Direct Access Genetic Testing: Lessons Learned from The Multiplex Initiative Colleen M. McBride, Ph.D. Direct Access Genetic Testing: Lessons Learned from The Multiplex Initiative Colleen M. McBride, Ph.D.

Take-home messages   Considerable self-selection in who seeks testing   Use of effective communication strategies provides adequate decision support   Testers can understand the limits of test feedback

Today’s remarks  Overview of Multiplex Initiative  Highlight data to support each take-home message

Multiplex Aims  In a population based sample, under “ ideal ” dissemination conditions:  How many people will consider and be interested in multiplex testing?  What factors will predict interest and uptake in testing  How will individuals be affected by test results?

 Henry Ford Health System clinical recruitment site −Group Health Cooperative Survey Center  Population-based sample  Healthy adults  Ages  Without diseases on test battery Study Design

Sampling strategy AA White NeighborhoodMenWomenMenWomen High Ed14%12%10% 9% Low Ed18%14%12% 10%

Multiplex Study Design Identify HFHS Sample Conduct Three-Month Follow-Up Conduct Baseline Survey Provide Access to Web Site Schedule Clinic Visit and Test Provide Results

Recruitment

Multiplex Prototype Test 8 health conditions & 15 genes  Diabetes  KCNJ11  CAPN10  PPARg  TCF7L2  Heart Disease  APOB  NOS3  CETP  High Cholesterol  LIPC  Hypertension  AGT  Lung cancer  MPO  Colon Cancer  MTHFR  Skin Cancer  MC1R  Osteoporosis  ESR1  IL6  COL1A1

Multiplex test feedback

Surveyed population N=1959 White37% Male gender47% HS+ educated75% Excellent self-rated health23% Mean worry about health conditions 7pt scale 4.0 (sd=1.54) BMI > 3035% Current smoker28% Want to change a health habit82% Mean confidence to use health care 7pt scale 4.8 (sd=.54) Mean confidence to understand genetics 7pt scale 5.7 (sd=1.06)

Self selection & social groups  African Americans ↑ likelihood of opting out of survey, website & testing  Less educated ↑ likelihood of opting out of survey & website  Men ↑ likelihood of opting out of survey Hensley-Alford et al., Public Health Genomics, 2010 Take home message 1

Multiplex Initiative Uptake 14% tested 31% considered testing Take home message 1

Best predictors of logging on   Demographic characteristics   Internet access   Perceived importance of learning about genetics Take home message 1

Best Predictors of Testing McBride et al., Genetics in Medicine, 2009 Take home message 1

Engagement with Website information Agreed to test (n=266) Mean pages Did not agree to test (n=260) Mean pages P-value Test info 4 available pages <.0001 Condition info 8 available pages <.0001 Gene info 15 available pages <.0001 Kaphingst et al., 2010 Take home message 2

Health condition pages viewed Percent of subjects Kaphingst et al., 2010 Take home message 2

Gene pages viewed Percent of participants Kaphingst et al., 2010 Take home message 2

Participants views of web content  Overall viewed content: −Easy to understand −Trustworthy −Satisfactory/sufficient −Helpful in deciding about testing  Testers viewed info more favorably than non-testers −Differences small, but significant Kaphingst et al., 2010 Take home message 2

Web usage & decision outcomes During web session  More web pages read  More confident to understand genetics  More value to learning about genetics Kaphingst et al., 2010 Greater ease in deciding about testing More likely to decide to test Take home message 2

Free & prompted recall of test feedback Percent recall Free: recalled without prompting having increased risk variant Prompted: correctly recalled having/not having risk variant Kaphingst et al., in preparation Take home message 3

Emotional reactions to test results Kaphingst et al., in preparation Strongly Agree (n=199) Take home message 3

Interpretation of test results Kaphingst et al., in preparation Strongly agree Take home message 3 (n=199)

Take home messages   Considerable self-selection in who seeks testing   Use of effective communication strategies provides adequate decision support   Testers can understand the limits of test feedback

Recommendations & Considerations Deploying direct access testing may be okay:   Use evidence-based communication strategies to present pros and cons of testing   Provide public health friendly support strategies (e.g., internet & telephone support)   Public should be able to understand limits of genetic testing & genetics Multiplex vs. DTC milieu  Multiplex test was free  Included only 15 variants  Testers were insured with access to preventive services

Acknowledgements National Human Genome Research Institute Larry Brody Andy Baxevanis Gretchen Gibney Kim Kaphingst Dave Kanney Chris Wade NHGRI ’ s Intramural Research Program Eric Green NCI ’ s Cancer Research Network Martin Brown Henry Ford Health System - Detroit Sharon Hensley Alford Noel Maddy Patients Group Health Cooperative - Seattle Eric Larson Robert Reid Julia Anderson Roy Pardee Cheryl Wiese Feedback Design David Farrell People ’ s Designs Web Design – Mark Fredriksen