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Journal article

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

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 outcomes/information domains were identified through systematic literature reviews, reviews of hospital information leaflets and interviews with patients. These were organized into 6 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 9-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 6 outcome/information categories.

Results

Data sources identified 1216 outcomes/information of 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 to 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 about survival, which was rated much more highly as a trial outcome than important piece of information for decision-making (mean difference 2.3, 95% CI 1.9-2.8, p<0.0001). Specific complications and quality-of-life domains were rated similarly (mean difference 0.18, 95% CI -0.1-0.4, p=0.2 and 0.2, 95% CI -0.1-0.5, 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.

Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.1186/s13063-016-1492-0

Authors

More by this author
Institution:
University of Oxford
Division:
MSD
Department:
NDORMS
Sub department:
Centre for Statistics in Medicine
Role:
Author


Publisher:
BioMed Central
Journal:
Trials More from this journal
Volume:
17
Issue:
344
Publication date:
2016-07-01
Acceptance date:
2016-07-06
DOI:
ISSN:
1745-6215


Pubs id:
pubs:632315
UUID:
uuid:18362031-658a-4d8c-8e5c-3a243c699fd9
Local pid:
pubs:632315
Source identifiers:
632315
Deposit date:
2016-07-07
ARK identifier:

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