Poor Reporting of Quality of Life Outcomes in Dermatology Randomized Controlled Clinical TrialsLe Cleach L.a · Chassany O.b · Levy A.c · Wolkenstein P.e · Chosidow O.d
aService de Dermatologie, Centre Hospitalier Sud Francilien, Corbeil-Essonnes, bDépartement de la Recherche Clinique (AP-HP), Hôpital Saint-Louis, cServices de Dermatologie, Hôpital Saint-Louis, Université Paris 7, Denis Diderot, dHôpital Tenon (AP-HP), Université Paris 6, Pierre et Marie Curie, Paris, eCHU Henri-Mondor (AP-HP), Université Paris 12, Créteil, France
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Article / Publication Details
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.
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