data presented by the Food and Drug Administration (FDA) on September 13 and 14, 2004, at a joint meeting of the Center for Drug Evaluation and Research's Psychopharmacologic Drugs Advisory Committee and the FDA's Pediatric Advisory Committee suggested that the number of children and teenagers who were prescribed antidepressants continued to increase in 2004, despite widespread publicity surrounding 2 FDA advisories regarding the potential for pediatric suicidality with selective serotonin reuptake inhibitor use. These results are contradictory to findings from the Medco Health Solutions, Inc, March 2004 analysis of pharmacy benefit claims and a separate subsequent analysis conducted

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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.

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were evaluated based on US and European PRO/HRQOL guidance criteria. RESULTS: The review identified 8 HRQOL measures used with EB patients: 3 generic (SF-36; EQ-5D, EQ-5DY); 4 dermatology-specific (DLQI, CDLQI, DQOLS, Skindex); and 1 EBspecific (QOLEB). Only the CDLQI and QOLEB were specifically designed for pediatric populations (ages 4-16 and Ն10 years, respectively). The QOLEB was the only instrument for which content was derived from EB patients; 26 patient interviews were conducted, of which 9 were with patients Ͻ18 years. Despite pediatric input during development, not all QOLEB content is relevant to children/adolescents; items assessing family and financial impact are not appropriate for these respondents. Psychometric properties have been established among pediatric EB patients only for the QOLEB (convergent validity [DLQI: R ϭ 0.774]; internal consistency [␣ ϭ 0.931]; test-retest reliability [ R ϭ 0.843]). CONCLUSIONS: Few published measures meet current regulatory standards for HRQOL evaluation in pediatric EB patients. Given the age range for EB, an HRQOL instrument that evaluates age-appropriate concepts was not identified. Further research is needed to document and assess HRQOL concepts in pediatric patients with EB. OBJECTIVES:To compare the rate and cost of traditional versus on line recruitment methods to medical surveys in 2 different patient populations. METHODS: We compared traditional to on line advertising in 2 separate projects (conducted in the UK) across the same time period using the same internet and social media recruitment methodologies allowing a comparison of the costs and effectiveness. By looking at 2 quite distinct populations -the first being cholesterol lowering agents, thus an older age with cardiovascular disease and the second women with problem periods, hence a younger and otherwise healthy group we could evaluate the recruitment methods. RESULTS: All costs are direct payments and exclude labour; Cholesterol lowering agents; Traditional methods -recruitment through chain of pharmacists using leaflets; 303 patients recruited over 9 months; cost/ survey £3.94. Internet/Social media -adverts placed on facebook.com, google and third party ad network; 3812 visitors to website; cost/ visitor £0.23; 572 survey completions over 11 weeks; cost/ survey £1.53. Problem Periods: Traditional methods -magazine adverts, exhibition stand, press releases; 232 Women recruited over 8 weeks; Cost/ survey £18; Internet/Social Media; Ͼ6000 visitors to website over 11 weeks; cost/ visitor £0.30; 1534 survey completions over 11 weeks; cost/ survey £1.51. CONCLUSIONS: Whilst traditional methods of recruiting participants were successful, they were generally slower and cost more per person recruited. Internet advertising and use of social media sites offers the potential of rapid, cost effective recruitment. This result however does not tell us if the traditional adverts were making it more likely people would search on line, thus driving the on line recruitment or if the statins population (our stat...