Herschbach P, Henrich G, Strasburger C J, Feldmeier H, Marín F, Attanasio A M, Blum W F
Institut und Poliklinik für Psychosomatische Medizin, Psychotherapie und Medizinische Psychologie der Technischen Universität München, Langerstrasse 3, 81675 Munich, Germany.
Eur J Endocrinol. 2001 Sep;145(3):255-65. doi: 10.1530/eje.0.1450255.
Adults with growth hormone (GH) deficiency (GHD) may experience physical and psychological disturbances, which can affect their quality of life (QOL).
To develop and validate a disease-specific module from the previously published QOL measure Questions on Life Satisfaction Modules (QLS(M)): the QLS(M)-H that specifically 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 efficacy of therapy in large, international clinical trials, thus providing additional clinical endpoints for these studies.
A preliminary German language version of the QLS(M)-H was developed from 26 semi-structured interviews of adults with GHD. The questionnaire was then independently translated into five other languages and applied in open, non-controlled, multicentre, longitudinal studies to patient (n=717) and normative populations (n=2700).
A revised, nine-item version of the questionnaire was developed, based on previously defined criteria, and was evaluated for reliability and validity. Sensitivity to detect changes after GH replacement was also assessed.
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 significantly during GH replacement therapy, with observed changes greater than those seen with the non-specific modules of the QLS(M), indicating the sensitivity of the scale.
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 efficacy of GH therapy.
患有生长激素（GH）缺乏症（GHD）的成年人可能会出现身体和心理方面的不适，这会影响他们的生活质量（QOL）。
从先前发表的生活满意度模块问题（QLS(M)）这一生活质量测量工具中开发并验证一个针对特定疾病的模块：QLS(M)-H，该模块专门针对垂体功能减退患者的需求。第二个目的是使该问卷适用于不同文化背景，以便在大型国际临床试验中评估治疗效果，从而为这些研究提供额外的临床终点指标。
QLS(M)-H的初步德语版本是通过对26名患有GHD的成年人进行半结构化访谈而开发的。然后，该问卷被独立翻译成其他五种语言，并应用于开放性、非对照、多中心纵向研究，涉及患者（n = 717）和正常人群（n = 2700）。
根据先前确定的标准，开发了一个修订后的九项问卷版本，并对其信度和效度进行了评估。还评估了该问卷对GH替代治疗后变化的敏感性。
根据最初患者访谈中项目/因素的相关性，初步问卷的16个项目减少到了9个项目。心理测量分析显示了九项量表的信度。克朗巴哈α系数得分在0.81至0.89之间，重测相关性在0.76至0.88之间，所有这些都表明随时间推移具有信度。在GH替代治疗期间，平均得分显著增加，观察到的变化大于QLS(M)非特定模块所观察到的变化，表明该量表具有敏感性。
QLS(M)-H问卷简洁、易于填写，并且可以在不同文化背景下有效应用。对该问卷的心理测量评估表明，它是一个有效、可靠且敏感的工具，可用于评估成年GHD患者受损的生活满意度，也可用于监测GH治疗的效果。
