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Evaluation of health-related quality of life (HRQL) in patients with a serious life-threatening illness

Amy H Peterman, PhD
Nan Rothrock, PhD
David Cella, PhD
Section Editors
Paul J Hesketh, MD
Robert M Arnold, MD
Deputy Editor
Diane MF Savarese, MD


Although difficult to define precisely, quality of life (QOL) has an inherent meaning to most people. It is comprised of broad concepts that affect global life satisfaction, including good health, adequate housing, employment, personal and family safety, interrelationships, education, and leisure pursuits. For matters related to health care, QOL has been applied specifically to those life concerns that are most affected by health or illness, hence the term "health-related quality of life" (HRQL) [1].

The concept of HRQL emerged from the broader concept of general QOL, and is, by definition, more focused on aspects of life quality that are influenced by or that can influence one’s health status directly. These aspects can include symptoms of disease and treatment side effects, treatment satisfaction, physical functioning and well-being, social functioning and life satisfaction, and mental health, including emotional well-being and cognitive functioning. HRQL does not typically include aspects of life that are often associated with the broader concept of QOL, such as income, financial resources, nutrition, and environmental conditions such as air quality, climate, political and personal freedoms, and public safety (crime). Some research has begun to look at some of these broader life QOL domains and their relationship with HRQL.

Specific measures to evaluate the outcome of a serious illness or its treatment include quantity and quality of life, and economic cost to the patient (ie, the financial burden of care). Although length of survival was previously considered the most important among these, the impact of illness on QOL has received increasing recognition. For more than 30 years, improvement in HRQL is one of two potential benefits that are considered by the US Food and Drug Administration (FDA) as a basis for full approval of new anticancer drugs [2]. More recently, the FDA released specific guidance for the development and validation of QOL measures that could be suitable for regulatory purposes. Further developed by FDA authors in 2016, the recommended QOL components for drug labeling purposes include disease-related symptoms, physical function, and patient-reported adverse events [3].

Historically, HRQL has been a fundamental concern of oncologic practice since 1949, when Karnofsky and Burchenal developed a clinical scale to quantify the functional performance of cancer patients (table 1) [4,5]. Increasing interest in the systematic assessment of HRQL in cancer patients using standardized, self-administered measures has emerged over the past three decades [6] and has become an important focus of benefit for newer therapies [7-9], as well as a basis for documenting and compensating for quality cancer care.

HRQL is a particularly important issue for patients who are in the advanced stages of a serious life threatening illness. Palliative care is an interdisciplinary medical specialty that focuses on preventing and relieving suffering and on supporting the best possible QOL for patients and their families facing serious illness. (See "Benefits, services, and models of subspecialty palliative care".)


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Literature review current through: Sep 2016. | This topic last updated: Jun 13, 2016.
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