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Purpose The aim of this study was to explore what methods should be used to determine the minimal important difference (MID) and minimal important change (MIC) in scores for the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43. Methods In an international multi-centre study, patients with head and neck cancer completed the EORTC QLQ-HN43 before the onset of treatment (t1), three months after baseline (t2), and six months after baseline (t3). The methods explored for determining the MID were: (1) group comparisons based on performance status; (2) 0.5 and 0.3 standard deviation and standard error of the mean. The methods examined for the MIC were patients' subjective change ratings and receiver-operating characteristics (ROC) curves, predictive modelling, standard deviation, and standard error of the mean. The EORTC QLQ-HN43 Swallowing scale was used to investigate these methods. Results From 28 hospitals in 18 countries, 503 patients participated. Correlations with the performance status were |r| Conclusions For determining MIDs of the remaining scales of the EORTC QLQ-HN43, we will omit comparisons of groups based on the Karnofsky Performance Score. Other external anchors are needed instead. Distribution-based methods worked well and will be applied as a starting strategy for analyses. For the calculation of MICs, subjective change ratings, predictive modelling, and standard-deviation based approaches are suitable methods whereas ROC analyses seem to be inappropriate.

This study aimed to evaluate the conceptual structure of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) by analyzing data collected from patients with major cancers in Taiwan. The conceptual structure underlying QLQ-C30, including higher-order factors, was explored by structural equation modeling (SEM). The Taiwan Chinese version of the EORTC QLQ-C30 was used as the measuring instrument. Higher-order models, including mental health/physical health, mental function/physical burden, symptom burden/function, single latent health-related quality of life, formative symptom burden/function, and formative health-related quality of life, were tested. Study subjects included 283 patients with breast, lung, and nasopharyngeal cancers. The original QLQ-C30 multi-factorial structure demonstrated poor composite reliability of the cognitive function subscale. The formative symptom/burden model was favored by model fit indices, further supporting causal–indicator duality, but was compromised by unexpected associations between symptomatic subscales and latent factors. The formative health-related quality of life was proposed with a single second-order latent factor where symptomatic subscales remained formative. Two additional symptom measures from the formal cognitive function subscale with the formative health-related quality-of-life model were proposed as the alterative conceptual structure for the Taiwan Chinese QLQ-C30. Results of the current study represent the complete SEM approach for the EORTC QLQ-C30. The formative health-related quality-of-life model with elimination of cognitive function enhances the conceptual structure of the Taiwan Chinese version with parsimonious fit and interpretability.

Purpose: Computerized adaptive test (CAT) methods, based on item response theory (IRT), enable a patient-reported outcome instrument to be adapted to the individual patient while maintaining direct comparability of scores. The EORTC Quality of Life Group is developing a CAT version of the widely used EORTC QLQ-C30. We present the development and psychometric validation of the item pool for the first of the scales, physical functioning (PF).Methods: Initial developments (including literature search and patient and expert evaluations) resulted in 56 candidate items. Responses to these items were collected from 1,176 patients with cancer from Denmark, France, Germany, Italy, Taiwan, and the United Kingdom. The items were evaluated with regard to psychometric properties.Results: Evaluations showed that 31 of the items could be included in a unidimensional IRT model with acceptable fit and good content coverage, although the pool may lack items at the upper extreme (good PF). There were several findings of significant differential item functioning (DIF). However, the DIF findings appeared to have little impact on the PF estimation.Conclusions: We have established an item pool for CAT measurement of PF and believe that this CAT instrument will clearly improve the EORTC measurement of PF.

Introduction Differential item functioning (DIF) analyses can be used to explore translation, cultural, gender or other differences in the performance of quality of life (QoL) instruments. These analyses are commonly performed using “baseline” or pretreatment data. We previously reported DIF analyses to examine the pattern of item responses for translations of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 QoL instrument, using only data collected prior to cancer treatment. We now compare the consistency of these results with similar analyses of on-treatment and off-treatment assessments and explore whether item relationships differ from those at baseline. Methods Logistic regression DIF analyses were used to examine the translation of each item in each multi-item scale at the three time points, after controlling for the overall scale score and other covariates. The consistency of results at the three time points was explored. Results For most EORTC QLQ-C30 subscales, the DIF results were very consistent across the three time points. Results for the Nausea and Vomiting scale varied the most across assessments. Discussion The results indicated that DIF analyses were stable across each time point and that the same DIF effects were usually found regardless of the treatment status of the respondent.

The purpose of this study was to test the validity and reliability of the Taiwan Chinese translation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30, version 3) and Quality of Life Questionnaire Lung Cancer-13 (QLQ-LC13) questionnaires. Consecutively 51 patients with lung cancer undergoing active chemotherapy and 48 such patients undergoing regular follow-up completed the questionnaires. The intraclass correlation between test and retest ranged from 0.46 to 0.85 for the QLQ-C30 and was 0.76 for dyspnea for the QLQ-LC13. The kappa coefficients between test and retest ranged from 0.51 to 0.73 for single items of the QLQ-C30 and 0.49-0.68 for five of the nine items in the QLQ-LC13. The Cronbach's alpha coefficients wereor = 0.70 for all scales of the two questionnaires apart from that of cognitive functioning. The correlation coefficients between indices measuring similar dimensions of the EORTC QLQ-C30 and the SF-36 questionnaires ranged from 0.43 to 0.73, and that between the dyspnea scales of the two EORTC questionnaires was 0.70. Patients in the follow-up group revealed higher scores of global status/quality of life, and lower scores of nausea/vomiting, as also physical functioning. The questionnaires could also detect expected adverse effects of radiotherapy, cisplatin, and paclitaxel.

The objective of this study was to investigate the quality of life (QOL) impact of urinary incontinence (UI) and to examine its relationship with treatment seeking in adult Taiwanese women. We conducted a cross-section in-person questionnaire interview of 1608 adult women living in the Taipei area. The characteristics and incontinence status were recorded. A short form incontinence impact questionnaire (IIQ-7) was used to evaluate the QOL impact of UI. Multiple logistic regression analysis was used to assess the determinative factors for treatment seeking. The mean IIQ-7 score of the 205 (12.7%) women who reported urinary leakage more than once per month in the preceding 12 months was 5.0 (range: 0–19), which showed a significant correlation with the severity of incontinence (r = 0.59, p 10 in contrast to 5% of those with an IIQ-7 score ≤ (p < 0.001) had sought medical care. On multiple logistic regression analysis, perceiving UI as a disease and a higher IIQ-7 score were independent factors predicting treatment seeking. We concluded that UI is a common problem that brings substantial QOL impact to Taiwanese women. The IIQ-7 questionnaire may provide a useful measurement to quantitate the degree of QOL impact, which is largely affected by the severity and type of incontinence. Women who perceive UI as a disease and those with a higher degree of QOL impact are more likely to seek medical help. Furthermore, treatment seeking in Taiwanese women with significant UI may be more common than thought as a great majority of women with higher IIQ-7 scores had sought medical help.

The authors followed the guidelines of translation and pilot testing of the EORTC QLQ-C30 and EORTC-QLQ-H&N35 questionnaires. The questionnaires were given to 50 nasopharyngeal carcinoma patients under active treatment and 50 under follow-up at our institution from November 2000 to June 2001. A retest was conducted 2 weeks after the first interview/form completion for the follow-up group. The intraclass correlation coefficients of the two questionnaires were moderate to high in the follow-up group. Cronbach's α coefficients of all scales of the two questionnaires were ≥ 0.70 except that of cognitive functioning. Correlation of scales measuring similar dimensions of the QLQ-C30 and the SF-36 were moderate to high, while that of the QLQ-H&N35 and the QLQ-C30 and the SF-36 were moderate to low. Patients in the active treatment group had more serious acute problems due to disease and chemotherapy. Patients in the follow-up group had more serious chronic problems due to radiation therapy. We concluded that the Taiwan Chinese version of the EORTC QLQ-C30 and the EORTC QLQ-H&N35 had moderate to high test–retest reliability, high internal consistency in most scales, and could show the expected differences between patients in active treatment and follow-up group.