Deriving a compound quality of life measure from the EORTC-QLQ-C30/LC13 instrument for use in economic evaluations of lung cancer clinical trials

2001 ◽  
Vol 37 (9) ◽  
pp. 1081-1088 ◽  
Author(s):  
A Bagust ◽  
M Barraza-Llorens ◽  
Z Philips
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Clinical Trials ◽  
Economic Evaluations ◽  
Cancer Clinical Trials ◽  
Life Measure ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

Difficulties with Measuring the Patient's Perspective in Non Hodgkin's Lymphoma - a Review of Patient Reported Outcome Measures

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4703-4703
Author(s):  
Jyotsna Mehta ◽  
Florence Joulain ◽  
Peter C Trask ◽  
Bonnie Teschendorf
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Clinical Benefit ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Medical Attention ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Pro Instruments

Abstract Abstract 4703 Aims: Patients with NHL present with a classic array of symptoms reflecting the origin of the cancer itself. Symptoms include painless swelling of lymph nodes, increased sensitivity to alcohol, weight loss which can be substantial, persistent fever, soaking night sweats, itchy skin, coughing, difficulty breathing, chest or upper back pain and persistent weakness and tiredness. The severity of symptoms alters the patient's perception of quality of life, their capacity to perform usual activities, and results in seeking medical attention. Due to profound symptoms, it is critical to use excellent measurement tools to record change and demonstrate clinical benefit in trials. The objective of the study was to describe and assess the PRO instruments used in lymphoma, summarize PROs used in ongoing clinical trials, identify gaps in existing PRO measures and evaluate the potential for labeling when using these measures for patient self-report in advanced NHL, particularly as it relates to selecting and implementing PROs. Methods: An in depth literature review was conducted. Elsevier and Medline databases were consulted using Embase platform. Studies were included if they were: published from 01/01–12/11, in English, and included terms related to lymphoma disease and PROs. A thorough review of abstracts was performed. Studies where PRO instruments were used and/or psychometric validation was performed were included. References for selected articles were used to identify other relevant sources. Clinical trials.gov was also used to search for lymphoma trials from 2001–2011. Results: Of 1278 hits, 17 articles met the search criteria. 7 PRO instruments were reported or used in NHL: 2 lymphoma specific questionnaires FACT-Lym (Functional Assessment of Cancer Therapy-Lymphoma module), FACT FLymSI-18 (FACT-Lymphoma Symptom Index), 5 cancer-specific instruments (EORTC-QLQ-C30, FACT-G, CARES (Cancer Rehabilitation Evaluation System), CARES-SF, QOL-CS (Quality of Life-Cancer Survivors), IOC (Impact Of Cancer scale). The 2 most widely used PROs were FACT-Lym and the EORTC QLQ C30. PRO instruments have been included in ongoing phase 2 and 3 clinical trials (Table 1) as secondary endpoints, including 2 in Diffuse Large B-cell lymphoma (DLBCL), 4 in Follicular lymphoma (FL), and 1 each in indolent NHL or mantle cell lymphoma (MCL). EORTC QLQ C30 was the most common instrument followed by FACT-Lym. No specific labeling claims were found in labels made to date for NHL related compounds to FDA or EMA. Conclusions: While there are some lymphoma specific measures, most ongoing trials are using only cancer specific instruments such as EORTC QLQ C30. Several instruments contain only general cancer related symptoms, but not NHL specific symptoms. To more completely understand the burden of disease and treatment effects with NHL through the eyes of patients, evaluation of existing instruments as well as potential instrument development/modification may be warranted. NHL symptom-specific measures could demonstrate therapeutic effectiveness, enhance our understanding of the impact of NHL and provide more evidence of clinical benefit for developing treatments. Disclosures: Mehta: Sanofi: Employment. Joulain:Sanofi: Employment, Equity Ownership. Trask:Sanofi: Employment.

scholarly journals Use of the lung cancer-specific Quality of Life Questionnaire EORTC QLQ-LC13 in clinical trials: A systematic review of the literature 20 years after its development

Cancer ◽  
2015 ◽  
Vol 121 (24) ◽  
pp. 4300-4323 ◽  
Author(s):  
Michael Koller ◽  
Sophie Warncke ◽  
Marianne J. Hjermstad ◽  
Juan Arraras ◽  
Cecilia Pompili ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Systematic Review ◽  
Clinical Trials ◽  
Life Questionnaire ◽  
Review Of The Literature ◽  
Quality Of Life Questionnaire ◽  
Eortc Qlq

Comparison of quality of life of patients on treatment with cisplatin and gemcitabine, carboplatin and gemcitabine, carboplatin and paclitaxel, carboplatin and pemetrexed for non-small cell lung cancer

2019 ◽  
Vol 25 (8) ◽  
pp. 1853-1859 ◽  
Author(s):  
K Saranya ◽  
K Sreejith ◽  
Ajaykumar
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Normal Saline ◽  
Small Cell ◽  
Small Cell Lung ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

Non-small cell lung cancer is a fatal disease associated with high morbidity. It is important to evaluate the effects of treatment on patient's quality of life. Quality of life can be assessed by using EORTC QLQ - C30 and EORTC QLQ - LC 13. Eighty-six patients were enrolled in the study. The patients were divided into four arms as follows: Patients in arm 1 received cisplatin 80 mg/m 2 and gemcitabine 1.25 g/m 2 as infusion separately in isotonic normal saline. Arm 2 received carboplatin 300 mg/m 2 and gemcitabine 1.2 mg/m 2 as infusion separately in 5% dextrose injection. Arm 3 received paclitaxel 100 mg/m 2 as infusion in isotonic normal saline and carboplatin 300 mg/m 2 as infusion in 5% dextrose injection. Arm 4 received pemetrexed 500 mg/m 2 as infusion in isotonic normal saline and carboplatin 300 mg/m 2 as infusion in 5% dextrose injection. The quality of life of the enrolled patients is based on EORTC QLQ - C30 and EORTC QLQ - LC 13 questionnaire. Prevalence of non-small cell lung cancer is more in males, 60–70 years of age. Most of the subjects were from rural areas and had only school-level education. The prevalence of non-small cell lung cancer was more with smokers, ex-smokers and patients with multiple social habits. Comorbidities also increase the risk of non-small cell lung cancer. By analyzing EORTC QLQ - C30 and EORTC QLQ - LC 13 questionnaires, it was found that diarrhea was found to be significant between the groups. Global health status and quality of life are distributed equally among each group. Quality of life and global health status are distributed equally among each sub groups.

scholarly journals Establishing anchor-based minimally important differences (MID) with the EORTC quality-of-life measures: a meta-analysis protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e019117 ◽  
Author(s):  
Zebedee Jammbe Musoro ◽  
Jean-Francois Hamel ◽  
Divine Ewane Ediebah ◽  
Kim Cocks ◽  
Madeleine T King ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Patient Data ◽  
Disease Stage ◽  
Healthcare Intervention ◽  
Life Questionnaire ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Eortc Quality

IntroductionAs patient assessment of health-related quality of life (HRQOL) in cancer clinical trials has increased over the years, so has the need to attach meaningful interpretations to differences in HRQOL scores between groups and changes within groups. Determining what represents a minimally important difference (MID) in HRQOL scores is useful to clinicians, patients and researchers, and can be used as a benchmark for assessing the success of a healthcare intervention. Our objective is to provide an evidence-based protocol to determine MIDs for the European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 (EORTC QLQ-C30). We will mainly focus on MID estimation for group-level comparisons. Responder thresholds for individual-level change will also be estimated.Methods and analysisData will be derived from published phase II and III EORTC trials that used the QLQ-C30 instrument, covering several cancer sites. We will use individual patient data to estimate MIDs for different cancer sites separately. Focus is on anchor-based methods. Anchors will be selected per disease site from available data. A disease-oriented and methodological panel will provide independent guidance on anchor selection. We aim to construct multiple clinical anchors per QLQ-C30 scale and also to compare with several anchor-based methods. The effects of covariates, for example, gender, age, disease stage and so on, will also be investigated. We will examine how our estimated MIDs compare with previously published guidelines, hence further contributing to robust MID guidelines for the EORTC QLQ-C30.Ethics and disseminationAll patient data originate from completed clinical trials with mandatory written informed consent, approved by local ethical committees. Our findings will be presented at scientific conferences, disseminated via peer-reviewed publications and also compiled in a MID ‘blue book’ which will be made available online on the EORTC Quality of Life Group website as a free guideline document.

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