residing smokers. These consisted of eight short message service (SMS) messages (statements) sent to the co-residing smoker(s) on a weekly basis over 8 weeks. Mapped on behaviour change techniques, these messages were designed to enhance knowledge, change attitude and increase intention to act. Family reminders were expected to influence behaviour change directly, and were hypothesised to have an added effect when coadministered with individual-based support.
Interventions All eligible and consenting participants were randomised to receive either individual-based support or individual-based support plus family reminders.
Randomisation and allocation Participants were randomly assigned to one of the two treatment conditions using a computer-generated allocation sequence. The system generated a permuted simple randomisation list for each site. For every consenting participant, a research assistant based at the respective site first collected some baseline information and then phoned the research office to allocate a numeric trial code from the allocation sequence. All trial patients in Arms 1 and 2 received individual-based support at the hospital. In addition, those allocated to Arm 2 received ‘family reminders’. Both research assistants were blinded to the alloca-
Individual-based support Individual-based support was a behavioural intervention delivered face-to-face using an educational
* The appendix is available in the online version of this article, at http://www.ingentaconnect.com/content/iuatld/ijtld/2015/ 00000019/00000002/art00020
TB and second-hand smoke
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Figure Trial flow chart.
tion and the primary outcome results until the trial database was locked at the end of the study.
ments were taken at baseline and at 1 and 2 months follow-up after randomisation.
Outcome measurements and follow-ups The primary outcome was participants’ exposure to SHS measured by urinary cotinine levels collected both at baseline and at 2-month follow-up after randomisation. Cotinine testing was carried out by a laboratory technician who received relevant training in conducting and interpreting the test. The test involved dipping an Accutestw NicAlertTM (Jant Pharmacal Corp, Encino, CA, USA) strip in a urine sample and reading the colour change in one of the zones (levels 0–6) on the strip. An absolute reduction in exposure would mean a change from level 1 or above down to level 0. The secondary outcomes included self-reported change in the number of homes where smoking restrictions resulted in smokers (residents and visitors) smoking: 1) only outside the home; 2) in one room only; 3) not in the presence of children; and 4) not in the presence of TB patients. TB clinical outcomes were also recorded from TB registers kept routinely within the designated TB facilities. These included a proportion of patients 1) who were cured, i.e., a smear-positive case becoming smear-negative in the last month of treatment and on at least one previous occasion; 2) who completed treatment; 3) who defaulted, i.e., whose treatment was interrupted for 72 consecutive months; 4) who died due to any cause; 5) who failed, i.e., who were initially smearpositive and who remained smear-positive at month 5 or later during treatment; and 6) who transferred out to another reporting unit and for whom the treatment outcome is not known. All self-reported measure-
Analysis All analyses were conducted using SAS v.9.3 statistical software (Statistical Analysis System, Cary, NC, USA) on an intention-to-treat basis, including all randomised participants. Summaries of the baseline characteristics of the participants are presented by trial arm. Although determining differences in the primary outcome between the two arms was not the primary purpose of this study, a comparison was undertaken to investigate the feasibility of studying this measurement and to calculate an estimate for the likely effect size. Ethical clearance for the trial was sought from the National Bioethics Committee of the Pakistan Medical and Research Council, Islamabad, Pakistan and the University of York, York, UK.
RESULTS Recruitment and retention The flow of the trial participants is presented in a CONSORT (Consolidated Standards Of Reporting Trials) diagram (Figure).20 Recruitment took place between November 2012 and May 2013. Of 2782 individuals presumed to have TB, 506 (18%) were diagnosed with pulmonary TB at the two sites. With one research assistant at each site, we could only assess 54% (273/506) of these patients for eligibility. Of those assessed for eligibility, 44% (122/273) were not recruited because they either did not live with a smoker or they smoked themselves. Of those eligible, we recruited 99% (150/151) of patients, with only one refusing to participate for personal reasons. The
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Table 1
Baseline characteristics of trial participants
Characteristic TB patient Total, n Mean age 6 SD, years
Arm 1: individual-based Arm 2: individual-based support only support þ family reminders n/N (%) n/N (%) P value 75 33 6 17
75 31 6 16
Sex Male Female
21/74 (28) 53/74 (72)
25/75 (33) 50/75 (67)
Education No formal schooling Formal education
29/74 (39) 45/74 (61)
25/75 (33) 50/75 (67)
Occupation Housewife Office worker Student Others‡
37/74 5/74 15/74 17/74
32/75 2/75 11/75 30/75
TB type§ Smear-positive Smear-negative
31/73 (42) 42/73 (58)
41/75 (55) 34/75 (45)
Co-habiting smoker(s) Total, n Mean age 6 SD
90 51 6 17
89 50 6 16
84/90 (92) 6/90 (8)
85/89 (96) 4/89 (4)
74/90 (82) 11/90 (12) 5/90 (6)
72/89 (82) 12/89 (13) 5/89 (5)
40/78 (51) 38/78 (49)
36/77 (47) 41/77 (53)
Number of rooms 1 .1
6/74 (8) 68/74 (92)
4/75 (5) 71/75 (95)
Number of smokers 1 .1
61/74 (82) 13/74 (18)
65/75 (87) 10/75 (13)
Sex Male Female Type of smoking Cigarettes only Hookah only Cigarette þ others (e.g., hookah) Number of cigarettes smoked/day ,10 .10
0.47* 0.59
0.5
0.12† (50) (7) (20) (23)
(43) (3) (15) (40) 0.14
0.74* 0.52
1
0.573
Household 0.53
0.5
* Paired t-test used to compare means. † Some cells have expected count less than 5. Fisher’s exact test was applied. ‡ Includes unemployed, self-employed, farmer, trader, labourer. § Data missing for two observations in Arm 1. TB ¼ tuberculosis; SD ¼ standard deviation.
non-smoking trial participants were predominantly females (68%) and younger (mean age 32.2 years), compared to mostly male (94%) and older (mean age 51 years) co-habiting smokers (Table 1). We retained all but one participant in each arm at 2 months follow-up. Four participants (1 in Arm 1 and 3 in Arm 2) subsequently died due to TB post follow-up but before the end of their 6-month anti-tuberculosis treatment. Allocation and treatment adherence Simple randomisation resulted in equal allocation, i.e., 75 participants in each arm. In Arm 1 (individualbased support only), 99% (74/75) of participants received the intervention, while in Arm 2, 100% (75/ 75) received individual-based support and family reminders. Both trial arms were balanced for all
confounders, including age and sex of non-smoking participants, and age, sex and smoking behaviour of co-habiting smokers (Table 1). Feasibility of measuring end points We measured (and interpreted) urinary cotinine levels among all participants at baseline and those we were able to follow up. However, among four participants at baseline, the cotinine levels were indicative of either active smoking or smokeless tobacco use. Given that we excluded those with high carbon monoxide measurements, this is likely to be due to smokeless tobacco use. TB outcome data were obtained in all but one patient in Arm 1. Likewise, information on smoking behaviour in the house, smoking in the presence of children and TB patients
TB and second-hand smoke
Table 2
241
Outcomes and their effect sizes before and after the intervention Baseline
Outcome
Trial arms*
Follow-up
Total n/N
% (95%CI)
Total, n/N
% (95%CI)
Reduction in exposure % (95%CI)
74/75 75/75
99 (93–100) 100
21/75 18/75
28 (18–38) 24 (16–35)
71 (61–79) 76 (67–83)
17 (11–28) 9 (5–18)
69/74 69/75
93 (85–97) 92 (84–92)
76 (67–83) 83 (74–89)
82 (72–89) 83 (73–90)
0/74 6/75
0 8 (4–16)
82 (73–88) 75 (66–82)
55 (44–66) 49 (38–60)
1/74 3/75
1 (0.2–7) 4 (1–11)
54 (44–63) 45 (36–55)
55 (44–66) 49 (38–60)
1/74 3/75
1 (0.2–7) 4 (1–11)
55 (45–64) 45 (36–55)
Primary outcome Exposure to SHS† Arm 1 Arm 2
Secondary outcomes: smoking behaviour Smoking outside house Arm 1 13/74 Arm 2 7/75 Smoking in the presence of children Arm 1 61/74 Arm 2 62/75 Resident smoking in the presence of the patient Arm 1 41/74 Arm 2 37/75 Visitor smoking in the presence of the patient Arm 1 41/74 Arm 2 37/75
Secondary outcomes: tuberculosis‡ (assessed 6 months post-randomisation) Cured Arm 1 Arm 2 Treatment completed Arm 1 Arm 2 Defaulted Arm 1 Arm 2 Died Arm 1 Arm 2 Transferred out Arm 1 Arm 2
22/74 30/75
30 (19.3–40.1) 41 (28.9–51.1)
45/74 38/75
61 (49.7–71.9) 51 (39.3–61.9)
5/74 2/75
7 (1.03–12.5) 3 (0.3–9.3)
1/74 3/75
1 (0–3.9) 4 (0–8.4)
1/74 1/75
1 (0–3.9) 1 (0–3.9)
* Arm 1 ¼ individual-based support only; Arm 2 ¼ individual-based support þ family reminders. † Urinary cotinine level 0 ¼ no exposure; level 71 ¼ SHS exposure. ‡ One case in Arm 2 had no treatment outcome documented. CI ¼ confidence interval; SHS ¼ second-hand smoke.
was only missing for one participant at baseline and for three at follow-up. Effect sizes A statistically significant absolute reduction was observed in non-smoking participants’ exposure to SHS, both in Arm 1 (71%, 95%CI 61–79) and Arm 2 (76%, 95%CI 67–83) between baseline and on follow-up at 2 months (Table 2). Among secondary outcomes, post-intervention change was observed as the co-habiting smokers began to smoke outside the home (76% [95%CI 67–83] and 83% [95%CI 74– 89] absolute increase in Arm 1 and Arm 2, respectively) and not in the presence of children (82% [95%CI 73–88] and 75% [95%CI 66–82] absolute reduction in Arm 1 and Arm 2, respectively). There was also a modest but significant reduction in smoking in the presence of non-smoking participants with TB (Table 2). Most patients recovered (cured or completed treatment) from TB in both arms (91% in Arm 1 and 92% in Arm 2), and only a small
proportion died (1% in Arm 1 and 4% in Arm 2) or defaulted (7% in Arm 1 and 3% in Arm 2). Lack of support from other family members, strong nicotine addiction, mental illnesses and physical disability among smokers were reported as some of key barriers to sustaining smoking restrictions at home.
DISCUSSION The trial was successful in securing 1) high recruitment rates, as the majority of TB patients who attended the two typical TB out-patient’s facility were eligible, and all but one were willing to participate; 2) low attrition rates, as most trial participants completed the study to the last follow-up date; 3) high treatment adherence rates, as almost all participants in different treatment conditions received the intervention; and 4) high feasibility for measuring outcomes, including self-reported measures, urinary cotinine levels and those obtained from routine data collection. We did not specify any progression criteria
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for a definitive trial. However, our study met all recruitment and retention targets specified in the protocol18 and should be able to progress to a definitive trial. This was not unexpected, as a previously conducted trial of smoking cessation in TB out-patient’s facilities in Pakistan also achieved high recruitment and low attrition rates.18 We also found a big drop in SHS exposure among participants after the intervention in both treatment conditions, as measured by assessing urinary cotinine levels. It is possible that some of the reduction in SHS exposure was due to patients moving away from places where smoking took place. However, changes observed in the self-reported secondary outcomes (smoking restrictions at home, smoking in the presence of children and of the TB patient) correlates well with those observed in the primary outcome, indicating that the reduction in SHS exposure was largely due to a shift in the smoker’s behaviour. These findings were remarkable but not surprising, as in a previous study in Pakistan the majority of smokers changed their behaviour as a result of a community-based intervention designed to raise awareness about the harms of SHS, particularly to children’s health.16 We restricted recruitment to only those who resided in the catchment districts. As patients were expected to attend regular follow-up visits, the trial posed a minimal research burden on TB patients. The intervention was considered appropriate by the study participants, despite concerns over the power imbalance between smokers (mostly men) and nonsmokers (mostly women and children) within households in patriarchal societies. The magnitude of change observed in smoking behaviour in this study is also remarkable but possible in a low- to middleincome country such as Pakistan, where public awareness of the harms of active and passive smoking is very limited.21 Furthermore, TB patients concerned about their condition and its consequences, along with newly acquired knowledge about the association between TB and smoking, might have been more motivated to implement smoking restrictions in their homes compared to the general public. Likewise, their family members and visitors who would have otherwise continued their smoking habit might have felt obliged to change their behaviour as part of caring for the patient. Similar shifts in smoking behaviour have been observed among parents who smoke when confronted with a sick child due to an associated condition22 or with measurements indicating high levels of exposure to SHS in their newborns.23 One potential limitation of this trial could be the absence of a control condition in which no intervention was offered. We favoured a two intervention arm study for this pilot to obtain parameters required for a future definitive trial using the most efficient design. As a pilot study, the trial was only expected to report
descriptive statistics to inform sample size estimations for a definitive trial and not inferential statistics to test a hypothesis requiring a control arm with no treatment conditions.24 This trial was also not powered to show a statistically significant difference between the two intervention arms.
CONCLUSION The high participant recruitment and retention rates make it feasible to conduct a definitive trial to assess the effectiveness of behavioural approaches to reduce SHS exposure in TB patients. The effect size observed in the two trial arms makes it worthwhile to conduct such a trial. Acknowledgements The authors are grateful to O Dogar, University of York, York, and M Siddiqi, University of Newcastle, Newcastle, UK, for proofreading this paper and giving helpful advice. Trial Registration Number: ISRCTN83630841. The study was funded by the National Health Service Leeds. Conflicts of interest: none declared.
References 1 Lin H H, Ezzati M, Murray M. Tobacco smoke, indoor air pollution and tuberculosis: a systematic review and metaanalysis. PLOS MED 2007; 4: e20. 2 Slama K, Chiang C-Y, Enarson D A, et al. Tobacco and tuberculosis: a qualitative systematic review and meta-analysis [Review Article]. Int J Tuberc Lung Dis 2007; 11: 1049–1061. 3 Yen Y F, Yen M Y, Lin Y S, et al. Smoking increases risk of recurrence after successful anti-tuberculosis treatment: a population-based study. Int J Tuberc Lung Dis 2014; 18: 492– 498. 4 Batista J A L, de Albuquerque M F P, de Alencar Ximenes R A, Rodrigues L C. Smoking increases the risk of relapse after successful tuberculosis treatment. Int J Epidemiol 2008; 37: 841–851. 5 Santha T, Garg R, Frieden T R, et al. Risk factors associated with default, failure and death among tuberculosis patients treated in a DOTS programme in Tiruvallur District, South India, 2000. Int J Tuberc Lung Dis 2002; 6: 780–788. 6 Bates M N, Khalakdina A, Pai M, Chang L, Lessa F, Smith K R. Risk of tuberculosis from exposure to tobacco smoke: a systematic review and meta-analysis. Arch Intern Med 2007; 167: 335–342. 7 Leong C. Passive smoking and tuberculosis. Arch Intern Med 2010; 170: 287–292. 8 Lin H-H, Ezzati M, Murray M. Tobacco smoke, indoor air pollution and tuberculosis: a systematic review and metaanalysis. PLOS MED 2007; 4: e20 9 Basu S, Stuckler D, Bitton A, Glantz S A. Projected effects of tobacco smoking on worldwide tuberculosis control: mathematical modelling analysis. BMJ 2011; 343: d5506. 10 World Health Organization. A WHO/The Union monograph on TB and tobacco control: joining efforts to control two related global epidemics. Geneva, Switzerland: WHO, 2007. 11 Bissell K, Fraser T, Chen-Yuan C, Enarson D A. Tobacco cessation interventions for tuberculosis patients: a guide for low-income countries. Paris, France: International Union Against TB and Lung Disease, 2010. 12 Siddiqi K, Khan A, Ahmad M, et al. Action to stop smoking in suspected tuberculosis (ASSIST) in Pakistan: a cluster
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randomized, controlled trial. Ann Intern Med 2013; 158: 667– 675. Been J V, Nurmatov U B, Cox B, Nawrot T S, van Schayck C P, Sheikh A. Effect of smoke-free legislation on perinatal and child health: a systematic review and meta-analysis. Lancet 2014; 383: 1549–1560. World Health Organization. Global tuberculosis control 2011. WHO/HTM/TB/2011.16. Geneva, Switzerland: WHO, 2011. Alam A Y, Iqbal A, Mohamud K B, Laporte R E, Ahmed A, Nishtar S. Investigating socio-economic-demographic determinants of tobacco use in Rawalpindi, Pakistan. BMC Public Health 2008; 8: 50. Siddiqi K, Sarmad R, Usmani R A, Kanwal A, Thomson H, Cameron I. Smoke-free homes: an intervention to reduce second-hand smoke exposure in households. Int J Tuberc Lung Dis 2010; 14: 1336–1341. Bloch M, Althabe F, Onyamboko M, et al. Tobacco use and secondhand smoke exposure during pregnancy: an investigative survey of women in 9 developing nations. Am J Public Health 2008; 98: 1833. Safdar N, Zahid R, Shah S, et al. TB patients learning about
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second hand smoke (TBLASS): a pilot individual randomised controlled trial. [Study protocol] SpringerPlus 2013; 2: 556. Michie S, Hyder N, Walia A, West R. Development of a taxonomy of behaviour change techniques used in individual behavioural support for smoking cessation. Addict Behav 2011; 36: 315–319. Campbell M K, Piaggio G, Elbourne D R, Altman D G. Consort 2010 statement: extension to cluster randomised trials. BMJ 2012; 345: e5661. Lee A C K, Siddiqi K, Khan M A, Ahmed M, Shams N, Nazir A. Local determinants of tobacco use in Pakistan and the importance of context. J Smok Cessat 2010; 5: 145–150. Priest N, Roseby R, Waters E, et al. Family and carer smoking control programmes for reducing children’s exposure to environmental tobacco smoke. Cochrane Database Syst Rev 2008; (4): CD001746. Wilson I, Semple S, Mills L M, et al. REFRESH—reducing families’ exposure to secondhand smoke in the home: a feasibility study. Tob Control 2013; 22: e8. Arain M, Campbell M J, Cooper C L, Lancaster G A. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol 2010; 10: 67.
Knowledge, attitude, motivation
Motivation
Social influences, Motivation, Belief about capabilities
Explore information on consequences (discussion around consequence)
Provide information about others’ approval
Determinants of behaviour
Theory of reasoned action, theory of planned behaviour, information motivation, behavioural skills model
Theory of reasoned action; theory of planned behaviour; socialcognitive theory
Information motivation, behavioural skills model
Link to theoretical framework
Information about what others think about the person’s behaviour and whether others will approve or disapprove of any proposed behaviour change
Information about the benefits and costs of action or inaction, focusing on what will happen if the person does or does not perform the behaviour
Information about behavioural risks e.g., susceptibility to poor health outcomes in relation to the behaviour; information about the benefits of action, focusing on what will happen if the person performs the behaviour in question
Definitions of BCTs Provide information about SHS, why it is harmful and to whom, etc. Positive messages about benefits Flip chart (slides 1–3) Initiate conversation about SHS, why it is harmful and to whom and the benefits of SFH with the smoker(s) at home Audio cassette/pictorial pamphlet Identification of perceived cost-benefit balance in relation to the discussion on SFH with smoker(s) in the household Flip chart (slides 4–6) Identification of perceived cost-benefit balance in relation to successful anti-tuberculosis treatment. Benefits as in better health outcomes for infants and children in the household as well as for pregnant women, if any, in the household Audio cassette/pictorial pamphlet The RA will discuss best practices around smoking/taking care of a sick person with the TB patient. The RA will share with the TB patient that a person who selfrestricts in consideration of a sick person will be considered a responsible and good person by others
Activity/process/materials
Application of a taxonomy of behaviour change techniques used in a smoke-free home intervention*
Provide information about behaviour health link
BCTs
Appendix Table
TB patient
Smoker(s)
TB patient
RA
TB patient
Smoker(s)
TB patient
RA
TB patient
Recipient
RA
Agent
TB and second-hand smoke
i
Prompt barrier identification
Prompt intention formation
BCTs
Appendix Table
Motivation
Determinants of behaviour
(continued)
Social cognitive theory
Theory of reasoned action, theory of planned behaviour, social cognitive theory, information motivation, behavioural skills model
Link to theoretical framework
Identify barriers to performing the behaviour and plan ways of overcoming them
Encouraging the person to decide to act or set a specific goal, e.g., to make a behavioural resolution such as ‘I will take more exercise next week’
Definitions of BCTs Activity/process/materials Flip chart (slide 7) The TB patient will discuss best practices for smoking/ taking care of sick person, with smoker(s)and share that a person who selfrestricts in consideration of a sick person will be considered a responsible and good person by others. Audio cassette/pictorial pamphlet Prepare and send text message/letter templates for smokers at home, presenting information on social norms. Understand and take into account the social norms of most TB patients and their family (only for Arm 2) Have a discussion with the TB patient to set a goal that they are confident they can achieve, such as raising the issue with smoker/family Use flip chart (slides 8–9) Have a discussion with smoker(s) to set a goal that they are confident they can achieve, such as smoking away from TB patient or smoking in veranda or smoking outside the house, etc. Audio cassette/pictorial pamphlet Identify/explore barriers to having the discussion with smoker(s) at home Check list and/or pictorial cards. Flip chart (10–13) to suggest steps to address common barriers
TB patient
Smoker(s) at home
RA
TB patient
TB patient
Smoker at home
Co-investigator
RA
Smoker(s)
Recipient
TB patient
Agent
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Motivation; attitude
Skills; motivation; knowledge
Set graded tasks
Determinants of behaviour
(continued)
Provide general encouragement
BCTs
Appendix Table
Social cognitive theory
Social cognitive theory
Link to theoretical framework
Set easy tasks and increase difficulty until target behaviour is performed
Praising or rewarding the person for effort or performance without this being contingent on specified behaviours or standards of performance
Definitions of BCTs Activity/process/materials The RA will do this exercise three times, i.e., on first contact (Month 0), second contact (Month 1) and first follow-up (Month 2) The TB patient will discuss the barriers to change in behaviour with the smoker(s) and encourage them to suggest solutions The RA will praise the intention and provide positive encouragement— building rapport during intervention and also during follow-up Placing SFH logo on TB01 patient card will also have an encouraging message The TB patient will praise the intention of the smoker for SFH and provide positive encouragement— building family engagement and praising resolve to go smoke-free Encourage the TB patient to identify small steps towards the goal of having the discussion about SFHs (4-week challenge). May want to discuss some suggestions and encourage the TB patient to come up with his own Flip chart (slides 14–15) Introduce SFH steps and 4week challenge: smoke away from TB patient – smoke in one room only – totally SFH – stay smokefree for at least 4 weeks Audio cassette/pictorial pamphlet
Smoker(s)
TB patient
Smoker(s)
TB patient
Smoker(s)
RA
TB patient
RA
TB patient
Recipient
TB patient
Agent
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Skills; social influences
Self-efficacy; skills; motivation
Model or demonstrate the behaviour/ rehearsal of relevant skills
Prompt specific goal setting
Determinants of behaviour
Motivation; memory
(continued)
Provide instruction
BCTs
Appendix Table
Control theory
Social cognitive theory
Social cognitive theory
Link to theoretical framework
Involves detailed planning of what the person will do, including a definition of the behaviour specifying timeframe, scope or duration and specification of at least one context, i.e., where, when, how or with whom
Telling the person how to perform a behaviour and/or preparatory behaviours (an expert shows the person how to correctly perform a behaviour, e.g., video/ role play)
Telling the person how to perform a behaviour and/or preparatory behaviours
Definitions of BCTs Verbally summarise the immediate steps to be taken by the TB patient, based on the strategy adopted by the TB patient to convince the smoker(s) at home to ensure a smokefree environment at home Flip chart (slide 16) The RA will write these tasks down on a specified place on the medicine box After discussion on SFH with the smoker(s) at home, the TB patient will verbally summarise the steps agreed to be taken by the smoker(s) Write down on a paper and place in a specific place provided on the medicine box The RA will perform a role play (or plan with the TB patient a scenario and dialogue between TB patient and smoker(s) at home, taking into account the expected barriers/ resistance (under consideration, feasibility of performing role play in hospital setting) The RA will add dates for completion of tasks written on the medicine box These dates will act as reminders to the TB patient to accomplish their task in time The TB patient will add dates as reminders against all steps agreed upon by the smoker(s) and written on medicine box
Activity/process/materials
TB patient
Smoker(s)
RA
TB patient
TB patient
Smoker(s)
TB patient
RA
TB patient
Recipient
RA
Agent
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Prompt selfmonitoring of behaviour
Prompt review of behavioural goals
BCTs
Appendix Table
Determinants of behaviour
Skills; attitude
(continued)
Control theory
Control theory
Link to theoretical framework
The person is asked to keep a record of specified behaviour(s) (e.g., in a diary)
Review and/or reconsideration of previously set goals or intentions
Definitions of BCTs When the patient comes for first follow-up at Month 2, the RA will prompt review of behavioural goals by reviewing the previously set goals pasted on the medicine box In case the goals could not be met, the RA will help the TB patient set new goals and place them on the medicine box The goals will be reviewed on subsequent visits Once the TB patient is successful in having a discussion with smoker(s) at home and setting goals for SFH, on subsequent discussion the TB patient will review the goals previously set by the smoker(s) and if not met, they will agree on new goals that will help move towards a SFH The RA will ask the TB patient to monitor his own behaviour by reviewing the tasks/goals written on the medicine box The TB patient will also teach the smoker(s) to monitor their own behaviour periodically to ensure SFH, for example, by using a calendar where they tick each day the home has been smoke-free
Activity/process/materials TB patient
Smoker(s) at home
TB patient
Smoker(s)
TB patient
RA
TB patient
Recipient
RA
Agent
TB and second-hand smoke
v
Memory, attention, decision process, action planning
Teach to use prompts or cues
Determinants of behaviour
Attitude; beliefs about consequences and capabilities
(continued)
Provide feedback on performance
BCTs
Appendix Table
Operant conditioning
Control theory
Link to theoretical framework
Teach the person to identify environmental cues that can be used to remind them to perform a behaviour, including times of day or elements of contexts
Providing data about recorded behaviour or evaluating performance in relation to a set standard or others’ performance, i.e., the person received feedback on their behaviour
Definitions of BCTs
On subsequent visits, the RA will review the goals mentioned on the medicine box If not achieved then ask what worked well/what did not work so well/ what could have been different Flip chart (slide 17) The TB patient will also review with the smoker(s) the goals written on the medicine box and discuss what worked well If we did not achieve what we could then suggest a change in strategy Append SFH logo and message to Patient TB01 card and record on appropriate place on patient card (TB02) This logo will also act as prompt to TB patient to initiate a conversation about SFH, for example, a reminder to initiate a conversation when the smoker next smokes inside the house in the presence of the TB patient The TB patient will place prompts/cues in the home to remind the smoker(s) to smoke outside the house. Prompts could be a calendar/no smoking signs, sticker on the mirror where the smoker brushes teeth in the morning
Activity/process/materials
TB patient
RA
TB patient
RA
Agent
Smoker(s)
TB patient
Smoker(s)
TB patient
Recipient
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Determinants of behaviour
Self-efficacy
Social influences
Plan social support or social change
Motivation; action planning
(continued)
Use follow-up prompts
Prompt practice
Agree on behavioural contracts
BCTs
Appendix Table
Social support theories
Operant conditioning
Operant conditioning
Link to theoretical framework
Prompt consideration of how others could change their behaviour to offer the person help or (instrumental) social support, including ‘buddy’ systems and/or providing social support
Contacting the person again after the main part of the intervention is complete
Prompt the person to rehearse and repeat the behaviour or preparatory behaviours
Agreement (i.e., signing) of a contract specifying behaviour to be performed so that there is a written record of the person’s resolution witnessed by another
Definitions of BCTs The RA will present an informal contract to the TB patient that reinforces the resolve to make their home smoke-free. The RA will read out the contract to the TB patient and obtain verbal agreement The TB patient will show the agreement to the smoker(s) at home, explain the agreement and obtain verbal agreement to make their home smoke-free Encourage the TB patient to rehearse discussion beforehand Flip chart (slide 18) Prepare the smoker(s) to think about dealing with specific situations such as when friends/relatives who are smokers visit Audio cassette/pictorial pamphlet The RA will follow up the TB patient twice after the intervention is completed: once in Month 2 and then in Month 6 and maintain record on the questionnaire (Under consideration, this is sensitive in our context, so we will try to find an alternative) The TB patient can involve an influential family member who can support the TB patient to influence smoker(s) Flip chart (slide)
Activity/process/materials
TB patient
Smoker(s)
TB patient
Smoker(s)
TB patient
RA
TB patient
RA
TB patient
Smoker(s) at home
TB patient
RA
TB patient
Recipient
RA
Agent
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Activity/process/materials The RA will explain to the TB patient that a smoker who chooses to smoke outside the home will be a role model for others The TB patient will explain to the smoker(s) that they will become role models for family members and relatives The RA will help the TB patient to identify possible triggers that could result in a relapse (resuming smoking in the house) The TB patient will identify possible triggers that could result in a relapse (smoking in the house) and discuss with the smoker(s), strategies to address them
Smoker(s) Smoker(s)
TB patient
Smoker(s)
TB patient Text message
RA
TB patient
Recipient TB patient
Agent RA
* Behaviour to be changed: smoking inside the home of a TB patient (non-smoker). The activities listed will be in the following scenario: Research Assistant TB patient Smoker (s) at home. BCT ¼ behaviour change technique; RA ¼ Research Assistant; TB ¼ tuberculosis; SHS ¼ second-hand smoke; SFH ¼ smoke-free home.
Relapse prevention therapy
Definitions of BCTs
Following initial change, help identify situations likely to result in readopting risk behaviour or failure to maintain new behaviours and help person plan to avoid/manage these situations
Self-efficacy; skills; beliefs about capabilities
Link to theoretical framework
Relapse prevention
Determinants of behaviour Indicating how the person may be an example to others and influence their behaviour or provide an opportunity for the person to set a good example
(continued)
Prompt identification as a role model
BCTs
Appendix Table
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RESUME
Le tabagisme passif est associ´e a` la tuberculose (TB). Il est n´ecessaire de prendre des mesures de protection des patients non-fumeurs de la fume´ e passive (SHS). Nous avons e´ labore´ une intervention comportementale afin d’encourager les patients tuberculeux a` mettre en œuvre des restrictions du tabagisme a` leur domicile au Pakistan. O B J E C T I F S : Evaluer la probabilit´e de succ`es d’une telle intervention et de pr´eparer une e´ tude de plus grande ampleur a` l’avenir. S C H E´ M A : Essai pilote randomis´e et control´ ˆ e dans lequel les patients tuberculeux non-fumeurs ont e´ t´e s´electionn´es au hasard pour b´en´eficier soit d’un «soutien individuel», soit de ce mˆeme soutien combin´e a` des «rappels familiaux». Nous avons recrut´e des patients vivant avec au moins un fumeur a` leur domicile. Notre CONTEXTES :
r´esultat principal e´ tait le dosage urinaire de nicotine, comme mesure de l’exposition a` la SHS, 2 mois apr`es la s´election. R E´ S U LT A T S : Parmi les 273 patients e´ valu´es pour leur e´ ligibilit´e, 150 (56%) ont e´ t´e recrut´es et tous sauf un ont e´ t´e retenus pour toute l’´etude. Une r´eduction absolue, statistiquement significative, a e´ t´e observ´ee en termes d’exposition a` la SHS pour les non-fumeurs, objectiv´ee par la nicotine urinaire, a` la fois dans le Bras 1 (71% ; IC95% 61–79) et le Bras 2 (76% ; IC95% 67–83) entre la mesure de d´epart et le suivi a` 2 mois. C O N C L U S I O N S : Le taux de recrutement et de r´etention observ´es dans cette e´ tude attestent de la faisabilit´e d’une e´ tude plus importante a` l’avenir. L’ampleur observ´e de l’effet justifie d’entreprendre cette nouvelle e´ tude.
RESUMEN M A R C O D E R E F E R E N C I A S: El tabaquismo pasivo se asocia con la tuberculosis (TB). Se precisan medidas que protejan del humo ajeno a los pacientes tuberculosos no fumadores. Se elaboro´ una intervencion ´ conductual encaminada a estimular a los pacientes tuberculosos a introducir restricciones al tabaquismo en el hogar, en Pakista´n. O B J E T I V O S: Evaluar la probabilidad de e´ xito de una intervencion ´ conductual de este tipo con el proposito ´ de informar la planeacion ´ de un estudio definitivo en el futuro. M E´ T O D O: Fue este un estudio preliminar comparativo y aleatorizado en el cual los pacientes tuberculosos no fumadores se distribuyeron en dos grupos, uno recib´ıa ‘apoyo individual’ exclusivo y en el otro grupo se enviaron adema´s ‘mensajes recordatorios a los familiares’. Se escogieron para el estudio pacientes que conviv´ıan como m´ınimo con un fumador. El criterio primario de evaluacion ´ fue la determinacion ´ urinaria de
cotinina, como medida de la exposicion ´ al tabaquismo pasivo, dos meses despu´es de la aleatorizacion. ´ R E S U L T A D O S: De los 273 pacientes en quienes se evaluaron los criterios de seleccion, ´ se incluyo´ 150 (56%), y todos permanecieron en el estudio hasta el final del mismo, con la excepcion ´ de un paciente. Se puso en evidencia una disminucion ´ estad´ısticamente significativa de la exposici on ´ al tabaquismo pasivo en los participantes no fumadores, medida mediante la determinacion ´ de la cotinina urinaria al comienzo del estudio y a los 2 meses de seguimiento, en el grupo que recibio´ un respaldo individual (71%; IC95% 61–79) y en el grupo que recibio´ mensajes recordatorios (76%; IC95% 67–83). ´ N: Las tasas de inclusion CONCLUSIO ´ y fidelizacion ´ de los participantes en este estudio preliminar hacen posible la realizacion ´ de un estudio definitivo en el futuro. La magnitud del efecto observado justifica la realizacion ´ del nuevo estudio.
