Use of breast-conserving surgery for treatment of stage I and stage II breast cancer.

PURPOSE: To assess the use of breast-conserving surgery in two states reported to differ with respect to surgical treatment of breast cancer. METHODS: A retrospective cohort study based on data collected from medical records and patients was performed among 1,514 patients diagnosed with early-stage breast cancer in Massachusetts and 1,061 patients in Minnesota. Patients were identified at 18 randomly selected hospitals in Massachusetts and at 30 hospitals in Minnesota. The rate of breast-conserving surgery in both states and the correlates of breast-conserving surgery among women eligible for the procedure were determined. RESULTS: The rate of breast-conserving surgery in both states was much higher than previously reported. Among those eligible for the procedure, nearly 75% underwent breast-conserving surgery in Massachusetts and nearly half did so in Minnesota. Significantly (P < .003) more women who underwent mastectomy in Minnesota (27%) than in Massachusetts (15%) reported that their surgeon did not discuss breast-conserving surgery with them. Among women who underwent mastectomy and who reported being informed of both surgical alternatives, more women (P < .001) in Minnesota (74%) than in Massachusetts (62%) said they ultimately chose mastectomy because their surgeon recommended it. In Massachusetts, women treated at teaching hospitals were twice as likely as other women to undergo breast-conserving surgery. In Minnesota, women over age 70 and those who lived in rural areas were less likely than other women to undergo breast-conserving surgery. CONCLUSION: Although the rate of breast-conserving surgery in each state was higher than expected based on earlier reports, the rates differed considerably between states. Additional studies are needed to determine whether variation in practice between geographic areas is due to differences in patients' preferences and values or to surgeons' propensity for one type of surgery based on where they practice.

Age-related patterns of care: evidence against ageism in the treatment of early-stage breast cancer.

PURPOSE: To assess whether the use of adjuvant systemic therapy in postmenopausal women with early-stage breast cancer is influenced by patient age. METHODS: A retrospective cohort study based on data collected from medical records and from patients and their surgeons was performed among 746 postmenopausal patients diagnosed with early-stage breast cancer at 30 hospitals located throughout Minnesota. The adjusted odds of receiving hormonal therapy, chemotherapy, and both hormonal therapy and chemotherapy as a function of age was determined. RESULTS: Among women with negative lymph nodes, 62% received some form of adjuvant drug therapy. For these women, the likelihood of receiving hormonal therapy or both hormonal therapy and chemotherapy did not vary with patient age and the likelihood of receiving chemotherapy declined with age. Among women with positive lymph nodes, 92% received some form of adjuvant therapy. For these women, the likelihood of receiving hormonal therapy increased with age and the likelihood of receiving chemotherapy declined with age, as did the likelihood of receiving both hormonal therapy and chemotherapy. CONCLUSION: The observed associations between age and the use of adjuvant systemic therapy appear to reflect, in general, available information about treatment efficacy and do not suggest underuse among elderly women with early-stage breast cancer. The use of adjuvant therapy depends on clinical factors that predict the increased risk of metastases or the increased likelihood of response to treatment, rather than other sociodemographic factors. Our results also suggest that younger postmenopausal women with positive lymph nodes compared with older women may be undertreated with respect to tamoxifen because of the substitution of chemotherapy for hormonal therapy.

Duration of, and temporal trends (1994-1997) in, prehospital delay in patients with acute myocardial infarction: the second National Registry of Myocardial Infarction.

BACKGROUND: Extent of delay in seeking medical care in persons with acute myocardial infarction (AMI) is receiving increasing attention, given the time-dependent benefits associated with early administration of coronary reperfusion therapy. OBJECTIVE: To examine recent data, and temporal trends therein, about duration of prehospital delay in a large (N = 364,131) cross-sectional sample of patients included in the second National Registry of Myocardial Infarction. METHODS: The medical records of patients hospitalized with AMI in 1624 US hospitals from June 1, 1994, to October 31, 1997, were reviewed for information about duration of prehospital delay. RESULTS: There was evidence of a slight decline in average delay times in patients hospitalized in 1997 (5.5 hours) compared with those hospitalized in 1994 (5.7 hours). Median delay times (2.1 hours) did not change. Approximately 20% of patients presented to the hospital within 1 hour of acute symptom onset, and slightly more than two thirds presented within 4 hours. Delay times were more prolonged for older patients, women, nonwhite patients, and patients with a history of diabetes or hypertension vs respective comparison groups. Patients in cardiogenic shock exhibited shorter delay times than less severely ill patients. Patients with previous AMI or who had undergone previous coronary angioplasty presented to the hospital with shorter delay times, as did individuals hospitalized in the Mountain and Pacific regions. CONCLUSIONS: These results provide insights into recent delay times and into groups at risk for prolonged delay.

Bowel habit in relation to age and gender. Findings from the National Health Interview Survey and clinical implications.

BACKGROUND: Constipation is widely considered to be a common problem among the elderly, as evidenced by the high rate of laxative use in this population. Yet, age-related prevalence studies of constipation generally do not distinguish between actual alteration in bowel movement frequency and subjective self-report of constipation. OBJECTIVE: To determine the relationship between advancing age and bowel habit. METHODS: We employed data collected on 42,375 subjects who participated in the National Health Interview Survey on Digestive Disorders based on interviews with a random nationwide sample of US households. We examined the following characteristics reported by this population according to selected age groupings by decade: constipation, levels of laxative use, and two bowel movements per week or less. RESULTS: Contrary to conventional wisdom, there was no age-related increase in the proportion of subjects reporting infrequent bowel movements. Nonetheless, the prevalence of self-report of constipation increased with advancing age, with a greater proportion of women reporting this symptom than men across all age groups. Laxative use also increased substantially with aging; while women were more likely to use laxatives than men, this effect attenuated with advancing age. A U-shaped relationship was observed between advancing age and bowel habit in men and women; 5.9% of individuals younger than 40 years reported two bowel movements per week or less compared with 3.8% of those aged 60 to 69 years and 6.3% of those aged 80 years or older. This relationship persisted after adjusting for laxative use. CONCLUSION: These findings suggest that a decline in bowel movement frequency is not an invariable concomitant of aging. In elderly patients who report being constipated, it is essential to take a careful physical, psychological, and bowel history rather than to automatically assume the need for laxative use.

Glucocorticoids and the risk for initiation of hypoglycemic therapy.

PURPOSE: To quantify risk for the occurrence of hyperglycemia requiring initiation of hypoglycemic therapy in patients treated with oral glucocorticoids. PATIENTS AND METHODS: A case-control study of enrollees in the New Jersey Medicaid program 35 years of age or older. The 11,855 case patients had newly initiated treatment with a hypoglycemic agent (oral or insulin) between 1981 and 1990. The 11,855 controls represented a random sample of other Medicaid enrollees. RESULTS: In patients using oral glucocorticoids, the estimated relative risk for development of hyperglycemia requiring treatment was 2.23 (95% confidence interval, 1.92 to 2.59) as compared with nonusers. Risk increased with increasing average daily steroid dose, in hydrocortisone-equivalent milligrams; the odds ratio was 1.77 for 1 to 39 mg/d, 3.02 for 40 to 79 mg/d, 5.82 for 80 to 119 mg/d, and 10.34 for 120 mg/d or more. The estimated effects persisted after adjustment for a variety of potentially confounding demographic, health service utilization, and medication use variables. CONCLUSION: The findings of this population-based study quantify the risk of developing hyperglycemia requiring hypoglycemic therapy after oral glucocorticoid use. The magnitude of risk increases substantially with increasing glucocorticoid dose. These findings demonstrate the utility of large-scale health claims databases in defining the risk of important adverse drug effects.

Noncompliance with congestive heart failure therapy in the elderly.

BACKGROUND: Noncompliance with long-term medication regimens, such as those employed in the treatment of congestive heart failure (CHF), has been found to be approximately 50%. However, no evaluation has been performed on a population-based cohort of elderly patients beginning the use of digoxin and followed up longitudinally for an extended observation period. METHODS: To study patterns of medication compliance, we conducted a retrospective follow-up of 7247 outpatients aged 65 to 99 years newly prescribed digoxin between 1981 and 1991, with the use of the complete prescription claims file of the New Jersey Medicaid program. Noncompliance was measured in terms of the number of days during the 12-month period after an initial digoxin prescription in which no CHF medication was available to the patient. RESULTS: Patients started on a regimen of digoxin were without digoxin or any other common alternative CHF drug for an average of 111 of the 365 days of follow-up. Only 10% of the population filled enough prescriptions to have daily CHF medication available for the entire year of follow-up. Compliance rates were higher in patients over 85 years of age, women, those taking multiple medications, and those with hospital or nursing home stays before the initiation of therapy. CONCLUSIONS: A large proportion of patients who begin digoxin therapy end CHF therapy or consume substantially less medication than expected in the first year of therapy. Such high rates of cessation could represent an important impediment to effective CHF therapy.

Atrial fibrillation and stroke prevention with warfarin in the long-term care setting.

BACKGROUND: While the benefits of warfarin sodium therapy for stroke prevention in patients with atrial fibrillation (AF) have been extensively documented, generalizing clinical trial results to the majority of elderly persons with AF, especially to those who reside in the long-term care setting, remains challenging. OBJECTIVES: To determine the prevalence of AF in the institutionalized elderly population and the proportion receiving anticoagulation therapy with warfarin: to identify the clinical and functional characteristics of institutionalized elderly persons with AF that are associated with the use of warfarin; and to assess the quality of prescribing and monitoring of warfarin therapy in institutionalized elderly persons with AF. METHODS: This study involved 30 long-term care facilities (total No. of beds, 6437) located in New England, Quebec, and Ontario. The proportion of patients with AF who were receiving treatment with warfarin was determined. The association between clinical and functional characteristics and the use of warfarin was examined with crude and multivariable-adjusted analyses. For study subjects with at least 2 weeks of warfarin therapy during the 12-month period preceding the date of medical record abstraction, we assessed the quality of warfarin prescribing based on all international normalized ratio or prothrombin time ratio values during this period. RESULTS: An electrocardiogram indicating AF was present in the records of 413 of 5500 long-term care residents (7.5%); 32% of such patients were being treated with warfarin. Only a history of stroke was found to be positively associated with the use of warfarin in this setting. Patients with a diagnosis of dementia and those in the oldest age group (> or = 85 years) were less likely to receive warfarin therapy. Warfarin was commonly prescribed to patients with a history of bleeding, substantial comorbidity and functional impairment, a history of falls, or concomitant potentiating drug therapy. Patients were maintained above or below the recommended therapeutic range 60% of the time. CONCLUSIONS: Atrial fibrillation is common in patients residing in long-term care facilities, but its management with warfarin is highly variable. A more systematic approach to decision making regarding the use of warfarin for stroke prevention in these patients is required. Among patients receiving warfarin, the quality of anticoagulation care warrants improvement.

Recent trends in hospital mortality of acute myocardial infarction--the Worcester Heart Attack Study. Have improvements been realized for all age groups?

BACKGROUND: While age-related differences in patterns of care for acute myocardial infarction have been demonstrated, temporal trends in clinical outcome for patients in different age groups have not been carefully examined. METHODS: We analyzed data collected as part of an ongoing communitywide study of 5480 patients hospitalized with validated acute myocardial infarction in Worcester, Mass, during 7 selected years spanning a 15-year period (1975 through 1990). Patients were stratified into three age groups: less than 65 years (n = 2220), 65 through 74 years (n = 1595), and 75 years or older (n = 1665). Within each age group, the odds of in-hospital death were determined by study year, with adjustments for selected demographic, clinical, and hospital characteristics. RESULTS: For patients less than age 65 years, the odds of dying during the acute hospital phase of myocardial infarction were reduced for all study years relative to the reference year (1975), reaching their lowest level in 1990 (adjusted odds ratio [OR], 0.16; 95% confidence interval [CI], 0.06 to 0.48). For patients aged 65 through 74 years, the odds of dying declined among patients hospitalized in 1978 (adjusted OR, 0.71; 95% CI, 0.39 to 1.29) and 1981 (adjusted OR, 0.36; 95% CI, 0.19 to 0.66) but remained essentially unchanged during the subsequent study years through 1990. For patients 75 years of age or older, the odds of dying declined through 1984 (adjusted OR, 0.42; 95% CI, 0.25 to 0.72) but increased over the following study years: 1986, 1988, and 1990. CONCLUSIONS: While the risk of in-hospital death following acute myocardial infarction has recently declined for patients less than 65 years of age, improvements have not been realized for older age groups. Current patterns of management of acute myocardial infarction in older patients require reexamination.

Age-related risks of long-term oral anticoagulant therapy.

Long-term oral anticoagulant therapy is critical to the optimal management of various thromboembolic and vascular disorders. To determine whether age is related to the development of bleeding complications in patients who are receiving long-term oral anticoagulant therapy, the records of 321 patients who were followed up in the university hospital outpatient anticoagulation clinic during an eight-year period were reviewed. During this period, 61 patients (19%) developed minor bleeding complications, and 14 patients (4.4%) developed major bleeding complications. In utilizing a life-table approach to adjust for varying lengths of follow-up, the risk of initial minor bleeding complications was found to be greatest within the first three months (14%). For major bleeding complications, risk increased throughout the first two years of anticoagulation clinic follow-up, with no particular period of greatest risk. No significant differences in the risk of initial minor or major bleeding complications were observed in the various age groups that were examined (less than 50, 50 to 59, 60 to 69, and greater than or equal to 70 years). A multivariate regression approach, controlling for several potentially confounding factors, confirmed the lack of an association of age with the risk of minor or major bleeding complications. The results of this retrospective follow-up study suggest that patient age, in and of itself, should not be considered a primary factor in assessing the risk of long-term oral anticoagulant therapy.

Use of aspirin, beta-blockers, and lipid-lowering medications before recurrent acute myocardial infarction: missed opportunities for prevention?

BACKGROUND: For patients who have had a previous myocardial infarction (MI), the use of aspirin, beta-blockers, and lipid-lowering agents reduces the risk of recurrent MI and death. OBJECTIVE: To examine trends in and determinants of receipt of these 3 medications before hospitalization for recurrent acute MI (AMI). METHODS: The study population consisted of 1710 patients with a previous history of MI hospitalized with a validated recurrent AMI in all hospitals in Worcester, Mass, during 1986, 1988, 1990, 1991, 1993, and 1995. Logistic regression analyses were used to assess the effect of demographic, clinical, and temporal factors on the receipt of aspirin, beta-blockers, and lipid-lowering medications before hospital admission for recurrent AMI. RESULTS: More than 47% of patients in each study year were not receiving each medication before admission, although significant increases in use were noted over time for aspirin (from 13.5% to 52.6%), beta-blockers (from 33.2% to 44.4%), and lipid-lowering medications (from 0.8% to 11.7%). In multivariate analyses, advancing age was associated with not receiving aspirin (odds ratio [OR], 0.67; 95% confidence interval [CI], 0.51-0.89), lipid-lowering medications (OR, 0.14; 95% CI, 0.08-0.25), and beta-blockers (OR, 0.75; 95% CI, 0.57-1.00), although this effect was of borderline significance for beta-blockers. Being a woman was associated with not receiving aspirin (OR, 0.78; 95% CI, 0.62-0.98) but was positively associated with receiving lipid-lowering medications (OR, 1.59; 95% CI, 1.04-2.43). Coexisting medical conditions and concurrent use of other cardiovascular medications were also associated with receipt of each medication. CONCLUSION: Despite encouraging increases over time, the low absolute levels of receipt of medications shown to be efficacious in the long-term treatment of patients after an MI, and their variation by age and sex, suggest that substantial opportunities may exist to prevent recurrent AMIs through the increased use of aspirin, beta-blockers, and lipid-lowering medications.

Prevalence and quality of warfarin use for patients with atrial fibrillation in the long-term care setting.

BACKGROUND: Evidence-based clinical practice guidelines recommend the use of warfarin sodium for stroke prevention in most patients with atrial fibrillation (AF) who do not have risk factors for hemorrhagic complications, irrespective of age. METHODS: The medical records of all residents of a convenience sample of long-term care facilities in Connecticut (n = 21) were reviewed. The percentages of all patients with AF (AF patients) and ideal candidates for warfarin therapy (ie, AF patients with no risk factors for hemorrhage) who received warfarin were determined; for patients receiving warfarin, the percentage of days spent in the therapeutic range of international normalized ratio (INR) values (2.0-3.0) was also assessed. The relationship between receipt of warfarin and the presence of stroke and bleeding risk factors was assessed in multivariate models. RESULTS: Atrial fibrillation was present in 429 (17%) of the 2587 long-term care residents. Overall, 42% of AF patients were receiving warfarin. However, only 44 (53%) of 83 ideal candidates were receiving this therapy. In residents who received warfarin therapy, the therapeutic range of INR values was maintained only 51% of the time. The odds of receiving warfarin in the study sample decreased with increasing number of risk factors for bleeding and increased (nonsignificant trend) with increasing number of stroke risk factors present. CONCLUSIONS: Atrial fibrillation is very common among residents of long-term care facilities. Even among apparently ideal candidates, warfarin therapy is underused for stroke prevention in patients with AF. Prescribing decisions and monitoring related to warfarin therapy in the long-term care setting warrant improvement.

The impact of clinical trials on the use of medications for acute myocardial infarction. Results of a community-based study.

BACKGROUND: The impact of clinical trials on medical practice remains controversial, in part because of weak study designs and nonrepresentative study samples. OBJECTIVE: To assess changes in trends in medication use in the setting of acute myocardial infarction (AMI) before and after publication of two large clinical trials: the Second International Study of Infarct Survival (ISIS-2) trial that supported the use of aspirin after AMI and the Multi-center Diltiazem Postinfarction Trial that reported no overall benefit from the use of calcium antagonists after AMI. METHODS: Study patients consisted of 2114 patients hospitalized with AMI in 16 hospitals in metropolitan Worcester, Mass, during 1986, 1988, and 1990. Data were obtained from medical records. We used multivariable logistic regression models to examine the rate of change in the use of selected medications before and after trial publication, controlling for medical history, characteristics and complications of AMI, medications taken, and procedures performed during hospitalization. The dependent variable was receipt of the specific medication under investigation. RESULTS: Before publication of ISIS-2, 26% of patients with AMI received aspirin while hospitalized compared with 66% after its publication. However, in-hospital aspirin use began to rise before ISIS-2 with an immediate increase in the level of use occurring after trial publication but with no significant change in the rate of increase. Before publication of the Multicenter Diltiazem Postinfarction Trial, 57% of patients with AMI were new recipients of calcium antagonists compared with 51% after trial publication. The decrease in calcium antagonist use began after trial publication (odds ratio, 0.79 per 6-month period; 95% confidence interval, 0.71 to 0.88). CONCLUSIONS: The published results of large trials of cardiovascular therapies have had variable impact on medication use. Efforts to assess the effects of publication of new scientific information on medical care need to consider prior trends in treatment patterns and the varying contexts of medical care. They should consider both direct and indirect routes of influence.

A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis.

BACKGROUND: To study the relation between reported drug performance in published trials and support of the trials by the manufacturer of the drug under evaluation, we studied a sample of trials of nonsteroidal anti-inflammatory drugs (NSAIDs) used in the treatment of arthritis. METHODS: All randomized control trials of NSAIDs published between September 1987 and May 1990 identified by MEDLINE were reviewed. If an article met the following criteria (n = 61), it was selected: trials involving adult patients with osteoarthritis or rheumatoid arthritis (n = 180), use of nonsalicylate NSAIDs marketed in the United States (n = 101), randomized control trial (n = 81), duration of the trial 4 or more days (n = 78), and use of an efficacy outcome measure (n = 61). Reviewers, "blinded" to manufacturer status, evaluated the narrative interpretation of results and extracted numeric data on efficacy and toxicity. Manufacturer-associated trials were defined as those that acknowledged an association with a pharmaceutical manufacturer. Because of the scarcity of non-manufacturer-associated trials (n = 9), we report only on the manufacturer-associated articles. RESULTS: Fifty-two publications (85.2%) representing 56 trials were associated with a manufacturer. The manufacturer-associated drug was reported as comparable with (71.4%) or superior to (28.6%) the comparison drug in all 56 trials. These narrative claims of superiority were usually justified with trial data. Of the trials identifying one drug as less toxic (n = 22), the manufacturer-associated drug's safety was reported as superior to the comparison drug in 86.4% of cases. Justification for the narrative interpretation of the trial findings regarding less toxicity was provided in only 12 (54.5%) of 22 trials. CONCLUSION: The manufacturer-associated NSAID is almost always reported as being equal or superior in efficacy and toxicity to the comparison drug. These claims of superiority, especially in regard to side effect profiles, are often not supported by trial data. These data raise concerns about selective publication or biased interpretation of results in manufacturer-associated trials.

Age-related trends (1986-1993) in the use of thrombolytic agents in patients with acute myocardial infarction. The Worcester Heart Attack Study.

OBJECTIVE: To examine age-related differences and temporal trends in the use of thrombolytic therapy in a community-wide study of patients hospitalized with acute myocardial infarction (AMI) between 1986 and 1993. METHODS: All hospitals in the Worcester, Mass, metropolitan area (1990 census population, 4370000) were included. A total of 3824 patients with validated AMI categorized according to age comprised the study sample: younger than 55 years (n = 577), 55 to 64 years (n = 758), 65 to 74 years (n = 1143), and 75 years or older (n = 1346). RESULTS: Use of thrombolytic therapy increased during the period under study in all patients hospitalized with AMI (9% in 1986; 26% in 1993). In 1986, the majority of treated patients received streptokinase; while increases over time in the use of tissue-type plasminogen activator were noted, streptokinase remained the thrombolytic agent of choice in 1993. Marked age-related trends in the use of thrombolytic therapy were observed, with the most striking increases in the use of thrombolytic therapy over time seen in those aged 65 years or older. Between 1986 and 1993 the relative increases in the use of thrombolytic therapy were observed in the following age groups: younger than 55 years (106%), 55 to 64 years (85%), 65 to 74 years (694%), and 75 years or older (571%). Despite these encouraging trends in the use of thrombolytic therapy in older patients, after controlling for a variety of potential confounding variables elderly patients were significantly less likely to receive thrombolytic therapy during hospitalization for AMI. Compared with patients aged 75 years or older, patients younger than 55 years were 6.4 times (95% confidence interval [CI], 4.8-8.5), patients aged 55 to 64 years were 4.9 times (95% CI, 3.8-6.4), and patients aged 65 to 74 years were 3.0 times (95% CI, 2.3-3.9) significantly more likely to receive thrombolytic therapy. These differences were in part related to the proportion of patients with myocardial infarction satisfying eligibility criteria for the receipt of thrombolytic therapy; patients aged 75 years or older were significantly less likely to meet these criteria (19%) than were those younger than 55 years (49%), those aged 55 to 64 years (38%), and those aged 65 to 74 years (28%). CONCLUSIONS: The present results show that while there have been substantial increases over time in the use of thrombolytic therapy in patients with AMI, most particularly in older individuals, the elderly remain appreciably less likely to receive these agents during hospitalization for AMI. These differences may be due to the smaller percentage of elderly patients satisfying criteria for the use of these agents compared with younger patients with coronary heart disease, as well as to a reluctance by physicians to use these agents in older patients. Continued monitoring of these trends remains important for examining changes in physicians' practice patterns regarding the use of thrombolytic therapy in this vulnerable population.

The diffusion of a novel therapy into clinical practice: the case of sildenafil.

BACKGROUND: Erectile dysfunction is a common condition, yet in the past most affected men did not seek medical treatment. OBJECTIVE: To examine how sildenafil (Viagra), a new medication for the treatment of erectile dysfunction, has been incorporated into general medical practice. SUBJECTS AND METHODS: The study population consisted of all male members of a group-model Massachusetts health maintenance organization (HMO) whose first prescription for sildenafil was dispensed during the first 24 weeks of its availability through the HMO as a plan benefit (April 24, 1998, through October 8, 1998). Data collected on each member in the study population included age, specialty of the prescribing physician, initial dose, use of prior treatments for erectile dysfunction, receipt of medications known to predispose to impotence, filling of a second prescription for sildenafil, and concomitant medical conditions (including hypertension, ischemic heart disease, hyperlipidemia, diabetes mellitus, and history of radical prostatectomy). Cross tabulations and logistic regression models were constructed to evaluate the potential associations between filling a second prescription for sildenafil and other characteristics of sildenafil users. RESULTS: We identified 899 members who filled a first-time sildenafil prescription in the 24-week period of interest. The majority of sildenafil prescriptions that were filled for the first time (85%) occurred in the first 12 weeks of its availability. Most sildenafil users (84%) were between 45 and 74 years of age (average age, 61 years; age range, 23 to 90 years), and approximately 40% had documentation of prior treatment for erectile dysfunction. Use was highest among those aged 55 to 64 years, with almost 5% of all male HMO members in that age group having received at least 1 sildenafil prescription. Our cohort of sildenafil users was significantly more likely to have hypertension (P<.01), hyperlipidemia (P<.01), and diabetes mellitus (P<.01) than persons who participated in a widely publicized clinical trial of the medication. Prescribing physicians were predominantly primary care physicians (78% were internists, and 11% were family practitioners). More than 60% of sildenafil users filled a second prescription within 3 months of the first prescription; in multivariate analyses, factors associated with filling a second prescription included younger age and prior treatment for erectile dysfunction. CONCLUSIONS: Sildenafil was rapidly adopted into the clinical practice of primary care physicians for the treatment of erectile dysfunction in the managed care setting. The patients for whom the drug was prescribed in the general practice setting differed across many medical characteristics from study subjects who participated in clinical trials of the drug. Arch Intern Med. 2000;160:3401-3405.

Prevention of glucocorticoid-induced osteoporosis: experience in a managed care setting.

BACKGROUND: Treatment with glucocorticoids is the leading cause of drug-induced osteoporosis. Currently available guidelines indicate that patients receiving long-term glucocorticoid therapy should receive measures to prevent osteoporosis. OBJECTIVES: To examine whether patients receiving long-term glucocorticoid therapy in a managed care setting received preventive therapy or prescribed medications for osteoporosis and to identify patient and provider characteristics associated with treatment. SUBJECTS AND METHODS: A cohort of 224 health plan enrollees 20 years and older who were dispensed at least 1 oral glucocorticoid prescription per quarter during the period October 1997 through September 1998 was identified from administrative data. Medical charts and administrative data were reviewed to determine use of preventive therapy and prescribed medications for osteoporosis. RESULTS: Of the 224 patients, 62% had at least 1 documented intervention aimed at osteoporosis prevention (counseling about calcium or vitamin D or weight-bearing exercise; prescription for estrogen, calcitonin, or bisphosphonate; or a bone mineral density study). Women were more likely than men to receive intervention (76% vs 44%; prevalence odds ratio, 4.41; 95% confidence interval, 2.17-9.10). Patients receiving a mean daily prednisone dose of 10 mg or more or 5 to less than 10 mg were no more likely to receive intervention than those receiving 5 mg or less prednisone daily. Sixty-two (90%) of 69 patients who were prescribed glucocorticoid therapy by rheumatologists had at least 1 intervention documented compared with 29 (48%) of 60 for internists, 26 (55%) of 47 for pulmonologists, and 22 (46%) of 48 for all other physicians. In a multiple logistic regression model, including patient age, sex, mean daily glucocorticoid dose, and physician specialty, women and patients prescribed glucocorticoids by a rheumatologist were significantly more likely to receive intervention aimed at osteoporosis prevention. CONCLUSIONS: A substantial proportion of patients receiving long-term glucocorticoid therapy do not receive preventive therapy for osteoporosis. Efforts should be made to reduce barriers to such treatment and increase the proportion of patients given preventive therapy.

Consultation between cardiologists and generalists in the management of acute myocardial infarction: implications for quality of care.

BACKGROUND: The rapid expansion of managed care in the United States has increased debate regarding the appropriate mix of generalist and specialist involvement in medical care. OBJECTIVE: To compare the quality of medical care when generalists and cardiologists work separately or together in the management of patients with acute myocardial infarction (AMI). METHODS: We reviewed the charts of 1716 patients with AMI treated at 22 Minnesota hospitals between 1992 and 1993. Patients eligible for thrombolytic aspirin, beta-blockers, and lidocaine therapy were identified using criteria from the 1991 American College of Cardiology guidelines for the management of AMI. We compared the use of these drugs among eligible patients whose attending physician was a generalist with no cardiologist input, a generalist with a cardiologist consultation, and a cardiologist alone. RESULTS: Patients cared for by a cardiologist alone were younger, presented earlier to the hospital, were more likely to be male, had less severe comorbidity, and were more likely to have an ST elevation of 1 mm or more than generalists' patients. Controlling for these differences, there was no variation in the use of effective agents between patients cared for by a cardiologist attending physician and a generalist with a consultation by a cardiologist. However, there was a consistent trend toward increased use of aspirin, thrombolytics, and beta-blockers in these patients compared with those with a generalist attending physician only (P<.05 for beta-blockers only). Differences between groups in the use of lidocaine were not statistically significant. The adjusted probabilities of use of thrombolytics for consultative care and cardiologist attending physicians were 0.73 for both. Corresponding probabilities were 0.86 and 0.85 for aspirin and 0.59 and 0.57 for beta-blockers, respectively. CONCLUSIONS: For patients with AMI, consultation between generalists and specialists may improve the quality of care. Recent policy debates that have focused solely on access to specialists have ignored the important issue of coordination of care between generalist and specialist physicians. In hospitals where cardiology services are available, generalists may be caring for patients with AMI who are older and more frail. Future research and policy analyses should examine whether this pattern of selective referral is true for other medical conditions.

Risk factors for adverse drug events among nursing home residents.

BACKGROUND: In a prospective study of nursing home residents, we found adverse drug events (ADEs) to be common, serious, and often preventable. To direct prevention efforts at high-risk residents, information is needed on resident-level risk factors. METHODS: Case-control study nested within a prospective study of ADEs among residents in 18 nursing homes. For each ADE, we randomly selected a control from the same home. Data were abstracted from medical records on functional status, medical conditions, and medication use. RESULTS: Adverse drug events were identified in 410 nursing home residents. Independent risk factors included being a new resident (odds ratio [OR], 2.8; 95% confidence interval [CI], 1.5-5.2) and taking anti-infective medications (OR, 4.0; CI, 2.5-6.2), antipsychotics (OR, 3.2; CI, 2.1-4.9), or antidepressants (OR, 1.5; CI, 1.1-2.3). The number of regularly scheduled medications was associated with increased risk of ADEs; the OR associated with taking 5 to 6 medications was 2.0 (CI, 1.2-3.2); 7 to 8 medications, 2.8 (CI, 1.7-4.7); and 9 or more, 3.3 (CI, 1.9-5.6). Taking supplements or nutrients was associated with lower risk (OR, 0.42; CI, 0.27-0.63). Preventable ADEs occurred in 226 residents. Independent risk factors included taking opioid medications (OR, 6.6; CI, 2.3-19.3), antipsychotics (OR, 4.0; CI, 2.2-7.3), anti-infectives (OR, 3.0; CI, 1.6-5.8), antiepileptics (OR, 2.2; CI, 1.1-4.5), or antidepressants (OR, 2.0; CI, 1.1-3.5). Scores of 5 or higher on the Charlson Comorbidity Index were associated with increased risk of ADEs (OR, 2.6; CI, 1.1-6.0). The number of regularly scheduled medications was also a risk factor: the OR for 7 to 8 medications was 3.2 (CI, 1.4-6.9) and for 9 or more, 2.9 (CI, 1.3-6.8). Residents taking nutrients or supplements were at lower risk (OR, 0.27; CI, 0.14-0.50). CONCLUSIONS: It is possible to identify nursing home residents at high risk of having an ADE. Particular attention should be directed at new residents, those with multiple medical conditions, those taking multiple medications, and those taking psychoactive medications, opioids, or anti-infective drugs.

Timeliness and quality of care for elderly patients with acute myocardial infarction under health maintenance organization vs fee-for-service insurance.

BACKGROUND: A commonly voiced concern is that health maintenance organizations (HMOs) may withhold or delay the provision of urgent, essential care, especially for vulnerable patients like the elderly. OBJECTIVE: To compare the quality of emergency care provided in Minnesota to elderly patients with acute myocardial infarction (AMI) who are covered by HMO vs fee-for-service (FFS) insurance. METHODS: We reviewed the medical records of 2304 elderly Medicare patients who were admitted with AMI to 20 urban community hospitals in Minnesota (representing 91% of beds in areas served by HMOs) from October 1992 through July 1993 and from July 1995 through April 1996. MAIN OUTCOME MEASURES: Use of emergency transportation and treatment delay (>6 hours from symptom onset); time to electrocardiogram; use of aspirin, thrombolytics, and beta-blockers among eligible patients; and time from hospital arrival to thrombolytic administration (door-to-needle time). RESULTS: Demographic characteristics, severity of symptoms, and comorbidity characteristics were almost identical among HMO (n = 612) and FFS (n = 1692) patients. A cardiologist was involved as a consultant or the attending physician in the care of 80% of HMO patients and 82% of FFS patients (P = .12). The treatment delay, time to electrocardiogram, use of thrombolytic agents, and door-to-needle times were almost identical. However, 56% of HMO patients and 51% of FFS patients used emergency transportation (P = .02); most of this difference was observed for patients with AMIs that occurred at night (60% vs 52%; P = .02). Health maintenance organization patients were somewhat more likely than FFS patients to receive aspirin therapy (88% vs 83%; P = .03) and beta-blocker therapy (73% vs 62%; P = .04); these differences were partly explained by a significantly larger proportion of younger physicians in HMOs who were more likely to order these drug therapies. All differences were consistent across the 3 largest HMOs (1 staff-group model and 2 network model HMOs). Logistic regression analyses controlling for demographic and clinical variables produced similar results, except that the differences in the use of beta-blockers became insignificant. CONCLUSIONS: No indicators of timeliness and quality of care for elderly patients with AMIs were lower under HMO vs FFS insurance coverage in Minnesota. However, two indicators of quality care were slightly but significantly higher in the HMO setting (use of emergency transportation and aspirin therapy). Further research is needed in other states, in different populations, and for different medical conditions.

Adherence to national guidelines for drug treatment of suspected acute myocardial infarction: evidence for undertreatment in women and the elderly.

BACKGROUND: Evidence-based guidelines for the treatment of patients with acute myocardial infarction (AMI) have been published and disseminated by the American College of Cardiology and the American Heart Association. Few studies have examined the rates of adherence to these guidelines in eligible populations and the influence of age and gender on highly effective AMI treatments in community hospital settings. METHODS: Medical records of 2409 individuals admitted to 37 Minnesota hospitals between October 1992 and July 1993 for AMI, suspected AMI, or rule-out AMI, and meeting electrocardiographic, laboratory, and clinical criteria suggestive of AMI were reviewed to determine the proportion of eligible patients who received thrombolytic, beta-blocker, aspirin, and lidocaine hydrochloride therapy. The effects of patient age, gender, and hospital teaching status on the use of these treatments were estimated using logistic regression models. RESULTS: Eligibility for treatment ranged from 68% (n=1627) for aspirin therapy, 38% (n=906) for lidocaine therapy, and 30% (n=734) for thrombolytic therapy to 19% (n=447) for beta-blocker therapy. Seventy-two percent of patients eligible to receive a thrombolytic agent received this therapy; 53% received beta-blockers; 81% received aspirin; and 88% received lidocaine. Among patients ineligible for lidocaine therapy (n=1503), 20% received this agent. Use of study drugs was lower among eligible elderly patients, especially those older than 74 years (thrombolytic agent: odds ratio, 0.2; 95% confidence interval, 0.1 to 0.4; aspirin: odds ratio, 0.4, 95% confidence interval, 0.3 to 0.6; beta-blocker: odds ratio, 0.4; 95% confidence interval, 0.2 to 0.8). Female gender was associated with lower levels of aspirin use among eligible patients (odds ratio, 0.7; 95% confidence interval, 0.6 to 0.9); and there was a trend toward lower levels of beta-blocker and thrombolytic use among eligible women. CONCLUSIONS: Use of lifesaving therapies for eligible patients with AMI is higher than previously reported, particularly for aspirin and thrombolytic use in nonelderly patients. Lidocaine is still used inappropriately in a substantial proportion of patients with AMI. Increased adherence to AMI treatment guidelines is required for elderly patients and women.