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自闭症成年患者的健康检查:一项整群随机对照试验的研究方案

Health checks for autistic adults: study protocol for a cluster randomised controlled trial.

作者信息

Parr Jeremy R, Taylor Helen, Wilson Colin, Scarlett Clare, Al-Asmori Sarah, Buckley Carole, Cooper Sally-Ann, Fernandez-Garcia Cristina, Finch Tracy, Lees Rhianna, Lennox Nicholas, Merrick Hannah, Moss Sebastian, Nicolaidis Christina, Osbourne Malcolm, Raymaker Dora M, Robinson Tomos, Urbanowicz Anna, Wason James M S, Ingham Barry

机构信息

Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.

Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Morpeth, UK.

出版信息

Trials. 2024 Dec 31;25(1):858. doi: 10.1186/s13063-024-08641-5.

Abstract

BACKGROUND

Autistic people commonly have physical and mental health conditions. They also frequently experience barriers to accessing healthcare, contributing to problems identifying and treating health conditions. These factors may lead to increased and earlier morbidity and lower average life expectancy for autistic people. Health checks specifically designed for autistic people, incorporating adjustments to healthcare, may help to overcome these barriers and reduce health inequalities. This trial aims to investigate the clinical and cost-effectiveness of a primary care health check for autistic adults and explore factors related to implementation such as acceptability and feasibility of delivery. The trial is co-designed and delivered by health professionals, autistic people, carers and supporters, and researchers.

METHODS

This is a clinical and cost-effectiveness, cluster randomised controlled trial of a primary care health check for autistic adults. Primary care practices will be randomised into one of two groups (intervention or control). Two hundred autistic adults (aged 18 years and over) who provide baseline data will be recruited via participating practices. Data will be collected through quantitative and qualitative methods. The primary outcome will be the incidence of new health needs/conditions detected and met at 9 months (data gathered from participant's GP records). Secondary outcomes will include the following: cost-effectiveness, measured as incremental cost per quality-adjusted life year gained over 9 months; the extent of health monitoring and health promotion needs met at 9 months; the incidence of social care needs identified at 9 months; changes in participant or carer general health; changes in quality of life; primary and secondary health and social care resource usage and costs. A qualitative study will explore views about the acceptability of the health check, its utility and future use.

DISCUSSION

This study will examine the effectiveness and cost-effectiveness of a primary care health check for autistic adults in identifying new health conditions and needs. If the intervention is effective, it would provide strong evidence for implementation into routine healthcare, therefore enabling earlier health condition diagnosis and opportunities for treatment, reducing the health inequalities experienced by autistic people.

TRIAL REGISTRATION

ISRCTN, retrospectively registered on 20 July 2023. https://www.isrctn.com/ISRCTN30156776 (ISRCTN registration number: 30156776).

摘要

背景

自闭症患者通常存在身心健康问题。他们在获得医疗保健方面也经常遇到障碍,这导致在识别和治疗健康问题时出现困难。这些因素可能导致自闭症患者发病率上升且发病时间提前,平均预期寿命降低。专门为自闭症患者设计的健康检查,结合对医疗保健的调整,可能有助于克服这些障碍并减少健康不平等。本试验旨在研究针对成年自闭症患者的初级保健健康检查的临床效果和成本效益,并探索与实施相关的因素,如可接受性和实施的可行性。该试验由健康专业人员、自闭症患者、护理人员和支持者以及研究人员共同设计和实施。

方法

这是一项针对成年自闭症患者初级保健健康检查的临床和成本效益的整群随机对照试验。初级保健机构将被随机分为两组(干预组或对照组)之一。将通过参与的机构招募200名提供基线数据的成年自闭症患者(年龄在18岁及以上)。数据将通过定量和定性方法收集。主要结局将是在9个月时检测到并满足的新健康需求/状况的发生率(从参与者的全科医生记录中收集的数据)。次要结局将包括以下方面:成本效益,以9个月内每获得一个质量调整生命年的增量成本来衡量;9个月时满足的健康监测和健康促进需求的程度;9个月时确定的社会护理需求的发生率;参与者或护理人员总体健康状况的变化;生活质量的变化;初级和二级健康及社会护理资源的使用和成本。一项定性研究将探讨对健康检查的可接受性、其效用和未来使用的看法。

讨论

本研究将考察针对成年自闭症患者的初级保健健康检查在识别新的健康状况和需求方面的有效性和成本效益。如果干预措施有效,将为将其纳入常规医疗保健提供有力证据,从而能够更早地诊断健康状况并提供治疗机会,减少自闭症患者所经历的健康不平等。

试验注册

ISRCTN,于2023年7月20日进行追溯注册。https://www.isrctn.com/ISRCTN30156776(ISRCTN注册号:30156776)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/743c/11686900/5920044d7077/13063_2024_8641_Fig1_HTML.jpg

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