1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 Topic NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Guideline scope Smoking cessation interventions and services This guideline will be a partial update of NICE guidelines on brief advice and referral for smoking cessation (PH1), smoking cessation services (PH10) and quitting smoking in pregnancy and following childbirth (PH26), as set out in the review decisions for PH1, PH10 and PH26. Who the guideline is for Providers of smoking cessation interventions and services, including those in the voluntary and community sectors who have a direct or indirect (for example, midwives offering routine antenatal care) role or responsibility for smoking cessation. Commissioners of smoking cessation services. It may also be relevant for: Members of the public who wish to give up smoking. NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. Equality considerations NICE has carried out an equality impact assessment during scoping. The assessment: lists equality issues identified, and how they have been addressed explains why any groups are excluded from the scope. (11 November to 9 December 2015) 1 of 10
28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 The guideline will look at inequalities relating to age, gender, race, geographical location and socioeconomic status. 1 What the guideline is about 1.1 Who is the focus? Adults and young people aged 12 and over who smoke tobacco. Particular emphasis will be given to groups with high smoking rates. These include: people working in routine or manual occupations people with a mental health disorder some black and minority ethnic groups, for example, Bangladeshi and Irish men, and Irish and black Caribbean women homeless people single parents people on a low income, on benefits or unemployed refugees and asylum seekers transient and travelling populations. Women, especially those under 21, who smoke tobacco and are planning a pregnancy or are pregnant. Women of all ages who smoke tobacco and who have an infant aged under 12 months. Women who have stopped smoking tobacco immediately before or during their pregnancy, or soon after childbirth. 1.2 Settings Settings that will be covered Primary care and community settings and all maternity services, including maternity services provided in secondary care. Settings that will not be covered Workplaces, residential and custodial settings. (11 November to 9 December 2015) 2 of 10
55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 Acute, secondary and mental health services 1 other than maternity care. 1.3 Activities, services or aspects of care Key areas that will be covered Areas from the published guidelines that will be updated 1 Brief advice (given typically in less than 10 minutes). 2 Very brief advice (given as the opportunity arises in less than 30 seconds). 3 Behavioural support (for example, delivered to a person or a group). 4 Exercise interventions for smoking cessation. 5 Telephone quitlines. 6 Pharmacotherapies (nicotine replacement therapy, including licenced 2 e-cigarettes 3 and bupropion). Note that guideline recommendations will normally fall within licensed indications; exceptionally, and only if clearly supported by evidence, use outside a licensed indication may be recommended. The guideline will assume that prescribers will use a medicine's summary of product characteristics to inform decisions made with individual patients. 7 Mass-media campaigns (for example, stop smoking poster, radio, and TV campaigns). 8 For pregnant women who smoke: opt-out of referral pathway incentives for smoking cessation, for example, vouchers nicotine replacement therapy for smoking cessation. 1 For examples see NICE's guideline on smoking cessation in secondary care: acute, maternity and mental health services. 2 The Medicines and Healthcare products Regulatory Agency (MHRA) will consider marketing authorisation applications for e-cigarettes for smoking cessation and harm reduction. Licenced e-cigarettes are those that state they are for health use and have been approved as a medicinal product. 3 Note that NICE's guideline on smoking: harm reduction is being reviewed at the time of publication of this scope. (11 November to 9 December 2015) 3 of 10
78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 Areas not in the published guidelines that will be included in the update 1 The role of digital media in smoking cessation interventions, for example, using text messages, the internet or social media to provide information and deliver campaigns or behavioural support. Areas that will not be covered Areas from the published guideline that will not be updated 1 From PH10: Care and advice in secondary care (recommendation has been partially updated in NICE's guideline on smoking cessation in secondary care). Workplace smoking cessation interventions. Varenicline. This is covered by NICE's technology appraisal guidance on varenicline for smoking cessation. 2 From PH26: Identifying pregnant women who smoke (actions for the public, community and voluntary sectors). Contacting referrals. Interventions with partners and others in the household who smoke. Training for practitioners to deliver interventions. Areas not covered by the published guidelines or the update 1 Programmes or interventions to prevent people from taking up smoking or some other use of tobacco. 2 Programmes or interventions dealing with cannabis use. 3 Consumer e-cigarettes 4 (or similiar consumer electronic nicotine delivery systems). 4 The term 'consumer' is used here to distinguish e-cigarettes on general sale from those, that in the future, may be licenced by the MHRA as medicinal products for smoking cessation and harm reduction. Consumer e-cigarettes that do not state they are for health use will also be subject to regulation by the MHRA (according to the revised European Union Tobacco Products Directive) but will not be awarded a licence for medicinal use. (11 November to 9 December 2015) 4 of 10
103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 Recommendations in areas that are not being updated may be edited to ensure that they meet current editorial standards, and reflect the current policy and practice context. 1.4 Economic aspects We will take economic aspects into account when making recommendations. For interventions already assessed by NICE, consideration will be given to whether the economic analyses need to be updated. For new interventions not covered by existing guidelines, we will review the economic evidence. We will use existing models, if possible, to consider cost effectiveness. The analyses will use a public- or multi-sector perspective as appropriate. 1.5 Key issues and questions While writing this scope, we have identified the following key issues, and key questions related to them: 1 Is brief advice from a community, health or social care professional effective and cost effective? Does effectiveness and cost effectiveness vary according to the status of the person delivering it and the way it is delivered? 2 Is very brief advice from a community, health or social care professional effective and cost effective? Does effectiveness and cost effectiveness vary according to the status of the person delivering it and the way it is delivered? 3 Is behavioural support (delivered to a person or a group) effective and cost effective? 4 Are exercise interventions effective and cost effective? 5 Are telephone quitlines effective and cost effective? 6 Are incentives (for example, vouchers to encourage smoking cessation among pregnant women) effective and cost effective? 7 Is nicotine replacement therapy (for example, patch, gum or spray) or bupropion, on their own or combined with behavioural support, effective and cost-effective? (11 November to 9 December 2015) 5 of 10
134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 8 Is nicotine replacement therapy (for example, patch, gum or spray) effective or cost effective for pregnant women who smoke? 9 Are mass-media campaigns (for example, stop smoking TV, radio and poster campaigns) effective and cost effective? 10 What type of support is effective and cost effective for pregnant women who have opted out after initial contact with a local stop smoking service? 11 What is the role of digital media in smoking cessation interventions? Does effectiveness and cost effectiveness vary with the use of digital media? The key questions may be used to develop more detailed review questions, which guide the systematic review of the literature. The reviews will consider the effectiveness of an intervention or service delivered alone or combined with other smoking cessation interventions or services. 1.6 Main outcomes The main outcomes that will be considered when searching for and assessing the evidence are: 1 Increase in the number of smokers who quit smoking. 2 Duration of quit attempt after the intervention or service: at least 1 month (short term) at least 3 months (medium term) at least 1 year (long term). 3 Relapse rates associated with different interventions. 4 Reduction in the number of women who: smoke before, during or after pregnancy start smoking again during or after pregnancy. 5 Reduction in infant mortality and morbidity, such as: the number of low birthweight babies the number of infant respiratory infections. 6 Behavioural outcomes (for example, positive changes in knowledge about, and attitudes to, smoking). (11 November to 9 December 2015) 6 of 10
165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 7 Quality of life. 8 Costs, savings, cost effectiveness. 2 Links with other NICE guidance, NICE quality standards, and NICE Pathways 2.1 NICE guidance NICE guidance that will be updated by this guideline Brief interventions and referral for smoking cessation in primary care and other settings (2006) NICE guideline PH1 Smoking cessation services (2008) NICE guideline PH10 (recommendations 1 4, 10, 11 and 12) Quitting smoking in pregnancy and following childbirth (2010) NICE guideline PH26 (recommendations 1, 4 and 5) NICE guidance that will be incorporated unchanged in this guideline Smoking cessation services (2008) NICE guideline PH10 (recommendations 7, 13 15 and 16; recommendation 5 has been updated by PH45, recommendation 6 has been partially updated by PH48 and recommendations 8 and 9 have been updated by PH26) Quitting smoking in pregnancy and following childbirth (2010) NICE guideline PH26 (recommendations 2, 3, 6, 7 and 8) NICE guidance about the experience of people using NHS services NICE has produced the following guidance on the experience of people using the NHS. This guideline will not include additional recommendations on these topics unless there are specific issues related to smoking cessation services and interventions: Patient experience in adult NHS services (2012) NICE guideline CG138 Service user experience in adult mental health (2011) NICE guideline CG136 Medicines adherence (2009) NICE guideline CG76 (11 November to 9 December 2015) 7 of 10
193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 2.2 NICE quality standards NICE quality standards that may need to be revised or updated when this guideline is published Smoking cessation: reducing tobacco use (2015) NICE quality standard 82 Smoking cessation: supporting people to stop smoking (2013) NICE quality standard 43 Antenatal care (2012) NICE quality standard 22 NICE quality standards that may use this guideline as an evidence source when they are developed Community pharmacy Maternal health Oral health promotion in the community 2.3 NICE Pathways When this guideline is published, the recommendations will be added to NICE Pathways. NICE Pathways bring together all related NICE guidance and associated products on a topic in an interactive topic-based flowchart. The smoking pathway will be reviewed and updated to integrate the updated recommendations from NICE's guidelines on brief interventions and referral for smoking cessation (PH1), smoking cessation services (PH10) and quitting smoking in pregnancy and following childbirth (PH26). 3 Context 3.1 Key facts and figures Smoking is still the main cause of preventable illness and premature death in England. In 2013/14, an estimated 453,700 NHS hospital admissions in England were attributable to smoking among adults aged 35 and over. It is estimated that 17% (78,200) of all deaths in this age group were caused by smoking. (Statistics on smoking Health and Social Care Information Centre). (11 November to 9 December 2015) 8 of 10
220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 Treating smoking-related illness is estimated to cost the NHS 2.7 billion a year ('Statistics on smoking') and the wider cost to society is approximately 13.8 billion a year (The local costs of smoking Action on Smoking and Health). See the NICE guidelines on brief advice and referral for smoking cessation, smoking cessation services and quitting smoking in pregnancy and following childbirth for more information. 3.2 Current practice There is a gap in evidence on practice specifically relating to the recommendations to be updated. 3.3 Policy, legislation, regulation and commissioning Policy This guideline will help local authorities and the NHS to reduce tobacco use as set out in Healthy lives, healthy people: a tobacco control plan for England (Department of Health). This 5-year strategy comes to an end in 2015. New targets to speed up the decline in smoking prevalence have been proposed by Action on Smoking and Health (Smoking still kills). This guideline will also help local authorities and the NHS to meet smokingrelated outcomes within the 'health improvement' domain in The public health outcomes framework 2013 to 2016 (Department of Health). Legislation, regulation and guidance The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a decision that all nicotine-containing products should be regulated once the European Commission's revised Tobacco Products Directive comes into effect in the UK. This is expected in May 2016. Commissioning Local authorities are responsible for commissioning tobacco control and smoking cessation services. They are guided by the Public Health Outcomes Framework, their local joint strategic needs assessment and joint health and (11 November to 9 December 2015) 9 of 10
249 250 251 252 253 254 255 wellbeing strategy. (Local stop smoking services service and delivery guidance National Centre for Smoking Cessation and Training). Historically, primary care trusts funded stop smoking services and other cessation interventions, for example, training and communications campaigns. But in recent years this model has changed in some areas ('Local stop smoking services service and delivery guidance'). 4 Further information This is the draft scope for consultation with registered stakeholders. The consultation dates are 11 November to 9 December 2015. The final scope will take Public Health England priorities into account to ensure that associated areas of work carried out by the 2 organisations complement each other. The guideline is expected to be published in October 2017. You can follow progress of the guideline. Our website has information about how NICE guidelines are developed. 256 (11 November to 9 December 2015) 10 of 10