Volume 16 Supplement 2

3rd International Clinical Trials Methodology Conference

Open Access

Core outcomes for randomized trials and core information for clinical decision-making: implications for outcome selection

  • Angus McNair1,
  • Robert Whistance1,
  • Rachel Forsythe1,
  • Rhiannon Macefield1,
  • Sara Brookes1,
  • Jane Blazeby1, 2 and
  • CONSENSUS-CRC working group1
Trials201516(Suppl 2):P65

https://doi.org/10.1186/1745-6215-16-S2-P65

Published: 16 November 2015

Introduction

Core outcomes sets (COS) are an agreed minimum group of outcomes to measure in trials. Core information sets (CIS) are defined as the agreed minimum information required for clinical decision-making. Theoretically, these concepts should be closely aligned, however, there is no evidence that COSs adequately inform CISs. This study compared COS and CIS for colorectal cancer (CRC) surgery.

Methods

All potential outcomes/information of importance were identified through systematic literature reviews, reviews of hospital information leaflets and patient interviews. This informed Delphi questionnaires which asked stakeholders (patients, surgeons and nurses) from a sample of UK CRC centres to rate the importance of 1) outcomes and 2) information on a five-point Likert scale. Respondents were resurveyed following feedback from stakeholder groups. Outcomes/information rated as less important were discarded according to pre-defined criteria. The final COS and CIS was agreed at separate international consensus meetings with professionals and patients. Comparisons were made between core set items.

Results

Data sources identified 1216 outcome/information of CRC surgery that informed a 116 item questionnaire. Centre response rates were 79% (64/81), including 93 surgeons and 11 clinical nurse specialists, and 97 of 267 patients. Stakeholders prioritized 51 and 23 items in the first and second surveys, and consensus meetings reduced this to a 9 item COS and 10 item COS. The sets were identical apart from additional length of hospital stay information.

Conclusion

Stakeholders largely agreed on the content of COS and CIS in CRC, but further research is needed to demonstrate this in other settings.

Authors’ Affiliations

(1)
University of Bristol
(2)
University Hospitals Bristol NHS Foundation Trust

Copyright

© McNair et al. 2015

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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