Meaningful Within-Patient Change on the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ): Analysis of Phase III Clinical Trial Data of Daridorexant - Pharmaceutical Medicine
Source : https://link.springer.com/article/10.1007/s40290-023-00484-w
Background The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a new validated 14-item patient-reported outcome (PRO) instrument for evaluating daytime functioning in people with insomnia. It comprises three domains: Alert/Cognition, Mood, and Sleepiness. Objective The aim of this analysis was to estimate the minimum within-patient change for IDSIQ scores that an adult patient with insomnia would consider meaningful.
Conclusion: This analysis demonstrates the meaningful within-patient change for the IDSIQ total score and domain scores, that the instrument is sensitive to changes in the patient experience of insomnia, and that it can be used in clinical trials to evaluate changes in daytime functioning.
• Source: Pharmaceutical Medicine
• Conclusion: “This analysis demonstrates the meaningful within-patient change for the IDSIQ [Insomnia Daytime Symptoms and Impacts Questionnaire] total score and domain scores, that the instrument is sensitive to changes in the patient experience of insomnia, and that it can be used in clinical trials to evaluate changes in daytime functioning.”
• The IDSIQ is a novel validated 14-item patient-reported outcome (PRO) instrument for assessing daytime functioning in insomnia patients. There are 3 domains: Alert/Cognition, Mood, and Sleepiness.
• In the current study, U.S. and international researchers assessed the minimum within-patient change for IDSIQ scores that would be meaningful to an adult. Data was derived from a larger patient population (n=930) from a phase III clinical trial of daridorexant in insomnia patients. Patients reported on night-time and daytime symptoms.
• “At the time when development work on the IDSIQ was initiated, there was a lack of validated fully relevant PRO instruments for assessing the impact of insomnia on daytime functioning. Dedicated PRO instruments such as the Sleep Functional Impact Scale and Sleep Impact on Activity Diary are now available. However, few sleep and insomnia instruments have included the validation step of evaluating clinically meaningful within-subject change to aid in interpretation of score changes over time,” the authors wrote.
• One limitation of the current study is that participants, who were mostly White and presented with moderate to severe insomnia, may not represent patients seen in a diverse real-world practice. Another limitation is that the study didn’t require a baseline level of daytime symptoms/impacts of insomnia, therefore the participants might not recapitulate the daytime experiences in the general insomnia population.