Patient specific other performances

Performing quality assurance evaluations of specific pharmacists performance does not measure patient outcomes, but rather, the process of delivering care. However, providing an acceptable or ideal process (or standard of care) should, by implication, create an environment conducive to better patient outcomes. However, to move from evaluating process to evaluating outcome, other specific tools must be used (see below). Appendix 2 is an example of a quality assurance form that might be used in a pharmacist-managed primary care clinic. 

The other important consideration is which patient popnlation to select. Again, it is ideal to validate a POCT method using samples that are taken from the target patient group in whom the test is to be used, as there may be patient-specific interference or matrix considerations. For example, a POCT that measures blood ketones may perform differently in extremely dehydrated patients admitted with ketoacidosis to a healthy diabetes out-patient population. However, it may also be valuable to undertake the test in a different population. At the very least, users undertaking a method validation, should consider which sample matrix to test and which sample population to study (see Box 2.2 for a case example). 

Other performance requirements and specifications such as efficiency must be stated. The battery energy density and size determine how long a patient can go between battery charges while meeting the requirement. 

Recent advances in the treatment of cancer of the colon and rectum now offer the potential to improve patient survival, but for many patients, improved disease- and progression-free survival represent equally important therapeutic outcomes. In the absence of the ability of a specific treatment to demonstrate improved survival, important outcome measures should include the effects of the treatment on patient symptoms, daily activities, performance status, and other quality-of-life indicators. Individualized patient care to balance the risks associated with treatment with the benefits of a specific treatment regimen is necessary to optimize patient outcomes. 

Approved clinical investigations follow three phases. In Phase 1, about 100 to 200 people are exposed to the drug to determine the tolerance, absorption, excretion, half-life, and other pharmacologic reactions the preferred route of administration and the safe dosage. In Phase 2, initial trials are conducted on 500 to 1000 patients to assess the treatment or prevention of the specific disease. Additional animal studies to indicate safety may be conducted concurrently. If these preliminary studies demonstrate sufficient promise. Phase 3 clinical trials are performed with several thousand patients. 

Performance trials and evaluation tests on the technique indicate that it is both rehable and accurate, and, in addition, that the specificity is sufficient to cope with most chnical requirements. An evaluation was made by Haeckel et al. [19]. If this approach is successful, the dispensers and tubes in laboratories will become redundant. It may well become possible for a clinical test to be undertaken close to the patient rather than in the laboratory. Whilst the techniques have as yet been used only for clinical analyses, there are many other potential applications, for example in the water industry. However, the very nature of the technique necessitates development by Eastman Kodak. Very few users will be able to influence the choice of analytical problems to be tackled by this unique approach. 

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