A Comparative Study of Mobile Electronic Data Entry Systems for Clinical Trials Data Collection

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A Comparative Study of Mobile Electronic Data
Entry Systems for Clinical Trials Data Collection

• Elodia B. Cole MS1, Etta D. Pisano MD1, Gregory
  J. Clary PhD2, Donglin Zeng PhD3, Marcia Koomen
  MD1, Bo Kyoung Seo MD PhD4, Yeon Hee Lee MD1, Dag
  Pavic MD1

Departments of 1Radiology and 3Biostatistics-Unive
rsity of North Carolina Chapel Hill, NC 2Mi-Co,
Research Triangle Park, NC and 4Department of
Diagnostic Radiology-Konkuk University School of
Medicine, Seoul, Korea
Study funded by
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Mi-Forms/ACRIN System Overview
Mi-Forms Software
ACRIN System
Oracle DBMS
XML
For Tablet PC or Digital Pen Validations XML
Generation
Validations XML Parsing
Windows 2000 or Windows XP PC
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UNC/NCI Study Aims

• Test four mobile data entry devices for speed,
  ease of use, accuracy, and user satisfaction in
  the radiologist task of recording mammographic
  findings on UNCs lab standard clinical report
  form.

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UNC/NCI Study Environment
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UNC/NCI Study Environment
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UNC/NCI Study - Tablet PC

• Pros
• Real time data validation
• Handwriting recognition verification
• Electronic handwritten source document
• Cons
• Hardware expense

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UNC/NCI Study - Digital Pen

• Pros
• Pen on paper
• Portable
• Inexpensive to implement
• Cons
• No real time data verification
• Not capable of automatic database upload

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Digital Pen Technology Background
Anoto Functionality
Paper
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UNC/NCI Study - PDA/Digitizer Hybrid

• Pros
• Pen on paper
• Source document
• Real-time validation
• Cons
• Navigation thru multi-page cumbersome
• Validation requires user to look at PDA screen
• Weight

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Next Generation Hybrid (Not yet studied)

• Pros
• Real-time validation
• Pen on paper
• Source document
• Light weight
• Cons
• Validation requires user to look at PDA screen

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UNC/NCI Study - PDA

• Pros
• Portable
• Cons
• Small screen
• Scrolling required
• No jumps

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Mobile Data Capture Solution
Mi-Forms software enables the process from form
design to information communication, independent
of hardware platform
Design Forms
Capture Data
Verify Data
Communicate
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Mobile Data Capture Solution
Mi-Forms software enables the process from form
design to information communication, independent
of hardware platform
Design Forms
Capture Data
Verify Data
Communicate
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Forms Designer
Easy Layout
User-Defined Business Rules
Simple Toolbars
Excellent Tutorial
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Digital Pen Usage
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Data Verification for Digital Pen Local or
Centralized
Show Ink
Show Field Values
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Tablet PC Input Mode
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Tablet PC Input Mode
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UNC/NCI Study Conclusions

• Tablet PC and Digital Pen with Mi-Forms software
  are faster and easier to use than the PDA and
  Hybrid alternatives.
• Tablet PC and Digital Pen with Mi-Forms software
  are equally fast and equally easy-to-use data
  entry methods.
• Users are more satisfied with these platforms
  than with the PDA and Hybrid alternatives.
• Mi-Forms handwriting recognition results review
  and correction for the Digital Pen is
  significantly faster and more accurate than
  secondary manual keyboard and mouse data entry.
  
• Scientific presentation 12/1/2004 1140-1150

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Other Clinical Forms Applications

• Skilled Nursing Visit Note
• OASIS
• Numerous Encounter Forms
• Audiological Evaluation
• Cardiology Registry
• Any form where data originator is mobile and data
  needed in computer system

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Mi-Co Mobile Data Capture Systems at RSNA

• infoRAD 9906 PDA-i, Elodia Cole, UNC
• Scientific Paper, SSK22-08, Elodia Cole, UNC
• 12/1/2004 1140-1150
• Hewlett Packard Hall A, Booth 5548
• Motion Computing Hall A

2 Davis Drive Research Triangle Park, NC
27709 Tel [phone] Web www.mi-corporation.co
m gclary_at_mi-corporation.com