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. 2020 Mar 26;18(1):81.
doi: 10.1186/s12955-020-01320-4.

Introduction and methods of the evidence-based guidelines for the diagnosis and management of autism spectrum disorder by the Italian National Institute of Health

Gian Paolo Morgano  1 , Francesca Fulceri  2 , Franco Nardocci  2 , Corrado Barbui  3 , Giovanni Ostuzzi  3 , Davide Papola  3   4 , Laura Maria Fatta  2 , Alice Josephine Fauci  5 , Daniela Coclite  5 , Antonello Napoletano  5 , Franco De Crescenzo  6   7 , Gian Loreto D'Alò  6   8 , Laura Amato  6 , Michela Cinquini  9 , Primiano Iannone  5 , Holger Jens Schünemann  10   11 , Maria Luisa Scattoni  12 ; Italian National Institute of Health guideline working group on Autism Spectrum Disorder
Collaborators, Affiliations

Introduction and methods of the evidence-based guidelines for the diagnosis and management of autism spectrum disorder by the Italian National Institute of Health

Gian Paolo Morgano et al. Health Qual Life Outcomes. .

Abstract

Background: 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.

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: Autism Spectrum disorder; Diagnosis; GRADE approach; Guideline; Healthcare decision; Italian National Institute of health; Italian national guidelines system; Recommendations; Treatment.

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Conflict of interest statement

Members of the GDG do not receive financial compensation for their work on the panel but receive payment or reimbursement by the ISS for travel related expenses for the guideline meetings. GPM, MC, and LA are members and HJS is co-chair of the GRADE working group.

Figures

Fig. 1
Fig. 1
Rating question importance using GRADEpro. GRADEpro interface. Panel members rate the importance of candidate guideline questions on a 1 to 9 scale. Lower ratings are indicative of lower importance
Fig. 2
Fig. 2
Generation of outcomes using GRADEpro. GRADEpro interface. Panel members suggest, separately for each question, any people-important outcomes that should be considered during the rating of the relative importance of outcomes
Fig. 3
Fig. 3
Rating relative importance of outcomes using GRADEpro. GRADEpro interface. Panel members rate the importance of people-important outcomes on a 1 to 9 scale. Lower ratings are indicative of lower importance
Fig. 4
Fig. 4
Collection of EtD judgments using PanelVoice. PanelVoice/GRADEpro interface. Judgments on the EtD criteria submitted by panel members are visible to guideline developers and can be used to facilitate the decision-making process online
Fig. 5
Fig. 5
Collection of votes on the strength and direction of recommendations using the GRADEpro/PanelVoice interface. Voting results for the direction and strength of the recommendation are visible to guideline developers and can be used to reach online agreement about the final recommendation
Fig. 6
Fig. 6
Distribution of registered stakeholders. Pie chart reporting affiliations of the stakeholders participating in the public consultation
See this image and copyright information in PMC

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