The Comprehensive Archive of PROMs in Oncology:
A Tool for
Patient-Centered Care
The PRO4ALL working group was set up in 2021 with the aim of understanding the role of the “patient voice” in clinical research and regulatory pathways, with a specific focus to Patient Reported Outcomes (PROs) and their measurement. The working group comprises Associazione Italiana Oncologia Medica (AIOM), Associazione Italiana di Miologia (AIM), Associazione Italiana Sclerosi Multipla (AISM), Federazione Italiana delle Associazioni di Volontariato in Oncologia (FAVO), Federazione dei Gruppi Cooperativi Oncologici Italiani (FICOG), Società Italiana di Neurologia (SIN), Federazione Italiana Malattie Rare (UNIAMO) together with SDA Bocconi and the unconditional funding from Roche.
Patient-reported outcomes refer to any data on a patient's health status that comes directly from the patient, without interpretation by the clinician or others. The measurement of PROs is done by means of instruments, scales and questionnaires, collectively called patient reported outcome measures (PROMs) which allow to gather the perspective of the individual living with the disease or receiving a given treatment on physical, emotional, cognitive, social functioning, and psychological well-being and health-related quality of life.
The PRO4ALL project has carried out several research projects over the last two years. One of the conclusion reached by the working group is that a harmonisation and standardisation of the use of PROs and PROMs in clinical research is required, together with a commitment of relevant institutions to ensure that patients are at the centre of evaluation processes at every stage of drug development.
In relation to this, we developed a comprehensive archive of patient-reported outcome measures (PROMs) in oncology and identified their main characteristics and target outcome domains. The main results of the archive are published in the scientific paper titled "The development of an archive of patient-reported outcome measures (PROMs) in oncology: The Italian PRO4All project." This archive represents a useful tool for guiding researchers and practitioners in selecting the most suitable measures and fostering a patient-centered approach in clinical trials, clinical practice, and regulatory activities.
Start searching the repository
Eventuale sottotitolo che invita a iniziare la ricerca
More information about the study
This table illustrates the analysis of ICD10 codes and anatomical categories, categorized according to the different types of Clinical Outcome Assessments.
| ICD10 | PROM (%) | ObsROM (%) | CROM (%) | Total (%) |
|---|---|---|---|---|
| Malignant neoplasms (C00-C97) | 160 (44.9) | 4 (30.8) | 9 (52.9) | 173 (44.8) |
| Malignant neoplasm of breast (C50-C50) | 32 (9,0) | 4 (0,0) | 0 (0,0) | 32 (8,3) |
| General population | 28 (7,9) | 0 (0,0) | 3 (17,6) | 31 (8,0) |
| Malignant neoplasms of digestive organs (C15-C26) | 23 (6,5) | 0 (0,0) | 0 (0,0) | 23 (6,0) |
| Malignant neoplasms of male genital organs (C60-C63) | 20 (5,6) | 0 (0,0) | 1 (5,9) | 21 (5,4) |
| Pediatric cancer | 8 (2,2) | 9 (69,2) | 4 (23,5) | 21 (5,4) |
| Malignant neoplasm of bronchus and lung (C34) | 15 (4,2) | 0 (0,0) | 0 (0,0) | 15 (3,9) |
| Malignant neoplasms of lip oral cavity and pharynx (C00-C14) | 14 (3,9) | 0 (0,0) | 0 (0,0) | 14 (3,6) |
| Malignant neoplasms of urinary tract (C64-C68) | 12 (3,4) | 0 (0,0) | 0 (0,0) | 12 (3,1) |
| Malignant neoplasms stated or presumed to be primary of lymphoid haematopoietic and related tissue (C81-C96) | 11 (3,1) | 0 (0,0) | 0 (0,0) | 11 (2,8) |
| Malignant neoplasms of eye brain and other parts of central nervous system (C69-C72) | 8 (2,2) | 0 (0,0) | 0 (0,0) | 8 (2,1) |
| Malignant neoplasms of bone and articular cartilage (C40-C41) | 5 (1,4) | 0 (0,0) | 0 (0,0) | 5 (1,3) |
| Malignant neoplasm of nasal cavity and middle ear (C30) | 2 (0,6) | 0 (0,0) | 0 (0,0) | 2 (0,4) |
| Malignant neoplasms of mesothelial and soft tissue (C45-C49) | 2 (0,6) | 0 (0,0) | 0 (0,0) | 2 (0,5) |
| Malignant neoplasms of thyroid and other endocrine glands (C73-C75) | 2 (0,6) | 0 (0,0) | 0 (0,0) | 2 (0,5) |
| Melanoma and other malignant neoplasms of skin (C43-C44) | 2 (0,6) | 0 (0,0) | 0 (0,0) | 2 (0,5) |
| Malignant neoplasm of larynx (C32) | 1 (0,3) | 0 (0,0) | 0 (0,0) | 1 (0,3) |
| Total | 356 (100) | 13 (100) | 17 (100) | 386 (100) |
The bubble chart in Figure 2 visualizes the frequency distribution of outcome domains within PROM items (n=6976) across various cancer types. For instance, items assessing "emotional functioning/well-being" (16.2%) were more prevalent in breast cancer PROMs, whereas "respiratory outcomes" (8.1%) were more commonly found in instruments for bronchus and lung neoplasms.
