'Constipation': One word, many meanings amongst persons with cancer: An observational study.

Background: Constipation is common in people with advanced cancer and is associated with significant morbidity and health economic burden, but it is often sub-optimally managed. Despite international consensus diagnostic criteria for functional and opioid-induced constipation (Rome IV diagnostic criteria), the term 'constipation' means different things to different people, impacting assessment, diagnosis and management.

Aim: To investigate the association between persons with advanced cancer self-reporting of constipation, response to the Rome IV diagnostic criteria statements for opioid-induced constipation and differences according to personal demographics.

Design: Multicentre prospective observational study.

Setting/participants: Twenty-four community, hospice and hospital research sites in 10 European countries recruited 1200 adults with cancer taking opioids for cancer/cancer-treatment related pain.

Results: In response to the simple question , 549 (45.5%) participants replied 'yes', 588 (49%) replied 'no' and 59 (5%) were 'unsure', but 713 (59.5%) participants met the Rome IV diagnostic criteria. Only 439 (61.5%) participants that met these criteria answered the simple question positively, whilst 230 (39%) answered negatively, although there was a statistically significant association between responses to the simple question and the criteria (χ(1,  = 1136) = 149.945,  = 0.00001). There were certain significant differences in self-reporting according to age and country of origin.

Conclusions: There is disparity between patients' self-reporting of constipation and the Rome IV diagnostic criteria. People with advanced cancer, especially those receiving opioid analgesics, need to be regularly assessed for constipation, but the use of a single question () is inadequate.Registry: European Study of Opioid Induced Constipation (E-StOIC), NCT05149833, https://clinicaltrials.gov/study/NCT05149833, 08/12/2021.