NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE PUBLIC HEALTH GUIDANCE SCOPE 1 Guidance title Identifying and managing tuberculosis among hard-to-reach groups 1.1 Short title Tuberculosis: hard-to-reach groups 2 Background a) The National Institute for Health and Clinical Excellence (NICE) has been asked by the Department of Health (DH) to develop guidance on a public health programme aimed at reducing the transmission of tuberculosis (TB) among hard-to-reach groups. b) NICE public health guidance supports the preventive aspects of relevant national service frameworks (NSFs), where they exist. If it is published after an NSF has been issued, the guidance effectively updates it. c) This guidance will support a number of related policy documents including: Stopping tuberculosis in England: an action plan from the Chief Medical Officer (DH 2004) The global plan to stop TB: 2006 2015 (Stop TB Partnership and World Health Organization 2006) Tuberculosis prevention and treatment: a toolkit for planning, commissioning and delivering high-quality services in England (DH 2007). Tuberculosis: hard-to-reach groups Page 1 of 13
d) This guidance will provide recommendations for good practice, based on the best available evidence of effectiveness, including cost effectiveness. It is aimed at professionals, commissioners and managers with public health as part of their remit working within the NHS, local authorities and the wider public, private, voluntary and community sectors. It is particularly aimed at those who come into contact with hard-to-reach groups. This includes those working within the criminal justice system and with people who are homeless, drug and alcohol services, and those with communicable disease prevention and control as part of their remit. It may also be of interest to people from hard-to-reach groups, their families, people who have had TB and other members of the public. e) The guidance will complement other NICE guidance on TB. For further details, see section 6. This guidance will be developed using the NICE public health programme process. 3 The need for guidance a) In 2008, there were 7970 reported cases of tuberculosis (TB) in England; an incidence of 15.5 cases per 100,000 people (Health Protection Agency 2009). In England, as in many high-income lowincidence countries, the epidemiology of TB is characterised by high levels among certain subpopulations. b) The incidence of TB is influenced by and associated with social risk factors. These include poor nutrition, poor access to healthcare, homelessness, problem drug use and imprisonment (Story et al. 2007; Lönnroth et al. 2009). These factors are also associated with poor adherence to treatment (Noyes and Popay 2007; World Health Organization 2003). In a cohort of TB patients in London, prevalence was estimated at 354.3 per 100,000 for Tuberculosis: hard-to-reach groups Page 2 of 13
problem drug users, 208.4 per 100,000 among prisoners and 788.1 per 100,000 among those living in hostels (Story et al. 2007). Information from TB and HIV databases indicates that in 2003 5.7% of people with TB in England and Wales also had HIV (Ahmed et al. 2007). c) The prevention and control of TB among hard-to-reach groups is complicated by delayed diagnosis (leading to potential onward transmission) and poor adherence to treatment (that can lead to the development of drug-resistant forms) (Story et al. 2006; van Hest and Story 2008). (For a definition of hard-to-reach groups see section 4.1.1.) In 2008, susceptibility test results indicated that 6.8% of UK culture-confirmed cases were resistant to at least one first-line drug at the start of treatment (Health Protection Agency 2009). Left untreated, pulmonary TB from one person may infect around 10 15 people every year (DH 2004) although this figure is likely to vary in different population subgroups. d) Control of TB is dependent on early identification of active cases, completion of treatment, and preventive therapy (that is, drug treatment for latent infection and vaccination). Typically, passive case finding has been used relying on symptomatic people to present themselves to health services. However, this may not be effective among hard-to-reach groups, whose social circumstances and lifestyle can mask clinical symptoms and compromise access to traditional health services. NICE has recommended previously that interventions to promote early detection can reduce transmission in hard-to-reach groups ( Tuberculosis, NICE clinical guideline 33, 2003). e) TB is curable but requires lengthy treatment for at least 6 months. Patients who do not complete treatment are at risk of a relapse and of developing a drug-resistant form of the disease, which is more difficult and slower to treat. The cost of treating normal TB is around 5000 for drug-resistant TB it is between 50,000 and Tuberculosis: hard-to-reach groups Page 3 of 13
70,000 (DH 2009). Interventions that maximise the number of people who complete a full course of treatment help to minimise the development of drug-resistant forms and reduce transmission. Such interventions are likely to be particularly important for hard-toreach groups, who are more likely not to complete treatment. 4 The guidance Public health guidance will be developed according to NICE processes and methods. For details see section 5. This document defines exactly what this guidance will (and will not) examine, and what the guidance developers will consider. The scope is based on a referral from the DH (see appendix A). 4.1 Who is the focus? 4.1.1 Groups that will be covered Hard-to-reach groups at risk of TB. Children, young people and adults whose social circumstances or lifestyle, or those of their parents or carers, make it difficult to: recognise the clinical onset of tuberculosis access diagnostic and treatment services self-administer treatment (or, in the case of children and young people, have treatment administered by a parent or carer) attend regular appointments for clinical follow-up. 4.1.2 Groups that will not be covered Those not in the groups detailed above. Tuberculosis: hard-to-reach groups Page 4 of 13
4.2 Activities 4.2.1 Activities/measures that will be covered This guidance will consider interventions to: Raise awareness of TB among hard-to-reach groups, including symptoms and how to prevent, diagnose and treat TB for example, using peer education. Raise awareness of TB among service providers and others working with hard-to-reach groups (such as those working in the criminal justice system or accident and emergency departments), including symptoms and how to prevent, diagnose and treat TB. Increase the opportunity for and uptake of targeted screening programmes to identify people from hard-to-reach groups who are infected with TB for example, mobile X-ray schemes. Identify people at risk of non-adherence with treatment. Reduce the barriers to TB diagnosis for example, by addressing any associated stigma or any language barriers to accessing services. Encourage people to complete the full course of treatment. This includes re-establishing contact with people previously diagnosed who are not known to have completed treatment (that is, lost to follow-up ). For example, interventions to increase the use of directly observed therapy (DOT); use of case workers to help people adhere to treatment; and multidisciplinary approaches that address broader health and social needs. These activities could target people in a range of settings (for example, prisons and services for people who are homeless) and be delivered by a range of professionals and non-professionals (for example, peer educators). PDGs may consider the principal and relevant complementary and alternative measures or approaches. They will also take reasonable steps to identify ineffective measures and approaches. Tuberculosis: hard-to-reach groups Page 5 of 13
4.2.2 Activities/measures that will not be covered BCG vaccination. The effectiveness of different tests for diagnosing active and latent TB. Drug treatment regimens (drugs used, dosage, frequency and duration). 4.3 Key questions and outcomes Below are the overarching questions that will be addressed, along with some of the outcomes that would be considered as evidence of effectiveness: Question 1: Which interventions are effective and cost effective at identifying and managing TB among hard-to-reach groups? Question 2: Which case management tools are most effective and cost effective at identifying those who may need support to complete treatment? Question 3: Which service models and organisational structures are most effective and cost effective at supporting TB diagnosis and treatment among hard-to-reach groups? Question 4: What factors help or hinder the uptake of TB diagnosis and treatment services by people from hard-to-reach groups, for example the acceptability of different testing modalities. How can the barriers be overcome? Expected outcomes: These may include a change in: number of TB diagnoses among hard-to-reach groups time that elapses between symptomatic TB infection and diagnosis transmission of TB among hard-to-reach groups uptake of TB screening awareness of TB, including the symptoms, diagnosis and treatment awareness of TB screening services number of opportunities for TB screening for hard-to-reach groups Tuberculosis: hard-to-reach groups Page 6 of 13
number and types of venue where TB screening is offered number of people from hard-to-reach groups completing treatment for TB number of multi-drug-resistant TB cases among hard-to-reach groups awareness of how hard-to-reach groups view TB and how they think the barriers to diagnosis and treatment can be overcome the settings where TB screening and treatment are delivered, or other changes that overcome the barriers to TB diagnosis and treatment for hardto-reach groups and service providers referrals to other services. For the purposes of economic modelling, mortality and health-related quality of life (HRQoL) outcomes will also be required. 4.4 Status of this document This is the final scope, incorporating comments from a 4 week consultation, which included a stakeholder meeting on 9 February 2010. 5 Further information The public health guidance development process and methods are described in The NICE public health guidance development process: An overview for stakeholders including public health practitioners, policy makers and the public (second edition, 2009) available at www.nice.org.uk/phprocess and Methods for development of NICE public health guidance (second edition, 2009) available at www.nice.org.uk/phmethods 6 Related NICE guidance Published Drug misuse: psychosocial interventions. NICE clinical guideline 51 (2007). Available from www.nice.org.uk/guidance/cg51 Clinical diagnosis and management of tuberculosis, and measures for its prevention and control. NICE clinical guideline 33 (2006). Available from www.nice.org.uk/guidance/cg33 Tuberculosis: hard-to-reach groups Page 7 of 13
Under development Tuberculosis: interferon gamma test (update). NICE clinical guideline (publication expected November 2010). Tuberculosis: hard-to-reach groups Page 8 of 13
Appendix A Referral from the Department of Health The Department of Health asked NICE to: 'Produce programme guidance on the effectiveness and cost effectiveness of interventions based on active case finding among hard-to-reach groups (findand-treat model) for reducing transmission of tuberculosis and related mortality and implications for service development'. Tuberculosis: hard-to-reach groups Page 9 of 13
Appendix B Potential considerations It is anticipated that the Programme Development Group (PDG) will consider the following issues: Who is responsible for commissioning and delivery. Whether the intervention is based on an underlying theory or conceptual model. Whether the intervention targets specific individuals or populations. Whether the intervention is effective and cost effective. Whether effectiveness and cost effectiveness vary according to the: diversity of the population (for example, in terms of age or gender) status, knowledge and influence of the person delivering the intervention way in which the intervention is delivered (for example, oneto-one or group-based) involvement of the target population in the planning, design or delivery content of different interventions frequency, intensity and duration of the intervention time and place the intervention is delivered. Whether the intervention is transferable to other hard-to-reach populations, other settings or other times. Any trade-offs between equity and efficiency: whether or not interventions have more of an effect on specific subpopulations. Any environmental, social and cultural factors that prevent or support uptake of TB screening. This might include people s perceptions of the risks and benefits, including knowledge that TB is a treatable condition. Tuberculosis: hard-to-reach groups Page 10 of 13
Any adverse or unintended effects. Current practice and service models for promoting TB diagnosis and treatment. Tuberculosis: hard-to-reach groups Page 11 of 13
Appendix C References Ahmed AB, Abubaker I, Delpech V et al. (2007) The growing impact of HIV infection on the epidemiology of tuberculosis in England and Wales: 1999 2003. Thorax 62: 672 6 Department of Health (2004) Stopping tuberculosis in England: an action plan from the Chief Medical Officer. London: Department of Health Department of Health (2007) Tuberculosis prevention and treatment: a toolkit for planning, commissioning and delivering high quality services in England. London: Department of Health Department of Health (2009) Supply of TB drugs to patients changes to regulations and advice on implementation [online]. Available from www.dh.gov.uk/en/publichealth/communicablediseases/tuberculosis/dh_07 8136 Health Protection Agency (2009) Tuberculosis in the UK. Annual report on tuberculosis surveillance in the UK. London: Health Protection Agency Lönnroth K, Jaramillo E, Williams BG et al. (2009) Drivers of tuberculosis epidemics: the role of risk factors and social determinants. Social Science and Medicine 68: 2240 6 Noyes J, Popay J (2007) Directly observed therapy and tuberculosis: how can a systematic review of qualitative research contribute to improving services? A qualitative meta-synthesis. Journal of Advanced Nursing 57: 227 43 Stop TB Partnership and World Health Organization (2006) The global plan to stop TB: 2006 2015 [online]. Available from www.stoptb.org/globalplan/assets/documents/globalplanfinal.pdf Story A, van Hest R, Hayward A (2006) Tuberculosis and social exclusion. British Medical Journal 333: 57 8 Tuberculosis: hard-to-reach groups Page 12 of 13
Story A, Murad S, Roberts W et al. (2007) Tuberculosis in London: the importance of homelessness, problem drug use and prison. Thorax 62: 667 71 van Hest R, Story A (2008) Tuberculosis control among homeless persons in the European Union: more than words alone. European Network of Homeless Health Workers Newsletter 6 World Health Organization (2003) Adherence to long-term therapies: evidence for action. Geneva: World Health Organization Tuberculosis: hard-to-reach groups Page 13 of 13