PROTEUS — PRACTICE
Considering the Ethical and Legal Issues: Chapter 16
In this excerpt (Chapter 16) from the PROTEUS-Practice Guide, you’ll explore topics such as how to maximize equity and inclusion when collecting patient-reported outcome measures (PROM) and how to appropriately disclose information about research goals of a patient-reported outcome measure (PRO) system to patients.
This webpage contains the entire contents of Chapter 16. You can also download the PROTEUS-Practice Guide by clicking here.
Key Points
- Equitable and inclusive patient-reported outcome (PRO) system development and implementation is vital to ensuring the utility of PRO measures (PROMs) for diverse patient populations
- PRO data has the potential to be used for multiple purposes. Having appropriate disclosures and consents in place are essential to ensure that this data can be ethically used
- Liability concerns, especially regarding how providers respond to PROM alerts, should be considered when designing PRO systems
Overview
The routine collection of PROs, particularly when they are well-documented and integrated into electronic health records, presents opportunities to use the data for multiple purposes and to be accessed by an increasing number of people. As a result, the best ways to disclose PRO activities, consent patients, and minimize sources of liability need to be considered.
When collecting PROMs from patients for use in clinical care, health systems can provide no disclosure at all about the purpose of PROM data collection, though this approach limits the ability to store and re-use this data and may not be compliant with existing regulations. Alternatively, patients can be provided with general or specific disclosure information. These disclosures may also be accompanied by opportunities to opt-in or opt-out of completing PROMs and/or including them in other databases. When considering data re-use or data use for multiple purposes, patients can be offered no consent at all, provided with a general disclosure about data re-use, or asked to formally consent to have their data re-used.
Liability considerations regarding the use of PROMs should be reviewed by legal experts, including those with experience in data privacy and security, research regulations, reportable events, and informed consent. Concerns regarding how providers respond to PROM alerts are among the most complicated to address.
Questions and Considerations
A. What are the diversity, equity, and inclusion considerations for PROM data use in clinical care?
- Collecting PROMs from diverse patient populations can inform understanding of how patient experiences vary across these groups
- When selecting a PROM for data collection, it is important to ensure it is valid and relevant for the patient population of interest
- While the use of electronic PRO capture may be useful to some, it may exacerbate disparities in care for others, such as those who lack internet access, or have low technology and/or health literacy
B. What disclosures could be presented to patients when collecting and using PROMs?
No disclosure
- Patients would be asked to complete PROMs but receive no information about how the data will be maintained/managed
- No verbal/written authorization from patients is requested
- May be easiest for individual fielding and completing the surveys, but may also decrease motivation to complete the survey if it is unclear how/why this data will be used
- May not comply with local laws and research regulations, and ability to use and publish data collected using this approach for research may be limited
General non-specific disclosure and opt-out
- All patients in the healthcare system are informed that PROMs are generally collected for use in clinical care, quality improvement, and research
- Patients can, for example, opt-out of completing PROMs, or opt-out of PROM data being linked to other databases
- This general disclosure may be insufficient for some types of research use, which would then require future consent
Brief specific disclosure
- All patients in the healthcare system are informed that PROMs will be collected and used in specifics ways (e.g. it will be used by their clinical care team to understand their health)
- Health systems can only use the PROM information for the informed purpose, unless it is also included in the consent that they can be used for other purposes without re-consent
- This option may be more respectful of individual decision-making, and is likely to be more consistent with many types of data uses
Robust specific disclosure with opt-in
- Patients are informed that PROMs will be collected and used in specific ways and are provided with information consistent with the Common Rule and other human research regulations regarding informed consent
- Individuals must indicate their willingness to participate and have their data used for explicit purposes
- Having this consent may increase the amount of time to complete the survey
- This option may be the most respectful of individual’s abilities to make decisions about how their data is used
C. What consent options can be considered when using PROM data for multiple purposes?
No consent for data re-use
- Data would be re-used without additional notification/authorization
- This approach is easy to integrate into the system, but limits opportunities for data re-use given that patients have not consented for re-use
General disclosures about data re-use
- Patients would be informed that the system uses PRO data stored in electronic health records for multiple uses
- Patients may lack a full understanding of this re-use
- Some may choose to opt-out due to lack of specificity about re-use
Specific disclosure and authorization (opt-in) for data re-use
- Patients would be informed about specific activities associated with the re-use of their data, including any possible risk/benefits, and asked to consent to this re-use
- Patients would have a greater understanding of the purpose of data re-use, but this option may be more difficult to integrate into clinical settings
D. What are some liability considerations related to the use of PROMs?
- Liability considerations should be reviewed by legal experts, including those with experience in data privacy and security, research regulations, reportable events, and informed consent
- As applies to all issues of consent, appropriate procedures are required to obtain consent from patients who are unable to provide consent for themselves due to cognitive limitations or other reasons, and to obtain assent from minors old enough to provide it
- Liability concerns regarding responses to PROM alert systems are particularly complicated. Questions in this area to consider for potential liability include:
- Is there a point at which a provider is obligated to respond to an alert?
- How imminent and likely is the potential harm from the alert?
- Is the provider or system positioned to respond to an alert?
- What constitutes a reasonable response to an alert? Does this vary situationally?
- How can responses to the alert be best documented?
Relevant Primary Resources
The information presented here is an overview for considering ethical and legal issues. For more detailed information please see the following sources:
Background And Citing The Proteus-Practice Guide
Nothing in this Guide should be construed to represent or warrant that persons using this Guide have complied with all applicable laws and regulations. All individuals and organizations using this template have the responsibility for complying with the applicable laws and regulations or regulatory requirements for the relevant jurisdiction.
Each chapter of the Guide lists the key foundational resources that informed its content. To appropriately recognize the foundational resources, we encourage you to cite both the Guide and the relevant foundational resource(s). Recommended citations are provided here.
Suggested Citation
The PROTEUS Guide to Implementing Patient-reported Outcomes in Clinical Practice
A synthesis of resources. Prepared by Crossnohere N, Brundage M, Snyder C, and the Advisory Group, 2023. Available at: TheProteusConsortium.org.
Further Reading
The Guide draws primarily from the foundational resources cited in each chapter. Please click here to find a selection of other relevant references.