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

A G K McNair^{1

2}, R N Whistance^{1

3}, R O Forsythe^{1

3}, J Rees¹, J E Jones⁴, A M Pullyblank⁵, K N L Avery¹, S T Brookes¹, M G Thomas⁶, P A Sylvester⁶, A Russell⁷, A Oliver⁷, D Morton⁸, R Kennedy⁹, D G Jayne¹⁰, R Huxtable¹¹, R Hackett¹², S J Dutton¹³, M G Coleman¹⁴, M Card⁶, J Brown¹⁵, J M Blazeby^{1

3}; CONSENSUS-CRC (Core Outcomes and iNformation SEts iN SUrgical Studies - ColoRectal Cancer) Working Group

Affiliations

¹ Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.
² Severn School of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
³ Division of Surgery Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
⁴ Colorectal Cancer Patient Representative, North Bristol NHS Trust, Bristol, UK.
⁵ Department of General Surgery, North Bristol NHS Trust, Bristol, UK.
⁶ Colorectal Surgery Unit, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
⁷ Colorectal Consumer Liaison Group, National Cancer Research Institute, London, UK.
⁸ Academic Department of Surgery, University of Birmingham, Birmingham, UK.
⁹ Department of Surgery, St Mark's Hospital and Academic Institute, Harrow, UK.
¹⁰ Academic Surgical Unit, St James' University Hospital NHS Trust, Leeds, UK.
¹¹ Centre for Ethics in Medicine, University of Bristol, Bristol, UK.
¹² Colorectal Network Site Specific Group, Avon, Somerset and Wiltshire Cancer Services, Bristol, UK.
¹³ Centre for Statistics in Medicine and Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
¹⁴ Department of Colorectal Surgery, Plymouth Hospitals NHS Trust, Plymouth, UK.
¹⁵ Clinical Trials Research Unit, University of Leeds, Leeds, UK.

PMID: 26058878
PMCID: PMC4744711
DOI: 10.1111/codi.13021

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

A G K McNair et al. Colorectal Dis. 2015 Nov.

. 2015 Nov;17(11):O217-29.

doi: 10.1111/codi.13021.

Authors

Affiliations

¹ Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.
² Severn School of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
³ Division of Surgery Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
⁴ Colorectal Cancer Patient Representative, North Bristol NHS Trust, Bristol, UK.
⁵ Department of General Surgery, North Bristol NHS Trust, Bristol, UK.
⁶ Colorectal Surgery Unit, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
⁷ Colorectal Consumer Liaison Group, National Cancer Research Institute, London, UK.
⁸ Academic Department of Surgery, University of Birmingham, Birmingham, UK.
⁹ Department of Surgery, St Mark's Hospital and Academic Institute, Harrow, UK.
¹⁰ Academic Surgical Unit, St James' University Hospital NHS Trust, Leeds, UK.
¹¹ Centre for Ethics in Medicine, University of Bristol, Bristol, UK.
¹² Colorectal Network Site Specific Group, Avon, Somerset and Wiltshire Cancer Services, Bristol, UK.
¹³ Centre for Statistics in Medicine and Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
¹⁴ Department of Colorectal Surgery, Plymouth Hospitals NHS Trust, Plymouth, UK.
¹⁵ Clinical Trials Research Unit, University of Leeds, Leeds, UK.

PMID: 26058878
PMCID: PMC4744711
DOI: 10.1111/codi.13021

Abstract

Aim: 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.

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 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.

Conclusion: 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.

Keywords: Colorectal cancer; core outcome set; patient-reported outcomes; surgery; systematic review.

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Figures

**Figure 1**
PRISMA (Preferred Reporting Items for Systematic Reviews) diagram of studies considered for the systematic review.

See this image and copyright information in PMC

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

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

Authors

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Abstract

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical