Applying for regulatory approval of a clinical trial of a medical device in the UK - A practical guide.

Seeking regulatory and ethical approval is a significant task that must be completed before conducting a clinical trial of a medical device. Currently in the UK, the Integrated Research Application System (IRAS) is a unified system for preparing regulatory, ethical and governance applications for the relevant bodies that must approve health and social research. This article outlines key aspects in planning a clinical trial of a medical device and how applications for approval can be prepared using IRAS.

Professionalism and non-technical skills in Radiology in the UK: a review of the national curriculum.

OBJECTIVE: To drive quality and safe clinical practice, professional values and non-technical skills need to be explicit in all postgraduate medical curricula and appropriate assessment tools should be available for teachers to apply. We interrogate a national Radiology curriculum for content on professionalism and assessment tools, comparing it with the Royal College of Physicians' 2005 document. RESULTS: We found that whilst the knowledge for practising with professional values is embedded in the curriculum, the skills that have to be acquired have not been comprehensively developed. This is reflected in the restricted assessment tools that are mapped to each generic area. The terminology used in the Radiology curriculum was varied and the most frequently used descriptor for professionalism or behaviours pertaining to non-technical aspects was Good Medical Practice; a term used by our regulator, the General Medical Council, and to which our curriculum is mapped. If terminology is to be standardized in Britain collaboration with our regulator is key. We need standardized terminology to permit effective research and sharing of best practice. The Radiology curriculum encompasses all the values set out in the seminal document produced by the Royal College of Physicians in 2005, Doctors in society: medical professionalism in a changing world.

Patients' Acceptability of Computer-Based Information on Hypodontia: A Randomized Controlled Trial.

OBJECTIVES: To compare patients' acceptability of a hypodontia-specific interactive computer-based education material (ICB-EM) versus a British Orthodontic Society (BOS) hypodontia leaflet. TRIAL DESIGN: Two-arm parallel randomized controlled trial, 1:1 allocation ratio. METHODS: The study was conducted at a specialized secondary care facility in the Greater London area. Ninety-six new hypodontia patients aged 14 y and older were randomly assigned to the control group ( n = 49) receiving the BOS leaflet or the intervention group ( n = 47) receiving the ICB-EM. The main outcome measure was patients' evaluation of the intervention measured by the treatment evaluation inventory. RESULTS: The analyzed sample comprised 76 participants: control group ( n = 38) and intervention group ( n = 38). The mean age of the sample was 19 y (SD = 7.24) and 20.3 y (SD = 6.9) for the control and intervention group, respectively. The intervention group was significantly more satisfied with the ICB-EM than individuals who received the BOS leaflet ( t = -3.53, P = 0.001). CONCLUSION: Patients preferred the computer-based information. KNOWLEDGE TRANSFER STATEMENT: Patients attending dental care in the 21st century are adept in the use of computerised facilities for obtaining information. The results of the study will provide valuable evidence for clinicians on the level of acceptability of the patients toward interactive computer based health education as opposed to traditional paper leaflets.

Assessment of two e-learning methods teaching undergraduate students cephalometry in orthodontics.

AIM: Cephalometry is important for orthodontic diagnosis and treatment planning and is part of the core curriculum for training dentists. Training involves identifying anatomical landmarks. The aim of this investigation was to assess whether e-learning improves learning efficiency; a programme specifically designed for this purpose was compared to commercially available software. METHODS: Thirty undergraduate students underwent traditional training of cephalometry consisting of lectures and tutorials. Tracing skills were tested immediately afterwards (T0). The students were then randomly allocated to three groups: 10 students served as control (CF); they were asked to improve their skills using the material provided so far. Ten students were given a program specifically designed for this study that was based on a power point presentation (PPT). The last group was given a commercially available program that included teaching elements (SW). The groups were tested at the end the six week training (T1). The test consisted of tracing 30 points on two radiographs and a point score improvement was calculated. The students were interviewed after the second test. RESULTS: Both e-learning groups improved more than the traditional group. Improvement scores were four for CF; 8.6 for PPT and 2.8 for SW. For PPT all participants improved and the student feedback was the best compared to the other groups. For the other groups some candidates worsened. CONCLUSIONS: Blended learning produced better learning outcomes compared to using a traditional teaching method alone. The easy to use Power Point based custom software produced better results than the commercially available software.

Does the Eastman correction over- or under-adjust ANB for positional changes of N?

Cephalometric analyses are useful for planning and provision of orthodontic treatment. A and B points are used to resemble the anterior part of maxilla and mandible and N represents the anterior part of the cranial base. The position of N may influence measurements of SNA, SNB, and ANB and changes of N in the antero-posterior plane are thought to have a larger influence on the above measurements than vertical ones. Several methods have been proposed to address this issue, such as the Wits appraisal, the 'Individualized ANB', and the 'Eastman correction'; the latter is mainly used in the UK. This study used a geometrical model of a lateral cephalogram with standard Caucasian average values for SN length, position of A and B points for male and female patients. Linear and angular measurements were digitized using Dolphin™ Imaging software. N was moved in antero-posterior and vertical planes and subsequent changes of SNA, SNB, and ANB were measured and the Eastman correction applied. The correction overestimated the SNA and ANB values in the opposite direction to the directly measured SNA and ANB when N moved posteriorly towards S: The directly measured values tended to show a Class II relationship but the correction indicated a Class III skeletal base. As N moved anteriorly, the Eastman correction overestimated the measured Class III skeletal relationship; SNA did not fall below 81 for correction in the opposite direction. Vertical positional changes had little impact on the underlying ANB and correction was not indicated clinically.

Social perceptions of adults wearing orthodontic appliances: a cross-sectional study.

This study ascertained the influence of orthodontic appliances on subjective ratings for social competence (SC), intellectual ability (IA), psychological adjustment (PA), and attractiveness in young adult orthodontic patients. A cross-sectional analytical questionnaire study was conducted with 130 undergraduates from the UK. Each participant was asked to look at a single, randomly assigned colour photograph of a young adult female and then asked to make judgements concerning her personal characteristics. Five modified photographs of the same young adult female were used: (1) no appliance, (2) stainless steel fixed orthodontic appliance, (3) ceramic fixed orthodontic appliance, (4) gold fixed orthodontic appliance, and (5) clear colourless aligner. Likert scales with higher scores indicating more positive ratings were used. The results were analysed using chi-square test, one-way univariate analysis of variance, and post hoc Tukey-B and Kruskal-Wallis tests. The results showed that greater perceived IA was associated with the appearance of no appliance (mean values: 7.56) rather than steel (6.67) or ceramic appliances (6.65) but similar to the gold (7.35) and aligner (7.08) appliances. No significant differences between the different orthodontic appliance appearances were found for SC and PA. A trend existed where the no appliance image (resembling a lingual appliance) or clear aligner was considered more attractive than the visible buccal fixed appliances. In the absence of other information, the judgements an individual young adult makes concerning the personal characteristics of a young adult are influenced by dental appearance and orthodontic appliance design. This may influence orthodontic appliance choice.

An in vitro investigation of peak insertion torque values of six commercially available mini-implants.

This study compared peak insertion torque values of six commercially available self-drilling mini-implants [Mini Spider® screw (1.5 × 8 mm), Infinitas® (1.5 × 9 mm), Vector TAS® (1.4 × 8 mm), Dual Top® (1.6 × 8 mm), Tomas Pin® (1.6 × 8 mm), and Ortho-Easy® (1.7 × 6, 8, and 10 mm)]. Twenty implants each were drilled into acrylic rods at a speed of 8 rpm using a motorized torque measurement stand, and the values were recorded in Newton centimetres (Ncm). A further 20 Ortho-Easy® implants with a length of 6 and 10 mm were tested at 8 rpm; 20 implants of 6 mm length were also tested at 4 rpm. Kaplan-Meier estimates of the peak torque values were compared using the log-rank test with multiple comparisons evaluated by Sidak's test. There were significant differences in the maximum torque values for different mini-implants with the same length. The Mini Spider® screw and Infinitas® showed the lowest average torque values (6.5 and 12.4 Ncm) compared with Vector TAS®, Dual ToP®, Tomas Pin®, and Ortho-Easy® (30.9, 29.4, 25.4, and 24.8 Ncm, respectively). There was no correlation between the diameter of the implants and torque values. The Tomas Pin® showed the largest standard deviation (7.7 Ncm) and the Dual Top® implant the smallest (0.6 Ncm). Different insertion speeds did not result in significant differences in peak torque values but the 6 mm mini-implants showed significantly higher torque values than the 8 and 10 mm implants. Using a 'torque limiting' screwdriver or pre-drilling cortical bone to reduce insertion, torque appears justified for some of the tested implants.

Comparison of 10 digital SLR cameras for orthodontic photography.

Digital photography is now widely used to document orthodontic patients. High quality intra-oral photography depends on a satisfactory 'depth of field' focus and good illumination. Automatic 'through the lens' (TTL) metering is ideal to achieve both the above aims. Ten current digital single lens reflex (SLR) cameras were tested for use in intra- and extra-oral photography as used in orthodontics. The manufacturers' recommended macro-lens and macro-flash were used with each camera. Handling characteristics, colour-reproducibility, quality of the viewfinder and flash recharge time were investigated. No camera took acceptable images in factory default setting or 'automatic' mode: this mode was not present for some cameras (Nikon, Fujifilm); led to overexposure (Olympus) or poor depth of field (Canon, Konica-Minolta, Pentax), particularly for intra-oral views. Once adjusted, only Olympus cameras were able to take intra- and extra-oral photographs without the need to change settings, and were therefore the easiest to use. All other cameras needed adjustments of aperture (Canon, Konica-Minolta, Pentax), or aperture and flash (Fujifilm, Nikon), making the latter the most complex to use. However, all cameras produced high quality intra- and extra-oral images, once appropriately adjusted. The resolution of the images is more than satisfactory for all cameras. There were significant differences relating to the quality of colour reproduction, size and brightness of the viewfinders. The Nikon D100 and Fujifilm S 3 Pro consistently scored best for colour fidelity. Pentax and Konica-Minolta had the largest and brightest viewfinders.

Natural head posture--considerations of reproducibility.

This three-part study investigated the reproducibility of natural head posture (NHP) using radiographs and photographs. In part 1, reproducibility of cephalograms 1 year after the introduction of NHP was investigated and found to be less favourable (Dahlberg coefficient of 2.99 degrees) than most other previous investigations. In order to minimize radiation exposure of patients, reproducibility of photographs and method agreement between photographs and cephalograms were investigated in part 2. Reproducibility of the two photographs was poor (2.71 degrees). However, method agreement between cephalograms and the photographs taken at the same time was good (1.39 degrees). Replacement of the radiographic method with the photographic method for assessing NHP reproducibility appeared justified. Changing the protocol for achieving NHP in part 3 of the study improved reproducibility substantially (1.41 degrees). Various statistical methods were used to assess reproducibility and method agreement. Bland and Altman's graphical representation was found to be the most appropriate for method agreement. The Dahlberg coefficient, commonly used to assess NHP repeatability/reproducibility, does not provide an extreme enough interval to allow a sufficient clinical assessment of a method to be undertaken, compared with the reproducibility coefficient. That is, the latter provides a 95 per cent range, compared with 52 per cent with Dahlberg.

Continuation of decline in prevalence of anemia in low-income children: the Vermont experience.

OBJECTIVE: To examine whether the prevalence of childhood anemia in white low-income children has continued to decline into the 1990s. DESIGN: An examination of 14 years of hematocrit data from the Centers for Disease Control and Prevention's Pediatric Nutrition Surveillance System in Vermont from 1981 through 1994. SETTING: Public health clinics for the Special Supplemental Nutrition Program for Women, Infants, and Children in Vermont. The same screening method and criteria for identifying and defining anemia and the same quality-assurance procedures were used during the 14 years. The program eligibility criteria were also consistent except for part of 1991 and 1992. MAIN OUTCOME MEASURE: The annual prevalence of anemia. RESULTS: Between 1981 and 1994, the prevalence of anemia halved (from 7.9% to 3.6%, P<.001). For children aged 6 to 24 months, this decline was from 7.8% to 4.6% (P<.001); for children aged 2 to 5 years, the decline was from 7.9% to 3.1% (P<.001). CONCLUSION: The decline in the prevalence of anemia among low-income children observed by the Centers for Disease Control and Prevention's Pediatric Nutrition Surveillance System up to the mid-1980s has continued into the 1990s in Vermont. This finding indicates that iron nutrition in infancy and early childhood is still improving.