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ObjectivesInforming research participants of the results of studies in which they took part is viewed as an ethical imperative. However, there is little guidance in the literature about how to do this. The Fluoxetine Or Control Under Supervision trial randomised 3127 patients with a recent acute stroke to 6 months of fluoxetine or placebo and was published in the Lancet on 5 December 2018. The trial team decided to inform the participants of the results at exactly the same time as the Lancet publication, and also whether they had been allocated fluoxetine or placebo. In this report, we describe how we informed participants of the results.DesignIn the 6-month and 12-month follow-up questionnaires, we invited participants to provide an email address if they wished to be informed of the results of the trial. We re-opened our trial telephone helpline between 5 December 2018 and 31 March 2019.SettingUK stroke services.Participants3127 participants were randomised. 2847 returned 6-month follow-up forms and 2703 returned 12-month follow-up forms; the remaining participants had died (380), withdrawn consent or did not respond.ResultsOf those returning follow-up questionnaires, a total of 1845 email addresses were provided and a further 50 people requested results to be sent by post. Results were sent to all email and postal addresses provided; 309 emails were returned unrecognised. Seventeen people replied, of whom three called the helpline and the rest responded by email.ConclusionIt is feasible to disseminate results of large trials to research participants, though only around 60% of those randomised wanted to receive the results. The system we developed was efficient and required very little resource, and could be replicated by trialists in the future.Trial registration numberISRCTN83290762; Post-results.

WW a 43 year old Caucasian Hospital Manager, first presented in July 08 complaining of transient mono-ocular visual loss in the right eye. She described sudden onset loss of vision – ‘like a curtain coming across the vision’. She then proceeded to have similar symptoms in the left eye. There was no history of a subsequent headache. The episode would between 30 seconds and 10 minutes and could occur up to 10 times a day. At times, the attack was also associated with some left arm numbness. She was initially reviewed by Dr Vu [ Stroke Consultant] who diagnosed Amaurosis Fugax and started her on standard anti-platelet therapy [combination of Aspirin and Dypyridamole]. She had very little in terms of vascular risk factors [nil hypertensive, minimal alcohol and a life-long non-smoker with a fasting cholesterol 3.12]. Her PMH history consisted of Gilberts’ Syndrome and endometriosis. She also suffered a DVT following a hysterectomy. Her initial investigations of a CT head and carotid duplex were normal.

For trans-tibial amputees maintenance over time of a quality fit of the prosthesis to the residual limb is an important clinical challenge. The purpose of this research was to compare diurnal and long-term (5 weeks to 6 months) interface stress changes as well as variance in the change in cross-sectional area down the length of the residual limb. If long-term changes were simply accentuated diurnal fluctuations then this result would suggest similar treatment methods should be used for both conditions. Interface pressures and shear stresses at 13 sites and residual limb shape were measured on eight trans-tibial amputee subjects using patellar-tendon-bearing prostheses. Data were collected at diurnal intervals (within the same day at least 5 h apart) as well as at long-term intervals (5, 10, 15, 20, and 25 weeks apart). Absolute diurnal interface stress changes were not significantly different from those at 5-weeks intervals but were significantly smaller than those at 15, 20, and 25-weeks intervals. Mean interface stress changes increased significantly (p

Interface pressures and shear stresses within the socket, in standing and walking, were measured for two unilateral, male, trans-tibial amputee subjects, during two sessions each. The ratios of equal weight-bearing standing stresses to peak walking stresses showed regional variation, ranging from 0.24:1 for pressure over the anterior region to 1.01:1 for resultant interface shear stress over the lateral region. Interface stresses in standing were only moderate predictors of peak walking stresses. The best correlation coefficient between standing in full weight-bearing and peak walking stress was 0.88 for pressure over the lateral region. As the amputees progressed from minimal to full weight-bearing in standing, and then to walking, the interface stresses increased in a nonlinear fashion, consistent with the assumption that the anterior tibia provides much resistance to the bending moment in the sagittal plane during walking.

Transjugular intrahepatic portocaval shunt (TIPS) is performed in patients with symptomatic Budd–Chiari syndrome (BCS) who do not have repairable hepatic veins. We report the case of a patient who had an inferior vena cava (IVC) stent placed previously as part of the management for BCS, and who subsequently required TIPS. The TIPS tract was created through the strut of the previously placed IVC stent; the TIPS stent was placed after dilatation of the liver parenchyma as well as the strut of the IVC stent. This novel technique of “strutplasty” of a previously placed stent as part of TIPS has not been reported in the literature.

The distribution of mechanical stress at the interface between a residual limb and prosthetic socket is an important design consideration in lower-limb prosthetics. Stresses must be distributed so that the amputee is stable and comfortable, while avoiding trauma to the tissues of the residual limb. Numerical estimation of the stresses at the interface through finite element (FE) modeling can potentially provide researchers and prosthetists with a tool to aid in the design of the prosthetic socket. This review addresses FE modeling of interface stresses in lower-limb external prosthetics. The modeling methodologies adopted by analysts are described. Verification of FE estimates of interface stress against experimental data by different analysts is presented and the likely sources of error discussed. While the performance of the models is encouraging, there are definite limitations to all of them, necessitating further improvements. Parametric analysis of the sensitivity of interface stress to model parameters provides a tool to identify model weaknesses and to suggest possible refinements. Parametric analyses by different analysts are also presented and potential refinements discussed. Finally, directions for future work in prosthetic FE modeling are suggested.

A preliminary investigation was conducted to characterize the magnitude and distribution of volume change in transtibial residua at two time intervals: upon prosthesis removal and at 2 week intervals. Six adult male unilateral transtibial amputee subjects, between 0.75 and 40.0 years since amputation, were imaged 10 times over a 35-minute interval with a custom residual limb optical scanner. Volume changes and shape changes over time were assessed. Measurements were repeated 2 weeks later. Volume increase on socket removal for the six subjects ranged from 2.4% to 10.9% (median 6.0% +/- standard deviation 3.6%). Rate of volume increase was highest immediately upon socket removal and decreased with time (five subjects). In four subjects, 95% of the volume increase was reached within 8 minutes. No consistent proximal-to-distal differences were detected in limb cross-sectional area change over time. Limb volume differences 2 weeks apart ranged from -2.0% to 12.6% (0.6% +/- 5.5%) and were less in magnitude than those within a session over the 35-minute interval (five subjects). Multiple mechanisms of fluid movement may be responsible for short-term volume changes, with different relative magnitudes and rates in different amputees.

A finite element (FE) model of the trans-tibial residual limb and prosthetic socket was developed. The three-dimensional model accounts for shape differences between the socket and residual limb, and incorporates material nonlinearities. Contact, frictional slip, and separation at the limb-socket interface were permitted using automated contact without gap elements. FE estimates of interface stresses after socket donning compared favorably with experimental measurements, suggesting that the model may potentially contribute to improved understanding of interface biomechanics.

When compared with automated contact methods of finite element (FE) analyses, gap elements have certain inherent disadvantages in simulating large slip of compliant materials on stiff surfaces. However, automated contact has found limited use in the biomechanical literature. A non-linear, three-dimensional, geometrically accurate, FE analysis of the trans-tibial limb-socket prosthetic system was used to compare an automated contact interface model with a gap element model, and to evaluate the sensitivity of automated contact to interfacial coefficient of friction (COF). Peak normal stresses and resultant shear stresses were higher in the gap element model than in the automated contact model, while the maximum axial slip was less. Under proximally directed load, compared with automated contact, gap elements predicted larger areas of stress concentration that were located more distally. Gap elements did not predict any relative slip at the distal end, and also transmitted a larger proportion of axial load as shear stress. Both models demonstrated non -linear sensitivity to COF, with larger variation at lower magnitudes of COF. By imposing physical connections between interface surfaces, gap elements distort the interface stress distributions under large slip. Automated contact methods offer an attractive alternative in applications such as prosthetic FE modeling, where the initial position of the limb in the socket is not known, where local geometric features have high design significance, and where large slip occurs under load.

The objective of the research is to determine if principal component analysis (PCA) provides an efficient method to characterise the normative shape of the proximal tibia. Bone surface data, converted to analytical surface descriptions, are aligned, and an auto-associative memory matrix is generated. A limited subset of the matrix principal components is used to reconstruct the bone surfaces, and the reconstruction error is assessed. Surface reconstructions based on just six (of 1452) principal components have a mean root-mean-square (RMS) reconstruction error of 1.05% of the mean maximum radial distance at the tibial plateau. Surface reconstruction of bones not included in the auto-associative memory matrix have a mean RMS error of 2.90%. The first principal component represents the average shape of the sample population. Addition of subsequent principal components represents the shape variations most prevalent in the sample and can be visualised in a geometrically meaningful manner. PCA offers an efficient method to characterise the normative shape of the proximal tibia with a high degree of dimensionality reduction.

A general method to generate hexahedral meshes for finite element analysis of residual limbs and similar biomedical geometries is presented. The method utilizes skeleton-based subdivision of cross-sectional domains to produce simple subdomains in which structured meshes are easily generated. Application to a below-knee residual limb and external prosthetic socket is described. The residual limb was modeled as consisting of bones, soft tissue, and skin. The prosthetic socket model comprised a socket wall with an inner liner. The geometries of these structures were defined using axial cross-sectional contour data from X-ray computed tomography, optical scanning, and mechanical surface digitization. A tubular surface representation, using B-splines to define the directrix and generator, is shown to be convenient for definition of the structure geometries. Conversion of cross-sectional data to the compact tubular surface representation is direct, and the analytical representation simplifies geometric querying and numerical optimization within the mesh generation algorithms. The element meshes remain geometrically accurate since boundary nodes are constrained to lie on the tubular surfaces. Several element meshes of increasing mesh density were generated for two residual limbs and prosthetic sockets, Convergence testing demonstrated that approximately 19 elements are required along a circumference of the residual limb surface for a simple linear elastic model. A model with the fibula absent compared with the same geometry with the fibula present showed differences suggesting higher distal stresses in the absence of the fibula. Automated hexahedral mesh generation algorithms for sliced data represent an advancement in prosthetic stress analysis since they allow rapid modeling of any given residual limb and optimization of mesh parameters.

8225 AI results in cumulative multi-lineage toxicity. In our previous study of filgrastim and epoetin alfa (G + EPO) with AI in chemo-naive pts, the incidence of neutropenic fever (NF) was 33% and red cell transfusions (PRBC Tx) 40% of cycles. The purpose of the present study was to evaluate safety, hematopoietic effects on progenitors, and efficacy of the new long-acting HGFs Peg-G + DPO in reducing the incidence of NF and PRBC Tx. AI (A 90 mg/m2; I 10 gm/m2) was administered on days 0–3. HGFs were administered SC once per cycle, with DPO (initial dose, 500 mcg) prior to (day 0) and Peg-G (6 mg) post (day 4) completion of AI. Cycles were repeated q 21 days (max 6 cycles). Bone marrow (BM) and peripheral blood progenitor cells were examined in cycle 1. The data for NF and PRBC Tx are shown below for both studies. The median duration of neutropenia during all 6 cycles remained ≤3 days with Peg-G as compared to a progressive increase in the duration with G (days ANC

The mechanical properties of 15 elastomeric liner products used in limb prosthetics were evaluated under compressive, frictional, shear, and tensile loading conditions. All testing was conducted at load levels comparable to interface stress measurements reported on transtibial amputee subjects. For each test configuration, materials were classified into four groups based on the shapes of their response curves. For the 15 liners tested, there were 10 unique classification sets, indicating a wide range of unique materials. In general, silicone gel liners classified within the same groups thus were quite similar to each other. They were of lower compressive, shear, and tensile stiffness than the silicone elastomer products, consistent with their lightly cross-linked, high-fluid content structures. Silicone elastomer products better spanned the response groups than the gel liners, demonstrating a wide range of compressive, shear, and tensile stiffness values. Against a skin-like material, a urethane liner had the highest coefficient of friction of any liner tested, although coefficients of friction values for most of the materials were higher than interface shear:pressure ratios measured on amputee subjects using Pelite liners. The elastomeric liner material property data and response groupings provided here can potentially be useful to prosthetic fitting by providing quantitative information on similarities and differences among products.

A mechanical digitizer was developed for use in prosthetics research where measurements of small differences in shape are of interest. Root-mean-square error was 0.075 mm in the radial direction, 0.05 degrees in the tangential direction, and 0.1 mm in the vertical direction. The system has potential use for time-dependent assessment of changes in socket and residuum cast shape, assessment of socket fabrication systems, and development of accurate prosthetic finite element models.