Adaptation of the QoL-AGHDA scale for adults with growth hormone deficiency in four Slavic languages

Health and Quality of Life Outcomes

Maria Koltowska-Häggström⁵  Mikulas Pura²  Vera Popovic⁶  Malgorzata Karbownik-Lewinska⁴  Václav Hána³  Sigrid R Crawford¹  James Twiss¹  Jeanette Wilburn¹  Stephen P McKenna¹ 

[1]Galen Research Ltd, Manchester, UK

[2]Department of Endocrinology, National Institute of Endocrinology & Diabetology, Lubochna, Slovakia

[3]Third Department of Internal Medicine, Charles University, Prague, Czech Republic

[4]Department of Oncological Endocrinology, Medical University of Lodz, Poland

[5]Pfizer Endocrine Care, Sollentuna, Sweden

[6]Institute of Endocrinology, University Clinical Centre, Belgrade, Serbia

关键词: Slovakia;    Serbia;    Poland;    Czech Republic;    QoL-AGHDA;    Validation;    Adaptation;   

Others  :  826530
DOI  :  10.1186/1477-7525-9-60

 received in 2011-02-18, accepted in 2011-08-02,  发布年份 2011

【 摘 要 】

Purpose

The Quality of Life in Adult Growth Hormone Deficiency Assessment (QoL-AGHDA) is a disease-specific quality of life measure specific to individuals who are growth hormone deficient. The present study describes the adaptation of the QoL-AGHDA for use in the following four Slavic languages; Czech, Polish, Serbian and Slovakian.

Methods

The study involved three stages in each language; translation, cognitive debriefing and validation. The validation stage assessed internal consistency (Cronbach's alpha), reproducibility (test-retest reliability using Spearman's rank correlations), convergent and divergent validity (Correlations with the NHP) and known group validity.

Results

The QoL-AGHDA was successfully translated into the target languages with minimal problems. Cognitive debriefing interviewees (n = 15-18) found the measures easy to complete and identified few problems with the content. Internal consistency (Czech Republic = 0.91, Poland = 0.91, Serbia = 0.91 and Slovakia = 0.89) and reproducibility (Czech Republic = 0.91, Poland = 0.91, Serbia = 0.88 and Slovakia = 0.93) were good in all adaptations. Convergent and divergent validity and known group validity data were not available for Slovakia. The QoL-AGHDA correlated as expected with the NHP scales most relevant to GHD. The QoL-AGHDA was able to distinguish between participants based on a range of variables.

Conclusions

The QoL-AGHDA was successfully adapted for use in the Czech Republic, Poland, Serbia and Slovakia. Further validation of the Slovakian version would be beneficial. The addition of these new lanaguage versions will prove valuable to multinational clinical trials and to clinical practice in the respective countries.

【 授权许可】

   
2011 McKenna et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

Figure 4.

【 参考文献 】

• [1]National Institute for Clinical Excellence: TA64 Human growth hormone (somatropin) in adults with growth hormone deficiency: Guidance[http://www.nice.org.uk/nicemedia/pdf/TA64_HGHadults_fullguidance.pdf] webcite 2003. Accessed 10 Jan 2010
• [2]Hoffman DM, O'Sullivan AJ, Freund J, Ho KK: Adults with growth hormone deficiency have abnormal body composition but normal energy metabolism. The Journal of clinical endocrinology and metabolism 1995, 80(1):72-7.
• [3]Salomon F: The effects of treatment with recombinant human growth hormone on body composition and metabolism in adults with growth hormone deficiency. The New England journal of medicine 1989, 321:1793-803.
• [4]Holmes SJ, Economou G, Whitehouse RW, Adams JE, Shalet SM: Reduced bone mineral density in patients with adult onset growth hormone deficiency. The Journal of clinical endocrinology and metabolism 1994, 78(3):669-74.
• [5]Cuneo RC, Judd S, Wallace JD, Perry-Keene D, Burger H, Lim-Tio S, Strauss B, Stockigt J, Topliss D, Alford F, Hew L, Bode H, Conway A, Handelsman D, Dunn S, Boyages S, Wah Cheung N, Hurley D: The Australian Multicenter Trial of Growth Hormone (GH) Treatment in GH-Deficient Adults. The Journal of clinical endocrinology and metabolism 1998, (1):107-16.
• [6]Rosen T: Cardiovascular risk factors in adult patients with growth hormone deficiency. Acta Endocrinologica 2010, 129:195-200.
• [7]Johansson JO: Growth hormone-deficient adults are insulin-resistant. Metabolism 1995, 44:1126-9.
• [8]Markussis V: Detection of premature atherosclerosis by high-resolution ultrasonography in symptom-free hypopituitary adults. Lancet 1992, 340:1188-92.
• [9]Gilchrist FJ, Murray RD, Shalet SM: The effect of long-term untreated growth hormone deficiency and 9 years of GH replacement on the quality of life (QoL) of GH-deficient adults. Clinical endocrinology 2002, 57:367-70.
• [10]Mårdh G, Lundin K, Borg G, Jonsson B, Lindberg A: Growth hormone replacement therapy in adult hypopituitary patients with growth hormone deficiency: combined data from 12 European palcebo-controlled clinical trials. Endocrinology and Metabolism 1994, 1(Suppl A):43-9.
• [11]Rosen T, Wiren L, Wilhelmsen L, Wiklund I, Bengtsson BA: Decreased psychological well-being in adult patients with growth hormone deficiency. Clinical endocrinology 1994, 40(1):111-6. (1994)
• [12]Falleti MG, Maruff P, Burman P, Harris A: The effects of growth hormone (GH) deficiency and GH replacement on cognitive performance in adults: a meta-analysis of the current literature. Psychoneuroendocrinology 2006, 31:681-691.
• [13]Holmes SJ, McKenna SP, Doward LC, Hunt SM, Shalet SM: Development of a questionnaire to assess the quality of life of adults with growth hormone deficiency. Endocrinology and Metabolism 1995, 2:63-9.
• [14]Hunt SM, McKenna SP: The QLDS: A scale for the measurement of quality of life in depression. Health Policy 1992, 22:307-319.
• [15]McKenna SP, Doward LC: Special Issue: The needs based approach to quality of life assessment. Value Health 2004, 7(Suppl 1):1-3.
• [16]Lagrou K, Xhrouet-Heinrichs D, Massa G, Vandeweghe M, Bourguignon JP, De Schepper J, de Zegher F, Ernould C, Heinrichs C, Malvaux P, Craen M: Quality of life and retrospective perception of the effect of growth hormone treatment in adult patients with childhood growth hormone deficiency. Journal of pediatric endocrinology and metabolism 2001, 14(Suppl 5):1249-60.
• [17]Mukherjee A, Tolhurst-Cleaver S, Ryder WD, Smethurst L, Shalet SM: The characteristics of quality of life impairment in adult growth hormone (GH)-deficient survivors of cancer and their response to GH replacement therapy. The Journal of clinical endocrinology and metabolism 2005, 90(3):1542-9.
• [18]Moock J, Albrecht C, Friedrich N, Völzke H, Nauck M, Koltowska-Haggström M, Kohlmann T, Wallaschofski H: Health-related quality of life and IGF-1 in GH-deficient adult patients on GH replacement therapy: analysis of the German KIMS data and the Study of Health in Pomerania. European journal of endocrinology 2009, 160(1):17-24.
• [19]Gutiérrez LP, Kołtowska-Häggström M, Jönsson PJ, Mattsson AF, Svensson D, Westberg B, Luger A: Registries as a Tool in Evidence - Based Medicine: example of KIMS (Pfizer International Metabolic Database). Pharmacoepidemiology and Drug Safety 2008, 17:90-102.
• [20]McKenna SP, Doward LC, Alonso J, Kohlmann T, Niero M, Prieto L, Wíren L: The QoL-AGHDA: An instrument for the assessment of quality of life in adults with growth hormone deficiency. Quality of Life Research 1999, 8:373-383.
• [21]Swaine-Verdier A, Doward LC, Hagell P, Thorsen H, McKenna SP: Adapting Quality of Life Instruments. Value in Health 2004, 7(suppl 1):27-30.
• [22]Hagell P, Hedin PJ, Meads DM, Nyberg L, McKenna SP: Effects of Method of Translation of Patient-Reported Health Outcome Questionnaires: A Randomized Study of the Translation of the Rheumatoid Arthritis Quality of Life (RAQoL) Instrument for Sweden. Value in Health 2010, 13:424-30.
• [23]Wilburn J, McKenna SP, Twiss J: Further developments of the rheumatoid arthritis quality of life scale (RAQoL). Value in Health 2009, 12(7):A447-A448.
• [24]Hunt SM, McEwen J, McKenna SP: Measuring health status. New Hampshire: Croom Helm; 1986.
• [25]Streiner DL, Norman GR: Health measurement scales: A practical guide to their development and use. Oxford England: Oxford University Press; 1989.
• [26]Weiner EA, Stewart BJ: Assessing individuals. Boston: Little Brown; 1984.
• [27]Burman P, Broman JE, Hetta J, Wiklund I, Erfurth EM, Hagg E, Karlsson FA: Quality of life in adults with growth hormone (GH) deficiency: response to treatment with recombinant human GH in a placebo-controlled 21-month trial. The Journal of clinical endocrinology and metabolism 1995, 80:3585-90.
• [28]Gilchrist FJ, Murray RD, Shalet SM: The effect of long-term untreated growth hormone deficiency (GHD) and 9 years of GH replacement on the quality of life (QoL) of GH-deficient adults. Clinical endocrinology 2002, 57:363-70.
• [29]McMillan CV, Bradley C, Gibney J, Healy ML, Russell-Jones DL, Sönksen PH: Psychological effects of withdrawal of growth hormone therapy from adults with growth hormone deficiency. Clinical endocrinology 2003, 59(4):467-75.
• [30]McKenna SP, Hunt SM, Tennant A: The development of a patient-completed index of distress from the Nottingham Health Profile: A new measure for use in cost-utility studies. British Journal of Medical Economics 1993, 6:13-24.
• [31]Nijsten T, Meads DM, de Korte J, Sampogna F, Gelfand JM, Ongenae K, Evers AW, Augustin M: Cross-Cultural Inequivalence of Dermatology-Specific Health related Quality of Life Instruments in Psoriasis Patients. Journal of Investigative Dermatology 2007, 127:2315-2322.
• [32]McKenna SP, Doward LC, Meads DM, Tennant A, Lawton G, Grueger J: Quality of life in infants and children with atopic dermatitis: Addressing issues of differential item functioning across countries in multinational clinical trials. Health and Quality of Life Outcomes 2007, 5:45. BioMed Central Full Text
• [33]Meads DM, McKenna SP, Doward LC: Assessing the cross-cultural comparability of the Centre for Epidemiologic Studies Depression Scale (CES-D). Value in Health 2006, 9(6):A324.