Outcomes reported in randomized controlled trials of rectal cancer treatment: A scoping review for the CORRECT...

The purpose of this scoping review was to systematically review the published literature of randomized controlled trials (RCT) in rectal cancer to generate a comprehensive list of study outcomes. The secondary objectives of this study were to describe trends in outcome reporting in rectal cancer RCTs with a particular focus on patient-reported outcome measures (PROM).

We systematically searched for rectal cancer RCTs suing several electronic databases. Eligible studies needed to be published after the year 2000 and had to evaluate a locoregional or systemic therapy for non-metastatic rectal cancer as its primary exposure. All reported outcomes were extracted verbatim from the article and subsequently re-categorized into "standardized outcome terms" and within OMERACT Core Areas of health. Data regarding the use of patient-reported outcome measures and the choice of primary outcome were also extracted.

In total, 89 RCT's were included: 56 (62.9 %) were considered neoadjuvant trials, 24 (27.0) surgical trials, and 9 (10.1 %) adjuvant trials. Fifty-three standardized outcome terms were identified and grouped into various domains and Core Areas. The primary outcomes utilized in each RCT were highly variable and differed by study type. In total, 37 (41.6 %) trials used one or more patient-reported outcome measure as an outcome, mainly consisting of health-related quality of life. There were no significant trends in outcome reporting by year or author specialty.

A comprehensive list of study outcomes categorized into several domains and Core Areas was generated.