Clinical and economic outcomes in the hypertension and COPD arms of a multicenter outcomes study.

OBJECTIVE: To evaluate the impact of pharmaceutical care on selected clinical and economic outcomes in patients with hypertension or chronic obstructive pulmonary disease (COPD) in ambulatory care settings. DESIGN: Clinic patients with hypertension or COPD were randomly assigned to a treatment group (pharmaceutical care) or a control group (traditional pharmacy care) over a six-month period. Clinical pharmacists and pharmacy residents conducted the protocols. There were 133 evaluable patients (63 treatment and 70 control) in the hypertension study arm and 98 evaluable patients (43 treatment and 55 control) in the COPD study arm. SETTING: 10 Departments of Veterans Affairs medical centers and 1 academic medical center. INTERVENTIONS: Patient-centered pharmaceutical care model (employing standardized care) implemented by clinical pharmacy residents. MAIN OUTCOME MEASURES: Patient knowledge, medication compliance, and health resource use. RESULTS: The hypertension treatment group had a significantly greater reduction in systolic blood pressure from visit 1 to visit 5 than did the control group. In the COPD study arm, trends were positive in the treatment group for patients ratings of symptom interference with activities and dyspnea measures. There was a significant difference between the hypertension treatment and control group for compliance. There were no significant changes in compliance scores in the COPD study arm. Mean number of hospitalizations and other health care provider visits was higher for the hypertension control group. For patients with COPD, hospitalizations increased in the control group, and the number of other health care provider visits was higher in the control group. CONCLUSION: Pharmacists' participation in a pharmaceutical care program resulted in disease state improvement in ambulatory patients with hypertension and COPD.

Development, implementation, and evaluation of a multicenter pharmaceutical care outcomes study.

OBJECTIVES: To: (1) develop a pharmaceutical care multicenter outcomes research project using clinical pharmacy residents and preceptors; (2) develop two research protocols to document pharmacists' impact on clinical, economic, and humanistic outcomes of therapy; (3) develop and implement a data collection process and methodology for outcomes research; (4) evaluate the effectiveness of the multicenter outcomes research process; and (5) prepare clinical pharmacy preceptors and residents to conduct outcomes research. DESIGN AND SETTING: Two research protocols were developed, each a randomized, parallel, open-label evaluation of patients at 10 Department of Veterans Affairs and 1 university medical center. One protocol focused on patients with chronic obstructive pulmonary disease (COPD) and the other on patients with hypertension. The study evaluated pharmacists' management of these two patient groups. PATIENTS AND OTHER PARTICIPANTS: 133 patients with hypertension and 98 patients with COPD; 33 pharmacy directors and preceptors; 45 pharmacy residents. MAIN OUTCOME MEASURES: Clinical, economic, and humanistic outcomes of pharmacists' interventions. The processes of developing a multicenter outcomes study were evaluated, including the data collection process. RESULTS: The two study protocols and an educational program for study participants were developed. A data collection process was developed and implemented, with the paper process being successful and the computer data collection process not implemented due to time constraints. Overall, the multicenter outcomes research process was successful. CONCLUSION: The study provides a framework of processes and sites for the future development of other outcomes research studies. Clinical, economic, and humanistic outcomes are reported in Parts 2 and 3.

Humanistic outcomes in the hypertension and COPD arms of a multicenter outcomes study.

OBJECTIVE: To evaluate the effects of pharmaceutical care on selected humanistic outcomes in patients with hypertension or chronic obstructive pulmonary disease (COPD). DESIGN: Clinic patients with hypertension or COPD were randomly assigned to a treatment group (pharmaceutical care) or a control group (traditional pharmacy care) over a six-month period. Clinical pharmacists and pharmacy residents conducted the protocols. There were 133 evaluable patients (63 treatment, 70 control) in the hypertension study arm and 98 evaluable patients (43 treatment, 55 control) in the COPD study arm. The Pharmaceutical Care Questionnaire evaluated patient satisfaction with care. Tests specific to the disease states assessed disease and disease management knowledge. Quality of life (QOL) was evaluated using the Health Status Questionnaire 2.0 (HSQ 2.0) in the COPD arm; in the hypertension arm, the Hypertension/Lipid TyPE Specification Form 5.1 was used. SETTING: Ambulatory care centers of 10 Department of Veterans Affairs (DVA) medical centers and 1 university medical center. INTERVENTIONS: Patient-centered pharmaceutical care model (employing standardized care) implemented by clinical pharmacy residents. MAIN OUTCOME MEASURES: Satisfaction with pharmaceutical care, disease and disease management knowledge, and QOL. RESULTS: Statistically significant differences in most satisfaction items were found, with treatment patients expressing greater satisfaction. Treatment groups in both arms strongly agreed that pharmacists helped them with confidence in use of their medication and understanding of their illness, gave complete explanations about their medications, made them feel that their care was a priority, and followed up on their questions and concerns. In the hypertension arm, treatment patients demonstrated significant increases in knowledge scores. Trends in QOL were positive for both hypertension groups, with a significant decrease found in number of treatment patients reporting problems with sexual function. In the COPD arm, improvement trends were significantly stronger for treatment patients. CONCLUSION: Although patients were not dissatisfied with traditional pharmacy care, they were more satisfied overall with the pharmaceutical care model.

Bar-code technology for documenting administration of large-volume intravenous solutions.

The failure to properly document dispensing, administration, charging, and crediting of large-volume plain i.v. solutions in a hospital, along with the potential for using bar-code technology to reduce documentation discrepancies, was investigated. Portable bar-code scanners and preprinted bar-code labels were employed to identify large-volume plain i.v. solutions administered on two selected nursing units of a 1000-bed, private, not-for-profit hospital. Inservice training sessions were conducted to instruct hospital personnel in the use of the scanning equipment. Comparisons of patient statements and medication administration records for large-volume plain i.v. solutions established the level of documentation errors in the study hospital. The causes of these errors were traced to three primary sources: (1) failure to document administration of a solution to a patient (38%), (2) failure to credit patients for i.v. solutions returned to the pharmacy (37%), and (3) administration of a solution to a patient other than the patient for whom the solution was dispensed (25%). Accountability for large-volume plain i.v. solution charges to patients was improved by 19% using bar-code technology. The pharmacy manager desiring to employ bar-code technology should determine convenient methods for applying bar-code labels to solutions and for scanning the bar codes, as well as provide programming that can compensate for erroneous scans.

Substrate irradiation stimulation of the in vitro lactate-pyruvate interconversion reactions mediated by lactic dehydrogenase.

Experimental studies of the Comorosan effect are presented for the LDH-mediated interconversions of lactate and pyruvate. Consistent with the findings of the Comorosan group, the rate of the lactate/LDH reaction was found increased for crystalline lithium lactate irradiated with green light for times t comprising the manifold t = 15+30n sec, n = 0,1,2... However, no upper limit to the number of activating times was encountered although the Comorosan group has always obtained only six such activations. The pyruvate/LDH reaction rate was found enhanced for crystalline sodium pyruvate irradiated t = 5+30n sec. Sharpness of activations for 5-sec and 65-sec irradiated samples was investigated and found to occur only within approximately +/- 0.5 sec of 5.0 and 65.0 sec, slightly broader than the +/- 0.15-sec peak reported by Comorosan for the 5-sec signal. The data contribute to the credibility of the phenomenon but reveal sensitivity of some properties to individual laboratory or procedural factors. The first support is provided for the "discriminating function" component of Comorosan's metabolic control hypothesis.

Inhibition of Streptococcus faecalis by long chain aliphatic monoamines: quantitative structure-activity studies.

Primary, secondary, and tertiary long chain aliphatic amines were synthesized, and their activity against Streptococcus faecalis was determined. Quantitative structure-activity analyses were carried out based on the Hansch extrathermodynamic model, using partition coefficients, CMC's, quantum mechanical charges on the amine nitrogen, and the Taft steric parameter. The best correlations were obtained with the CMC. Steric properties of the ammonium head become important for tertiary amines. The structural feature of these compounds that dominates biological activity is the length of the alkyl tail. Ammonium head substituents are of only secondary importance.

The Comorosan effect: single- and double-blind studies on the urea/urease system.

Characteristic alterations of enzymatic reaction rates by irradiation of the crystalline substrates for fixed periods with an Hg vapor lamp were reported by Comorosan in 1969. Results of single- and double-blind studies reported here support the validity of the key features of this striking and potentially important phenomenon.

Structure-activity studies on inhibition of Streptococcus mutans by long-chain aliphatic diamines.

A series of long-chain aliphatic diamines, R1R2N(CH2)mNR3-CnH2n+1' was tested for in vitro inhibition of Streptococcus mutans. In general, high activity was found for all analogs with alkyl chains containing 14 to 18 carbons. The nature of the substituents on the remainder of the alkylenediamine were of secondary importance. N-hydroxyethyl substituents tend to decrease activity. Good correlations of activity with quadratic functions of diamine critical micelle concentrations were obtained.

Quantitative studies of in vitro inhibition of Streptococcus mutans plaque formation by organic amines.

The abilities of five, long-chain aliphatic monamines to inhibit the deposition of plaque formed by Streptococcus mutans on stainless-steel wires were determined. The compounds along with their relative inhibitory potencies that were studied are N-methyltetradecylamine, hexadecylamine, dodecylamine, N-ethyldodecylamine, and octylamine. Activities are compared with critical micelle concentrations, partition coefficients, and quantum mechanical charges on the amine nitrogens.

Synthesis and CMC determination of a series of aliphatic diamines.

Fifteen aliphatic diamines substituted with one long alkyl chain (C10-C18), a varying number of methylene groups separating the nitrogens (two to six), and various aliphatic substituents were synthesized and their CMC's were determined. While the length of the long alkyl chain plays a dominant role in influencing the CMC, the other N-alkyl substituents as well as the length of the methylene chain separating the two nitrogens of the diamine are significant factors.

Resonance stabilization of cycle groups of hydrogen-bonded water molecules.

A quantum-mechanical resonance effect can be associated with cyclic groups of hydrogen-bonded water molecules and, conceivably, might influence the structure of liquid water (M. Ageno, these PROCEEDINGS, 57, 567 (1967)). However, from the calculations presented here, this resonance stabilization appears to be too small (<0.1 kcal/mole) to over come the thermal motion of the water molecules and consequently cannot significantly influence the liquid water structure. The model developed here permits the estimation of an upper limit to the stabilization. The bridge protons are imagined to be simultaneously tunneling through the barriers of equivalent symmetric double-well potentials, and the resulting energy-level splittings are related to the resonance stabilization.