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Pilot study combines patient-reported outcomes and medical records

Quintiles concludes patients can be recruited directly for observational studies

A pilot study combining patient-reported outcomes and medical records suggests patients recruited from an internet database can be relied on to self-report their diagnosis.

The quality of the information provided by patients is one of the greatest concerns about online direct-to-patient observational studies.

But the study by Quintiles concluded patients can be recruited directly for observational study designs that include patient-reported outcomes and medical record (PRO+MR) data with over 75 per cent data completeness.

“Confirmation of the validity of patient-reported data in observational, direct-to-patient remote studies is an essential step forward toward scaling up this method in real-world research. As direct-to-patient observational studies grow in number and size, experience and insights from these designs can be considered for integration into interventional clinical trials,” the researchers wrote in the Journal of Medical Internet Research.

The real-world, observational pilot study involved gout patients recruited from Quintiles' own online medication monitoring patient community MediGuard.

The researchers invited US MediGuard.org members, aged 18 to 80 years and selected on the basis that their community profiles cited a diagnosis of gout or use of a gout treatment (allopurinol or colchicine), to participate in the study via emails sent in July 2011.

Participants who completed the online survey and returned the paper medical record release form within 2 weeks were offered a $50 MasterCard gift card as compensation for their time.

After completing the online survey, participants also completed an electronic release form consenting to a medical record review to confirm the diagnosis of gout reported by the patient.

A total of 108 of the 1,250 invited MediGuard.org members (8.64 per cent) accessed study information before the study was closed at 50 completed surveys. Of the 108 members who took the screener, 50 (46.3 per cent) completed the study, 19 (17.6 per cent) did not pass the screening, 5 (4.6 per cent) explicitly declined to participate due to the medical record requirement, and 34 (31.5 per cent) closed the browser without completing the survey screener.

Ultimately, the researchers obtained 38 of 50 charts (76 per cent) and 37 cited a gout diagnosis (35 charts) or use of a gout medication (2 charts). Only 1 chart lacked any mention of gout.

But the researchers acknowledge some limitations with their study, notably the small sample size, restriction of the medical record review to just the previous two years and the use of an existing online community, membership of which may indicate participants' willingness to join online studies.

They also note that efforts to date, including Pfizer's unsuccessful REMOTE study, have so far proved inconclusive.

16th October 2012

From: Marketing

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