Patient-reported outcome measures in prostate research: a scoping review

To summarise how patient-reported outcome measures (PROMs) are used in prostate research, specifically in the 10 years after the 2010 CONsolidated Standards Of Reporting Trials (CONSORT) guidelines were introduced.

The search was focussed on randomised controlled trials (RCTs) reporting in the top 15 journals in oncology, urology, and medicine, during 2011-2020 and identified through PubMed®. For each article the following items were identified: the condition being treated, the intervention(s) of interest, the study design, the specific PROM(s) used, when they were included in the treatment pathway, how they were analysed, and whether methods to deal with multiplicity or missing data were considered.

There were 361 potentially eligible articles identified from the PubMed search, of which 121 were eligible for the full-text review. The articles were RCTs assessing interventions for lower urinary tract symptoms (n = 54) or prostate cancer (n = 67), for which the most commonly reported PROMs were the International Prostate Symptom Score (50/54) and Functional Assessment of Cancer/Chronic Illness Therapy questionnaires (28/67), respectively. Details on the analysis and handling of PROMs were difficult to obtain; notably, 60% of articles failed to mention whether any methods had been used for dealing with multiplicity or missing data. An incidental finding was that sexually inactive men were excluded from analyses in some of the articles.

Our scoping review highlights the need to refine the way PROMs are incorporated and analysed in prostate randomised trials, so their findings can be efficiently applied in further research and clinical practice. Adherence to the CONSORT guidelines, specifically clear reporting of the timing of PROMs, the handling of missing data, and multiplicity, should be encouraged. RCTs in prostate cancer would benefit from core outcome and measurement sets, to avoid unnecessary overlap and facilitate evidence synthesis.