Validity,reliability and clinical relevance of EORTC QLQ-C30 and LC13 in patients with chest malignancies in a palliative setting

Aims To evaluate the reliability and validity of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and LC13 questionnaire in a palliative setting, and to undertake a broad clinical evaluation of the questionnaire. Patients One hundred and twelve patients with advanced lung cancer or pleural mesothelioma, not amenable to curative or life-prolonging treatment, were consecutively included. Methods Construct validity and reliability of the EORTC questionnaire were examined by multitrait analysis and internal consistency. Criterion validity was examined by variance by and correlation with an array of clinical measures, including tumour stage, performance status, 6-min walk test, spirometry, and blood tests. Concurrent validity was evaluated by established scales for emotional distress and pain. Results With the exception of cognitive functioning, reliability and construct validity of the QLQ-C30 was confirmed. Criterion and concurrent validity was supported for most of the functioning and symptom scales. In a multivariate stepwise regression analysis, EORTC physical functioning was predicted by performance status and 6-min walk distance (r ² = .70), emotional functioning by HADS anxiety ratings (r ² = .59), and global quality of life by performance status, HADS depression ratings, and FEV1 %predicted (r ² = .50). Conclusion The results support the validity and clinical relevance and of the EORTC questionnaire in a palliative setting.     

Listen to their answers! Response behaviour in the measurement of physical and role functioning

Background Quality of life (QoL) is considered to be an indispensable outcome measure of curative and palliative treatment. However, QoL research often yields findings that raise questions about what QoL measurement instruments actually assess and how the scores should be interpreted. Objective To investigate how patients interpret and respond to questions on the EORTC-QLQ-C30 over time and to find explanations to account for counterintuitive findings in QoL measurement. Methods Qualitative investigation was made of the response behaviour of small-cell lung cancer patients (n = 23) in the measurement of QoL with the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). Focus was on physical functioning (PF, items 1 to 5), role functioning (RF, items 6 and 7), global health and QoL rating (GH/QOL, items 29 and 30). Interviews were held at four points: at the start of the chemotherapy, 4 weeks later, at the end, and 6 weeks after the end of chemotherapy. Patients were asked to ‘think aloud’ when filling in the questionnaire. Results Patients used various response strategies when answering questions about problems and limitations in functioning, which impacted the accuracy of the scale. Patients had scores suggesting they were less limited than they actually were by taking the wording of questions literally, by guessing their functioning in activities that they did not perform, and by ignoring or excluding certain activities that they could not perform. Conclusion Terminally ill patients evaluate their functioning in terms of what they perceive to be normal under the circumstances. Their answers can be interpreted in terms of change in the appraisal process (Rapkin and Schwartz 2004; Health and Quality of Life Outcomes, 2, 14). More care should be taken in assessing the quality of a set of questions about physical and role functioning.     

Repeatability of a Rasch Model of the AQ20 over Five Assessments

Rasch analysis is now used widely to assess the measurement properties of health status questionnaires. This study tested the stability of the AQ20 – a dichotomous-response measure of health status in asthma, using parameters estimated by a Rasch model. One hundred forty-four asthma patients completed the AQ20 on five occasions over 3 months. At visit 1, two items showed significant misfit and were deleted. At each visit, the overall mean item–person and item–trait interaction statistics from the remaining 18 items (AQ18) were very similar. The repeatability of the item calibrations was excellent (intraclass correlation coefficient 0.95), despite the patients’ health having changed (repeated-measures ANOVA: FEV₁ and AQ18 score p<0.0001). Tests of differential item functioning (DIF) over time showed that one item increased in severity. This item refers to ability to garden, and changes in response patterns could be related to seasonal changes over the study period. We conclude that this study has highlighted the usefulness of multiple repeat assessments which allow items to be tested for DIF over time. This is important as inclusion of ‘time-dependent’ items in a questionnaire may reduce the reliability of the instrument.     

Quality of life and pain in Chinese lung cancer patients: Is optimism a moderator or mediator?

Objective To clarify if optimism exerts a primarily moderating or mediating influence on the pain–QoL association in Chinese lung cancer patients. Methods About 334 Chinese lung cancer patients were interviewed at baseline during the first outpatient visit (Baseline), at 4 months after Baseline (FU1), and at 8 months after Baseline (FU2). Respondents completed the Chinese version of the FACT-G version-3 scale (FACT-G (Ch)). Optimism and pain were assessed using two 11-point self-rated items. Linear mixed effects (LME) models tested the moderating and mediating effects of optimism on QoL. Results Optimism, pain, and QoL were most strongly correlated at FU1. LME models failed to show any moderating effect by optimism on the pain–QoL association (standardized β = −0.049, 95% CI −0.097 to 0.001). After adjustment for age, cancer stage, and disease recurrence, a modest mediating effect was observed for optimism on the pain–QoL association over the duration of the study (standardized β = 0.047; Sobel test z = −4.317, p<0.001). Conclusions Optimism qualifies as a mediator between pain and QoL suggesting that pessimistic lung cancer patients are likely to experience greater QoL decrements in response to pain in the early post-diagnostic period. Effective pain control may be enhanced by inclusion of interventions that facilitate optimistic perspectives in patients. This study lends further support to the view that lung cancer patients’ psychological needs are important in both pain control and QoL.     

Self-efficacy,adjustment style and well-being in breast cancer patients: a longitudinal study

Purpose  

As many patients experience distress after breast cancer, we investigated whether perceived self-efficacy predicts breast cancer patients’ emotional, physical and social well-being and whether mental adjustment styles mediate this association.     

Measurement accuracy in assessing patient’s quality of life: to weight or not to weight domains of quality of life

Purpose  Health-related quality of life (HRQOL) measures typically do not incorporate patients’ preferences for domains such as physical, emotional, functional and social/family well-being, which may compromise precision. Method  A forced-choice domain-preference measure was developed to assess the importance of HRQOL domains. About 194 cancer patients completed the domain-preference measure, along with measures of HRQOL, coping, adjustment, and life satisfaction. Results  Patients ranked emotional well-being as most important and the loss of social-family well-being as the most difficult to do without. A weighting algorithm revealed no advantage to incorporating individuals’ domain preferences in HRQOL assessment; however, preliminary evidence suggested that HRQOL measurement may be more accurate in predicting outcomes for individuals with no distinct domain preferences than those with distinct preference profiles. Conclusion  This study provides preliminary evidence for the validity of current measures of HRQOL, which may inherently take into account patients’ domain preferences.     

How to reveal disguised paternalism

In a Swedish setting physicians are unlikely to give explicitly paternalistic reasons when asked about their attitudes towards patients’ involvement in decision-making. There is considerable risk that they will disguise their paternalism by giving ‘socially correct answers’. We suggest that disguised paternalism can be revealed with the help of indexes based on certain responses in postal questionnaires. The indexes were developed using material from a study examining attitudes of Swedish physicians to physician-assisted suicide (PAS). Apart from being asked about their attitudes, they were asked to prioritise between different arguments for and against PAS. One argument for PAS was: “PAS should be permitted out of respect for patients’ autonomy”. One argument against PAS was: “PAS should not be permitted since the non-maleficence principle in this case takes precedence over respecting patients’ autonomy”. Responses to the latter argument formed the cornerstone of a disguised-paternalism index, while an autonomy index was based on answers to the former argument. Applying our indexes to data from the PAS survey, we found that female GPs, surgeons, and older male physicians were least paternalistic. Among female physicians one finds both the most autonomy-respecting groups (female surgeons and GPs) and the least autonomy-respecting groups (female oncologists and psychiatrists); together with older male physicians in general, female GPs are the group displaying least disguised paternalism. We suggest that questionnaires exploring paternalism might be improved by including case-specific questions or statements by which to explore disguised paternalism. Here our indexes might be useful tools.     

Conceptual equivalence and health-related quality of life: an exploratory study in Japanese and Dutch cancer patients

Research into the equivalence of Western and Japanese conceptualizations of health-related quality of life (HR-QOL) is scarce. We used the Western (European Organization for Research and Treatment of Cancer, EORTC-QLQ-C30) and the Japanese (HRQoL-20) questionnaire in order to analyze the conceptual similarity of HR-QOL factors, and the associations between specific symptom items with overall HR-QOL in Japanese (n = 265) and Dutch (n = 174) patients with various types of cancer. Both populations completed both instruments. In both patient groups, the overall health scale of the EORTC-QLQ-C30 correlated highly (r = 0.59; p < 0.001) with the HRQOL-20 composite average score, indicating substantial conceptual comparability. Relationships between all EORTC-QLQ-C30 symptom items with HR-QOL were examined by ranking their correlations with the two overall measures of HR-QOL. Comparable patterns in the Japanese and Dutch samples were observed. The results suggest a considerable conceptual equivalence of HR-QOL in Japanese and Dutch cancer patients, and indicate a satisfactory structural and cross-cultural equivalence for the EORTC-QLQ-C30 with regard to items measuring functioning and specific symptoms. Longitudinal studies are needed to examine the impact of specific symptoms on general quality of life.     

Utility-based Quality of Life Measures in Alzheimer’s Disease

Objectives: To explore whether Alzheimer’s disease patients could rate their quality of life (QOL) using utility-based health indexes, and to provide new knowledge about the measurement properties of these instruments for patient and caregiver proxy ratings. Methods: A convenience sample of 60 mild-moderate AD patients and their caregivers were randomized to complete the Quality of Well-Being Scale (QWB), Health Utilities Index (HUI3) or EQ-5D and visual analogue scale (VAS) on two occasions. Test–retest reliability (intraclass correlation coefficients) and convergent validity (Spearman correlations) of utility scores with global health status, activities of daily living, comorbidity, mood, cognition and other utility measures were assessed. Results: Completion time was shortest for the combined EQ-5D and VAS. For patients with mild dementia and for proxies, reliability was ≥ 0.70 for the EQ-5D, QWB and HUI3. The EQ-5D had a ceiling effect for patient ratings. Convergent validity was demonstrated for patient and proxy ratings, with the strongest validity for EQ-5D ratings and the weakest validity for HUI3 patient ratings. Mean patient utility scores were significantly higher than mean proxy scores for all measures (p<0.001). Conclusions: For patient and proxy ratings, the EQ-5D had the best combination of measurement properties, although it had a substantial ceiling effect for patient ratings. Proxy QOL ratings did not accurately reflect patients’ ratings.     

A partnership in like-minded thinking-generating hopefulness in persons with cancer

A conceptual model of a partnership in ‘like-minded thinking’ consists of the following components: a relationship, a shared goal with mutual agreement to work toward that goal, and reciprocal encouragement between two people. A like-minded alliance is a relationship that offers support while at the same time encourages hope and establishes a reciprocating emotional attitude of hopefulness. The discussion focuses on the principles of such a model that is designed primarily as a lay intervention for anyone who has a close friend with cancer and who wants to assist the friend in maintaining a hopeful attitude in the face of illness. While this model is not directed at healthcare professionals it may be transferable into psychosocial interventions to assist persons toward sustaining hopefulness in the context of the cancer trajectory. Much has been written in the literature about how hopelessness spawns despair for individuals who have cancer and in those near the end of life; it may even create a desire for hastened death (Breitbart W., Heller K.S.: 2003, ‘Reframing Hope: Meaning-Centered Care for Patients Near the End of Life’. Journal of Palliative Medicine 6, 979–988; Jones J.M., Huggins M.A., Rydall A.C., Rodin G.M.: 2003, ‘Symptomatic distress, hopelessness, and the desire for hastened death in hospitalized cancer patients’, Journal of Psychosomatic Research 55, 411–418). Therefore, the aim of this paper is to explore how like-minded thinking for a person with cancer and his or her support person provides a framework for a personal shared worldview that is hope-based, meaningful and coherent.     

Reliability, validity and responsiveness of the German Short Musculoskeletal Function Assessment Questionnaire in patients undergoing surgical or conservative inpatient treatment

Objective: The patient-based evaluation of outcome is gaining increased importance. The aim of the study was to demonstrate the reliability, validity and responsiveness of the German version of the Short Musculoskeletal Function Assessment Questionnaire (SMFA-D) in patients undergoing surgical or conservative treatment. Methods: Three hundred and thirty-two patients suffering from osteoarthritis of the hip or knee, rheumatoid arthritis or rotator cuff tear undergoing surgical or medical inpatient treatment were followed up for 12 month. Patients underwent both SMFA-D and other assessments and clinical as well as radiological examinations. Reliability, validity and responsiveness of the SMFA-D were evaluated. Results: Values of the SMFA-D subscales, Function index (M 22–49, SD 12–20, range 0–96) and Bother index (M 29–52, SD 15–23, range 0–100), showed a normal distribution. Internal consistency (0.88–0.97) and retest reliability (0.71–0.96) coefficients were satisfactory to excellent. In most cases, the SMFA-D correlated significantly with function tests, physicians’ function ratings, patients’ pain ratings and other quality-of-life questionnaires in all patient subgroups. The results support both the construct and criterion validity of the measure. Different patient groups and subgroups could be discriminated with the SMFA-D scales. The standardized response means of SMFA-D subscales were in surgical patients better than in conservatively treated patients and comparable to those of the SF-36 Physical Component Summary scale. Conclusions: The German version of SMFA is a reliable, valid and responsive questionnaire in patients with osteoarthritis of the hip or knee, rheumatoid arthritis or rotator cuff tear undergoing surgical or medical inpatient treatment. Thus, the use of the SMFA-D in these patients can be recommended.     

Survival-weighted health profile for long-term survivors of acute myelogenous leukemia

The objective of this study was to use survival-weighted psychometric scores (SWPS) to construct a health profile for long-term survivors of acute myelogenous leukemia (AML). The study cohort included all patients who had been diagnosed and treated in our institution from 1985 to 1999 and achieved complete remission after standard chemotherapy (n = 259). One hundred and four patients were interviewed by the European Organization for the Research and Treatment of Cancer (EORTC)-QLQ-C30 questionnaire and the brief form of World Health Organization quality of life questionnaire (WHOQOL-BREF) to estimate the quality of life (QOL) function of the cohort. Forty-one patients underwent bone marrow transplantation (BMT) as consolidation or salvage therapy; 63 received chemotherapy alone. SWPS for every functioning domain and symptom item was obtained by direct integration of the mean QOL function with the survival function of the cohort. A Monte Carlo method was used to extrapolate the life-long SWPS beyond the follow-up limit. The mean scores of EORTC-QLQ-C30 and WHOQOL-BREF did not differ significantly between patients who received BMT or those who received chemotherapy only (p > 0.01). In mean SWPS, patients who received BMT had significantly (p < 0.01) better SWPS in all of the functioning domains and symptom items of EORTC-QLQ-C30 and all four domains of WHOQOL-BREF. However, when the life-long extrapolation of SWPS was made, these differences diminished in global health and several symptom items of EORTC-QLQ-C30 as well as in the social and environmental domains of WHOQOL-BREF. Patients' perspective on QOL may be domain-specific and may evolve over time. SWPS may be useful to evaluate the efficacy of different treatment strategies for AML. Confirmation of the relative merit of BMT vs. chemotherapy alone from prospective studies is needed.     

Brazilian version of the QLQ-LC13 lung cancer module of the European Organization for Research and Treatment of Cancer: preliminary reliability and validity report

This study reports the reliability and validity of the Brazilian Portuguese version of QLQ-LC13. After translation and cross-cultural adaptation, the questionnaire was administered, together with the QLQ-C30 core questionnaire, to 82 patients with lung cancer. The analysis was based on 60 patients who completed two interviews, and who received chemotherapy alone or in combination with radiotherapy. The reliability or internal consistency of dyspnea scale was 0.79. The pain scale needed to be combined with the QLQ-C30 pain items to reach a satisfactory value of 0.73. The construct validity was supported by the ability of the questionnaire to discriminate patients regarding their performance status and type of treatment. However, the change over time, although in the expected direction for all items, was statistically significant in four of the 10 items studied. The criterion-related validity was supported by the statistically significant correlation between all four side effect items and the physicians’ reports of toxicity, while the evolutive changes in the performance status were statistically significant in only four items. Most psychometric properties of the Brazilian version of the QLQ-LC13 were adequately supported in this analysis. However, a wider utilization of this module is necessary to fully ascertain its reliability and validity properties.     

Different perceptions of the burden of upper GI endoscopy: an empirical study in three patient groups

Background Few studies have evaluated patients’ perceived burden of cancer surveillance tests. Cancer screening and surveillance, however, require a large number of patients to undergo potentially burdensome tests with only some experiencing health gains from it. We investigated the determinants of patients’ reported burden of upper gastrointestinal (GI) endoscopy by comparing data from three patient groups. Patients and methods A total of 476 patients were included: 180 patients under regular surveillance for Barrett esophagus (BE), a premalignant disorder; 214 patients with non-specific upper GI symptoms (NS), and 82 patients recently diagnosed with upper GI cancer (CA). We assessed pain, discomfort and overall burden experienced during endoscopy, symptoms in the week afterwards and psychological distress over time (Hospital Anxiety and Depression scale and Impact of Event Scale). Results Two-thirds (66%) of patients reported discomfort and overall burden of upper GI endoscopy. Only 23% reported any pain. BE patients reported significantly less discomfort, pain and overall burden than the other patients: those with NS reported more discomfort, CA patients more pain, and both more overall burden. These differences could be statistically explained by the number of previous endoscopies and whether sedation was provided or not, but not by patient characteristics. Conclusion The perception of upper GI endoscopy varies by patient group, due to potential adaptation after multiple endoscopies and aspects of the procedure.     

Fathers’ Involvement with their Preschool-age Children: How Fathers Spend Time with Their Children in Different Family Structures

The purpose of this study was to describe how fathers (n = 263) spent time with their preschool-age children and to compare it in different family structures. Data were gathered by structured questionnaires. The instrument included five categories of variables for the time spent: the quantity of time, physical activities, fathers’ attitude towards interaction with children, time spent on other activities and conflicts related to the time spent. Fathers’ family structure was associated with father–child involvement. Divorced fathers and fathers in non-traditional families appreciated interaction with children more compared with fathers in traditional families. The findings can be used to develop the knowledge base on fathers and to further develop practical measures and forms of support.     

Checklist Content on a Standardized Patient Assessment: An Ex Post Facto Review

While checklists are often used to score standardized patient based clinical assessments, little research has focused on issues related to their development or the level of agreement with respect to the importance of specific items. Five physicians independently reviewed checklists from 11 simulation scenarios that were part of the former Educational Commission for Foreign Medical Graduate’s Clinical Skills Assessment and classified the clinical appropriateness of each of the checklist items. Approximately 78% of the original checklist items were judged to be needed, or indicated, given the presenting complaint and the purpose of the assessment. Rater agreement was relatively poor with pairwise associations (Kappa coefficient) ranging from 0.09 to 0.29. However, when only consensus indicated items were included, there was little change in examinee scores, including their reliability over encounters. Although most checklist items in this sample were judged to be appropriate, some could potentially be eliminated, thereby minimizing the scoring burden placed on the standardized patients. Periodic review of checklist items, concentrating on their clinical importance, is warranted.     

Mental Health Research with Latino Farmworkers: A Systematic Evaluation of the Short CES-D

Mental health research among Latino farmworkers is hampered by the absence of measurement evaluation that ensures farmworkers understand and can consistently and appropriately respond to questions about mental health. Cross-sectional data were obtained from 409 farmworkers via interviewer-administered survey questionnaires. Mental health was operationalized with the short-form Center for Epidemiologic Studies, Depression (CES-D) scale. The structured interviewer-administered survey questionnaires included measures to capture personal and work-related factors that could affect farmworkers’ ability to understand and respond to mental health questions probed by the CES-D. Good variability in item response was observed across the 10 short-form CES-D items. There was no evidence of differential response across sub-groups of farmworkers for six of the 10 items. Responses to four of the 10 items differed by educational attainment, country of origin, and language preference. Overall, the internal consistency of the 10 items exceeded standard conventions, and observed differences in depressive symptoms were as expected. Researchers in farmworker mental health must remain attentive to the strength and validity of available measures for migrants, different ethnic groups and different socioeconomic backgrounds. Nevertheless, the overall pattern suggests that the CES-D is a viable tool for advancing farmworker mental health research.     

Assessment of Behavioral Distress and Depression in a Pediatric Population

Using a multitrait-multimethod approach, measures designed to assess emotional distress in medical populations were compared with depression measures standardized on healthy children. In a hospitalized sample of children ages 4 to 12 years old, parent ratings of child distress were compared to nurse ratings and children's responses to a pictorial measure. An assessment battery was administered to 70 mothers and children; 32 nurse ratings were also obtained. Results indicated overlap between information obtained from measures of depression and pediatric-specific measures of distress. However, the findings provide some evidence that measures that incorporate the pediatric context in assessment may be more suitable for medically ill children.     

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 ). 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 adclition, 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.M.-A. Hsu is currently with Pfizer, New York, NY, USA.     

Development of a Computer-adaptive Test for Depression (D-CAT)

Depression is one of the most prevalent mental health problems and measuring depressive symptoms becomes increasingly important in science as well as medical practice. Computer Adaptive Tests (CAT) based on the Item Response Theory (IRT) promise to enhance measurement precision and reduce respondent’s burden. Our aim was to develop a CAT application to measure depressive symptoms. Three thousand two hundred seventy psychosomatic patients answered an overall of 11 mental health questionnaires at the University Clinic in Berlin. Three independent reviewers rated 144 items out of these questionnaires as indicative of depressive symptoms. All items underwent six empirical steps to analyze unidimensionality, local independence and item discrimination. Finally 64 items could be used to calculate item parameters applying a Generalized Partial Credit Model (GPCM). CAT scores were estimated using an ‘expected a posteriori’ algorithm (EAP). Two simulation experiments showed that for theta values within the range of 2SD around the mean (98% of the cases), the latent trait can be estimated out of approximately six items with a predefined standard error of ⩽ 0.32 (reliability ρ ⩾ 0.90). The CAT-scores correlated high with scores of all depression items (r = 0.95), with the Beck Depression Inventory (r = 0.79) and with a CES-D 8 item short form (r = 0.76). We conclude that the Depression-CAT measures depressive symptoms with high precision and low respondent burden.