|Year : 2018 | Volume
| Issue : 2 | Page : 584-585
Author's Reply: Progesterone with or without hypothermia in patients with acute severe traumatic brain injury
Department of Neurosurgery and Spine Services, Paras Hospital, Gurugram, Haryana, India
|Date of Web Publication||15-Mar-2018|
Dr. Sumit Sinha
Department of Neurosurgery and Spine Services, Paras Hospital, Gurugram, Haryana
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Sinha S. Author's Reply: Progesterone with or without hypothermia in patients with acute severe traumatic brain injury. Neurol India 2018;66:584-5
We thank the author for his kind comments. Nowhere in the manuscript is it mentioned that “restricted randomization” was used. Probably, the allocation ratio of 1:1:1:1 was misunderstood and appeared to show that a restricted randomization had been done. The larger the study size, it is more likely that the groups are similar with respect to the baseline characteristics, thus it is incorrect to assume that randomization “guarantees” balance of groups with respect to baseline characteristics.
We used the method of 'Block Randomization' with a variable block size (2 and 4) to generate a sequence of random numbers. Simple randomization has several problems; one of them is an unequal group size, as correctly mentioned in the query. The use of simple randomization to generate sequence of random numbers, particularly in small trials, is discouraged. There is no study which is free from bias; however, in our study, there was no “allocation bias” as we have used block randomization with a variable block size as recommended in any text book on clinical trials. This is used as a parameter in most of the clinical trials, particularly of a small size.
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Conflicts of interest
There are no conflicts of interest.
| » References|| |
Sinha S, Raheja A, Samson N, Goyal K, Bhoi S, Selvi A, Sharma BS. A randomized placebo-controlled trial of progesterone with or without hypothermia in patients with acute severe traumatic brain injury. Neurol India 2017;65:1304-11.
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Raina SK. Bias in randomized trials. Neurol India 2018:66:581-2.