How much attention was paid to patient-reported outcomes in randomized trials and meta-analyses of rectal cancer surgery?

Tags: Poster
Nishizaki D1, Sumii A1, Hida K1, Sakai Y1
1Department of Surgery, Kyoto University Graduate School of Medicine

Background: high-quality surgical procedures should be based on good surgical outcomes and, ideally, the outcomes should be assessed together with patient involvement. Rectal surgery is associated with high morbidity including sexual, urinary, and bowel dysfunctions. Laparoscopic surgery is considered less invasive than open surgery and has the potential to preserve urogenital function. Currently, several less-invasive approaches have been used in clinical practice. However, the amount of attention that has been paid to patient-reported outcomes (PROs) in conducting randomized controlled trials (RCTs) of rectal cancer surgery and in incorporating such outcomes into meta-analyses (MAs) remains unclear.

Objective: to clarify how many RCTs and MAs paid attention to PROs for incorporating patient preferences into studies or reviews.

Methods: this was a cross-sectional analysis. We comprehensively searched MEDLINE and the Cochrane Library for topics that included rectal cancer and laparoscopic surgery. We included people with rectal cancer who underwent laparoscopic surgery and other procedures, including open, robotic, and transanal surgery, in our study. We included RCTs and MAs that compared laparoscopic surgery with other procedures.

Results: we identified 63 articles on 37 studies and 59 articles of systematic reviews with MA. Of the 37 RCTs, 12 studies (32%) measured PROs, including numerical rating scales or visual analogue scales on pain, quality-of-life questionnaires, study-specific questionnaires, and urogenital symptom scores. Six of the studies that measured PROs were international, multicentre studies. The remaining 20 studies assessed surgical and oncological outcomes without PROs. As for systematic reviews with MA, only seven reviews (12%), including one Cochrane Review, set PROs as their outcome, five of which also included non-randomized studies. We integrated pain scales and urogenital function scores into the meta-analyses, but not quality-of-life scores.

Conclusions: the findings of our study suggest a need to encourage the use of PROs. Incorporating PROs into study outcomes may allow patient perspectives to be reflected in research. Although a time lag might occur before the measured PROs are reported, future MAs should incorporate PROs.

Patient or healthcare consumer involvement: since rectal cancer surgery complications are frequent and affect the postoperative lives of cancer survivors, shared decision-making that considers evidence on PROs and the assessment of safety and oncological outcomes is needed.