OBJECTIVES: Choosing the most adequate measure of patient-reported outcomes (PROs) in clinical trials, clinical practice, and post-authorization studies is not straightforward. This study aimed to develop a comprehensive archive of patient-reported outcome measures (PROMs) in oncology and identify their main characteristics and target outcome domains.

METHODS: As part of the PRO4All project, we retrieved the available PROMs in oncology by searching facit.org, eortc.org, eprovide.mapi-trust.org, ema.europa.eu (European Public Assessment Reports), and published reviews. We developed a data extraction form to collect information on: PROM name, cancer area (based on ICD-10), type of questionnaire (i.e., self-reported, proxy-reported or caregiver’s report), questionnaire variant(s), recall period (e.g., last week) and number of items. Moreover, we assigned each item a specific domain according to a predefined 38-item taxonomy for outcome classification.

RESULTS: A total of 308 PROMs were identified and fully analyzed. Over half (n=156, 50.6%) were cancer type-specific (e.g., breast cancer n=27, 8.8%), 132 (42.9%) were generic for cancer and 20 (6.5%) were intended for the general population but also recommended or used for cancer patients. 48 (15.6%) were variants of another questionnaire. The great majority of questionnaires (93.2%) were self-reported, 3.2% were proxy-reported (e.g., by parents), and 3.6% were related to caregiver’s status. In almost half of the cases (47.1%) the recall period was last week. The mean number of items per questionnaire was 22.5 (range: 1- 130). In total, 6921 items were assigned an outcome domain, which was emotional functioning/wellbeing in 21.5% of cases, physical functioning in 15.0%, general outcomes in 9.9% and delivery of care in 9.6%.

CONCLUSIONS: This review study highlighted a significant heterogeneity of PROMs in oncology. The newly developed archive represents a useful tool for guiding researchers and practitioners in selecting the most suitable measures for cancer patients and fostering a patient-centered approach.

ISPOR Europe 2023

12 - 15 November

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