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Chapter 5124to enable evidence-based general ID care and measuring effectiveness of innovative therapies.Reported outcomesFrom a total of 312 studies, there were 438 different reported outcomes clustered into 91 different outcomes. We encountered large differences in terminology for similar constructs, such as ‘aberrant behaviors’, ‘challenging behaviors’, ‘behavioral problems’, and ‘severe behavioral manifestations’. This may conflict with generalizability and clarity among clinical trials, demonstrating the need for semantic harmonization. Similarly, overlap in PROs across the International Consortium for Health Outcomes Measurement (ICHOM) standard sets was recently examined, identifying 307 different PROs referring to 22 unique PRO concepts.37 Furthermore, (HR-)QoL was reported in 74 clinical trials, using 23 different instruments. Although HR-QoL is an important outcome, this broad, abstract, and multidimensional concept can cover different concepts, obscuring the construct to be measured. According to the FDA, an HR-QoL measure should at a minimum capture physical, psychological (including emotional and cognitive), and social functioning.1Outcome measurement instrumentsWe identified 457 different outcome measurement instruments to measure patient-reported outcomes (n=213), clinician-reported outcomes (n=54), observer-reported outcomes (n=48), and performance outcomes (n=157), with 288 instruments (63%) only used in one clinical trial in the past decade. The large number of different instruments used in clinical trials is not surprising, considering the heterogeneity in levels of intellectual functioning, patients and researcher preferences, availability of instruments that are appropriate to specific conditions, and regional preferences. Furthermore, for novel drugs with yet unknown efficacy, multiple domains might be studied requiring different instruments, to investigate effectiveness and identify potential subgroups who benefit most from the intervention. This is also reflected by the large amount of ad-hoc designed symptom- and conditionspecific instruments, hampering extrapolation and interpretation of the results. Yet, it is laborious to examine validity, reliability, and responsiveness of so many instruments. It underlines the need for consensus on outcomes and instruments, such as the Outcome Measures Working Groups and Annelieke Muller sHL.indd 124 14-11-2023 09:07