The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 health-related quality of life questionnaire is one of the most widely used cancer-specific health-related quality of ...life questionnaires worldwide. General population norm data can facilitate the interpretation of QLQ-C30 data obtained from cancer patients. This study aimed at systematically collecting norm data from the general population to develop European QLQ-C30 norm scores and to generate comparable norm data for individual countries in Europe and North America.
We collected QLQ-C30 data from the general population across 11 European Union (EU) countries, Russia, Turkey, Canada and United States (n ≥ 1000/country). Representative samples were stratified by sex and age groups (18–39, 40–49, 50–59, 60–69 and ≥ 70 years). After applying weights based on the United Nations population distribution statistics, we calculated QLQ-C30 domain scores to generate a ‘European QLQ-C30 Norm’ based on the EU countries. Further, we calculated QLQ-C30 norm scores for all 15 individual countries.
A total of 15,386 respondents completed the online survey. For the EU sample, most QLQ-C30 domains showed differences by sex/age, with men scoring somewhat better health than women, while age effects varied across domains. Substantially larger differences were seen in inter-country comparisons, with Austrian and Dutch respondents reporting consistently better health compared with British and Polish respondents.
This study is the first to systematically collect EORTC QLQ-C30 general population norm data across Europe and North America applying a consistent data collection method across 15 countries. These new norm data facilitate valid intra-country as well as inter-country comparisons and QLQ-C30 score interpretation.
•Updated general population norm data for EORTC QLQ-C 30 based on 15,386 persons across 13 European countries, Canada, and USA.•Study strength: all individual country QLQ-C30 norm data collected based on a common sampling strategy and survey design.•New normative data facilitate valid intracountry and especially intercountry comparisons and QLQ-C30 score interpretation.
Patient-reported physical function (PF) is a key endpoint in cancer clinical trials. Using complex statistical methods, common metrics have been developed to compare scores from different ...patient-reported outcome (PRO) measures, but such methods do not account for possible differences in questionnaire content. Therefore, the aim of our study was a content comparison of frequently used PRO measures for PF in cancer patients.
Relying on the framework of the International Classification of Functioning, Disability and Health (ICF) we categorized the item content of the physical domains of the following measures: EORTC CAT Core, EORTC QLQ-C30, SF-36, PROMIS Cancer Item Bank for Physical Function, PROMIS Short Form for Physical Function 20a, and the FACT-G. Item content was linked to ICF categories by two independent reviewers.
The 118 items investigated were assigned to 3 components ('d - Activities and Participation', 'b - Body Functions', and 'e - Environmental Factors') and 11 first-level ICF categories. All PF items of the EORTC measures but one were assigned to the first-level ICF categories 'd4 - Mobility' and 'd5 - Self-care', all within the component 'd - Activities and Participation'. The SF-36 additionally included item content related to 'd9 - Community, social and civic life' and the PROMIS Short Form for Physical Function 20a also included content related to 'd6 - domestic life'. The PROMIS Cancer Item Bank (v1.1) covered, in addition, two first-level categories within the component 'b - Body Functions'. The FACT-G Physical Well-being scale was found to be the most diverse scale with item content partly not covered by the ICF framework.
Our results provide information about conceptual differences between common PRO measures for the assessment of PF in cancer patients. Our results complement quantitative information on psychometric characteristics of these measures and provide a better understanding of the possibilities of establishing common metrics.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Abstract Objectives To investigate self-reported chronic pain and other sequelae in a nationally representative sample of long-term breast cancer survivors (BCS). Design Age-stratified random sample ...of 2,000 female BCS ⩾ 5 years after primary surgery without recurrence drawn from the Danish Breast Cancer Cooperative Group register, which is representative regarding long-term BCS in Denmark. Assessment Self-administered questionnaire including questions on sociodemography, chronic pain (⩾6 months), health-related quality of life (HRQOL) and other sequelae related to breast cancer . Associations with treatment were investigated. Report of chronic pain was compared to normative data. Results The response rate was 79%. Chronic pain prevalence of 42% was significantly higher in BCS compared to general population women (SRR: 1.32; 95% CI: 1.23–1.42). Sequelae related to breast cancer were paraesthesia 47%, chronic pain 29%, arm/shoulder swelling 25%, phantom sensations 19%, and allodynia 15%. Chronic pain related to breast cancer was significantly associated with poorer HRQOL and higher medicine consumption, and, in multiple logistic regression analysis, with age (<70 years), short education, being single (divorced, widowed, separated), radiotherapy, and time since operation <10 years. Radiotherapy and younger age were significantly associated with most sequelae. Conclusion Chronic pain was more prevalent in BCS compared to the general population. Significant predictors for sequelae related to breast cancer were radiotherapy and younger age. Future research should therefore prioritize sequelae prevention.
Cancer patients may experience a decrease in cognitive functioning before, during and after cancer treatment. So far, the Quality of Life Group of the European Organisation for Research and Treatment ...of Cancer (EORTC QLG) developed an item bank to assess self-reported memory and attention within a single, cognitive functioning scale (CF) using computerized adaptive testing (EORTC CAT Core CF item bank). However, the distinction between different cognitive functions might be important to assess the patients' functional status appropriately and to determine treatment impact. To allow for such assessment, the aim of this study was to develop and psychometrically evaluate separate item banks for memory and attention based on the EORTC CAT Core CF item bank. In a multistep process including an expert-based content analysis, we assigned 44 items from the EORTC CAT Core CF item bank to the memory or attention domain. Then, we conducted psychometric analyses based on a sample used within the development of the EORTC CAT Core CF item bank. The sample consisted of 1030 cancer patients from Denmark, France, Poland, and the United Kingdom. We evaluated measurement properties of the newly developed item banks using confirmatory factor analysis (CFA) and item response theory model calibration. Item assignment resulted in 31 memory and 13 attention items. Conducted CFAs suggested good fit to a 1-factor model for each domain and no violations of monotonicity or indications of differential item functioning. Evaluation of CATs for both memory and attention confirmed well-functioning item banks with increased power/reduced sample size requirements (for CATs greater than or equal to 4 items and up to 40% reduction in sample size requirements in comparison to non-CAT format). Two well-functioning and psychometrically robust item banks for memory and attention were formed from the existing EORTC CAT Core CF item bank. These findings could support further research on self-reported cognitive functioning in cancer patients in clinical trials as well as for real-word-evidence. A more precise assessment of attention and memory deficits in cancer patients will strengthen the evidence on the effects of cancer treatment for different cancer entities, and therefore contribute to shared and informed clinical decision-making.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
This study aimed at developing a shortened version of the EORTC QLQ-C30, one of the most widely used health-related quality of life questionnaires in oncology, for palliative care research. The study ...included interviews with 41 patients and 66 health care professionals in palliative care to determine the appropriateness, relevance and importance of the various domains of the QLQ-C30. Item response theory methods were used to shorten scales. Patients and health care professionals rated pain, physical function, emotional function, fatigue, global health status/quality of life, nausea/vomiting, appetite, dyspnoea, constipation, and sleep as most important. Therefore, these scales/items were retained in the questionnaire. Four scales were shortened without reducing measurement precision. Important dimensions not covered by the questionnaire were identified. The resulting 15-item EORTC QLQ-C15-PAL is a ‘core questionnaire’ for palliative care. Depending on the research questions, it may be supplemented by additional items, modules or questionnaires.
The computer-adaptive test (CAT) of the European Organisation for Research and Treatment of Cancer (EORTC), the EORTC CAT Core, assesses the same 15 domains as the EORTC QLQ-C30 health-related ...quality of life questionnaire but with increased precision, efficiency, measurement range and flexibility. CAT parameters for estimating scores have been established based on clinical data from cancer patients. This study aimed at establishing the European Norm for each CAT domain based on general population data.
We collected representative general population data across 11 European Union (EU) countries, Russia, Turkey, Canada and the United States (n ≥ 1000/country; stratified by sex and age). We selected item subsets from each CAT domain for data collection (totalling 86 items). Differential item functioning (DIF) analyses were conducted to investigate cross-cultural measurement invariance. For each domain, means and standard deviations from the EU countries (weighted by country population, sex and age) were used to establish a T-metric with a European general population mean = 50 (standard deviation = 10).
A total of 15,386 respondents completed the online survey (n = 11,343 from EU countries). EORTC CAT Core norm scores for all 15 countries were calculated. DIF had negligible impact on scoring. Domain-specific T-scores differed significantly across countries with small to medium effect sizes.
This study establishes the official European Norm for the EORTC CAT Core. The European CAT Norm can be used globally and allows for meaningful interpretation of scores. Furthermore, CAT scores can be compared with sex- and age-adjusted norm scores at a national level within each of the 15 countries.
•This study establishes the official European Norm for the computer-adaptive test EORTC CAT Core based on 15,386 persons.•The European CAT Norm can be used globally and allows for meaningful interpretation of scores derived from EORTC CAT Core.•EORTC CAT Core scores can also be compared with sex- and age-adjusted norm scores at national levels of 15 included countries.
Little is known about the need for palliative care among advanced cancer patients who are not in specialist palliative care. The purpose was to identify prevalence and predictors of symptoms and ...problems in a nationally representative sample of Danish advanced cancer patients. Patients with cancer stage 3 or 4 from 54 hospital departments (n = 1630) received the EORTC QLQ-C30 questionnaire. Mean scores were calculated according to the scoring manual and in addition a ‘symptom/problem’ and a ‘severe symptom/problem’ was defined and calculated. Multiple logistic regression was used to identify predictors. In total, 977 (60%) patients participated. The most frequent symptoms/problems were fatigue (57%; severe 22%) followed by reduced role function, insomnia and pain. Age, cancer stage, primary tumour, type of department, marital status and whether the patient had recently been hospitalized or not were associated with several symptoms and problems. This is probably the first nationally representative study of its kind. It shows that advanced cancer patients in Denmark have symptoms and problems that deserve attention and that some patient groups are especially at risk.
Aim
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ‐C30) assesses the health‐related quality of life of patients in cancer trials. ...There are currently no minimally important difference (MID) guidelines for the EORTC QLQ‐C30 for colorectal cancer (CRC). This study aims to estimate MIDs for the EORTC QLQ‐C30 scales in patients with advanced CRC treated with chemotherapy and enrolled in clinical trials.
Method
The data were obtained from three published EORTC trials that treated CRC patients using chemotherapy. Potential anchors were selected from clinical variables based on their correlation with EORTC QLQ‐C30 scales. Anchor‐based MIDs for within‐group change and between‐group change were estimated via the mean change method and linear regression, respectively, and summarized using weighted correlation. Distribution‐based MIDs were also examined.
Results
Anchor‐based MIDs were determined for deterioration in 8 of the 14 EORTC QLQ‐C30 scales and in 9 scales for improvement, and varied by scale, direction of change and anchor. MIDs for improvement (deterioration) ranged from 6 to 18 (−11 to −5) points for within‐group change and 5 to 15 (−10 to −4) for between‐group change. Summarized MIDs (in absolute values) per scale mostly ranged from 5 to 10 points.
Conclusions
These findings have clinical relevance for the interpretation of treatment efficacy and the design of clinical trials by informing sample size requirements.
Purpose
Writing an Advance Directive (AD) is often seen as a part of Advance Care Planning (ACP). ADs may include specific preferences regarding future care and treatment and information that ...provides a context for healthcare professionals and relatives in case they have to make decisions for the patient. The aim of this study was to get insight into the content of ADs as completed by patients with advanced cancer who participated in ACP conversations.
Methods
A mixed methods study involving content analysis and descriptive statistics was used to describe the content of completed My Preferences forms, an AD used in the intervention arm of the ACTION trial, testing the effectiveness of the ACTION Respecting Choices ACP intervention.
Results
In total, 33% of 442 patients who received the ACTION RC ACP intervention completed a My Preferences form. Document completion varied per country: 10.4% (United Kingdom), 20.6% (Denmark), 29.2% (Belgium), 41.7% (the Netherlands), 61.3% (Italy) and 63.9% (Slovenia). Content analysis showed that ‘maintaining normal life’ and ‘experiencing meaningful relationships’ were important for patients to live well. Fears and worries mainly concerned disease progression, pain or becoming dependent. Patients hoped for prolongation of life and to be looked after by healthcare professionals. Most patients preferred to be resuscitated and 44% of the patients expressed maximizing comfort as their goal of future care. Most patients preferred ‘home’ as final place of care.
Conclusions
My Preferences forms provide some insights into patients’ perspectives and preferences. However, understanding the reasoning behind preferences requires conversations with patients.
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