In this way, although the user defined the data collection set via SDTM variables, he becomes able to collect the requested data from the EHRs sources that can provide the EHR data of the eligible patients through SALUS common information model.
In order to assess the validity of the data collection set calculated by PMSST, we have conducted a comparative analysis.
Those empty columns in the resultant data collection set were also missing in the data warehouse.
The data collection setting was a surgical ward at a teaching hospital in Sweden.
For instance, demographic analysis on Lombardy region data warehouse shows that 38.22% of ACS patients are females which is equal to the percentage of "Female" in "Sex" column of the resultant PMSST data collection set.
The PMSST, introduced in this paper, enables clinical researches to define data collection set schemas on which the postmarketing safety studies will be conducted without being concerned about the structure of the underlying data sources.
One problem we observed during the analysis is that many items of data collection set defined in Roche use case were actually empty.
The numbers of cases clinically identified as hyperkinetic disorders, concordant and discordant cases, results of DAWBA interviews, response rates and data missing at each stage in the data collection process are set out in figure 1.
The most important differences among the methods used for UK and the QALY Brazil group were the number of health states used to estimate the value sets and modifications in the data collection process, both proposed by Kind (2009).
TU helped in the data collection.
