Quantifying Clinically Significant Change: A Brief Review of Methods and Presentation of a Hybrid Approach
Abstract
Treatment outcome researchers in orthopaedics frequently report only tests of statistical significance between group means to evaluate the effectiveness of a given intervention. Although important in establishing that mean differences are not caused by chance, these methods do not reflect the extent to which an intervention produces improvements that are meaningful and represent a return to health. This is an issue that is often of great interest to patients and clinicians. Other methods use a percentage change in an outcome measure (eg, 25% reduction in pain score) to classify treatment responders but often do not indicate whether the treatment restored a patient to normal. Researchers have developed several indices that provide a metric for statistically defining the amount of change that patients consider to be important. In this article, we focus on the concept of "clinical significance" and the different methods that have been developed to define clinically significant change using statistics. We then present a hybrid method that can classify whether a patient has returned to normal function. We apply this method to real patient data to illustrate its use with different outcome instruments commonly used in orthopaedic sports medicine. We advocate that the addition of these methods to reports from clinical outcome studies can deepen our understanding of the impact of interventions on patients' lives.
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A medium effect size of 0.5 corresponds to a change that a careful observer would notice.
“Clinically, a medium effect size (d = 0.5) corresponds to an amount of change that is noticeable to a careful observer.[28][29][30]”
From Effectiveness of Virtual Reality in Children With Cerebral Palsy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials (2018) · cites this paper as [28]
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- Authors
- Mann, B. J., Gosens, T., & Lyman, S.
- Affiliations
- American Orthopaedic Society for Sports Medicine (US)
- Elisabeth-TweeSteden Ziekenhuis (NL)
- Hospital for Special Surgery (US)
- Corresponding author
- Mann, Barton J.
- Venue
- The American Journal of Sports Medicine
- Publisher
- SAGE Publications
- Published
- 2012-09-07
- Volume
- 40
- Issue
- 10
- Pages
- 2385-2393
- ISSN
- 0363-5465 (ISSN-L)
- 1552-3365
- OpenAlex
- W2122788751
- Cited by
- 10
- References
- 23
- Citations by year
- 2025: 1 · 2022: 1 · 2020: 1 · 2017: 1 · 2016: 1 · 2014: 2 · 2013: 3
- FWCI
- 1.53
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The American Journal of Sports Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Keywords
- clinically significant change, minimal clinically important difference, treatment response classification, orthopaedic sports medicine, patient-reported outcome measures, treatment outcome reporting, hybrid classifier
- MeSH terms
- Humans, Joint Diseases, Models, Theoretical, Psychometrics, Treatment Outcome, Recovery of Function
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