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Inicio Colombian Journal of Anesthesiology The thin line between non-inferiority clinical trials and type II errors
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Vol. 44. Núm. 1.
Páginas 73 (Enero - Marzo 2016)
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Vol. 44. Núm. 1.
Páginas 73 (Enero - Marzo 2016)
Letter to the Editor
DOI: 10.1016/j.rcae.2015.11.002
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The thin line between non-inferiority clinical trials and type II errors
La delgada línea de ensayos clínicos de no inferioridad y el error tipo II
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Luis Enrique Chaparroa,
Autor para correspondencia
lechaparro@gmail.com

Corresponding author at: 12th Floor, 123 Edward Street, Toronto, Ontario M5G 1E2, Canada.
, Laura Girón-Arangob
a MD, Department of Anesthesia, University of Toronto, Toronto, Canada
b MD, Anesthesiology Resident, Universidad CES, Medellín, Colombia
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We welcome a randomized clinical trial (RCT) evaluating the sedation1 strategies for low-risk patients requiring spinal anesthesia.2 The authors conclude that there is no difference between groups except for higher withdrawal reflex and/or pain from puncture in the group that only received midazolam. In a purely academic spirit, we would like to underscore a few ideas.

  • 1.

    Ideally, an RCT requires one person to administer the medication and a second one to assess the outcomes. If this is not possible, the effect of the intervention may be over-estimated (around 40%).3 However, we empathize with those authors that sacrifice their own resources for the sake of science.4

  • 2.

    The primary outcome variable – sample size calculation – should be explicit. This is a usual issue with RCT.5

  • 3.

    When designing the essay: were the authors looking for the advantages of combination therapy versus the use of midazolam or on the contrary, were they looking for equivalence among interventions? – equivalence trials require hundreds and some times thousands of participants to avoid type II errors (assuming no difference when in fact there was a difference).6

  • 4.

    We don’t want to look heartless, but would it be unreasonable to consider a placebo group (no sedation) or background music7 for patients who just need a spinal injection?… sedation enhances the tolerance to the procedure but may deteriorate patient's cooperation for positioning.

Funding

The authors did not receive sponsorship to undertake this article.

Conflicts of interest

The authors have no conflicts of interest to declare.

References
[1]
P. Ibarra, M. Galindo, A. Molano, C. Niño, A. Rubiano, P. Echeverry, et al.
Recomendaciones para la sedación y la analgesia por médicos no anestesiólogos y odontólogos de pacientes mayores de 12 años.
Rev Colomb Anestesiol, 40 (2012), pp. 67-74
[2]
F.J. Bermúdez-Guerrero, D. Gómez-Camargo, R. Palomino-Romero, W. Llamas-Bustos, E. Ramos-Clason.
Comparación de 3 pautas de sedación para pacientes sometidos a anestesia subaracnoidea. Ensayo clínico aleatorizado, simple ciego.
Rev Colomb Anestesiol, 43 (2015), pp. 122-128
[3]
K.F. Schulz, I. Chalmers, R.J. Hayes, D.G. Altman.
Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials.
JAMA, 273 (1995), pp. 408-412
[4]
J.A. Calvache, L.E. Chaparro, A. Chaves, M. Beatriz Delgado, N. Fonseca, F.R. Montes, et al.
Strategies and obstacles to research development in anesthesiology programs: consensus document in Colombia.
Rev Colomb Anestesiol, 40 (2012), pp. 256-261
[5]
A. McKeown, J.S. Gewandter, M.P. McDermott, J.R. Pawlowski, J.J. Poli, D. Rothstein, et al.
Reporting of sample size calculations in analgesic clinical trials: ACTTION systematic review.
[6]
G. Piaggio, D.R. Elbourne, S.J. Pocock, S.J. Evans, D.G. Altman, CONSORT Group.
Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement.
JAMA, 308 (2012), pp. 2594-2604
[7]
C. Lepage, P. Drolet, M. Girard, Y. Grenier, R. DeGagné.
Music decreases sedative requirements during spinal anesthesia.
Anesth Analg, 93 (2001), pp. 912-916

Please cite this article as: Chaparro LE, Girón-Arango L. La delgada línea de ensayos clínicos de no inferioridad y el error tipo II. Rev Colomb Anestesiol. 2016;44:73.

Copyright © 2015. Sociedad Colombiana de Anestesiología y Reanimación
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