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. 2016 Aug 9;13(8):e1002071.
doi: 10.1371/journal.pmed.1002071. eCollection 2016 Aug.

Core Outcomes for Colorectal Cancer Surgery: A Consensus Study

Angus G K McNair  1   2 , Robert N Whistance  1   3 , Rachael O Forsythe  1   3 , Rhiannon Macefield  1 , Jonathan Rees  1 , Anne M Pullyblank  4 , Kerry N L Avery  1 , Sara T Brookes  1 , Michael G Thomas  3 , Paul A Sylvester  3 , Ann Russell  5 , Alfred Oliver  5 , Dion Morton  6 , Robin Kennedy  7 , David G Jayne  8 , Richard Huxtable  9 , Roland Hackett  10 , Susan J Dutton  11 , Mark G Coleman  12 , Mia Card  3 , Julia Brown  13 , Jane M Blazeby  1   3
Affiliations

Core Outcomes for Colorectal Cancer Surgery: A Consensus Study

Angus G K McNair et al. PLoS Med. .

Abstract

Background: Colorectal cancer (CRC) is a major cause of worldwide morbidity and mortality. Surgical treatment is common, and there is a great need to improve the delivery of such care. The gold standard for evaluating surgery is within well-designed randomized controlled trials (RCTs); however, the impact of RCTs is diminished by a lack of coordinated outcome measurement and reporting. A solution to these issues is to develop an agreed standard "core" set of outcomes to be measured in all trials to facilitate cross-study comparisons, meta-analysis, and minimize outcome reporting bias. This study defines a core outcome set for CRC surgery.

Methods and findings: The scope of this COS includes clinical effectiveness trials of surgical interventions for colorectal cancer. Excluded were nonsurgical oncological interventions. Potential outcomes of importance to patients and professionals were identified through systematic literature reviews and patient interviews. All outcomes were transcribed verbatim and categorized into domains by two independent researchers. This informed a questionnaire survey that asked stakeholders (patients and professionals) from United Kingdom CRC centers to rate the importance of each domain. Respondents were resurveyed following group feedback (Delphi methods). Outcomes rated as less important were discarded after each survey round according to predefined criteria, and remaining outcomes were considered at three consensus meetings; two involving international professionals and a separate one with patients. A modified nominal group technique was used to gain the final consensus. Data sources identified 1,216 outcomes of CRC surgery that informed a 91 domain questionnaire. First round questionnaires were returned from 63 out of 81 (78%) centers, including 90 professionals, and 97 out of 267 (35%) patients. Second round response rates were high for all stakeholders (>80%). Analysis of responses lead to 45 and 23 outcome domains being retained after the first and second surveys, respectively. Consensus meetings generated agreement on a 12 domain COS. This constituted five perioperative outcome domains (including anastomotic leak), four quality of life outcome domains (including fecal urgency and incontinence), and three oncological outcome domains (including long-term survival).

Conclusion: This study used robust consensus methodology to develop a core outcome set for use in colorectal cancer surgical trials. It is now necessary to validate the use of this set in research practice.

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Conflict of interest statement

I have read the journal's policy and the authors of this manuscript have the following competing interests: AR received travel reimbursement from my home for attendance at Bristol University. AR is a patient member of the NCRI Consumer Forum and Primary Care Clinical Studies Group. AR is a patient member of the NCRI Colorectal Clinical Studies Group Adjuvant and Advanced Disease and Surgical Sub-groups. AR is a member of the Independent Cancer patient Voice organisation.

Figures

Fig 1
Fig 1. Flow diagram of Delphi process.
See this image and copyright information in PMC

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