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A new pilot study from Quintiles’ Digital Patient Unit (DPU) confirms the reliability of patient-reported outcomes collected via patients recruited over the internet, demonstrating the viability of a new method for observational research that combines patient-reported outcomes and medical record data (PRO+MR).
Findings demonstrate that patients can be recruited, screened and enrolled directly from online patient communities for observational studies that collect patient-reported-outcomes and clinical data with ~75% of physicians contributing medical record information.
A Quintiles-authored article on the PRO+MR study, “Conducting Research on the Internet: Medical Record Data Integration with Patient-Reported Outcomes,” has been published by the peer-reviewed Journal of Medical Internet Research. The study profiled in the article found that patients can be recruited directly for observational study designs that include patient-reported outcomes and clinical data with ~75% of physicians contributing medical record information. In the study pilot, nearly all charts confirmed patient-reported diagnoses.
“Results of this pilot study are a positive step forward in confirming the viability of the PRO+MR direct-to-patient study approach,” said study co-author and Quintiles DPU Vice President Elisa Cascade. “This pilot validates the use of patient-reported outcomes when collected in this manner. It is a foundational step toward broader use of this design in collecting real-world, observational data.”
“Utilizing direct-to-patient techniques for real-world data collection not only work in pilot, but we are also leveraging in practice,” added Rich Gliklich, MD, president of Quintiles Outcome. “Given the widespread demand for rapid data collection, direct-to-patient studies will become an increasingly important component of real world evidence development for understanding appropriate cohorts from treatment patterns to safety information.”
Founded in 1999, the Journal of Medical Internet Research (JMIR) is a leading health informatics and health services/health policy journal (ranked first by impact factor in these disciplines) focusing on emerging technologies in health, medicine, and biomedical research. JMIR was the first open access journal covering health informatics, and the first international scientific peer-reviewed journal on all aspects of research, information and communication in the healthcare field using Internet and Internet-related technologies.