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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

  • Research organization, registry, and patients use standard-based interoperability to exchange information in a secure environment.
  • Participating surgical facilities have the capability and resources required to collect data and metadata and submit it electronically to the registry.

Post conditions

  • A registry is available for quality improvement and research.
  • Meta-data is included with each record that captures the terms of use.
  • A system is in place for obtaining and tracking all approvals and data use activities in an ethical and efficient manner

Alternatives

  • The state mandates submission of data to the registry.

Considerations

  • The decision to use identifiable or deidentified data
  • Capturing patient perspective/voice and the effect their engagement has on collecting PROs
  • Feasibility of individuals requesting and submitting their own electronic health record data to PROs to the registry
  • Role of government in mandating the submission of identifiable data for public health reporting that is re-used for research under IRB approval

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

 

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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