Patient Survey Data Results: Reminder Preferences in Patient- Reported Outcomes Studies

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Patient Survey Data Results: Reminder Preferences in Patient- Reported Outcomes Studies Mark Wade Director, Patient Focused Solutions Almac @AlmacClinTech

Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, Drug Information Association Inc., DIA and DIA logo are registered trademarks. All other trademarks are the property of their respective owners. 2

Objectives 1 Identify the most common reasons why patients can be non-compliant with their patient diaries 2 Identify reminder modes patients prefer and evaluate reminder strategies preferences and mode feasibility 3 Plan future implementation of reminders on PROs based on patient preferences and the feasibility of reminder modes

Keeping Patients Engaged PROs keep patients engaged by directly involving them in patientcentered research Reminders can be a beneficial feature of ecoas which can keep patients engaged, while also promoting optimal compliance Important to plan an effective reminder strategy that would work best for engaging the patient during the trial To identify effective reminder strategies, survey data that focused on patient preferences for reminders in PROs was investigated

Patient Preferences in Completing Patient Diaries To better understand patient preferences when participating in PROs, Almac conducted survey research in 2013 Global sample; N=405 Included patients who participated in at least 1 clinical trial with patient diaries in the past 2 years Internet-based survey; ~20-30 minutes Previous diary experiences, preferences, future suggestions, personal technology behaviors

Survey Demographics 23.4% Region 12.6% Europe Gender 64. N. America Rest of World 52. 48. Male Female N=405 Age N=404 17. 32.1% 21.2% 29.6% 18-29 30-39 40-49 50+ N=405

Patient Compliance Based on Most Recent Clinical Trial

Diary-Use in Most Recent Clinical Trial Patient Compliance with Completing Diaries 53.6% 46.4% Non-compliant Compliant N=398 Subjects were asked to report if they were always compliant with patient diaries in their most recent clinical trial Compliance is often inflated when self-reported by patients Compliance is quite low as self-reported by patients, and if this is inflated, compliance may need some enhancement in clinical trials

Diary-Use in Most Recent Clinical Trial Non-compliance: Demographic Characteristics Age 10 N=398 8 6 Non-compliant Compliant 4 2 18-29 30-39 40-49 50+ (p=.07)

Diary-Use in Most Recent Clinical Trial Non-compliance: Overall satisfaction with diary experience Patient Satisfaction N=398 10 8 6 4 Non-compliant Compliant 2 Positive Satisfaction Dissatisfaction (p=0.001)

Diary-Use in Most Recent Clinical Trial Non-compliance: Negative experience factor = hard to remember 75% N=398 6 45% 3 Non-compliant Compliant 15% Did Not Select (n=317) Selected Negative Factor (n=81) (p<.01)

Diary-Use in Most Recent Clinical Trial Reasons for Non-compliance of Non-compliant Respondents 6 N=185 45% 3 15% They Forgot Too Busy Diary Access Other

Planning for Future PRO Trials Based on Patient Recommendations

Future Clinical Trials: Helpfulness Ratings of Reminders for Patient Diaries 9 75% 6 45% 3 15% 77.2% 22.8% N=403 High Attractiveness Rating (5-7) Low/OK Attractiveness Rating (1-4)

Future Clinical Trials: Helpfulness Ratings of Reminders for Patient Diaries Gender N=403 9 75% 6 83.9% 71.4% High Attractiveness Rating (5-7) 45% 3 16.2% 28.6% Ok/Low Attractiveness Rating (1-4) 15% Female Male (p<.01)

Future Clinical Trials: Helpfulness Ratings of Reminders for Patient Diaries Reminders were annoying 9 79. N=398 75% 6 56.4% 43.6% High Attractiveness Rating (5-7) 45% 3 15% 21. Ok/Low Attractiveness Rating (1-4) Did Not Select Selected Negative Factor (p<.01)

Future Clinical Trials: Preferred Reminders Modes 75% 67.2% N=403 6 45% 3 15% 34.3% 32.6% 18. 16.1% 6.2% 5.7% 0.5%

Future Clinical Trials: When Patients Want To Be Reminded to Complete Diary Entries 45% 3 39.2% 25.3% 32.3% N=403 15% 2.8% 0.5%

Future Clinical Trials: When Patients Want To Be Reminded to take study meds 45% 33.8% N=403 3 20.6% 16.6% 15.9% 15% 5. 5.7% 2.5%

Future Clinical Trials: When Patients Want To Be Reminded of study visits 45% 33.8% N=403 3 20.6% 15% 5. 5.7% NO Reminder On day of appt 1 day BEFORE 2 days BEFORE

Future Clinical Trials: When Patients Want To Be Reminded to collect study samples 6 53.9% N=403 45% 3 28.8% 15% 5.5% 11.9% NO Reminder 1 day BEFORE 1x on the day 2x on the day

Future Clinical Trials: Patient Suggested Improvements to Enhance epro Experience 45% 34.1% N=403 3 15% 28.4% 27.7% 21.5% 19.8% 14.6% 13.3% 12.1%

Patient Technology Behaviors

Patient Technology Behaviors: Types of Technologies/ Devices Owned by Subjects 9 81.2% N=403 75% 60.5% 6 49.9% 49.4% 45% 37. 3 15% Computer Smart Phone Landline Cell Phone w/ Unlimited Texting Tablet 16.8% Cell Phone w/o Unlimited Texting 1. None

Patient Technology Behaviors: Hours Per Day Spent Using a Computer 45% 42. N=403 3 24.7% 16.3% 15% 9.1% 8. <=2 hrs 3-5 hrs 6-8 hrs 9-12 hrs >=13 hrs

Patient Technology Behaviors: Checking Text Messages vs. Emails Upon Receipt 6 52.9% N=403 45% 3 15% 15.1% Text Messages Emails (p<.0001)

Conclusions

Planning Reminder Strategies Well Patient preferences for reminders related to diaries and other study tasks should be given careful consideration Top non-compliance reason is forgetting suggesting that reminders can be helpful in enhancing compliance Results show that patients prefer to be reminded Results suggest incorporating optimal reminder strategies can positively affect patient experience and compliance With today s technologies, study design must keep pace with patients behaviors and preferences when developing effective reminder strategies

Thank you Mark Wade Director, Patient Focused Solutions Almac @AlmacClinTech Join the conversation #dia2014 29