OBJECTIVES: The growth in patient empowerment and increase in on-line patient pools has given rise to new direct-to-patient research methods (i.e., direct recruitment of patients, without physician sites).  One key concern, however, is the absence of physician-reported data to validate diagnosis and provide other study data. The objective of this study was to employ a direct-to-patient approach to collect patient-reported outcomes (PRO) and medical record (MR) information. METHODS: In July 2011, a random sample of US MediGuard.org members age 18 to 80 were invited to participate via email based on a gout treatment or diagnosis in their profile.  Interested members clicked on an email link to access study information and screen based on self-reported diagnosis and willingness to release medical records.  The first 50 consenting participants continued on to complete an online survey and electronic and paper medical release forms.  Completed forms were provided to Outcomes Health Information Solutions to contact physicians and obtain participant charts. RESULTS: A total of 120 members clicked on 1250 emails sent (9.6%). 5 members (4%) explicitly declined to participate due to the medical record requirement, although this could be as high as 38% if all individuals closing the browser are included.  Of the 50 participants completing the on-line survey and electronic release, 42 (84%) returned the paper form.  With these forms, we obtained 38 of 50 charts (76%): 28 of 38 (74%) with electronic and 10 of 38 (26%) with paper;  35 charts had a gout diagnosis and an additional 2 had a gout medication; only 1 chart was missing any mention of gout. CONCLUSIONS: Patients can be recruited directly for observational study designs that include PRO and MR data with over 75% data completeness.  Although concern exists regarding validity of self-reported diagnosis, in this PRO+MR pilot, nearly all (37 of 38) charts confirmed patient-reported data.