Patient Reported Outcomes

Survey's save lives

The US Food and Drug Administration (FDA) first suggested the term Patient-Reported Outcome (PRO) as a neutral phrase to reflect the complete spectrum of therapeutic effects that are best reported directly from patients. Patient reports are a vital component in capturing the effects of sickness and medical therapies on people's everyday lives and wellbeing. The patient-generated health data (PGHD) that comes from these surveys and forms must be produced, documented, or acquired from the patient. With this information, together, the patient and the clinician may develop a better treatment plan with the use of PGHD (ultimately giving them better personalized care!) .

Many site workers currently give patients forms like paper diaries to keep track of PROs. But choosing which PROs to utilize involves taking into account a number of best practices and using validated questionnaires to reduce any inconsistencies in the patient's interpretation which might then provide a broad range of results and eventually useless data. 

And given the potential value of Real World Evidence (RWE) being enhanced by PROs there has been a growing adoption of  mobile apps, web platforms, and artificial intelligence-driven algorithms targeting the clinical trials market with ePRO solutions. This targeting is mostly because real-world long-term safety studies are receiving more and more interest from the pharmaceutical sector.

This type of data is extremely valuable but can be undermined in the absence of representative PRO data collecting. One example - due to a lack of language support, non-english speaking patients are often not included in patient-reported outcome measurements. So it matters that underserved populations are included in this data to fully reflect socioeconomic, demographic, and health status variables that effect wellbeing. Excluding them in PGHD for any reason undermines research and therapy results.

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In the News

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Patient-Reported outcomes (PROs) and Patient-Reported Outcome Measures (PROMs)

NCBI

Patients See Utility in Digital Patient-Reported Outcomes Tools

Patient Engagement Hit

Language Barriers Limit Patient-Reported Outcomes in Cancer Care

Patient Engagement Hit

Patients with limited English proficiency (LEP) are excluded from patient-reported outcome measures due to language barriers. Leaving them out reduces the opportunity for better cancer treatment and outcomes, according to a recent study. LEP patients generally had positive attitudes towards oral cancer-directed therapies (OCDT). Electronic Patient-Reported Outcomes (ePROs) can be helpful in improving communication barriers between patients and care teams, researchers say.

Reporting patient outcomes in clinical trials: Why moving to electronic PROs makes sense

Nutritional Outlook

Innovations in Patient Reported Outcomes Lead to Better Care

OncLive

Patient reported outcome assessment must be inclusive and equitable

Nature Medicine