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Biomedical subjects

J Avorn

Publications and source records attributed to J Avorn.

At least 109 records · Page 6Linked to original sources

Balancing costs, efficacy, and side effects.

Drug approval processes in most developed countries generally do not provide the comparative information necessary for clinicians, patients or policymakers to make informed choices between similar agents, balancing efficacy and toxicity. These questions have been made exponentially more complex with the addition of cost as a third dimension to consider in making therapeutic choices. Application of cost-containment pressure in the absence of adequate data provides a poor foundation for optimal decision making. A systematic, disciplined process is needed for the comparison of similar drugs along each of the three dimensions of efficacy, safety, and cost. Such an inquiry will require use of several methodologies, from conventional randomised controlled trials, to pharmacoepidemiological studies and cost-effectiveness analyses. Such information need not form the basis for drug registration, but instead would be made available to practitioners, patients, and payers to inform their therapeutic choices. The cost of such an ambitious research endeavour would be more than offset by the opportunity for enormously greater efficiencies in the rational use of cost-effective drug therapy.

Cost-Benefit Analysis↗

Old age and race as determinants of initiation of glaucoma therapy.

Demographic differences in the prevalence of blindness may be partly due to undertreatment of susceptible population subgroups. The authors examined the relation of age, race, and other demographic characteristics with initiation of treatment for glaucoma and compared treatment rates with expected rates based on known disease prevalence. Data were from Medicaid enrollees aged 65-99 years in New Jersey between March 1981 and February 1990. Based on review of all claims for prescription medications and laser and incisional surgery, there were 6,173 cases with at least 6 months of documented system eligibility before their initial treatment for glaucoma. The overall rate of new treatment was 11.5 cases per 1,000 person-years, and increased throughout the 1980s. The age-adjusted relative rate of new treatment was 1.58 times higher in blacks compared with whites; however, this was less than half the relative rate expected based on estimated relative incidence rates. Similarly, enrollees aged 70-99 years had only 7% to 27% higher treatment rates than those aged 65-69 years, substantially less than expected. Treatment for glaucoma was also less likely to be initiated in nursing home residents, compared with those living in the community. Blacks and the very old are much less likely to have treatment for glaucoma initiated than would be predicted based on the magnitude of disease burden in these populations.

Black or African American↗

A controlled trial of educational outreach to improve blood transfusion practice.

OBJECTIVE: To determine whether brief, face-to-face educational outreach visits can improve the appropriateness of blood product utilization. DESIGN: Randomized, controlled multicenter trial with 6-month follow-up. SETTING: Surgical and medical services of two pairs of matched community and teaching hospitals in Massachusetts. PARTICIPANTS: One hundred one transfusing staff surgeons and attending medical physicians. INTERVENTION: A professionally based transfusion specialist presented one surgical- or medical-service-wide lecture emphasizing appropriate indications, risks, and benefits of red blood cell transfusions; brief, graphic, printed educational guidelines; and one 30-minute visit with each transfusing physician. No data feedback was provided. Educational messages emphasized the lack of utility of the traditional threshold for red blood cell transfusions (hematocrit, 30%) and transfusion risks (eg, viral hepatitis). MEASURES: Proportion of red blood cell transfusions classified as compliant or noncompliant with blood transfusion guidelines, or indeterminate 6 months before and 6 months after an experimental educational intervention. RESULTS: Based on analyses of 1449 medical record audits of red blood cell transfusions that occurred 6 months before and 6 months after the educational intervention, the average proportion of transfusions not in compliance with criteria declined from 0.40 to 0.24 among study surgeons (-40%) compared with an increase from 0.40 to 0.44 (+9%) among control surgeons (P = .006). These effects were consistent across procedure type and specialty. On average, study surgeons in the postintervention period performed transfusions when hematocrits were 2.0 percentage points lower than before the intervention (28.3% preintervention vs 26.3% postintervention), and lower than in the control group (28.3% preintervention and postintervention; P = .04). Likely savings in blood use for surgical services probably exceeded program costs, even without considering reduced risks of infection. No effects were observed among transfusions occurring in medical services, possibly because of substantially lower transfusion rates and lower pretransfusion hematocrits. CONCLUSIONS: Brief, focused educational outreach visits by transfusion specialists can substantially improve the appropriateness and cost-effectiveness of blood product use in surgery. More data are needed regarding the durability of changes in practice patterns and the health and economic benefits of such interventions.

Blood Transfusion↗

Anticholinergic drug use and bowel function in nursing home patients.

BACKGROUND: We sought to measure the relationship between the use of anticholinergic drugs and bowel dysfunction in nursing home patients. METHODS: The study population consisted of 800 residents (average age, 84.7 years; range, 65 to 105 years) from 12 intermediate-care facilities in Massachusetts. Patient characteristics and actual medication use were documented during a 1-month observation period. Neuropsychological and functional testing was performed on all residents receiving psychoactive medications. Constipation was assessed by measuring the frequency of laxative use. RESULTS: Laxatives were used daily by 74% of residents; 45% received more than one laxative a day. After adjusting for potential confounding by logistic regression modeling, we found that daily laxative use was significantly more common in residents taking highly anticholinergic antidepressants such as amitriptyline (odds ratio, 3.12), diphenhydramine (odds ratio, 2.18), highly anticholinergic neuroleptics such as thioridazine (odds ratio, 2.01), and in the very old (odds ratio, > or = 85 years = 2.23). Gender, decreased functional status, impaired cognitive function, and the use of benzodiazepines or antiparkinsonian agents were not associated with increased use of laxatives. CONCLUSIONS: A strong association exists in institutionalized elderly between the use of specific anticholinergic medications and constipation, as reflected in the increased use of laxatives. This effect was not seen with nonanticholinergic sedatives, nor was it explained by the patients' cognitive or functional status. These drugs may be responsible for substantial iatrogenic effects on bowel function in elderly patients.

Aged↗

Antihypertensive drug therapy and the initiation of treatment for diabetes mellitus.

OBJECTIVE: To quantify the risk for the occurrence of hyperglycemia requiring initiation of therapy among patients taking various antihypertensive regimens. DESIGN: Case-control study. SETTING: New Jersey Medicaid program. PATIENTS: The study included New Jersey Medicaid enrollees 35 years of age or older. The 11,855 case patients were newly started on a hypoglycemic agent (oral agent or insulin) between 1981 and 1990. The 11,855 controls were selected randomly from among other Medicaid enrollees. MEASUREMENTS AND MAIN RESULTS: The frequency of initiation of hypoglycemic therapy was increased for users of virtually all antihypertensive agents relative to nonusers after adjustment for age, gender, race, nursing home residency, number of days hospitalized, total number of prescriptions, and selected medication exposures. The estimated relative risk for initiation of hypoglycemic therapy was 1.40 for patients receiving thiazide diuretics (95% CI, 1.26 to 1.58) and ranged from 1.56 to 1.77 for patients receiving other antihypertensive medications, depending on the medication category. A higher risk was associated with multiple-agent regimens, whether they excluded a thiazide diuretic (odds ratio, 1.76; CI, 1.49 to 2.07) or included one (odds ratio, 1.93; CI, 1.75 to 2.13). When the analysis was restricted to users of antihypertensive agents (n = 8005), the risk associated with other single-agent antihypertensive regimens was not significantly different from that associated with thiazide diuretics. However, patients receiving multiple-agent regimens continued to be at increased risk for hyperglycemia requiring hypoglycemic therapy relative to those who used thiazide diuretic therapy alone. CONCLUSION: The association between antihypertensive therapy and the initiation of treatment for diabetes mellitus is more closely related to the intensity of therapy than to the individual agent used. Our data do not support the hypothesis that thiazide diuretics are more strongly associated with the initiation of hypoglycemic therapy than are other antihypertensive agents.

Adult↗

Influence of knowledge and attitudes on the quality of physicians' transfusion practice.

Studies evaluating relationships between physician background characteristics (e.g. years of practice and medical training) and quality of care have found few consistent associations. Site of practice variables have been better predictors of quality than have characteristics of individual physicians. This study explores the relationship between physicians' knowledge and attitudes regarding the use of blood products, and the quality of their transfusion practice, based on in-depth physician interviews and medical record reviews. The sample includes 296 transfusion episodes ordered by 17 physicians in 2 teaching hospitals. The physicians had participated in a larger survey of staff surgeons and anesthesiologists in these hospitals. The quality of transfusion practice was defined as the proportion of a physicians' transfusion episodes scored as justified, as determined by explicit chart audit plus implicit physician review. Large baseline differences were observed between the 2 hospitals; 48% of transfusions in hospital A were justified compared with 81% in hospital B. At the physician level, knowledge of transfusion indications and receptivity to input from colleagues were significantly associated with higher quality transfusion practice (standardized betas = 0.41 (P = 0.01), and 0.40 (P = 0.02), respectively). These findings suggest that in addition to organizational context, physician characteristics may be associated with the quality of care related to a specific clinical practice.

Academic Medical Centers↗

Depressive symptoms in blood donors notified of HIV infection.

OBJECTIVES: Understanding more about the psychological state of persons notified of human immunodeficiency virus (HIV) infection is critical for designing notification and counseling programs that will have the most positive effect. METHODS: The subjects were blood donors who had been notified of HIV infection by the New York Blood Center. A nurse elicited a medical history, performed a limited medical examination, and asked the subjects to complete a questionnaire that included questions about drug use, sexual behavior, and psychological characteristics. The subjects completed another questionnaire approximately 2 weeks later. RESULTS: The average depressive symptom scores for both men and women were substantially higher than scores typically found in representative population samples. More than a quarter of the men and more than a third of the women reported seeking psychological or psychiatric services in the first few weeks following notification. CONCLUSIONS: Anticipating and meeting individuals' psychological needs may be necessary if HIV screening programs are to address effectively the needs of persons infected with HIV.

Adaptation, Psychological↗

Treatment for glaucoma: adherence by the elderly.

OBJECTIVES: The purpose of this study was to determine the extent of nonadherence to treatment for glaucoma among elderly patients. METHODS: This was a retrospective cohort study of 2440 patients older than age 65 who were enrolled in the New Jersey Medicaid Program and who were newly initiated on a topical agent for the treatment of glaucoma. Two patient-specific measures of nonadherence were employed: (1) no filled prescription for any glaucoma medication over a 12-month period after the initiation of therapy and (2) number of days without therapy for glaucoma during this 12-month period. RESULTS: By the first measure, 569 patients (23%) were found to be nonadherent. The mean number of days without therapy during the study year was 112. Factors associated with nonadherence included the use of glaucoma medication requiring more than 2 administrations per day and the presence of multiple other medications in the patient's drug regimen. Patients started on multiple glaucoma medication were more adherent than those started on a single agent. Age and sex were not found to be predictors of nonadherence. CONCLUSIONS: Substantial nonadherence was found to be common in this population. More attention to the issue of nonadherence could result in important benefits in the preservation of sight.

Aged↗

The exclusion of the elderly and women from clinical trials in acute myocardial infarction.

OBJECTIVE: To determine the extent to which the elderly have been excluded from trials of drug therapies used in the treatment of acute myocardial infarction, to identify factors associated with such exclusions, and to explore the relationship between the exclusion of elderly and the representation of women. DATA SOURCES: We conducted a systematic search of the English-language literature from January 1960 through September 1991 to identify all relevant studies of specific pharmacotherapies employed in the treatment of acute myocardial infarction. To accomplish this, we searched MEDLINE, major cardiology textbooks, meta-analyses, reviews, editorials, and the bibliographies of all identified articles. STUDY SELECTION: Only trials in which patients were randomly allocated to receive a specific therapeutic regimen or a placebo or nonplacebo control regimen were included for review. DATA EXTRACTION: Studies were abstracted for year of publication, source of support, performance location, drug therapies to which patients were randomized, use of invasive diagnostic tests or therapeutic procedures, exclusion criteria, size and demographic characteristics of the randomized study population, and principal outcome measures. DATA SYNTHESIS: A total of 214 trials met inclusion criteria, involving 150,920 study subjects. Over 60% of trials excluded persons over the age of 75 years. Studies published after 1980 were more likely to have age-based exclusions compared with studies published before 1980 (adjusted odds ratio, 4.92; 95% confidence interval, 2.33 to 10.54). Trials of thrombolytic therapy involving an invasive procedure were more likely to exclude elderly patients compared with other studies (adjusted odds ratio, 2.45; 95% confidence interval, 1.10 to 5.47). Studies with age-based exclusions had a smaller percentage of women compared with those without such exclusions (18% vs 23%; P = .0002), with the mean age of the study population significantly associated with the proportion of women participants (P = .0001, R2 = .29). CONCLUSIONS: Age-based exclusions are frequently used in clinical trials of medications used in the treatment of acute myocardial infarction. Such exclusions limit the ability to generalize study findings to the patient population that experiences the most morbidity and mortality from acute myocardial infarction.

Age Factors↗

A randomized trial of a program to reduce the use of psychoactive drugs in nursing homes.

BACKGROUND: Although psychoactive medications have substantial side effects in the elderly, these drugs are used frequently in nursing homes. Few interventions have succeeded in changing this situation, and little is known about the clinical effects of such interventions. METHODS: We studied six matched pairs of nursing homes; at one randomly selected nursing home in each pair, physicians, nurses, and aides participated in an educational program in geriatric psychopharmacology. At base line we determined the type and quantity of drugs received by all residents (n = 823), and a blinded observer performed standardized clinical assessments of the residents who were taking psychoactive medications. After the five-month program, drug use and patient status were reassessed. RESULTS: Scores on an index of psychoactive-drug use, measuring both the magnitude and the probable inappropriateness of medication use, declined significantly more in the nursing homes in which the program was carried out (experimental nursing homes) than in the control nursing homes (decrease, 27 percent vs. 8 percent; P = 0.02). The use of antipsychotic drugs was discontinued in more residents in the experimental nursing homes than in the control nursing homes (32 percent vs. 14 percent); the comparable figures for the discontinuation of long-acting benzodiazepines were 20 percent vs. 9 percent, and for antihistamine hypnotics, 45 percent vs. 21 percent. In the experimental nursing homes residents who were initially taking antipsychotic drugs showed less deterioration on several measures of cognitive function than similar residents in the control facilities, but they were more likely to report depression. Those who were initially taking benzodiazepines or antihistamine hypnotic agents reported less anxiety than controls but had more loss of memory. Most other measures of clinical status remained unchanged in both groups. CONCLUSIONS: An educational program targeted to physicians, nurses, and aides can reduce the use of psychoactive drugs in nursing homes without adversely affecting the overall behavior and level of functioning of the residents.

Aged↗

Aging and the anticoagulant response to warfarin therapy.

OBJECTIVE: To assess the effect of aging on the anticoagulant response to warfarin. DESIGN: Retrospective cohort study. SETTING: A university hospital outpatient anticoagulation clinic. PATIENTS: All patients (n = 530) monitored in the anticoagulation clinic over a 10-year period (1980 to 1990). The 530 study patients had a mean age of 61.5 (+/- 14.7) years (age range, 12 to 90 years). The patients were stratified into four age groups: younger than 50 years (n = 97); 50 to 59 years (n = 107); 60 to 69 years (n = 149); and 70 years or older (n = 177). MEASUREMENTS: For each patient, a dose-adjusted mean prothrombin time ratio was calculated by dividing the mean prothrombin time ratio by the mean daily warfarin dose. RESULTS: Older patients were more likely to be female (P less than 0.001), to have more medical problems (P less than 0.001), to be taking more medications (P less than 0.001), and to weigh less than younger patients (P less than 0.001). Across age groups, there were no significant differences in the use of medications that potentiated or inhibited the anticoagulant effects of warfarin. The prothrombin time ratio, when adjusted for dose, was significantly increased in older patients (P less than 0.001). The increased anticoagulant response to warfarin seen with increasing patient age persisted even after simultaneously controlling for relevant demographic and clinical variables in a multivariate model. Other factors significantly associated with an increased sensitivity to warfarin included use of a medication with a potentiating interactive effect with warfarin, female gender, and overall medication use. Increased body weight and duration of warfarin use exceeding 6 months were found to be inversely related to anticoagulant response. CONCLUSION: The anticoagulant response to warfarin is exaggerated with advancing age. This finding emphasizes the need for close monitoring of older patients treated with warfarin therapy.

Adolescent↗

Computer-assisted drug data collection.

Computerized systems for recording information about medication prescribing and use are important for studies in health services and pharmacoepidemiology. Such systems, if properly designed, can facilitate analysis as well as data collection. Although drug information systems exist for pharmacy service delivery applications, there are currently no descriptions of systems developed primarily for research applications in this area. This paper describes a computerized data collection system, developed for researchers, usable on portable equipment, and containing error checking features; the system has been extensively tested in over 850 study subjects taking part in a study of medication use in nursing homes that examines the impact of educational interventions for doctors and nurses on prescribing practices.

Clinical Pharmacy Information Systems↗

Improving the quality and cost-effectiveness of prescribing.

The 1980s witnessed the evolution of a number of programmes designed to improve the quality and economy of medication use. In the approach known as 'academic detailing', the effective communications techniques of the pharmaceutical industry are employed in the service of programmes designed to promote rational medication use, rather than to maximise sales of a particular product. Using this method, a balanced, concise presentation of the best available current research and cost literature is put into an engaging, readable format, and presented to the physician in a one-on-one interactive educational session by a pharmacist. In randomised controlled trials in 5 states, this approach has been shown to be effective in reducing inappropriate prescribing; benefit-cost analyses have shown that it generates savings that exceed programme costs. On the other hand, the 1980s also saw the implementation of several alternative approaches to changing prescribing practice, often through crude bureaucratic measures uninformed by the realities of clinical practice. Many such policies have proven to be either ineffective or counterproductive clinically and/or economically. As the issue of drug utilisation review receives increasing attention in the 1990s, it will be important to assimilate the lessons of the last 10 years to design programmes in both the public and private sectors that will enhance the quality of drug therapy while containing its costs.

Cost-Benefit Analysis↗

Cardiovascular responses to phlebotomy and sitting in middle-aged and elderly subjects.

BACKGROUND: Responding appropriately to hypotensive challenges is an important determinant of health and functional independence in elderly individuals. Cardiovascular responses to phlebotomy and postural change were evaluated using a large database developed in a study designed to establish the safety of blood donation by older individuals. METHODS: The groups studied included 464 subjects aged 65 years and younger (range, 52 to 65 years) and 532 subjects more than 65 years old (range, 66 to 78 years old). Blood pressure and pulse rate measurements were followed by the withdrawal of 500 mL of blood. These measurements were repeated, first in the supine and then in the sitting position. RESULTS: Nearly all individuals studied remained hemodynamically stable after these two challenges. Age was not an independent predictor of blood pressure change after either phlebotomy or postural change. Large decreases in diastolic blood pressure were equally rare in both age groups. However, more older subjects (15.2%) exhibited a decline of 20 mm Hg or more in systolic blood pressure following phlebotomy, compared with the middle-aged group (6.9%). These age-related differences did not persist after controlling for the higher initial systolic blood pressures observed in the older subjects. Postphlebotomy postural change to the sitting position had little additional effect. CONCLUSIONS: These results indicate that the ability to respond to hypovolemia and postural change remains relatively intact in healthy elderly individuals. The higher prevalence of a significant drop in systolic blood pressure after phlebotomy, orthostasis, and possibly other homeostatic challenges in older subjects is probably due to the presence of higher basal blood pressure readings, including hypertension. In spite of these differences, blood donation is appropriate and should be encouraged in healthy elderly individuals in this age group.

Aged↗

Effects of Medicaid drug-payment limits on admission to hospitals and nursing homes.

BACKGROUND: Many state Medicaid programs limit the number of reimbursable medications that a patient can receive. We hypothesized that such limitations may lead to exacerbations of illness or to admissions to institutions where there are no caps on drug reimbursements. METHODS: We analyzed 36 months of Medicaid claims data from New Hampshire, which had a three-drug limit per patient for 11 of those months, and from New Jersey, which did not. The study patients in New Hampshire (n = 411) and a matched comparison cohort in New Jersey (n = 1375) were Medicaid recipients 60 years of age or older who in a base-line year had been taking three or more medications per month, including at least one maintenance drug for certain chronic diseases. Survival (defined as remaining in the community) and time-series analyses were conducted to determine the effect of the reimbursement cap on admissions to hospitals and nursing homes. RESULTS: The base-line demographic characteristics of the cohorts were nearly identical. In New Hampshire, the 35 percent decline in the use of study drugs after the cap was applied was associated with an increase in rates of admission to nursing homes; no changes were observed in the comparison cohort (RR = 1.8; 95 percent confidence interval, 1.2 to 2.6). There was no significantly increased risk of hospitalization. Among the patients in New Hampshire who regularly took three or more study medications at base line, the relative risk of admission to a nursing home during the period of the cap was 2.2 (95 percent confidence interval, 1.2 to 4.1), and the risk of hospitalization was 1.2 (95 percent confidence interval, 0.8 to 1.6). When the cap was discontinued after 11 months, the use of medications returned nearly to base-line levels, and the excess risk of admission to a nursing home ceased. In general, the patients who were admitted to nursing homes did not return to the community. CONCLUSIONS: Limiting reimbursement for effective drugs puts frail, low-income, elderly patients at increased risk of institutionalization in nursing homes and may increase Medicaid costs.

Aged↗