International validation of the EORTC QLQ-PRT20 module for assessment of quality of life symptoms relating to radiation proctitis: a phase IV study.
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ABSTRACT:
SUBMITTER: Halkett GKB
PROVIDER: S-EPMC6116442 | biostudies-literature | 2018 Aug
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND:Given the high cure-rate for testicular cancer (TC) and the patients' young age, comprehensive evaluation of health-related quality of life (HRQOL) is an important consideration in this patient population. The EORTC QLQ-TC26 questionnaire module has been developed to supplement the EORTC QLQ-C30 in assessing TC-specific HRQOL in clinical trials and routine clinical practice. This international, multicentre phase IV validation study evaluated the psychometric properties of the new module. METHODS:This international, multicentre phase IV validation study enrolled testicular cancer patients from seven European countries. Patients completed the EORTC quality of life core questionnaire EORTC QLQ-C30 and the QLQ-TC26 at two consecutive time points and a debriefing questionnaire regarding the QLQ-TC26 after baseline assessment. Psychometric evaluation included examination of the hypothesized module scale structure, internal consistency and test-retest reliability, known-groups validity, responsiveness to change over time and cross-cultural acceptability. RESULTS:Data from 313 patients (mean age 38.6, SD 9.5) were analysed. All items exhibited a high completion rate with less than 2.4% missing values except for the sexuality items (up to 8.8%). The confirmatory factor analysis supported the hypothesised scale structure of the QLQ-TC26. Test-retest reliability was good for 8 of 12 scales (intraclass correlation: R t1|t2 ranged from 0.71-0.91) and four scales did not meet the acceptable criteria. Internal consistency was good for all twelve scales (Cronbach alpha?=?0.79-0.90), except Communication (alpha?=?0.67) and Sexual Functioning (alpha?=?0.62). The module was able to distinguish clearly between patients with differing clinical status. Responsiveness to change over time was acceptable. CONCLUSION:The EORTC QLQ-TC26 is a valid, reliable and well-accepted condition-specific questionnaire, supplementing the EORTC QLQ-C30, for the assessment of testicular cancer patients' HRQOL in clinical trials.
| S-EPMC6233273 | biostudies-literature
Project description:Hodgkin lymphoma (HL) has become 1 of the most curable cancers. Therefore, rigorous assessment of health-related quality of life (HRQoL) and symptom burden of these patients is essential to support informed clinical decisions. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group previously developed the EORTC Quality of Life Questionnaire (QLQ) Hodgkin Lymphoma 27. This paper reports the final results of an international study by the EORTC group to develop a HRQoL disease-specific measure for these patients: the EORTC QLQ-HL27. Patients with a confirmed diagnosis of HL (N = 381) were enrolled from 12 countries and completed the EORTC QLQ-C30, QLQ-HL27, and a debriefing questionnaire at baseline (any time after diagnosis). A subset completed a retest (n = 126) or responsiveness-to-change analyses (RCA) second measurement (n = 98). Psychometrics were evaluated. Confirmatory factor analysis showed an acceptable fit of the 27 items of the QLQ-HL27 on its 4 scales (symptom burden, physical condition/fatigue, emotional impact, and worries about health/functioning). Test-retest reliability, convergent validity, known-group comparisons, and RCA find satisfactory results. Symptom burden and fatigue was higher among patients on treatment (with 36%-83% reporting at least a few problems) compared with those who had completed treatment (19%-61% reporting at least a few problems). Prevalence of worries about health and functioning (reporting at least some worry) was similar for patients on treatment (51%-81%) vs those who had completed treatment (52%-78%). Implementation of the EORTC QLQ-HL27 in research and clinical applications will increase sensitivity of HRQoL assessment in patients with HL. High quality data generated through use of this questionnaire are expected to facilitate clinical decision making in the HL setting.
| S-EPMC10694520 | biostudies-literature
Project description:Interventions: Plan of Investigation
The primary objective of Phase IV of the study will be to test the scale structure, reliability and validity and cross-cultural applicability of the proctitis module (EORTC QLQ-PRT23) to be used alone or together with the EORTC Quality of Life Questionnaire (EORTC QLQ-C30) in patients who are receiving radiation therapy to their pelvic region.
Participants
Patients will be recruited from collaborating hospitals in Australia, Norway, Germany, Italy and France. This will enable the testing of the questionnaire in Anglo-Saxon countries, Northern Europe and Southern Europe.
We aim to recruit patients who have received a curative dose of radiation therapy to their pelvic region (50-70Gy). This will include tumours located in the following sites: prostate, cervix and rectum. Patients will be eligible for the study if they are receiving a radical course of pelvic irradiation (50-70 Gy) and able to converse freely in the language that the questionnaire is written. Participants will be ineligible for the study if they have previously received radiation therapy, the radiation dose prescribed is less than 50 Gy and they are participating in other Quality of Life trials that might interfere with this study.
Trial Design
This is a cross-sectional longitudinal descriptive study, which collects Quality of Life data alongside socio-demographic and clinical background data at three time points during the patients’ radiation therapy treatment. The following time points will be used to test for acute proctitis:
1.At least two (2) weeks prior to radiotherapy treatment (when they see their clinician);
2.During the first (1st) week of treatment;
3.At the end of treatment;
4.At the three (3) to six (6) months scheduled
Primary outcome(s): Proctitis symptoms will be measured using the proctitis module developed (EORTC PRT-23)
Proctitis is an unpleasant recurrent clinical syndrome that is manifest by bouts of the following symptoms: anorectal pain, profuse rectal bleeding or blood clots, explosive bowel urgency, frequent diarrhoea, profuse mucous discharge, faecal and/or mucous incontinence[Prior to radiation therapy
During first week of treatment
Completion of treatment
Post treatment (3-6 months)]
Study Design: Purpose: Screening;Duration: Longitudinal;Selection: Defined population;Timing: Prospective
| 2455292 | ecrin-mdr-crc
Project description:BackgroundThe European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire for non-muscle invasive bladder cancer (QLQ-NMIBC24) has been available and applied for some years now, but has yet to undergo a full comprehensive psychometric evaluation. The aim of this study was to investigate the psychometric properties of the Dutch version of the EORTC QLQ-NMIBC24 questionnaire in patients with low, intermediate and high risk NMIBC.MethodsWe included patients newly diagnosed with NMIBC participating in the multicenter, population-based prospective cohort studies UroLife or BlaZIB. Psychometric evaluation included examination of the structural validity, reliability (i.e. internal consistency and test-retest reliability), construct validity (i.e. divergent validity and known-groups validity), responsiveness and interpretability.ResultsA total of 1463 patients who completed the baseline questionnaire of UroLife (n = 541, response rate 50%) or BlaZIB (n = 922, response rate 58%) were included. The percentage of missing responses were low for all non-sex related scales (< 1%) and ranged between 6.9% to 50.0% for sex-related scales. More than 15% of the patients obtained the lowest possible scores on nearly each scale (floor effect). The structural validity was adequate; the confirmatory factor analysis showed satisfactory results and all items of multiple items scales had higher within- than between-scale correlations. Reliability of the questionnaire was adequate for most multiple item scales (Cronbach's α ≥ 0.70 and intraclass correlation coefficient ≥ 0.70), with exception of the scales 'malaise' and 'bloating and flatulence'. The questionnaire also showed good construct validity; it showed low correlations with the items of the EORTC core questionnaire and was able to measure differences between risk-based subgroups. The responsiveness of the questionnaire was good, but the interpretability, i.e. minimal important change, could not be determined.ConclusionsThis study shows that the measurement properties of the EORTC QLQL-NMIBC24 are good; it has a good structural validity, reliability (i.e. internal consistency and test-retest reliability), construct validity (i.e. divergent validity and known-group validity), and responsiveness. Interpretability could not be assessed. This questionnaire can be used to measure and monitor health-related quality of life of patients with NMIBC.
| S-EPMC8452806 | biostudies-literature
Project description:IntroductionThis study translated and validated the Urdu version of the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) and Brain Module (QLQ-BN20) amongst patients with primary brain tumors (PBT) in Pakistan, and assessed the correlation of QoL with resilience, depression, and anxiety.MethodsTranslation of the EORTC QLQ-C30 and QLQ-BN20 was performed as per EORTC guidelines. A survey comprising of Urdu translations of EORTC QLQ-C30, QLQ-BN20, Wagnild and Young Resilience Scale (RS-14) and Hospital Anxiety and Depression Scale was administered to patients with PBT at a tertiary care hospital in Pakistan. Reliability (via Cronbach alpha), content validity index (CVI) scores, construct validity, and inter-scale correlations were assessed.ResultsOur sample consisted of 250 patients with PBT, most commonly glioma (46.8%) and meningioma (21.2%). All patients were able to understand the Urdu translations. The Cronbach alphas for the QLQ-C30 and the QLQ-BN20 were 0.860 and 0.880, respectively. The CVI scores for clarity and relevance were high for both the EORTC QLQ-C30 (0.98 and 0.96, respectively) and the QLQ-BN20 tool (0.81 and 0.95, respectively). The global QoL domain (EORTC QLQ-C30) showed significant positive correlations with resilience (r = 0.422), and significant negative correlations with depression (r = - 0.541) and anxiety (r = - 0.502). Strong inter-scale correlations were observed between physical functioning and insomnia (r = - 0.690) and role functioning and insomnia (r = - 0.641).ConclusionOur study confirms the Urdu versions of the EORTC QLQ-C30 and QLQ-BN20 as valid clinical tools for the measurement of QoL in primary brain tumors patients within the cultural and socioeconomic context of Pakistan.
| S-EPMC8421474 | 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:BackgroundQuality of Life (QoL) of bladder cancer patients has been largely neglected. This is partly due to the lack of well-validated QoL questionnaires. The aim of this study is to examine the structural validity, reliability (i.e., internal consistency and test-retest reliability), construct validity (i.e., divergent validity and known group validity) and responsiveness of the Dutch version of the European Organisation for Research and Treatment of Cancer QoL questionnaire for muscle invasive bladder cancer (EORTC-QLQ-BLM30).MethodsPatients with newly diagnosed muscle invasive bladder cancer (MIBC) participating in the population-based 'Blaaskankerzorg In Beeld' (BlaZIB) study who completed the EORTC-QLQ-BLM30 at baseline were included. BlaZIB is a Dutch nationwide population-based prospective cohort study collecting clinical data and QoL data of bladder cancer patients. QoL is assessed with a self-administered questionnaire at four points in time: 6 weeks (baseline), 6 months, 12 months and 24 months after diagnosis. Confirmatory factor analysis and multitrait scaling analysis were used to investigate and adapt the scale structure. Reliability, construct validity and responsiveness of the revised scales were evaluated.ResultsOf the 1542 patients invited to participate, 650 patients (42.2%) completed the QLQ-BLM30 at baseline. The questionnaire's scale structure was revised into seven scales and eight single items. Internal consistency and test-reliability were adequate for most scales (Cronbach's α ≥0.70 and intraclass correlation coefficient ≥ 0.70, respectively), with the exception of the revised urostomy problem scale and abdominal bloating and flatulence scale. The questionnaire exhibited little overlap with the EORTC-QLQ-C30: all correlations were < 0.40, except for the correlation between emotional function (QLQ-C30) and future worries (QLQ-BLM30). The questionnaire was able to distinguish between patient subgroups formed on the basis of physical function, but not - as hypothesized- based on stage. Changes in health due to treatment were captured by the questionnaire, indicating that the questionnaire is responsive to change.ConclusionsThis study shows that the adapted scale structure of the EORTC-QLQ-BLM30 generally exhibits good measurement properties in Dutch patients, but needs to be validated in other languages and settings.Trial registrationBlaZIB, NL8106, www.trialregister.nl.
| S-EPMC9798594 | biostudies-literature
Project description:BACKGROUND: Quality of life is an important end point in clinical trials, yet there are few quality of life questionnaires for neuroendocrine tumours. METHODS: This international multicentre validation study assesses the QLQ-GINET21 Quality of Life Questionnaire in 253 patients with gastrointestinal neuroendocrine tumours. All patients were requested to complete two quality of life questionnaires - the EORTC Core Quality of Life questionnaire (QLQ-C30) and the QLQ-GINET21 - at baseline, and at 3 and 6 months post-baseline; the psychometric properties of the questionnaire were then analysed. RESULTS: Analysis of QLQ-GINET21 scales confirmed appropriate aggregation of the items, except for treatment-related symptoms, where weight gain showed low correlation with other questions in the scale; weight gain was therefore analysed as a single item. Internal consistency of scales using Cronbach's α coefficient was >0.7 for all parts of the QLQ-GINET21 at 6 months. Intraclass correlation was >0.85 for all scales. Discriminant validity was confirmed, with values <0.70 for all scales compared with each other.Scores changed in accordance with alterations in performance status and in response to expected clinical changes after therapies. Mean scores were similar for pancreatic and other tumours. CONCLUSION: The QLQ-GINET21 is a valid and responsive tool for assessing quality of life in the gut, pancreas and liver neuroendocrine tumours.
| S-EPMC3566824 | biostudies-other
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