The EORTC core quality of life questionnaire (QLQ-C30): validity and reliability when analysed with patients treated with palliative radiotherapy

The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items. 247 patients completed the EORTC QLQ-C30 before palliative radiotherapy and 181 after palliative radiotherapy. The questionnaire was well accepted with a high completion rate in the present patient population consisting of advanced cancer patients with short life expectancy. In addition, the questionnaire was found to be useful to detect the effect of palliative radiotherapy over time. The scale reliability was excellent for all scales except the role functioning scale. Excellent criterion validity was found for the emotional functioning scale where it was correlated with GHQ-20. Performance of the questionnaire was improved after the second evaluation as compared with the first. The present study shows that the EORTC QLQ-C30 is found to be practical and valid in measuring quality of life in patients with advanced disease.     

Are frequency-induced transitions in rhythmic coordination mediated by a drop in amplitude?

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.     

The development and psychometric validation of a brain cancer quality-of-life questionnaire for use in combination with general cancer-specific questionnaires

A self-report questionnaire module consisting of 24 items, comprising 5 scales and 7 single items, has been developed for measuring health-related quality of life in patients with brain cancer. Module development proceeded through several stages, including a listing of patient, family and health care professional concerns, the writing of items, field testing in 105 patients with brain cancer and subsequent item reduction and scale construction after multitrait scaling analysis and assessment of internal consistency (Cronbach's coefficient alpha). The final version of the module exhibits reasonable test-retest stability over a period of one week. Differences in the responses between patients with recently-diagnosed and recurrent cancer and between patients with a Karnofsky Performance Score (KPS) of 50-70 and 80-100 were in the expected direction, indicating that the module of questions is responsive to differing conditions. Patients with either mental confusion, motor deficit or dysphasia indicated problems in several domains and single items as compared to patients without these neurological deficits. Thus, differences in the responses to the items in the brain cancer module appear to reflect differences in neurological status. In addition, deteriorating neurological status was accompanied by a marked increase in emotional distress, future uncertainty and motor dysfunction. A comparison of the responses in the module with the KPS and with a modified Barthel Activities of Daily Living Index (BADLI) shows moderate correlations, primarily with scales and items that pertain to motor dysfunction, while other scales (such as emotional distress, visual disorder and communication deficit) and most single items are not associated with the KPS or BADLI. Since the emotional distress scale of the module was found to be highly correlated with the emotional function scale of the EORTC QLQ-C30, it could be omitted when the module is used in combination with the QLQ-C30. This would reduce the module to a total of 20 items with four scales and seven single items. The intention is to combine this module of questions with other core or general quality-of-life questionnaires when studying patients with brain cancer in clinical trials.     

Comparison of patient and proxy EORTC QLQ-C30 ratings in assessing the quality of life of cancer patients

The aim of this study was to examine whether significant others can provide useful proxy information on the health-related quality of life (QL) of cancer patients. We examined the level and pattern of agreement between patient and proxy ratings of the EORTC QLQ-C30, the reliability and validity of both types of information, and the influence of several factors on the extent of agreement. QL ratings were obtained for 307 and 224 patient-proxy pairs (at baseline and follow-up, respectively). Agreement was moderate to good (ICC = 0.42 to 0.79). Multitrait-multimethod analysis showed good convergence and discrimination of specific QL domains. Comparison of mean scores revealed a small but systematic bias between patient and proxy ratings. The maximum level of disagreement was found at intermediate levels of QL, with smaller discrepancies noted for patients with either a relatively poor or good QL. Both patient and proxy QL ratings were reliable and responsive to changes over time. Several characteristics of the patients and their significant others were found to be associated with the level of agreement, but explained less than 15% of the variance in patient-proxy differences. In conclusion, the present findings lend support to the viability of employing significant others as proxy respondents of cancer patients' quality of life where this is necessary.     

The Functional Assessment of Cancer Therapy scale: development and validation of the general measure

PURPOSE: We developed and validated a brief, yet sensitive, 33-item general cancer quality-of-life (QL) measure for evaluating patients receiving cancer treatment, called the Functional Assessment of Cancer Therapy (FACT) scale. METHODS AND RESULTS: The five-phase validation process involved 854 patients with cancer and 15 oncology specialists. The initial pool of 370 overlapping items for breast, lung, and colorectal cancer was generated by open-ended interview with patients experienced with the symptoms of cancer and oncology professionals. Using preselected criteria, items were reduced to a 38-item general version. Factor and scaling analyses of these 38 items on 545 patients with mixed cancer diagnoses resulted in the 28-item FACT-general (FACT-G, version 2). In addition to a total score, this version produces subscale scores for physical, functional, social, and emotional well-being, as well as satisfaction with the treatment relationship. Coefficients of reliability and validity were uniformly high. The scale's ability to discriminate patients on the basis of stage of disease, performance status rating (PSR), and hospitalization status supports its sensitivity. It has also demonstrated sensitivity to change over time. Finally, the validity of measuring separate areas, or dimensions, of QL was supported by the differential responsiveness of subscales when applied to groups known to differ along the dimensions of physical, functional, social, and emotional well-being. CONCLUSION: The FACT-G meets or exceeds all requirements for use in oncology clinical trials, including ease of administration, brevity, reliability, validity, and responsiveness to clinical change. Selecting it for a clinical trial adds the capability to assess the relative weight of various aspects of QL from the patient's perspective.     

A cross-validation of the European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC QLQ-C30) for Japanese with lung cancer

The EORTC QLQ-C30 was developed in English-speaking cultures. To determine if this instrument could cross a broad cultural divide and be used in Japan, the cross-cultural validity of its Japanese version was estimated. In evaluating psychometric testing, internal consistency by Cronbach's alpha, item-discrimination by multitrait scaling analysis, and validity analysis with ECOG performance score (PS) and Karnofsky Performance Status Scale (KPS) were performed. The QLQ-C30 (version 1.0) was given to 105 patients with lung cancer. Although the response rate was low in patients with PS 4, the questionnaire was well accepted by patients with PS 0-3. The Japanese QLQ-C30 has a weak scale of role functioning in terms of item discriminative validity. It also has a weak scale of cognitive functioning in items of discriminative validity and internal consistency. However, known-groups comparison showed the expected clinical validity with PS for all the scales except for financial impact, and longitudinally clinical validity with KPS was shown in scales of cognitive functioning, fatigue, and nausea and vomiting. Multitrait scaling analysis showed that the predicted scales constituting quality of life (QOL) in the English-speaking culture were extracted from the Japanese QLQ-C30, and found to be valid in Japan, indicating its possible usefulness as an instrument that is universally applicable across cultures.     

Women's knowledge about breast cancer. Dimensions of knowledge and scale development

Evidence suggests that knowledge about breast cancer may influence secondary prevention, care-seeking behavior, and participation in treatment decision-making. Yet few standardized measures of breast cancer knowledge are in existence. Using factor analysis, this paper describes the structure of women's knowledge about breast cancer and uses that structure to develop a measurement scale. Principal axis factoring and varimax rotation yielded a nine factor solution, which accounted for 59.3% of the common variance. Interpretation of the conceptual structure of these factors suggests that knowledge is organized around breast cancer treatment, misconceptions, risk factors, symptoms, menstruation, and prevalence. Considering only those items with factor loadings of .35 and greater, and including only those factors containing three or more items, a 16-item scale, which included four factor-based subscales covering knowledge about breast cancer treatment, misconceptions, risks, and symptoms was developed. Internal consistency reliability of the total scale and of the four subscales was high (alphas = .76-.95). Using chi square analysis, it was found that levels of knowledge on the total scale and on the treatment and symptom subscales are associated with age, education, income, and history of breast cancer. Knowledge on the misconceptions subscale was associated with age, education, and income. Knowledge on the risks subscale was associated with age and education. Issues of reliability and validity of the scale as well as directions for future research in this area are discussed.     

Role of bradykinin B2 receptors in neonatal kidney growth

OBJECTIVES: As the incidence of prostate cancer in the United States exceeds 330,000 in 1997, increasingly more men are faced with treatment choices for which there is no clear approach. At every stage of disease, these treatment choices may involve clinically equivalent modalities that differ in side effects and impact upon quality of life (QOL). Comprehensive, yet efficient, questionnaires are needed to measure QOL in patients with prostate cancer. METHODS: Developed as a disease-specific adjunct to the Functional Assessment of Cancer Therapy (FACT) measurement system, a 12-item prostate cancer subscale (PCS) was developed and tested in three independent samples: a subscale development sample (n = 43), validity sample 1 (n = 34), and validity sample 2 (n = 96). The 12 items ask about symptoms and problems specific to prostate cancer. These questions are added to the general (FACT-G) instrument, thereby comprising a 47-item questionnaire. RESULTS: Internal consistency of the PCS ranged from 0.65 to 0.69, with coefficients for FACT-G subscales and aggregated scores ranging from 0.61 to 0.90. Concurrent validity was confirmed by the ability to discriminate patients by disease stage, performance status, and baseline prostate-specific antigen (PSA) level. Sensitivity to change in performance status and PSA score over a 2-month period suggested that some subscales of the FACT-Prostate (P) (including the PCS) are sensitive to meaningful clinical change. CONCLUSIONS: Our findings support use of the FACT-P as a meaningful component of QOL evaluation in men undergoing therapy for prostate cancer.     

Analysis of radiation- and 5-FU-induced inhibition of cell proliferation by an automatic colony analyser

PURPOSE: To determine the significance to patients of changes in health-related quality-of-life (HLQ) scores assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30). PATIENTS AND METHODS: A subjective significance questionnaire (SSQ), which asks patients about perceived changes in physical, emotional, and social functioning and in global quality of life (global QL) and the QLQ-C30 were completed by patients who received chemotherapy for either breast cancer or small-cell lung cancer (SCLC). In the SSQ, patients rated their perception of change since the last time they completed the QLQ-C30 using a 7-category scale that ranged from "much worse" through "no change" to "much better." For each category of change in the SSQ, the corresponding differences were calculated in QLQ-C30 mean scores and effect sizes were determined. RESULTS: For patients who indicated "no change" in the SSQ, the mean change in scores in the corresponding QLQ-C30 domains was not significantly different from 0. For patients who indicated "a little" change either for better or for worse, the mean change in scores was about 5 to 10; for "moderate" change, about 10 to 20; and for "very much" change, greater than 20. Effect sizes increased in concordance with increasing changes in SSQ ratings and QLQ-C30 scores. CONCLUSION: The significance of changes in QLQ-C30 scores can be interpreted in terms of small, moderate, or large changes in quality of life as reported by patients in the SSQ. The magnitude of these changes also can be used to calculate the sample sizes required to detect a specified change in clinical trials.     

On the validity of the California Psychological Inventory Socialization Scale: A multivariate approach.

Isolated groups homogeneous in role-taking ability and described them on dimensions of the California Psychological Inventory (CPI) Socialization (So) scale. Ss were 189 Swedish delinquent and nondelinquent 19-31 yr old males. 6 subscales were constructed by factor analysis. A latent profile analysis of responses to 18 items, selected from the subscales, yielded a low (n = 78 and a high (n = 106) socialization group. 75% of the delinquents were classified as the low group. In a discriminant analysis of subscale scores, the latent profile analysis groups were significantly separated. 5 subscale means were significantly different. Results support the validity of some of the subscales as indicators of the role-taking construct underlying the So scale. (38 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Ankle osteoarthritis scale

Although there is a wide array of outcome tools for assessing patients with symptomatic ankle arthritis, no disease-specific instrument for ankle arthritis has been shown to be reliable and valid. The purpose of this study was to develop a simple, reliable, and validated outcome measure for the clinical assessment of ankle osteoarthritis. We modified the Foot Function Index, a visual analog-based scale used to assess rheumatoid foot problems, to measure patient symptoms and functional limitations stemming from osteoarthritis of the ankle joint. Test-retest reliability and criterion and construct validity were determined for the overall Ankle Osteoarthritis Scale and its two subscales (pain and disability). Overall reliability (r=0.97; 95% confidence interval [CI], 0.94-0.99), pain subscale reliability (r=0.95; 95% CI, 0.90-0.98), and disability subscale reliability (r=0.94; 95% CI, 0.88-0.97) were excellent. Criterion validity testing of the instrument with the WOMAC (a disease-specific scale for osteoarthritis) and the SF-36 (a general health survey) showed a high degree of concordance for related subscales. Construct validity using a physical measure of ankle function demonstrated sensitivity of the instrument to the degree of joint dysfunction. Normative data were obtained from 562 individuals who were not patients (264 men and 298 women). The responses were analyzed for trends in gender, body mass index, presence of arthritis, history of fracture in relation to the response levels, and age. A small but statistically significant main effect for gender was found, with women consistently reporting higher pain, disability, and total index scores. Body mass index and arthritis were also found to correlate with response answers across the subscale and total index scores; however, these factors only accounted for 12% of the variation. The Ankle Osteoarthritis Scale is a reliable and valid self-assessment instrument that specifically measures patient symptoms and disabilities related to ankle arthritis.     

Incomplete quality of life data in randomized trials: missing items

Missing data has been a problem in many quality of life studies. This paper focuses upon the issues involved in handling forms which contain one or more missing items, and reviews the alternative procedures. One of the most widely practised approaches is imputation using the mean of all observed items in the same subscale. This, together with the related estimation of the subscale score, is based upon traditional psychometric approaches to scale design and analysis. We show that it may be an inappropriate method for many of the items in quality of life questionnaires, and would result in biased or misleading estimates. We provide examples of items and subscales which violate the psychometric foundations that underpin simple mean imputation. A checklist is proposed for examining the adequacy of simple imputation, and some alternative procedures are indicated.     

MMPI profiles in PTSD as a function of comorbidity

A sample of 135 Vietnam veteran inpatients with combat-related PTSD was sorted into three groups, depending upon the presence of concurrent psychiatric disorders: Depression (n = 68), Psychosis (n = 31), and Other (n = 36). Pairwise comparisons were made on the MMPI with respect to the validity indicators, clinical scales, four relevant Harris-Lingoes subscales, the Psychoticism content scale, and the MMPI-PTSD subscale. Results indicate variations in scale elevations as a function of comorbid diagnosis. Various items and scales appear to differentiate the Psychosis group due to greater psychopathology. In general, the results spotlight the heterogeneous aspects that comorbidity brings to PTSD assessment.     

Selective and rapid uptake of adeno-associated virus type 2 in brain

Quality of life (QL) assessments are increasingly being included in clinical trials, but their use in clinical practice is still uncommon. The objectives of this study were to investigate the feasibility of introducing individual QL assessments into the daily routine of an out-patient oncology clinic, and the potential impact of such assessments on doctor-patient communication. The study sample included six physicians and 18 of their patients from the out-patient clinic of the Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital in Amsterdam, The Netherlands. For each patient, three follow-up consultations were observed. The first visit was employed for the purpose of a baseline measurement. At the two subsequent visits, the patients were asked to complete the EORTC QLQ-C30, a standardised cancer-specific QL questionnaire. The patients' responses were computer-scored and transformed into a graphic summary. The summary included current scores as well as those elicited at the previous visit. Both the physicians and the patients received a copy of the summary just prior to the medical consultation. Completing, scoring and printing the QL data could be done during waiting room time. The availability of the summary did not lengthen the average consultation time. A small increase was noted in the average number of QL issues discussed per consultation. However, the most notable trend was the increased responsibility taken by the physicians in raising specific QL issues for discussion. When the QL summary was available, the physicians raised three times as many topics than was the case prior to its use (P < 0.05). All six physicians and the majority of patients believed that the QL summary facilitated communication, and expressed interest in continued use of the procedure. The introduction of individual QL assessments in routine out-patient oncology practice is feasible and appears to stimulate physicians to inquire into specific aspects of the health and well-being of their patients. However, given the methodological limitations of this pilot study, the results should be interpreted with caution.     

Development and validation of an attributional style questionnaire for adolescents.

We describe the development and psychometric characteristics of a new version of the Attributional Style Questionnaire (ASQ; Seligman, Abramson, Semmell, & Von Baeyer, 1979)—a version called the Attributional Style Questionnaire for Adolescents (ASQ-A)—using 3 samples (Ns = 547, 438, and 240) of Spanish secondary school students. In Study 1, the initial pool of 87 items was reduced to 54. Study 2 further analyzed the 54 scale items and revealed that the Internality, Stability, and Globality subscale scores had good reliability, good factorial construct validity, and satisfactory associations with maladaptive mood ratings. In Study 3, the regression analyses showed good and specific predictive validities of ASQ-A subscales for the attributions that the adolescents made about a particular real-life stressful situation. Study 4 showed that over an 8-month period the changes in the Stability and Globality subscales depended on the intensity of stressful life events experienced in this period. Overall, the studies revealed that the new ASQ-A served as an appropriate instrument to assess attributional style in adolescents. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Quality of life after surgical therapy of bronchogenic carcinoma

Quality of life (QL) after the "curative" resection of non-small cell bronchogenic carcinoma was assessed by patients using the EORTC QL questionnaire (QLQ) and by a psychologist using the Spitzer Index. Quality of life was assessed in 52 patients on one occasion 12 months postoperatively and in 20 patients regularly starting with a preoperative assessment. Self- and external evaluation showed a significant correlation (r = 0.41), but QL was assessed as being higher by the external observer. After surgery it was mainly affected by restrictions related to physical activities, job and household tasks, and disease symptoms, whereas limitations in emotional, social, and financial domains were found less frequently and less severely. Of the different medical (surgical procedures, tumor recurrence) and social factors (sex, marital and employment status), only tumor recurrence was determined to have a significant and negative influence on postoperative QL (P < 0.02). When compared to the preoperative assessment, QL had deteriorated on discharge from hospital but was restored within 3-6 months postoperatively in disease-free patients.     

An acculturation scale for Southeast Asians

This article reports the development of an acculturation scale for Southeast Asian immigrants. From factor analyses of responses on 13 items obtained from samples of three different Southeast Asian ethnic groups, i.e., Cambodians, Laotians, and Vietnamese, two subscales were derived: (1) proficiency in languages (land of origin versus English), and (2) language, social and food (LSF) preferences. Inter-item reliability of the scales was demonstrated for each of the three ethnic groups, with Cronbach alpha coefficients of 0.76 or above. Construct validity was also established within each of the three ethnic groups by demonstrating expected associations of the subscales with current age, years in the USA, total years of education, percentage of lifetime in the USA, and age on entering the USA. Multivariate analyses within each of the ethnic groups revealed that, once controlling for years of education, percentage of lifetime in the USA, and type of health care coverage, although not significant for the Cambodians (P = 0.08) males tended to show higher scores for the proficiency in language subscale in comparison to females. Similar multivariate analyses for the LSF preference subscale showed that although slightly higher for the males, the differences between the genders was not significant for the Cambodians (P = 0.78); both the Laotian (P = 0.23) and Vietnamese (P = 0.01) females showed higher scores in comparison to males although only just reaching significance for the Vietnamese.     

Assessment of quality of life in a multicultural cancer patient population.

Quality of life (QOL) is increasingly assessed in cancer patients. In this article, the authors examined the psychometric performance of a commonly used QOL questionnaire, the Quality of Life Questionnaire--Cancer 30 (QLQ-C30; N. K. Aaronson et al., 1993), in multiethnic cancer patients. Content validation studies in patients and clinicians identified possible new items. Multiple-group confirmatory factor analysis supported equivalent structure across ethnic groups (Caucasians and Asian/Pacific Islanders [APIs]). A higher order QOL factor appeared to directly affect functioning scales and symptom count. Exploratory factor analysis examined effects of new items. Ten factors were extracted, 6 consistent with the original instrument and 4 reflecting potentially new aspects of QOL: Positive Social Support, Coping, Existential Well-Being, and Sexuality/Intimacy. The QLQ-C30 appears appropriate for use in API cancer patients. Further work needs to ensure that it includes all important domains. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Validation of a diabetes-specific quality-of-life scale for patients with type 1 diabetes

OBJECTIVE: To validate a diabetes-specific quality-of-life scale and to assess its psychometric properties in a large sample of patients with type 1 diabetes. RESEARCH DESIGN AND METHODS: To assess the quality of diabetes care in a population-based study, a representative sample of 684 patients with type 1 diabetes was examined. A total of 657 patients (42% female; mean age 36 years; mean diabetes duration 18 years) completed the diabetes-specific quality-of-life scale (DSQOLS), which comprised 64 items on individual treatment goals (10 items), satisfaction with treatment success (10 items), and diabetes-related distress (44 items). Statistical examinations covered factor analysis, internal consistency of subscales, and construct and discriminant validity. RESULTS: Factor analysis of the 44 items on diabetes-specific burdens revealed six reliable components (Cronbach's alpha): social relations (0.88), physical complaints (0.84), worries about future (0.84), leisure time flexibility (0.85), diet restrictions (0.71), and daily hassles (0.70). All six subscales were significantly correlated with a validated well-being scale (r = -0.35 to -0.53, P < 0.001) and treatment satisfaction (r = 0.28 to 0.43, P < 0.001). Physical complaints (r = 0.24) and worries about future (r = 0.17) showed the highest correlations with HbA1c (P < 0.001). A flexible insulin therapy, a liberalized diet, the absence of late complications, and a higher social status were significantly associated with more favorable scores in different domains. CONCLUSIONS: The DSQOLS is a reliable and valid measure of diabetes-specific quality of life. The scale is able to distinguish between patients with different treatment and dietary regimens and to detect social inequities. Use of the DSQOLS for assessment of individual treatment goals as defined by the patients may be helpful to identify motivational deficits and to tailor individual treatment strategies.