scholarly journals Psychometric validation of the EORTC QLQ-HCC18 in patients with previously treated unresectable hepatocellular carcinoma

2021 ◽  
Author(s):  
Daniel Serrano ◽  
Lauren Podger ◽  
Gisoo Barnes ◽  
James Song ◽  
Boxiong Tang
Keyword(s):  
Hepatocellular Carcinoma ◽  
Discriminant Validity ◽  
Psychometric Validation ◽  
Life Questionnaire ◽  
Quality Of Life Questionnaire ◽  
Point Estimates ◽  
Convergent And Discriminant Validity ◽  
Previously Treated ◽  
Eortc Qlq

AbstractTo demonstrate the measurement properties of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Hepatocellular Carcinoma 18-question module (EORTC QLQ-HCC18) within a previously treated, unresectable hepatocellular carcinoma (HCC) clinical trial population that was distinct from the published QLQ-HCC18 validation population. Analyses were conducted using data from BGB-A317-208, an open label, international, clinical trial assessing efficacy and safety of the monoclonal antibody tislelizumab in adult HCC patients. The EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and QLQ-HCC18 instruments were assessed at baseline and weeks 3 and 9 follow-up visits. Per US Food and Drug Administration guidance, psychometric validation of the QLQ-HCC18 included reliability (internal consistency and test–retest), construct validity (convergent and discriminant validity and known-groups validity), ability to detect change, and meaningful within-patient change (MWPC). Known-groups validity and MWPC analyses were also stratified on several pre-defined subgroups. A total of 248 patients were included. Only the QLQ-HCC18 fatigue, nutrition, and index domains demonstrated acceptable internal consistency; acceptable test–retest reliability was found for fatigue, body image, nutrition, pain, sexual interest, and index domains. The QLQ-HCC18 fatigue domain achieved the pre-specified criterion defining acceptable convergent and discriminant validity for 13 of 16 correlations, whereas the index domain achieved the pre-specified criterion for 14 of 16 correlations. Clear differentiation of the QLQ-HCC18 change scores between improvement and maintenance anchor groups were observed for body image, fatigue, pain, and index domains, whereas differentiation between deterioration and maintenance anchor groups were observed for fever and fatigue domains. MWPC point estimates defining improvement for the QLQ-HCC18 fatigue and index domains were −7.18 and −4.07, respectively; MWPC point estimates defining deterioration were 5.34 and 3.16, respectively. The EORTC QLQ-HCC18 fatigue and index domains consistently demonstrated robust psychometric properties, supporting the use of these domains as suitable patient-reported endpoints within a previously treated, unresectable HCC patient population.

scholarly journals Psychometric Validation of the EORTC QLQ-HCC18 in Patients with Previously Treated Unresectable Hepatocellular Carcinoma

2021 ◽  
Author(s):  
Daniel Serrano ◽  
Lauren Podger ◽  
Gisoo Barnes ◽  
James Song ◽  
Boxiong Tang
Keyword(s):  
Quality Of Life ◽  
Hepatocellular Carcinoma ◽  
Concurrent Validity ◽  
Psychometric Validation ◽  
Life Questionnaire ◽  
Quality Of Life Questionnaire ◽  
Point Estimates ◽  
Previously Treated ◽  
Eortc Qlq

Abstract Purpose: Demonstrate the measurement properties of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Hepatocellular Carcinoma 18-question module (EORTC QLQ-HCC18) within a previously treated, unresectable HCC clinical trial population that was distinct from the published QLQ-HCC18 validation population. Methods: Analyses were conducted using data from BGB-A317-208, an open label, international, clinical trial of the monoclonal antibody tislelizumab in adult HCC patients. The EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and QLQ-HCC18 were assessed at baseline as well as weeks 3 and 9. Psychometric validation of the QLQ-HCC18 included reliability, construct validity, ability to detect change, and meaningful within-patient change (MWPC). Known-groups validity and MWPC analyses were also stratified on several pre-defined subpopulations. Results: A total of 248 patients were included. The QLQ-HCC18 fatigue, nutrition, and index domains demonstrated acceptable internal consistency; acceptable test-retest reliability was found for fatigue, body image, nutrition, pain, sexual interest, and index domains. The QLQ-HCC18 fatigue domain achieved acceptable concurrent validity for 13 of 16 correlations; the index domain achieved acceptable concurrent validity for 15 of 16 correlations. Clear differentiation of the QLQ-HCC18 change scores between improvement and maintenance anchor groups were observed for body image, fatigue, pain, and index domains. Differentiation between deterioration and maintenance anchor groups were observed for fever and fatigue domains. MWPC point estimates defining improvement for the QLQ-HCC18 fatigue and index domains were -7.18 and -4.07, respectively; MWPC point estimates defining deterioration were 5.34 and 3.16, respectively. Conclusions: The EORTC QLQ-HCC18 fatigue and index domains consistently demonstrated robust psychometric properties, supporting the use of these domains as suitable patient-reported endpoints within a previously treated, unresectable HCC patient population.

Disease specific quality of life instruments in multiple sclerosis: Validation of the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS)

2001 ◽  
Vol 7 (2) ◽  
pp. 119-130 ◽  
Author(s):  
S M Gold ◽  
C Heesen ◽  
H Schulz ◽  
U Guder ◽  
A Mönch ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Internal Consistency ◽  
Discriminant Validity ◽  
Life Questionnaire ◽  
Quality Of Life Questionnaire ◽  
Convergent And Discriminant Validity ◽  
Patient Groups ◽  
Disease Specific

Quality of life (QoL) is discussed as an additional outcome measure in multiple sclerosis (MS). However, few questionnaires assessing disease specific QoL in MS have been published. On the basis of the literature and interviews with clinicians and MS patients, we have developed a disease specific QoL instrument and validated it in a broad range of patients with MS. In this study, a heterogeneous sample of n=237 MS patients completed the newly developed Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS, in German language) and a battery of already validated questionnaires. They further underwent neurological scoring and objective tests. By these means, we investigated its validity, appropriateness, internal consistency, and retest reliability. Internal consistency and retest coefficients were high and satisfied psychometric standards. Convergent and discriminant validity was supported by direction, magnitude and pattern of correlations with other health measures. HAQUAMS subscales and its total score distinguished between patient groups of varied disease severity, cognitive impairment, and affective symptomatology. No floor or ceiling effects were found in either of the HAQUAMS subscales. The HAQUAMS is a reliable, valid and appropriate instrument for QoL assessment in multiple sclerosis. Data of responsiveness are currently being obtained.

Tu1693 - Translation and Psychometric Validation of the Sinhala Version of the Eortc QLQ-CR29 Quality of Life Questionnaire

2018 ◽  
Vol 154 (6) ◽  
pp. S-1353-S-1354
Author(s):  
Dakshitha Wickramasinghe ◽  
Praveen V. Dayasena ◽  
Pragathi L. Weerakkody ◽  
Sanjeewa Seneviratne ◽  
Dharmabandhu N. Samarasekera
Keyword(s):  
Quality Of Life ◽  
Psychometric Validation ◽  
Life Questionnaire ◽  
Quality Of Life Questionnaire ◽  
Eortc Qlq

scholarly journals Avaliação da Qualidade de Vida e Prevalência de Sintomas Depressivos em Pacientes Oncológicos Submetidos à Radioterapia

2020 ◽  
Vol 66 (1) ◽  
Author(s):  
Antonio Augusto Claudio Pereira ◽  
Nayara De Paula Passarin ◽  
Jordana Henriques Coimbra ◽  
Gabriela Grasso Pacheco ◽  
Marcel Pereira Rangel
Keyword(s):  
Quality Of Life ◽  
Life Questionnaire ◽  
European Organization ◽  
Quality Of Life Questionnaire ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

Introdução: A qualidade de vida de pacientes oncológicos tem sido objeto de estudo em muitos trabalhos brasileiros. Contudo, apesar da alta prevalência de indivíduos submetidos a radioterapia, poucos estudos com ênfase nesse grupo de pacientes foram identificados. Objetivo: Avaliar a qualidade de vida e a prevalência de sintomas depressivos em pacientes com neoplasias malignas durante o tratamento radioterápico. Método: Estudo transversal quantitativo realizado com 153 pacientes oncológicos em vigência de tratamento radioterápico em um centro especializado em oncologia e radioterapia, localizado no Noroeste do Estado do Parana. Os dados foram coletados entre marco e setembro de 2018. O European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) e o Inventario de Depressão de Beck foram utilizados para avaliar a qualidade de vida e os sintomas depressivos, respectivamente. Resultados: Os domínios “qualidade de vida”, “função cognitiva” e “função social” foram os que menos se mostraram prejudicados na amostra estudada, enquanto “insônia”, “perda de apetite” e “dificuldades financeiras” destacaram-se entre os maiores preditores de baixa qualidade de vida. Ademais, contatou-se que 22% dos indivíduos avaliados apresentaram algum grau de transtorno de humor, sendo 11% diagnosticados com depressão. Conclusão: O declínio na qualidade de vida e a prevalência de sintomas depressivos em pacientes oncológicos, mesmo os em vigência de radioterapia, enaltecem a importância de intervenções precoces que visem a restabelecer a funcionalidade e o bem-estar.

scholarly journals The impact of sociodemographic factors on quality of life and functional impairment in patients treated of oropharyngeal carcinoma

2019 ◽  
Vol 76 (6) ◽  
pp. 598-606
Author(s):  
Jovica Milovanovic ◽  
Dragoslava Andrejic ◽  
Ana Jotic ◽  
Vojko Djukic ◽  
Oliver Toskovic ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Oropharyngeal Cancer ◽  
Oropharyngeal Carcinoma ◽  
Life Questionnaire ◽  
European Organization ◽  
Quality Of Life Questionnaire ◽  
Hpv Status ◽  
Eortc Qlq ◽  
The Impact

Backround/Aim. Considering the distinct increase in the incidence of oropharyngeal cancer over oral cavity cancers and changing epidemiology with human papilloma virus (HPV) infection emerging as an important risk factor, there is a need to establish better treatment choices in specific groups of patients with oropharyngeal cancer. The aim of this study was to assess the quality of life (QOL) and functional performance and the impact of different demographical data, stage of disease, and treatment type on these parameters in patients with oropharyngeal cancer with successfully achieved locoregional control a year after the treatment. Methods. Study included 87 patients who underwent QOL and functional impairment assessment 12 to 14 months after finished oncological treatment with the following questionnaires: the European Organization for Research and Treatment of Cancer Quality-of Life-Questionnaire-C30 (EORTC QLQ-C30), European Organization for Research and Treatment of Cancer Quality of- Life Questionnaire-Head and Neck 35 (EORTC QLQ-H&N35) and The Karnofsky Performance Scale (KPS). Results. Specific groups of patients had significantly different post-treatment QOL scores. The factors associated with the worse QOL scores were female gender, not being in a partnership, level of education and HPV status. Conclusion. Clinicians should consider socioeconomic factors and HPV status in planning the recovery after treatment of patients with oropharyngeal carcinoma. Gender, education level and employment are the variables that form a certain risk profiles associated with the lower QOL.

scholarly journals Psychometric Validation of the German Translation of the Quality of Life Questionnaire-Bronchiectasis (QOL-B)—Data from the German Bronchiectasis Registry PROGNOSIS

2022 ◽  
Vol 11 (2) ◽  
pp. 441
Author(s):  
Laura Quellhorst ◽  
Grit Barten-Neiner ◽  
Andrés de Roux ◽  
Roland Diel ◽  
Pontus Mertsch ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Social Functioning ◽  
Emotional Functioning ◽  
Psychometric Validation ◽  
Life Questionnaire ◽  
Retest Reliability ◽  
German Translation ◽  
Quality Of Life Questionnaire ◽  
Test Retest Reliability

Patients with bronchiectasis feature considerable symptom burden and reduced health-related quality of life (QOL). We provide the psychometric validation of the German translation of the disease-specific Quality of Life Questionnaire-Bronchiectasis (QOL-B), version 3.1, using baseline data of adults consecutively enrolled into the prospective German bronchiectasis registry PROGNOSIS. Overall, 904 patients with evaluable QOL-B scores were included. We observed no relevant floor or ceiling effects. Internal consistency was good to excellent (Cronbach’s α ≥0.73 for each scale). QOL-B scales discriminated between patients based on prior pulmonary exacerbations and hospitalizations, breathlessness, bronchiectasis severity index, lung function, sputum volume, Pseudomonas aeruginosa status and the need for regular pharmacotherapy, except for Social Functioning, Vitality and Emotional Functioning scales. We observed moderate to strong convergence between several measures of disease severity and QOL-B scales, except for Social and Emotional Functioning. Two-week test-retest reliability was good, with intraclass correlation coefficients ≥0.84 for each scale. Minimal clinical important difference ranged between 8.5 for the Respiratory Symptoms and 14.1 points for the Social Functioning scale. Overall, the German translation of the QOL-B, version 3.1, has good validity and test-retest reliability among a nationally representative adult bronchiectasis cohort. However, responsiveness of QOL-B scales require further investigation during registry follow-up.

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