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Stakeholder Organisation British Medical Association (BMA) Evidence submitted BMA letter.pdf Section Comments Please insert each new comment in a new row. 4.3 Question: Which interventions are effective and cost effective in helping women to quit smoking immediately before or during pregnancy and following childbirth? Education from an early age is essential to increase awareness of the serious implications of smoking during pregnancy and following childbirth. Health promotion and advice the role of healthcare professionals Healthcare professionals have a vital role in providing information to parents about the risks that smoking during pregnancy, parental smoking and exposure to second-hand smoke (SHS) can cause to their children s health. There is strong evidence that brief advice from a doctor increases quit rates in the general population. 1 A review from 2004 concluded that advice from nurses could also have a positive impact on quit rates. 2 Response Please respond to each comment Thank you for your letter of support and detailed feedback. We will pass these and your references to the collaborating centre undertaking the reviews of effectiveness and costeffectiveness. You may also be interested to know that stakeholder comments are circulated to the independent Public Health Intervention Advisory Committee (PHIAC) responsible for developing the guidance and recommendations. Healthcare professionals have a responsibility to help their patients to stop smoking. This includes providing opportunistic interventions, support and advice on how to quit, prescribing appropriate treatment such as NRT, and referral to specialist smoking cessation services where necessary. Cont d 1 Silagy C (2004) Physician advice for smoking cessation. Cochrane Database of Systematic Reviews 2004, Issue 4. 2 Rice VH & Stead LF (2004) Nursing interventions for smoking cessation. Cochrane Database of Systematic Reviews 2004, Issue 1. 1

British Medical Association (BMA) 4.3 Cessation in pregnancy A Cochrane review 3 of smoking cessation interventions for pregnant women shows that they can make a difference. Overall, this amounts to an additional six women quitting in every 100. The most successful strategies involve social support and a rewards system. In these groups an additional 23 women in every 100 quit. The review also shows that cessation can make a difference to neonatal health outcomes. The interventions lead to a mean increase in birth-weight of 33g, a reduction in low birth-weight rates by 19 per cent and reduced premature births by 16 per cent. Use of pharmacotherapies to help pregnant women stop smoking In 2005, the UK Committee on Safety of Medicines (CSM) and Medicines and Healthcare Regulatory Authority (MHRA) licensed NRT for use in pregnant women. Research in Wales suggests that three quarters of women want to stop smoking when pregnant, and that more than two thirds (68%) would find it acceptable to be prescribed 4 3 NRT. The recent Cochrane review showed that interventions using NRT were similar in effectiveness to other interventions (i.e. that they led to an additional six women in every hundred quitting). The data were very limited however, and more research is needed. The MHRA guidance 5 notes that, although there is little clinical research about the use of NRT in pregnancy, the known dangers of smoking are likely to outweigh the potential risks of using nicotine in pregnancy. Cont d 3 Lumley J, Oliver SS, Chamberlain C et al (2004) Interventions for promoting smoking cessation during pregnancy. Cochrane Database of Systematic Reviews 2004, Issue 4. 2

British Medical Association (BMA British Medical Association (BMA) It is recommended that pregnant women should stop smoking without using NRT if possible, but that NRT may be prescribed if it is needed to help pregnant women to stop smoking. 4.3 Important factors for supporting pregnant smokers to quit A 2006 English study 6 identified three beacon services for smoking cessation in pregnancy. Their success rates ranged from 35 per cent to 48 per cent of smokers setting a quit date being abstinent at four weeks. The authors identified the following factors as being important: local midwives make most of the referrals (training for midwives centres on how to refer smokers, rather than how to treat them) NRT is offered to almost all pregnant smokers, and an efficient prescription system is in place flexible home visits intensive multi-session treatment by a small number of key staff. 4 Griffiths AN, Woolley JL, Avasarala S et al (2005) Survey of antenatal women's knowledge of maternal and fetal risks of tobacco smoking and acceptability of nicotine replacement products in pregnancy. Journal of Obstetrics and Gynaecology. 25: 432-4. 5 Medicines and Healthcare products Regulatory Agency (2006) Report of the committee on safety of medicines working group on nicotine replacement therapy. 6 Lee M, Hajek P, McRobbie H et al (2006) Best practice in smoking cessation services for pregnant women: results of a survey of three services reporting the highest national returns, and three beacon services. Journal of the Royal Society for the Promotion of Health 126: 233-8. 3

British Medical Association (BMA) 4.3 Question: Which interventions are effective and cost effective in preventing women who have quit smoking to take up the habit again during pregnancy and following childbirth? Women who quit smoking while pregnant have very high rates of relapse after giving birth. Between 70 per cent and 85 per cent of women who quit while they are pregnant begin smoking again after their baby is born. 7 There is very little evidence about how to prevent smokers who have quit successfully from beginning to smoke again. 8 A Cochrane review of stop smoking interventions in pregnancy found none that reduced relapse 3 rates. A review in 2004 8 of smoking cessation programmes aimed at pregnant women smokers concluded that the risk of relapse may be reduced if the following considerations are incorporated into interventions: smoking habits of partners, others living in the home, and close friends support, positive encouragement understanding that successful interventions take time and financial commitment support from women s social networks take place throughout pregnancy and early childhood care differentiation between those who have concrete plans for not relapsing and those who have not thought out possible challenges. 7 Fang WL, Goldstein AO, Butzen AY et al (2004) Smoking cessation in pregnancy: a review of postpartum relapse prevention strategies. Journal of the American Board of Family Practice 17: 264-75. 8 Hajek P, Stead LF, West R et al (2005) Relapse prevention interventions for smoking cessation. Cochrane Database of Systematic Reviews 2005, Issue 1. 4

British Medical Association (BMA) 4.3 Question: Which interventions are effective and cost effective in encouraging the establishment of smoke-free homes? Two qualitative studies in Liverpool 9 and Australia 10 have identified the following factors that might prevent parents from adopting smoke-free homes: inability to leave children unsupervised in order to smoke lack of appropriate outside space for smoking lack of comfort or privacy outside home addiction to tobacco difficulties in requesting visitors not to smoke in the home lack of support from friends and family lack of knowledge about health risks of SHS for children. These factors should be considered when developing interventions to promote smoke-free homes. The use of high impact media campaigns is also an important consideration for promoting smokefree homes. In New Zealand, a hard hitting media campaign was launched alongside the introduction of smoke-free legislation, and this is likely to have contributed to the decline in exposure to SHS that occurred in the following three years. 11 Cont d 9 Robinson J & Kirkcaldy A (2005) Passive smoking: Qualitative research in Merseyside. Research Report 99/05. University of Liverpool, Health and Community care Research Unit: Liverpool. 5

British Medical Association (BMA) In 2003, the DH ran a high impact television campaign about children s exposure to SHS, with the strap-line when you smoke, they smoke. The evaluation of the campaign showed that unprompted awareness that SHS harmed children s health rose from less than a third (28%) of respondents to half (50%). Three per cent of smokers said that these ads had prompted them to quit, while one fifth (19%) said that it had stopped them from smoking around children. 10 Hill L, Farquharson K & Borland R (2003) Blowing smoke: strategies smokers use to protect non-smokers from ETS in the home, Health Promotion Journal of Australia 14: 196-201. 11 Waa A & McGough S (2006) Reducing exposure to second hand smoke: changes associated with the implementation of the amended New Zealand Smoke-free Environments Act 1990: 2003-2006. Wellington: Health Sponsorship Council Research and Evaluation Unit. 6

British Medical Association (BMA) 4.3 Question: What factors aid delivery of effective interventions? What are the barriers to successful delivery? There are a number of risk factors for smoking during pregnancy, which can act as barriers to effective interventions including: low income low socioeconomic status unemployment young age lower educational attainment no partner or with a partner who smokes having an unplanned pregnancy. 12 Smoking is correlated with social deprivation. Those who live on low incomes are more likely to smoke. In 2004, one in four (25%) adults in the UK were smokers. Nearly one in three (31%) of people in manual groups were smokers, compared with fewer than one in five (18%) in professional and managerial groups. The highest smoking rates were found among those who were economically inactive, but had last worked in manual jobs nearly half (45%) of people in this category were smokers. 13 Cont d 12 British Medical Association (2007) Breaking the cycle of children s exposure to tobacco smoke. BMA: London. 13 National Statistics (2006) General household survey 2005. 7

British Medical Association (BMA) Smoking remains a major cause of health and economic inequalities. Smokers living in deprived areas are about 40 per cent more likely to be classified as hardcore smokers (i.e. those who are very resistant to quitting) than those in the most affluent areas. 14 People who live in deprived areas are at greater risk of starting to smoke, likely to be more heavily addicted, and have lower chances of quitting successfully, compared with more affluent smokers. 15 It is important that smoking cessation services are targeted at high risk groups including those in the lower socioeconomic groups, pregnant mothers, those with mental health problems and children who are looked after by the state, in foster care or in institutional settings. There is also a need for further research to develop and evaluate new cessation approaches focusing on disadvantaged, pregnant women (and partners). 14 Jarvis MJ, Wardle J & Waller J et al (2003) Prevalence of hardcore smoking in England, and associated attitudes and beliefs: cross sectional study. British Medical Journal 326: 1061. 15 Bobak M, Jha P & Nguyen S et al (2000) Poverty and smoking. In: Jha P & Chaloupka F (ed) Tobacco control in developing countries. Oxford: Oxford University Press and WHO. 8

British Medical Association (BMA) 1 Silagy C (2004) Physician advice for smoking cessation. Cochrane Database of Systematic Reviews 2004, Issue 4. 2 Rice VH & Stead LF (2004) Nursing interventions for smoking cessation. Cochrane Database of Systematic Reviews 2004, Issue 1. 3 Lumley J, Oliver SS, Chamberlain C et al (2004) Interventions for promoting smoking cessation during pregnancy. Cochrane Database of Systematic Reviews 2004, Issue 4. 4 Griffiths AN, Woolley JL, Avasarala S et al (2005) Survey of antenatal women's knowledge of maternal and fetal risks of tobacco smoking and acceptability of nicotine replacement products in pregnancy. Journal of Obstetrics and Gynaecology. 25: 432-4. 5 Medicines and Healthcare products Regulatory Agency (2006) Report of the committee on safety of medicines working group on nicotine replacement therapy. 6 Lee M, Hajek P, McRobbie H et al (2006) Best practice in smoking cessation services for pregnant women: results of a survey of three services reporting the highest national returns, and three beacon services. Journal of the Royal Society for the Promotion of Health 126: 233-8. 7 Fang WL, Goldstein AO, Butzen AY et al (2004) Smoking cessation in pregnancy: a review of postpartum relapse prevention strategies. Journal of the American Board of Family Practice 17: 264-75. 8 Hajek P, Stead LF, West R et al (2005) Relapse prevention interventions for smoking cessation. Cochrane Database of Systematic Reviews 2005, Issue 1. Cont d 9

British Medical Association (BMA) 9 Robinson J & Kirkcaldy A (2005) Passive smoking: Qualitative research in Merseyside. Research Report 99/05. University of Liverpool, Health and Community care Research Unit: Liverpool. 10 Hill L, Farquharson K & Borland R (2003) Blowing smoke: strategies smokers use to protect non-smokers from ETS in the home, Health Promotion Journal of Australia 14: 196-201. 11 Waa A & McGough S (2006) Reducing exposure to second hand smoke: changes associated with the implementation of the amended New Zealand Smoke-free Environments Act 1990: 2003-2006. Wellington: Health Sponsorship Council Research and Evaluation Unit. 12 British Medical Association (2007) Breaking the cycle of children s exposure to tobacco smoke. BMA: London. 13 National Statistics (2006) General household survey 2005. 14 Jarvis MJ, Wardle J & Waller J et al (2003) Prevalence of hardcore smoking in England, and associated attitudes and beliefs: cross sectional study. British Medical Journal 326: 1061. 15 Bobak M, Jha P & Nguyen S et al (2000) Poverty and smoking. In: Jha P & Chaloupka F (ed) Tobacco control in developing countries. Oxford: Oxford University Press and WHO. County Durham and Darlington PCT 1 (g) Wrong to advise pregnant women to cut down Thank you for your comment. The evidence regarding advice to cut down during pregnancy will be reviewed to inform the development of this guidance. 10

County Durham and Darlington PCT County Durham and Darlington PCT County Durham and Darlington PCT County Durham and Darlington PCT County Durham and Darlington PCT 4 This would obviously include those having fertility treatment 4.2.1 Consider incentive schemes Second hand smoke campaign There should be mandatory Brief Intervention training for all health staff, specially G.P s and consultants Cut down only as last resort, that is if they have failed with NRT. There should be monitoring system set up for pregnancy specialists to monitor this. Agreed. The search strategy will be inclusive so if there are studies of incentive schemes for the population groups outlined in the scope they will be considered for inclusion. The review of effectiveness should pick this up if such evidence is available. We cannot pre-empt the deliberations of the independent Public Health Intervention Advisory Committee (PHIAC) responsible for developing the guidance and recommendations There will however, be an opportunity for all stakeholders to comment on the guidelines later in the process. NICE has published guidance on brief interventions for smoking cessation which can be accessed at http://www.nice.org.uk/guidance/ph1 We cannot pre-empt the deliberations of the independent Public Health Intervention Advisory Committee responsible for developing the guidance and recommendations. There will however, be an opportunity for all stakeholders to comment on the guidelines later in the process. 11

County Durham and Darlington PCT County Durham and Darlington PCT Department for Children, Schools and Families Department for Children, Schools and Families 4.3 Again, try out incentives Again health consequences of cutting down this should be last resort and should be carried out by specialists only with special monitoring forms designed for this programme. General We would welcome a stronger specific focus in the guidelines on young pregnant women who smoke and the interventions that work with them, including examples of good practice. The key message in Teenage Parents Next Steps (cited in para 2.1) does not come across strongly enough that smoking during pregnancy is estimated to contribute to 40% of all infant deaths and teenage mothers are more likely than older mothers to have been smoking before they became pregnant and are less likely to stop smoking during their pregnancy. 2c) Probably need to also refer to the joint DCSF/DH Child Health Strategy due to be published shortly please come back to me on this point before the end of the consultation deadline. A planned review of effectiveness of interventions should pick this up if such evidence is available. Thank you for your comment. The evidence regarding advice to cut down during pregnancy will be reviewed to inform the development of this guidance. Thank you for your comment. This point is already covered in the scope but we will look at it again to see if it can be strengthened. Thank you for this suggestion. As the strategy has now been published we will add it to the scope. 12

Department for Children, Schools and Families Department for Children, Schools and Families 3c) Shouldn t the document refer to low birth weight as a consequence of smoking during pregnancy at this point? Teenage mothers have a 25% higher chance of babies with low birth weight which is thought to be associated with their greater tendency to smoke during pregnancy than older women. Low birth weight is referred to further on (para 4.3), with a reduction in it being a positive of fewer women smoking during pregnancy but we think this should signalled be earlier on in the document. 4.1.1. Glad that the guidance will focus on pregnant women and mothers aged 20 and under. Most such young women are from deprived backgrounds and their risk of smoking is higher than for older women, even taking into account their socio-economic group.. Thank you for your comment. Section 3c is concerned with socio-demographic and behavioural factors associated with smoking during pregnancy. We will signal the issue of low birth weight earlier by including it in Section 3a which focuses on the health consequences of smoking during pregnancy. Thank you for your comment and support. 13

Department for Children, Schools and Families 4.2..2 Needs to spell out what can be prescribed to pregnant women, especially those aged under 18, to help them to quit. Until about 2 years ago, health practitioners rarely prescribed nicotine replacement therapy (NRT) to pregnant teenagers on grounds of their young age and their pregnancy. Smoking cessation leads in DH advised us that guidance advising them not to prescribe NRT to this age group no longer applies but some practitioners still do not do so, leaving pregnant teenagers without the aids to quitting smoking that older pregnant women receive. We cannot pre-empt the deliberations of the independent Public Health Intervention Advisory Committee responsible for developing the guidance and recommendations. These issues may be included in the final guidance, depending on the evidence available and there will however, be an opportunity for all stakeholders to comment on the guidelines later in the process. NICE guidance on smoking cessation services currently includes the following recommendation: Explain the risks and benefits of using NRT to young people aged from 12 to 17, pregnant or breastfeeding women, and people who have unstable cardiovascular disorders. To maximise the benefits of NRT, people in these groups should also be strongly encouraged to use behavioural support in their quit attempt. Full details can be accessed at http://www.nice.org.uk/guidance/index.jsp?action=download&o=395 94 Department of Health General We believe that it may be worth considering whether the scope could include the commissioning of specific advice, as this is a timely issue in local areas and one which primary care trusts often struggle with. Thank you for this suggestion. We cannot pre-empt the deliberations of the independent Public Health Intervention Advisory Committee (PHIAC). You may be interested to know that stakeholder comments are circulated to PHIAC. There will however, be an opportunity for all stakeholders to comment on the guidelines later in the process. 14

Department of Health Department of Health Heart of England Foundation Trust -HEFT Heart of England Foundation Trust -HEFT 4.3 Regarding the question which interventions are effective and cost effective in encouraging the establishment of smoke-free homes?; in our view, the expected outcomes omit the outcome of a reduction in infant mortality and morbidity, such as a reduction in incidence of Sudden Infant Death Syndrome, and a reduction in the number of infant respiratory infections. 4.3 Regarding the question what factors aid delivery of effective interventions, and what are the barriers to successful delivery?:although it could be deemed as a process outcome, we feel that it would be useful to understand effective tools in gathering local intelligence of barriers to accessing local services. Increasingly pregnant women across the country are being offered routine carbon monoxide (CO) breath testing at the booking visit. Will PHIAC examine the effectiveness/cost effectiveness of this intervention? Some maternity services (driven by local stop smoking services) are referring all pregnant women who smoke or who have a positive CO breath test at booking to a local stop smoking service. To our knowledge no other group of smokers are automatically referred to their local stop smoking service. Will PHIAC examine the effectiveness/cost effectiveness of this activity? Thank you. The list of expected outcomes was not intended to be exhaustive, we will clarify this in the final version of the scope. We cannot pre-empt the deliberations of PHIAC but this may be an area for which specific recommendations could be developed. There will however, be an opportunity for all stakeholders to comment on the guidelines later in the process. The search strategy will be inclusive so if there are published interventions which utilise CO testing they will be considered for inclusion in the planned review of effectiveness of interventions. The search strategy will be inclusive so if there are studies of the effectiveness of this approach they will be considered for inclusion in the effectiveness and cost effectiveness reviews. 15

Heart of England Foundation Trust -HEFT Lambeth PCT Lambeth PCT Lambeth PCT London and South East Smoking in Pregnancy Will PHIAC examine any available qualitative evidence of the impact of routine CO testing and/or referral on pregnant women i.e. what are women s views/experiences of these initiatives? 6 Interventions to help pregnant women cut down is there evidence to suggest that this would be beneficial (with regard to compensatory smoking)? 9 Cutting down Will NRT be considered as to its effectiveness for cutting down the amount of cigarettes and guarding against compensatory smoking? General General Are you are consulting directly with pregnant women and new mothers who have accessed and used the pregnancy stop smoking services, as stakeholders during the drafting of these guidelines. The document is comprehensive and clear on the whole. The review is not restricted to quantitative studies and will include factors that act as facilitators and barriers. Thus, studies on the views and experiences of interventions will be considered for inclusion in the review. Thank you for your comment. Interventions to help pregnancy women cut down and the health consequences of cutting down during pregnancy will be considered in the review of evidence. Thank you for your comment. Interventions to help pregnancy women cut down and the health consequences of cutting down during pregnancy will be considered in the review of evidence. The review of effectiveness may pick up qualitative evidence regarding the views of pregnant women and new mothers. The draft recommendations are field tested with key target audiences for clarity, relevance, usefulness, effectiveness, barriers to implementation and feasibility. Resources permitting, the fieldwork will include representatives of pregnant women and new mothers (though not the women directly) who may also be invited to give testimony at a committee meeting. Thank you for your comment. 16

London and South East Smoking in Pregnancy London and South East Smoking in Pregnancy London and South East Smoking in Pregnancy Will there be scope to consider Intensive Cognitive Behavioural therapy sessions for pregnant women who wish to stop smoking without the use of NRT? 4.1.1 This section focuses on the particular help to be given to groups in which smoking rates are high. This includes; Aged 20 years or younger. Black or from other minority ethnic groups. Refugees or asylum seekers These individuals may well be living with parents or in extended families. This seems to go against the emphasis on partners only in section, 4.2.1, although to be fair section 4.1.1 does also state The guidance will also consider anyone who smokes and lives in the same dwelling. Parameters too narrow. Women often more sexually active are less likely too comply with contraception as their child gets older. Perhaps all women with pre school children should be considered. The search strategy will be inclusive so if there are studies on intensive CBT for pregnant women who smoke they will be considered for inclusion in the effectiveness review. Thank you, noted. Thank you for your suggestion. To keep the work to a manageable size and to retain as much overlap as possible with the Department of Health referral to produce guidance on reducing infant mortality we have focused on women who are pregnant, planning a pregnancy or have an infant aged less than 12 months. For this group NICE guidance on smoking cessation services is relevant. Full details can be accessed at http://www.nice.org.uk/guidance/index.jsp?action=download &o=39594 17

London and South East Smoking in Pregnancy 4.1.2 Women who smoke who are not planning a pregnancy are listed in the document as being in a group not covered by the guidance. This seems unwise, as many pregnancies are unplanned. Research on the Department of Health website Teenage mothers and their children: Factors affecting their health and development found that almost all the teenage mothers in the study said their pregnancies were unplanned. MCH 08-43 Sarah Meadows and Nona Dawson. Graduate School of Education. University of Bristol. 7.2.04 Krishen, M. et al found that around half of all pregnancies in the UK are unplanned. Contraception in crisis. Journal of Family Planning and Reproductive Health Care. 2006 :32[4] Therefore this is too limiting. All sexually active women of child bearing age should be included. Many of the women our members have seen have not planned their pregnancies. Thank you for this suggestion. Women who smoke who are not planning a pregnancy were considered for possible inclusion. However, the intention is to provide guidance to professionals in contact with women who are planning a pregnancy, are pregnant women or women who have recently given birth. For women who are not pregnant other NICE guidance will apply. The scope will be amended to clarify this. 18

London and South East Smoking in Pregnancy The guidance is again very limiting. It should include any household where a child is resident. A blanket smoke-free homes policy should be promoted as any child / adult is vulnerable to the effects of second hand smoke. Thank you for your suggestion. The referral was to develop guidance on stopping smoking during pregnancy and following childbirth. However, the review activities do include interventions to eliminate exposure to tobacco smoke in the home. If you feel this issue warrants separate guidance, please consider referring the issue through our topic referral system. Stakeholders can suggest future topics for consideration at http://www.nice.org.uk/getinvolved/suggestatopic/suggest_a _topic.jsp London and South East Smoking in Pregnancy London and South East Smoking in Pregnancy 4.2.1 Activities that could be covered are: rolling audio visual presentations in GP and hospital waiting areas highlighting local stop smoking services and facts related to smoking in pregnancy and second hand smoke. Under Activities/Measures that will be covered ; Interventions to help the partners of a pregnant woman, or women planning a pregnancy or who have recently given birth. Other family members are not included here. Thank you for your suggestions. The search strategy is intended to be inclusive so if there are studies of the effectiveness of these approaches they will be considered for inclusion in the effectiveness and cost effectiveness reviews. The scope refers to partners and significant others. Significant others could include other family members. 19

London and South East Smoking in Pregnancy London and South East Smoking in Pregnancy London and South East Smoking in Pregnancy London and South East Smoking in Pregnancy Point of contact dispensing of NRT at the time of assessment would also capture the moment. Interventions to help pregnant women or women who have recently given birth to cut down on the number of cigarettes they smoke Does this not directly contradict the emphasis elsewhere in the document, on quitting? Especially considering the section quoted below from Key questions and outcomes. Smoke free homes campaigns with a blanket approach rolled out by the HV service and children s centres would make a smoke free home a universal expectation. Increasing access to stop smoking advisers in the wider community i.e. Children s centres, workplaces, colleges, schools, family planning services, retail outlets i.e. supermarkets, Mother care and GP surgeries also home visits for intervention by HVs, MWs and the specialist smoking and pregnancy adviser Thank you for this suggestion. Whilst we cannot pre-empt the deliberations of PHIAC this may be an area that could form the basis of a recommendation. There will however, be an opportunity for all stakeholders to comment on the recommendations later in the process. Thank you noted. The intention is to review the evidence on cutting down during pregnancy and consider the associated health consequences. Thank you for this suggestion. Whilst we cannot pre-empt the deliberations of PHIAC this may be an area that could form the basis of a recommendation. There will however, be an opportunity for all stakeholders to comment on the guidelines later in the process. Thank you for this suggestion. Whilst we cannot pre-empt the deliberations of PHIAC this may be an area that could form the basis of a recommendation. There will however, be an opportunity for all stakeholders to comment on the guidelines later in the process. 20

London and South East Smoking in Pregnancy London and South East Smoking in Pregnancy London and South East Smoking in Pregnancy London and South East Smoking in Pregnancy If pregnant smokers are advised to cut down they are more likely to cut down than stop. Cutting down should be seen as the last resort and then with NRT and an eventual quit in mind. 4.3 Expected outcomes. Increase in the number of women who quit rather than cut down during pregnancy A PGD or direct dispensing to smokers would help capture the enthusiasm after the initial motivating assessment. Nowhere in Expected outcomes are the finding out of effective strategies for communication with this client group and encouraging behaviour change, mentioned. I would also have expected some mention of useful NRT aids and of the best practice organisation of quit programmes to be mentioned as expected outcomes, which they are not. Thank you noted. The intention is to review the evidence on cutting down during pregnancy and consider the associated health consequences. Whilst we cannot pre-empt the deliberations of PHIAC this may be an area that could form the basis of a recommendation. There will however, be an opportunity for all stakeholders to comment on the guidelines later in the process. Thank you, this outcome is already included in Section 4.3. Thank you for this suggestion. Whilst we cannot pre-empt the deliberations of PHIAC this may be an area that could form the basis of a recommendation. There will however, be an opportunity for all stakeholders to comment on the guidelines later in the process. Thank you for these suggestions. The review will include evidence on factors that facilitate or act as barriers. This may yield an evidence base which could inform the development of effective communication strategies. Similarly, evidence on best practice and therapeutic aids including pharmacotherapies will be considered as part of this work. 21

London and South East Smoking in Pregnancy London and South East Smoking in Pregnancy London and South East Smoking in Pregnancy HVs, SHN s and MW s should have smoking in pregnancy and the effects of second hand smoke as part of their mandatory training. Midwives and HVs should have smoking cessation included in their core work. They have universal access to people s homes with babies and young children. They are conducting needs assessments with every new mother. Meeting the needs of the smoker through smoking cessation support or damage limitation in supporting smoke free homes is fundamental to their work. SHNs are also routinely seeing sexually active young people. PNs and family planning nurses are constantly in touch with sexually active men and women and are in an ideal situation to offer an extra service for smoking cessation. The specialist smoking and pregnancy nurse would then train, support and update these community bases services. For partners to access stop smoking services they need to be in the community in which they live and work. Preventing post natal relapse back to smoking, could be initially addressed by the midwives who see the women immediately postnataly and then by the HV who continues that relationship. Thank you for these suggestions. Whilst we cannot preempt the deliberations of PHIAC this may be an area that could form the basis of a recommendation. Please note that PHIAC receive a copy of all the comments on the scope made by stakeholder and can take these into account when they consider the evidence. Thank you, noted. On a related note, NICE published guidance on identifying and supporting adults most at risk of dying prematurely from CVD and other smoking related disease which may be of interest to you. It is available at: http://www.nice.org.uk/guidance/ph15/guidance/doc/ Thank you for these suggestions. Whilst we cannot preempt the deliberations of PHIAC this may be an area that could form the basis of a recommendation. Please note that PHIAC receive a copy of all the comments on the scope made by stakeholder and can take these into account when they consider the evidence. 22

London and South East Smoking in Pregnancy Creating a smoke free home is often the first step towards making a quit attempt. When parents are taking a new born home midwives could include smoke free cars and homes as one of their key health promotion messages. Thank you noted. London and South East Smoking in Pregnancy London and South East Smoking in Pregnancy London and South East Smoking in Pregnancy NHS Health Scotland 3(g) The number of advisers across the community should also be increased through existing services so that an eventual quit attempt is supported HVs and MWs are already doing home visits so can promote smoke free homes in their key messages. This could be work done with the fire service when they are promoting smoke detectors as we know that cigarettes are a major reason for house fires. GPs and Health professionals in hospitals should also be promoting smoke free homes were possible to prevent the many childhood admissions and consultations that are directly related to SHS. Again mandatory training should be required for all Health professionals who are in touch with young families and pregnant smokers. In the penultimate line, replace the word give with given. Thank you for these suggestions. Whilst we cannot preempt the deliberations of PHIAC this may be an area that could form the basis of a recommendation. Please note that PHIAC receive a copy of all the comments made by stakeholder and can take these into account when they consider the evidence. Thank you for this observation. Thank you for this suggestion. Thank you noted, we will forward to the editor. 23

NHS Health Scotland NHS Health Scotland NHS Health Scotland NHS Health Scotland NHS Health Scotland NHS Health Scotland 4.2.1 Include interventions which are effective in increasing referrals of pregnant women to smoking cessation services. 4.2.1 Include interventions which are effective in maintaining the quit. 4.2.1 / 4.3 When focusing on effective interventions in each case, also focus on model used (and describe it), and focus on who deliverer of interventions is (e.g. smoking cessation adviser/specialist, primary care worker, pharmacist, midwife). 4.3 Questions - reword questions from Which interventions are effective and cost-effective... to Which interventions (including modes of delivery and type of deliverer) are effective and costeffective in helping... to quit... and to remain/maintain being quit? 4.3 Expected outcomes - include Increase in the number of... who remain quit at a specified time period (e.g. 1-month, 3-months, 12-months post quit-date). 4.3 Expected outcomes - include Increases in the numbers who are referred to smoking cessation services. Thank you for this suggestion, this may be an area that could form the basis of a recommendation. On a related note, NICE published guidance on identifying and supporting adults most at risk of dying prematurely from CVD and other smoking related disease which may be of interest to you. It is available at: http://www.nice.org.uk/guidance/ph15/guidance/doc/ Thank you this is already covered by the second bullet point under section 4.2.1 Thank you, these are important considerations and will be reflected in the evidence review where this information is provided in the studies. Thank you for this suggestion. The scope sets out the overarching questions. Each overarching question is underpinned by a set of detailed research questions covering a range of issues including type of setting and type of deliverer. As far as the evidence allows the review will address these detailed questions as they are crucial to the process of developing recommendations. Thank you for this suggestion, the emphasis will be on lifelong quitting. However, monitoring the duration of a quit attempt at different intervals is an area that could form the basis of a recommendation. Thank you for this suggestion. We will clarify that the list is not intended to be exhaustive but we will amend to include this particular outcome. 24

NHS Health Scotland NHS Health Scotland General / 4.2.1 / 4.3 General / 4.2.1 / 4.3 Would be worth investigating the evidence/effectiveness evidence for an opt-out approach in smoking cessation, and based on CO (carbon monoxide) monitoring (and whether this increases referrals and ultimate quits). One of the recommendations from the NHS Health Scotland audit of smoking cessation support in pregnancy conducted by Susan MacAskill, Linda Bauld, David Tappin and Douglas Eadie - http://www.healthscotland.com/uploads/documents /7578-Smoking%20in%20Pregnancy.pdf was around this. E.g. this is done at Glasgow s Southern General Hospital in which all women are CO-monitored; those whose CO reading would indicate that they are a smoker, are automatically referred for smoking cessation support. CO monitoring and its role should be considered. Thank you for these suggestions. Whilst we cannot preempt the deliberations of PHIAC this may be an area that could form the basis of a recommendation. Please note that PHIAC receive a copy of all the comments made by stakeholder and can take these into account when they consider the evidence. Thank you for this suggestion, noted. 25

NHS Health Scotland General / 4.2.1 / 4.3 NRT and specific details on products for use with pregnant women should be considered. We cannot pre-empt the deliberations of the independent Public Health Intervention Advisory Committee responsible for developing the guidance and recommendations. NICE guidance on smoking cessation services currently includes the following recommendation: Explain the risks and benefits of using NRT to young people aged from 12 to 17, pregnant or breastfeeding women, and people who have unstable cardiovascular disorders. To maximise the benefits of NRT, people in these groups should also be strongly encouraged to use behavioural support in their quit attempt. Full details can be accessed at http://www.nice.org.uk/guidance/index.jsp?action=download &o=39594 National Childbirth Trust (NCT) National Childbirth Trust (NCT) General General (section 3d and elsewhere) What is the evidence about the relative effects of giving up at different stages of pregnancy? Surely it makes a significant difference? An intervention in week 1 may have more benefits than the same intervention in week 38. There does not seem to be any reference to stage of pregnancy. NHS cessation services and other references to services available gives a very narrow impression of the diversity of possible providers of cessation support e.g. it could be a buddying scheme. NHS commissioners need to be aware of the diversity of possible providers. Thank you noted. The areas covered by the current scope are already quite broad; the differential effects of giving up at different stages in the pregnancy would require a separate review which is not feasible within the time and resources available. However, we will ask the team carrying out the review to report this information if they come across it. Thank you noted. Please be reassured that the search for evidence will not be limited to the NHS stop smoking services. 26

National Childbirth Trust (NCT) Section 3(d) This para is slightly confusing and, I would suggest, needs rewording as it implies that women do not stop during pregnancy, although previous paras have explained that around half currently do. The Lawrence study referred to followed women who did not stop smoking during pregnancy or immediately afterwards and reports the correlation between their report and their urinary cotinine levels. Thank you for your observation, we will look at this again. National Childbirth Trust (NCT) National Childbirth Trust (NCT) Section 4.1.1 and 4.1.2 and in general Planning a pregnancy is the surely wrong way to look at it. What is the correlation between unplanned pregnancies and smoking? What evidence is there that targeting at women who are planning a pregnancy is more effective than targeting all women in particular likely-to-getpregnant categories, for example an age group? Of course some interventions require a woman to identify herself as planning a pregnancy, but others (adverts, peer groups, advice) do not need to target in this way. 4.1.1 We support the inclusion of all those in the pregnant woman or baby s household and the emphasis on low income, younger and other groups where smoking rates are highest. Thank you, noted. Women who smoke who are not planning a pregnancy were considered for possible inclusion. However, the intention is to provide guidance to professionals in contact with women who are planning a pregnancy, are pregnant or who have recently given birth. For women who are not pregnant other NICE guidance will apply. The scope will be amended to clarify this. Thank you, noted. 27

National Childbirth Trust (NCT) 4.2.2 Although it is obviously necessary to limit the search strategy and focus on a manageable number of interventions, it would be helpful to leave open the possibility that studies with other interventions, such as counselling, cognitive or behavioural therapy may help women to stop stopping. For example one randomised, controlled study of obese women found that cognitive group therapy not aimed at weight loss but at mental wellbeing resulted in significant weight loss. Women were randomised into those receiving cognitive therapy with no focus on weight loss, those receiving behaviour therapy weight loss programme and a control no treatment group. The cognitive group and behaviour therapy group had significant weight loss but the control group did not. Depression and anxiety were reduced significantly in the cognitive therapy group. It would be a pity to miss a comparable study that led to a cessation or reduction in smoking as some of the women who have most difficulty in stopping smoking feel they need the psychological support that they experience smoking provides for them. Thank you noted. The types of interventions will not be limited. However, the primary focus of the guidance is on smoking cessation around the time of pregnancy and up to 12 months after birth. To be included in the review, studies will need to report on the population groups set out in the scope and include data on smoking cessation and /or relapse prevention. 28

National Childbirth Trust (NCT) Oxfordshire PCT Oxfordshire PCT Section 4.3 Breaking it down in this way into micro-outcomes means that the big picture is missed. The whole point is that a % of women have given up for life/a long time and this has huge benefits on their health and on the child, who grows up at least with a nonsmoking mum and at best in a smoke-free house. This has long term benefits, not least that the child is less likely to start smoking in turn. This has to be captured or the effects and cost-effectiveness will be grossly under-estimated. Continuing with the same point, why do we only look at infants? Effects on asthma, e.g., go beyond that it is more than the immediate effects of not starting off life in a smoky womb..this is similar to saying for example, that breastfeeding only benefits the infant, when we know there are significant longer-term benefits as the child grows. 4.1.1 Too limiting. All sexually active women of child bearing age should be included/ Many of the women I have seen have not planned their pregnancies. 4.1.1 Parameters too narrow. Women often more sexually active less likely too comply with contraception as their child gets older. Perhaps all women with pre school children should be considered. Thank you for these helpful observations. We agree it is important to emphasize the long term, multiple benefits that arise from encouraging women of child bearing age who smoke stop. All comments made by stakeholders are shared with PHIAC, the independent committee responsible for developing the recommendations. Thank you, noted. Women who smoke who are not planning a pregnancy were considered for possible inclusion. However, the intention is to provide guidance to professionals in contact with women who are planning a pregnancy, are pregnant or who have recently given birth. For women who are not pregnant other NICE guidance will apply. The scope will be amended to clarify this. Thank you for your suggestion. To keep the work to a manageable size and to retain as much overlap as possible with the Department of Health referral to produce guidance on reducing infant mortality we have focused on women who are pregnant, planning a pregnancy or have an infant aged less than 12 months. 29

Oxfordshire PCT 4.1.1 The guidance is again very limiting. It should include any household where a child is resident. A blanket smoke-free homes policy should be promoted as any child / adult is vulnerable to the effects of second hand smoke. Thank you noted. This may be an area that could form the basis of a recommendation. Please note that PHIAC receive a copy of all the comments made by stakeholders and can take these into account when they consider the evidence. Oxfordshire PCT Oxfordshire PCT Oxfordshire PCT Oxfordshire PCT 4.1.2 Excluding women who are not planning a pregnancy, or who have not given birth within the past 12months is excluding the very women who will be vulnerable to pregnancy. Many of the pregnancies in the in groups were smoking rates are high are often unplanned. 4.2 Activities that could be covered are: rolling audio visual presentations in GP and hospital waiting areas highlighting local stop smoking services and facts related to smoking in pregnancy and second hand smoke. Point of contact dispensing of NRT at the time of assessment would also capture the moment. Smoke free homes campaigns with a blanket approach rolled out by the HV service and children s centres would make a smoke free home a universal expectation. Thank you for this observation. The current guidance will apply to women who are pregnant regardless of whether the pregnancy was planned. For women who are not pregnant other NICE guidance will apply. The scope will be amended to clarify this. Thank you for these suggestions. As mentioned above, stakeholders comments are shared with PHIAC, the independent committee responsible for developing the recommendations. Thank you, noted. As indicated above, stakeholders comments are shared with PHIAC, the independent committee responsible for developing the recommendations. Thank you noted. This may be an area that could form the basis of a recommendation. Please note that PHIAC receive a copy of all the comments made by stakeholders and can take these into account when they consider the evidence. 30

Oxfordshire PCT Oxfordshire PCT Oxfordshire PCT Oxfordshire PCT Oxfordshire PCT Increasing access to stop smoking advisers in the wider community i.e. Children s centres, workplaces, colleges, schools, family planning services, retail outlets i.e. supermarkets, Mother care and GP surgeries also home visits for intervention by HVs, MWs and the specialist smoking and pregnancy adviser If pregnant smokers are advised to cut down they are more likely to cut down than stop. Cutting down should be seen as the last resort and then with NRT and an eventual quit in mind. 4.3 A PGD or direct dispensing to smokers would help capture the enthusiasm after the initial motivating assessment. HVs, SHN s and MW s should have smoking in pregnancy and the effects of second hand smoke as part of their mandatory training. Midwives and HVs should have smoking cessation included in their core work. They have universal access to people s homes with babies and young children. They are conducting needs assessments with every new mother. Meeting the needs of the smoker through smoking cessation support or damage limitation in supporting smoke free homes is fundamental to their work. SHNs are also routinely seeing sexually active young people. PNs and family planning nurses are constantly in touch with sexually active men and women and are in an ideal situation to offer an extra service fpr smoking cessation. The specialist smoking and pregnancy nurse would then train, support and update these community bases services. For partners to access stop smoking services they need to be in the community in which they live and work. Thank you noted. This may be an area that could form the basis of a recommendation. Please note that PHIAC receive a copy of all the comments made by stakeholders and can take these into account when they consider the evidence. Thank you noted. The evidence relating to cutting down will be reviewed so it may be an area that could form the basis of a recommendation. Thank you for this helpful suggestion. Thank you for these helpful suggestions. Education and training of relevant health professionals may be an area that could form the basis of a recommendation. Please note that PHIAC receive a copy of all the comments made by stakeholders and can take these into account when they consider the evidence. Thank you for this observation. 31