Autism Spectrum Disorder (ASD) is a neuro-developmental disorder that affects communication and behavior with a prevalence of approximately 1% worldwide. Health outcomes of interventions for ASD are largely Participant Reported Outcomes (PROs). Specific guidelines can help support the best care for people with ASD to optimize these health outcomes but they have to adhere to standards for their development to be trustworthy. The goal of this article is to describe the new methodological standards of the Italian National Institute of Health and novel aspects of this guideline development process. This article will serve as a reference standard for future guideline development in the Italian setting. We applied the new standards of the Italian National Institute of Health to the two guidelines on diagnosis and management of children/adolescents and adults with ASD, with a focus on the scoping, panel composition, management of conflict of interest, generation and prioritization of research questions, early stakeholders’ involvement, and PROs. Recommendations are based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence-to-Decision frameworks. Following a public application process, the ISS established two multidisciplinary panels including people with ASD and/or their caregivers. Seventy-nine research questions were identified as potentially relevant for the guideline on children and adolescents with ASD and 31 for the one on adults with ASD. Questions deemed to have the highest priority were selected for inclusion in the guidelines. Other stakeholders valued their early involvement in the process which will largely focus on PROs. The panels then successfully piloted the development of recommendations using the methodological standards and process set by the ISS with a focus on PROs. In this article, we describe the development of practice guidelines that focus on PROs for the diagnosis and management of ASD based on novel methods for question prioritization and stakeholder involvement. The recommendations allow for the adoption or adaptation to international settings.

中文翻译：

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意大利国立卫生研究院对自闭症谱系障碍进行诊断和管理的循证指南的介绍和方法。

自闭症谱系障碍（ASD）是一种神经发育障碍，会影响交流和行为，全球患病率约为1％。ASD干预措施的健康结果主要是参与者报告的结果（PRO）。特定的指南可以帮助为ASD患者提供最佳护理，以优化这些健康结果，但他们必须遵守其发展的标准才能值得信赖。本文的目的是描述意大利国立卫生研究院的新方法标准以及该指南制定过​​程的新颖方面。本文将用作将来在意大利环境中制定指南的参考标准。我们将意大利国立卫生研究院的新标准应用于诊断和管理ASD儿童/青少年和成人的两项准则，重点是范围界定，小组组成，利益冲突管理，研究的产生和优先级问题，早期利益相关者的参与以及专业人士。建议基于建议评估，制定和评估（GRADE）的证据到决定框架。在公开申请程序之后，国际空间站建立了两个跨学科的小组，包括自闭症患者和/或其护理人员。已确定有79个研究问题与ASD儿童青少年指南有关，而对于ASD成人有31个研究问题。选择被认为具有最高优先级的问题，将其纳入指南。其他利益相关者重视他们早期参与该过程的过程，该过程将主要关注PRO。然后，小组利用国际空间站制定的方法论标准和流程成功地试行了建议的制定，重点是专业人士。在本文中，我们描述了基于针对问题优先级和利益相关者参与的新方法的，针对PRO的ASD诊断和管理实践指南的开发。这些建议允许采用或适应国际环境。然后，小组使用国际空间站制定的方法论标准和流程成功地试行了建议的制定，重点是专业人士。在本文中，我们描述了基于针对问题优先级和利益相关者参与的新方法的，针对PRO的ASD诊断和管理实践指南的开发。这些建议允许采用或适应国际环境。然后，小组使用国际空间站制定的方法论标准和流程成功地试行了建议的制定，重点是专业人士。在本文中，我们描述了基于针对问题优先级和利益相关者参与的新方法的，针对PRO的ASD诊断和管理实践指南的开发。这些建议允许采用或适应国际环境。