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IPT and ICF Guidelines Update

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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IPT and ICF Guidelines Update

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  1. IPT and ICF Guidelines Update Reuben GranichHIV/AIDS DepartmentWorld Health Organization Haileyesus GetahunSTOP TB DepartmentWorld Health Organization

  2. TB related questions • Background • Guidelines Review Committee (GRC) • Timeline • GRC process • Committee • PICOT Questions • Criteria • Other considerations

  3. Havlir, Getahun et al. 2008 JAMA 300(4):423-430 CD4 level is associated with TB incidence "TB death zone" Courtesy Abhishek Sharma_adapted from Havlir et al

  4. A. Establish NTP-NACP collaborative mechanisms 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 settings 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 Introduce ARVs WHO 2004 policy on collaborative TB/HIV activities

  5. WHO/UNAIDS 1998 IPT Policy

  6. WHO TB/HIV Clinical Manual

  7. WHO Guidelines for National TB Programmes on the management of children

  8. WHO HIV/AIDS Department Priority Interventions (IAS Mexico 2008) IPT is recommended for PLHIV

  9. Implementation progress

  10. Call for rigor and transparency &

  11. Guidelines Review Committee rationale 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

  12. Reporting standard and process 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 10.Dissemination

  13. IPT/ICF guideline revision process • Ideal recommendations • Screening algorithm for IPT and further TB evaluation • Recommendations regarding diagnostic methods for ruling out TB • Preferred regimen for adults and children • Answer questions regarding duration, toxicity, cost, and resistance • Populations being considered • HIV+ adults, adolescents and children • HIV+ pregnant women • Relevant outcomes • Mortality • Disease progression (morbidity) • Severe or regimen limiting adverse events • Adherence and retention on IPT • Durability of IPT regimen effect • Cost effectiveness

  14. Expected functions of the guideline group 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) Formulate recommendations Review drafts of guideline document Review and approve final recommendations

  15. PICOT framework 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?

  16. Judgments about the strength of a recommendation –criteria to consider for WHO

  17. GRADE profile

  18. Considering cost 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

  19. End of the day…Recommendation(s)

  20. Other WHO guidelines • WHO normative guidelines • 2009 IPT/ICF Guidelines • 2009 ART Guidelines • 2009 PMTCT • 2010 MDR TB Guidelines • 2010 WHO HIV/TB research • 2010 Opportunististic Infections • Ongoing WHO IMAI

  21. Laws, like sausages, cease to inspire respect in proportion as we know how they are made. Otto von Bismarck 1930

  22. Thank you Review Team: Georgina Russell (NHS) Date, Anand (CDC/CCID/NCHHSTP) Abhishek Sharma Martina Penazatto Chair (TBD) Writer (TBD) WHO Committee 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)

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