Although it is well documented that obesity is strongly associated with morbidity and mortality, less is known about the impact of obesity on functional status and health-related quality of life (HRQL). However, in recent years research has been conducted to estimate the impact of obesity on HRQL, and to determine the effects of weight reduction on HRQL. The majority of published studies indicate that obesity impairs HRQL, and that higher degrees of obesity are associated with greater impairment. Obesity-associated decrements on HRQL tend to be most pronounced on physical domains of functioning. Studies of the effect of obesity surgery among morbidly obese patients indicate that this procedure produces significant and sustained improvements in the majority of HRQL indices; among mild-to-moderately obese persons, modest weight reduction derived from lifestyle modification also appears to improve HRQL, at least in the short term. Additional research is needed to (1) further characterize the effect that obesity has on HRQL; (2) estimate the short- and long-term effects of various methods of weight reduction (e.g. surgery, lifestyle modification) on HRQL; (3) improve both the conceptualization and measurement of HRQL to incorporate the personal preferences and values of the patient; and (4) develop ways to enhance and sustain positive changes in HRQL, even if weight maintenance is elusive.

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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.

Obesity is a major public health problem associated with increased health risks, chronic pain, and decrements in functional health status and subjective well-being. To examine the impact of pain on Health-Related Quality-of-Life (HRQL). 312 consecutive persons seeking medically-supervised weight loss treatment completed a sociodemographic questionnaire, the Medical Outcomes Study Short-Form Health Survey (SF-36), and underwent a series of clinical evaluations. Forty-eight percent of the patients when asked to rate "How much pain have you had in the last four weeks?" reported at least moderate pain in the four weeks prior to treatment. In analyses adjusted for sociodemographic factors, body-mass index (BMI) (kg/m2), and depression, obese patients reporting pain scored significantly lower on all SF-36 domains than those not reporting pain. Findings indicate that the pain itself is independently associated with impaired HRQL in nearly half of obese persons seeking treatment. These data demonstrate that pain is a strong covariate of obesity and, therefore, may need to be considered in the design and development of obesity treatments.

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