Title: NorthWise Services
1NorthWise Services
A Comparison Between Electronic and Paper
Patient Diaries
By Dr. Philip M. North ABEMEP Symposium Electroni
c Data Capture Friday 11TH June 2004
NorthWise Services
ABEMEP 2004
2NorthWise 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
3NorthWise 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
4NorthWise Services
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
5NorthWise Services
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
NorthWise Services
ABEMEP 2004
6NorthWise Services
Objectives of Electronic Patient Diary Use
Key objectives are
- Improve patient compliance to protocol
- Improve quality of data collected
NorthWise Services
ABEMEP 2004
7NorthWise Services
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
NorthWise Services
ABEMEP 2004
8NorthWise 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
NorthWise Services
ABEMEP 2004
9NorthWise Services
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
10NorthWise Services
Results reported in the BMJ paper
Paper diary Electronic diary (n40)
(n40)
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
2445 2435 126 7 11(8 to 14) 94(92
to 96) 90 (86 to 94) 2445 134 20 (14 to
25) 95 (92 to 98)
NorthWise Services
ABEMEP 2004
11NorthWise Services
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
NorthWise Services
ABEMEP 2004
12NorthWise Services
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 patients lifestyle
- Durable
- Water resistant (possibly)
- Long-lasting power source
NorthWise Services
ABEMEP 2004
13NorthWise Services
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
NorthWise Services
ABEMEP 2004
14NorthWise Services
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
NorthWise Services
ABEMEP 2004
15NorthWise Services
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
NorthWise Services
ABEMEP 2004
16NorthWise Services
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
17NorthWise Services
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
18NorthWise Services
Key Contact Details
- Telephone
- 44 (0) 1795 411571
- Email
- philip.north_at_northwiseservices.com
- Website
- www.northwiseservices.com
NorthWise Services
ABEMEP 2004