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Lilly Research Laboratories, Eli Lilly & Co. (W.F.B., D.J.E., M.R., M.L.H., F.M., D.V., A.F.A.), Indianapolis, Indiana 46285; Pharma Support, Inc. (E.P.S.), 191119 St. Petersburg, Russia; Department of Internal Medicine, Erasmus University Medical Center (A.J.v.d.L.), 3015 GD Rotterdam, The Netherlands; Medizinische Klinik Innenstadt (C.J.S.), 80336 Munich, Germany; and Institut und Poliklinik für Psychosomatische Medizin, Medizinische Psychologie und Psychotherapie (G.H., P.H.), 81675 Munich, Germany
Address all correspondence and requests for reprints to: Dr. Werner F. Blum, Eli Lilly & Co., Saalburgstrasse 153, D-61350 Bad Homburg, Germany. E-mail: blum_werner{at}lilly.com.
To develop reference ranges for the Questions on Life Satisfaction Hypopituitarism Module (QLS-H), a new quality of life questionnaire for patients with hypopituitarism, data from 8177 adults were collected in France, Germany, Italy, The Netherlands, Spain, the United Kingdom, and the United States QLS-H scores declined with age, were lower in females than males, and differed significantly among countries. From these reference ranges we derived equations for z-scores, which adjust for age, gender, and country. QLS-H results from 957 adults with GH deficiency (GHD) participating in clinical trials were analyzed. At baseline, QLS-H scores were lower in females and differed significantly among countries. QLS-H scores significantly increased after GH treatment (6–8 months), but differences by country persisted. Calculating z-scores for patients eliminated all gender and most country differences. Pooled z-scores (mean ± SD) from all patients increased from -0.99 ± 1.39 at baseline to -0.14 ± 1.30 after GH treatment. Quality of life assessment in adults with GHD requires the use of z-scores to correct for age, gender, and country differences. This approach allows pooling of data from different cohorts and comparison with general populations. QLS-H scores in adults with GHD were significantly decreased at baseline and were almost normalized after 6–8 months of GH therapy.
This work was supported by Eli Lilly & Co.
Abbreviations: AGHDA, Assessment of GH Deficiency in Adults; DV, deviation scale; GHD, GH deficiency; LS, least squares; QLS-H, Questions on Life Satisfaction Hypopituitarism Module; QoL, quality of life.
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