Long-term quality assurance of fMRI and MRS on a 3.0T clinical scanner

Functional MRI (fMRI) and Magnetic Resonance Spectroscopy (MRS) are being increasingly used in clinical protocols. Subsequenly it is crucial to develop a routine quality assurance protocol (QA)of both techniques. This work describes a long-term variability study, as apart of the QA of fMRI and MRS on our institution clinical 3.0 T MR scanner.

Direct restorative materials use in Australia in 2002

Background: This study aimed to determine the reasons for dentists' choice of materials, in particular amalgam and resin composite, in Australia. Method: A questionnaire was developed to elicit this information. The names and addresses of 1000 dentists in Australia were selected at random. The questionnaire was mailed to these dentists with an explanatory letter and reply-paid envelope. Results: A total of 560 replies were received. Regarding choice of material, 99 per cent of respondents cited clinical indication as an influencing factor, although patients' aesthetic demands (99 per cent), patients' financial situation (82 per cent), and lecturers' suggestions (72 per cent) were also reported to influence respondents' choice of materials. Twelve per cent of respondents used composite 'always', 29 per cent 'often', 32 per cent 'sometimes', 23 per cent 'seldom' and 4 per cent 'never' in extensive load-bearing cavities in molar teeth. For composite restorations in posterior teeth, 84 per cent 'always', 'often' or 'sometimes' used the total etch technique, 84 per cent used a thick glass-ionomer layer and 36 per cent never used rubber dam. Fifty-nine per cent of respondents reported a decreased use of amalgam over the previous five years. Sixty-eight per cent of respondents agreed with the statement 'discontinuation of amalgam restricts a dentist's ability to adequately treat patients'. Seventy-five per cent considered that the growth in the use of composites increased the total cost of oral health care. Conclusions: Of the respondents from Australia 73 per cent place large composite restorations in molar teeth and their choice of material is influenced greatly by clinical indications, and patients' aesthetic demands.

Evaluating Patient Education Materials about Radiation Therapy

Targeted treatment education for cancer patients has the potential to promote adjustment through assisting patients to participate in treatment decision making, comply with treatment regimens and cope more effectively with treatment side effects. A quasi-experimental longitudinal pre-test post-test and follow-up design was used to assess the effect of a patient education video about radiation therapy on patients' psychological distress, knowledge about radiation therapy, self-efficacy about coping with treatment and physical symptoms. Patients with head and neck (n = 26) and breast cancer (n = 66) were recruited into the study and allocated into control and intervention groups. No significant differences were found between the control and intervention groups on any of the outcome variables. However, patients in the intervention group reported high levels of satisfaction with the video and all reported that they would recommend the video to other patients preparing for radiation therapy. As well, 90% of patients in the intervention group reported that some or all of the information in the video was new to them. Education materials that have excellent face validity and that are well received by patients may fail to produce significant change using standard controlled study designs. Future research in this area may need to consider alternative paradigms for evaluating the helpfulness of such materials. (C) 2003 Elsevier Science Ireland Ltd. All rights reserved.

Inter- and intralaboratory variation of in vitro diffusion cell measurements: An international multicenter study using quasi-standardized methods and materials

In vitro measurements of skin absorption are an increasingly important aspect of regulatory studies, product support claims, and formulation screening. However, such measurements are significantly affected by skin variability. The purpose of this study was to determine inter- and intralaboratory variation in diffusion cell measurements caused by factors other than skin. This was attained through the use of an artificial (silicone rubber) rate-limiting membrane and the provision of materials including a standard penetrant, methyl paraben (MP), and a minimally prescriptive protocol to each of the 18 participating laboratories. Standardized calculations of MP flux were determined from the data submitted by each laboratory by applying a predefined mathematical model. This was deemed necessary to eliminate any interlaboratory variation caused by different methods of flux calculations. Average fluxes of MP calculated and reported by each laboratory (60 +/- 27 mug cm(-2) h(-1), n = 25, range 27-101) were in agreement with the standardized calculations of MP flux (60 +/- 21 mug cm(-2) h(-1), range 19-120). The coefficient of variation between laboratories was approximately 35% and was manifest as a fourfold difference between the lowest and highest average flux values and a sixfold difference between the lowest and highest individual flux values. Intra-laboratory variation was lower, averaging 10% for five individuals using the same equipment within a single laboratory. Further studies should be performed to clarify the exact components responsible for nonskin-related variability in diffusion cell measurements. It is clear that further developments of in vitro methodologies for measuring skin absorption are required. (C) 2005 Wiley-Liss, Inc.

Analysis of stroke patients' and carers' reading ability and the content and design of written materials: Recommendations for improving written stroke information

Objective: This study (a) evaluated the reading ability of patients following stroke and their carers and the reading level and content and design characteristics of the written information provided to them, (b) explored the influence of sociodemographic and clinical characteristics on patients' reading ability, and (c) described an education package that provides well-designed information tailored to patients' and carers' informational needs. Methods: Fifty-seven patients and 12 carers were interviewed about their informational needs in an acute stroke unit. Their reading ability was assessed using the Rapid Estimate of Adult Literacy in Medicine (REALM). The written information provided to them in the acute stroke unit was analysed using the SMOG readability formula and the Suitability Assessment of Materials (SAM). Results: Thirteen (22.8%) patients and 5 (41.7%) carers had received written stroke information. The mean reading level of materials analysed was 11th grade while patients read at a mean of 7-8th grade. Most materials (89%) scored as only adequate in content and design. Patients with combined aphasia read significantly lower (4-6th grade) than other patients (p = 0.001). Conclusion: Only a small proportion of patients and carers received written materials about stroke and the readability level and content and design characteristics of most materials required improvement. Practice implications: When developing and distributing written materials about stroke, health professionals should consider the reading ability and informational needs of the recipients, and the reading level and content and design characteristics of the written materials. A computer system can be used to generate written materials tailored to the informational needs and literacy skills of patients and carers. (c) 2005 Elsevier Ireland Ltd. All rights reserved.

Tear film lipids:dynamic composition and clinical performance

Purpose: Meibomian-derived lipid secretions are well characterised but their subsequent fate in the ocular environment is less well understood. Phospholipids are thought to facilitate the interface between aqueous and lipid layers of the tear film and to be involved in ocular lubrication processes. We have extended our previous studies on phospholipid levels in the tear film to encompass the fate of polar and non-polar lipids in progressive accumulation and aging processes on both conventional and silicone-modified hydrogel lenses. This is an important aspect of the developing understanding of the role of lipids in the clinical performance of silicone hydrogels. Method: Several techniques were used to identify lipids in the tear film. Mass-spectrometric methods included Agilent 1100-based liquid chromatography coupled to mass spectrometry (LCMS) and Perkin Elmer gas chromatography mass spectrometry (GCMS). Thin layer chromatography (TLC) was used for separation of lipids on the basis of increasing solvent polarity. Routine assay of lipid extractions from patient-worn lenses was carried out using a Hewlett Packard 1090 liquid chromatograph coupled to both uv and Agilent 1100 fluorescence detection. A range of histological together with optical, and electron microscope techniques was used in deposit analysis. Results: Progressive lipid uptake was assessed in various ways, including: composition changes with wear time, differential lipid penetrate into the lens matrix and, particularly, the extent to which lipids become unextractable as a function of wear time. Solvent-based separation and HPLC gave consistent results indicating that the polarity of lipid classes decreased as follows: phospholipids/fatty acids > triglycerides > cholesterol/cholesteryl esters. Tear lipids were found to show autofluorescence—which underpinned the value of fluorescence microscopy and fluorescence detection coupled with HPLC separation. The most fluorescent lipids were found to be cholesteryl esters; histological techniques coupled with fluorescence microscopy indicated that white spots (’’jelly bumps’’) formed on silicone hydrogel lenses contain a high proportion of cholesteryl esters. Lipid profiles averaged for 30 symptomatic and 30 asymptomatic contact lens wearers were compiled. Peak classes were split into: cholesterol (C), cholesteryl esters (CE), glycerides (G), polar fatty acids/phospholipids (PL). The lipid ratio for ymptomatic/symptomatic was 0.6 ± 0.1 for all classes except one—the cholesterol ratio was 0.2 ± 0.05. Significantly the PL ratio was no different from that of any other class except cholesterol. Chromatography indicated that: lipid polarity decreased with depth of penetration and that lipid extractability decreased with wear time. Conclusions: Meibomian lipid composition differs from that in the tear film and on worn lenses. Although the same broad lipid classes were obtained by extraction from all lenses and all patients studied, quantities vary with wear and material. Lipid extractability diminishes with wear time regardless of the use of cleaning regimes. Dry eye symptoms in contact lens wear are frequently linked to lipid layer behaviour but seem to relate more to total lipid than to specific composition. Understanding the detail of lipid related processes is an important element of improving the clinical performance of materials and care solutions.

Ocular compatibility of hydrogel contact lenses:deposition and clinical performance

Currently over 50 million people worldwide wear contact lenses, of which over 75% wear hydrogel lenses. Significant deposition occurs in approximately 80% of hydrogel lenses and many contact lens wearers cease wearing lenses due to problems associated with deposition. The contact lens field is not alone in encountering complications associated with interactions between the body and artificial devices. The widespread use of man-made materials to replace structures in the body has emphasised the importance of studies that examine the interactions between implantation materials and body tissues.This project used carefully controlled, randomized clinical studies to study the interactive effects of contact lens materials, care systems, replacement periods and patient differences. Of principal interest was the influence of these factors on material deposition and their subsequent impact on subjective performance. A range of novel and established analytical techniques were used to examine hydrogel lenses following carefully controlled clinical studies in which clinical performance was meticulously monitored. These studies established the inter-relationship between clinical performance and deposition to be evaluated. This project showed that significant differences exist between individuals in their ability to deposit hydrogel lenses, with approximately 20% of subjects displaying significant deposition irrespective of the lens material. Additionally, materials traditionally categorised together show markedly different spoilation characteristics, which are wholly attributable to their detailed chemical structure. For the first time the in vivo deposition kinetics of both protein and lipid in charged and uncharged polymers was demonstrated. In addition the importance of care systems in the deposition process was shown, clearly demonstrating the significance of the quality rather than the quantity of deposition in influencing subjective performance.

A study in radiopaque polymeric materials

The problems associated with x-ray-transparent denture base are defined and conventional approaches to their solution are assessed. Consideration of elemental absorption parameters leads to the postulation that atoms such as zinc, and bromine, may be effective radiopacifiers over at least part of the clinical x-ray spectrum. These elements had hitherto been considered too light to be effective. Investigation of copolymers of methylmethacrylate and p-bromostyrene revealed no deleterious effects arising from the aromatically brominated monomer (aliphatic bromination caused UV destabilisation). For effective x-ray absorption a higher level of bromination would be necessary, but the expense of suitable compounds made further study unjustifiable. Incorporation of zinc atoms into the polymer was accomplished by copolymerisation of zinc acrylate with methylmethacrylate in solution. At high zinc levels this produced a powder copolymer convenient for addition to dental polymers in the dough moulding process. The resulting mouldings showed increasing brittleness at high loadings of copolymer. Fracture was shown to be through the powder particles rather than around them, indicating the source of weakness to be in the internal structure of the copolymer. The copolymer was expected to be cross-linked through divalent zinc ions and its insolubility and infusibility supported this. Cleavage of the ionic cross links with formic acid produced a zinc-free linear copolymer of high molecular weight. Addition of low concentrations of acrylic acid to the dough moulding monomer appeared to 'labilise' the cross links producing a more homogeneous moulding with adequate wet strength. Toxicologically the zinc-containing materials are satisfactory and though zinc is extracted at a measurable rate in an aqueous system, this is very small and should be acceptable over the life of a denture. In other respects the composite is quite satisfactory and though a marketable product is not claimed the system is considered worthy of further study.

The antimicrobial efficacy of copper alloy furnishing in the clinical environment:a crossover study

Objective. To determine whether copper incorporated into hospital ward furnishings and equipment can reduce their surface microbial load. Design. A crossover study. Setting. Acute care medical ward with 19 beds at a large university hospital. Methods. Fourteen types of frequent-touch items made of copper alloy were installed in various locations on an acute care medical ward. These included door handles and push plates, toilet seats and flush handles, grab rails, light switches and pull cord toggles, sockets, overbed tables, dressing trolleys, commodes, taps, and sink fittings. Their surfaces and those of equivalent standard items on the same ward were sampled once weekly for 24 weeks. The copper and standard items were switched over after 12 weeks of sampling to reduce bias in usage patterns. The total aerobic microbial counts and the presence of indicator microorganisms were determined. Results. Eight of the 14 copper item types had microbial counts on their surfaces that were significantly lower than counts on standard materials. The other 6 copper item types had reduced microbial numbers on their surfaces, compared with microbial counts on standard items, but the reduction did not reach statistical significance. Indicator microorganisms were recovered from both types of surfaces; however, significantly fewer copper surfaces were contaminated with vancomycin-resistant enterococci, methicillin-susceptible Staphylococcus aureus, and coliforms, compared with standard surfaces. Conclusions. Copper alloys (greater than or equal to 58% copper), when incorporated into various hospital furnishings and fittings, reduce the surface microorganisms. The use of copper in combination with optimal infection-prevention strategies may therefore further reduce the risk that patients will acquire infection in healthcare environments.

Clinical performance of daily disposable soft contact lenses using sustained release technology

Purpose: Polyvinyl alcohol (PVA) is a successful tear film stabiliser and is widely used in comfort drops and some soft contact lens materials. A PVA-containing lens, nelfilcon A has been modified to include additional (non-functional) PVA in order to provide improved comfort. This study aims to examine the clinical performance of this nelfilcon A lens with AquaRelease™ (AquaRelease). Methods: Two contralateral, investigator masked, open label, subjective and objective evaluations were conducted. The first examined the effect of adding increased molecular weight PVA to nelfilcon A (n = 5), and the second compared this AquaRelease lens to ocufilcon B (n = 34). The principal measures were non-invasive break-up time (NIBUT) and subjective comfort, which were assessed at the beginning and end of a week of daily wear, and three times throughout 1 day at 8, 12 and 16 h. Results: All subjects successfully completed the daily wearing schedule of 16 h. On initial insertion, subjective comfort and NIBUT improved for AquaRelease than original nelfilcon A lenses (p < 0.05). Initial comfort was better for AquaRelease compared to ocufilcon B lenses (p = 0.01); however, NIBUT was not statistically different (11.7 ± 15.6 s versus 8.4 ± 6.8 s; p = 0.26). Subjective comfort decreased with time (p < 0.001), but there was no significant difference between AquaRelease and ocufilcon B lenses (p = 0.16). NIBUT was not significantly affected by time (p = 0.56) or between lenses (p = 0.33). At the end of a weeks' wear, subjective initial, end-of-day, overall comfort and vision were rated significantly better with AquaRelease than ocufilcon B (p < 0.01). Conclusions: Release of additional non-functionalised PVA from the nelfilcon A lenses appears to enhance comfortable contact lens wear. © 2006 British Contact Lens Association.

Consistent reduction of postprandial glucagon and insulin by lixisenatide in the GetGoal clinical trial programme

Background and aims: Glucagon-like peptide-1 (GLP-1) receptor agonists improve islet function and delay gastric emptying in subjects with type 2 diabetes mellitus. We evaluated 2-hour glucose, glucagon and insulin changes following a standardized mixed-meal tolerance test before and after 24 weeks of treatment with the once-daily prandial GLP-1 receptor agonist lixisenatide (approved for a therapeutic dose of 20 μg once daily) in six randomized, placebo-controlled studies within the lixisenatide Phase III GetGoal programme. In the studies, the mixed-meal test was conducted before and after: (1) lixisenatide treatment in patients insufficiently controlled despite diet and exercise (GetGoal-Mono), (2) lixisenatide treatment in combination with oral antidiabetic drugs (OADs) (GetGoal-M and GetGoal-S), or (3) lixisenatide treatment in combination with basal insulin ± OAD (GetGoal-Duo 1, GetGoal-L and GetGoal-L-Asia).Materials and methods: A meta-analysis was performed (lixisenatide n=1124 vs placebo n=707) combining ANCOVA least squares (LS) mean values using an inverse variance weighted analysis. Results: Lixisenatide significantly reduced 2-hour postprandial glucose from baseline (LS mean difference vs placebo: -4.9 mmol/L, p<0.0001, Figure) and glucose excursions (LS mean difference vs placebo: -4.5 mmol/L, p<0.0001). As measured in two studies, lixisenatide also reduced postprandial glucagon (LS mean difference vs placebo: -19.0 ng/L, p<0.0001) and insulin (LS mean difference vs placebo: -64.8 pmol/L, p<0.0001), although the glucagon/insulin ratio was increased (LS mean difference vs placebo: 0.15, p=0.02) compared with placebo. Conclusion: The results show that lixisenatide potently reduces the glucose excursion after meal ingestion in subjects with type 2 diabetes, in association with marked reductions in glucagon and insulin levels. It is suggested that diminished glucagon secretion and slower gastric emptying contribute to reduced hepatic glucose production and delayed glucose absorption, enabling postprandial glycaemia to be controlled with less demand on beta-cell insulin secretion. Clinical Trial Registration Number: NCT00688701; NCT00712673; NCT00713830; NCT00975286; NCT00715624; NCT00866658 Supported by: Sanofi

Interview with Dr. J. Patrick O'Leary, the Founding Executive Associate Dean for Clinical Affairs of Florida International University Herbert Wertheim College of Medicine

A series of interviews with the founding deans of Florida Interanational University Herbert Wertheim College of Medicine conducted on April 6, 2011 by Bohyun Kim, the Digital Access Librarian at Florida International University Medical Library. This audio recording is the interview with Dr. J. Patrick O'Leary, the Founding Executive Associate Dean for Clinical Affairs at Herbert Wertheim College of Medicine, Florida International University, and the format of the audio file is MP3.

College of Medicine Updated Materials

Documents to be reviewed pertaining to the establishment of the College of Medicine's M.D. program. Includes Executed Annual Operating Agreement with Jackson Public Health Trust; Course Forms for Clinical Medicine I and II; Updated ED-10; Academic Calendar for the first year; Tables for Teaching Format Hours and Evaluation Plan for YEar 1; Overview of Professional Development Strand; and Faculty Roster by Department and Educational Role.

Hiring Schedule: Deans Office, Finance and Administration, Teaching Faculty Y1 and Y2, Clinical Sciences

A hiring schedule for the Dean's Office based on a three year plan.