Julia Hippisley-Cox
University of Nottingham
19th March 2010
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Probably has many meanings
Working definition here:
◦ Research where results can be directly applied into
clinical care
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Need a very clear research question
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What exactly do I hope to find out?
Is it important?
Is it original?
Is it interesting?
Is it answerable ?
Is it timely?
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Leads to
◦ Novel application of existing methods
◦ Development of new methods
◦ Better utilisation different data sources
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Leads to
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Lively academic debate!
Changes in policy and guidance
New utilities to implement research findings
(hopefully) Better patient care
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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?
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Once question clear then early stats advice
What is the study design?
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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?
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Once design is clear then
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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.
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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
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Single outcome
Single intervention
Precise measurements
Powered for outcome
Good estimation
benefit
Underpowered for ADR
Selected populations
Clinical trials
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Multiple outcomes
Multiple interventions
Imprecise
measurements
Better for unintended
effects
Good powers
Representative
populations
Observational Data
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Three main UK databases
◦ QResearch
◦ THIN
◦ GPRD
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All very good
All need application form, protocol, ethics
Same answer for 90% of studies
Some special features for each
Different terms and conditions
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Set up in 2002
Not-for-profit venture between EMIS &
Nottingham University
◦ Management board
◦ National advisory board
◦ Scientific review board
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Practice feedback in 2010
QResearch
THIN
GPRD
Year data started
1988/9
1988/9
1988/9
coverage
UK
UK
UK
Size
600 practices
450 practices
500 practices
Basic content
V similar
V similar
V similar
Quality etc
fine
fine
fine
Ethics required
yes
yes
Yes
Basic linkages
Deprivation &
deaths
Deprivation &
deaths (soon)
Deprivation &
deaths
Additional
linkages
Exploring
options and
risks
Exploring
options and
risks
MINAP
Cancer
HES
QResearch
THIN
GPRD
Ownership
UoN & EMIS
EPIC company
Secretary State
(MHRA)
Core Funding
None
None
Yes +++++
Training
None
yes
yes
Licensing
Specific cuts
data for specific
projects
Data cuts or
entire database
Data cuts or
entire database
Pharma studies
No (unless
significant
safety issue)
Yes
Yes
cost
Cost per dataset
10K+VAT start
up cost. Then
bespoke.
Academic =
190K+VAT over
4 years or per
data cut
Free under MRC
license
QResearch
THIN
GPRD
status
Not for profit
Commercial
Commercial
Sample size
calculations
No unless
funded
yes
Not sure
Speed of access
3 months+
Check with THIN Check with
GPRD
Publication
requirement
Yes – everything
must be
published
No
No
Identification
patients
Not possible
Yes
Yes
Identification
practices
No
yes
yes
Free text data
No
Yes
yes
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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?
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Two free online searchable databases
◦ Public health indicators
◦ Chest and allergy diseases
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Self register at www.qresearch.org
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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
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Specify protocol
Specify data required
Complete application process
Obtain funding
On receipt of data, check it
Data preparation
Data analysis
Preparation of paper
dissemination
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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
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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?