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Dermatology. 2008;216(1):46-55.

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

Author information

1
Service de Dermatologie, Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France. laurence.lecleach@free.fr

Abstract

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.

PMID:
18032899
DOI:
10.1159/000109358
[Indexed for MEDLINE]

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