Measurements clinical

Pharmacoeconomics is a nascent discipline which has not yet provided clinicians and budget managers with the level of information necessary for confident decision-making. This is particularly true in psychiatry where the dearth of acceptable, reliably measurable clinical end points makes pharmacoeconomic evaluation even more complex and open to debate. Nonetheless, the data reviewed in this book, when placed alongside clinical data, do provide a framework for decision-making which is better informed and more realistic than any exclusively clinical assessment could be. Economic evaluations in all major mental illnesses, while some way from conclusive, are certainly providing valuable guidance to decision-makers both at policy level and in the clinic. 

Recommendations in this section may change based on the results from the recent EPO-3 trial (epoetin alfa versus placebo). A difference in red blood cell transfusion rates was not observed between groups. Epoetin alpha therapy improved survival in trauma patients. Epoetin alfa did not have a measurable clinical benefit in medical/surgical non-trauma patients. Epoetin alpha therapy was associated with an increased thrombotic event rate, particularly in patients not receiving pharmacological deep vein thrombosis prophylaxis. 

Beck, A. T., Epstein, N., Brown, G.,. Steer, R. A. (1988). An inventory for measuring clinical anxiety Psychometric properties. Journal of Consulting and Clinical Psychology, 56, 893-897. 

Plasma brain natriuretic peptide concentrations, plasma aldosterone, heart failure hemodynamic measurements, clinical symptoms of heart failure, routine blood chemistries, blood pressure for hypotension and pulse rate for abnormalities (hypotension is dose-limiting/dose-dependent)... 

Conley et al. (121) reported a large, double-blind study comparing risperidone with olanzapine. This study included about 400 patients randomly assigned to a flexible dose of risperidone (2 to 6 mg) or olanzapine (5 to 20 mg) for 8 weeks. On many measures, clinical improvement was the same however, risperidone did produce a slightly greater improvement than olanzapine on positive symptoms and on the anxiety/depression subscale. Most patients on risperidone received 4 to 6 mg/day, whereas half the patients on olanzapine received 10 mg and 10% received 5 mg. The mean dose of risperidone was 4.8 mg/day and for olanzapine 14.3 mg/day. 

Khalil OS. Spectroscopic and clinical aspects of noninvasive glucose measurements. Clinical Chemistry 1999, 45, 165-177. 

Measure clinical and economic outcomes in first LTCF 1 month... 

Relationship with demographic measures, clinical variables, and diagnostic subtypes. CNS Spectr 7 43-48. 

A potentially important device was displayed at a recent American Diabetes Association meeting. The poster, authored by Gabriely et al., acquired spectral data from the thumb and used it to measure clinically relevant plasma glucose [2], Scanning from 400- to 1700-nm with a fiber optic probe, spectra were acquired at 40-sec intervals. 

Lightcap ES, McCormack TA, Pien CS, Chau V, Adams J, Elliott PJ. 2000. Proteasome inhibition measurements clinical application. Clin. Chem. 46 673-83... 

Additional markers of catecholamine overproduction have been employed to improve the biochemical detection of neuroblastomas. Free dopamine may be abnormal in urine from neuroblastoma patients with VMA and HVA excretion. Combined testing for VMA, HVA, and dopamine may therefore improve tumor detection, and in 1993 an international consensus report on neuroblastoma diagnosis added dopamine to the Hst of acceptable measurements to document the adrenergic nature of the tumor. Plasma measurements of dopamine and L-dopa, the amino acid precursor of dopamine, may also have clinical value and allow the alternate use of plasma. Measurement of methylated metabolites, especially normetanephrine, has also been explored. When urinary normetanephrine, metanephrine, methoxytyra-mine, dopamine, norepinephrine, VMA, and HVA were measured, clinical sensitivity for detection of neuroblastomas was 97% to 100% when results of normetanephrine testing were coupled either with VMA in the infants or with HVA in children greater than age 1. Even with an extended panel of catecholamines and metabolite measurements, a low incidence of nonsecreting tumors continues to be identified and should be considered in the interpretation of a negative test result. 

For economic outcomes, we can use pharmacoecon-omy as the main tool. " There is a great variety of clinical indicators that we can relate to drugs efficacy and safety. These clinical indicators, obtained with designs from clinical epidemiology (observational and experimental),are excellent to measure clinical outcomes. To obtain indicators for humanistic outcomes, such as satisfaction and quality of life, we have different tools, such as surveys, and different qualitative research methods (interviews, focus groups, etc.). " ... 

West NX, Maxwell A, Hughes JA, Parker DM, Newcombe RG, Addy M A method to measure clinical erosion the effect of orange juice consumption on erosion of enamel. J Dent 1998 26 329-335. Cowell CR An appliance for the study of tooth tissue in vivo. Brit Dent J 1974 137 61-62. Cowell CR, Allen RWB A comparison of dentine wear on prepared tooth sections in vivo using two toothpastes. Brit Dent J 1979 146 339-342. 

Moreno and Margolis [1] developed a computer program, which could be used to calculate the DS with respect to many CaPi phases. To calculate the DS in plaque fluid, the main inorganic ions, especially the concentrations of Ca and Pi, the ionic strength and the pH have to be measured. Clinical studies... 

Nitroprusside has a rapid onset of action and a duration of action of less than 10 minutes, necessitating its administration by continuous intravenous infusion. This allows for precise dose titration based on measured clinical and hemodynamic parameters. It, like other vasodilators used in heart failure, should be initiated at a low dose (0.1 to 0.2 mcg/kg per minute) to avoid excessive hypotension and then increased by small increments (0.1 to 0.2 mcg/kg per minute) every 5 to 10 minutes as needed and tolerated. Usually effective doses range from 0.5 to 3 mcg/kg per minute. A rebound phenomenon has been reported after abrupt withdrawal of nitroprusside in patients with heart failure and is apparently due to reflex neurohormonal... 

Randomised controlled trials (RCTs) were devised to measure drug efBcacy and probably offer the greatest precision. However, they are not without problems and alternative approaches may be sufficient or optimum, depending on the specific clinical question. RCTs measure chnical efficacy (how well a drag works in ideal conditions). Pragmatic (or naturahstic) trials measure clinical effectiveness (how well a drag works in usual chnical practice). 

PAGGIARO, P.L. CHAN-YEUNG, M. (1987) Pattern of specific airway response in asthma due to western red cedar (Thuja plicata) relationship with length of exposure and lung function measurements. Clinical Allergy, 17, 333-339. 

The surface irradiance has been measured clinically in some intraoperative scenarios, for example, during irradiation of the entire peritoneal cavity for ovarian cancer by placing several small photodiodes directly on the tissue surface at representative points. Clearly, such measurements could also be done using fiberoptic probes. 

Nothing can be said about the affinity of any of the drugs based on the information provided above. (Remember that affinity is a measure of the "strength" of binding between the drug and its receptor, and cannot be measured clinically). 

A Hepatitis B DNA vaccine may be a much more suitable candidate to es-tabhsh a first DNA vaccine product and to successfully pass all clinical hurdles. There is a well-known, single antigen that confers protection, whose serological responses are easily measured and can be correlated with protective effects. Other DNA vaccine candidates include antitumor vaccines [111-113], which may pass clinical phases more rapidly than prophylactic vaccines, as their efficacy could be a directly measurable clinical effect, such as tumor regression or reduced or absent metastases. Furthermore, their use could be justified even with a partial effect and some unresolved safety concerns, whereas for a prophylactic vaccine for healthy people, higher standards must be met. 

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