Lawrence J. Appel, MD, MPH Professor of Medicine Welch Center for Prevention,

1. Use of the Internet to Recruit Study Participants: One Size Does Not Fit All(Beta-Version of Presentation) ORR Luncheon September 17, 2009 Lawrence J. Appel, MD, MPH Professor of Medicine Welch Center for Prevention, Epidemiology and Clinical Research Johns Hopkins University Disclosures and conflict of interest: None

2. Alternative Topics • What can you expect (and what can’t your expect) from your PI? • Recruiting participants: Better (or worse) than ever • Recruitment and Retention Journal Club The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009

3. Is Appel Qualified to Give this Talk? (Maybe) • Use the internet at work and home (a lot) • Recruit participants ( > 3,000) • Constantly thinks about novel approaches to recruit participants • Used the internet to recruit in 5 trials Conclusion: he’s no less (and probably no more) qualified than anyone else on Monument Street The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009

4. Outline • Context • Types of internet-based strategies • A tour of websites • Where’s the beef (data)? The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009

5. Context • Use of web is commonplace and increasing, overall and in key, often high risk subgroups • Web is replacing paper • Postal mail • Newspapers The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009

6. Context • Burgeoning number of recruitment websites • Trial-specific websites • Disease-specific websites • Recruitment search engines • National (nonprofit, for-profit) • Local (home institution) The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009

7. Use of the Internet in Studies

8. Enrollment Process for In-Person Trials: Traditional vs Web-enhanced Approaches

9. Two Types of Individuals • Unengaged person (unaware of your study) • Goal: make person aware of and potentially interested in your study • Engaged person (actively looking for a study) • Goal: make it easy to find your study and start enrollment process The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009

10. Websites for the ‘engaged’ individual

11. Basic, Information Only Web Site Trial: OmniCarb http://www.omnicarb.org/index.html The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009

12. POWER Trial: Mailed Brochure, then Registration Website The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009

13. www.powerhopkins.org/registration

14. For-Profit Search Engine Clinical Connection Website http://www.clinicalconnection.com The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009

15. Non-Profit Search Engine CISCRP (Center for Information and Study on Clinical Research Participation) http://www.ciscrp.org/ The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009

16. Non-Profit Search Engine Clinical Trials Registration Site http://clinicaltrials.gov/ The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009

17. Search for Trials at Hopkins Home Page of Hopkins Medicine http://www.hopkinsmedicine.org/ The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009

18. Search for Trials at Vanderbilt http://www.vanderbilthealth.com/main/ https://www.vanderbilthealth.com/clinicaltrials/ The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009

19. Internet Strategies to Make Initial Contact with the ‘Unengaged’ • Intranet newsletters (e.g. Inside Hopkins) • Broadcast emails to prior participants • Electronic mailing lists (EML) • Single message to the list address (e.g. LISTSERV) • Moderated • Unmoderated • Bulletin boards • Web ads, e.g. banners The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009

20. Finding Electronic Medical Lists • Example: finding a listserv to recruit patients with Lupus • Goggle search terms: Lupus listserv Lupus bulletin board Lupus support group http://www.google.com/ The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009

21. Question: How effective are internet strategies in recruiting participants in comparison to other types of recruitment strategies? Answer: uncertain, but limited published data (and personal experience) suggest web-based recruitment is - less effective for in-person trials - more effective for surveys The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009

22. Three recruitment strategies: • Web-based, on-line sampling (WHBS-IVBS): 8 weeks of sampling • Web-based direct marketing, e.g banners (WHBS-DM): 8 weeks of ads • Venue-based time-location sampling (NHBS): 54 weeks of sampling The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009

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26. *Short, text-only ads on websites, inc clinicaltrials.gov, www.aboutibs.org, and craigslist.com.

28. Question: Do participants recruited through the internet differ from: - the general population? - participants recruited through other strategies? Answer: Yes, but that is true of recruitment strategies in general The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009

29. Compared to general population, internet-recruited participants tended to be: • Younger • More educated • More motivated to quit • Smoked more • Compared to other trial participants, internet-recruited participants tended to have: • More negative attitudes to smoking • Higher self-efficacy scores • Greater addition to tobacco The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009

30. Participants Recruited via the Web Tended to be: • Younger • Worse disease (incontinence)

31. Question: Can the internet increase the enrollment of underrepresented minorities in clinical trials? Answer: maybe, but evidence to date suggests the opposite (fewer minorities from internet-based recruitment) The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009

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33. Other Issues • Technical and costs aspects of developing, managing and updating study-specific website • Limited personnel at Hopkins • Accuracy of self-reported data, including potential for fabrication • Newer technologies, e.g. twitter • Use of incentives to promote internet-based enrollment The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009

34. Summary • Internet-based recruitment appears promising, but evidence is limited that such approaches: • increase efficiency • reduce costs especially for traditional, in-person trials The Office of Recruitment and Retention Lunch Lecture Series September 17, 2009