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Background: The ending of a clinical trial may be challenging, particularly if staff are required to withdraw the investigated treatment(s); however, this aspect of trial work is surprisingly under-researched. To address this gap, we explored the experiences of staff involved in closing out a trial that entailed withdrawal of treatment (insulin pumps) from some patients.Methods: Interviews were conducted with n = 22 staff, recruited from seven trial sites. Data were analysed thematically.Results: Staff described a myriad of ethical and emotional challenges at closeout, many of which had been unforeseen when the trial began. A key challenge for staff was that, while patients gave their agreement to participate on the understanding that pump treatment could be withdrawn, they often found themselves benefitting from this regimen in ways they could not have foreseen. Hence, as the trial progressed, patients became increasingly anxious about withdrawal of treatment. This situation forced staff to consider whether the consent patients had given at the outset remained valid; it also presented them with a dilemma at closeout because many of those who had wanted to remain on a pump did not meet the clinical criteria required for post-trial funding. When deciding whether to withdraw treatment, staff not only had to take funding pressures and patient distress into account, but they also found themselves caught between an ethic of Hippocratic individualism and one of utilitarianism. These conflicting pressures and ethical considerations resulted in staff decision-making varying across the sites, an issue that some described as a further source of ethical unease. Staff concluded that, had there been more advanced planning and discussion, and greater accountability to an ethics committee, some of the challenges they had confronted at closeout could have been lessened or even prevented.Conclusions: The same kinds of ethical issues that may vex staff at the beginning of a trial (e.g. patients having unrealistic expectations of trial participation; staff experiencing conflicts between research and clinical roles) may re-present themselves at the end. To safeguard the wellbeing of staff and patients, greater planning, coordination and ethical oversight should go into the closeout of trials involving withdrawal of treatment(s).Trial Registration: International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ISRCTN61215213 . Registered on 11 May 2011. [ABSTRACT FROM AUTHOR]

Building information modeling (BIM) tools hold promise for owners in terms of collecting the information needed for facility operations. The introduction of BIM technology has increased the need for project teams to deliver information earlier in the project timeline. BIM has been a catalyst for process change in the architecture, engineering, and construction (AEC) industry in terms of earlier decision making and in identifying the need for more precise and accurate information throughout the design and construction process. Because of the use of collaborative project delivery methods, and the owner's participation on the project team, the same catalyst is now forcing owners to decide and specify in more detail their informational needs and deliverables. To date, owners are dependent on broad recommendations regarding what information they should collect as well as what methods may be used to collect it. To assist owners with specific recommendations, this study examined a microlevel view of the information required for owners to help them specify their closeout deliverables. The methodology included a Delphi panel of facility management personnel employed by universities in 18 states who were surveyed to establish a consensus resulting in a basic list of building information needs. The Delphi panel questions addressed the issue from the perspective of providing value as determined by the perceived need for product information in operations and maintenance (O&M), as well as the frequency of use of the product information categories. The final research results provide an established base list of product information needs for specifying project deliverables, i.e., a list of products and product formats, which can be used by owners integrating BIM in their facilities management (FM) efforts. [ABSTRACT FROM AUTHOR]

Background The HALT Polycystic Kidney Disease Trials Network consisted of two randomized, double blind, placebo-controlled trials among patients with autosomal dominant polycystic kidney disease. The trials involved 5–8 years of participant follow-up with interventions in blood pressure and antihypertensive therapy. We provide a framework for designing and implementing closeout near the end of a trial while ensuring patient safety and maintaining scientific rigor and study morale. Methods We discuss issues and resolutions for determining the last visit, tapering medications, and unblinding of participants to study allocation and results. We also discuss closure of clinical sites and Data Coordinating Center responsibilities to ensure timely release of study results and meeting the requirements of regulatory and funding authorities. Results Just over 90% of full participants had a 6-month study visit prior to their last visit preparing them for trial closeout. Nearly all patients wanted notification of study results (99%) and treatment allocation (99%). All participants were safely tapered off study and open label blood pressure medications. Within 6 months, the trials were closed, primary papers published, and 805 letters distributed to participants with results and allocation. DCC obligations for data repository and clinicaltrials.gov reporting were completed within 12 months of the last study visit. Conclusions Closeout of our trials involved years of planning and significant human and financial resources. We provide questions for investigators to consider when planning closeout of their trials with focus on (1) patient safety, (2) dissemination of study results and (3) compliance with regulatory and funding responsibilities. [ABSTRACT FROM AUTHOR]

In the absence of a universally accepted procedure for the credit valuation adjustment (CVA) calculation, we compare a number of different bilateral counterparty valuation adjustment (BVA) formulas. First we investigate the impact of the choice of the closeout convention used in the formulas. Important consequences on default contagion manifest themselves in a rather different way depending on which closeout formulation is used (risk-free or replacement), and on default dependence between the two entities in the deal. Second we compare the full bilateral formula with an approximation that is based on subtracting two unilateral credit valuation adjustment (UCVA) formulas. Although the latter might be attractive for its instantaneous implementation once one has a unilateral CVA system, it ignores the impact of the first-to-default time, when closeout procedures are ignited. We illustrate in a number of realistic cases both the contagion effect due to the closeout convention, and the CVA pricing error due to ignoring the first-to-default time. [ABSTRACT FROM AUTHOR]

Abstract: Clinical trials are often stopped prematurely by Data and Safety Monitoring Boards, sponsors, or the investigators for reasons such as unexpected harmful effects of the intervention, clear lack of benefit, or futility due to sluggish recruitment or an unexpectedly low outcome rate in the placebo group. Planning for closeout, however, usually does not begin until after the trial is well underway. This article describes the experience of the Heart and Estrogen/progestin Replacement Study (HERS) investigators when data from the first year of follow-up revealed a clear but non-significant divergence in outcome rates between the treatment groups, and planning for early closure was initiated. Three advantages of beginning early to plan for closeout are described and approaches to planning closeout are suggested. [Copyright &y& Elsevier]

Abstract: In the U.S., as in most countries with well-developed securities markets, derivative securities enjoy special protections under insolvency resolution laws. Most creditors are “stayed” from enforcing their rights while a firm is in bankruptcy. However, many derivatives contracts are exempt from these stays. Furthermore, derivatives enjoy netting and closeout, or termination, privileges which are not always available to most other creditors. The primary argument used to motivate passage of legislation granting these extraordinary protections is that derivatives markets are a major source of systemic risk in financial markets and that netting and closeout reduce this risk. To date, these assertions have not been subjected to rigorous economic scrutiny. This paper critically re-examines this hypothesis. These relationships are more complex than often perceived. We conclude that it is not clear whether netting, collateral, and/or closeout lead to reduced systemic risk, once the impact of these protections on the size and structure of the derivatives market has been taken into account. [Copyright &y& Elsevier]

Formal project management is vital for effectively applying organizational resources to competing demands within and across projects. However, using project management is predicated upon valid and accurate project specifications. Introducing biases into the formulation of specifications can lead to compromised or failed projects. In many cases, biases arise from project personnel applying heuristics. Project personnel can offset bias impact by recognizing and understanding these heuristics and their potential effects. This study surveys project personnel, attempting to identify heuristics and their use in IS projects. [ABSTRACT FROM AUTHOR]