Mastering Questionnaire Data in Respiratory Studies: A Dive into Time-to-Event Endpoints

For respiratory clinical studies, the assessment of a participant’s health and their quality of life heavily relies on the utilization of questionnaires. These often come in the form of patient diaries, providing data that is essential for understanding respiratory disease progression and treatment efficacy.

However, the sheer volume of questionnaire data poses significant challenges in its analysis and interpretation.

In her presentation at the PHUSE US Connect 2024 conference titled “It is time to get answers: handling of questionnaire data in Respiratory studies,” Senior Statistical Programmer Valeriia Oreshko shared the intricacies of handling questionnaire data, particularly focusing on the calculation of time-to-event (TTE) endpoints.

Beyond the conventional

Unlike conventional TTE endpoints, where events occur at specific time points, respiratory studies demand endpoints that capture the duration of events, such as symptom exacerbations, over a defined period.

Oreshko took the biometrics crowd at PHUSE through the complexities of the TTE endpoint calculation, offering insights gleaned from her extensive practical experience. One of the key highlights of the presentation was clarifying a traceable pathway from a clinical trial participant’s responses to meaningful analytical outputs.

This approach ensures robustness and reliability in the derived endpoints, essential for drawing accurate conclusions from the clinical study data.

Common pitfalls and strategies

Throughout the PHUSE presentation, common pitfalls inherent in TTE design and implementation in the ADaM Basic Data Structure (BDS) are thoughtfully addressed. Oreshko sheds light on:

• strategies for dealing with missing data,
• the nuances of TTE calculations, and
• stringent requirements pertaining to baseline values.

Moreover, she connects the crucial distinctions between event and censor date descriptions for the audience, sharing best practices to mitigate potential discrepancies.

Link to full presentation coming soon