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Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
Health Protection Network Scottish Guidance
Adapted from NICE guidelines for Scottish use
March 2009
The Health Protection Network (HPN) is a network of existing professional organisations and networks in the health protection community across Scotland. It aims to promote, sustain, and coordinate good practice. The HPN supports a systematic approach to development, appraisal and adaptation of guidelines, seeking excellence in health protection practice. Supported by Health Protection Scotland Health Protection Scotland (HPS) is a non-profit, public sector organisation which is part of the Scottish National Health Service. It is dedicated to the protection of the publics health. Health Protection Network site: http://www.hps.scot.nhs.uk/about/HPN.aspx Citation for this document Health Protection Network. Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland. Health Protection Network Scottish Guidance 5. Health Protection Scotland, Glasgow, 2008. Published by Health Protection Scotland, Clifton House, Clifton Place, Glasgow G3 7LN. Health Protection Scotland is a division of NHS National Services Scotland. First published March 2009 Health Protection Network 2009 The Health Protection Network has made every effort to trace holders of copyright in original material and to seek permission for its use in this document and the associated quick reference guide. Should copyrighted material have been inadvertently used without appropriate attribution or permission, the copyright holders are asked to contact the Health Protection Network so that suitable acknowledgement can be made at the first opportunity. Health Protection Network consents to the photocopying of this document for the purpose of implementation in NHSScotland. All other proposals for reproduction of large extracts should be addressed to: Health Protection Network Health Protection Scotland 1 Cadogan Square Cadogan Street Glasgow G2 7HF Tel: +44 (0) 141 300 1100 Email: hpsenquiries@hps.scot.nhs.uk Designed and typeset by: Graphics Team, Health Protection Scotland
Table of Contents
Foreword List of abbreviations Introduction Patient-centred care Key priorities for implementation
Management of active TB Improving adherence New entrant screening BCG vaccination Definitions used in this guideline
i ii 1 2 3
3 4 4 4 5
Guidance
1.1 Diagnosis
1.1.1 Diagnosing latent TB 1.1.2 Diagnosing active TB
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8 9
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13 14
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17 18 18 19 19 19 20
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Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
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23 24 24 26
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31 32 33 33 34 34
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35 37 38 39 39 40 42 43 43
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43 45 46 47
2 3
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Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
Research recommendations
4.1 Interferon-gamma tests 4.2 Directly observed therapy 4.3 New entrant screening and treatment for latent TB infection 4.4 Protective effects of BCG 4.5 Quality of life 4.6 Contact tracing in household contacts and homeless people 4.7 Incentives for attending new entrant screening 4.8 Incentives for homeless people attending chest X-ray screening
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49 50 50 50 51 51 51 52
Review date
52 53 56 58 59 61
Appendix A: Grading scheme Appendix B: Guideline development Appendix C: The guideline review panel Appendix D: Technical detail on the criteria for audit Appendix E: The algorithms
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
Foreword
Tuberculosis (TB) is an age old problem. In Scotland, there were great advances in managing TB during the last century. Scotlands pioneering successes in TB control included addressing poor social conditions, encouraging screening and introducing antibiotic treatments. These measures resulted in dramatic reductions in the number of Scots living with active tuberculosis, leading to optimism that the problems of TB were largely a thing of the past. During the past decade, Scotland has seen a decline to a steady level of TB cases of around 350-400 cases per year, which compares very favourably with figures 10 or 100 times greater, which were seen in the 1940s and the 1900s respectively. However, in more recent years, TB has provided new challenges for public health. Sadly, the re-emergence of TB as a global public health threat has gone hand in hand with the global spread of HIV infection. At the same time we have witnessed the global emergence of multi-drug resistant TB (MDR-TB) and extremely drug resistant TB (XDR-TB). Together, these issues have generated large increases in the numbers of new cases of TB in Sub-Saharan Africa, Asia and more recently, caused problems in parts of Europe. In response to these global challenges Health Protection Scotland has undertaken detailed surveillance to monitor TB in the Scottish population. Unlike the situation in England, Scotland has enjoyed a period over the last decade of relative stability in cases recorded (around 350-400 cases per year). However this period has seen a changing pattern of disease in which the number of TB cases who are thought to have acquired their infection out with the UK has increased each year. This pattern has seen us moving closer to the situation seen in England where the majority diagnosed with TB are born abroad or have likely acquired their infection abroad during prolonged travel in areas with a high burden of TB. Provisional figures for new cases diagnosed in Scotland in 2008 (approximately 450 cases) indicate that our case numbers cases are now increasing. Action is now needed in Scotland to reduce our TB numbers, whilst at the same time contributing to the international control of TB. The production of the Guideline Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland represents the first step in the development of a Scottish Action Plan to tackle the problems of TB and to reduce the burden of this disease in Scotland. This document is adapted from the NICE TB Guidelines which were issued in 2006 for use in England. They have been developed for use in Scotland using the AGREE instrument. Importantly, these Scottish TB Guidelines contain useful practical suggestions and best practice points as well as suggesting areas for research and development for the future. Dr Harry Burns Chief Medical Officer
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
List of abbreviations
BCG BNF BNF-C CNS CPHM CT DOT HIV HPS IMT MDR MRI MTB NHS NICE PAG SHTM TB XDR Bacille Calmette-Gurin British National Formulary British National Formulary for children Central Nervous System Consultant in Public Health Medicine Computed Tomography Directly Observed Therapy Human Immunodeficiency Virus Health Protection Scotland Incident Management Team Multi-Drug Resistant Magnetic Resonance Imaging Mycobacterium tuberculosis National Health Service National Institute for Clinical Excellence Problem Assessment Group Scottish Technical Health Memorandum Tuberculosis Extensively Drug Resistant
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Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
Introduction
The incidence of tuberculosis (TB) is influenced by risk factors such as exposure to, and susceptibility to, TB and levels of deprivation (poverty, housing, nutrition and access to healthcare), and differs in different parts of the United Kingdom. Where scientific evidence supports it, this guideline makes recommendations on service organisation, as well as for individual teams of healthcare professionals. The guideline aims to focus NHS resources where they will combat the spread of TB, and some sections deal with high- and low-incidence areas separately. The guideline was designed for use in the National Health Service in England and Wales and adapted for use in Scotland. Readers in other countries, particularly where the incidence of TB is higher, should exercise caution before applying the recommendations. The guideline has introduced resource issues, audit points and research recommendations. Resource issues are areas that the guideline group felt were important in the clinical diagnosis or management of tuberculosis but has implications on current NHS resources. Audit points are areas that have timescales and are an opportunity to measure action in these areas over time. The Scottish TB guideline group endorses the original NICE research recommendations with the addition of using molecular typing techniques to translate epidemiological information into action. Scottish amendments within this document are shown in italicised blue text with a Saltire flag in the margin.
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
Patient-centred care
This guideline offers best practice advice on the care of people with, or at risk of contracting, TB. Treatment and care should take into account patients individual needs and preferences. People with, or at risk of contracting, TB should have the opportunity to make informed decisions about their care and treatment. If patients do not have the capacity to make decisions, healthcare professionals should follow the Department of Health guidelines Reference guide to consent for examination or treatment (2001) (available from http://www.dh.gov.uk). From April 2007 healthcare professionals need to follow a code of practice accompanying the Adults with Incapacity (Scotland) Act 2000 (http://www.opsi.gov.uk/SI/ si2005/20051790.htm). Good communication between healthcare professionals and patients is essential. It should be supported by the provision of evidence-based information offered in a form that is tailored to the needs of the individual patient. The treatment, care and information provided should be culturally appropriate and in a form that is accessible to people who have additional needs, such as people with physical, cognitive or sensory disabilities, and people who do not speak or read English. Unless specifically excluded by the patient, carers and relatives should have the opportunity to be involved in decisions about the patients care and treatment. Carers and relatives should also be provided with the information and support they need.
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
Management of active TB
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 in: adults not known to be HIV-positive adults who are HIV-positive children. 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 20-40mg if on rifampicin, otherwise 10-20mg children - equivalent to prednisolone 1-2mg/kg, maximum 40mg with gradual withdrawalII of the glucocorticoid considered, starting within 23 weeks of initiation.
II
TB affecting the lungs, pleural cavity, mediastinal lymph nodes or larynx. In adults initiation steroids should be continued for two months followed by a gradually reduced dose over the following two months. Children may tolerate a more rapid tail off.
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
Improving adherence
All patients should have a risk assessment for adherence to treatment (see appendix C, VIII). Use of directly observed therapy (DOT) is not usually necessary in the management of most cases of active TB. 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 patients who misuse alcohol patients and or families with likely poor adherence, in particular those who have a history of non-adherence 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.
BCG vaccination
Neonatal BCG vaccination for any baby at increased risk of TB should be discussed with the parents or legal guardian. In Scotland any baby at an increased risk of TB should be offered a BCG following discussion with parents and consent from parents or legal guardian. NHS areas with a high incidence of TBII should consider vaccinating all neonates soon after birth (currently none in Scotland).
New entrants are defined as people who have recently arrived in or returned to the UK from highincidence countries, with an incidence of more than 40 per 100,000 per year, as listed by the Health Protection Agency (go to http://www.hpa.org.uk and search for WHO country data TB). Incidence of more than 40 per 100,000 (listed by the Health Protection Agency as above)
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Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
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This list is not definitive and new procedures may be introduced which also generate aerosols.
High-incidence country A country with more than 40 cases per 100,000 per year; these are listed by the Health Protection Agency go to http://www.hpa.org.uk and search for WHO country data TB
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
Key Worker is a named healthcare worker responsible for overseeing the care and management of a person with TB. Latent TB when a person is infected with TB but showing no signs or symptoms of TB disease. MTB Complex includes isolates identified as M. tuberculosis, M. bovis, M. africanum, M. microti or M. canettii. New entrants People who have recently arrived in or returned to the UK from highincidence countries having lived there for three months or more. Non Respiratory TB TB affecting areas other then the lungs, pleural cavity, mediastinal lymph nodes or larynx. Rapid liquid methods fast laboratory tests confirming TB from a liquid culture. Rapid molecular diagnostic tests fast laboratory tests confirming TB using molecular techniques. Respiratory TB TB affecting the lungs, pleural cavity, mediastinal lymph nodes or larynx. Solid Methods traditional laboratory tests used to confirm TB by solid culture techniques. Sputum negatives are cases with three negative sputum samples taken on three separate days. Sputum samples should be spontaneously produced sputum (or induced sputum if this is not possible) taken on three separate days, ideally early morning. If these are not available, three early morning gastric lavage or bronchoscopy samples should be obtained. Gastric lavage samples should be obtained ideally on three separate days, however the bronchoscopy samples may be taken from a single bronchoscopy session. Susceptible patient is defined as a patient thought to be at risk of contracting tuberculosis. Standard recommended regimen The 6-month, four-drug initial regimen of 2 months of isoniazid, rifampicin, pyrazinamide and ethambutol, followed by 4months of isoniazid and rifampicin.
The WHO classification for a pulmonary TB case is a patient with TB of the lung parenchyma or the tracheobroncial tree (including larynx). An extra-pulmonary TB case is a patient with TB of organs other than the lungs or tracheobronchial tree. A patient with both pulmonary and extra-pulmonary TB is classified as pulmonary.
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
The following guidance is evidence based. Appendix A shows the grading scheme used for the recommendations: A, B, C, D or good practice point D(GPP); recommendations on diagnostic tests are graded A(DS), B(DS), C(DS) or D(DS). A summary of the evidence on which the guidance is based is provided in the full original NICE guideline.
1 Guidance
1.1 Diagnosis
1.1.1 Diagnosing latent TB
Evidence is emerging on the performance of interferon-gamma tests. If this new evidence is significant, the guideline group will consider updating the guideline. 1.1.1.1 To diagnose latent TB:
D
Mantoux testing should be performed in line with the Green Book (Evidence issue) those with positive results (or in whom Mantoux testing may be less reliable) should then be considered for interferon-gamma immunological testing, if available. if testing is inconclusive, the person should be referred to a TB specialist (see section 1.6 for management of latent TB).
In this guideline the Green Book is the 2006 edition of Immunisation against infectious disease, published by the Department of Health. Available from http://www.dh.gov.uk/PolicyAndGuidance/ HealthAndSocialCareTopics/GreenBook/fs/en); a printed version was published during 2006. The Green Book contains details of at risk groups who may have suppressed responses to tuberculin skin testing.
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
1.1.2.2 To diagnose active non-respiratory TB: advantages and disadvantages of both biopsy and needle aspiration should be discussed with the patient, with the aim of obtaining adequate material for diagnosis B(DS) if non-respiratory TB is a possibility, part or all of any of the following samples should be placed in a dry sterile container (and not all placed in formalin) and sent for TB microscopy and culture: D(GPP) (Resource Issue) lymph node biopsy pus aspirated from lymph nodes pleural biopsy any radiological sample sent for routine culture microbiology staff should routinely perform TB culture on the above samples (even if it is not requested) D(GPP) microbiology staff should have a low threshold for performing culture on the following samples even when not specifically requested: D(GPP) histology samples aspiration samples autopsy samples the appropriate treatment regimen should be started without waiting for culture results if the histology and clinical picture are consistent with a diagnosis of TB (see sections 1.2 and 1.3)
C(DS)
all patients with non-respiratory TB should have a chest X-ray to exclude or confirm coexisting respiratory TB; in addition, tests as described in table 1 should be considered D(GPP) the appropriate drug regimen (see sections 1.2 and 1.3) should be continued even if subsequent culture results are negative but where TB is still clinically suspected. D(GPP)
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Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
Table 1: Suggested site-specific investigations in the diagnosis and assessment of TB Site Lymph node Bone/joint Plain X-ray and computed tomography (CT) Magnetic resonance imaging (MRI) Gastrointestinal Ultrasound CT abdomen Genitourinary Intravenous urography Ultrasound CT (kidney, ureter, bladder) Disseminated Chest X-ray CT (chest and abdomen) Lung Liver Bone marrow Omentum Bowel Site of disease Imaging Node1 Site of disease Biopsy Microscopy/Culture Node or aspirate Biopsy or paraspinal abscess Site or joint fluid
Biopsy Ascites Early morning urine Site of disease Endometrial curettings Bronchial wash Liver Bone marrow Blood CSF
CT brain MRI
Tuberculoma
Cerebrospinal fluid
Skin Pericardium Cold/liver abscess Lung Echocardiogram Ultrasound Posterior-anterior chest X-ray Possible CT Thorax
Site of disease Pericardial fluid Site of disease Sputum Bronchial washing NG aspirate Gastric lavage
Pleural cavity
Mediastinal biopsy
Larynx
Laryngeal biopsy
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
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1.1.2.3 Rapid molecular diagnostic tests for Mycobacterium tuberculosis complex (Mtuberculosis, M bovis, M africanum, M microti and M canetti) on primary specimens should be used providing the following conditions are met: (D(GPP) resource issue) rapid confirmation of a TB diagnosis in a sputum smearpositive person would alter their care, or before conducting a large contact-tracing initiative. In the event of uncertainty the Scottish Mycobacteria Reference laboratory should be contacted for further advice.
1.1.2.4 Clinicians should still consider a diagnosis of non-respiratory TB if rapid diagnostic tests are negative, for example in pleural fluid, cerebrospinal fluid and urine. B(DS) 1.1.2.5 Clinical signs and other laboratory findings consistent with TB meningitis should lead to treatment (see section 1.3.1), even if a rapid diagnostic test is negative, because the potential consequences for the patient are severe. D(GPP) 1.1.2.6 Before conducting a large contact-tracing initiative (for example, in a school or hospital), the species of mycobacterium should be confirmed to be MTB complex by rapid diagnostic tests on microscopy- or culture-positive material. Clinical judgement should be used if tests are inconclusive or delayed. D(GPP) 1.1.2.7 If a risk assessment suggests a patient has multi drug resistant (MDR) TB or extensively drug resistant (XDR) TB (see section 1.5.1): D(GPP) rapid diagnostic tests should be conducted for rifampicin and isoniazid resistance infection control measures and treatment for MDR TB should be started as described in section 1.5, pending the result of the tests. 1.1.2.8 Rapid diagnostic tests for MTB complex identification may be conducted on biopsy material where the sample has been inappropriately placed in formalin and histology is consistent with mycobacterial infection. D(GPP)
Scottish Mycobacteria Reference Laboratory, Royal Infirmary of Edinburgh, Little France, Edinburgh, EH16 4SA. Tel : 0131 242 6016, Fax: 0131 242 6008
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Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
1.1.2.9 Clinical samples should ideally be sent for culture by automated liquid methods in addition to solid methods, bearing in mind that laboratories need a certain level of throughput to maintain quality control. D(GPP) (resource issue)
1.2.1.2 A daily 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 in: adults not known to be HIV-positive adults who are HIV-positive children.
B B A
This regimen is referred to as standard recommended regimen in this guideline and is outlined in the current British National Formulary (BNF) or BNF for children (BNF-C) (http://www.bnf. org/bnf/ and http://bnfc.org/bnfc/).
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
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1.2.1.3 Where possible, fixed-dose combination tablets should be used as part of any TB treatment regimen. C 1.2.1.4 There are two main approaches for administering the regimen, either daily or thrice weekly dosing. The doses for each approach are different and are listed in the current BNF and BNF-C. D(GPP) 1.2.1.5 A daily or thrice-weekly dosing regimen (using the dosages given in BNF and BNF-C) should be considered for patients receiving directly observed therapy (DOT) (see section1.4.2). 1.2.1.5 A twice-weekly dosing regimen should not be used for the treatment of active TB. D(GPP)
D(GPP)
Scottish Health Technical Memorandum 2025 Ventilation in healthcare premises (available from http:// www.hfs.scot.nhs.uk/publications/view-category.php?sec=1&cat=27)
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Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
1.2.2.1 All patients with proven or suspected TB should have risk assessments for multi drug resistance (see section 1.5) and for HIV immediately on admission. Based on this risk assessment, a decision should be made with regard to their placement in a cubicle with negative pressure. This does not apply to transient patients residing in areas for less than eight hours. D(GPP) 1.2.2.2 Unless there is a clear clinical or socioeconomic need, such as children or homelessness, people with TB at any site of disease should not be admitted to hospital for diagnostic tests or for care. D(GPP) 1.2.2.3 If admitted to hospital, patients with suspected respiratory TB should be given a single room, preferably a negative-pressure room. The door should remain closed as much as possible. If a negative pressure cubicle is unavailable the infection control team should risk assess whether the patient is best served by management in a single room or transfer to another hospital with an available negative-pressure facility. Patients with proven or suspected MDR TB should always be admitted to a negative-pressure facility. D(GPP) 1.2.2.4 Patients with respiratory TB should be separated from immunocompromised patients, either by admission to a single room (negative pressure if available) on a separate ward, or to a negative-pressure room on the same ward or undergo isolation in a single room. D(GPP) 1.2.2.5 Any visitors to a child with TB in hospital should be screened as part of contact tracing (as covered in section 1.8.1.2), and kept separate from other patients until they have been excluded as the source of infection. D(GPP) 1.2.2.6 There is an increasing prevalence of HIV positive patients in general medicine wards in hospital, many of whom remain undiagnosed. TB patients admitted to a setting where care is provided for HIV-positive or other immunocompromised patients should be considered infectious and should stay in a negative-pressure room until: D(GPP) For people who were sputum smear positive at admission: 1. the patient has had at least 2 weeks of appropriate multiple drug therapy, and 2. there is definite clinical improvement on treatment, for example remaining afebrile for at least 48 hours
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
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3. if moving to accommodation (inpatient or home) with HIVpositive or immunocompromised patients, the patient has had at least three negative microscopic smears on separate occasions over a 3-day period, and 4. the patient is showing tolerance to the prescribed treatment and an ability and agreement to adhere to treatment. D(GPP) Patients admitted to a care setting where there are no immunocompromised patients are considered infectious and must stay in a negative-pressure room until: the patient has had at least 2 weeks treatment and there is definite clinical improvement.
D(GPP)
For people who were sputum smear negative at admission; the infection risk to others is very small and as a result these patients can be nursed on an open ward (if no side room is available). D(GPP)
1.2.2.7 For settings where care is delivered to patients with or suspected to have TB, there should be a risk assessment carried out. This risk assessment should include an engineering assessment of anywhere where aerosol generating procedures are performed (for example bronchoscopy suites, outpatient clinics etc) which states that it is safe to do so. Aerosol generating procedures should not be carried out in an open ward setting when patients have or are suspected to have TB. D(GPP) 1.2.2.8 Healthcare workers caring for people with TB should wear FFP3 fit tested masks (see 1.5.3.2) and use standard infection control precautions when: D(GPP) MDR TB is suspected (see section 1.5.3.1) aerosol-generating procedures are being performed Intensive nursing intervention is required if the healthcare worker is likely to have close contact (equivalent to household contact) for a cumulative total for eight hours or more When such respiratory protection is used, the reason should be explained to the person with TB. The equipment should meet the standards of the Health and Safety Executive. See section 1.5.3 for further details of MDR TB infection control.
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Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
1.2.2.9 An increasing number of immunocompromised patients are being managed in hospital. Inpatients with smear-positive respiratory TB should be asked (with explanation) to wear a surgical mask whenever they leave their room until they have had 2 weeks drug treatment. This is to reduce the chance of exposure to immunocompromised patients. D(GPP)
II
Please note this differs from the previous guidance issued in 1998 In adults, initiation steroids should be continued for two months followed by a gradually reduced dose over the following two months. However, children may tolerate a more rapid tail off of steroids.
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
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1.3.2.2 Patients with active peripheral lymph node TB who have had an affected gland surgically removed should still be treated with the standard recommended regimen. D(GPP) 1.3.2.3 Drug treatment of peripheral lymph node TB should normally be stopped after 6 months, regardless of the appearance of new nodes, residual nodes or sinuses draining during treatment. D(GPP)
1.3.3.2 Clinicians prescribing treatment for active bone and joint tuberculosis should consider as first choice: a daily dosing schedule
B D
1.3.3.3 A computed tomography (CT) or magnetic resonance (MR) scan should be performed on patients with active spinal TB who have neurological signs or symptoms. If there is direct spinal cord involvement (for example, a spinal cord tuberculoma), management should be as for meningeal TB (see section 1.3.1).
D(GPP)
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Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
1.3.5 Pericardial TB
1.3.5.1 For patients with active pericardial TB, the first choice of treatment should: be the standard recommended regimen (see section 1.2.1 for details) B use a daily dosing schedule include combination tablets.
B D
1.3.5.2 In addition to anti-TB treatment, patients with active pericardial TB should be offered: for adults, a glucocorticoid equivalent to prednisolone at 60mg/day A for children, a glucocorticoid equivalent to prednisolone 1 mg/kg/day (maximum 40 mg/day) with gradual withdrawal of the glucocorticoid considered, starting within 23 weeks of initiation. D(GPP)
In adults, initiation steroids should be continued for 2 months followed by a gradually reduced dose over the following 2 months. However, children may tolerate a more rapid tail off of steroids.
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
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1.3.6.2 Treatment of disseminated (including miliary) TB should be started even if initial liver function tests are abnormal. If the patients liver function deteriorates significantly on drug treatment, advice on management options should be sought from clinicians with specialist experience of these circumstances. D(GPP) 1.3.6.3 Patients with disseminated (including miliary) TB should be tested for central nervous system (CNS) involvement by: brain scan (CT or MRI) and/or lumbar puncture for those with CNS signs or symptoms lumbar puncture for those without CNS signs and symptoms. If evidence of CNS involvement is detected, treatment should be the same as for meningeal TB (see section 1.3.1). D(GPP)
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Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
patients with likely poor adherence, in particular those who have a history of non-adherence. D(GPP) Use of directly observed therapy (DOT) is not usually necessary in the management of most cases of active TB. A
1.4.2.2 Clinicians who are planning to start a patient on a course of DOT should consider ways to mitigate the environmental, financial and psychosocial factors that may reduce adherence, including stability of accommodation and transport. The setting, observer and frequency of treatment should be arranged to be most practicable for the person with TB. The person with TB and his or her assigned key worker should be involved in deciding these arrangements. DOT should also be supported by frequent contact with the key worker (see 1.4.3.2). In appropriate circumstances, the key worker may transfer responsibility for certain tasks (e.g. administering drugs) to a member of the patients family or primary care team, for example a health visitor or district nurse. D(GPP)
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
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patient diary
random urine tests and other monitoring (for example, pill counts) D(GPP) help or advice about where and how to get social security benefits, housing and social services. D(GPP) use an identified pharmacist to issue medication on a more frequent basis D(GPP) Centralised supplies of anti-TB drugs
D(GPP)
Combined care for other co-occurring conditions Prescriptions for TB medication were made free in Scotland from 1 October 2007
The NHS (Charges for Drugs and Appliances)(Scotland) (No.2) Regulations 2007 came into force on 1 October 2007 and provide the supply of medicines for the treatment of Tuberculosis to be supplied free of charge.
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Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
1.4.3.4 Pharmacies should make liquid preparations of anti-TB drugs readily available to TB patients who may need them for example, children and people with swallowing difficulties. D(GPP) 1.4.3.5 TB services should assess local language and other communication needs and, if there is a demonstrated need, provide patient information accordingly. D(GPP)
Patient information should be drawn from national high-quality resources if available; for examples, see http://www.hpa.org.uk. Information on TB will be added to the National Knowledge Service website (http://www.nks.nhs.uk) over the coming months. Countries with more than 40 cases per 100,000 per year, as listed by the Health Protection Agency (go to http://www.hpa.org.uk and search for WHO country data TB).
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Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
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1.5.1.3 Response to treatment should be closely monitored in patients at increased risk of drug resistance. If there is no clinical improvement within 2 months or if cultures remain positive after the 4th month of treatment (treatment failure), compliance issues or drug resistance should be suspected and treatment reviewed with a clinician experienced in the treatment of MDR TB. D(GPP) (See section 1.2.1 for details of the standard recommended regimen.)
1.5.2 Referral
1.5.2.1 The care of patients with MDR TB should be undertaken by a specialist in MDR TB in conjunction with a microbiologist with expertise in TB. The views of the patient should be sought and taken into account, and shared care should be considered. D(GPP)
For a local list of specialists in MDR TB contact the local consultant in public health medicine. A UK wide virtual community of experts on MDR TB management is also available by contacting MDRTBservice@ctc. nhs.uk or 0151 600 142. Specialist expertise in the public health management of MDR-TB cases is available from Health Protection Scotland 0141 300 1100 Countries with a high incidence of MDR TB are available from the http://www.who.int and searching for MDR TB country data. The WHO 2008 MDR TB and XDR TB world report is available at http://www.who.int/ tb/challenges/mdr/mdrtbfacts_june08.pdf
II
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Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
1.5.3.2 Staff should wear FFP3 masks during contact with a patient with suspected or known MDR TB while the patient is considered infectious. Wearers of FFP3 masks should undergo facepiece fit testingII before use to ensue that the mask fits correctly. The number of staff entering the isolation room during this time should be restricted to a minimum. D(GPP) Visitors to patients with known or suspected MDR TB should wear a mask. Where possible this should be a FFP3 mask and wearers should undergo facepiece fit testing. The number of visitors entering during this time should be restricted to a minimum. D(GPP)
1.5.3.3 Before the decision is made to discharge a patient with suspected or known MDR TB from hospital (i.e. patient demonstrated to be non-infectious by three negative smears, culture negative (most rapidly confirmed by liquid methods) and tolerating treatment), secure arrangements for the supervision and administration of all anti-TB therapy should have been agreed with the patient and carers. D(GPP) 1.5.3.4 The decision to discharge a patient with suspected or known MDR TB should be discussed with the infection control team, the local microbiologist, the local TB service, the consultant in public health medicine and other multidisciplinary agencies. Many patients with MDR TB have a history of poor compliance so a risk assessment for DOT should be carried out in these patients with an option for daily dosing. D(GPP) 1.5.3.5 Negative-pressure rooms used for infection control in MDR TB should meet the standards as defined by NHS Health Facilities ScotlandIII, and should be clearly identified for staff, for example by a standard sign. Such labelling should be kept up to date. D(GPP) For a summary of recommendations on infection control, see the algorithm on isolation decisions for patients with suspected respiratory TB (appendix E algorithm I).
European standard EN149:2001; masks should meet the standards in Respiratory protective equipment at work: a practical guide HSG53 published by the Health and Safety Executive (2005). Available from http://www.hsebooks.com/Books Information on this can be accessed on the HPS website at http://www.documents.hps.scot.nhs.uk/hai/ infection-control/sicp/ppe/mic-p-ppe-2007-02.pdf Scottish Health Technical Memorandum 2025 Ventilation in healthcare premises (available from http:// www.hfs.scot.nhs.uk/guest/decontamination/CDVer2/Contents1.pdf)
II III
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individualised
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Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
Children aged 015 years identified through opportunistic screening to be: - strongly Mantoux positive (15 mm or greater), and - interferon-gamma positive (if this test has been performed), and - without prior BCG vaccination. People with evidence of TB scars on chest X-ray, and without a history of adequate treatment who are likely to become immunosuppressed. 1.6.1.2 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. Mantoux testing may be unreliable in people with HIV. The reliability of interferon gamma testing in HIV positive individuals is not yet well understood. D(GPP) (Evidence issue) 1.6.1.3 Treatment for latent TB infection should not routinely be started in close contacts of people with sputum smear-positive MDR TB who are strongly Mantoux positive (15 mm or greater). The decision to treat contacts of MDR TB cases is difficult due to the large number of side effects and the lack of evidence. The decision should be made on an individual basis and discussed with an expert in MDR TB and the patient. Long-term monitoring should be undertaken for active disease (annually for five years). D(GPP) 1.6.1.4 Adults who have agreed to receive treatment for latent TB infection should be started on one of the following regimens:
C
either 6 months of isoniazid (6H) or 3 months of rifampicin and isoniazid (3RH) for people aged 1635 not known to have HIV A either 6 months of isoniazid (6H) or 3 months of rifampicin and isoniazid (3RH) for people older than 35 in whom treatment for latent TB infection is recommended (see 1.6.1.1), and who are not known to have HIV D(GPP) 6 months of isoniazid (6H) for adults of any age who have HIV A
Close contacts may include a boyfriend or girlfriend and frequent visitors to the home of the index case, in addition to household contacts.
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6 months of rifampicin (6R) for contacts of people with isoniazid-resistant TB. D(GPP) Adults eligible for treatment of latent TB infection, but who decline to take this treatment, should be given Inform and advise information about TB and have chest X-rays at 3 and 12 months later. D(GPP)
1.6.1.5 Neonates (aged 0-4 weeks) 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. D(GPP) The baby should be started on isoniazid 5 mg/kg/day for 3months and then a Mantoux test performed after 3months treatment. If the Mantoux test is positive (6 mm or greater) the baby should be assessed for active TB (see section 1.1.2). If this assessment is negative, then isoniazid should be continued for a total of 6months. If the Mantoux test is negative (0-5 mm), then isoniazid should be stopped and a BCG vaccination performed (see section 1.7). See section 1.8 for recommendations on assessment if the index case has other types of TB.
1.6.1.6 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. D(GPP) The child should be started on isoniazid 5 mg/kg/day 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 1.1.2). If active TB is ruled out, full treatment for latent TB infection should be given (see 1.6.1.8). If the Mantoux test is negative (0-5 mm), then isoniazid should be continued and the Mantoux test repeated after 6 weeks. If the repeat Mantoux test is negative, isoniazid may be stopped and BCG vaccination performed (see section 1.7).
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If the repeat Mantoux test is positive (6 mm or greater), an interferon-gamma test should be conducted, if available. If this is positive, full treatment for latent TB infection should be given. If the test is not available, the child should be started on treatment for latent TB infection after a positive repeat Mantoux test result. Contact tracing for children younger than 2 years when the index case is sputum smear-positive is summarised in an algorithm (appendix E algorithm III). See section 1.8 for recommendations on assessment if the index case has other types of TB.
1.6.1.7 BCG-vaccinated children older than 4 weeks but younger than 2years, in close contact with people with sputum smearpositive respiratory TB, should be treated as follows. The child should have a Mantoux test. If this is positive (15mm or greater), the child should be assessed for active TB (see section 1.1.2). If active TB is excluded, then treatment for latent TB infection should be given (see section 1.6.1.8). If the result of the test is as expected for prior BCG (less than 15mm), it should be repeated after 6weeks. If the repeat test is also less than 15mm, no further action is needed. If the repeat test becomes more strongly positive (15mm or greater and an increase of 5 mm or more over the previous test), an interferon-gamma test should be conducted, if available. If this is positive, the child should be assessed for active TB (see section 1.1.2). If the interferon-gamma test is not available, the child should be assessed for active TB after a positive repeat Mantoux test result. If active TB is excluded, treatment for latent TB infection should be given. 1.6.1.8 For children aged 4 weeks to 15 years requiring treatment for latent TB infection, a regimen of either 3months of rifampicin and isoniazid (3RH) or 6 months of isoniazid (6H) should be planned and started, unless the child is known to be HIVpositive, in which case 6H should be given (see 1.6.1.4). D(GPP) If someone under observation for latent TB develops symptoms or worsening symptoms of TB this must be brought to the attention of the physician who will assess the risk and manage the patient appropriately.
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1.6.1.9 Healthcare workers should be aware that certain groups of people are more susceptible to TB disease and those with latent TB are at increased risk of going on to develop active TB, including people who: D(GPP) are HIV-positive are injecting drug users have had solid organ transplantation have a malignancy have had a jejunoileal bypass have chronic renal failure or receive haemodialysis have had a gastrectomy are receiving anti-TNF-alpha treatment (resource issue) have silicosis have diabetes are receiving chemotherapy are receiving immunosuppressants are very old or very young Patients in these groups should be advised of the risks and symptoms of TB, on the basis of an individual risk assessment, usually in a standard letter of the type referred to as Inform and advise information.
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II III
See the British HIV Association guideline for details of further action in HIV-positive patients. Available from http://www.bhiva.org More than 40 cases per 100,000 per year, as listed by the Health Protection Agency (go to http://www. hpa.org.uk and search for TB rate bands). The Green Book; Immunisation against infectious disease, 2006
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II III
Available from http://www.sehd.scot.nhs.uk/cmo/CMO(2005)05.pdf This is inline with the Green Book recommendations rather than the NICE document. More than 40 cases per 100,000 per year, as listed by the Health Protection Agency (go to http://www. hpa.org.uk and search for TB WHO country data).
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and
are previously unvaccinated (that is, without adequate documentation or a characteristic scar) , B and are aged: - younger than 16 years,
D(GPP) or
- 16 to 35 yearsII from sub-Saharan Africa or a country with a TB incidence of 500 per 100,000 (see appendix VI and VII). D(GPP)
Audit Point
II
People who have recently arrived in or returned to the UK from high-incidence countries (for a period of three months or more). The November 1995 draft of the Green Book recommends BCG for new entrants only up to the age of 16. However in this guideline BCG is recommended for those aged up to 35 who come from the countries with the very highest rates of TB because there is some evidence of cost-effectiveness (see full guideline). Workers involved in direct patient care includes doctors, dentists, midwives, nurses, paramedics, ambulance drivers, occupational therapists, physiotherapists and radiographers. BCG is also recommended for technical staff in microbiology and pathology departments, attendants in autopsy rooms and others considered to be a high risk. BCG is not recommended for non-clinical staff in healthcare setting such as receptionists, porters and cleaners as stated in the Green Book As outlined in the Green Book, there is not sufficient age-specific evidence to make recommendations on BCG vaccination for people older than 35 (see full guideline for details). However, in this guideline BCG vaccination is recommended for healthcare workers of all ages because of the increased risk to them and consequently the patients they care for if they remain unvaccinated.
III
IV
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Audit Point
Audit Point
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6 weeks after most recent contact with a case: an interferongamma test (if available) should be carried out otherwise a Mantoux test should be used. There should also be consideration of BCG or treatment for latent TB infection once active TB has been ruled out, for those who: - are previously unvaccinated and - are household contacts of a person with sputum-smear positive TB and - are Mantoux negative (0-5 mm) chest X-ray (if there are no contraindications) for those older than 35, possibly leading to further investigation for active TB. The recommendations on asymptomatic household and other close contacts of people with active TB are summarised in an algorithm (appendix E algorithm II).
1.8.1.3 For people with sputum smear-positive TB, other close contacts should be assessed. A risk assessment should be undertaken that would include consideration of: the degree of infectivity of the index case the length of time the index case was in contact with others whether contacts are unusually susceptible to infection the proximity of contact. These may include boyfriends or girlfriends and visitors to the home of the index case who have a cumulative 8 hour or greater exposure over the period which the patient is believed to have been infectious. Occasionally, a workplace associate may be judged to have had contact equivalent to that of household contacts, and should be assessed in the same way. D(GPP) See section 1.6.1.6 for contact tracing for children younger than 2years who are close contacts of people with sputum smearpositive TB.
1.8.1.4 Casual contacts of people with TB, who will include the majority of workplace contacts, should not normally be assessed. C
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Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
1.8.1.5 The need for tracing casual contacts of people with TB should be further assessed if: D(GPP) the index case is judged to be particularly infectious (for example, highly infectious as evidenced by transmission of active TB to more than 10% of close contacts), or any casual contacts are known to possess features that put them at special risk of infection (see section 1.6.1.9). 1.8.1.6 Inform and advise information should be offered to all contacts of people with smear-positive TB. D(GPP)
, and either
or
- the index case coughed frequently during the flight. D(GPP) The CPHM, in liaison with HPS, will risk assess and may provide the airline with Inform and advise information to send to passengers seated in the same part of the aircraft as the index case. D(GPP)
1.8.2.3 If the TB index case is an aircraft crew member, contact tracing of other members of staff is appropriate, in accordance with the usual principles for screening workplace colleagues (see section 1.8.1). B 1.8.2.4 If the TB index case is an aircraft crew member, contact tracing of passengers should not routinely take place. D(GPP)
Published evidence does not allow for a precise definition, but such contact tracing on aircraft has often included only people within three rows on either side of the index case.
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1.8.5 Contact tracing: cases in hospital inpatients and care home settings
1.8.5.1 Following diagnosis of TB in a hospital inpatient, a Problem Assessment Group (PAG) or Incident Management Team (IMT) should be formed and a risk assessment should be undertaken (see 1.8.1.3) including consideration of the period of time before the infectious patient was isolated. D(GPP) The risk assessment should be undertaken by the appropriate infection control team in collaboration with the local Department of Public Health. D(GPP)
1.8.5.2 Patients should be regarded as at risk of infection if they spent more than 8 hours in the same bay as an inpatient with sputum smear-positive TB who had a cough. The hospital Consultant caring for the contact should be informed of the risk in writing. The contact should be given Inform and advise information, and their GP should be informed. D(GPP) 1.8.5.3 The PAG or IMT should consider whether any patients were exposed to a sputum smear-positive TB patient and considered to be equivalent to household contacts (as determined by a risk assessment), or whether any exposed patient is known to be particularly susceptible to infection. The management of these patients should be as household contacts and they should be offered screening (see section 1.8.1). D(GPP) 1.8.5.4 If an inpatient with sputum smear-positive TB is found to have MDR TB, or if exposed patients are HIV-positive, contact tracing should be in line with The Interdepartmental Working Group on Tuberculosis guidelines. D(GPP)
The Interdepartmental Working Group on Tuberculosis (1998) The prevention and control of tuberculosis in the United Kingdom: UK guidance on the prevention and control of transmission of 1. HIV-related tuberculosis 2. drug-resistant, including multiple drug-resistant, tuberculosis. London: Department of Health. Available from http://www.dh.gov.uk/en/index.htm
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1.8.5.5 In cases of doubt when planning contact tracing after diagnosing sputum smear-positive TB in an inpatient, further advice should be sought from Health Protection Scotland and people experienced in the field. D(GPP) 1.8.5.6 In general staff contacts do not require screening unless they are particularly susceptible to infection. See 1.9.2.1 for Inform and Advise. D(GPP) 1.8.5.7 If the case is a staff member the PAG or IMT should consider the risks to the patients and staff and will offer advice based on general principles of risk assessment and tailored to the situation. D(GPP)
provide BCG vaccination to those in high-risk groups who are not infected and who are previously unvaccinated D(GPP) provide relevant information to all new entrants.
D(GPP)
1.8.6.2 New entrant screening for tuberculosis should be incorporated within larger health screening programmes for new entrants, linked to local services in particular in primary care. D(GPP) 1.8.6.3 See algorithm IV on new entrant screening in appendix E for a summary. Assessment for, and management of, TB in new entrants should consist of the following. D(GPP) History (and examination as clinically indicated)b Submission of sputum sample (or other sample if clinically indicated)b Reliable evidence of a normal chest X-ray in the last 6 months, unless they are younger than 11 or are possibly pregnant.
http://www.hpa.org.uk/infections/topics_AZ/tb/epidemiology/who_table1.htm
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Specialist clinical assessment for those with an abnormal chest Xray. 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. A Mantoux test for people with normal recent chest X-ray who are: - younger than 16, or - aged 1635, from sub-Saharan Africa or a country with a TB incidence greater than 500 per 100,000 (see appendix VI). A Mantoux test for - children younger than 11 years - pregnant women. Interferon-gamma test (if available) if Mantoux test is positive (6-14 mm) in someone who has not had BCG vaccination, or strongly positive (15 mm or greater) in someone who has been vaccinated. Assessment for active TB if Mantoux or interferon-gamma test (if available) is positive; interpret chest X-ray first if it is not contraindicated. Treatment for latent TB infection: for people aged 35 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 (if this test was available), and who are: - younger than 16, or - aged 1635, from sub-Saharan Africa or a country with a TB incidence greater than 500 per 100,000.
http://www.who.int/globalatlas/dataQuery/default.asp
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Consideration of BCG for unvaccinated people under 16 who are Mantoux negative (0-5mm) or 16 to 35 years from sub-Saharan Africa or a country with a TB incidence of 500 or more per 100,000. D(GPP) (see section 1.7.4 & Green Book). Inform and advise information for people who do not have active TB and are not being offered BCG or treatment for latent TB infection. See algorithm IV on new entrant screening in appendix E for a summary.
1.8.6.4 New entrants should be identified for TB screening from the following information: new registrations with primary care Port of Arrival reports
D(GPP) D(GPP) B
links with statutory and voluntary groups working with new entrants. D(GPP) 1.8.6.5 Any healthcare professional working with new entrants should encourage them to register with a GP. D(GPP)
The November 1995 draft of the Green Book recommends BCG for new entrants only up to the age of 16. However in this guideline BCG is recommended for those aged up to 35 who come from the countries with the very highest rates of TB because there is some evidence of cost-effectiveness (see full guideline).
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II
Please see http://www.scotland.gov.uk/Resource/Doc/221201/0059484.pdf for the latest health clearance advice from the CMO Contact with clinical materials includes processing of clinical samples but not transporting
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1.9.1.4 If an employee new to the NHS has no (or inconclusive) evidence of prior BCG vaccination, a Mantoux or interferongamma test (if available) (see section 1.1.1) should be performed. D(GPP) 1.9.1.5 Employees who will be working directly with patients or clinical specimens and who are Mantoux negative (0-5 mm) should have an individual risk assessment for HIV infection before BCG vaccination is given. BCG vaccination is contra-indicated in those who are HIV positive. D(GPP) 1.9.1.6 Employees new to the NHS should be offered BCG vaccination, if they will have direct contact with patients and/or clinical specimens, are Mantoux negative (0-5 mm) and have not been previously vaccinated. Those aged over 35 years should not routinely be immunised but should have a risk assessment carried out to determine their risk of exposure to TB. Over 35s who work in high risk areas should be immunised unless contraindicated. Staff requiring BCG must avoid work in high risk areas until 6 weeks post BCG. D(GPP) 1.9.1.7 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 a Mantoux test. For those who have not previously received BCG vaccine, if their Mantoux is negative (0-5 mm), recommendations 1.9.1.4 and 1.9.1.5 should be followed. If positive (6 mm or greater), the person should be referred for clinical assessment for diagnosis and possible treatment of latent infection or active disease. For those who have previously received BCG vaccine, if their Mantoux is negative (0-14 mm), no further action is required. If positive (15 mm or greater), the person should be referred for clinical assessment for diagnosis and possible treatment of latent infection or active disease. D(GPP) 1.9.1.8 If a new employee from the UK or other low-incidence setting, without prior BCG vaccination, has a positive Mantoux (>5mm) or interferon-gamma test, they should have a medical assessment by an occupational health physician and a chest Xray. 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. D(GPP)
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1.9.1.9 If a prospective or current healthcare worker who is Mantoux negative (0-5 mm) declines BCG vaccination, the risks should be explained and the oral explanation supplemented by written advice and recorded in their occupational health record and signed by the employee. If the person still declines BCG vaccination, he or she should not work where they are deemed to be at increased risk of exposure to TB and should report signs and symptoms suggestive of TB urgently to the occupational health service. The employer will need to consider each case individually, taking account of employment and health and safety obligations. D(GPP) 1.9.1.10 Clinical students, agency and locum staff and contract ancillary workers who have contact with patients or clinical materials should be screened for TB to the same standard as new employees in the NHS, according to the recommendations set out above. Documentary evidence of screening to this standard should be sought from locum agencies and contractors who carry out their own screening. D(GPP) 1.9.1.11 NHS boards arranging care for NHS patients in non-NHS settings should ensure that healthcare workers who have contact with patients or clinical materials in these settings have been screened for TB to the same standard as new NHS employees (see recommendations 1.9.1.18). D(GPP) See the algorithm on screening new NHS employees (appendix E algorithm V) for a summary.
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1.9.2.2 If no documentary evidence of prior screening is available, staff in contact with patients or clinical material that are transferring jobs within the NHS should be screened as for new employees (see section 1.9.1). D(GPP) 1.9.2.3 The risk of TB for a new healthcare worker who knows he or she is HIV-positive at the time of recruitment should be assessed as part of the occupational health checks. D(GPP) 1.9.2.4 The employer, through the occupational health department, should be aware of the settings with increased risk of exposure to TB, and that these pose increased risks to HIV-positive healthcare workers. D(GPP) 1.9.2.5 Healthcare workers who are found to be HIV-positive during employment should have medical and occupational assessments of TB risk, and may need to modify their work to reduce exposure. D(GPP)
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1.9.3.5 If a prisoner is being treated for active or latent TB, the prison medical services should draw up as early as possible a contingency plan for early discharge, which could happen directly from a court appearance. This plan should include firm arrangements for clinical follow-up and treatment monitoring in the intended district of residence, and should take into account that there may not be a fixed residence arranged for the prisoner after release. The prisoner should be given contact details for a named key worker, who will visit and monitor the prisoner after release and liaise between services involved. D(GPP) 1.9.3.6 Prison service staff and others who have regular contact with prisoners (for example, education and social workers) should have pre- and on-employment screening at the same level as for healthcare workers with patient contact (see sections 1.9.1 and 1.9.2). D(GPP)
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4 Research recommendations
The Guideline Development Group has made the following recommendations for research, on the basis of its review of the evidence. The Group regards these recommendations as the most important research areas to improve NICE guidance and patient care in the future. THe Scottish TB guideline group also endorses these recomendations.
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Why it is important
The current guideline recommendations are based on a health economic model, which attempts to target effort on those people at highest risk. This would be more useful if more accurate cost-effectiveness estimates were evaluated for the current UK scenario.
Why it is important
There is little up-to-date evidence on the duration of BCG protection in the UK across various age ranges and population groups. This information would aid the development of future BCG vaccination policies in these groups.
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Why it is important
Patients views on their quality of life would be more accurately reflected in future work. There are currently no quality-of-life estimates in the guideline models based on data drawn directly from patients. Cost effectiveness estimates in the form of QALYs would increase the accuracy of health economic models.
Why it is important
Evidence from one non-analytic study suggests that contact tracing identifies fewer cases of TB in the homeless than in contacts who were housed. Depending on the outcome, the research findings could have implications for modifying conventional contact tracing so that it is tailored to the needs of the homeless population.
Why it is important
Currently there is no evidence from controlled studies in this area. If incentives were found to improve attendance for TB screening among this population, then this method would be a more effective way of reaching and treating this patient group.
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Why it is important
Currently there is no evidence from controlled studies in this area. If incentives were found by the research evidence to improve attendance for chest X-ray screening among this population, then this method would be a more effective way of reaching and treating this patient group.
5 Review date
The process of reviewing the evidence is expected to begin 4 years after the date of issue of the guideline. Reviewing may begin before this if significant evidence that affects the guideline recommendations is identified. The updated guideline will be available within 4years of the start of the review process.
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D(GPP)
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2+
2 3 4
Evidence Studies with level of evidence Ia or Ib Studies with level of evidence II Studies with level of evidence III Studies with level of evidence IV
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Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
Dr Neil Hamlet Consultant in Public Health Medicine, NHS Fife Dr Adam Hill Respiratory Physician, NHS Lothian Dr Nick Kennedy Infectious Diseases Physician, NHS Lanarkshire Dr Ian Laurenson Director, Scottish Mycobacteria Reference Laboratory Dr Jim Miller*** Consultant in Public Health Medicine, NHS Lanarkshire Dr Jim McMenamin Consultant Epidemiologist, Health Protection Scotland Ceri McSparron TB Nurse Specialist, NHS Lothian Dr Jimmy Paton Paediatric Respiratory Physician, NHS Greater Glasgow and Clyde Dr Alex Sanchez-Vivar Co-ordinator, Health Protection Network Eisin Shakir (Editorial) Epidemiologist, Health Protection Scotland Dr Jon Spencer Consultant Occupational Physician, NHS Tayside Dr Janet Stevenson Consultant in Public Health Medicine, NHS Lothian Dr Elizabeth Stewart Senior Medical Officer, Scottish Government Mary Waugh Health Protection Nurse Specialist, NHS Dumfries and Galloway Christine Weir TB Nurse Specialist, NHS Lanarkshire
* ** ***
Left the group in April 2007 replaced by Dr Oliver Blatchford Left the group in December 2007 and not replaced Left the group in June 2007 and replaced by Dr Janet Stevenson
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Criterion 3. Process measure: percentage of TB patients in possession of current correct key workers details 4. a) Process measure: percentage of patients with meningeal TB receiving rifampicin, isoniazid, pyrazinamide and ethambutol (or other fourth drug) for the first 2months of treatment b) Process measure: percentage receiving/having received glucocorticoids c) Outcome measure: percentage cure and completion rate (12 months) 5. a) Process measure: percentage of new entrants referred or recorded who are contacted for screening b) Process measure: percentage of new entrants contacted for screening who complete the screening c) Process measure: percentage of new entrants contacted for screening who are referred to secondary care TB teams 6. a) Process measure: percentage of neonates vaccinated with BCG b) Process measure: percentage of eligible neonates vaccinated with BCG
Definition of terms Key worker will have been named as specified in recommendations. b) Any patient who received glucocorticoids for at least 2 weeks.
A. Any people sought but not found B. Loss to follow-up, including not returning for Mantoux test to be read, chest X-ray to be taken, treatment for latent TB infection to be started, etc.
b) Any person who completes the screening process according to the algorithm is counted.
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Admit to a negative pressure room or single room with restrictions if not available
Yes
No
Yes
No
Yes
No
Immunocompromised or HIV+ individuals on ward? Yes No Ideally a negativepressure room. If not a single room on ward with restrictions Ideally a negativepressure room. If not a single room on ward with restrictions
Please see section 1.2.2 on infection control in conjunction with this algorithm
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II: Testing and treating asymptomatic household and other close contacts of all cases of active TB1
No
Yes
Mantoux testiii
5 mm?
Normal?
Had BCG?iii
Chest X-ray
No
Normal?
Discharge
Yes
Interferongamma testvi
Normal?
Mantoux testiii
15 mm?
i ii iii iv v vi
For children aged between 4 weeks and 2 years old who are contacts of people with sputum smearpositive TB, use the algorithm III. Previous BCG vaccination cannot be accepted as evidence of immunity in HIV-infected patients. A negative test in immunocompromised people does not exclude TB infection. People advised to have treatment for latent TB infection, but who decline, should have Inform and advise information reinforced and chest X-ray follow-up at 3 and 12 months. People screened less than 6 weeks from first exposure and high risk only. If Interferon gamma test is not available presume the result is positive. The next steps involve clinical review and a chest X-ray at which the risk for TB will be assessed.
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Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
Discharge
No
Yes
Yes
Yes
Investigate
Yes
No
No
Interferongamma testvi
No
Yes
Yes
No
No
Discharge
No Yes
+ > 6mm
Continue isoniazid; repeat Mantoux test in 6 weeks Repeat Mantoux after 6 weeks
Yes
Yes
Interferongamma test
-
Interferongamma test
+
No Yes
No
Yes
III: Testing and treating asymptomatic children older than 4 weeks but younger than 2 years who are contacts of people with sputum smearpositive TB
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
No action
63
No
Chest X-ray
No
Abnormal?
Yes
No
No
Selected group?i
Yes
Yes
Had BCG?
No
Mantoux test
Mantoux test
No
Yes
Yes
No
+ or not available
Interferongamma test
-
No action
Yes
Abnormal?
No
Select new entrants for further screening/action if they are: age < 16 age 16-35 from sub-Saharan Africa or a country with incidence > 500 per 100,000 Timing of chest X-ray and/or BCG may depend on pregnancy status. Interpret existing chest X-ray if one has been taken recently.
ii
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Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
No
New entranti?
Yes
Normal?
Yes
TB clinic Normal?
Yes
Yes
Yes No
Medical assessment
Yes
No
Risk assessment
Yes
No
TB clinic
No action
TB clinic
New entrants are people arriving in or returning to the UK from a stay of three months or more in a highincidence country (more than 40 cases per 100,000 per year, as listed by the Health Protection Agency; go to http://www.hpa.org.uk and search for WHO country data TB)
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
65
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Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
VII Countries with 500 or more cases of TB per 100 000 population
Botswana Cambodia Djibouti Kenya Lesotho Swaziland Timor-Leste Zambia Zimbabwe 670 cases per 100,000 510 cases per 100,000 734 cases per 100,000 619 cases per 100,000 696 cases per 100,000 1226 cases per 100,000 556 cases per 100,000 680 cases per 100,000 674 cases per 100,000
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
67
68 CLINICAL GATEWAYS Clinical Improvement/Deterioration If productive cough continues for a month after start of treatment, send sputum for repeat AAFB. Request RPOB gene testing on the above sample. Repeat CXR Hospital admission if required Side-Effects Discuss with medical staff Moderate: LFTs - If c/o nausea arrange prescription for an anti-emetic - If c/o pruritis arrange prescription for an anti-pruritic - Stop treatment & arrange consultant follow-up - LFTs - Reintroduction of drugs as per clinic protocol
Male. ................................................ 1 White. ............................................... 1 Born in UK........................................ 1 Language difficulties..................... 2 Lives alone...................................... 2 Temporary Housing........................ 4 Street homeless.............................. 8 Drug misuse: Crack............................................... 9 Heroin.............................................. 8 Methadone. .................................... 0
Severe:
Poor adherence with initial management Repeat risk assessment to establish if the individual needs to step up a pathway Referrals and support Ensure that the patient is referred to appropriate services if any of the following are
Alcohol Misuse. ............................... 8 Prison. ............................................... 8 Cognitive disorder/ Mental Health Illness...................... 6 Previous TB/ Relapsed disease........................... 4 Previous poor adherence............. 9 Poor adherence with other follow up............................... 4 Unemployed................................... 2 Understands TB diagnosis ........... 2 Accepts TB diagnosis.................... -1 Understands treatment regime............................................ -2 4 Self Medicate 5 8 Dossette Box 9 10+ DOT
The table below provides a tool for risk assessment on adherence. It provides a structure for the audit of adherence and may be useful for local teams
Permission to use this risk assessment granted by Ceri McSparron, TB Nurse Specialist, NHS Lothian
Assessment Score:
Date
Result
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
Pathway
Notes
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland
Notes
Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland