Using Research Metrics to Improve Timelines: Proceedings from the 2nd Annual CTSA Clinical Research Management Workshop

The Clinical and Translational Science Award (CTSA) Consortium Workshop was conceived as a venue to foster communication among Academic Medical Centers (AMCs) in the development of methods to improve clinical research management. The consortium, comprised of 46 awardee sites as of 2009, many with multiple AMCs, is expected to expand to 60 sites when fully implemented. At the 2nd Annual CTSA Clinical Research Management Workshop held on June 22 nd and 23 rd , 2009, on the National Institutes of Health (NIH) campus, consortium members and potential CTSA sites gathered with stakeholders from private industry, the NIH, the Food and Drug Administration, and private research organizations, to formulate a plan to address challenges in clinical research management. Specific aims included improving protocol processing and sharing process improvement initiatives in the expectation that best practices will be implemented and improvements will be measured and reported. The findings presented at this workshop indicated significant variance in Institutional Review Board approval of protocols and contract execution by AMC and CTSA sites. Most represented marked delays compared to non-AMC sites and that, as a likely consequence, AMCs were later to enroll patients and/or meet enrollment targets compared to dedicated or professional sites. Clin Trans Sci 2010; Volume 3: 305–308Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/79218/1/j.1752-8062.2010.00246.x.pd

Affleck-Dine baryogenesis in the local domain

For Affleck-Dine baryogenesis to proceed, there must have been two types of phase transitions. One is the destabilized-stabilized phase transition of the flat direction, which is in general induced by the Hubble parameter. The other is the phase transition related to the A-term, which induces the misalignment of the relative phase of the flat direction. In the conventional Affleck-Dine baryogenesis they are supposed to start almost simultaneously. Of course these phase transitions can take place separately, but the latter must not be later than the former because the phase transition of the A-term can not produce any baryon number when there is no condensate of the relative charge. In this paper we try to construct models where the original idea of Affleck-Dine baryogenesis is realized in a different way. We show examples in which the local domain of the false vacuum with the required condensate is formed after inflation and collapses in a safe way so that the domain wall problem is avoided. We also show examples where the phase transition of the A-term starts before the decay of the condensate. As in the conventional Affleck-Dine mechanism, the phase transition of the A-term produces baryon number in the local domain of the condensate. We construct scenarios where our mechanism produces sufficient baryon asymmetry of the Universe.Comment: 18pages, latex2e, to appear in PR

Enhanced baryon number violation due to cosmological defects with localized fermions along extra dimension

We propose a new scenario of baryon number violation in models with extra dimensions. In the true vacuum, baryon number is almost conserved due to the localization mechanism of matter fields, which suppresses the interactions between quarks and leptons. We consider several types of cosmological defects in four-dimensional spacetime that shift the center of the localized matter fields, and show that the magnitudes of the baryon number violating interactions are well enhanced. Application to baryogenesis is also discussed.Comment: 12pages, latex2e, added references, to appear in PR

Baryon number violation, baryogenesis and defects with extra dimensions

In generic models for grand unified theories(GUT), various types of baryon number violating processes are expected when quarks and leptons propagate in the background of GUT strings. On the other hand, in models with large extra dimensions, the baryon number violation in the background of a string is not trivial because it must depend on the mechanism of the proton stabilization. In this paper we argue that cosmic strings in models with extra dimensions can enhance the baryon number violation to a phenomenologically interesting level, if the proton decay is suppressed by the mechanism of localized wavefunctions. We also make some comments on baryogenesis mediated by cosmological defects. We show at least two scenarios will be successful in this direction. One is the scenario of leptogenesis where the required lepton number conversion is mediated by cosmic strings, and the other is the baryogenesis from the decaying cosmological domain wall. Both scenarios are new and have not been discussed in the past.Comment: 20pages, latex2e, comments and references added, to appear in PR

The CTSA Consortium's Catalog of Assets for Translational and Clinical Health Research (CATCHR)

The 61 CTSA Consortium sites are home to valuable programs and infrastructure supporting translational science and all are charged with ensuring that such investments translate quickly to improved clinical care. Catalog of Assets for Translational and Clinical Health Research (CATCHR) is the Consortium's effort to collect and make available information on programs and resources to maximize efficiency and facilitate collaborations. By capturing information on a broad range of assets supporting the entire clinical and translational research spectrum, CATCHR aims to provide the necessary infrastructure and processes to establish and maintain an open‐access, searchable database of consortium resources to support multisite clinical and translational research studies. Data are collected using rigorous, defined methods, with the resulting information made visible through an integrated, searchable Web‐based tool. Additional easy‐to‐use Web tools assist resource owners in validating and updating resource information over time. In this paper, we discuss the design and scope of the project, data collection methods, current results, and future plans for development and sustainability. With increasing pressure on research programs to avoid redundancy, CATCHR aims to make available information on programs and core facilities to maximize efficient use of resources.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/106893/1/cts12144.pd

Hens ranked as highly feed efficient have an improved albumen quality profile and increased polyunsaturated fatty acids in the yolk

The shelf-life of eggs which contain elevated levels of polyunsaturated fatty acids (PUFA) is compromised due to the relative instability and therefore greater potential for lipid peroxidation of unsaturated fatty acids (FA). Poultry that are highly feed efficient (HFE) exhibit higher systemic levels of antioxidant enzymes, and therefore may produce eggs with improved albumen quality and favorable FA profiles that are stable over time. We tested the hypothesis that HFE laying hens produce eggs with improved internal egg quality and a favorable yolk FA profile prior to and following storage. Following an initial screening phase (7 weeks) using 140 Isa Brown layers (28 week old), the 10 most efficient (FCR 2.30 ± 0.05) hens were identified and designated as high feed efficiency (HFE) and low feed efficiency (LFE) groups respectively. Internal quality and composition were determined on eggs (n = 10 per group) stored at 150C for 0, 14 and 28 d. At 0, 14 & 28 d, the albumen weight, albumen height, Haugh unit (HU) and albumen:yolk ratio of eggs from the HFE group were significantly higher (P < 0.01), whereas the eggs from the LFE group had heavier (P < 0.01) yolk than the HFE group. After 28 d storage, the yolk color score of the LFE group was lower (paler; P < 0.05) compared to that of the HFE group. The relative proportions of total PUFA and the ratio of total PUFA and total saturated fatty acids (SFA) were higher (P < 0.05) in HFE group of eggs. The LFE group of eggs contained higher (P < 0.05) levels of lipid peroxidation markers (thiobarbituric acid reactive substances; TBARS) values both in fresh and stored eggs. The results suggest that HFE hens produce eggs with greater albumen quality and higher levels of yolk PUFA both at lay and after storage

The CTSA Consortium's Catalog of Assets for Translational and Clinical Health Research (CATCHR): The Ctsa Consortium's Catchr

The 61 CTSA Consortium sites are home to valuable programs and infrastructure supporting translational science and all are charged with ensuring that such investments translate quickly to improved clinical care. CATCHR (Catalog of Assets for Translational and Clinical Health Research) is the Consortium’s effort to collect and make available information on programs and resources to maximize efficiency and facilitate collaborations. By capturing information on a broad range of assets supporting the entire clinical and translational research spectrum, CATCHR aims to provide the necessary infrastructure and processes to establish and maintain an open-access, searchable database of consortium resources to support multi-site clinical and translational research studies. Data is collected using rigorous, defined methods, with the resulting information made visible through an integrated, searchable web-based tool. Additional easy to use web tools assist resource owners in validating and updating resource information over time. In this article, we discuss the design and scope of the project, data collection methods, current results, and future plans for development and sustainability. With increasing pressure on research programs to avoid redundancy, CATCHR aims to make available information on programs and core facilities to maximize efficient use of resources

Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR): study protocol for a phase II randomised feasibility study of a multidisciplinary rehabilitation package following hip fracture

Objective: To conduct a rigorous feasibility study for a future definitive parallel-group randomised controlled trial (RCT) and economic evaluation of an enhanced rehabilitation package for hip fracture.Setting: Recruitment from 3 acute hospitals in North Wales. Intervention delivery in the community.Participants: Older adults (aged ≥65) who received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by clinical team) and received rehabilitation in the North Wales area.Intervention: Remote randomisation to usual care (control) or usual care+enhanced rehabilitation package (intervention), including six additional home-based physiotherapy sessions delivered by a physiotherapist or technical instructor, novel information workbook and goal-setting diary.Primary and secondary outcome measures: Primary: Barthel Activities of Daily Living (BADL). Secondary measures included Nottingham Extended Activities of Daily Living scale (NEADL), EQ-5D, ICECAP capability, a suite of self-efficacy, psychosocial and service-use measures and costs. Outcome measures were assessed at baseline and 3-month follow-up by blinded researchers.Results: 62 participants were recruited, 61 randomised (control 32; intervention 29) and 49 (79%) completed 3-month follow-up. Minimal differences occurred between the 2 groups for most outcomes, including BADL (adjusted mean difference 0.5). The intervention group showed a medium-sized improvement in the NEADL relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen's d 0.63), and a trend for greater improvement in self-efficacy and mental health, but with small effect sizes. The mean cost of delivering the intervention was £231 per patient. There was a small relative improvement in quality-adjusted life year in the intervention group. No serious adverse events relating to the intervention were reported.Conclusions: The trial methods were feasible in terms of eligibility, recruitment and retention. The effectiveness and cost-effectiveness of the rehabilitation package should be tested in a phase III RCT