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closeFurther clarification regarding study and methods.
Posted by atbeat on 25 Sep 2015 at 00:31 GMT
Dear Editor: I find that the methods section requires some issues to be clarfied and strongly feel this section requires correction/amendments. The authors claim that this was a prospective observational study and fail to get the value of the main variable in close to 50% of patients that they appear to enroll in this study. On page 2, in the “Patients and methods section” authors state that a total of 3329 patients were enrolled and of these 1659 patients were excluded as the information about serum GGT, the main variable being studied in the study, was not available. How the authors were unable to get the value of the main variable in over 50% of patients enrolled when the study was prospective. It appears that the study was NOT a prospective observational study and in fact is a retrospective analysis of the data from the Clinical Research Center (CRC) Registry that likely is/was being collected prospectively. It appears that the current study itself was not a prospective study that is likely the reason that GGT was not measured in all registrants in the registry at the start.
RE: Further clarification regarding study and methods.
kimyongkyun replied to atbeat on 28 Sep 2015 at 20:00 GMT
Dear editor,
As he commented, a total of 3,329 patients were enrolled and of these 1,659 patients were excluded as the information about serum GGT, the main variable being studied in the study, was not available. It is a good point.
In protocol of this study, measurement of serum GGT levels was not mandatory because measurement of serum GGT level is expensive in Korea. However, this study is a multicenter prospective observational cohort study started at April 2009 from 31 medical centers in Korea. The thing that makes prospective cohort studies prospective is that they were designed prospectively, and subjects were enrolled and had baseline data collected before any of them developed any of the outcomes of interest. In this study, all patients were followed at 6-month interval until death or the end of the study, with censoring of data at the time that a patient underwent renal transplantation or was lost to follow-up because of patient withdrawal or transfer to a nonparticipating hospital. For each death and hospitalization, the principal investigators of the clinical center completed a form including the cause of death or hospitalization according to the CRC for ESRD study classification. Therefore, this is a prospective study.
Thanks for comment.