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Trends that are driving the field toward e-consenting.
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Patients and E-Access:
Why consider e-consenting Susan Brink, DrPHPresident & CEO, ConsentSolutions, Inc.
Marshall McLuhan
• 1964 – Understanding Media– Media as technological extensions of the body – Hot (print,radio,TV) vs Cool (smart phones,
Internet, texting, iPads, computers, uTube)– Global village (Arab Spring, Assange,
Wikipedia, crowd sourcing, social networking)
• 1967 – The Media is the Massage
“ all media works us over completely”
“ the medium is the message”
HOT VERSUS COOL MEDIA
TRENDS THAT MAY DRIVE CONSENT PROCESS CHANGES
• Trends – Lack of progress in literacy
– Increasing use by public of media for information – Push toward e-electronic medical records– Acceptance of web for health information – Increasing use of all types of digital signature and id– Aging of the population – Increasing use of E-consenting in other industries
E-INFORMED CONSENT
WHAT IS HAPPENING
• 5% of US cancer patients enrolled in trials• Enrollment rates are dropping to 59% in 2006• Retention rates are falling – 48% in 2006• Consent forms are getting longer • Informed consent: major area of FDA citations
Citations: Getz, 2008
WHY CANDIDATE/PATIENT E-CONSENTING ?
•Patient Needs
•Patient Response
•Technology Reach
•Sponsor Benefit
PATIENT RESPONSE COMPARED EFFECTIVENESS OF MULTIMEDIA AND PAPER-
BASED CONSENT
Number ofPeople Needed
Paper-based
Multimedia
Moekel and Brady Pharmaceutical Executive, December, 2003
RESPONSE TO RANDOMIZED CROSSOVER COMPARISON
Multimedia Easy to read More accessible Interesting,
informative More effective and
exciting Faster More comprehensible
• Brink, 2006
Paper Perceived as faster
process Perceived as less
wordy Perceived as
containing more explanation
More personal
PATIENT NEEDS
Comprehension?•14% of US adults are functionally illiterate (NALS 03)
•29% have marginal literacy skills (NALS 03)
•Only 13% US adults can perform complex literary tasks
WHAT DO THEY NOT UNDERSTAND?
•Limited knowledge of terminology (cancer related, test related)
•Polyp, growth, lesion•Vomit (well-understood); orally (slightly over 1/3 understand); malignant and terminal (under 20%)
•Limited knowledge of their bodies and the terms used to describe location of an anatomical part (colon, bowel)
•Confuse terms (DRE and a sigmoidoscopy)
Davis et al. CA: Cancer J for Clinicians 2002:52:134-149.
WHAT MIGHT HELP?
• Can be included in e-consenting – Use pictures and stories– Self-assessment – Clarify the decision•
• By clinical staff, after viewing consent – Use “teach back”
• Change at the sponsor/investigator/IRB level– Use “living room language
Davis et al. CA: Cancer J for Clinicians 2002:52:134-149.
WHY NOT?
13
TECHNOLOGY / REACH
•How people get information
•Transmittal of information
•Where can they get information
•World-wide Penetration
HOW DO PEOPLE GET INFORMATION
» Newspaper» TV
Traditional Media» Books
» Internet New Media
» Social media sites
» friends, family, acquaintances
GLOBAL ICT DEVELOPMENTS 2000-2010
WHO USES WHAT IN THE US?
July 2007 – US population 301,000,000
Mid-2007 ~ 239,000,000 cell phone
subscribers
73% have computers
73% are Internet users
58% of Americans 50-64 have Internet access
Over 65• 22% use computers (an increase of 47% since
2000)
MULTIMEDIA VS PAPER STUDY
Study Population:
30 volunteers
50% African-American
63% over 50 years old
66% female
Over 50% had participated in a clinical trial
MULTIMEDIA VS PAPER STUDY
Time Spent on 1st Consent Read Time Spent on 2nd Consent Read
0
5
10
15
20
25
30
Computer Paper
Min
ute
s
0
5
10
15
20
25
Computer After Paper Paper After Computer
Min
ute
s
MULTIMEDIA VS PAPER STUDY
Computer Preference Paper Preference
Familiarity with medium
Easier to return to for review
Easier to read
Perceived as a faster process
Perceived consent as less wordy
Perceived as containing more explanation
More personal
E-informed consent What is it?
A spectrum of choice
Supplements IRB approved paper-based consent
– Video explanation
– Graphics/ animation
– Text
– Audio explanation
Full consent • Presented in electronic
means
• Full IRB approved text
• Provides patient/subject specific audit trail
• Electronic signature
• Candidate/subject Education
• Amendment facility
• Voice
22
E-INFORMED CONSENT WHAT IS IT?A SPECTRUM OF CHOICE
Supplements IRB approved paper-based consent
• Video explanation
• Graphics/ animation
• Text
• Audio explanation
Full consent
• Presented in electronic means
• Full IRB approved text
• Provides patient/subject specific audit trail
• Electronic signature
• Candidate/subject Education
• Amendment facility
• Voice
WHAT TO CONSIDER
•ROI•Fewer the number of subjects the higher the cost per subject•Larger trials /registries
•Lower cost per subject •Time in planning
•More upfront time needed with IRB and consent •Availability of technology according to the setting/sites/population
•Wifi •Mobile devices
•Security
INFORMED CONSENT IN THE INFORMATION AGE
How do we turn
information
into
Comprehension, Action and Collaboration
PARTICIPANT DECISION-MAKING MODEL
INFORMATION
What do I need to know?
VALUES
How does this coincide with my personal values and
preferences?
MY DAILY LIFE
How does this fit with my life?
Informed Participant
CANDIDATE KNOWLEDGE
Easily accessible education• Graphic animation Embedded Explanation graphic
/video
CANDIDATE KNOWLEDGE SELF-ASSESSMENT
CANDIDATE VALUES & PREFERENCES
WHY CONSIDER A MEDIA BASED CONSENT?
Benefit to prospective study participants
• Understanding of trial and their role
• Presentation Preference
• Retention of information
• Engagement
Leading to more efficient recruitment and cost savings for the trial
– (Jimison et al. 1998; Verheggen & van Wijmen 1997; Fureman et al. 1997; Brady 2003; Moeckel 2005; Brink 2006 ).
