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Guideline Summary
Guideline Title
Tuberculosis. Clinical diagnosis and management of tuberculosis, and measures for its prevention and control.
Bibliographic Source(s)
National Collaborating Centre for Chronic Conditions. Tuberculosis. Clinical diagnosis and management of tuberculosis, and measures for its prevention and control. London (UK): National Institute for Health and Clinical Excellence (NICE); 2011 Mar. 64 p. (Clinical guideline; no. 117). 
Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: National Collaborating Centre for Chronic Conditions. Tuberculosis: clinical diagnosis and management of tuberculosis, and measures for its prevention and control. London (UK): Royal College of Physicians; 2006. 215 p. [386 references]

Scope

Disease/Condition(s)

Tuberculosis (TB), including latent TB infection and active TB infection of the following sites:

  • Respiratory (lung, bronchus, pleura, thoracic lymph nodes)
  • Meningeal
  • Pericardial
  • Bone and joint
  • Peripheral lymph nodes
  • Genitourinary
  • Disseminated (including miliary)

Note: The guideline does not extend to comorbidities such as human immunodeficiency virus (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 long-term care. It considers only the Mycobacterium tuberculosis complex of bacteria, and therefore does not provide guidance on other mycobacterial infections.

Guideline Category
Diagnosis
Management
Prevention
Risk Assessment
Screening
Treatment
Clinical Specialty
Family Practice
Infectious Diseases
Internal Medicine
Pediatrics
Preventive Medicine
Pulmonary Medicine
Intended Users
Advanced Practice Nurses
Health Care Providers
Managed Care Organizations
Nurses
Patients
Physician Assistants
Physicians
Public Health Departments
Guideline Objective(s)

To set out best practice guidance for the diagnosis, treatment, prevention, and control of tuberculosis (TB) in the National Health Service (NHS) in England and Wales

Target Population

Adults and children with, or at risk of contracting, tuberculosis

Interventions and Practices Considered

Diagnosis

  1. Diagnosing latent tuberculosis (TB)
    • Mantoux testing
    • Interferon-gamma testing
  2. Diagnosing active TB
    • Posterior-anterior chest X-ray
    • Multiple sputum samples for microscopy and culture
    • Site-specific investigations for non-respiratory TB (X-ray, computed tomography, magnetic resonance imaging, ultrasound, echocardiogram, intravenous urography, biopsies, culture)
    • Use of rapid diagnostic tests, ideally sent for culture by automated liquid methods

Management

Respiratory TB

  1. Drug treatment with standard regimen (6 months of isoniazid and rifampicin supplemented in the first 2 months with pyrazinamide and ethambutol)
  2. Infection control and isolation procedures in hospital settings (e.g., negative-pressure rooms, single rooms vented to outside, wards)

Non-respiratory TB

  1. Drug treatment with standard or alternative regimen
  2. Adjunctive glucocorticoid treatment in patients with meningeal and pericardial TB
  3. Consideration of dosing schedules and combination tablets
  4. Spinal fusion for spinal TB in specific cases
  5. Testing for central nervous system involvement (brain scan, lumbar puncture) in patients with disseminated (including miliary) TB

Monitoring and Risk Assessment

  1. Monitoring for adherence and treatment completion and interventions to improve adherence, such as reminder letters, counselling, and home visits
  2. Use of directly observed therapy
  3. Risk assessment of patients for drug resistance and tests for rifampicin resistance

Latent TB

  1. Consideration of drug treatment in specific populations based on results of screening tests
  2. Drug treatment for latent TB (regimens consisting of isoniazid and rifampicin)
  3. Provision of "inform and advise" information in people eligible for treatment who decline treatment
  4. Special considerations for neonates and children in close contact with people with sputum smear-positive TB

Prevention/Screening

  1. Bacille Calmette-Guerin (BCG) vaccination
  2. Active case finding through contact tracing
  3. Screening of people at increased risk, including street homeless, new entrants to the country, healthcare workers, and prisoners and prison staff
Major Outcomes Considered
  • Diagnostic performance of tests for tuberculosis (TB) (sensitivity, specificity, speed)
  • Cure rate
  • Relapse rate associated with drug regimens
  • Mortality and rate of severe residual disability
  • Rate of treatment completion and treatment adherence
  • Rate of drug resistance
  • Efficacy of Bacille Calmette-Guerin (BCG) vaccination for preventing pulmonary TB disease, TB deaths, TB meningitis, laboratory-confirmed TB cases, and disseminated TB
  • Case yields of latent tuberculosis infection

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

Developing Evidence-Based Questions

The technical team drafted a series of clinical questions that covered the guideline scope. The Guideline Development Group (GDG) and Project Executive refined and approved these questions. See Appendix A in the full version of the original guideline document for details of the questions (see the "Availability of Companion Documents" field).

Systematically Searching for the Evidence

The information scientist developed a search strategy for each question. Key words for the search were identified by the GDG. Papers that were published or accepted for publication in peer-reviewed journals were considered as evidence by the GDG. Each clinical question dictated the appropriate study design that was prioritised in the search strategy but the strategy was not limited solely to these study types. Conference paper abstracts and non-English language papers were excluded from the searches. The research fellow identified titles and abstracts from the search results that appeared to be relevant to the question. Exclusion lists were generated for each question together with the rationale for the exclusion. The exclusion lists were presented to the GDG. Full papers were obtained where relevant. See Appendix A in the full version of the original guideline document for literature search details.

Health Economic Evidence

Due to the appointment of the health economist midway through the guideline development, the areas for health economic modelling were considered after the formation of the clinical questions. The health economist reviewed the clinical questions to consider the potential application of health economic modelling, and these priorities were agreed with the GDG.

The health economist performed supplemental literature searches to obtain additional data for modelling. Assumptions and designs of the models were explained to and agreed by the GDG members during meetings, and they also commented on subsequent revisions.

2011 Update

The updated sections of this guideline were developed in accordance with the process for short clinical guidelines set out in "The guidelines manual" (2009) (see www.nice.org.uk/GuidelinesManual External Web Site Policy).

The guideline was developed in accordance with a specified scope, which detailed the remit of the guideline originating from the Department of Health (DH) and specified those aspects of tuberculosis (TB) to be included and excluded.

For the sections published in 2006 literature searches were repeated for all of the evidence-based questions at the end of the GDG development process allowing any relevant papers published up until 30 November 2004 to be considered. For the section on the diagnosis of latent TB published in 2011 literature searches were not repeated because the development process was only a few months long. The section on diagnosing latent TB includes relevant papers published up until December 2009.

See Appendix B in the full version of the original guideline document for literature search details.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Hierarchy of Evidence and Recommendation Classification

Levels of Evidence Classification of Recommendations
Level Type of Evidence Class Evidence
1++ High-quality meta-analysis (MA), systematic reviews (SR) of randomised controlled trials (RCTs), or RCTs with a very low risk of bias. A Level 1++ and directly applicable to the target population or level 1+ and directly applicable to the target population AND consistency of results. Evidence from NICE technology appraisal.
1+ Well-conducted MA, SR or RCTs, or RCTs with a low risk of bias.
1− MA, SR of RCTs, or RCTs with a high risk of bias. Not used as a basis for making a recommendation.
2++ High-quality SR of case-control or cohort studies. High-quality case-control or cohort studies with a very low risk of confounding, bias or chance and a high probability that the relationship is causal. B Level 2++, directly applicable to the target population and demonstrating overall consistency of results or extrapolated evidence from 1++ or 1+.
2 Well-conducted case-control or cohort studies with a low risk of confounding, bias or chance and a moderate probability that the relationship is causal.
2− Case-control or cohort studies with a high risk of confounding, bias or chance and a significant risk that the relationship is not causal Not used as a basis for making a recommendation.
3 Non-analytic studies (for example case reports, case series). C Level 2+, directly applicable to the target population and demonstrating overall
Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence

Critically Appraising the Evidence

The research fellow or health economist, as appropriate, critically appraised the full papers obtained from the literature search. In general no formal contact was made with authors; however, there were ad hoc occasions when this was required in order to clarify specific details. Critical appraisal checklists were compiled for each full paper. One research fellow undertook the critical appraisal and data extraction. The evidence was considered carefully by the Guideline Development Group (GDG) for accuracy and completeness.

All procedures are fully compliant with the:

  • National Institute for Health and Clinical Evidence (NICE) methodology as detailed in the Technical Manual
  • National Collaborating Centre for Chronic Conditions (NCC-CC) Quality Assurance document & Systematic Review paper available at http://www.ncgc.ac.uk/ External Web Site Policy

Distilling and Synthesising the Evidence and Writing Recommendations

The evidence from each full paper was distilled into an evidence table and synthesised into evidence statements before being presented to the GDG. This evidence was then reviewed by the GDG and used as a basis upon which to formulate recommendations.

Grading the Evidence Statements and Recommendations

The evidence statements and recommendations were graded in accordance with Table 2 of the original guideline document (see the "Rating Scheme for the Strength of the Evidence"). The level of evidence and classification of recommendations were also included for diagnostic studies.

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

Guideline Development Group

The Guideline Development Group (GDG) met monthly for 15 months (2004 to 2005) and comprised a multidisciplinary team of professionals, service users, carers, and user organisation representatives who were supported by the technical team.

The GDG membership details including patient representation and professional groups are detailed in the GDG membership section in appendix M of the full version of the guideline (see the "Availability of Companion Documents" field).

Agreeing the Recommendations

The sign-off workshop employed formal consensus techniques to:

  • Ensure that the recommendations reflected the evidence base
  • Approve recommendations based on lesser evidence or extrapolations from other situations
  • Reach consensus recommendations where the evidence was inadequate
  • Debate areas of disagreement and finalise recommendations

The sign-off workshop also reached agreement on the following:

  • Seven key priorities for implementation
  • Eight key research recommendations
  • Five algorithms

In prioritising key recommendations for implementation, the sign-off workshop also took into account the following criteria:

  • High clinical impact
  • High impact on reducing variation
  • More efficient use of National Health Service (NHS) resources
  • Allowing the patient to reach critical points in the care pathway more quickly

The audit criteria provide suggestions of areas for audit in line with the key recommendations for implementation.

Writing the Guideline

The first draft version of the guideline was drawn up by the technical team in accord with the decision of the GDG.

2011 Update

The GDG met every 6 weeks over a 5-month period from February until June 2010. The group comprised a multidisciplinary team of professionals, patients and carers who were supported by the technical team. The GDG membership details can be found in appendix N of the full length guideline document.

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

Partial Update Health Economics Introduction

A decision model based on the previous guideline was used to compare the expected cost effectiveness of four strategies of testing for latent infection in both adult (aged more than 18 years) populations described above. The strategies compared were:

  • Mantoux test
  • Interferon-gamma test (IGT)
  • Mantoux test followed by IGT
  • No test

In the model, treatment follows current policy; with appropriate therapy for people diagnosed with active and latent tuberculosis (TB). The analysis did not compare different types of skin tests or IGTs because this was outside the scope of this guideline.

The key areas that were updated were the test accuracies and the relevant costs. All costs were updated to current prices and were validated by the Guideline Development Group (GDG). The test accuracies were based on published reviews which calculated sensitivities and specificities again after validation by the GDG.

The assumptions made in the initial guideline were still applicable unless stated otherwise. Whenever possible, input parameters and assumptions were based on empirical evidence, but some key parameters were estimated by the health economist and GDG. The model considers the quality-adjusted life years (QALYs) lost because of infection, adverse events and developing TB. Therefore, the interventions with the smallest QALY loss are the most effective. Throughout the analysis incremental cost-effectiveness ratios (ICERs) will be compared with a common base line (usually no test) and net monetary benefits will be calculated. Net monetary benefit quantifies which treatment option provides the greatest health benefit for a given threshold. A threshold of £20,000 per QALY gained was used in this analysis. Probabilistic sensitivity analysis was considered, however some of the estimates of the means of variables were assumptions and it was therefore considered more instructive to do a series of one way sensitivity analysis rather than a probabilistic sensitivity analysis.

Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

The guideline was validated through two consultations.

  1. The first draft of the guideline (The full guideline, National Institute for Clinical Excellence (NICE) guideline and Quick Reference Guide) were consulted with Stakeholders and comments were considered by the Guideline Development Group (GDG).
  2. The final consultation draft of the Full guideline, the NICE guideline and the Information for the Public were submitted to stakeholders for final comments.

The final draft was submitted to the Guideline Review Panel for review prior to publication.

Recommendations

Major Recommendations

Recommendations are marked as [2006], [2006, amended 2011], o r[new 2011].

  • [2006] indicates that the evidence has not been updated and reviewed since the original guideline.
  • [2006, amended 2011] indicates that the evidence has not been updated and reviewed since 2006 but a small amendment has been made to the recommendation.
  • [new 2011] indicates that the evidence has been reviewed and the recommendation has been updated or added.

Diagnosis

Diagnosing Latent Tuberculosis (TB)

Offer Mantoux testing in line with the Green Book* to diagnose latent TB in people who are:

  • Household contacts (aged 5 years and older) of all people with active TB
  • Non-household contacts (other close contacts for example, in workplaces and schools). [new 2011]

*In this guideline the "Green Book" is the 2006 edition of "Immunisation against infectious disease," published by the Department of Health (available from www.dh.gov.uk External Web Site Policy). The Green Book contains details of people who may have suppressed responses to tuberculin skin testing.

Consider interferon-gamma testing for people whose Mantoux testing shows positive results, or in people for whom Mantoux testing may be less reliable, for example Bacille Calmette-Guerin (BCG)-vaccinated people. [new 2011]

If Mantoux testing is inconclusive, refer the person to a TB specialist. [new 2011]

New Entrants from High-Incidence Countries

Offer a Mantoux test to children aged 5–15 years. If positive, follow with an interferon-gamma test. [new 2011]

Offer either an interferon-gamma test alone or a dual strategy in people aged 16–35 years. For people aged 35 years or older, consider the individual risks and benefits of likely subsequent treatment, before offering testing. (Refer to other sections for other groups, for example, immunocompromised.) [new 2011]

Offer Mantoux testing as the initial diagnostic test for latent TB infection in children younger than 5 years who have recently arrived from a high-incidence country. If the initial test is positive (taking into account the BCG history):

  • Refer to a TB specialist to exclude active disease and
  • Consider treating latent TB [new 2011]

Household Contacts Aged 2–5 Years

For children younger than 2 years see recommendations under "Treatment of Latent TB Infection" below.

Offer Mantoux testing as the initial diagnostic test for latent TB infection in child household contacts between the ages of 2 and 5 years. If the initial test is positive taking into account the BCG history:

  • Refer to a TB specialist to exclude active disease and
  • Consider treating latent TB [new 2011]

If the initial Mantoux test is negative but the child is a contact of a person with sputum-smear-positive disease, offer an interferon-gamma test after 6 weeks and repeat the Mantoux test to increase the sensitivity (to reduce false negative results). [new 2011]

Contacts – Outbreak Situation

In an outbreak situation when large numbers of people may need to be screened, consider a single interferon-gamma test for people aged 5 years and older. [new 2011]

People Who are Immunocompromised

If latent TB is suspected in children who are immunocompromised, refer to a TB specialist. [new 2011]

For people with human immunodeficiency virus (HIV) and CD4 counts less than 200 cells/mm3, offer an interferon-gamma test and a concurrent Mantoux test. If either test is positive:

  • Perform a clinical assessment to exclude active TB and
  • Consider treating latent TB infection [new 2011]

For people with HIV and CD4 counts of 200–500 cells/mm3, offer an interferon-gamma test alone or an interferon-gamma test with a concurrent Mantoux test. If either test is positive:

  • Perform a clinical assessment to exclude active TB and
  • Consider treating latent TB infection [new 2011]

For other people who are immunocompromised, offer an interferon-gamma test alone or an interferon-gamma test with a concurrent Mantoux test. If either test is positive:

  • Perform a clinical assessment to exclude active TB and
  • Consider treating latent TB. [new 2011]

Healthcare Workers

Offer a Mantoux test to new National Health Service (NHS) employees who will be in contact with patients or clinical materials if the employees:

  • Are not new entrants from high-incidence countries and
  • Have not had BCG vaccination (for example, they are without scar, other documentation or reliable history).* [new 2011]

*If there is reliable evidence of BCG vaccination, refer to the Green Book.

If the Mantoux test is negative, refer to the Green Book for BCG immunisation guidance. If the Mantoux test is positive, offer an interferon-gamma test. [new 2011]

Offer an interferon-gamma test to new NHS employees who have recently arrived from high-incidence countries or who have had contact with patients in settings where TB is highly prevalent. [new 2011]

Healthcare workers who are immunocompromised should be screened in the same way as other people who are immunocompromised. [new 2011]

Hard-To-Reach Groups

Offer people from hard-to-reach groups a single interferon-gamma test. [new 2011]

Diagnosing Active TB

To diagnose active respiratory TB:

  • A posterior–anterior chest X-ray should be taken; chest X-ray appearances suggestive of TB should lead to further diagnostic investigation.
  • Multiple sputum samples (at least three, with one early morning sample) should be sent for TB microscopy and culture for suspected respiratory TB before starting treatment if possible or, failing that, within 7 days of starting.
  • Spontaneously produced sputum should be obtained if possible; otherwise induction of sputum or bronchoscopy and lavage should be used.
  • 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.
  • If there are clinical signs and symptoms consistent with a diagnosis of TB, treatment should be started without waiting for culture results (see "Drug Treatment" below).
  • The standard recommended regimen should be continued in patients whose subsequent culture results are negative.
  • Samples should be sent for TB culture from autopsy samples if respiratory TB is a possibility. [2006]

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.
  • If non-respiratory TB is a possibility, part or all of any of the following samples should be placed in a dry pot (and not all placed in formalin) and sent for TB culture:
    • Lymph node biopsy
    • Pus aspirated from lymph nodes
    • Pleural biopsy
    • Any surgical sample sent for routine culture
    • Any radiological sample sent for routine culture
    • Histology sample
    • Aspiration sample
    • Autopsy sample
  • Microbiology staff should routinely perform TB culture on the above samples (even if it is not requested).
  • 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 "Management of Respiratory TB" and "Management of Non-Respiratory TB" below).
  • 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 the table below should be considered.
  • The appropriate drug regimen (see "Management of Respiratory TB," "Management of Non-Respiratory TB," and "Risk Assessment and Infection Control in Drug-Resistant TB" below) should be continued even if subsequent culture results are negative. [2006]
Table. Suggested Site-Specific Investigations in the Diagnosis and Assessment of Nonrespiratory TB
Site Imaging Biopsy Culture
Lymph node  
  • Node
  • Node or aspirate
Bone/Joint
  • Plain X-ray and computed tomography (CT)
  • Magnetic resonance imaging (MRI)
  • Site of disease
  • Biopsy or paraspinal abscess
  • Site or joint fluid
Gastrointestinal
  • Ultrasound
  • CT abdomen
  • Omentum
  • Bowel
  • Biopsy
  • Ascites
Genitourinary
  • Intravenous urography
  • Ultrasound
  • Site of disease
  • Early morning urine
  • Site of disease
  • Endometrial curettings
Disseminated
  • High resolution CT thorax
  • Ultrasound abdomen
  • Lung
  • Liver
  • Bone marrow
  • Bronchial wash
  • Liver
  • Bone marrow
  • Blood
Central nervous system
  • CT brain
  • MRI
  • Tuberculoma
  • Cerebrospinal fluid (CSF)
Skin  
  • Site of disease
  • Site of disease
Pericardium
  • Echocardiogram
  • Pericardium
  • Pericardial fluid
Cold/liver abscess
  • Ultrasound
  • Site of disease
  • Site of disease

Rapid diagnostic tests for Mycobacterium tuberculosis complex (M. tuberculosis, M. bovis, M. africanum) on primary specimens should be used only if:

  • Rapid confirmation of a TB diagnosis in a sputum smear-positive person would alter their care, or
  • Before conducting a large contact-tracing initiative [2006]

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. [2006]

Clinical signs and other laboratory findings consistent with TB meningitis should lead to treatment, (see "Meningeal TB" below), even if a rapid diagnostic test is negative, because the potential consequences for the patient are severe. [2006]

Before conducting a large contact-tracing initiative (for example, in a school or hospital), the species of Mycobacterium should be confirmed to be M. tuberculosis complex by rapid diagnostic tests on microscopy- or culture-positive material. Clinical judgement should be used if tests are inconclusive or delayed. [2006]

If a risk assessment suggests a patient has multi-drug resistant (MDR) TB (see "Risk Factors" below):

  • Rapid diagnostic tests should be conducted for rifampicin resistance
  • Infection control measures and treatment for MDR TB should be started as described in "Risk Assessment and Infection Control in Drug-Resistant TB," pending the result of the tests. [2006]

Rapid diagnostic tests for M. tuberculosis complex identification should be conducted on biopsy material only if:

  • All the sample has been inappropriately placed in formalin, and
  • Acid-fast bacilli (AFB) are visible on microscopy [2006]

Clinical samples should ideally be sent for culture by automated liquid methods, bearing in mind that laboratories need a certain level of throughput to maintain quality control. [2006]

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

Drug Treatment

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. The TB service should include specialised nurses and health visitors. 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. [2006]

A 6-month, 4-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. [2006]

Fixed-dose combination tablets should be used as part of any TB treatment regimen. [2006]

A thrice-weekly dosing regimen should be considered for patients receiving directly observed therapy (DOT) (See "Improving Adherence: Directly Observed Therapy" below). [2006]

A twice-weekly dosing regimen should not be used for the treatment of active TB. [2006]

Infection Control

The recommendations below deal with three levels of isolation for infection control in hospital settings:

  • Negative pressure rooms, which have air pressure continuously or automatically measured, as defined by NHS Estates*
  • Single rooms that are not negative pressure but are vented to the outside of the building
  • Beds on a ward, for which no particular engineering standards are required

*NHS Estates (2005) in patient accommodation: options for choice. Isolation facilities in acute settings HBN4 supplement 1. London: The Stationary Office. Available from www.dh.gov.uk External Web Site Policy.

All patients with TB should have risk assessments for drug resistance (see "Risk Assessment and Infection Control in Drug-Resistant TB" and for HIV. If risk factors for MDR TB are present, see "Infection Control" below for recommendations on infection control. [2006]

Unless there is a clear clinical or socioeconomic need, such as homelessness, people with TB at any site of disease should not be admitted to hospital for diagnostic tests or for care. [2006]

If admitted to hospital, patients with suspected respiratory TB should be given a single room. [2006]

Patients with respiratory TB should be separated from immunocompromised patients, either by admission to a single room on a separate ward, or in a negative pressure room on the same ward. [2006]

Any visitors to a child with TB in hospital should be screened as part of contact tracing and kept separate from other patients until they have been excluded as the source of infection. [2006]

Smear-positive TB patients without risk factors for MDR TB (see "Risk Factors" below) should be cared for in a single room, until:

  • They have completed two weeks of the standard treatment regimen (see "Drug Treatment" under "Management of Respiratory Tuberculosis" above) , or
  • They are discharged from hospital [2006]

Aerosol-generating procedures such as bronchoscopy, sputum induction, or nebuliser treatment should be carried out in an appropriately engineered and ventilated area for:

  • All patients on an HIV ward, regardless of whether a diagnosis of TB has been considered
  • All patients in whom TB is considered a possible diagnosis, in any setting [2006]

Healthcare workers caring for people with TB should not use masks, gowns, or barrier nursing techniques unless:

  • MDR TB is suspected
  • Aerosol-generating procedures are being performed

When such equipment 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 "Infection Control" under "Risk Assessment and Infection Control in Drug-Resistant TB" below for further details of MDR TB infection control. [2006]

TB patients admitted to a setting where care is provided for people who are immunocompromised, including those who are HIV positive, should be considered infectious and, if sputum smear positive at admission, should stay in a negative-pressure room until:

  1. The patient has had at least two weeks of appropriate multiple drug therapy, and
  2. If moving to accommodation (inpatient or home) with people who are immunocompromised, including those who are HIV positive, the patient has had at least three negative microscopic smears on separate occasions over a 14-day period, and
  3. The patient is showing tolerance to the prescribed treatment and an ability and agreement to adhere to treatment, and either
  4. Any cough has resolved completely, or
  5. There is definite clinical improvement on treatment, for example remaining afebrile for a week.

For people who were sputum smear negative at admission (that is, three negative samples were taken on separate days; samples were spontaneously produced sputum if possible, or obtained by bronchoscopy or lavage if sputum samples were not possible): all of 1, 2, 3 and 5 above should apply. [2006, amended 2001]

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 two weeks' drug treatment. [2006]

Management of Non-Respiratory TB

Meningeal TB

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 two months, followed by isoniazid and rifampicin for the rest of the treatment period
  • A glucocorticoid at the normal dose range
    • Adults–equivalent to prednisolone 20–40 mg if on rifampicin, otherwise 10 to 20 mg
    • Children–equivalent to prednisolone 1–2 mg/kg, maximum 40 mg

    with gradual withdrawal of the glucocorticoid considered, starting within 2–3 weeks of initiation. [2006]

Clinicians prescribing treatment for active meningeal TB should consider as first choice:

  • A daily dosing schedule
  • Using combination tablets [2006]

Peripheral Lymph Node TB

For patients with active peripheral lymph node tuberculosis, the first choice of treatment should:

  • Be the standard recommended regimen (see "Drug Treatment" under "Management of Respiratory TB" above for further details)
  • Use a daily dosing schedule
  • Include combination tablets [2006]

Patients with active peripheral lymph node TB who have had an affected gland surgically removed should still be treated with the standard recommended regimen. [2006]

Drug treatment of peripheral lymph node TB should normally be stopped after six months, regardless of the appearance of new nodes, residual nodes, or sinuses draining during treatment. [2006]

Bone and Joint Tuberculosis: Drug Treatment

The standard recommended regimen (see "Drug Treatment" under "Management of Respiratory TB" above) should be planned and started in people with:

  • Active spinal TB
  • Active TB at other bone and joint sites [2006]

Clinicians prescribing treatment for active bone and joint tuberculosis should consider as first choice:

  • A daily dosing schedule
  • Using combination tablets

See "Drug Treatment" under "Management of Respiratory TB" above for details. [2006]

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 "Meningeal TB" above). [2006]

Bone and Joint TB: Routine Therapeutic Surgery

In patients with spinal TB, anterior spinal fusion should not be performed routinely. [2006]

In patients with spinal TB, anterior spinal fusion should be considered if there is spinal instability or evidence of spinal cord compression. [2006]

Pericardial TB

For patients with active pericardial TB, the first choice of treatment should:

  • Be the standard recommended regimen (see "Drug Treatment" under "Management of Respiratory TB" above for details)
  • Use a daily dosing schedule
  • Include combination tablets [2006]

In addition to anti-TB treatment, patients with active pericardial TB should be offered:

  • For adults, a glucocorticoid equivalent to prednisolone at 60 mg/day
  • For children, a glucocorticoid equivalent to prednisolone 1 mg/kg/day (maximum 40 mg/day)

    with gradual withdrawal of the glucocorticoid considered, starting within two to three weeks of initiation [2006]

Disseminated (Including Miliary) TB

For patients with disseminated (including miliary) TB, the first choice of treatment should:

  • Be the standard recommended regimen (see "Drug Treatment" under "Management of Respiratory TB" above for details)
  • Use a daily dosing schedule
  • Include combination tablets [2006]

Treatment of disseminated (including miliary) TB should be started even if initial liver function tests are abnormal. If the patient's liver function deteriorates significantly on drug treatment, advice on management options should be sought from clinicians with specialist experience of these circumstances. [2006]

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 "Meningeal TB" under "Management of Non-respiratory TB" above). [2006]

Other Sites of Infection

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 "Drug Treatment" under "Management of Respiratory TB" above for details)
  • Use a daily dosing schedule
  • Include combination tablets [2006]

Monitoring, Adherence, and Treatment Completion

Treatment Completion and Follow-up

Follow-up clinic visits should not be conducted routinely after treatment completion. [2006]

Patients should be told to watch for 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. [2006]

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. [2006]

Improving Adherence: Directly Observed Therapy (DOT)

Use of DOT is not usually necessary in the management of most cases of active TB.

All patients should have a risk assessment for adherence to treatment, and DOT should be considered for patients who have adverse factors on their risk assessment, in particular:

  • Street- or shelter-dwelling homeless people with active TB
  • Patients with likely poor adherence, in particular those who have a history of non-adherence [2006]

Clinicians who are planning to offer a course of DOT should consider ways to mitigate the environmental, financial and psychosocial factors that may reduce adherence, including stability of accommodation, prescription charges 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 "Other Strategies to Improve Adherence" below). [2006, amended 2011]

Other Strategies to Improve Adherence

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. [2006]

The TB service should tell each person with TB who their named key worker is, and how to contact them. This key worker should facilitate education and involvement of the person with TB in achieving adherence. [2006]

TB 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
  • Patient-centred interview and health education booklet
  • Home visits
  • Patient diary
  • Random urine tests and other monitoring (for example, pill counts)
  • Information about help with paying for prescriptions
  • Help or advice about where and how to get social security benefits, housing and social services [2006]

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. [2006]

TB services should assess local language and other communication needs and, if there is a demonstrated need, provide patient information accordingly.* [2006]

*Patient information should be drawn from national high-quality resources if available; for examples, see www.hpa.org.uk External Web Site Policy.

Risk Assessment and Infection Control in Drug-Resistant TB

Risk Factors

A risk assessment for drug resistance should be made for each patient with TB, based on the risk factors listed below:

  • History of prior TB drug treatment; prior TB treatment failure
  • Contact with a known case of drug-resistant TB
  • Birth in a foreign country, particularly high-incidence countries as defined by the Health Protection Agency (HPA) on its website (Go to www.hpa.org.uk External Web Site Policy and search for 'WHO country data TB").
  • HIV infection
  • Residence in London
  • Age profile, with highest rates between ages 25 and 44
  • Male gender [2006]

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 when they become available (see "Diagnosing Active TB" above). [2006]

Response to treatment should be closely monitored in patients at increased risk of drug resistance. If there is no clinical improvement, or if cultures remain positive after the fourth month of treatment ("treatment failure"), drug resistance should be suspected and treatment reviewed with a clinician experienced in the treatment of MDR TB. [2006]

(See "Drug Treatment" under "Management of Respiratory TB" above for details of the standard recommended regimen.)

Referral

The options for organising care for people with MDR TB should be discussed with clinicians who specialise in this. The views of the patient should be sought and taken into account, and shared care should be considered. [2006]

Infection Control

Patients with suspected or known infectious MDR TB who are admitted to hospital should be admitted to a negative pressure room. If none are 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. [2006]

Staff and visitors should wear FFP3 masks* during contact with a patient with suspected or known MDR TB while the patient is considered infectious. [2006]

*European standard EN149:2001; masks should meet the standards in the Health and Safety Executive's Respiratory protective equipment at work: a practical guide HSG53)

Before the decision is made to discharge a patient with suspected or known MDR TB from hospital, secure arrangements for the supervision and administration of all anti-TB therapy should have been agreed with the patient and carers. [2006]

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, and the consultant in communicable disease control. [2006]

Negative pressure rooms used for infection control in MDR TB should meet the standards of the Interdepartmental Working Group on Tuberculosis* and should be clearly identified for staff, for example by a standard sign. Such labelling should be kept up to date. [2006]

*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 www.dh.gov.uk External Web Site Policy.

Treatment of Non-MDR Drug-Resistant TB

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 the table below. [2006]

Table. Recommended Regimens for Non-MDR Drug-resistant TB

Drug Resistance Initial Phase Continuation Phase
S 2RHZE 4RH
H known prior to treatment 2RZSE 7RE

found after starting treatment

2RZE 10RE
Z 2RHE 7RH
E 2RHZ 4RH
R (only if confirmed isolated resistance) 2HZE 16HE
S+H 2RZE 10RE
Other Individualised
Note on Drug Regimen Abbreviations: 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 = isoniazid, R = rifampicin, Z = pyrazinamide, E = ethambutol, S = streptomycin. For example, 2HRZE/4HR is the standard regimen. 2HRE/7HR is 2 months of isoniazid, rifampicin, and ethambutol followed by 7 months of isoniazid and rifampicin.

Management of Latent TB

Treatment of Latent TB Infection

Treatment of latent TB infection should be considered for people in the following groups, once active TB has been excluded by chest X-ray and examination:

  • People identified through screening who are:
    • 35 years or younger (because of increasing risk of hepatotoxicity with age)*
    • Any age with HIV
    • Any age and a healthcare worker

    *For people aged 36 or older, consider risks and benefits for the individual before offering treatment.

    and are either:

    • Mantoux positive (6 mm or greater), and without prior Bacille Calmette-Guerin (BCG) vaccination, or
    • Strongly Mantoux positive (15 mm or greater), interferon-gamma positive, and with prior BCG vaccination
  • Children aged 1 to 15 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. [2006, amended 2011]

People with HIV who are in close contact* with people with sputum smear-positive respiratory TB should have active disease excluded and then be given treatment for latent TB infection (see "People Who Are Immunocompromised" above). [2006, amended 2011]

*Close contacts may include a boyfriend or girlfriend and frequent visitors to the home of the index case, in addition to household contacts.

Treatment for latent TB infection should not be started in close contacts of people with sputum smear-positive MDR TB who are strongly Mantoux positive (15 mm or greater), as no regimen is of proven benefit, and only a small proportion of people infected will develop the disease. Long-term monitoring should be undertaken for active disease. [2006]

People who have agreed to receive treatment for latent TB infection should be started on one of the following regimens:

  • Either 6 months of isoniazid (6H) or 3 months of rifampicin and isoniazid (3RH) for people aged 16–35 not known to have HIV
  • 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 "Treatment of Latent TB Infection") and who are not known to have HIV
  • 6 months of isoniazid (6H) for people of any age who have HIV
  • 6 months of rifampicin (6R) for contacts, aged 35 or younger, of people with isoniazid-resistant TB

People 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 3 and 12 months later. [2006]

Neonates who have been in close contact with people with sputum smear-positive TB who have not received at least two weeks' anti-tuberculosis drug treatment should be treated as follows.

  • The baby should be started on isoniazid (according to the current "British national formulary for children") for 3 months and then a Mantoux test performed after 3 months' treatment.
  • If the Mantoux test is positive (6 mm or greater) the baby should be assessed for active TB (see section "Diagnosing Active TB" above). If this assessment is negative, then isoniazid should be continued for a total of 6 months.
  • If the Mantoux test is negative (less than 6 mm), it should be repeated together with an interferon-gamma test. If both are negative then isoniazid should be stopped and a BCG vaccination performed (see "BCG Vaccination" below). [2006, amended 2011]

Children older than 4 weeks but younger than 2 years who have not had BCG vaccination and are in close contact with people with sputum smear-positive TB should be treated as follows.

  • The child should be started on isoniazid (according to the current "British national formulary for children") and a Mantoux test performed.
  • If the Mantoux test is positive (6 mm or greater), the child should be assessed for active TB (see section "Diagnosing Active TB" above). If active TB is ruled out, full treatment for latent TB infection should be given (see recommendation below in this section)
  • If the Mantoux test is negative (less than 6 mm), then isoniazid should be continued for 6 weeks, and then a repeat Mantoux test together with an interferon-gamma test should be carried out.
  • If the repeat tests are negative, isoniazid may be stopped and BCG vaccination performed (see "BCG Vaccination" below).
  • If either repeat test is positive (6 mm or greater), then the child should be assessed for active TB (see section "Diagnosing Active TB" above) and consider treating for latent TB. Contact tracing for children younger than 2 years when the index case is sputum smear positive is summarised in an algorithm (see appendix C in the original guideline document). [2006, amended 2011]

BCG-vaccinated children aged older than 4 weeks but younger than 2 years, in close contact with people with sputum smear-positive respiratory TB, should be treated as follows.

  • The child should have a Mantoux test. If this is positive (15 mm or greater), the child should be assessed for active TB (see "Diagnosing Active TB" above). If active TB is excluded, then treatment for latent TB infection should be given (see next recommendation).
  • If the result of the test is as expected for prior BCG (less than 15 mm), it should be repeated after 6 weeks together with an interferon-gamma test.
  • If the repeat Mantoux test is also less than 15 mm, and the interferon-gamma test is also negative, no further action is needed.
  • If the repeat Mantoux test becomes more strongly positive (15 mm or greater and an increase of 5 mm or more over the previous test), or the interferon-gamma test is positive the child should be assessed for active TB (see section "Diagnosis of Active TB" above). If active TB is excluded, treatment for latent TB infection should be given. [2006, amended 2011]

For children requiring treatment for latent TB infection, a regimen of either 3 months of rifampicin and isoniazid (3RH) or 6 months of isoniazid (6H) should be planned and started, unless the child is known to be HIV positive, when 6H should be given (see recommendation above). [2006]

Healthcare workers should be aware that certain groups of people with latent TB are at increased risk of going on to develop active TB, including people who:

  • Are HIV positive
  • Are injecting drug users
  • Have had solid organ transplantation
  • Have a haematological malignancy
  • Have had a jejunoileal bypass
  • Have chronic renal failure or receive haemodialysis
  • Have had a gastrectomy
  • Are receiving anti-tumour necrosis factor (TNF)-alpha treatment
  • Have silicosis

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. [2006]

BCG Vaccination

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. [2006]

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* [2006]

*See the British HIV Association guideline for details of further action in HIV-positive patients. Available from www.bhiva.org External Web Site Policy

BCG Vaccination For Neonates

Neonatal BCG vaccination for any baby at increased risk of TB should be discussed with the parents or legal guardian. [2006]

Primary care organisations with a high incidence of TB (as defined by the HPA; go to www.hpa.org.uk External Web Site Policy and search for 'tuberculosis rate bands') should consider vaccinating all neonates soon after birth. [2006]

In areas with a low incidence of TB (as defined by the HPA; go to www.hpa.org.uk External Web Site Policy and search for 'tuberculosis rate bands'), primary care organisations should offer BCG vaccination to selected neonates who:

  • Were born in an area with a high incidence of TB (as defined by the HPA; go to www.hpa.org.uk External Web Site Policy and search for "tuberculosis rate bands"), or
  • Have one or more parents or grandparents who were born in a high-incidence country, or
  • Have a family history of TB in the past five years [2006]

BCG Vaccination For Infants and Older Children

Routine BCG vaccination is not recommended for children aged 10 to 14.

  • Healthcare professionals should opportunistically identify unvaccinated children older than 4 weeks and younger than 16 years at increased risk of TB (see "Treatment of Latent TB Infection" above) who would have qualified for neonatal BCG and provide Mantoux testing and BCG (if Mantoux negative).
  • This opportunistic vaccination should be in line with the Chief Medical Officer's advice on vaccinating this age group following the end of the school-based programme (available from www.dh.gov.uk External Web Site Policy). [2006]

Mantoux testing should not be done routinely before BCG vaccination in children younger than 6 years unless they have a history of residence or prolonged stay (more than 1 month) in a country with a high incidence of TB* [2006]

*More than 40 cases per 100,000 per year, as listed by the Health Protection Agency (go to www.hpa.org.uk External Web Site Policy and search for "TB WHO country data").

BCG Vaccination For New Entrants from High-Incidence Areas

BCG vaccination should be offered to Mantoux-negative new entrants (people who have recently arrived in or returned to the UK from high-incidence countries) who:

  • Are from high-incidence countries, and
  • Are previously unvaccinated (that is, without adequate documentation or a characteristic scar), and
  • Are aged:
    • Younger than 16 years, or
    • 16-35 years* from sub-Saharan Africa or a country with a TB incidence of 500 per 100,000 [2006]

*The Green Book recommends BCG for new entrants only up to the age of 16 years. However, in this guideline BCG is recommended for those up to 35 years who come from the countries with the very highest rates of TB because there is some evidence of cost effectiveness.

BCG Vaccination For Healthcare Workers

BCG vaccination should be offered to healthcare workers, irrespective of age*, who:

  • Are previously unvaccinated (that is, without adequate documentation or a characteristic scar), and
  • Will have contact with patients or clinical materials, and
  • Are Mantoux (or interferon-gamma) negative

*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 the full version of the original guideline document 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.

See sections "Healthcare Environments: New NHS Employees" and "Healthcare Environments: Occupational Health" below. [2006]

BCG Vaccination for Contacts of People with Active TB

BCG vaccination should be offered to Mantoux-negative contacts of people with respiratory TB (see section "Contract Tracing: Human to Human Transmission" below for details of contact tracing) if they are previously unvaccinated (that is, without adequate documentation or a characteristic scar) and are:

  • Aged 35 or younger
  • Aged 36 and older and a healthcare or laboratory worker who has contact with patients or clinical materials (see "BCG vaccination for Healthcare Workers" section above) [2006]

BCG Vaccination For Other Groups

BCG vaccination should be offered to previously unvaccinated, Mantoux-negative people aged 35 or younger in the following groups at increased risk of exposure to TB, in accordance with the Green Book:

  • 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 going to live or work with local people for more than 1 month in a high-incidence country. (see "BCG Vaccination for Healthcare Workers" section for advice on healthcare workers.

See section "BCG Vaccination for Healthcare Workers" for advice on healthcare workers. [2006]

Active Case Finding

Contact Tracing: Human-to-Human Transmission

Once a person has been diagnosed with active TB, the diagnosing physician should inform relevant colleagues so that the need for contact tracing can be assessed without delay. Contact tracing should not be delayed until notification. [2006]

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. Screening should comprise:

  • Standard testing for latent TB for those aged 35 or younger, and consideration of BCG or treatment for latent TB infection once active TB has been ruled out
  • Interferon-gamma test six weeks after the Mantoux test, and 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 (less than 6 mm)
  • Chest X-ray (if there are no contraindications) for those older than 35, possibly leading to further investigation for active TB [2006]

For people with sputum smear-positive TB, other close contacts should be assessed. These may include boyfriends or girlfriends and frequent visitors to the home of the index case. 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. [2006]

Casual contacts of people with TB, who will include the great majority of workplace contacts, should not normally be assessed. strong>[2006]

The need for tracing casual contacts of people with TB should be assessed if:

  • The index case is judged to be particularly infectious (for example, evidenced by transmission to close contacts), or
  • Any casual contacts are known to possess features that put them at special risk of infection (See "Treatment of Latent TB Infection" above) [2006]

"Inform and advise" information should be offered to all contacts of people with smear-positive TB. [2006]

Contact Tracing: Cattle-to-Human Transmission

"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. [2006]

Contact Tracing: Cases on Aircraft

Following diagnosis of TB in an aircraft traveller, contact tracing of fellow passengers should not routinely be undertaken. [2006]

The notifying clinician should inform the relevant consultant in communicable disease control (CCDC) if:

  • Less than three months has elapsed since the flight and the flight was longer than eight hours, and
  • The index case is sputum smear positive, and either
    • The index case has MDR TB, or
    • The index case coughed frequently during the flight.

The CCDC should provide the airline with "inform and advise" information to send to passengers seated in the same part* of the aircraft as the index case. [2006]

*Published evidence does not allow for a precise definition, but such contact tracing on aircraft has often only included people within three rows on either side of the index case.

If the TB index case is an aircraft crew member, contact tracing of passengers should not routinely take place. [2006]

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 "Contact Tracing: Human to Human Transmission" above) [2006]

Contact Tracing: Cases in Schools

Following diagnosis of TB in a school pupil or member of staff, the CCDC should be prepared to explain the prevention and control procedures to staff, parents and the press. Advice on managing these incidents and their public relations is available from the Health Protection Unit (HPU). [2006]

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. [2006]

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. [2006]

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 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 [2006]

Secondary cases of sputum-smear-positive TB should be treated as index cases for contact tracing. [2006]

If the index case of a school pupil's TB infection is not found, and the child is not in a high-risk group for TB, contact tracing and screening (by either symptom enquiry or chest X-ray) should be considered for all relevant members of staff at the school. [2006]

Contact Tracing: Community Childcare

When an adult who works in childcare (including people who provide childcare informally) is diagnosed with sputum smear-positive TB, management is as for contact tracing (see "Contact Tracing: Human-to-Human Transmission" above). [2006]

Contact Tracing: Cases in Hospital Inpatients

Following diagnosis of TB in a hospital inpatient, a risk assessment should be undertaken. This should take in to account:

  • The degree of infectivity of the index case
  • The length of time before the infectious patient was isolated
  • Whether other patients are unusually susceptible to infection
  • The proximity of contact

Contact tracing and testing should be carried out only for patients for whom the risk is regarded as significant. [2006]

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 risk should be documented in the contact's clinical notes, for the attention of the contact's consultant. The contact should be given "inform and advise" information, and their general practitioner (GP) should be informed. [2006]

If patients were exposed to a patient with sputum smear-positive TB for long enough to be equivalent to household contacts (as determined by the risk assessment), or an exposed patient is known to be particularly susceptible to infection, they should be managed as equivalent to household contacts (see "Contact Tracing: Human-to-Human Transmission" above). [2006]

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.* [2006]

*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.

In cases of doubt when planning contact tracing after diagnosing sputum-smear-positive TB in an inpatient, further advice should be sought from the regional or national Health Protection Agency and/or people experienced in the field. [2006]

Screening New Entrants

Healthcare professionals, including primary care staff, responsible for screening new entrants* should maintain a coordinated programme to:

  • Detect active TB and start treatment.
  • Detect latent TB and start treatment.
  • Provide BCG vaccination to those in high-risk groups who are not infected and who are previously unvaccinated.
  • Provide relevant information to all new entrants [2006]

*In this guideline, new entrants are defined as people who have recently arrived in or returned to the UK from high-incidence countries, as defined by the HPA; go to www.hpa.org.uk External Web Site Policy and search for "WHO country data TB".

New entrant screening for TB should be incorporated within larger health screening programmes for new entrants, linked to local services. [2006]

Assessment for and management of TB in new entrants should consist of the following.

  • Risk assessment for HIV, including HIV prevalence rates in the country of origin, which is then taken into account for Mantoux testing and BCG vaccination.
  • Assessment for active TB if interferon-gamma test is positive; which would include a chest X-ray.
  • Treatment for latent TB infection for people aged 35 years or younger in whom active TB has been excluded, with a positive Mantoux test inconsistent with their BCG history, and a positive interferon-gamma test.
  • Consideration of BCG for unvaccinated people who are Mantoux negative (see "BCG Vaccination for New Entrants from High-incidence Areas" above).
  • "Inform and advise" information for people who do not have active TB and are not being offered BCG or treatment for latent TB infection. [2006, amended 2011]

New entrants should be identified for TB screening from the following information:

  • Port of Arrival reports
  • New registrations with primary care
  • Entry to education (including universities)
  • Links with statutory and voluntary groups working with new entrants [2006]

Any healthcare professional working with new entrants should encourage them to register with a GP. [2006]

Street Homeless

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. [2006]

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. [2006]

Preventing Infection in Specific Settings

Healthcare Environments: New NHS Employees

Employees new to the NHS who will be working with patients or clinical specimens should not start work until they have completed a TB screen or health check, or documentary evidence is provided of such screening having taken place within the preceding 12 months. [2006]

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. [2006]

Health checks for employees new to the NHS who will have contact with patients or clinical materials should include:

  • Assessment of personal or family history of TB
  • Symptom and signs enquiry, possibly by questionnaire
  • Documentary evidence of TB skin testing (or interferon-gamma testing) and/or BCG scar check by an occupational health professional, not relying on the applicant's personal assessment
  • Mantoux result within the last five years, if available [2006]

See recommendations "Healthcare Workers" above for screening new NHS employees for latent TB. [2006, amended 2011]

Employees who will be working with patients or clinical specimens and who are Mantoux negative (less than 6 mm) should have an individual risk assessment for HIV infection before BCG vaccination is given. [2006]

Employees new to the NHS should be offered BCG vaccination, whatever their age, if they will have contact with patients and/or clinical specimens, are Mantoux negative (less than 6 mm), and have not been previously vaccinated. [2006]

Employees of any age who are new to the NHS and are from countries of high TB incidence, or who have had contact with patients in settings with a high TB prevalence should have an interferon-gamma test. If negative, offer BCG vaccination as with a negative Mantoux result (see recommendations above). If positive, the person should be referred for clinical assessment for diagnosis and possible treatment of latent infection or active disease. [2006, amended 2011]

If a new employee from the UK or other low-incidence setting, without prior BCG vaccination, has a positive Mantoux and a positive interferon-gamma test, they should have a medical assessment and a chest X-ray. They should be referred to a TB clinic for consideration of TB treatment if the chest X-ray is abnormal, or for consideration of treatment of latent TB infection if the chest X-ray is normal. [2006, amended 2011]

If a prospective or current healthcare worker who is Mantoux negative (less than 6 mm), declines BCG vaccination, the risks should be explained and the oral explanation supplemented by written advice. If the person still declines BCG vaccination, he or she should not work where there is a risk of exposure to TB. The employer will need to consider each case individually, taking account of employment and health and safety obligations. [2006]

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 healthcare environments, 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. [2006]

NHS trusts 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 employees in healthcare environments (see recommendations above).

See the algorithm on screening new NHS employees (appendix C in the original guideline document) for a summary. [2006]

Healthcare Environments: Occupational Health

These recommendations set the standard for NHS organisations and therefore should apply in any setting in England and Wales where NHS patients are treated.

  • 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:
    • Are in regular contact with TB patients or clinical materials, or
    • Have worked in a high-risk clinical setting for 4 weeks or longer
  • One-off reminders should be given after a TB incident on a ward. [2006]

If no documentary evidence of prior screening is available, staff in contact with patients or clinical material who are transferring jobs within the NHS should be screened as for new employees (see "Healthcare Environments: New NHS Employees" above). [2006]

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. [2006]

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. [2006]

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. [2006]

Prisons and Remand Centres

Healthcare workers providing care for prisoners and remand centre detainees should be aware 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. [2006]

Prisoners should be screened for TB by:

  • A health questionnaire on each entry to the prison system, then
  • For those with signs and symptoms of active TB, a chest X-ray and three sputum samples taken in 24 hours for TB microscopy, including a morning sputum sample (see "Diagnosing Active TB" above) [2006]

All prisoners receiving treatment for active or latent TB should receive DOT. [2006]

Prison medical services should have liaison and handover arrangements to ensure continuity of care before any prisoner on TB treatment is transferred between prisons. [2006]

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. [2006]

Prison service staff and others who have regular contact with prisoners (for example, probation officers and education and social workers) should have pre- and on-employment screening at the same level as for healthcare workers with patient contact (see "Healthcare Environments: New NHS Employees" and "Healthcare Environments: Occupational Health" above). [2006]

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is not specifically stated for each recommendation.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate diagnosis of primary cases of tuberculosis (TB), identification of secondary cases, treatment of active disease, control of latent infection, and prevention of further transmission. At a population level, the combined result of these activities should be to curb and then reverse the increase in TB seen in England and Wales in recent years.

Potential Harms

Adverse effects of drug therapy and reactions to Bacille Calmette-Guerin (BCG) vaccination

Contraindications

Contraindications
  • Bacille Calmette Guerin (BCG) is a live vaccine and as such is contraindicated in a number of situations where the immune system may be compromised, particularly if the person is known or suspected to be human immunodeficiency virus (HIV) positive, because of the risk of generalised BCG infection.
  • Isoniazid and rifampicin, pyrazinamide and ethambutol are contraindicated in meningeal tuberculosis, central nervous system (CNS) involvement and drug resistance.

Qualifying Statements

Qualifying Statements
  • This guidance represents the view of the National Institute for Health and Clinical Excellence (NICE), which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. However, the guidance does not 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, and informed by the summary of product characteristics of any drugs they are considering.
  • Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties.
  • The guideline is designed for use in the National Health Service in England and Wales. Readers in other countries, particularly where the incidence of tuberculosis (TB) is higher, should exercise caution before applying the recommendations.

Implementation of the Guideline

Description of Implementation Strategy

National Institute for Clinical Excellence (NICE) has developed tools to help organisations implement this guidance (see http://guidance.nice.org.uk/CG117/ External Web Site Policy; see also the "Availability of Companion Documents" field).

Key Priorities for Implementation

The following recommendations have been identified as priorities for implementation.

Management of Active Tuberculosis (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 human immunodeficiency virus (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 to 40 mg if on rifampicin, otherwise 10 to 20 mg
      • Children – equivalent to prednisolone 1 to 2 mg/kg, maximum 40 mg with gradual withdrawal of the glucocorticoid considered, starting within 2–3 weeks of initiation.

Improving Adherence

  • Use of directly observed therapy (DOT) is not usually necessary in the management of most cases of active TB. All patients should have a risk assessment for adherence to treatment, and DOT should be considered for patients who have adverse factors on their risk assessment, in particular:
    • Street- or shelter-dwelling homeless people with active TB
    • Patients 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 (Bacille Calmette Guerin) Vaccination

  • Neonatal BCG vaccination for any baby at increased risk of TB should be discussed with the parents or legal guardian.
  • Primary care organisations with a high incidence of TB should consider vaccinating all neonates soon after birth.
Implementation Tools
Audit Criteria/Indicators
Clinical Algorithm
Foreign Language Translations
Patient Resources
Resources
Slide Presentation
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)
National Collaborating Centre for Chronic Conditions. Tuberculosis. Clinical diagnosis and management of tuberculosis, and measures for its prevention and control. London (UK): National Institute for Health and Clinical Excellence (NICE); 2011 Mar. 64 p. (Clinical guideline; no. 117). 
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2006 (revised 2011 Mar)
Guideline Developer(s)
National Collaborating Centre for Chronic Conditions - National Government Agency [Non-U.S.]
Source(s) of Funding

National Institute for Health and Clinical Excellence (NICE)

Guideline Committee

Guideline Development Group

Composition of Group That Authored the Guideline

2011 Guideline Development Group: Ibrahim Abubakar, Consultant Epidemiologist and Head of Tuberculosis Section, Health Protection Agency, Colindale; Christine Bell, TB Coordinator and Lead Nurse for TB, Manchester Royal Infirmary; Steve Bradley, Patient and carer member; Ann Chapman, Consultant in Infectious Diseases and Tropical Medicine, Royal Hallamshire Hospital, Sheffield; Timothy Collyns, Consultant in Medical Microbiology, Leeds Teaching Hospitals NHS Trust; Francis Drobniewski, Professor of Tuberculosis and Mycobacterial Diseases, Queen Mary College, London; Damien Longson, Chair, Consultant Liaison Psychiatrist, Manchester Mental Health and Social Care Trust; Tessa Marshall, Patient and carer member, TB Alert; Pamela Mellors, Consultant in Occupational Medicine, Leeds Teaching Hospitals NHS Trust; Sandy Moffitt, GP, Huddersfield; Professor L Peter Ormerod, Consultant Chest Physician, East Lancashire Hospitals NHS Trust; Sarath Ranganathan, Clinical Senior Lecturer in Paediatrics, Brighton and Sussex Medical School

Guideline Development Group Members: Ms Sue Appleby, Specialist Nurse in Health Protection, Dorset & Somerset Health Protection Unit; Dr Gerry Bryant, Director of Public Health, Derbyshire Dales & South Derbyshire Primary Care Trust; Dr Ian Campbell, Consultant Physician, Cardiff and Vale NHS Trust; Mr Michael Carter, Patient and Carer Representative, London; Mr Malcolm Cocksedge, Senior Clinical Nurse Specialist, Barts and The London NHS Trust; Ms Sue Dart, TB Nurse Manager, Haringey Teaching Primary Care Trust; Professor Peter Davies, Consultant Physician, Cardiothoracic Centre, Liverpool NHS Trust; Mrs Bernadette Ford, Information Scientist, National Collaborating Centre for Chronic Conditions, London; Mr Rob Grant, Senior Project Manager, National Collaborating Centre for Chronic Conditions, London; Mr Ashley Green, Patient and Carer Representative, London; Professor Chris Griffiths, Professor of Primary Care, Queen Mary's School of Medicine and Dentistry, University of Lonodn; Professor Andy Hall, Professor of Epidemiology, London School of Hygiene and Tropical Medicine, University of London, Representative of the Joint Committee on Vaccination and Immunisation, Department of Health; Dr Andrew Hayward, Senior Lecturer in Infectious Disease Epidemiology, Royal Free and University College Medical School, University of London; Dr John Hayward, (Public Health Adviser, Chair of the Clinical Sub-Group of the GDG), Director of Public Health, Newham Primary Care Trust and General Practitioner, London; Dr Bernard Higgins, Director of the National Collaborating Centre for Chronic Conditions and Consultant Respiratory Physician, Newcastle upon Tyne Hospitals NHS Trust; Dr John Innes, Consultant Physician, Birmingham Heartlands and Solihull (Teaching) NHS Trust; Dr Jane Jones, Consultant Epidemiologist, Centre for Infections, Health Protection Agency, London; Dr Ian Lockhart, Health Services Research Fellow in Guideline Development, National Collaborating Centre for Chronic Conditions, London; Ms Joanne Lord, Health Economics Advisor, National Institute for Health and Clinical Excellence; Dr John Magee, Director, Health Protection Agency, Health Protection Agency Newcastle Regional Laboratory; Dr Jonathan Mant (Chair of the Prevention and Control Sub-group of the GDG), Senior Lecturer in Primary Care, University of Birmingham Medical School; Dr John Moore-Gillon, Consultant Physician, Barts and The London NHS Trust; Ms Helen Murshali, Patient and Carer Representative, London; Ms Ndidi Okonta, Patient and Carer Representative, London; Professor L Peter Ormerod, (Clinical Advisor), Professor of Medicine and Consultant Physician in Respiratory and General Medicine, East Lancashire Hospitals NHS Trust; Dr Delane Shingadia, Senior Lecturer in Paediatric Infectious Diseases, Barts and The London Medical and Dental School; Ms Caroline Trevithick, Lead Infection Control Nurse, University Hospitals of Leicester NHS Trust; Mrs Susan Varney, Health Services Research Fellow in Guideline Development, National Collaborating Centre for Chronic Conditions, London; Dr Irving Wells, Consultant Radiologist, Plymouth Hospitals NHS Trust; Dr Martin Wiselka, Consultant Physician and Honorary Senior Lecturer in Infectious Diseases, University Hospitals of Leicester NHS Trust

Financial Disclosures/Conflicts of Interest

Members of the Guideline Development Group declared any interests in accordance with the National Institute for Health and Clinical Excellence (NICE) technical manual.

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: National Collaborating Centre for Chronic Conditions. Tuberculosis: clinical diagnosis and management of tuberculosis, and measures for its prevention and control. London (UK): Royal College of Physicians; 2006. 215 p. [386 references]

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) format from the National Institute for Health and Clinical Excellence (NICE) Web site External Web Site Policy.

Availability of Companion Documents

The following are available:

  • Tuberculosis. Clinical diagnosis and management of tuberculosis, and measures for its prevention and control. Full guideline. London (UK): National Institute for Health and Clinical Excellence (NICE); 2011 Mar. 325 p. (Clinical guideline; no. 117). Electronic copies: Available in Portable Document Format (PDF) format from the National Institute for Health and Clinical Excellence (NICE) Web site External Web Site Policy.
  • Tuberculosis. Audit support. Implementing NICE guidance. London (UK): National Institute for Health and Clinical Excellence (NICE); 2011. 12 p. (Clinical guideline; no. 117). Electronic copies: Available from the NICE Web site External Web Site Policy.
  • Tuberculosis. Clinical diagnosis and management of tuberculosis, and measures for its prevention and control. Baseline assessment. Implementing NICE guidance. London (UK): National Institute for Health and Clinical Excellence (NICE); 2011. Various p. (Clinical guideline; no. 117). Electronic copies: Available from the NICE Web site External Web Site Policy.
  • Tuberculosis (partial update). Costing statement. London (UK): National Institute for Health and Clinical Excellence (NICE); 2011 Mar. 6 p. (Clinical guideline; no. 117). Electronic copies: Available in Portable Document Format (PDF) from the NICE Web site External Web Site Policy.
  • Tuberculosis (TB): clinical diagnosis and management of tuberculosis and measures for its prevention and control. Costing report. Implementing NICE guidance in England. London (UK): National Institute for Health and Clinical Excellence (NICE); 2006 Mar. 37 p. (Clinical guideline; no. 33). Electronic copies: Available in Portable Document Format (PDF) from the NICE Web site External Web Site Policy.
  • Tuberculosis: clinical diagnosis and management of tuberculosis, and measures for its prevention and control. Costing template. London (UK): National Institute for Health and Clinical Excellence (NICE); 2006 Mar. Various p. (Clinical guideline; no. 33). Electronic copies: Available from the NICE Web site External Web Site Policy.
  • Diagnosis and management of tuberculosis, and measures for its prevention and control. Implementing NICE guidance. Slide set. London (UK): National Institute for Health and Clinical Excellence (NICE); 2011 Mar. 20p. (Clinical guideline; no. 117). Electronic copies: Available from the NICE Web site External Web Site Policy.
  • NICE pathways. Tuberculosis. London (UK): National Institute for Health and Clinical Excellence (NICE); 2011. Various pages. Available from the NICE Web site External Web Site Policy.
  • The guidelines manual 2009. London (UK): National Institute for Health and Clinical Excellence (NICE); 2009 Jan. Electronic copies: Available in PDF from the NICE Web site External Web Site Policy.
Patient Resources

The following is available:

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This summary was completed by ECRI on July 18, 2006. The information was verified by the guideline developer on September 29, 2006. This NGC summary was updated by ECRI Institute on February 27, 2012.

The National Institute for Health and Clinical Excellence (NICE) has granted the National Guideline Clearinghouse (NGC) permission to include summaries of their clinical guidelines with the intention of disseminating and facilitating the implementation of that guidance. NICE has not yet verified this content to confirm that it accurately reflects that original NICE guidance and therefore no guarantees are given by NICE in this regard. All NICE clinical guidelines are prepared in relation to the National Health Service in England and Wales. NICE has not been involved in the development or adaptation of NICE guidance for use in any other country. The full versions of all NICE guidance can be found at www.nice.org.uk External Web Site Policy.

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This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

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