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Indian Journal of Medical Sciences, Vol. 63, No. 9, September, 2009, pp. 415-417 Letter To Editor Authors' Reply Bibhu R. Das, Aparna A. Bhanushali, R. Khadapkar, Kanchan D. Jeswani 1 , Mita Bhavsar1 , A. Dasgupta1 Research and Development, 1 Department of Hematology, SRL Ranbaxy Ltd., Andheri (East), Mumbai, India Correspondence Address: Dr. B. R. Das, SRL Ranbaxy Ltd., Plot No. 113, MIDC, 15th Street, Andheri (East), Mumbai - 400 093, India Code Number: ms09077 We would like to thank Dr. Tamhankar [1] for his interest in the article [2] and respond to his queries. Dr. Tamhankar would like to know how informed consent was obtained and whether parental /guardian's consent for the pediatric population was also obtained. As the subjects included in this study were part of our Corporate Health Check program, before enrolling them for this study, the objective and the requirements (clinical history, family history and whole blood specimen) of this study were discussed with each and every participant. Only those that consented and agreed to be part of this study were enrolled. While enrolling for this study, a detailed questionnaire was filled up by each participant. Refer enclosed Annexure 1 for format of questionnaire followed for this study, which was signed by all the participants. Only 1 subject, belonging to the female group (n= 132), was 15 years of age. Since the mother of this girl was also part of the study, parental consent was received for the same. Regarding the option of accessing their results and ethics committee approval, it may be stated that before entering into the study, each participant was informed that lymphocyte enumeration data will not be shared. This was agreed to and accepted by the participants. The study design and the objectives were approved by the internal core scientific team of Super Religare Laboratories Ltd. According to Dr. Tamhankar, the sample size of 252 appears comparatively small. The objective of the study was to establish the reference ranges for lymphocyte subsets in healthy population of western India, as per Clinical and Laboratory Standards Institute (CLSI -formerly National Committee for Clinical Laboratory Standards NCCLS) guidelines (reference - NCCLS: How to Define and Determine Reference Intervals in the Clinical Laboratory, Second Edition). As a standard of general practice, the subcommittee of CLSI supports the recommended minimum of 120 values for defining the population-specific reference ranges. Hence we feel a sample size of 252 is sufficient to draw statistically sound conclusions. In response to Dr. Tamhankar's statement that the investigators had skipped basic clinical examination to rule out lymphadenopathy, etc., we state that this is not factual. Since these subjects were part of Corporate Health Check program, the following clinical investigations were performed
Individuals with normal results of all the above investigations were deemed "healthy" and accordingly enrolled for the study. Also, we have not considered absolute lymphocyte value as a criterion for exclusion. Exclusion was done based on the clinical status of the individuals, as mentioned above. References
Copyright 2009 - Indian Journal of Medical Sciences |
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