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PEER-ProTECT Study

PEER-ProTECT Study. Neal Dickert , MD, PhD Emory University School of Medicine Co-authors: Victoria Mah , MPH Rebecca Pentz , PhD. PEER-ProTECT. Population= 85 enrollees/surrogates in ProTECT III Methods= Telephone interviews conducted by central contractor 12 sites participating

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PEER-ProTECT Study

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  1. PEER-ProTECT Study Neal Dickert, MD, PhD Emory University School of Medicine Co-authors: Victoria Mah, MPH Rebecca Pentz, PhD

  2. PEER-ProTECT • Population= 85 enrollees/surrogates in ProTECT III • Methods= Telephone interviews conducted by central contractor • 12 sites participating • Structured, interactive interview guide adapted from PEER RAMPART study • Allow participants to develop views • Allow insight into participants’ understanding of questions/issues

  3. PEER-ProTECT • Different parent study from RAMPART • Placebo-controlled vs. active control • Promising preliminary data; potential benefit • Existing treatment is poor • High mortality and major morbidity • Wide range of sites • Greater interview standardization

  4. Interview Guide Domains • Prior research experience and attitude toward research • Knowledge of the study • Views on having been included in the study • Views on acceptability of EFIC in research- in this study and in general • Views on placebo • Views on randomization • Views on conversations with investigators/study staff • Views on community consultation • Impact of public disclosure • Trust in researchers and in clinical research • Demographics and medical background

  5. Population (n=85)

  6. PEER-ProTECT Sites

  7. Views on ProTECT and EFIC

  8. Views on ProTECT and EFIC

  9. RAMPART vs. ProTECT

  10. Reasons for Negative Views

  11. Placebo and Randomization

  12. Other Findings • Substantially better understanding of the study than PEER-RAMPART • Many people felt they were enrolled under surrogate consent • Because consent was obtained very early • Reasons for negative views were very similar to PEER-RAMPART

  13. Summary • Acceptance as high or higher than most CC • CC does not appear to overestimate acceptance • Surveys may significantly underestimate • Real questions about understanding in CC • Open question how much is enough • Again illustrates that engaging people in discussion about EFIC is challenging • Very positive interactions with study staff. This makes a difference!

  14. Acknowledgments • Co-PI: Rebecca Pentz • Study Coordinator: Victoria Mah • Co-Investigators: • David Wright • PEER-ProTECT sites • Funding: • Greenwall Foundation

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