Costs of adverse events among patients with HIV infection treated with nonnucleoside reverse transcriptase inhibitors.

OBJECTIVES: The aim of the study was to assess the incidence and costs of adverse events (AEs) among patients with HIV infection treated with nonnucleoside reverse transcriptase inhibitors (NNRTIs) from the health care system perspective. METHODS: US medical and pharmacy claims during 2004-2009 were examined to select adult new NNRTI users with HIV infection. The incidence of selected AEs and time to occurrence were assessed during the first year. Episodes of care for each AE were identified using claims associated with AE management. For each AE, a propensity score model was used to match patients with an AE to those without (1:4) based on the propensity of having an AE. Mean total health care costs, AE-associated costs and incremental costs per episode, and annual total health care costs per patient were calculated. RESULTS: Of the 2548 NNRTI-treated patients, 29.3% experienced AEs. The incidence ranged from 0.4 episodes/1000 person-years for suicide/self-injury to 14.9 episodes/1000 person-years for dizziness, 49.8 episodes/1000 person-years for depression and 150.3 episodes/1000 person-years for lipid disorder. The mean AE-associated cost (duration) per episode ranged from $586 (88 days) for lipid disorder to $975 (33 days) for rash, $2760 (73 days) for sleep-related symptoms and $4434 (41 days) for nausea/vomiting. The mean incremental cost per episode ranged from $1580 for rash to $2032 for lipid disorder, $8307 for sleep-related symptoms and $12 833 for nausea/vomiting. During the 12 months following NNRTI initiation, the mean annual total health care cost was $27 299 (efavirenz: $26 185; other NNRTIs: $34 993) and AE-associated costs were $608 (efavirenz: $554; other NNRTIs: $979) among all NNRTI users. CONCLUSIONS: With treatment increasing patient survival, comparisons of therapeutic regimens should consider treatment-associated AEs. Findings from this study could be informative for clinicians and payers in managing HIV infection with NNRTIs.

The perspective of patients with haemophilia with inhibitors and their care givers: preferences for treatment characteristics.

Treatment preferences of haemophilia patients with inhibitors have not been well documented. This study sought to identify treatment attributes that patients/caregivers consider most important in the USA, inasmuch as those preferences may affect patient adherence to treatment plans. A discrete choice experiment was conducted to elicit treatment preferences. Haemophilia patients with inhibitors, or their caregivers on their behalf, completed a written survey that elicited preferences for treatment features and levels synthesized from the medical literature including: risk of viral transmission, rise in inhibitor titre, reduction in thromboembolic events, number of infusions, preparation time, infusion time/volume, time required to stop bleeding/alleviate pain, use of prophylaxis, use of major surgery and medication cost. Relative importance (RI) of preferences was modelled using a multinomial logit function. Most respondents were male (49 of 51, 96.1%); mean age, 20.7 years (SD = 18.8) and 88.5% of patients had haemophilia type A. The three most important patient-identified treatment attributes were as follows: time required to stop bleeding (RI = 19.3), possibility that the level of inhibitor may rise (RI = 14.3) and risk of contracting a virus from the product (RI = 13.5). Haemophilia patients with inhibitors and their caregivers appear to be willing to accept treatments that may be more inconvenient and painful as long as the treatments are effective in quickly controlling bleeds, do not increase inhibitor levels and do not pose a risk for viral contraction. Study findings provide meaningful input to the clinical community from patients and caregivers and support the importance of physicians understanding their patients' treatment preferences.

Health-related quality of life and productivity impact in haemophilia patients with inhibitors.

To measure health-related quality of life (HRQL), its determinants, and its association with patient and caregiver productivity among a sample of haemophilia patients with inhibitors in the United States (US). Data on demographical and clinical characteristics, treatment patterns, HRQL (SF-12v2), and productivity outcomes were reported for 53 patients. Mean SF-12v2 domain and mental (MCS) and physical (PCS) component summary scores were assessed and compared with US norms. Regression analyses explored the association of patient and treatment factors with HRQL and productivity. Patients' mean age was 20.7 years (SD = 18.8), 88.5% were type A, and 39.6% received on-demand therapy as their only mode of treatment. Mean PCS was significantly lower than the US norm (PCS, 39.9, P < 0.01) and mean MCS showed no significant difference (MCS, 49.9, P = ns). On-demand treatment (B = -0.336, P < 0.05) and number of haemorrhages (B = -0.366, P < 0.05) were negatively associated with PCS; and PCS was associated with patients' missed work or school days [incidence rate ratio (IRR) = 0.93, P < 0.001] and perceived impact on daily activities (OR = 0.72, P < 0.05). Younger age (IRR = 0.91, P < 0.01), lower PCS (IRR = 0.94, P < 0.01), more haemorrhages (IRR = 1.05, P < 0.05), and surgery (IRR = 2.74, P < 0.05) were associated with fewer patients' productive days. Physical functioning among inhibitor patients in the US is compromised and is negatively associated with their daily activities and productivity. These data suggest a positive association of prophylactic and immunotolerance therapy with HRQL, specifically physical impairment.

Timely confirmation of gastro-esophageal reflux disease via pH monitoring: estimating budget impact on managed care organizations.

BACKGROUND: Current guidelines recommend the use of pH monitoring to confirm the diagnosis of acid reflux in patients with a normal endoscopy. This analysis evaluated the financial impact of pH monitoring with the wireless pH capsule on a managed care organization (MCO) in the United States. METHODS: A decision model was constructed to project total 1-year costs to manage GERD symptoms with and without the adoption of wireless pH capsules in a hypothetical MCO with 10 000 eligible adult enrollees, of whom 600 presented with GERD-like symptoms. Costs of GERD diagnosis, treatment, and symptom management for those in whom a GERD diagnosis was ruled out by pH monitoring were assessed. The incremental per-member-per-month (PMPM) and per-treated-member-per-month (PTMPM) costs were the primary outcomes. Data sources included literature, expert input, and standardized fee schedules. RESULTS: An increase of 10 percentage points in the use of pH monitoring with wireless pH capsules yielded incremental PMPM and PTMPM costs of $0.029 and $0.481, respectively. The costs of proton pump inhibitor (PPI) therapy to the plan dropped to $236,363 from $238,086, while increases were observed in pH monitoring (from $16 739 to $21 973) and non-GERD therapy costs (from $1392 to $1740). The results were sensitive to the percentage of patients requiring repeat endoscopy before wireless pH monitoring and the cost of PPIs. CONCLUSIONS: Timely and increased use of pH monitoring as recommended in published guidelines leads to less unnecessary use of PPIs with a modest budgetary impact on health plans.

Physicians' preferences towards coagulation factor concentrates in the treatment of Haemophilia with inhibitors: a discrete choice experiment.

This study sought to identify attributes of treatment important to haematologists in making their decisions regarding optimal care for inhibitor patients in the United States. A conjoint analysis using a discrete choice experiment was conducted to elicit factors that are most important to haematologists. Twelve product attributes were chosen based on published literature and expert opinion: risk of human viral infections, possibility that the titre of the inhibitor may rise, reduction in the likelihood of dose-related thromboembolic events, the number of infusions required to stop haemorrhage, infusion preparation time, infusion time, infusion volume, time required to stop bleeding, time required to alleviate pain, prophylaxis use, ability to undergo major surgery and cost of medications. Thirty haematologists completed the questionnaires via face-to-face interviews at a scientific meeting in April 2006. Data were analysed using a multinomial logit model to obtain the relative importance of each attribute. Responding haematologists had considerable experience in treating haemophilia patients with inhibitors (average : 13 +/- 9 years). 'Time required to stop bleeding' was the most important factor affecting treatment decisions [relative importance (RI) = 16.3%]. Physicians also preferred treatments that resulted in quick pain relief [RI = 12.9%], reduced the possibility that the titre of inhibitor may rise [RI = 12.8%], required fewer number of infusions to stop a haemorrhage [RI = 12.7%] and reduced the risk of human viral infection [RI = 10.8%]. This study revealed that certain clinical outcomes attributes are the most preferred and important. These findings can assist decision makers in their assessments of optimal first-line care.

A systematic literature review of the clinical and epidemiological burden of acute lymphoblastic leukaemia (ALL).

Our goal was to identify and summarize the published literature pertaining to the incidence, prevalence, mortality, aetiology, clinical diagnosis, and management of acute lymphoblastic leukaemia (ALL). Acute lymphoblastic leukaemia represents 12% of all leukaemia cases, with a worldwide incidence projected to be 1-4.75 per 100,000 people. Italy, the United States (US), Switzerland, and Costa Rica are the countries with the highest incidence of ALL. Hereditary link, genetic defects, and possibly radiation or chemical exposures are listed amongst the most significant risk factors. Acute lymphoblastic leukaemia is predominantly a disease of childhood, but it affects adults as well. It accounts for 80% of all leukaemia cases in children. The incidence is slightly higher in men than in women and greater in white people than in black people. In 2003 in the US, there were an estimated 5800 deaths from ALL. Presenting signs and symptoms of ALL are fairly non-specific and include fever, anaemia, petechiae, and bone and joint pain. Staging of the disease and patient risk profile are routinely performed to define ALL subtypes and guide management. Chemotherapy, cranial radiation in patients with high-risk disease, and stem cell transplantation for selected patients are the prevalent therapies. Complete remission rates are high, especially amongst children (even 100%); however, long-term survival at 10 years (event-free survival) is in the range of 63% for children and 25-35% for adults. This implies that there is still a strong need for new therapies to maintain remission and prolong survival. Future treatment strategies may be driven by the patient's minimal residual disease status, a measure that more precisely defines remission, prognosis, responsiveness to therapy, and expected long-term survival.

The clinical and epidemiological burden of chronic lymphocytic leukaemia.

The purpose of this literature review was to identify and summarize published studies describing the epidemiology and management of chronic lymphocytic leukaemia (CLL). Chronic lymphocytic leukaemia represents 22-30% of all leukaemia cases with a worldwide incidence projected to be between < 1 and 5.5 per 100,000 people. Australia, the USA, Ireland and Italy have the highest CLL incidence rates. Chronic lymphocytic leukaemia presents in adults, at higher rates in males than in females and in whites than in blacks. Median age at diagnosis is 64-70 years. Five-year survival rate in the USA is 83% for those < 65 years old and 68% for those 65 + years old. Hereditary and genetic links have been noted. Persons with close relatives who have CLL have an increased risk of developing it themselves. No single environmental risk factor has been found to be predictive for CLL. Patients are usually diagnosed at routine health care visits because of elevated lymphocyte counts. The most common presenting symptom of CLL is lymphadenopathy, while difficulty exercising and fatigue are common complaints. Most patients do not receive treatment after initial diagnosis unless presenting with clear pathologic conditions. Pharmacological therapy may consist of monotherapy or combination therapy involving glucocorticoids, alkylating agents, and purine analogs. Fludarabine may be the most effective single drug treatment currently available. Combination therapy protocols have not been shown to be more effective than fludarabine alone. As no cure is yet available, a strong unmet medical need exists for innovative new therapies. Experimental treatments under development include allogeneic stem cell transplant, mini-allogeneic transplants, and monoclonal antibodies (e.g. alemtuzumab against CD52; rituximab against CD20).

Quality of life aspects of bladder cancer: a review of the literature.

Not much is generally known regarding the burden imposed by bladder cancer upon patient health-related quality of life (HRQL). The role of HRQL in affecting patient preferences and utility assessment and, ultimately, the selection of therapeutic regimen, or patient satisfaction with that selection, is considered increasingly important by the medical community. Therefore, the main focus of this evaluation was to review the international medical literature to better understand the impact of bladder cancer on patient HRQL. A search was performed using electronic and manual databases for published articles on HRQL and bladder cancer for the years 1966 onward. Thirty-five references dealing with HRQL were analyzed as part of this review. Of these, 29 were published after 1989. Most studies have identified urinary and sexual HRQL domains as being of greatest concern to patients. However, little is known about the short- and long-term impacts of specific therapeutic options for either superficial bladder cancer (SBC) or invasive bladder cancer (IBC). Increased awareness and use of the HRQL instruments such as the FACT-BL as well as the EORTC-QLQ-BLS24 and the EORTC-QLQ-BLM30 (when they are validated for SBC and IBC, respectively), should increase our understanding of the impact of this disease and its management options on patient HRQL.

Quality of life of patients with Fabry disease.

This paper is the first of its kind to study the impact of Fabry disease (FD) in affected males, and shows that FD is associated with a significant decline in several domains. Using the medical outcomes study (MOS) SF-36 and a FD-specific questionnaire, we compared the observations found among these patients with that obtained for the general US population and other chronic disease states, including Gaucher disease (GD) (another lysosomal storage disorder), end-stage renal disease, stoke and AIDS. Patients with FD have a score profile most similar to patients with AIDS. In comparison with patients with GD, Fabry patients score substantially lower across all domains. Using simple linear regression, potential predictors of health-related quality of life (HRQOL) for Fabry patients were also determined. As in the general population, stroke, cardiac problems and renal disease lead to substantial decrement in HRQOL. In addition, two disease specific symptoms (acroparesthesia and anhidrosis) and pain are also predictors of decreased quality of life. Currently, no specific therapy for FD exists. As enzyme therapy for FD becomes increasingly available, it will be interesting to evaluate the therapy's impact on the quality of life of patients.

Racial differences in the cost of treating men with early-stage prostate cancer.

OBJECTIVE: To compare the cost and resource utilization in the evaluation, treatment, and 6-month follow-up of African-American and White men undergoing either external beam radiation therapy (XRT) or radical prostatectomy (RP) for early-stage prostate cancer. DESIGN: Retrospective analysis of cost and resource utilization data from encrypted patient-specific hospital inpatient, hospital outpatient, and physician/supplier data files. SETTING: National Medicare claims data from 1993 through 1996. PARTICIPANTS: A random 5% national sample of Medicare beneficiaries from the Health Care Financing Administration Public Use Files for 1993 through 1996. MEASUREMENTS: Inpatient, outpatient, and physician/supplier Medicare costs. RESULTS: African-American men undergoing RP for early-stage prostate cancer had significantly higher costs ($21,878 vs $18,786, P < .0001) than did White men. Most of the difference occurred in the inpatient setting. African-American men undergoing XRT had significantly greater costs ($18,131 vs $15,734, P < .0001) than did White men. Most of this difference was generated by longer duration of XRT treatments. CONCLUSIONS: In early-stage prostate cancer, charges for RP and XRT in African-American men are higher when compared with those for White men.

A nationwide charge comparison of the principal treatments for early stage prostate carcinoma.

BACKGROUND: The diagnosis and treatment of men with early stage prostate carcinoma is expensive and controversial, yet the similarities in reported survival rates has underscored the importance of ascertaining the relative charges of different forms of therapy. METHODS: Patient specific data on demographic characteristics, hospital and physician resource use, and charges were obtained from the Health Care Financing Administration for 1993 through 1996. The inpatient, outpatient, and part B claims from men with a new diagnosis of prostate carcinoma were captured from the quarter of the year in which biopsy was performed through the two quarters after treatment. Charges are reported in inflation-unadjusted dollars. RESULTS: Of 10,107 men treated for early stage prostate carcinoma, 58% received external beam radiation therapy (XRT), 35% had radical prostatectomy, and 7% underwent brachytherapy. Over the 4 years, use of XRT decreased 19% whereas use of brachytherapy increased 21%. Men aged 65-69 years were more likely to have radical prostatectomy, but after age 70 years, XRT predominated. The most expensive treatments were radical prostatectomy with adjuvant XRT ($31,329) and brachytherapy with pretreatment XRT ($24,407). Cost of radical prostatectomy alone was more than XRT alone ($19,019 vs. 15,937; P < 0.05) or brachytherapy alone ($15,301; P < 0.05). Treatment utilization varied with age, race, and geographic region. CONCLUSIONS: The mean charges for the workup, treatment, and 6 month follow-up of patients treated for early stage prostate carcinoma ranged between $15,301 and $31,329, with significant treatment group differences. Without a clear survival advantage from one form of treatment, issues such as costs, quality of life, and patient preferences take on paramount importance.

The reliability and validity of the impact on lifestyle questionnaire in patients with acromegaly.

OBJECTIVES: Treatments for acromegaly, a growth hormone disorder, can be burdensome to patients, often requiring multiple self-administered injections daily. We developed the Impact on Lifestyle Questionnaire (ILQ) to measure the impact on patient's lifestyle imposed by the burden of injectable treatments for acromegaly. The primary objective of this study was to establish the reliability and validity of the ILQ. METHODS: The ILQ consists of the SF-12 and 30 additional questions. Thirty-four patients, from two sites, completed the ILQ and scales measuring related concepts. Fourteen patients also completed a retest survey 4 weeks later. Survey sample data were combined with ILQ data from another 56 patients with acromegaly for a factor analysis. Reliability was assessed with Cronbach's alpha and test-retest. Zero-order correlations were examined between ILQ subscales and symptoms, depression, SF-12 mental and physical components, a measure of self-care burden, appraisal of illness, and single-item measures of quality of life and satisfaction. RESULTS: The preconceived subscale structure was supported by factor analysis. These factors were internally consistent and stable over time. Good convergent validity was demonstrated between the Burden and Disruption scales with other measures of the burden of treatment. Patients indicated that they were generally compliant with therapy, and that treatment was not particularly burdensome or disruptive. Results based on the ILQ were consistent with other scales and qualitative responses. CONCLUSIONS: The ILQ has three subscales, Burden, Lifestyle Disruption, and Compliance, that are reliable and demonstrate preliminary evidence of construct validity.

Incidence of small-bowel obstruction and adhesiolysis after open colorectal and general surgery.

PURPOSE: The study contained herein was undertaken to establish the incidence of small-bowel obstruction, adhesiolysis for obstruction, and additional abdominal surgery after open colorectal and general surgery. METHODS: A retrospective cohort study was performed using patient-specific Health Care Financing Administration data to evaluate a random 5 percent sample of all Medicare patients who underwent surgery in 1993. Of these, 18,912 patients had an index abdominal procedure. Two-year follow-up data documented outcomes of hospitalizations with obstruction, adhesiolysis for obstruction, and/or additional open colorectal or general surgery. RESULTS: Within two years of incision, excision, and anastomosis of intestine (International Classification of Dis eases (ICD)-9 code 45), 14.3 percent of patients had obstructions, 2.6 percent required adhesiolysis for obstructions, and 12.9 percent underwent additional open colorectal or general surgery. After other operations of intestine (ICD code 46), 17 percent of patients had obstructions, 3.1 percent required adhesiolysis for obstructions, and 20.2 percent underwent additional open colorectal or general surgery. After operations of rectum, rectosigmoid, and perirectal tissue (ICD code 48), 15.3 percent of patients had obstructions, 5.1 percent required adhesiolysis for obstructions, and 16.4 percent underwent additional open colorectal or general surgery. After other operations on the abdominal region (ICD code 54), 12.4 percent of patients had obstructions, 2.3 percent required adhesiolysis for obstructions, and 8.8 percent underwent additional open colorectal or general surgery. CONCLUSIONS: In this retrospective study of Medicare patients, we learned that bowel obstruction, adhesiolysis for obstructions, and additional abdominal surgery occurred more often after abdominal surgery than was previously published.

Use of cardiac procedures and outcomes in elderly patients with myocardial infarction in the United States and Canada.

BACKGROUND: Acute myocardial infarction is a leading cause of morbidity and mortality in the United States and Canada. We performed a population-based study to compare the use of cardiac procedures and outcomes after acute myocardial infarction in elderly patients in the two countries. METHODS: We compared the use of invasive cardiac procedures and the mortality rates among 224,258 elderly Medicare beneficiaries in the United States and 9444 elderly patients in Ontario, Canada, each of whom had a new acute myocardial infarction in 1991. RESULTS: The U.S. patients were significantly more likely than the Canadian patients to undergo coronary angiography (34.9 percent vs. 6.7 percent, P< 0.001), percutaneous transluminal coronary angioplasty (11.7 percent vs. 1.5 percent, P<0.001), and coronary-artery bypass surgery (10.6 percent vs. 1.4 percent, P<0.001) during the first 30 days after the index infarction. These differences in the use of cardiac procedures narrowed but persisted through 180 days of follow-up. The 30-day mortality rates were slightly but significantly lower for the U.S. patients than for the Canadian patients (21.4 percent vs. 22.3 percent, P=0.03). However, the one-year mortality rates were virtually identical (34.3 percent in the United States vs. 34.4 percent in Ontario, P= 0.94). CONCLUSIONS: Short-term mortality after an acute myocardial infarction was slightly lower in the United States than in Ontario, but these differences did not persist through one year of follow-up. The strikingly higher rates of use of cardiac procedures in the United States, as compared with Canada, do not appear to result in better long-term survival rates for elderly U.S. patients with acute myocardial infarction.

Defining outcomes in older patients with cardiovascular disease.

It is now possible to track a comprehensive range of outcomes in elderly cardiac patients. Beside vital clinical end-points, these include health-related quality of life, satisfaction with care, and economic outcomes. This range of outcomes, each set complementing the others, can support patient care that is more effective from both the physician's and the patient's perspective. In this summary article, quality of life, satisfaction and economic outcomes are explored relative to the treatment of elderly cardiac patients. This is not meant to diminish the importance of the clinical measures that can and must be readily appreciated by physicians managing their cardiac patients. Instead, the measures discussed here augment the armamentarium that physicians can use to implement their patient care responsibilities.

Variation in the use of cardiac procedures after acute myocardial infarction.

BACKGROUND: There are large geographic differences in the frequency with which coronary angiography and revascularization are performed. We attempted to assess whether differences in case mix or in the treatment of specific groups of patients may explain this variability. We also assessed the consequences of various patterns of treatment. METHODS: We studied patients covered by Medicare who were 65 to 79 years of age and were admitted to 478 hospitals with acute myocardial infarctions during 1990 in New York (1852 patients), where the rate of use of cardiac procedures is low, and in Texas (1837 patients), where the rate of use of such procedures is high. We compared the patterns of treatment of clinically similar groups of patients in the two states. We also compared mortality rates and measures of the health-related quality of life. RESULTS: Coronary angiography was performed more often in Texas than in New York (45 percent vs. 30 percent, P < 0.001). The frequency of use in Texas was significantly higher than that in New York for all the clinical subgroups of patients analyzed except those at greatest risk for reinfarction. Over a two-year period, the adjusted likelihood of death was lower in New York than in Texas (hazard ratio, 0.87; 95 percent confidence interval, 0.78 to 0.98). Patients from Texas were 41 percent more likely to report angina (P = 0.002) and 62 percent more likely to say they could not perform activities requiring energy expenditure of 5 or more metabolic equivalents than patients from New York approximately two years after infarction (P < 0.001). CONCLUSIONS: Physicians in Texas were more likely to perform angiography than physicians in New York for patients whose conditions allowed more discretion in the use of cardiac procedures. On average, there appears to be no advantage with respect to mortality or health-related quality of life to performing the procedures at the higher rate used in Texas.

Permanent pacemaker selection and subsequent survival in elderly Medicare pacemaker recipients.

BACKGROUND: Dual-chamber pacemakers have been in use for more than 15 years. Although they may confer a physiological advantage over single-chamber ventricular pacemakers, they are more expensive and have a generally shorter service life than single-chamber devices. We carried out the present study to identify patient subgroups who were preferentially receiving greater or lesser proportions of dual-chamber devices and to determine whether the selection of different types of pacemakers was associated with differences in mortality. METHODS AND RESULTS: We analyzed a 20% random national sample of all Medicare beneficiaries aged 65 years or older who underwent initial placement of a permanent pacemaker and were discharged in 1988, 1989, or 1990 (n = 36,312). The minimum follow-up for vital status was 1 year. The relation of pacemaker type to patient and provider characteristics was determined using logistic regression analysis. The relation between pacemaker type and mortality was determined using the Cox proportional hazards method. The proportion of dual-chamber systems that were received increased from 27.2% in 1988 to 37.0% in 1990 (P < .001). Dual-chamber pacemaker recipients were younger (P < .001) than ventricular pacemaker recipients. Other independent correlates of dual-chamber pacemaker selection included male sex (odds ratio and 95% confidence intervals, 1.18 and 1.12 to 1.24, respectively), atrioventricular block (1.59 and 1.51 to 1.67), congestive heart failure (1.14 and 1.08 to 1.20), atrial fibrillation (0.36 and 0.34 to 0.39), and the presence of a major noncardiac diagnosis (0.86 and 0.83 to 0.89). Nonmedical predictors of dual-chamber pacemaker selection included Medicaid eligibility (0.78 and 0.71 to 0.86), implantation in the western United States (1.19 and 1.10 to 1.29), implantation by a rural provider (0.70 and 0.65 to 0.76), hospitalization in a 500-bed-or-larger hospital (1.20 and 1.13 to 1.28), hospitalization in a private hospital (1.19 and 1.10 to 1.28), or hospitalization in a hospital with a catheterization laboratory (1.47 and 1.38 to 1.56). Dual-chamber pacemaker selection was an independent predictor of survival at 1 year (0.82 and 0.77 to 0.87) and at 2 years (0.82 and 0.77 to 0.87) after controlling for potentially confounding patient-level and hospital-level characteristics. CONCLUSIONS: The present study describes important variations in the clinical practice of cardiac pacing, many of which are not based on clinical characteristics. Furthermore, the selection of a dual-chamber pacemaker is associated with increased survival. These results underscore the need for prospective, outcome-based clinical trials of pacemaker mode selection.

Knowledge and practices of generalist and specialist physicians regarding drug therapy for acute myocardial infarction.

BACKGROUND: The respective roles of generalist and specialist physicians in the care of patients is currently a matter of debate. Information is limited about the knowledge and practices of generalist and specialist physicians regarding conditions that both groups treat, such as myocardial infarction. METHODS: We therefore surveyed 1211 cardiologists, internists, and family practitioners in the states of New York and Texas about four treatments demonstrated by randomized clinical trials to be associated with improved survival after myocardial infarction (thrombolytic therapy, immediate and long-term use of aspirin, and long-term use of beta-blockers) and two treatments for which such evidence is lacking (diltiazem for patients with pulmonary congestion and prophylactic lidocaine). We asked physicians about the effect of each treatment on survival and the likelihood that they would prescribe each class of drugs. RESULTS: For the four beneficial treatments, the cardiologists believed more strongly than the internists and family physicians that survival was improved by the treatment, and they were more likely to prescribe these drugs (P < 0.001). For example, 94.1 percent of cardiologists said they were very likely to prescribe thrombolytic agents to treat an acute myocardial infarction, as compared with 82.0 percent of internists and 77.3 percent of family practitioners. Conversely, for the two treatments for which trials showed no evidence of a survival benefit, cardiologists were less likely than internists and family practitioners to think there was such a benefit and less likely to prescribe the drugs (P < 0.001). For example, 4.7 percent of cardiologists reported that they were very likely to use prophylactic lidocaine, as compared with 13.1 percent of internists, and 16.5 percent of family practitioners. When we used logistic regression to adjust for potential confounders, all the differences between the cardiologists and the internists and family practitioners remained significant (P < 0.02). CONCLUSIONS: Internists and family practitioners are less aware of or less certain about key advances in the treatment of myocardial infarction than are cardiologists. This finding underscores the need to improve the dissemination of information from clinical trials to generalist physicians, particularly if they are to have an enlarged role in the evolving health care system.

Using Medicare claims for outcomes research.

Medicare claims databases have several advantages for use in constructing episodes of care for outcomes research. They are population-based, relatively inexpensive to obtain, include large numbers of cases, and can be used for long-term follow-up. However, the sheer size of these claims databases, along with their primarily administrative (as opposed to clinical) nature, requires that researchers take special care in using them. The 10 PORTs using Medicare claims provided information on their approach to several key issues in working with these data, including: 1) identifying the index cases or patient cohorts to be studied; 2) defining the length of the episode; and 3) measuring outcomes. This paper reports the experience and knowledge gained by these PORTs in using these claims to create and analyze episodes of care.