Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Feb;44(2):306-311.
doi: 10.1007/s00246-022-03039-z. Epub 2022 Nov 2.

Randomized Controlled Trials in Pediatric Cardiology: A Power Struggle?

Francisco E Herrera-Carrillo  1 , Riddhi Patel  2 , Saul Flores  3   4 , Enrique G Villarreal  1 , Juan S Farias  5 , Rohit S Loomba  2   6
Affiliations

Randomized Controlled Trials in Pediatric Cardiology: A Power Struggle?

Francisco E Herrera-Carrillo et al. Pediatr Cardiol. 2023 Feb.

Abstract

Sample size and statistical power are often limited in pediatric cardiology studies due to the relative infrequency of specific congenital malformations of the heart and specific circulatory physiologies. The primary aim of this study was to determine what proportion of pediatric cardiology randomized controlled trials achieve an 80% statistical power. Secondary aims included characterizing reporting habits in these studies. A systematic review was performed to identify pertinent pediatric cardiology randomized controlled trials. The following data were collected: publication year, journal, if "power" or "sample size" were mentioned if a discrete, primary endpoint was identified. Power analyses were conducted to assess if the sample size was adequate to demonstrate results at 80% power with a p-value of less than 0.05. A total of 83 pediatric cardiology randomized controlled trials were included. Of these studies, 48% mentioned "power" or "sample size" in the methods, 49% mentioned either in the results, 12% mentioned either in the discussion, and 66% mentioned either at any point in the manuscript. 63% defined a discrete, primary endpoint. 38 studies (45%) had an adequate sample size to demonstrate differences with 80% power at a p-value of less than 0.05. A majority of these are not powered to reach the conventionally accepted 80% power target. Adequately powered studies were found to be more likely to report "power" or "sample size" and have a discrete, primary endpoint.

Keywords: Biostatistics; Pediatric cardiology; Randomized controlled trials; Sample size; Statistical power.

PubMed Disclaimer

Comment in

  • Response to Letter to the Editor.
    Herrera-Carrillo FE, Patel R, Flores S, Villarreal EG, Farias JS, Loomba RS. Herrera-Carrillo FE, et al. Pediatr Cardiol. 2023 Jan;44(1):261-262. doi: 10.1007/s00246-022-03061-1. Epub 2022 Nov 24. Pediatr Cardiol. 2023. PMID: 36422653 No abstract available.

References

    1. Serdar CC, Cihan M, Yucel D, Serdar MA (2021) Sample size, power and effect size revisited: simplified and practical approaches in pre-clinical, clinical and laboratory studies. Biochem Med (Zagreb) 31(1):010502. https://doi.org/10.11613/BM.2021.010502 - DOI
    1. Andreu MF, Ballve LPD, Verdecchia DH, Monzon AM, Carvalho TD (2021) Is the p-value properly interpreted by critical care professionals? Online survey. Rev Bras Ter Intensiva. 33(1):88–95. O valor de p e adequadamente interpretado pelos profissionais de terapia intensiva? Uma pesquisa on-line. https://doi.org/10.5935/0103-507X.20210009
    1. Palesch YY (2014) Some common misperceptions about P values. Stroke 45(12):e244–e246. https://doi.org/10.1161/STROKEAHA.114.006138 - DOI
    1. Biau DJ, Jolles BM, Porcher R (2010) P value and the theory of hypothesis testing: an explanation for new researchers. Clin Orthop Relat Res 468(3):885–892. https://doi.org/10.1007/s11999-009-1164-4 - DOI
    1. Neyman J, Pearson ES (1933) On the problem of the most efficient tests of statistical hyptheses. Trans R Soc Lond Series. 231(694–706):289–337

Publication types