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Implementing NICE guidance

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1 Implementing NICE guidance
Diagnosis and management of tuberculosis, and measures for its prevention and control Implementing NICE guidance ABOUT THIS PRESENTATION: This slide set was updated in May 2012 to include details of NHS Evidence and the NICE Pathway and enable minor editorial changes. Please note, CG117 has not been updated . This presentation has been written to help you raise awareness of the NICE clinical guideline on Tuberculosis: clinical diagnosis and management of tuberculosis, and measures for its prevention and control (partial update). New recommendations on using interferon gamma tests (IGTs) for the diagnosis of latent tuberculosis (TB) have been added. This guideline has been written for doctors, nurses and other staff who care for people with TB and staff involved in screening for TB. The guideline is designed for use in the NHS in England and Wales. Readers in other countries, particularly where the incidence of TB is higher, should exercise caution before applying the recommendations. This presentation covers only the new and updated recommendations. The guideline, which shows all the recommendations, is available in a number of formats, including a quick reference guide. These can be found on the NICE website. You can add your own organisation’s logo alongside the NICE logo. We have included notes for presenters, broken down into ‘key points to raise’, which you can highlight in your presentation, and ‘additional information’ that you may want to draw on, such as a rationale or an explanation of the evidence for a recommendation. Where necessary, the recommendation will be given in full. DISCLAIMER This slide set is an implementation tool and should be used alongside the published guidance. This information does not supersede or replace the guidance itself. PROMOTING EQUALITY Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way which would be inconsistent with compliance with those duties. 2nd edition May 2012 NICE clinical guideline 117

2 Updated guidance This guideline updates and replaces ‘Tuberculosis: clinical diagnosis and management of tuberculosis, and measures for its prevention and control’ NICE clinical guideline (2006). New recommendations, to , on using interferon gamma tests (IGTs) for the diagnosis of latent tuberculosis (TB), have been added. 11 other recommendations have been amended. NOTES FOR PRESENTERS: Key points to raise: This guideline is a partial update of NICE clinical guideline 33 (published March 2006). New recommendations on using IGTs for the diagnosis of latent TB have been added ( to ). NICE is developing guidance on: Tuberculosis: hard-to-reach groups. NICE public health guidance. Publication expected March (details available from

3 What this presentation covers
Scope Background and definitions Epidemiology Key priorities for implementation New 2011 recommendations Costs and savings Discussion NICE PH37: TB among hard-to-reach groups NICE Pathway, NHS Evidence and Find out more NOTES FOR PRESENTERS: In this presentation we will start by providing some background to the guideline and why it is important. We will then identify some helpful definitions and provide an overview of which recommendations have remained unchanged and which ones have been amended or added. We will then present the key priorities for implementation. The presentation will then focus on the new recommendations. Then we will open the meeting up for discussion with a list of questions on local issues for incorporating the guidance into practice. We will then give an overview of the recent NICE public health guidance PH37 on identifying and managing tuberculosis among hard-to-reach groups. Finally, we will end the presentation with further information about NHS Evidence, the NICE Pathway and the support provided by NICE.

4 Scope The update covered:
the diagnosis of latent TB using interferon-gamma tests (IGT’s) alone or in combination with a tuberculin skin test, compared with tuberculin skin test alone in  – adults and children at increased risk of infection – adults and children who are immunocompromised. Other aspects of diagnosis and treatment of TB were not covered. NOTES FOR PRESENTERS: Key clinical issues covered in the guideline update: Diagnosis of latent TB using interferon-gamma tests (IGT’s) alone or in combination with tuberculin skin tests The following population subgroups were considered: Adults, young people and children at increased risk of infection by Mycobacterium tuberculosis complex (M. tuberculosis, M. africanum, M. bovis), specifically if they: have arrived or returned from high-prevalence countries within the last 5 years were born in high-prevalence countries live with people diagnosed with active TB have close contact with people diagnosed with active TB, for example at school or work are homeless or problem drug users are, or have recently been, in prison. Adults, young people and children who are immunocompromised because of: prolonged steroid use (equivalent to 15 mg prednisolone daily for at least 1 month) TNF-alpha antagonists such as infliximab and etanercept anti-rejection drugs such as cyclosporin, various cytotoxic treatments and some treatments for inflammatory bowel disease, such as azathioprine the use of immunosuppression-causing  drugs comorbid states affecting the immune system, for example HIV, chronic renal disease, many haematological and solid cancers, and diabetes. Clinical issues not covered: a) Diagnosis of latent TB using tuberculin skin tests alone, unless as a comparator for IGTs. b) Diagnosis of latent TB using purified protein derivative based IGTs. c) Diagnosis of active TB. d) Treatment of TB.

5 Background: TB Mycobacterium tuberculosis causes TB.
The body’s immune system is stimulated once the bacteria have been inhaled. Latent TB –the bacteria lie dormant in the body. Active TB – symptoms, signs or abnormal chest X-ray. NOTES FOR PRESENTERS: TB is caused by the bacterium Mycobacterium tuberculosis (also known as M. tuberculosis or M. Tb). It spreads when a person inhales it in droplets coughed or sneezed by someone with infectious TB. TB in organs other than the lungs or latent TB are rarely infectious to others. Once inhaled, the bacteria reach the lung and grow slowly over several weeks. The body’s immune system is stimulated, which can be shown by a Mantoux test. In over 80% of people, the immune system kills the bacteria. The person is left with only a positive skin test as a marker of exposure. In a small number of cases a defensive barrier is built round the infection but the TB bacteria are not killed and lie dormant (known as latent TB). People with latent TB do not have symptoms or signs of disease. If the immune system fails to build the defensive barrier, or the barrier later fails, latent TB can spread within the lung (pulmonary TB) or into the lymph glands within the chest (intrathoracic respiratory TB) or develop in other parts of the body it has spread to (extrapulmonary TB). 10–15% of adults with latent TB will develop symptoms (known as active TB), and the risk to children and young people may be much higher. About half the cases of active TB develop within a few years of the original infection, particularly in children and young adults. The other half of active TB cases arise from reactivation of the latent infection many years later.

6 Background: TB testing
Until recently only Mantoux tests could indicate exposure. They can be inaccurate in certain groups. IGTs were developed to be more specific by removing false-positive results. NOTES FOR PRESENTERS: Until recently, only Mantoux tests were available to show if someone had been exposed to TB and may have latent TB. Mantoux tests are cheap and relatively easy to do, but have problems. The test results have to be interpreted within a certain timescale, and patients who do not return, or delay returning, to the clinic could have either no or inaccurate results. False-positive results can occur because the immune system is sensitised by either prior BCG vaccination or opportunist environmental Mycobacteria. False-negative results can occur because of reduced immunity, particularly from co-infection with HIV, but also from cytotoxic or immunosuppressive drugs. Extensive TB (pulmonary or miliary) can itself temporarily suppress immunity, and can lead to a paradoxically negative Mantoux test. More recently, selective immunological tests (IGTs) were developed to be more sensitive and specific. They detect the TB antigens early secretion antigen target 6 (ESAT-6), culture filtrate protein 10 (CFP-10) and TB7.7, which are not present in BCG, and are found in only a few species of environmental Mycobacteria. These tests aim to be more specific by removing false-positive results, and to better correlate with latent infection or dormant organisms. The tests are done on cells or cell products derived from blood.

7 Definitions Close contacts Green Book Hard to reach groups
High-incidence country High-incidence primary care organisation Household contacts ‘Inform and advise’ information New entrants Respiratory TB Standard recommended regimen Dual strategy NOTES FOR PRESENTERS: Close contacts These can include a boyfriend or girlfriend and frequent visitors to the home of the index case, in addition to household contacts Green Book The 2006 edition of ‘Immunisation against infectious disease’, published by the Department of Health. Updated chapters are available online (www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/GreenBook/fs/en) Hard to reach groups 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 TB 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. High-incidence country Country with more than 40 cases per 100,000 per year; these are listed by the Health Protection Agency – go to and search for ‘WHO country data TB’ High-incidence primary care organisation A primary care organisation with more than 40 cases per 100,000 per year; these are listed by the Health Protection Agency – go to and search for ‘TB average case reports’ Household contacts People sharing a bedroom, kitchen, bathroom or sitting room with the index case ‘Inform and advise’ information Advice on the risks and symptoms of TB, usually given in a standard letter New entrants People who have recently arrived in or returned to the UK from high-incidence countries Respiratory TB TB affecting the lungs, pleural cavity, mediastinal lymph nodes or larynx Standard recommended regimen The ‘6-month, four-drug initial regimen’ of 2 months of isoniazid, rifampicin, pyrazinamide and ethambutol, followed by 4 months of isoniazid and rifampicin Dual strategy A Mantoux test followed by an interferon-gamma test if the Mantoux is positive.

8 Epidemiology There are marked differences in the incidence of TB in different parts of England and Wales, with most new cases occurring in cities. In 2009 in the UK, 9040 cases of TB were reported. This is an increase of 4.2% compared with 2008. Majority of cases in people who were not born in the UK (73%) and those aged 15–44 years (60%). NOTES FOR PRESENTERS: Key points to raise: This data is taken from the 2010 Health Protection Agency report therefore the quoted figures are for cases in 2009. There are marked differences in the incidence of TB in different parts of England and Wales, with most new cases occurring in cities. In 2009 in the UK, 9040 cases of TB were reported, a rate of 15 per 100,000 population. This represents an increase of 4.2% in the rate of the disease compared with 2008. The majority of TB cases continue to occur in the non-UK-born population (73% of cases) and those aged 15–44 years (60% of cases). The rate of TB among the non-UK-born population is 86 per 100,000. Rates in the UK-born population, at around 4 per 100,000, are not declining. 79% of cases of TB in non-UK-born people were diagnosed 2 or more years after arrival in the UK. The London region accounted for 38% of cases (44.4 per 100,000) in 2009. Reference Health Protection Agency (2010) Report on tuberculosis surveillance in the UK Available from [accessed January 2011]

9 Overview of the recommendations
7 key priorities for implementation – identified in 2006 18 recommendations were added to the recommendations – identified by the label ‘[new 2011]’ 11 recommendations were amended since 2006 – identified by the label ‘[2006, amended 2011]’ Of the 11 amended recommendations there are ten recommendations where it is believed the amendment may influence clinical practice NOTES FOR PRESENTERS: This NICE guideline contains 151 recommendations of which 18 are classified as new recommendations and 17 have been classified as amended recommendations. Recommendations classified as new (identified with [new 2011]) are those in which the evidence about latent TB has been reviewed and the recommendation has added. The focus of this update was the diagnosis of latent TB to reflect the fact that IGTs are now commonly used in the diagnosis of latent TB. The 18 new recommendations in this guideline reflect the guidance development group’s review of the evidence in this area. Recommendations classified as amended (identified with [2006, amended 2011]) are those for which the evidence has not been updated and reviewed since 2006 but an amendment has been made to the recommendation. Recommendations (Management of latent TB) , , (treatment of latent TB infection), (New entrants) and , , (healthcare environments: new NHS employees) have been amended in order to bring them in line with the new recommendations. The amendments may influence clinical practice. These recommendations will be presented in more detail in this slide set. Recommendations (management of respiratory TB) and (management of latent TB) have been amended and the amendment may influence clinical practice. Please refer to pages 11 and 21 for details of these recommendations. The amendments to the remaining recommendation labelled as [2006, amended 2011] is only a small amendment. Recommendations which remain unchanged since 2006 are identified with [2006].

10 Key priorities for implementation
There are seven key priority recommendations. Two have been amended and five remain unchanged. The key priorities cover the following areas: Management of active TB (two recommendations). Improving adherence (two recommendations). New entrants screening (one recommendation). BCG vaccination ( two recommendations). NOTES FOR PRESENTERS: These key priorities for implementation are not about diagnosis of latent TB, which was the focus of the update, but are included here because they remain the key priorities for implementation for this guideline. A 6-month, four-drug initial regimen (6 months of isoniazid and rifampicin supplemented in the first 2 months with pyrazinamide and ethambutol) should be used to treat active respiratory TB (TB affecting the lungs, pleural cavity, mediastinal lymph nodes or larynx) in: adults not known to be HIV-positive, adults who are HIV-positive, children. [ ] [2006] This regimen is referred to as ‘standard recommended regimen’ in this guideline. Patients with active meningeal TB should be offered: a treatment regimen, initially lasting for 12 months, comprising isoniazid, pyrazinamide, rifampicin and a fourth drug (for example, ethambutol) for the first 2 months, followed by isoniazid and rifampicin for the rest of the treatment period a glucocorticoid at the normal dose range adults – equivalent to prednisolone 20–40 mg if on rifampicin, otherwise 10–20 mg children – equivalent to prednisolone 1–2 mg/kg, maximum 40 mg with gradual withdrawal of the glucocorticoid considered, starting within 2–3 weeks of initiation. [ ] [2006] Use of directly observed therapy (DOT) is not usually necessary in the management of most cases of active TB. All patients should have a risk assessment for adherence to treatment, and DOT should be considered for patients who have adverse factors on their risk assessment, in particular: street- or shelter-dwelling homeless people with active TB; and patients with likely poor adherence, in particular those who have a history of non-adherence. [ ] [2006] The TB service should tell each person with TB who their named key worker is, and how to contact them. This key worker should facilitate education and involvement of the person with TB in achieving adherence. [ ] [2006] New entrants should be identified for TB screening from the following information: Port of Arrival reports, new registrations with primary care, entry to education (including universities), links with statutory and voluntary groups working with new entrants. [ ] [2006] Neonatal Bacille Calmette-Guerin(BCG) vaccination for any baby at increased risk of TB should be discussed with the parents or legal guardian. [ ] [2006] Primary care organisations with a high incidence of TB should consider vaccinating all neonates soon after birth. [ ] [2006]

11 Diagnosing latent TB: general principles
Offer Mantoux testing to diagnose latent TB in people who are household and non-household contacts. If Mantoux testing is positive or may be less reliable for example in BCG-vaccinated people, consider IGT. If Mantoux testing is inconclusive, refer the person to a TB specialist. NOTES FOR PRESENTERS: Key points to raise: Offer Mantoux testing in line with the Green Book to diagnose latent TB in people who are: household contacts (aged 5 years and older) of all people with active TB non-household contacts (other close contacts for example, in workplaces and schools). [ ] [new 2011] Consider interferon-gamma testing for people whose Mantoux testing shows positive results, or in people for whom Mantoux testing may be less reliable, for example BCG-vaccinated people. [ ] [new 2011] Recommendation [ ] [new 2011] is shown in full on the slide (bullet 3). Additional information See slides 15 and 16 for more details of the diagnosis of latent TB in those under 5 years of age. Overall the specificity of IGTs seemed better, and there was less potential for false-positive results over Mantoux tests. However, the guideline development group agreed that in the absence of good quality longitudinal studies, the relative benefit of IGT over Mantoux test in determining the need for treatment of latent infection is not certain. The Guideline Development Group made recommendations for populations in which they considered IGT to be of clear benefit especially if IGT would reduce the uncertain diagnosis of Mantoux tests (see slides 12–16). The evidence reviewed by the guideline development group showed how a previous BCG vaccination would confound the Mantoux test results but not affect the IGT results. In general, the cost-effectiveness model supported a two-step approach with an initial Mantoux tests, followed by an IGT to confirm positivity. The guideline development group members also supported this because of clinical utility and feasibility. Specific testing recommendations were identified for certain groups; however overall, when diagnosing latent TB in people who were in close contact with active TB, the Guideline Development Group concluded that owing to a lack of strong evidence there was uncertainty about which testing strategy was the optimal choice. The Guideline Development Group therefore considered that both tests should be offered and that depending on operational issues, the most appropriate should be used.

12 Diagnosing latent TB: high-risk countries
Offer a Mantoux test to children aged 5–15 years. If positive, follow with an IGT. Offer either an IGT alone or a dual strategy in people aged 16–34 years. For people aged 35 or older, consider risks and benefits of likely subsequent treatment before offering testing. Offer Mantoux as the initial diagnostic test for latent TB infection in children under 5 years old who have recently arrived from a high-incidence country – if positive refer to TB specialist. NOTES FOR PRESENTERS: Key points to raise: Recommendation [ ] [new 2011] is shown in full on the slide (bullet 1). See slides 15 and 16 for diagnosis of latent TB in children younger than 5 years. Offer either an interferon-gamma test alone or a dual strategy in people aged 16–35 years. For people aged 35 years or older, consider the individual risks and benefits of likely subsequent treatment, before offering testing. (Refer to other sections for other groups, for example, people who are immunocompromised on slide 13). [ ] [new 2011] Offer Mantoux testing as the initial diagnostic test for latent TB infection in children younger than 5 years who have recently arrived from a high-incidence country. If the initial test is positive (taking into account the BCG history) – refer to a TB specialist to exclude active disease and consider treating latent TB. [ ] [new 2011]  Related recommendation Assessment for, and management of TB in new entrants should consist of the following. Risk assessment for HIV, including HIV prevalence rates in the country of origin, which is then taken into account for Mantoux testing and BCG vaccination. Assessment for active TB if interferon-gamma test is positive; which would include a chest X-ray. - Treatment for latent TB infection for people aged 35 years or younger in whom active TB has been excluded, with a positive Mantoux test inconsistent with their BCG history, and a positive interferon-gamma test. - Consideration of BCG for unvaccinated people who are Mantoux negative (see section 1.7.4). - ‘Inform and advise’ information for people who do not have active TB and are not being offered BCG or treatment for latent TB infection. [ ] [2006, amended 2011] Additional information: Please note recommendations about the incidence level cut-off for people aged 16–34 years who are eligible for Mantoux test has been reduced and now applies to those from high incidence countries (40 cases per 100,000 per year). Small changes in the quoted prevalence rate of TB and the rate of conversation from latent to active TB can influence conclusions about whether IGT or Mantoux is the most cost-effective testing strategy. There is some uncertainty about the prevalence and conversion rates; therefore, the Guideline Development Group concluded that the dual strategy should be recommended because it was a less expensive strategy and it would be more effective in low-incidence areas and, in particular, there were still issues over the operation of the tests and inter-person variability. These recommendations should be considered alongside the recommendations in section in the NICE guideline. High incidence countries are those with more than 40 cases per 100,000 per year

13 Diagnosing latent TB: outbreaks and people who are immunocompromised
Contacts – outbreak situation When large numbers may need to be screened offer IGT to people aged 5 and older. People who are immunocompromised If latent TB is suspected in children who are immunocompromised, refer to a TB specialist. For people who are immunocompromised, depending on the degree of immunosuppression, offer IGT alone or an IGT with a Mantoux test. NOTES FOR PRESENTERS: Key points to raise: Contacts –outbreak situation In an outbreak situation when large numbers of individuals may need to be screened, consider a single interferon-gamma test for people aged 5 years and older. [ ] [new 2011] People who are immunocompromised Recommendation [ ] [new 2011] is shown in full on the slide (bullet 2). For people with HIV and CD4 counts less than 200 cells/mm3, offer an interferon-gamma test and a concurrent Mantoux test. If either test is positive: perform a clinical assessment to exclude active TB and consider treating latent TB infection. [ ] [new 2011] For people with HIV and CD4 counts of 200–500 cells/mm3, offer an interferon-gamma test alone or an interferon-gamma test with a concurrent Mantoux test. If either test is positive: perform a clinical assessment to exclude active TB and consider treating latent TB infection. [ ] [new 2011] For other people who are immunocompromised, offer an interferon-gamma test alone or an interferon-gamma test with a concurrent Mantoux test. If either test is positive: perform a clinical assessment to exclude active TB and consider treating latent TB. [ ] [new 2011] Related recommendation People with HIV who are in close contact with people with sputum-smear-positive respiratory TB should have active disease excluded and then be given treatment for latent TB infection (see recommendations above). [ ] [2006, amended 2011] Additional information The Guideline Development Group concluded that, in general, IGTs may identify more truly positive latent TB infections than Mantoux tests in people who are immunocompromised, but the value of such tests varies with the nature and the degree of immunosuppression. The Guideline Development Group agreed that on the basis of the evidence presented that a CD4 count below 200 cells/mm3 was significantly associated with an indeterminate result. The group also felt that people with HIV who have a CD4 count of 500 cells/mm3 or more should be tested in the same way as people who are immunocompetent because the tests would perform in a similar way in these two groups of people.

14 Diagnosing latent TB: healthcare workers and hard to reach groups
Offer a Mantoux test to new NHS employees who are not from high-incidence countries and have not had BCG. Offer IGT to new NHS employees who have recently arrived from high-incidence countries or have had contact with patients in settings where TB is highly prevalent. Hard-to-reach populations Offer a single IGT. NOTES FOR PRESENTERS: Key points to raise: Healthcare workers Offer a Mantoux test to new NHS employees who will be in contact with patients or clinical materials if the employees: are not new entrants from high-incidence countries and have not had BCG vaccination (for example, they are without scar, other documentation or reliable history). [ ] [new 2011] If the Mantoux test is negative, refer to the Green book for BCG immunisation guidance. If the Mantoux test is positive, offer an interferon-gamma test. [ ] [new 2011] Offer an interferon-gamma test to new NHS employees who have recently arrived from high-incidence countries or who have had contact with patients in settings where TB is highly prevalent. [ ] [new 2011] Healthcare workers who are immunocompromised should be screened in the same way as other people who are immunocompromised. [ ] [new 2011] Hard-to-reach populations Offer people from ‘hard-to-reach’ populations a single interferon-gamma test. [ ] [new 2011] Related amended recommendations: See for screening new NHS employees for latent TB. [ ] [2006, amended 2011] Employees of any age who are new to the NHS and are from countries of high TB incidence, or who have had contact with patients in settings with a high TB prevalence should have an interferon-gamma test. If negative, offer BCG vaccination as with a negative Mantoux result (see recommendations and ). If positive, the person should be referred for clinical assessment for diagnosis and possible treatment of latent infection or active disease.  [ ] [2006, amended 2011] If a new employee from the UK or other low-incidence setting, without prior BCG vaccination, has a positive Mantoux and a positive interferon-gamma test, they should have a medical assessment and a chest X-ray. They should be referred to a TB clinic for consideration of TB treatment if the chest X-ray is abnormal, or for consideration of treatment of latent TB infection if the chest X-ray is normal. [ ] [2006, amended 2011] High incidence countries are those with more than 40 cases per 100,000 per year

15 Diagnosing latent TB: contacts under 5 years (1)
Household contacts aged 2–5 years In children between 2 and 5 years offer Mantoux test as the initial diagnostic test for latent TB infection. If initial Mantoux test is negative but the child is a contact of sputum-smear-positive disease offer IGT after 6 weeks and repeat Mantoux test. Neonates who have been in close contact with sputum- smear-positive TB Who have not received at least 2 weeks anti-TB drug treatment should receive isoniazid, Mantoux test and IGT. NOTES FOR PRESENTERS: Key points to raise: Household contacts aged 2–5 years Offer Mantoux testing as the initial diagnostic test for latent TB infection in child household contacts between the ages of 2 and 5 years. If the initial test is positive taking into account the BCG history: refer to a TB specialist to exclude active disease and consider treating latent TB. [ ] [new 2011] If the initial Mantoux test is negative but the child is a contact of sputum-smear-positive disease, offer an interferon-gamma test after 6 weeks and repeat the Mantoux test to increase the sensitivity (to reduce false negative results). [ ] [new 2011] Related amended recommendation Neonates in contact with sputum-smear-positive TB Neonates who have been in close contact with people with sputum-smear-positive TB who have not received at least 2 weeks’ anti-tuberculosis drug treatment should be treated as follows. The baby should be started on isoniazid (according to the current British national formulary for children) for 3 months and then a Mantoux test performed after 3 months’ treatment. If the Mantoux test is positive (6 mm or greater) the baby should be assessed for active TB (see section in the NICE guideline). If this assessment is negative, then isoniazid should be continued for a total of 6 months. If the Mantoux test is negative (less than 6 mm), it should be repeated together with an interferon-gamma test. If both are negative then isoniazid should be stopped and a BCG vaccination performed (see 1.7 in the NICE guideline). [ ] [2006, amended 2011] Additional information Smear positive is a term used to describe people with bacteria that can be seen on simple microscope examination of the sputum. Because of their underdeveloped immune system, children are more likely to develop active and more serious disease if they have latent infection. This risk is greater in children aged under 5 years. Indeterminate IGT results occur more frequently in younger children. The Guideline Development Group thought that IGTs perform less well in younger children. The group also agreed that careful consideration should be given to high-risk young children, especially those aged under 5 years because false-negative results could have substantial implications. The guideline development group acknowledged the difficulty of phlebotomy and obtaining enough blood in children.

16 Diagnosing latent TB: contacts under 5 years (2)
The guideline details the assessment and management of children older than 4 weeks but younger than 2 years who have: not had a BCG had a BCG been in close contact with a person with sputum-smear-positive TB. NOTES FOR PRESENTERS. These recommendations are not new but have been included here because they have been amended in order to bring them in line with the new recommendations. It is believed the amendment may influence clinical practice Children older than 4 weeks but younger than 2 years who have not had BCG vaccination and are in close contact with people with sputum-smear-positive TB should be treated as follows. The child should be started on isoniazid (according to the current British national formulary for children) and a Mantoux test performed. If the Mantoux test is positive (6 mm or greater), the child should be assessed for active TB (see section in the NICE guideline). If active TB is ruled out, full treatment for latent TB infection should be given (see of the NICE guideline). If the Mantoux test is negative (less than 6 mm), then isoniazid should be continued for 6 weeks, and then a repeat Mantoux test together with an interferon-gamma test should be carried out. If the repeat tests are negative, isoniazid may be stopped and BCG vaccination performed (see section 1.7 of the NICE guideline). If either repeat test is positive (6 mm or greater), then the child should be assessed for active TB (see section in the NICE guideline) and consider treating for latent TB. Contact tracing for children younger than 2 years when the index case is sputum-smear-positive is summarised in figure 2 of the quick reference guide (page 15) [ ] [2006, amended 2011] BCG-vaccinated children older than 4 weeks but younger than 2 years, in close contact with people with sputum smear-positive respiratory TB, should be treated as follows. The child should have a Mantoux test. If this is positive (15 mm or greater), the child should be assessed for active TB (see section of the NICE guideline). If active TB is excluded, then treatment for latent TB infection should be given (see recommendation in the NICE guideline). If the result of the test is as expected for prior BCG (less than 15 mm), it should be repeated after 6 weeks together with an interferon-gamma test.  If the repeat Mantoux test is also less than 15 mm, and the interferon-gamma test is also negative, no further action is needed. If the repeat Mantoux test becomes more strongly positive (15 mm or greater and an increase of 5 mm or more over the previous test), or the interferon-gamma test is positive the child should be assessed for active TB (see section in the NICE guideline). If active TB is excluded, treatment for latent TB infection should be given. [ ][2006, amended 2011] Additional information: The Guideline Development Group agreed that most paediatricians would choose to treat a high-risk child if they had a positive Mantoux test and negative IGT because there was limited evidence to suggest that a negative IGT could completely exclude infection.

17 Costs and savings Implementing this update is unlikely to result in a significant change in resource use in the NHS. However, recommendations in the following areas may result in additional costs or savings depending on local circumstances: Offer IGT or dual strategy to people aged 16–35 who are recent arrivals from highly prevalent countries (may have local cost implications if dual strategy employed). Consider single IGT for people aged 5 years and older in an outbreak situation (potential saving if both TST and IGT are currently being used). NOTES FOR PRESENTERS: NICE has found that implementing this guideline is unlikely to result in any significant changes in resource use, based on national assumptions. However, different areas may vary from the national average and it is important to look at the recommendations most likely to have a resource impact to make sure that local practice matches the national average. These recommendations are: New entrants from high-incidence countries: Offer either an interferon-gamma test alone or a dual strategy in people aged 16–35 years. For people aged 35 years or older, consider the individual risks and benefits of likely subsequent treatment, before offering testing. (Refer to other sections for other groups, for example, immunocompromised.) [ ] [new 2011] The updated guidance allows for a dual strategy option for screening new entrants aged 16 to 35 which means they would undergo both a skin test and blood test, so there may be more screening for new entrants if this option is taken up by local services. Outbreak situation In an outbreak situation when large numbers of people may need to be screened, consider a single interferon-gamma test for people aged 5 years and older. [ ] [new 2011] Implementing recommendations for tests relating to contact tracing in outbreak situations may lead to some savings. This is because previous guidance recommended testing with IGT if there was a positive tuberculin skin test (TST) whereas the updated guidance recommends the use of IGT only. 2012: Costs and savings assumptions were not reviewed for the second edition of this slide set

18 Relevant NICE guidance
PH37: Identifying and managing tuberculosis among hard-to-reach groups was issued in March 2012. The guidance aims to improve the way tuberculosis among hard-to-reach groups is identified and managed and sets out how commissioners and services can achieve this. Areas covered include: Commissioning multidisciplinary TB support for hard-to-reach groups - Identifying and managing active TB in prisons or immigration removal centres - Provision of rapid-access TB services NOTES FOR PRESENTERS: NICE has produced the following tools to help those who are responsible for putting the guidance into practice: Baseline assessment tool Costing report Costing template Podcast The guidance and tools can be accessed from

19 Discussion How can we ensure our organisation has access to IGTs?
Are our policies for new entrants from high incidence countries concordant with the recommendations in this guideline? If not, how can we update them? How can we ensure that our staff understand which diagnostic tests should be used for which groups? Who do we need to update regarding the new advice for neonates children and young people? NOTES FOR PRESENTERS: These questions are suggestions that have been developed to help provide a prompt for a discussion at the end of your presentation – please edit and adapt these to suit your local situation. Additional questions The recommendations about children aged under 5 may increase the number of IGTs we conduct in this group. How can we ensure we have access to paediatric phlebotomy services for this purpose?

20 NICE Tuberculosis Pathway
NICE Pathway This NICE Pathway covers: Commissioning Preventing the spread of TB Diagnosing and managing active TB Identifying and managing TB among hard to reach groups NICE Tuberculosis Pathway NOTES FOR PRESENTERS: If you are showing this presentation when in slideshow and connected to the internet, click on the orange button to go to the NICE Pathways overview. NICE Pathways: guidance at your fingertips Our new online tool provides quick and easy access, topic by topic, to the range of guidance from NICE, including quality standards, technology appraisals, clinical and public health guidance and NICE implementation tools. Simple to navigate, NICE Pathways allows you to explore in increasing detail NICE recommendations and advice, giving you confidence that you are up to date with everything we have recommended. The NICE pathway can be found at When you visit the pathway click on the recommendations which interest you.

21 NHS Evidence Tuberculosis topic page
Visit NHS Evidence for the best available evidence on tuberculosis diagnosis, treatment and management NHS Evidence Tuberculosis topic page NOTES FOR PRESENTERS: If you are showing this presentation when in slideshow and connected to the internet, click on the blue button to go straight to the NHS Evidence website search page, where you can search for resources on tuberculosis. There are also topic pages for over 80 other topics. For the home page go to

22 Find out more Visit www.nice.org.uk/guidance/CG117 for: the guideline
the quick reference guide ‘Understanding NICE guidance’ costing statement audit support baseline assessment tool. NOTES FOR PRESENTERS: You can download the guidance documents from the NICE website. The NICE guideline – all the recommendations. A quick reference guide – a summary of the recommendations for healthcare professionals. ‘Understanding NICE guidance’ – information for patients and carers. The full guideline – all the recommendations, details of how they were developed, and reviews of the evidence they were based on. NICE has developed tools to help organisations implement this guideline, which can be found on the NICE website. Costing statement – details of the likely costs and savings when the cost impact of the guideline is not considered to be significant. Audit support – for monitoring local practice. Baseline assessment tool – to help identify which areas of practice may need more support, decide on clinical audit topics and prioritise implementation activities.

23 What do you think? Did the implementation tool you accessed today meet your requirements, and will it help you to put the NICE guidance into practice? We value your opinion and are looking for ways to improve our tools. Please complete this short evaluation form. If you are experiencing problems accessing or using this tool, please NOTES FOR PRESENTERS: Additional information: This final slide is not intended to be part of the presentation, it asks for feedback on whether this implementation tool meets your requirements and whether it will help you to put this NICE guidance into practice - your opinion would be appreciated. To open the links on this slide right click over the link and choose ‘open link’ To open the links on this slide right click over the link and choose ‘open link’


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