Hybrid Approach to Development of a Patient-Reported Outcomes (PRO) Instrument to Assess the Impact of Tardive Dyskinesia (IMPACT-TD PRO) in Adults

Abstract: Background: Patient-reported outcomes (PROs) are important for assessing disease burden. Specific measures characterizing the multidimensional impact of tardive dyskinesia (TD) are lacking. This study focused on creating and evaluating the validity of the IMPACT-TD PRO, a TD-specific PRO measure comprising items from 4 Neuro-QoL™ item banks (upper extremity, chorea, speech difficulties, swallowing difficulties). Methods: Twenty-two items from the Neuro-QoL banks were selected using a clinical outcome assessment concept mapping approach, matching concepts defining the TD experience based on the literature and expert input. Items were revised minimally to simplify wording. Two global items were added. Adults with TD and schizophrenia, major depressive disorder, or bipolar disorder or their caregivers provided feedback on draft items through individual, semistructured cognitive debriefing (CD) interviews. Results informed revisions to create the IMPACT-TD PRO. As a hybrid approach, factor analysis and psychometric properties are being evaluated in a real-world study. Results: Nineteen patients and 5 caregivers participated in CD interviews. Overall, participants found the items relevant and easy to understand and answer. Based on participant feedback, 4 items were added addressing embarrassment, sleep, and pain to ensure the comprehensiveness of the measure. Conclusions: The ease with which participants related to, understood, and completed the draft questionnaire suggests that the IMPACT-TD PRO was effectively designed and appropriate for use in adults with TD. Testing in a real-world study is underway to provide evidence of the internal validity using factor analyses and to evaluate internal consistency and test-retest reliability, construct validity, and ability to detect change.Short Description: Patient-reported outcomes (PROs) are important for determining disease burden, but measures characterizing the multidimensional impact of tardive dyskinesia (TD) are lacking. As a result, a TD-specific questionnaire, IMPACT-TD PRO, was derived from existing question item banks selected for their relevance to TD. Patient and caregiver feedback indicated that the IMPACT-TD PRO was effectively designed and appropriate for using to understand the full impact of TD. IMPACT-TD PRO validity is being evaluated in a real-world study.Name of Sponsoring Organization(s): Teva Branded Pharmaceutical Products R&D, Inc.