Peer-reviewed Original Research Articles Research Articles

Press Releases and News Stories Often Contain Exaggerated Claims

Healthcare institutions use press releases to convey the results of research studies to news media; however, some press releases exaggerate findings and lack appropriate caveats. In this study, researchers determined how often press releases and news stories contained claims and advice that distorted or exaggerated those presented in corresponding peer-reviewed original research articles. The researchers identified …

Cost-effectiveness analyses of targeted oral anti-cancer drugs: a systematic review.

Over the last 15 years, a paradigm shift in oncology has led to the approval of dozens of targeted oral anti-cancer medications (OAMs), which have become the standard of care for certain cancers. While more convenient for patients than infused drugs, the possibility of non-adherence and the frequently high costs of targeted OAMs have proven controversial. Our objective was to perform the first comprehensive review of cost-effectiveness analyses (CEAs) of targeted OAMs. A literature search in PubMed, The Cochrane Library, and the Health Technology Assessment (HTA) reports published by the National Institute for Health Research HTA Programme in the UK was performed, covering articles published in the 5 years prior to 30 September 2013. Our inclusion criteria were peer-reviewed English-language full-text original research articles with a primary focus on CEA related to targeted OAMs. We categorized these articles by treatment setting (i.e. cancer site/type, line of therapy, and treatment and comparator) and synthesized information from the articles into summary tables. We identified 41 CEAs covering nine of the 18 targeted OAMs approved by the US FDA as of December 2012. These medications were studied in seven cancers, most often as second-line therapy for advanced-stage patients. In over half of treatment settings where a targeted OAM was compared with treatment that was not a targeted OAM, targeted OAMs were considered cost effective. Limitations in interpreting these findings include the risk of bias due to author conflicts of interest, cross-country variation, and difficulties in generalizing clinical trial evidence to community practice. Several types of cost-effectiveness studies remain under-represented in the literature on targeted OAMs, including those for follow-on indications approved after the initial indication for a drug and for off-label indications, head-to-head comparisons of targeted OAMs with other targeted OAMs and targeted intravenous therapies, and studies that adopt a perspective other than the payer's. Keeping up with the increasing number of approved targeted OAMs will also prove an important challenge for economic evaluation.

Epidemiology and risk factors for drug allergy

The aim of this review was to describe the current evidence-based knowledge of the epidemiology, prevalence, incidence, risk factors and genetic associations of drug allergy. Articles published between 1966 and 2010 were identified in MEDLINE using the key words adult, adverse drug reaction reporting systems, age factors, anaphylactoid, anaphylaxis, anaesthetics, antibiotics, child, drug allergy, drug eruptions, ethnic groups, hypersensitivity, neuromuscular depolarizing agents, neuromuscular nondepolarizing agents, sex factors, Stevens Johnson syndrome and toxic epidermal necrolysis. Additional studies were identified from article reference lists. Relevant, peer-reviewed original research articles, case series and reviews were considered for review. Current epidemiological studies on adverse drug reactions (ADRs) have used different definitions for ADR-related terminology, often do not differentiate immunologically and non-immunologically mediated drug hypersensitivity, study different study populations (different ethnicities, inpatients or outpatients, adults or children), utilize different methodologies (spontaneous vs. non-spontaneous reporting, cohort vs. case-control studies), different methods of assessing drug imputability and different methods of data analyses. Potentially life-threatening severe cutaneous adverse reactions (SCAR) are associated with a high risk of morbidity and mortality. HLA associations for SCAR associated with allopurinol, carbamazepine and abacavir have been reported with the potential for clinical use in screening prior to prescription. Identification of risk factors for drug allergy and appropriate genetic screening of at-risk ethnic groups may improve the outcomes of drug-specific SCAR. Research and collaboration are necessary for the generation of clinically-relevant, translational pharmacoepidemiological and pharmacogenomic knowledge, and success of health outcomes research and policies on drug allergies.

Creative Arts Occupations in Therapeutic Practice: A Review of the Literature

The purpose of this study was to conduct a matrix method literature review of published research on the use of creative arts occupations in therapeutic practice. Peer-reviewed original research articles, published between the years 2000 and 2008, were included in the review. The research articles studied creative arts occupations as a therapeutic medium. Twenty-three articles, located through multiple electronic searches, were identified as meeting the criteria of the review. Data analysis included quantitative analysis and qualitative analysis. The findings suggest that the use of creative arts occupations in therapeutic practice may have important qualitative value related to health and wellbeing. Six predominant outcomes were most frequently identified across the studies: enhanced perceived control, building a sense of self, expression, transforming the illness experience, gaining a sense of purpose and building social support. The results suggest that qualitative research may well be the methodology of choice for the study of this topic and raise questions about the paucity of research in this area. Further research into the use of creative arts occupations as a therapeutic approach in occupational therapy and other health and social care disciplines is warranted.

The Aging of Human-Immunodeficiency-Virus-Associated Neurocognitive Disorders

This special issue proposes a new era for studies of the humanimmunodeficiency-virus-type-one (HIV-1) -associated neurological disorders serving to highlight cognitive abnormalities in infected aging patients. It has been 15 years since the “Third Workshop on NeuroAIDS” was held (Black and Sager 1994). At that time, NeuroAIDS (or the AIDS dementia complex) was the principal manifestation of cognitive, behavioral, and motor abnormalities in patients with the acquired immunodeficiency syndrome (AIDS). This has all but changed. Indeed, after introduction of highly active antiretroviral therapy (HAART) in 1996 and1997, the prevalence of severe manifestations of NeuroAIDS was significantly reduced, and the HIV patients show reduced disease morbidities and mortality. According to the Centers for Disease Control, the number of people 50 years and older infected with HIV has increased from 77% from 2001 to 2005. As HIV disease becomes a treatable medical disorder, morbidities in the HAART era abound including those linked to antiretroviral toxicities and viral infection per se as well as common disorders that all aging patients face, such as chronic obstructive pulmonary disease, diabetes, atherosclerosis-linked heart, vascular and kidney failure, bleeding ulcers, depression, cancers, and osteoporosis. Recent studies on aged HIV patient brain suggest a new type of neurological disorders distinct from HIV-1-associated dementia (HAD) and now termed HIV-associated neurocognitive disorders (HAND). HAND in aged population is linked, in part, to early signs of beta-amyloidosis or microtubule-associated tau aggregation commonly seen in Alzheimer’s disease (AD) or tauopathy brain. However, whereas extracellular amyloid plaques (senile plaques) are the major amyloid pathology in AD, HAND brains show intraneuronal amyloid accumulation or perivascular diffuse amyloid deposition, indicating distinct mechanisms and brain disease development. Considering the increase in the aged HIV population, this issue of the Journal of Neuroimmune Pharmacology will specifically focus for the first time on age-associated neurodegeneration in HIV patients. Special emphasis was made on beta-amyloidosis contributed by an outstanding line of seven investigators representing the cutting edge of HAND research activities. Peer-reviewed original research and review articles provide clear direction for forthcoming HAND research directives. The issue is lead by a comprehensive review of neurodegeneration and aging in the HAART era (Brew et al. 2009). This review discusses the history of NeuroAIDS, HAART, and persistent neurodegeneration in HAARTtreated patients. The implication of neurodegeneration in post-HAART patients is provocative and highlighted in its association with HIV, aging, and inflammation. Potential mechanisms common to specific diseases, such as AD and Parkinson’s disease, and therapeutic inventions are proposed. HAND pathogenesis, in the context of selective vulnerability of specific neuronal populations, epidemiology, and risk factors, is reviewed by Jayadev and Garden (2009). This article discusses a variety of host and viral factors that are associated with increased risk of developing HAND, and some of which are associated with the development of AD. Here, they propose a different view of how viral J Neuroimmune Pharmacol (2009) 4:161–162 DOI 10.1007/s11481-009-9155-5

Monitoring of IgE-mediated food allergy in childhood.

The prevalence of IgE-mediated food allergy (FA) in childhood varies from 6% to 8% in the first year of life compared to 1% to 2% in adults. In contrast to adults, FA in childhood, often part of the "allergic march", resolves in more than 85% of children, especially those with hypersensitivity to cow's milk and egg. This paper explains the rationale for continuing care for childhood FA and describes how children should be monitored for resolution/persistence of FA. A clinical, multidisciplinary approach and management algorithm based on relevant, peer-reviewed original research articles and reviews using the keywords anaphylaxis, atopic eczema, children, milk allergy, double-blind placebo-controlled food challenge, egg allergy, epinephrine, failure to thrive, food allergy, food challenge, food hypersensitivity, immunoglobulin E, nutrition, natural history, paediatrics, peanut allergy, prevalence, psychosocial factors, quality of life, radioallergosorbent test, and tolerance from years 1966 to 2003 in MEDLINE. Additional studies were identified from article reference lists. A combination of outcome measures, a multidisciplinary approach involving a dietitian and allergy nurse specialist, and a management algorithm are useful tools in clinical management. Prospective studies of non-selected children, optimally from birth cohorts, are needed to evaluate the effects of such management programmes regarding FA in childhood.

Anaphylaxis during surgical and interventional procedures

To describe the current evidence-based knowledge of the causes, diagnostic evaluation, and treatment of patients with anaphylaxis associated with surgical and interventional procedures. Articles published between 1966 and 2003 were identified in MEDLINE using the keywords anaphylactoid, anaphylaxis, anesthetics, antibiotics, cephalosporins, contrast media, colloids, flow cytometry, hypersensitivity, latex, neuromuscular depolarizing agents, neuromuscular nondepolarizing agents, penicillins, radioallergosorbent test, skin test, and vancomycin. Additional studies were identified from article reference lists. Relevant, peer-reviewed original research articles and reviews. Neuromuscular blocking agents, natural rubber latex, antibiotics, and induction agents are the most common causes of anaphylaxis during surgical and interventional procedures. Colloids, opioids, and radiocontrast media probably account for less than 10% of all reactions. Newer agents implicated in anaphylaxis include isosulphan blue and chlorhexidine. Skin tests are useful for evaluating allergic reactions to anesthetic agents and penicillins and for selecting alternative agents. Skin testing and specific IgE measurements for latex vary in allergen standardization and sensitivity and specificity, respectively. Flow cytometric allergen stimulation tests show promise in differentiating allergic from idiosyncratic ("pseudoallergic") reactions. Drug desensitization has been shown to be useful for penicillin anaphylaxis. Premedication with histamine receptor antagonists and corticosteroids helps prevent or attenuate radiocontrast media reactions. Anaphylaxis during surgical and interventional procedures may be difficult to evaluate because of the rapid, successive use of multiple drugs or diagnostic agents. Careful analysis of anesthetic records and diagnostic tests for all the putative agents are necessary to ensure a complete evaluation.

Icodextrin: Overview of Clinical Experience

To review all clinical studies and experience gained with icodextrin to date; primarily its use in peritoneal dialysis in patients with end-stage renal failure, but also its use as an intraperitoneal vehicle. Peer-reviewed original research articles in the literature; abstracts from international scientific meetings; data generated from the compassionate use programme. All published studies to date are included, some 10-20 studies being included in this review. Data have not been specifically extracted from studies; results have been described in the context of overall experience. Over ten years of clinical experience with icodextrin have now been accumulated, in both continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD). A small number of patients have received icodextrin for over five years, with no loss of effect. Icodextrin produces sustained ultrafiltration over long dwells while being iso-osmolar, by the process of colloid osmosis. Icodextrin represents the first viable alternative osmotic agent to glucose, for use in solutions for peritoneal dialysis. It also has a potential use as a vehicle solution for intraperitoneal drug delivery.