Objective of EBR related to IAPCOI 19 th February 2012, IMA House, New Delhi

1. Objective of EBR related to IAPCOI19th February 2012, IMA House, New Delhi Vipin M. Vashishtha, MD, FIAP Convener, 2011-13 vipinipsita@gmail.com

2. Why the NEED?? IJMR 2008; 127: 502-03 Indian Pediatrics, 2009,; 46: 1021-23 PEDIASCENE June-Sept. 2001,

3. Aims & Objectives: • To develop a uniform approach to making explicit the evidence base for IAPCOI recommendations; • To develop, evaluate and apply a system to make evidence based recommendations (both existing and future) for the IAPCOI

4. Activities & Guiding Principles: • Main focus should be on scientific evidence and transparency so that the system can be reproducible and can also be reviewed by other experts; • Every attempt should be made to avoid bias creeping anywhere;

5. Activities & Guiding Principles: • The recommendations should entirely be based on available scientific evidences & where no evidence can be found, it should be mentioned clearly in the text • Extrapolations should ideally be avoided as far as possible!!

6. Activities & Guiding Principles: • No consideration should be given to any other attribute like practicability, feasibility, affordability, etc • While grading recommendations, grade them for the both, individual and community health

7. Activities & Guiding Principles: What ought to be reviewed? • Existing evidence from the country • Guidelines of various agencies (GoI, ACIP, AAP, EMEA etc) • Existing recommendations of IAP COI • Revise EBR on each vaccine (newer vaccines should be prioritized!!)

8. Activities & Guiding Principles: Key elements for consideration: • Burden of Illnesses • Safety & Efficacy of the available vaccines, • Cost-effectiveness and economic studies should not be graded!!

9. Proposed format of EBRs(Methodology of issuing recommendations) • Need to answer few questions: • What is the evidence? • How to look for it? How to access? • How to assess & analyze? • Which is the better evidence? (Hierarchy of evidence) • How to grade the available evidence to issue recommendations? • What are the models available? • Which one to choose?

10. (GRADE) framework: • Grades of Recommendation Assessment, Development and Evaluation (GRADE) framework

11. Proposed format of EBRs: Description of Evidence Grades • Proposed evidence grades for safety and efficacy, • A, B, C, D June 2010 ACIP Meeting

12. Description of Evidence Grades: Note: Grades reflect the confidence in the estimated effect on health outcomes based on a body of evidence. Further research may not always be possible.

13. Proposed recommendation categories: • Category I (recommendation for, or recommendation against) • Universal recommendation • Risk-based recommendation • Category II (recommendation for individual clinical decision making) • No recommendation/unresolved issue

14. Examples: • Recommendation: ACIP recommends vaccination of U.S. infants with three doses of rotavirus vaccine administered orally at ages 2, 4, and 6 months • (Recommendation category: I, Evidence grade: A). • Remarks: • Nearly every child in the U.S. is infected with rotavirus by age 5 years, resulting in approximately 410,000 physician visits, 205,000–272,000 emergency department visits, and 55,000–70,000 hospitalizations each year. Benefits of vaccination are large compared to potential harms.

15. Examples: • IAPCOI recommends TWO/THREE doses of RV1/RV-5 administered orally at ages 6 & 10 OR 6, 10, 14 weeks • (Category: ? Evidence: ? )

16. Examples: • IAPCOI recommends OPV …… • (Category: I Evidence: A ) • IAPCOI recommendations on Typhoid vaccine: • Vi-PS (Category: I ? Evidence: A/B ) • Vi Conjugate (Category: II Evidence: C/D?)

17. Examples: Hepatitis A vaccines: • Recommendations for use: (Category : ? ? Evidence: ? ) • Killed vaccine: TWO doses (Category: I Evidence: A) • Live H2 strain: TWO doses (Category: II ? Evidence: B/C )

18. Thank You!!