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Abstract:
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Although the term pragmatic clinical trial (PCT) dates back to the 1960’s, there has been a recent surge of interest in performing these types of studies. As the audience for PCTs is healthcare decision-makers such as policy makers, regulators, payers, clinicians, and patients, a wide range of study outcomes are required to fully assess the benefits and risks of healthcare interventions relevant to these stakeholders. In order to holistically accomplish this and answer real-world research questions, endpoints that address clinical, economic and humanistic outcomes are needed. Therefore, multiple sources of data that are integrated at the patient level are essential. Clinical data from study specific electronic data capture systems or patient care focused electronic health records, economic data from administrative claims, and patient reported outcomes data from survey questionnaires and instruments, along with how they can be integrated into a single analytic file, will be described. In addition, use of retrospective data from the potential population of interest to inform protocol feasibility and design as well as recruitment of sites and patients will also be discussed.
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