Effective IT Support for the Generation of Research Results to Participants: Lessons Learned from the Jackson Heart Study

Background: There is growing literature supporting the need to share study results of clinical relevance to all study participants irrespective of type of study. However, to prepare study results for participants study investigators require dedicated resources, commitment and customization of the reports. Given the current trend of sharing results with participants and the increasing demands of participants to know their results, the primary focus of this presentation is to share the lessons learned in generating results reports for JHS participants since the baseline examination (2000-2004). JHS is the largest single-site observational cohort study designed to assess the etiology and progression of CVD in African Americans. Methods: Using Crystal Reports, the JHS Data Coordinating Center developed a reporting module that interfaced with the Database Management System (DMS), designed using ClinTrialTM, to produce customized results report. Results: The timeframe for preparing and mailing of results reports for participants was decreased from 2-3 months to 5-6 weeks from clinic visit date considering a waiting time of 4 weeks for the transfer of laboratory and processed imaging data from the JHS Central Laboratory and Reading Centers. Also, the person hours dedicated to preparing these results was significantly reduced by 50-55% after the Reading Centers' data were integrated with the clinic visit data in the JHS DMS. Discussion: The use of web applications to automate the process of generating clinical results reports for research participants is efficient and effective. It saves duplication in datasets which are challenging to maintain and reduces a potentially labor-intensive activity.