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Background Hypopituitarism is a recognized sequela of traumatic brain injury (TBI) and may worsen the quality of life (QoL) in survivors. Aims To assess the prevalence of post‐traumatic hypopituitarism (PTHP) and growth hormone deficiency (GHD), and determine their correlation with QoL. Methods Survivors of moderate to severe TBI were recruited from two Algerian centres. At 3 and 12 months, pituitary function was evaluated using insulin tolerance test (ITT), QoL by growth hormone deficiency in adults’ questionnaire (QoL‐AGHDA), and 36‐item short‐form (SF‐36) health survey. Results Of 133 (M: 128; F: 5) patients aged 18‐65 years, PTHP and GHD were present at 3 and 12 months in 59 (44.4%) and 23 (17.29%), 41/116 (35.3%) and 18 (15.5%). Thirteen patients with GHD at 3 months tested normally at 12 months, while 9 had become GHD at 12 months. At 3 and 12 months, peak cortisol was, Hypopituitarism is a recognized sequela of traumatic brain injury (TBI) and may worsen the prognosis and quality of life (QoL) of survivors. PTHP and GHD are common after TBI both are linked to QoL one year after injury. AGHDA is a more specific measure of QoL in GHD than SF‐36. Full pituitary evaluation and QoL‐AGHDA 12 months after TBI are recommended.

Background: The Nottingham Health Profile (NHP) is a generic measure of perceived distress that has been used widely as an outcome measure in clinical practice and trials. The availability of two Brazilian datasets provided the opportunity to assess the psychometric performance of the NHP in different populations - adult growth hormone deficiency (GHD) and pulmonary hypertension (PH). The purpose of the study was to see how valuable the NHP could be in assessing outcomes in diseases where no disease-specific measures are available. Methods: Secondary analyses were performed with NHP data. Patients diagnosed with adult GHD or PH were administered the NHP during clinic visits on two occasions, two weeks apart. A disease-specific measure of quality of life (QoL) was also administered to the relevant sample of patients on each occasion. Results: The psychometric properties of the NHP were good for both disease groups. As expected, both samples reported high scores on energy level, the PH sample scored high on physical functioning and the GHD sample on emotional reactions. For both samples, most of the NHP sections were able to distinguish between groups of respondents with different ratings of perceived general health. While most sections of the NHP were relatively highly correlated with the QoL measures, pain and sleep did not seem to be important predictors of QoL in either of the samples. Conclusions: The use of the NHP in adult GHD and PH populations in Brazil is not recommended as there are high-quality disease-specific measures available for each disease. However, where no disease-specific measures are available, the NHP can provide good descriptive information of the impact of disease on different patient populations.

OBJETIVO: Este estudo relata o processo de adaptação da versão brasileira do questionário QoL-AGHDA (Quality of Life - Assessment of Growth Hormone Deficiency in Adults) para pacientes com deficiência do hormônio de crescimento (DGH). MATERIAIS E MÉTODOS: A tradução adotou a metodologia de duplo painel. O questionário foi testado por intermédio de entrevistas direcionadas com 16 pacientes com DGH. No estágio final, dados de 120 pacientes com DGH (81 com teste/reteste) foram analisados para consistência interna, confiabilidade teste/reteste, validade convergente e validade entre grupos conhecidos. RESULTADOS: Os grupos de tradução foram bem-sucedidos e a versão final foi adaptada seguindo sugestões obtidas das entrevistas com os 16 pacientes. O coeficiente alfa de Cronbach foi 0,90, confiabilidade teste/reteste 0,88, escores QoL-AGHDA se correlacionaram com o NHP (p < 0,01) e também com a saúde geral relatada pelos pacientes (p < 0,01). CONCLUSÕES: A adaptação do QoL-AGHDA para a população brasileira foi bem-sucedida, e a nova versão demonstrou ser válida e confiável. OBJECTIVE: This study reports on the Brazilian Portuguese adaptation of the QoL-AGHDA (Quality of Life Assessment of Growth Hormone Deficiency in Adults) for use in adult growth hormone deficient (GHD) patients. MATERIALS AND METHODS: The translation process adopted the dual panel methodology. The questionnaire was tested through field-test interviews (16 GHD patients). In the final stage, data from 120 GHD patients (81 included in a test-retest analysis) were analyzed for internal consistency, test-retest reliability, convergent validity and validity among known groups. RESULTS: The translation panels were successful and the draft version was amended to improve the wording as a result of the field-test interviews. Cronbach's alpha was 0.90 and test-retest reliability 0.88. QoL-AGHDA scores had the expected pattern of association with NHP scale scores and QoL-AGHDA was able to differentiate significantly between patients based on patient-reported general health (p < 0.01) and QoL (p < 0.01). CONCLUSIONS: The adaptation of the QoL-AGHDA for a Brazilian population was successful and the adapted questionnaire was shown to be reliable and valid.

CNPq - Conselho Nacional de Desenvolvimento Científico e Tecnológico Diante do limitado corpo de evidências com relação à melhora da morbidade e mortalidade cardiovasculares associadas com a deficiência de hormônio de crescimento (DGH)( do ingês – GH: growth hormone ), modificações no bem-estar geral e qualidade de vida (QV) têm sido uma das maiores razões para o uso do GH em pacientes adultos com DGH. Vários estudos demonstraram melhora da QV desses pacientes tratados com GH nos últimos anos, principalmente através do questionário Quality of Life - Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA), que é utilizado como ferramenta de acompanhamento. No Brasil, somente recentemente algumas secretarias de saúde têm liberado o GH para pacientes adultos com DGH, apesar de não existir um protocolo de liberação baseado em QV. Portanto, seria de grande utilidade a validação de um questionário que pudesse ser utilizado como instrumento para orientar médicos e órgãos públicos com critérios objetivos para indicação e manutenção do tratamento com GH em adultos. Isso permitiria o uso racional do GH, um tratamento prolongado e de alto custo, como já acontece em outros países. Nosso estudo desenvolveu as etapas de validação de uma versão em português do questionário QoL-AGHDA, para utilização em adultos com DGH. O processo de tradução adotou a metodologia de duplo painel ( de indivíduos bilíngues e de indivíduos leigos ). O questionário foi testado quanto à aplicabilidade, compreensão e relevância através de entrevistas com pacientes portadores de DGH. Na etapa final, dados de 120 pacientes foram analizados quanto à consistência interna ( coeficiente alfa de Cronbach), confiabilidade por teste/reteste ( correlacionando-se os scores do questionário obtidos em 2 ocasiões diferentes), validade convergente ( correleção entre score do questionário QoL-AGHDA e de outro questionário, o Notingham Health Profile [NHP]) e validade por grupos conhecidos ( comparação dos scores dos pacientes com suas autoavaliações de saúde e QV). A adaptação do questionário para a língua portuguesa foi bem-sucedida, tendo a nova versão se mostrado válida e confiável. O coeficiente alfa de Cronbach demonstrou que todos os itens contribuíram para a escala e uma boa reprodutibilidade foi confirmada nas avaliações por teste/reteste. Também houve boa correlação com o NHP e o questionário se mostrou capaz de distinguir bem os pacientes baseados nas suas autoavaliações de saúde. Esses resultados mostram, de modo geral, que a versão brasileira do questionário QoL-AGHDA é válida e conceitualmente equivalente à versão original do Reino Unido. Concluímos que a nova versão em português do questionário QoL-AGHDA é uma medida válida e confiável da QV de pacientes com DGH, podendo ser utilizada em ensaios clínicos e na prática diária. Esse instrumento pode ajudar nas decisões clínicas quanto à terapia de reposição com GH baseada em QV para os pacientes com DGH. In face of the scarce evidence for definitive improvement in cardiovascular morbidity and mortality associated with growth hormone deficiency (GHD), the changes in well-being and quality of life have been one of the most compelling reason for the use of GH in patients with GHD. Many studies have shown improvements in quality of life of patients treated with GH in the last years, mainly using the Quality of Life - Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA) as the questionnaire follow-up instrument. In Brazil, only recently some health authorities are supplying selected adult GHD patients with GH, although still not on a protocol- based decision related to poor quality of life. Therefore, it would be quite useful to have a validated questionnaire which could be utilized as an instrument to possibly guide doctors and public organs with objective criteria concerning initiation and maintenance of GH therapy in adults. This would ultimately permit a rational use of this high cost prolonged treatment in GHD adults, as adopted in other countries. This study developed a validated adaptation of a Brazilian Portuguese version of the QoL-AGHDA for use in adult growth hormone deficient patients. The translation process adopted the dual panel methodology (bilingual and lay panels).The questionnaire was tested for applicability, comprehension, and relevance through field test interviews. In the final stage, data from 120 patients were analyzed for internal consistency (Cronbach´s alpha coefficients), test- retest reliability (correlating scores on the scales obtained from two different occasions), convergent validity (correlation between QoL-AGHDA and Nottingham Health Profile [NHP]) scores and known groups validity (comparison of scores to patient-reported general health). The adaptation of the QoL-AGHDA for a Brazilian population was successful with the adapted questionnaire shown to be reliable and valid. Cronbach´s alpha coefficients showed that all items contributed to the scale, and good reproducibility was confirmed by the test-retest assessment. Scale scores correlated well with NHP scores and the questionnaire distinguished well between patients based on their self-reported general health. These results overall show that this validated Brazilian version of the QoL-AGHDA is conceptually equivalent to the UK-English version. In conclusion, the Portuguese version of the QoL-AGHDA is a reliable and valid measure of QoL, suitable for inclusion in clinical studies and routine clinical practice. This instrument may ultimately help clinical decision concerning GH therapy based on QoL for GHD patients.

OBJECTIVE: This study reports on the Brazilian Portuguese adaptation of the QoL-AGHDA (Quality of Life Assessment of Growth Hormone Deficiency in Adults) for use in adult growth hormone deficient (GHD) patients. MATERIALS AND METHODS: The translation process adopted the dual panel methodology. The questionnaire was tested through field-test interviews (16 GHD patients). In the final stage, data from 120 GHD patients (81 included in a test-retest analysis) were analyzed for internal consistency, test-retest reliability, convergent validity and validity among known groups. RESULTS: The translation panels were successful and the draft version was amended to improve the wording as a result of the field-test interviews. Cronbach's alpha was 0.90 and test-retest reliability 0.88. QoL-AGHDA scores had the expected pattern of association with NHP scale scores and QoL-AGHDA was able to differentiate significantly between patients based on patient-reported general health (p < 0.01) and QoL (p < 0.01). CONCLUSIONS: The adaptation of the QoL-AGHDA for a Brazilian population was successful and the adapted questionnaire was shown to be reliable and valid.

The goals of this thesis are to evaluate quality of life (QoL) in adult patients with growth hormone deficiency (GHD) in relation to population normative data, to construct a preference-weighted index (utility) from a disease-specific QoL measure and to assess it in a clinical context. The study included samples from the general population and patients with GHD from four European populations: England & Wales, the Netherlands, Spain and Sweden. The country-specific patient cohorts were retrieved from KIMS (Pfizer International Metabolic Database). A questionnaire was developed that contained items from existing QoL questionnaires including, among others, Quality of Life Assessment in Growth Hormone Deficiency in Adults (QoL-AGHDA) and the EQ-5D. The QoL-AGHDA is a disease-specific measure for use in adults with GHD. The EQ-5D is a generic instrument which describes health states for which country-specific preference-based weights are available. Thus, it was possible to generate preference-weighted indices (utilities) based on data generated by both instruments. This thesis reports QoL-AGHDA normative values for the populations of England & Wales, the Netherlands, Spain and Sweden, and confirms the extent of QoL impairment in patients with GHD in comparison with the general population. Long-term GH replacement resulted in sustained improvements in overall QoL towards normative country-specific values, as well in most of the dimensions that were impaired before treatment. For use in health economic evaluations, models for generating utilities (QoL-AGHDAutility) from QoL-AGHDA were developed. It is believed that these models may facilitate medical decision making, given that they provide a tool for obtaining utilities in the absence of directly collected preference-weighted indices. QoL-AGHDAutility effectively monitored treatment effects in patients with GHD. Moreover, this study confirmed a QoL-AGHDAutility deficit before treatment and a gain after starting GH replacement. The novel aspect of the present approach was to apply preference-weighted indices derived from a disease-specific measure to assess QoL in the clinical context, together with patient demographic and clinical characteristics. The robustness of this analysis is reinforced by the fact that utilities in both general and patient populations were generated using the same methodology.

OBJECTIVES: The objectives were (1) to report the preliminary development of the Hormone Deficiency-dependent Quality of Life (HDQoL) questionnaire, a new individualized questionnaire in which respondents rate personally applicable domains for importance and impact of hormonal deficiency and its treatment; (2) to evaluate the HDQoL's psychometric properties for adults with hypopituitarism including growth hormone deficiency (GHD). METHODS: Internal consistency reliability, aspects of validity, and sensitivity to change of the HDQoL were investigated in: (1) a cross-sectional survey of 157 adults with treated or untreated GHD; (2) a randomized, placebo-controlled study of 3 months' growth hormone (GH) withdrawal from 12 of 21 GH-treated adults. RESULTS: Thirteen of the original 18 HDQoL domains were relevant and important for GH-deficient adults. The shorter 13-item HDQoL had excellent internal reliability (Cronbach's alpha coefficient = 0.914, n = 109), and was sensitive to sex differences (cross-sectional study): women perceived worse present QoL than men [t(149.8) = 2.33, P = 0.021]. The HDQoL was sensitive to change (GH-withdrawal study) with a significant between-group difference in change in domain scores for things I can do physically[t(16) = 2.47, P = 0.025, 2-tailed], patients withdrawn from GH reporting greater negative impact of hormone deficiency on this domain at end-point. Qualitative work resulted in the addition of seven new HDQoL domains, including energy and bodily pain. CONCLUSION: The HDQoL, although at an early stage of development, proved useful in identifying expected changes following GH withdrawal. The extended 20-item version is recommended for further evaluation in assessing the impact of hypopituitarism on QoL.

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.