The Queensland study of melanoma : Environmental and genetic associations (Q-MEGA); Study design, baseline characteristics, and repeatability of phenotype and sun exposure measures

Cutaneous malignant melanoma (CMM) is a major health issue in Queensland, Australia, which has the world’s highest incidence. Recent molecular and epidemiologic studies suggest that CMM arises through multiple etiological pathways involving gene-environment interactions. Understanding the potential mechanisms leading to CMM requires larger studies than those previously conducted. This article describes the design and baseline characteristics of Q-MEGA, the Queensland Study of Melanoma: Environmental and Genetic Associations, which followed up 4 population-based samples of CMM patients in Queensland, including children, adolescents, men aged over 50, and a large sample of adult cases and their families, including twins. Q-MEGA aims to investigate the roles of genetic and environmental factors, and their interaction, in the etiology of melanoma. Three thousand, four hundred and seventy-one participants took part in the follow-up study and were administered a computer-assisted telephone interview in 2002-2005. Updated data on environmental and phenotypic risk factors, and 2777 blood samples were collected from interviewed participants as well as a subset of relatives. This study provides a large and well-described population-based sample of CMM cases with follow-up data. Characteristics of the cases and repeatability of sun exposure and phenotype measures between the baseline and the follow-up surveys, from 6 to 17 years later, are also described.

Repeatability and validity of lens densitometry measured with Scheimpflug imaging

Purpose To assess the repeatability and validity of lens densitometry derived from the Pentacam Scheimpflug imaging system. Setting Eye Clinic, Queensland University of Technology, Brisbane, Australia. Methods This prospective cross-sectional study evaluated 1 eye of subjects with or without cataract. Scheimpflug measurements and slitlamp and retroillumination photographs were taken through a dilated pupil. Lenses were graded with the Lens Opacities Classification System III. Intraobserver and interobserver reliability of 3 observers performing 3 repeated Scheimpflug lens densitometry measurements each was assessed. Three lens densitometry metrics were evaluated: linear, for which a line was drawn through the visual axis and a mean lens densitometry value given; peak, which is the point at which lens densitometry is greatest on the densitogram; 3-dimensional (3D), in which a fixed, circular 3.0 mm area of the lens is selected and a mean lens densitometry value given. Bland and Altman analysis of repeatability for multiple measures was applied; results were reported as the repeatability coefficient and relative repeatability (RR). Results Twenty eyes were evaluated. Repeatability was high. Overall, interobserver repeatability was marginally lower than intraobserver repeatability. The peak was the least reliable metric (RR 37.31%) and 3D, the most reliable (RR 5.88%). Intraobserver and interobserver lens densitometry values in the cataract group were slightly less repeatable than in the noncataract group. Conclusion The intraobserver and interobserver repeatability of Scheimpflug lens densitometry was high in eyes with cataract and eyes without cataract, which supports the use of automated lens density scoring using the Scheimpflug system evaluated in the study

Within- and between-day repeatability and variability in children's physiological responses during submaximal treadmill exercise

The purpose of this study was to verify within- and between-day repeatability and variability in children's oxygen uptake (VO^sub 2^), gross economy (GE; VO^sub 2^ divided by speed) and heart rate (HR) during treadmill walking based on self-selected speed (SS). Fourteen children (10.1 ± 1.4 years) undertook three testing sessions over 2 days in which four walking speeds, including SS were tested. Within- and between-day repeatability were assessed using the Bland and Altman method, and coefficients of variability (CV) were determined for each child across exercise bouts and averaged to obtain a mean group CV value for VO^sub 2^, GE, and HR per speed. Repeated measures analysis of variance showed no statistically significant differences in within- or between-day CV for VO^sub 2^, GE, or HR at any speed. Repeatability within- and between-day for VO^sub 2^, GE, and HR for all speeds was verified. These results suggest that submaximal VO^sub 2^ during treadmill walking is stable and reproducible at a range of speeds based on children's SS.

Repeatability of measuring corneal subbasal nerve fiber length in individuals with Type 2 Diabetes

Purpose: To analyze the repeatability of measuring nerve fiber length (NFL) from images of the human corneal subbasal nerve plexus using semiautomated software. Methods: Images were captured from the corneas of 50 subjects with type 2 diabetes mellitus who showed varying severity of neuropathy, using the Heidelberg Retina Tomograph 3 with Rostock Corneal Module. Semiautomated nerve analysis software was independently used by two observers to determine NFL from images of the subbasal nerve plexus. This procedure was undertaken on two occasions, 3 days apart. Results: The intraclass correlation coefficient values were 0.95 (95% confidence intervals: 0.92–0.97) for individual subjects and 0.95 (95% confidence intervals: 0.74–1.00) for observer. Bland-Altman plots of the NFL values indicated a reduced spread of data with lower NFL values. The overall spread of data was less for (a) the observer who was more experienced at analyzing nerve fiber images and (b) the second measurement occasion. Conclusions: Semiautomated measurement of NFL in the subbasal nerve fiber layer is highly repeatable. Repeatability can be enhanced by using more experienced observers. It may be possible to markedly improve repeatability when measuring this anatomic structure using fully automated image analysis software.

Repeatability and comparison of peripheral eye lengths with two instruments

Purpose: To assess intrasessional and intersessional repeatability of two commercial partial coherence interferometry instruments for measuring peripheral eye lengths and to investigate the agreement between the two instruments. Methods: Central and peripheral eye lengths were determined with the IOLMaster (Carl-Zeiss Meditec AG, Jena, Germany) and the Lenstar (Haag Streit, Bern, Switzerland) in seven adults. Measurements were performed out to 35° and 30° from fixation for horizontal and vertical visual fields, respectively, in 5° intervals. An external fixation target at optical infinity was used. At least four measurements were taken at each location for each instrument, and measurements were taken at two sessions. Results: The mean intrasessional SDs for the IOLMaster along both the horizontal and vertical visual fields were 0.04 ± 0.04 mm; corresponding results for the Lenstar were 0.02 ± 0.02 mm along both fields. The intersessional SDs for the IOLMaster for the horizontal and vertical visual fields were ±0.11 and ±0.08 mm, respectively; corresponding limits for the Lenstar were ±0.05 and ±0.04 mm. The intrasessional and intersessional variability increased away from fixation. The mean differences between the two instruments were 0.01 ± 0.07 mm and 0.02 ± 0.07 mm in the horizontal and vertical visual fields, but the lengths with the Lenstar became greater than those with the IOLMaster as axial length increased (rate of approximately 0.016 mm/mm). Conclusions: Both the IOLMaster and the Lenstar demonstrated good intrasessional and intersessional repeatability for peripheral eye length measurements, with the Lenstar showing better repeatability. The Lenstar would be expected to give a slightly greater range of eye lengths than the IOLMaster across the visual field.

Repeatability of confocal microscopy measurements on the central and peripheral cornea

Purpose To assess confocal microscopy repeatability (ConfoScan3, Nidek, Italy) when assessing the morphology of the limbus, midperipheral and central cornea. Method The central, mid-peripheral and limbal cornea (temporal and nasal) of the right eye of 8 subjects were examined with a ConfoScan3 in two different visits, at least six months apart. Bland-Altman repeatability was measured for 29 parameters: basal cell density and size, anterior and posterior keratocyte densities (AKD/PKD), endothelial cell density, polymegethism, pleomorphism, mean area and sides of endothelial cells - in the five different corneal areas examined. Results As a percentage of the mean absolute values, repeatability of 0–10% was classified as “excellent”, between 10–30% as “acceptable” and over 30% as “poor”. Repeatability was excellent for 14% of parameters and acceptable for 52% of parameters. The number of endothelial cell sides in the central cornea demonstrated the best repeatability (2.0%) whilst mid-temporal PKD showed the poorest repeatability (53.7%). Conclusions Confocal microscopy is at least an adequately repeatablemethodof evaluating the various corneal layers at different locations. Our dataset supports the ongoing use of the technique in research and clinical practice.

Repeatability or reproducibility in Australian Patent Law

This article considers the extent to which a claimed process must be repeatable or reproducible in order to be patentable according to Australian patent law. It asks whether a process must yield identical or near-identical results each time the process is invoked, or if not, what degree of repeatability is required. The question is relevant when considering, among other things, the patentability of some methods of medical treatment and diagnosis, biotechnology inventions and business methods.

Repeatability of static load bearing exercises during rehabilitation of individuals with transfemoral amputation fitted with osseointegrated implant

Bone-anchored prostheses, relying on implants to attach the prosthesis directly to the residual skeleton, are the ultimate resort for patients with transfemoral amputations (TFA) experiencing severe socket discomfort. The first patient receiving a bone-anchored prosthesis underwent the surgery in 1990 in the Sahlgrenska University Hospital (Sweden). To date, there are two commercially available implants: OPRA (Integrum, Sweden) and ILP (Orthodynamics, Germany). The key to success to this technique is a firm bone-implant bonding, depending on increasing mechanical stress applied daily during load bearing exercises (LBE). The loading data could be analysed through different biomechanical variables. The intra-tester reliability of these exercises will be presented here. Moreover the effect of increase of loading, axes of application of the load and body weight as well as the difference between force and moment variables will be discussed.

Development of a new ultrasound-based system for tracking motion of the human lumbar spine: Reliability, stability and repeatability during forward bending movement trials

The aim of this study was to develop a new method for quantifying intersegmental motion of the spine in an instrumented motion segment L4–L5 model using ultrasound image post-processing combined with an electromagnetic device. A prospective test–retest design was employed, combined with an evaluation of stability and within- and between-day intra-tester reliability during forward bending by 15 healthy male patients. The accuracy of the measurement system using the model was calculated to be ± 0.9° (standard deviation = 0.43) over a 40° range and ± 0.4 cm (standard deviation = 0.28) over 1.5 cm. The mean composite range of forward bending was 15.5 ± 2.04° during a single trial (standard error of the mean = 0.54, coefficient of variation = 4.18). Reliability (intra-class correlation coefficient = 2.1) was found to be excellent for both within-day measures (0.995–0.999) and between-day measures (0.996–0.999). Further work is necessary to explore the use of this approach in the evaluation of biomechanics, clinical assessments and interventions.

Preoperative visual acuity of cataract patients. Repeatability of visual acuity and refractive error measurements in clinical settings

Visual acuities at the time of referral and on the day before surgery were compared in 124 patients operated on for cataract in Vaasa Central Hospital, Finland. Preoperative visual acuity and the occurrence of ocular and general disease were compared in samples of consecutive cataract extractions performed in 1982, 1985, 1990, 1995 and 2000 in two hospitals in the Vaasa region in Finland. The repeatability and standard deviation of random measurement error in visual acuity and refractive error determination in a clinical environment in cataractous, pseudophakic and healthy eyes were estimated by re-examining visual acuity and refractive error of patients referred to cataract surgery or consultation by ophthalmic professionals. Altogether 99 eyes of 99 persons (41 cataractous, 36 pseudophakic and 22 healthy eyes) with a visual acuity range of Snellen 0.3 to 1.3 (0.52 to -0.11 logMAR) were examined. During an average waiting time of 13 months, visual acuity in the study eye decreased from 0.68 logMAR to 0.96 logMAR (from 0.2 to 0.1 in Snellen decimal values). The average decrease in vision was 0.27 logMAR per year. In the fastest quartile, visual acuity change per year was 0.75 logMAR, and in the second fastest 0.29 logMAR, the third and fourth quartiles were virtually unaffected. From 1982 to 2000, the incidence of cataract surgery increased from 1.0 to 7.2 operations per 1000 inhabitants per year in the Vaasa region. The average preoperative visual acuity in the operated eye increased by 0.85 logMAR (in decimal values from 0.03to 0.2) and in the better eye 0.27 logMAR (in decimal values from 0.23 to 0.43) over this period. The proportion of patients profoundly visually handicapped (VA in the better eye <0.1) before the operation fell from 15% to 4%, and that of patients less profoundly visually handicapped (VA in the better eye 0.1 to <0.3) from 47% to 15%. The repeatability visual acuity measurement estimated as a coefficient of repeatability for all 99 eyes was ±0.18 logMAR, and the standard deviation of measurement error was 0.06 logMAR. Eyes with the lowest visual acuity (0.3-0.45) had the largest variability, the coefficient of repeatability values being ±0.24 logMAR and eyes with a visual acuity of 0.7 or better had the smallest, ±0.12 logMAR. The repeatability of refractive error measurement was studied in the same patient material as the repeatability of visual acuity. Differences between measurements 1 and 2 were calculated as three-dimensional vector values and spherical equivalents and expressed by coefficients of repeatability. Coefficients of repeatability for all eyes for vertical, torsional and horisontal vectors were ±0.74D, ±0.34D and ±0.93D, respectively, and for spherical equivalent for all eyes ±0.74D. Eyes with lower visual acuity (0.3-0.45) had larger variability in vector and spherical equivalent values (±1.14), but the difference between visual acuity groups was not statistically significant. The difference in the mean defocus equivalent between measurements 1 and 2 was, however, significantly greater in the lower visual acuity group. If a change of ±0.5D (measured in defocus equivalents) is accepted as a basis for change of spectacles for eyes with good vision, the basis for eyes in the visual acuity range of 0.3 - 0.65 would be ±1D. Differences in repeated visual acuity measurements are partly explained by errors in refractive error measurements.

Spirometric studies on the adult general population of Helsinki : bronchodilation responses, determinants, and intrasession repeatability of FEV1, FEV6, FVC, and forced expiratory time

Spirometry is the most widely used lung function test in the world. It is fundamental in diagnostic and functional evaluation of various pulmonary diseases. In the studies described in this thesis, the spirometric assessment of reversibility of bronchial obstruction, its determinants, and variation features are described in a general population sample from Helsinki, Finland. This study is a part of the FinEsS study, which is a collaborative study of clinical epidemiology of respiratory health between Finland (Fin), Estonia (Es), and Sweden (S). Asthma and chronic obstructive pulmonary disease (COPD) constitute the two major obstructive airways diseases. The prevalence of asthma has increased, with around 6% of the population in Helsinki reporting physician-diagnosed asthma. The main cause of COPD is smoking with changes in smoking habits in the population affecting its prevalence with a delay. Whereas airway obstruction in asthma is by definition reversible, COPD is characterized by fixed obstruction. Cough and sputum production, the first symptoms of COPD, are often misinterpreted for smokers cough and not recognized as first signs of a chronic illness. Therefore COPD is widely underdiagnosed. More extensive use of spirometry in primary care is advocated to focus smoking cessation interventions on populations at risk. The use of forced expiratory volume in six seconds (FEV6) instead of forced vital capacity (FVC) has been suggested to enable office spirometry to be used in earlier detection of airflow limitation. Despite being a widely accepted standard method of assessment of lung function, the methodology and interpretation of spirometry are constantly developing. In 2005, the ATS/ERS Task Force issued a joint statement which endorsed the 12% and 200 ml thresholds for significant change in forced expiratory volume in one second (FEV1) or FVC during bronchodilation testing, but included the notion that in cases where only FVC improves it should be verified that this is not caused by a longer exhalation time in post-bronchodilator spirometry. This elicited new interest in the assessment of forced expiratory time (FET), a spirometric variable not usually reported or used in assessment. In this population sample, we examined FET and found it to be on average 10.7 (SD 4.3) s and to increase with ageing and airflow limitation in spirometry. The intrasession repeatability of FET was the poorest of the spirometric variables assessed. Based on the intrasession repeatability, a limit for significant change of 3 s was suggested for FET during bronchodilation testing. FEV6 was found to perform equally well as FVC in the population and in a subgroup of subjects with airways obstruction. In the bronchodilation test, decreases were frequently observed in FEV1 and particularly in FVC. The limit of significant increase based on the 95th percentile of the population sample was 9% for FEV1 and 6% for FEV6 and FVC; these are slightly lower than the current limits for single bronchodilation tests (ATS/ERS guidelines). FEV6 was proven as a valid alternative to FVC also in the bronchodilation test and would remove the need to control duration of exhalation during the spirometric bronchodilation test.

Spatial repeatability of dynamic tyre forces generated by heavy vehicles

Road damage due to heavy vehicles is thought to be dependent on the extent to which lorries in normal traffic apply peak forces to the same locations along the road. A validated vehicle simulation is used to simulate 37 leaf-sprung articulated vehicles with parametric variations typical of vehicles in one weight class in the highway vehicle fleet. The spatial distribution of tyre forces generated by each vehicle is compared with the distribution generated by a reference vehicle, and the conditions are established for which repeated heavy loading occurs at specific points along the road. It is estimated that approximately two-thirds of vehicles in this class (a large proportion of all heavy vehicles) may contribute to a repeated pattern of road loading. It is concluded that dynamic tyre forces are a significant factor influencing road damage, compared to other factors such as tyre configuration and axle spacing.

Investigation of spatial repeatability using a tire force measuring mat

A portable mat for measuring the dynamic tire forces of commercial vehicles is described. The mat is 56 m long and 13 mm thick and has 141 capacitative strip sensors spaced at 0.4-m intervals. The accuracy of the mat for measuring dynamic tire forces generated by heavy commercial vehicles is assessed using an instrumented vehicle. The spatial repeatability of dynamic wheel loads generated by 14 uninstrumented articulated vehicles is investigated, and it is concluded that approximately half of the vehicles tested are likely to contribute to a repeatable pattern of road loading.