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The basic problem that causes the frequent failure of a standard randomized parallel placebo-controlled clinical trial with a high placebo response rate is the underestimation of the treatment effect by the observed relative treatment difference. A two-period sequential parallel enrichment design has been proposed where the first period is a standard parallel design and at the end of the first period, the placebo non-responders are identified and re-randomized in the second period. Based on such a design, available methods have primarily focused on testing either the first period treatment null hypothesis or the global null hypothesis defined as the joint period 1 and period 2 treatment effect null hypothesis by a test statistic which is either derived from a combined statistic or defined directly as a weighted z-score where the weights are functions of some population and design parameters satisfying certain power optimality criterion. However, in some cases, it is not clear what their combined statistics are estimating and in others, the combined statistics are estimating the apparent treatment effect; but generally, there is no discussion of the need to provide a proper assessment of the treatment effect for the intended study population. It should be clear that an appropriate assessment of the treatment effect for the intended study population is critical for the benefit/risk analysis as well as the proper dosage recommendation. Any benefit/risk analysis and dosage recommendation that are based on an apparent treatment effect from a standard parallel design such as the first period of a sequential parallel enrichment design tend to underestimate the benefit/risk ratio which in turn may lead to overdosing recommendation. It is the purpose of this paper to introduce the concept of an adjusted treatment effect which is derived by adjusting the apparent treatment effect from the first period of a sequential parallel enrichment design with information from the second period subject to a consistency condition. The adjustment properly compensates for the high placebo response rate. It is proposed that this adjusted treatment effect should be used to assess the treatment effect for the intended study population and should be the basis for the benefit/risk analysis and the dosage recommendation.

In 1978, a longitudinal study commenced in England to illuminate criteria for the evaluation of hospital wards as clinical learning environments for student nurses. It derived measures to quantify the clinical learning experienced by 71 students in three cohorts in three training hospitals over their entire programme. In 2003, a second study, based in one English School of Health Studies, using clinical placements in three NHS trusts, employed a retrospective, cross-sectional, analytic survey design with anonymised, self-completion questionnaires, to map the clinical learning of 272 students as part of a quality assurance and enhancement initiative. This paper explores changes over time by comparing data based on five key indices, devised in the first study and revisited in the second. Concepts of clinical learning and supervision are reviewed as part of this changing context and background together with limitations implicit in the comparison. The findings suggest an average 20% improvement in the quality of hospital based clinical learning environments over a 25 year period, based mainly on trained staff personally supervising students more extensively, testing their theoretical knowledge more frequently and spending more time performing practical procedures with them. However, unacceptable variations in clinical learning opportunities persist for some students.

This paper presents an analysis of industrial relations (IR) and human resource (HR) perspectives on conflict in the employment relationship. While both perspectives recognize the existence of employment relationship conflict, IR's premises about such conflict are that it stems from an employer–employee power imbalance, is enduring, often requires institutional interventions in the forms of unionism and legislation to correct the power imbalance, and can be constructive even when the conflict is dealt with in adversarial, nonproblem-solving fashion. HR's premises about employment relationship conflict, by contrast, are that such conflict stems from poor management, can be partially reduced by organizational and workplace innovations that build an employer–employee unity of interests, can be still further reduced through cooperative, mutual gains-oriented problem-solving techniques, and, as a consequence of improved management, will fade from the employment scene. These premises are then examined in relation to case and empirical evidence on grievance procedures, employment discrimination, and employee involvement/participation programs. The analysis finds some support for, but also important limitations on, each of these key perspectives. Recommendations are offered to enable members of the IR and HR communities to incorporate into their respective domains key lessons from each other's dominant perspective on employment relationship conflict.

In response to public-sector collective-bargaining conflict in Wisconsin and other states, Employment Policy Researcher Network researchers wrote a white paper, "Getting it Right: Empirical Evidence and Policy Implications from Research on Public-Sector Unionism and Collective Bargaining."

Seven explanted hearts from a total of 288 heart transplants performed at UCLA Medical Center had histologic evidence of hypersensitivity myocarditis (prevalence = 2.4%). Three patients had a clinical history of drug allergy, and two had a clinically documented drug reaction prior to transplant. Three patients had peripheral eosinophilia prior to transplant. Five patients with hypersensitivity myocarditis had dilated cardiomyopathy, one had congenital abnormalities, and one had ischemic heart disease. In the period up to 3 weeks posttransplant, four patients had episodes of acute rejection (ISHLT grade 2 to 4) with eosinophils histologically. Results suggest that hypersensitivity myocarditis may have an increasing prevalence in the native heart before transplant and in the newly transplanted heart.

Control of Traumatic Chylothorax with EUS-Guided Thoracic Duct Injection Sclerotherapy David H. Robbins, Mark Block, David Lewin, Michael Wallace, Brenda Hoffman Chylothorax due to thoracic duct (TD) trauma is traditionally treated with duct ligation at thoracotomy.We describe a novel endoscopic approach to this difficult management dilemma using endoscopic ultrasound (EUS) and fine needle injection (FNI) of the TD. A 41 year-old male was involved in a high-speed motor vehicle accident resulting in ejection from the vehicle and severe chest injuries. During his hospitalization refractory hiccups and nausea prompted a chest CT scan. A 4.9 3 3.1 cm focal fluid collection was identified between the esophagus and aorta in the subcarinal region. Bilateral pleural effusions were seen but no pulmonary mass or adenopathy was present. Rupture of the thoracic duct was considered and anEUS confirmed a 6 cmfluid collection under the aortic arch. A dilated 2.2 mm thoracic duct could be tracked into the collection and 35 ml of milky, straw colored fluid was aspirated; pathology confirmed a chyloma. In preparation for thoracic duct occlusion the following day and to optimize TD visualization, the patient was fed 2 canisters of high fat Ensure. The next day the fluid had fully re-accumulated and the thoracic duct was again identified. Color flow Doppler interrogation of surrounding structures confirmed its relation to the azygous vein. Twenty ml was again aspirated, fully collapsing the collection. Because of its safety profile and sclerosant properties, 1.5 ml of sodiummorrhuate (NaM) was directly into the TD under EUS control. There were no complications. The nausea and hiccups resolved and the patient was discharged uneventfully. No surgical intervention or chest tube placement was required. To our knowledge, this represents a novel and minimally invasive approach to manage traumatic chylothorax. We have replicated this approach in swine models and will present gross and histopathologic proof of principle. *T1552 A Prospective Multi-centre Study of the Safety and Accuracy of Combined Endoscopic Ultrasound (EUS) guided Fine Needle Aspiration (FNA) and Trucut Needle Biopsy (TNB) William Tam, Guru Aithal, Jeremy Dean, Stephen P. Pereira Background: There are few data on the specimen yield, safety and accuracy of EUS-guided TNB using a novel 19G needle (Quick-Core, Wilson-Cook) compared with standard 22GEUS-guided FNA (Echo-Tip,Wilson-Cook). Aims: To prospectively evaluate the safety and accuracy of combined EUS-FNA and TNB, and to determine the additional benefit of EUS-TNB. Methods: 59 patients (34M: 25F, median age 61 yrs) with mediastinal (n=23), gastric (n=3) or pancreaticobiliary (transgastric approach in 20, transduodenal approach in 13) mass lesions underwent EUS-FNA and EUS-TNB. Twenty patients had had previous negative biopsy and/or cytology results obtained percutaneously or at ERCP. Tissue sampling was defined as adequate if i) five cellular smears following EUS-FNA and ii) two cores after EUS-TNB, were obtained. An on-site cytopathologist was not available. Results: The diagnostic accuracy of combined EUS-FNA and EUS-TNB was 95%, with a prevalence of malignancy of 69% (median follow-up 29 weeks, IQR 11-40). Both EUS techniques had comparable sensitivity, specificity and predictive values (Table). In 8 patients, EUS-TNB allowed further tumour characterisation. Optimal tissue sampling was achieved in 88% of target lesions by EUS-FNA and in 76% by EUS-TNB (p>0.05). Five needle failures were encountered during transduodenal EUS-TNB. There were no immediate or late complications. Conclusions: EUS-guided FNA and TNB have equivalent safety profiles and both are effective means of obtaining tissue for the diagnosis ofmediastinal and gastrointestinalmass lesions.Histological assessment of core biopsies obtained from EUS-TNB may improve tumour characterisation. Transduodenal EUS-TNB is associated with a higher technical failure rate than either the mediastinal or transgastric approach.