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National Collaborating Centre for Chronic Conditions (UK); Centre for Clinical Practice at NICE (UK). Tuberculosis: Clinical Diagnosis and Management of Tuberculosis, and Measures for Its Prevention and Control. London: National Institute for Health and Clinical Excellence (UK); 2011 Mar. (NICE Clinical Guidelines, No. 117.)

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Tuberculosis: Clinical Diagnosis and Management of Tuberculosis, and Measures for Its Prevention and Control.

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2Methodology - 2006

Created: ; Updated: 2011.

2.1. Aim

With this document the National Collaborating Centre for Chronic Conditions (NCC-CC) has aimed to provide a user-friendly, clinical, evidence-based guideline for the NHS in England and Wales that:

  • offers best practice advice for TB
  • is based on best published evidence and expert consensus
  • takes into account patient choice and informed decision-making
  • defines the major components of the care provision for tuberculosis such as the diagnosis and management of both latent and active TB, and measures for its prevention and control
  • indicates areas suitable for clinical audit
  • details areas of uncertainty or controversy requiring further research
  • provides a choice of guideline versions for differing audiences (full version, short version, quick reference guide and public version) in electronic or printed format.

In contrast to most clinical guidelines commissioned by NICE, the prevention and control sections of this guideline include recommendations on service organisation where good quality evidence exists to support them.

2.2. Scope

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 TB to be included and excluded.

Before development of the guideline began, the scope was subjected to stakeholder consultation in accordance with processes established by NICE.{1}(National Institute for Health and Clinical Excellence 2005) The scope is given in Appendix E.

2.3. Audience

The guideline is intended for use with the following people or organisations:

  • all healthcare professionals
  • people with, or at risk from, tuberculosis, and their carers
  • patient support groups
  • commissioning organisations
  • service providers.

Involvement of people with TB

The NCC-CC was keen to ensure the views and preferences of people with TB and their carers informed all stages of the guideline. This was achieved by:

  • consulting the Patient Information Unit (PIU) housed within NICE during the pre-development (scoping) and final validation stages of the guideline
  • having two former TB patients and two user organisation representatives on the Guideline Development Group (GDG).

The patient and carer representatives were present at every meeting of the GDG. They were therefore involved at all stages of the guideline development process and were able to consult with their wider constituencies.

2.4. Guideline limitations

These include:

  • the diagnosis and treatment chapters of this guideline (510), except rapid diagnostic techniques (5.3 and 5.4), do not cover issues of service delivery, organisation or provision (as this was not specified in the remit from the DH)
  • NICE is primarily concerned with health services and so recommendations are not provided for Social Services and the voluntary sector. However, the guideline may address important issues in how NHS clinicians interface with these other sectors
  • generally the guideline does not cover rare, complex, complicated or unusual conditions.

2.5. Other work relevant to the guideline

Readers of this guideline should also be aware of the following publications:

  • Stopping tuberculosis in England and Wales, the Chief Medical Officer's TB Action Plan{2}
  • Immunisation against infectious disease (the ‘Green Book’){3}
  • The clinical and cost-effectiveness of diagnostic tests for the detection of mycobacterial infection, a health technology appraisal due for publication mid 2006 (see www.ncchta.org).

The National Knowledge Service is a relatively new national NHS body which is investigating ways of making patient and public information available to patients and the NHS, amongst other functions. One of the initial pilot projects is in tuberculosis, and is linked to this guideline. See www.hpa.org.uk/tbknowledge for more detail.

The Secretary of State for Health is advised on broader national policy on vaccination by the DH's Joint Committee on Vaccination and Immunisation (JCVI) (http://www.dh.gov.uk/ab/jcvi/index.htm).

Information on TB epidemiology in the UK and abroad, as well as some background information for patients and the public, is available through the Health Protection Agency's website at www.hpa.org.uk. This is referred to at relevant points in this guideline.

2.5.1. Related NICE guidance

Published

Under development

NICE is developing the following guidance (details available from www.nice.org.uk):

  • Tuberculosis: hard-to-reach groups. NICE public health guidance. Publication expected March 2012.

2.6. Background

The development of this evidence-based clinical guideline draws upon the methods described by the NICE Guideline Development Methods manual{1} (www.nice.org.uk/page.aspx?o=201982) and the methodology pack{4} specifically developed by the NCC-CC for each chronic condition guideline (http://www.ncgc.ac.uk/). The developers' roles and remit are summarised below.

National Collaborating Centre for Chronic Conditions2

The National Collaborating Centre for Chronic Conditions (NCC-CC) was set up in 2001 and is housed within the Royal College of Physicians (RCP). The NCC-CC undertakes commissions received from the NICE.

A multiprofessional partners board inclusive of patient groups and NHS management governs the NCC-CC.

NCC-CC technical team

The technical team met approximately two weeks before each GDG meeting and comprised:

  • the GDG group leader
  • the GDG clinical advisor
  • an information scientist
  • a research fellow
  • a health economist
  • a project manager
  • administrative personnel.

Guideline Development Group

The 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

(Members of the GDG declared any interests in accordance with the NICE technical manual. A register is available from the NCC-CC for inspection upon request ( ku.ca.nodnolpcr@cc-ccn).) ( ku.ca.cgcn@seiriuqne/).

Guideline Project Executive

The Project Executive was involved in overseeing all phases of the guideline. It also reviewed the quality of the guideline and compliance with the DH remit and NICE scope.

The Project Executive comprised:

  • the NCC-CC director
  • the NCC-CC manager
  • an NCC-CC senior research fellow
  • the NICE commissioning manager
  • the technical team.

Sign-off workshop

At the end of the guideline development process the GDG met to review and agree the guideline recommendations.

2.7. The process of guideline development

There are nine basic steps in the process of developing a guideline.

First step: Developing evidence-based questions

The technical team drafted a series of clinical questions that covered the guideline scope. The GDG and Project Executive refined and approved these questions. See Appendix A for details of the questions.

Second step: 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 for literature search details.

Third step: Critically appraising the evidence

The research fellow or health economist, as appropriate, critically appraised the full papers. 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 GDG for accuracy and completeness.

All procedures are fully compliant with the:

Fourth step: 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.

Evidence tables are available at www.rcplondon.ac.uk/pubs/books/TB/index.asp

Fifth step: Grading the evidence statements and recommendations

The evidence statements and recommendations were graded in accordance with Table 2. The level of evidence and classification of recommendations were also included for diagnostic studies.

Table 2. Hierarchy of evidence and recommendation classification.

Table 2

Hierarchy of evidence and recommendation classification.

Sixth step: 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.

Seventh step: Agreeing the recommendations

The sign-off workshop employed formal consensus techniques{1} 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 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.

Eighth step: Structure of the full version of the guideline

The guideline is divided into sections for ease of reading. For each section the layout is similar and is described below:

The clinical introduction sets a succinct background and describes the current clinical context.

The methodological introduction describes any issues or limitations that were apparent when reading the evidence base.

Evidence statements provide a synthesis of the evidence base and usually describe what the evidence showed in relation to the outcomes of interest.

Health economics presents an overview of the cost-effectiveness evidence base of relevance to the area under address.

‘From evidence to recommendations’ highlights the debate of the GDG. This section sets out the GDG decision-making rationale, providing a clear and explicit audit trail from the evidence to the evolution of the recommendations.

The recommendations section provides stand-alone, action-orientated recommendations.

Evidence tables are not published as part of the full guideline but are available online at www.rcplondon.ac.uk/pubs/books/TB/index.asp. These describe comprehensive details of the primary evidence that was considered during the writing of each section.

Ninth step: 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. The guideline was then submitted for two formal rounds of public and stakeholder consultation prior to publication. The registered stakeholders for this guideline are detailed at the NICE website (www.nice.org.uk). Editorial responsibility for the full guideline rests with the GDG7.

Table 3 describes the various versions of the guideline that are available.

Table 3. Versions of this guideline.

Table 3

Versions of this guideline.

2.8. Healthcare needs assessment

In contrast to many NICE guidelines, the scope requires service guidance in the prevention and control chapters of this guideline (chapters 1113) and for rapid diagnostic techniques (sections 5.3 and 5.4). The NCC-CC conducted a rapid and simple healthcare needs assessment in order to establish current practice and resources, and to identify areas where these did not match the clinical need. This collected information through a review of the epidemiology of TB in England and Wales, and a review of current service by questionnaire among a sample of TB service providers.

Review of epidemiology

At the outset of the guideline development the prevention and control research fellow, Dr Ian Lockhart, compiled epidemiological data relevant to England and Wales from a number of national sources into a report to inform GDG discussions. This was refined through discussion at GDG meetings, is presented in this guideline in the Appendix G and in section 4.2, and will be described in a forthcoming paper.

Survey of current services

The NCC-CC sought information on current service provision in terms of staffing, location of specific services and caseload. Dr Sooria Balasegaram coordinated this survey through TB nurses and the Health Protection Agency's local and regional services. Further details are given in section 4.2 and will be described in a forthcoming paper.

2.9. Funding

The National Collaborating Centre for Chronic Conditions was commissioned by the National Institute for Health and Clinical Excellence to undertake the work on this guideline.

2.10. Methodology – 2011

The Department of Health formally asked NICE to produce a short clinical guideline on interferon gamma testing for diagnosing latent TB.

The following population subgroups were considered:

  • Adults, young people and children at increased risk of infection by Mycobacterium tuberculosis complex (M. tuberculosis, M. africanum, M. bovis), specifically if they:

    have arrived or returned from high-prevalence countries within the last 5 years

    were born in high-prevalence countries

    live with people diagnosed with active TB

    have close contact with people diagnosed with active TB, for example at school or work

    are homeless or problem drug users

    are, or have recently been, in prison.

  • Adults and children who are immunocompromised because of:

    prolonged steroid use (equivalent to 15 mg prednisolone daily for at least 1 month)

    TNF-α antagonists such as infliximab and etanercept

    anti-rejection drugs such as cyclosporin, various cytotoxic treatments and some treatments for inflammatory bowel disease, such as azathioprine

    the use of immunosuppressive drugs

    comorbid states affecting the immune system, for example HIV, chronic renal disease, many haematological and solid cancers, and diabetes.

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). There is more information about how NICE clinical guidelines are developed on the NICE website (www.nice.org.uk/HowWeWork). A booklet, ‘How NICE clinical guidelines are developed: an overview for stakeholders, the public and the NHS’ (fourth edition, published 2009), is available from NICE publications (phone 0845 003 7783 or email ku.gro.ecin@snoitacilbup and quote reference N1739).

2.11. Partial update scope

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 TB to be included and excluded.

Before development of the guideline began, the scope was subjected to stakeholder consultation. The scope is given in Appendix F

2.12. Partial update Guideline Development Group

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.

Members of the GDG declared any interests in accordance with the NICE guidelines manual. These can be found in appendix N.

2.13. Updating the guideline

NICE clinical guidelines are updated so that recommendations take into account important new information. New evidence is checked 3 years after publication, and healthcare professionals and patients are asked for their views; we use this information to decide whether all or part of a guideline needs updating. If important new evidence is published at other times, we may decide to do a more rapid update of some recommendations. Please see our website for information about updating the guideline.

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.

Disclaimer

Healthcare providers need to use clinical judgement, knowledge and expertise when deciding whether it is appropriate to apply guidelines. The recommendations cited here are a guide and may not be appropriate for use in all situations. The decision to adopt any of the recommendations cited here must be made by the practitioner in light of individual patient circumstances, the wishes of the patient, clinical expertise and resources.

The British National Formulary (BNF){5} should be consulted alongside any drug recommendations cited in this guideline and note taken of the indications, contraindications, cautions and product characteristics.

NICE guidelines will normally only make drug recommendations that fall within licensed indications. If a drug is recommended outside of its licensed indication this will be made clear in the guideline. This guideline contains recommendations for prescribing the following, all of which are within current licensed indications:

The NCC-CC and NICE disclaim any responsibility for damages arising out of the use or non-use of these guidelines and the literature used in support of these guidelines.

In April 2009 the NCC-CC merged with three other national collaborating centres, to form the National Clinical Guideline Centre (NCGC)

Footnotes

2

In April 2009 the NCC-CC merged with three other national collaborating centres, to form the National Clinical Guideline Centre (NCGC)

Sections 2.1 to 2.9, Copyright © 2006, Royal College of Physicians of London. Sections 2.10 to 2.13, Copyright © 2011, National Institute for Health and Clinical Excellence.

For 2006 original guideline text, no part of the content may be reproduced in any form (including photocopying or storing it in any medium by electronic means and whether or not transiently or incidentally to some other issue of this publication) without the written permission of the Royal College of Physicians of London. Applications for the Royal College of Physicians of London's written permission to reproduce any part of this publication should be addressed to the publisher.

For 2011 updated text, the material may be freely reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the express written permission of NICE.

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