The project will gather input from broad communities producing, analyzing, synthesizing, disseminating and implementing clinical research (evidence) and recommendations for clinical care (clinical practice guidelines) to determine the data exchange needs for interoperable knowledge assets in these realms.

This project will identify and define the initial set of key FHIR resources related to the domain of clinical research evidence and clinical practice guideline development. These resources will be defined using the available FHIR tooling and in accordance with documented quality guidelines.

The co-primary objectives are to meet the needs of the evidence processing and guideline development communities and to facilitate interoperability between these communities and the patient care communities.

EBM knowledge assets to be shared include but are not limited to:

• Risk of Bias assessments of research studies – eg one group conducts the analysis to perform a systematic review for one research question, another group can reuse the analysis when considering this study when performing a systematic review for a related research question
• Research Results Data Extraction – similar to the example above, but applied to the data extraction of quantitative results to be entered in meta-analyses for different systematic reviews
• Summary of Findings tables – data representing the results of systematic review development could be more easily imported for use in developing clinical practice guidelines, patient decision aids, and other clinical decision support applications
• Recommendations – data representing the recommendations produced in guideline development could be more easily imported for implementation in clinical decision support services, including the rationale and judgments made to justify the recommendations

This project may create new FHIR resources. The current scope is the universal realm.

The precise specification of FHIR Resources to be developed is the goal of this project but resources created since this project started in 2018 include:

1. Evidence – The Evidence Resource provides a machine-interpretable expression of an evidence concept including the evidence variables (e.g., population, exposures/interventions, comparators, outcomes, measured variables, confounding variables), the statistics, and the certainty of this evidence.
2. EvidenceVariable – The EvidenceVariable resource describes an element that knowledge (Evidence) is about.
3. Citation – The Citation Resource enables reference to any knowledge artifact for purposes of identification and attribution. The Citation Resource supports existing reference structures and developing publication practices such as versioning, expressing complex contributorship roles, and referencing computable resources.
4. ArtifactAssessment – to express our confidence in the knowledge expressed in the other resources, concepts that answer the question “How well do we know?” – This Resource provides one or more comments, classifiers or ratings about a Resource and supports attribution and rights management metadata for the added content.

In the EBM communities (evidence analysis, systematic reviews, clinical practice guidelines) a common organizational framework used for the research question, the systematic review focus, and the recommendation focus is PICO which stands for Population, Intervention, Comparison, and Outcome.   There are variations such as PECO for research questions about non-interventional exposures, PICOT for adding time conventions, and PICOTS for adding system context, but PICO is the most prominent organizational framework across the EBM knowledge assets activities.

This project will build an EBMonFHIR community to coordinate input and dissemination across the many communities described in this PSS.