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Brink Why Consider E Consenting For Clinical Trials

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The document discusses moving informed consent to electronic formats to improve patient understanding and engagement by using multimedia like graphics, videos and self-assessments that are more accessible than written text. Electronic consent could help address issues like low health literacy and challenges in enrolling and retaining patients in clinical trials. It may provide benefits to patients through easier access to study information and better comprehension while also reducing costs for trial sponsors.

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Patients and E-Access: Why consider e-consenting Susan Brink, DrPH President & 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 Paper-based Multimedia Number of People Needed Moekel and Brady Pharmaceutical Executive, December, 2003
RESPONSE TO RANDOMIZED CROSSOVER COMPARISON Multimedia Paper Easy to read Perceived as faster More accessible process Interesting, informative Perceived as less wordy More effective and Perceived as containing exciting more explanation Faster More personal More comprehensible Brink, 2006
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 損 Newspaper 損 TV Traditional Media 損 Books 損 Internet New Media 損 Social media sites 損 friends, family, acquaintances
Brink Why Consider E Consenting For Clinical Trials
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 30 25 25 20 20 Minutes Minutes 15 15 10 10 5 5 0 0 Computer Paper Computer After Paper Paper After Computer
MULTIMEDIA VS PAPER STUDY Computer Preference Paper Preference Perceived as a faster process Familiarity with medium Perceived consent as less wordy Easier to return to for review Perceived as containing more explanation Easier to read More personal
E-informed consent What is it? A spectrum of choice Supplements IRB Full consent approved paper-based Presented in electronic consent means Full IRB approved text Video explanation Provides patient/subject Graphics/ animation specific audit trail Text Electronic signature Audio explanation Candidate/subject Education Amendment facility Voice 22
E-INFORMED CONSENT WHAT IS IT?A SPECTRUM OF CHOICE Supplements IRB approved paper- Full consent based consent Video explanation Presented in electronic Graphics/ animation means Text Full IRB approved text Audio explanation 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 VALUES How does this coincide with my personal values and preferences? INFORMATION Informed What do I need to know? Participant MY DAILY LIFE How does this fit with my life?
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 ).
Susan Brink, Dr.PH President & CEO ConsentSolutions, Inc 202-497-9633 sbrink@consentsolutions.com

More Related Content

Brink Why Consider E Consenting For Clinical Trials

  • 1. Patients and E-Access: Why consider e-consenting Susan Brink, DrPH President & CEO, ConsentSolutions, Inc.
  • 2. 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
  • 4. 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
  • 6. 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
  • 7. WHY CANDIDATE/PATIENT E-CONSENTING ? Patient Needs Patient Response Technology Reach Sponsor Benefit
  • 8. PATIENT RESPONSE COMPARED EFFECTIVENESS OF MULTIMEDIA AND PAPER- BASED CONSENT Paper-based Multimedia Number of People Needed Moekel and Brady Pharmaceutical Executive, December, 2003
  • 9. RESPONSE TO RANDOMIZED CROSSOVER COMPARISON Multimedia Paper Easy to read Perceived as faster More accessible process Interesting, informative Perceived as less wordy More effective and Perceived as containing exciting more explanation Faster More personal More comprehensible Brink, 2006
  • 10. 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
  • 11. 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.
  • 12. 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.
  • 13. WHY NOT? 13
  • 14. TECHNOLOGY / REACH How people get information Transmittal of information Where can they get information World-wide Penetration
  • 15. HOW DO PEOPLE GET INFORMATION 損 Newspaper 損 TV Traditional Media 損 Books 損 Internet New Media 損 Social media sites 損 friends, family, acquaintances
  • 18. 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)
  • 19. 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
  • 20. MULTIMEDIA VS PAPER STUDY Time Spent on 1st Consent Read Time Spent on 2nd Consent Read 30 25 25 20 20 Minutes Minutes 15 15 10 10 5 5 0 0 Computer Paper Computer After Paper Paper After Computer
  • 21. MULTIMEDIA VS PAPER STUDY Computer Preference Paper Preference Perceived as a faster process Familiarity with medium Perceived consent as less wordy Easier to return to for review Perceived as containing more explanation Easier to read More personal
  • 22. E-informed consent What is it? A spectrum of choice Supplements IRB Full consent approved paper-based Presented in electronic consent means Full IRB approved text Video explanation Provides patient/subject Graphics/ animation specific audit trail Text Electronic signature Audio explanation Candidate/subject Education Amendment facility Voice 22
  • 23. E-INFORMED CONSENT WHAT IS IT?A SPECTRUM OF CHOICE Supplements IRB approved paper- Full consent based consent Video explanation Presented in electronic Graphics/ animation means Text Full IRB approved text Audio explanation Provides patient/subject specific audit trail Electronic signature Candidate/subject Education Amendment facility Voice
  • 24. 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
  • 25. INFORMED CONSENT IN THE INFORMATION AGE How do we turn information into Comprehension, Action and Collaboration
  • 26. PARTICIPANT DECISION-MAKING MODEL VALUES How does this coincide with my personal values and preferences? INFORMATION Informed What do I need to know? Participant MY DAILY LIFE How does this fit with my life?
  • 27. CANDIDATE KNOWLEDGE Easily accessible education Graphic animation Embedded Explanation graphic /video
  • 29. CANDIDATE VALUES & PREFERENCES
  • 30. 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 ).
  • 31. Susan Brink, Dr.PH President & CEO ConsentSolutions, Inc 202-497-9633 sbrink@consentsolutions.com