Reliability of a modified medication appropriateness index in ambulatory older persons.

OBJECTIVE: To evaluate the reliability of a medication appropriateness index (MAI) modified for elderly outpatients in a non-Veterans Affairs setting. DESIGN: Reliability study. SETTING: General community. PARTICIPANTS: Ten community-dwelling elderly (> 65 y) taking five or more regularly scheduled medications and participating in a university-based health service intervention study. MAIN OUTCOME MEASURES: Interrater reliability of MAI ratings of 65 medications made by two clinical pharmacists for individual items and for an overall summed score was calculated by use of kappa statistics and intraclass correlation coefficient. RESULTS: The interrater agreement for each of the individual MAI items was high for both appropriate and inappropriate ratings and ranged from 80% to 100% (overall kappa = 0.64). Overall agreement for the summed score was good (intraclass correlation = 0.80). CONCLUSIONS: The modified MAI is a reliable instrument for evaluation of medication appropriateness in a non-Veterans Affairs, ambulatory, elderly population and may provide pharmacists with a practical and standard method to evaluate patients' drug regimens and identify some potential drug-related problems.

Characteristics predicting incorrect metered-dose inhaler technique in older subjects.

OBJECTIVE: To determine whether cognitive status, hand strength, and demographic variables are predictive of correct use of metered-dose inhalers by older subjects. METHODS: Clinic patients (n = 29) and healthy volunteers (n = 42) older than 50 years with no previous or limited metered-dose inhaler use were enrolled. After cognitive (Mini-Mental State Examination) and hand strength assessments, subjects received extensive instruction in proper metered-dose inhaler technique. Technique was independently assessed by two evaluators immediately after instruction and 1 week later. Correct technique was defined as (1) activating the canister in the first half of inhalation, (2) continuing to inhale slowly and deeply, and (3) holding breath at full inspiration (5 seconds). Data for the two subject groups were pooled for analyses. RESULTS: The mean age of the subjects was 69.7 years. Forty subjects (56%) demonstrated correct metered-dose inhaler technique at 1 week. Logistic regression showed that hand strength measurement (odds ratio, 0.68; 95% confidence interval, 0.55 to 0.84), Mini-Mental State Examination score less than 24 (odds ratio, 3.66; 95% confidence interval, 1.07 to 12.4), and male gender (odds ratio, 5.01; 95% confidence interval, 1.07 to 23.5) were significant predictors of incorrect inhaler use. Correct use of the metered-dose inhaler was unrelated to age, education, or subject status. CONCLUSIONS: Clinicians should consider cognitive status and hand strength when metered-dose inhaler therapy is initiated for an older adult. Patients with cognitive impairment and hand strength deficits may require more extensive training, frequent follow-up, or alternative dosage forms.

Assessment of interrater and intrarater reliability in the evaluation of metered dose inhaler technique.

STUDY OBJECTIVE: To determine if a training session using videotaped metered dose inhaler (MDI) performances can result in high interrater and intrarater reliability of five evaluators assessing MDI technique. DESIGN: Five evaluators (three pharmacists, two pulmonary fellows) were trained to evaluate MDI technique during a 2-h training session. The training session consisted of verbal instruction and practical experience in evaluating MDI technique using video-taped MDI performances of six nonstudy subjects. After the training session, the evaluators independently observed the same videotaped MDI demonstrations of 14 subjects on two occasions separated by a 7- to 10-day interval. Interrater and intrarater reliability was determined for individual steps by calculating percent agreement and intraclass correlation (ICC) coefficient. RESULTS: Interrater. The interrater reliability for individual steps ranged from 29 to 86 percent (ICC coefficient = 0.13 to 0.81). Steps in which evaluators were in agreement for less than 9 of the 14 subjects were shaking the inhaler before inhalation, exhaling, continuing to inhale slowly, and adequate breath hold. Intrarater: The overall percent agreement by step ranged from 74 to 97 percent. Exhaling to functional residual volume (76 percent) and continuing to inhale slowly and deeply (74 percent) had the lowest overall agreement between the first and second observation day. The consistency of evaluating a step between the two observation days varied considerably depending on the step and evaluator. CONCLUSIONS: High interrater and intrarater reliability in MDI evaluation is difficult to obtain. Clinicians and researchers involved in MDI evaluation and education should be trained to achieve consistency. A single training session using videotaped MDI demonstrations was not adequate in achieving consistency among evaluators. To improve accuracy of research results, researchers should include at least two evaluators to assess MDI technique or take other measures to show and report reliability.

Statistical and research quality of the medical and pharmacy literature.

The statistical and research quality of reports published in two U.S. medical journals and two U.S. pharmacy journals over a 12-month period was determined. A 50% random sample of issues of New England Journal of Medicine, Annals of Internal Medicine, American Journal of Hospital Pharmacy, and Drug Intelligence and Clinical Pharmacy published in 1979 was reviewed, and all citable items were classified as one of nine types of communications. Items classified as original evaluative research reports were evaluated for experimental design and research goals and rated for appropriateness of statistical testing and overall research quality according to a set of objective criteria. Reports that were not immediately classifiable were reviewed by one additional person, and classifications or ratings were assigned by mutual consent. Of a total of 1506 citable items, 120 met the criteria for original evaluative research reports. The two medical journals had the highest percentages of reports for which statistical methods were rated as correct but also had the most reports for which statistical methods could not be rated as a result of incomplete documentation or publication errors. Reports in the medical journals had conclusions based on a logical progression of hypothesis, methods, and analysis of results more frequently than did reports in pharmacy journals. Reports in the medical and pharmacy journals differed greatly according to research design and research goals. Improvement is needed in the statistical quality and research quality of original research reports published in the pharmacy literature.

Bioavailability of a commercial sustained-release quinidine tablet compared to oral quinidine solution.

The bioavailability of quinidine sulfate after oral administration of a commercial sustained-release quinidine tablet was compared with that of oral quinidine sulfate solution in 18 normal subjects. Three hundred milligrams of each product was administered to each subject in standard cross-over fashion on separate occasions, with plasma quinidine levels measured for 46 h after each dose. Although peak plasma quinidine levels were lower, and occurred later, after tablet administration than after solution, analysis of the area under the plasma quinidine level-time curve (AUC) values for each product indicated that the products were equivalent, in terms of the extent of absorption, with the mean AUC (0-46 h) value for the tablet, 8744 . 4 ng x h ml-1, comparable to that of the solution, 9145 . 9 ng x h ml-1.

Pharmaceutical services in hospices.

Hospices were surveyed to identify the types of pharmaceutical services provided. The directors of 75 hospice organizations were sent questionnaires regarding: (1) the type and scope of pharmaceutical services and (2) their conception of the future of the hospice movement. Of the 48 usable responses, 37 reported pharmacist affiliation. Of the 11 organizations that did not have a pharmacist affiliated, 10 reported they anticipated using a pharmacist's services in the future. Most (68%) pharmacists who worked in hospices were consultants. Pharmaceutical services included the development of policies and procedures regarding drug storage and handling, inservice education, drug information, and patient education. Of the organizations without a pharmacist, 91% provided only outpatient care; of hospices with pharmacists, 51% provided outpatient, 14% inpatient, and 36% outpatient and inpatient care. Forty-six percent of the hospice directors considered the pharmacist affiliated with their organization to be a member of the interdisciplinary team; 55% of such pharmacists worked full-time with the hospice. Hospice directors expressed a need for greater pharmacist involvement in inservice education, staff consultation, and research on pain.

"Alternative" controls in a case-control study of endometrial cancer and exogenous estrogen.

To address the issue of detection bias among endometrial cancer cases and controls, women admitted to the North Carolina Memorial Hospital for dilatation and curettage (D&C) during 1970-1976 were selected as one of three control groups in a study of endometrial cancer and exogenous estrogen. Study subjects included 256 cases, 316 D&C controls, 224 gynecology controls and 321 community controls. The D&C controls had a higher frequency of estrogen use than either of the other control groups or the cases. These differences existed for both blacks and whites. When white cases were compared to either gynecology or community controls, relative risks were increased for long duration estrogen use and for recent use prior to diagnosis. With D&C controls, relative risks were not significantly different from unity irrespective of duration or recency of estrogen use. Exclusion of hyperplasias from the D&C controls had no substantive effect of these results. Bleeding was a presenting complaint for 92% of cases, 82% of D&C controls and 22% of gynecology controls. Both among cases and gynecology controls, there was no statistically significant association between bleeding and estrogen use, whereas this association was evident among D&C controls, and specifically among those who did not have pathologic evidence of endometrial hyperplasia. These data support the presence of detection bias among D&C controls but they do not provide evidence of this bias among endometrial cancer cases.

Estrogen and endometrial cancer: cases and two control groups from North Carolina.

PIP: The relationship between exogenous estrogen and risk of endometrial carcinoma was investigated in 256 women with pathologically confirmed cases, 224 gynecology controls, and 321 community controls. Sources of data included personal interviews, physicians' records, and hospital records; diagnoses were verified by 2 outside pathologists. Black women revealed no difference in estrogen use between the cases and both sets of controls, while white women revealed risk of 3.6 and 4.1 after 3 1/2 years of estrogen use. Shorter duration of use, irrespective of dose or type of estrogen, did not increase risk. There was no increased risk in obese women, who prosumably produce increased amounts of exogenous estrogen. The highest risk was found after 3 1/2 years or more of use in nonobese, nonhypertensive women. It was also demonstrated that there is a latency period of 3-6 years after first administration, and that an estrogen-free interval of 2 years is sufficient to reduce elevated risks to nonuser level. Risks of cancer were high for Stage 1A and Grade 1 lesions with estrogen use of long duration.^ieng

Research in clinical pharmacy: needs and priorities.

The importance of research to a service profession such as pharmacy is established. The current state of research in clinical pharmacy, and some proposed priorities for the future, are outlined. General requirements for research staff, facilities, and funding are listed. To produce accurate and meaningful results, three guidelines must be borne in the minds of researchers: (1) select research topics that will have recognized impact on the quality of patient care and education; (2) design and conduct studies which can withstand the scrutiny of the established scientific community; and (3) communicate meaningful information to all who can facilitate its utilization.

Renin profiling in hypertension and its use in treatment with propranolol and chlorthalidone.

We compared methods of classifying hypertension according to plasma renin activity in 54 patients with essential hypertension and examined the validity of using these classifications to choose between two hypotensive drugs. A prospective, double-blind crossover study was used. Normal values for plasma renin activity were established from 111 control subjects. Plasma renin activity was related to race and inversely to age in hypertensive patients (P less than 0.05) but not in normal subjects. Three methods of classification correlated well but did not identify exactly the same renin-suppressed patients. Chlorthalidone produced a greater reduction in blood pressure and restored blood pressure to normal in a larger percentage of patients in both low-renin (59 per cent) and normal-renin (32 per cent) subgroups than propranolol (12 and 16 per cent). Renin determinations are of limited benefit in the choice of therapy for most patients with essential hypertension.