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Vol. 216, No. 1, 2008
Issue release date: November 2007
Dermatology 2008;216:46–55

Poor Reporting of Quality of Life Outcomes in Dermatology Randomized Controlled Clinical Trials

Le Cleach L. · Chassany O. · Levy A. · Wolkenstein P. · Chosidow O.
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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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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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