Using clinical databases for translational research

1. Using clinical databases for translational research Julia Hippisley-Cox University of Nottingham 19th March 2010

2. Translational research • Probably has many meanings • Working definition here: • Research where results can be directly applied into clinical care

3. The Research Cycle‘clinically useful epidemiology - new knowledge & utilities to improve patient care’

4. Getting the question right • Need a very clear research question • What exactly do I hope to find out? • Is it important? • Is it original? • Is it interesting? • Is it answerable ? • Is it timely?

5. Change in research question • Leads to • Novel application of existing methods • Development of new methods • Better utilisation different data sources • Leads to • Lively academic debate! • Changes in policy and guidance • New utilities to implement research findings • (hopefully) Better patient care

6. But is the answer which is critical • Who needs to know the answer? • When do they need to know the answer and why? • What will they do with it? • How will it affect clinical practice? • How will you communicate it? • How will you implement it? • Is a negative result worth knowing? • What are the consequences of not doing the study?

7. Study design • Once question clear then early stats advice • What is the study design? • Cross sectional survey • Cohort study • Case control study • Case series study • Randomised controlled trial • ? Other (specify) • What are the outcome measures? • What are the exposures? • What are the confounders? • Sample size calculation?

8. Analytical techniques • Once design is clear then • Type of analysis needed? • Handling of missing data? • Hierarchical data? • Accounting for bias and confounding? • Whose skills & experience needed to prepare data and undertake analysis.

9. Data sources • What type of data do I need? • Purpose designed cohort or clinical trial • Routinely collected NHS data • Primary care? • Secondary care? • Other • Anonymised or identifiable? • Supplementary data needed? • Data linkage require? • questionnaires or blood tests

10. Clinical trials vs observational • Single outcome • Single intervention • Precise measurements • Powered for outcome • Good estimation benefit • Underpowered for ADR • Selected populations • Multiple outcomes • Multiple interventions • Imprecise measurements • Better for unintended effects • Good powers • Representative populations Clinical trials Observational Data

11. GP data sources • Three main UK databases • QResearch • THIN • GPRD • All very good • All need application form, protocol, ethics • Same answer for 90% of studies • Some special features for each • Different terms and conditions

12. QResearch – www.qresearch.org • Set up in 2002 • Not-for-profit venture between EMIS & Nottingham University • Management board • National advisory board • Scientific review board • Practice feedback in 2010

13. Compare & contrast

14. Compare & contrast

15. Compare & contrast

16. QResearch special requirements • Did you have the original idea for this research project? • To your knowledge is this work original and capable of publication as original research in a peer- reviewed journal? • Are you free to undertake this study and publish its findings without needing to clear it with the funding source or any other organisation? • Do you agree to acknowledge the source of QRESEARCH data in any publication, paper or report? • Do you agree NOT to attempt to identify patient(s) or practice(s)? • Do you undertake to provide a copy of the final report of the project and copies of any publications within one year of the project completion? • Do you agree NOT to release the data to any third party including the funder, sponsor or other such body? • Do you undertake to check the data you are given within a month of receipt and report back any problems within that time? • Do you have a statistician on the project team who has contributed to the design of the study and will advise on the analysis? • Do you have a clinician who will act as clinical guarantor for the data?

17. Qweb tools • Two free online searchable databases • Public health indicators • Chest and allergy diseases • Self register at www.qresearch.org • For new funded research projects we will • send you a login to researcher QWeb tools • ask you to define the query you need • You will need a clinician who understands GP data

18. Next steps in research process • Specify protocol • Specify data required • Complete application process • Obtain funding • On receipt of data, check it • Data preparation • Data analysis • Preparation of paper • dissemination

19. Summary What is needed • Good question • Clear protocol • Funding • Data source appropriate to study • Hardware/software • IT skills -handling large dataset • Statistics – advanced techniques • Epidemiology • Clinical academic • Writing skills

20. Does the university want a data service • What is the service? • How will it be delivered? • Who will deliver it? • Who will use it? • Which data sources? • How will it be funded? • What service levels? • Criteria for prioritising applications? • How evaluate it?

21. The Research Cycle‘clinically useful epidemiology - new knowledge & utilities to improve patient care’