Outcomes specific areas

The more complex the system or process to be evaluated, the more essential is the need for a HAZOP study. The HAZOP study is conducted in much the same way as the what-if analysis, usually by the same review team. There are minor differences, however, in terminology and approach. In the HAZOP study, certain guidewords are normally used to aid the review team and help identify specific areas where deviations from design intent can occur. Guidewords can include pressure, flow, level, temperature, and power. HAZOP also attempts to identify the severity of the outcome if such deviations from the norm occur as well as the probability or likelihood of occurrence. The hazard risk matrix established and explained in Chapter 2 (Table 2.3) can be used for this purpose since it provides both severity and probability rankings for a given hazardous situation. 

Accountability is a specific outcome of responsibility. Whereas responsibility in general involves authority and the ability to make decisions and act independently, accountability involves the requirement to take responsibility for conduct and duties in specific areas. 

For the safety-specific dimensions we could substitute equivalent dimensions related to other specific areas of organizational functioning, such as patient satisfaction, quality, or employee retention. We would likely find similar patterns of influence on these outcomes as we find for safety. 

Pharmacokinetic parameters such as area under the concentration-time curve (AUC) and maximal plasma concentration can be predictive of treatment outcome when specific ratios of AUC or maximal plasma concentration to the minimum inhibitory concentration (MIC) are achieved. For... 

Reading the literature on mammalian semiochemistry over the past decade, a chemist is impressed by the enormous volume of biological information that has been gathered in well planned and meticulously executed studies of the modulation of the behavior of mammals by the chemicals released by con-specifics. One cannot, however, escape the impression that the chemical basis of many of these studies is lacking. Some of the problem areas were pointed out in the foregoing sections. To a certain extent there seems to be lack of appreciation of the diffusion rates of compounds with different volatilities and of the extent to which these differences can influence the outcome of behavioral tests. It is difficult to make an estimate of the persistence of semiochemicals that are released into the laboratory atmosphere or that are left on objects or surfaces in arenas in which tests are conducted. From what is known about the evaporation rate of some heavy compounds that are considered to be semiochemicals, it could take several weeks or even months for these compounds to be depleted to levels that cannot be detected by currently available instrumentation levels at which meaningful information could still be available to experimental animals. This then leaves the question unanswered as to when it would be safe to conduct behavioral experiments in a laboratory or arena that had been occupied by conspecifics. 

Because this literature has become so vast and has morphed in so many different ways, we focus on a subset. Specifically, we review three types of studies. First, we review evidence based on comparisons of spending and outcomes across Organization for Economic Cooperation and Development (OECD) countries. Second, we describe a number of studies focusing on specific countries (namely, the United States and Canada). These studies have examined the impact of pharmaceutical spending levels on health outcomes using variation across administrative units and over time within individual countries. Finally, we introduce the growing literature examining the value of pharmaceuticals relative to specific disease areas. 

As an example, a recent intercomparison (37) included three N02 measurement techniques aTDLAS-based system and two chemical-based systems— the photolysis-ozone chemiluminescence system diagramed in Figure 7 and an instrument based on N02 plus luminol chemiluminescence. Above 2 ppbv the three instruments gave similar results, but at sub-ppbv the results from the three techniques became dissimilar. Tests on the prepared mixtures showed that the luminol results were affected by expected interferences from 03 and PAN. No interferences were found in the TDLAS system, but near the detection limit the data analysis procedures calculated levels of N02 that were too high. The outcome of this intercomparison was close to the ideal the sensitivity, specificity, accuracy, and precision of each instrument were objectively analyzed previous data sets taken by different systems can now be reliably evaluated and each investigator was able to perceive areas in which the technique could be improved. 

We are using the term inadequate sleep instead of sleep deprivation in our title for a number of reasons. First, few studies have aimed specifically to deprive children or adolescents of sleep. We describe some research on experimental sleep restriction in children but most of these studies fall far short of common deprivation paradigms in animals or even adult humans. Instead, most research in younger humans has assessed outcome measures such as school grades, self-reported sleepiness, and so forth as a function of variations in self-selected or usual sleep patterns with the expectation that children and adolescents who obtain lower than normal amounts of sleep will manifest deficits. Thus, inadequate sleep is defined by sleep characteristics of a sample. We also wanted to note some of the literature on sleep that is disturbed or disrupted due to disease processes such as apnea or periodic leg movements the duration of sleep in sleep disorders may or may not be shortened or restricted although it is likely fragmented and otherwise abnormal. We decided on the term inadequate sleep with the hope that it would encompass these different areas of concern. 

At the initiation of a project, the choice of vendor may be limited. A specific piece of customized equipment may be needed during manufacturing, a key intermediate may be available in lab-scale quantities only, or a particular investigator may be the only expert in a narrow therapeutic area. An evaluation of how this may impact the overall outcome of the project should be done in parallel with working with the single-source vendor. Does the vendor have the capability to purchase more customized equipment Can the intermediate be scaled to the tens of kilos Is there another domestic or international clinical expert available ... 

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