Safety and efficacy of the combination of trastuzumab with docetaxel for HER2-positive women with advanced breast cancer : a review of the existing clinical trials and results of the expanded access programme in the UK

Trastuzumab is a humanised monoclonal antibody against the extracellular domain of HER2 (human epidermal growth factor receptor-2) that is overexpressed in about 25% of human breast cancers. It has shown clinical benefit in HER2-positive breast cancer cases when used alone or in combination with chemotherapy. Trastuzumab increases the response rate to chemotherapy and prolongs survival when used in combination with taxanes. In this article, we review the clinical trials where trastuzumab has been administered together with docetaxel, and we present the results of the trastuzumab expanded access programme (EAP) in the UK. Combination of trastuzumab with docetaxel results in similar response rates and time-to-progression with the trastuzumab/paclitaxel combinations. The toxicity of the combination and the risk of heart failure are low. The clinical data for the docetaxel/trastuzumab combination indicate a favourable profile from both the efficacy and the safety point of view and confirm the feasibility and safety of trastuzumab administration both as monotherapy and in combination with docetaxel. © 2004 Blackwell Publishing Ltd.

A review of sedation scales for the cardiac catheterization laboratory

Sedation scales have the potential to facilitate effective procedural sedation and analgesia in the cardiac catheterization laboratory (CCL). For this potential to become realised, a scale that is suitable for use in the CCL either needs to be identified or developed. To identify sedation scales, a review of Medline and CINHAL was conducted. One sedation scale for the CCL, the NASPE SED, and 15 Intensive Care Unit (ICU) scales met the inclusion and exclusion criteria. Analysis of the scale’s item structures and psychometric properties was then performed. None of these scales were deemed suitable for use in the CCL. As such, further research is required to develop a new scale. The new scale should consist of more than one item because it will be the most effective for tracking the patient’s response to medications. Specific tests required to conduct a rigorous evaluation of the new scale’s psychometric properties are outlined in this paper.

The effectiveness of non-pharmacological interventions in improving psychological outcomes for heart transplant recipients : a systematic review

Background Post-heart transplant psychological distress may both directly hinder physiological health as well as indirectly impact on clinical outcomes by increasing unhealthy behaviours, such as immunosuppression non-adherence. Reducing psychological distress for heart transplant recipients is therefore vitally important, in order to improve patients’ overall health and well-being but also clinical outcomes, such as morbidity and mortality. Evidence from other populations suggests that non-pharmacological interventions may be an effective strategy. Aim To appraise the efficacy of non-pharmacological interventions on psychological outcomes after heart transplant. Method A systematic review was conducted using the Joanna Briggs Institute methodology. Experimental and quasi-experimental studies that involved any non-pharmacological intervention for heart transplant recipients were included, provided that data on psychological outcomes were reported. Multiple electronic databases were searched for published and unpublished studies and reference lists of retrieved studies were scrutinized for further primary research. Data were extracted using a standardised data extraction tool. Included studies were assessed by two independent reviewers using standardised critical appraisal instruments. Results Three studies fulfilled the inclusion and exclusion criteria, which involved only 125 heart transplant recipients. Two studies reported on exercise programs. One study reported a web-based psychosocial intervention. While psychological outcomes significantly improved from baseline to follow-up for the recipients who received the interventions, between-group comparisons were not reported. The methodological quality of the studies was judged to be poor. Conclusions Further research is required, as we found there is insufficient evidence available to draw conclusions for or against the use of non-pharmacological interventions after heart transplant.

Acquisition of expertise in cricket fast bowling : perceptions of expert players and coaches

Objectives: Experiential knowledge of elite athletes and coaches was investigated to reveal insights on expertise acquisition in cricket fast bowling. Design: Twenty-one past or present elite cricket fast bowlers and coaches of national or international level were interviewed using an in-depth, open-ended, semi-structured approach. Methods: Participants were asked about specific factors which they believed were markers of fast bowling expertise potential. Of specific interest was the relative importance of each potential component of fast bowling expertise and how components interacted or developed over time. Results: The importance of intrinsic motivation early in development was highlighted, along with physical, psychological and technical attributes. Results supported a multiplicative and interactive complex systems model of talent development in fast bowling, in which component weightings were varied due to individual differences in potential experts. Dropout rates in potential experts were attributed to misconceived current talent identification programmes and coaching practices, early maturation and physical attributes, injuries and lack of key psychological attributes and skills. Conclusions: Data are consistent with a dynamical systems model of expertise acquisition in fast bowling, with numerous trajectories available for talent development. Further work is needed to relate experiential and theoretical knowledge on expertise in other sports.

Experiential knowledge of expert coaches can help identify informational constraints on performance of dynamic interceptive actions

Coordination of dynamic interceptive movements is predicated on cyclical relations between an individual's actions and information sources from the performance environment. To identify dynamic informational constraints, which are interwoven with individual and task constraints, coaches’ experiential knowledge provides a complementary source to support empirical understanding of performance in sport. In this study, 15 expert coaches from 3 sports (track and field, gymnastics and cricket) participated in a semi-structured interview process to identify potential informational constraints which they perceived to regulate action during run-up performance. Expert coaches’ experiential knowledge revealed multiple information sources which may constrain performance adaptations in such locomotor pointing tasks. In addition to the locomotor pointing target, coaches’ knowledge highlighted two other key informational constraints: vertical reference points located near the locomotor pointing target and a check mark located prior to the locomotor pointing target. This study highlights opportunities for broadening the understanding of perception and action coupling processes, and the identified information sources warrant further empirical investigation as potential constraints on athletic performance. Integration of experiential knowledge of expert coaches with theoretically driven empirical knowledge represents a promising avenue to drive future applied science research and pedagogical practice.

Relationship between head contractors and subcontractors in the construction industry : a critical review

The interaction between head contractor and subcontractor in modern construction often contributes to the degree of success or failure of any large-scale construction project. In this paper, previous research on the relationship and interaction between head contractor and subcontractor is examined in order to establish how these relationships will affect the overall performance of a project. Based on the review, research questions on how to best manage the interaction and relationship between these two vital project participants are proposed and future research direction discussed.

Cardiac safety concerns for ondansetron, an antiemetic commonly used for nausea linked to cancer treatment and following anaesthesia

Introduction: Ondansetron is a 5-HT3 receptor antagonist commonly used as an anti-emetic to prevent the nausea and vomiting associated with anti-cancer drugs, cancer radiotherapy, or postoperatively. Recently, the US Food and Drug Administration (FDA) issued a warning for ondansetron due to a potential for prolongation of the QT interval of the electrocardiogram (ECG), a phenomenon that is associated with an increased risk of the potentially fatal arrhythmia torsade de pointes. Areas covered: We undertook a review of the cardiac safety of ondansetron. Our primary sources of information were PubMed (with downloading of full articles), and the internet. Expert opinion: The dose of ondansetron that the FDA has concerns about is 32 mg iv (or several doses that are equivalent to this), which is only used in preventing nausea and vomiting associated with cancer chemotherapy. This suggests that ondansetron may be safe in the lower doses used to prevent the nausea and vomiting in radiation treatment or postoperatively. However, as there is a report that a lower dose of ondansetron prolonged the QT interval in healthy volunteers, this needs to be clarified by the FDA. More research needs to be undertaken of the relationship between QT prolongation and torsades in order that the FDA can produce clear-cut evidence of pro-arrhythmic risk when introducing warnings for this.

Cardiac safety concerns for domperidone, an antiemetic and prokinetic, and galactogogue medicine

Introduction: Domperidone is a dopamine D2-receptor antagonist developed as an antiemetic and prokinetic agents. Oral domperidone is not approved in the US, but is used in many countries to treat nausea and vomiting, gastroparesis, and as a galactogogue (to promote lactation). The US Food and Drug Administration (FDA) have issued a warning about the cardiac safety of domperidone. Areas covered: The authors undertook a review of the cardiac safety of oral domperidone. Expert opinion: The data from preclinical studies are unambiguous in identifying domperidone as able to produce marked hERG channel inhibition and action potential prolongation at clinically relevant concentrations. The compound’s propensity to augment instability of action potential duration and action potential triangulation are also indicative of proarrhythmic potential. Domperidone should not be administered to subjects with pre-existing QT prolongation/LQTS, subjects receiving drugs that inhibit CYP3A4, subjects with electrolyte abnormalities or with other risk factors for QT-prolongation. With these provisos, it is possible that domperidone may be used as a galactogogue without direct risk to healthy breast feeding women but more safety information should be sought in this situation. Also, more safety information is required regarding risk to breast feeding infants or before domperidone is routinely used in gastroparesis or gastroesphageal reflux in children.

A Century of American Economic Review : Insights on Critical Factors in Journal Publishing

By using information collected from numerous American Economic Review publications from the last 100 years, Torgler and Piatti examine the top publishing institutions to determine their most renowned AER papers based on citation success. Areas of interest include how often an individual can publish in the AER, how equally successful citations are distributed and who the top AER publishing authors are. The book explores what the level of cooperation is among authors and what drives systems such as the alphabetical name ordering. Torgler and Piatti critically examine the individual characteristics of AER authors, editors, editorial board members and referees and even tackle more intricate details such as the frequency of female publications in the AER. The authors observe and analyse the relationship between academic age and publication performance to see if there is any pattern on these factors and citation success. The book then goes on to analyse data concerning awards, and whether awards can increase the probability of publishing in the AER at a later stage

Commentary on Nutrition and older Indigenous Australians : service delivery implications in remote communities. A narrative review

Indigenous Australians are the most socially and economically disadvantaged population group in Australia and have the poorest health status. The statistics describe and highlight the degree of sicknesses and disadvantage along with lower life expectancy, elevated mortality rate and increased risk of cardiovascular disease, cancer, diabetes, respiratory disease and kidney disease. While these statistics reflect poor health status and a high level of illness within Indigenous communities, it is known that individual, family and community behaviours play a key role in Indigenous health and wellbeing outcomes. These behavioural issues include use of tobacco, alcohol and other substances along with lack of physical activity and poor nutrition. The paper Nutrition and older Indigenous Australians: Service delivery implications in remote communities. A narrative view explores some of the issues specific to nutrition. Bronwyn Fredericks was invited to provide this commentary by the Editor of the Australasian Journal on Aging.

Frontier Techniques for Measuring and Estimating Airport Efficiency : An Empirical Review with Practical Guidelines for Analysis and Future Research

Airport efficiency is important because it has a direct impact on customer safety and satisfaction and therefore the financial performance and sustainability of airports, airlines, and affiliated service providers. This is especially so in a world characterized by an increasing volume of both domestic and international air travel, price and other forms of competition between rival airports, airport hubs and airlines, and rapid and sometimes unexpected changes in airline routes and carriers. It also reflects expansion in the number of airports handling regional, national, and international traffic and the growth of complementary airport facilities including industrial, commercial, and retail premises. This has fostered a steadily increasing volume of research aimed at modeling and providing best-practice measures and estimates of airport efficiency using mathematical and econometric frontiers. The purpose of this chapter is to review these various methods as they apply to airports throughout the world. Apart from discussing the strengths and weaknesses of the different approaches and their key findings, the paper also examines the steps faced by researchers as they move through the modeling process in defining airport inputs and outputs and the purported efficiency drivers. Accordingly, the chapter provides guidance to those conducting empirical research on airport efficiency and serves as an aid for aviation regulators and airport operators among others interpreting airport efficiency research outcomes.

Postoperative chemotherapy for non-small cell lung cancer : a systematic review and meta-analysis

Background Postoperative chemotherapy is currently not recommended for resected non-small cell lung cancer in many countries and centers. Recently, results of several large randomized clinical trials were reported with conflicting evidence. Accordingly, we sought to determine whether postoperative chemotherapy is associated with improved survival compared with that after surgical intervention alone. Methods Randomized clinical trials with cisplatin- or uracil plus ftorafur-containing regimens were included and evaluated separately. A systematic review that included randomized clinical trials performed before 1995 was identified and found to be of adequate quality. Further randomized controlled trials were identified by searching MEDLINE, EMBASE, and the Cochrane Controlled Trials Register from 1995 through 2004. In addition, the reference lists of articles and conference abstracts were searched. The logarithm of the hazard ratio and its standard error were calculated, and a fixed-effect model was used to combine the estimates. Results There were 7200 patients enrolled in 19 trials included in the analyses. An overall estimate of 13% relative reduction in mortality (95% confidence interval, 7%-19%) was found. There was 11% relative reduction in mortality associated with postoperative cisplatin (95% confidence interval, 4%-18%; P = .004) and 17% associated with uracil plus ftorafur (95% confidence interval, 5%-27%; P = .006) compared with that after surgical intervention alone. This means that there would be an additional survivor at 5 years for 25 patients treated with cisplatin or for 30 patients treated with uracil plus ftorafur. Conclusions Postoperative chemotherapy is associated with improved survival compared with that after surgical intervention alone. Selected patients with completely resected non-small cell lung cancer should be offered chemotherapy. Copyright © 2004 by The American Association for Thoracic Surgery.

A review of the removal of anions and oxyanions of the halogen elements from aqueous solution by layered double hydroxides

The application of layered double hydroxides (LDHs) and thermally activated LDHs for the removal of various fluorine (F-, BF-4), chlorine (Cl-,ClO-4), bromine (Br-, BrO-3) and iodine (I-, IO-3) species from aqueous solutions has been reviewed in this article. LDHs and thermally activated LDHs were able to significantly reduce the concentration of selected anions in laboratory scale experiments. The M2+:M3+ cation ratio of the LDH adsorbent was an important factor which influenced anion uptake. Though LDHs were able to remove some target anion species through anion exchange and surface adsorption thermal activation and reformation generally produced better results. The presence of competing anions including carbonate, phosphate and sulphate had a significant impact on uptake of the target anion as LDHs typically exhibit lower affinity towards monovalent anions compared to anions with multiple charges. The removal of fluoride and perchlorate from aqueous solution by a continuous flow system utilising fixed bed columns packed with LDH adsorbents has also been investigated. The adsorption capacity of the columns at breakpoint was heavily dependent on the flow rate and lower than result reported for the corresponding batch methods. There is still considerable scope for future research on numerous topics summarised in this article.

Review of the nutrition policy of the Arnhem Land Progress Association

The process of implementation and the effect of the nutrition policy of the Arnhem Land Progress Association (ALPA) were reviewed three years after implementation of the policy in five remote Aboriginal community retail stores in May 1990. In 1993, compliance with the policy varied among stores. Recommended foods were available regularly in most communities; however, promotional and educational components of the policy were not widely implemented. Dietary improvements were evident in those communities where stores most complied with the policy. Some aspects of the ALPA nutrition policy require modification, and renewed commitment to the policy is likely to improve further the diet in the Aboriginal communities involved. The ALPA nutrition policy is a potential model for the development of other local food and nutrition policies in remote Aboriginal communities.