Introduction: Radical cystectomy (RC) with urinary diversion (UD) remains the standard of care for localised muscle invasive bladder cancer (MIBC). Several patient reported outcomes (PROs) instruments have been used in this population but it is unclear whether the coverage of domains appropriately captures the issues of concern to patients and identify the symptoms that affected patients most.
Methods: A systematic search of MEDLINE, EMBASE, PubMed, Cinahl, Cochrane was conducted from January 2000 to May 2023 for original articles. Two reviewers (J.L. and S.N.) independently screened the titles of articles, assessed full text for eligibility and extracted data, specifically the PRO measures used, PRO domains reported and scores in the first 12 months following surgery and after 12 months, separately for studies of neobladder (NB) or ileal conduit (IC). We then used a conservative threshold of <70 for functional domains and >30 for symptom domains to determine which PRO domains were potentially concerning to patients in each study. Quality assessment of studies was performed using the QUALSYST appraisal tool.
Results: We identified 35 studies that met our inclusion criteria, which included a total of 8 unique PRO instruments. Whilst scores for functional domains improved over 12 months for patients with NB and IC, symptom burden worsened in most scales, especially with sexual function and future worries for both groups. According to our criteria for patient-perceived domains of concern or clinical relevance, physical functioning was deemed concerning in 75% of 16 reported instances for patients with NB at less than 12 months, compared to 100% of 10 trials in patients with IC at less than 12 months. Physical, social, functional, emotional, role, cognitive, urinary, mental, and sexual functioning were all identified in at least one study as concerning domains for patients who had RC with NB, at both before and after 12 months. Despite this, these domains are not covered in all instruments. The instrument that covered the largest number of concerning domains overall was the combination of the EORTC QLQ-C30 and BLM-30
Conclusions: Future studies of NB and IC in MIBC should consider which domains are of most importance to patients when selecting a PRO instrument. Due to differences in the symptoms and aspects of functioning that are deemed important in the acute recovery phase compared to 12 months post-surgery, and differences between IC versus NB, the choice of instrument may differ according to the specific aims of the study.