■大多数新生血管性年龄相关性黄斑变性治疗涉及疾病活动的长期随访。家庭监控将减轻患者和他们赖以生存的交通负担,并释放其他患者的诊所预约。该研究旨在评估三种家庭监测测试,用于检测活动性新生血管性年龄相关性黄斑变性,与通过医院随访诊断活动性新生血管性年龄相关性黄斑变性相比。
■有五个目标:评估三个家庭监测测试的准确性,以检测活动性新生血管性年龄相关性黄斑变性。确定家庭监测对患者和护理人员的可接受性以及对家庭监测的依从性。探索招聘中是否存在不平等,参与者自我测试的能力以及他们在随访期间对每周测试的依从性。提供有关家庭监测准确性的试点数据,以检测单侧新生血管性年龄相关性黄斑变性患者的同侧眼中新生血管性年龄相关性黄斑变性的转化。描述在实施家庭监控测试时遇到的挑战。
■诊断测试准确性队列研究,自开始治疗以来按时间分层。
■六家英国医院眼科服务黄斑诊所(贝尔法斯特,利物浦,Moorfields,詹姆斯·佩吉特,南安普敦,格洛斯特)。
■通过医院随访监测至少一只研究眼睛的患者。
■眼科医生在医院随访中检测到活动性新生血管性年龄相关性黄斑变性。
■KeepSightJournal:以文字谜题形式呈现的纸质近视力测试。MyVisionTrack®:电子测试,在平板设备上查看。MultiBit:电子测试,在平板设备上查看。参与者每周提供考试成绩。医院随访之间的原始分数汇总为平均值。
■二百九十七名患者(平均年龄74.9岁)参加。至少对317只研究眼睛进行了一次医院随访,包括在随访期间合格的9只第二眼,261名参与者(1549次完整访问)。中位数测试频率为3次/月。对于所有指数测试,受试者工作曲线下的估计面积均<0.6,只有KeepSightJournal总结评分与病变活动显著相关(比值比=3.48,95%置信区间1.09~11.13,p=0.036)。年龄较大和对家庭住址的剥夺与较低的参与率相关(χ2分别=50.5和24.3,p<0.001),但不具备自我测试的能力或依从性。受试者工作曲线下的面积似乎较高,以将双眼转化为新生血管性年龄相关性黄斑变性(KeepSightJournal为0.85),但估计精度较低。几乎一半的参与者拨打了研究求助热线,通常是由于无法进行电子测试。
■未达到预先指定的样本量;参与者使用设备的困难;电子测试并非始终可用。
■没有指数测试提供足够的测试准确性来识别在随访诊所中被诊断为活跃的病变。如果用于检测转换,患者仍需要在医院接受监测。年龄较大和贫困与研究参与的关系凸显了此类干预措施不平等的可能性。提供可靠的电子测试具有挑战性。
■评估类似技术的未来研究应考虑:基于测试性能的具有明确停止规则的独立监视。在患者自己的设备上部署应用程序,因为提供设备并没有减少参与方面的不平等和复杂的家庭测试。总结随访前一段时间多个分数的替代方法。
■本试验注册为ISRCTN79058224。
■该奖项由美国国立卫生与护理研究所(NIHR)卫生技术评估计划(NIHR奖参考:15/97/02)资助,并在《卫生技术评估》中全文发布。28号32.有关更多奖项信息,请参阅NIHR资助和奖励网站。
新生血管性年龄相关性黄斑变性的治疗,50岁以上视力丧失的最常见原因,包括定期眼部注射和频繁的随访预约。这对于患者来说是不方便的,并且在医院眼科服务中引起容量问题。寻找可以在家中进行的测试,可以检测是否需要进一步注射和住院预约,这将增加观察视力丧失风险最高的人的能力,并减轻患者及其护理人员的负担。我们调查了三个不同的视觉功能测试,iPodTouchTM平板电脑上的一个纸质应用程序和两个应用程序(苹果,库比蒂诺,CA,美国)。我们想看看他们是否能检测到需要治疗的疾病活动增加,与传统医院眼科门诊的视网膜专家根据临床检查和视网膜成像做出的决定相比。为了鼓励那些没有智能手机或家庭互联网的人参与,我们为iPodTouch和移动无线保真设备提供了移动合同。这些测试都没有表现得足够好,无法在家中安全地监测患者。那些愿意参加的人往往更年轻,以前有使用智能手机的经验,发送电子邮件和互联网访问,比那些选择不参加的人更富裕。一些参与者还遇到了使用所提供设备和成功上传数据的困难,这些困难与以前的信息技术经验无关。研究团队也面临着重大的技术挑战。研究求助热线被大量使用,比我们预期的要多得多。这些测试还没有准备好在这种情况下使用。涉及移动医疗技术的未来研究需要仔细考虑如何接触那些不太可能参与的人,并提供足够的技术支持以支持长期随访。
UNASSIGNED: Most neovascular age-related macular degeneration treatments involve long-term follow-up of disease activity. Home monitoring would reduce the burden on patients and those they depend on for transport, and release clinic appointments for other patients. The study aimed to evaluate three home-monitoring tests for patients to use to detect active neovascular age-related macular degeneration compared with diagnosing active neovascular age-related macular degeneration by hospital follow-up.
UNASSIGNED: There were five objectives: Estimate the accuracy of three home-monitoring tests to detect active neovascular age-related macular degeneration. Determine the acceptability of home monitoring to patients and carers and adherence to home monitoring. Explore whether inequalities exist in recruitment, participants\' ability to self-test and their adherence to weekly testing during follow-up. Provide pilot data about the accuracy of home monitoring to detect conversion to neovascular age-related macular degeneration in fellow eyes of patients with unilateral neovascular age-related macular degeneration. Describe challenges experienced when implementing home-monitoring tests.
UNASSIGNED: Diagnostic test accuracy cohort study, stratified by time since starting treatment.
UNASSIGNED: Six United Kingdom Hospital Eye Service macular clinics (Belfast, Liverpool, Moorfields, James Paget, Southampton, Gloucester).
UNASSIGNED: Patients with at least one study eye being monitored by hospital follow-up.
UNASSIGNED: Detection of active neovascular age-related macular degeneration by an ophthalmologist at hospital follow-up.
UNASSIGNED: KeepSight Journal: paper-based near-vision tests presented as word puzzles. MyVisionTrack®: electronic test, viewed on a tablet device. MultiBit: electronic test, viewed on a tablet device. Participants provided test scores weekly. Raw scores between hospital follow-ups were summarised as averages.
UNASSIGNED: Two hundred and ninety-seven patients (mean age 74.9 years) took part. At least one hospital follow-up was available for 317 study eyes, including 9 second eyes that became eligible during follow-up, in 261 participants (1549 complete visits). Median testing frequency was three times/month. Estimated areas under receiver operating curves were < 0.6 for all index tests, and only KeepSight Journal summary score was significantly associated with the lesion activity (odds ratio = 3.48, 95% confidence interval 1.09 to 11.13, p = 0.036). Older age and worse deprivation for home address were associated with lower participation (χ2 = 50.5 and 24.3, respectively, p < 0.001) but not ability or adherence to self-testing. Areas under receiver operating curves appeared higher for conversion of fellow eyes to neovascular age-related macular degeneration (0.85 for KeepSight Journal) but were estimated with less precision. Almost half of participants called a study helpline, most often due to inability to test electronically.
UNASSIGNED: Pre-specified sample size not met; participants\' difficulties using the devices; electronic tests not always available.
UNASSIGNED: No index test provided adequate test accuracy to identify lesion diagnosed as active in follow-up clinics. If used to detect conversion, patients would still need to be monitored at hospital. Associations of older age and worse deprivation with study participation highlight the potential for inequities with such interventions. Provision of reliable electronic testing was challenging.
UNASSIGNED: Future studies evaluating similar technologies should consider: Independent monitoring with clear stopping rules based on test performance. Deployment of apps on patients\' own devices since providing devices did not reduce inequalities in participation and complicated home testing. Alternative methods to summarise multiple scores over the period preceding a follow-up.
UNASSIGNED: This trial is registered as ISRCTN79058224.
UNASSIGNED: This award was funded by the National Institute of Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 15/97/02) and is published in full in Health Technology Assessment; Vol. 28, No. 32. See the NIHR Funding and Awards website for further award information.
Treatment for neovascular age-related macular degeneration, the most common cause of sight loss in those over 50 years, involves regular eye injections and frequent follow-up appointments. This is inconvenient for patients and causes capacity issues in the hospital eye service. Finding tests that could be undertaken at home that could detect if a further injection and hospital appointment was required or not would increase capacity to see those at highest risk of sight loss and also reduce the burden on patients and their carers. We investigated three different visual function tests, one paper-based and two applications on an iPod TouchTM tablet (Apple, Cupertino, CA, USA). We wanted to see if they could detect an increase in disease activity that would require treatment, compared to the decision by a retinal specialist at a traditional hospital eye outpatient visit based on clinical examination and retinal imaging. To encourage those without a smartphone or home internet to participate, we provided both an iPod Touch and Mobile Wireless-Fidelity device with a mobile contract. None of the tests performed well enough to safely monitor patients at home. Those who were willing to participate tended to be younger, had previous experience of using smartphones, sending e-mail and internet access and were more well-off than those who chose not to participate. Some participants also experienced difficulties with the devices provided and successfully uploading the data which were not related to the extent of previous information technology experience. There were also significant technical challenges for the research team. The study helpline was used heavily, considerably more than we anticipated. These tests are not ready to be used in this context. Future studies involving mobile health technology need to carefully consider how to reach those unlikely to participate and provide sufficient technical support to support long-term follow-up.