Involving Diverse Communities in Clinical Research

1. Involving Diverse Communities in Clinical Research Anna Nápoles-Springer, Ph.D. May 22, 2007

2. Outline • NIH mandate • Introduce recruitment issues in diverse groups • Review framework and critical questions for designing recruitment approaches • Involving communities in research

3. Background:History of Research Abuse and Neglect • 1960’s elderly cancer patients in Jewish Chronic Disease Hospital in Brooklyn, NY injected with live cancer cells to measure immunologic reactions • Tuskegee Syphilis Study in Alabama 1932-1972: untreated progression of syphilis in hundreds of poor Black men • 1980’s Women’s movement pushed for more involvement in research-aspirin study to determine efficacy in reducing heart attack risk-1982-men only

4. Background:NIH Mandate to Recruit Minorities • 1993 NIH Revitalization Act: women and minorities must be included in clinical research supported by NIH • For clinical trials, recruitment methods must yield sufficient numbers to allow valid evaluation of ethnic differences • Need to provide scientific evidence to inform health policy or standard of care that is relevant for major ethnic groups

5. 4 Basic Recruitment Issues in Diverse Groups • Mismatch between priorities of researchers and communities • Barriers to participation include historical, social, financial and attitudinal factors • Need for more evidence as to what works • Requires special strategies, additional resources, and flexibility

6. Mismatch in priorities

7. Identifying Community Priorities and Attitudes about Research • Survey: conducted a mail survey of 117 San Francisco and Oakland CBOs serving African Americans and Latinos, identified through community resource listings and prior outreach efforts • Focus groups: conducted 4 focus groups with 36 low-income residents (aged 58-84) of Bayview Hunters Point, Western Addition and Mission District

8. CBO Survey Unmet Needs of African American and Latino Elders Percent Needing Lots/Huge RankUnmet Need Amount of Help 1 Affordable housing 71 2 Enough money to meet needs 70 3 Transportation 60 4 Safer neighborhoods 60 5 Medical care 53 6 Help with household tasks 45 7 Care for depression or anxiety 45 Nápoles-Springer A et al., Research on Aging. 2000;22(6):668-691. .

9. Focus GroupsSocial Priorities • Urban isolation and vulnerability • Racism and discrimination in housing and health care • Social impotence, hopelessness • Personal safety of elders • Affordable and easy access to housing

10. Focus GroupsHealth Priorities • Need for community-based health centers • Access to new prevention and treatment options • Better communication with physicians • Better insurance coverage

11. Historical, financial, and attitudinal barriers

12. CBO SurveyTrust in Researchers % Neither % AgreeA nor D% Disagree L and AA do not take part due to distrust 65 29 6 L and AA afraid due to discrimination 43 39 18 Studies guard health of participants 41 45 14 Researchers protect rights of participants 35 55 10 Participants treated as guinea pigs 30 46 24 Good reason not to trust health researchers 25 43 32 Researchers are condescending to minorities 25 62 13

13. Focus GroupsBarriers to Participation in Research • Distrust of doctors, researchers, institutions • Lack of information • Lack of follow-up if adversely affected • Inconvenience • Lack of transportation • Caregiver obligations • 31% of African Americans and 95% of Latinos agreed to be re-contacted

14. Focus GroupsExperimentation “They don’t know if people are tellin’ the truth. You know, they will tell you you’re gonna get in this research. Well, what IS this research? Are you REALLY gonna do what you say you’re gonna do? Or are you gonna tell me, are you puttin’ me, and then injectin’ me with the AIDS virus, or a syphilis virus, or something else, and I’m not aware? …People are afraid. They just don’t know enough about these programs.”

15. Focus GroupsBenefits of Research • Advance scientific knowledge • To preserve one’s health • To learn more about a specific disease • To teach researchers about cultural differences • Access to new treatments

16. Focus GroupsLack of Tangible Benefits “Me, I would have to know that the information they get is gonna benefit the community, as well as me, in some way. If I knew…the findings would benefit the community, and something would be DONE with those findings. They’ve got researchers from UC everywhere, have been out here to research the soil, the air, everything. And then after, they go, that’s the last we hear of it.”

17. Researchers Working For Communities CBO respondent “Researchers need to spend time in agencies and in community or clients’ homes to develop trust. Paying people and providing transportation is not enough to increase participation. The study has to have some intrinsic worth to the research participant. Communicating the results back to the agency and participants is crucial to developing trust.”

18. Conclusions • Need to improve fit between the priorities of researchers and those of the community • AA & L community members place a great value on knowledge, especially if it improves their health or their communities’ health • AA & L are willing to participate if: • we openly address their concerns • we reduce barriers to participating

19. Lack of evidence on recruitment

20. Lack of Evidence on Recruitment • Diverse groups underrepresented in research • Studies that do include minorities seldom present recruitment by ethnicity • Rigorous studies and reporting of recruitment effectiveness seldom conducted

21. Lack of Evidence on Recruitment • 65 recruitment studies (‘93-95) + all articles with human subjects from NEJM and Circulation (‘95) • 59% of studies reported ethnicity of enrolled subjects vs. 91% reporting on age and 80% on gender Ness R. 1997AEP,7:7; 472-8

22. Lack of Evidence cont. • Of 600 articles 1970-2003 on community-level obesity-lifestyle interventions in general population, only 5 presented ethnic-specific data Yancey AK, et al. 2004. Prev Chronic Disease, 1:1-18

23. Lack of Evidence on Recruitment • Review of U.S. Phase III cancer prevention and treatment trials, 1990-2000 with at least 100 participants: 205 treatment and 56 prevention • Age/gender reported in ≈ 92% • R/E reported in 35% of tx and 54% of prevention RCTs • No tx RCTs used R/E as selection criteria while gender specified in 44% and age in 29% Swanson GM,2002 Cancer:95(5); 950-9.

24. When Consent Rates are Available by Race/ethnicity… …minorities may be just as willing to participate …Latinos may be slightly more likely than Whites: OR=1.33 (95% CI 1.08, 1.65) - Reviewed NHIS 2000, NHANES 2000, NIS2000, 10 clinical interventions studies, and 7 surgical trials Wendler D, et al., 2006. PLoS Med;3(2):e19

25. Recruitment Effectiveness • Very few experimental studies of methods by ethnic subgroups • Observational data indicate: • Whites may refuse at higher rates • AA and Latinos require greater efforts to enroll • Personal and media approaches in combination yield good results • Community involvement is key

26. Attention to recruitment strategies and resources

27. Recruitment Factors Sampling frame Individual/family factors Study characteristics Recruitment methods Personnel characteristics Stages of Participation Invitation to participate Establishing contact and eligibility Initial response Study retention and completion Recruitment Framework

28. Sampling Strategies • Use lists and identify surnames • 80% sensitive and specific for Latinos • Very sensitive and specific for Vietnamese • Target census tracts based on high-density areas for subpopulations • Budget additional $ to screen for ethnicity if not available in sampling frame • Allow for misclassification of ethnicity • Harder (more $) to recruit older adults

29. Factors and Stages of Recruitment: Critical Questions Stage 1: Invitation to participate • Is sampling frame likely to yield representative sample of targeted subgroups (adequate coverage)? • Does initial contact method account for literacy, culture, education, language, familiarity with and acceptance of research? • Are messages appealing to targeted audience? • Are there pre-recruitment strategies that might help (e.g., radio ads, outreach)?

30. Factors and Stages of Recruitment: Critical Questions Stage 2: Establishing Contact and Eligibility • How accurate is the contact information? • Is ethnicity available/accurate? • When is the best time to attempt contact? • Do I have to obtain the consent of other family members? • Is no response a soft refusal? • Will poor health/high mortality affect recruitment? • Are eligibility criteria a barrier?

31. Factors and Stages of Recruitment: Critical Questions Stage 3: Responding • How do I deal with those who do not respond? • How do I deal with refusals? • Is the respondent burden reasonable? • Are there tangible benefits to participating? • Are the setting, approach and personnel welcoming? • Is the research relevant and interesting to participants?

32. Factors and Stages of Recruitment: Critical Questions Stage 4: Study Completion • How do participants feel about the study? • How do I retain people in the study? • How can I maintain current contact information? • Is the respondent burden reasonable? • Are there tangible benefits to participating? • Are the setting, approach and personnel welcoming? • How do I feed back the results to participants and the communities involved?

33. Aims of IPC Recruitment Study • Achieve equal representation of 4 ethnic- language groups in a telephone survey of the interpersonal processes of care (communication with MD, decision making, interpersonal style of MD) • Assess response status at various stages by ethnic-language group • Assess effectiveness of ethnically-tailored letter on minority recruitment

34. Recruitment Methods • General approach: Initial contact letter with phone follow-up to patients in clinic database • Pre-testing of envelopes, letters for clarity, readability, appeal • Bilingual materials and personnel • Randomized trial of ethnically-tailored initial contact letters for African Americans and Latinos • Enhanced follow-up protocol with Latinos due to smaller numbers; ↑ no. of calls, search for wrong phone nos.

35. Initial Contact Letter Project Logo YourOpinionsMatter Help Us Improve Communication Between Doctors and Patients Please Consider Taking Part In This Study • Ethnically-tailored initial contact letters for non-Whites referred to: • shortage of ethnic concordant MDs • need for input of patients from their ethnic group

36. IPC Recruitment Results

37. IPC Recruitment Results

38. IPC Response Rates by Letter Type

39. Summary of IPC Recruitment Results • Primary subject loss is prior to contact • Unable to contact: bad numbers, no household contact, no individual contact • Ranged from 27% (LS) to 48% (W) • Most noncontact of W due to no household contact (e.g., answering machines, no answer) • Once contacted, response rates are fairly high • Higher in LS (75%) and AA (70%) • Lower in LE (68%) and W (66%)

40. Recruitment: General Guidelines • Develop strategies to avoid or deal with incorrect contact information • Develop strategies for “soft refusals” (no answer, individual not at home, busy right now) • Design methods and materials to be culturally sensitive; pretest • Anticipate barriers to extent possible • Develop recruitment tracking system • Obtain community support for project

41. What Works and What Doesn’t? • Use multiple strategies, personal approaches, community involvement, tangible benefits, culturally similar research personnel • Address language, economic, transportation, childcare needs • Openly address issues of distrust and fear • Set recruitment goals, track on-going results, adjust methods as needed

42. Practical Recruitment Advice • Build credibility of research institution through community service • address issues of distrust • Increase awareness of resources available at the research institution for the community • lectures, medical and referral services, translations, health screenings, clinical trials, grant writing • Increase access to research information • community forums, outreach, convenience, newsletters, responsiveness to community priorities

43. Practical Recruitment Advice • Budget for time to develop recruitment strategies • Pretest recruitment messages and strategies • e.g. pre-test ethnically tailored flyers, contact letters, envelopes • Ongoing monitoring of recruitment results is critical, adjust as necessary • Report results by ethnicity • to build evidence of effectiveness of methods

44. Why an Increased Focus on Communities? • To broaden our models of health to include individual, social and environmental influences • Expansion of outcomes from morbidity and mortality to include well-being and QoL • Managed care focus on enrolled populations and health maintenance • Challenges of addressing health disparities

45. IOM Concept of Primary Care: New Facets • Integrated, accessible health care services • Attend to wide range of individual needs • Long-term partnership with clients • Attend to broader family and community context of health care - social and economic factors affecting the health and well-being of individuals, families and communities • Utilizes specific community-based empowering strategies, e.g. use community assets to improve health Primary Care America’s Health in a New Era, IOM, 1996.

46. Working with Communities to Conduct Health Disparities Research • Expands our perspective • Shifts focus from how to recruit minority populations and how to engage/interest them in research… … to having minority communities involved as partners in research from the beginning

47. Key Principles of Community-based Participatory Research (CBPR) • Recognizes community as an important aspect of individual and collective identity • Builds on strengths and resources of community to improve health • Facilitates collaborative partnerships through all phases of research • Integrates knowledge and action for mutual benefit of all partners (Israel B. Annu Rev Public Hlth. 1998. 19:173-202)

48. Key Principles of CBPR • Shared learning and empowering to address social inequalities • Iterative process: partnership development and maintenance, assessment, goal-setting, development of methods, data collection, interpretation, dissemination, policy, action, sustainability • Positive and ecological perspective of health • Dissemination of findings to all partners (Israel B. Annu Rev Public Hlth. 1998. 19:173-202)

49. Methodological Issues • Flexibility to tailor methods to objectives, context, and interests of community • Involve community members in all stages • Conduct community assessment • Develop training and educational opportunities • Involve partners in dissemination • Interdisciplinary research teams

50. Other Issues • Community individuals and agencies often volunteer their time (as do research staff) • CBPR may not carry same promotional weight in academia as other types of research • More difficult to obtain funding • Lack of support for relationship building and facilitating community change • Need for more in-depth publications of processes and outcomes of CBPR