You are on page 1of 80

5

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

8
8
8 9

1.2 Management of respiratory TB


1.2.1 Drug treatment 1.2.2 Infection control

13
13 14

1.3 Management of non-respiratory TB


1.3.1 Meningeal TB 1.3.2 Peripheral lymph node TB 1.3.3 Bone and joint TB: drug treatment 1.3.4 Bone and joint TB: routine therapeutic surgery 1.3.5 Pericardial TB 1.3.6 Disseminated (including miliary) TB 1.3.7 Other sites of infection

17
17 18 18 19 19 19 20

1.4 Monitoring, adherence and treatment completion


1.4.1 Treatment completion and follow-up 1.4.2 Improving adherence: directly observed therapy 1.4.3 Other strategies to improve adherence

21
21 21 22

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

1.5 Risk assessment and infection control in drug-resistant TB


1.5.1 Risk factors 1.5.2 Referral 1.5.3 Infection control 1.5.4 Treatment of non-MDR drug resistant TB 

23
23 24 24 26

1.6 Management of latent TB


1.6.1 Treatment of latent TB infection

26
26

1.7 BCG vaccination


1.7.2 BCG vaccination for neonates 1.7.3 BCG vaccination for infants and older children  1.7.4 BCG vaccination for new entrants from high-incidence areas 1.7.5 BCG vaccination for healthcare workers 1.7.6 BCG vaccination for contacts of people with active TB 1.7.7 BCG vaccination for other groups

31
31 32 33 33 34 34

1.8 Contact Tracing


1.8.1 Contact tracing: human to human transmission 1.8.2 Contact tracing: cases on aircraft 1.8.3 Contact tracing: cases in schools 1.8.4 Contact tracing: community childcare 1.8.5 Contact tracing: cases in hospital inpatients and care home settings 1.8.6 New entrants from a high incidence country  1.8.7 Street homeless 1.8.8 Contact tracing in higher education settings 1.8.9 Contact tracing: cattle to human transmission

35
35 37 38 39 39 40 42 43 43

1.9 Preventing infection in specific settings


1.9.1 Healthcare environments: new NHS employees 1.9.2 Healthcare environments: occupational health 1.9.3 Prisons and remand centres 1.9.4 Social care (for example care homes/residential homes/domiciliary care):

43
43 45 46 47

2 3

Notes on the scope of the guidance Implementation in the NHS

48 48

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

49
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

This page is intentionally left blank

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

ii

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

Key priorities for implementation


The following recommendations have been identified as priorities for implementation.

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.

New entrant screening


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.

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)

II

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

Definitions used in this guideline


Active TB when a person is currently unwell with TB disease. Aerosol generating procedure an intervention or procedure which results in a fine droplet spray of extremely small (approx 0.001mm in diameter) respiratory secretions in the air. Aerosol generating procedures include bronchoscopy, chest physiotherapy, intubation, nasopharyngeal aspiration, nebulised therapies that result in increased respiratory secretions, sputum generating procedures (e.g. sputum induction), suctioning material from the respiratory tract, tracheostomy care and any procedure which induces a cough response. Contacts can be defined as close contacts or casual contacts. Close contacts may include a boyfriend or girlfriend and visitors to the home of the index case with eight hours cumulative exposure, in addition to household contacts. Casual contacts may include work colleagues. Directly Observed Therapy (DOT) People with TB can be given treatment to take under direct observation by a healthcare professional or other suitable person where swallowing of the medication is observed. Drug resistance is defined as resistance to one or more anti-TB drug at the start of treatment. This includes multi-drug resistance (MDR) and extensively drug resistance (XDR). MDR is resistance to at least isoniazid and rifampicin. XDR is resistance to isoniazid AND rifampicin AND resistance to a fluoroquinolone AND resistance to one of more of the following injectable drugs: amikacin, capreomycin or kanamycin. High-incidence NHS area An NHS area with more than 40 cases of TB per 100,000 population per year.II Household contacts People sharing a bedroom, kitchen, bathroom or sitting room with the index case. Immunocompromised describes patients in whom the immune response is reduced or defective due to immunosuppression (for example HIV positive individuals, organ transplant recipients, those with malignancy or receiving chemotherapy). Such patients are vulnerable to opportunistic infections. Inform and advise information and advice on the risks and symptoms of TB, usually given in a standard letter.

 II

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

Drug regimen abbreviations for TB treatment


Drug regimens are often abbreviated to the number of months a phase of treatment lasts, followed by letters for the drugs administered in that phase: H is isoniazid, R rifampicin, Z pyrazinamide, E ethambutol, S streptomycin For example: 2HRZE/4HR is the standard recommended regimen. 2HRE/7HR is 2 months of isoniazid, rifampicin and ethambutol followed by 7months of isoniazid and rifampicin.

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

1.1.2 Diagnosing active TB


1.1.2.1 To diagnose active respiratory TB: a posterioranterior chest X-ray should be taken; chest X-ray appearances suggestive of TB should lead to further diagnostic investigation C(DS) multiple sputum samples should be sent for TB microscopy and culture for suspected respiratory TB before starting treatment if possible or, failing that, within 7days of starting. C(DS) Sputum samples should ideally but not necessarily be three early morning samples D(GPP) spontaneously produced sputum should be obtained if possible; otherwise induction of sputum or bronchoscopy and lavage should be used B(DS) in children unable to expectorate sputum, induction of sputum should be considered if it can be done safely, with gastric washings considered as third line B(DS) if there are clinical signs and symptoms consistent with a diagnosis of TB, treatment should be started without waiting for culture results (see section 1.2.1 for details) D(GPP) the standard recommended regimen should be continued in patients whose subsequent culture results are negative unless treatment is contra-indicated or an alternative diagnosis has been made D(GPP) autopsy samples should be sent for TB microscopy and culture in a dry sterile container (and not placed in formalin) if TB is a possibility. D(GPP)

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)

10

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

Central nervous system

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 Pericardium Site of disease

Site of disease Pericardial fluid Site of disease Sputum Bronchial washing NG aspirate Gastric lavage

Pleural cavity

Posterior-anterior chest Pleural biopsy X-ray Ultrasound Possible CT Thorax

Pleural fluid Pleural biopsy

Mediastinal lymph nodes

Posterior-anterior chest Mediastinal biopsy X-ray CT chest

Mediastinal biopsy

Larynx

Posterior-anterior chest Laryngeal biopsy X-ray CT Neck and chest

Laryngeal biopsy

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

11

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

12

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 Management of respiratory TB


Respiratory TB is defined as active TB that is affecting any of the following: lungs pleural cavity mediastinal lymph nodes larynx.

1.2.1 Drug treatment


1.2.1.1 Once a diagnosis of active TB is made, the clinician responsible for care should refer the person with TB to a physician with training in, and experience of, the specialised care of people with TB. TB in children should be managed either by a paediatrician with experience and training in the treatment of TB, or by a general paediatrician with advice from a specialised physician. If these arrangements are not possible, advice should be sought from more specialised colleagues throughout the treatment period. C The TB service for adults and children should include specialised TB nurses and health visitors D(GPP)

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

13

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)

1.2.2 Infection control


Engineering controls are important to prevent TB transmission in hospitals. NHS boards that care for patients with or suspected of having TB should have the appropriate facilities in which to care for them. In recognition of the challenges posed by MDR TB for infection control, there should be an adequate arrangements for provision of suitable negative-pressure rooms for all NHS board areas for treating respiratory (and suspected respiratory) TB (resource issue). The recommendations below deal with the levels of isolation for infection control in hospital settings: negative-pressure rooms, which have air pressure continuously or automatically measured, as defined by NHS Health Facilities Scotland in SHTM 2025 single rooms that are not negative pressure but are vented to the outside of the building A member of the hospital infection control team and/or physicians should carry out a risk assessment on each patient. This risk assessment should include the engineering controls. Rooms where TB patients are nursed and aerosol generating procedures performed should form the basis of a facilities needs assessment.

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)

14

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

15

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.

16

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)

1.3 Management of non-respiratory TB


1.3.1 Meningeal TB
1.3.1.1 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 D(GPP) a glucocorticoid at the normal dose range adults: equivalent to prednisolone 20-40mg if on rifampicin, otherwise 10-20mg A (evidence issue) children: equivalent to prednisolone 1-2mg/kg, maximum 40mg D(GPP) with gradual withdrawalII of the glucocorticoid considered, starting within 23 weeks of initiation. D(GPP) 1.3.1.2 Clinicians prescribing treatment for active meningeal TB should consider as first choice: a daily dosing schedule
B D

using combination tablets.

 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

17

1.3.2 Peripheral lymph node TB


1.3.2.1 For patients with active peripheral lymph node tuberculosis, the first choice of treatment should: be the standard recommended regimen (see section 1.2.1 for further details) B use a daily dosing schedule include combination tablets.
B D

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 Bone and joint TB: drug treatment


1.3.3.1 The standard recommended regimen (see section 1.2.1 for details) should be planned and started in people with: active spinal TB
B C

active TB at other bone and joint sites.

1.3.3.2 Clinicians prescribing treatment for active bone and joint tuberculosis should consider as first choice: a daily dosing schedule
B D

using combination tablets.

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)

18

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

1.3.4 Bone and joint TB: routine therapeutic surgery


1.3.4.1 In patients with spinal TB, anterior spinal fusion should not be performed routinely. B 1.3.4.2 In patients with spinal TB, anterior spinal fusion should be considered if there is spinal instability or evidence of spinal cord compression. D(GPP)

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)

1.3.6 Disseminated (including miliary) TB


1.3.6.2 For patients with disseminated (including miliary) 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

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

19

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)

1.3.7 Other sites of infection


1.3.7.1 For patients with: active genitourinary TB, or active TB of any site other than: - respiratory system - CNS (typically meninges) - peripheral lymph nodes - bones and joints - pericardium - disseminated (including miliary) disease 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

20

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

1.4 Monitoring, adherence and treatment completion


1.4.1 Treatment completion and follow-up
1.4.1.1 Follow-up clinic visits should not be conducted routinely after treatment completion D unless there are clinical concerns about a high risk of relapse or secondary complications. D(GPP) 1.4.1.2 Patients should be alerted to the risk and signs and symptoms of relapse and how to contact the TB service rapidly through primary care or a TB clinic. Key workers should ensure that patients at increased risk of relapse are particularly well informed about symptoms. D(GPP) 1.4.1.3 Patients who have had drug-resistant TB should be considered for follow-up for 12 months after completing treatment. Patients who have had MDR TB should be considered for prolonged follow-up with an annual review or assessment for 5 years. D(GPP)

1.4.2 Improving adherence: directly observed therapy


1.4.2.1 All patients should have a risk assessment for adherence to treatment (see appendix VIII), 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
B

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

21

1.4.3 Other strategies to improve adherence


1.4.3.1 To promote adherence, patients should be involved in treatment decisions at the outset of treatment for active or latent TB. The importance of adherence should be emphasised during discussion with the patient when agreeing the regimen. D(GPP) 1.4.3.2 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. D(GPP) 1.4.3.3 TB services (and primary care services) should consider the following interventions to improve adherence to treatment for active or latent TB if a patient defaults: reminder letters in appropriate languages health education counselling
B B B

patient-centred interview and health education booklet home visits


D(GPP) D(GPP)

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.

22

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)

1.5 Risk assessment and infection control in drugresistant TB


1.5.1 Risk factors
1.5.1.1 A risk assessment for drug resistance should be made for each patient with TB, based on the risk factors listed below: C 1. history of prior TB drug treatment; prior TB treatment failure 2. contact with a known case of drug-resistant TB 3. birth in a foreign country, particularly high-incidence countriesII 4. HIV infection 5. residence in London or another area with a known prevalence of greater than 40 cases per 100,000 population 7. age profile, with highest rates between ages 25 and 44 8. male gender. 1.5.1.2 The TB service should consider the risk assessment for drug resistance and, if the risk is regarded as significant, urgent molecular tests for rifampicin resistance should be performed on smear-positive material or on positive cultures if appropriate. 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).

II

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

23

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)

1.5.3 Infection control


1.5.3.1 Patients with suspected or known infectious MDR TB who are admitted to hospital should be admitted to a negativepressure room. If none is available locally, the patient should be transferred to a hospital that has these facilities and a clinician experienced in managing complex drug-resistant cases. Care should be carried out in the negative-pressure room until the patient is found to be non-infectious or non-resistant, and ideally until cultures are negative. D(GPP) Risk factors for MDR TB Risk factors for drug resistant TB (see section 1.5.1.1) A contact of MDR TB case Foreign born person from a country with a high incidence of MDR TBII (>10% of TB cases MDR TB). Travel or residence (3 months or more) in a country or setting with high incidence of MDR TB

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

24

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

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

25

1.5.4 Treatment of non-MDR drug resistant TB


1.5.4.1 Patients with drug resistant TB, other than MDR, should be under the care of a specialist physician with appropriate experience in managing such cases. First-choice drug treatment is set out in table2.
Table 2 Recommended regimens for non-MDR drug resistant TB Drug resistance S H known before treatment found after starting treatment Z E R (only if confirmed isolated resistance) S+H Other
See definitions for details of abbreviations

Initial phase 2RHZE 2RZSE 2RZE 2RHE 2RHZ 2HZE 2RZE

Continuation phase 4RH 7RE 10RE 7RH 4RH 16HE 10RE

individualised

1.6 Management of latent TB


1.6.1 Treatment of latent TB infection
1.6.1.1 Treatment of latent TB infection should be considered for people in the following groups, once active TB has been excluded by chest Xray and examination. D(GPP) People identified through screening (see section 1.8.1.2) who are: - younger than 36 years (because of increasing risk of hepatotoxicity with age) - any age with HIV - any age and a healthcare worker and are either: - Mantoux positive (6-14 mm), interferon gamma positive (if available) and without prior BCG vaccination, or - strongly Mantoux positive (15 mm or greater), interferon-gamma positive (if available), and with prior BCG vaccination.

26

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.

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

27

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).

28

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

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.

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

29

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.

30

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

1.7 BCG vaccination


1.7.1.1 When BCG is being recommended, the benefits and risks of vaccination and remaining unvaccinated should be discussed with the person (or, if a child, with the parents), so that they can make an informed decision. This discussion should be tailored to the person, be in an appropriate language, and take into account cultural sensitivities and stigma. D(GPP) 1.7.1.2 People identified for BCG vaccination through occupational health, contact tracing or new entrant screening who are also considered to be at increased risk of being HIV positive, should be offered HIV testing before BCG vaccination. D(GPP)

1.7.2 BCG vaccination for neonates


1.7.2.1 Neonatal BCG vaccination for any baby at increased risk of TB should be discussed with the parents or legal guardian. D(GPP) 1.7.2.2 NHS areas with a high incidence of TBII should consider vaccinating all neonates soon after birth. Currently no NHS areas in Scotland are high incidence areas. D(GPP) 1.7.2.3 In line with the most current Green BookIII, NHS areas in Scotland with a low incidence of TB must ensure BCG vaccination is offered to neonates who: D(GPP) were born in an area with a high incidence of TB, or have one or more parents or grandparents who were born in a high-incidence country

 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

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

31

1.7.3 BCG vaccination for infants and older children


1.7.3.1 Routine BCG vaccination is not recommended for children aged 1014 years. Healthcare professionals should opportunistically identify unvaccinated children older than 4 weeks and younger than 16years at increased risk of TB who would have qualified for neonatal BCG and provide Mantoux testing and BCG (if Mantoux negative). C This opportunistic vaccination should be in line with the Chief Medical Officers (Scotland) advice on vaccinating this age group following the end of the universal school-based programme. D(GPP) 1.7.3.2 Mantoux testing should be performed in line with the Green Book. A Tuberculin skin test is necessary prior to BCG vaccination for All individuals over the age of six Infants and children under 6 years with a history of residence or prolonged stay (more than 3 monthsII) in a country with a high incidence of TBIII Those who have had close contact with a person with known TB Those who have a family history of TB within the last 5 years D(GPP)

 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).

32

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

1.7.4 BCG vaccination for new entrants from high-incidence areas


1.7.4.1 BCG vaccination should be offered to Mantoux-negative new entrants who: are from high-incidence countries ,
B

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)

1.7.5 BCG vaccination for healthcare workers


1.7.5.1 BCG vaccination should be offered in conjunction with a clinical risk assessment to healthcare workers involved in direct patient careIII, irrespective of ageIV, who: D(GPP) are previously unvaccinated (that is, without adequate documentation or a characteristic scar or a clear and reliable history of vaccination), and are Mantoux (or interferon-gamma) negative, and will have direct clinical contact (not social contact) with patients or direct contact with clinical materials (not just the transfer of enclosed samples). See sections 1.9.1 and 1.9.2 for details of occupational health screening.

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

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

33

1.7.6 BCG vaccination for contacts of people with active TB


1.7.6.1 BCG vaccination should be offered to Mantoux-negative contacts of people with respiratory TB (see section 1.8.1 for details of contact tracing) if they are previously unvaccinated (that is, without adequate documentation or a characteristic scar) and are: D(GPP) aged 35 or younger aged 36 and older and a healthcare worker involved in direct patient care or laboratory worker who has direct contact with patients or clinical materials (see section 1.7.5).

1.7.7 BCG vaccination for other groups


1.7.7.1 BCG vaccination should be offered to previously unvaccinated, Mantoux-negative people younger than 35 in the following groups at increased risk of exposure to TB, in accordance with the Green Book: D(GPP) veterinary and other staff such as abattoir workers who handle animal species known to be susceptible to TB, such as simians prison staff working directly with prisoners staff of care homes for elderly people staff of hostels for homeless people and facilities accommodating refugees and asylum seekers people aged less than 16 years who are going to live or work with local people for more than 3 months in a high-incidence country. See section 1.7.5 for advice on healthcare workers.

34

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

1.8 Contact Tracing


Rationale for contact tracing
Contact tracing is crucial to preventing TB transmission. Overall, a low proportion of contacts go on to develop active TB disease, with most developing disease within the first year after exposure. The maximal risk is in household contacts where 1 in 3 contacts have a risk of being infected with TB with a 10% lifetime risk of developing active TB (if HIV negative). A further proportion will develop latent TB infection.

1.8.1 Contact tracing: human to human transmission


1.8.1.1 Once a person has been diagnosed with active TB (i.e. commenced on anti-tuberculosis treatment), the diagnosing physician should inform relevant colleagues (including consultants in public health medicine, TB nurses, and infection control nurses) within 24 hours so that the need for contact tracing can be assessed without delay. Whilst a written notification is required, contact tracing should not be delayed until written notification is made. D(GPP) 1.8.1.2 Screening should be offered to the household contacts of any person with active TB, irrespective of the site of infection. Household contacts are defined as those who share a bedroom, kitchen, bathroom or sitting room with the index case. All contacts should be screened within 6 weeks. High risk contacts (such as children, those who are symptomatic, and where the index case has a long history of infection) should be screened within 7 days. Screening should comprise: D(GPP) Within 6 weeks of most recent contact with a case: standard testing for latent TB (see section 1.1.1) for those aged 35 or younger should be undertaken. However to reflect the clinical circumstance (for example someone initially tested a few weeks after their exposure) it may be necessary to repeat such tests at the end of the six weeks after their exposure. There should also be consideration of BCG or treatment for latent TB infection once active TB has been ruled out.

Audit Point

Audit Point

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

35

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

36

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)

1.8.2 Contact tracing: cases on aircraft


1.8.2.1 Following diagnosis of TB in an aircraft traveller, contact tracing of fellow passengers should not routinely be undertaken. D(GPP) 1.8.2.2 The notifying clinician should inform the relevant Consultant in Public Health Medicine (CPHM) if: less than 3 months has elapsed since the flight and the flight was longer than 8 hours aircraft doors closed to aircraft doors open D(GPP) , and the index case is sputum smear-positive - the index case has MDR TB
C , 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.

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

37

1.8.3 Contact tracing: cases in schools


1.8.3.1 The CPHM of the Department of Public Health will lead on the risk assessment for the incident. D(GPP) 1.8.3.2 Following diagnosis of TB in a school pupil or member of staff, the CPHM should provide advice on prevention and control procedures to staff, parents and the press. Advice on managing these incidents and their public relations is available from the local Department of Public Health. D(GPP) 1.8.3.3 If a school pupil is diagnosed with sputum smear-positive TB, the rest of his or her class (if there is a single class group), or the rest of the year group who share classes, should be assessed as part of contact tracing. B 1.8.3.4 If a teacher has sputum smear-positive TB, the pupils in his or her classes during the preceding 3 months should be assessed as part of contact tracing. C In practice, pupils who may have been exposed to a sputum smear-positive teacher during the believed period of infectivity should be assessed. D(GPP) 1.8.3.5 Clinicians conducting contact tracing in a school should consider extending it to include children and teachers involved in extracurricular activities, and non-teaching staff, on the basis of the risk assessment criteria outlined in section 1.8.1.3. D(GPP) 1.8.3.6 Secondary cases of sputum smear-positive TB should be treated as index cases for contact tracing and will require further incident management action. See 1.8.3.14 for class of recommendation 1.8.3.7 Screening should be considered for all relevant members of staff at the school if the index case of a school pupils TB disease is not found, and the child is not in a high-risk group for TB. D(GPP)

38

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

1.8.4 Contact tracing: community childcare


1.8.4.1 When an adult who works in childcare (including people who provide childcare informally) is diagnosed with sputum smearpositive TB, management is as for contact tracing (see section 1.8.1). D(GPP)

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

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

39

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)

1.8.6 New entrants from a high incidence country


1.8.6.1 NHS Bboards are responsible for screening new entrants and should maintain a coordinated programme to: detect active TB and start treatment detect latent TB and start treatment
B B

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

40

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

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

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

41

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

entry to education (including universities)

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)

1.8.7 Street homeless


1.8.7.1 Active case finding should be carried out among street homeless people (including those using direct access hostels for the homeless) by chest X-ray screening on an opportunistic and/or symptomatic basis. Simple incentives for attending, such as hot drinks and snacks, should be considered. D(GPP) 1.8.7.2 Healthcare professionals working with people with TB should reinforce and update education about TB, and referral pathways, to primary care colleagues, social workers and voluntary workers who work with homeless people. 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).

42

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

1.8.8 Contact tracing in higher education settings


1.8.8.1 Similar practice points to schools apply to higher education settings D(GPP)

1.8.9 Contact tracing: cattle to human transmission


1.8.9.1 Inform and advise information should be given to people in contact with TB-diseased animals. Diagnostic tests for latent TB should be considered only for children younger than 16 who have not had BCG vaccination and have regularly drunk unpasteurised milk from animals with TB udder lesions. D(GPP)

1.9 Preventing infection in specific settings


1.9.1 Healthcare environments: new NHS employees
1.9.1.1 Employees new to the NHS who will be working directly with patients or clinical specimens should not start work until they have completed a TB screen (health check), or documentary evidence is provided of such screening having taken place within the preceding 12months. D(GPP) 1.9.1.2 Employees new to the NHS who will not have contact with patients or clinical specimens should not start work if they have signs or symptoms of TB. D(GPP) 1.9.1.3 Health checks for employees new to the NHS who will have direct clinical contact with patients or clinical materialsII should include: D(GPP) assessment of personal and family history of TB symptom and signs enquiry, possibly by questionnaire documentary evidence of TB skin testing (or interferongamma testing), and/or a clear, reliable history of BCG vaccination and/or BCG scar check by an occupational health professional. Mantoux result within the last 5 years, if available.

 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

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

43

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)

44

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

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.

1.9.2 Healthcare environments: occupational health


These recommendations set the standard for NHS organisations and therefore should apply in any setting in Scotland where NHS patients are treated. 1.9.2.1 Reminders of the symptoms of TB, and the need for prompt reporting of such symptoms, should be included with annual reminders about occupational health for staff who: D(GPP) are in regular contact with TB patients or clinical materials, or have worked in a high-risk clinical setting for 4 weeks or longer within the previous 12 months. One-off reminders should be given after a TB incident on a ward and Inform & Advise information given to potentially exposed staff.

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

45

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)

1.9.3 Prisons and remand centres


1.9.3.1 Healthcare workers providing care for prisoners and remand centre detainees should be alert of the signs and symptoms of active TB. TB services should ensure that awareness of these signs and symptoms is also promoted among prisoners and prison staff. D(GPP) 1.9.3.2 Prisoners should be screened for TB by: a health questionnaire on each entry to the prison system D(GPP) , then for those with signs and symptoms of active TB a single cell should be used for holding until investigations are complete. A chest X-ray C , and ideally three early morning sputum samples taken on three separate days for TB microscopy (see section1.1.2). D(GPP) 1.9.3.3 All prisoners receiving treatment for active or latent TB should receive DOT. D(GPP) 1.9.3.4 Prison medical services should have liaison and handover arrangements to ensure continuity of care before any prisoner on TB treatment is transferred between prisons. D(GPP)

46

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

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)

1.9.4 Social care (for example care homes/residential homes/domiciliary care):


1.9.4.1 Pre-employment screening (section 1.9.1) and contact tracing (see 1.8.1) as for NHS employees

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

47

2 Notes on the scope of the guidance


This guidelines was developed in accordance with a scope document that defines what the guideline will and will not cover. The scope of this guideline was established, after a period of consultation, at the start of the guideline development process. This guideline sets out best practice guidance for the diagnosis, treatment, prevention and control of TB in the NHS in Scotland. It covers latent TB infection and active TB of the following sites: respiratory (lung, bronchus, pleura, thoracic lymph nodes) meningeal pericardial bone and joint peripheral lymph nodes genitourinary disseminated (including miliary). The guideline does not extend to comorbidities such as HIV, drug dependencies, diabetes, hepatic disease, renal disease, or mental illness, nor does it give guidance on highly specialised and individualised activities such as treatment of multidrug-resistant (MDR) TB. It does not include special guidance for patients who are pregnant, planning pregnancy or unconscious, or for older people in longterm care. It considers only the M. tuberculosis complex of bacteria, and therefore does not provide guidance on other mycobacterial infections.

3 Implementation in the NHS


The Healthcare Commission will assess the performance of NHS organisations in meeting core and developmental standards set by the Department of Health in Standards for better health issued in July 2004. Implementation of clinical guidelines forms part of the developmental standard D2. Core standard C5 says that national agreed guidance should be taken into account when NHS organisations are planning and delivering care.

48

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

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.

4.1 Interferon-gamma tests


A diagnostic and qualitative study is needed to assess whether interferon-gamma tests are acceptable to patients and are more effective than tuberculin skin tests for: predicting subsequent development of active TB, or diagnosing or ruling out current active TB when undertaking TB screening in: new entrants from high TB prevalence countries healthcare workers children in high-risk areas who missed neonatal BCG contacts of people with sputum smear-positive TB HIV positive patients. This study should compare the strategies of Mantoux test only, Mantoux test then interferon gamma test if positive, and interferon gamma test only.

Why this is important


These are new diagnostic tests and there is not yet evidence to show increased effectiveness in predicting subsequent development of active TB, which could enable better targeting of preventive treatment. Also, the acceptability of the tests to various screening groups has not been investigated.

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

49

4.2 Directly observed therapy


A cluster randomised controlled trial of directly observed therapy (DOT) compared with self-administered treatment for latent and/or active TB should be conducted in a UK population. This should be targeted at homeless people, and those with a history of non-adherence, alcoholism, drug abuse, or mental illness.

Why this is important


There is currently no evidence from controlled studies on the use of DOT in the UK. If a UK programme of DOT is found to promote adherence to treatment in these populations, then patients would be less likely to experience future relapse, drug resistance or transmit TB to other patients.

4.3 New entrant screening and treatment for latent TB infection


A study is needed of people found by new entrant screening (as set out in section 1.8.6) to be Mantoux positive and interferon-gamma positive, to establish better estimates of the cost-effectiveness of screening and treatment for latent TB infection in this population. This could identify factors predisposing people to developing active TB so that more effective targeted treatment programmes can be developed for latent TB infection.

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.

4.4 Protective effects of BCG


A case-control study is needed, comparing people who developed active or latent TB with those who did not, and comparing the proportions of people in each group who had been vaccinated and the time since vaccination. The aim will be to derive improved estimates of protective efficacy and duration of protection of the BCG vaccine.

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.

50

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

4.5 Quality of life


A study is needed to ascertain quality-of-life score estimates from those with TB (both active disease and latent infection), including adverse treatment effects, using an appropriate quality-of-life instrument. This will improve economic decision-making throughout TB care.

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.

4.6 Contact tracing in household contacts and homeless people


Research is needed to determine whether contact tracing is more effective (in terms of identifying cases of latent infection and active disease) among household contacts than among street homeless contacts of patients with confirmed TB disease (including those using direct-access hostels for the homeless).

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.

4.7 Incentives for attending new entrant screening


Research is needed to determine whether Port of Arrival scheme referrals with incentives for attending screening identify more cases of latent TB infection and active TB disease in new entrants than Port of Arrival scheme referrals with no incentives.

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.

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

51

4.8 Incentives for homeless people attending chest Xray screening


Research is needed to determine whether incentives for attending chest X-ray screening achieve better coverage in the homeless population, or identify more cases of latent TB infection and active TB disease, than no incentives.

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.

52

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

Appendix A: Grading scheme


The classification of recommendations and the levels of evidence for intervention studies used in this guideline are adapted from the Scottish Intercollegiate Guidelines Network (SIGN 50: a guideline developers handbook), and summarised in the following tables.

Classification of recommendations on interventions


Recommendation grade Evidence At least one meta-analysis, systematic review, or randomised controlled trial (RCT) that is rated as 1++, and is directly applicable to the target population, or A A systematic review of RCTs or a body of evidence that consists principally of studies rated as 1+, is directly applicable to the target population and demonstrates overall consistency of results, or Evidence drawn from a NICE technology appraisal A body of evidence that includes studies rated as 2++, is directly applicable to the target population and demonstrates overall consistency of results, or Extrapolated evidence from studies rated as 1++ or 1+ A body of evidence that includes studies rated as 2+, is directly applicable to the target population and demonstrates overall consistency of results, or Extrapolated evidence from studies rated as 2++ Evidence level 3 or 4, or D Extrapolated evidence from studies rated as 2+, or Formal consensus A good practice point (GPP) is a recommendation for best practice based on the experience of the Guideline Development Group Extrapolated from level 2 clinical evidence, supplemented with healtheconomic modelling

D(GPP)

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

53

Levels of evidence for intervention studies


Level of evidence 1++ 1+ 1 Type of evidence High-quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias High-quality systematic reviews of casecontrol or cohort studies 2++ High-quality casecontrol or cohort studies with a very low risk of confounding, bias or chance and a high probability that the relationship is causal Well-conducted casecontrol or cohort studies with a low risk of confounding, bias or chance and a moderate probability that the relationship is causal Casecontrol or cohort studies with a high risk of confounding, bias, or chance and a significant risk that the relationship is not causal Non-analytical studies (for example, case reports, case series) Expert opinion, formal consensus

2+

2 3 4

Classification of recommendations on diagnostic tests


Grade A(DS) B(DS) C(DS) D(DS)
DS, diagnostic studies.

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

54

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

Levels of evidence for studies of the accuracy of diagnostic tests


Levels of evidence Type of evidence Systematic review (with no or minor variations in the directions and degrees of results between studies) of level-1 studies, which are studies that use: Ia a blind comparison of the test with a validated reference standard (gold standard) a sample of patients that reflects the population to whom the test would apply Ib Level-1 studies Level-2 studies, which are studies that have only one of the following: the population is narrow (the sample does not reflect the population to whom the test would apply) II a poor reference standard is used (defined as that where the test is included in the reference, or where the testing affects the reference) the comparison between the test and reference standard is not blind the study is a casecontrol study Systematic reviews of level-2 studies III Level-3 studies, which are studies that have at least two of the features listed for level-2 studies Systematic reviews of level-3 studies IV Expert committee reports, opinions and/or clinical experience without explicit critical appraisal; or based on physiology, bench research or first principles

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

55

Appendix B: Guideline development


This guidance is written in the following context This guideline is based on the NICE Clinical Guideline 33 Tuberculosis: clinical diagnosis and management of tuberculosis, and measures for its prevention and control. Available from http://www.nice.org.uk/nicemedia/pdf/ CG033niceguideline.pdf This guidance represents the views of the Scottish TB guideline group, which was arrived at after careful consideration of the original NICE TB guideline and the evidence available using the AGREE methodology under the auspice of the Health Protection Network. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. The guidance does not, however, override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer. 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. This 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.

The guideline development group


Dr Syed Ahmed* Consultant in Public Health Medicine, NHS Greater Glasgow and Clyde Dr Oliver Blatchford Consultant in Public Health Medicine, NHS Greater Glasgow and Clyde Dr Jim Chalmers** Consultant in Public Health Medicine, ISD, National Services Scotland Annemarie Deans TB Nurse Specialist, NHS Fife Susan Duthie TB Nurse Specialist, NHS Grampian

56

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

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

57

Appendix C: The guideline review panel


Health Protection Nurses Group Helen Tissington Senior Occupational Physicians Group Dr S Blair Paediatric Physicians Dr Andrew Cant Dr Julia Clark Consultants in Public Health Medicine Dr Chris McGuigan Specialist TB Nurses Susan Duthie Scottish Microbiology forum Dr Mary Hanson Scottish Thoracic Society Royal College of Physicians and Surgeons in Glasgow Dr James Beaton Royal College of Physicians and Surgeons in Edinburgh President Infectious Diseases Dr Nick Kennedy Health Protection Network Dr Alex Sanchez-Vivar Scottish Public Health Network Respiratory physician Dr Mark Cotton Scottish Government Policy: Gareth Brown CMO: Dr Harry Burns, Dr Malcolm McWhirter Health Protection Agency Dr Pete Borriello Dr John Watson Dr Ibrahim Abubakar

58

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

Appendix D: Technical detail on the criteria for audit


Data collection
Data for criteria 1, 2 and 4 can be collected from patient notes or prescribing software. Given the small number of patients receiving directly observed therapy (DOT), retrospective data collection across a year will be needed to provide an accurate proportion. Criterion 3 will be useful only for local or national comparative audit and discussion; it is not possible to determine a target. These data probably need to be collected from patients during a clinic visit (at a consistent point in their treatment for comparability), which also provides an opportunity to collect qualitative data on interaction with, or understanding of the roles of, key workers. Data for criterion 5 can be collected in primary care trusts, where the sources of names (such as records from ports of arrival, GP registration, educational institutions) are all compiled at one point, and where it is possible to remove duplicated names. Criterion 6 should be assessed retrospectively on a population-wide basis by the primary care trust. The table below summarises some of the issues that could be addressed through the use of audit. Its appropriateness and completeness is left to local teams to modify for their own purpose.
Criterion 1.a) Process measure: percentage of patients with active TB receiving rifampicin, isoniazid, pyrazinamide and ethambutol (or other fourth drug) for the first 2 months of treatment b) Outcome measure: percentage cure and completion rate 2. Process measure: percentage of patients with active TB who are treated with DOT Patients on DOT are any patients who have been prescribed anti-TB drugs as directly observed therapy (regardless of observer) for part or all of their treatment. Exception Contraindications, meningeal TB, CNS involvement, drug resistance Definition of terms

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

59

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

Exception Hospital inpatients

Definition of terms Key worker will have been named as specified in recommendations. b) Any patient who received glucocorticoids for at least 2 weeks.

Contraindications, drug resistance

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.

Informed refusal, HIV

60

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

Appendix E: The algorithms


I: Isolation decisions for patients with suspected respiratory TB
Patient admitted via GP or Accident and Emergency with respiratory TB

Admit to a negative pressure room or single room with restrictions if not available

Sputum smear positive? (1 or more from 3 samples)

Yes

No

Risk for MDR TB?

Risk for MDR TB?

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

Negative-pressure room mandatory*

Negative-pressure room mandatory*

* Until the patient meets the criteria described in section 1.2.2.6

Please see section 1.2.2 on infection control in conjunction with this algorithm

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

61

II: Testing and treating asymptomatic household and other close contacts of all cases of active TB1
No

Give BCG if under 35

Index case sputum smear positive

Mantoux and Interferon-gamma testvi after 6 weeksv

Yes

Chest X-ray and clinical exam

Mantoux testiii

5 mm?

Normal?

Had BCG?iii

Inform and advise

Chest X-ray

No

Normal?

Discharge

Yes

Age < 35?

Chest X-ray and clinical exam

Interferongamma testvi

Normal?

Mantoux testiii

15 mm?

Inform and advise

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.

62

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

Discharge

No

Treatment for latent TB infectioniv

Yes

Yes

Yes

Investigate

Yes

No

No

Treatment for latent TB infection if under 35iv

Interferongamma testvi

No

Yes

Yes

Investigate further for active TB or other

No

No

Discharge

No Yes

Prior BCG? Perform initial Mantoux test

Start isoniazid 5mg/kg and perform initial Mantoux test


- 0-5mm - 0-14mm + > 15mm

+ > 6mm

Continue isoniazid; repeat Mantoux test in 6 weeks Repeat Mantoux after 6 weeks

Mantoux +ve >6 mm and increase on initial test >5 mm


No No

Mantoux >15 mm and increase on initial test >5mm

Yes

Yes

Interferongamma test
-

Interferongamma test
+

Assess for TB clinical disease

Assess for TB clinical disease

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

Treat for latent TB infection: 3RH or completion of 6H Treat and notify

Stop isoniazid; advise BCG

No action

Treat for latent TB infection; start 6H or 3RH

Treat and notify

63

IV: New entrant screening


This algorithm sets out the actions for screening new entrants (or people returning after a prolonged stay) to the UK from a country with a high incidence of TB (as defined by the Health Protection Agency; go to http://www.hpa.org.uk and search for WHO country data TB). It does not apply to people who are known to be HIV-positive, who should be referred to an HIV team. People coming to the UK to work in healthcare who will have contact with patients or clinical material should be screened in line with algorithm V on new NHS employees. This algorithm applies to dedicated new entrant screening services, and therefore does not detail the systems for detecting new entrants, nor the clinic activities that follow. Service providers with a different service model may need to adapt this to their individual processes.
Chest X-ray taken recently?
Yes

No

Chest X-ray

No

Age < 11, or possibly pregnant?


Yes

Abnormal?
Yes

No

TB service (diagnostic work-up)

No

Selected group?i

Yes

Yes

Had BCG?

No

Inform and advise information

Mantoux test

Mantoux test

No

Mantoux >15 mm?

Yes

Yes

Mantoux >6 mm?

No

Inform and advise information

+ or not available

Interferongamma test
-

Consider BCG (individual risk assessmenti,ii)

Consider chest X-rayii

No action

Yes

Abnormal?

No

TB service (diagnostic work-up) i

TB service (chemoprophylaxis for selected groupsi)

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

64

Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland

V: Screening new NHS employees


Pre-employment questionnaire

No

New entranti?

Yes

Chest X-ray Suspicious symptoms?


Yes No No

Medical assessment by OHP, chest X-ray

Normal?
Yes

TB clinic Normal?
Yes

Working with patients or clinical materials?


No No

Yes

Prior BCG (scar or documented, or a clear and reliable history)?

Yes No

Mantoux/interferon-gamma test (if available), unless performed in past 5 years

Medical assessment

Yes

Mantoux or interferon-gamma test positive (>5mm)?

No

Suspicious symptoms or circumstances?

Risk assessment

Yes

No

If deemed to work in medium/ high risk area

Chest X-ray normal? Offer BCG


Yes No

TB clinic

No action

Inform and advise, consider treatment for latent TB infection

TB clinic

Record refusals Notify occupational health

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

VI Sub-Saharan African countries


Angola Benin Botswana Burkina Faso Burundi Cameroon Cape Verde Central African Republic Chad Comoros Congo Cte dIvoire Democratic Republic of the Congo Equatorial Guinea Eritrea Ethiopia Gabon Gambia Ghana Guinea Guinea-Bissau Kenya Lesotho Liberia Madagascar Malawi Mali Mauritius Mozambique Namibia Niger Nigeria Rwanda Sao Tome and Principe Senegal Seychelles Sierra Leone Somalia South Africa Swaziland Togo Uganda United Republic of Tanzania Zambia Zimbabwe (Correct at time of publication)

66

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

(Correct at time of publication)

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

VIII Adherence Risk Assessment

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

You might also like