1. CTU survey Dr Oluseun Adeogun NIHR Research Methods Fellow in Health Informatics University Of Liverpool / North West Hub for Trials Methodology Research / MRC HeRC North / Farr Institute 23 rd June 2014 1

2. Purpose of survey Aims: To discover types of resources used by CTUs across the country Identify experiences of using electronic databases to support clinical trials: Feasibility assessment Identifying and contacting eligible patients Outcome data collection Questionnaire completed by 35 of 45 CTUs Overall response rate of 78% 2

3. Feasibility assessments using routine data sources Have you used electronic databases to estimate the numbers of eligible patients? Yes: 22 (63%)No: 13 (37%) 3

4. Distribution of electronic databases used to assess feasibility 4

5. Snapshot: ways in which results were used “To estimate the number of GP practices required to approach enough potential study participants to meet target recruitment”. “Estimate likely number of eligible patients. Estimate potential number of sites.” “Decided not to - data accuracy concerns”. “…to estimate the likely number of people consulting with the condition of interest over a specified time period. We are always very cautious to not take the figures from this feasibility exercise to represent the likely recruitment rate as we cannot always apply our inclusion/exclusion criteria to this data nor account for the consent rate”. 5

6. Identifying and contacting eligible patients Have you used electronic databases to identify eligible patients for studies? Yes: 19 (54%)No: 16 (46%) 6

7. 7 Options: Contact the data provider to act as a third party to contact patients | Contact the general practice surgeries who contacted the patients | Other

8. Categories: ways of approaching eligible patients Sending letters of invitation/study information by mail 10 (56%) Health professionals approached patients at clinics/GP surgeries 6 (33%) Study publicised using several methods: social networking, local media, public engagement events 1 (5.5%) Popups on GP electronic systems to alert GP during consultation when appropriate codes are entered 1 (5.5%) 8 One response said that patients were not approached since it was a cluster trial

9. Outcome data collection using the EHR Have you used electronic databases to obtain outcome data in trials? Yes: 25 (71%)No: 10 (29%) 9

10. Categories: Outcome data collection using the EHR Lab Data 4 Health Economics Data 2 Death/Mortality Data 9 Unscheduled Medical Contact 1 Cancer Data 3 Pregnancy Data 1 Hospital Data 6 Therapeutic Data 1 Not Specified 5 10

11. Outcome data collection using the EHR Was there another source of the same outcome data e.g. paper CRF? Yes: 18 (72%)No: 7 (28%) If Y (to previous question), was there a comparison made to the electronic database? Yes: 16 (89%)No: 2 (11%) 11

12. Comparisons of electronic outcome data versus data on paper 11 responses give details of data comparisons made 12 These will be followed up to see how they compare with: Tudur Smith, C., Stocken, D.D., Dunn, J., Cox, T., Ghaneh, P., Cunningham, D. & Neoptolemos, J.P. (2012) 'The Value of Source Data Verification in a Cancer Clinical Trial'. PLoS ONE, 7(12).

13. Snapshot: Advantages of using electronic databases for trial feasibility and participant identification Accuracy, ease of use Allows large numbers of participants to be identified and invited at low cost Cheaper to use and less invasive of time of participating centres More reliable than surgeon guess on likely numbers - surgeons over estimate! Speed, once access obtained Useful to judge feasibility of doing the research It has reduced workload of trial unit staff 13

14. Snapshot: Disadvantages of using electronic databases for trial feasibility and participant identification Accessing some of the databases and potential inaccuracies. Delays between data entry and availability. Difficult as real data may not give you exact eligible population but an approximation based on what data are available. Cost, especially for relatively small studies as the set-up cost is high. It is difficult to establish eligibility if data is not complete. Lack of granularity in data. Timeliness of data Need to be careful with queries as easy to over- or under- include Restricted by the variables in the database…may often not able to apply all eligibility criteria when estimating patient numbers. Routine data is not so clean as trial data 14

15. Summary Described the results of the survey Highlighted the following: Feasibility assessment Identifying and contacting eligible patients Outcome data collection Summarised the advantages and disadvantages of using electronic databases for trial feasibility 15

16. Acknowledgements Saeeda Bashir for disseminating the questionnaire All the 35 CTUs that responded Co-applicants of the grant: Prof P. Williamson, Prof C. Gamble, Dr C. Tudur- Smith, Prof M. Clarke, Prof J. Brown, Dr D.O’Reilly, Dr M. Lay, Dr A. Lane, Prof J. Carpenter, Prof H. Snooks, Prof I. Ford, Prof L. Smeeth MRC Hub for Trials Methodology Research Network for funding 16

17. Questions? 17