Patient Consent: Protocols When Collecting Outcome Data

Patient signs a document with their doctor

If you have any experience with or in the healthcare field, you likely have encountered the importance of informed consent. When we talk about informed consent we typically refer to the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention for which the patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention.

Considering the growing use of patient-reported outcome measures (PROMs) in clinical decision-making and research, questions regarding consent and PROM data collection and/or dissemination arise frequently. In this blog, we hope to shed some light on some of these questions and help provide clarification.

Prospective Collection of PROMs

PROM data is usually collected prospectively (i.e. in the present continuing into the future) in two settings: (1) clinical and (2) research. In the clinical setting, PROMs are typically collected when a patient sees a provider in the clinic. The PROM data can be used to track a patient’s progress throughout care as well as to inform the provider or the institution on elements such as quality improvement. In the research setting, PROMs are typically used to answer a question or gain information that is meant to be disseminated in an academic nature.

When referring to the ethics of consenting patients for medical procedures, documentation of consent requires the following elements: (1) the nature of the procedure, (2) the risks and benefits and the procedure, (3) reasonable alternatives, (4) risks and benefits of alternatives, and (5) the assessment of the patient’s understanding of these elements. In similar fashion, the purpose, risks and benefits, and the alternatives of the PROM collection should be informed to patients regardless of the setting. The ethics of this process is somewhat easier to ensure in the research setting with entities such as an Institutional Review Board (IRB). In the clinical setting, oversight is not usually required as long as the provider observes the aforementioned elements of consent with the patient. To ensure no violation of the principle of justice, PROM collection should also be conducted for all conditions that present to the clinic rather than just a target population or range of diseases.

Retrospective Analysis of PROM Data

Retrospective analysis of PROM data refers to the query and analysis of data that was prospectively collected. This is typically what is done when using PROM data for purposes such as retrospective research studies and quality improvement work. When it comes to these, the data accessed has already been collected for which a consent process should have either occurred or waived as appropriate.

Regardless, some clinicians and researchers tend to be hesitant when using PROM data for research or quality improvement purposes, usually citing a concern with ethical violations. In fact, healthcare systems and institutions are increasingly incorporating PROM data into the electronic medical record (EMR) and classifying it as EMR data(2). When classified as such, PROM data therefore resembles other data points such as age, sex, and BMI among others that can be retrospectively accessed under the appropriate conditions. In the case of research, as long as the study is overseen by the IRB, no formal consent is needed from the patient to access PROM data. In the case of initiatives such as quality improvement projects, access of PROM data can occur without involvement from the IRB as long as the project is approved as such.

It is always important when handling EMR and PROM data to safeguard patient-protected health information (PHI) and avoid identifiers whenever possible. As long as these principles are followed, retrospective analysis of PROM data is exempt from patient consent.

What has been said about the ethics of using PROMs?

The use of PROMs in healthcare has undergone formal ethical scrutiny. In 2022, experts at the Patient-Reported Outcomes Ethics Steering Group published guidelines regarding the ethical use of PROMs in clinical research(3). While patient consent was addressed in these guidelines, the guidelines mostly focused on other topics such as the attrition of PROM data. The scarce commentary on consent was limited to consent in the prospective collection of PROM data.

Summary

Misconceptions on the relationship between informed consent and patient-reported outcome data collection and dissemination can be common. Obtaining consent is typically important when it comes to the prospective collection of patient-reported outcomes, be it in the clinical or research setting. Regarding the retrospective use of patient-reported outcome data, consent is typically not required as long as PHI is protected.

With many variables to consider regarding consent with PROs, our recommendation is to evaluate each circumstance on an individual basis and consult legal counsel to determine the best practice for your organization.

Resources

Informed Consent | Provider perspectives on the integration of patient-reported outcomes in an electronic health record | Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research: The PRO Ethics Guidelines

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