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Sensitivity and specificity were modelled simultaneously using random centre effects.
Centre effects were strongest in males and at G2/B2.
Ignoring centre effects results in the larger sample size in the absence of interaction.
Potential centre effects will be tested by including centre and physician as a random effect.
Separate sets of centre effects were simulated for each scenario and each simulation 1-1000.
However, many trials may adjust for both prognostic covariates and centre effects, and it is therefore worth considering whether the methods we have discussed in this paper will apply when also accounting for centre effects.
Similar(16)
Cluster randomisation (at the clinician level) will not be employed since it would severely disrupt clinical routine and might result in undesired between-centre effects.
Measures of the third category (the non-standardized questionnaire scores) would be expected to reveal age, gender, and study-centre effects.
These models consider centre and treatment-by-centre effects to be random, and are especially relevant when the number of sites is large" [ 13].
The G-BA VerfO (Section 4.2.5.5 Suppl. G-BA VerfO) further specifies that the effect modifiers sex, age, disease severity or disease stage as well as country and study centre-effects should always be analysed.
Therefore, any attempt to minimise between-centre differences will necessarily lead to an analysis that accounts for centre-effects.
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