Health Related Quality of Life (HRQoL) is the most established of currently available patient reported outcome (PRO) measures and was developed to evaluate the impact of disease and interventions on emotional, social and physical functioning from the patient's perspective. It has extended outcome assessment beyond traditional efficacy and safety. In recent years, as well as being an important element for demonstrating product value, there has been an increased trend towards reporting PRO results in regulatory documents and approved labels.
There are two main types of instrument available for measuring HRQoL: generic and disease specific. Generic measures are useful in comparing the impact of a wide variety of diseases and treatments on HRQoL, but may lack precision in a particular condition for which disease-specific measures are better suited. Many studies include both types of instrument.
Commonly used generic instruments include The Medical Outcomes Study 36-Item Short Form (SF-36) health survey and The EuroQol Instrument (EQ-5D). Other examples include:
Examples of disease specific measures include:
With several hundred available instruments, mainly disease specific, careful consideration has to be given to the selection of an appropriate tool and commonly used criteria include:
Given the international nature of many studies it is also crucial to ensure that instruments have been properly validated in all of the required languages.
When including a HRQoL measure in any type of study there are important considerations during study design and performance including:
The extent to which PROs such as HRQoL, can be used to evaluate and communicate the benefit of therapeutic interventions is still evolving including their use as primary outcome measures, however the value of a patient's perspective is clearly established as:
The demand for HRQoL and other PRO information will continue to increase. To find out more and discuss the right Quality of Life tool for your study, contact the PACE Group.
We are a leading global bio/pharmaceutical services organization that helps clients expedite time-to-market through our development and launch services. These include a broad range of clinical development capabilities, integrated advanced technologies, regulatory affairs consulting, and commercialization services.