IPT and ICF Guidelines Update. Reuben Granich HIV/AIDS Department World Health Organization. Haileyesus Getahun STOP TB Department World Health Organization. TB related questions. Background Guidelines Review Committee (GRC) Timeline GRC process Committee PICOT Questions Criteria
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Reuben GranichHIV/AIDS DepartmentWorld Health Organization
Haileyesus GetahunSTOP TB DepartmentWorld Health Organization
CD4 level is associated with TB incidence
"TB death zone"
Courtesy Abhishek Sharma_adapted from Havlir et al
Set up coordinating bodies for effective TB/HIV activities
at all levels
Conduct surveillance of HIV prevalence among TB cases
Carry out joint TB/HIV planning
Monitor and evaluate collaborative TB/HIV activities
B. Decrease burden of TB among PLHIV (the "Three I's")
Establish intensified TB case finding
Introduce INH preventive therapy
Ensure TB infection control in health care and congregate
C. Decrease burden of HIV among TB patients
Provide HIV testing and counselling
Introduce HIV prevention methods
Introduce co-trimoxazole preventive therapy
Ensure HIV/AIDS care and support
WHO 2004 policy on collaborative TB/HIV activities
IPT is recommended for PLHIV
For principle and/or controversial recommendations:
Synthesis of ALL available evidence
Evidence summaries for group meetings using standard template
Formal assessment of quality of evidence
Consideration of resource use and costs
Link evidence to recommendations, explaining reasons for judgements
Standards for evidence: GRADE system
IPT/ICF guideline revision process
HIV/AIDS and STOP TB Departments (Getahun and Granich)
1. Scoping the document: reasons for choosing the topic, problems with existing guidelines, variations and gaps,
2. Group composition
3. Conflict of interest
4. Formulations of the questions and choice of the relevant outcomes
5. Evidence retrieval, evaluation and synthesis (balance sheet, evidence table)
6. Benefit/risk profile: integrating evidence with values and preferences, equity and costs
Benefit/risk profile: affected community
7. Formulation of the recommendations
8. Committee review/finalization (January 25th 2010)
Reporting standard and process
9. Submission to GRC for approval
Review scope and questions for guideline
Identify outcomes critical for decision making
Provide end user input
Assist in evidence retrieval, evaluation and synthesis (balance sheet, evidence table)
Review drafts of guideline document
Review and approve final recommendations
P opulation of interest
I ntervention to be assessed
C omparison with current standard of care
Outcomesfor patients and community
T imeline in which each outcome needs to be assessed
What is the best combination of signs, symptoms and diagnostic procedures (e.g., smear microscopy, radiography, serum-based tests such as IGRA, etc.) as a screening tool to determine eligibility for LTBI treatment and to diagnose TB among PLHIV?
What is the optimal duration and drug regimen (e.g., INH, RIF, etc.) for treatment of LTBI to reduce the risk of developing Tuberculosis among PLHIV?
What is the optimal time to start considering IPT? (i.e., should immune status be considered and should IPT be started with ART)?
Does treatment for LTBI among PLHIV lead to significant development of mono-resistance against the drugs used for LTBI treatment?
Should PLHIV who had received TB treatment in the past be provided secondary treatment of LTBI to prevent re-infection or recurrence of Tuberculosis?
Will low adherence rates to LTBI treatment be a barrier to implementation of LTBI treatment among PLHIV?
Is provision of treatment for LTBI cost-effective?
Resource implications, including health system changes, for each recommendation in a WHO guideline should be explored. At the minimum, a qualitative description that can serve as a gross indicator of the amount of resources needed, relative to current practice, should be provided.
A scenario approach can be used, and will also need to include health system implications of the recommendations, from training, changes in supervision, monitoring and evaluation, advocacy, etc.
Ideally models should be made available and designed to allow for analysts to make changes in key parameters and reapply results in their own country.
Users of the guidelines need to work out the cost implications for their own service
End of the day…Recommendation(s) to consider for WHO
Laws, like sausages, cease to inspire respect in proportion as we know how they are made.
Otto von Bismarck 1930
Georgina Russell (NHS)
Date, Anand (CDC/CCID/NCHHSTP)
Haileyesus Getahun (STOP TB Co-lead)
Andrew Doupe (HIV/AIDS)
Christian Gunneberg (STOP TB)
Lulu Mussa Muhe (HIV/AIDS and CAH)
Malgorzata Grzemska (STOP TB)
Reuben Granich (HIV/AIDS)
Siobhan Crowley (HIV/AIDS)