Development of the NICE TB Guidelines

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Development of the NICE TB Guidelines

• Prof Peter Ormerod
• Blackburn Royal Infirmary
• and Lancashire Postgraduate School of Medicine
  and Health

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NICE Guidelines

• Commissioned by DoH and Welsh Assembly
• To replace BTS Treatment (1998) and Control and
  Prevention (2000) Guidelines
• Process began in Nov 2003
• First draft for consultation on the web in June
  2005

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STAKEHOLDERS

• Respiratory Physicians (BTS)
• ID Physicians via RCP
• Paediatricians (RCPCH)
• TB Nurses (RCN)
• Infection Control Nurses
• HPA Epidemiology and Laboratory
• CCDC Faculty of Public Health Medicine
• Patient and carers representatives
• Occupational Health

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Executive Team

• Chair of CEEU (for consensus meetings)
• Chair of Guideline
• Guideline Coordinator
• Clinical Advisor
• Systematic reviewer
• Information scientist

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NICE Guidelines 2

• Questions developed
• Approximately 30 per guideline
• Information Scientist produces papers from search
• Systematic reviewer(s) look at papers order full
  paper and systematically appraise those meeting
  critera
• SIGN evidence categories

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SIGN Evidence Criteria

• 1 High quality meta-analysis, systematic
  reviews of RCTs or RCTs with low risk of bias
• 1 Well conducted meta-analysis, systematic
  reviews of RCTs or RCTs with low risk of bias
• 1- Meta-analysis, systematic reviews or RCTs
  with high risk of bias

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SIGN Evidence criteria (2)

• 2 High quality reviews of case-control or
  cohort studies, with low risk of confounding
• 2 as above with moderate risk of confounding
• 2- as above with high confounding risk
• 3 Non-analytical studies
• 4 Expert opinion. Formal consensus

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NICE Recommendations

• A 1 or 1 data or NICE technology
• 
  appraisal
• B - 2 or extrapolated from 1
• C 2 evidence or extrapolated from 2
• D Evidence level 3 or 4, extrapolated
• from 2, formal consensus
• D(GPP) recommendation for best
• practice from GDG experience

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Example 1

• Q. Six-month short-course chemotherapy
• Over 900 papers found by information scientist
• approx 50 plus 2 Cochrane reviews systematically
  analysed
• Evidence SIGN 1 (A)
• Virtually all trials with a 4-drug initial
• regimen

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Example 2

• Q. Efficacy of treatment of latent infection
• (1) Isoniazid duration
• Cochrane review 11 placebo-controlled trials,
  HIV-negative, 2 years plus follow-up after
  treatment 77000 patients.
• Smieja et al.
• NO additional benefit over 6H of longer duration
  (except doubled toxicity!)

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Example 2 (B)

• Protective efficacy 65
• SIGN Category 1
• UK (NICE) 6H based on this extensive
• evidence (A)
• USA (CDC/ATS) recommend 9H in
• supposedly evidence based guidelines
• despite overwhelming evidence to the
• contrary

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Example 2 (C)

• Q. Efficacy of 3RH
• Controlled MRC Clinical trial plus good
• Clinical studies
• Protective efficacy approx 60
• SIGN 1 (A)
• UK recommendation 3RH (A)
• USA recommend 4R based on a small
• uncontrolled study (D) level evidence

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NICE Guidelines (3)

• For each question
• Draft Clinical introduction (Clinical Advisor)
• Evidence Statements with grading
• From evidence to recommendations
• Draft recommendation(s) on that topic
• Discussed by Guidelines Development Group (GDG)
  and refined

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BCG Questions

• Chair BCG Subcommittee JCVI co-opted for these
  questions
• BCG Committee of JCVI looked at Schools BCG
  programme and made own decision on cessation
  (supported by NICE Economic appraisal)
• Still a few subtle differences in emphasis,
  particularly age limits. Those for NICE are
  evidence based (though not much evidence)

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NICE Guidelines 4

• At end of process of evidence appraisal all draft
  recommendations voted on by all members.
• Those not reaching a given level of consensus
  then debated and re-voted on
• Web June 2005 for public comment
• Reassessed Aug 2005 (First GDG)
• 2nd version Web Sept 2005 for comment
• Final version Nov 2005 (Last GDG)
• Published as NICE approved guideline March 2006

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Key messages

• A Category data mainly for treatment areas
• B category data at best for control and
  prevention areas
• Not ethical to do controlled trials in some
  areas e.g. contact tracing, as cannot have a
  no-intervention group

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Named Key-worker

• Each person with TB should have a named
  key-worker, know who they are and how to contact
  them. The key-worker should facilitate education
  and involvement of the peron with TB achieving
  adherence

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Treatment (1)

• 6 month regimen for all except CNS TB
• 2RHZE/4RH
• 4 drug initial phase for all because of the
  rising incidence of isoniazid resistance
• TB Meningitis 12 month treatment
• Corticosteroids for all TBM
• PCR test to see if TB or Rifampicin resistance
  but NOT for diagnosis

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Treatment (2)

• Universal DOT is not recommended (A)
• All persons to have a risk assessment for
  adherence
• Risk assessment for MDR-TB
• Selective DOT for those with risk factors for
  adherence particularly street homeless or
  hostel dwellers.

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Infection Control/Drug resistance

• Little change in infection control
  recommendations for drug-resistant and MDR-TB
• Principles of MDR-TB treatment same as 1998
  only in or in conjunction with specialised
  units, and in close liaison with HPA
  Mycobacteriology service

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BCG

• Neonates if born in an area of 40/100000 or
  parent/grandparent born in high incidence country
• Supported scrapping Schools BCG (economics)
• Mantoux negative new entrants to age 35 (Green
  book 16)

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BCG (2)

• Unvaccinated HCWs irrespective of age because of
  continuing risk, if tuberculin negative
• Unvaccinated tuberculin negative contacts of
  respiratory TB up to age 35
• Other categories as per Green Book

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Contact Tracing

• Algorithm updated, and now includes
  Gamma-interferon blood test to confirm tuberculin
  positivity (economic)
• Less to do for human contacts of cattle
• Less to do for aircraft contacts
• Schools similar to before
• Community childcare
• Hospital inpatients

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New Entrant screening

• Reassessed in light of limited evidence and
  economic appraisal
• New entrant screening only cost-effective
  without prophylaxis at a TB rate of 4
• Political policy is to move to X-ray prior to
  entry.
• Investigation limited to chest X-ray, other than
  for 0-16, and Subsaharan African

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Health Care Screening

• Revised
• Includes gamma-interferon blood tests to confirm
  tuberculin-positivity
• New entrants to be screened by chest x-ray,
  irrespective of symptoms

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Service models

• Centralised
• Central with satellites
• General hospital/community level
• Specialist hospital based model but going out
  into the community

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