scholarly journals Establishing anchor-based minimally important differences (MID) with the EORTC quality-of-life measures: a meta-analysis protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e019117 ◽  
Author(s):  
Zebedee Jammbe Musoro ◽  
Jean-Francois Hamel ◽  
Divine Ewane Ediebah ◽  
Kim Cocks ◽  
Madeleine T King ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Patient Data ◽  
Disease Stage ◽  
Healthcare Intervention ◽  
Life Questionnaire ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Eortc Quality

IntroductionAs patient assessment of health-related quality of life (HRQOL) in cancer clinical trials has increased over the years, so has the need to attach meaningful interpretations to differences in HRQOL scores between groups and changes within groups. Determining what represents a minimally important difference (MID) in HRQOL scores is useful to clinicians, patients and researchers, and can be used as a benchmark for assessing the success of a healthcare intervention. Our objective is to provide an evidence-based protocol to determine MIDs for the European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 (EORTC QLQ-C30). We will mainly focus on MID estimation for group-level comparisons. Responder thresholds for individual-level change will also be estimated.Methods and analysisData will be derived from published phase II and III EORTC trials that used the QLQ-C30 instrument, covering several cancer sites. We will use individual patient data to estimate MIDs for different cancer sites separately. Focus is on anchor-based methods. Anchors will be selected per disease site from available data. A disease-oriented and methodological panel will provide independent guidance on anchor selection. We aim to construct multiple clinical anchors per QLQ-C30 scale and also to compare with several anchor-based methods. The effects of covariates, for example, gender, age, disease stage and so on, will also be investigated. We will examine how our estimated MIDs compare with previously published guidelines, hence further contributing to robust MID guidelines for the EORTC QLQ-C30.Ethics and disseminationAll patient data originate from completed clinical trials with mandatory written informed consent, approved by local ethical committees. Our findings will be presented at scientific conferences, disseminated via peer-reviewed publications and also compiled in a MID ‘blue book’ which will be made available online on the EORTC Quality of Life Group website as a free guideline document.

scholarly journals Minimally important differences for the EORTC QLQ-C30 in prostate cancer clinical trials

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Eva M. Gamper ◽  
Jammbe Z. Musoro ◽  
Corneel Coens ◽  
Jean-Jacques Stelmes ◽  
Claudette Falato ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Clinical Trials ◽  
Group Differences ◽  
Life Questionnaire ◽  
Change Over Time ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Over Time

Abstract Background The aim of the study was to estimate the minimally important difference (MID) for interpreting group-level change over time, both within a group and between groups, for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scores in patients with prostate cancer. Methods We used data from two published EORTC trials. Clinical anchors were selected by strength of correlations with QLQ-C30 scales. In addition, clinicians’ input was obtained with regard to plausibility of the selected anchors. The mean change method was applied for interpreting change over time within a group of patients and linear regression models were fitted to estimate MIDs for between-group differences in change over time. Distribution-based estimates were also evaluated. Results Two clinical anchors were eligible for MID estimation; performance status and the CTCAE diarrhoea domain. MIDs were developed for 7 scales (physical functioning, role functioning, social functioning, pain, fatigue, global quality of life, diarrhoea) and varied by scale and direction (improvement vs deterioration). Within-group MIDs ranged from 4 to 14 points for improvement and − 13 to − 5 points for deterioration and MIDs for between-group differences in change scores ranged from 3 to 13 for improvement and − 10 to − 5 for deterioration. Conclusions Our findings aid the meaningful interpretation of changes on a set of EORTC QLQ-C30 scale scores over time, both within and between groups, and for performing more accurate sample size calculations for clinical trials in prostate cancer.

scholarly journals Smartphone Sensors for Monitoring Cancer-Related Quality of Life: App Design, EORTC QLQ-C30 Mapping and Feasibility Study in Healthy Subjects

2019 ◽  
Vol 16 (3) ◽  
pp. 461 ◽  
Author(s):  
Sabina Asensio-Cuesta ◽  
Ángel Sánchez-García ◽  
J. Alberto Conejero ◽  
Carlos Saez ◽  
Alejandro Rivero-Rodriguez ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Life Questionnaire ◽  
European Organization ◽  
Daily Monitoring ◽  
Phone Calls ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

Quality of life (QoL) indicators are now being adopted as clinical outcomes in clinical trials on cancer treatments. Technology-free daily monitoring of patients is complicated, time-consuming and expensive due to the need for vast amounts of resources and personnel. The alternative method of using the patients’ own phones could reduce the burden of continuous monitoring of cancer patients in clinical trials. This paper proposes monitoring the patients’ QoL by gathering data from their own phones. We considered that the continuous multiparametric acquisition of movement, location, phone calls, conversations and data use could be employed to simultaneously monitor their physical, psychological, social and environmental aspects. An open access phone app was developed (Human Dynamics Reporting Service (HDRS)) to implement this approach. We here propose a novel mapping between the standardized QoL items for these patients, the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and define HDRS monitoring indicators. A pilot study with university volunteers verified the plausibility of detecting human activity indicators directly related to QoL.

United States Utility Algorithm for the EORTC QLU-C10D, a Multiattribute Utility Instrument Based on a Cancer-Specific Quality-of-Life Instrument

2021 ◽  
pp. 0272989X2110035
Author(s):  
Dennis A. Revicki ◽  
Madeleine T. King ◽  
Rosalie Viney ◽  
A. Simon Pickard ◽  
Rebecca Mercieca-Bebber ◽  
...  
Keyword(s):  
Quality Of Life ◽  
United States ◽  
Emotional Functioning ◽  
Health State ◽  
Life Questionnaire ◽  
Multiattribute Utility ◽  
Value Set ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

Background The EORTC QLU-C10D is a multiattribute utility measure derived from the cancer-specific quality-of-life questionnaire, the EORTC QLQ-C30. The QLU-C10D contains 10 dimensions (physical, role, social and emotional functioning, pain, fatigue, sleep, appetite, nausea, bowel problems). The objective of this study was to develop a United States value set for the QLU-C10D. Methods A US online panel was quota recruited to achieve a representative sample for sex, age (≥18 y), race, and ethnicity. Respondents undertook a discrete choice experiment, each completing 16 choice-pairs, randomly assigned from a total of 960 choice-pairs. Each pair included 2 QLU-C10D health states and duration. Data were analyzed using conditional logistic regression, parameterized to fit the quality-adjusted life-year framework. Utility weights were calculated as the ratio of each dimension-level coefficient to the coefficient for life expectancy. Results A total of 2480 panel members opted in, 2333 (94%) completed at least 1 choice-pair, and 2273 (92%) completed all choice-pairs. Within dimensions, weights were generally monotonic. Physical functioning, role functioning, and pain were associated with the largest utility weights. Cancer-specific dimensions, such as nausea and bowel problems, were associated with moderate utility decrements, as were general issues such as problems with emotional functioning and social functioning. Sleep problems and fatigue were associated with smaller utility decrements. The value of the worst health state was 0.032, which was slightly greater than 0 (equivalent to being dead). Conclusions This study provides the US-specific value set for the QLU-C10D. These estimated health state scores, based on responses to the EORTC QLQ-C30 questionnaire, can be used to evaluate the cost-utility of oncology treatments.

Psychometric properties of the EORTC Quality of Life Questionnaire in inpatient cancer rehabilitation in Germany

2004 ◽  
Vol 2 (2) ◽  
pp. 115-124 ◽  
Author(s):  
JÖRG DIRMAIER ◽  
SILKE ZAUN ◽  
UWE KOCH ◽  
TIMO HARFST ◽  
HOLGER SCHULZ
Keyword(s):  
Quality Of Life ◽  
Psychometric Properties ◽  
Cancer Patients ◽  
Scale Structure ◽  
Cancer Rehabilitation ◽  
Life Questionnaire ◽  
European Organization ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

Objective: Recent years have shown an increase in the use of questionnaires measuring health-related quality of life to verify the quality of treatment in the field of oncology. An often used cancer-specific questionnaire is the “Quality of Life Core Questionnaire of the European Organization for the Research and Treatment of Cancer” (EORTC QLQ-C30). The purpose of this study is to analyze the psychometric properties of the EORTC QLQ-C30 (version 1) in order to determine the feasibility and appropriateness for its use in inpatient cancer rehabilitation in Germany with heterogeneous diagnoses.Methods: The questionnaire was administrated to a sample of 972 cancer patients at the beginning of treatment and to 892 patients after treatment. Besides descriptive analysis, the statistical analyses include confirmatory analysis and the multitrait/multimethod approach to test the questionnaire's postulated scale structure (factorial validity) and its reliability (internal consistencies). The analysis also includes a comparison of responsiveness indices (effect size, reliable change index) to test the sensitivity of the instrument.Results: The EORTC QLQ-C30 showed satisfactory levels of reliability and sensitivity, but the postulated scale structure could not be confirmed. The results illustrate that the varimax-rotated solution of a principal component analysis does not confirm the scale structure postulated by the authors. Correspondingly, the selected fit indices within the scope of the confirmatory factor analysis do not show satisfactory results either.Significance of results: We therefore consider version 1 of the EORTC QLQ-C30 to be only limitedly useful for the routine assessment of changes in the quality of life of cancer patients in inpatient rehabilitation in Germany, especially because of the instrument's length and possible redundancies. For this reason, a scoring procedure limited to a subset of items is suggested, revealing satisfactory to good psychometric indices. However, further psychometric tests are necessary, especially with regard to validity and sensitivity.

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 Qualidade de Vida Relacionada à Saúde de Pacientes com Câncer de Mama: Revisão Integrativa da Literatura

2020 ◽  
Vol 66 (1) ◽  
Author(s):  
Monique Binotto ◽  
Gilberto Schwartsmann
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Cáncer De Mama ◽  
Life Questionnaire ◽  
European Organization ◽  
Quality Of Life Questionnaire ◽  
Cancer Breast ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

Introdução: O câncer de mama pode alterar a qualidade de vida relacionada à saúde das pacientes. Objetivo: Compreender o impacto da quimioterapia para câncer de mama na qualidade de vida relacionada à saúde de pacientes. Método: Trata-se de uma revisão integrativa da literatura, compreendendo artigos publicados entre 2007 e 2019, disponíveis nas bases de dados PubMed, LILACS e SciELO. Analisaram-se 25 artigos na íntegra. Resultados: Os questionários mais frequentemente utilizados nos estudos foram o European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) e o módulo complementar European Organization for Research and Treatment of Cancer Breast Cancer-specific Quality of Life Questionnaire (EORTC QLQ-BR23). Em relação às alterações da qualidade de vida, a saúde global diminui durante a quimioterapia, mas pode melhorar após o término do tratamento. O aumento dos sintomas é relatado em diversos estudos e prejudicou a qualidade de vida relacionada à saúde das pacientes. Entretanto, os sintomas diminuem após o término da quimioterapia, exceto para algumas escalas. As escalas de imagem corporal, função sexual e funcionamento físico pioram ao longo do tratamento. A qualidade de vida mental/psicológica tem oscilações durante o tratamento, assim como a escala sobre as relações sociais. Conclusão: A qualidade de vida relacionada à saúde de mulheres com câncer de mama é afetada negativamente pelo tratamento quimioterápico, expressando maior impacto nas escalas de sintomas.

Test/retest study of the European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire.

1995 ◽  
Vol 13 (5) ◽  
pp. 1249-1254 ◽  
Author(s):  
M J Hjermstad ◽  
S D Fossa ◽  
K Bjordal ◽  
S Kaasa
Keyword(s):  
Quality Of Life ◽  
Cancer Patients ◽  
Reliability And Validity ◽  
Life Questionnaire ◽  
European Organization ◽  
Retest Reliability ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Test Retest Reliability

PURPOSE The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is a well-validated instrument that assesses health-related quality of life (HRQOL) in cancer patients. It is used in cancer clinical trials in Europe, Canada, and the United States, and has demonstrated high reliability and validity in different groups of cancer patients. Despite thorough testing of reliability and validity, we have not identified any reports on its test/retest reliability; thus, a test/retest study was performed at the Norwegian Radium Hospital (NRH). MATERIALS AND METHODS Cancer patients from the outpatient clinic who were off treatment for > or = 3 months were eligible for the study. The EORTC QLQ-C30 was given to the patients when they presented for their visit. The second questionnaire was received by the patients 4 days later. Of 291 eligible patients, 270 (93%) agreed to participate and 190 (73%) completed both questionnaires. RESULTS The test/retest reliability measured by Pearson's correlation coefficient was high for all functional scales, with a range from .82 for cognitive and role function to .91 for physical function. The r value for global HRQOL was .85. For the symptom scales--nausea/vomiting, fatigue, and pain--the coefficients were .63, .83, and .86, respectively. The single-item coefficients ranged from .72 for diarrhea to .84 for financial impact. The Spearman rank correlation was in the same range for all dimensions. CONCLUSION The EORTC QLQ-C30 seems to yield high test/retest reliability in patients with various cancer diagnoses whose condition is not expected to change during the time of measurement.

scholarly journals Quality of life among Ethiopian cancer patients

2020 ◽  
Vol 28 (11) ◽  
pp. 5469-5478
Author(s):  
Yemataw Wondie ◽  
Andreas Hinz
Keyword(s):  
Quality Of Life ◽  
Cancer Patients ◽  
Depression Scale ◽  
Developed Countries ◽  
Anxiety And Depression ◽  
Life Questionnaire ◽  
European Organization ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

Abstract Purpose Cancer is of increasing prevalence in less-developed countries. However, research on the patients’ quality of life (QoL) in these countries is very limited. The aim of this study was to examine QoL of cancer patients in Africa. Method A sample of 256 cancer patients treated in an Ethiopian hospital was examined with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire EORTC QLQ-C30, the Multidimensional Fatigue Inventory, and the Hospital Anxiety and Depression Scale. A group of 1664 German cancer patients served as a comparison group. Results Most of the scales of the EORTC QLQ-C30 showed acceptable reliability in the Ethiopian sample. Compared with the German cancer patients, the Ethiopian patients showed lower QoL in most dimensions, especially in financial difficulties, physical functioning, pain, and appetite loss (effect sizes between 0.52 and 0.75). Illiteracy, tumor stage, and treatment (surgery and chemotherapy) were associated with QoL in the Ethiopian sample. QoL was strongly correlated with fatigue, anxiety, and depression. Conclusion The EORTC QLQ-C30 is a suitable instrument for measuring QoL in Ethiopia. The detriments in QoL in the Ethiopian patients indicate specific cancer care needs for the patients in a developing country.

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