1. ProTECT III Community Consultation Study Neal W Dickert, MD, PhD, Victoria Mah, MPH, Michelle H Biros, MD, Deneil Harney, MPH, MSW, Robert E Silbergleit, MD, Jeremy Sugarman, MD, MA, MPH, Emir Veledar, PhD, Kevin P Weinfurt, PhD, David W Wright, MD, Rebecca D Pentz, PhD

2. Why are we studying CC? CC requirement is unique to EFIC CC is confusing Multiple potential goals Multiple methods Community consultation can be a barrier to important research

3. CC Feedback Varies in NETT MN State Fair Survey for RAMPART (Survey at Community Event) Biros et al. Resuscitation. 2009. Agree (n=1901) “My own EFIC enrollment in this study would be acceptable.” 45% RAMPART CC Study (Existing Group Meetings) Govindarajan et al. Academic Emergency Medicine. Forthcoming. Agree (n=207) “Would you agree to participate in this study?” 70%

4. Knowledge Gaps No study has examined CC results across multiple sites for the same study Little is know about impact/role of different CC methods Rates of EFIC/study acceptance Level of understanding among respondents How to use feedback ProTECT CC study was a collaborative effort to address these issues within NETT

5. Methods Survey instrument/assessment tool Developed in consultation with HSP-WG Cognitively pre-tested Research purpose and reporting mechanism 2 forms of the survey available Self-contained form for self-administration (included disclosure/description of ProTECT) Survey alone for administration after a CC event Did not include sites who had previously developed site or method-specific tools

6. Design Instrument designed to characterize the range of feedback and address 3 hypotheses: 1.Interactive CC methods lead to greater acceptance of EFIC in general and personal EFIC enrollment. 2.Interactive methods increase knowledge of study details. 3.Increased study knowledge predicts EFIC acceptance.

7. Statistical Methods CC methods categorized by interactivity Interactive: interviews, focus groups, existing meeting groups, investigator-initiated meetings, town hall/open forums Non-interactive: surveys at events, surveys online/email 5-point Likert-scale questions collapsed Knowledge-based questions summed as a 10-point composite score Regression models and GLM created

8. Demographics Data SourceCC Study SampleEntire CC Pop. n26128835 Age, Mean (SD)40.2 (16.6)40.8 (16.3) Sex Male1131 (44.0%)3280 (42.3%) Female1439 (56.0%)4470 (57.7%) Ethnicity Hispanic135 (5.4%)395 (7.3%) Not Hispanic2363 (94.6%)5034 (92.7%) Race White1931 (76.4%)5799 (78.5%) Black318 (12.6%)1007 (13.6%) Other*279 (11.0%)581 (7.9%) Education High school or <349 (13.6%)1289 (18.1%) College or >2209 (86.4%)5837 (81.9%) Know TBI Victim(s) Yes (self, family or loved one) 631 (24.6%)1670 (24.8%) No (other/none)1935 (75.4%)5058 (75.2%)

9. Range of Methods InteractiveNon-Interactive Total In- person interview Focus group Existing group Investig initiated Town hall /open forum Survey- community event Survey- web or email # Events 4 (4.9%) 5 (6.1%) 43 (52.4%) 3 (3.7%) 4 (4.9%) 21 (25.6%) 2 (2.4%) 82 # Participants 51 (1.9%) 43 (1.6%) 847 (32.4%) 44 (1.7%) 54 (2.1%) 1111 (42.5%) 462 (17.7%) 2612 # Hubs 228226212

10. Recall of Study Information QuestionTotalInteractive Non- Interactive Unadj OR Medication studied correct 2291 (87.7%) 978 (94.1%) 1313 (83.5%) 3.17 [2.37-4.25] Study design correct 2189 (83.8%) 917 (88.3%) 1272 (80.9%) 1.78 [1.42-2.23] Randomization correct 2006 (76.8%) 848 (81.6%) 1158 (73.6%) 1.59 [1.31-1.93]

11. Recall of Study Information QuestionTotalInteractive Non- Interactive Unadj OR Risks correct 1671 (64.0%) 578 (55.6%) 1093 (69.5%) 0.55 [0.47-0.65] Benefits correct 1336 (51.2%) 634 (61.0%) 702 (44.6%) 1.94 [1.66-2.28] Composite knowledge score- high 1856 (71.1%) 801 (77.1%) 1055 (67.1%) 1.65 [1.38-1.98]

12. Views on EFIC and CC QuestionTotalInteractive Non- Interactive Unadj OR Agree w/EFIC in general for ProTECT 1370 (54.1%) 622 (62.6%) 748 (48.7%) 1.76 [1.50-2.08] Agree w/personal EFIC enrollment in ProTECT 1801 (70.8%) 762 (76.6%) 1039 (67.1%) 1.60 [1.34-1.92 Agree w/enrollment by a surrogate in ProTECT 2192 (86.4%) 881 (88.8%) 1311 (84.9%) 1.41 [1.11-1.80] Yes, given enough info to decide if OK to do study 2088 (82.5%) 871 (87.8%) 1217 (79.1%) 1.90 [1.52-2.39]

13. EFIC Acceptance- MVLR Interactive vs. Non-interactive Race: Black vs. White Race: Other vs. White Education: College vs. HS Yes vs. No Know TBI Victim(s) Accept EFIC in General 2.02 [1.65-2.47] 0.86 [0.67-1.11] 0.47 [0.36-0.63] 0.99 [0.77-1.26] 1.27 [1.04-1.55] Accept Personal EFIC Enrollment 1.81 [1.45-2.27] 0.78 [0.60-1.03] 0.58 [0.44-0.77] 1.27 [0.98-1.64] 1.23 [0.99-1.55] *Age, gender, and community type were not significant in the models

14. Composite Knowledge- GLM

15. EFIC Acceptance by Site

16. EFIC Acceptance by Method

17. Summary Overall acceptance is reasonably high Interactive CC methods associated with greater acceptance of EFIC enrollment Interactive CC associated with greater recall about study elements except risks Significant variability in acceptance at community-meeting based CC events Lower EFIC acceptance among “other” races vs. whites, but no significant difference between black and white

18. Implications Choice of method impacts EFIC acceptance and CC participants’ level of understanding of the study being discussed Types of feedback are meaningfully different Public reaction versus more considered opinion Not sure what to make of the risk difference Variability among interactive events is not surprising but has important implications Can’t read too much off a simple acceptance rate Some sources of variability are good Some may be problematic

19. Implications Growing body of evidence will provide benchmarks and method-specific knowledge Will need data across different types of studies Better characterize local variability Different methods target different goals Lingering questions Whose views matter most? What level of “acceptance” is enough? How much CC is sufficient?

20. Acknowledgments ProTECT Boss- David Wright HSP Working Group Participating sites