Biomedical subjects

Jerry Avorn

Publications and source records attributed to Jerry Avorn.

At least 73 records · Page 4Linked to original sources

PubMed2004

Racial differences in screening for prostate cancer in the elderly.

BACKGROUND: Black men are more likely than white men to be diagnosed as having advanced prostate cancer, and their prostate cancer mortality rates are more than twice as high. Low screening rates among black men may contribute to these disparities, but there are few data on racial differences in prostate cancer screening. OBJECTIVES: To present a case-control study of racial differences in the use of prostate-specific antigen (PSA) as a screening test among Medicare beneficiaries in New Jersey and to assess the degree to which race is associated with prostate cancer screening. METHODS: The study used a statewide database of claims data from Medicare Parts A and B, Medicaid, and the state's Pharmaceutical Assistance for the Aged and Disabled program. Prevalent cases of prostate cancer were excluded using the state's cancer registry. Of 139 672 men who underwent PSA screening, 34 984 were randomly selected along with an identical number of controls matched by month and year of birth. After men with International Classification of Diseases, Ninth Revision, Clinical Modification,or Current Procedural Terminology codes indicative of prostate cancer were excluded, 33 463 case patients and 33 782 control subjects remained. RESULTS: The use of PSA screening was strongly and inversely associated with black race (odds ratio [OR] = 0.50; P<.001), poverty (OR = 0.33; P<.001), and near poverty (OR = 0.69; P<.001). Multivariate logistic regression analysis after age, socioeconomic status, comorbidity, and use of health care services were controlled for revealed that black race remained a strong predictor of not undergoing PSA screening (OR = 0.65; 95% confidence interval, 0.60-0.70). CONCLUSIONS: Elderly blacks are substantially less likely to undergo PSA screening than elderly whites. Differences in socioeconomic status and comorbid conditions explain only a small part of the racial differences in screening rates.

Black or African American↗

PubMed2004

Therapeutic delay and reduced functional status six months after thrombolysis for acute myocardial infarction.

Thrombolytic therapy decreases the mortality rate in patients with acute myocardial infarction (AMI), and the timing of thrombolysis has proved to be critical for decreasing the short-term mortality rate. Much less is known about the longer term consequences of delays in thrombolysis, particularly for outcomes other than the mortality rate. We assessed the effect of time to thrombolysis and other clinical predictors on cardiac functional status 6 months after AMI. We used InTIME II, a multicenter trial, to test the efficacy of alteplase and lanoteplase. This component of the trial was conducted in 147 North American centers. Patients were > or =18 years of age with ST-elevated AMI. Functional status was measured by the Duke Activity Status Index, which was administered 6 months after AMI. After multivariate adjustment for baseline characteristics, delay in presentation to hospital and delay in initiation of thrombolysis were significantly and independently associated with decreased cardiac functional status 6 months later. Each additional hour from symptom onset to hospital presentation was associated with a 16% increase (95% confidence interval 3% to 31%) in the likelihood of functional impairment (Duke Activity Status Index score < or =30). In addition, each additional delay of 1 hour from hospital presentation to thrombolysis independently increased the probability of functional impairment by 38% (12% to 71%). Thus, in patients with AMI, earlier presentation to the hospital and more rapid initiation of thrombolysis could prevent significant decreases in functional status months after the initial infarct.

Activities of Daily Living↗

PubMed2004

Relationship between COX-2 specific inhibitors and hypertension.

There is controversy whether cyclooxygenase-2 (COX-2) specific inhibitors are associated with elevations in blood pressure requiring treatment in typical clinical practice. We examined the risk of new onset hypertension in a retrospective case-control study involving 17 844 subjects aged > or =65 years from 2 US states. Multivariable logistic models were examined to assess the relative risk of new onset hypertension requiring treatment in patients who used celecoxib or rofecoxib compared with patients taking either the other COX-2 specific inhibitor, a nonspecific NSAID, or no NSAID. During the 1999 to 2000 study period, 3915 patients were diagnosed and began treatment for hypertension; 4 controls were selected for every case. In no model was celecoxib significantly associated with the development of hypertension. Rofecoxib users were at a significantly increased relative risk of new onset hypertension compared with patients taking celecoxib (odds ratio [OR] 1.6; 95% confidence interval [CI], 1.2 to 2.1), taking a nonspecific NSAID (OR 1.4; 95% CI, 1.1 to 1.9), or taking no NSAID (OR 1.6; 95% CI, 1.3 to 2.0). There were no clear dosage or duration effects. In patients with a history of chronic renal disease, liver disease, or congestive heart failure, the relative risk of new onset hypertension was twice as high in those taking rofecoxib compared with celecoxib (OR 2.1; 95% CI, 1.0 to 4.3). In this retrospective case-control study of patients aged > or =65 years, rofecoxib use was associated with an increased relative risk of new onset hypertension; this was not seen in patients taking celecoxib.

Aged↗

PubMed2004

The quality of pharmacologic care for vulnerable older patients.

BACKGROUND: Although pharmacotherapy is critical to the medical care of older patients, medications can have considerable toxicity in this age group. To date, research has focused on inappropriate prescribing and policy efforts have aimed at access, but no comprehensive measurement of the quality of pharmacologic management using explicit criteria has been performed. OBJECTIVE: To evaluate the broad range of pharmacologic care processes for vulnerable older patients. DESIGN: Observational cohort study. SETTING: 2 managed care organizations enrolling older persons. PATIENTS: Community-dwelling high-risk patients 65 years of age or older continuously enrolled in the managed care organizations from 1 July 1998 to 31 July 1999. MEASUREMENTS: Patients' receipt of care as specified in 43 quality indicators covering 4 domains of pharmacologic care: 1) prescribing indicated medications; 2) avoiding inappropriate medications; 3) education, continuity, and documentation; and 4) medication monitoring. RESULTS: Of 475 vulnerable older patients, 372 (78%) consented to participate and had medical records that could be abstracted. The percentage of appropriate pharmacologic management ranged from 10% for documentation of risks of nonsteroidal anti-inflammatory drugs to 100% for avoiding short-acting calcium-channel blockers in patients with heart failure and avoiding beta-blockers in patients with asthma. Pass rates for quality indicators in the "avoiding inappropriate medications" domain (97% [95% CI, 96% to 98%]) were significantly higher than pass rates for "prescribing indicated medications" (50% [CI, 45% to 55%]); "education, continuity, and documentation" (81% [CI, 79% to 84%]); and "medication monitoring" (64% [CI, 60% to 68%]). LIMITATIONS: Fewer than 10 patients were eligible for many of the quality indicators measured, and the generalizability of these findings in 2 managed care organizations to the general geriatric population is uncertain. CONCLUSIONS: Failures to prescribe indicated medications, monitor medications appropriately, document necessary information, educate patients, and maintain continuity are more common prescribing problems than use of inappropriate drugs in older patients.

Aged↗

PubMed2004

Economic implications of evidence-based prescribing for hypertension: can better care cost less?

CONTEXT: Deviation from evidence-based guidelines in hypertension treatment is common, but its economic impact has not been rigorously studied. Suboptimal prescribing patterns contribute to the high cost of medications for elderly patients as well as the difficulty in providing affordable prescription drug benefits for older Americans. OBJECTIVE: To calculate the potential savings from the perspective of health care payers that would result from increased adherence to evidence-based recommendations for managing hypertension in patients older than 65 years. DESIGN: Comparative analysis of medications prescribed vs potential regimens suggested by evidence-based guidelines tailored to each patient's medical history, with calculation of the costs of both the actual and the evidence-based regimens. SETTING AND PATIENTS: A total of 133,624 patients being treated for hypertension during 2001 who were enrolled in a large state pharmaceutical assistance program that provides prescription drug insurance for elderly persons. MAIN OUTCOME MEASURE: Cost difference between medications actually prescribed and regimens suggested by evidence-based guidelines. RESULTS: The patients studied filled more than 2.05 million prescriptions for antihypertensive medications in 2001, at an annual program cost of 48.5 million dollars (363 dollars per patient). We identified 815,316 prescriptions (40%) for which an alternative regimen appeared more appropriate according to evidence-based recommendations. Such changes would have reduced the costs to payers in 2001 by 11.6 million dollars (nearly a quarter of program spending on antihypertensive medications), as well as being more clinically appropriate overall. Replacement of calcium channel blockers resulted in the largest potential savings. Use of pricing limits similar to those in the Medicaid program would have resulted in even larger potential savings of 20.5 million dollars (42% of program costs). CONCLUSIONS: Adherence to evidence-based prescribing guidelines for hypertension could result in substantial savings in prescription costs for elderly patients with hypertension that would amount to savings of about 1.2 billion dollars nationally. Identification of similar areas in which prescribing can be improved will be critical for the affordability of prescription drug benefit programs.

Aged↗

PubMed2004

Relationship between selective cyclooxygenase-2 inhibitors and acute myocardial infarction in older adults.

BACKGROUND: Although cyclooxygenase-2 inhibitors (coxibs) were developed to cause less gastrointestinal hemorrhage than nonselective nonsteroidal antiinflammatory drugs (NSAIDs), there has been concern about their cardiovascular safety. We studied the relative risk of acute myocardial infarction (AMI) among users of celecoxib, rofecoxib, and NSAIDs in Medicare beneficiaries with a comprehensive drug benefit. METHODS AND RESULTS: We conducted a matched case-control study of 54 475 patients 65 years of age or older who received their medications through 2 state-sponsored pharmaceutical benefits programs in the United States. All healthcare use encounters were examined to identify hospitalizations for AMI. Each of the 10 895 cases of AMI was matched to 4 controls on the basis of age, gender, and the month of index date. We constructed matched logistic regression models including indicators for patient demographics, healthcare use, medication use, and cardiovascular risk factors to assess the relative risk of AMI in patients who used rofecoxib compared with persons taking no NSAID, taking celecoxib, or taking NSAIDs. Current use of rofecoxib was associated with an elevated relative risk of AMI compared with celecoxib (odds ratio [OR], 1.24; 95% CI, 1.05 to 1.46; P=0.011) and with no NSAID (OR, 1.14; 95% CI, 1.00 to 1.31; P=0.054). The adjusted relative risk of AMI was also elevated in dose-specific comparisons: rofecoxib < or =25 mg versus celecoxib < or =200 mg (OR, 1.21; 95% CI, 1.01 to 1.44; P=0.036) and rofecoxib >25 mg versus celecoxib >200 mg (OR, 1.70; 95% CI, 1.07 to 2.71; P=0.026). The adjusted relative risks of AMI associated with rofecoxib use of 1 to 30 days (OR, 1.40; 95% CI, 1.12 to 1.75; P=0.005) and 31 to 90 days (OR, 1.38; 95% CI, 1.11 to 1.72; P=0.003) were higher than >90 days (OR, 0.96; 95% CI, 0.72 to 1.25; P=0.8) compared with celecoxib use of similar duration. Celecoxib was not associated with an increased relative risk of AMI in these comparisons. CONCLUSIONS: In this study, current rofecoxib use was associated with an elevated relative risk of AMI compared with celecoxib use and no NSAID use. Dosages of rofecoxib >25 mg were associated with a higher risk than dosages < or =25 mg. The risk was elevated in the first 90 days of use but not thereafter.

Aged↗

PubMed2004

Which patients with knee problems are likely to benefit from nonarthroplasty surgery? Development of a clinical prediction rule.

BACKGROUND: We examined factors associated with the clinical presentation of patients judged likely by orthopedic surgeons to benefit from nonarthroplasty knee surgery. METHODS: Consecutive patients presenting to orthopedic surgeons were eligible for the study and 103 were recruited. A trained research assistant took histories, performed physical examinations, and administered a standardized questionnaire. Surgeons provided diagnoses and, in each case, rated their confidence that nonarthroplasty knee surgery would help the patient. We assessed the relationship between patient characteristics and the orthopedic surgeon's level of confidence that the patient was likely to benefit from knee surgery. RESULTS: In multivariable logistic regression models, the following characteristics were associated with a surgeon's judgment that a patient would likely benefit from knee surgery: a history of sports-related trauma, low functional status, limited knee flexion or extension, medial or lateral knee joint line tenderness, a click or pain noted with the McMurray test, and a positive Lachmann or anterior drawer test (c statistic from model, 0.83). These items were combined into a clinical prediction score, and low-, medium-, and high-risk categories were identified. Independent evaluation by surgeons indicated that only 8% of patients in the low-risk category but 84% of patients in the high-risk category were judged likely to benefit from surgery (P for trend <.001). CONCLUSION: Using a small group of easily accessible patient characteristics, we developed a clinical prediction score that clearly differentiated patients who were viewed by experienced orthopedic knee surgeons as likely or not likely to benefit from nonarthroplasty knee surgery.

Adult↗

PubMed2004

Clinical and economic consequences of a reimbursement restriction of nebulised respiratory therapy in adults: direct comparison of randomised and observational evaluations.

OBJECTIVE: To compare the results of a randomised and an observational evaluation of the same policy that restricted reimbursement for nebulised respiratory medications in adult patients in a community setting. DESIGNS: Cluster randomised controlled trial and observational time series with historical controls. SETTING: Pharmacare, the government funded drug benefits plan for elderly people and patients receiving social assistance in British Columbia, Canada. PARTICIPANTS: In the randomised controlled trial 104 clusters of medical practices, pair matched by geography and approximately by practice size, were randomised to the intervention group (449 patients affected by the policy on 1 March 1999), and the control group (offered a six month exemption, affecting 386 patients). The observational analysis included all Pharmacare beneficiaries (excluding the 386 exempt patients) who had used any nebulised drugs six months before the policy (4624 patients). INTERVENTION: Pharmacare restricted reimbursement for nebulised bronchodilators, steroids, and cromoglycate to patients whose doctors applied for an individual patient's exemption, giving an appropriate clinical reason. MAIN OUTCOME MEASURES: Number of contacts with doctors and services, emergency admissions to hospital, and utilisation of and expenditure for respiratory drugs in databases of British Columbia's Ministry of Health. RESULTS: Contacts with doctors or emergency admissions to hospital did not increase in association with the restriction, regardless of the analytical approach. In the observational analysis, we found a reduction of C24 dollars per patient month in all nebulised drug use (95% confidence interval 19 to 29) and an increase of C3 dollars per patient month in all expenditure for inhalers (1.4 to 4.5). The randomised evaluation found savings of C8 dollars per patient month for nebulisers (P = 0.24) and no increase in spending on inhalers (P = 0.79). Correcting for 60% non-compliance by exempt doctors in a sensitivity analysis yielded similar results as the observational evaluation. CONCLUSIONS: Observational as well as randomised analyses found moderate net savings and no increase in unintended healthcare outcomes after restricting reimbursement for nebulised respiratory drugs. Randomised policy trials are feasible and, if carefully implemented, likely to be concordant with observational evaluations.

Administration, Inhalation↗

PubMed2004

How well do patients report noncompliance with antihypertensive medications?: a comparison of self-report versus filled prescriptions.

PURPOSE: To address poor patient compliance with antihypertensives, clinicians and researchers need accurate measures of adherence with prescribed regimens. Although self-reports are often the only means available in routine practice, their accuracy and agreement with other data sources remain questionable. METHODS: A telephone survey was conducted on 200 hypertensive patients treated with a single antihypertensive agent in a large health maintenance organization (HMO) or a Veterans Affairs medical center (VAMC) to obtain self-reports of the frequency of missing antihypertensive therapy. We then analyzed records of all filled prescriptions to calculate the number of days that patients actually had antihypertensive medications available for use. Agreement between the two data sources was measured with correlation coefficients and kappa statistics. Logistic regression models were used to identify demographic, clinical and psychosocial correlates of overstating compliance. RESULTS: There was very poor agreement between self-reported compliance and days actually covered by filled prescriptions (Spearman correlation coefficient = 0.15; 95%CI: 0.01, 0.28). Very poor agreement was also observed between a categorical measure of self-reported compliance (ever vs. never missing a dose) and categories of actual compliance defined by filled prescriptions (< 80% vs > 80% of days covered; kappa = 0.12, 95%CI: -0.02, 0.26). Surprisingly, few factors were associated with inaccurate self-reporting in either crude or adjusted analyses; fewer visits to health care providers was significantly associated with overstating compliance. CONCLUSIONS: Compliance was markedly overstated in this sample of patients and few characteristics identified those who reported more versus less accurately. Clinicians and researchers who rely on self-reports should be aware of these limits and should take steps to enhance their accuracy.

Aged↗

PubMed2004

Potential savings from increased use of generic drugs in the elderly: what the experience of Medicaid and other insurance programs means for a Medicare drug benefit.

BACKGROUND: Generic medications provide the same clinical effect at lower cost than brand name drugs but little is known about the extent to which such savings are achieved in drug benefit programs serving the elderly. METHODS: Using patient-level claims data for participants aged 65 or more in one state Medicaid program and in a non-Medicaid drug insurance program for the elderly, we compared the expenditures in each program for brand name prescriptions with the amount that would have been paid for generic versions of the same agents. We then estimated potential savings from increased use of substitutable brand name drugs. RESULTS: There was an unrealized annual savings of 3.4 million dollars (3.6% of total drug expenditure) in the Medicaid program studied and 13.7 million dollars (9.5% of total drug expenditure) in the non-Medicaid drug insurance program for the elderly, with corresponding reductions in mean annual per-patient drug costs. CONCLUSIONS: More widespread use of generic medications represents an important source of unrealized savings in drug coverage programs for the elderly. The Medicaid program limits the excess spending on brand name drugs by imposing pricing restrictions, but many non-Medicaid programs could realize even larger savings from reducing the use of brand name drugs when identical generic products are available. These findings offer some insight into the potential expense of a Medicare prescription drug benefit.

Aged↗

PubMed2004

Accuracy of Medicare claims-based diagnosis of acute myocardial infarction: estimating positive predictive value on the basis of review of hospital records.

BACKGROUND: Many cardiovascular epidemiologic studies rely on diagnosis codes in health care claims databases. Despite important changes in the care and diagnosis of acute myocardial infarction (AMI), the validity of hospital discharge diagnosis codes for AMI in the US Medicare system has not been recently examined. Our objective was to examine the accuracy of International Classification of Diseases--ninth revision--Clinical Modifications (ICD-9-CM) discharge diagnosis codes and diagnosis-related groups (DRG) codes for AMI in a Medicare claims database. METHODS: We sampled hospitalization episodes from Medicare beneficiaries in Pennsylvania during 1999, 2000, or both. We used Medicare data to identify patients with hospitalizations containing indicators of AMI (ICD-9-CM diagnosis codes 410.X0 and 410.X1 or DRG codes 121, 122, and 123). Hospital records for these episodes were reviewed by trained abstractors using World Health Organization criteria for diagnosing AMI. We then calculated the positive predictive value of Medicare claims-based definitions of AMI. RESULTS: Of 2200 hospitalization episodes with Medicare diagnosis codes suggestive of AMI, 2022 hospital records (91.9%) were obtained. The positive predictive value for a primary Medicare claims-based definition was 94.1% (95% CI, 93.0%-95.2%). Positive predictive values for alternative claims-based definitions ranged slightly, with the definition including DRG codes and length-of-stay restrictions yielding the highest positive predictive value, 95.4% (95% CI, 94.3%-96.4%). Subjects with a history of myocardial infarction had a significantly lower positive predictive value than subjects without a history of myocardial infarction (88.1% vs 94.6%, P <.001). CONCLUSIONS: In this study, we observed high positive predictive values for a Medicare claims-based diagnosis of AMI and a diagnosis based on structured hospital record review.

Aged↗

PubMed2004

Use of the case-crossover design to study prolonged drug exposures and insidious outcomes.

PURPOSE: The case-crossover design was originally intended to study brief exposures with immediate and transient effects, and acute outcomes with abrupt onsets. We investigated whether case-crossover methods can be used to study prolonged exposures and insidious outcomes. METHODS: We conducted a case-crossover study of 8220 patients aged > or = 65 years enrolled in several health benefits programs in New Jersey during the period between 1991 and 1995. All had episodes of central nervous system (CNS) adverse events (e.g., delirium). Drug exposures were assessed during case time periods and control time periods lasting 1, 2, 3, or 4 months. Exposures included 3 active regimens with established deleterious CNS effects (corticosteroids, digoxin, and opiates) and 2 inactive regimens without such effects (multivitamins and statins). RESULTS: In conditional logistic regression models, significantly elevated risks were observed for all three active drugs, regardless of which time windows were used. The magnitude of these risks generally increased with longer time windows. No significantly increased risks were observed for the 2 inactive drugs, regardless of the window duration. CONCLUSIONS: These results suggest that with lengthened exposure assessment windows, case-crossover methods may be useful for studying exposures with prolonged effects and outcomes with insidious onsets.

Adrenal Cortex Hormones↗

PubMed2004

Pre-randomization decisions and group stratification in a randomized controlled trial to improve prescribing.

OBJECTIVE: To select and evaluate characteristics of primary care practice groups relevant for stratification prior to randomization. METHOD: Structured telephone interviews and pre- and post-intervention prescription data. SETTING: Additional study in an RCT to rationalize prescribing in primary care, addressing groups of pharmacists and doctors. Representatives of 61 primary care practice groups in the Netherlands. MAIN OUTCOME MEASURES: Identification and evaluation of primary care practice group characteristics related to changes in prescribing. These characteristics were evaluated by estimation of incidence rate ratios (Poisson regression). RESULTS: Of practice groups 40 representatives (66%) participated in our study. Three characteristics were found to be most relevant for stratification: the purpose of the practice groups (whether they participated in information exchange (n = 14) or binding consensus on pharmacotherapy (n = 26)), the use of a formulary (22 practice groups did and 18 groups did not) and the use of feedback data (22 groups did and 18 groups did not). These characteristics strongly modified the effect of the program on prescribing behaviour. While the overall effect of the program was to significantly reduce the prescribing of the targeted drugs, this change was not consistent in all strata. CONCLUSION: Assessment of the characteristics of practice groups made it possible to define factors to be used for a stratified randomization of practice groups which in retrospect indeed modified the effect of an educational intervention directed to change prescribing. Such pre-randomization assessments can be a useful tool in interventions designed to improve practice patterns in groups of physicians.

Communication↗

PubMed2004

Consistency of performance ranking of comorbidity adjustment scores in Canadian and U.S. utilization data.

OBJECTIVE: The performance of standard comorbidity scores to control confounding is poorly defined in health care utilization data across elderly populations. We sought to evaluate and rank the performance of comorbidity scores across selected U.S. and Canadian elderly populations using health care utilization databases. DESIGN: Cross-population validation study. PARTICIPANTS: Study participants were residents age 65 years or older who had prescription drug coverage through state-funded programs selected from several large health care utilization databases available to the investigators: British Columbia, BC (N = 141,161), New Jersey, NJ (N = 235,881), and Pennsylvania, PA (N = 230,913). MEASUREMENTS: We calculated 6 commonly used comorbidity scores for all subjects during the baseline year (1994 for NJ and PA, and 1995 for BC). These included scores based on diagnoses (Romano, Deyo, D'Hoore, Ghali) and prescription drugs (CDS-1, CDS-2). The study outcome was 1-year mortality. The performance of scores was measured by c-statistics derived from multivariate logistic regression that included age and gender. MAIN RESULTS: Across these 4 large elderly populations, we found the same rank order of performance in predicting 1-year mortality after including age and gender in each model: Romano (c-statistic 0.754 to 0.771), Deyo (c-statistic 0.753 to 0.768), D'Hoore (c-statistic 0.745 to 0.760), Ghali (c-statistic 0.733 to 0.745), CDS-1 (c-statistic 0.689 to 0.738), CDS-2 (c-statistic 0.677 to 0.718), and age and gender alone (c-statistic 0.664 to 0.681). Performance was improved by an average of 6% by adding the number of different prescription drugs received during the past year. CONCLUSIONS: Performance ranking of 6 frequently used comorbidity scores was consistent across selected elderly populations. We recommend that investigators use these performance data as one important factor when selecting a comorbidity score for epidemiologic analyses of health care utilization data.

Aged↗

PubMed2004

Patterns of bone mineral density testing: current guidelines, testing rates, and interventions.

OBJECTIVES: To identify potential obstacles to bone mineral density (BMD) testing, we performed a structured review of current osteoporosis screening guidelines, studies of BMD testing patterns, and interventions to increase BMD testing. DESIGN: We searched medline and HealthSTAR from 1992 through 2002 using appropriate search terms. Two authors examined all retrieved articles, and relevant studies were reviewed with a structured data abstraction form. MEASUREMENTS AND MAIN RESULTS: A total of 235 articles were identified, and 51 met criteria for review: 24 practice guidelines, 22 studies of screening patterns, and 5 interventions designed to increase BMD rates. Of the practice guidelines, almost one half (47%) lacked a formal description of how they were developed, and recommendations for populations to screen varied widely. Screening frequencies among at-risk patients were low, ranging from 1% to 47%. Only eight studies assessed factors associated with BMD testing. Female patient gender, glucocorticoid dose, and rheumatologist care were positively associated with BMD testing; female physicians, rheumatologists, and physicians caring for more postmenopausal patients were more likely to test patients. Five articles described interventions to increase BMD testing rates, but only two tested for statistical significance and no firm conclusions can be drawn. CONCLUSIONS: This systematic review identified several possible contributors to suboptimal BMD testing rates. Osteoporosis screening guidelines lack uniformity in their development and content. While some patient and physician characteristics were found to be associated with BMD testing, few articles carefully assessed correlates of testing. Almost no interventions to improve BMD testing to screen for osteoporosis have been rigorously evaluated.

Bone Density↗

PubMed2004

An algorithmic computerised order entry approach to assist in the prescribing of new therapeutic agents: case study of activated protein C at an academic medical centre.

BACKGROUND: Academic medical centres face the need to care for patients with complex medical conditions, educate physicians-in-training and conduct research, all with increasingly constrained budgets. The adoption of new therapeutic technology presents challenges and opportunities in each of these areas. Severe sepsis remains a major cause of morbidity and mortality, especially in tertiary-care facilities. Recombinant human activated protein C reduces mortality in patients with severe sepsis, but trial data indicate that the benefit of the drug is confined to the more seriously ill patients, while the risk of bleeding complications can be considerable. The cost of the drug is approximately USD 6000-8000 per treated patient. Integration of this product into routine care has produced unique challenges concerning clinical decision making, safety and cost. OBJECTIVES: To describe one hospital's multidisciplinary approach to the adoption of this new medication. METHODS: Before activated protein C was approved for use, Brigham and Women's Hospital (BWH) convened a working group to formulate clinical guidelines proactively. This new agent did not fit into an obvious therapeutic category but cut across multiple clinical disciplines requiring the involvement of several hospital departments in developing policy. As new data on efficacy emerged during the US FDA review of the drug, the working group had to devise a method for using the available information to assist clinical decision making while placing appropriate restrictions on the use of activated protein C. The goal was to make accurate information available to guide ordering physicians' decision making interactively, 24 hours a day. RESULTS: The committee developed a utilisation policy for activated protein C that provided guidance on patient selection, contraindications and risk stratification. Interactive computer-based order entry screens were developed to guide physicians through a complex set of clinical criteria to ensure appropriate evidence-based use. A careful review of contraindications is required as a second step. To risk stratify patients in accordance with the trial subset analyses and the FDA labelling guidelines, ordering physicians are guided in calculating an APACHE II (Acute Physiology and Chronic Health Evaluation) score for the patient. Physicians from several specialties are available for advice and consultation on patients with difficult or controversial conditions. Approximately two-thirds of completed orders passed the clinical algorithm; an additional 35% of patients did not meet the medication criteria but received the drug after the attending physician requested an override of the guidelines. CONCLUSION: The BWH approach to activated protein C used an innovative multidisciplinary approach and computer-assisted order entry to guide clinical use of a new agent with substantial clinical efficacy, risks and costs. This approach provides a model for strategies to deal with other new and complex medical technologies.

Academic Medical Centers↗

PubMed2004

The role of pharmacoepidemiology and pharmacoeconomics in promoting access and stimulating innovation.

Answering the demanding questions asked of pharmacotherapy in the 21st century will require more reliance on the disciplines of pharmacoepidemiology and pharmacoeconomics. Pharmacoepidemiology can help assess patterns and appropriateness of drug utilisation, provide explanations for poor compliance, quantify the frequency and severity of side effects, and aid in the design and evaluation of interventions to improve drug use and outcomes. Pharmacoeconomics can help determine whether a new costlier product offers sufficient clinical advantage over its predecessors to justify the increased cost. Taken together, pharmacoepidemiology and pharmacoeconomics represent the next logical step in the evolution of medication assessment; their judicious deployment can help ensure both access to new medicines and innovation.

Cooperative Behavior↗

PubMed2004

Should clozapine continue to be restricted to third-line status for schizophrenia?: a decision-analytic model.

BACKGROUND: Clozapine is currently restricted to patients who have failed at least two trials of other antipsychotic medications because of concerns that its use as a first-line agent would lead to greater mortality, mainly through agranulocytosis. AIMS OF THE STUDY: We sought to determine the cost-effectiveness of allowing clozapine to be a first-line treatment versus the current policy of restricting clozapine to third-line status. METHODS: We performed a cost-effectiveness analysis using published data from randomized controlled trials and epidemiologic studies. The target population was patients with schizophrenia in an acute psychotic episode, with a lifetime time horizon and societal perspective. Outcome measures included life expectancy, quality-adjusted life expectancy, costs, and cost-effectiveness ratios. RESULTS: Using clozapine as a first agent would lead to modest gains in life-expectancy as well as quality-adjusted life expectancy, relative to restricting its use to patients who failed 2 conventional antipsychotics. The cost-effectiveness ratio of using clozapine first vs. using clozapine third would be $24,100 per quality-adjusted life year (QALY). In 1-way and probabilistic sensitivity analyses, these findings were robust to a variety of assumptions. DISCUSSION: Allowing clozapine to be a first-line agent may lead to small gains in life expectancy at moderate but acceptable costs. IMPLICATIONS: While these results do not shed light on whether clozapine should be the preferred first-line strategy, they do suggest that clozapine should be added to the armamentarium of possible treatments for treatment-sensitive as well as treatment-resistant schizophrenia.

Adult↗