HRQOL Assessment Tools

Note: While HRQOL has been gaining more attention in recent years, many physicians in clinical practice do not assess their patients' HRQOL. There is a wide variation on its use. For example, the SGRQ—a standard in clinical trials—is generally not used by practicing physicians. In fact, many physicians may be unfamiliar with this assess­ment tool. When practicing clinicians do assess HRQOL, they do so through global assess­ment and may use general assessment tools (eg, SF‑36), not disease-specific assess­ments (eg, SGRQ).

The emphasis on HRQOL has grown in recent years for several reasons. First, patients are more concerned about their symptoms and ability to function than about objective measures such as expiratory airflow rates. Second, HRQOL is a measurement that can be identified and quantified, yet is different from physiologic measures or survival risks. Third, the goals of therapy have been expanded from solely increasing airflow to relieving symptoms and improving HRQOL. Endpoints now include both physiologic measures and HRQOL measures. Finally, understanding the factors with the most impact on HRQOL can influence a patient’s care plan.

Health assessment questionnaires should include the following markers:

• symptom levels (frequency, duration, and severity)
• activity levels (ability to exercise, perform activities of daily living)
• fatigue (severity and frequency)
• dyspnea (severity when exercising, performing activities of daily living)
• emotional functioning (depression, attitudes toward coping)
• social functioning (ability to engage in social functions in and out of the home)
• general feeling of well-being
• patient view of overall health

A number of tools have been developed to measure a patient's quality of life. Each was designed to provide a standard method to evaluate the levels of health impairment in both individual patients as well as in groups of patients. There are 3 different types of instruments:

Utility scale: This instrument quantifies states of health based upon a continuum that ranges from perfect health to death. A utility scale is particularly helpful to health economists.

General or generic health measures: These quantify a wide range of disease states via a continuum that ranges from perfect health to the worst possible health. While these measures can provide a valid estimate of health impairment in chronic respiratory diseases, they appear to be insensitive to minor changes in health status that are the result of therapy intervention. Examples of commonly used questionnaires include the SF-36 questionnaire and the Nottingham Health Profile.

The SF‑36 consists of 36 questions that cover 9 domains (eg, physical functioning, social functioning, vitality).  While SF-36 is a valid instrument to measure HRQOL in patients with COPD, it is recommended that it be used in combination with COPD-specific evaluations such as the SGRQ.

Disease-specific measures: These instruments were developed to consider the major or key factors that influence the HRQOL in patients with a specific disease and are used primarily in clinical studies, not clinical practice. The CRQ is used specifically for COPD, for example, and measures dyspnea, fatigue, emotional function, and physical mastery. The CRQ requires patients to identify activities that are personally affected by the disease.  This individualized approach, however, is not standardized and therefore makes it difficult to compare different populations or results of different studies.

As noted in the first section, 2 assessments (the SGRQ and the BDI/TDI), are used to determine the severity of dyspnea.  These tests are also used to assess a patient’s HRQOL.  The SGRQ, a COPD-specific questionnaire, includes 76 weighted responses to 50 questions.  There are 3 components: Symptoms—distress associated with respiratory symptoms; Activity—distress associated with limitation of physical activity and mobility; and Impacts—distress associated with disturbances to social life, daily activities, and psychological well-being.  A total score is calculated from the component scores.  A change of -4 indicates a meaningful clinical improvement.  A high score is indicative of a poor HRQOL.

The BDI/TDI is used to measure the severity of breathlessness in symptomatic patients.  An interviewer-administered ques­tionnaire, the BDI/TDI rates functional impairment (the impact of breathlessness on the ability to carry out activities); magnitude of task (the type of task that causes breathlessness); and the magnitude of effort (the level of effort that results in breathlessness).  At baseline, each of these components is rated on a 0-4 basis, and the BDI is determined.  The TDI scores obtained at subsequent visits, which record the change from baseline, are rated -3 to +3.  The TDI Focal score is the sum of the 3 components.  A higher score indicates improvement in the patient’s dyspnea.  A 1 unit change in the Focal score is considered significant.