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CPS2102 Iris Reinhard
               The β and γ are fixed effects for the covariates xij and zij, respectively, and ai
               and bi are random effects generating the within-subject correlation and the
               between-subject heterogeneity. It is assumed that



               where



               Simulation study
                   In a simulation study the performance of the two-part model is evaluated
               in terms of type I error and the mean squared error (MSE) of the estimates.
               The  data  generation  process  is  thereby  based  on  the  distribution
               characteristics of an empirical data set coming from a controlled prospective
               intervention
                   study which is investigating the cost-effectiveness of an intervention to
               reduce  compulsory  admission  into  inpatient  psychiatric  treatment.  So  it  is
               possible to deduce more generalized conclusions for health services research.
               Thereby  a  mixture  distribution  framework  involving  a  two-step  process  is
               applied. To generate the covariates, random samples from a bivariate normal
               distribution with different values of correlation (e.g.  ρx1x2=-0.2 or  ρx1x2=0) are
               drawn. We employ six repeated measurements and manipulate the sample
               size at four levels: sparse (N=50), small (N=100), medium (N=200) and large
               (N=500). The true model incorporates two fixed effects for each component
               (two covariates): βk (Normal), γs (Binary); k,s=1,2, as well as two random effects,
               each scalar quantities, one for each component (for the binary part bi / for the
               normal  part  ai),  correlated  or  uncorrelated  (ρab=-0.4  or  ρab=0).  For  each
               scenario 5000 replications are conducted. The nominal α is set to 0.05.
                   The performance of the mixed two-part model is evaluated under the null
               hypothesis H0: βk=0 resp. γs=0, for estimating the significance level and under
               the H1 for estimating the parameters. Criteria are (i) the type I error and (ii)
               the mean squared error (MSE) of the estimates. As a control model to examine
               the consequences of ignoring zero modified data the classical linear mixed
               model is used.
                   The programming environment for the implementation of the two-part
               model is SAS 9.4, where the procedure NLMIXED is employed (see e.g. Liu et
               al., 2010, Tooze et al., 2002). This procedure directly maximizes an approximate
               integrated likelihood. Here an adaptive Gaussian quadrature approximation is
               chosen.  As  an  optimization  algorithm  to  carry  out  the  maximization,  a
               Newton-Raphson  optimization  is  applied  which  combines  a  line-search
               algorithm  with  ridging.  This  technique  uses  the  gradient  and  the  Hessian
               matrix.

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