Improving interpretation of clinical studies by use of confidence levels, clinical significance curves, and risk-benefit contours

The process of interpreting the results of clinical studies and translating them into clinical practice is being debated. Here we examine the role of p values and confidence intervals in clinical decision-making, and draw attention to confusion in their interpretation. To improve result reporting, w...

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Bibliographic Details
Published in:The Lancet (British edition) 2001-04, Vol.357 (9265), p.1349-1353
Main Authors: Shakespeare, Thomas P, Gebski, Val J, Veness, Michael J, Simes, John
Format: Article
Language:English
Subjects:
Antibiotics
Biological and medical sciences
Clinical decision making
Clinical medicine
Clinical significance
Clinical Trials as Topic - statistics & numerical data
Computerized, statistical medical data processing and models in biomedicine
Confidence Intervals
Contours
Data Interpretation, Statistical
Decision Making
Dissection
Humans
Hypotheses
Hypothesis testing
Mathematical analysis
Medical sciences
Medical statistics
Neoplasms - therapy
Researchers
Risk
Risk Assessment
Statistical analysis
Statistical methods
Studies
Toxicity
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Summary:The process of interpreting the results of clinical studies and translating them into clinical practice is being debated. Here we examine the role of p values and confidence intervals in clinical decision-making, and draw attention to confusion in their interpretation. To improve result reporting, we propose the use of confidence levels and plotting of clinical significance curves and risk-benefit contours. These curves and contours provide degrees of probability of both the potential benefit of treatment and the detriment due to toxicity. Additionally, they provide clinicians with a mechanism of translating the results of studies into treatment for individual patients, thus improving the clinical decision-making process. We illustrate the application of these curves and contours by reference to published studies. Confidence levels, clinical significance curves, and risk-benefit contours can be easily calculated with a hand calculator or standard statistical packages. We advocate their incorporation into the published results of clinical studies.
ISSN:0140-6736
1474-547X
DOI:10.1016/S0140-6736(00)04522-0