Comparative Analysis of Health-Related Quality of Life in Pulmonary Embolism Survivors Pulmonary Embolism Quality of Life Questionnaire (PEmb-QoL) versus EuroQol five-dimension questionnaire (EQ-5D) Instruments

Lead Investigator: Daniel Adam Blanco, Inari Medical, Inc.
Title of Proposal Research: Comparative Analysis of Health-Related Quality of Life in Pulmonary Embolism Survivors Pulmonary Embolism Quality of Life Questionnaire (PEmb-QoL) versus EuroQol five-dimension questionnaire (EQ-5D) Instruments
Vivli Data Request: 9474
Funding Source: The work will be conducted by full-time employees of Inari Medical, Inc., the applicant.
Potential Conflicts of Interest: Full-time employee of Inari Medical, Inc. (Salary and Stock compensation). Inari Medical, Inc. is involved in research and development and sales of medical devices for venous thromboembolism, including pulmonary embolism and deep vein thrombosis. Research findings will be subject to rigorous peer-review process during publication and be made available to the public. Any real or potential conflict of interests will be declared in the publication.

Summary of the Proposed Research:

Project Background:
Pulmonary Embolism (PE) is a serious condition that occurs when a blood clot blocks an artery in the lungs. It can cause significant health complications and impact a patient’s quality of life. To understand and improve the well-being of individuals who have experienced PE, researchers use various tools to measure their health-related quality of life (HRQoL). This project aims to compare two such tools: the Pulmonary Embolism Quality of Life Questionnaire (PEmb-QoL) and the EuroQol five-dimension five-level questionnaire (EQ-5D-5L). The PEmb-QoL is specifically designed for PE patients, while the EQ-5D is a generic tool used for many conditions to assess quality of life.

Necessity of Research:
The primary aim of this research is to develop a mapping algorithm that can convert PEmb-QoL results into EQ-5D-5L utility weights. This conversion is essential because it allows for the comparison of PE patient outcomes with those of other conditions and can be used in health economic evaluations such as cost-effectiveness modelling. By achieving a reliable conversion, we can expand the applicability of PEmb-QoL data, making it a more robust tool for researchers and healthcare providers. This research is important because it helps researchers better understand the health of people with pulmonary embolism (PE) by integrating insights from a disease specific instrument (PEmb-QoL) and a broader health measure (EQ-5D-5L). This comprehensive approach will help physicians make better decisions about treatment and improve the quality of life for PE patients.

Research Conduct:
The research will involve collecting data from the PREFER VTE registry database that tracks the health outcomes of PE patients over time. The study will involve analyzing data from a registry of PE patients, comparing their responses on the PEmb-QoL with their results on the EQ-5D-5L. Through statistical methods, we will establish a conversion formula, or ‘mapping’, between the two questionnaires. This will enable us to translate PEmb-QoL scores into EQ-5D-5L utility weights, which are a standard measure used in health economics to represent the value of health states. Statistical analyses will be used to determine the reliability and validity of the conversion algorithm.

Explanation of Technical Terms:
• Health-Related Quality of Life (HRQoL): A person’s overall well-being, including physical, mental, and social health, as it is affected by medical conditions or treatments.
• Utility Weights: Numbers that represent the preference for a given health state, used in calculating quality-adjusted life years (QALYs) in health economics.
• Mapping: The process of developing a statistical relationship between two different HRQoL measures so that one can be estimated from the other.

• PE: Pulmonary Embolism
• PEmb-QoL: Pulmonary Embolism Quality of Life Questionnaire
• EQ-5D-5L: EuroQol five-dimension five-level questionnaire
• HRQoL: Health-Related Quality of Life
• QALYs: Quality-Adjusted Life Years

Requested Studies:

Prevention of Thromboembolic Events – European Registry in Venous Thromboembolism (PREFER in VTE)
Data Contributor: Daiichi Sankyo, Inc.
Study ID: DSE-VTE-01-12
Sponsor ID: DSE-VTE-01-12