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Published in: Trials 1/2016

Open Access 01-12-2016 | Research

Trial outcomes and information for clinical decision-making: a comparative study of opinions of health professionals

Authors: Angus G. K. McNair, Sara T. Brookes, Robert N. Whistance, Rachael O. Forsythe, Rhiannon Macefield, Jonathan Rees, James Jones, George Smith, Anne M. Pullyblank, Kerry N. L. Avery, Michael G. Thomas, Paul A. Sylvester, Anne Russell, Alfred Oliver, Dion Morton, Robin Kennedy, David G. Jayne, Richard Huxtable, Rowland Hackett, Susan J. Dutton, Mark G. Coleman, Mia Card, Julia Brown, Jane M. Blazeby, On behalf of the CONSENSUS-CRC (Core Outcomes and iNformation SEts iN SUrgical Studies – ColoRectal Cancer) working group

Published in: Trials | Issue 1/2016

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Abstract

Background

Trials are robust sources of data for clinical practice; however, trial outcomes may not reflect what is important to communicate for decision-making. The study compared clinicians’ views of outcomes to include in a core outcome set for colorectal cancer (CRC) surgery, with what clinicians considered important information for clinical practice (core information).

Methods

Potential outcome/information domains were identified through systematic literature reviews, reviews of hospital information leaflets and interviews with patients. These were organized into six categories and used to design a questionnaire survey that asked surgeons and nurses from a sample of CRC centers to rate the importance of each domain as an outcome or as information on a nine-point Likert scale. Respondents were re-surveyed (round 2) following group feedback (Delphi methods). Comparisons were made by calculating the difference in mean scores between the outcomes and information domains, and paired t tests were used to explore the difference between mean scores of the six outcome/information categories.

Results

Data sources identified 1216 outcome/information items for CRC surgery that informed a 94-item questionnaire. First-round questionnaires were returned from 63/81 (78 %) of centers. Clinicians rated 76/94 (84 %) domains of higher importance to measure in trials than information to communicate to patients in round 1. This was reduced to 24/47 (51 %) in round 2. The greatest difference was evident in domains regarding survival, which was rated much more highly as a trial outcome than an important piece of information for decision-making (difference in mean 2.3, 95 % CI 1.9 to 2.8, p <0.0001). Specific complications and quality-of-life domains were rated similarly (difference in mean 0.18, 95 % CI −0.1 to 0.4, p = 0.2 and difference in mean 0.2, 95 % CI −0.1 to 0.5, p = 0.2, respectively).

Conclusions

Whilst clinicians want to measure key outcomes in trials, they rate these as less important to communicate in decision-making with patients. This discrepancy needs to be explored and addressed to maximize the impact of trials on clinical practice.
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Metadata
Title
Trial outcomes and information for clinical decision-making: a comparative study of opinions of health professionals
Authors
Angus G. K. McNair
Sara T. Brookes
Robert N. Whistance
Rachael O. Forsythe
Rhiannon Macefield
Jonathan Rees
James Jones
George Smith
Anne M. Pullyblank
Kerry N. L. Avery
Michael G. Thomas
Paul A. Sylvester
Anne Russell
Alfred Oliver
Dion Morton
Robin Kennedy
David G. Jayne
Richard Huxtable
Rowland Hackett
Susan J. Dutton
Mark G. Coleman
Mia Card
Julia Brown
Jane M. Blazeby
On behalf of the CONSENSUS-CRC (Core Outcomes and iNformation SEts iN SUrgical Studies – ColoRectal Cancer) working group
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1492-0

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