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Review
. 2021 Sep;10(5):523-529.
doi: 10.1016/j.jshs.2020.11.002. Epub 2020 Nov 11.

Most ankle sprain research is either false or clinically unimportant: A 30-year audit of randomized controlled trials

Chris M Bleakley  1 , Mark Matthews  2 , James M Smoliga  3
Affiliations
Review

Most ankle sprain research is either false or clinically unimportant: A 30-year audit of randomized controlled trials

Chris M Bleakley et al. J Sport Health Sci. 2021 Sep.

Abstract

Background: Lateral ankle sprain is the most common musculoskeletal injury. Although clinical research in this field is growing, there is a broader concern that clinical trial outcomes are often false and fail to translate into patient benefits.

Methods: We audited 30 years of experimental research related to lateral ankle sprain management (n = 74 randomized controlled trials) to determine if reports of treatment effectiveness could be validated beyond statistical certainty.

Results: A total of 77% of trials reported positive treatment effects, but there was a high risk of false discovery. Most trials were unregistered and relied solely on statistical significance, or lack of statistical significance, rather than on interpreting key measures of minimum clinical importance (e.g., minimal detectable change, minimal clinically important difference).

Conclusion: Future clinical trials must adopt higher standards of reporting and data interpretation. This includes consideration of the ethical responsibility to preregister their research and interpretation of clinical outcomes beyond statistical significance.

Keywords: Ankle sprain; False discovery; MCID; MDC.

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Conflict of interest statement

Competing interests The authors declare that they have no competing interests.

Figures

Image, graphical abstract
Graphical abstract
Fig 1
Fig. 1
Flow diagram summarizing trial selection. CAI = chronic ankle instability; RCT = randomized controlled trial.
Fig 2
Fig. 2
Area plots subgrouping p values (n = 966) by (A) level of significance, (B) primary outcomes, and (C) pre-registration. Each square represents ∼10 p values generated from between-group comparisons White squares = no statistical significance (p > 0.05). Shaded squares represent: (A) statistically significant – primary or secondary outcomes; (B) statistically significant – primary outcomes only, any trial; and (C) statistically significant – primary outcomes, pre-registered trials only.
Fig 3
Fig. 3
Violin plot summarizing false-positive risk in trials reporting significant (p < 0.05) effects in their primary outcome.
Fig 4
Fig. 4
Venn diagram illustrating n trials meeting more than 1 FAIR criteria. FAIR = false-positive risk, a priori registration, importance, replication.
See this image and copyright information in PMC

References

    1. Gribble PA, Bleakley CM, Caulfield BM. 2016 consensus statement of the International Ankle Consortium: Prevalence, impact and long-term consequences of lateral ankle sprains. Br J Sports Med. 2016;50:1493–1495. - PubMed
    1. Hootman JM, Dick R, Agel J. Epidemiology of collegiate injuries for 15 sports: Summary and recommendations for injury prevention initiatives. J Athl Train. 2007;42:311–319. - PMC - PubMed
    1. Hupperets MD, Verhagen EA, Heymans MW, Bosmans JE, van Tulder MW, van Mechelen W. Potential savings of a program to prevent ankle sprain recurrence: Economic evaluation of a randomized controlled trial. Am J Sports Med. 2010;38:2194–2200. - PubMed
    1. Hiller CE, Nightingale EJ, Raymond J. Prevalence and impact of chronic musculoskeletal ankle disorders in the community. Arch Phys Med Rehabil. 2012;93:1801–1807. - PubMed
    1. Gribble PA, Bleakley CM, Caulfield BM. Evidence review for the 2016 International Ankle Consortium consensus statement on the prevalence, impact and long-term consequences of lateral ankle sprains. Br J Sports Med. 2016;50:1496–1505. - PubMed

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