Outcome metrics

What are the appropriate primary and secondary clinical outcome metrics for determination of drug effect ... 

Both activity and outcome metrics are needed to understand fully the performance of the system—that a particular activity is being conducted and the outcome or quality of the activity. For example, the system may measure the activity of carrying out MOC—how many are conducted and their frequency. The audit of the MOC system coupled with a change in the number of incidents or near misses associated with the MOC system describes the outcome or quality of the MOC program. 

Clear definitions and shared understanding help establish strategy, tactics, expected outcomes, metrics, and more. It is not that... 

One final metric that may be chosen to assess SMS performance is the level of residual risk itself. It could be argued that an optimal SMS will ensure that all hazards are mitigated to as low as reasonably practicable thus where there are risks which are insufficiently controlled this represents deficiencies in the process itself. This approach can be attractive to manufacturers who don t necessarily have access to the outcome metrics available to healthcare organisations. 

Traditionally, risk outcomes have focused on mortality and complications, but the spectrrrm of outcome metrics has been expanded to include indicators such as re-admissions, functional status and qirality of life (Lazar et al. 2013). Dissimilarities of patient populations complicate the interpretation of outcome metrics across geographic regions and facilities. Statistical approaches are used... 

Of course, the first and last outcomes are desired, whereas the second and third outcomes are not. Quality assessment of any binary method requires simultaneous assessment of two method properties (1) its ability to alarm when a true positive is encountered, and (2) its ability to avoid alarming when a true negative is encountered. For a given set of N test samples of known class used to evaluate the method, these properties are most commonly conveyed using the metrics sensitivity and specificity, respectively ... 

Arylation of alkenes catalyzed by palladium compounds is known as the Heck reaction [65]. While these reactions are very sensitive to steric effects, subtle electronic contributions to the regiochemical outcome may be assessed by comparing reactions of alkenes with similar substitution patterns. The arylating agents, being the nucleophilic arylpalladium species, tend to dictate the facility of their reaction with unsym-metrical, electron-deficient alkenes. 

Operational metrics must be developed that will facilitate the assessment of the effects of sleep loss and fatigue on key outcomes such as patient health and safety, education effectiveness, resident health and professionalism, and health care economics. (See Table 1.)... 

Another widely used metric is the Kirton Adaption-Innovation Inventory. This is based on the Kirton Adaption-Innovation Theory, which considers that, before people can feel comfortable when tackling a problem they will differ amongst them on what structure they require and whether there is a need for a consensus on that structure. Another important factor is how important is the outcome of the problem solving, what is the reward or alternatively the punishment to be felt by the people concerned. This is called the cognitive style [C-50],... 

R2. Ramey, J. W., Seltman, H. J., and Toner, J. P., Superior analytic characteristics of an immuno-metric assay for gonadotropins also provides useful clinical prediction of in vitro fertilization outcomes. Fertil. Steril. 65, 661-663 (1996). 

Selection of the appropriate metric for use in the risk assessment can have a significant impact on the outcome of an assessment. Regardless of the mathematical approach used, it is important that harmonized guidance exists for metric selection. Guidance should be based on a number of considerations, including data quality, data quantity, distribution type, duration of exposure and nature of the toxicology endpoint. Based on personal experience with numerous deterministic exposure assessments, it is clear that regulatory authorities differ with respect to input and output metric selections. 

Measurement Systems Analysis starts with translating customer and process requirements into metrics (measurable outcomes). These metrics can be based on subjective qualitative data (taste, appearance, etc.), or objective quantitative data (e.g., seconds, number of defects). The type of data determines the type of MSA ... 

Another difficulty arises from the use of cumulative exposure (the product of exposure duration x intensity) as a surrogate exposure metric in the available studies. Finkelstein (1995) noted that the use of cumulative exposure requires the assumption that duration and intensity are equally important in determining the effective dose. Finkelstein further noted that if exposure estimates are inaccurate or inconsistently measured (which can be the case for many retrospective epidemiology studies), a finding of a statistically significant association between cumulative exposure and a health outcome can mislead one in having confidence in an apparent exposure-response relationship that is principally influenced by duration of exposure and not by exposure intensity. 

Chapter 3—Process Safety Management Metrics commonly used in process safety management systems including leading, lagging, and near miss and activity and outcome, external and internal metrics as well as characteristics of successful metrics... 

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