The impact of generalized malignant melanoma on quality of life evaluated by the EORTC questionnaire technique

Eighty-nine patients with generalized malignant melanoma, 63% men and median age 53 years, were included in a longitudinal quality of life (QOL) study before the start of chemotherapy. QOL was assessed by the EORTC core questionnaire technique (QLQ-C36), a study-specific melanoma (MM) module and the Hospital Anxiety and Depression (HAD) scale. The questionnaires displayed good psychometric qualities and were able to document the florid symptomatology of disseminated melanoma. They were well accepted by the patients. Before treatment the patients reported a relatively low symptom burden, good physical and social functioning, moderate psychological distress and a high overall QOL rating during the past week. Fatigue and pain were the most frequent symptoms reported. The QOL measurement differentiated between subgroups of patients differing in performance status and the tumour burden. We conclude that the EORTC questionnaire technique is feasible and clinically relevant in generalized malignant melanoma patients.This study was made possible by grants from the King Gustav V Jubilee Fund, Stockholm, Sweden.     

Health-related quality of life in the oncology departments of the hospital of Navarra. The EORTC Quality of Life Group

Quality of life assessment is one of the key elements of the care that is offered to cancer patients. The aim of this work is to present the research line on quality of life that has been carried out since 1992 in the Oncology Departments of the Hospital de Navarra. These departments actively collaborate with the European Organisation of Research and Treatment of Cancer - EORTC - Quality of Life Group in creating questionnaires and also in other projects of this group. Our institution has coordinated the development process of the EORTC information module. Different EORTC questionnaires have been validated for use in our country. Quality of life studies have been carried out in the main tumour sites and in other areas, such as patients' satisfaction with care. This research line has a direct benefit on the attention that patients receive.     

A prospective comparison of quality of life measures for patients with esophageal cancer

Among the most widely used instruments to assess quality of life (QOL) in patients with cancer are the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30) and the Functional Assessment of Chronic Illness Therapy, cancer instrument (FACT-G). This study compared these approaches in patients who had undergone esophagectomy for cancer. The EORTC core questionnaire and esophageal module and the FACT-G and esophageal scale were completed by 57 patients. Missing data, relationships between QOL scales and analyses of patients preferences were examined. There were 14/2736 (0.5%) missing items from EORTC questionnaires and 45/2565 (1.8%) from FACT instruments (p < 0.01). Relationships between corresponding generic EORTC and FACT scales were average to good (r 0.57) except for the social function scale (r = 0.01). EORTC symptom scores were moderately correlated with the FACT general scale, but poorly related to the FACT esophageal scale (r < 0.28). EORTC swallowing scores were moderately correlated with all FACT scales. The FACT-E and EORTC QLQ-C30 measure assess similar generic aspects of QOL (except social function). EORTC esophageal symptom scores relate poorly to FACT esophageal scales, except for swallowing. Choice of QOL measure after esophagectomy for cancer depends upon outcomes of interest. Future studies will determine which instruments are appropriate in each context.     

Translation and validation of the Standard Chinese version of the EORTC QLQ-C30

The majority of quality of life (QOL) questionnaires have been developed and used in English-speaking or Western European countries. The aims of this study were to provide the Standard Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30 version 2.0), and evaluate its psychometric properties. The translation process included independent translation, back translation, a pilot test with gynecological cancer patients, and a review and approval by the original developers. Participants in the major study included gestational trophoblastic disease patients (n = 68), ovarian cancer patients (n = 105), and other types of gynecological cancer patients (n = 18). The average completion time of the Standard Chinese version was 8.1 ± 2.9 min. All item-subscale correlation coefficients exceeded the criterion of item-convergent validity (r > 0.40) except item 1, 5, 20, and 25, and all items correlated significantly higher with their own subscale than with other subscales except item 1, 20, and 25. The correlation coefficients among all subscales were significant but modest (r = 0.40–0.70). Seven out of nine subscales met the minimal standards of reliability (Cronbach's > 0.70). In conclusion, the Standard Chinese version of the EORTC QLQ-C30 is a valid instrument overall in assessing the QOL of Chinese gynecological cancer patients.     

Quality of life in gynecological inpatients undergoing surgery

This study investigates the changes in the quality of life (QOL) of gynecological patients undergoing surgery, and the relationship between these changes and clinical/demographic factors. Ninety patients were examined on three occasions using the Japanese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-core30 (EORTC QLQ-C30). Although the global QOL and physical function decreased before discharge, the emotional function was lowest before surgery. There was no difference between the benign and malignancy groups in most QOL subscales. With regard to the relationship between global QOL and physical function before discharge and other demographic/clinical factors, multiple regression analysis suggested that these were explained by employment status, benign/malignancy, region of tumor, chemotherapy, postoperative complication, and psychological symptoms during hospitalization.     

Quality of Life in Gynecological Inpatients Undergoing Surgery

This study investigates the changes in the quality of life (QOL) of gynecological patients undergoing surgery, and the relationship between these changes and clinical/demographic factors. Ninety patients were examined on three occasions using the Japanese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–core30 (EORTC QLQ-C30). Although the global QOL and physical function decreased before discharge, the emotional function was lowest before surgery. There was no difference between the benign and malignancy groups in most QOL subscales. With regard to the relationship between global QOL and physical function before discharge and other demographic/clinical factors, multiple regression analysis suggested that these were explained by employment status, benign/malignancy, region of tumor, chemotherapy, postoperative complication, and psychological symptoms during hospitalization.     

Validation of the FACT-BRM with interferon-α treated melanoma patients

The somatic, neurocognitive, and psychiatric side effects of biological response modifiers (BRMs) have been documented in specific patient samples. Although these side effects likely have a predictable impact on patients quality of life (QOL), no instrument currently measures the cumulative effect of the various complaints patients’ report. The current study investigated the reliability and validity of the Functional Assessment of Cancer Treatment-Biological Response Modifier (FACT-BRM) scale for measuring QOL in a sample of melanoma patients receiving interferon. Measures of distress, depression, and fatigue were also obtained using standardized, well-validated instruments. Results indicate increased symptom burden, depression, and fatigue, and decreased quality of life over 4months of IFN therapy. The FACT-BRM demonstrated good psychometrics and sensitivity to change, and thus appears to be a good instrument for measuring QOL in patients receiving BRMs.     

How quality of life data contribute to our understanding of cancer patients' experiences? A study of patients with lung cancer

A prospective study was conducted to measure quality of life in newly diagnosed lung cancer patients attending a chest clinic in a large teaching and district general hospital in a geographically defined area (northern sector of Glasgow, Scotland). Quality of life was assessed at two points in time, pre-diagnosis (baseline) and 3 months after diagnosis (follow-up) using three standard measures; the Nottingham Health Profile (NHP); the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and its lung cancer supplement (QLQ-LC13). Out of 133 lung cancer patients diagnosed during the study period, 129 patients (97%) were interviewed pre-diagnosis. Of these, only 63% of the patients had an active treatment. Ninety-six patients were alive at follow-up, of whom 82 patients were re-interviewed. Thus, only 82 patients who had complete data were used in the analysis. Comparing patients' pre-diagnosis and follow-up scores on the NHP, only sleep difficulties improved slightly. Patients reported increased perceived health problems of all other characteristics studied (energy, p = 0.0004; physical mobility, p = 0.0008). Similar results were observed on the EORTC questionnaires indicating that patients' functioning and global quality of life had decreased. The only significant improvement after 3 months was seen in patients' cough (p = 0.006). There were marked increases in hair loss (p > 0.0001), constipation (p = 0.007), and sore mouth (p = 0.0004). The findings suggest that patient-centred variables should receive sufficient consideration in the treatment of lung cancer. The study results clearly indicate that information on quality of life contributes to our understanding of patients' experiences of their cancer treatment.     

Minimal clinically important differences in the EORTC QLQ-BM22 and EORTC QLQ-C15-PAL modules in patients with bone metastases undergoing palliative radiotherapy

Purpose

Validated tools for evaluating quality of life (QOL) in patients with bone metastases include the EORTC QLQ-BM22 and QLQ-C15-PAL modules. A statistically significant difference in metric scores may not be clinically significant. To aid in their interpretation, we performed analyses to determine the minimal clinically important differences (MCID) for these QOL instruments.

Methods

Both anchor-based and distribution-based methods were used to determine the MCID among patients with bone metastases enrolled in a randomized phase III trial. For the anchor-based approach, overall QOL as measured by the QLQ-C15-PAL module was used as the anchor and only the subscales with moderate or better correlation were used for subsequent MCID analysis. In the anchor-based approach, patients were classified as improved, stable or deteriorated by the change in the overall QOL score from baseline to follow-up after 42 days. The MCID and confidence interval was then calculated for all subscales. In the distribution-based approach, the MCID was expressed as a proportion of the standard deviation and standard error measurement from the subscale score distribution.

Results

A total of 204 patients completed the questionnaires at baseline and follow-up. Only the dyspnea and insomnia subscales did not have at least moderate correlation with the overall QOL anchor. Using the anchor-based approach, 10/11 subscales had an MCID score significantly different than 0 for improvement and 3/11 subscales had a significant MCID score for deterioration. The magnitude of MCID scores was higher for improvement in comparison with deterioration. For improvement, the anchor-based approach showed good agreement with the distribution-based approach when using 0.5 SD as the MCID. However, there was greater lack of agreement between these approaches for deterioration.

Conclusion

We present the MCID scores for the EORTC QLQ-BM22 and QLQ-C15-PAL QOL instruments. The results of this study can guide clinicians in the interpretation of these instruments.

Clinical Trials Registry

NCT01248585.

     

The European Organization for Research and treatment of cancer approach to quality of life assessment: guidelines for developing questionnaire modules

The EORTC Study Group on Quality of Life (the Study Group) has adopted a modular approach to quality of life (QOL) assessment in cancer clinical trials. A core instrument—the QLQ-C30—has been designed to cover a range of QOL issues relevant to a broad spectrum of cancer patients. It is intended that this QLQ-C30 be supplemented by more specific subscales (modules) to assess aspects of QOL of particular importance to specific subgroups of patients. Since individual members of the Study Group were to be involved in module development, guidelines were required to standardize the module development process in order to ensure uniformly high quality across modules. These guidelines are presented in this paper. The term module is defined, the composition of modules is outlined, and the criteria used to develop modules are specified. The module development process, consisting of four phases (generation of relevant QOL issues, operationalization of the QOL issues into a set of items, pretesting the module questionnaire, and large-scale field-testing) is described in detail. Further, issues related to cross-cultural instrument development, and the need for monitoring the module development process from within the Study Group are discussed. Finally, experiences with developing two site-specific modules (i.e., for head and neck, and breast cancer), are presented and the extent to which the guidelines meet practical requirements is discussed. The guidelines appear to provide a practical tool for module construction, that can facilitate the development of a comprehensive system for assessing the QOL of cancer patients internationally.This work was supported, in part, by grants from the Dutch Cancer Society (NKI 90-A), the Imperial Cancer Research Fund (ICRF), and the Norwegian Cancer Society.     

夜班护理人员生活质量影响因素研究

目的 探讨夜班护理人员生活质量及其影响因素,为制定提高夜班护理人员生活质量的干预措施提供科学依据.方法 采用整群随机抽样的方法抽取某市三级甲等医院全体夜班护理人员做为调查对象,用世界卫生组织编制的生活质量测定量表(WHOQOL-BREF)中文版进行问卷调查,测定并评价其生活质量现状.结果 发放问卷398份,收回有效问卷385份,主观总体生活质量平均分为2.90分(满分为5分),主观总体健康状况平均分为2.64分(满分为5分),生活质量各领域得分分别为:生理领域(13.21±2.18)分、心理领域(13.38±2.28)分、社会关系领域(14.71±2.32)分、环境领域(11.36±2.31)分,各领域得分均低于常模,差异有统计学意义(P＜0.01).有序多分类logistic回归分析显示,生理领域的影响因素包括工作年限、睡眠时间、胃肠疾病、家庭和睦状况及饮食规律性;心理领域的影响因素包括家庭和睦状况及胃肠疾病;社会关系领域的影响因素包括工作性质、家庭和睦状况;环境领域的影响因素包括职称、睡眠时间、胃肠疾病和饮食规律性.结论 夜班护理人员的生活质量低于普通人群,应针对性地采取相应措施来提高夜班护理人员的生活质量.

Abstract：

Objective To explore the situation of quality of life ( QOL ) of nurses working in night shifts and the major factors influencing the QOL, and to provide scientific basis of the further effective intervention for the quality of life. Methods The nurses working in night shift were sampled randomly in Grade 3A-hospitals of Tianjin, and investigated using WHO Quality of Life-BREF Scale. Results Three hundred eighty five questionnaires were collected from 398 questionnaires. The average score of subjective QOL perception was 2.90 (the full score is 5), subjective health perception was 2.64 (the full score is 5). The score of physical domain of QOL was 13.21 ±2.18; psychological domain of QOL was 13.38 ±2.28; social domain of QOL was 14.71±2.32; environmental domain of QOL was 11.36±2.31, all of which were significantly lower than norm value (P<0.01). The results analyzed by ordinal logistic regression showed that the factors affecting physical domain of QOL were years of working experience, sleep time, gastrointestinal disorders, family harmony status and regular diet; the factors affecting psychological domain of QOL were family harmony status and gastrointestinal disorders; the factors affecting social domain of QOL were the nature of nursing work and family harmony status; the factors affecting environmental domain of QOL were job title, sleep time, gastrointestinal disorders and regular diet. Conclusion The QOL of nurses working in night shifts is lower than that of general people. The corresponding measures should be taken to raise the quality of life of nurses in night shifts.     

Quality of life in low-income patients with metastatic prostate cancer: Divergent and convergent validity of three instruments

Few studies have evaluated Quality Of Life (QOL) among low-income patients with cancer. Information is needed about the feasibility and psychometric characteristics of QOL instruments in these populations. The purpose of this study was to examine the convergent and discriminant relationships between scales of three QOL instruments: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC), Functional Assessment of Cancer Therapy – General (FACT), and Quality of Life Index (QLI). Participants included 110 men with metastatic prostate cancer of whom 94% were low income and 62% were African-American. Interviewers administered the questionnaires. Cronbach internal consistency reliabilities were 0.57 to 0.90 for the EORTC, 0.65 to 0.86 for the FACT, and 0.63 for the QLI. Convergent validity was supported for the EORTC and FACT scales measuring emotional, physical, and role/functional dimensions (r = 0.54 to 0.72), but not on scales measuring social function (r = 0.12). Divergent validity was supported between dissimilar scales (r = 0.14 to 0.38). Analysis with receiver operating characteristics curves provided empirical support for the EORTC and FACT as multidimensional measures. These findings suggest that, even in busy clinical settings with low literacy patients, interviewer-administered EORTC and FACT QOL instruments can provide valid and reliable information.     

General life satisfaction and domain-specific quality of life in chronic schizophrenic patients

Subjective quality of life (QOL) has often been assessed through questionnaires or structured interviews focusing on the person's satisfaction with various life domains. In particular, most QOL instruments for psychiatric patients are based on this concept. We report on a study casting some doubts on the rationale of this approach. We investigated the QOL of 48 chronic schizophrenic outpatients with a long-term disease history (at least 20 years) using a German version of the Lancashire QOL Profile. The interrelations between general life satisfaction, satisfaction with specific life domains, psychological well-being and psychopathology were studied using correlation analysis and multiple linear regression. Of the life domains assessed, only two, namely social relations and health, contributed significantly to the patients' general life satisfaction, while the others (including work, leisure, family relations and housing) did not. The subscales on psychological well-being (self-esteem, affective state) as well as psychopathology were found to be more closely associated with general life satisfaction than almost all life domains considered. The findings are discussed with regard to the specific situation of the group of patients investigated. They give indications that the life domain approach to measuring QOL has its limitations, in particular when applied to patients having adapted to a very restricted everyday life.     

Quality of life and nutritional state in patients on home enteral tube feeding

OBJECTIVE: We assessed quality of life (QOL) in patients on home enteral tube feeding (HETF). The data should contribute to ethically justified decision making. METHODS:We used a prospective cross-sectional study (study 1) in 155 consecutive patients and a prospective longitudinal study (study 2) with a follow-up of 4 mo in 56 patients. QOL was assessed by proxy rating (Karnofsky and Spitzer indices) and self-rating (European Organization for Research and Treatment of Cancer [EORTC] QLQ C30) extended by a specific module. RESULTS: In study 1, weight losses 3 mo before HETF were 10.5 +/- 8.4% and 7.9 +/- 6.3% in competent (P < 0.05) and non-competent (P < 0,05) patients, respectively. The prevalences of severe malnutrition and weight loss were 50% and 73%, respectively. When compared with EORTC reference data for a general population, QOL was lower in HETF patients. The lowest QOL was seen in non-competent patients. Nutrition status explained up to 13% of the variance in QOL. In study 2, nutrition status stabilized or increased slightly in response to HETF. This was true for competent and non-competent patients and for patients with malignant and benign diseases. Concomitantly, physical functioning improved, whereas fatigue decreased. QOL increased in response to HETF in competent and non-competent patients, and 50% of the non-competent patients became competent CONCLUSIONS: .Measures of QOL research can be used in HETF patients. QOL is reduced in patients on HETF. Part of this effect is explained by malnutrition. HETF can prevent further weight loss and improve some aspects of QOL, thus allowing physicians to focus on patients.     

Quality of life scores: An independent prognostic variable in a general population of cancer patients receiving chemotherapy

This report examines the prognostic associations between QOL scores measured by the EORTC QLQ-C30 and survival in a large heterogeneous population of cancer patients. Eight hundred and fifty-one cancer patients who were to receive chemotherapy were enrolled in two National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) antiemetic trials. All patients completed the EORTC QLQ-C30 immediately prior to their first chemotherapy. Survival data were available and obtained for 474 of 639 patients (74%). Cox's proportional hazards model was used to assess the independent impact of QOL and demographic variables on survival. Presence of metastatic disease, diagnosis of lung or ovarian cancer, ECOG performance status, global quality of life and emotional functioning were significantly associated with survival. Global QOL was predictive in all patients, in subgroups of patients with metastatic disease, with breast and lung cancer and other tumour types. In patients with low global quality of life scores, patients with low emotional functioning ratings lived longer than did patients with high emotional functioning ratings. Patients with high global QOL live significantly longer than do patients with low global QOL. The relationship between emotional functioning in patients with low global QOL and survival needs confirmation.     

The European Organization for Research and Treatment of Cancer Approach to Developing Questionnaire Modules: An Update and Overview

The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Study Group has adopted a modular approach to quality of life (QoL) assessment in cancer clinical trials. The core instrument (the EORTC QLQ-C30) covers a range of QoL issues relevant to a broad spectrum of patients with cancer. The QLQ-C30 is designed to be supplemented by more specific subscales (‘modules’) to assess aspects of QoL of particular importance to specific subgroups of patients. Since individual members of the study group were to be involved in module development, guidelines were established. The primary aim of these guidelines was to standardize the module development process in order to ensure uniformly high quality across modules. This paper gives an update of the work completed to date. First, while the guidelines proved practical for module development, producing modules that exhibit adequate levels of psychometric and cross-cultural validity, experience pointed to three areas where the guidelines required more precision. These amendments will be provided and include (1) stricter monitoring of the developmental process from within the study group, (2) the explicit requirement of involvement of the study group and (3) a more precise definition of the criteria to be fulfilled before modules are allowed to be called ‘EORTC modules’. Second, an overview of the modules currently under development or available for general use is provided. These modules include those for body image, high-dose chemotherapy, leukaemia, myeloma, palliative care and the following cancers: bladder, brain, breast, colorectal, head and neck, lung, oesophageal, ophthalmic, ovarian, pancreas and prostate. Finally, the need for the coordination of efforts in module development, both from within and outside the EORTC, is discussed. This revised version was published online in June 2006 with corrections to the Cover Date.     

Validation of the care notebook for measuring physical,mental and life well-being of patients with cancer

To measure patients QOL in the daily practice of clinical oncology, we developed and tested the Care Notebook. This instrument has 24 questions expressed in single words or short phrases to make it more acceptable to patients. The Care Notebook, EORTC QLQ-C30 and FACIT-Sp-12 were administered to 249 outpatients with cancer. Construct validity was investigated by cluster analysis and multitrait scaling analysis. The results showed that three scales (physical well-being, mental well-being, and life well-being) could explain 55 of the variance in scores. The life well-being scale could be divided into subscales of Daily Functioning, Social Functioning, and Subjective QOL. Multitrait scaling analysis confirmed convergent and discriminant validity of these scales and subscales. Internal consistency and test-retest reliability were favorable. Differences in Care Notebook scores were also consistent with differences in performance status rating (known-groups validity), and Care Notebook scores correlated with EORTC QLQ-C30 and FACT-Sp-12 scores (concurrent validity). The Care Notebook allows clinical oncologists to easily collect valid and reliable QOL information of physical, mental, and life well-being repeatedly and with minimal burden on patients.     

Infant mortality Social inequality in a Swedish city

Infant mortality rates for geographical areas of Göteborg(Gothenburg), Sweden, were studied for 78,357 infants livingin Göteborg from 1971 to 1985. During this time 637 infantdeaths occurred. The 32 parishes of Göteborg were dividedinto three groups referred to as high, medium and low incomeareas. The difference in infant mortality among the areas wasstatistically significant and increased over time. The relativerisk of Infant death was 1.8 in the medium and 2.0 in the lowcompared to the high income areas in 1981–1985. The infantmortality rate varied from 3.8 to 7.6/1000. The high incomeareas had lower death rates overall, in congenital malformationsand in perinatal conditions. The low income areas had a significantlyhigher rate of sudden infant death syndrome than the other groups.Political and administrative decentralization was implementedin Sweden in the 1980s. Local area research thus has a directrelevance for policy, planning and provision of services. Theresults reflect the social segregation, associated not onlywith economic stratification but also with differences in lifestylesand cultural environment. Further analyses are necessary toprovide Information on preventable risk factors In order todecrease the observed socio-economic differences. The resultscan, however, be used for targeting infant mortality levelsand for the allocation of resources.