MCW Experience Implementing Community Consultation: Strengths and Weaknesses

1. MCW Experience Implementing Community Consultation: Strengths and Weaknesses Tom P. Aufderheide, M.D., FACEP, FAHA Professor of Emergency Medicine Associate Chair of Research Affairs Medical College of Wisconsin

2. Presenter Disclosure Information • Tom P. Aufderheide, M.D., FACEP, FAHA • Presentation: MCW Experience Implementing Community Consultation: Strengths and WeaknessesFinancial Disclosure: • Grants: ROC (NHLBI), Immediate Trial (NHLBI), ResQTrial (NHLBI), NETT (NINDS) • Consultant: Medtronic, Take Heart America, JoLife • Unlabeled/Unapproved Uses Disclosure: • I have performed studies with the ResQPOD ™ and have no equity, patent, or financial interest in the ResQPOD ™

3. MCW Community Consultation • Suggested content • Nature and purpose of the study • Meaning of informed consent • Informed consent will not be obtained • Risks and benefits of the study • Feedback from community about the research • Suggested methods (variable by study and site) • Town Hall Meetings • Focus Group Sessions • Random Digit Dialing • Combination • Surrogate community to derive feedback

4. MCW Community Consultation • Not community consent • IRB should be integrally involved in community consultation • Document feedback about controversial issues • Identify objections from the community • Obtain overall sense of acceptance or lack of acceptance from the community for proceeding with the study • Determine if acceptable community consultation has occurred • Purpose of community consultation is: • Derive feedback from a surrogate community regarding a specific research protocol • Determine if it is acceptable to proceed with the study based on that feedback from the community

5. MCW Experience with EFIC • Public Access Defibrillation (PAD) Trial • Impedance Threshold Device (ITD) for Improving Standard CPR • ResQTrial • Resuscitation Outcomes Consortium • Hypertonic Saline Trial • PRIMED Trial • NETT

6. MCW Approach to Community Consultation • Community Consultation has evolved and improved over the years based on our experience • Initial study (PAD Trial) • Implemented CC developmental meetings • IRB Chair, members of the Bioethics Department at MCW and Children’s Hospitals • Final authority over process and content • Investigator served as a consultant to the group • IRB and Bioethics members helped define and approve the process and content of Community Consultation • Investigator implemented that process • This approach • Has been very successful • Engendered confidence by the IRB in the process (because they developed it) • Never been IRB concerns about community consultation • Positive feedback from the IRB regarding completion of community consultation in all of our studies • Strongly recommend IRBs and investigators consider using this model when developing their first community consultation

7. Town Hall Meeting Model

8. Town Hall Meeting Model • Meeting takes place outside MCW (Italian Community Center) • Research presentation (30 minutes: content approved by IRB) followed by open questions, answers, and discussion by attendees • Town Hall Meeting videotaped (for documentation and review) • A representative from each IRB will be in attendance (listening, not involved in discussion) • Public invitation through the media • Invited stakeholders • Survivors of cardiac arrest, family members of survivors of cardiac arrest, family members of non-survivors of cardiac arrest, politicians, civic leaders, stakeholder organizations(AHA), invitations to ethnic groups reflective of cardiac arrest patient population in Milwaukee

9. Invited Stakeholders • American Red Cross • Visiting Nurse Association • Milwaukee Chapter of the Black Nurses Association • Black Health Coalition • La Guadalupena Senior Center • Department on Aging • Milwaukee County Health Programs • Medical Society of Milwaukee Co. • Milwaukee Academy of Medicine • American Heart Association • Hmong American Women’s Assn • 16th St. Community Health Center • American Diabetes Association • Paramedic Training Center • Sethi Medical Services • Shafi Medical Clinic • Rainbow Community Health Center • Southeast Asian Consulting Service • American Lung Association • St. Anthony’s Church • Milwaukee Jewish Home • Healthcare for the Homeless • Healthwatch Community Advocates • Rev. Benjamin Nabors • Latino Health Organization • Salvation Army Clinic • Cream City Medical Society • Acting Commissioner of Health • AARP • DHHS • Milwaukee Mayor’s Office • Milwaukee County Executive • President of Public Advocacy • Isaac Coggs Health Center • SET Ministry

10. Community Consultation at MCW • In addition to answering questions during the community consultation, investigators provide phone number, email address, and website where attendees can get additional information or provide feedback at a later date • The day after the community consultation, investigators and IRBs meet to determine if acceptable community consultation occurred and recommend next steps • Meeting minutes taken and distributed to IRBs • All feedback from Community Consultation is documented by investigators and provided in writing to the IRBs

11. Town Hall Meeting Strengths • Provides direct interaction between community members and investigators • Provides a forum for discussion among community members on study issues • Allows questions from the community to be directly answered by investigators • Provides the IRB with an overall sense of acceptance or lack of acceptance from the community for proceeding with the study • Previous MCW Town Hall Meetings have been rigorous, interactive, well-attended, and helpful

12. Town Hall Meeting Weaknesses • To achieve a successful Town Hall meeting we must: • Have a research assistant invite potential participants 40 hours/week for 4 months • Confirm positive responses with a follow up letter (including location, time, date, and map) • Call positive responses 1 week prior to the meeting • For 2000 positive responses, 168 attended • Most investigators don’t invest that kind of effort • Town Hall Meetings in other locations are usually poorly attended • Published experience indicates < 20 attendees/meeting • Attendees often have a reason for being motivated to attend and the collective feedback may not represent the broader community • Poor and potentially biased attendance make this approach possibly the least rigorous and least reflective of community feedback

13. Focus Group Sessions

14. Focus Group Sessions • Perform community consultation with targeted focus groups • Governmental organizations • County Board Meetings • Community Organizations • Rotary Clubs, Parent-Teacher Organizations, Church Groups, Activity Centers, Senior Centers • Survivors of similar conditions proposed in the study

15. Focus Group Strengths • Better attendance assured because group has a standing meeting • Provides direct interaction between focus group and investigators • Provides a forum for discussion among focus group members on study issues • Allows questions from focus group members to be directly answered by investigators • Focus group meetings tend to be better attended than Town Hall Meetings • Published experience = > 20 (range: 7-99) • Provides the IRB with an overall sense of acceptance or lack of acceptance from the focus group for proceeding with the study

16. Focus Group Weaknesses • Feedback is generated from the perspective of the specific focus group and may not reflect the general community • Requires a larger number of meetings • Targeting a broad spectrum of groups that are potential stakeholders in the proposed study • IRB needs to assess conglomerate feedback taking into account the perspective of specific groups

17. Random Digit Dialing

18. Random Digit Dialing • Structured telephone survey of the population residing in the geographic area of the study • Implemented by an experienced, independent company without investment in the study • Hebert Research Inc., Bellevue, WA • Survey developed in collaboration with investigator and approved by the IRB

19. Random Digit Dialing • Minimum of 500 respondents • Distributed by zip code to be representative of the geographic area • Random sampling of numbers listed in the telephone directory • Demographic data obtained from the US Census bureau • Demographic sample parameters compared with population parameters and adjustments made to account for response bias • Sampling weights calculated and applied to the survey sample to ensure that various demographic sub-groups are properly represented

20. Random Digit Dialing Survey • Description of the proposed research project in lay language • Description of the potential risks and benefits of being included in the study • Regulations surrounding EFIC • Asked opinions regarding inclusion in the study • Opinion on justification for EFIC • Specific questions regarding reasons for supporting or objecting to the study • All comments made during this process recorded verbatim and included in a final report to the IRBs • Demographic data are collected from respondents and comprehensive statistics reported to the IRB

21. Random Digit Dialing • Random Digit Dialing • 65% - 78% of respondents willing to be entered in the study • 56% - 71% support inclusion of children • Town Hall Meeting • Nearly 100% support • Focus Groups • Approximately 80% support

22. Random Digit Dialing Strengths • Distributing calls by zip code is representative of the entire region • Results can be adjusted based on population demographics to provide a reasonable representation of the study community • Well-established approach commonly used for marketing research and political polling • Comprehensive statistics provided to IRB with calculated margins of error (50 page report) • Relatively large number of responding community members • 500 versus < 20 for Town Hall Meetings • Allows community consultation for study populations unlikely to attend meetings (trauma populations) • Potentially least biased of community consultation approaches

23. Random Digit Dialing Weaknesses • May still be some selection bias among those whose choose to complete the survey • Responses may be affected by the language used in the script • Opportunity for direct interaction with the investigators is limited • Cost • $15,000 for survey with 500 respondents • Non-English speaking minorities may be under-represented in this approach • Surveys can be conducted in other languages • Difficult to explore attitudes and beliefs in depth

24. Random Digit Dialing • Random Digit Dialing is only one component of a comprehensive effort to involve the community at each site • In addition to RDD surveys, information about the study can be provided via media campaigns which included television, radio, local newspapers, and advertisements • Web sites can be established with contact information to provide feedback to investigators • Additional focus groups can also be employed

25. Inclusion of Children

26. Inclusion of Children • EFIC should assess: • Feedback from adults and parents • Address assent of minor • Assent of minor can be addressed by: • Inclusion of children in a Town Hall Meeting • Inclusion of assent of minor questions in random digit dialing surveys of both adults and children • Pediatric focus groups

27. Inclusion of Children • MCW Hypertonic Saline Trial • Random Digit Dialing • Asked questions of adults whether it was appropriate to enter children aged 15 – 17 in the study • Asked questions of children aged 15 – 17 whether they would be willing to be entered in the study • 7 additional pediatric focus groups • Presented the study, potential risks and benefits • Followed by discussion and feedback on willingness to be entered in the study • Combination of Random Digit Dialing and Focus Groups was perceived as the optimal approach to date to comprehensively assess relatively unbiased community feedback and provide direct contact with investigators (address assent of minor for children)

28. Summary

29. Summary • There is no magic bullet for community consultation • Each method has its strengths and weaknesses • The local IRB has responsibility to approve the process for CC, determine if adequate CC has occurred, modify the study based on feedback from the community, if appropriate, and approve proceeding with the study • Strongly recommend the local IRB, local ethicists, and investigators implement CC developmental meetings and collectively agree on a CC process prior to IRB submission

30. Summary • MCW experience with EFIC has resulted in an evolving process for community consultation • Town Hall Meetings: Poor and potentially biased attendance make this approach possibly the least rigorous and least reflective of community feedback • Can succeed with substantial investment in time, effort, and money • Focus Groups: Feedback is generated from the perspective of the specific focus group and may not reflect the general community • Provides direct interaction between investigator and potential subjects • Random Digit Dialing: Potentially the most comprehensive and least biased of community consultation approaches • May still be some selection bias • Provides no direct interaction with investigators • Inclusion of children requires addressing assent of minor in the method for community consultation

31. Summary • MCW experience with EFIC has evolved to using a combination of these methods • Random Digit Dialing combined with Focus Groups captures many strengths of these methods and is submitted for consideration as a compelling option • There is no “correct” way for performing community consultation • The optimal approach should be developed collaboratively by investigators, ethicists, and the local IRB, based on an understanding of the local community, and approved by the local IRBs

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33. Thank you!