Abstract 589P
Background
Patient-reported outcomes (PROs) is defined by US Food and Drug Administration as any report of the status of a patient’s health condition that comes directly from the patient without interpretation of the patient’s response by clinical or anyone else. Value of PROs measures have evolved over the years where few regulatory agencies have mandated to measure the success of clinical outcomes in regulatory decision making. PRO instruments are most often used in understanding of patient experience around their disease burden, symptoms, impacts, and preferences including treatment burden. There are no consensus or standardized methods on application on which PROs are best for regulatory approval, obtaining reimbursement, comparative effectiveness research, toxicity assessment, health-related quality of life (QOL) or symptom monitoring.
Methods
A comprehensive literature search on PubMed was performed using generative artificial intelligence to identify studies published in English from 1 January 2004 to 16 July 2024. The following keywords were searched: patient reported outcomes, patient centered research, clinical effectiveness, oncology, health economics outcome research, validated instruments, questionnaire, interview, survey, US, Canada, EU5 (France, Germany, Italy, Spain, UK) and Asia Pacific (APAC).
Results
A total of 2,611 articles were screened. US led in generation of PROs data followed by EU5, APAC and Canada. The PROs were most frequently used to assess treatment impact on QOL (41.7%), monitor patient’s symptoms (23.5%) while less than 10% PROs data were generated for regulators and payers. Cancer specific PROs measures were most reported among breast cancer patients proceeded by genitourinary cancer, thoracic cancer, and gynecological cancer. Across the regions, 8% of PROs studies were conducted without ethics approval.
Conclusions
Emerging evidence demonstrated PROs significantly improve patient cancer care through strengthening patient-clinician communication, QOL, and economic benefits. With growing importance of patient voice and shift of patient centricity in cancer patient care, PROs measures will become a standard practice in research and clinic despite limitations to using PROs in practice.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
IQVIA Asia Pacific.
Funding
Has not received any funding.
Disclosure
Y. Lee, S. Sridhar, J. Sarkar: Financial Interests, Personal, Full or part-time Employment: IQVIA Asia Pacific.