Journal club on Randomised control trial.pptx

It contains a detailed conceptual discussion on randomised control trial cluster type

1. Journal club Presenter-Dr Rajesh Nandi Moderator-Dr Mamta Facilitator-Dr Abhishek

2. Title of the article Seeds of prevention: The impact on health behaviors of young adolescent girls in Uttar Pradesh, India, a cluster randomized control trial Authors- Nandita Kapadia-Kundu & Geetali Trivedi 1 , Douglas Storey & Basil Safi 2 , Rama Tupe 3 , G. Narayana 4

3. 1- Johns Hopkins Bloomberg School of Public Health, Center for Communication Programs, Nehru Place, New Delhi, India 2- Johns Hopkins Bloomberg School of Public Health, Center for Communication, Baltimore, USA 3- Genesis Research, Delhi, India 4- Futures International , Haryana, India

4. About the journal Name – Social science and medicine Impact factor- 5.4 Published – September 2014 Volume-120 Pages -169-179

5. Plan of presentation Introduction and Rationale Objective Methodology Results Discussion

6. Introduction and rationale Early adolescent girls are vulnerable to health challenges Effective health interventions were scarce Intergenerational low birth weight , anemia and under nutrition Leads to “Cycle of failure” Early adolescent is a gateway to build nutritional and health reserves

7. Aim To provide a foundation of healthy behavior that will benefit two generations: young adults and girls in their adulthood and their children

8. Methodology Study design- Cluster randomised control trial Study setting- Hardoi , district of Uttar Pradesh Study participants- Adolescent girls (11-14 years) Study period -January 2010 to October 2011

9. Sample size – For cluster RCT (ESS= mk /DE) ESS =effective sample size Number of schools/clusters (k) = 30 Number of girls per school (m) = 60 Total number =1800 Design effect = 1+ rho(m-1) = 1+0.017(29) =1.4 ESS=1800/1.4=1205 adolescents girls

10. Data collection- Face to face interviews were conducted Statistical analysis -Qualitative data was analysed in proportion using chi square while quantitative data was analysed using t test between intervention and control groups

11. Hardoi district (19 blocks) Stratification of blocks into 3 categories by distance 41-60 kms from Hardoi <20 kms from Hardoi 21- 40 kms from Hardoi Randomly 2 blocks selected from which 5 schools were randomly selected 40 girls from each school were randomly selected from class 7-8 Randomly 2 blocks selected from which 5 schools were randomly selected 40 girls from each school were randomly selected from class 7-8 Randomly 2 blocks selected from which 5 schools were randomly selected 40 girls from each school were randomly selected from class 7-8 Baseline survey of girls

12. Baseline survey Random assignment of blocks <20km from Hardoi city Random assignment of blocks 20-40 kms from Hardoi city Random assignment of blocks 41-60 kms from Hardoi city Intervention block Control block 5 schools 40 girls/school SSKY + Pilot 5 schools 40 girls/school 5 schools 40 girls/school 5 schools 40 girls/school 5 schools 40 girls/school 5 schools 40 girls/school Intervention block Control block Control block Intervention block SSKY + Pilot SSKY + Pilot SSKY SSKY SSKY

13. Saloni swasthya kishori yojana For school going adolescent girls (10-19 years) Address the problem of anemia Administration of weekly IFA tablets, bi annual deworming and annual health check ups

14. Saloni pilot intervention Addition to SSKY implemented in government schools Promoted 19 health behaviors 5 health seeking ,6 nutrition,3 reproductive health and 5 hygiene A structured teachers manual A saloni diary for the girls

15. Saloni diary – provided to girls with aim to promote healthy behaviors in a more interactive way ( colourful pictorial representations) Contents Personal information Family details Daily activities Daily food intake Health behaviors (reproductive health, nutrition and hygiene) Intergenerational communication – sharing learning with parents

16. Delivery of interventions Saloni diary Education on inter generational communication(with mothers, fathers and other family members) Role plays and posters promoting intergenerational communication and enforcing healthy behaviors Community support ( school teachers) Ten monthly education sessions one hour each ( by the teachers)

17. Consent for participation was taken from their guardians or parents and from the girls themselves Face to face interviews were conducted at the end of the intervention

18. Only 11.4 – 9.5% girls live in brick houses- indicative of high level of poverty Increase in number of nuclear families in the endline is not explained

19. Results Significant increase in consumption of iron folic acid tablets after the intervention

20. The above table shows significant increase in having 3 meals + snack in both the groups but more in intervention group

21. There was an improvement in menstrual hygiene in both the groups but due to some social constraints the improvement was limited

22. Discussion Seeds of prevention need to be sown in early ages Saloni intervention focused on early adolescence as gateway moment Early adolescence girls are potentially receptive Integrated intervention on reproductive and sexual health ,nutrition and hygiene Evidence of concurrent changes in more than one behavior across different health issues Findings can be applied to the target population

23. Limitations Short duration of study Sustainability of behavioral changes unknown

24. CONSORT checklist 28 Content Recommendation Report Title Identification as a randomized trial in the title Yes Abstract Structured summary of trial design, methods, results, and conclusions Mentioned but not in a structured format Introduction Scientific background and explanation of rationale Background and problem statement explained Objectives Specific objectives or hypotheses Not clearly stated under a separate heading Trial design Description of trial design Important changes to methods after trial commenced No changes were made to protocol after commencing the study

25. CONSORT checklist (cont.) Content Recommendation Report Participants Eligibility criteria Settings and locations where the data were collected Mentioned Interventions Interventions for each group with sufficient details to allow replication Mentioned but in detailed delivery of interventions not given Outcomes Completely defined pre-specified outcome measures, including how and when they were assessed Any changes to outcomes after the trial commenced Primary outcome and secondary outcome not mentioned under separate heading , analysis of results not mentioned clearly Sample size How sample size was determined Explained.

26. CONSORT checklist (cont.) Content Recommendation Report Random sequence generation Method, type of randomization, details of any restriction Not mentioned Allocation concealment Mechanism used, describing any steps taken to conceal the sequence until interventions Not mentioned Implementation Who generated the random allocation sequence, who enrolled and assigned interventions Not mentioned Blinding If done, who was blinded after assignment to interventions and how Not mentioned clearly Statistical methods Methods used to compare groups for outcomes Methods for additional analyses Mentioned.

27. CONSORT checklist (cont .) Content Recommendation Report Outcomes and estimation For each primary and secondary outcome, results for each group, and estimated effect size and precision For binary outcomes, presentation of both absolute and relative effect sizes is recommended No primary and secondary outcomes mentioned seperately Ancillary analyses Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory Not done Harms Important harms or unintended effects in each group No harm Limitations Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses short duration Sustainability of changes unknown

28. CONSORT checklist (cont.) Content Recommendation Report Generalizability External validity & applicability of the trial findings Generalizable only to target population Registration Registration number and name of trial registry Not mentioned Protocol Where the full trial protocol can be accessed Could not be accessed Funding Sources of funding and other support, role of funders Not mentioned

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