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Patient-Reported Outcomes

Final FDA Guidance Prioritizes Patient Input in Medical Device Studies

January 28, 2022
Kendall Shadley

While healthcare organizations have prioritized patient experience improvements for years, finalized guidance from the US Food and Drug Administration (FDA) highlights the need for collecting and incorporating patient input into medical device clinical studies.

The two guidance documents include minor revisions from previous drafts and focus specifically on using patient-reported outcomes (PROs) in medical device evaluation and patient engagement in the design and facilitation of clinical studies.

Patient-Reported Outcomes in Medical Device Evaluation

In its guidance, the FDA outlines principles for “selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation.” The intended purpose of incorporating PROs in medical device evaluation is to help evaluate and improve the patient experience during studies.

In addition to capturing safety and efficacy outcomes, the use of PROs, the FDA notes, helps to support “the regulatory and healthcare decision-making process” while also providing patient education.

The FDA does warn, however, that PRO instruments should be specific to the “intended use population” and should not “include items that could be misinterpreted.” This prefaces an entire section within the guidance specific to health literacy – ensuring that PRO collection methods are understandable and do not burden patients unnecessarily.

Patient Engagement in the Design and Facilitation of Clinical Studies

FDA guidance specific to clinical study design and facilitation focuses on engaging patients in clinical studies and incorporating patient input.

To begin, the FDA provides definition of patient engagement – a term that continues to take on a variety of meanings from patient education to patient experience..  Per the FDA,  patient  engagement  is  defined as  intentional,  meaningful interactions  with  patients  that provide  opportunities  for mutual learning,  and  effective collaborations.

More tactically, the FDA guides sponsors on when and how to obtain patient feedback and craft patient-centered study designs that are thoughtful about trial access, structure, and communication.

FDA guidance on the design and facilitation of clinical studies was recommended by the entity’s own Patient Engagement Advisory Committee (PEAC). Sponsors are encouraged to design clinical studies to ensure optimal levels of patient engagement and a positive patient experience.

The PatientIQ Approach

From its founding, PatientIQ has always believed a PRO instrument  is one of the most powerful tools to measure the effects of a medical intervention or changes in the health status of a patient. The FDA shares this position and is now guiding sponsors to consider the broader patient engagement strategy of the trial - another area in which PatientIQ has demonstrated deep expertise.

From the most apparent standpoint, an organization cannot effectively collect PROs and assess patient outcomes without effectively engaging patients to participate. Therefore, PatientIQ takes a patient-centered approach to outreach conducted on behalf of leading healthcare organizations and medical device sponsors nationwide when designing clinical studies.

Additionally, PatientIQ recognizes the need for a holistic patient experience supported by simplified IT deployments. Therefore, PatientIQ offers more than PRO collection on one platform – it incorporates patient education, patient communication, patient satisfaction surveying, and more.

When patients are engaged, PatientIQ customers are empowered to better understand their clinical outcomes and act on that information – improving care quality for the populations they serve.

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