1. Conference for EEF evaluators: Building evidence in education Hannah Ainsworth, York Trials Unit, University of York Professor David Torgerson, York Trials Unit, University of York Professor Carole Torgerson, School of Education, Durham University Session 3: Implementation

2. Trial registration and CONSORT (HA – 10 mins.) Trial management (HA - 30mins) Model/approach (HA – 5mins) –Discussion (5mins) Protocol and other tools (HA – 5mins) –Discussion (5mins) Relationship with delivery partner (HA – 5mins) –Discussion (5mins) Recruitment and retention (CT – 20 mins.)

3. Trial registration Register trial with Current Controlled Trials at outset before beginning recruitment. You will be allocated an ISRCTN http://www.controlled-trials.com/isrctn/submission/

4. Why is it important to register trials? »Public knowledge »Reduce duplication »Increase opportunities for collaboration »Reduce selective reporting and over reporting »Reduce publication bias

5. CONSORT Conduct and report trial to the CONSORT standards http://www.consort-statement.org/consort- statement/http://www.consort-statement.org/consort- statement/ What is CONSORT? Why is it important? How can it help?

6. CONSORT checklist

8. CONSORT flow diagram

9. CONSORT flow diagram cluster trials From Campbell MK, Piaggio G, Elbourne DR, Altman DG; for the CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012 Sep 4;345:e5661.

10. Trial management Trial management approach/model Developing a trial protocol and other trial management tools Relationship with delivery partner

11. Trial management model/approach Current EEF model: Light touch approach to trial management as delivery partner is often taking responsibility for many of the ‘usual’ trial management responsibilities Think about everything you would normally do/take responsibility for as trial manager. document this and share with delivery partner. Offer advice and guide the process

12. Discussion What are YOUR experiences of trial management within EFF evaluations? What are the advantages and disadvantages of the current model/approach? Possible solutions?

13. Trial Protocol and other tools Develop a trial protocol as evaluation team Discuss and develop trial protocol with delivery partner Produce clear timeframes/deadlines which both evaluation team and delivery partner can work to

14. Produce evaluation diagrams Control Group Primary Schools N = 12 No intervention Primary School Randomisation Intervention Group Primary Schools N = 12 Intervention in Year 6 continued intervention in Year 7 in Secondary Schools. Children in target group n = 288 (based on average 12 children per school) Primary Schools n = 24 Secondary Schools n = 3 Long term follow up Routine test results and pupil characteristics recorded in National Pupil Database Baseline data collection Information on all Year 6 pupils including Key stage 2 English Teacher Assessments from Dec 2012 Follow up data collection Dec 2013 Progress in English 11 (long form) (Conducted in Secondary School)

15. Clear timeframes

16. Provide clear information Help delivery partner develop information for schools, parents and children Work with delivery partner to ensure clear instructions are given to schools Help delivery partner develop school agreement documents Help develop parent consent forms/opt out forms

17. Discussion Has the trial protocol been a useful shared document? What other tools have YOU used to aid the process?

18. Relationship with delivery partner Intervention developer has a lot invested in the intervention Evaluator must remain in equipoise Can be a challenging relationship Try to explain that it is important you remain impartial Refrain from voicing your own opinions about the intervention – let the research speak for itself

19. Relationship with delivery partner Manage expectations Be clear from outset who is responsible for what Be clear from outset on the data you will require, when and the format you will require it in Provide clear instructions for secure data transfer

20. Discussion What are YOUR experiences of the relationship with the delivery partner? How can challenges be overcome?

21. Recruitment and retention (CT) Randomisation ensures absence of selection bias Selection bias can still be introduced during recruitment or because of attrition

22. Recruitment bias Potential sources: »Developer-led recruitment »Timing »Randomisation of clusters before recruitment of individuals »Teacher not linked to class before randomisation Possible solutions: »Evaluators fully involved in recruitment process »Randomise after recruitment of clusters and within clusters »Ensure teachers are linked to classes before randomisation

23. Attrition bias Attrition after randomisation can introduce bias »Those who leave a trial tend to be different from those who remain in the trial »If there is unequal attrition this is worrying »All efforts must be made to retain participants after randomisation for post-tests even if they don’t receive the intervention

24. Example of attrition bias Random allocation 160 children 8 from Each school 76 children allocated to control 76 allocated to intervention group 1 school 8 children withdrew N = 17 children replaced following discussion with teacher

25. Discussion Discuss any issues you have experienced with the developer-led recruitment.