1. © 2009 Perceptive Informatics. A PAREXEL ® Company IVRS Feasibility Sue Rizzo, RN 24 May 2010

2. 2 © 2009 Perceptive Informatics, Inc. A PAREXEL ® Company Alphabet soup: What is ePRO? What is IVRS? © 2009 Perceptive Informatics, Inc. A PAREXEL ® Company

3. 3 What is ePRO?  electronic Patient Reported Outcomes  Describes any patient self reported assessment or diary, symptom questionnaire, scale, or HRQL instrument  Alternative to paper collection of patient reported data  Modes of collection include: –IVR (Interactive Voice Response) –IWR (Interactive Web Response) –Handheld device (PDA or Tablet) –Desktop computer

4. Interactive Voice Response (IVR)  Telephone is interface to a computerized system via touch tone technology  Caller hears prompts  Caller key their responses  Data stored directly to central database Central Database (Source) Toll Free DATA © 2009 Perceptive Informatics, Inc. A PAREXEL ® Company

5. 5 Uses of IVR? © 2009 Perceptive Informatics, Inc. A PAREXEL ® Company

6. ePRO Experience  Asthma  Allergy  Attention Deficit Hyperactivity Disorder  Pneumonia  GERD  Gastro paresis  Depression  Breast pain  Migraine  Insomnia  Sexual dysfunction  Osteoarthritis  Irritable bowel syndrome  Parkinson’s disease  Women’s health  Ulcerative colitis  Post herpetic neuralgia  Neuropathic pain  Anxiety (GAD, SAD)  Bronchitis  Oncology 6 280+studies 80countries 100K+patients 10K+sites © 2009 Perceptive Informatics, Inc. A PAREXEL ® Company

7. 7 ePRO Studies by Data Type © 2009 Perceptive Informatics, Inc. A PAREXEL ® Company Primary 27% Secondary 20% Eligibility 6% Other 16% Safety Alone 2% Exploratory 2% Secondary & Other 1% Primary & Other 7% Primary & Secondary 19%

8. 8 ePRO Studies by Target Population Meacham et. al., ISPOR, 2008 © 2009 Perceptive Informatics, Inc. A PAREXEL ® Company

9. 9 ePRO Studies by Assessment Frequency Meacham et. al., ISPOR, 2008 © 2009 Perceptive Informatics, Inc. A PAREXEL ® Company

10. 10 © 2009 Perceptive Informatics, Inc. A PAREXEL ® Company Mean vs. Median Compliance Meacham et. al., ISPOR, 2008 © 2009 Perceptive Informatics, Inc. A PAREXEL ® Company

11. Do reminders make a difference?  SMS Texts –Those who consented were 3.44% (n=8) and 23.97 (n=33) more compliant for dx1 and dx2 respectively –No apparent correlation between lack of consent and timeliness of making scheduled call –Only 22% consented; affect of countries and demographics unknown  Outbound calls: –Seem to/no to have an impact in x% of the time…  Too early to make a judgment 11 © 2009 Perceptive Informatics, Inc. A PAREXEL ® Company

12. Achieving High Compliance  Quality user instruction manuals (site and patient)  Set expectations with sites  Alert sites to non-compliant patients  Alert patients directly via SMS text messaging or outbound calls  Consider a compliance threshold during the run-in period  Don’t lose sight of patient burden –Avoid unneeded complexity / duration 12 © 2009 Perceptive Informatics, Inc. A PAREXEL ® Company

13. 13 © 2009 Perceptive Informatics, Inc. A PAREXEL ® Company Patient experience with IVR Patient experience with IVR © 2009 Perceptive Informatics, Inc. A PAREXEL ® Company

14. 14 © 2009 Perceptive Informatics, Inc. A PAREXEL ® Company Interaction with IVR  Patient interacts directly with the system in a confidential manner  Direction is given as to frequency of required calls  Training system is available to help with comfort level of patient  Site provides patient with a secure envelope which contains an access code –Site maintains patient record, system does not record patient details (i.e. name, personal information) –Patient chooses their own PIN –Combination of supplied access code and patient’s PIN allows access to the system

15. 15 © 2009 Perceptive Informatics, Inc. A PAREXEL ® Company Interaction with IVR  Patient makes calls as directed (i.e. daily, weekly, etc.)  Reports are provided to sites to assist with tracking of compliance  Non-compliance can be handled in different ways: –Site personnel follows up directly with patient –SMS message is sent to patient automatically as a reminder –Outbound calls can be made from system with an automated message for patient –Call centers can be utilized to follow up similar to site follow up above  It is important to take patient confidentiality into account with the above measures

16. 16 Our experience with IVR ePRO  Adult and elderly patients able and willing to use IVR ePRO –Elderly patients almost always more compliant  Disorder (except for those not practical e.g. Schizophrenia) has not been shown to be an influencing factor on compliance  Even more severely ill patients can use IVR ePRO  A burden of twice daily, 5 minute calls for 8-12 weeks has been shown to be acceptable e.g. eszopiclone  Patients are more compliant with routine reporting (daily or weekly) © 2009 Perceptive Informatics, Inc. A PAREXEL ® Company

17. 17 Questions? © 2009 Perceptive Informatics, Inc. A PAREXEL ® Company