Steven Teerenstra | PubMed Health

PubMed2006

Conductivity-based hematocrit measurement during cardiopulmonary bypass.

OBJECTIVE: In a recent clinical study on the reliability of a point-of-care (POC) analyzer, we described a downward bias in hematocrit measurement during cardiopulmonary bypass leading potentially to overtreatment with packed red cells. We hypothesized that the detected deviation is caused by variations in electrolyte concentration rather than by colloids used. METHODS: Blood was sampled from patients before cardiac surgery to obtain undiluted anticoagulated whole blood samples (n = 53). From each sample, four dilution series covering a hematocrit range of 15-30% were made using NaCl (0.9%), modified gelatine (4%), hydroxyethylstarch (6%), or a potassium-based (16 mEq/l) solution, respectively. In each dilution series, hematocrit was measured by POC and via the "golden standard" microcentrifugal method to determine whether the deviation of the POC-analyzer to the microcentrifuge was dependent on the type and dilution level of the solution used. RESULTS: In contrast to the colloid-based dilution series, the crystalloids revealed a significant downward bias of the POC-analyzer with respect to the microcentrifuge (p < 0.05). Due to the correction algorithm for sodium in the POC-analyzer, this deviation was nearly constant for NaCl (mean of difference: -1.8 +/- 0.1%), but increased significantly in case of the potassium-based solution (up to -8.2 +/- 0.4% after 1.5-times dilution). The starch- and gelatine-based solutions led to a significant upward bias (p < 0.05) that increased with progressing dilution (up to 1.2 +/- 0.1% for hydroxyethylstarch and up to 1.3 +/- 0.1% for modified gelatine after 1.5-times dilution). CONCLUSIONS: Conductivity-based POC hematocrit measurement suffers from biases due to changes of the plasma constituents. The downward bias in hematocrit as often seen during cardiopulmonary bypass is driven by changes of different electrolyte concentration rather than by colloids used per se.

Algorithms↗

PubMed2005

Pseudo cluster randomization: a treatment allocation method to minimize contamination and selection bias.

In some clinical trials, treatment allocation on a patient level is not feasible, and whole groups or clusters of patients are allocated to the same treatment. If, for example, a clinical trial is investigating the efficacy of various patient coaching methods and randomization is done on a patient level, then patients who are receiving different methods may come into contact with each other and influence each other. This would create contamination of the treatment effects. Such bias might be prevented by randomization on the coaches level. The patients of a coach constitute a cluster and all the subjects in that cluster receive the same treatment. Disadvantages of this approach may be reduced statistical efficiency and recruitment bias, as the treatment that a subject will receive is known in advance. Pseudo cluster randomization avoids this, because in pseudo cluster randomization, not everybody in a certain cluster receives the same treatment, just the majority. There are two groups of clusters: in one group the majority of subjects receive treatment A, while a limited number receive treatment B. In the other group of clusters the proportions are reversed. The statistical properties of this method are described. When contamination is present, the method appears to be more efficient than randomization on a patient level or on a cluster level.

Bias↗