babe x protocol manuscript

7/28/2019 Babe x Protocol Manuscript

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A cluster randomised controlled trial of a brief tobacco

cessation intervention for low income communities in India:Study Protocol

Journal: Addiction

Manuscript ID: ADD-13-0114

Manuscript Type: Trial Protocol

Date Submitted by the Author: 12-Feb-2013

Complete List of Authors: Sarkar, Bidyut; University College London, Epidemiology and Public health;

Public Health Foundation of India, Future FacultyShahab, Lion; University College London, Epidemiology and Public healthArora, Monika; Public Health Foundation of India, Centre for Tobacco

control and Health PromotionLorencatto, Fabiana; University College London, NCSCTReddy, KSrinath; Public Health Foundation of India,West, Robert; University College London, Epidemiology and Public health

SUBSTANCE: tobacco

METHOD: clinical trials

FIELD OF STUDY: epidemiology

Keywords: tobacco cessation, intervention, trial, India, non-pharmacological

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A cluster randomised controlled trial of a brief tobacco cessation intervention for low

income communities in India: Study Protocol

Bidyut K Sarkar a,b

, Lion Shahab b

, Monika Aroraa, Fabiana Lorencatto

c, K Srinath Reddy

aand

Robert West b

aPublic Health Foundation of India, New Delhi, India

bDepartment of Epidemiology and Public Health, University College London, London, UK

c NCSCT, University College London, London, U.K

Reprints and correspondence: Bidyut K Sarkar; Address: Public Health Foundation of India,

New Delhi, India; E-mail: [email protected]; Tel: +91 9818196320

Running head: Brief tobacco cessation intervention trial

Word count: 3505

Declaration of Conflict of interest

BKS has a UKC-Wellcome trust capacity strengthening strategic award to PHFI and has no

conflict of interest to declare. MA and KSR have no conflict of interest to declare. LS has

received honoraria for talk and travel expenses from manufacturers of medications for

smoking cessation to attend meetings and workshops. FL has received travel funds and

hospitality from manufacturers of medications for smoking cessation. RW undertakes

consultancy and research for and receives travel funds and hospitality from manufacturers of

medications for smoking cessation.

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Abstract

Background: India has 275 million adult tobacco users and tobacco use kills more than a

million people in the country each year. There is an urgent need to develop and evaluate

affordable and scalable interventions to promote cessation of tobacco use. Since tobacco use

is so harmful, an increase of as little as one percentage point in long term quit success rates

can have an important public health impact. Brief advice from a physician has been shown to

have a small but meaningful effect on smoking cessation in developed countries. This study

aims to evaluate the effectiveness of a brief scalable smoking cessation intervention from a

trained health professional, to promote tobacco use cessation offered through outreach into

poor urban communities in India. It is the first such trial in a low-middle income country.

Methods/ Design: This is a pragmatic community based cluster randomised trial of tobacco

users with two arms. The treatment arm is a brief intervention comprising brief advice

including training in craving control using simple yogic breathing exercises (YBA) and the

control arm is very brief advice (VBA). Out of a total of 32 clusters, 16 clusters will be

allocated to the intervention arm and 16 clusters to the control arm. Each cluster will have 31

participants making a total of 992 participants. The primary outcome measure will follow the

Russell Standard: self-report of sustained abstinence for at least 6 months following the

intervention confirmed at the follow up by salivary cotinine. Secondary outcome measures

will be: 1-week point prevalence abstinence at the 7-month follow-up point confirmed by

saliva cotinine assessment; attempts to stop smoking between the intervention and the 1-

month follow up; 1-week self-reported point prevalence abstinence at the 1 month follow up.

The study will involve checks on fidelity of delivery of the intervention.

Discussion: This trial will inform national and international policy on delivery of a brief

outreach intervention as a scalable and affordable intervention for tobacco use cessation.

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Trial registration: ISRCTN23362894 Acronym BABEX




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Introduction

Background and objectives

India has 275 million tobacco users including 164 million smokeless tobacco users, 69

million smokers and another 42 million using both combustible and smokeless forms of

tobacco(1). Tobacco use is a risk factor for six out of the eight leading causes of death in the

world(2). Tobacco use kills 5.4 million people globally each year (3) and an estimated one

million people in India alone(4). Since tobacco use is so harmful, an increase of as little as

one percentage point in long-term quit success rates can have an important public health

impact (5).

Brief advice is a low cost intervention which can be delivered en masse by trained

counsellors, nurses and physicians (6). Systematic reviews have reported that brief advice to

quit has been shown to be better than no advice OR-1.66 (1.42-1.94), increasing 12 months

quit rates by1-3% (7-10). A recent review of quit advice for smoking cessation which

assessed brief interventions of less than 10 minutes without follow up counselling showed an

increase in the frequency of quit attempts RR-1.24 (1.16-1.33), and that offering assistance

generated more quit attempts RR-1.69 (1.24-2.31) than giving advice to quit on medical

grounds (11). Further, providing brief advice to all smokers, irrespective of their interest to

quit, has been reported “to be more effective than offering assistance only to those who

express an interest in doing so”(11). However, whilst there is extensive evidence for the

benefits of brief advice in the developed world, its effectiveness has yet to be evaluated in a

randomised trial in low or middle income countries, and the effect size of this type of

intervention in these settings is not known. Neither is it known whether such advice can

reduce smokeless tobacco use.

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Unlike in developed countries such as the UK where behavioural therapy and/or

pharmacotherapy is provided with no or little cost to patients in smoking cessation clinics,

there is a very limited support service available for quitting tobacco use in India. England is

at one extreme worldwide with complete coverage of the population with smoking cessation

support through its National Health Service (12). By contrast, India had established just 19

Tobacco cessation clinics (TCCs) with WHO support by 2010 for a country with 275 million

tobacco users, and even these few clinics were unable to provide free NRT or

pharmacotherapy(13). Hence, there is an urgent need to identify and evaluate low cost,

affordable, non-resource intensive, easily scalable interventions to promote cessation of

tobacco use in India.

In the context of these considerations, and the high cost of pharmacotherapy, a promising,

affordable and culturally appropriate option to enhance brief advice and aid smoking

cessation in the Indian context is the use of breathing exercises, known as “Pranayama”

within Yoga. Yoga originated in India as a traditional method of achieving good physical and

mental health. Therefore, yogic breathing exercises are expected to have a high degree of

acceptability as a tobacco cessation method. Although, relatively little research has been

undertaken to test the hypothesis directly that yogic breathing exercises may improve quitting

rates, the research that exists, is promising.

McClernon et al (14) observed that controlled deep breathing significantly reduces smoking

withdrawal symptoms, including craving for cigarettes and negative affect (being tense and

irritable), while resulting in the maintenance of baseline arousal levels (being wide awake,

able to concentrate). More recently, Shahab et al have reported a significant positive acute

effect of yogic breathing exercises in yoga-naïve smokers abstinent for at least 10 hours on

withdrawal symptoms (15). Given that there is good evidence that the experience of severe

cravings early on in quit attempts is an important mediator of relapse (16, 17), yogic




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breathing exercises may therefore increase smoking cessation rates. Indeed, Kochupillai et al

(18) reported a positive impact of yogic breathing exercises on tobacco abstinence and found

the 12 month abstinence rates of the yoga breathing exercises group to be similar to the

pharmacological agent Bupropion.

Given these promising findings and the need to adopt high-reach and less specialist based,

affordable methods for tobacco cessation in India and in the concomitant absence of

empirical data on the impact of brief interventions, such as quit advice, in low-to-middle

income countries (19), this trial aims to evaluate the effectiveness of a single session of face

to face quit advice with a single session training on yogic breathing exercises as a brief

intervention on tobacco users in low income communities in India to promote tobacco use

cessation. A cluster randomised design is adopted because of the risk of contamination

between conditions given the close nature of the communities and the non-feasibility and

ethical issues of individual randomisation within a community in a community based trial in

these settings.

Methods and design

Study Design and timing

This is a two arm cluster randomized trial comparing two interventions: the treatment arm is

a brief intervention consisting of a single face to face session of quit advice plus single

session training on yogic breathing exercises (YBA) and the control arm of very brief advice

alone (VBA). The participants will be followed up after one and seven months after the

intervention to assess tobacco use status (the primary and secondary outcomes).

The proposed study area has a total population of approx. 36,000 adults living in randomly

selected administrative blocks of 32 large slum areas of low income residents spread over a

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wide geographical area in the city of Delhi, India. Each of these blocks will be considered as

a cluster for randomisation in the study. Each of the selected low income administrative

blocks can be one of two types of community: an authorised government rehabilitation

known as “resettlement colony” with slightly better facilities and the other is an unauthorised

settlement known as “J.J. cluster”. J.J. stands for “Jhuggi-Jhopri” meaning huts in local

language. Equal numbers of both types of community were selected for inclusion in the

study.

Recruitment into the study started in January 2012 and it is currently ongoing. The study is

anticipated to conclude in September 2013.

Trial interventions and delivery

The intervention will be delivered at the individual level to participants in both arms. A

written standard operating procedure (S.O.P) will be followed. The treatment arm is a single

session of face to face quit advice including single session training in yogic breathing

exercises (YBA) and the control arm is very brief advice (VBA). For both groups, the

baseline interview will be conducted at the door step of the tobacco user’s residence and both

YBA and VBA will be delivered face to face either individually or, for YBA, in very small

groups of two to four participants using a standard script. All content is delivered in non-

technical and local language, i.e. Hindi. The scripts were translated in Hindi from English and

the interview questionnaire prepared in both English and local Hindi. The consent form was

translated from English to Hindi and also back translated to English.

The yogic breathing arm (YBA), a brief intervention comprising advice to quit and breathing

exercises will cover the following content:




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• Explain the important groups of chemicals present and released on smoking and

chewing tobacco and the specific diseases caused by tobacco use including cancer,

respiratory and cardiovascular diseases.

• Identify the personal health risks associated with the individual’s specific form of

tobacco use and also the economic burden and implications of tobacco use including

cost of hospitalization and treatment of tobacco use related diseases.

• Explain how quitting can reverse lot of the harm, and the benefits of early and

complete abstinence.

• Explain that the chances of success are higher with the use of some support as most

persons experience temporary withdrawal symptoms as well as the importance of

avoiding for a while places, situations and company which could precipitate relapse

and advise to quit within the next month. Advice to seek support of family members

and close friends in your quitting effort.

• Explain the support options available for quitting including medications such as NRT,

pharmacotherapy with cost implications and low cost non-pharmacological

interventions like yogic breathing exercises.

• Perform training in two yogic breathing exercises (Kapalbhati and Anulom-vilom)

with the help of a standard training video of breathing exercises (see Table 1 for

details on instructions).

• Check “receipt” (comprehension) of the intervention by the participant by a brief

practice session of breathing exercises by the tobacco user for 2-3 minutes. Ask to use

these breathing exercises once in the morning (both exercises) and then ( Anulom

Vilom) whenever they experience cravings for tobacco during the day. Provide a

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blank calendar and request to tick mark the dates on which they use the breathing

exercises to document “enactment” (adherence).

• Provide a handout of breathing exercise instructions in local language for reference.

• Inform will follow up after one month and again after 7 months.

For an assessment of the full effect of this brief intervention the control condition would

ideally involve no advice on tobacco use, but this was considered unethical by relevant

review boards. Therefore any effect size estimate produced by this trial is likely to be

conservative. Very Brief Advice (VBA) will cover the following content:

• Explain that tobacco use is very harmful and causes major diseases such as cancer.

• Explain that quitting is the most important step they can take for their health.

• State that will follow up after one month and 7months.

Descriptions of the content of the intervention and control conditions were coded into

component behaviour change techniques (BCTs) using the established taxonomy of smoking

cessation BCTs (20). BCTs identified at least once within each condition are listed in Table

2. BCTs marked with an ‘*’ have been shown to be significantly associated with improved

four-week CO-validated quit outcomes, and are therefore considered to be evidence-based

(21).

Fidelity of intervention

Fidelity will be promoted by following standard guidelines on checking delivery, participant

receipt and enactment (22). The brief intervention will be delivered by using a standard

checklist and script for advice to quit and use of a standard video for training in yogic

breathing exercises. The delivery team will consist of one trained health professional and two




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field health workers trained and initially supervised by the same health professional. The first

10 episodes of quit advice will be tape recorded and the recording checked against the script

by the trained health professional. If discrepancies are discovered at this stage, retraining will

be undertaken to increase fidelity to the protocol and script. The “participant receipt” of the

intervention will be checked by practice of breathing exercises by the participant in presence

of the person delivering the intervention. “Enactment” of the intervention or adherence by the

participant will be captured by requesting participants to tick mark on a blank calendar

provided as a handout after the intervention and checked at the 4 week follow up.

Randomisation

As low income blocks in the study area are stratified into two community types (“J.J cluster”

and “resettlement colony”), an equal number of each are identified for inclusion prior to

randomisation. Further, a list of all eligible tobacco user participants for recruitment is also

finalized within each cluster prior to randomisation of clusters to the intervention or control

arm.

The random sequence for allocation of clusters to the intervention and control arm is

independently generated by computer using a random number generator in SPSS software

with a uniform distribution and blocked so that an equal number of each community type are

allocated to the intervention and control condition. Therefore 16 clusters (8 from each

community type) will be randomly allocated to the yogic breathing exercises arm (YBA) and

16 clusters (8 from each community type) to the very brief advice (VBA) arm.

Participant recruitment

Following a census survey of each cluster, tobacco users identified will be invited for

participation in this trial. Each cluster will be divided into three to four geographical parts

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(streets/ lanes/ outer/ inner) comprising an equal number of households from which an equal

number of participants will be invited for participation. Those willing to provide consent will

be checked for fulfilment of the inclusion criteria given below and formal consent taken. In

case of multiple eligible participants in the same household, only one participant from each

household will be recruited.

Inclusion criteria:

• Any current self- reported daily user of any tobacco product

• Age of 23 years or more

• Willing to provide consent to participate.

• Residing in the study community at the time of the trial

Exclusion criteria:

• Pregnancy

As a previous research study conducted in the same area undertook interventions for tobacco

cessation in the age group 10-19 years - who would be 22 years old by the time recruitment

for the current study, is completed - an older age cohort is the target for inclusion to avoid

contamination with the previous research study. In addition, as the practice of yogic breathing

exercises involves abdominal movements, the effect of which has not been evaluated in

pregnant women, this group will not be advised to use them.

Consent

All participants are adults. Informed written consent will be taken from all participants.

Those who cannot read or write will be read out the patient information sheet and will be

requested to affix their thumb impression in the presence of a literate witness who will




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counter sign the consent form. Due to the nature of the intervention, blinding the participant

to the intervention would not be feasible. However, since all the participants in a cluster will

receive the same intervention, contamination is unlikely.

Measures

Baseline measures

At the first visit, tobacco users will be asked to provide socio-demographic information (age,

gender, occupation, education and income), information about their tobacco use history, any

previous quit attempts, knowledge, attitudes and quitting intentions, nicotine dependence and

screening for current depression. Nicotine dependence will be assessed with the Fagerstrom

test for nicotine dependence (FTND)(23) modified for smokeless users as proposed by Karl

Fagerstrom (24). Saliva samples will be collected for baseline salivary cotinine level

assessment of various forms of tobacco use in India in a randomly selected 30 percent of

participants in both arms.

Primary outcome measure

The primary outcome measure will follow the Russell Standard of self-reported abstinence: a

maximum of 5 cigarettes/Bidis or 5 times use of chewing tobacco (or any other form of

tobacco) in the 6 months preceding the follow up at 7 months after intervention delivery,

validated by salivary cotinine level of less than 20ng/ml. Cotinine will be assessed by ELISA

(25). As this tends to yield slightly higher levels than GC-MS because of inclusion of

metabolites (26), the usual cut-off for GC-MS of 13ng/ml was increased by the ratio of the

typical ELISA to GC-MS value.

Secondary outcome measures

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The secondary outcome measures will be one week point prevalence abstinence assessed at 4

weeks and 7 months after intervention delivery. Attempts to stop tobacco use will also be

documented. Further, immediately before and after the-intervention tobacco-related

cognitions (intention to stop tobacco use and self-efficacy regarding tobacco use cessation)

will be assessed using validated measures (27). Smokers will be asked to indicate their

intention to stop tobacco use in the next month on two 7-point Likert-type response scales

ranging from “very likely” to “very unlikely” or from “definitely will not” to “definitely

will”. Self-efficacy (the belief that one can do something, e.g., change a given behaviour) will

be assessed by asking participants on 7-point rating scales how confident they are to be able

to stop tobacco use (from “very confident” to “not at all confident”).

In addition, satisfaction with the yogic breathing exercises will be assessed immediately at

the end of the delivery of intervention in the YBA group only. Participants will also be asked

questions about the usefulness of yogic breathing and the frequency of use of these exercises

at the 4 week follow up.

Sample Size

For a two group comparison of proportions of a binary outcome with a standard alpha of

0.05, 390 individuals per group, or a total of 780 individuals, would provide 90% power to

detect a difference of 5% between the intervention (YBA) group (7%) and the control (VBA)

group (2%) in two-tailed analysis (28). As this sample size is based on individual

randomisation, this sample size has to be inflated for the design effect (Deff ) of clustering.

The sample size taking into account the clustering designated as mcluster is obtained by

multiplying the individual randomisation sample size by the design effect. Therefore, the

sample size required is calculated as mcluster = Deff x m individual. The design effect is calculated

as = 1 + (n* - 1) x ICC where n* = average cluster size and ICC = intra-cluster correlation co-




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efficient. The ICC is defined as the ratio of the between cluster variance to the total variance.

Since there are no directly applicable values of ICC for our study, it is advised to calculate

the sample size for a range of design effects.

Intra-cluster correlation co-efficient values in the public health context are typically very

small at around 0.001 (28). Given the fixed number of clusters and estimates from the

uncorrected power analysis, the average cluster size is approximately 24.4 [=780/32],

resulting in a design effect of 1.024 [=1+ (25-1) x0.001] or, using an ICC a magnitude larger

at 0.01, in a design effect of 1.24. The required total sample size to detect an effect with 90%

power is therefore 967 [=780x1.24], i.e. around 484 participants in each arm, or a minimum

of 30.2 [=967/32] participants from each cluster, assuming equal cluster size. Rounding this

off to the next whole number, it is proposed to recruit a total of 992 [=31x32] participants

into this study. This sample size provides sufficient power at 90% to detect significant

differences for an expected design effect of 1.24 and at 80% power for correspondingly

higher design effects of up to 1.84 (or ICCs of up to 0.035).

Data analysis and management

Case report forms (CRF) will be prepared. All data will be entered directly into the CRF;

there will be no other source documents. Data entry will be into an SPSS database. Data will

be cleaned to check for any data entry errors or inconsistencies prior to analysis. On

completion, data will be analysed using the SPSS statistical package. The database will be

prepared with English labels and variable names. Data analysis will be undertaken by the

investigators and members of the study team as appropriate.

Main analysis

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An intention to treat analysis will be conducted to account for any participants lost to follow

up. The odds ratio and 95% confidence interval for tobacco cessation rates, provided by the

primary and secondary outcome, in the intervention compared with control condition will be

calculated with univariate logistic regression analysis using complex samples procedure to

adjust for clustering. In sensitivity analysis, both groups will also be compared using a

complex samples multivariate logistic regression model, adjusting for all baseline

characteristics, in order to account for chance imbalances in the distribution of predictive

baseline characteristics. Comparisons on other secondary outcomes will be by complex

samples chi-square, logistic regression or analyses of variance depending on the scale of

measurement.

Subgroup analyses

Planned subgroup analyses will involve separate estimation of effect sizes for users of

smokeless and combustible tobacco products.

Discussion

This study is set up to be a pivotal trial evaluating a low cost, easily scalable, non-

pharmacological intervention for supporting adult tobacco users to quit tobacco use,

specifically designed for application in low to middle income countries such as India.

It attempts to follow the MRC guideline for developing and evaluating complex interventions

which states that “complex interventions may work best if tailored to local circumstances

rather than being completely standardised” (29). Ideally a no-intervention control arm would

be included to test the full effect of the experimental intervention. However, in anticipation

that this would be considered unethical, a very brief advice condition is used as the control.

Thus the effect of the experimental intervention may be underestimated. Moreover, it is




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recognised that the design will not permit dissociation of the effect of the breathing exercises

from quit advice. However, a three-arm trial would be too costly. Since the priority at this

stage is to identify a cost-effective, scalable intervention that is maximally effective, this

pragmatic study design was adopted.

Quit advice has been proven to be slightly more effective if there are follow up sessions (9),

but since follow up sessions would not be an easily scalable intervention, only a single quit

advice session without any follow up visits was selected for evaluation. Following the same

rationale, only a single session of training for simple beginner level, effective, yogic

breathing exercises instead of multiple training sessions for yogic breathing exercises were

adopted for this study.

If the intervention is found to be effective, it could inform tobacco cessation support policy at

the national and international level by providing a low cost, non-physician dependent, easily

scalable option for the government to deliver to the 275 million tobacco users in India and

benefit millions of tobacco users in the country to quit.

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Governance and Ethical considerations

The trial will conform to the UCL ethical procedures and subject to oversight by the UCL

Ethics Committee, London, U.K. and PHFI Ethics Committee, New Delhi, India. UCL Ethics

Registration ID: 3051/ 002; Data Protection Registration: Ref No Z6364106/ 2011/ 05/ 37.

The study has received approval from UCL Research Ethics (3051/002 dated 20 Oct’2011)

and Institutional Ethics Committee, Public Health Foundation of India, New Delhi, India

(TRC-IEC-122/11 dated 23 Feb’2012). The protocol has also been registered at ISRCTN

with trial registration No: ISRCTN23362894 and acronym BABEX.

Funding

This work was supported by a Wellcome Trust Capacity Strengthening Strategic Award to

Public Health Foundation of India & a consortium of U.K Universities (WTP grant reference

no: 6936) with additional support from Cancer Research, U.K.




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complex interventions: the new MRC guidelines. British Medical Journal. 2008;337:a1655.




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Tables

Table 1: Breathing exercise instructions^

KAPALBHATI

Normal inhalation-forceful exhalation

(1-2 minutes-on empty stomach once in

morning)

ANULOM VILOM

Alternate nostril inhalation-exhalation

(3 minutes in morning and then for

cravings during the day)

• Start by breathing deeply: inhale

slowly and deeply filling up your

abdomen, then fill up your rib

cage up to your collar bone and

then exhale slowly, emptying

your rib cage and then pull in

your abdomen emptying it fully.

Repeat a few times.• Now, inhale your breath

naturally and exhale forcefully

(moderate force) with drawing

in/ pulling in of the abdomen

• Do this natural inhale- forcefully

exhale cycle repeatedly for a

period of 1 minute and then rest

by breathing normally.

• Do this for one minute at a time,rest by normal breathing in

between to a total duration of 2

to 3 minutes for the first few

days and then you can gradually

increase the duration.

• Increase the duration to 5

minutes over a period of 2

months.

• Do not strain yourself and stop atany point time if you feel

exhausted.

• Rest by breathing normally for

half a minute before next

exercise.

• Sit in a comfortable position with

the back straight and upright

• Fold the fore and middle fingers

of your hand into the palm and

position your hand on the bridge

of your nose to enable use of your

thumb and the ring finger to close

the nostrils alternatively.• Close the right nostril with the

thumb of your right hand and

breathe in deeply inhaling through

the left nostril, then close the left

nostril with your ring finger and

release the thumb from the right

nostril and now exhale through

the right nostril

• Then inhale through the rightnostril, close the right nostril and

exhale through the left nostril

• Now inhale through the leftnostril, close the left nostril and

exhale through right nostril.

^ In this study a set of two simple, beginner level breathing exercises will be taught to participants.

These breathing exercises are based on yogic “pranayama” recommended by Yoga Guru Swami

Ramdev, Haridwar, India, for use for the general population. The participants will be shown a shortvideo demonstration of the breathing exercises and will then be trained to undertake the exercises on

their own for about 5 minutes.The breathing exercises should be done in an upright sitting position. This

can then be repeated during the day based on need and feasibility.

Page 20Addiction



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Table 2: BCT analysis of intervention and control conditions of the BABEX trial

INTERVENTION CONDITION

(Brief advice + yogic breathing)

CONTROL

(Very brief advice)

BM1- provide information on the

consequences of smoking and smoking

cessation

BM1-provide information on the

consequences of smoking and smoking

cessationBM5- Provide normative information on

others’ behaviours and experiences

RC4- Provide expectations regarding the

treatment programme

BM9- Help identify reasons for wanting

and not wanting to stop smoking

*BS2- Relapse prevention and coping

BS3- facilitate action planning/develop

treatment plan

BS6- prompt self-recording

BM10- Emphasise the importance of

abrupt cessation

BS11- Advise on avoidance of cues for

smokingBS14- Teach relaxation techniques

*A1- Advise on stop smoking

medications

*A2- Advise on/facilitate use of social

support

RC4- Provide expectations regarding the

treatment programme

RC5- offer/direct towards appropriate

written materials

RC6- provide information on withdrawal

symptoms

*RC9- Summarise information/ confirm

client decisions

*Indicates BCT shown to be associated with improved four-week CO-validated quit outcomes in English

Smoking Cessation services (21)


babe x protocol manuscript

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