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Eye-Rubbing Detection Tool Using Artificial Intelligence on a Smartwatch in the Management of Keratoconus. 基于智能手表的人工智能擦眼检测工具在圆锥角膜治疗中的应用。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-12-02 DOI: 10.1167/tvst.13.12.16
Ines Drira, Ayoub Louja, Layth Sliman, Vincent Soler, Maha Noor, Abdellah Jamali, Pierre Fournie

Purpose: Eye rubbing is considered to play a significant role in the progression of keratoconus and of corneal ectasia following refractive surgery. To our knowledge, no tool performs an objective quantitative evaluation of eye rubbing using a device that is familiar to typical patients. We introduce here an innovative solution for objectively quantifying and preventing eye rubbing. It consists of an application that uses a deep-learning artificial intelligence (AI) algorithm deployed on a smartwatch.

Methods: A Samsung Galaxy Watch 4 smartwatch collected motion data from eye rubbing and everyday activities, including readings from the gyroscope, accelerometer, and linear acceleration sensors. The training of the model was carried out using two deep-learning algorithms, long short-term memory (LSTM) and gated recurrent unit (GRU), as well as four machine learning algorithms: random forest, K-nearest neighbors (KNN), support vector machine (SVM), and XGBoost.

Results: The model achieved an accuracy of 94%. The developed application could recognize, count, and display the number of eye rubbings carried out. The GRU model and XGBoost algorithm also showed promising performance.

Conclusions: Automated detection of eye rubbing by deep-learning AI has been proven to be feasible. This approach could radically improve the management of patients with keratoconus and those undergoing refractive surgery. It could detect and quantify eye rubbing and help to reduce it by sending alerts directly to the patient.

Translational relevance: This proof of concept could confirm one of the most prominent paradigms in keratoconus management, the role of abnormal eye rubbing, while providing the means to challenge or even negate it by offering the first automated and objective tool for detecting eye rubbing.

目的:在屈光手术后圆锥角膜和角膜扩张的进展中,揉眼被认为起着重要的作用。据我们所知,没有工具可以使用典型患者熟悉的设备对揉眼进行客观的定量评估。我们在这里介绍一种创新的解决方案,客观量化和预防揉眼。它包括一个应用程序,该应用程序使用部署在智能手表上的深度学习人工智能(AI)算法。方法:三星Galaxy Watch 4智能手表从揉眼和日常活动中收集运动数据,包括陀螺仪、加速度计和线性加速度传感器的读数。模型的训练使用了长短期记忆(LSTM)和门控循环单元(GRU)两种深度学习算法,以及随机森林、k近邻(KNN)、支持向量机(SVM)和XGBoost四种机器学习算法。结果:该模型达到了94%的准确率。开发的应用程序可以识别、计数和显示进行的眼部按摩次数。GRU模型和XGBoost算法也表现出良好的性能。结论:深度学习人工智能自动检测揉眼是可行的。这种方法可以从根本上改善圆锥角膜患者和接受屈光手术的患者的管理。它可以检测和量化眼部摩擦,并通过直接向患者发送警报来帮助减少这种情况。翻译相关性:这一概念的证明可以证实圆锥角膜治疗中最突出的范例之一,即异常擦眼的作用,同时通过提供第一个检测擦眼的自动化和客观工具,提供挑战甚至否定它的手段。
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引用次数: 0
Author Response: Effect of Depth-Dependent Integrated Visual Field on Vision-Related Quality of Life in Glaucoma. 深度依赖综合视野对青光眼患者视觉相关生活质量的影响。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-12-02 DOI: 10.1167/tvst.13.12.2
Andrew Turpin, Allison M McKendrick
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引用次数: 0
The Strain Response to Intraocular Pressure Increase in the Lamina Cribrosa of Control Subjects and Glaucoma Patients. 对照组和青光眼患者视网膜层对眼压升高的应变反应。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-12-02 DOI: 10.1167/tvst.13.12.7
Cameron A Czerpak, Michael Saheb Kashaf, Brandon K Zimmerman, Rebecca Mirville, Nicolas C Gasquet, Harry A Quigley, Thao D Nguyen

Purpose: The purpose of this study was to measure biomechanical strains in the lamina cribrosa (LC) of living human eyes undergoing intraocular pressure (IOP) increase.

Methods: Healthy control subjects and patients with glaucoma underwent optical coherence tomographic (OCT) imaging of the LC before and after wearing of swim goggles that increased IOP (57 image pairs, 39 persons). Digital volume correlation was used to measure biomechanical strains in optic nerve head tissue and change in depth of the anterior border of the LC.

Results: The mean IOP increase in both glaucoma and control eyes was 7.1 millimeters of mercury (mm Hg) after application of the goggles. Among glaucoma eyes, strains that were significant were: contractile Ezz (average = -0.33%, P = 0.0005), contractile Eθθ (average = -0.23%, P = 0.03), Emax (average = 0.83%, P < 0.0001), and Γmax (average = 0.95%, P < 0.0001), whereas the average anterior LC depth (ALD) decreased by 2.39 µm (anterior; P = 0.0002). In glaucoma eyes, shear strain Ezθ was greater with worse mean deviation (MD) and visual function index (P = 0.044 and P = 0.006, respectively, multivariate models). Strain compliance for Erθ, Ezθ, and Eθθ all increased with greater MD worsening prior to imaging (P = 0.04, P = 0.007, and P = 0.03).

Conclusions: LC strains were measurable 20 minutes after IOP increase, producing axial compression and greater peripheral strain than centrally. Some strain compliances were greater with worse existing visual field loss or with more progressive past field loss.

Translational relevance: Biomechanical strains are related to measures of glaucoma damage, supporting the hypothesis that optic nerve head biomechanical responses represent a noninvasive biomarker for glaucoma.

目的:测定眼压(IOP)升高时人眼筛板(LC)的生物力学应变。方法:对健康对照者和青光眼患者配戴游泳镜前后的LC进行光学相干层析成像(OCT),提高IOP(57对图像,39人)。采用数字体积相关测量视神经头组织的生物力学应变和LC前缘深度的变化。结果:使用护目镜后,青光眼和对照眼的平均IOP升高7.1毫米汞柱。青光眼中,有显著差异的应变有:可收缩的Ezz(平均= -0.33%,P = 0.0005)、可收缩的Eθθ(平均= -0.23%,P = 0.03)、Emax(平均= 0.83%,P < 0.0001)和Γmax(平均= 0.95%,P < 0.0001),而前路LC深度(ALD)平均减少2.39µm(前路;P = 0.0002)。青光眼剪切应变Ezθ越大,平均偏差(MD)和视功能指数越差(多变量模型P = 0.044和P = 0.006)。Erθ、Ezθ和Eθθ的应变顺应性随影像学前MD恶化程度的增加而增加(P = 0.04、P = 0.007和P = 0.03)。结论:IOP升高20分钟后可测LC应变,产生轴向压缩,周边应变大于中心应变。一些应变顺应性更大的严重现有的视野丧失或更严重的过去的视野丧失。翻译相关性:生物力学应变与青光眼损伤的测量有关,支持视神经头生物力学反应是青光眼非侵入性生物标志物的假设。
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引用次数: 0
Visual Quality and Accommodation With Novel Optical Designs for Myopia Control. 用新型光学设计控制近视的视觉质量和调节。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-12-02 DOI: 10.1167/tvst.13.12.6
Sara Aissati, Tianlun Zou, Sabyasachi Goswami, Len Zheleznyak, Susana Marcos

Purpose: We evaluated through-focus visual performance and accommodative response in young subjects through three segmented multifocal designs for myopia control, mapped on the spatial light modulator of a monocular adaptive optics visual simulator (AOVS), and compared with single vision (SV).

Methods: The segmented multifocal patterns included a 4 mm diameter center distance zone and offset peripheral defocus (MP1), astigmatism and coma (MP2), or a combination (MP3). High-contrast logMAR visual acuity (VA) was measured with monochromatic stimuli (555 nm). Ocular aberrations were measured using the Hartmann-Shack aberrometry channel. Measurements were taken for distance viewing and five accommodative demands (AD, up to 4.5 D). Accommodative lag was calculated from the dioptric shift of the maximum retinal image quality metric from the corresponding wave aberrations.

Results: Best-corrected logMAR VA was -0.11 ± 0.02 (SV) and slightly reduced by multifocal patterns (-0.08 ± 0.03 [MP1], -0.07 ± 0.04 [MP2], -0.05 ± 0.04 [MP3]). Accommodative lag with SV was lower in emmetropes than myopes (by 0.43D for the largest demand). MP1 significantly decreased accommodative lag in myopes (P = 0.03), unlike MP2 or MP3. Multifocal patterns reduced pupil diameter in myopes at all distances. MP1 improved accommodative response in myopes without compromising distance vision.

Conclusions: AOVS helped to understand the interplay of physiological and lens design factors, potentially guiding custom corrections. A center distance with off-centered positive power in the lens periphery could feature suitable properties (peripheral focus and accommodative focus control) for myopia control.

Translational relevance: We demonstrate a two-zone contact lens design that provides excellent visual quality and accommodative response, important properties for myopia control lenses.

目的:通过对三种分段多焦点设计的近视控制,在单眼自适应光学视觉模拟器(AOVS)的空间光调制器上进行映射,并与单眼视觉(SV)进行比较,评估青年受试者的通焦视觉表现和调节反应。方法:分割的多焦模式包括直径为4mm的中心距离区和偏移的周围离焦(MP1)、散光和彗差(MP2)或两者的组合(MP3)。采用单色刺激(555 nm)测量高对比度logMAR视敏度(VA)。眼像差测量采用哈特曼-夏克像差测量通道。测量了距离观看和五种调节需求(AD,高达4.5 D)。调节滞后是根据最大视网膜图像质量度量从相应的波像差的屈光移来计算的。结果:最佳校正logMAR VA为-0.11±0.02 (SV),多焦模式略有降低(-0.08±0.03 [MP1], -0.07±0.04 [MP2], -0.05±0.04 [MP3])。大城市与SV的调节滞后小于近视(最大需求为0.43 3d)。与MP2或MP3不同,MP1显著降低了近视的调节滞后(P = 0.03)。在所有距离的近视眼中,多焦模式均可减小瞳孔直径。MP1在不影响远视力的情况下改善了近视眼的调节反应。结论:AOVS有助于理解生理因素和晶状体设计因素的相互作用,可能指导定制矫正。晶状体外围离心正度数的中心距离具有较好的控制近视眼的特性(外围聚焦和调节聚焦)。翻译相关性:我们展示了一种双区隐形眼镜设计,它提供了出色的视觉质量和适应性反应,这是近视控制镜片的重要特性。
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引用次数: 0
Clinical Validation of M-TONX: A Novel Combo Rebound Tonometer and Pachymeter. M-TONX的临床验证:一种新型复合回弹眼压计和血肿计。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-12-02 DOI: 10.1167/tvst.13.12.34
Naveed Nilforushan, Mozafar Yousefi, Ankica Babic, Arash Gharehbaghi

Purpose: This study aims to perform a clinical investigation of an innovative rebound technology-based device, the M-TONX, to simultaneously measure intraocular pressure (IOP) and central corneal thickness (CCT).

Methods: The IOP and CCT of the patients were first measured by the M-TONX. Then, the measurements were repeated by the Goldman applanation (GAT) and the Pentacam corneal topographer, as the standard devices. For the statistical analysis, the patients were stratified based on their IOPs to group 1 (IOP < = 16 millimeters of mercury [mm Hg]), group 2 (16 mm Hg < IOP < 23 mm Hg), and group 3 (IOP > = 23 mm Hg). The stratification was also performed for the CCTs as: class 1 (CCT < = 475 µm), class 2 (475 < CCT < 574 µm), and class 3 (CCT > = 575 µm).

Results: Of the 374 eyes (225 subjects and 43% women), 262, 66, and 46 eyes belonged to group 1, group 2, and group 3, respectively. Very high IOP (>35 mm Hg) was observed in 12 eyes. The overall confidence interval of the deviation (confidence level = 95%) from the standard devices was estimated to be 0.7 to 1.2 mm Hg for IOP, and -12.7 to -5.4 µm for CCT. The stratified analysis showed substantial agreement with the standard devices with the intraclass correlation > 0.65 and the Pearson Correlation > 0.8 calculated for all the groups and classes.

Conclusions: The M-TONX exhibited a reliable performance concerning the standards for measuring IOP and CCT. Its accuracy remains stable for a broad range of IOP and CCT. The M-TONX successfully incorporates two separate functionalities into a single compact user-friendly device.

Translational relevance: This study uncovers the conformity of the technology with the standards, linking fundamental research to clinical care.

目的:本研究旨在对一种创新的基于反弹技术的设备M-TONX进行临床研究,该设备可以同时测量眼压(IOP)和角膜中央厚度(CCT)。方法:先用M-TONX眼压仪测定眼压和CCT。然后,用Goldman平眼仪(GAT)和Pentacam角膜地形仪作为标准设备重复测量。为了进行统计分析,根据患者的IOPs分为1组(IOP < = 16 mm汞柱[mm Hg])、2组(16 mm汞柱< IOP < 23 mm汞柱)和3组(IOP > = 23 mm Hg)。对CCT也进行分层:1级(CCT < = 475µm), 2级(475 < CCT < 574µm)和3级(CCT > = 575µm)。结果:374只眼(受试者225只,女性43%)中,1组262只,2组66只,3组46只。高眼压12眼(眼压>35 mm Hg)。与标准装置偏差的总体置信区间(置信水平= 95%)估计为IOP为0.7至1.2 mm Hg, CCT为-12.7至-5.4µm。分层分析显示与标准装置基本一致,所有组和类别计算的类内相关>.65和Pearson相关> 0.8。结论:M-TONX在测量IOP和CCT方面表现出可靠的性能。它的精度在大范围内保持稳定的IOP和CCT。M-TONX成功地将两个独立的功能集成到一个紧凑的用户友好型设备中。转化相关性:本研究揭示了技术与标准的一致性,将基础研究与临床护理联系起来。
{"title":"Clinical Validation of M-TONX: A Novel Combo Rebound Tonometer and Pachymeter.","authors":"Naveed Nilforushan, Mozafar Yousefi, Ankica Babic, Arash Gharehbaghi","doi":"10.1167/tvst.13.12.34","DOIUrl":"10.1167/tvst.13.12.34","url":null,"abstract":"<p><strong>Purpose: </strong>This study aims to perform a clinical investigation of an innovative rebound technology-based device, the M-TONX, to simultaneously measure intraocular pressure (IOP) and central corneal thickness (CCT).</p><p><strong>Methods: </strong>The IOP and CCT of the patients were first measured by the M-TONX. Then, the measurements were repeated by the Goldman applanation (GAT) and the Pentacam corneal topographer, as the standard devices. For the statistical analysis, the patients were stratified based on their IOPs to group 1 (IOP < = 16 millimeters of mercury [mm Hg]), group 2 (16 mm Hg < IOP < 23 mm Hg), and group 3 (IOP > = 23 mm Hg). The stratification was also performed for the CCTs as: class 1 (CCT < = 475 µm), class 2 (475 < CCT < 574 µm), and class 3 (CCT > = 575 µm).</p><p><strong>Results: </strong>Of the 374 eyes (225 subjects and 43% women), 262, 66, and 46 eyes belonged to group 1, group 2, and group 3, respectively. Very high IOP (>35 mm Hg) was observed in 12 eyes. The overall confidence interval of the deviation (confidence level = 95%) from the standard devices was estimated to be 0.7 to 1.2 mm Hg for IOP, and -12.7 to -5.4 µm for CCT. The stratified analysis showed substantial agreement with the standard devices with the intraclass correlation > 0.65 and the Pearson Correlation > 0.8 calculated for all the groups and classes.</p><p><strong>Conclusions: </strong>The M-TONX exhibited a reliable performance concerning the standards for measuring IOP and CCT. Its accuracy remains stable for a broad range of IOP and CCT. The M-TONX successfully incorporates two separate functionalities into a single compact user-friendly device.</p><p><strong>Translational relevance: </strong>This study uncovers the conformity of the technology with the standards, linking fundamental research to clinical care.</p>","PeriodicalId":23322,"journal":{"name":"Translational Vision Science & Technology","volume":"13 12","pages":"34"},"PeriodicalIF":2.6,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11681916/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142898346","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Development of an Open-Source Dataset of Flat-Mounted Images for the Murine Oxygen-Induced Retinopathy Model of Ischemic Retinopathy. 缺血性视网膜病变小鼠氧诱导视网膜病变模型平面图像开源数据集的开发。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-12-02 DOI: 10.1167/tvst.13.12.4
Kyle V Marra, Jimmy S Chen, Hailey K Robles-Holmes, Kristine B Ly, Joseph Miller, Guoqin Wei, Edith Aguilar, Felicitas Bucher, Yoichi Ideguchi, Fritz Gerald P Kalaw, Andrew C Lin, Napoleone Ferrara, J Peter Campbell, Martin Friedlander, Eric Nudleman

Purpose: To describe an open-source dataset of flat-mounted retinal images and vessel segmentations from mice subject to the oxygen-induced retinopathy (OIR) model.

Methods: Flat-mounted retinal images from mice killed at postnatal days 12 (P12), P17, and P25 used in prior OIR studies were compiled. Mice subjected to normoxic conditions were killed at P12, P17, and P25, and their retinas were flat-mounted for imaging. Major blood vessels from the OIR images were manually segmented by four graders (JSC, HKR, KBL, JM), with cross-validation performed to ensure similar grading.

Results: Overall, 1170 images were included in this dataset. Of these images, 111 were of normoxic mice retina, and 1048 were mice subject to OIR. The majority of images from OIR mice were obtained at P17. The 50 images obtained from an external dataset, OIRSeg, did not have age labels. All images were manually segmented and used in the training or testing of a previously published deep learning algorithm.

Conclusions: This is the first open-source dataset of original and segmented flat-mounted retinal images. The dataset has potential applications for expanding the development of generalizable and larger-scale artificial intelligence and analyses for OIR. This dataset is published online and publicly available at dx.doi.org/10.6084/m9.figshare.23690973.

Translational relevance: This open access dataset serves as a source of raw data for future research involving big data and artificial intelligence research concerning oxygen-induced retinopathy.

目的:描述氧诱导视网膜病变(OIR)模型小鼠平板视网膜图像和血管分割的开源数据集。方法:收集先前OIR研究中使用的出生后12天(P12)、P17和P25死亡小鼠的平板视网膜图像。在P12、P17和P25处死常温条件下的小鼠,将其视网膜平装成像。通过四个分级器(JSC, HKR, KBL, JM)对OIR图像中的主要血管进行手动分割,并进行交叉验证以确保相似的分级。结果:该数据集共包含1170幅图像。在这些图像中,111张是正常小鼠的视网膜,1048张是受OIR影响的小鼠。OIR小鼠的大部分图像是在P17获得的。从外部数据集OIRSeg获得的50张图像没有年龄标签。所有图像都被手动分割,并用于先前发布的深度学习算法的训练或测试。结论:这是第一个原始和分割的平板视网膜图像的开源数据集。该数据集在扩展可推广和更大规模的人工智能和OIR分析的发展方面具有潜在的应用。该数据集在线发布,并可在dx.doi.org/10.6084/m9.figshare.23690973.Translational上公开获取:该开放获取数据集可作为未来研究的原始数据来源,涉及大数据和人工智能研究有关氧诱导视网膜病变。
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引用次数: 0
Risk of Bias When Using Early Failure Criteria in Randomized Clinical Trials With Stereoacuity Outcomes. 在立体视力结果的随机临床试验中使用早期失败标准时的偏倚风险。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-12-02 DOI: 10.1167/tvst.13.12.1
Meet Panjwani, Jonathan M Holmes

Purpose: The purpose of this study was to explore the effects of early failure criteria for participants in randomized clinical trials (RCTs) on overall trial conclusions.

Method: We simulated 10,000 hypothetical RCTs with 2 treatments, 1 linear improvement and 1 with increasing rate of improvement and 6 follow-up visits. Each RCT had 400 participants, with the same baseline stereoacuity distribution. We incorporated random test-retest noise for every visit, and scores were rounded to the nearest observable score. Early failure was defined as worsening of two or more levels. We compared mean outcome stereoacuity between treatment groups, with and without the failure rule, using the two-sample t-test and the proportion of erroneous RCTs (significantly different mean outcome values, where truth is known to be no different). Sensitivity analyses were performed to explore the influence of sample size, baseline distribution of stereoacuity, overall magnitude of mean improvement, magnitude of change for the failure rule, and distribution of noise.

Results: A greater proportion of 10,000 simulated RCTs had an erroneous mean difference in outcome with the early failure rule than without (5.49%, 95% confidence interval [CI] = 5.05% to 5.94% vs. 0, 0%, 95% CI = 0% to 0.000001%, difference 5.49%, P < 0.0001). Sensitivity analysis revealed that increased sample size and wider distribution of noise had the greatest influence on increasing proportions of erroneous RCT conclusions.

Conclusions: Study designs incorporating participant-level early failure rules increase the risk of erroneous RCT conclusions and should be avoided.

Translational relevance: We provide data informing the design of future clinical trials. Earlier failure rules at the participant level should be avoided.

目的:本研究的目的是探讨随机临床试验(rct)参与者早期失败标准对总体试验结论的影响。方法:模拟1万组随机对照试验,2组治疗,1组线性改善,1组改善率增加,6组随访。每个RCT有400名参与者,具有相同的基线立体视敏度分布。我们将每次访问的随机重测噪声纳入其中,并将得分四舍五入到最接近的可观察得分。早期衰竭被定义为两级或两级以上的恶化。我们使用双样本t检验和错误rct的比例(平均结果值显著不同,其中真理已知没有差异),比较了有和没有失败规则的治疗组之间的平均结果立体锐度。进行敏感性分析以探讨样本量、立体敏锐度基线分布、平均改善的总体幅度、失效规则的变化幅度和噪声分布的影响。结果:在10,000个模拟rct中,有早期失效规则的结果平均误差比没有早期失效规则的结果平均误差大(5.49%,95%置信区间[CI] = 5.05% ~ 5.94%比0,0%,95% CI = 0% ~ 0.000001%,差5.49%,P < 0.0001)。敏感性分析显示,样本量的增加和噪声分布的扩大对RCT错误结论比例的增加影响最大。结论:纳入参与者水平早期失败规则的研究设计增加了错误RCT结论的风险,应避免。翻译相关性:我们为未来临床试验的设计提供数据。应该避免参与者级别的早期故障规则。
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引用次数: 0
Patient-Reported Experience Measurements From Individuals With Inherited Retinal Disorders Involved in Observational Research. 参与观察性研究的遗传性视网膜疾病患者报告的经验测量。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-12-02 DOI: 10.1167/tvst.13.12.9
Malena Daich Varela, Shaima Hashem, Dayyanah Sumodhee, Michel Michaelides

Purpose: Inherited retinal disorders (IRD) are a complex group of conditions. By developing the first patient-reported experience measurement (PREM) questionnaire tailored for individuals with IRD participating in natural history studies, we gathered information on individuals' views of their experience while they are involved in research.

Methods: Adults with IRD who (i) were enrolled in a natural history study taking place at Moorfields Eye Hospital (London, UK), (ii) had attended at least two study visits, (iii) the most recent one being less than two weeks before the questionnaire, and (iv) who were not involved in interventional research, were considered for participation.

Results: Fifty individuals completed the PREM questionnaire at a mean age of 31.1 ± 11 years old and were diagnosed at a mean age of 14 ± 9.7 years old. Most individuals rated "getting closer to receiving treatment' as their main motivation to enroll in the study, and their biggest influence was their own curiosity. Individuals were more satisfied with the care they received, and least satisfied with the efficiency of the visit. After validity and reliability assessments, the final PREM was created, with 27 questions and five sections, and Cronbach alpha coefficient between 0.316 and 0.756 in each section.

Conclusions: The PREM instrument allowed us to assess the overall satisfaction of individuals with IRD involved in research, detect possible barriers to research participation, and ways of improving our care.

Translational relevance: The final version can be included in future research and other sites worldwide, to maintain high quality standards.

目的:遗传性视网膜疾病(IRD)是一组复杂的疾病。通过开发首个为参与自然史研究的IRD患者量身定制的患者报告体验测量(PREM)问卷,我们收集了个人在参与研究时对其体验的看法的信息。方法:患有IRD的成年人(i)参加了在Moorfields眼科医院(伦敦,英国)进行的自然历史研究,(ii)参加了至少两次研究访问,(iii)最近一次是在问卷调查前不到两周,(iv)没有参与介入性研究,被考虑参加。结果:50例患者平均年龄(31.1±11岁)完成PREM问卷,平均年龄(14±9.7岁)确诊。大多数人认为“更接近接受治疗”是他们参加这项研究的主要动机,他们最大的影响是自己的好奇心。个人对他们得到的护理更满意,而对访问的效率最不满意。经过效度和信度评估,形成最终的PREM,共27题,5个部分,每个部分的Cronbach alpha系数在0.316 ~ 0.756之间。结论:PREM工具使我们能够评估参与研究的IRD患者的总体满意度,发现参与研究的可能障碍,以及改善我们护理的方法。翻译相关性:最终版本可以包含在未来的研究和世界各地的其他网站中,以保持高质量标准。
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引用次数: 0
Using Hierarchical Bayesian Modeling to Enhance Statistical Inference on Contrast Sensitivity. 基于层次贝叶斯模型的对比敏感度统计推断。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-12-02 DOI: 10.1167/tvst.13.12.17
Yukai Zhao, Luis Andres Lesmes, Michael Dorr, Zhong-Lin Lu

Purpose: The purpose of this study is to introduce a nonparametric hierarchical Bayesian model (HBM) that enables advanced statistical inference on contrast sensitivity (CS) both at individual spatial frequencies (SFs) and across multiple SFs in clinical trials, where CS measurements are crucial for assessing safety and efficacy.

Methods: The HBM computes the joint posterior distribution of CS at six Food and Drug Administration-designated SFs across the population, individual, and test levels. It incorporates covariances at both population and individual levels to capture the relationship between CSs across SFs. A Bayesian inference procedure (BIP) is also used to estimate the posterior distribution of CS at each SF independently. Both methods are applied to a quantitative CSF (qCSF) dataset of 112 subjects and compared in terms of precision, test-retest reliability of CS estimates, sensitivity, accuracy, and statistical power in detecting CS changes.

Results: The HBM reveals correlations between CSs in pairs of SFs and provides significantly more precise estimates and higher test-retest reliability compared to the BIP. Additionally, it improves the average sensitivity and accuracy in detecting CS changes for individual subjects, as well as statistical power for detecting group-level CS changes at individual and combinations of multiple SFs between luminance conditions.

Conclusions: The HBM establishes a comprehensive framework to enhance sensitivity, accuracy, and statistical power for detecting CS changes in hierarchical experimental designs.

Translational relevance: The HBM presents a valuable tool for advancing CS assessments in the clinic and clinical trials, potentially improving the evaluation of treatment efficacy and patient outcomes.

目的:本研究的目的是引入一种非参数层次贝叶斯模型(HBM),该模型能够对临床试验中单个空间频率(sf)和多个空间频率下的对比敏感度(CS)进行高级统计推断,其中CS测量对于评估安全性和有效性至关重要。方法:HBM计算六个食品和药物管理局指定的sf在人群、个体和测试水平上的CS的联合后验分布。它结合了总体和个体水平上的协方差,以捕捉各个sf之间的CSs之间的关系。使用贝叶斯推理程序(BIP)独立估计每个SF处CS的后验分布。这两种方法应用于112名受试者的定量CSF (qCSF)数据集,并在CS估计的精度、重测信度、灵敏度、准确性和检测CS变化的统计能力方面进行了比较。结果:与BIP相比,HBM揭示了sf对中CSs之间的相关性,并提供了更精确的估计和更高的重测信度。此外,它提高了检测个体被试CS变化的平均灵敏度和准确性,以及检测个体和多个亮度条件之间sf组合的群体水平CS变化的统计能力。结论:HBM建立了一个全面的框架,以提高在分层实验设计中检测CS变化的灵敏度、准确性和统计能力。转化相关性:HBM为推进临床和临床试验中的CS评估提供了一个有价值的工具,有可能改善治疗疗效和患者预后的评估。
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IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-12-02 DOI: 10.1167/tvst.13.12.38
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Translational Vision Science & Technology
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