Determination of the clinical importance of study results
- 1 June 2002
- journal article
- review article
- Published by Springer Science and Business Media LLC in Journal of General Internal Medicine
- Vol. 17 (6), 469-476
- https://doi.org/10.1046/j.1525-1497.2002.11111.x
Abstract
Formal statistical methods for analyzing clinical trial data are widely accepted by the medical community. Unfortunately, the interpretation and reporting of trial results from the perspective of clinical importance has not received similar emphasis. This imbalance promotes the historical tendency to consider clinical trial results that are statistically significant as also clinically important, and conversely, those with statistically insignificant results as being clinically unimportant. In this paper, we review the present state of knowledge in the determination of the clinical importance of study results. This work also provides a simple, systematic method for determining the clinical importance of study results. It uses the relationship between the point estimate of the treatment effect (with its associated confidence interval) and the estimate of the smallest treatment effect that would lead to a change in a patient's management. The possible benefits of this approach include enabling clinicians to more easily interpret the results of clinical trials from a clinical perspective, and promoting a more rational approach to the design of prospective clinical trials.Keywords
This publication has 58 references indexed in Scilit:
- The Effect of Spironolactone on Morbidity and Mortality in Patients with Severe Heart FailureNew England Journal of Medicine, 1999
- Therapeutic BenefitStroke, 1999
- Normative comparisons for the evaluation of clinical significance.Journal of Consulting and Clinical Psychology, 1999
- Normative comparisons for the evaluation of clinical significance.Journal of Consulting and Clinical Psychology, 1999
- Randomized Trial of Estrogen Plus Progestin for Secondary Prevention of Coronary Heart Disease in Postmenopausal WomenJama-Journal Of The American Medical Association, 1998
- Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor strokeThe Lancet, 1993
- Measurement of health status: Ascertaining the minimal clinically important differenceControlled Clinical Trials, 1989
- Using economic analysis to determine the resource consequences of choices made in planning clinical trialsJournal of Chronic Diseases, 1985
- The Threshold Approach to Clinical Decision MakingNew England Journal of Medicine, 1980
- The Importance of Beta, the Type II Error and Sample Size in the Design and Interpretation of the Randomized Control TrialNew England Journal of Medicine, 1978