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Assessors were blinded to group allocation and scored the infant's 12-week GAS performance from video.
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In the initial allocation of scored items to domains, 25 were allocated to Living Environment, 42 to Therapeutic Environment, 34 to Treatments and Interventions, 32 to Self-management and Autonomy, eight to Social Policy and Citizenship, eight to Clinical Governance, 19 to Social Interface, 30 to Human Rights and 25 to Recovery Based Practice.
The effect of group allocation on continuously scored outcome measures at the 4-month and 12-month follow-ups will be analysed using linear regression models with baseline scores entered into the linear regression models as covariates.
Every identified discharge error was presented, in the form of a case study outlining clinical, diagnostic and medication details, to six independent assessors, blinded to study allocation, who retrospectively scored the potential for harm using a validated, reliable visual analogue scale (VAS) (0=no harm, 10=death) 33 previously used for this purpose.
General linear models will be used to assess the effect of group allocation on continuously scored secondary outcome measures.
Allocation concealment was scored according to the scale used by Schulz 1995.[ 17] A = trials that have taken measures that ensure allocation concealment (central randomisation; serially numbered, opaque, sealed envelopes; or other description with convincing elements of concealment).
A second analysis of primary outcomes is a multilevel regression analysis (using SPSS and MLwin), which uses adherence to the primary outcomes of lifestyle change as the dependent variables and group allocation and pre-intervention scores as independent variables.
We also intend to use a multilevel regression analysis (using MLwin) which uses e.g. self-efficacy and attitudes at T1 as the dependent variables and group allocation and pre-intervention scores as independent variables.
1. Inter-rater reliability of DSAT scores; two raters, who are blind to group allocation, will independently score pre and post intervention simulated call audio tapes.
Table 4 shows the allocation of scoring points based on the regression coefficients.
The allocation of tumors and scoring of staining by the two investigators was similar.
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