Aim The aim of this study was to investigate the prevalence of opioid-induced constipation (OIC) using different diagnostic criteria, and specifically the new Rome IV criteria.
Methods This was a prospective, multi-centre, observational study of 350 patients with cancer who were receiving regular opioid analgesia for cancer pain. Patients were assessed for the presence of OIC using: a) Simple question (‘are you constipated?’); b) Camilleri definition; c) EAPC definition (constipation); d) Rome IV criteria; and e) comprehensive Specialist Palliative Care (SPC) clinician assessment (‘gold standard’). Patients also completed the Bowel Function Index ( to assess the adequacy of treatment), the PAC-QOL (to assess related quality of life), and the MSAS-SF (to assess correlation between constipation and other physical and psychological symptoms).
Results The prevalence of OIC according to the different diagnostic criteria was:
‘Simple’ question: 32.8%
EAPC definition: 27.7%
Camilleri definition: 59.4%
Rome IV criteria: 23.4%
Specialist Palliative Care clinician assessment: 60.8%.
Of the 213 patients that were deemed to have OIC by comprehensive SPC clinician assessment, only 79 were Rome IV positive (and 134 were Rome IV negative). Thus, the sensitivity of Rome IV criteria was only 37.4%, (specificity 98%). In contrast, there was a good correlation between the SPC clinician assessment and the Camilleri definition (sensitivity 85.7%; specificity 73.2%). Data on the other PROMS will be presented in the full report.
Conclusions Asking a simple question (‘are you constipated’) will miss many patients with OIC. The ‘gold standard’ appears to be a comprehensive SPC clinician assessment, although the Camilleri definition appears to be a useful screening question for clinical practice. The Rome IV criteria does not appear to be a sensitive method for diagnosing OIC.
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