Appendix C The evidence

Introduction

This appendix lists the evidence statements from 2 reviews which were combined into 1 report and provided by an external contractor (see appendix A and appendix E). It links them to the relevant recommendations. See appendix B for the meaning of the (++), (+) and (-) quality assessments referred to in the evidence statements.

This appendix also sets out a brief summary of findings from the economic analysis.

The evidence statements are short summaries of evidence in a review.

Evidence statement number 1 indicates that the linked statement is numbered 1 in the review 'Systematic review of effectiveness of smokeless tobacco interventions for South Asians and a review of contextual factors relating to smokeless tobacco use among South Asian users and the views of healthcare providers'.

The review and economic analysis are available at the NICE website. Where a recommendation is not directly taken from the evidence statements, but is inferred from the evidence, this is indicated by IDE (inference derived from the evidence).

Where the Public Health Interventions Advisory Committee (PHIAC) has considered other evidence, it is linked to the appropriate recommendation below. It is also listed in the additional evidence section of this appendix.

Recommendation 1: Evidence statements 32, 34, 35.

Recommendation 2: Evidence statements 16, 17, 18.

Recommendation 3: IDE

Recommendation 4: Additional evidence (West et al. 2004).

Recommendation 5: Evidence statements 2, 3, 5, 33, 34, 42.

Recommendation 6: Evidence statements 27, 43, 44.

Evidence statements

Please note that the wording of some evidence statements has been altered slightly from those in the evidence reviews to make them more consistent with each other and NICE's standard house style. The superscript numbers refer to the studies cited beneath each statement. The full references for those studies can be found in the reviews.

Evidence statement 2 Behavioural support – counselling alone

Brief advice and encouragement

There was moderate evidence from one (+) UK quasi-experimental study1 that brief advice and encouragement can have a positive effect on quitting tobacco among South Asians. Findings showed that of those who completed the 4-week Bangladeshi Stop Tobacco Project (BSTP) and reported successfully quitting tobacco, 17% used brief advice and encouragement without nicotine replacement therapy (NRT) as their method of cessation. This evidence is applicable to a UK setting as this study was conducted in the UK.

Focus group discussions

There was weak evidence from one (-) Indian interventional cohort study2 that focus group discussion sessions had a positive effect on self-reported tobacco quit rates in South Asians. Quit rates following the first, second, third, fourth, fifth and sixth focus group sessions of the World No Tobacco Day (WNTD) cessation programme were 30%, 44%, 48%, 46%, 46% and 48% respectively – with an overall quit rate of 40% at the end of the study. This evidence is partially applicable to people of South Asian origin living in the UK who may have maintained cultural and social practices related to smokeless tobacco use.

1 Croucher et al. 2003a

2 Mishra et al. 2009

Evidence statement 3 Behavioural support – counselling and pharmacotherapy

There was moderate evidence from one (+) UK quasi-experimental study1, one (+) UK retrospective review of client records2 and one (-) Indian interventional cohort study3 that behavioural support and pharmacotherapy in combination can have a positive effect on stopping tobacco use among South Asians. One (+) study2 found that use of NRT with behavioural support was an independent predictor of a successful cessation attempt (odds ratio [OR] = 5.38, 95% confidence interval [CI] 2.71, 10.70), while another (+) study1 found that at the end of the 4-week BSTP cessation programme, 19.5% of completers had stopped tobacco use – of which 22% had received NRT in addition to behavioural support. Furthermore, BSTP clients who chose the addition of NRT made a significantly greater reduction in their salivary cotinine scores at final review compared to baseline.

In the (-) study of the WNTD cessation programme3, five tobacco users were offered pharmacotherapy. One employee quit tobacco while two employees did not comply with the pharmacotherapy because of side effects following the use of bupropion. The overall quit rate among the pharmacotherapy and behavioural support group was 20% .This evidence is partially applicable to UK settings and to people of South Asian origin living in the UK who may have maintained cultural and social practices related to smokeless tobacco use.

1 Croucher et al. 2003a

2 Croucher et al. 2011c

3 Mishra et al. 2009

Evidence statement 5 Adverse events and withdrawal symptoms

There is moderate evidence from one (+) UK quasi-experimental study1, one (+) UK pilot study2, one (-) UK progress review study3 and one (-) Indian interventional cohort study4 that adverse events and withdrawal symptoms can affect quit success among South Asians. Interim results from a study of the BSTP3 reported that clients who experienced a lower mean number of withdrawal symptoms or lower mean number of adverse events at first follow-up at 2 weeks were more likely to make a successful quit attempt. Another (+) study2 found that BSTP clients with fewer withdrawal symptoms at first follow-up was significantly associated with a successful quit attempt (p = 0.005). Fewer NRT-related adverse events at first follow-up were also significantly associated with a successful quit attempt (p = 0.028) while those reporting oral pain and discomfort at first follow-up were less likely to make a successful quit attempt (p = 0.034). One (+) study1 found that oral pain was reported as a barrier to successful oral tobacco cessation by 62% of the volunteers at final review.

The (-) study4 of the WNTD programme showed that employees who relapsed after initial quitting stated physical discomfort like constipation as a reason for relapse and not achieving successful cessation. This evidence is partially applicable to UK settings and to people of South Asian origin living in the UK who may have maintained cultural and social practices related to smokeless tobacco use.

1 Croucher et al. 2003a

2 Croucher et al. 2011b

3 Croucher et al. 2011a

4 Mishra et al. 2009

Evidence statement 16 Local community-based initiatives to raise awareness: tobacco use prevalence rates

There is moderate evidence from one (+) Indian randomised controlled trial (RCT)1 that showed tobacco education interventions which raise awareness about the harmful effects of tobacco can have a positive effect on prevalence rates of tobacco use among South Asians. Post-intervention, results from the Anti-Tobacco Community Education Program (ATCEP) showed a decline in rates from baseline to final assessment at 3 years – with a 10.2% decrease for males in the experimental area compared to 2.1% and 0.5% decrease in the control areas (p < 0.0001). For females, there was a 16.3% reduction in the experimental area compared to 2.9% and 0.6% in the control areas (p < 0.0001). Post-intervention, there was a 5.6% reduction in the percentage of males who reported tobacco chewing compared to 1.2% and 0% reduction in the control areas (p < 0.0001) This evidence is partially applicable to people of South Asian origin living in the UK who may have maintained cultural and social practices related to smokeless tobacco use.

1 Anantha et al. 1995

Evidence statement 17 Local community-based initiatives to raise awareness: initiation rates of tobacco use

There is mixed evidence from one (+) Indian RCT1 that showed tobacco education interventions which raise awareness about the harmful effects of tobacco can have a positive effect on decreasing initiation rates of tobacco use among South Asians. Baseline initiation rates of tobacco use from the ATCEP showed that male rates were comparable between the experimental and control areas. However, the rate among females was different. Initiation rates of tobacco use in the experimental area showed a statistically significant decline in males (p < 0.01) and females (p = 0.005) between the baseline and the first follow-up surveys at 2 years. At the final 3-year assessment, males in the first control area did not show a statistically significant decline in the initiation rate (p = 0.16). At the final 3-year assessment, the initiation rate of chewing among males was 0.2% and that of smoking 0.1% in the experimental area. In control area one, the initiation rate of chewing was 0.1% compared with 0.3% for smoking. In control area two, the initiation rates were 0.4% and 0.9% for chewing and smoking respectively. This evidence is partially applicable to people of South Asian ancestry living in the UK who may have maintained cultural and social practices related to smokeless tobacco use.

1 Anantha et al. 1995

Evidence statement 18 Local community-based initiatives to raise awareness: quit rates

There is mixed evidence from one (+) Indian RCT1 that showed tobacco education interventions which raise awareness about the harmful effects of tobacco can have a positive effect on increasing quit rates of tobacco use among South Asians. Results from the ATCEP indicated that the numbers and rates of persons who had quit using tobacco at the time of first repeat survey at 2 years was much higher in the experimental area compared with the control areas (in males, 26.5% in the experimental area versus 3.2% and 1.1% in control areas one and two, respectively; and in females, 40.7% in the experimental area versus 2.4% and 0.2% in control areas one and two, respectively). By the end of follow-up at 3 years, results from the experimental area showed a decrease in quitters by 4.0% in females and no change in the rate for males. The quit rate among male chewers also showed a decrease over time as well – with the percentage of quitters declining from 32.0% to 30.2% between the first follow-up survey at 2 years and the final survey at 3 years. This evidence is partially applicable to people of South Asian origin living in the UK who may have maintained cultural and social practices related to smokeless tobacco use.

1 Anantha et al. 1995

Evidence statement 27 Deliverers of intervention components

There is moderate evidence from one (+) Indian cluster RCT1 study that showed tobacco preventive interventions delivered by teachers and peers can have a positive effect on intervention outcomes. A process evaluation of project 'Mobilizing youth for tobacco—related initiatives in India' (MYTRI) found that the proportion of teachers trained in a school correlated with better implementation of objectives (r = 0.58, p < 0.02) and superior communication between peer leaders and students (r = 0.75, p < 0.001). It was also of greater benefit in lowering the susceptibility to chewing tobacco (r = 0.53, p < 0.05). Furthermore, the communication between students and peer leaders (r = 0.66, p < 0.005) and higher proportion of students participating in the classroom discussions (r = 0.70, p < 0.005) correlated with better outcomes. Schools with a higher proportion of teachers trained also had better communication between the students and peer leaders. This evidence is partially applicable to people of South Asian origin living in the UK who may have maintained cultural and social practices related to smokeless tobacco use.

1 Goenka et al. 2010

Evidence statement 32 Characteristics of users

Moderate evidence from eight UK studies including two reports (both [+])1,2 and six cross sectional surveys (four [+])3,4,5,6; (two [++])7,8 reported on how many respondents used smokeless tobacco. One (+) study2 showed that 8% of the South Asians in Leicester used smokeless tobacco products. Another (++) study8 found that 30% of Bangladeshi men within Tower Hamlets were users of smokeless tobacco. Another (+) study6 showed that betel-quid use was highest in Hindus from Leicester (21%) followed by 5% of Muslims and Jains. In a (+) Bangladeshi sample from Tower Hamlets5, 78% chewed paan, with 52% adding tobacco. In another (++) study in Tower Hamlets7 half (49%) of female Bangladeshis used smokeless tobacco. A separate (+) Tower Hamlet study3 reported betel quid chewing was over 80% with no gender difference, and tobacco was added to paan by more women (43%, n = 32) than men (29%, n = 19) (p = 0.09). In an (+) East London study4, 28% of Bangladeshi adolescents sampled used betel quid, with 12% adding tobacco.

1 HDA 2000

2 Rees 2007

3 Ahmed et al. 1997

4 Bedi and Gilthorpe 1995

5 Pearson et al. 1999

6 Vora et al. 2000

7 Croucher et al. 2002

8 Croucher et al. 2007

Evidence statement 33 Social acceptability

Moderate evidence from one (+) UK qualitative study1 set in Tower Hamlets and two UK cross-sectional studies (both [+])2,3 set in Birmingham and Tower Hamlets examined social acceptability of smokeless tobacco use among the genders. The studies found that smokeless tobacco is traditionally and culturally more appropriate for the female gender among South Asian communities. One (+) study2 found that females appeared to be more accepting of their own chewing habits, while men did not, and there was a general consensus that children should not be using betel quid.

1 Croucher and Choudhury 2007

2 Ahmed et al. 1997

3 Bedi and Gilthorpe 1995

Evidence statement 34 Gendered use patterns

Contradictory evidence was found regarding gendered patterned use of smokeless tobacco in four UK cross-sectional studies (all [+])1,2,3,4. In a (+) Birmingham study1 there were similar levels of betel quid use for Bangladeshi men (92%) and females (96%). In a (+) study set in East London3, similar betel quid use between genders in a Bangladeshi sample was noted. In contrast, in the (+) Birmingham study1 more Bangladeshi women (81%) added tobacco to their quids than men (37%). Furthermore, a (+) Tower Hamlets study2 reported a greater proportion of Bangladeshi women were chewing more than men, and females were more likely to add tobacco to their paans than males (p < 0.01). According to a (+) Yorkshire study of first generation Bangladeshi women4, paan was used by 95% (282/295) of women and 62% (174/295) of paan users added leaf tobacco.

1 Bedi and Gilthorpe 1995

2 Pearson et al. 1999

3 Prabhu et al. 2001

4 Summers et al. 1994

Evidence statement 35 Onset of use

Moderate evidence from one (+) UK qualitative report1, and four UK cross-sectional studies (all [+]) 2,3,4,5 investigated the age and location of onset of smokeless tobacco use. Smokeless tobacco use was more prevalent among older South Asians; however, younger UK-born South Asians are using smokeless tobacco products1. In a (+) Tower Hamlets study2, 75% of smokeless tobacco users started in Bangladesh, but 25% of both sexes started chewing paan in London and were younger (average age 34 years) than those who started in Bangladesh (average age 44 years). The mean age of onset of Bangladeshi users in Tower Hamlets was aged 20 years (range 6–56). By 17 years 50% were chewing paan, with more males commencing chewing paan by 15 years of age than females (p < 0.05)3. According to evidence from a (+) study in East London4, the median age of first chewing was as early as age 9 with most (86%) starting their chewing habits while living in London. In a (+) Yorkshire study5, 18% (51/295) were chewing by age 10 years with a mean onset of 17 years.

1 HDA 2000

2 Ahmed et al. 2007

3 Pearson et al. 1999

4 Prabhu et al. 2001

5 Summers et al. 1994

Evidence statement 42 Substitution for cigarettes

Moderate evidence from one (+) UK qualitative paper1 revealed younger Bangladeshi men from Tower Hamlets may use paan as a way to obtain tobacco without smoking cigarettes, although problems of addiction to smokeless tobacco may still be present, making quitting difficult.

1 Croucher and Choudhury 2007

Evidence statement 43 Awareness and advice from dentists

Moderate evidence from two UK cross-sectional survey studies (both [+])1,2 of dental professionals in the UK examined awareness and advice of dental professionals. Dentists from Harrow were almost twice as likely to neglect to offer areca cessation to patients than neglect to provide smoking tobacco cessation counselling, citing that awareness of the issues and lack of understanding of support needed was a barrier2. Of dentists that were aware of oral health impacts caused by smokeless tobacco use, half believed that it was a significant problem for their patients and this was especially true for dentists in Bradford and Kirklees than in Leeds1.

1 Csikar et al. not published

2 Nathan 2010

Evidence statement 44 Barriers and support needed for practitioners

Moderate evidence from three UK cross-sectional survey studies (all [+])1,2,3 examined barriers and support needed for counselling on smokeless tobacco. In a (+) survey of Yorkshire dentists1: 75% (279/372) wanted access to resources; 32% (90/372) required information on discussing smokeless tobacco; 30% (84/372) wanted waiting room resources; 22% (62/372) indicated assistance with oral cancer detection and 15% (43/372) wanted training. Another (+) study2 revealed that dentists had a lack of information about counselling and did not feel equipped to help. Ethnicity of dentists plays a role in counselling as 75% of Asian/African dentists were more likely to provide support than white dentists (43%) (p < 0.006). The (+) Tower Hamlets study3 showed that language barriers between South Asian clients and practitioners exist, as 73% of first generation Bangladeshi Tower Hamlets residences experienced language issues while visiting health professionals, with more females (94%) than males (58%) experiencing this problem (p < 0.001); resulting in only 20% registered with a dentist, and only 33% had visited a dentist in the past year, while 25% never visited a dentist.

1 Csikar et al. not published

2 Nathan 2010

3 Pearson et al. 1999

Additional evidence

West R, McNeill A, Raw M (2004) Smokeless tobacco cessation guidelines for health professionals in England. British Dental Journal 196 (10): 611–8.

Economic modelling

The review of economic evaluations did not identify any studies of interventions to help South Asian populations in England quit using smokeless tobacco. Instead, an economic analysis was undertaken to estimate the long-term costs and effects if someone stops using these products.

Four disease models (for cardiovascular disease, oral cancer, pancreatic cancer and periodontal disease) were combined in a single framework. To estimate the costs and effects of quitting the use of smokeless tobacco, an average person was compared with someone at increased risk of these diseases due to using these products.

The results differed according to age: the older the person was, the smaller were the expected health gains and the resulting savings. The results also differed by gender, with females expected to gain more benefits for a lower cost. However, when a discount rate was applied to the cost and effects, the results changed. With discounting, the expected savings appeared greatest around the age of 50 for both males and females – and for each of the three diseases modelled.

The maximum costs per quitter for a strategy to be called 'cost effective', when using a limit of £20,000 or £30,000 per quality-adjusted life year (QALY), may depend on age and gender. For someone aged between 20 and 70 years, the cost per quitter ranged from £1758 to £3525 for males, and from £1328 to £2520 for females (when the QALY threshold was set at £20,000). At a QALY threshold of £30,000, the cost ranged from £2408 to £4991 for males and from £1795 to £3549 for females.

However, the estimates need to be treated with caution due to the severe data limitations:

  • lack of published evidence on the effectiveness of interventions

  • lack of data on the incidence and mortality associated with the types of smokeless tobacco used in England and, importantly, used predominantly by South Asians in England

  • uncertainty about the time lag between quitting and gaining any health benefits – and the extent to which the damage from smokeless tobacco is irreversible.

Fieldwork findings

Fieldwork aimed to test the relevance, usefulness and feasibility of putting the recommendations into practice. PHIAC considered the findings when developing the final recommendations. For details, go to the fieldwork section in appendix B and 'Helping people of South Asian origin to stop using smokeless tobacco: fieldwork report'.

Fieldwork participants who work with smokeless tobacco users of South Asian origin were very positive about the recommendations and their potential to help promote cessation.

Many participants stated that the guidance would be an important step towards raising the problem of smokeless tobacco use among both professionals and the wider community. Some of the recommendations were considered easy to implement, while others would face potential barriers, including funding and lack of practitioner time, motivation and knowledge.

Participants welcomed the advice to integrate smokeless tobacco cessation services within mainstream smoking cessation services.

The voluntary and community sectors were both seen as an important 'way in' to working with local communities. Participants noted that religious institutions, in particular, are an important lever for raising awareness. Overcoming the cultural issues associated with the use of smokeless tobacco products was seen as a key challenge.

Participants suggested the need to make reference to the new public health organisations and structures, post-2013, to help improve clarity and feasibility (this includes clinical commissioning groups [CCGs] and health and wellbeing boards [HWBs]). They also suggested giving more guidance on who should be responsible for recording health outcomes.

  • National Institute for Health and Care Excellence (NICE)