Long-Term Improvement of Quality of Life During Growth Hormone (GH) Replacement Therapy in Adults with GH Deficiency, as Measured by Questions on Life Satisfaction-Hypopituitarism (QLS-H) (original) (raw)
The Journal of Clinical Endocrinology & Metabolism, 2003
tionnaire 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 in-creased 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. (J Clin Endocrinol Metab 88: 4158 -4167, 2003)
European Journal of Endocrinology, 2001
Background: Adults with growth hormone (GH) de®ciency (GHD) may experience physical and psychological disturbances, which can affect their quality of life (QOL). Objectives: To develop and validate a disease-speci®c module from the previously published QOL measure Questions on Life Satisfaction Modules (QLS M ): the QLS M -H that speci®cally addressed the needs of patients with hypopituitarism. A second aim was for the questionnaire to be applicable across different cultural backgrounds in order to evaluate the ef®cacy of therapy in large, international clinical trials, thus providing additional clinical endpoints for these studies. Design: A preliminary German language version of the QLS M -H was developed from 26 semistructured interviews of adults with GHD. The questionnaire was then independently translated into ®ve other languages and applied in open, non-controlled, multicentre, longitudinal studies to patient n 717 and normative populations n 2700X Methods: A revised, nine-item version of the questionnaire was developed, based on previously de®ned criteria, and was evaluated for reliability and validity. Sensitivity to detect changes after GH replacement was also assessed. Results: The 16 items of the preliminary questionnaire were reduced to nine items on the basis of the correlation of items/factors from initial patient interviews. Psychometric analysis revealed the reliability of the nine-item scale. The Cronbach's alpha scores ranged from 0.81 to 0.89 and the test± retest correlations ranged from 0.76 to 0.88, all of which indicate reliability over time. Mean scores increased signi®cantly during GH replacement therapy, with observed changes greater than those seen with the non-speci®c modules of the QLS M , indicating the sensitivity of the scale. Conclusions: The QLS M -H questionnaire is concise, easy to complete, and can be effectively applied across different cultural backgrounds. Psychometric evaluation of the questionnaire reveals that it is a valid, reliable and sensitive tool useful for assessing impaired life satisfaction in adult patients with GHD and also for monitoring the ef®cacy of GH therapy.
The Journal of Clinical Endocrinology and Metabolism, 2001
Patients with hypopituitarism often have a multitude of physical and psychological complaints, collectively referred to as low quality of life (QoL). It has been asserted that GH deficiency (GHD) is the causative factor, and improved QoL scores have been reported during GH replacement. Qol-assessment of GHD (QoL-AGHDA) is the newest psychometric instrument with the purportedly high specificity for the issues encountered by patients with GHD. QoL-AGHDA was administered to 30 normal control subjects, 20 patients with severe GHD, and 22 patients with active acromegaly. QoL-AGHDA scores in
Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 1999
Several studies have shown that growth hormone deficiency in adults leads to poor well-being and other clinical consequences, and that these improve when the hormone is replaced. However, the studies employed generic measures of health status that miss important aspects of the patients' experience and that have inadequate reliability and responsiveness. This paper describes the European development and testing of the Quality of Life-Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA), a condition-specific quality of life measure for use in clinical trials and for the routine monitoring of patients. The instrument was produced in five languages; English, Swedish, Italian, German and Spanish. Each language version is shown to have good reliability, internal consistency and construct validity. The QoL-AGHDA is currently included in an international database monitoring the long-term efficacy and safety of growth hormone replacement therapy and in clinical trials in a numbe...
Clinical Endocrinology, 2008
Objectives To examine quality of life (QoL) measured by a utility-weighted index in GH-deficient adults on GH replacement and analyse the impact of demographic and clinical characteristics on changes in utilities during treatment. Design Utilities for items in the QoL-Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA utility ) were estimated based on data obtained from the general population in England and Wales (E&W). These estimates were used to calculate QoL changes in GH-treated patients and compare these with normative population values. Patients A total of 894 KIMS patients (53% women) from E&W were followed for 1 to 6 years.
One-year follow-up of quality of life in adults with untreated growth hormone deficiency
Clinical Endocrinology, 1998
OBJECTIVE The aim of the study was to evaluate the impact on health-related quality of life (HRQoL) in untreated GHD patients using the disease-specific Assessment of Growth Hormone Deficiency in Adults (AGHDA) questionnaire. DESIGN AND PATIENTS A cohort of 356 consecutive adult GHD patients, diagnosed after the age of 18 years, from the endocrinology units of 37 Spanish hospitals were included over a 6-month period in a longitudinal observational quality-of-life study. In addition, patients' HRQoL scores were compared to those obtained from a random sample of 963 subjects from the general population recruited by trained interviewers in a 6-month period and matched by age and sex to figures of the 1991 Spanish census. MEASUREMENTS Patients were evaluated at baseline and after 12-months. Socio-demographic and health variables such as age,sex, level of education, income level, number of chronic diseases and self-reported health status were recorded at baseline and follow-up visits. Patients underwent physical and analytical examination and completed the AGHDA questionnaire. A survey including socio-demographic, selfreported health status and the AGHDA questionnaire was administered at the individuals' homes. RESULTS Mean score for patients at baseline was 9•4 (CI ¼ 8•4-10•4) and at 12 months 10 (CI ¼ 8•8-11). HRQoL was worse in the case of older patients with a low level of education, lower income levels, reporting having an associated chronic disease and poor self-reported health status (P < 0•01). Untreated GHD patients maintain or slightly worsen their HRQoL after 12 months of follow-up, with high individual variability. Although AGHDA scores worsened during the observation period, differences were not statistically significant. AGHDA mean score in controls was 5•49 (CI ¼ 5•27-5•71). Comparison of the mean AGHDA scores between patients and controls previously standardized by level of education and age were statistically different (P < 0•01), indicating that patients declared a worse HRQoL than the general population except for those aged 60-69 years. GHD patients presented a deterioration in HRQoL almost double that of the general population. CONCLUSIONS These results permit comparison of patients' scores against reference scores with regard to the desirable effect of treatment. Future use of the AGHDA questionnaire in clinical trials should try to establish a relationship between biological and HRQoL changes.
2005
Background: Patients with growth hormone deficiency (GHD) frequently report to suffer from an impaired Quality of Life (QoL) and growth hormone (GH) substitution is found to improve this. However, the same test may be used for measuring QoL, well-being or health status in different studies. QoL has been defined as the subjective appraisal of one's current life based primarily on psychological function. The most important in the appraisal of well-being is mental function and concerning health status patients evaluate physical function as most important. To differentiate the effects of GH replacement on psychological variables in patients with GHD we carried out a number of meta-analyses, classifying questionnaires into instruments measuring QoL, psychological well-being and health status. Methods: We searched the electronic databases PUBMED and PiCarta from 1985 to 2004. Studies were included that evaluated the effect of GH on patient-reported outcomes in adults with GHD (aged 18 years and above). According to generally accepted definitions we classified the questionnaires as instruments measuring QoL, well-being and health status. By means of metaanalyses the average effect size (d) for QoL, well-being and health status was calculated. Results and Discussion: Based on open studies GH replacement is found to improve QoL with a small effect size (d = 0.18), well-being with a medium effect size (d = 0.47) and health status with a small effect size (d = 0.26). As the effect size of well-being is most pronounced the generally reported effects of GH replacement on QoL may be overestimated and actually reflect the effect on well-being. Conclusion: To get more insight in the specific psychological effects of GH treatment it is recommended that instruments selected for these studies should be more consistently classified as instruments measuring QoL, well-being or health status.
Growth Hormone Therapy and Quality of Life in Adults and Children
PharmacoEconomics, 2004
children is improvement in quality of life (QOL). Assessments of the therapeutic role of GH depend on its effectiveness in meeting this and other goals (including improved metabolic status in adults and improved growth in children) in relation to economic parameters. However, there are difficulties in interpreting data on GH treatment and QOL. These include controversy about appropriate definitions and measures for assessing QOL, disease adaptation, comorbid conditions, and potential patient selection bias. In GH-deficient adults who have completed linear growth, there is considerable evidence that GH exerts effects on body composition, serum lipids, and bone