title: Synthesis and summary of patient-reported outcome measures to inform the development of a core outcome set in colorectal cancer surgery.
abstract: OBJECTIVE
  Patient-reported outcome (PRO) measures (PROMs) are standard measures in the assessment of colorectal cancer (CRC) treatment, but the range and complexity of available PROMs may be hindering the synthesis of evidence. This systematic review aimed to: (i) summarize PROMs in studies of CRC surgery and (ii) categorize PRO content to inform the future development of an agreed minimum 'core' outcome set to be measured in all trials.
  
  
  METHODS
  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 the number of items documented. All items were extracted and independently categorized by content by two researchers into 'health domains', and discrepancies were discussed with a patient and expert. Domain popularity and the distribution of items were summarized.
  
  
  RESULTS
  Fifty-eight different PROMs were identified from the 104 included studies. There were 23 generic, four cancer-specific, 11 disease-specific and 16 symptom-specific questionnaires, and three ad hoc measures. The most frequently used PROM was the EORTC QLQ-C30 (50 studies), and most PROMs (n = 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.
  
  
  CONCLUSIONS
  There is major heterogeneity of PRO measurement and a wide variation in content assessed in the PROMs available for CRC. A core outcome set will improve PRO outcome measurement and reporting in CRC trials.
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.|Severn School of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: A G K
authors.initials: AG
authors.lastname: McNair
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.|Division of Surgery Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: R N
authors.initials: RN
authors.lastname: Whistance
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.|Division of Surgery Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: R O
authors.initials: RO
authors.lastname: Forsythe
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: J
authors.initials: J
authors.lastname: Rees
authors.affiliation: Colorectal Cancer Patient Representative, North Bristol NHS Trust, Bristol, UK.
authors.forename: J E
authors.initials: JE
authors.lastname: Jones
authors.affiliation: Department of General Surgery, North Bristol NHS Trust, Bristol, UK.
authors.forename: A M
authors.initials: AM
authors.lastname: Pullyblank
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: K N L
authors.initials: KN
authors.lastname: Avery
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: S T
authors.initials: ST
authors.lastname: Brookes
authors.affiliation: Colorectal Surgery Unit, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: M G
authors.initials: MG
authors.lastname: Thomas
authors.affiliation: Colorectal Surgery Unit, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: P A
authors.initials: PA
authors.lastname: Sylvester
authors.affiliation: Colorectal Consumer Liaison Group, National Cancer Research Institute, London, UK.
authors.forename: A
authors.initials: A
authors.lastname: Russell
authors.affiliation: Colorectal Consumer Liaison Group, National Cancer Research Institute, London, UK.
authors.forename: A
authors.initials: A
authors.lastname: Oliver
authors.affiliation: Academic Department of Surgery, University of Birmingham, Birmingham, UK.
authors.forename: D
authors.initials: D
authors.lastname: Morton
authors.affiliation: Department of Surgery, St Mark's Hospital and Academic Institute, Harrow, UK.
authors.forename: R
authors.initials: R
authors.lastname: Kennedy
authors.affiliation: Academic Surgical Unit, St James' University Hospital NHS Trust, Leeds, UK.
authors.forename: D G
authors.initials: DG
authors.lastname: Jayne
authors.affiliation: Centre for Ethics in Medicine, University of Bristol, Bristol, UK.
authors.forename: R
authors.initials: R
authors.lastname: Huxtable
authors.affiliation: Colorectal Network Site Specific Group, Avon, Somerset and Wiltshire Cancer Services, Bristol, UK.
authors.forename: R
authors.initials: R
authors.lastname: Hackett
authors.affiliation: Centre for Statistics in Medicine and Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
authors.forename: S J
authors.initials: SJ
authors.lastname: Dutton
authors.affiliation: Department of Colorectal Surgery, Plymouth Hospitals NHS Trust, Plymouth, UK.
authors.forename: M G
authors.initials: MG
authors.lastname: Coleman
authors.affiliation: Colorectal Surgery Unit, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: M
authors.initials: M
authors.lastname: Card
authors.affiliation: Clinical Trials Research Unit, University of Leeds, Leeds, UK.
authors.forename: J
authors.initials: J
authors.lastname: Brown
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.|Division of Surgery Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: J M
authors.initials: JM
authors.lastname: Blazeby
mesh_terms: D015179:Colorectal Neoplasms / Q000601:surgery*; D003107:Colorectal Surgery / Q000379:methods*; D006801:Humans; D063868:Patient Outcome Assessment; D057566:Self Report; D011795:Surveys and Questionnaires
keywords: Colorectal cancer; core outcome set; patient-reported outcomes; surgery; systematic review