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NorthWise Services Patient Diaries – Electronic or Paper ? By Dr. Philip M. North ACRP Meeting, Budapest Friday 6 th June 2003 NorthWise Services

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Page 1: NorthWise Services Patient Diaries – Electronic or Paper ? By Dr. Philip M. North ACRP Meeting, Budapest Friday 6 th June 2003 NorthWise Services

NorthWise Services

Patient Diaries – Electronic or Paper ?

ByDr. Philip M. North

ACRP Meeting, Budapest

Friday 6th June 2003

NorthWise Services

Page 2: NorthWise Services Patient Diaries – Electronic or Paper ? By Dr. Philip M. North ACRP Meeting, Budapest Friday 6 th 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

Page 3: NorthWise Services Patient Diaries – Electronic or Paper ? By Dr. Philip M. North ACRP Meeting, Budapest Friday 6 th June 2003 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

Page 4: NorthWise Services Patient Diaries – Electronic or Paper ? By Dr. Philip M. North ACRP Meeting, Budapest Friday 6 th June 2003 NorthWise Services

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

Page 5: NorthWise Services Patient Diaries – Electronic or Paper ? By Dr. Philip M. North ACRP Meeting, Budapest Friday 6 th June 2003 NorthWise Services

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

Page 6: NorthWise Services Patient Diaries – Electronic or Paper ? By Dr. Philip M. North ACRP Meeting, Budapest Friday 6 th June 2003 NorthWise Services

NorthWise Services

NorthWise Services

Objectives of Electronic Patient Diary Use

Improve patient compliance to protocol

Improve quality of data collected

Key objectives are:

Page 7: NorthWise Services Patient Diaries – Electronic or Paper ? By Dr. Philip M. North ACRP Meeting, Budapest Friday 6 th June 2003 NorthWise Services

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

Page 8: NorthWise Services Patient Diaries – Electronic or Paper ? By Dr. Philip M. North ACRP Meeting, Budapest Friday 6 th June 2003 NorthWise Services

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

Page 9: NorthWise Services Patient Diaries – Electronic or Paper ? By Dr. Philip M. North ACRP Meeting, Budapest Friday 6 th June 2003 NorthWise Services

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

Page 10: NorthWise Services Patient Diaries – Electronic or Paper ? By Dr. Philip M. North ACRP Meeting, Budapest Friday 6 th June 2003 NorthWise Services

NorthWise Services

Results reported in the BMJ paper

NorthWise Services

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)

Page 11: NorthWise Services Patient Diaries – Electronic or Paper ? By Dr. Philip M. North ACRP Meeting, Budapest Friday 6 th June 2003 NorthWise Services

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:

Page 12: NorthWise Services Patient Diaries – Electronic or Paper ? By Dr. Philip M. North ACRP Meeting, Budapest Friday 6 th June 2003 NorthWise Services

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

Page 13: NorthWise Services Patient Diaries – Electronic or Paper ? By Dr. Philip M. North ACRP Meeting, Budapest Friday 6 th June 2003 NorthWise Services

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

Page 14: NorthWise Services Patient Diaries – Electronic or Paper ? By Dr. Philip M. North ACRP Meeting, Budapest Friday 6 th June 2003 NorthWise Services

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

Page 15: NorthWise Services Patient Diaries – Electronic or Paper ? By Dr. Philip M. North ACRP Meeting, Budapest Friday 6 th June 2003 NorthWise Services

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

Page 16: NorthWise Services Patient Diaries – Electronic or Paper ? By Dr. Philip M. North ACRP Meeting, Budapest Friday 6 th June 2003 NorthWise Services

NorthWise Services

NorthWise Services

Key Contact Details

• Telephone

+44 (0) 1795 411571

• Email

[email protected]

• Website

www.northwiseservices.com