CTU surveyDr Oluseun AdeogunNIHR Research Methods Fellow in Health InformaticsUniversity Of Liverpool / North West Hub for Trials Methodology Research / MRC HeRC North / Farr Institute
23rd June 2014 1
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
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
Distribution of electronic databases used to assess feasibility
4Lo
cal Gen
eral P
ractice
Electr
onic Hea
lth Reco
rd sy
stems
Local
Hospita
l Elec
tronic H
ealth
Record
syste
ms
CPRD GOLD/ G
PRD
QResearc
h
THIN data
baseHSC
IC
Other ele
ctronic d
atabase
(s)0%
5%
10%
15%
20%
25%
30%
Types of electronic databases
% o
f CTU
s who
hav
e us
ed e
lect
roni
c dat
abas
es
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
Identifying and contacting eligible patients
Have you used electronic databases to identify eligible
patients for studies?
Yes: 19 (54%)
No: 16 (46%)6
7Contact data
providerContact GP Other Contact data
provider and GPContact data
provider, GP and other
Contact GP & other
Contact data provider and
other
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Ways in which CTUs contacted eligible patients%
of C
TUs
Options: Contact the data provider to act as a third party to contact patients | Contact the general practice surgeries who contacted the patients | Other
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%)
8One response said that patients were not approached since it was a cluster trial
Outcome data collection using the EHR
Have you used electronic databases to obtain outcome
data in trials?
Yes: 25 (71%)
No: 10 (29%)9
Categories: Outcome data collection using the EHRLab 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
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
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).
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
staff13
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
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
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
Questions?
17
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