Table 1.

NIH Health Care Systems Collaboratory Core Groups

Core/working group	Key foci and deliverables for year 1
Phenotype, data standards, and data quality	Criteria for assessing utility of phenotypes and data quality from EHRs in PCTs; identification and validation of phenotype definitions for demonstration projects; methods for validating phenotype definitions in multisite trials; ‘Table 1 project’ for standardized clinical/research data reporting
Electronic health records	Technical approaches for extracting information from multiple EHRs and clinical systems for research use; explore existing distributed research networks and open-source tools for distributed queries
Patient-reported outcomes	Reusable and sustainable models for incorporation of patient-reported outcomes and assessments in EHRs and research study management tools
Provider–health systems interactions	Well-catalogued issues and challenges; guidance documents; strategies to minimize disruption and maximize engagement in healthcare systems; strategies for driving behavioral change to implement PCTs and cluster randomized trials (CRTs); updated and generalized HMO Research Network Toolkit resources ; updated CRT toolkit; guide to PCTs for stakeholder organizations
Regulatory and ethics	Fundamentals of patient informed consent for PCTs; fundamentals of determining minimal risk; use of central institutional review boards in PCTs
Biostatistics and study design	Key issues in extracting usable data from EHRs for PCTs; assessing statistical power in CRTs
Stakeholder engagement	Overcoming barriers to conducting PCTs within healthcare delivery systems

EHR, electronic health record; PCT, pragmatic clinical trial.