NorthWise Services
A Comparison Between Electronic
and Paper Patient Diaries
By
Dr. Philip M. North
ABEMEP Symposium
Electronic Data Capture
Friday 11TH June 2004
NorthWise Services
ABEMEP 2004
NorthWise Services
Background of the Company
 CRO specialising in services in data
management and statistics
 Work with electronic patient diaries is a natural
extension of this
 Specific knowledge of a number of electronic
patient diaries
 Staff recruitment agency
NorthWise Services
ABEMEP 2004
NorthWise Services
Background of the Speaker
 Consultant statistician
 24 years in CRO industry, following academic career
 Early interest in ecological statistics
 Extensive experience of business development and
management.
 Growing interest in electronic data capture generally
and electronic patient diaries in particular
NorthWise Services
ABEMEP 2004
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Patient Diary Cards - Background

Some studies require use of patient diary
cards for collection of data

Sometimes the patient self report is on
the primary endpoint, or an important
secondary endpoint

Traditional approach is to use paper
patient diary cards

One objective: reduce the amount of
paper used

Related objective: make best use of
modern technology
NorthWise Services
ABEMEP 2004
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Problems with Paper Diary Cards
 Patients complete them retrospectively, just before
appointment with investigator
 Patients also complete them prospectively
 They are not filled in accurately
 Patients can write extensive comments
• They are often incomplete, inconsistent, inaccurate,
biased
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ABEMEP 2004
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Objectives of Electronic Patient Diary Use
Key objectives are:
 Improve patient compliance to protocol
 Improve quality of data collected
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ABEMEP 2004
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Compliance, Checks and Patient Experience
 Patient compliance can be tracked – particularly
important in early stages of study
 Audit trail is produced
 Automatic data entry checks can be built in
 Diary devices can be used to accurately record
patient experience
 Quality of life data can be collected
• Collect data in real time
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ABEMEP 2004
NorthWise Services
Time and Costs
 Use of new technology reduces development
time, hence time to market for a product – leads
to increased revenue for the pharmaceutical
company
 When all related costs are taken into account
devices can be cheaper than paper diaries
 Potential for multiple use
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ABEMEP 2004
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Published Comparison - Electronic vs. Paper
 Key publication : Patient non-compliance with
paper diaries (BMJ, Vol 324, 18 May 2002)
 Data quality and compliance from paper diaries
might be poor, but how can we tell which are the
poor data ?
 Money is wasted if spent on collecting poor
quality data
NorthWise Services
ABEMEP 2004
NorthWise Services
Results reported in the BMJ paper
Paper diary
(n=40)
30 minute window
Total number of episodes
Number of excluded episodes
Mean % compliance (95% CI)
Actual
Reported
90 minute window
Total number of episodes
Number of excluded episodes
Mean % compliance (95% CI)
Actual
Reported
Electronic diary
(n=40)
2445
126
2435
7
11(8 to 14)
90 (86 to 94)
94(92 to 96)
2445
134
20 (14 to 25)
95 (92 to 98)
NorthWise Services
ABEMEP 2004
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Desirable Features of an Electronic Patient Diary
(1)
The device needs to be or have:
 Very portable (light, compact, fitting into pocket or
handbag)
Note: laptop computers or large devices are not
portable enough
 Easy to use
 Acceptable/attractive to patients across wide age
range
• Reminders for patients
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ABEMEP 2004
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Desirable Features of an Electronic Patient Diary
(2)
 Capable of customisation – study dictates what is
on the device rather than other way round
 Accommodation of patient’s lifestyle
 Durable
• Water resistant (possibly)
• Long-lasting power source
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ABEMEP 2004
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Desirable Features of an Electronic Patient Diary
(3)
 Capable of handling questionnaires
 Secure data storage
 Easy and regular downloading of data
 Easy access to data for appropriate users
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ABEMEP 2004
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Desirable Features of an Electronic Patient Diary
(4)
 Comprehensive audit trail
 Validated and accepted by regulatory authorities
FDA 21 CFR Part 11 compliant
 Multilingual capability
• Cost-effective
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ABEMEP 2004
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Features of Electronic Diary Use
 Patient interacts with the data collection device and
not the investigator and other site personnel
 The user interface and device design are keys to
successful patient compliance
 Data capture and processing are highly efficient,
compared to paper diary processing
 Dedicated industry suppliers provide technology
solutions and support
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ABEMEP 2004
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Collecting Primary Endpoint Information
- Remarks
 Evidence to suggest that use of electronic diaries
can increase the statistical power of the study.
 Possibility that study size could be reduced.
 Improved return on investment for sponsor
 Regulatory authorities might require sponsors to
consider use of electronic diaries.
NorthWise Services
ABEMEP 2004
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Conclusions
 Can be problems with use of paper diaries
 Compared with paper, use of electronic diaries can
lead to:
 Improved patient compliance
 Better quality data
 Tighter study management
 Cost savings
NorthWise Services
ABEMEP 2004
NorthWise Services
Key Contact Details
• Telephone
+44 (0) 1795 411571
• Email
[email protected]
• Website
www.northwiseservices.com
NorthWise Services
ABEMEP 2004