Saturday, July 13, 2024

Framework for Classifying Patient-Reported Outcome Measures and IRB Oversight

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The increasing integration of patient-reported outcome measures (PROMs) into clinical practice highlights their significance in enhancing patient-centered care. As tools that capture patients’ symptoms and health status, PROMs are pivotal for tailoring healthcare towards outcomes that truly matter to patients. This article delves into the diverse applications of PROM data—from clinical care to research and quality improvement—emphasizing the challenges institutional review boards (IRBs) face in distinguishing between these applications. By establishing a framework to classify PROM use cases and outlining the necessary IRB oversight, the article provides practical guidance for both IRB staff and clinicians.

Classifying PROM Use Cases

PROMs are deployed across various domains, including direct clinical care, human subjects research, and quality improvement initiatives. Identifying the primary use case is crucial for determining the level of IRB oversight required. For instance, PROMs used solely for clinical care may not necessitate IRB review, as they don’t constitute human subjects research. However, when these tools are utilized for research or quality improvement, different regulatory considerations come into play.

Considerations for IRB Staff

The article outlines specific characteristics of PROMs that influence their classification: the data platform used, the setting where surveys are conducted, the length of the questionnaires, and the interfaces for both patients and clinicians. These factors are critical in assessing whether the primary intention is clinical care or research. PROMs intended for clinical care often have streamlined interfaces and shorter questionnaires, aiding in their seamless integration into routine practice.

The secondary use of PROM data, gathered during clinical care, introduces another layer of complexity. Projects involving such data might straddle the line between human subjects research and quality improvement. The article underscores the importance of IRB oversight in these scenarios, ensuring that ethical standards are upheld while facilitating valuable insights into patient care and system performance.

Market Access Insights

From a market access perspective, the classification framework and IRB guidelines can significantly impact how quickly and efficiently PROMs are implemented in clinical settings. The following inferences can be made:

  • Clear guidelines on IRB oversight can lower barriers for healthcare providers, accelerating the adoption of PROMs.
  • A well-defined framework enhances regulatory compliance, ensuring smoother market entry for new PROM tools.
  • Streamlined IRB processes can facilitate broader data collection, enriching the evidence base for market access decisions.

The article concludes that a structured approach to classifying PROMs and determining IRB oversight is essential for optimizing their use in clinical practice. This framework aids IRB staff and clinicians alike, ensuring ethical standards are met while maximizing the benefits of patient-reported data.

Original Article:

Ethics Hum Res. 2024 Jul-Aug;46(4):27-37. doi: 10.1002/eahr.500216.

ABSTRACT

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The use of patient-reported outcome measures (PROMs) is increasingly common in routine clinical practice. As tools to quantify symptoms and health status, PROMs play an important role in focusing health care on outcomes that matter to patients. The uses of PROM data are myriad, ranging from clinical care to survey-based research and quality improvement. Discerning the boundaries between these use cases can be challenging for institutional review boards (IRBs). In this article, we provide a framework for classifying the three primary PROM use cases (clinical care, human subjects research, and quality improvement) and discuss the level of IRB oversight (if any) necessary for each. One of the most important considerations for IRB staff is whether PROMs are being used primarily for clinical care and thus do not constitute human subjects research. We discuss characteristics of PROMs implemented primarily for clinical care, focusing on: data platform; survey location; questionnaire length; patient interface; and clinician interface. We also discuss IRB oversight of projects involving the secondary use of PROM data that were collected during the course of clinical care, which span human subjects research and quality improvement. This framework provides practical guidance for IRB staff as well as clinicians who use PROMs as communication aids in routine clinical practice.

PMID:38944884 | DOI:10.1002/eahr.500216

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