Needs assessment risk factors

The functional capacity of the musculoskeletal system is mostly assessed using questionnaires, functional tests and observational methods. This evaluation is important to indentify the risk of musculoskeletal disorders, to assess the results of occupational interventions and for research. The pros and cons of each method have been discussed previously (Barrero et al., 2009, Wind et al., 2005, Takala et al., 2010) and the need for research in new technologies to assess risk factors and task demands has been identified (Govindu and Babski-Reeves, 2012). 

These so-called Pareto-based techniques do not force consolidation over multiple criteria in advance and aim to return a representation of the set of optimal compounds. They support discussion between team members who may have different views on the downstream impacts of different risk factors perhaps, for example, one team member may know that there is a reliable biomarker for one potential side-effect. This would then mean that assessing this risk need not consume much development time and cost, and the risk factor can have a reduced weighting within the target product profile being evolved by the team. 

In patients with borderline-high blood cholesterol (200 to 239 mg/dL), assessment of risk factors is needed to more clearly define disease risk. 

Except for issues such as risk assessment and factors that would indicate the need to determine the potential effect of test article on immune function, the various guidelines are fairly consistent in what tests are recommended. ICH S8 contains a table suggesting the parameters that should be assessed in nonclinical toxicology studies these parameters do not differ significantly from other guidelines (see Table 2.1). The... 

FIGURE 8.1 The risk curve lines shown represent thresholds between different types of decisions (based on ECOFRAM 1999a and 1999b). These thresholds would be determined by decision makers and may move location subject to other factors that affect the decision (e.g., pesticide benefits). The bottom graph shows an example risk curve with uncertainty bounds. The curve clearly fits within the acceptable risk category however the upper uncertainty bound does not, indicating a need for risk mitigation or further refinement of the risk assessment. 

In our experience, it is crucial for a project team to be aware of hERG inhibition as the main LQT risk factor during the early phases of drug discovery and to have easy access to training materials and internal experts if consultation is needed. During lead selection, use of appropriate hERG assays and early LQT risk assessments must be done in the context of a lead series represented by at least ten compounds (Figure 16.5). 

In the assessment of risk for violence one needs to take into consideration the risk factors outlined in Table 50.1. Most aggressive youths are impulsive and non-compliant, often continuing to be at risk despite active treatment. 

Ten patients who had taken lithium for less than 1 year and 13 who had taken it for more than 3 years were assessed for alterations in bone metabolism and parathyroid function (654). There were no differences in bone mineral density, serum calcium concentration, or PTH concentration, but both groups had increased bone turnover and the longterm group had nonsignificantly higher calcium and PTH concentrations (including one hyperparathyroid patient who had an adenoma excised). The authors conclusion that lithium therapy is not a risk factor for osteoporosis needs to be tempered by the small sample size, the case of adenoma, and the blood concentration trends. 

ED and vascular disease commonly coexist. They share the same risk factors and endothelial dysfunction is the common denominator. ED may develop in an otherwise asymptomatic male and be an important predictor of subsequent acute or chronic cardiac events. ED may therefore offer an opportunity for risk assessment and therapeutic intervention to reduce the chance of a subsequent cardiac presentation. Cardiac patients with ED need a careful assessment to judge the safety of sexual activity and suitability for ED treatment. Properly assessed and counselled patients can safely enjoy sexual activity. ED therapy with phosphodiesterase type five inhibitors is safe and effective providing the patient and partner are advised on their use and the importance of avoiding drug interactions, especially with nitrates. 

Anticoagulants are indicated in the elderly. In the very elderly the overall benefit and risks need careful assessment. Aspirin is less effective than warfarin at preventing emboli but may be appropriate if there are no other risk factors for stroke. Aspirin 75 mg once daily may be used. 

It is less likely in other forms of liver disease, such as acute hepatitis and cirrhosis. Cirrhosis may actually protect against atherosclerosis [5, 8, 9]. The reasons for this are not clear. Secondary hypercholesterolaemia frequently occurs in cholestatic conditions, but usually does not require treatment [10]. Other risk factors for hyperlipidaemia and cardiovascular disease should be assessed, as their presence may independently indicate a need for medical intervention [9]. In PBC, patients with severe, chronic disease do not appear to have an increased cardiovascular risk as a result of their hypercholesterolaemia this may be due to the presence of cirrhosis. In contrast, in less severe PBC... 

Contractual framework Ae contractual framework for any project will need to take account of Ae risk factors which are relevant to Ae specific features of Ae project. It involves caieAl planning on Ae identity of Ae contracting parties and assessment of Aeir capacity to discharge their obligations, Ae scope of Ae positive obligations under each contract and Ae effect of limitations of liability. 

For pharmacists, the message is clear To improve adherence to pharmacotherapy, and hence to improve health outcomes, we must assess each patient individually, then provide targeted interventions that are responsive to his or her unique risk factors and needs (see Fig. 1). Research, such as the American Pharmaceutical Association Foundation s Project ImPACT Hyperlipidemia, has clearly documented the value of pharmacist-led patient care in fostering better adherence and outcomes. 

---