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家庭监测青光眼患者的可行性:I-TRAC 混合方法研究。

Feasibility of in-home monitoring for people with glaucoma: the I-TRAC mixed-methods study.

机构信息

Health Services Research Unit, University of Aberdeen, Aberdeen, UK.

Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.

出版信息

Health Technol Assess. 2024 Aug;28(44):1-163. doi: 10.3310/GTWD6802.

Abstract

BACKGROUND

Glaucoma is a chronic disease of the optic nerve and a leading cause of severe visual loss in the UK. Once patients have been diagnosed, they need regular monitoring at hospital eye services. Recent advances in technology mean patients with glaucoma can now monitor their disease at home. This could be more convenient for patients and potentially reduce costs and increase capacity for the NHS. However, it is uncertain whether self-monitoring would be acceptable or possible for patients with glaucoma.

OBJECTIVES

The objectives were to: identify which patients are most appropriate for home monitoring; understand views of key stakeholders (patients, clinicians, researchers) on whether home glaucoma monitoring is feasible and acceptable; develop a conceptual framework for the economic evaluation of home glaucoma monitoring; and explore the need for and provide evidence on the design of a future study to evaluate the clinical and cost-effectiveness of digital technologies for home monitoring of glaucoma.

DESIGN

In-home Tracking of glaucoma: Reliability, Acceptability, and Cost (I-TRAC) was a multiphase mixed-methods feasibility study with key components informed by theoretical and conceptual frameworks.

SETTING

Expert glaucoma specialists in the UK recruited through professional glaucoma societies; study site staff and patient participants recruited through three UK hospital eye services (England, Scotland, Northern Ireland); and UK research teams recruited though existing networks.

INTERVENTION

Home tonometer that measures intraocular pressure and a tablet computer with a visual function application. Patients were asked to use the technology weekly for 12 weeks.

RESULTS

Forty-two patients were recruited. Retention and completion of follow-up procedures was successful, with 95% ( = 40) completing the 3-month follow-up clinic visits. Adherence to the interventions was generally high [adherence to both devices (i.e. ≥ 80% adherence) was 55%]. Overall, patients and healthcare professionals were cautiously optimistic about the acceptability of digital technologies for home monitoring of patients with glaucoma. While most clinicians were supportive of the potential advantages glaucoma home monitoring could offer, concerns about the technologies (e.g. reliability and potential to miss disease progression) and how they would fit into routine care need to be addressed. Additionally, clarity is required on defining the ideal population for this intervention. Plans for how to evaluate value for money in a future study were also identified. However, the study also highlighted several unknowns relating to core components of a future evaluative study that require addressing before progression to a definitive effectiveness trial.

LIMITATIONS

The main limitation relates to our sample and its generalisability, for example, the over-representation of educated persons of white ethnicity who were generally experienced with technology and research motivated.

CONCLUSIONS

The In-home Tracking of glaucoma: Reliability, Acceptability, and Cost study has demonstrated 'cautious optimism' when considering patients' and healthcare professionals' views on the acceptability of digital technologies for home monitoring of patients with glaucoma. However, the study also highlighted several unknowns relating to the research question and design of a future evaluative study that require addressing before progression to a randomised controlled trial.

FUTURE WORK

Further research is required to determine the appropriate population (i.e. low vs. high risk of progression) and further refine the intervention components and delivery for planning of future evaluation studies.

STUDY REGISTRATION

This study is registered as Research Registry #6213.

FUNDING

This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR129248) and is published in full in ; Vol. 28, No. 44. See the NIHR Funding and Awards website for further award information.

摘要

背景

青光眼是一种慢性视神经疾病,也是英国严重视力丧失的主要原因。一旦患者被诊断出患有青光眼,他们就需要在医院眼科服务中心定期进行监测。最近的技术进步意味着青光眼患者现在可以在家中监测自己的病情。这可能对患者更方便,并且可能降低 NHS 的成本并增加容量。然而,尚不确定青光眼患者是否接受或可能接受自我监测。

目的

目的是:确定哪些患者最适合家庭监测;了解关键利益相关者(患者、临床医生、研究人员)对青光眼家庭监测是否可行和可接受的看法;为家庭青光眼监测的经济评估制定概念框架;并探讨未来研究的需求并提供证据,以评估数字技术在家中监测青光眼的临床和成本效益。

设计

青光眼在家中追踪:可靠性、可接受性和成本(I-TRAC)是一项多阶段混合方法可行性研究,主要组成部分是根据理论和概念框架提供的。

设置

通过专业的青光眼协会在英国招募青光眼专家;通过三个英国医院眼科服务中心(英格兰、苏格兰、北爱尔兰)招募研究现场工作人员和患者参与者;通过现有的网络招募英国研究团队。

干预措施

家庭眼压计,用于测量眼内压和带有视觉功能应用程序的平板电脑。患者被要求每周使用该技术 12 周。

结果

共招募了 42 名患者。随访程序的保留和完成取得了成功,95%(=40)的患者完成了 3 个月的随访门诊就诊。对干预措施的依从性总体较高[对两种设备的依从性(即≥80%的依从性)为 55%]。总体而言,患者和医疗保健专业人员对数字技术在家中监测青光眼的可接受性持谨慎乐观态度。虽然大多数临床医生都支持青光眼家庭监测可能带来的潜在优势,但需要解决他们对技术(例如可靠性和潜在的疾病进展遗漏)的担忧,以及它们如何适应常规护理。此外,还需要明确界定适合这种干预措施的理想人群。还确定了如何在未来的研究中评估物有所值的计划。然而,该研究还强调了未来评估性研究的几个核心要素,在推进到确定性有效性试验之前,这些要素需要加以解决。

局限性

主要的局限性与我们的样本及其普遍性有关,例如,受教育程度较高的白种人代表比例过高,他们通常具有丰富的技术经验并且有研究动力。

结论

In-home Tracking of glaucoma:Reliability,Acceptability,and Cost 研究表明,在考虑患者和医疗保健专业人员对数字技术在家中监测青光眼的可接受性时,存在“谨慎乐观”的态度。然而,该研究还强调了未来评估性研究的几个未知问题和研究设计,在推进到随机对照试验之前,需要解决这些问题。

未来工作

需要进一步研究以确定适当的人群(即低风险与高风险进展),并进一步改进干预措施的组成部分和交付方式,以为未来的评估研究制定计划。

注册

本研究在 Research Registry #6213 注册。

资金

该奖项由英国国家健康与保健卓越研究所(NIHR)健康技术评估计划(NIHR 奖 REF:NIHR129248)资助,并在 ; 第 28 卷,第 44 期全文发表。有关该奖项的更多信息,请访问 NIHR 资助和奖项网站。

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