286P Breast-cancer specific comprehensive archive of patient-reported outcome measures (PROMs) for clinical research and clinical practice in oncology: Results from the PRO4All project

Inclusion of patient-reported outcomes (PROs) in oncology clinical trials is strongly recommended. However, selecting the most appropriate patient-reported outcome measures (PROMs) is not easy. This study aimed to develop a breast cancer specific comprehensive archive of PROMs and to identify their main characteristics and target outcome domains. As part of the PRO4All project, we identified available PROMs in oncology by searching facit.org, eortc.org, eprovide.mapi-trust.org, ema.europa.eu (European Public Assessment Reports) and published reviews. For this analysis, only breast cancer specific tools were extracted. We described information about PROM name, type of questionnaire (self-reported, proxy-reported or caregiver's report), questionnaire variant(s), recall period, number of items, and presence of minimum clinically important difference (MCID) reference in literature. In addition, we assigned each item to a specific domain according to a predefined taxonomy of 38 items for outcome classification. We identified and analysed 376 PROMs. Of these, 29 were breast cancer specific, but 2 were excluded because the full-text questionnaires were not available. So, we fully examined a total of 27 breast cancer specific PROMS. 6 (22.2%) were variants of another questionnaire. All questionnaires (100%) were self-reported. In 6 cases (22.2%) the recall period to consider was the "last week". The mean number of items per questionnaire was 25.81 (range 6-71). In total, 602 items were assigned an outcome domain: emotional functioning/wellbeing in 26.6% of cases, physical functioning in 14.1%, delivery of care in 10.8%, and general outcomes in 10.5%. MCID reference was found only in 4 (14.8%) cases. Similar to the findings obtained from a general search for PROMs, this research highlighted the availability of many instruments specifically developed for breast cancer. The newly developed archive could represent a useful tool to optimize the use of PROMs in the evaluation of treatments in patients with cancer, promoting a patient-centered approach both in clinical research and practice.