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Indian Journal of Medical Sciences, Vol. 63, No. 8, August, 2009, pp. 365-366 Letter To Editor Authors' reply Aggarwal Pakhee, Zutshi Vijay, Batra Swaraj Department of Obstetrics and Gynaecology, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi Correspondence Address:C-I/11, Ansari Nagar, A.I.I.M.S. Campus (E), New Delhi - 110 029 pakh_ag@yahoo.com Code Number: ms09067 Sir, Thank you for your comments and observations.[1] The cornerstone of obtaining valid informed consent involves a free choice given to the potential study subjects to be enrolled in the study or not, as the case may be, without compromising on their medical care. This was also followed in the present study. All women consented to being included in the study; perhaps as the study involved potential analgesic effects on labor,[2] the women were more than willing. In reply to your second query, it may be stated that a process of consecutive randomization was carried out if they fulfilled the inclusion criteria. The study was blinded at two levels, neither the patients nor the assessors/ raters (who were residents in Obstetrics and Gynecology) knew about the content of the syringes or the group allocation. Also, the nurses administering the drug were not aware of its content. Hence it can be said that the internal validity was not compromised. Indeed, it was not a triple-blind study, as the data analyzer/ principal investigator was not blinded to the group allocation at the time of analyzing the results. As regards registration of trials, it is still not completely centralized in India, as is the case in other parts of the world; however, the process has started. References
Copyright 2009 - Indian Journal of Medical Sciences |
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