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Biomedical subjects

T D Moore

Publications and source records attributed to T D Moore.

At least 19 recordsLinked to original sources

Quality-of-life assessment in cancer treatment protocols: research issues in protocol development.

BACKGROUND: Interest in incorporating quality of life as an end point in clinical studies of cancer treatment has intensified in recent years. PURPOSE: We provide practical suggestions that will assist investigators considering including quality-of-life assessment in phase III therapeutic trials. METHODS: We discuss issues important in study planning, including quality-of-life definition, priority studies for quality-of-life assessment, eligibility requirements, and design. CONCLUSIONS: Many of the problems that quality-of-life studies have encountered, from protocol approval to data analysis, could be addressed and alleviated during protocol development. This discussion is intended to assist and stimulate investigators conducting research in this area.

Clinical Protocols

Assessing quality of life in head and neck cancer.

Comprehensive assessment of the impact of head and neck cancer goes beyond traditional biomedical outcomes to include quality of life. This paper examines the methods used in reported studies on quality of life in head and neck cancer patients with respect to definitions, approaches to measurement, and types of findings. Analysis reveals little consensus in defining or assessing quality of life, although deficits in patient well-being were well-documented. A number of current efforts to develop and validate quality of life instruments specific to cancers of the head and neck have been reported. Future research should be sensitive to the issue of defining quality of life; a definition which includes both patient perceptions and objective functioning in a number of areas is advisable. Investigators should build on recent and ongoing efforts at instrument development and make efforts to incorporate quality of life assessment in clinical trials of cancer treatments. The distinctive aspects of head and neck cancer illustrate the importance of considering characteristics of the patient population in quality of life research and also the way that quality of life data can contribute to the multidisciplinary team of caregivers.

Data Interpretation, Statistical

The translation initiation site of recombinant Trypanosoma brucei ornithine decarboxylase varies with different promoters.

Expression of the Trypanosoma brucei ornithine decarboxylase (ODC) gene in Escherichia coli behind the lambda phage PR promoter led to the production of a recombinant enzyme having the same subunit molecular weight as the native enzyme [4]. However, when the same gene is expressed behind the tac promoter or the phoA promoter, the ODCs produced by the transformed E. coli have subunit molecular weights approximately 2 kDa higher than that of the native enzyme. Amino terminal sequencing of the recombinant proteins indicates that the ODC synthesized under control of the lambda PR promoter actually starts at the second methionine (Met23) of the open reading frame, whereas those produced in the latter two cases begin at the first methionine (Met1). Analysis of the 5'-end of T. brucei ODC mRNA supports the conclusion that translation initiates at Met23. We postulate that, for the lambda PR promoter, translation initiates at Met23 instead of Met1 because of the formation of a stable secondary structure in the region of the Met1 and the presence of a good E. coli consensus translation initiation site upstream of Met23. We have constructed a new plasmid using the pho A promoter to express recombinant T. brucei ODC starting at Met23 in large quantities.

Amino Acid Sequence

Building quality of life assessment into cancer treatment studies.

Quality of life is increasingly recognized as an important outcome of cancer treatment. However, quality of life research poses considerable problems in design and implementation. This article provides guidelines for the preparation of phase III therapeutic protocols that include quality of life assessment. The guidelines emphasize the distinct requirements of quality of life research and provide specific recommendations for the questions that need to be addressed in protocol development.

Clinical Trials as Topic

Hemorrhagic cardiomyopathy and hemothorax in vitamin K deficient mice.

The cause of a fatal condition characterized by hemorrhagic cardiomyopathy, hemothorax, and coagulation defects in hysterectomy-derived male mice was investigated. Microscopic heart alterations included multifocal hemorrhage and necrosis with variable degrees of acute inflammation and fibroplasia that were most severe in the region of the atrioventricular junction. A spontaneous outbreak was arrested by increasing menadione Na-bisulfite (vitamin K) in the feed to 20 ppm. The complete syndrome including hemorrhagic cardiomyopathy was readily reproduced in germ-free male mice given a vitamin K-free diet, and in conventional male and female mice given Warfarin in the diet. We concluded that the cause of this condition was vitamin K deficiency.

Animals

Systemic treatment of advanced and recurrent endometrial carcinoma: current status and future directions.

Multiple systemic therapies have been used to treat patients with endometrial cancer. Although progestins have been the standard initial treatment for metastatic disease for the past 30 years, they are effective in only 20% of patients, and several large randomized trials have failed to demonstrate any benefit in the adjuvant setting. Alternative agents such as tamoxifen have shown modest activity. Few studies have investigated combinations of hormonally active drugs. Doxorubicin and cisplatin are the most active cytotoxic agents; a current randomized study is comparing the combination of these drugs with single-agent doxorubicin. Maximizing the effectiveness of established drugs, possibly with hematopoietic growth factors, and identifying alternative hormonal and cytotoxic agents with a sound scientific rationale will hopefully increase the effective treatment options for these patients.

Antineoplastic Agents

Stability of mean values of organic analytes in lyophilized quality control serum. A study utilizing data from the Quality Assurance Service (QAS) Program of the College of American Pathologists.

The long-term stability of mean values of six organic analytes in 48 commercial pools of lyophilized chemistry quality control serum is evaluated. These pools, provided by five manufacturers, have been used by nine Regional Quality Control Programs participating in the College of American Pathologists Quality Assurance Service. Creatinine yielded stable mean values in 88% of the pools studied. Both albumin and urea nitrogen demonstrated manufacturer and method-related changes in mean values. Bilirubin, cholesterol, and uric acid changes in mean values were independent of control serum manufacturer, predominant in calibrator-standardized automated procedures, and were clustered by years.

Bilirubin

Quality control of agar diffusion susceptibility tests.

Since its beginning in 1974 over 180 laboratories have participated in the Microbiology Program of The College of American Pathologists Quality Assurance Service submitting a total of 2,372,000 individual antibiotic determinations on three quality control reference stains. Eighty-nine and five tenths percent of these determinations were obtained using the standard Bauer-Kirby method; 8.4% using the agar overlay modification of Barry and associates. Standard statistical analysis of data obtained using the Bauer-Kirby method have been reported for each antimicrobic/reference strain combination. Comparisons have been made between the QAS data and those data obtained in earlier collaborative studies which currently serve as precision and accuracy control limits. In many cases QAS data exceed the existing control limits.

Agar

Administrative approach to disaster preparedness in the pharmacy.

Disaster planning for a hospital pharmacy department is discussed. During a crisis, the type of behavior exhibited by hospital personnel and the community can be used to predict the situation's severity and to prepare a response. During disasters, it is important to focus on accomplishing tasks by defining employees' roles, establishing chains of communication, delegating authority to competent persons, limiting decision-making by persons other than those in command and defining the boundaries of pharmacy's involvement in the disaster. A case study of pharmacy operations during a crisis is presented, with guidelines for assessing the situation, establishing priorities, identifying resources and executing a response. Hospital pharmacy administrators must display a high degree of creativeness and responsibility during disasters, but training in the principles of disaster management can be helpful.

Behavior

Developing reimbursable clinical pharmacy programs: pharmacokinetic dosing service.

The development, operation and evaluation of a pharmacy-conducted pharmacokinetic dosing service is described. Pharmacists recommend individualized drug dosing regimens based on pharmacokinetic models and equations clinically tested for accuracy by the pharmacy department. Pharmacokinetic values are determined with the aid of online computer programs developed by the department. Drug assays are provided by the hospital's laboratory. All of the department's pharmacists were trained to provide the 24-hour service. The pharmacy department's $20 pharmacokinetic dosing service fee is reimbursed by Blue Cross. The pharmacokinetic dosing service is the first nonteaching, nonproduct-oriented pharmaceutical service whose cost-effectiveness has been recognized by a third-party payer.

Body Surface Area

Relationship of metal metabolism to vascular disease mortality rates in Texas.

The annual mortality rates for 1968 of six types of cardiovascular diseases among those persons over 45 years of age in 24 Texas communities were compared with respective community drinking water and urine metal levels of calcium, magnesium, potassium, lithium, strontium, and silicon. Numerous inverse correlations were found between mortality rates and the levels of various metals in both drinking water and urine. Positive correlations were also observed between several of the mortality rates and the ratio of the concentration of sodium to that of the other metals in both water and urine. Mean community urinary levels of lithium, magnesium, strontium, and silicon showed a direct correlation to the levels of exposure via the drinking water. The results of this study suggest that calcium, magnesium, lithium strontium, and silicon may protect against cardiovascular mortality; possibly, by competing with sodium and potassium for transport in the intestinal lumen, increasing excretion of sodium, or other mechanism.

Calcium

Long-term stability of glucose in lyophilized quality control serum. A study utilizing data from the Quality Assurance Service (QAS) Program of the College of American Pathologists.

The long-term stability of glucose in 45 commercial pools of lyophilized quality control serum is evaluated. The pools have been used in conjunction with the Quality Assurance Service (QAS) of the College of American Pathologists by laboratories participating in Regional Quality Control Programs. Directional instability of glucose was detected by at least one analytic method in 69% of the pools studied. Two distinct and opposite directional trends in glucose concentration were found. Increasing concentration of analyte, averaging 4.7 mg/dl per year, were observed with manual and automated glucose oxidase methods and the automated neocuproine procedure in approximately one fourth of pool--method combinations. Decreasing concentrations of glucose, averaging 3.0 mg/dl per year, were found with automated ferricyanide and hexokinase methods and the manual orthotoluidine procedure in approximately one third of pool--method combinations. The results are best explained by postulating that in affected pools there is a gradual diminution of free and bound glucose and/or a shift of glucose from the protein-bound to the free state.

Autoanalysis