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Abstract

Health-related quality of life (HRQL) outcomes evaluation is becoming an important component of clinical trials of new pharmaceuticals and medical devices. HRQL research provides patients, providers, and decision makers with important information on the impact of disease and treatment on physical, psychological, and social functioning and well-being. These outcomes are also useful to the pharmaceutical and device industries as they attempt to understand and communicate product value to physicians, patients, health insurers and others. HRQL labeling and promotional claims in the US are likely to increase over the next few years. The evidentiary requirements to make such a claim should be based on accepted scientific standards of HRQL evaluation and consistent with the regulatory requirements for clinical efficacy. This report outlines the scientific practices that should be considered in the evaluation of evidence for an HRQL claim, including the selection of appropriate domains, evidence to support the reliability and validity of HRQL measurement, considerations in research design and statistical analyses, and the issue of clinical significance. Representatives from the pharmaceutical and device industries, regulatory agencies, and the HRQL scientific community should work together to make certain the use of HRQL in labeling and promotion are based on sound scientific evidence, and that these messages are clearly and accurately reported to the consumers.

The impact of tinnitus on adult Nigerians: health related Quality of Life assessment of sufferers using the Hospital Anxiety and Depression Scale (HADS) and the RAND-36 item health survey 1.0 questionnaire

“…Health related Quality of life (HRQoL) has been defined as a broad range of human experiences related to an individual's overall wellbeing 1 . It encompasses the impact of impairment on the psychological, psychosocial, emotional and health effects of an individual 2 .…”

Quality of life and health of opioid-dependent subjects in India

“…[12] Studies on QoL have recently started to involve the field of drug addiction to go beyond the presence and severity of addiction symptoms and the side effects of treatments by examining how drug-addicted patients perceive and experience the repercussions on their daily life. [13] The nature of heroin dependence makes consideration of QoL, particularly overall QoL, highly relevant. First, addiction to illicit drugs is a cluster of physiological, behavioral, and cognitive phenomena,[14] which can damage individuals’ physical and mental health, role performance, and social adaptation.…”

The application of the drug user quality of life scale (DUQOL) in Australia

“…Ideally, the objective of evaluating QoL among drug-dependent individuals should be not only to evaluate patients with regard to the presence or absence of symptoms or adverse reaction to treatment, but also to focus on how drug-dependent individuals experience their daily lives [15,16]. In the area of substance use, though, the evaluation of QoL of substance users has been conducted mainly using generic QoL instruments [17].…”