Attitudinal barriers to participation in oncology clinical trials: factor analysis and correlates of barriers.

Patient participation in cancer clinical trials is low. Little is known about attitudinal barriers to participation, particularly among patients who may be offered a trial during an imminent initial oncology consult. The aims of the present study were to confirm the presence of proposed subscales of a recently developed cancer clinical trial attitudinal barriers measure, describe the most common cancer clinical trials attitudinal barriers, and evaluate socio-demographic, medical and financial factors associated with attitudinal barriers. A total of 1256 patients completed a survey assessing demographic factors, perceived financial burden, prior trial participation and attitudinal barriers to clinical trials participation. Results of a factor analysis did not confirm the presence of the proposed four attitudinal barriers subscale/factors. Rather, a single factor represented the best fit to the data. The most highly-rated barriers were fear of side-effects, worry about health insurance and efficacy concerns. Results suggested that less educated patients, patients with non-metastatic disease, patients with no previous oncology clinical trial participation, and patients reporting greater perceived financial burden from cancer care were associated with higher barriers. These patients may need extra attention in terms of decisional support. Overall, patients with fewer personal resources (education, financial issues) report more attitudinal barriers and should be targeted for additional decisional support.

Safety and effectiveness of bevacizumab treatment for metastatic colorectal cancer: final results from the Avastin(®) Registry - Investigation of Effectiveness and Safety (ARIES) observational cohort study.

AIMS: The Avastin(®) Registry - Investigation of Effectiveness and Safety (ARIES) observational cohort study (OCS) was designed to prospectively examine outcomes associated with bevacizumab-containing treatment for metastatic colorectal cancer (mCRC) in a community-based setting, where patient populations are less restricted than those in randomised trials. MATERIALS AND METHODS: Patients with mCRC who were eligible for bevacizumab in combination with chemotherapy in first- or second-line treatment were enrolled from November 2006 to September 2008. There were no protocol-specified treatment regimens; the dose and schedule of bevacizumab and chemotherapy were at the treating physician's discretion. The objectives in the ARIES OCS included analyses of progression-free survival (PFS), overall survival, treatment patterns and safety in each of the first- and second-line treatment cohorts. RESULTS: ARIES enrolled 1550 patients with mCRC receiving first-line therapy with bevacizumab. The median follow-up time was 20.6 months. The median PFS in this cohort was 10.2 months (95% confidence interval 9.8-10.6) and the median overall survival was 23.2 months (95% confidence interval 21.2-24.8). In a separate cohort of 482 patients with second-line mCRC, the median follow-up time was 16.9 months, the median PFS and overall survival from the start of second-line treatment to the end of follow-up was 7.9 months (95% confidence interval 7.2-8.3) and 17.8 months (95% confidence interval 16.5-20.7), respectively. Incidences of known bevacizumab-associated adverse events in ARIES were generally consistent with those previously reported in OCSs and randomised trials. CONCLUSION: Results from the prospective ARIES OCS add further evidence to support the effectiveness and safety of bevacizumab when added to first- and second-line treatment regimens for patients with mCRC in community treatment settings.

A role of beta oscillatory synchrony in biasing response competition?

Beta-range oscillatory activity measured over the motor cortex and beta synchrony between cortex and spinal cord can be up- or downregulated in anticipation of a postural challenge or the initiation of movement. Based on these properties of beta activity in the preparation for future events, the present investigation addressed whether simultaneous up- and downregulation of beta activity might act as an online mechanism to suppress and select competing responses. Measures of local and long-range beta synchrony were obtained from electroencephalographic and electromyographic signals recorded during a cued choice reaction task. Analyses focused on task-related changes in beta synchrony during a 2-s delay period between cue and response signal. Analyzed separately, none of the beta measures (spectral power, corticospinal coherence, corticospinal phase synchronization) showed simultaneous up- and downregulation over opposite hemispheres controlling the competing responses. However, the combined pattern of beta measures showed beta power desynchronization associated with selection of a response and increased corticospinal coherence and phase synchronization associated with suppression of a response. These results indicate that concurrent up- and downregulation of different components of beta oscillatory activity is likely to have a functional role in response selection, resembling attentional modulation of alpha activity in visual selection.

Maintaining grip: anticipatory and reactive EEG responses to load perturbations.

Previous behavioral work has shown the existence of both anticipatory and reactive grip force responses to predictable load perturbations, but how the brain implements anticipatory control remains unclear. Here we recorded electroencephalographs while participants were subjected to predictable and unpredictable external load perturbations. Participants used precision grip to maintain the position of an object perturbed by load force pulses. The load perturbations were either distributed randomly over an interval 700- to 4,300-ms (unpredictable condition) or they were periodic with interval 2,000 ms (predictable condition). Preparation for the predictable load perturbation was manifested in slow preparatory brain potentials and in electromyographic and force signals recorded concurrently. Preparation modulated the long-latency reflex elicited by load perturbations with a higher amplitude reflex response for unpredictable compared with predictable perturbations. Importantly, this modulation was also reflected in the amplitude of sensorimotor cortex potentials just preceding the long-latency reflex. Together, these results support a transcortical pathway for the long-latency reflex and a central modulation of the reflex grip force response.

The effect of ankle ligament damage and surgical reconstructions on the mechanics of the ankle and subtalar joints revealed by three-dimensional stress MRI.

Common image-based diagnostic techniques used to detect ankle ligament injuries or the effects of those injuries (e.g., mechanical instability) include magnetic resonance imaging (MRI) and stress radiography. Each of these techniques has limitations. The interpretation of the results obtained through stress radiography, a two-dimensional technique, is highly controversial. MRI can facilitate visualization of soft tissue, but three-dimensional visualization of the full length of the ligaments or detecting partial ligament damage is difficult. This work is part of a long-term study aimed at improving the diagnostic ability of MRI by utilizing it not only to visualize the ligaments but also to detect the mechanical instability produced at the ankle and subtalar joints due to ligament damage. The goal of the present study was to evaluate the ability of a previously developed technique called 3D stress MRI (sMRI) to detect in vitro the effect of damage to the lateral collateral ligaments and the stabilizing effect produced by two common surgical reconstruction techniques. MRI data were collected from eight cadaver limbs in a MR compatible ankle-loading device in neutral, inversion, and anterior drawer. Each specimen was tested intact, after cutting the anterior talo-fibular ligament followed by the calcaneo-fibular ligament and after applying two reconstructions. Ligament injuries produced significant changes in the response of the ankle and subtalar joints to load as detected by the 3D stress MRI technique. Both surgical procedures restored mechanical stability to the joints but they differed in the amount and type of stabilization achieved. We concluded that 3D sMRI can extend the diagnostic power of MRI from the current practice of slice-by-slice visualization to the assessment of mechanical function, the compromise in this function due to injury, and the effects of surgery.

Mechanics of the ankle and subtalar joints revealed through a 3D quasi-static stress MRI technique.

A technique to study the three-dimensional (3D) mechanical characteristics of the ankle and of the subtalar joints in vivo and in vitro is described. The technique uses an MR scanner compatible 3D positioning and loading linkage to load the hindfoot with precise loads while the foot is being scanned. 3D image processing algorithms are used to derive from the acquired MR images bone morphology, hindfoot architecture, and joint kinematics. The technique was employed to study these properties both in vitro and in vivo. The ankle and subtler joint motion and the changes in architecture produced in response to an inversion load and an anterior drawer load were evaluated. The technique was shown to provide reliable measures of bone morphology. The left-to-right variations in bone morphology were less than 5%. The left-to-right variations in unloaded hindfoot architecture parameters were less than 10%, and these properties were only slightly affected by inversion and anterior drawer loads. Inversion and anterior drawer loads produced motion both at the ankle and at the subtalar joint. In addition, high degree of coupling, primarily of internal rotation with inversion, was observed both at the ankle and at the subtalar joint. The in vitro motion produced in response to inversion and anterior drawer load was greater than the in vivo motion. Finally, external motion, measured directly across the ankle complex, produced in response to load was much greater than the bone movements measured through the 3D stress MRI technique indicating the significant effect of soft tissue and skin interference.

The effect of a perceptual cognitive task on exercise performance: the dual-task condition after brain injury.

OBJECTIVE: To examine the effect of additional cognitive demand on cycling performance in individuals with acquired brain injury (ABI). DESIGN: Prospective observational study. SETTING: Rivermead Rehabilitation Centre. PARTICIPANTS: Ten individuals with ABI (7 men, 3 women) (traumatic brain injury 7, tumour 1, stroke 2) and 10 healthy controls (6 men, 4 women). INTERVENTION: Individuals were asked to maintain a set cadence during a three-stage incremental cycling test in both single-task (no additional task) and dual-task (whilst performing an additional cognitive task) conditions. RESULTS: The ABI group showed a slight slowing in cadence in stages 1 and 3 of the graded exercise test from the single- to the dual-task condition, although this was not significant (p < or = 0.05). The control group showed no slowing of cadence at any incremental stage. When directly comparing the ABI with the control group, the change in cadence observed in dual-task conditions was only significantly different in stage 3 (p < or = 0.05). CONCLUSIONS: Clinicians should be aware of the possibility that giving additional cognitive tasks (such as monitoring exercise intensity) while individuals with acquired brain injury are performing exercises may detrimentally affect performance. The effect may be more marked when the individuals are performing exercise at higher intensities.

Sequencing batch reactor technology: the key to a BP refinery (Bulwer Island) upgraded environmental protection system--a low cost lagoon based retro-fit.

BP Refinery (Bulwer Island) Ltd (BP) located on the eastern Australian coast is currently undergoing a major expansion as a part of the Queensland Clean Fuels Project. The associated wastewater treatment plant upgrade will provide a better quality of treated effluent than is currently possible with the existing infrastructure, and which will be of a sufficiently high standard to meet not only the requirements of imposed environmental legislation but also BP's environmental objectives. A number of challenges were faced when considering the upgrade, particularly; cost constraints and limited plot space, highly variable wastewater, toxicity issues, and limited hydraulic head. Sequencing Batch Reactor (SBR) Technology was chosen for the lagoon upgrade based on the following; SBR technology allowed a retro-fit of the existing earthen lagoon without the need for any additional substantial concrete structures, a dual lagoon system allowed partial treatment of wastewaters during construction, SBRs give substantial process flexibility, SBRs have the ability to easily modify process parameters without any physical modifications, and significant cost benefits. This paper presents the background to this application, an outline of laboratory studies carried out on the wastewater and details the full scale design issues and methods for providing a cost effective, efficient treatment system using the existing lagoon system.

Hyperphosphatasemia: report of three cases.

We report the radiographic findings in three cases of hyperphosphatasemia. Often classified as a congenital bone dysplasia, the skeletal manifestations of this disorder are diagnostic. These features simulate Paget's disease both radiographically and with respect to salient biochemical markers. Typically, presentation is at early childhood with skull deformity, refusal to weight bear, and bowing of the extremities. Notable radiographic features include bowing of the long bones, thickening of the cortex, osteopenia, coarsened trabecular pattern, expansion of the medullary cavity, and thickening of the intramembranous portion of the calvarium. Histologic features include absence of lamellar bone and haversian systems, with thick osteoid seams and increased number of osteoclasts. An autosomal recessive pattern of inheritance has been suggested, although autosomal dominant varieties have been postulated.

Creating a digital radiographic teaching file and database using a PC and common software.

OBJECTIVE: We wanted to design an inexpensive, convenient database to store digital radiographic images of multiple formats. CONCLUSION: We designed a database that could be saved in a standard format using readily available software. Users of our database can save images in a Joint Photographic Experts Group (JPEG) format, allowing their easy incorporation into other programs.

Does osteolysis of the distal clavicle occur following spinal cord injury?

OBJECTIVE: To determine whether there is an association between spinal cord injury and "atraumatic" osteolysis of the distal clavicle. PATIENTS AND DESIGN: Seventy-seven consecutive spinal cord injury patients without upper extremity injuries were studied. Of these, 39 each had a pair of chest radiographs--one at admission and one at least 1 month later--which included both acromioclavicular joints. Each radiograph was evaluated by two independent musculoskeletal radiologists, who were masked as to which radiograph was the baseline. RESULTS: Ten of 76 acromioclavicular joints demonstrated osteolysis of the distal clavicle: three bilateral, three left side only, and one right side only. There was one case in which the admission radiograph was read as osteolysis but reverted to normal at 35 months follow-up. CONCLUSION: There is an apparent association between spinal cord injury and osteolysis of the distal clavicle.

Obsessive-compulsive disorder, trichotillomania, and anorexia nervosa: a case report.

We report a case study of an 18-year-old female who presented with symptoms associated with several discrete diagnostic syndromes: obsessive-compulsive disorder, trichotillomania, major depression, and anorexia nervosa. Improvement in each occurred after treatment with the serotonin selective reuptake inhibitor, fluoxetine, suggesting that such syndromes share a common serotonin neurotransmitter disturbance. Furthermore, the combined effects of medication and psychotherapy resulted in improvement in assertiveness, sense of security, self-worth, flexibility, and self-regulation. We discuss the pharmacological and psychotherapeutic implications of possible psychophysiologic similarities among the previously mentioned syndromes.

Mechanism of interference with the Jaffé reaction for creatinine.

We investigated the mechanism of the Jaffé reaction for determination of creatinine by studying the spectrophotometric, kinetic, and equilibrium properties of the reaction of picrate with creatinine and with cyclic and aliphatic ketones. Absorbance spectra for the reaction products of picrate with all the ketones were superimposable with that of creatinine (Amax, 490 nm). Cyclic ketones not containing nitrogen had a molar absorptivity less than half that of creatinine and equilibrium constants approximately 0.01 that of creatinine. Aliphatic ketones, except for benzylacetone, had molar absorptivities similar to that of creatinine, but all of these compounds had equilibrium constants approximately a tenth or less that of creatinine. The common structure for all of the compounds reacting with picrate is the carbonyl group. The variable magnitude of interference for aliphatic and cyclic ketones is ascribable to the different rate constants, molar absorptivities, and equilibrium constants as compared with creatinine. Structures adjacent to the carbonyl group significantly affect the absorptivity and equilibrium constant, but steric hindrance is the major factor affecting the rate of reaction. We postulate that the carbonyl group is required for the Jaffé reaction, and we suggest a mechanism for the reaction.

Use of computer-aided design in the preparation of technical manuscripts.

Decreased computing costs and constantly improving capability are transforming microcomputers into general rather than specialized productivity tools. This has made it possible to increase personal productivity in ways that were not previously cost-effective. We are using computer-aided design (CAD) to prepare technical illustrations for chemical and geochemical manuscripts. CAD offers several advantages over hand-drawn illustrations. Chemical structures are stored in a library of shapes and may be combined or modified to form other structures in subsequent drawings. An original drawing only has to be drawn once with a computer. The drawing may then be scaled to any size and placed in a draft of a manuscript. Revisions require a fraction of the time needed to revise a drawing by hand. All or part of the drawing may be plotted to provide a sequence of drawings without changing the original drawing.