Main data collection included: timing of diagnosis of severe sepsis/septic shock and treatment with PMX-HP; hemodynamic status; septic organ function impairment; outcome at 28 days, ICU and hospital discharge.
Data collection time varied across cities, due to differences in timing for human subjects approvals, logistics, and speed of sampling.
There are a number of well known challenges, for example, to PRO data collection, appropriate timing of assessment, adequate statistical analysis and outcome interpretation [ 9, 10].
Some of these differences may result from the timing of data collection, with collection of data later in the course of the patient's illness including symptoms of diarrhea that may be associated with antibiotic therapy.
First, the retrospective nature and the non-uniformity in data collection (different timings for acquisition of the late H/M ratio, ranging from 2 to 7 h after tracer injection, with different dosages of MIBG, different gamma cameras, and different collimators) should be acknowledged.
9, 10 The overall incidence of multiple primary neoplasms among cancer survivors varies widely in the literature from 1%to37%7%, depending on the type of analysis used, timing of data collection, and ethnicity of the subjects studied.
The epidemic timing, objectives of data collection, and availability of resources will also determine the method used.
Table 1 lists the various outcome measures, the timing of data collection and the source of the data.
However, thought needs to be given to the timing of data collection and the heterogeneity of the sample.
These differences may be due to the timing of data collection in the progression of disease (which may have occurred earlier in British Columbia); the fact that the case-patients in the Australian studies were all hospitalized (and probably more seriously ill); and differences in study methods, medical practices, and strain characteristics.
