Psychometric Validation of the Growth Hormone Deficiency-Child Impact Measure (GHD-CIM).
2021
OBJECTIVE The aim of this study was to perform psychometric testing of the Growth Hormone Deficiency-Child Impact Measure (GHD-CIM): a patient-reported outcome (PRO) for children with GHD aged 9 to 0.70), as was test-retest reliability for the SWB, EWB and overall (above 0.70). At least one convergent validity hypotheses for each domain and overall was proven (r > 0.40). Known-groups validity hypotheses for the EWB and SWB domains were significant (p < 0.05). Associated effect sizes ranged from - 0.40 to - 0.58, indicating that the GHD-CIM is sensitive to change. Anchor-based patient and clinician ratings of severity of disease suggest a preliminary minimally important difference of 5 points for the overall score, and 5 for PHYS, 7 for EWB, and 5 for SWB. CONCLUSIONS The GHD-CIM ObsRO was found to be a reliable and valid measure to assess disease-specific functioning, which will provide a more complete patient-centric picture to the growth hormone therapy experience in children. TRIAL REGISTRATION ClinicalTrials.gov NCT02580032, first posted 20 October 2015.
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