BackgroundThe growth in the number of patients seeking health information online has given rise to new direct-to-patient research methods, including direct patient recruitment and study conduct without use of physician sites. While such patient-centric designs offer time and cost efficiencies, the absence of physician-reported data is a key concern, with potential impact on both scientific rigor and operational feasibility.ObjectiveTo (1) gain insight into the viability of collecting patient-reported outcomes and medical record information in a sample of gout patients through a direct-to-patient approach (ie, without the involvement of physician sites), and (2) evaluate the validity of patient-reported diagnoses collected during a patient-reported outcomes plus medical record (PRO+MR) direct-to-patient study.MethodsWe invited a random sample of MediGuard.org members aged 18 to 80 years to participate via email based on a gout treatment or diagnosis in their online profiles. Interested members clicked on an email link to access study information, consent to participate electronically, and be screened for eligibility. The first 50 consenting participants completed an online survey and provided electronic and wet signatures on medical record release forms for us to obtain medical charts from their managing physicians.ResultsA total of 108 of 1250 MediGuard.org members (8.64%) accessed study information before we closed the study at 50 completed surveys. Of these 108 members who took the screener, 50 (46.3%) completed the study, 19 (17.6%) did not pass the screening, 5 (4.6%) explicitly declined to participate due to the medical record requirement, and 34 (31.5%) closed the browser without completing the survey screener. Ultimately, we obtained 38 of 50 charts (76%): 28 collected using electronic signature and 10 collected based on wet signature on a paper form. Of the 38 charts, 37 cited a gout diagnosis (35 charts) or use of a gout medication (2 charts). Only 1 chart lacked any mention of gout.ConclusionsPatients can be recruited directly for observational study designs that include patient-reported outcomes and medical record data with over 75% data completeness. Although the validity of self-reported diagnosis is often a concern in Internet-based studies, in this PRO+MR study pilot, nearly all (37 of 38) charts confirmed patient-reported data.

core-set were also obtained both at baseline and 4 week apart. These included tender joint count (out of 28), swollen joint count (out of 28), physician's and patient's global assessment of disease activity, pain score and Westergren erythrocyte sedimentation rate (ESR). Disease activity was measured using the DAS28 score, which was obtained at baseline and at the end of the study for each patient. RESULTS: The median age of the 60 study patients was 48 yr Ϯ9.5SD and the median duration of symptoms was 17 months Ϯ5.5SD. Thirty of these received the English version of the HAQ and the other 30 received the Hindi version. Baseline HAQ values for English and Hindi groups were 1.84Ϯ0.48 and 1.91Ϯ0.49, respectively. After treatment, the HAQ values changed to 0.71Ϯ0.42 and 0.62Ϯ0.51, respectively, demonstrating a very good sensitivity to change (Student's unpaired t-test: pϽ0.05). Construct validity was assessed using Pearson's correlation coefficient between the corresponding values of HAQ and DAS28, both at baseline (rϭ0.47, pϽ0.05) and after intervention (rϭ0.60, pϽ0.01). CONCLUSIONS: These results support the validity, and reliability of the IND-HAQ as a measure that captures the impact of RA on patients' health-related quality of life. OBJECTIVES:The ENSEMBLE MDS is a battery of phenotypic generic patient-reported instruments designed for use in clinical studies or comparative effectiveness research. The component instruments assess baseline patient characteristics that are believed to be either predictors (health status, illness burden, depression, anxiety, and perceived stress) or effect-modifying factors (perceived social status, objective social status, perceived social support, income) of clinical outcomes and/or treatment response. We sought to evaluate the equivalence of the MDS across two different modes of administration -paper and web. METHODS: This study was a data collection effort that used a randomized cross-over design in the United States (English) and Singapore (Simplified Chinese). Participants were outpatients with a clinical diagnosis of one of five targeted health conditions: depression, type 2 diabetes, psoriasis, rheumatoid arthritis and chronic kidney disease. Those enrolled were randomized to initially complete the MDS on paper or web format, and returned 24 hours later to complete the alternate format. Equivalence was evaluated by the intraclass correlation coefficient (ICC) with equivalency defined at or above the minimal acceptable level of 0.70. These analyses were performed individually for each of the nine MDS component measures. RESULTS: A total of 314 participants (258 in US, 56 in Singapore) were analyzed. In the US, mean age was 49Ϯ13 years, 61% were female; in Singapore mean age was 57Ϯ12, 59% female. The ICCs between paper and web administration of the different components of the ENSEMBLE MDS ranged between 0.74 and 0.98 in the US, and between 0.75 and 0.97 in Singapore. CONCLUSIONS: Equivalence between paper and webbased administration of the ENSEMBLE MDS was demonstrated stati...