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Max Contractor is working under contract by the state to create a Statewide Orthopedic Registry. The state received federal funding to create a registry of outcome measures for individuals that have received total knee and hip replacement surgeries, and contracted with 20 health systems for a 2-year project. The registry is not housed within a HIPAA covered entity. Surgical units agree to electronically transfer a “registry data set” includes basic demographic information, a survey of functional status outcome measures, a unique identifier that can be used for repeated measures, and information about the surgery itself. The registry’s primary use is quality reporting. Similar to the state’s Cancer Registry, all sites also agree to secondary use of the data for research as part of the contract.
In preparation for the project, Max meets with operations teams at 20 major health systems across the state to discuss and it becomes apparent that each health system has a different process for PRO questionnaire administration. While the reporting of electronic clinical data to registries for public health and quality improvement are established practices of clinical operations, there are no standard practices for how procedures for collecting Patient Reported Outcomes (PROs) should be implemented or approved. Some sites record PROs into EHRs during encounters, others collect the PROs from iPads in the waiting room, others send web surveys to individuals over email, and others outsource the data collection to third parties who conduct phone interviews.
Variations among IRB procedures exist as well. Some health systems use a Regional IRB, while others used their own IRBs. Not all health systems or IRBs consider the activities to be Human Subjects Research. Max Contractor creates template documents for consideration, but in order to achieve the goals of the project, the procedures are left to each participating institution’s counsel, privacy board, or IRB. For surgical facilities that consider the project to be human subjects research, informed consent is obtained at the time PROs[i] are collected. For facilities that collect data in the EHR without formal patient approval data is transferred under a waiver of authorization from the IRB or Privacy Board.
A governance policy has been established for the use and maintenance of the registry data.
Questions:
- 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?
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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.
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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
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Alternatives | - The state mandates submission of data to the registry.
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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
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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 |
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."
