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A Comparison Between Electronic and Paper
Patient Diaries

By Dr. Philip M. North ABEMEP Symposium Electroni
c Data Capture Friday 11TH June 2004
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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

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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

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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

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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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Objectives of Electronic Patient Diary Use
Key objectives are

• Improve patient compliance to protocol
• Improve quality of data collected

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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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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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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

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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)
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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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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

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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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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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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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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.

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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

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Key Contact Details

• Telephone
• 44 (0) 1795 411571
• Email
• philip.north_at_northwiseservices.com
• Website
• www.northwiseservices.com

NorthWise Services
ABEMEP 2004