Comments on “Effect of coolant spray on rib fracture pain of geriatric blunt thoracic trauma patients: a randomized controlled trial”

This paper¹ aimed to evaluate the effectiveness of cryotherapy in elderly patients with rib fractures due to blunt thoracic trauma via a prospective randomized controlled study (coolant spray group, n=51; placebo spray group, n=50). The authors concluded that coolant spray therapy can be used as a component of multimodal therapy to provide adequate analgesia due to rib fractures in geriatric patients; however, some points of this research do not support this conclusion.

First of all, the authors did not describe the study hypothesis (this weakens the results). Second, they did not present the minimal clinically important change of the VAS on the patients’ pain level (making it impossible to analyze clinical relevance). Comparisons of outcomes in clinical trials should consider the minimal clinically important change of the mean differences because the p-value only shows statistical significance, which interpretation translates just a hypothesis test governed by a probability of previously defined error (α)²,³. Third, they did not present the assess the effect size (e.g., Cohen's d=[M1–M2]/S_pooled)⁴,⁵ of the comparisons between the times and groups (making it impossible [again] to analyze clinical relevance). Fourth, they should have assessed the patients’ disability for pre- and post-intervention comparisons.

As such, the new conclusion is as follows: although this study has shown significant differences between coolant spray therapy and placebo (used as a component of multimodal therapy to provide adequate analgesia due to rib fractures in geriatric patients), its clinical relevance is yet unknown.

• Funding: This work was partially supported by the Coordination of Improvement of Higher Education Personnel (CAPES, BR – code 001). However, the funding source had no involvement in the study design, collection, analysis, interpretation of data, writing of the report, nor in the decision to submit the article for publication.

ACKNOWLEDGMENTS

National Council for Scientific and Technological Development (CNPq).

REFERENCES

• ¹
  Akbaş İ, Dogruyol S, Kocak AO, Dogruyol T, Koçak MB, Gur STA, et al. Effect of coolant spray on rib fracture pain of geriatric blunt thoracic trauma patients: a randomized controlled trial. Rev Assoc Med Bras (1992). 2023;69(1):30-6. https://doi.org/10.1590/1806-9282.20220048
  » https://doi.org/10.1590/1806-9282.20220048
• ²
  Pontes-Silva A. Statistical significance does not show clinical relevance: we need to go beyond the p-value. J Clin Exp Hepatol. 2022;12(5):1402. https://doi.org/10.1016/j.jceh.2022.04.017
  » https://doi.org/10.1016/j.jceh.2022.04.017
• ³
  Andrade C. The p value and statistical significance: misunderstandings, explanations, challenges, and alternatives. Indian J Psychol Med. 2019;41(3):210-5. https://doi.org/10.4103/IJPSYM.IJPSYM_193_19
  » https://doi.org/10.4103/IJPSYM.IJPSYM_193_19
• ⁴
  Cohen J. Statistical power analysis for the behavioral sciences. England: Routledge; 1988. https://doi.org/10.4324/9780203771587
  » https://doi.org/10.4324/9780203771587
• ⁵
  Larner AJ. Effect size (Cohen's d) of cognitive screening instruments examined in pragmatic diagnostic accuracy studies. Dement Geriatr Cogn Dis Extra. 2014;4(2):236-41. https://doi.org/10.1159/000363735
  » https://doi.org/10.1159/000363735

Publication Dates

• Publication in this collection
  19 May 2023
• Date of issue
  2023

History

• Received
  22 Jan 2023
• Accepted
  02 Feb 2023