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- How should patient perspective be captured? How might patients influence the PROs collected and data management procedures in taxpayer-funded efforts?
- Is it feasible for individuals to request and submit their own electronic health data and PROs to the registry without introducing bias? If so, how might this submission process be implemented in a way that minimizes burdens to health systems?
- What other factors or issues directly affect patient and should be considered in relation to this scenario?
- There is extensive documentation of the challenges associated with governance, legal and IRB interpretations, and PRO data collection like those describe above. What possible solutions exist to increase concordance between organizations for projects such as these?
- It is common for states to mandate submitting identifiable data for public health reporting that is re-used for research under IRB approval. What distinguishes Cancer Registries from a mandated registry of PROs? What should the role of the government be in this process?
- What types of governance might the registry put into place for data use and re-identification?
Title | Response |
Description | Creation of PRO Data Registry. Activity includes (1) obtaining approval for PRO data collection and (2) data collection and (3) transmission of data by health systems from multiple sites. |
Primary actor/participant | Registry Creation Contractor, Health System Compliance bodies, Research Participant. |
Support actor/participant | Health system staff collecting data, third party data collection contractors operating on behalf of the health system |
Preconditions |
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Post conditions |
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Alternatives |
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Considerations |
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Data Elements Considered | Electronic health data from multiple sites and patient reported outcomes |
Purpose of the Data Collection | Clinical care, tracking patient outcomes, creating a registry for quality improvement and research use |
Purpose of Data Use | Quality Improvement, analysis under a specific research protocol
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Terms of Transfer to the Data Holders | Heterogeneous: agreements, waivers of authorization, and/or consent |
Terms of Transfer to Researchers | (Researcher access to data not contemplated in this scenario – See Use a Registry that Includes Patient Reported Outcomes) |
[i] The National Quality Forum defined PROs as "any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else."
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