Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer

This international study aimed to test the measurement properties of the updated European Organisation for Research and Treatment of Cancer (EORTC) questionnaire module for colorectal cancer, the QLQ-CR29.The QLQ-CR29 was administered with the QLQ-C30, core questionnaire, to 351 patients from seven countries. Questionnaire scaling and reliability were established and clinical and psychometric validity examined. Patient acceptability and understanding were assessed with a debriefing questionnaire.Multi-trait scaling analyses and face validity refined the module to four scales assessing urinary frequency, faecal seepage, stool consistency and body image and single items assessing other common problems following treatment for colorectal cancer. Scales distinguished between clinically distinct groups of patients and did not correlate with QLQ-C30 scales, demonstrating construct validity. The QLQ-CR29 scores were reproducible over time in stable health.The EORTC QLQ-CR29 demonstrates sufficient validity and reliability to support its use to supplement the EORTC QLQ-C30 to assess patient-reported outcomes during treatment for colorectal cancer in clinical trials and other settings.     

Assessing quality of life in patients with colorectal cancer: an update of the EORTC quality of life questionnaire

The European Organisation for Research and Treatment of Cancer (EORTC) has a portfolio of questionnaire modules to supplement the QLQ-C30 to assess patient reported outcomes in cancer clinical trials. This study updated the module for colorectal cancer. A review of the literature identified 20 articles that used the EORTC colorectal module. Eight papers did not report data from scales addressing sexual function and 8 added additional scales to assess ano-rectal function. Interviews with patients (n=79) and professionals (n=11) informed item selection, reduction and modification. A new 29 item module was devised and further patient interviews (n=120) examined its format and content validity. Patients found the new module acceptable with relevant content. The new module, the EORTC QLQ-CR29, is hypothesised as containing 6 scales and 11 single items. An international study examining its clinical and psychometric validity will be performed.     

Development and Validation of a Simplified Chinese Version of EORTC QLQ-CR38 to Measure the Quality of Life of Patients with Colorectal Cancer

Objectives: This study aimed to develop and validate the simplified Chinese version of the EORTC Quality of Life Questionnaire for Colorectal Cancer, QLQ-CR38. Methods: It was developed by the strict translation procedure of EORTC translation guidelines, including translation, back translation, a pilot test and a cultural adaptation. Three instruments (QLQ-CR38, Quality of Life Instruments for Cancer Patients-Colorectal Cancer, and Functional Assessment of Cancer Therapy-Colorectal) were used on a sample of 110 patients with colorectal cancer at the time of their admission to the hospital and 1-2 days after hospitalization, and a subsample of patients was measured a third time at discharge. The psychometric properties were evaluated by correlational analysis, multi-trait scaling analysis, factor analysis, and t tests. Results: Multi-trait scaling analysis and correlation analysis among domains and items of the three instruments showed good construct validity and criterion-related validity. Cronbach's α and the test-retest reliability coefficients were greater than 0.70 for all domains (except chemotherapy side effects, 0.44 and 0.60, respectively). All domains had statistically significant changes after treatment with the standardized response mean ranging from 0.44 to 2.47. Conclusions: The simplified Chinese version of QLQ-CR38 has good validity, reliability, and responsiveness and can be used to measure the quality of life of Chinese patients with colorectal cancer.     

The EORTC quality of life questionnaire for patients with colorectal cancer: EORTC QLQ-CR29 validation study for Spanish patients

Introduction  

The EORTC Quality of Life (QL) Group has developed a questionnaire -the EORTC QLQ-CR29- for evaluating QL in colorectal cancer. The aim of this study is to assess the psychometric properties of the EORTC QLQ-CR29 when applied to a sample of Spanish patients.     

Development of an EORTC disease-specific quality of life questionnaire for use in patients with liver metastases from colorectal cancer

Quality of life (QL) is an important outcome measure within clinical trials. This paper describes the development of a QL module for patients with liver metastases from colorectal cancer (CRC) to supplement the European Organization for Research and Treatment of Cancer (EORTC) core QL questionnaire, the EORTC QLQ-C30. Phases 1-3 of the EORTC QL Group guidelines for developing QL modules were followed. The literature search generated 71 QL issues. Semi-structured interviews with eight healthcare professionals and 47 patients from the United Kingdom, France, Germany and Austria reduced the list to 23 issues. Questionnaire items were formulated to be compatible with the EORTC QLQ-C30. The provisional module was further tested in 102 patients resulting in a 21-item module, the QLQ-LMC21 (Liver Metastases Colorectal). A combination of the core questionnaire and the QLQ-LMC21 will provide essential QL information regarding the use of treatments in both the curative and palliative settings.     

Translation and Validation of the Sinhala Version of the EORTC-QLQ-CR29 Questionnaire

Purpose: To validate the Sinhalese version of the EORTC QLQ-CR29 quality of life questionnaire for colorectal cancer. Method: We translated and pilot-tested (n=10) the questionnaire in Sri Lanka. We then assessed the reliability, factor structure and construct validity according to the EORTC guidelines. The testing was done in two tertiary care hospitals in Sri Lanka. Results: Of 110 participants, 103 (93%) returned the questionnaire, and 15 out of 20 (75%) returned the repeat-test questionnaire within a period of two weeks. Out of the original four scales three had better reliability than the original scales: urinary frequency (Cronbach α - 0.82), blood and mucus in stools (α-0.85), defaecation problems (α-0.76). The body image scale showed low reliability (α – 0.33).  However, when one of the 3 items in the scale was omitted, it showed sufficient reliability (α – 0.74). Factor analysis showed good reliability for overall assessment of the two item scale for stool frequency (α – 0.82) and six item scale for defaecation problems (α – 0.76). Correlations between the subscales of CR29 and C30 questionnaires were below 0.40, except for body image, which correlated moderately (r-0.44) with emotional functioning. This confirmed satisfactory overall construct validity  Conclusion: The scales for urinary frequency, blood and mucus in stools and defaecation problems which were reliable and had good validity. Body image scale failed to show sufficient reliability with the three-item scale and we suggest omitting one of the items to improve the overall reliability of the questionnaire. Construct validity was comparable to published data.     

Validation of EORTC IN-PATSAT 32 in Morocco: Methods and Processes

Background. The EORTC IN-PATSAT32 questionnaire was developed by the EORTC Quality of Life (QL) Group to assess the satisfaction of patients affected by cancer and hospitalized in oncology centers. The aim of this study is to assess the psychometric properties of the EORTC IN-PATSAT32 administered to Moroccan patients. Methods. A total of 133 hospitalized patients affected by cancer in different sites completed the translated EORTC IN-PATSAT32 questionnaire in oncology hospitals. The internal consistence reliability, reproducibility and construct validity were assessed. Results. The homogeneity was good for all scales with Cronbach’s coefficients from 0.72 to 0.95 for all scales. Reproducibility test-retest was very satisfactory and the intra-class correlations coefficients (ICCs) for the scales were all above 0.70 except for the single general satisfaction with a ICC of 0.67. All items were highly correlated with own rather than other scales. Conclusion. The results of this study confirm that the Moroccan Arabic version of the EORTC IN-PATSAT32 has acceptable reliability and validity, comparable to those reported for other languages.     

The EORTC Quality of Life Questionnaire for patients with prostate cancer: EORTC QLQ-PR25. Validation study for Spanish patients

Objectives  The EORTC Quality of Life (QL) Group has developed a questionnaire, the EORTC QLQ-PR25, for evaluating QL in prostate cancer. The aim of this study is to assess the psychometric properties of the EORTC QLQPR25 when applied to a sample of Spanish patients. Materials and methods  One hundred and thirty-seven prostate cancer patients with localised disease who started radiotherapy with radical intention combined with or without hormonotherapy prospectively completed the EORTC QLQ-C30 and EORTC QLQ-PR25 questionnaires three times: on the first and last day of radiotherapy and in the follow-up period. Psychometric evaluation of the questionnaires’ structure, reliability and validity was conducted. Results  Multitrait scaling analysis showed that many of the item-scale correlation coefficients met the standards of convergent and discriminant validity. Exceptions appeared mainly in the scales for bowel symptoms and for hormonal-treatment-related symptoms. Cronbach’s coefficients of the scales were good (0.72–0.86) for the urinary symptoms and sexual function scales but they were lower (<0.70) for the bowel and hormonal treatment scales. Most scales of the EORTC QLQ-PR25 had low to moderate intercorrelations. Correlations between the scales of the QLQ-C30 and the module were generally low. Group comparison analyses showed better QL in patients with higher Performance Status. Changes in QL appeared throughout the measurements. These were in line with the treatment process. Conclusions  The EORTC QLQ-PR25 was a reliable and valid instrument when applied to a sample of Spanish prostate cancer patients. These results are in line with those of the EORTC validation study.     

Clinical and psychometric validation of a questionnaire module, the EORTC QLQ-STO 22, to assess quality of life in patients with gastric cancer

The purpose of this study was to define the measurement properties and clinical validity of the European Organisation for Research and Treatment of Cancer (EORTC) questionnaire module to assess health-related quality of life (HRQL) in gastric cancer. The EORTC gastric cancer module, QLQ-STO 22, was administered with the QLQ-C30, core questionnaire, to 219 patients undergoing treatment with curative or palliative intent before and after treatment. Reliability and validity of the module was tested and patients' debriefing comments analysed. Compliance rates were high, questionnaires well accepted and less than 4% of items had missing data. Multi-trait scaling analyses and face validity refined the module to five scales and four single items. Scales distinguished between clinically distinct groups of patients and demonstrated treatment-induced changes over time. Test-retest scores demonstrated good reliability. The EORTC QLQ-STO 22 demonstrates psychometric and clinical validity that supports its use to supplement the EORTC QLQ-C30 to assess quality of life in patients with gastric cancer undergoing surgery, surgery and chemoradiotherapy, palliative chemotherapy, palliative surgery and best supportive care.     

The cognitive-spiritual dimension - an important addition to the assessment of quality of life: Validation of a questionnaire (SELT-M) in patients with advanced cancer

Questions of meaning and challenge by illness, i.e., the spiritual dimension of quality of life (QL) traditionally played an important role in anthroposophically oriented medicine and have gained importance in palliative medicine and supportive care. In the context of a research project on QL in patients with advanced cancer, we therefore investigated the psychometric properties of a questionnaire covering spiritual QL issues, with the aim of providing a module for the assessment of cognitive-spiritual QL.Patients and methods: We investigated 89 patients with advanced breast and gastro-intestinal cancer. Construct validity of a modified version of the SELT (Skalen zur Erfassung von Lebensqualität bei Tumorkranken), the SELT-M was tested by multitrait scaling analysis. Discriminant and convergent validity were also tested. The EORTC QLQ-C30 was used as a standard for validation.Results showed the SELT-M as feasible in administration. Four of the five SELT-M subscales were internally consistent (Cronbach's Alpha = >0.7). The subscale on spiritual QL showed higher within than outside subscale correlations for six of its eight items. Association of the SELT-M with the EORTC QLQ-C30 was good for the items and subscales covering the same aspects of QL in both questionnaires: emotional (Spearman r = 0.61), physical functioning (r = –0.54) and fatigue (r = –0.75). In accordance with expectations, there was no association between spiritual QL with any EORTC QLQ-C30 subscales. Self-assessed spiritual QL in the SELT-M corresponded well with interviewer assessments (test for trend accross ordered groups, P = 0.0023).Conclusions: Overall there is confirming evidence for the hypothesised structure of the SELT-M, especially for the newly developed module on spiritual QL. This module may be used as a module together with other cancer specific QL questionnaires.     

Development of an EORTC disease-specific quality of life module for use in patients with gastric cancer

Quality of life (QL) is an important outcome in clinical trials in oncology. There is currently no valid international QL measure for gastric cancer. This paper describes the development of a QL module for gastric cancer to supplement the European Organization for Research and Treatment of Cancer (EORTC) Quality of life (QLQ-C30) questionnaire. Phases I to III of module development were conducted in the United Kingdom, France, Germany and Spain according to EORTC QL Group guidelines. Twenty relevant QL issues were generated from the literature and interviews with health professionals (n=24) and patients (n=58). This produced a 24 item provisional module. Further testing in 115 patients resulted in the QLQ-STO22, containing 22 questions, conceptualised into five scales and four single items, related to disease symptoms, treatment side-effects and emotional issues specific to gastric cancer. The use of the QLQ-C30 supplemented by the QLQ-STO22 will provide a comprehensive QL measure for international trials in gastric cancer.     

Validation of the Polish version of the EORTC QLQ‐CX24 module for the assessment of health‐related quality of life in women with cervical cancer

The aim of our study was to undertake a prospective validation study of the Polish version of the EORTC cervical cancer (EORTC QLQ‐CX24) module used alongside the EORTC core measure. The translated module was pilot‐tested according to the established EORTC guidelines. Patients with histological confirmation of cervical cancer were eligible for the study. All patients filled out the Polish version of the EORTC QLQ‐CX24 module in addition to EORTC QLQ‐C30 and a demographic questionnaire. Standardised validity and reliability analyses were performed. One hundred and seventy‐one patients were enrolled into the study, mean age ± SD: 52.1 ± 9.6. Cronbach alpha coefficients, range 0.81–0.88, showed positive internal consistency. Re‐test was undertaken with 40 patients (23.4%). Interclass correlations for the EORTC QLQ‐CX24 ranged from 0.85 to 0.89 and proved appropriate test–retest reliability. Satisfactory convergent and discriminant validity in multi‐trait scaling analyses was seen. Concluding, the Polish version of the EORTC QLQ‐CX24 module is a reliable and valid tool for measuring HRQoL in patients with cervical cancer. It can be fully recommended for use in clinical and epidemiological settings in the Polish population.     

An international validation study of the EORTC QLQ-INFO25 questionnaire: An instrument to assess the information given to cancer patients

AimThe EORTC Quality of Life (QOL) Group has developed an instrument to evaluate the information received by cancer patients. This study assessed the psychometric characteristics of the EORTC INFO module in a large international/multi-cultural sample of cancer patients.MethodsThe provisional 26-item information module (EORTC INFO26) was administered with the EORTC QLQ-C30 and the information scales of the inpatient satisfaction module EORTC IN-PATSAT32 on two occasions during the patients’ treatment and follow-up period. Questionnaire-hypothesised scale structure, reliability, validity and responsiveness to changes were evaluated through standard psychometric analyses. Patient acceptability was assessed with a debriefing questionnaire.ResultsThe study comprised 509 patients from 8 countries (7 European countries and Taiwan) with different cancers and disease stages. Multi-trait scaling analysis led to the deletion of one item but confirmed the hypothesised 4 multi-item scales (information about disease, medical tests, treatment and other services) and eight single items. Internal consistency for all scales was good (α > 0.70), as was test–retest reliability (intraclass correlations > 0.70). All items can be combined to generate a single score (α > 0.90). Convergent validity was supported by significant correlations with related areas of IN-PATSAT32 (r > 0.40). Low correlations with EORTC QLQ-C30 scales confirmed divergent validity (r < 0.30) The EORTC INFO-25 module discriminated among groups based on gender, age, education, levels of anxiety and depression, information wishes and satisfaction. Only one scale captured changes over time.ConclusionsThe EORTC QLQ-INFO 25 is a reliable and valid self-reported instrument. The module can be used in cross-cultural observational and intervention studies.     

Cultural Adaptation and Validation of the Moroccan Version of the EORTC QLQ-CR29 in Patients with Colorectal Cancer

The increasing incidence of colorectal cancer in Morocco has generated a need for a disease-specific quality-of-life measuring instrument. The present study aims to translate and evaluate the reliability and validity of the Moroccan Arabic version of the EORTC QLQ-C29 measure in Moroccan subjects with colorectal cancer (CRC). Methods: Following translation to Moroccan Arabic, The QLQ-C30 and QLQ-C29 were administered to 135 patients treated for colorectal cancer (CRC) at the national oncology institute of Rabat, in the period from February 2016 to June 2018. Statistical analysis included reliability, convergent, and discriminant validity as well as known-groups comparisons. Results: (89 %) patients completed the questionnaires of the EORTC QLQ C-29 and EORTC QLQ C-30. The test –retest, administered to 25 patients and the ICCs for each item ranged from 0.61 to 0.93 indicating good to excellent reproducibility. The internal consistency coefficients for body image, urinary frequency, stool frequency scales were acceptable (Cronbach’s alpha ≥ 0.70), while the blood and mucus in the stool dimensions had lower reliability (0.65).  Multi-trait scaling analysis showed that multi-item scales met standards of convergent and discriminate validity. All Correlations between the EORTC QLQ C-29 and EORTC QLQ C-30 scores were low (r < 40). The known- group comparisons showed differences between group of patients based on tumor location and with/ without a stoma. Conclusion: The Moroccan Arabic Dialectal version of the QLQ-C 29 is a valid and reliable measure of health related quality of life (HRQOL) in patients with colorectal cancer.     

The development and utilisation of the European Organisation for research and treatment of cancer quality of life group item bank

One of the problems in assessing patients' quality of life (QL) is the availability of good robust measures that have demonstrated validity, reliability and sensitivity for changes over time, but also have been validated across a large group of culturally diverse nations. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) has recognised this and has established a substantial research programme with the aim of developing such tools, with particular relevance to cancer clinical trials. However, the management of a large set of items in multiple languages is difficult and very labour-intensive. Thus, to support the EORTC QLG research agenda, a computerised web-based database of all EORTC QLG measures and individual questionnaire items was developed. This database allows access to a pool of over 500 validated items in some 6000 translated versions. The database speeds up module development, ensures that questionnaires items have similar wording and provides rapid access to multiple translations.     

The EORTC cancer in-patient satisfaction with care questionnaire: EORTC IN-PATSAT32

Objectives  The EORTC Quality of Life (QL) Group has developed a questionnaire (the EORTC IN-PATSAT32) to assess the satisfaction of cancer inpatients with hospital-based care. In this study we assess the psychometric properties of the EORTC IN-PATSAT32 applied to a sample of Spanish patients. Materials and methods  Eighty cancer patients with different tumour sites completed the EORTC QLQ-C30 and EORTC IN-PATSAT32 questionnaires. Psychometric evaluation of the structure, reliability and validity was conducted. Results  Multitrait scaling analysis showed that most itemscale correlation coefficients met the standards of convergent and discriminant validity. Cronbach’s coefficients were good (0.77–0.97) for all scales except hospital access. Correlations between the scales and single items of the QLQ-C30 and EORTC IN-PATSAT32 were generally low. Correlations between the Oberst scales and an item on intention to recommend the hospital or ward to others with the EORTC IN-PATSAT32 were moderate. Patients with higher scores on the Oberst scales and the item on intention to recommend the hospital or ward showed higher satisfaction with care levels in all EORTC IN-PATSAT32 areas but one. Conclusions  The EORTC IN-PATSAT32 appears to be a reliable and valid instrument when applied to a sample of Spanish cancer patients. These results are in line with those of the EORTC validation study.     

肿瘤患者生命质量量表维文版测试效果评价

[目的]分析维文版EORTC QLQ-C30（V3）生命质量量表、维文版QLICP-GM（V1.0）量表的信度和效度。[方法]将EORTC QLQ-C30（V3）生命质量量表、我国自主研制的中文版QLICPGM（V1.0）量表进行翻译、回译及部分文化调适后分别产生维文量表,分别对497例在新疆维吾尔族自治区肿瘤医院住院确诊的恶性肿瘤患者进行问卷调查,分析量表的内部一致性、重测信度、内容效度、区分效度和结构效度等指标。[结果]QLICP-GM量表的内部一致性优于EORTC QLQ-C30量表,但重测信度不如EORTC QLQ-C30量表。QLICP-GM量表的内容效度、区分效度均优于EORTC QLQ-C30量表。[结论]维文版QLICP-GM量表具有良好的信度和效度,更适合应用于新疆公共卫生和其它医学领域。     

The European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life questionnaire cervical cancer module: EORTC QLQ-CX24

BACKGROUND: The authors report on the development and validation of a cervical cancer module for the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life (QoL) questionnaire (QLQ), which was designed to assess disease-specific and treatment-specific aspects of QoL in patients with cervical cancer. METHODS: The cervical cancer module (EORTC QLQ-CX24) was developed in a multicultural, multidisciplinary setting to supplement the EORTC QLQ-C30 core questionnaire. The QLQ-C30 and the cervical cancer module were administered to 346 patients with cervical cancer who underwent radical hysterectomy and received radiotherapy and chemotherapy. Psychometric analyses were performed by using data from 2 independent samples. RESULTS: The QLQ-CX24 consists of 3 multiitem scales and 5 single-item scales. Multitrait scaling analyses revealed high internal consistencies for the subscales with Cronbach alpha coefficients ranging from .72 to .87 (Symptom Experience, .72; Body Image, .86; Sexual/Vaginal Functioning, .87). Convergent and discriminant validity were fulfilled with scaling errors below 3%. The QLQ-CX24 was capable of discriminating between clinical subgroups. All items exhibited good compliance with <3% missing values. Most patients completed the EORTC QLQ-C30 and the QLQ-CX24 in <15 minutes (86%), and many did not require any assistance to complete the questionnaires (65%). CONCLUSIONS: The current psychometric analyses supported the content and construct validity and the reliability of the EORTC QLQ-CX24 module. This newly developed module is a useful instrument for assessing the QoL of patients who are treated for cervical cancer both in clinical trials and in clinical practice.     

Quality of life of head and neck cancer patient: validation of the European organization for research and treatment of cancer QLQ-C30 and European organization for research and treatment of cancer QLQ-H&N 35 in Indian patients

AIMS: To present the first cross-culture validation of the European organization for research and treatment of cancer (EORTC) quality of life questionnaires, the EORTC-QLQ-C30, and the QLQ-H&N 35 in India. SETTINGS AND DESIGN: These questionnaires were translated into two vernacular languages and pilot test was done on 15 patients. Two hundred head and neck cancer patients completed the QLQ-C30 and the QLQ-H&N 35 at two time points during their treatment. Psychometric evaluation of the structure, reliability, and validity of the questionnaire was undertaken. RESULTS: The data supports the reliability of the scales. Validity was tested by item-scale, scale--scale correlation and by performing known group comparisons. The results demonstrated that the items correlated with their respective scale and no significant correlation was found between scales. The questionnaire was responsive to change over a period of time. SUMMARY: This data suggests that the EORTC QLO-C30 and the QLQ-H&N 35 are reliable and valid questionnaires when applied to a sample of head and neck cancer patients in India.     

Validity and reliability of the MSKCC Bowel Function instrument in a sample of Italian rectal cancer patients

Aims

The purpose of this study was to translate the Memorial Sloan Kettering Cancer Centre (MSKCC) Bowel Function Instrument into Italian and to test its psychometric validity and reliability in a sample of Italian rectal cancer patients.

Methods

The MSKCC questionnaire was translated into Italian using a standard procedure of double-back translation. Construct validity was tested using a factor analysis and internal reliability was estimated using the Cronbach’s alpha coefficient. Concurrent validity was determined by correlations with European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-CR38 quality of life scales. A non-parametric analysis of variance was used to establish the discriminant validity of the questionnaire. Test-retest reliability was assessed using the intra-class correlation coefficient.

Results

124 rectal cancer patients participated in the validation study. The number of missing items was 2.2%. The factorial structure was found to be quite similar to the original one and the internal reliability was 0.7 for urgency, 0.6 for frequency, and 0.7 for dietary subscale. The test-retest reliability was acceptable with one exception: the dietary subscale showed a low reproducibility (ICC = 0.4). All three subscales showed a significant correlation with the QLQ-C30 and QLQ-CR38 domains and were able to discriminate several groups of clinical relevance.

Conclusions

The Italian version of the MSKCC Bowel Function Instrument shows acceptable psychometric properties and can be considered a valuable and specific instrument to assess bowel functions in rectal cancer patients, both for research purposes and in clinical practise.