5.9.0 Exclusion Criteria at NP Testing at Baseline Assessment

DAS-II Summary IQ

Automatic stop measure: DAS-II Summary IQ = 55 (if during testing the child’s performance appears poor, be sure DAS-II is scored within 48 hours)
- Complete Neuropsychological Abnormal Test Log (NPAB)
DAS-II Exclusion criteria at Baseline Assessment
- If at all possible, information should be given to the Coordinator related to the performance of the child on the DAS-II concerning the = 55 cut-off prior to the family leaving after baseline NP testing, so that randomization can take place so that they can inform the coordinator if the child looks like they may be scoring in the neighborhood of the cut-off. Most likely, this will involve the examiner having to drop below most all expected item sets.
- In case it is not possible to specifically determine the child will have a GCA > 55, a maximum of 48 hours is allowed for formal scoring prior to randomization.
Stop/Safety Change Measure
- For cases wherein the child scores 55 > GCA < 70, a written protocol needs to be established at each site, consistent with IRB, for who will contact the family and give timely feedback.
- After feedback is given, check the appropriate boxes on Administrative Form (NPAB) related to the status of Follow-Up procedures for the child (i.e., “Parent Informed?”, “Site PI Informed?”, “DCC Informed?”, “Follow-UP?”)

5.9.1 Stop/Safety Change Measure

If NP testing reveals a DAS-II summary score of = 69 (summary IQ)
- The parent/guardian will be notified and the participant will be referred to his primary physician.
- A medical referral form (MRF) must be completed
DAS-II Overall IQ decline of 1.5 SD during follow up assessment
- Complete Neuropsychological Abnormal Test Log (NPAB)

Feedback to parents will be handled on a site-specific basis in accordance with clinical and IRB policies

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Childhood Adenotonsillectomy Trial