Comparison of the performance of HPV tests in women with abnormal cytology: results of a study within the NHS cervical screening programme.

OBJECTIVE: The use of testing for human papillomavirus (HPV) is now recognized as an efficient means of triaging women with low-grade cytological abnormalities to either immediate referral to colposcopy or return to routine recall. We aimed to determine the sensitivity and specificity of each of four newer tests for HPV relative to the Qiagen Hybrid Capture 2 (HC2) assay in order to determine whether they could be approved for use in triage in the NHS cervical screening programme. METHODS: We compared the performance of each of four different HPV assays (Abbott M2000, Roche Cobas, Hologic Cervista and Gen-Probe APTIMA) with that of HC2 in order to determine the sensitivity and specificity of each test relative to HC2 for the detection of cervical intraepithelial neoplasia (CIN) grade 2 or worse, using routine cytology samples reported as borderline (atypical squamous cells) or mild dyskaryosis (low-grade squamous intraepithelial lesion) from six laboratories in England. All women who were found to be HPV positive on any test were referred to colposcopy. RESULTS: Between 2072 and 4217 tests were performed with each assay. All four assays were shown to have a relative sensitivity of no worse than 95% compared with HC2 when a cut-off of 2 relative light units (RLU) was used. All assays had higher relative specificity than HC2 for both borderline and mild cytology referrals (1.06-1.61). CONCLUSIONS: All assays tested met the criteria required. Consequently, all have now been approved for use in HPV triage in the NHS cervical screening programme.

The establishment of a 3D breast photography service in medical illustration.

This paper aims to describe the development of a 3D breast photography service managed by the Medical Illustration Department, in the Belfast Health and Social Care Trust, Northern Ireland. Dedicated 3D breast photography equipment was installed in Medical Illustration for 18 months. Women were referred for a variety of indications including pre- and post-surgical assessment. A dedicated 3D breast photography protocol was developed locally and this requires further refinement to allow reproducibility in other centres. There are image/data artefacts associated with this technology and special techniques are required to reduce these. Specialist software is necessary for clinicians and scientists to use 3D breast photography data in surgical planning and measurement of surgical outcome.

Variation in radiographic protocols in paediatric interventional cardiology.

The aim of this work is to determine current radiographic protocols in paediatric interventional cardiology (IC) in the UK and Ireland. To do this we investigated which imaging parameters/protocols are commonly used in IC in different hospitals, to identify if a standard technique is used and illustrate any variation in practice. A questionnaire was sent to all hospitals in the UK and Ireland which perform paediatric IC to obtain information on techniques used in each clinical department and on the range of clinical examinations performed. Ethical and research governance approval was sought from the Office for Research Ethics Committees Northern Ireland and the individual trusts. A response rate of 79% was achieved, and a wide variation in technique was found between hospitals. The main differences in technique involved variations in the use of an anti-scatter grid and the use of additional filtration to the radiation beam, frame rates for digital acquisition and pre-programmed projections/paediatric specific programming in the equipment. We conclude that there is no standard protocol for carrying out paediatric IC in the UK or Ireland. Each hospital carries out the IC procedure according to its own local protocols resulting in a wide variation in radiation dose.

A pragmatic randomised controlled trial to evaluate the cost-effectiveness of a physical activity intervention as a treatment for depression: the treating depression with physical activity (TREAD) trial.

OBJECTIVE: The TREAting Depression with physical activity (TREAD) study investigated the cost-effectiveness of a physical activity intervention, in addition to usual general practitioner care, as a treatment for people with depression. DESIGN: An individually randomised, pragmatic, multicentre randomised controlled trial with follow-up at 4, 8 and 12 months. A subset of participants took part in a qualitative study that investigated the acceptability and perceived benefits of the intervention. SETTING: General practices in the Bristol and Exeter areas. PARTICIPANTS: Aged 18-69 years with an International Statistical Classification of Diseases and Related Health Problems, 10th Edition (ICD-10) diagnosis of depression and scoring ≥ 14 on the Beck Depression Inventory (BDI). Those who were unable to complete self-administered questionnaires in English, with medical contraindications to physical activity or with psychosis, bipolar disorder or serious drug abuse were excluded. INTERVENTIONS: We devised an intervention designed to encourage choice and autonomy in the adoption of physical activity. It consisted of up to three face-to-face and ten telephone contacts delivered by a trained physical activity facilitator over an 8-month period. MAIN OUTCOME MEASURES: The primary outcome was the BDI score measured at 4 months. Secondary outcomes included depressive symptoms over the 12 months and quality of life, antidepressant use and level of physical activity. RESULTS: The study recruited 361 patients, with 182 randomised to the intervention arm and 179 to the usual care arm; there was 80% retention at the 4-month follow-up. The intervention group had a slightly lower BDI score at 4 months [-0.54, 95% confidence interval (CI) -3.06 to 1.99] but there was no evidence that the intervention improved outcome for depression. Neither was there any evidence to suggest a difference in the prescription of or self-reported use of antidepressants. However, the amount of physical activity undertaken by those who had received the intervention was increased (odds ratio 2.3, 95% CI 1.3 to 3.9) and was sustained beyond the end of the intervention. From a health-care perspective, the intervention group was more costly than the usual care group, with the cost of the intervention £220 per person on average. It is therefore extremely unlikely that the intervention is cost-effective as a treatment for depression using current willingness-to-pay thresholds. CONCLUSIONS: This physical activity intervention is very unlikely to lead to any clinical benefit in terms of depressive symptoms or to be a cost-effective treatment for depression. Previous research has reported some benefit and there are three possible reasons for this discrepancy: first, even though the intervention increased self-reported physical activity, the increase in activity was not sufficiently large to lead to a measurable influence; second, only more vigorous activity might be of benefit; and third, previous studies had recruited individuals with a pre-existing commitment to physical activity. Future research is needed to identify and explain the mechanisms by which depression might be effectively treated, including, in particular, specific guidance on the optimum type, intensity and duration of physical activity required to produce a therapeutic effect. TRIAL REGISTRATION: Current Controlled Trials ISRCTN16900744. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 10. See the HTA programme website for further project information.

Validation of a passive stereophotogrammetry system for imaging of the breast: a geometric analysis.

The overall aim of this study was to assess the accuracy, reproducibility and stability of a high resolution passive stereophotogrammetry system to image a female mannequin torso, to validate measurements made on the textured virtual surface compared with those obtained using manual techniques and to develop an approach to make objective measurements of the female breast. 3D surface imaging was carried out on a textured female torso and measurements made in accordance with the system of mammometrics. Linear errors in measurements were less than 0.5mm, system calibration produced errors of less than 1.0mm over 94% over the surface and intra-rater reliability measured by ICC=0.999. The mean difference between manual and digital curved surface distances was 1.36 mm with maximum and minimum differences of 3.15 mm and 0.02 mm, respectively. The stereophotogrammetry system has been demonstrated to perform accurately and reliably with specific reference to breast assessment.

Temperature elevation during simulated polymethylmethacrylate (PMMA) cranioplasty in a cadaver model.

The aims of this study were to: (i) obtain temperature measurements during in vitro polymerisation of polymethylmethacrylate (PMMA) disks of a range of thicknesses; and (ii) obtain tissue temperature measurements at various locations within a skull defect during a simulated PMMA cranioplasty procedure using a cadaver. In vitro, higher temperatures were recorded with increasing PMMA thickness. During the simulated cranioplasty, the maximum temperature was observed inside the PMMA sample, with nearby tissues being exposed to temperatures of greater than 50 degrees C over prolonged periods. There is conflicting information in the literature concerning the sensitivity of brain tissue and bone to elevated temperatures. Preoperatively fabricated PMMA cranioplasty prostheses are recommended.

Algorithms for digital image processing in diabetic retinopathy.

This work examined recent literature on digital image processing in the field of diabetic retinopathy. Algorithms were categorized into 5 steps (preprocessing; localization and segmentation of the optic disk; segmentation of the retinal vasculature; localization of the macula and fovea; localization and segmentation of retinopathy). The variety of outcome measures, use of a gold standard or ground truth, data sample sizes and the use of image databases is discussed. It is intended that our classification of algorithms into a small number of categories, definition of terms and discussion of evolving techniques will provide guidance to algorithm designers for diabetic retinopathy.

Technical validation of the Di3D stereophotogrammetry surface imaging system.

The purpose of this work was to assess the technical performance of a three-dimensional surface imaging system for geometric accuracy and maximum field of view. The system was designed for stereophotogrammetry capture of digital images from three-dimensional surfaces of the head, face, and neck. A mannequin head was prepared for imaging by adding texture in the form of red paint, and facial landmarks as black ink dots. The mannequin was imaged at the manufacturer's recommended settings for human studies. Colour-coded surface difference images among repeated exposures were computed. We compared measurements of physical linear distance with digital measurements. The three-dimensional stereophotogrammetry system had a mean error in the three-dimensional surfaces of 0.057mm, a repeatability error (variance) of 0.0016mm, a mean error of 0.6mm in linear measurements compared with manual measurements, and a field of view of 170 degrees horizontally and 102 degrees vertically.

Effect of suprarenal fixation of aortic stent-grafts on the renal artery ostia: assessment of morphological changes by virtual intravascular endoscopy.

PURPOSE: To investigate the morphological effects of suprarenal fixation of aortic stent-grafts on the renal artery ostia (RaO) by analysis of suprarenal stent wire distribution and vascular calcification across the RaO using virtual intravascular endoscopy (VIE). METHODS: Fourteen consecutive patients (11 men; mean age 75 years) from a single institution were studied following endovascular aortic aneurysm repair (EVAR) using the Zenith endograft system from September 1999 to March 2002. Imaging assessment included computed tomographic (CT) measurement of renal artery intraluminal ostial diameter and quantification and analysis of uncovered stent struts across the RaO and radiological determination of RaO calcification. Morphological changes following EVAR at 3 time points (before and within 1 week after stent-grafting, and at the most recent follow-up) were compared for each patient to determine whether suprarenal stent struts or RaO calcification affected intraluminal ostial diameter. Renal function was assessed by temporal measurements of serum creatinine concentration and creatinine clearance. RESULTS: The renal ostium was distorted to variable degrees in all cases at a mean follow-up of 41+/-6.6 months. An increase in ostial diameter was identified in most patients if the right RaO was calcified when comparing the 1-week postoperative and most recent follow-up CT images (p<0.05). There was no direct relationship between the number of stent struts crossing the RaO and the morphological/dimensional changes (p>0.05). Renal function was not significantly affected. CONCLUSION: Patients undergoing suprarenal fixation of aortic stent-grafts experienced morphological changes of the RaO to a variable extent at midterm follow-up. Although the presence of stent struts did not significantly affect dimensional changes, we observed that calcification at the renal artery ostium may influence the development of atherosclerotic effects as a direct relationship between the calcification and ostial diameter. Future studies utilizing VIE to determine the long-term safety of this technique in these particular patients requires investigation.

Development of an educational 'toolkit' for health professionals and their patients with prediabetes: the WAKEUP study (Ways of Addressing Knowledge Education and Understanding in Pre-diabetes).

AIMS: To identify key messages about pre-diabetes and to design, develop and pilot an educational toolkit to address the information needs of patients and health professionals. METHODS: Mixed qualitative methodology within an action research framework. Focus group interviews with patients and health professionals and discussion with an expert reference group aimed to identify the important messages and produce a draft toolkit. Two action research cycles were then conducted in two general practices, during which the draft toolkit was used and video-taped consultations and follow-up patient interviews provided further data. Framework analysis techniques were used to examine the data and to elicit action points for improving the toolkit. RESULTS: The key messages about pre-diabetes concerned the seriousness of the condition, the preventability of progression to diabetes, and the need for lifestyle change. As well as feedback on the acceptability and use of the toolkit, four main themes were identified in the data: knowledge and education needs (of both patients and health professionals); communicating knowledge and motivating change; redesign of practice systems to support pre-diabetes management and the role of the health professional. The toolkit we developed was found to be an acceptable and useful resource for both patients and health practitioners. CONCLUSIONS: Three key messages about pre-diabetes were identified. A toolkit of information materials for patients with pre-diabetes and the health professionals and ideas for improving practice systems for managing pre-diabetes were developed and successfully piloted. Further work is needed to establish the best mode of delivery of the WAKEUP toolkit.

Suprarenal fixation of endovascular aortic stent grafts: assessment of medium-term to long-term renal function by analysis of juxtarenal stent morphology.

OBJECTIVE: The effect of suprarenal stent fixation during endovascular aortic aneurysm repair (EVAR) on renal function remains unclear. A unique validated three-dimensional intraluminal imaging technique was used to analyze the effect of suprarenal stent position relative to renal artery orifices. Also analyzed was its medium-term to long-term effects on renal function. METHODS: The study cohort comprised 29 of 34 consecutive patients who underwent EVAR with the Zenith endograft system from September 1999 to March 2002 at a single institution. The precise locations of the uncovered suprarenal stent struts were assessed by a virtual endoscopic imaging technique. Anatomic and quantitative categorization of patients was made according to the configuration of uncovered stent struts across the renal artery ostia (RAO). The anatomic subgroups were defined as struts located centrally or peripherally across both RAO. The quantitative subgroups were defined as RAO crossed by multiple struts, a solitary strut, or no struts. The subgroups were compared for their renal function, as assessed by temporal measurements of serum creatinine concentration and creatinine clearance, and renal parenchymal perfusion defects, as assessed using contrast-enhanced computed tomography (CT). RESULTS: Mean follow-up was 52.7 months. Separate subgroup analysis for both anatomic and quantitative configurations did not demonstrate any significant difference in renal function between the different strut permutations (P > .05). Follow-up imaging confirmed one case of renal infarction secondary to an occluded accessory renal artery, although this patient had normal serum creatinine levels. CONCLUSION: RAO coverage by suprarenal uncovered stents does not appear to have a significant effect on renal function as evaluated by creatinine measurements in patients with normal preoperative renal function.

Patient dose from 3D rotational neurovascular studies.

The use of image-guided interventional radiological techniques is increasing in prevalence and complexity. Imaging system developments have helped improve the information available to interventionalists to plan and guide procedures. Information on doses to patients resulting from alternative imaging techniques or protocols is useful for both the process of justifying particular procedures and in optimizing the resultant exposures. Such information is not always available, especially for new or developing imaging techniques. We have undertaken a study of doses to patients associated with two alternative imaging methods for pre-intervention assessment of intracranial aneurysms. In the first technique the aneurysm is assessed from a series of digital subtraction angiography (DSA) runs taken at different imaging projections. The second technique involved acquiring images from one single image run while the imaging system rotated 180 degrees around the patient's head. In this technique, the aneurysm was then evaluated from a 3D reconstruction of the projection images. Effective doses were calculated using a computer model to simulate the exposure geometry and parameters. The mean dose from the DSA protocol used at our centre was 3.4 mSv and from the 3D rotational angiography (RA) technique was 0.20 mSv.

Image registration and subtraction for the visualization of change in diabetic retinopathy screening.

Diabetic retinopathy (DR) is a leading cause of blindness in people of working age in developed countries. DR is characterized by lesions of the retinal microvasculature. This paper describes a technique for visualizing the changes which occur in retinal pathology over a 1 year interval. Pairs of retinal images of the same eye were acuired 12 months apart within a DR screening programme. The images were normalized, registered and subtracted to generate a contrast-enhanced difference image displaying changes in retinal appearance. The normalization factor and registration error were quantified for 104 pairs of retinal images.

3D surface accuracy of CAD generated skull defect contour.

The creation of a satisfactory cosmetic outcome in the repair of cranial defects relies on manual skill. However, computer aided design is gaining acceptance in the creation of custom cranial implants. The purpose of this work is to demonstrate the accuracy of a CAD generated skull defect contours using 3D difference maps. 3D multi-slice CT scanning was carried out on a life size plastic skull. Surface models were generated of the original skull and of temporofrontal and parietal defects. Surface contours were interpolated towards the centre of the defect from the edges where it was blended. The CAD contour deviation ranged from 0.0 mm to 2.0 mm with 80% of the total defect area less than 0.66 mm as measured by difference maps. CAD techniques can be used to produce contours for the repair of cranial defects with minimum deviation from the original skull contour. This enables accurate design and production of cranial implants.

"Virtual unwrapping" of a mummified hand.

The purpose of this work is to demonstrate the feasibility of medical virtual reality technologies in the investigation of a mummified hand. The Ulster Museum obtained the mummy hand, which originated from Thebes, without any identifying information. The mummified hand was investigated using conventional X-ray and 3D multi-slice Computed Tomography (CT). Imaging revealed a range of fractures of the wrist, metacarpals and phalanges whilst 3D CT demonstrated internal structures using volume rendering. The absence of any features of bone healing at the fracture sites would imply that they occurred just prior to death or in the mummified state possibly during excavation. Conventional X-ray imaging indicated that the hand, although small, was likely to have originated from an adult. Medical imaging and virtual reality display will enable us to produce a rapid prototyped model using fused deposition technology. Therefore, further paleopathological research can be performed on the replica without the need to handle the original specimen.

The NHS breast screening programme (pathology) EQA: experience in recent years relating to issues involved in individual performance appraisal.

BACKGROUND: The original role of the National Health Service breast screening programme (pathology) external quality assessment (EQA) scheme was educational; it aimed to raise standards, reinforce use of common terminology, and assess the consistency of pathology reporting of breast disease in the UK. AIMS/METHODS: To examine the performance (scores) of pathologists participating in the scheme in recent years. The scheme has evolved to help identify poor performers, reliant upon setting an acceptable cutpoint. Therefore, the effects of different cutpoint strategies were evaluated and implications discussed. RESULTS/CONCLUSIONS: Pathologists who joined the scheme improved over time, particularly those who did less well initially. There was no obvious association between performance and the number of breast cancer cases reported each year. This is not unexpected because the EQA does not measure expertise, but was established to demonstrate a common level of performance (conformity to consensus) for routine cases, rather than the ability to diagnose unusual/difficult cases. A new method of establishing cutpoints using interquartile ranges is proposed. The findings also suggest that EQA can alter a pathologist's practice: those who leave the scheme (for whatever reason) have, on average, marginally lower scores. Consequently, with the cutpoint methodology currently used (which is common to several EQA schemes) there is the potential for the cutpoint to drift upwards. In future, individuals previously deemed competent could subsequently be erroneously labelled as poor performers. Due consideration should be given to this issue with future development of schemes.

Impact of a national external quality assessment scheme for breast pathology in the UK.

BACKGROUND: This article presents the results and observed effects of the UK National Health Service Breast Screening Programme (NHSBSP) external quality assurance scheme in breast histopathology. AIMS/METHODS: The major objectives were to monitor and improve the consistency of diagnoses made by pathologists and the quality of prognostic information in pathology reports. The scheme is based on a twice yearly circulation of 12 cases to over 600 registered participants. The level of agreement was generally measured using kappa statistics. RESULTS: Four main situations were encountered with respect to diagnostic consistency, namely: (1) where consistency is naturally very high-this included diagnosing in situ and invasive carcinomas (and certain distinctive subtypes) and uncomplicated benign lesions; (2) where the level of consistency was low but could be improved by making guidelines more detailed and explicit-this included histological grading; (3) where consistency could be improved but only by changing the system of classification-this included classification of ductal carcinoma in situ; and (4) where no improvement in consistency could be achieved-this included diagnosing atypical hyperplasia and reporting vascular invasion. Size measurements were more consistent for invasive than in situ carcinomas. Even in cases where there is a high level of agreement on tumour size, a few widely outlying measurements were encountered, for which no explanation is readily forthcoming. CONCLUSIONS: These results broadly confirm the robustness of the systems of breast disease diagnosis and classification adopted by the NHSBSP, and also identify areas where improvement or new approaches are required.

Impediments to policy implementation: the offer of free installation of central heating to an elderly community has limited uptake.

OBJECTIVES: Increasing the warmth of homes in the UK to combat excess winter mortality has become an important part of public policy. This study examined the success of a local initiative to provide free installation of central heating for a group of elderly people. STUDY DESIGN: Cohort study. METHODS: The uptake of the offer of central heating was monitored through its different stages. Where possible, comments were invited from the elderly tenants to whom the offer was made; a sub-sample was interviewed about their views. RESULTS: Of 1181 tenants approached, only around one-quarter finally received central heating within the year. Reasons for the low uptake included inaccuracies in estimating those eligible as well as tenants' worries over upheaval and mess, health concerns and fear of increased heating costs. CONCLUSION: Successful policy implementation requires not only command of appropriate financial resources and the backing of local 'implementers', but also the local resources with which the policy will engage, especially local knowledge, and the 'targets' of the policy initiative, in this case the elderly tenants.

Diagnostic value of CT virtual intravascular endoscopy in aortic stent-grafting.

PURPOSE: To investigate the diagnostic value of postprocessing techniques for 3-dimensional (3D) computed tomography (CT), with emphasis on CT virtual intravascular endoscopy (VIE), in patients with abdominal aortic aneurysms (AAA) treated with suprarenal stent-grafts. METHODS: The preprocedural and postprocedural CT datasets from 47 AAA patients (40 men; mean age 75 years, range 61-87) undergoing aortic stent-grafting with suprarenal fixation were examined. The CT datasets were processed to create various 3D reconstructions: shaded surface display (SSD), maximum intensity projection (MIP), and VIE. Three independent radiologists assessed various diagnostic parameters for each 3D reconstruction method and compared them to axial CT images. RESULTS: Scores for VIE reconstructions were inferior to axial CT images in the visualization of normal arterial branches, measurement of the aneurysm diameter and neck length, as well as assessment of vessel patency and presence of endoleaks. VIE was rated superior to axial CT and other 3D imaging methods in visualizing the configuration of stent struts relative to the aortic branch ostia and the number of stent wires crossing the ostia in >80% of cases. CONCLUSIONS: VIE was not found to play a role in most preoperative situations compared to axial CT images. However, VIE provided additional postgrafting information on the 3D relationship of the suprarenal stent struts to the aortic branch ostia (in particular the renal and superior mesenteric arteries). VIE findings might aid clinicians in accurately assessing the effect of suprarenal stent-grafting on the renal arteries.