Abstract

Patient satisfaction and global ratings of study medications are increasingly used as secondary outcome measures in pain clinical trials. However, little is known about the factors that underlie and contribute to these ratings. 191 patients who participated in a randomized trial of parenteral parecoxib sodium followed by oral valdecoxib for pain following laparoscopic cholecystectomy versus standard care rated their satisfaction with the overall performance of the study medications (postoperative days 1 and 7) and also provided global evaluation of the analgesics on postoperative day 7. Analyses indicated that treatment regimen, age, worst pain experienced, pain interference with functioning, morphine equivalent dose taken, and number of opioid-related symptoms (e.g. nausea, fatigue) were all associated with satisfaction with the overall performance of the study medications at day 1. Controlling for all of the predictors, pain interference and morphine equivalent dose use made independent contributions to the prediction of the day 1 global rating. These results were replicated in the prediction of day 7 ratings, except that at day 7, treatment regimen also made a significant independent contribution to the prediction of satisfaction. These findings indicate that the study participants considered more than one factor when estimating their satisfaction with the study medications, and that the changes produced by the treatment (e.g. decreased pain, opioid-related symptoms) mediated, in part, the effects of treatment on treatment satisfaction.

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