General Spanish population normative data analysis for the EORTC QLQ-C30 by sex, age, and health condition.
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ABSTRACT: Purpose
General population normative data for the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire facilitates interpretation of data assessed from cancer patients. This study aims to present normative data of the general Spanish population.Methods/patients
Data were obtained from a prior larger study collecting EORTC QLQ-C30 norm data across 15 countries. Data were stratified by sex and age groups (18-39, 40-49, 50-59, 60-69 and > 70 years). Sex and age distribution were weighted according to population distribution statistics. Sex- and age-specific normative values were analysed separately, as were participants with versus those without health conditions. Multiple linear regression was used to estimate the association of each of the EORTC QLQ-C30 scales with the determinants age, sex, sex-by-age interaction term, and health condition.Results
In total, 1,165 Spanish individuals participated in the study. Differences were found by sex and age. The largest sex-related differences were seen in fatigue, emotional functioning, and global QOL (Quality of Life), favouring men. The largest age differences were seen in emotional functioning, insomnia, and pain, with middle-aged groups having the worst scores. Those > 60 years old scored better than those < 60 years old on all scales except for physical functioning. Participants with no health conditions scored better in all QLQ-C30 domains.Conclusions
The present study highlights differences in HRQOL between specific sex/age strata and especially between people with and without a health condition in the general Spanish population. These factors must be considered when comparing general population HRQOL data with that of cancer patients.
SUBMITTER: Arraras JI
PROVIDER: S-EPMC8404330 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND:The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 is a widely used cancer-specific questionnaire assessing 15 domains of health-related quality of life (HRQoL). Our aim was to facilitate the interpretation of scores on this questionnaire by providing Austrian normative data based on a general population sample. METHODS:The calculation of normative data was based on the EORTC QLQ-C30 data collected from an Austrian general population sample that was part of an international online panel study on the development of European normative data. Data reported herein were stratified and weighted by age and sex. Normative data were calculated for all 15 HRQoL domains of the EORTC QLQ-C30. For precise predictions of EORTC QLQ-C30 scores, a regression model based on sex, age and the presence of health conditions was built. RESULTS:The Austrian sample comprised 1002 Austrian participants (50.1% female, 51.4% when weighted by age and sex based on United Nation statistics). The mean age was 53.7?years (weighted: 47.7?years) and 53.6% (weighted: 47.4%) reported at least one health condition. Men reported better physical (Cohen's d?=?0.17) and emotional (Cohen's d?=?0.17) functioning as well as less fatigue (Cohen's d?=?0.18) and insomnia (Cohen's d?=?0.25) compared with women. Younger individuals (<?40?years) reported less dyspnea (Cohen's d?=?0.61) and pain (Cohen's d?=?0.51), whereas older individuals (?60?years) reported better emotional functioning (Cohen's d?=?0.55). CONCLUSIONS:We present Austrian normative data for the EORTC QLQ-C30. Differences by age and sex are mostly in line with the findings of other European normative studies. The Austrian population sample shows higher HRQoL and lower morbidity compared with other European countries. The normative data in this study will facilitate the interpretation of EORTC QLQ-C30 scores in oncological practice and research at a national and international level (including cross-cultural comparisons).
| S-EPMC7425034 | biostudies-literature
Project description:AimThe aim of the present study was to generate up-to-date normative data for health-related quality of life (QoL) measured with the "European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30)" in a random sample of the population in Northern Germany.MethodsWe conducted a population-based survey of a random sample of 10,000 persons aged 16 years or older. The postal questionnaire included questions regarding lifetime prevalence of common diseases and quality of life. EORTC QLQ-C30 scales were scored according to standard procedures. The results were stratified for age and sex.ResultsThe questionnaire was completed by 4,684 (47%) of 9,928 eligible persons. Mean age of the participants was 51.7 years (standard deviation: 18.5) and 57% were females. Missing values for the EORTC QLQ-C30 scales and items were sparse (minimum: 0.2%, maximum: 1.5%). Self-reported health related QoL varied by age and sex. Generally, men reported better functioning and fewer symptoms than women. In both sexes function declined and symptoms increased with increasing age. Symptoms most frequently reported were fatigue, pain and insomnia. Compared to the German reference data published in 2001 our participants scored more than 10 points higher on the latter three scales/items. The most frequently reported diseases were hypertension (36%), hyperlipidemia (26%) and arthritis (30%). Lifetime prevalence of depression was 16% in women and 11% in men.ConclusionOur study participants are representative for the German general population with regard to age, sex and education. Of special interest is the high proportion of participants reporting depression which is also mirrored by high fatigue, pain and insomnia scores. The normative data provided should be used as comparison health-related QoL data when evaluating the QoL in German cancer patients.
| S-EPMC3769241 | biostudies-literature
Project description:Background The impact of disease and treatment on the patient's overall well-being and functioning is a topic of growing interest in clinical research and practice. The aim of this study is to obtain reference data on quality of life of Croatian general population. Further, we aim to assess the impact of the disease and its primary systemic treatment on their health related quality of life (HrQoL) in multiple myeloma (MM) patients. Patients and methods Participants for the first part of the study were randomly selected from adult Croatian population. In the clinical part of the study MM patients were included as prospectively diagnosed within two years in two major Croatian haematological centres. The EORTC QLQ-C30 in both trials and QLQ-MY20 in MM patients only were applied for HrQoL assessment. Results Gender, age and place of residence have great impact on quality of life scores in Croatian population. The MM patients at the time of diagnosis have lower QLQ-C30 scores for global quality of life, functional and symptom scale scores, as well as single items. The type of disease followed by the choice of therapy options are important HrQoL determinants. Conclusions The norm values available now for Croatian population will help to interpret HrQoL for clinicians and aid in planning cancer care interventions. This study identified treatment effect consistent with those from other observational studies and provided new data on HrQoL across two different treatment choices for MM patients.
| S-EPMC6765165 | biostudies-literature
Project description:PurposeWe aimed to investigate measurement invariance (MI) in the European Organisation for research and treatment of cancer quality of life questionnaire core 30 (EORTC QLQ-C30) in a heterogeneous sample of patients with cancer.MethodsData from 12 studies within the PROFILES registry were used for secondary analyses (n = 7007). We tested MI by successive restrictions on thresholds, loadings, and intercepts across subgroups based on primary cancer sites, age, sex, time since diagnosis, and life stage, using multigroup confirmatory factor analysis (MGCFA) for ordered categorical measures. We also evaluated the impact of potentially miss-specified parameter equality across groups on latent factor means by releasing threshold and loading equality constraints for each item at a time.ResultsResults showed that the highest level of MI (invariance of thresholds, loadings, and intercepts) was found across groups based on time since diagnosis and life stage and to a lesser extent across groups based on sex, age, and primary tumor site. On item level, however, changes in the item's associated factor means were relatively small and in most cases canceled each other out to some extent.ConclusionsGiven only a few instances of non-invariance in our study, there is reason to be confident that valid conclusions can be drawn from between-group comparisons of QLQ-C30 latent means as operationalized in our study. Nonetheless, further research into MI between other subgroups for the QLQ-C30 (i.e., treatment effects and ethnicity) is warranted. We stress the importance of including MI evaluations in the development and validation of measurement instruments.
| S-EPMC8921013 | biostudies-literature
Project description:In oncology, health-related quality of life (HRQoL) data are often collected using disease-specific patient questionnaires while generic, patient-level utility data required for health economic modeling are often not collected.We developed a mapping algorithm for multiple myeloma that relates HRQoL scores from the European Organization for Research and Treatment of Cancer (EORTC) questionnaires QLQ-C30 and QLQ-MY20 to a utility value from the European QoL-5 Dimensions (EQ-5D) questionnaire. Data were obtained from 154 multiple myeloma patients who had participated in a multicenter cohort study in the UK or Germany. All three questionnaires were administered at a single time point. Scores from all 19 domains of the QLQ-C30 and QLQ-MY20 instruments were univariately tested against EQ-5D values and retained in a multivariate regression model if statistically significant. A 10-fold cross-validation model selection method was also used as an alternative testing means. Two models were developed: one based on QLQ-C30 plus QLQ-MY20 scores and one based on QLQ-C30 scores alone. Adjusted R-squared, correlation coefficients, and plots of observed versus predicted EQ-5D values were presented for both models.Mapping revealed that Global Health Status/QoL, Physical Functioning, Pain, and Insomnia were significant predictors of EQ-5D utility values. Similar results were observed when QLQ-MY20 scores were excluded from the model, except that Emotional Functioning and became a significant predictor and Insomnia was no longer a significant predictor. Adjusted R-squared values were of similar magnitude with or without inclusion of QLQ-MY20 scores (0.70 and 0.69, respectively), suggesting that the EORTC QLQ-MY20 adds little in terms of predicting utility values in multiple myeloma.This algorithm successfully mapped EORTC HRQoL data onto EQ-5D utility in patients with multiple myeloma. Current mapping will aid in the analysis of cost-effectiveness of novel therapies for this indication.
| S-EPMC4007827 | biostudies-other
Project description:BackgroundThe 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.MethodsWe 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.ResultsTwo 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.ConclusionsOur 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.
| S-EPMC8496068 | biostudies-literature
Project description:BackgroundMinimally important differences (MIDs) allow interpretation of the clinical relevance of health-related quality of life (HRQOL) results. This study aimed to estimate MIDs for all European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) scales for interpreting group-level results in brain tumor patients.MethodsClinical and HRQOL data from three glioma trials were used. Clinical anchors were selected for each EORTC QLQ-C30 scale, based on correlation (>0.30) and clinical plausibility of association. Changes in both HRQOL and the anchors were calculated, and for each scale and time period, patients were categorized into one of the three clinical change groups: deteriorated by one anchor category, no change, or improved by one anchor category. Mean change method and linear regression were applied to estimate MIDs for interpreting within-group change and between-group differences in change over time, respectively. Distribution-based methods were applied to generate supportive evidence.ResultsA total of 1687 patients were enrolled in the three trials. The retained anchors were performance status and eight Common Terminology Criteria for Adverse Events (CTCAE) scales. MIDs for interpreting within-group change ranged from 4 to 12 points for improvement and -4 to -14 points for deterioration. MIDs for between-group difference in change ranged from 4 to 9 for improvement and -4 to -16 for deterioration. Most anchor-based MIDs were closest to the 0.3 SD distribution-based estimates (range: 3-10).ConclusionsMIDs for the EORTC QLQ-C30 scales generally ranged between 4 and 11 points for both within-group mean change and between-group mean difference in change. These results can be used to interpret QLQ-C30 results from glioma trials.
| S-EPMC8328025 | biostudies-literature
Project description:BackgroundThe types of outcomes measured collected in clinical studies and those required for cost-effectiveness analysis often differ. Decision makers routinely use quality adjusted life years (QALYs) to compare the benefits and costs of treatments across different diseases and treatments using a common metric. QALYs can be calculated using preference-based measures (PBMs) such as EQ-5D-3L, but clinical studies often focus on objective clinician or laboratory measured outcomes and non-preference-based patient outcomes, such as QLQ-C30. We model the relationship between the generic, preference-based EQ-5D-3L and the cancer specific quality of life questionnaire, QLQ-C30 in patients with breast cancer. This will result in a mapping that allows users to convert QLQ-C30 scores into EQ-5D-3L scores for the purposes of cost-effectiveness analysis or economic evaluation.MethodsWe use data from a randomized trial of 602 patients with HER2-positive advanced breast cancer provided 3766 EQ-5D-3L observations. Direct mapping using adjusted, limited dependent variable mixture models (ALDVMM) is compared to a random effects linear regression and indirect mapping using seemingly unrelated ordered probit models. EQ-5D-3L was estimated as a function of the summary scales of the QLQ-C30 and other patient characteristics.ResultsA four component mixture model outperformed other models in terms of summary fit statistics. A close fit to the observed data was observed across the range of disease severity. Simulated data from the model closely aligned to the original data and showed that mapping did not significantly underestimate uncertainty. In the simulated data, 22.15% were equal to 1 compared to 21.93% in the original data. Variance was 0.0628 in the simulated data versus 0.0693 in the original data. The preferred mapping is provided in Excel and Stata files for the ease of users.ConclusionA four component adjusted mixture model provides reliable, non-biased estimates of EQ-5D-3L from the QLQ-C30, to link clinical studies to economic evaluation of health technologies for breast cancer. This work adds to a growing body of literature demonstrating the appropriateness of mixture model based approaches in mapping.
| S-EPMC8600775 | biostudies-literature
Project description:BackgroundPatients with newly diagnosed early stage prostate cancer (PCa) face a difficult choice of different treatment options with curative intention. They must consider both goals of optimising quantity and quality of life. The quality of life (QoL) is a psychometric outcome which is measured using validated questionnaires. Only few data are published concerning pre - and postoperative QoL.MethodsThis study investigated pre perative QoL of 185 patients who consecutively underwent open radical retropubic prostatectomy for organ-confined PCa to postoperative QoL of another 185 patients. The EORTC QLQ-C30, EORTC QLQPR25 module and 24 h ICS pad test were used (mean follow-up 28.6 months).ResultsThe examined symptom scores of the EORTC QLQ-PR25 were on lowest level. In the dyspnoea symptom score differences of age emerged: the amount of patients who are short of breath rose significantly in older patients after surgery (p < 0.05 paired, two-tailed student's t-test).. Lastly, the urinary symptom score was found postal-therapeutically low; this fact was age independent. The results of sexual symptom score need to be taken into consideration, since prostatectomy resulted in a significant reduction of sexual activity independent of age. All functioning scales postoperatively reached high values without significant changes (p > 0.05 student's t-test ), which implies a high QoL after surgery. A reliable and satisfying status of continence was found in our patients after retropubic prostatectomy. A high rate of patients (89.2%) would choose retropubic prostatectomy again.ConclusionRetropubic prostatectomy represents a reliable and accepted procedure in the treatment of organ-confined PCa. For the first time it could be shown that patients` QoL remained on a high level after retropubic prostatectomy. Nevertheless, the primary avoidance or postoperative therapy of erectile dysfunction should be in the focus of surgeons.
| S-EPMC3238231 | biostudies-literature
Project description:PurposeThe European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core Questionnaire (QLQ-C30) is a widely used generic self-report measure of health-related quality of life (HRQOL) for cancer patients. However, no validated voice script for interviewer-led telephone administration was previously available. The aim of this study was to develop a voice script for interviewer administration via telephone.MethodsFollowing guidelines from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) PRO Mixed Modes Good Research Practices Task Force, a randomised cross-over equivalence study, including cognitive debriefing, was conducted to assess equivalence between paper and telephone administration modes. Assuming an expected intraclass correlation coefficient (ICC) of 0.70 and a minimally acceptable level of 0.50, a sample size of 63 was required.ResultsCognitive interviews with five cancer patients found the voice script to be clear and understandable. Due to a protocol deviation in the first wave of testing, only 26 patients were available for analyses. A second wave of recruitment was conducted, adding 37 patients (n = 63; mean age 55.48; 65.1% female). Total ICCs for mode comparison ranged from 0.72 (nausea and vomiting, 95% CI 0.48-0.86) to 0.90 (global health status/QoL, 95% CI 0.80-0.95; pain, 95% CI 0.79-0.95; constipation, 95% CI 0.80-0.95). For paper first administration, all ICCs were above 0.70, except nausea and vomiting (ICC 0.55; 95% CI 0.24-0.76) and financial difficulties (ICC 0.60; 95% CI 0.31-0.79). For phone first administration, all ICCs were above 0.70.ConclusionsThe equivalence testing results support the voice script's validity for administration of the QLQ-C30 via telephone.
| S-EPMC8921039 | biostudies-literature