Background: We aimed to quantify the difference in patient reported outcome (PRO) data between clinical studies and the (patient initiated) EUPROMS study for sexual functioning and urinary incontinence after radical prostatectomy (RP) and external beam radiotherapy (RT).
Methods: Europa Uomo, the patient organization of men with prostate cancer (PCa) in Europe, initiated the EUPROMS study. Data involved 1101 men with PCa treated with RP and 304 patients treated with RT. In a literature search we identified investigator-initiated studies which matched EUPROMS characteristics. The observed scores in the literature were compared to the scores calculated using the EUPROMS-models. Data from EUPROMS was used to develop four regression models for men treated with RP and RT.
Results: The time between diagnosis and questionnaire completion was estimated to be 3/4 years for men after RP, and 5 for RT. Eight studies were identified which reported PRO data using the EPIC with comparable follow-up. Large heterogeneity was observed in reported literature. For sexual function, the difference in calculated and observed scores is at most 24 points (range 3-24 points) and differences between studies were less evident; for urinary incontinence, the difference between calculated and observed scores is at most 15 points (range 1.5-15) (4 scores above the MID) and previous studies underreported the actual effect compared to the current study.
Conclusions: Previous clinical investigator studies underreported the actual effect for urinary incontinence compared to the EUPROMS study. Clinicians should be aware of a potential underestimation of the reported PRO in the patient-physician communication.
Link: Sexual and urinary function in prostate cancer clinical studies and the Europa Uomo Patient Reported Outcome Study: does it match? – PubMed (nih.gov)