The authors examined 32 studies published between January 1990 and June 2004. Fifteen compared HRQOL in HCV patients with that of healthy patients. They showed that HCV patients had a diminished HRQOL, most dramatically in social and physical function, general health, and vitality. Nine studies stratified HRQOL by response to treatment measures. They indicated that HRQOL is consistently worse in patients who fail to achieve sustained viral response. Six studies examined HRQOL by neuropsychosocial effects, such as cognitive dysfunction, depression, emotional distress and stigmatization. These studies revealed large HCV-related HRQOL differences. Finally, five studies stratified HRQOL by traditional markers of liver disease. These showed that subtle histological or biochemical changes were not perceived as clinically important by patients, though large differences in HRQOL were found in patients with cirrhosis.

The expert panel concluded that the vitality scale best captured the HRQOL effects relevant to HCV patients. They generated a mean MCID of 4.2 points on the vitality scale. "This value can be used in everyday clinical practice and in clinical trials," the authors suggest. "For example, physicians can measure patient outcomes by administering the 6-item SF vitality scale during office visits. If a patient fails to achieve an increase of 4.2 points over time, then it implies that the ongoing care has failed to perceptively improve the patient's HRQOL. In clinical trials, the MCID can be used as a yardstick to determine whether patients have benefited from the study intervention."

Since the analysis was limited by estimations of MCID based on existing data, the authors suggest that future research directly measure the MCID. Further, they caution, the vitality scale alone may not capture all the key aspects of HRQOL in HCV.

Still, their findings offer a numb
'"/>

Contact: David Greenberg
dgreenbe@wiley.com
201-748-6484
John Wiley & Sons, Inc.
25-Mar-2005