18,448 research outputs found

    Mapping Functions in Health-Related Quality of Life: Mapping From Two Cancer-Specific Health-Related Quality-of-Life Instruments to EQ-5D-3L.

    Get PDF
    BACKGROUND: Clinical trials in cancer frequently include cancer-specific measures of health but not preference-based measures such as the EQ-5D that are suitable for economic evaluation. Mapping functions have been developed to predict EQ-5D values from these measures, but there is considerable uncertainty about the most appropriate model to use, and many existing models are poor at predicting EQ-5D values. This study aims to investigate a range of potential models to develop mapping functions from 2 widely used cancer-specific measures (FACT-G and EORTC-QLQ-C30) and to identify the best model. METHODS: Mapping models are fitted to predict EQ-5D-3L values using ordinary least squares (OLS), tobit, 2-part models, splining, and to EQ-5D item-level responses using response mapping from the FACT-G and QLQ-C30. A variety of model specifications are estimated. Model performance and predictive ability are compared. Analysis is based on 530 patients with various cancers for the FACT-G and 771 patients with multiple myeloma, breast cancer, and lung cancer for the QLQ-C30. RESULTS: For FACT-G, OLS models most accurately predict mean EQ-5D values with the best predicting model using FACT-G items with similar results using tobit. Response mapping has low predictive ability. In contrast, for the QLQ-C30, response mapping has the most accurate predictions using QLQ-C30 dimensions. The QLQ-C30 has better predicted EQ-5D values across the range of possible values; however, few respondents in the FACT-G data set have low EQ-5D values, which reduces the accuracy at the severe end. CONCLUSIONS: OLS and tobit mapping functions perform well for both instruments. Response mapping gives the best model predictions for QLQ-C30. The generalizability of the FACT-G mapping function is limited to populations in moderate to good health

    Health-related quality of life in KEYNOTE-010 : a phase II/III study of pembrolizumab versus docetaxel in patients with previously treated advanced, programmed death ligand 1-expressing NSCLC

    No full text
    Introduction: In the phase II/III KEYNOTE-010 study (ClinicalTrials.gov, NCT01905657), pembrolizumab significantly prolonged overall survival over docetaxel in patients with previously treated, programmed death ligand 1-expressing (tumor proportion score >= 1%), advanced NSCLC. Health-related quality of life (HRQoL) results are reported here. Methods: Patients were randomized 1:1:1 to pembrolizumab 2 or 10 mg/kg every 3 weeks or docetaxel 75 mg/m(2) every 3 weeks. HRQoL was assessed using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLC) Core 30 (C30), EORTC QLQ-Lung Cancer 13 (LC13), and EuroQoL-5D. Key analyses included mean baseline-to-week-12 change in global health status (GHS)/quality of life (QoL) score, functioning and symptom domains, and time to deterioration in a QLQ-LC13 composite endpoint of cough, dyspnea, and chest pain. Results: Patient reported outcomes compliance was high across all three instruments. Pembrolizumab was associated with better QLQ-C30 GHS/QoL scores from baseline to 12 weeks than docetaxel, regardless of pembrolizumab dose or tumor proportion score status (not significant). Compared with docetaxel, fewer pembrolizumab-treated patients had "deteriorated" status and more had "improved" status in GHS/QoL. Nominally significant improvement was reported in many EORTC symptom domains with pembrolizumab, and nominally significant worsening was reported with docetaxel. Significant prolongation in true time to deterioration for the QLQ-LC13 composite endpoint emerged for pembrolizumab 10 mg/kg compared to docetaxel (nominal two-sided p = 0.03), but not for the 2-mg/kg dose. Conclusions: These findings suggest that HRQoL and symptoms are maintained or improved to a greater degree with pembrolizumab than with docetaxel in this NSCLC patient population. (C) 2019 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

    Psychosocial interventions for patients with head and neck cancer.

    Get PDF
    BACKGROUND: A diagnosis of head and neck cancer, like many other cancers, can lead to significant psychosocial distress. Patients with head and neck cancer can have very specific needs, due to both the location of their disease and the impact of treatment, which can interfere with basic day-to-day activities such as eating, speaking and breathing.ย There is a lack of clarity on the effectiveness of the interventions developed to address the psychosocial distress experienced by patients living with head and neck cancer. OBJECTIVES: To assess the effectiveness of psychosocial interventions to improve quality of life and psychosocial well-being for patients with head and neck cancer. SEARCH METHODS: We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the most recent search was 17 December 2012. SELECTION CRITERIA: We selected randomised controlled trials and quasi-randomised controlled trials of psychosocial interventions for adults with head and neck cancer. For trials to be included the psychosocial intervention had to involve a supportive relationship between a trained helper and individuals diagnosed with head and neck cancer. Outcomes had to be assessed using a validated quality of life or psychological distress measure, or both. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, extracted data and assessed the risk of bias, with mediation from a third author where required. Where possible, we extracted outcome measures for combining in meta-analyses. We compared continuous outcomes using either mean differences (MD) or standardised mean differences (SMD) and 95% confidence intervals (CI), with a random-effects model. We conducted meta-analyses for the primary outcome measure of quality of life and secondary outcome measures of psychological distress, including anxiety and depression. We subjected the remaining outcome measures (self esteem, coping, adjustment to cancer, body image) to a narrative synthesis, due to the limited number of studies evaluating these specific outcomes and the wide divergence of assessment tools used. MAIN RESULTS: Seven trials, totaling 542 participants, met the eligibility criteria. Studies varied widely on risk of bias, interventions used and outcome measures reported. From these studies, there was no evidence to suggest that psychosocial intervention promotes global quality of life for patients with head and neck cancer at end of intervention (MD 1.23, 95% CI -5.82 to 8.27) as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This quality of life tool includes five functional scales, namely cognitive, physical, emotional, social and role. There was no evidence to demonstrate that psychosocial intervention provides an immediate or medium-term improvement on any of these five functional scales. From the data available, there was no significant change in levels of anxiety (SMD -0.09, 95% CI -0.40 to 0.23) or depression following intervention (SMD -0.03, 95% CI -0.24 to 0.19). At present, there is insufficient evidence to refute or support the effectiveness of psychosocial intervention for patients with head and neck cancer. AUTHORS' CONCLUSIONS: The evidence for psychosocial intervention is limited by the small number of studies, methodological shortcomings such as lack of power, difficulties with comparability between types of interventions and a wide divergence in outcome measures used. Future research should be targeted at patients who screen positive for distress and use validated outcome measures, such as the EORTC scale, as a measure of quality of life. These studies should implement interventions that are theoretically derived. Other shortcomings should be addressed in future studies, including using power calculations that may encourage multi-centred collaboration to ensure adequate sample sizes are recruited

    Psychometric properties and measurement equivalence of the Multidimensional Fatigue Syndrome Inventory- Short Form (MFSI-SF) amongst breast cancer and lymphoma patients in Singapore.

    Get PDF
    BackgroundCurrently, several fatigue measurement instruments are available to evaluate and measure cancer-related fatigue. Amongst them, Multidimensional Fatigue Syndrome Inventory-Short Form (MFSI-SF) is a self-reported instrument and a multidimensional scale that aims to capture the global, somatic, affective, cognitive and behavioural symptoms of fatigue. This study examines the psychometric properties and measurement equivalence of the English and Chinese versions of MFSI-SF in breast cancer and lymphoma patients in Singapore.MethodsPatients were recruited from National Cancer Centre Singapore. Validity, reliability and responsiveness of MFSI-SF were evaluated in this study. Convergent validity was evaluated by correlating total and subscales of MFSI-SF to known related constructs in EORTC QLQ-C30. Known group validity was assessed based on patients' cancer stage, pain, insomnia and depression symptoms. Reliability was evaluated by Cronbach's ฮฑ. Responsiveness analyses were performed with patients who have undergone at least one cycle of chemotherapy. Multiple regression was used to compare the total and subscale scores of MSFI-SF between the two language versions.ResultsData from 246 (160 English and 86 Chinese version) breast cancer and lymphoma patients were included in the study. Moderate to high correlations were observed between correlated MFSI-SF subscales and EORTC QLQ-C30 domains (|r|โ€‰=โ€‰0.524 to 0.774) except for a poor correlation (rโ€‰=โ€‰0.394) observed between MFSI-SF vigour subscale and EORTC QLQ-C30 role functioning subscale. Total MFSI-SF scores could differentiate between patients with higher depression, pain and insomnia status. Internal consistency of MFSI-SF was also high (ฮฑโ€‰=โ€‰0.749 to 0.944). Moderate correlation was observed between change in total MFSI-SF score and change in fatigue symptom scale score and global QoL score on EORTC QLQ-C30 (|r|โ€‰=โ€‰0.478 and 0.404 respectively). Poor correlations were observed between change in scores of hypothesised subscales (|r|โ€‰=โ€‰0.202 to 0.361) except for a moderate correlation between change in MFSI-SF emotional fatigue score and change in EORTC QLQ-C30 emotional functioning domain score. Measurement equivalence was established for all subscales and total MFSI-SF score except for the emotional and vigour subscales.ConclusionsThis study supports the use of MFSI-SF as a reasonably valid scale with good internal consistency for measuring fatigue levels in the Singapore cancer population

    Deriving a preference-based measure for cancer using the EORTC QLQ-C30 : a confirmatory versus exploratory approach

    Get PDF
    Background: To derive preference-based measures from various condition-specific descriptive health-related quality of life (HRQOL) measures. A general 2-stage method is evolved: 1) an item from each domain of the HRQOL measure is selected to form a health state classification system (HSCS); 2) a sample of health states is valued and an algorithm derived for estimating the utility of all possible health states. The aim of this analysis was to determine whether confirmatory or exploratory factor analysis (CFA, EFA) should be used to derive a cancer-specific utility measure from the EORTC QLQ-C30. Methods: Data were collected with the QLQ-C30v3 from 356 patients receiving palliative radiotherapy for recurrent or metastatic cancer (various primary sites). The dimensional structure of the QLQ-C30 was tested with EFA and CFA, the latter based on a conceptual model (the established domain structure of the QLQ-C30: physical, role, emotional, social and cognitive functioning, plus several symptoms) and clinical considerations (views of both patients and clinicians about issues relevant to HRQOL in cancer). The dimensions determined by each method were then subjected to item response theory, including Rasch analysis. Results: CFA results generally supported the proposed conceptual model, with residual correlations requiring only minor adjustments (namely, introduction of two cross-loadings) to improve model fit (increment ฯ‡2(2) = 77.78, p 75% observation at lowest score), 6 exhibited misfit to the Rasch model (fit residual > 2.5), none exhibited disordered item response thresholds, 4 exhibited DIF by gender or cancer site. Upon inspection of the remaining items, three were considered relatively less clinically important than the remaining nine. Conclusions: CFA appears more appropriate than EFA, given the well-established structure of the QLQ-C30 and its clinical relevance. Further, the confirmatory approach produced more interpretable results than the exploratory approach. Other aspects of the general method remain largely the same. The revised method will be applied to a large number of data sets as part of the international and interdisciplinary project to develop a multi-attribute utility instrument for cancer (MAUCa)

    Translation and validation of EORTC QLQ-C30 into Indonesian version for cancer patients in Indonesia.

    Get PDF
    The Indonesian version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 can be used as a questionnaire to assess quality of life in Indonesian cancer patients with high-emetogenic treatments

    Health-Related Quality of Life and Needs of Care and Support of Adult Tanzanians with Cancer: A Mixed-Methods Study.

    Get PDF
    Cancer is among the three leading causes of death in low income countries and the highest increase with regard to incidence figures for cancer diseases are found in these countries. This is the first report of the health-related quality of life (HRQOL) and needs of care and support of adult Tanzanians with cancer. A mixed-methods design was used. The study was conducted at Ocean Road Cancer Institute (ORCI) in Dar es Salaam, Tanzania. One hundred and one patients with a variety of cancer diagnoses treated and cared for at ORCI answered the Kiswahili version of the EORTC QLQ-C30 investigating HRQOL. Thirty-two of the patients participated in focus group interviews discussing needs of care and support. Data from focus group interviews were analyzed with content analysis. The findings show that the patients, both women and men, report a low quality of life, especially with regard to physical, role, and social function and a high level of symptoms and problems especially with financial difficulties and pain. Financial difficulties are reported to a remarkably high extent by both women and men. The patients, both women and men report least problems with emotional function. A content analysis of the interview data revealed needs of food and water, hygienic needs, emotional needs, spiritual needs, financial needs, and needs of closeness to cancer care and treatment services. The high score for pain points out that ORCI is facing severe challenges regarding care and treatment. However, when considering this finding it should be noted that the pain subscale of the Kiswahili version of the EORTC QLQ-C30 did not reach acceptable internal consistency and showed less than satisfactory convergent validity. This also applies to the subscales cognitive function and global health/quality of life. Attention should be drawn to meet the identified needs of Tanzanian cancer patients while hospitalized but also when at home. Increased accessibility of mosquito nets, pads, and pain-killers would help to fulfil some needs
    • โ€ฆ
    corecore