Integrating data from heterogeneous systems Survey Question: (Yes/No) Did you experience any challenges related to: Data were collected from Collaboratory demonstration project representatives between August 20, 2020, and June 30, 2021. If the participants answered “yes”, then they were prompted to elaborate on their experiences. (2) Which EHR data elements are you using for your study? To the best of your knowledge, are they standardized across the EHR systems used in your study? (3) What key question(s) would you ask of EHR vendors to assess their readiness to support research? and (4) What data or functions would you like to see standardized across all EHR systems? Sixteen structured questions pertained to challenges relating specifically to data and data access issues, requiring either “yes” or “no” responses ( Supplementary Table S1). 20, 36, 37 The survey included 4 open-ended questions: (1) Is there EHR functionality that you would like to have for your study, but didn’t? If yes, please explain. The semistructured survey was created by members of the EHR Core and consisted of 20 questions, informed by known challenges. A centralized Coordinating Center and the Core groups assist with the design, conduct, and logistical challenges of the projects and disseminate generalizable knowledge about PCT methods and enabling factors. To apply lessons learned from ongoing projects and to provide expertise to the Demonstration Projects, 7 Core working groups were created: EHRs phenotypes, data standards, and data quality patient-reported outcomes healthcare systems interactions ethics and regulatory biostatistics and study design and stakeholder engagement cores. The portfolio includes 6 new projects that are part of the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM), which are part of the HEAL SM (Helping to End Addiction Long Term) Initiative. The Collaboratory is currently supporting 21 large-scale, high-impact PCTs (or Demonstration Projects) that address issues of major health importance, such as hospital-based infections, chronic pain, the opioid crisis, colorectal cancer, medication adherence, and suicide, 8–32 all in different phases of completion ( Table 1). 6, 7 The trials often involve cluster randomization (of hospitals, clinics, or primary care providers, etc.), the interventions may be implemented by health system personnel, and data are collected as part of routine clinical care. The Health Care Systems Research Collaboratory (hereafter, “Collaboratory”) is supported by the National Institutes of Health (NIH) Common Fund and was designed to strengthen the national capacity to implement cost-effective, large-scale PCTs that are embedded in routine care and conducted in partnership healthcare systems. 3, 4 PCTs are “pragmatic” in that they are embedded in the workflows of diverse healthcare systems and aim to leverage existing data streams in the electronic health record (EHR) to limit the costs and burden of research data collection while maximizing the ability to answer important clinical questions and deliver better-quality care. 1, 2 Their advantage is the ability to determine if health interventions actually work in practice, and hence such trials can generate “real-world evidence” to inform implementation, clinical practice, and regulatory decision-making. Pragmatic clinical trials (PCTs) are randomized controlled trials designed for generalizability, often involving multiple clinical sites with broad eligibility criteria.
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