Transplantation of hematopoetic stem cells or kidney
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: older than 18 years
Exclusion criteria
Exclusion criteria: No informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The CLSI EP09-A guideline is adapted. EP9 assumes that the two methods being compared will yield essentially identical results. The Medically Allowable Error is defined 15%. This Medical Allowable Error will be used to determine: 1. the maximum allowable difference between specimens across methods, 2. the maximum allowable difference between duplicate specimens for the same method, 3. the distance between the scatter plot bounds and the regression line. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outlier determination. The outlier identification process is quite complex. (See the EP9 document for details). In general, an outlier is detected either when duplicate results for the same method are too different, or when a pair of results across methods is too different. In either case, all results for both specimens are declared to be outliers. Test for adequate range of results. Computation of key statistics: regression slope, intercept, and standard error of estimate; 95% confidence interval for predicted Medical Decision Points. Visual check for linearity. Visual check for "uniform scatter". The purpose of this test is to decide how to compute the medical decision points: by Partitioned Residuals or by Deming regression.(13) Whereas the ordinary linear regression method assumes that only the Y measurements are associated with random measurement errors, the Deming method takes measurement errors for both methods into account. Examination of the bias plot. The bias at the high end and the bias at the low end will be compared. | — |
Countries
Netherlands
Outcome results
None listed