Development and psychometric properties of a disease-specific quality of life questionnaire for adult patients with growth hormone deficiency

Abstract

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.

Heterogeneity in responsiveness of perceived quality of life to body composition changes between adult- and childhood-onset Japanese hypopituitary adults with GH deficiency during GH replacement

“…Some studies have reported a significant association between baseline QoL score and body mass index (22,23). In semi-structured interviews, adult patients with GHD report excess fat mass as a major reason for poor body image and thus body image has been included as a major item in GHDspecific questionnaires, such as AGHDA (24) and Questions on Life Satisfaction-Hypopituitarism (QLS-H) (25). The strong association of the general health subscale with fat mass status in our studies is consistent with these findings, although the possibility of chance correlation cannot be excluded.…”

A randomized, placebo-controlled trial on the effects of soy protein containing isoflavones on quality of life in postmenopausal women

“…The questionnaire produces total scores for each module separately. 22 The GDS is a self-rated screening instrument especially designed to measure depression in the elderly. 23 The GDS consists of 30 items with only two possible answers (yes/no).…”

Central effects of the somatotropic system

“…The questionnaires existing at the moment are the modified impact scale (IS), the modified life fulfillment scale (LFS) (110), the growth hormone deficiency questionnaire (GHDQ) (106), the QOL-AGHDA (111), and the Questions on Life Satisfaction Modules -Hypopituitarism (QLS M -H) (112). Interestingly, in one trial, placebo-controlled for 6 months and open-label for another 6 months, that evaluated the effectiveness of GH substitution using the NHP and the GHDQ, significant improvements were seen in some aspects of the NHP but no change in scores were seen for the GHDQ (106).…”