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.


CONCLUSIONS
Our analysis highlighted methodological weaknesses in the use of QOL questionnaire and poor reporting of QOL outcomes in randomized clinical trials.
Le Cleach
Laurence
L
Service de Dermatologie, Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France. laurence.lecleach@free.fr
Chassany
Olivier
O
Levy
Annabelle
A
Wolkenstein
Pierre
P
Chosidow
Olivier
O
D003879:Dermatologic Agents / Q000627:therapeutic use; D003880:Dermatology; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods / Q000592:standards*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards*; D012107:Research Design / Q000592:standards*; D012871:Skin Diseases / Q000188:drug therapy; D011795:Surveys and Questionnaires
D003879:Dermatologic Agents