Development of a new standard set of core outcomes to improve health outcomes for patients receiving vitreoretinal surgery: The Finesse Study.

制定一套新的核心结果标准，以改善接受玻璃体视网膜手术的患者的健康结果：Finesse 研究。

• 批准号: MR/W03042X/1
• 负责人: Maria Sandinha
• 金额: $ 10.08万
• 依托单位: University of Liverpool
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2022
• 资助国家: 英国
• 起止时间: 2022 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FW03042X%2F1
• 关键词: Development; new; standard; set; core

Most cases of retina conditions that require surgery (vitreoretinal surgery) rely on visual acuity charts to measure success but for some conditions eye charts fail to fully capture patient's symptoms. This is particularly true for conditions such as epiretinal membrane (ERM) or macula pucker; these are scar tissues that grow as a result of ageing on the surface of the central part of the retina. They are very common and are present in about a quarter of all people over 60 years. In about 1 in 20 people, ERM affects the very central bit of the retina called the macula and can contract and pull the retina out of shape. This can result in reduced and distorted vision. Surgeons commonly remove the ERM with an operation called vitrectomy and membrane peeling. This operation is usually successful in removing the scar tissue but exactly how much the vision improves is variable. The operation also carries some risk and usually causes cataracts. Often the affected eye can be improved as measured by the number of lines read on the chart but vision in the treated eye may constantly interfere with the good vision in the other eye. Distortion is not something that can be easily quantified, but can be so troublesome that it often severely affects the patient's quality of life. There are also a host of other symptoms including micropsia (objects are perceived smaller) and diplopia (double vision). This can happen to the extent that some patients need to wear a patch to cover the good eye. Quality of life is currently measured mainly on visual function and less on patients' reports of their own well-being so we need to determine which outcomes patients value most. Patient-reported outcomes are important to them. Patient-reported outcome measures (PROMs) are increasingly being used to measure the success or failure of treatment, how to manage a patients' treatment and care, and are also part of how healthcare is funded. PROM-tools are a series of standardised and validated questions to gain patients perspectives of their own health. A recent review by our group found that there were no specific PROMS available for retina surgery. This research will bring together clinicians and patients (including carers of those with significant impairments) to meet face-to-face and on a virtual platform to reach consensus on what outcomes are important to measure and what tools, are already available to measure these outcomes. We will ask patients if these tools are specific enough to measure their experiences or if specific PROMS need to be developed. We will set up a working group with 20 participants, the majority from different centres in the UK, including patients, nurses and doctors, but a few international consultants will also attend. The group will meet for discussions via teleconferences but there will be the option to dial in or join in by video to make it inclusive to all patients. Clinicians and patients will meet separately to make a list of outcomes important to be measured when patients present with this condition. Once it is drawn up, the list will be refined through 2 rounds of independent voting (online survey) and group discussions. We will also set up 2 focus groups with patients from St Paul's Eye Department to encourage open discussions on the PROMS that are available to measure patient-reported outcomes (for example quality of life) and see if we need to develop any new questionnaires in another project.This set of outcomes will reflect agreement by all participants. This research will produce recommendations for measures to be used by vitreoretinal surgeons and researchers and it will ultimately help to improve clinical practice, patient pathways and outcomes. Pilot studies will then follow to test strategies to relay data back to clinical teams and patients. Having these measures will also help more accurately quantify and compare the benefits of different treatment options at a global scale.

大多数需要手术的视网膜疾病（玻璃体视网膜手术）依赖于视力表来衡量是否成功，但对于某些情况，视力表不能完全捕捉患者的症状。对于视网膜前膜（ERM）或黄斑褶皱等情况尤其如此；这些疤痕组织是由于视网膜中央部分表面的老化而生长的。它们很常见，在60岁以上的人群中，约有四分之一的人患有这种疾病。大约每20人中就有1人，ERM会影响视网膜的中心部位黄斑，并会收缩，使视网膜变形。这可能导致视力下降和扭曲。外科医生通常通过玻璃体切除和膜剥离手术切除ERM。这种手术通常能成功地去除疤痕组织，但视力究竟能改善多少是可变的。这种手术也有一定的风险，通常会导致白内障。通常情况下，受影响的眼睛可以通过图表上读取的线数来衡量，但治疗后眼睛的视力可能会不断干扰另一只眼睛的良好视力。扭曲不是一件容易量化的事情，但它非常麻烦，经常严重影响患者的生活质量。还有许多其他症状，包括小视症（感觉物体变小）和复视（重视）。这种情况可能会发生，以至于一些患者需要戴上眼罩来遮盖正常的眼睛。目前衡量生活质量的标准主要是视觉功能，而不是患者对自身健康状况的报告，因此我们需要确定患者最看重的结果是什么。患者报告的结果对他们来说很重要。患者报告的结果测量（PROMs）越来越多地被用于衡量治疗的成功或失败，如何管理患者的治疗和护理，也是医疗保健资金的一部分。prom工具是一系列标准化和有效的问题，以获得患者对自己健康的看法。我们小组最近的一篇综述发现，视网膜手术没有特定的PROMS。这项研究将把临床医生和患者（包括那些有严重损伤的人的护理人员）聚集在一起，面对面地在一个虚拟平台上会面，就哪些结果是重要的测量结果以及哪些工具已经可用来测量这些结果达成共识。我们将询问患者这些工具是否足够具体，以衡量他们的经历，或者是否需要开发特定的PROMS。我们将成立一个由20名参与者组成的工作组，其中大多数来自英国不同的中心，包括患者、护士和医生，但也会有一些国际顾问参加。该小组将通过电话会议进行讨论，但也可以选择拨打电话或通过视频加入，以使其涵盖所有患者。临床医生和患者将分别开会，列出患者出现这种情况时需要衡量的重要结果。名单一经确定，将通过两轮独立投票（网络调查）和小组讨论进行细化。我们还将与圣保罗眼科的患者建立两个焦点小组，以鼓励对PROMS进行公开讨论，这些PROMS可用于衡量患者报告的结果（例如生活质量），并看看我们是否需要在另一个项目中开发任何新的问卷。这一组成果将反映所有参与者的一致意见。这项研究将为玻璃体视网膜外科医生和研究人员提供建议措施，并最终有助于改善临床实践、患者途径和结果。然后，试点研究将遵循测试策略，将数据传回临床团队和患者。拥有这些措施还将有助于在全球范围内更准确地量化和比较不同治疗方案的益处。