We read with interest the study on a quality improvement (QI) initiative
for extubation in newborns [1]. Failed extubation is a common problem
faced by healthcare workers across all neonatal intensive care units
[2,3] and a QI initiative designed to improve this is a welcome step. We
have two observations regarding this reasonably well- conducted study.
Authors have stated that ethical approval was not
obtained as this study was a quality improvement initiative. Multiple
articles have questioned this approach of not obtaining ethics approval
for QI studies [4,5]. We feel ethics committee approval should be sought
for all QI studies when it directly impacts patient care.
Secondly, authors have not specified if they have
calculated sample size, as primary objective was to reduce extubation
failure rates by 25% from baseline.
In Table I of the article, extubation failure in
PDCA-1 is mentioned as 23.8% (5/21) while in figure 2 it is mentioned as
10/21. The other two categories ie, baseline and PDCA-2 figures
are appropriate.
1. Prasad R, Mishra AK. Improvement in successful
extubation in newborns after a protocol driven approach: A quality
improvement initiative. Indian Pediatr. 2019;56:749-52.
2. Sinha S, Donn S. Weaning from assisted
ventilation: art or science? Arch Dis Child Fetal Neonatal Ed. 2000;83:
F64-70.
3. Saikia B, Kumar N, Sreenivas V. Prediction of
extubation failure in newborns, infants and children: brief report of a
prospective (blinded) cohort study at a tertiary care paediatric centre
in India. Springerplus. 2015;4:827
4. Flaming D, Barrett-Smith L, Brown N,
Corcoran J. "Ethics? But it’s only quality improvement!". Healthc
Q. 2009;12:50-5.
5. Fiscella K, Tobin JN, Carroll JK, He H, Ogedegbe G. Ethical
oversight in quality improvement and quality improvement research: new
approaches to promote a learning health care system. BMC Med Ethics.
2015;16:63.