An advantage of the former is that it incorporates the patient or caregiver voice using data from an external indicator (anchor), whereas distribution-based methods, typically used for cross-sectional data, consider the properties of the measure itself, such as 0.5 or 0.2 standard deviations of the measure of interest at baseline or the standard error of the measurement (Coon & Cappelleri, 2016 Fayers & Hays, 2014 Food & Drug Administration, 2018 Norman et al., 2003 Revicki et al., 2008). Within-person MCTs can be calculated using approaches such as anchor-based methods and distribution-based methods (Coon & Cappelleri, 2016 Food & Drug Administration, 2018 Revicki et al., 2008). The within-person MCT is the magnitude of change in a clinical outcome assessment that needs to be observed in order to interpret whether there has been a meaningful improvement or, in some indications, deterioration (Coon & Cappelleri, 2016 Revicki et al., 2008). Interpreting score changes and the clinical meaningfulness of these changes can be done either at the group level, called the clinically important difference (CID), or at the individual level, called the within-person meaningful change threshold (MCT) (Food & Drug Administration, 2018). Furthermore, the AIM has been used to detect symptom improvements after short-term interventions (Mazurek et al., 2020).Ĭlinical outcome measures used to evaluate the effectiveness of treatments must not only be sensitive to symptom changes but should also be able to demonstrate the clinical meaningfulness of those changes and, thus, of potential treatment effects. Five symptom domains have been identified in the assessment of the AIM’s structural validity: repetitive behavior, atypical behavior, communication, social reciprocity, and peer interaction (Mazurek et al., 2018). Cross-sectional studies have demonstrated that AIM has good test–retest reliability, cross-informant reliability, and convergent validity with other measures of ASD symptoms (Houghton et al., 2019 Kanne et al., 2014). Therefore, the AIM could also be a suitable tool for real-world monitoring of pediatric ASD symptomology (Houghton et al., 2019). Key advantages of the AIM include that it has been designed for use as an outcome measure specifically for ASD, is less time-consuming than other interview-administered measures, and, importantly, it does not require trained personnel for administration. The AIM measures frequency of symptom occurrence and associated functional impact, which are both important for understanding symptom severity and permitting prioritization of interventions (Kanne et al., 2014 Mazurek et al., 2018). Food and Drug Administration (FDA) recommends that the individual experiencing the symptoms report these themselves, a parent or caregiver may also report on observations of the individual’s experience, if that individual is a child or lacks cognitive insight (Food & Drug Administration, 2018). The Autism Impact Measure (AIM) is a caregiver-reported questionnaire designed to characterize core symptoms of ASD in individuals aged 3–18 years (Kanne et al., 2014 Mazurek et al., 2018). Development of psychometrically validated outcome measures and calculating clinically meaningful thresholds are key priorities for autism research (Bolte & Diehl, 2013). The commonly used measures to assess core ASD symptoms were originally designed for screening or diagnostic purposes, and, thus, are not well-suited for measuring short-term improvement or deterioration (Ghosh et al., 2013 Grzadzinski et al., 2020 Kanne et al., 2014). For these to be evaluated, validated outcome measures with the ability to show meaningful changes in the core characteristics of ASD are required. A variety of treatments and interventions are under development. The diagnosis of ASD worldwide is increasing, either because of changes in diagnostic criteria, changes in primary diagnosis, an actual increase in incidence, or a combination of the above (Polyak et al., 2015). The expression of both core and associated symptoms is broad and varied, ranging from mild to severe impairment (Diagnostic and Statistical Manual of Mental Disorders (DSM-5), 2013). Autism spectrum disorder (ASD) is a neurodevelopmental condition that is categorized by deficits in core symptoms of social communication, social interaction, and restricted, repetitive behaviors (Diagnostic and Statistical Manual of Mental Disorders (DSM-5), 2013).
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