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Quality of Life as a Patient-Reported Outcome

In recent months in this error of COVID-19, there has been a lot of discussion about Quality of Life, work-life balance, and other trends that cause a person to think about the actions or inaction of tasks and responsibilities. The conversations that focus on enjoying the better life, and living your best life, among other catchy phrases, generally take on a new meaning when a person faces loss, is impacted by significant life-changing events, or there is a value or belief challenge.

The basis for every medical advancement in society comes down to the impact on one's quality of life. Whether to regain or improve it, the goal is all the same to achieve a peaceful and joyous quality of life. The World Health Organization (WHO) defines the quality of life as an individual's perception of their position in life in the context of the culture and value systems in which they live and their goals, expectations, standards, and concerns. When researching QOL, The Institute of Medicine (IOM) views the concept of "quality" similarly to "grade" and "rank." To grade or rank means researching how QOL will be measured often takes on a grading and ranking system. To measure QOL, researchers will compare your economic, social, political, and psychological levels with others within your community, communities, backgrounds, and of course, your prior self. With this in mind, it is essential to note that QOL can mean something different to everyone, but in healthcare, we must take a broad approach to advance society.

QOL is vital when conducting clinical trials. While clinical trials test the effectiveness of certain investigational products that may become medications, these trials include QOL. For example, an investigative product will undergo several clinical studies that prove the product is effective in helping conditions for the intended use; however, it may not do anything to improve QOL. For some people, QOL matters most. Some people are content with their illness not being curable so long as it doesn't decrease their QOL immensely.

In healthcare, we must understand this and use it as a tool. We must find a balance between effectiveness and favorable QOL. One could argue that if the drug is effective, it will automatically improve QOL, years of research show that is not always the case, and there is no direct correlation. The IOM goes into more depth about this correlation in their article "Is quality of life determined by expectations or experience?". The article explains how human life is complex, and determining the "correct" choice regarding QOL can be tricky and ultimately falls into the hands of the patient and their wishes. There have been cases of patients choosing to no longer receive treatment or prefer not to receive it to improve their QOL immediately.

An example is a patient who voluntarily chooses to amputate a problematic limb. In cases like this, these patients grow tired of constantly undergoing treatments and facing issues with the limb, and while this doesn't mean that the drug/treatment didn't work, it could have ultimately only been a temporary fix. At the same time, amputation of the limb would provide a permanent fix and a somewhat instant improvement of QOL. In this example, should the patient not have chosen the first option, they could have ultimately dealt with more complications. As a result, those complications could have vastly adverse effects that could drastically decrease their QOL and, in extreme cases, end life altogether.

It is important to remember that, in the end, our purpose is to serve our patients, and this is done so by ensuring the best possible QOL for every one of them.

To evaluate QOL in a clinical trial, a sponsor will use tools that meet scored or validated criteria to provide repeatable, consistent responses across multiple factors and groups. Data collection occurs at intervals throughout the clinical trial. The compilation of results provides insight into what the patient is experiencing. Patient Reported Outcomes (PROs) encompass QOL and a lot more. The PROs include valuable information that can improve the administration and management of adverse events.

Bracane Company is a global service provider for the life science industry. We help our clients develop PROs and QOL measures for clinical trials. We support GXP audit readiness and project management and ensure clinical projects in Phase I-IV are on schedule. Lifesciences companies chose us to meet their needs during a clinical trial's startup, active, or closeout phases.

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