Recruitment for a large-scale clinical study via the World Wide Web and the internet

Purpose. The Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study is a five-year observational study with an ambitious recruitment goal of 1,000 keratoconus patients in 10 months. To the best of our knowledge, the CLEK Study is the first NIH-sponsored study to recruit subjects via a page on the World Wide Web (WWW): http://spectacle.berkeley.edu/CLEK/CLEK.html. Methods. The CLEK Study WWW Page provides a brief description of keratoconus and the CLEK Study with a list of the locations of the 16 CLEK Participating Clinics across the US. It includes pointers to the NEI and NIH Web Sites. Initially, we contacted all individuals with eye-related Web Sites. Most were willing to add a pointer to the CLEK Study page. We also contacted all the Web Searchers/Directories. Now, if a patient searches for "keratoconus," he or she will find the CLEK Study Web Site. Results. Over a 40-day period (9/20/95 to 10/30/95) the CLEK WWW home page was visited 399 times. More interested visitors probably went to the "CLEK Clinics" page, which was visited 168 times. Eighty-six visitors' home bases could not be identified; 153 were commercial users (eg, aol), and 57 were non-US based. Sixty-nine inquiries were from universities, and 21 were from government-based email addresses. Eight were from organizations. Between June 26, 1995 and November 27, 1995, the Study Chairman was contacted by email by 33 interested patients or potential referring doctors. Conclusion. The Internet is an innovative and effective means of communicating with eligible patients for large-scale clinical studies.