1. Julia Hippisley-Cox University of Nottingham 19 th March 2010

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

4.  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.  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.  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.  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.  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.  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 trialsObservational Data  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

11.  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.  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. QResearchTHINGPRD Year data started1988/9 coverageUK Size600 practices450 practices500 practices Basic contentV similar Quality etcfine Ethics requiredyes Yes Basic linkagesDeprivation & deaths Deprivation & deaths (soon) Deprivation & deaths Additional linkages Exploring options and risks MINAP Cancer HES

14. QResearchTHINGPRD OwnershipUoN & EMISEPIC companySecretary State (MHRA) Core FundingNone Yes +++++ TrainingNoneyes LicensingSpecific cuts data for specific projects Data cuts or entire database Pharma studiesNo (unless significant safety issue) Yes costCost per dataset 10K+VAT start up cost. Then bespoke. Academic = 190K+VAT over 4 years or per data cut Free under MRC license

15. QResearchTHINGPRD statusNot for profitCommercial Sample size calculations No unless funded yesNot sure Speed of access3 months+Check with THINCheck with GPRD Publication requirement Yes – everything must be published No Identification patients Not possibleYes Identification practices Noyes Free text dataNoYesyes

16.  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.  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.  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.  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.  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?