northwise services patient diaries – electronic or paper ? by dr. philip m. north acrp meeting,...
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NorthWise Services
Patient Diaries – Electronic or Paper ?
ByDr. Philip M. North
ACRP Meeting, Budapest
Friday 6th June 2003
NorthWise Services
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 4 electronic patient diaries
NorthWise Services
NorthWise Services
NorthWise Services
Background of the Speaker
Consultant statistician
23 years in CRO industry, following academic career
Growing interest in electronic data capture generally and electronic patient diaries in particular
NorthWise Services
NorthWise 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
NorthWise 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
• They are often incomplete, inconsistent, inaccurate, biased
NorthWise Services
NorthWise Services
Objectives of Electronic Patient Diary Use
Improve patient compliance to protocol
Improve quality of data collected
Key objectives are:
NorthWise Services
NorthWise 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
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
NorthWise Services
NorthWise 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
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Results reported in the BMJ paper
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30 minute windowTotal number of episodesNumber of excluded episodesMean % compliance (95% CI)
ActualReported
90 minute window Total number of episodes Number of excluded episodes Mean % compliance (95% CI)
ActualReported
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)
Paper diary Electronic diary (n=40) (n=40)
NorthWise Services
NorthWise Services
Desirable Features of an Electronic Patient Diary Device (1)
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
The device needs to be or have:
NorthWise Services
NorthWise Services
Desirable Features of an Electronic Patient Diary Device (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
NorthWise Services
NorthWise Services
Desirable Features of an Electronic Patient Diary Device(3)
Secure data storage
Easy and regular downloading of data
Easy access to data for appropriate users
NorthWise Services
NorthWise Services
Desirable Features of an Electronic Patient Diary Device(4)
Comprehensive audit trail
Validated and accepted by regulatory authorities
FDA 21 CFR Part 11 compliant
Multilingual capability
• Cost-effective
NorthWise Services
NorthWise Services
Features of Diary Device 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
NorthWise Services
Key Contact Details
• Telephone
+44 (0) 1795 411571
• Website
www.northwiseservices.com