Synthesis and summary of patient-reported outcome measures to inform the development of a core outcome set in colorectal cancer surgery.

Aim: Patient reported outcome measures (PROMs) are standard in the assessment of colorectal cancer (CRC) treatment, but the range and complexity of available PROMs may be hindering evidence synthesis. This systematic review aimed to 1) summarise PROMs in studies of CRC surgery and 2) categorise PRO content to inform the future development of an agreed minimum 'core' outcome set to be measured in all trials. Method: All PROMs were identified from a systematic review of prospective CRC surgical studies. The type and frequency of PROMs in each study were summarized, and numbers of items documented. All items were extracted and independently categorized by content by two researchers into 'health domains' and discrepancies discussed with a patient and expert. Domain popularity and distribution of items were summarized. Results: 58 different PROMs were identified from the 104 included studies. There were 23 generic, 4 cancer specific, 11 disease and 16 symptom specific questionnaires, and 3 ad hoc measures. The most frequently used PROM was the EORTC QLQ-C30 (50 studies), and most PROMs (40,69%) were used in only one study. Detailed examination of the 50 available measures identified 917 items, which were categorized into 51 domains. The domains comprising the most items were 'anxiety' (n=85,9.2%), 'fatigue' (n=67,7.3%), and 'physical function' (n=63,6.9%). No domains were included in all PROMs Conclusion: There is major heterogeneity of PRO measurement and wide variation in content assessed by PROMs available for CRC. A core outcome set will improve PRO outcome measurement and reporting in CRC trials.