Although non-operative treatment is known to be effective for the treatment of uncomplicated acute appendicitis in children, randomised trial data comparing important outcomes of non-operative ...treatment with those of appendicectomy are lacking.
The objectives were to ascertain the feasibility of conducting a multicentre randomised controlled trial comparing the clinical effectiveness and cost-effectiveness of a non-operative treatment pathway with appendicectomy for the treatment of uncomplicated acute appendicitis in children.
This was a mixed-methods study, which included a feasibility randomised controlled trial, embedded and parallel qualitative and survey studies, a parallel health economic feasibility study and the development of a core outcome set.
This study was set in three specialist NHS paediatric surgical units in England.
Children (aged 4-15 years) clinically diagnosed with uncomplicated acute appendicitis participated in the feasibility randomised controlled trial. Children, their families, recruiting clinicians and other health-care professionals involved in caring for children with appendicitis took part in the qualitative study. UK specialist paediatric surgeons took part in the survey. Specialist paediatric surgeons, adult general surgeons who treat children, and children and young people who previously had appendicitis, along with their families, took part in the development of the core outcome set.
Participants in the feasibility randomised controlled trial were randomised to a non-operative treatment pathway (broad-spectrum antibiotics and active observation) or appendicectomy.
The primary outcome measure was the proportion of eligible patients recruited to the feasibility trial.
Data were sourced from NHS case notes, questionnaire responses, transcribed audio-recordings of recruitment discussions and qualitative interviews.
Overall, 50% (95% confidence interval 40% to 59%) of 115 eligible patients approached about the trial agreed to participate and were randomised. There was high acceptance of randomisation and good adherence to trial procedures and follow-up (follow-up rates of 89%, 85% and 85% at 6 weeks, 3 months and 6 months, respectively). More participants had perforated appendicitis than had been anticipated. Qualitative work enabled us to communicate about the trial effectively with patients and families, to design and deliver bespoke training to optimise recruitment and to understand how to optimise the design and delivery of a future trial. The health economic study indicated that the main cost drivers are the ward stay cost and the cost of the operation; it has also informed quality-of-life assessment methods for future work. A core outcome set for the treatment of uncomplicated acute appendicitis in children and young people was developed, containing 14 outcomes. There is adequate surgeon interest to justify proceeding to an effectiveness trial, with 51% of those surveyed expressing a willingness to recruit with an unchanged trial protocol.
Because the feasibility randomised controlled trial was performed in only three centres, successful recruitment across a larger number of sites cannot be guaranteed. However, the qualitative work has informed a bespoke training package to facilitate this. Although survey results suggest adequate clinician interest to make a larger trial possible, actual participation may differ, and equipoise may have changed over time.
A future effectiveness trial is feasible, following limited additional preparation, to establish appropriate outcome measures and case identification. It is recommended to include a limited package of qualitative work to optimise recruitment, in particular at new centres.
Prior to proceeding to an effectiveness trial, there is a need to develop a robust method for distinguishing children with uncomplicated acute appendicitis from those with more advanced appendicitis, and to reach agreement on a primary outcome measure and effect size that is acceptable to all stakeholder groups involved.
Current Controlled Trials ISRCTN15830435.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in
; Vol. 25, No. 10. See the NIHR Journals Library website for further project information.
Currently, the routine treatment for acute appendicitis in the United Kingdom is an appendicectomy. However, there is increasing scientific interest and research into non-operative treatment of ...appendicitis in adults and children. While a number of studies have investigated non-operative treatment of appendicitis in adults, this research cannot be applied to the paediatric population. Ultimately, we aim to perform a UK-based multicentre randomised controlled trial (RCT) to test the clinical and cost effectiveness of non-operative treatment of acute uncomplicated appendicitis in children, as compared with appendicectomy. First, we will undertake a feasibility study to assess the feasibility of performing such a trial.
The study involves a feasibility RCT with a nested qualitative research to optimise recruitment as well as a health economic substudy. Children (aged 4-15 years inclusive) diagnosed with acute uncomplicated appendicitis that would normally be treated with an appendicectomy are eligible for the RCT. Exclusion criteria include clinical/radiological suspicion of perforated appendicitis, appendix mass or previous non-operative treatment of appendicitis. Participants will be randomised into one of two arms. Participants in the intervention arm are treated with antibiotics and regular clinical assessment to ensure clinical improvement. Participants in the control arm will receive appendicectomy. Randomisation will be minimised by age, sex, duration of symptoms and centre. Children and families who are approached for the RCT will be invited to participate in the embedded qualitative substudy, which includes recording of recruitment consultants and subsequent interviews with participants and non-participants and their families and recruiters. Analyses of these will inform interventions to optimise recruitment. The main study outcomes include recruitment rate (primary outcome), identification of strategies to optimise recruitment, performance of trial treatment pathways, clinical outcomes and safety of non-operative treatment. We have involved children, young people and parents in study design and delivery.
In this study we will explore the feasibility of performing a full efficacy RCT comparing non-operative treatment with appendicectomy in children with acute uncomplicated appendicitis. Factors determining success of the present study include recruitment rate, safety of non-operative treatment and adequate interest in the future RCT. Ultimately this feasibility study will form the foundation of the main RCT and reinforce its design.
ISRCTN15830435 . Registered on 8 February 2017.
Abstract Purpose To establish a relationship between the diameter and depth position of vessels in the superior and inferior corneo-scleral limbus using ultra-high resolution optical coherence ...tomography (UHR-OCT). Methods Volumetric OCT images of the superior and inferior limbus were acquired from 14 healthy subjects with a research-grade UHR-OCT system. Differences in vessel diameter and depth between superior and inferior limbus were analyzed using repeated measured ANOVA in SPSS and R. Results The mean (± SD) superior and inferior diameters were 29 ± 18 μm and 24 ± 18 μm respectively, and the mean (± SD) superior and inferior depths were 177 ± 109 μm and 207 ± 132 μm respectively. The superior limbal vessels were larger than the inferior ones (RM-ANOVA, p = 0.004), and the inferior limbal vessels were deeper than the superior vessels (RM-ANOVA, p = 0.041). There was a positive linear association between limbal vessel depth and size within the superior and inferior limbus with Pearson correlation coefficients of 0.803 and 0.754, respectively. Conclusion This study demonstrated that the UHR-OCT was capable of imaging morphometric characteristics such as the size and depth of vessels in the limbus. The results of this study suggest a difference in the size and depth of vessels across different positions of the limbus, which may be indicative of adaptations to chronic hypoxia caused by the covering of the superior limbus by the upper eyelid. UHR-OCT may be a useful tool to evaluate the effect of contact lenses on the microvascular properties within the limbus.
To use physical attributes of redness to determine the accuracy of four bulbar redness grading scales, and to cross-calibrate the scales based on these physical measures.
Two image-processing ...metrics, fractal dimension (D) and percentage of pixel coverage (% PC), as well as photometric chromaticity were selected as physical measures, to describe and compare grades of bulbar redness among the McMonnies/Chapman-Davies scale, the Efron Scale, the Institute for Eye Research scale, and a validated scale developed at the Centre for Contact Lens Research. Two sets of images were prepared by using image processing: The first included multiple segments covering the largest possible region of interest (ROI) within the bulbar conjunctiva in the original images; the second contained modified scale images that were matched in size and resolution across scales, and a single, equally-sized ROI. To measure photometric chromaticity, the original scale images were displayed on a computer monitor, and multiple conjunctival segments were analyzed. Pearson correlation coefficients between each set of image metrics and the reference image grades were calculated to determine the accuracy of the scales.
Correlations were high between reference image grades and all sets of objective metrics (all Pearson's r >or= 0.88, P <or= 0.05); each physical attribute pointed to a different scale as being most accurate. Independent of the physical attribute used, there were wide discrepancies between scale grades, with almost no overlap when cross-calibrating and comparing the scales.
Despite the generally strong linear associations between the physical characteristics of reference images in each scale, the scales themselves are not inherently accurate and are too different to allow for cross-calibration.
While non-operative treatment has emerged as an alternative to surgery for the treatment of uncomplicated acute appendicitis in children, comparative patient-centred outcomes are not well documented. ...We investigated these in a feasibility randomised trial. Of 57 randomised participants, data were available for 26. Compared with appendicectomy, children allocated to non-operative treatment reported higher short-term quality of life scores, shorter duration of requiring analgesia, more rapid return to normal activities and shorter parental absence from work. These preliminary data suggest differences exist in recovery profile and quality of life between these treatments that are important to measure in a larger RCT. Trial registration number is ISRCTN15830435.
BackgroundAcute appendicitis is one of the most common acute surgical emergencies in children and accounts for an annual cost of approximately £50 million to the National Health Service. ...Investigating alternative treatment options offers the best prospect of enhancing the quality of care for patients and potential opportunities for cost savings through better allocative efficiency. A feasibility randomised controlled trial (RCT) comparing a non-operative treatment pathway with appendicectomy for children with acute uncomplicated appendicitis is underway (CONTRACT feasibility RCT).AimsThe prime objective of this economic substudy conducted alongside the CONTRACT feasibility RCT is to better understand and assess: (1) cost data collection tools and cost drivers by identifying patients’ pathways and (2) patient quality of life by assessing alternative paediatric health-related quality of life (HRQoL) instruments. Outcomes from this study will inform a future efficacy RCT assessing the effectiveness and cost-effectiveness of non-operative treatment pathway for the treatment of acute uncomplicated appendicitis in children.MethodsThe economic substudy will use individual-level data and will be conducted from the health system perspective over the study’s 6-month follow-up period. Microcosting will include health resource and service use, while potential benefits acquired will be measured using the HRQoL measures, Child Health Utility 9D (CHU-9D) and Euroqol-5 dimensions and 5 levels (EQ-5D-5L). We will assess the appropriateness of using the cost per quality-adjusted life year framework in the future RCT, as well as testing and identifying the most suitable HRQoL instrument.ConclusionsThe outcomes of the investigational economic substudy will be used to inform the design of our future definitive RCT. However, the result from this economic study will also provide a detailed description and account of the issues inherent in paediatric Economic Evaluations Alongside Clinical Trials with an emphasis on costing methods of interventions taking place in secondary care settings.Trial registration numberISRCTN1583043.
To determine the impact of wavefront-guided laser in situ keratomileusis (LASIK) for hyperopia on corrected distance visual acuity (CDVA), contrast sensitivity, and higher-order aberrations (HOAs).
...Centre for Contact Lens Research, University of Waterloo, Waterloo, Ontario, Canada.
Case series.
This study comprised patients who had LASIK for hyperopia. The HOAs up to the 4th order (5.0 mm pupil) in right eyes were analyzed.
The study enrolled 31 patients. The preoperative mean values were sphere, +2.60 diopters (D) ± 1.15 (SD) (range +1.00 to +5.00 D); astigmatism, -0.87 ± 0.74 D (range 0.00 to -3.75 D); and spherical equivalent (SE), +2.16 ± 1.00 D (range +0.63 to +4.50 D). The postoperative refractive SE was within ±0.50 D in 71.0% of eyes. The uncorrected distance visual acuity was 20/20 or better in 87.2% of eyes. There was no significant change in CDVA or contrast sensitivity (all P>.05). There was a significant change in Zernike coefficients Z(0,4), Z(-1,3), Z(-3,3), and Z(3,3) (range of mean absolute change ± SEM: 0.092 ± 0.013 μm to 0.208 ± 0.018 μm; all P<.001). Coefficients Z(-1,3) and Z(3,3) increased and Z(0,4) and Z(-3,3) decreased in magnitude; each had a reversal of sign. The only significant postoperative association was between low-contrast CDVA and Z(0,4) (r=0.617, P<.001).
Low-contrast CDVA after LASIK surgery for hyperopia was correlated with Z(0,4). There were no significant changes in CDVA or contrast sensitivity. The relative risk for losing low-contrast CDVA increased if more than 1 Zernike term had a sign change.
To describe the geographic distribution of corneal fluorescein staining across the five corneal zones, among non contact lens wearers who report symptoms of dry eye and determine which corneal zone ...most frequently exhibited the worst staining.
Prior studies conducted at the Centre for Ocular Research & Education, Canada, were reviewed for inclusion in the analysis. Each study assessed dry eye symptoms using OSDI and also assessed corneal fluorescein staining in five corneal zones. For each subject, the corneal zones were ranked 1–5 according to their relative staining grade, Rank-1 representing the highest grade.
Data from 13 studies and 368 subjects were included. The total number of zones assigned Rank-1 (worst) staining was 449 (across 264 subjects). The inferior zone had the most Rank-1 counts of all zones at 193/43%, which involved 52.5% of all subjects. The nasal zone had 77/17% involving 20.9% of subjects, followed by the temporal (69/15.5%, 18.8% subjects) and superior zones (63/14%, 17.1% subjects). The central zone had the lowest count of Rank-1 designations, at only 47/10.5%, involving 12.8% of subjects. Bayesian analysis was used to generate distributions of the credible proportions of subjects likely to present with staining in a single peripheral zone, with or without central zone staining. It illustrated that staining in a peripheral zone without central staining was more credible. The worst single zone staining was most likely to present in the inferior zone (67.9%), followed by the nasal zone (11.3%), the superior zone (9.2%), and the temporal zone (5.6%).
In the presence of dry eye symptoms, the inferior zone typically presents the most severe grade of corneal staining, more likely without central zone staining. This knowledge is valuable when developing a strategy to treat dry eye signs, as the inferior corneal zone has the highest grade of staining thus has the potential to exhibit the greatest reduction in staining post-treatment.
In many sports, athletes rely on visual information from the environment to perform. Some literature suggests athletes have superior visual abilities to non-athletes, particularly on tasks ...representative of the visual demands of their sport, such as dynamic acuity, eye movement accuracy and speed, and peripheral vision. Other literature suggests there is no difference between athletes and non-athletes, at least when standard clinical assessments are employed. A limitation of the literature is that almost none of the research has been conducted with standardized, validated tools. This is partly caused by a lack of readily available tools to measure tasks representative of the visual demands of sport, and available tests have typically not been validated against current clinical standards. The purpose of this study is to examine the validity and repeatability of a novel visual acuity system (moV V&MP Vision Suite) recently developed in the Vision & Motor Performance Lab (V&MP). moV& permits the measurement of many visual function parameters including dynamic visual acuity with predictable, random, and jittering target motion.
Twenty-five participants attended two study visits, separated by a minimum of 2 weeks. At each visit, static and dynamic visual acuity was measured using Snellen, ETDRS, and moV& charts. Static visual acuities were compared to determine the validity of moV&, and both static and dynamic visual acuities were compared between visits to determine the test-retest repeatability.
moV& static visual acuities are clinically similar to visual acuities measured with the ETDRS chart (moV&, -0.09 ± 0.13; ETDRS, -0.03 ± 0.11, concordance correlation coefficient 0.726). Additionally, all static, dynamic, and jitter visual acuities demonstrate good test-retest repeatability (Lin's concordance correlation coefficient range 0.451-0.953).
moV& provides good clinical measures of static visual acuity that are comparable to both Snellen and ETDRS measures. Dynamic visual acuity measures demonstrate good test-retest repeatability.
First, to examine how wearing high and low modulus lenses with two different base curves affected lens fit, and the corneal tissue and bulbar conjunctival vascular tissue (bulbar redness and blood ...velocity). Secondly, to quantify the associations between these baseline and outcome variables and the third purpose was to correlate these variables with end of day comfort.
Thirty participants wore higher (PureVision (PV) 8.3, 8.6) and lower (Acuvue Advance (AA) 8.3, 8.7) modulus silicone hydrogel lenses for two weeks on a daily wear basis. Lens fitting characteristics were examined. Corneal epithelial thickness was measured and the cornea and conjunctiva were assessed. RBC velocity was estimated from high magnification bulbar conjunctival images. Subjective comfort/dryness was reported by participants using visual analogue scales.
AA lenses were rated the most comfortable (ANOVA, p=0.041). The least movement was while using the AA 8.3 base curve lens (Tukey p=0.028). Steep AA and PV lenses showed significantly higher conjunctival staining at the 2 week visit (ANOVA, p=0.029). There was a significant decrease in RBC velocity with both steeper AA lenses vs PV lenses (Tukey, p=0.001). Comparing baseline and 2 week visits, there was a significant negative correlation for the PV 8.3 between comfort and superior bulbar staining (r=−0.53). For both the PV 8.3 and AA 8.3 reduced RBC velocity was correlated with dryness (r=0.61 and r=0.91, respectively).
Physical differences in contact lenses affect structural and vascular functional aspects of the ocular surface and these may be associated with symptoms of dryness.
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