PUBLIC HEALTH DRAFT GUIDANCE

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE PUBLIC HEALTH DRAFT GUIDANCE Issue date: May 2010 How to stop smoking in pregnancy and following childbirth NICE public health guidance X Introduction The Department of Health (DH) asked the National Institute for Health and Clinical Excellence (NICE) to produce public health guidance on a public health intervention aimed at stopping smoking in pregnancy and following childbirth. The guidance is for NHS and other commissioners, managers and practitioners who have a direct or indirect role in, and responsibility for, helping people to stop smoking in pregnancy and following childbirth. This includes those working in: local authorities, education and the wider public, private, voluntary and community sectors. It may also be of interest to women who are planning a pregnancy, or are pregnant or who have an infant aged up to 12 months, as well as their partners and families and other members of the public. This guidance will also complement, but will not replace, other NICE guidance on smoking prevention and cessation as well as guidance on identifying and supporting people most at risk of dying prematurely and behaviour change. (For further details, see section 7.) The Public Health Interventions Advisory Committee (PHIAC) has considered both the reviews of the evidence and the economic analysis. This document sets out the Committee's preliminary recommendations. It does not include all sections that will appear in the final guidance. NICE is consultation draft Page 1 of 50

now inviting comments from stakeholders (listed on our website at www.nice.org.uk). Note that this document does not constitute NICE's formal guidance on how to stop smoking in pregnancy and following childbirth. The recommendations made in section 1 are provisional and may change after consultation with stakeholders and fieldwork. The stages NICE will follow after consultation (including fieldwork) are summarised below. The Committee will meet again to consider the comments, reports and any additional evidence that has been submitted. After that meeting, the Committee will produce a second draft of the guidance. The final, formal guidance will be signed off by the NICE Guidance Executive. For further details, see The public health guidance development process: an overview for stakeholders including public health practitioners, policy makers and the public (this document is available at www.nice.org.uk/phprocess). The key dates are: Closing date for comments: 8 January 2010. Second Committee meeting: 12 March 2010. Members of PHIAC are listed in appendix A and supporting documents used to prepare this document are listed in appendix E. This guidance was developed using the NICE public health intervention process. consultation draft Page 2 of 50

Contents 1 Recommendations... 4 2 Public health need and practice... 16 3 Considerations... 19 4 Implementation... 23 5 Recommendations for research... 24 6 Updating the recommendations... 24 7 Related NICE guidance... 24 8 Glossary... 24 9 References... 25 Appendix A: membership of the Public Health Interventions Advisory Committee (PHIAC), the NICE Project Team and external contractors... 27 Appendix B: summary of the methods used to develop this guidance... 32 Appendix C: the evidence... 39 Appendix D: gaps in the evidence... 49 Appendix E: supporting documents... 50 consultation draft Page 3 of 50

1 Recommendations When writing the recommendations, the Public Health Interventions Advisory Committee (PHIAC) (see appendix A) considered the evidence of effectiveness and cost effectiveness. Note: this document does not constitute NICE s formal guidance on this intervention. The recommendations are preliminary and may change after consultation. The evidence statements underpinning the recommendations are listed in appendix C. A brief description of the interventions is given below, immediately before the list of recommendations. The evidence reviews, supporting evidence statements and economic analysis are available at www.nice.org.uk/guidance/phg/wave20/1 Effective interventions A range of interventions have been proven to be effective in helping women who are pregnant or breastfeeding to quit smoking. They include: cognitive behaviour therapy and motivational interviewing, self-help materials and support from NHS Stop Smoking Services. Quit-smoking interventions which have been proven to be effective with the general population include: brief advice ( Brief interventions and referral for smoking cessation NICE public health guidance 1), workplace support ( Workplace interventions to promote smoking cessation NICE public health guidance 5), individual behavioural counselling, group behaviour therapy, pharmacotherapy, self-help materials, telephone counselling, quitlines and mass-media campaigns ( Smoking cessation services NICE public health guidance 10). It is worth noting that interventions which are generally effective will not necessarily work around the time of pregnancy (that is, with the partners of women who are pregnant and significant others such as family members or close friends). consultation draft Page 4 of 50

Effective smoking cessation services are: flexible and coordinated. They take place in locations and at times that make them easily accessible. In addition, they are tailored to individual needs. Effective programmes are delivered in a non-judgmental way. They are sensitive to the difficult circumstances many women who smoke find themselves in. They also take into account other sociodemographic factors such as age and ethnicity and are culturally relevant. (See Identifying and supporting people most at risk of dying prematurely NICE public health guidance 15, available at www.nice.org.uk/ph15.) Recommendation 1: identifying women who smoke and referring them to NHS Stop Smoking Services Who is the target population? Women who smoke and are planning a pregnancy, are already pregnant or who have an infant aged under 12 months. Who should take action? Those responsible for providing health and support services for the women listed above and their partners. This includes: midwives (at first booking), GPs and health visitors those working in fertility clinics. What action should they take? Ask the woman if she smokes. Use the carbon monoxide (CO) breath test to overcome under- and misreporting and to aid discussion. Record smoking status and CO level in the notes. Refer all those who smoke, even those unwilling to consider quitting or with a CO reading of more than 7 parts per million, to a specialist pregnancy or intensive NHS Stop Smoking Service. Explain that this is part of normal practice and that a specialist midwife or adviser will phone to talk about smoking. (See also, recommendation 3.) (Note: during the initial telephone consultation draft Page 5 of 50

conversation with the specialist, women who decide that they do not wish to quit should be sent information about smoking and pregnancy and on how to get help later if they so wish.) Record outcome in the notes. Use local arrangements to make an appointment and give the NHS Pregnancy Smoking Helpline number: 0800 1699 169. At the next appointment, check if the referral was taken up. If not, ask if they are interested in stopping smoking. Offer another referral to the service and record this offer in the notes. If the referral is declined, accept the answer non-judgmentally, leave the offer of help open, record in notes and review at a later appointment. Offer smoking cessation services in a sensitive, non-judgmental manner. Highlight the flexibility of many NHS Stop Smoking Services for pregnant women (for example, some offer home visits). Provide information (for example, leaflets) about the risks of smoking for the unborn child and the hazards of exposure to secondhand smoke for the mother and baby. Details of other ways of identifying people who smoke, improving services for them and retaining them can be found in Identifying and supporting people most at risk of dying prematurely NICE public health guidance 15 (available at www.nice.org.uk/ph15). consultation draft Page 6 of 50

consultation draft Page 7 of 50 DRAFT

Recommendation 2: referring women who smoke to NHS Stop Smoking Services Who is the target population? Women who smoke and are planning a pregnancy, are already pregnant or who have an infant aged under 12 months. Who should take action? Those responsible for providing health and support services for the women listed above and their partners. This includes: dentists, occupational health professionals and hospital and community pharmacists those working in children s centres and voluntary organisations. What action should they take? Ask the woman if she smokes. If she does, explain how NHS specialist pregnancy services and intensive NHS Stop Smoking Services can help people to quit. Give the NHS Pregnancy Smoking Helpline number: 0800 1699 169. In addition, those with specialist training in smoking cessation for pregnant women should provide information (for example, leaflets) about the risks that smoking poses to the unborn child and the hazards of exposure to secondhand smoke for the mother and baby. Refer using local arrangements. Record in notes. Recommendation 3: NHS specialist pregnancy services and NHS Stop Smoking Services for women who smoke Who is the target population? Women who smoke who are planning a pregnancy, are already pregnant or who have an infant aged under 12 months. consultation draft Page 8 of 50

Who should take action? NHS specialist pregnancy services and NHS Stop Smoking Services. Other providers of intensive interventions to help people quit smoking. What action should they take? Telephone all women who have been referred for help. Discuss smoking and pregnancy with them and the issues they face in a non-judgemental manner (that is, adopt a client-centred approach). Invite them to the clinic. Consider offering to visit women at home or at another venue if it is difficult for them to attend specialist services. Send information on smoking and pregnancy to those who opt out during the initial telephone call. This should include details on how to get help to quit at a later date, if they so wish. Address the factors which prevent these women from using smoking cessation services. This could include a lack of confidence in their ability to quit, lack of knowledge about the services on offer or difficulty accessing them. It could also include a fear of failure and concerns about being stigmatised. During the first face-to-face meeting, discuss how much and how frequently she smokes and ask if anyone else in the household smokes (this includes her partner if she has one). Provide information about the risks of smoking to the unborn child and the hazards of exposure to secondhand smoke. Address any concerns she and her partner or family may have about stopping smoking 1. 1 This is an edited version of a recommendation that appears in Smoking cessation services NICE public health guidance 10. It does not constitute a change to the original recommendation. consultation draft Page 9 of 50

Offer personalised information, advice and support on how to stop smoking 2. Encourage partners and other family members who smoke to quit. Provide intensive and ongoing support (brief interventions alone are unlikely to be sufficient) throughout pregnancy and beyond. This includes monitoring smoking status regularly using CO tests. Biochemically validate self-reported quitting at quit date and 4 weeks after. Cotinine tests are preferable for validating quit attempts as they can confirm that someone has abstained from smoking for approximately 7 days (as opposed to 24 hours using CO readings). Record the method used to quit smoking, including whether or not women received help and support. Follow up 12 months after the date they set to quit. Discuss the risks and benefits of nicotine replacement therapy (NRT) with pregnant women who smoke, particularly those who do not wish to accept the offer of help from NHS Stop Smoking Services. If a woman expresses a clear wish to receive NRT, use professional judgement when deciding whether to offer a prescription 3. Advise pregnant women using nicotine patches to remove them before going to bed 3. NRT should be prescribed as part of an abstinent-contingent treatment in which the woman who smokes makes a commitment to stop on or before a particular date (target stop date). The prescription of NRT should be sufficient to last only until 2 weeks after the target stop date. Normally this will be after 2 weeks of NRT therapy. Subsequent prescriptions should be 2 This is an extract from a recommendation that appears in Smoking cessation services NICE public health guidance 10. 3 This is an extract from a recommendation that appears in Smoking cessation services NICE public health guidance 10. consultation draft Page 10 of 50

given only to women who have demonstrated, on re-assessment, that their quit attempt is continuing 4. Neither varenicline or bupropion should be offered to pregnant or breastfeeding women 5. Establish links with contraceptive services, fertility clinics and ante- and postnatal services. Ensure everyone working for these services knows how to refer people to local NHS Stop Smoking Services and NHS specialist pregnancy services. Ensure they understand what these specialist services offer. Involve the women being targeted (see above) in the planning and development of services. Details of other methods for identifying people who smoke and improving the services on offer to them can be found in Identifying and supporting people most at risk of dying prematurely NICE public health guidance 15 (available at www.nice.org.uk/ph15). Recommendation 4: NHS specialist pregnancy services and NHS Stop Smoking Services for partners and significant others Who is the target population? Partners and others who smoke and live in the same household as a woman who is pregnant, planning a pregnancy or who has an infant aged under 12 months (regardless of whether or not the woman smokes). Who should take action? NHS specialist pregnancy services and NHS Stop Smoking Services. 4 This is an edited version of a recommendation that appears in Smoking cessation services NICE public health guidance 10. It does not constitute a change to the original recommendation. 5 This is an extract from a recommendation that appears in Smoking cessation services NICE public health guidance 10. consultation draft Page 11 of 50

Other organisations providing intensive interventions to help people quit smoking. What action should they take? Offer a multi-component intervention. Two packages which have been found to be effective comprise: free NRT patches combined with smoking cessation resources and multiple telephone counselling sessions video and print materials on smoking cessation combined with multiple contacts with the smoking cessation adviser. When deciding which interventions to use and in which order, discuss the options with the client and take into account 6 : whether a first offer of referral to the NHS Stop Smoking Services has been made contra-indications and the potential for adverse effects the client s personal preferences the availability of appropriate counselling or support the likelihood that the client will follow the course of treatment their previous experience of smoking cessation aids. Do not favour one medication over another. The practitioner and client should choose the one that seems most likely to succeed taking into account the above 7. Recommendation 5: training Who is the target population? Healthcare professionals who come into contact with women who smoke who are planning a pregnancy, are already pregnant or who have an infant aged under 12 months. 6 This is an extract from Smoking cessation services (NICE public health guidance 10). 7 This is a edited version of a recommendation that appears in Smoking cessation services NICE public health guidance 10. It does not constitute a change to the original recommendation. consultation draft Page 12 of 50

Who should take action? Commissioners of NHS specialist pregnancy services and NHS Stop Smoking Services. Maternity services. Professional bodies and organisations. NHS Centre for Smoking Cessation and Training. What action should they take? Ensure all healthcare professionals know how to refer the women being targeted (see above) to local NHS Stop Smoking Services and NHS specialist pregnancy services. They should also know what these services offer. Ensure all midwives, health visitors, doctors, nurses, pharmacists and other healthcare professionals understand the impact of smoking and exposure to secondhand smoke on women and their unborn children. Ensure these healthcare professionals are also trained in the dangers of exposing pregnant women and their unborn child to secondhand smoke. Train all midwives in how to encourage women who are pregnant and smoke to quit. Ensure NHS Stop Smoking Services staff are trained to the minimum national standard, or on the basis of forthcoming updates from the NHS Centre for Smoking Cessation and Training. For the minimum national standard see Standard for training in smoking cessation treatments (www.nice.org.uk/page.aspx?o=502591). Provide additional specialised training for NHS Stop Smoking Services staff who are working with pregnant women who smoke. Ensure training addresses the perceived barriers to tackling smoking with someone who is pregnant. This may include practitioners concerns that it might damage their relationship with the pregnant woman, the belief that consultation draft Page 13 of 50

current information and advice is insufficient or inadequate, limited skills and lack of knowledge of the types of intervention available. Ensure training addresses the important role that partners and significant others can play in helping a woman who is pregnant or has recently given birth to quit smoking. This includes the need to consider quitting themselves if they smoke. Recommendation 6: incentives Who is the target population? Women who smoke who are planning a pregnancy, are pregnant or who have an infant aged under 12 months. Who should take action? Smoking cessation commissioners and practitioners. Policy makers. What action should they take? Practitioners, policy makers and commissioners should only endorse incentive schemes to encourage people to quit smoking if they are evaluated. An evaluation should: biochemically validate smoking status before and after treatment specify the content of the intervention and how it is delivered investigate any unintended consequences (for example, misreporting of smoking status, or someone deliberately delaying their quit attempt until an incentive is available) measure the impact of incentives on smoking cessation services: recruitment, retention (for example, attendance at appointments) and outcomes (effectiveness) consultation draft Page 14 of 50

use appropriate process and outcome measures (for example, to determine intermediate outcomes such as knowledge, attitudes and skills, as well as effectiveness, acceptability, feasibility, equity and safety) include a range of indicators to evaluate not only what works, but in what context, as well as the experiences of those involved collect data on costs: staff time, training and overheads (premises, power, equipment), products (for example, incentives, pharmaceutical treatments, leaflets) and the client s own expenses. PCTs should consult with other trusts and local universities if they want to get involved in research to assess the effectiveness of incentive schemes. Such research should meet the minimum criteria recommended by NICE (see sections 3 and 5 in Methods for the development of NICE public health guidance [Second edition 2009]). Recommendation 7: preventing a smoking relapse Who is the target population? Women who have given up smoking in the 12 months before pregnancy, during pregnancy or who have an infant aged under 12 months. Who should take action? Practitioners providing support to help women stop smoking or to prevent a return to smoking (relapse). Commissioners of smoking cessation services. What action should they take? Practitioners and commissioners should only endorse schemes to prevent a smoking relapse if they are evaluated. An evaluation should: consultation draft Page 15 of 50

biochemically validate smoking status before and after treatment specify the content of the intervention and how it is delivered investigate any unintended consequences measure the impact of relapse prevention on smoking cessation services: recruitment, retention (for example, attendance at appointments) and outcomes (effectiveness) use appropriate process and outcome measures (for example, to determine intermediate outcomes such as knowledge, attitudes and skills, as well as effectiveness, acceptability, feasibility, equity and safety) include a range of indicators to evaluate not only what works, but in what context, as well as the experiences of those involved collect data on costs: staff time, training and overheads (premises, power, equipment), products (for example, incentives, pharmaceutical treatments, leaflets) and the client s own expenses. PCTs should consult with other trusts and local universities if they want to get involved in research to assess the effectiveness of relapse prevention schemes. Such research should meet the minimum criteria recommended by NICE (see sections 3 and 5 in Methods for the development of NICE public health guidance [Second edition 2009]). 2 Public health need and practice According to research conducted in 2005, nearly a third (32%) of mothers in England smoked in the 12 months before or during pregnancy (British Market Research Bureau 2007). However, other research (including studies which biochemically validated smoking status), suggest the number may be even greater (French et al. 2007; Lawrence et al. 2005; Owen and McNeill 2001). Although nearly half (49%) gave up at some stage before the birth, three in ten (30%) were smoking again less than a year after giving birth. One in six consultation draft Page 16 of 50

(17%) continued to smoke throughout their pregnancy. Around one in ten (11%) of mothers who smoke during pregnancy cut down the amount they smoke (British Market Research Bureau 2007). However, studies using biochemical measures of exposure to tobacco smoke suggest their intake of toxins have not actually reduced (Lawrence et al. 2003). In 2005, almost four in ten mothers in England (38%) lived in a household where at least one person smoked during their pregnancy (British Market Research Bureau 2007). In most cases the person who smoked was the mother s partner. A sizeable minority of those who smoked did try to give up after the woman gave birth. Fifteen per cent who smoked during the pregnancy were not smoking when the baby was aged 4 10 weeks; this had risen to almost a quarter (24%) when the baby was aged 4 6 and 8 10 months (British Market Research Bureau 2007). Health risks Smoking during pregnancy can cause serious health problems. These include: complications during labour and an increased risk of miscarriage, premature birth, still birth, low birth-weight and sudden unexpected death in infancy (Royal College of Physicians 1992). Smoking during pregnancy also increases the risk of infant mortality by an estimated 40% (Department of Health 2007). Children exposed to tobacco smoke in the womb are more likely to experience wheezy illnesses in childhood. In addition, all infants of parents who smoke are more likely to suffer from serious respiratory infections (such as bronchitis and pneumonia), symptoms of asthma and problems of the ear, nose and throat (including glue ear). This includes infants who were born prematurely and those who have other underlying medical conditions. Almost half of all children in the UK are exposed to tobacco smoke at home (Jarvis et al. 2000). consultation draft Page 17 of 50

Key factors Smoking during pregnancy is strongly associated with a number of socioeconomic and other factors including age and social economic position. Mothers aged 20 or under are five times more likely than those aged 35 and over to have smoked throughout pregnancy (45% and 9% respectively) (British Market Research Bureau 2007). Mothers in routine and manual occupations are more than four times as likely to smoke throughout pregnancy compared to those in managerial and professional occupations (29% and 7% respectively) (British Market Research Bureau 2007). Pregnant women are also more likely to smoke if they are less educated, live in rented accommodation and are single or have a partner who smokes. When the factors are combined to measure the cumulative effects of disadvantage, the number who continue to smoke during pregnancy increases tenfold from the least to the most deprived group (Penn and Owen 2002). Smoking cessation services NHS smoking cessation services report that it is difficult to get pregnant women who smoke to quit. Those working for the services doubt that brief interventions alone are effective. Almost nine in ten mothers (87%) who were smoking before or during their pregnancy said they received some type of advice or information about the habit (British Market Research Bureau 2007). Mothers who had only been advised to give up were much more likely to quit compared with those who were advised to cut down (36% and 8% respectively). Mothers who were only advised to cut down were more likely to take this option (69%) less than 1% tried to quit. Mothers who received mixed messages (to stop completely and cut down) were much more likely to cut down rather than give up completely (58% and 14% respectively) (British Market Research Bureau 2007). It is unclear how much support is provided to help women stop smoking following pregnancy. consultation draft Page 18 of 50

3 Considerations PHIAC took account of a number of factors and issues when developing the recommendations. 3.1 PHIAC recognises that many of the women most likely to smoke during pregnancy live in circumstances which make it difficult for them to quit the habit. It believes that strategies which seek to address the wider socioeconomic factors linked to smoking would increase their chances of success. 3.2 The role of the family is important. The attitude of the family, including the woman s partner, towards smoking can have an effect on her smoking behaviour (and her health, if they smoke). 3.3 A range of effective interventions and services, such as NHS Stop Smoking Services, are available to help people quit smoking. Nevertheless, only a small number of women who are pregnant or postpartum take up the offer of help. PHIAC believes it is important to ensure local services get the support they need to develop a range of approaches to increase the number of these women targeted, referred and receiving help. 3.4 A range of evidence suggests that it is important for a woman who is pregnant to quit smoking altogether rather than just cutting down. For example, the children of parents who smoke are highly likely to take up the habit. In addition, the harms associated with exposure to secondhand smoke would remain for both mother and child. Moreover, biochemical measures of women who said they had reduced the amount they smoked during pregnancy showed that this did not necessarily reduce their exposure to toxins. PHIAC believes that pregnant women who smoke must be encouraged to quit rather than simply cutting down and as early as possible into the pregnancy. consultation draft Page 19 of 50

3.5 Women who are pregnant may receive mixed messages from health professionals about the benefits of cutting down as opposed to quitting smoking altogether. PHIAC was concerned that some health professionals who find it particularly difficult to raise the issue of smoking may opt to give advice to cut down if this option is presented here. 3.6 US-based trials show that financial incentives are an effective way to encourage women who are pregnant to quit smoking. However, UK-based research is needed to take account of any cultural differences before a nationwide recommendation can be made. Please note, the committee is keen to avoid a proliferation of local evaluations which are insufficiently powered or inappropriately designed to determine whether incentives are effective. 3.7 In 2005, the Medicines and Healthcare Products Regulatory Authority reviewed the licensing indications for nicotine replacement therapy (NRT). As a result, it is now available for women who smoke and who are pregnant or breastfeeding. (It is also available for young people aged 12 17 who smoke.) However, a recent meta-analysis of NRT in pregnancy (see expert report 1, appendix E) indicates that there is still insufficient evidence about whether it helps pregnant women to quit. The authors also concluded that there was no evidence that NRT either increases or reduces the risk of low birthweight. In addition, they found insufficient data to link NRT to stillbirth or special care admissions. 3.8 Studies show that self-reported data underestimate true smoking rates. The extent to which this type of data is used to identify smoking during pregnancy means that the prevalence of smoking among pregnant women is underestimated. It also means women are not referred to stop-smoking services when they may need this type of support. consultation draft Page 20 of 50

3.9 PHIAC could not recommend giving brief advice to pregnant women who smoke, due to a lack of evidence of its effectiveness (see Brief interventions and referral for smoking cessation in primary care and other settings NICE public health guidance 1). Evidence suggests that relatively intensive interventions are required for women who are pregnant and smoke such as those offered by NHS Stop Smoking Services. 3.10 PHIAC is concerned to ensure health professionals in contact with pregnant women are not put off if their first offer of help to quit smoking is refused. As a result, the recommendations emphasise the importance of offering to help throughout the woman s pregnancy and beyond. 3.11 PHIAC believes that many professional barriers to tackling smoking among women who are pregnant or postpartum can be addressed by referring them for specialist help as a part of normal practice. Professional barriers include: lack of time, lack of resources and concerns about jeopardising the professional relationship with the client. 3.12 Although many women quit smoking during their pregnancy, relapse rates are high and the majority start smoking again within the first 6 months postpartum. PHIAC noted that the types of interventions which had been examined had failed to prevent this happening. 3.13 If the pregnant woman s partner smokes, she is more likely to continue to smoke during pregnancy and her partner s behaviour may impact on any efforts she makes to quit. There is limited evidence on how to encourage partners to help the woman to quit (during pregnancy and postpartum). 3.14 Pregnancy provides an opportunity to address the smoking habits of the woman s partner both for the partner s own health and that of their children. Moderate evidence shows that multi-component consultation draft Page 21 of 50

interventions encourage partners who smoke to stop, provided they include free NRT. 3.15 PHIAC noted that interventions which are generally effective will not necessarily work around the time of pregnancy. For example, the following were not effective with expectant fathers : media education campaigns, booklets given to them by their partner, counselling, biofeedback-based interventions and self-help guidance. 3.16 None of the studies of women who were pregnant and their families included significant others as a target group (that is, friends, roommates and other family members). Rather, all the studies focused on the expecting father. 3.17 The committee considered there was insufficient evidence from well-conducted studies to recommend specific interventions on establishing smokefree homes. It believes further research is needed in this area. 3.18 PHIAC acknowledged that encouraging practitioners to refer all pregnant women who smoke even those who are currently unwilling to consider quitting may lead to a need for additional stop smoking resources. It also acknowledged that this may lead, at least initially, to lower success rates. Nevertheless, the committee believes this is crucial to tackling the problem of smoking in pregnancy. 3.19 The cost-effectiveness model showed that interventions to encourage women who are pregnant to quit smoking were cost effective (in the main, they were more effective and less costly than no intervention). However, due to insufficient data, not all the effects of smoking during pregnancy were modelled. For instance, the model did not include the impact on subsequent infant morbidity and quality of life or healthcare costs for children aged over 5 years. If these factors had been included in the analysis, PHIAC consultation draft Page 22 of 50

believes the interventions would have probably been more cost effective. Therefore, its views on the cost-effectiveness of the interventions remain unchanged. This section will be completed in the final document. 4 Implementation NICE guidance can help: NHS organisations, social care and children's services meet the requirements of the DH's 'Operating framework for 2008/09' and 'Operational plans 2008/09 2010/11'. NHS organisations, social care and children's services meet the requirements of the Department of Communities and Local Government's 'The new performance framework for local authorities and local authority partnerships'. National and local organisations within the public sector meet government indicators and targets to improve health and reduce health inequalities. Local authorities fulfil their remit to promote the economic, social and environmental wellbeing of communities. Local NHS organisations, local authorities and other local public sector partners benefit from any identified cost savings, disinvestment opportunities or opportunities for re-directing resources. Provide a focus for multi-sector partnerships for health, such as local strategic partnerships. NICE will develop tools to help organisations put this guidance into practice. Details will be available on our website after the guidance has been issued (www.nice.org.uk/phxx). consultation draft Page 23 of 50

5 Recommendations for research This section will be completed in the final document. More detail on the gaps in the evidence identified during development of this guidance is provided in appendix D. 6 Updating the recommendations This section will be completed in the final document. 7 Related NICE guidance Published Antenatal care: routine care for the healthy pregnant woman. NICE clinical guideline 62 (2008). Available from www.nice.org.uk/cg62 Smoking cessation services. NICE public health guidance 10 (2008). Available from www.nice.org.uk/ph10 Identifying and supporting people most at risk of dying prematurely. NICE public health guidance 15 (2008). Available from www.nice.org.uk/ph15 Behaviour change. NICE public health guidance 6 (2007). Available from www.nice.org.uk/ph6 Workplace interventions to promote smoking cessation. NICE public health guidance 5 (2007). Available from www.nice.org.uk/ph5 Brief interventions and referral for smoking cessation in primary care and other settings. NICE public health guidance 1 (2006). Available from www.nice.org.uk/ph1 Postnatal care: routine postnatal care of women and their babies. NICE clinical guideline 37 (2006). Available from www.nice.org.uk/cg37 consultation draft Page 24 of 50

Under development School-based interventions to prevent smoking. NICE public health guidance (publication expected February 2010) Hypertensive disorders during pregnancy. NICE clinical guideline (publication expected April 2010) Pregnancy and complex social factors. NICE clinical guideline (publication expected August 2010) Weight management in pregnancy. NICE public health guidance (publication expected June 2010) Weight management following childbirth. NICE public health guidance (publication expected July 2010) 8 References British Market Research Bureau (2007) Infant feeding survey 2005. A survey conducted on behalf of the Information Centre for Health and Social Care and the UK Health Departments. Southport: The Information Centre Department of Health (2007) Review of the health inequalities infant mortality PSA target. London: Department of Health French GM, Groner JA, Wewers ME et al. (2007) Staying smoke free: an intervention to prevent postpartum relapse. Nicotine and Tobacco Research 9 (6): 663 70 Jarvis MJ, Goddard E, Higgins V et al. (2000) Children s exposure to passive smoking in England since the 1980s: cotinine evidence from population surveys. BMJ 321: 343 5 Lawrence T, Aveyard P, Croghan E (2003) What happens to women s selfreported cigarette consumption and urinary cotinine levels in pregnancy? Addiction 98: 1315 20 consultation draft Page 25 of 50

Lawrence T, Aveyard P, Cheng KK et al. (2005) Does stage-based smoking cessation advice in pregnancy result in long-term quitters? 18-month postpartum follow-up of a randomised controlled trial. Addiction 110: 107 16 Owen L, McNeill A (2001) Saliva cotinine as an indicator of cigarette smoking among pregnant women. Addiction 96 (7): 1001 6 Penn G, Owen L (2002) Factors associated with continued smoking during pregnancy: analysis of socio-demographic, pregnancy and smoking related factors. Drug and Alcohol Review 21: 17 25 Royal College of Physicians (1992) Smoking and the young. London: Royal College of Physicians consultation draft Page 26 of 50

Appendix A Membership of the Public Health Interventions Advisory Committee (PHIAC), the NICE project team and external contractors Public Health Interventions Advisory Committee NICE has set up a standing committee, the Public Health Interventions Advisory Committee (PHIAC), which reviews the evidence and develops recommendations on public health interventions. Membership of PHIAC is multidisciplinary, comprising public health practitioners, clinicians (both specialists and generalists), local authority officers, teachers, social care professionals, representatives of the public, academics and technical experts as follows. Professor Sue Atkinson CBE Independent Consultant and Visiting Professor, Department of Epidemiology and Public Health, University College London Mr John F Barker Associate Foundation Stage Regional Adviser for the Parents as Partners in Early Learning Project, DfES National Strategies Professor Michael Bury Emeritus Professor of Sociology, University of London. Honorary Professor of Sociology, University of Kent Professor K K Cheng Professor of Epidemiology, University of Birmingham Ms Joanne Cooke Programme Manager, Collaboration and Leadership in Applied Health Research and Care for South Yorkshire Mr Philip Cutler Forums Support Manager, Bradford Alliance on Community Care Ms Lesley Michele de Meza Personal, Social, Health and Economic (PSHE) Education Consultant, Trainer and Writer consultation draft Page 27 of 50

Professor Ruth Hall CB Public Health Physician; Visiting Professor at the University of the West of England. Ms Amanda Hoey Director, Consumer Health Consulting Limited Mr Alasdair J Hogarth Head Teacher, Archbishops School, Canterbury Mr Andrew Hopkin Assistant Director, Local Environment, Derby City Council Dr Ann Hoskins Director, Children, Young People and Maternity, NHS North West Ms Muriel James Secretary, Northampton Healthy Communities Collaborative and the King Edward Road Surgery Patient Participation Group Dr Matt Kearney General Practitioner, Castlefields, Runcorn. GP Public Health Practitioner, Knowsley PCT CHAIR Professor Catherine Law Professor of Public Health and Epidemiology, UCL Institute of Child Health Mr David McDaid Research Fellow, Department of Health and Social Care, London School of Economics and Political Science Mr Bren McInerney Community Member Professor Susan Michie Professor of Health Psychology, BPS Centre for Outcomes Research and Effectiveness, University College London Dr Stephen Morris Professor of Health Economics, Department of Epidemiology and Public Health, University College London Dr Adam Oliver RCUK Senior Academic Fellow, Health Economics and Policy, London School of Economics Dr Mike Owen General Practitioner, William Budd Health Centre, Bristol Dr Toby Prevost Reader in Medical Statistics, Department of Public Health Sciences, King's College London consultation draft Page 28 of 50

Ms Jane Putsey Lay Member, Registered Tutor, Breastfeeding Network Dr Mike Rayner Director, British Heart Foundation Health Promotion Research Group, Department of Public Health, University of Oxford Mr Dale Robinson Chief Environmental Health Officer, South Cambridgeshire District Council Ms Joyce Rothschild Children s Services Improvement Adviser, Solihull Metropolitan Borough Council Dr Tracey Sach Senior Lecturer in Health Economics, University of East Anglia Professor Mark Sculpher Professor of Health Economics, Centre for Health Economics, University of York Dr David Sloan Retired Director of Public Health Dr Stephanie Taylor Reader, Applied Research, Centre for Health Sciences, Barts and The London School of Medicine and Dentistry Dr Stephen Walters Reader, Medical Statistics, University of Sheffield Dr Dagmar Zeuner Joint Director of Public Health, Hammersmith and Fulham PCT Expert co-optees to PHIAC: Doris Gaga Smoking Cessation Counsellor, Southwark Stop Smoking Services for Pregnant Women/Parents Susie Hill Health Campaign Manager, Tommy s (the baby charity) Richard Windsor Professor of Public Health, George Washington University Medical Center Expert testimony to PHIAC: Linda Bauld Professor of Social Policy, University of Bath consultation draft Page 29 of 50

Susan Baxter Research Fellow, School of Health and Related Research (ScHARR), University of Sheffield Peter Hajek Professor of Clinincal Psychology, Queen Mary University, London Natalie Hemsley Tobacco Research Co-ordinator, University of British Colombia Chizimuzo Okoli Postdoctoral Fellow, University of British Colombia NICE project team Mike Kelly CPHE Director Antony Morgan Associate Director Lesley Owen Lead Analyst and Technical Adviser (Health Economics) Dylan Jones Analyst Karen Peploe Analyst External contractors Reviewers: effectiveness reviews Review 1: 'Which interventions are effective and cost effective in encouraging the establishment of smokefree homes?' was carried out by the School of Health and Related Research (ScHARR), University of Sheffield. The principal authors were: Susan Baxter, Lindsay Blank, Louise Guillaume, Josie Messina, Emma Everson-Hock and Julia Burrows. consultation draft Page 30 of 50

Review 2: 'Factors aiding delivery of effective interventions' was carried out by ScHARR, University of Sheffield. The principal authors were: Susan Baxter, Lindsay Blank, Louise Guillaume, Josie Messina, Emma Everson-Hock and Julia Burrows. Review 3: 'The health consequences of pregnant women cutting down as opposed to quitting' was carried out by ScHARR, University of Sheffield. The principal authors were: Susan Baxter, Lindsay Blank, Louise Guillaume, Josie Messina, Emma Everson-Hock and Julia Burrows. Reviewers: economic analysis 'The economic analysis of interventions for smoking cessation aimed at pregnant women' was carried out by the York Health Economics Consortium, University of York. The principal author was Matthew Taylor. Reviewers: expert reports Expert report 1: 'The effectiveness of smoking cessation interventions during pregnancy: a briefing paper' was carried out by the UK Centre for Tobacco Control Studies. The principal authors were: Linda Bauld and Tim Coleman. Expert report 2: 'Interventions to improve partner support and partner cessation during pregnancy' was carried out by the Centre of Excellence for Women's Health, British Columbia. The principal authors were: Natalie Hemsing, Renee O Leary, Katharine Chan, Chizimuzo Okoli and Lorraine Greaves. Expert report 3: 'Rapid review of interventions to prevent relapse in pregnant ex-smokers' was carried out by Barts and The London School of Medicine and Dentistry, London. The principal authors were: Katie Myers, Oliver West and Peter Hajek. consultation draft Page 31 of 50

Appendix B Summary of the methods used to develop this guidance Introduction The reviews, expert reports and economic analysis include full details of the methods used to select the evidence (including search strategies), assess its quality and summarise it. The minutes of the PHIAC meetings provide further detail about the Committee s interpretation of the evidence and development of the recommendations. All supporting documents are listed in appendix E and are available at www.nice.org.uk/guidance/phg/wave20/1 consultation draft Page 32 of 50

Guidance development The stages involved in developing public health intervention guidance are outlined in the box below. 1. Draft scope released for consultation 2. Stakeholder meeting about the draft scope 3. Stakeholder comments used to revise the scope 4. Final scope and responses to comments published on website 5. Evidence review(s) and economic analysis undertaken 6. Evidence and economic analysis released for consultation 7. Comments and additional material submitted by stakeholders 8. Review of additional material submitted by stakeholders (screened against inclusion criteria used in review/s) 9. Evidence and economic analysis submitted to PHIAC 10. PHIAC produces draft recommendations 11. Draft guidance released for consultation and for field testing 12. PHIAC amends recommendations 13. Final guidance published on website 14. Responses to comments published on website Key questions The key questions were established as part of the scope. They formed the starting point for the reviews of evidence and were used by PHIAC to help develop the recommendations. The overarching questions were: consultation draft Page 33 of 50

1. Which interventions are effective and cost effective in helping women to quit smoking immediately before or during pregnancy and following childbirth? 2. Which interventions are effective and cost effective in encouraging partners (and significant others ) help a woman quit smoking during her pregnancy and following childbirth? 3. 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? 4. Which interventions are effective and cost-effective in encouraging partners (and 'significant others') who smoke to stop smoking themselves? 5. Which interventions are effective and cost effective in encouraging the establishment of smokefree homes? 6. What factors aid delivery of effective interventions? What are the barriers to successful delivery? 7. What are the health consequences of pregnant women cutting down on their cigarette consumption as opposed to quitting? These questions were made more specific for the reviews (see reviews for further details). Reviewing the evidence of effectiveness Three reviews of effectiveness were conducted. Identifying the evidence The following databases were searched from 1990 to 2009 for: interventions that encourage smokefree homes; factors which help or discourage pregnant women who smoke to use smoking cessation interventions; and the health consequences of pregnant women cutting down as opposed to quitting. consultation draft Page 34 of 50

Applied Social Sciences Index and Abstracts (ASSIA) British Nursing Index Cumulative Index to Nursing and Allied Health Literature (CINAHL) Embase Maternity and Infant Care MEDLINE PsycINFO Science Citation Index Social Science Citation Index. Web of Science Cited Reference and Google Scholar were used to search for citations and internal topic experts were consulted. In addition, the reference lists of papers and reviews that were retrieved in the search process (but not included in the review, due to study type) were sifted. Selection criteria Studies were included in the effectiveness reviews if they: included women who smoked who were planning a pregnancy, were pregnant or had an infant aged less than 12 months included anyone who smoked and lived in the same dwelling as a pregnant woman or one who was planning a pregnancy, or where an infant aged less than 12 months lived covered interventions aimed at making homes smokefree addressed factors that aided the delivery of effective interventions looked at the health consequences of pregnant women cutting down, as opposed to quitting smoking. Studies were excluded if they: focused on women who did not smoke or who lived in a smokefree household focused on women who smoked but were not planning a pregnancy, were not pregnant, or did not have a child aged under 12 months. consultation draft Page 35 of 50

Quality appraisal Included papers were assessed for methodological rigour and quality using the NICE methodology checklist, as set out in the NICE technical manual Methods for the development of NICE public health guidance (see appendix E). Each study was graded (++, +, ) to reflect the risk of potential bias arising from its design and execution. Study quality ++ All or most of the methodology checklist criteria have been fulfilled. Where they have not been fulfilled, the conclusions are thought very unlikely to alter. + Some of the methodology checklist criteria have been fulfilled. Those criteria that have not been fulfilled or not adequately described are thought unlikely to alter the conclusions. Few or no methodology checklist criteria have been fulfilled. The conclusions of the study are thought likely or very likely to alter. Expert reports Three expert reports were conducted as follows: Expert report 1 reviewed effective interventions for pregnant women who smoke before or during pregnancy. It identified 12 papers published between 2006 and 2009. It also included findings from the latest Cochrane review on a wider range of smoking cessation interventions for pregnant women who smoke. Expert report 2 reviewed interventions to improve partner support and partner cessation during pregnancy. It identified18 papers published between 1990 and 2009. Expert report 3 reviewed interventions to prevent women who have quit smoking during pregnancy and after childbirth from taking up the habit again. It identified 35 papers published between 1990 and 2009. It also included findings from the latest Cochrane review on relapse prevention. consultation draft Page 36 of 50