1. IAPCOI Subcommittee on Evidence based Recommendations (EBR) 2011-2013

2. IAPCOI Subcommittee on Evidence based Recommendations (EBR): Formed on 24-25 Dec 2011 Chair: T. Jacob John Convener: Panna Choudhury Co-Convener: Nitin Shah Members: Vipin M. Vashishtha, Suhas Prabhu, S. G. Kasi Expert advisors: HPS Sachdev; Piyush Gupta; Dheeraj Shah

3. Aims and 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 IAP COI.

4. IAPCOI subcommittee of EBR Meeting Venue: IMA, New Delhi Date: 19-02-2012 Dr. T. Jacob John), Dr. Vipin M Vashishtha;Dr. Panna Choudhury;Dr. H.P.S. Sachdev;Dr. Piyush Gupta ;Dr. S.G. Kasi;Dr. Dheeraj;Dr. A.J. Chitkara (Special Invitee); Dr. Shyam Kukreja (Special Invitee); Dr. Nitin Shah (Co-Convener EBR) and Dr. Suhas Prabhu (Member EBR) expressed inability to attend the meet.

5. Salient points of minutes (1): Code of Conduct and Conflict of Interest EBR committee will follow code of conduct as decided by IAPCOI……………….. all office bearers and members of IAPCOI (including its subcommittees) should disclose any financial, professional or other interests…….. CIAP will appoint a committee of 3-5 eminent and neutral persons to decide whether the competing interests are significant enough to preclude the expert from participation in the deliberations of IAPCOI

6. Salient points of minutes (2): Guidelines for EBR to be followed Guidelines for Evidence based review are available from ACIP, SAGE/WHO, ECDC. It was agreed to broadly follow the adapted model of WHO Guidelines. GRADE approach would be followed for scoring the quality of evidence. It is noted that working group at WHO requires 6-12 months for addressing 1 recommendation, ultimate work are mostly outsourced.

7. Salient points of minutes (3): The key activities involved in creating evidence-based recommendations by IAPCOI should be as follows i) Definition of the questions to inform recommendations. ii) Identification of the critical questions for which an in-depth review of evidence is needed. iii) Systematic review of the literature with or without meta-analysis. iv) Review the quality of the evidence, in particular through assessment of the risk of bias and confounding. v) Scoring of the quality of the evidence (using the GRADE approach) for data on safety and effectiveness. vi) Discussion, deliberation and formulation of recommendation by IAP COI. vii) Submission of recommendation of IAP COI to IAP EB.

8. Salient points of minutes (4): Process…. As per WHO Guidelines GRADE scoring can be done for no more than 5 critical questions. IAPCOI also need to identify mechanism how these critical questions would be addressed through GRADE approach either by outsourcing or identifying person/persons supported with reasonable remuneration or volunteers with credibility in this field(It is pointed out that it is hugely costly when outsourced ).

9. On 24 th May, 2012 IAPCOI/CIAP identified persons for doing the systematic review of burden of rotavirus diarrhea in under five children. IAPCOI identified two specific issues: Burden of Rotavirus diarrhea in India and efficacy of current rotavirus vaccines in India

10. Research Questions being addressed Identification of the proportion of diarrheal diseases caused by rotavirus in hospitals Identification of the proportion of diarrheal diseases caused by rotavirus in community Case fatality of rotavirus disease measured among hospitalized children and community Identification of molecular epidemiology of rotavirus diarrhea in under-five children of India

11. Data Sources under Search The primary databases searched were Medline through PubMed and IndMed Other sources including National Sample Survey, WHO, UNICEF, National Family Health Survey and Ministry of Health and Family Welfare Related articles and the reference lists of included publications to identify additional studies Not included: any unpublished data, data available within specific institutions at the national, state or local level, or data unavailable in the public domain

12. Inclusion and Exclusion Criteria We included all types of publications available in scientific public domain and reporting on rotavirus infection in India by direct data collection through clinical examination, and/or laboratory testing No particular time frame was set. We limited our search in humans, and articles published in English language Participants Infants:1-23 month and preschool children:2- 5 years

13. Searching the Literature For searching the PubMed, a search string was devised by converting each research question into PICO format Mesh headings were looked for the research theme in question and added to the PubMed search builder Salient keywords were included during search A search for MESH headings for rotavirus, revealed Rotavirus, infections, which was relevant and yielded 31 subheadings

14. Searching the Literature For assessing the epidemiology of rotavirus diarrhea in India, we searched PubMed using the search string: (epidemiolog* OR burden OR morbidity OR morbidity OR mortality or incidence OR prevalence OR profile) AND (rotavirus OR rotavirus diarrhea OR rotavirus gastroenteritis OR rotavirus disease) AND india

15. Searching the Literature An additional search was made for the secondary research questions by combining keywords/MESH terms for the secondary research question using the search string (*) AND (rotavirus, infections) AND India, where the asterisk represents the Mesh term/keywords for the secondary research question To search the IndMed, the search string was kept simple using search keywords. The detailed search strings used are shown in Table I

16. TABLE I RESEARCH QUESTIONS AND SEARCH STRINGS USED

17. Full text articles have been analyzed in the following format (Table 2) TABLE 2 SUMMARY OF ARTICLES

18. References 1.Taneja DK, Malik A. Burden of rotavirus in India--is rotavirus vaccine an answer to it? Indian J Public Health. 2012 Jan-Mar;56(1):17-21. 2. Simpson E, Wittet S, Bonilla J, Gamazina K, Cooley L, Winkler JL. Use of formative research in developing a knowledge translation approach to rotavirus vaccine introduction in developing countries. BMC Public Health. 2007 Oct 5;7:281. 3. Gladstone BP, Ramani S, Mukhopadhya I, et al. Protective effect of natural rotavirus infection in an Indian birth cohort. N Engl J Med. 2011 Jul 28;365(4):337-46. 4. Tate JE, Chitambar S, Esposito DH, Sarkar R, Gladstone B, Ramani S, et al. Disease and economic burden of rotavirus diarrhoea in India. Vaccine. 2009;27:F18-24. 5. Menon S, Gupta P. UNICEF-PHFI Series on newborn and child health, India: methodology for systematic reviews on child health priorities for advocacy and action. Indian Pediatr. 2011;48:183-9.