Prostate-specific antigen screening among young men in the United States.

Background: Disagreement exists on the use of prostate-specific antigen (PSA) tests for cancer-risk stratification in young men in the United States. Little is known about the use of PSA testing in these men. To understand policy implications of risk stratification, the authors sought to characterize PSA use among young men.

Use of larger versus smaller drug-safety databases before regulatory approval: the trade-offs.

Although efforts to revamp the drug-safety system have been directed at strengthening postmarketing surveillance, strategies for the preapproval stage may be useful. One strategy would be to require larger sample sizes in preapproval safety databases. To evaluate the potential benefits and costs of this approach, we developed a hypothetical model to estimate the expected incremental number of adverse drug events that could be avoided in a postapproval population.

Study of the impact of oseltamivir on the risk for pneumonia and other outcomes of influenza, 2000-2005.

Context: Influenza results in large numbers of secondary complications and hospitalizations.

Objective: To assess the impact of oseltamivir on influenza-related complications and hospitalizations by analyzing health insurance claims data for 6 influenza seasons.

Design: A retrospective cohort study utilizing claims data from the 2000-2005 influenza seasons.

Identification of patients with diabetic macular edema from claims data: a validation study.

Objective: To assess the validity of an algorithm for identifying patients with diabetic macular edema (DME) using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes in administrative billing data from a convenience sample of physician offices.

Methods: A convenience sample of 12 general ophthalmologists and 10 retina specialists applied prespecified algorithms based on ICD-9-CM diagnosis codes to the billing claims of their practices and selected the associated medical records. Four ophthalmologists abstracted data from the medical records, which were then compared with the coded diagnoses.

Association between the Medicare Modernization Act of 2003 and patient wait times and travel distance for chemotherapy.

Context: The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) altered reimbursements for outpatient chemotherapy drugs and drug administration services. Anecdotal reports suggest that these adjustments may have negatively affected access to chemotherapy for Medicare beneficiaries.

Objective: To compare patient wait times and travel distances for chemotherapy before and after the enactment of the MMA.

Sensitivity of International Classification of Diseases codes for hyponatremia among commercially insured outpatients in the United States.

Background: Administrative claims are a rich source of information for epidemiological and health services research; however, the ability to accurately capture specific diseases or complications using claims data has been debated. In this study, the authors examined the validity of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes for the identification of hyponatremia in an outpatient managed care population.

Methods: We analyzed outpatient laboratory and professional claims for patients aged 18 years and older in the National Managed Care Benchmark Database from Integrated Healthcare Information Services.

Cost-effectiveness of the oral adsorbent AST-120 versus placebo for chronic kidney disease.

Aim: This study was designed to evaluate the cost-effectiveness of AST-120, an oral adsorbent that attenuates the progression of chronic kidney disease.

Methods: We developed a Markov model with six health states, including four levels of serum creatinine, haemodialysis and death, using data from a randomized clinical trial conducted in Japan. Direct costs relevant to chronic kidney disease were calculated from a Japanese reimbursement perspective.

Outcomes of second revascularization procedures after stent implantation.

Drug-eluting stents (DES) reduce subsequent revascularization procedures. Although randomized trials have compared DES to brachytherapy and balloon angioplasty (PTCA) for in-stent restenosis, few long-term comparisons have been made to bare metal stents (BMS) or bypass surgery (CABG), particularly following second procedures. We sought to assess the association between revascularization modality and long-term clinical outcomes of patients receiving a second procedure for coronary artery disease.

Consistency of financial interest disclosures in the biomedical literature: the case of coronary stents.

Background: Disclosure of authors' financial interests has been proposed as a strategy for protecting the integrity of the biomedical literature. We examined whether authors' financial interests were disclosed consistently in articles on coronary stents published in 2006.

Methodology/principal Findings: We searched PubMed for English-language articles published in 2006 that provided evidence or guidance regarding the use of coronary artery stents.

Updated estimates of survival and cost effectiveness for imatinib versus interferon-alpha plus low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukaemia.

Background: For trials in which participants are followed beyond the main study period to assess long-term outcomes, economic evaluations conducted using short-term data should be systematically updated to reflect new information.

Methods: We used 60-month survival data from the IRIS (International Randomized study of Interferon vs STI571) trial to update previously published cost-effectiveness estimates, based on 19 months of follow-up, of imatinib versus interferon (IFN)-alpha plus low-dose cytarabine in patients with chronic-phase chronic myeloid leukaemia. For patients treated with imatinib, we used the 60-month data to calibrate the survival curves generated from the original cost-effectiveness model.

Using health communication best practices to develop a web-based provider-patient communication aid: the CONNECT study.

Objective: Although there is broad consensus that careful content vetting and user testing is important in the development of technology-based educational interventions, often these steps are overlooked. This paper highlights the development of a theory-guided, web-based communication aid (CONNECT), designed to facilitate treatment decision-making among patients with advanced cancer.

Methods: The communication aid included an on-line survey, patient skills training module and an automated physician report.

Postdialysis outcomes associated with consistent anemia treatment in predialysis patients with chronic kidney disease.

Aims: Anemia and cardiovascular (CV) events are major complications of chronic kidney disease (CKD) during dialysis. We conducted a retrospective observational study in CKD patients with anemia to evaluate the association between predialysis use of erythropoiesis-stimulating agents (ESAs) and postdialysis CV outcomes.

Methods: The study analyzed claims data on incident hemodialysis patients aged > or = 18 years (identified between January 2000 and November 2005).

Expectations of benefit in early-phase clinical trials: implications for assessing the adequacy of informed consent.

Background: Participants in early-phase clinical trials have reported high expectations of benefit from their participation. There is concern that participants misunderstand the trials to which they have consented, which is based on assumptions about what patients mean when responding to questions about likelihood of benefit.

Methods: Participants were 27 women and 18 men in early-phase oncology trials at 2 academic medical centers in the United States.

Impact of heart failure on patients undergoing major noncardiac surgery.

Background: Changes in the demographics and epidemiology of patients with cardiovascular comorbidities who undergo major noncardiac surgery require an updated assessment of which patients are at greater risk of mortality or readmission. The authors evaluated short-term outcomes among patients with heart failure, coronary artery disease (CAD), or neither who underwent major noncardiac surgery.

Methods: Patients were aged 65 and older, had Medicare fee-for-service coverage, and underwent 1 of 13 major noncardiac procedures from 2000 through 2004, excluding patients with end-stage renal disease and patients who did not have at least 1 yr of Medicare fee-for-service eligibility before surgery.

Evidence-based perspectives on pay for performance and quality of patient care and outcomes in emergency medicine.

Pay for performance is gaining momentum as a means to improve the quality of clinical care. Recently, the Centers for Medicare & Medicaid Services has expanded pay for performance initiatives to incorporate 9 emergency care metrics, including indicators for cardiac, pneumonia, and stroke care. The American College of Cardiology and American Heart Association (ACC/AHA) have published methodology for the selection and creation of performance measures for quantifying the quality of cardiovascular care.

Does reimportation reduce price differences for prescription drugs? Lessons from the European Union.

Objective: To examine the effect of parallel trade on patterns of price dispersion for prescription drugs in the European Union.

Data Sources: Longitudinal data from an IMS Midas database of prices and units sold for drugs in 36 categories in 30 countries from 1993 through 2004.

Study Design: The main outcome measures were mean price differentials and other measures of price dispersion within European Union countries compared with within non-European Union countries.

Incidence and prevalence of heart failure in elderly persons, 1994-2003.

Background: Recent analyses have presented conflicting evidence regarding the incidence and prevalence of heart failure in the United States. We sought to estimate the annual incidence and prevalence of heart failure and associated survival in elderly persons from January 1, 1994, through December 31, 2003.

Methods: We conducted a retrospective cohort study of 622,789 Medicare beneficiaries 65 years or older who were diagnosed as having heart failure between 1994 and 2003.

Pharmacogenetic testing of CYP2C9 and VKORC1 alleles for warfarin.

American College of Medical Genetics statements and guidelines are designed primarily as an educational resource for medical geneticists and other health care professionals to help them provide quality medical genetic services. Adherence to these standards and guidelines does not necessarily ensure a successful medical outcome. These statements and guidelines should not be considered inclusive of all proper procedures and tests or exclusive of other procedures and tests that are reasonably directed to obtaining the same results.

Racial/ethnic variation in perceptions of medical information sources in Durham County, North Carolina.

Background: Concerns about health and health care disparities have led some groups to promote better communication of medical information as a potential means of empowering patients to overcome barriers to health care and to practice healthy behaviors. We examined the independent effect of race/ethnicity on perceptions of the usefulness of different sources of health information.

Methods: We analyzed data from a cross-sectional telephone survey of black, Latino, and white adults (n = 515) in Durham County North Carolina, in 2002.

Medical costs of abnormal serum sodium levels.

An abnormal serum sodium level is the most common electrolyte disorder in the United States and can have a significant impact on morbidity and mortality. The direct medical costs of abnormal serum sodium levels are not well understood. The impact of hyponatremia and hypernatremia on 6-mo and 1-yr direct medical costs was examined by analyzing data from the Integrated HealthCare Information Services National Managed Care Benchmark Database.

Challenges in enrollment of minority, pediatric, and geriatric patients in emergency and acute care clinical research.

Study Objective: Emergency department (ED) -based clinical research has the potential to include patient populations that are typically underrepresented in clinical research. The objective of this study is to assess how emergency clinical care and research processes, informed consent, and patient demographic factors (age, sex, and ethnicity/race) affect enrollment and consent in clinical research in the ED.

Methods: This was an analysis of prospectively collected data of all patients (aged 2 to 101 years) eligible for one of 7 clinical research studies from February 2005 to April 2007 in an academic ED.

Economic implications of potential changes to regulatory and reimbursement policies for medical devices.

Objective: To evaluate the impact of regulatory scenarios on the financial viability of medical device companies.

Design: We developed a model to calculate the expected net present value of a hypothetical product throughout preclinical development, clinical testing, regulatory approval, and postmarketing. We tested 3 scenarios: (1) the current regulatory environment; (2) a scenario in which medical devices are subject to the same evidence standards required for pharmaceuticals; and (3) a scenario consistent with the Coverage with Evidence Development: Coverage with Study Participation (CSP) policy proposed by the Centers for Medicare and Medicaid Services, whereby Medicare will pay for beneficiaries to receive new devices that are not currently determined to be "reasonable and necessary" if the patients participate in clinical studies or registries.

Characteristics of nontraumatic subarachnoid hemorrhage in the United States in 2003.

Objective: Substantial progress has been made in the diagnosis and treatment of subarachnoid hemorrhage (SAH). However, studies of SAH in the United States do not include information more recent than 2001, precluding analysis of shifts in treatment methods. We examined the epidemiology and in-hospital outcomes of nontraumatic SAH in the United States.