Patients' perspectives on antiepileptic medication: relationships between beliefs about medicines and adherence among patients with epilepsy in UK primary care.

BACKGROUND: Nonadherence to antiepileptic drugs (AEDs) can result in suboptimal outcomes for patients. AIM: This study aimed to assess the utility of a theory-based approach to understanding patient perspectives on AEDs and adherence. METHOD: Patients with epilepsy, identified by a GP case note review, were mailed validated questionnaires assessing their perceptions of AEDs and their adherence to them. RESULTS: Most (84.9%) of the 398 AED-treated respondents accepted the necessity of AEDs, but over half expressed doubts, with 55% disagreeing or uncertain about the statement 'I would prefer to take epilepsy medication than risk a seizure'. Over a third (36.4%) expressed strong concerns about the potential negative effects of AEDs. We used self-report and medication possession ratio to classify 36.4% of patients as nonadherent. Nonadherence was related to beliefs about medicines and implicit attitudes toward AEDs (p<0.05). Adherence-related attitudes toward AEDs were correlated with general beliefs about pharmaceuticals (BMQ General: General Harm, General Overuse, and General Benefit scales) and perceptions of personal sensitivity to medicines (PSM scale). CONCLUSION: We identified salient, adherence-related beliefs about AEDs. Patient-centered interventions to support medicine optimization for people with epilepsy should take account of these beliefs.

The pathogenesis of degeneration of the intervertebral disc and emerging therapies in the management of back pain.

This article reviews the current knowledge of the intervertebral disc (IVD) and its association with low back pain (LBP). The normal IVD is a largely avascular and aneural structure with a high water content, its nutrients mainly diffusing through the end plates. IVD degeneration occurs when its cells die or become dysfunctional, notably in an acidic environment. In the process of degeneration, the IVD becomes dehydrated and vascularised, and there is an ingrowth of nerves. Although not universally the case, the altered physiology of the IVD is believed to precede or be associated with many clinical symptoms or conditions including low back and/or lower limb pain, paraesthesia, spinal stenosis and disc herniation. New treatment options have been developed in recent years. These include biological therapies and novel surgical techniques (such as total disc replacement), although many of these are still in their experimental phase. Central to developing further methods of treatment is the need for effective ways in which to assess patients and measure their outcomes. However, significant difficulties remain and it is therefore an appropriate time to be further investigating the scientific basis of and treatment of LBP.

Design of a surgical instrument for removing bone to provide screw access to a spinal fusion cage.

A surgical instrument to aid implantation of a range of lumbar spinal fusion cages has been developed. Once the cage is in position, the entrance to screw holes is partially blocked by the edge of the vertebral body. In order to insert fixation screws to secure the cage between the vertebrae, some part of the blocking edge has to be removed. Rongeurs are currently being used, but they can be time consuming and have the disadvantage that they may remove more bone than is necessary and may cause damage to the fusion cage if not used with care. In addition, access around some of the screw holes may be difficult. The aim of this instrument was to overcome these shortcomings. This paper describes the design of a surgical instrument for cutting edges from vertebral bodies. The development and evaluation of concept designs are presented and discussed. Potential risks were considered and modifications were performed on the selected concept. Functional prototypes were manufactured and tested on sheep lumbar vertebrae. The results showed that the newly designed cutting instrument functions as required and removes the required amount of bone from the vertebral body edge.

Range of motion of the metacarpophalangeal joint in rheumatoid patients, with and without a flexible joint replacement prosthesis, compared with normal subjects.

BACKGROUND: The metacarpophalangeal is commonly affected by rheumatoid arthritis. This may lead to joint replacement with a flexible prosthesis. The aims of this study were to determine the effects of rheumatoid arthritis on joint motion and to determine whether joint replacement needs to restore the full range of motion. METHODS: Three-dimensional motion analysis was used to measure the range of motion of the metacarpophalangeal joint in rheumatoid patients with and without a flexible silicone arthroplasty, when performing pinch and key grips, when making a fist and when spreading the fingers. The results were compared with those from younger and older normal subjects. FINDINGS: There appeared to be a trend for a decrease in range of motion from younger normal to older normal to rheumatoid (no prosthesis) to rheumatoid (with prosthesis) subject groups. However, statistically different (p<0.05) results were only observed for some movements (mostly involved in making a fist), in some fingers and between some subject groups. The only exception to this apparent trend was in flexion/extension when spreading the fingers into abduction. INTERPRETATION: Making a fist is the most sensitive simple measure of range of motion in the metacarpophalangeal joint. Successful replacement of the metacarpophalangeal joint in patients with rheumatoid arthritis need not restore the normal range of motion.

Effect of side holes in cervical fusion cages: a finite element analysis study.

The objective of this study was to investigate the effect of side holes on the predicted von Mises stress levels in cervical spinal fusion cages subjected to compressive loading. Models with between zero and ten side holes were developed. Finite element analysis (FEA) was used to simulate compression of the cage, made from the polymer PEEK (polyetheretherketone), between two adjacent vertebrae. The analyses were validated by experimental tests. In all of the models, the von Mises stress was highest at the cage-vertebrae interface with peak stresses of between 14 and 18 MPa. Increasing the Young's modulus of the vertebrae from 12 to 30 GPa increased the peak stress on average by 29 per cent. The stresses in the models were lower than the compressive strength of PEEK (118 MPa), and are well within the PEEK fatigue strength reported (60 MPa at 10 million cycles). This study suggests that the number of side holes had a negligible effect on the stress distribution within the cage; the stress magnitudes were fairly constant across all of the models and did not change substantially with the number of holes. Hence, a cervical cage with side holes is unlikely to fail in compression.

Pedicle Screw Surgery in the UK and Ireland: A Questionnaire Study.

Pedicle screw (PS) malpositioning rates are high in spine surgery. This has resulted in the use of computed navigational aids to reduce the rate of malposition; but these are often expensive and limited in availability. A simple mechanical device to aid PS insertion might overcome some of these disadvantages. The purpose of this study was to determine the demand and design criteria for a simple device to aid PS placement, as well as to collect opinions and experiences on PS surgery in the UK and Ireland. A postal questionnaire was sent to 422 spinal surgeons in the UK and Ireland. 101 questionnaires were received; 67 of these (16% of total sent) contained useful information. 78% of surgeons experienced problems with PS placement. The need for a simple mechanical device to aid PS placement was expressed by 59% of respondent surgeons. The proportion of respondents that inserted PSs in the cervical spine was 14%; PSs are mainly inserted in the thoracic, lumbar and sacral spine, but potential exists for a PS placement aid for the cervical and thoracic spine. From the experiences of these 67 surgeons, there is evidence to suggest that surgeons would prefer a pedicle aid that is multiple use, one-piece, hand-held, radiolucent, unilateral and uses the line of sight principle in traditional open surgery. Based on the experiences of 67 surgeons, there is evidence to suggest that computed navigational aids are not readily used in PS surgery and that a simple mechanical device could be a better option. This paper provides useful data for improving the outcomes of spinal surgery.

Lower limb involvement in spinal function and low back pain.

AIM: To evaluate evidence for involvement of the lower limb in spinal function and low back pain (LBP). DESIGN: A hypothesis based on a critical review of the relevant biomechanical and clinical literature. RESULTS: The spine resembles an inverted pendulum that supports the weight of the upper body; its stability requires a moving base that is provided by the joints of the lower limb, especially the hip. However, the sacroiliac joints are unlikely to be important for spinal function. The changing pattern of gait and development of lumbar lordosis, in early childhood, provide evidence for the inter-dependence of spinal curvature and lower limb action. Clinical signs associated with LBP may be associated with an inability to rotate the trunk about the hips. These include disorientation of the pelvis and weakness or tightness of muscles around the hip. The "sway back" posture seen in LBP involves flexion of the hip, knee and ankle to compensate for abdominal and back muscle weakness. CONCLUSIONS: In order to understand the varied clinical presentation of LBP patients, the function of the spine should be considered in the context of the whole body, especially the lower limb.

A review of the design process for implantable orthopedic medical devices.

The design process for medical devices is highly regulated to ensure the safety of patients. This paper will present a review of the design process for implantable orthopedic medical devices. It will cover the main stages of feasibility, design reviews, design, design verification, manufacture, design validation, design transfer and design changes.

Frequency dependence of viscoelastic properties of medical grade silicones.

Cylinders of medical grade silicone elastomers, (29 mm in diameter and 13 mm thick), immersed in physiological saline solution at 37 degrees C, were investigated by dynamic mechanical analysis (DMA). A sinusoidal cyclic compression of 40 +/- 5 N was applied over a frequency range, f, of 0.02-100 Hz. Values of the storage, E', and loss, E'', moduli for the cylinders were found to depend on f; the dependence of E' or E'' on the logarithm (base 10) of f was represented by a third-order polynomial. Above about 0.3 Hz, the cylindrical specimens appeared to be undergoing the onset of a transition from the rubbery to the glassy state. There was no significant difference between results obtained at 37 and 23 degrees C; pretreatment of specimens in physiological saline at 37 degrees C for 24 h and 29 days had no appreciable effect on the results.

Accelerated aging for testing polymeric biomaterials and medical devices.

Elevated temperature is frequently used to accelerate the aging process in polymers that are associated with medical devices and other applications. A common approach is to assume that the rate of aging is increased by a factor of 2(DeltaT/10), where DeltaT is the temperature increase. This result is a mathematical expression of the empirical observation that increasing the temperature by about 10 degrees C roughly doubles the rate of many polymer reactions. It is equivalent to assuming that the aging process is a first order chemical reaction with an activation energy of 10R/log(e)2, where R is the universal gas constant. A better approach would be to determine the activation energy for the process being considered but this is not always practicable. The simple approach does not depend on the temperature increase, provided that it is not so great that it initiates any physical or chemical process that is unlikely to be involved in normal aging. If a temperature increment theta were to increase a given polymer reaction rate n times, then an elevated temperature would increase the rate of aging by a factor of n(DeltaT/theta).

Viscoelastic properties of composites of calcium alginate and hydroxyapatite.

Calcium alginate was reinforced with hydroxyapatite (HA) particles, whose dimensions were a few micrometres, with mass fraction, mf, values in the range 0-0.8. Cylindrical samples of these composite materials were subjected to cyclic compression in the frequency range f = 0.001-20 Hz; in these tests a sinusoidal load of amplitude 1 N was applied either side of a static compression of 2 N. Storage and loss moduli, E' and E'', respectively, were found to be independent of particle size; however, E' increased with frequency consistent with the materials undergoing a glass transition. Above frequencies of about 0.05 Hz, E' > E'' for all materials. For each frequency, the dependence of the moduli on log10f could be represented by a third order polynomial; these equations can be used to calculate E' and E'' for a range of compositions. Approximate values of (E*) = square root of E'2 + E''2 are predicted by a Reuss model.

Finite element modelling of the Ilizarov external fixation system.

This study describes a computational method for predicting the mechanical response of any configuration of the Ilizarov external fixation system. Mechanical testing of each of the individual components (ring, threaded rod, and wire) of the Ilizarov system was used to determine the stiffness of each component. Finite element (FE) analysis was then used to model each of the individual components. Each model was tuned to match the mechanical testing. A modular FE modelling system, using a master input file, was then developed where the tuned FE models of the individual components could be generated, positioned, and interconnected to replicate a range of fixator configurations. The results showed that the stiffness predications from the FE modelling of the fixator configurations were consistently 10 per cent higher than the stiffness values obtained from the mechanical testing. The FE modelling system can be used to predict the characteristic response of the fixator configurations and clearly shows the relative changes in that response for variations in the number of components used.

Mechanical properties of calcium sulphate/hydroxyapatite cement.

Setting times, volume after setting, injectability and hardness (at 37 degrees C in contact with Ringer's solution) were determined for cements made of mixtures of calcium sulphate hemihydrate (CS) and hydroxyapatite (HA) with a range of compositions. The purpose of these experiments was to determine the behaviour of a mixture that could be used as an injectable cement for orthopaedic applications, including spinal fusion. A suitable mixture consisted of 60% CS and 40% HA by mass; a slurry was made by mixing solid (36 g) with water (15 cm(3)). The slurry had initial and final setting times of 5.7+/-1.3 min and 19.6+/-0.7 min (mean +/- standard deviation), respectively. The hardness of the cement did not systematically increase or decrease in the 72 h following the final setting time. The volume of the cement was 99.8+/-0.4% of the volume of the initial slurry, i.e. there was negligible shrinkage on setting. It was able to withstand a pressure of 7.3+/-1.2 MPa, applied by a hemispherical indenter before the onset of permanent damage, indicating adequate strength for spinal fusion.

Determination of the pressure required to cause mitral valve failure.

A method has been developed for applying water pressure to a closed mitral valve on the side corresponding to the heart's left ventricle. The pressure is increased until fluid flows through the valve, i.e. until it fails. A specific dissection technique has been developed to produce a specimen with two annular rings, mitral annulus and papillary muscle annulus. Since the valve is maintained intact, with its leaflets attached to papillary muscles by the chordae tendineae, this method allows the effects of ruptured chordae and their surgical repair or replacement to be assessed in vitro. The chamber that holds the valve supports both the mitral annulus and papillary muscle annulus of the specimen. The mitral annulus is sutured onto rubber sheeting held in the chamber. The papillary muscle annulus is held in place by a Perspex support. The main part of the apparatus consists of a water pump connected through flexible tubing to the chamber that holds the valve in place. The pressure at failure is measured using a pressure transducer. Preliminary experiments demonstrate that anterior leaflet marginal chordae, but not strut chordae, are vital to valve function. Posterior leaflet chordae have been found to be important for valve competence.

Wire tension in the Ilizarov system: accuracy of the wire-tensioning device.

The Ilizarov fixator consists of tensioned wires that attach bone segments to a modular frame. The aim of this study was to establish the accuracy and precision of the wire-tensioning device supplied with the Ilizarov external fixation system. The device was used to tension a wire in direct opposition to a calibrated load cell. Five subjects tested three devices, at each of their four tension settings, in two separate sessions. Subjects could not see the true tension during the test. There were significant differences between the results for different subjects (p < 0.01) and instruments (p < 0.01) but not for different tension settings or between the two sessions. Overall mean measured tensions were 4.9 per cent (standard deviation, 4.4 per cent) below intended values. Tensions obtained at the maximum edge (completely occluded) on the scale markings were significantly (p < 0.001) closer to the nominal values (mean discrepancy, 3.6 per cent) than those at the minimum edge (mean discrepancy, 17.6 per cent). Several factors influence wire tension. Tensioning devices are not identical and the results obtained with them depend on the user. If the scale markings are completely occluded, the discrepancy between intended and actual tensions of around 5 per cent is likely to be adequate for clinical practice since surgeons do not select the most suitable tension following quantitative data assessment, but rather it is a judgement based on surgical experience and consideration for the patient weight and expected level of activity.

Influence of fibril taper on the function of collagen to reinforce extracellular matrix.

Collagen fibrils provide tensile reinforcement for extracellular matrix. In at least some tissues, the fibrils have a paraboloidal taper at their ends. The purpose of this paper is to determine the implications of this taper for the function of collagen fibrils. When a tissue is subjected to low mechanical forces, stress will be transferred to the fibrils elastically. This process was modelled using finite element analysis because there is no analytical theory for elastic stress transfer to a non-cylindrical fibril. When the tissue is subjected to higher mechanical forces, stress will be transferred plastically. This process was modelled analytically. For both elastic and plastic stress transfer, a paraboloidal taper leads to a more uniform distribution of axial tensile stress along the fibril than would be generated if it were cylindrical. The tapered fibril requires half the volume of collagen than a cylindrical fibril of the same length and the stress is shared more evenly along its length. It is also less likely to fracture than a cylindrical fibril of the same length in a tissue subjected to the same mechanical force.

Preventing encrustation in indwelling urethral catheters.

Encrustation is the main problem encountered with indwelling urethral catheters. A promising new approach to overcoming this problem is described here, which may have implications for catheter design.

Thermal stability and structure of cancellous bone mineral from the femoral head of patients with osteoarthritis or osteoporosis.

BACKGROUND: Cancellous bone from patients with osteoarthritis (OA) has been reported to be undermineralised and that from patients with osteoporosis (OP) is more liable to fracture. Changes in the mineral component might be implicated in these processes. OBJECTIVES: To investigate the thermal stability and the mineral structure of cancellous bone from femoral heads of patients with either OA or OP. METHODS: Powdered bone was prepared from femoral heads of patients with either OA or OP and a control group. Composition and thermal stability were determined using a thermogravimetric analyser coupled to a mass spectrometer. Unit cell dimensions and the crystallite size of the mineral were measured using x ray diffraction. RESULTS: Thermal stability of the bone matrix, or of the mineral phase alone, was little altered by disease, though OA bone contained less mineral than OP or control bone. In all three groups, x ray diffraction showed that the mineral unit cell dimensions and crystallite sizes were the same. The mean carbonate content in the mineral from all three groups was between 7.2 and 7.6% and is suggested to be located in both the A site (that is, substituting for hydroxyl groups), and the B site (that is, substituting for phosphate groups). CONCLUSIONS: These results confirm that there is a lower mass fraction of mineral in OA bone, and indicate that the nature of the mineral is not a factor in either disease process.

Effect of the proportion of organic material in bone on thermal decomposition of bone mineral: an investigation of a variety of bones from different species using thermogravimetric analysis coupled to mass spectrometry, high-temperature X-ray diffraction, and Fourier transform infrared spectroscopy.

Thermogravimetric analysis linked to mass spectrometry (TGA-MS) shows changes in mass and identifies gases evolved when a material is heated. Heating to 600 degrees C enabled samples of bone to be classified as having a high (cod clythrum, deer antler, and whale periotic fin bone) or a low (porpoise ear bone, whale tympanic bulla, and whale ear bone) proportion of organic material. At higher temperatures, the mineral phase of the bone decomposed. High temperature X-ray diffraction (HTXRD) showed that the main solids produced by decomposition of mineral (in air or argon at 800 degrees C to 1000 degrees C) were beta-tricalcium phosphate (TCP) and hydroxyapatite (HAP), in deer antler, and CaO and HAP, in whale tympanic bulla. In carbon dioxide, the decomposition was retarded, indicating that the changes observed in air and argon were a result of the loss of carbonate ions from the mineral. Fourier transform infrared (FTIR) spectroscopy of bones heated to different temperatures, showed that loss of carbon dioxide (as a result of decomposition of carbonate ions) was accompanied by the appearance of hydroxide ions. These results can be explained if the structure of bone mineral is represented by [Formula: see text] where V(Ca) and V(OH) correspond to vacancies on the calcium and hydroxide sites, respectively, and 2-x-y = 0.4. This general formula is consistent in describing both mature bone mineral (i.e., whale bone), with a high Ca/P molar ratio, lower HPO4(2-) content, and higher CO3(2-) content, and immature bone mineral (i.e., deer antler), with a low Ca/P ratio, higher HPO4(2-), and lower CO3(2-) content.

Short communication: fused deposition models from CT scans.

Fused deposition modelling (FDM) is a new method for rapid prototyping, a technique that produces models of objects from computer files. The most commonly used rapid prototyping technique for medical applications is stereolithography, but FDM has several potential advantages. This paper is concerned with the accuracy of an FDM model of a sheep lumbar vertebra using data from a CT scan. The model and the original vertebra were compared by making measurements with vernier callipers and by laser scanning. Visually, the model reproduced the features of the original object; this conclusion was supported by a comparison of the laser scans. Discrepancies in measurements were comparable with those of models produced using other rapid prototyping techniques, demonstrating that FDM is a viable method for making models for clinical use.