Value of quality of life analysis in liver cancer: A clinician's perspective.
ABSTRACT: Health related quality of life (HRQOL) is increasingly recognized as an important clinical parameter and research endpoint in patients with hepatocellular carcinoma (HCC). HRQOL in HCC patients is multifaceted and affected by medical factor which encompasses HCC and its complications, oncological and palliative treatment for HCC, underlying liver disease, as well as the psychological, social or spiritual reaction to the disease. Many patients presented late with advanced disease and limited survival, plagued with multiple symptoms, rendering QOL a very important aspect in their general well being. Various instruments have been developed and validated to measure and report HRQOL in HCC patients, these included general HRQOL instruments, e.g., Short form (SF)-36, SF-12, EuroQoL-5D, World Health Organization Quality of Life Assessment 100 (WHOQOL-100), World Health Organization Quality of Life Assessment abbreviated version; general cancer HRQOL instruments, e.g., the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, Functional Assessment of Cancer Therapy (FACT)-General, Spitzer Quality of Life Index; and liver-cancer specific HRQOL instruments, e.g., EORTC QLQ-HCC18, FACT-Hepatobiliary (FACT-Hep), FACT-Hep Symptom Index, Trial Outcome Index. Important utilization of HRQOL in HCC patients included description of symptomatology and HRQOL of patients, treatment endpoint in clinical trial, prognostication of survival, benchmarking of palliative care service and health care valuation. In this review, difficulties regarding the use of HRQOL data in research and clinical practice, including choosing a suitable instrument, problems of missing data, data interpretation, analysis and presentation are examined. Potential solutions are also discussed.
Project description:<b>Background:</b> A key component to monitoring and investigating patient QOL is through patient reported health related quality of life (HRQOL) outcome measures. Many instruments have been used to assess HRQOL in bladder cancer and each instrument varies in its development, validation, the context of its usage in the literature and its applicability to certain disease states. <b>Objective:</b> In this review, we sought to summarize how clinicians and researchers should most appropriately utilize the available HRQOL instruments for bladder cancer. <b>Methods:</b> We performed a comprehensive literature search of each instrument used in bladder cancer, paying particular attention to the outcomes assessed. We used these outcomes to group the available instruments into categories best reflecting their optimal usage by stage of disease. <b>Results:</b> We found 5 instruments specific to bladder cancer, of which 3 are validated. Only one of the instruments (the EORTC-QLQ-NMIBC24) was involved in a randomized, prospective validation study. The most heavily used instruments are the EORTC-QLQ-BLM30 for muscle-invasive disease and the FACT-Bl which is used across all disease states. Of the 5 available instruments, 4 are automatically administered with general instruments, while the BCI lacks modularity, and requires co-administration with a generalized instrument. <b>Conclusion:</b> There are multiple strong instruments for use in gauging HRQOL in bladder cancer patients. We have divided these instruments into three categories which optimize their usage: instruments for use following NMIBC treatments (EORTC-QLQ-NMIBC24), instruments for use following radical cystectomy (FACT-Bl-Cys and EORTC-QLQ-BLM30) and more inclusive instruments not limited by treatment modality (BCI and FACT-Bl).
Project description:Introduction:Acute myeloid leukemia (AML) can negatively impact quality of life (QOL). Few QOL instruments are specific to and have been validated in AML. This review aims to identify QOL instruments that have been validated in patients with AML and other cancers and summarize their psychometric properties reported in published literature. A literature review search was performed using PubMed and OVID (Biosis, Embase, MEDLINE) databases through June 25, 2020. Search terms included: QOL, health-related QOL, patient-reported outcomes and validity, reliability, validated, tools, instruments, test-retest, and leukemia myeloid acute, leukemia, myeloid, acute, acute myeloid leukemia. Articles were included if they focused on cancer and reported psychometric properties that could be extracted. Abstracts and their references were reviewed for inclusion. Results:Twelve evaluating ten instruments were included. Functional Assessment of Cancer Therapy Leukemia (FACT-Leu) showed internal consistency (IC) of ? = 0.86 to >0.9, correlation with EQ-5D-3L of r > 0.50, correlation with European Organisation for Research and Treatment of Cancer (EORTC) QLQ-Leu of ? = 0.29-0.63, test-retest reliability of ? = 0.861. FACT-F showed correlations with EORTC QLQ-C30 of r = 0.40-0.83. Hematological Malignancy Patient-Reported Outcome (HM-PRO) showed intraclass correlation coefficient (ICC) of 0.94-0.98. EORTC-8D and EQ-5D-3L showed ICC = 0.595, correlations with each other of ? = 0.137-0.634 and with EORTC QLQ-C30 of r = 0.651-0.917. EORTC QLQ-C30 showed person separation reliability of 0.47 to 0.90 and patient-observer agreement of 0.85. Life Ingredient Profile (LIP) showed IC of ? = 0.29-0.77 and test-retest reliability of ? = 0.42-1.0. QOL-E showed correlation with FACT-general of R = 0.71, internal validity of ? = 0.7, and test-retest reliability of standardized Cronbach's ? = 0.7-0.92. EORTC QLQ-Leu showed IC of ? = 0.6-0.79. The Acute Myeloid Leukemia-Quality of Life (AML-QOL) instrument showed IC of ? = 0.72, correlations with EORTC QLQ-30 of magnitudes ? = 0.59-0.72, and test-retest reliability of ICC = 0.52-0.91. Conclusion:Although several QOL instruments have been validated, more research is needed to determine the most clinically useful instruments in patients with AML.
Project description:<h4>Objectives</h4>Breast cancer is one of the major cancers in Chinese women. European Organization for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ-C30 and QLQ-BR23) are now the most common and well developed instruments assessing the health-related quality of life (HRQOL) of breast cancer patients internationally, whereas there are relatively few Chinese studies. This study has two aims: to investigate the HRQOL and explore which dimensions of HRQOL play more important roles in breast cancer patients' overall quality of life in China and to explore the latent factor structure and the potential complementary relationship between these two EORTC questionnaires.<h4>Methods</h4>This cross-sectional and descriptive study was performed from October 2014 to February 2015 in Qingdao Municipal Hospital, China. A total of 621 women breast cancer patients were enrolled. EOTRC QLQ-C30 and QLQ-BR23 were used to evaluate the HRQOL of the participants. The nonparametric test, multiple linear regression, and exploratory factor analysis (EFA) were the main statistical methods we used.<h4>Results</h4>608 participants completed the questionnaires with a response rate of 97.9%. The mean age of the participants was 48.0 years (SD=9.6). About 33% were illiterate or only finished primary school education. Almost half participants (47.4%) only adopted chemotherapy. HRQOL was significantly different with regard to patients' social-demographic and clinical characteristics. Age, residence, educational level, employment status, and TNM stage were five significant predictors for global health status. Pain, dyspnea, sexual enjoyment, and systemic therapy side-effect were main subscales which had a significant impact on the global health status for patients in different TNM stage. The EFA result suggested that QLQ-C30 and QLQ-BR23 were complementary questionnaires.<h4>Conclusions</h4>The EORTC QLQ-C30 and QLQ-BR23 questionnaires provide complementary information regarding breast cancer patients' HRQOL, and depending on the different cancer staging functional/symptom scales which significantly contributed to the overall HRQOL differed.
Project description:BACKGROUND:Breast cancer is the second most prevalent malignancy in Ethiopia and severely affects patients' health-related quality of life (HRQOL). We aimed to assess HRQoL, factors influencing HRQoL, and utilities among breast cancer patients at Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia. METHODS:A hospital-based cross-sectional study was conducted in Tikur Anbessa Specialized Hospital from December 2017 to February, 2018. A total of 404 breast cancer patients were interviewed using the validated Amharic version of the European Organization for Research and Treatment of Cancer module (EORTC QLQ-C30), EORTC QLQ-BR23, and Euro Quality of Life Group's 5-Domain Questionnaires 5 Levels (EQ-5D-5 L) instruments. Mean scores and mean differences of EORTC- QLQ-C30 and EORTC- QLQ-BR23 were calculated. One-way ANOVA test was employed to determine the significance of mean differences among dependent and independent variables while stepwise multivariate logistic regression was used to identify factors associated with the global quality of life (GQOL). Coefficients and level specific utility values obtained from a hybrid regression model for the Ethiopian population were used to compute utility values of each health state. Data was analyzed using SPSS version 23. RESULTS:The mean age of patients was 43.94 ± 11.72 years. The mean score for GQoL and visual analog scale was 59.32 ± 22.94 and 69.94 ± 20.36, respectively while the mean utility score was 0.8 ± 0.25. Predictors of GQoL were stage of cancer (AOR = 7.94; 95% CI: 1.83-34.54), cognitive functioning (AOR = 2.38; 95% CI: 1.32-4.31), pain (AOR = 7.99; 95% CI: 4.62-13.83), financial difficulties (AOR = 2.60; 95% CI: 1.56-4.35), and future perspective (AOR = 2.08; 95% CI: 1.24-3.49). CONCLUSIONS:The overall GQoL of breast cancer patients was moderate. Targeted approaches to improve patients' HRQoL should consider stage of cancer, cognitive functioning, pain, financial status and worries about the patient's future health. This study also provides estimates of EQ-5D utility scores that can be used in economic evaluations.
Project description:PURPOSE:Development of innovative drugs for melanoma is occurring rapidly. Incremental gains in overall survival amongst innovative products may be difficult to measure in clinical trials, and their use may be associated with increased toxicity profiles. Therefore, HTA agencies increasingly require information on HRQoL for the assessment of such drugs. This study explored the feasibility of social media to assess patient perspectives on HRQoL in melanoma, and whether current cancer- and melanoma-specific HRQoL questionnaires represent these perspectives. METHODS:A survey was distributed on the social media channels of Melanoma Patient Network Europe to assess melanoma patients' perspectives regarding HRQoL. Two researchers independently conducted content analysis to identify key themes, which were subsequently compared to questions from one current cancer-specific and two melanoma-specific HRQoL questionnaires (i.e. EORTC QLQ-C30, EORTC QLQ-MEL38, FACT-M). RESULTS:In total, 72 patients and 17 carers completed the survey. Patients indicated that family, having a normal life, and enjoying life were the three most important aspects of HRQoL for them. Carers indicated that being capable, having manageable adverse events, and being pain-free were the three most important aspects of HRQoL for patients. Respondents seem to find some questions from HRQoL questionnaires relevant (e.g. 'Have you felt able to carry on with things as normal?') and others less relevant (e.g. 'Have you had swelling near your melanoma site?'). Additionally, wording may differ between patients and HRQoL questionnaires, whereby patients generally use a more positive tone. CONCLUSIONS:Social media may provide a valuable tool in assessing patient perspectives regarding HRQoL. However, differences seem to emerge between patient and carer perspectives. Additionally, patient perspectives did not seem to fully correlate to questions posed in cancer- (i.e. EORTC QLQ-C30) and melanoma-specific (i.e. EORTC QLQ-MEL38, FACT-M) HRQoL questionnaires examined.
Project description:PURPOSE: Women undergoing radical cystectomy (RC) and urinary diversion for bladder cancer experience substantial limitations in health-related quality of life (HRQOL). However, the level of discomfort caused by different urinary diversion has been never evaluated in long term survivors. The aim of this multicenter study is to evaluate differences in HRQOL among recurrence-free women undergoing cutaneous ureterostomy (CUS), Bricker's ileal conduit (BK-IC) and Orthotopic neobladder VIP (ONB-VIP) in disease-free females treated with radical cystectomy (RC), with long-term follow up (mean 60.1 months; range 36-122 months). MATERIALS AND METHODS: All consecutively treated female patients from two urological institutions who underwent RC and urinary diversion from January 2000 to December 2008, with no evidence of tumor recurrence at a minimum follow up of 36 months, were included. Patients received the European Organisation for Research and Treatment of Cancer (EORTC) generic (QLQ-C30) and bladder cancer-specific instruments (QLQ-BLM30) and the Functional Assessment of Cancer Therapy for Bladder Cancer (FACT-BL). Clinical data and questionnaire results were analyzed in order to evaluate the HRQOL differences among diversion groups. RESULTS: We identified 37 females (median age: 68, range 45-82 years), including 12 status-post CUS, 16 who underwent BK-IC, and 9 who underwent ONB-VIP. Most were healthy (24/37 with no comorbidities, 4/37 Charlson 1-2, 9/37 Charlson 3 or greater - we didn't considered bladder cancer in Charlson evaluation because bladder cancer was the main inclusion criteria). Women undergoing CUS endorsed worse FACT-BL scores compared with BK-IC and ONB-VIP patients, worse HRQOL regarding physical and emotional well-being (p=0.008 and p=0.02, respectively), and a trend toward worse EORTC QLQ-C30 scores for appetite loss and fatigue (p=0.05 for both). CONCLUSIONS: In our study long-term disease-free females treated with CUS endorsed worse HRQOL compared with women who underwent BK-IC or ONB-VIP, mostly due to worse physical and emotional perception of their body image.
Project description:BACKGROUND:To be clinically useful, an instrument assessing health-related quality of life (HRQOL) should be easy to understand and quick to answer. Few instruments have been designed to be short, simple, and easily understandable by patients from all educational levels. The aim of the present study was to evaluate the psychometric properties of a brief general instrument developed to assess HRQOL. METHODS:Results from a preliminary study regarding the initial development of the Barretos Short Instrument for Assessment of Quality of Life (BSIqol) with 80 cancer patients are presented. Out of all the patients, 59 completed the BSIqol on two occasions in order to evaluate the reproducibility test-retest. Validity analyses were done comparing scores from BSIqol with EORTC QLQ-C30 and Edmonton Symptom Assessment System (ESAS). In addition, BSIqol scores were analyzed in function of ECOG-PS, work activity, and financial income. RESULTS:BSIqol demonstrated good internal consistency (Cronbach's ? = 0.79) and adequate test-retest reliability, with intraclass coefficient correlation (ICC) varying from 0.736 to 0.946. There were adequate correlations between scores of BSIqol, EORTC QLQ-C30 and ESAS. The BSIqol was capable of discriminating between clinical subgroups, with different ECOG-PS and work activity. Patients completed the BSIqol in a median time <2 min. Only one patient reported some difficulty to answer the instrument. CONCLUSIONS:BSIqol seems to be a straightforward and useful instrument for rapidly assessing HRQOL from cancer patients. Further studies are necessary to evaluate BSIqol in different populations and also to assess its responsiveness and define its minimal clinically important differences.
Project description:In oncology, health-related quality of life (HRQoL) data are often collected using disease-specific patient questionnaires while generic, patient-level utility data required for health economic modeling are often not collected.We developed a mapping algorithm for multiple myeloma that relates HRQoL scores from the European Organization for Research and Treatment of Cancer (EORTC) questionnaires QLQ-C30 and QLQ-MY20 to a utility value from the European QoL-5 Dimensions (EQ-5D) questionnaire. Data were obtained from 154 multiple myeloma patients who had participated in a multicenter cohort study in the UK or Germany. All three questionnaires were administered at a single time point. Scores from all 19 domains of the QLQ-C30 and QLQ-MY20 instruments were univariately tested against EQ-5D values and retained in a multivariate regression model if statistically significant. A 10-fold cross-validation model selection method was also used as an alternative testing means. Two models were developed: one based on QLQ-C30 plus QLQ-MY20 scores and one based on QLQ-C30 scores alone. Adjusted R-squared, correlation coefficients, and plots of observed versus predicted EQ-5D values were presented for both models.Mapping revealed that Global Health Status/QoL, Physical Functioning, Pain, and Insomnia were significant predictors of EQ-5D utility values. Similar results were observed when QLQ-MY20 scores were excluded from the model, except that Emotional Functioning and became a significant predictor and Insomnia was no longer a significant predictor. Adjusted R-squared values were of similar magnitude with or without inclusion of QLQ-MY20 scores (0.70 and 0.69, respectively), suggesting that the EORTC QLQ-MY20 adds little in terms of predicting utility values in multiple myeloma.This algorithm successfully mapped EORTC HRQoL data onto EQ-5D utility in patients with multiple myeloma. Current mapping will aid in the analysis of cost-effectiveness of novel therapies for this indication.
Project description:BACKGROUND:The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 is a widely used cancer-specific questionnaire assessing 15 domains of health-related quality of life (HRQoL). Our aim was to facilitate the interpretation of scores on this questionnaire by providing Austrian normative data based on a general population sample. METHODS:The calculation of normative data was based on the EORTC QLQ-C30 data collected from an Austrian general population sample that was part of an international online panel study on the development of European normative data. Data reported herein were stratified and weighted by age and sex. Normative data were calculated for all 15 HRQoL domains of the EORTC QLQ-C30. For precise predictions of EORTC QLQ-C30 scores, a regression model based on sex, age and the presence of health conditions was built. RESULTS:The Austrian sample comprised 1002 Austrian participants (50.1% female, 51.4% when weighted by age and sex based on United Nation statistics). The mean age was 53.7?years (weighted: 47.7?years) and 53.6% (weighted: 47.4%) reported at least one health condition. Men reported better physical (Cohen's d?=?0.17) and emotional (Cohen's d?=?0.17) functioning as well as less fatigue (Cohen's d?=?0.18) and insomnia (Cohen's d?=?0.25) compared with women. Younger individuals (<?40?years) reported less dyspnea (Cohen's d?=?0.61) and pain (Cohen's d?=?0.51), whereas older individuals (?60?years) reported better emotional functioning (Cohen's d?=?0.55). CONCLUSIONS:We present Austrian normative data for the EORTC QLQ-C30. Differences by age and sex are mostly in line with the findings of other European normative studies. The Austrian population sample shows higher HRQoL and lower morbidity compared with other European countries. The normative data in this study will facilitate the interpretation of EORTC QLQ-C30 scores in oncological practice and research at a national and international level (including cross-cultural comparisons).
Project description:To describe the health-related quality of life (HRQoL) of an unselected population of patients with chronic lymphocytic leukaemia (CLL) including untreated patients.HRQoL was measured by the EORTC QLQ-C30 including the CLL16 module, EQ-5D, and VAS in an observational study over multiple years. All HRQoL measurements per patient were connected and analysed using area under the curve analysis over the entire study duration. The total patient group was compared with the general population, and three groups of CLL patients were described separately, i.e. patients without any active treatment ("watch and wait"), chlorambucil treatment only, and patients with other treatment(s).HRQoL in the total group of CLL patients was compromised when compared with age- and gender-matched norm scores of the general population. CLL patients scored statistically worse on the VAS and utility score of the EQ-5D, all functioning scales of the EORTC QLQ-C30, and the symptoms of fatigue, dyspnoea, sleeping disturbance, appetite loss, and financial difficulties. In untreated patients, the HRQoL was slightly reduced. In all treatment stages, HRQoL was compromised considerably. Patients treated with chlorambucil only scored worse on the EORTC QLQ-C30 than patients who were treated with other treatments with regard to emotional functioning, cognitive functioning, bruises, uncomfortable stomach, and apathy.CLL patients differ most from the general population on role functioning, fatigue, concerns about future health, and having not enough energy. Once treatment is indicated, HRQoL becomes considerably compromised. This applies to all treatments, including chlorambucil, which is considered to be a mild treatment.