Page 121 - Demo

Outcomes and outcome measurement instruments1195Sample sizes of identified trials ranged from 1 to 452 (median=40) participants. Interventions included drug (n=123, 39%), diet or supplement (n=14, 4%), and non-drug interventions such as behavioral interventions (n=175, 56%). Randomization was used in 224 (72%) of the studies. Studies were not blinded (n=155, 50%), single-blinded (n=10, 3%), double-blinded (n=85, 27%) or blinding was unclear (n=62, 20%). In 7 (2%) of the clinical trials, it was explicitly mentioned that affected individuals or representatives were involved in the choice of outcome measures. Reported outcomesThere were 438 different outcomes reported, which we clustered into 91 different outcomes based on the most commonly used terminology (Table 2). Cognitive function was measured most frequently (n=333, 28% of the measurements). Twenty-eight reported outcomes (31%) consisted of a combination of several outcomes, such as cognitive function and motor function. Table 2. Reported outcomes and number of outcome measurement instruments used, clustered according to frequency of use. Reported outcomesFrequencyNumber of different outcome measurement instruments usedPROClinROObsROPerfOCognitive function 333 141 33 16 15 269(HR-)QoL 74 23 72 2 0 0Aberrant behavior (e.g., challenging / maladaptive / dysfunctional / destructive behavior / (severe) behavioral problems / manifestations)64 18 59 2 3 0(Clinical) global impression (including severity/improvement)64 16 15 49 0 0Communication 59 35 11 0 13 35Behavior (general / not specified) 45 23 36 3 6 0Adaptive behavior 33 5 29 2 2 0Depression and mood disorders 33 15 27 3 3 0Autism 31 14 15 11 5 0Annelieke Muller sHL.indd 119 14-11-2023 09:07