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Achieving provisional certification would be based on outcomes data and mentor opinion and would be the start of independent practice that is, the trainer not in the room.
The approach of developing a generic disease progression submodel and calibrating its parameters based on outcomes data was taken because of the lack of biological data needed to directly estimate these parameters.
We classified each serum bicarbonate value into clinical categories using cutpoints that were based on outcomes data in published epidemiologic studies [ 1, 2, 10], clinical practice guidelines [ 4], and proposals for clinical practice [ 3, 11]: low (<22 mEq/L), normal (22 26 mEq/L), and high (>26 mEq/L).
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The glucose-based criteria for the diagnosis of diabetes are based on outcome data (the risk of micro- and macrovascular disease) correlated with plasma glucose concentrations both fasting and 2 h after a glucose load assayed in an accredited laboratory (1).
"We see an opportunity as data accrues to the system over time for a use case in predicting therapy… based on outcome data… but we're not making these claims today," said DuRoss.
We therefore sought to conduct an exploratory cost-effectiveness analysis based on outcome data from the CLEAR post-hoc analysis, complemented by assumptions for the analysis time period between one and 5 years.
This meta-analysis was based on outcome data from a total of 6603 participants (86 independent comparisons).
By including FRS as a covariate in the model based on outcome data from this cohort, we were in effect recalibrating their risk.
The new strategy included intensive glycemic control (IGC) and optimal foot care based on outcome data drawn from key UK and Swedish studies, as well as others.
Conversely, because our study is based on outcome data collected at a single time point and no confirmation of laboratory data was obtained in the following weeks, we might have slightly overestimated rates of virological and immunological failure due to measurement errors or to individual temporal variability in biological markers (e.g. HIV viral blips).
We therefore conducted preliminary statistical analyses to investigate this issue based on outcome data that could provisionally be extracted from each of the 11 further eligible studies (i.e. in advance of contacting study authors, with one exception - see 'Potential impact of studies with no useable data', below).
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