Research is important to establish which therapies are safe and effective for pain and which patients might benefit most from them. But clinical pain trials are plagued by low response rates in the early stages and high dropout rates once studies commence. Failure to attract and maintain the appropriate sample size can compromise results and waste valuable resources.
With this in mind, the research team set out to enhance recruitment during a multi-center trial to study women who suffer from vulvar pain. Using funding provided through the National Institutes of Health, they designed a recruitment website that offered multiple methods for attracting and interacting with potential subjects.
The goal was a "one-stop shopping" site to address informational needs, recruitment into the clinical trial and follow-up of patients who suffer from the painful disorder. Containing these functions within a single website, linked to a secure database, offers a significant advantage, according to the researchers.
"Despite the deeply personal and traumatic nature of vulvodynia, women suffering from it are a highly engaged target population that we can reach out to," said Ian Brooks, PhD, director of the Office of Biomedical Informatics, University of Tennessee Health Science Center in Memphis, Tenn., and an author on the study. "Everyone uses the Internet to look for information nowadays, and our website is designed to provide them this information at the same time as screening them for our clinical trial."
The site contains prescreening questionnaires and informational videos specifically tailored to communicate to the target audience. The website also links to the main, Web-based data coordinating center for the trial. The system generates automatic emails, alerting research staff when a potential subject registers on the website, and allows study coordinators to view accrued applicant information. Web analytics collect data on keyword searches, geographic location, bounce-rate and time-on-page, which allows the researchers to constantly tailor and refine the site. Applicants personal information is securely stored and only viewable by the appropriate research staff.
The researchers described a number of advantages to their method. Using Web-based technology allows the team to reach greater numbers of more diverse potential subjects across the state. The site also offers many ways for potential subjects to communicate with study coordinators. Eligible subjects may choose to provide their information through the website or they may call or email the data coordinator in their area. Further, the potential subjects can be prescreened on a few major eligibility criteria before ever setting foot in a research center. Finally, the enhanced recruitment method is expected to be more cost effective than conventional recruitment.
Dr. Brooks said that the technology behind the website is easy to implement, and the current system could be used as a guide for other researchers running similar clinical trials. His group hopes to make the data coordinating system and recruiting website combination available as a standalone tool in the near future.