Poor reporting of quality of life outcomes in dermatology randomized controlled clinical trials

Background: Because many dermatological diseases are chronic but not life- threatening, consideration of their impact on health-related quality of life (QOL) seems essential. Objective: To analyze the use of QOL as an evaluation endpoint in randomized clinical trials concerning skin diseases. Methods: Studies identified by computerized search of 3 bibliographical databases were selected, and their data on QOL as an evaluation endpoint were collected and analyzed. Results: Among the 67 studies retained, 87% did not adequately describe the questionnaires; 75% did not address handling of missing data; 95% did not calculate the number of subjects needed to obtain the desired statistical power; 95% did not disclose before-and-after results as means of overall scores and each dimension. Conclusion: Our analysis highlighted methodological weaknesses in the use of QOL questionnaire and poor reporting of QOL outcomes in randomized clinical trials. Copyright (C) 2008 S. Karger AG, Basel.