Theories behind Bacillus Calmette-Guérin failure in high-risk non-muscle-invasive bladder cancer and update on current management.

Bladder cancer encapsulates a wide spectrum of disease severities, with non-muscle invasive bladder cancer (NMIBC) representing an entirely different entity from muscle-invasive disease. Bacillus Calmette-Guérin (BCG) is one of the most successful intravesical treatment methods for patients diagnosed. However, a considerable proportion of patients fail to respond to BCG treatment.

Current process and outcomes of the surgical management of LUTS due to benign prostatic enlargement: how consistent are we? - results from the multi-institutional audit of surgical management of BPE (AuSuM BPE) in the United Kingdom.

Objective: In view of changing landscape of surgical treatment for LUTS secondary to BPE, this audit was undertaken to assess key aspects of the processes and outcomes of the current interventional treatments for BPE, across different units in the UK.

Materials And Method: A multi-institutional snapshot audit was conducted for patients undergoing interventions for LUTS/BPE over 8-week period. Using Delphi process two-part proforma was designed to capture data.

Systematic Literature Review of the Burden of Disease and Treatment for Transfusion-dependent β-Thalassemia.

Purpose: β-Thalassemia is an inherited blood disorder characterized by reduced or no production of adult hemoglobin. Systematic identification of the burden of β-thalassemia with contemporary treatments is lacking in published literature. Thus, a gap exists in understanding the baseline burden on which to assess future treatments.

Health state utilities associated with treatment for transfusion-dependent β-thalassemia.

Objectives: Transfusion-dependent β-thalassemia (TDT) is a genetic disease that affects production of red blood cells. Conventional treatment involves regular red blood cell transfusions and iron chelation, which has a substantial impact on quality of life. While potentially curative, allogeneic hematopoietic stem cell transplantation (allo-HSCT) is associated with risk of complications, including graft-versus-host disease (GvHD).

Increased Abundance and Nursery Habitat Use of the Bull Shark (Carcharhinus leucas) in Response to a Changing Environment in a Warm-Temperate Estuary.

A general northward shift in marine species distributions has been observed in the western North Atlantic Ocean, which may have significant ecological consequences. Large coastal sharks can have wide migratory distributions but show fidelity to specific nursery habitats. Here we show evidence for nursery range expansion into Pamlico Sound, North Carolina by a marine apex predator, the Bull Shark (Carcharhinus leucas).

Delineation and mapping of coastal shark habitat within a shallow lagoonal estuary.

Estuaries function as important nursery and foraging habitats for many coastal species, including highly migratory sharks. Pamlico Sound, North Carolina, is one of the largest estuaries in the continental United States and provides a variety of potential habitats for sharks. In order to identify and spatially delineate shark habitats within Pamlico Sound, shark catch and environmental data were analyzed from the 2007-2014 North Carolina Division of Marine Fisheries (NCDMF) gillnet and longline surveys conducted within the estuary.

The Early Engagement Model in Product Development: Linking "Proof of Concept" to "Proof of Medical Value".

In a rapidly changing health care environment, it is more important than ever that pharmaceutical manufacturers improve the quality and efficiency of their research and development efforts in order to help ensure the right drug gets to the right patient at the right time. The evolving role of the Medical Affairs, Health Economics & Outcomes Research (HEOR) and other functions engaged in evidence generation within the pharmaceutical industry is leading to earlier involvement in the clinical development process so that the proof of concept for new therapies can be more strongly linked to the proof of medical value. In this article, the authors outline key components of an Early Engagement Model that connects the proof of concept to proof of medical value through a systematic approach linking molecular profile with early insights on disease, unmet needs, stakeholder requirements, and patient-centric differentiation.

Every ward is a 'Nut Island'? Preventing good health-care teams 'going bad'.

This article explores how Levy's 'Nut Island effect' can be used to help identify health-care teams at risk of becoming isolated, disenchanted and separated physically and psychologically from senior management. Such isolation can lead to disastrous effects.

A perspective on the epidemiology of acetaminophen exposure and toxicity in the United States.

Acetaminophen is a commonly-used analgesic in the US and, at doses of more than 4 g/day, can lead to serious hepatotoxicity. Recent FDA and CMS decisions serve to limit and monitor exposure to high-dose acetaminophen. This literature review aims to describe the exposure to and consequences of high-dose acetaminophen among chronic pain patients in the US.

Outpatient RSV lower respiratory infections among high-risk infants and other pediatric populations.

Objective: To identify the frequency of outpatient, non-hospitalized visits for respiratory syncytial virus (RSV) lower respiratory tract infection (LRI) among children and high-risk infants.

Study Design: Published studies that reported population-based rates of outpatient RSV illness were reviewed. In addition, we conducted a retrospective cohort study from a national claims database including preterm and full term infants born between April 2004 and April 2006 <6 months of age and continuously enrolled through their first RSV season.

Value of biologic therapy: a forecasting model in three disease areas.

Objective: Forecast the return on investment (ROI) for advances in biologic therapies in years 2015 and 2030, based upon impact on disease prevalence, morbidity, and mortality for asthma, diabetes, and colorectal cancer.

Methods: A deterministic, spreadsheet-based, forecasting model was developed based on trends in demographics and disease epidemiology. 'Return' was defined as reductions in disease burden (prevalence, morbidity, mortality) translated into monetary terms; 'investment' was defined as the incremental costs of biologic therapy advances.

Evaluation of resource utilization and cost burden before and after an employer-based migraine education program.

Objectives: Study objectives were to determine the impact of migraine and severe headache on employer burden, resource utilization, and workplace productivity before and after a migraine education program; estimate the associated costs in an employed sample; and evaluate whether a migraine management program can help manage costs.

Methods: Employees of three US companies were informed of a company-specific web site with information regarding the study as well as a validated migraine screening questionnaire. Employees who screened positive for migraine completed a baseline survey examining migraine frequency and severity, Migraine Disability Assessment (MIDAS) grade, medical resource utilization, and impact on workplace productivity.

Can managed care organizations partner with manufacturers for comparative effectiveness research?

Objective: To describe 2 published pragmatic or practical clinical trials (PCTs) as case studies illustrating successful partnerships between managed care organizations (MCOs) and pharmaceutical manufacturers.

Study Design: In today's environment, there is increasing concern about the comparative effectiveness of medical interventions. Various opinion leaders and stakeholders lament the dearth of such evidence and are calling for the public and private sectors to invest up to billions of dollars to create better comparative evidence.

Cardiovascular disease and risk factors in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

Objective: To compare the prevalence of cardiovascular diseases and their risk factors between patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) and control subjects.

Methods: Data for patients continuously enrolled in an integrated outcomes database between January 1, 2001, and December 31, 2002, with International Classification of Diseases, 9th Revision codes of 714.x (RA), 696.

Estimating costs of care for patients with newly diagnosed metastatic colorectal cancer.

Background: This study examines the resource use patterns and costs of care for patients with incident metastatic colorectal cancer (mCRC) based on analyses of retrospective claims data from selected health plans in the United States.

Patients And Methods: A case-control analysis was performed using claims from years 1998-2004. Incident mCRC cases were identified based on evidence of a colorectal cancer diagnosis and a metastatic disease diagnosis.

The return on investment in health care: from 1980 to 2000.

Objective: To estimate the return on US investment (ROI) in overall health as well as four specific conditions.

Methods: The study utilized three distinct approaches to "triangulate" the evidence as related to ROI in health care: 1) an estimation of the average ROI in additional health-care service expenditures in the United States for the year 2000 compared with the year 1980, based on US summaries of health expenditures and health outcomes; 2) an estimate of the ROI in Medicare services for the period from 1985 to 2000 for treatment of heart attack, stroke, type 2 diabetes, and breast cancer, based on National Long-term Care Survey data and Medicare claims; and 3) an estimate of the ROI for selected major treatment innovations for the same four conditions during the period from 1975 to 2000.

Results: We calculated that each additional dollar spent on overall health-care services produced health gains valued at Dollars 1.

Assessment of quality of care for managed care and fee-for-service patients based on analysis of avoidable hospitalizations.

As managed care has grown to dominate the US health care delivery system, questions have been raised about the impact on the quality of care provided to its enrollees. Two important aspects of health care quality are access to care and the appropriateness of care. This analysis evaluated the occurrence of preventable hospitalizations among managed care (MCO) versus fee for service (FFS) populations to compare access to and appropriateness of preventive, primary, and surgical health care services.

A respiratory therapist-directed protocol for managing inpatients with asthma and COPD incorporating a long-acting bronchodilator.

This prospective study was designed to determine whether incorporating formoterol into a standardized respiratory therapist-directed protocol for administering bronchodilators to hospitalized patients with obstructive airway disease would reduce health care resource use and provide a safety advantage. All patients admitted to Washington Hospital Center with asthma and chronic obstructive pulmonary disease (CODP) are administered bronchodilators under a standardized respiratory therapist-directed protocol. Formoterol was the primary bronchodilator for the intervention period from January through March 2002, with levalbuterol, albuterol, and ipratropium available as needed.

Economic impact of respiratory syncytial virus-related illness in the US: an analysis of national databases.

Objective: To determine the impact of respiratory syncytial virus (RSV) infection on healthcare resource use and costs in the US from the third-party payer perspective.

Design: The study retrospectively analysed cross-sectional medical encounter data from three federally funded databases that comprise nationally representative samples of hospital inpatient stays, physician office visits and visits to hospital outpatient departments and emergency rooms.

Methods: Identification of RSV infection-related medical encounters was based on the occurrence of RSV-specific International Classification of Diseases (9th Edition)-Clinical Modification diagnosis codes (079.

Aeroallergens, allergic rhinitis, and sedating antihistamines: risk factors for traumatic occupational injury and economic impact.

Background: The U.S. workplace injury burden is significant.

Divalproex sodium versus olanzapine in the treatment of acute mania in bipolar disorder: health-related quality of life and medical cost outcomes.

Background: Divalproex sodium is a mood stabilizer used in the United States for the treatment of acute mania associated with bipolar disorder. Recently, olanzapine, an atypical antipsychotic, was approved for the treatment of acute mania. This study compares the clinical, health-related quality of life (HRQL), and economic outcomes of divalproex and olanzapine in the treatment of acute mania associated with bipolar disorder.