Divine E. Ediebah

A global analysis of multitrial data investigating quality of life and symptoms as prognostic factors for survival in different tumor sites.

The objective of this study was to examine the prognostic value of baseline health‐related quality of life (HRQOL) for survival with regard to different cancer sites using 1 standardized and validated patient self‐assessment tool.

Does change in health-related quality of life score predict survival? Analysis of EORTC 08975 lung cancer trial

Background:Little is known about whether changes in health-related quality of life (HRQoL) scores from baseline during treatment also predict survival, which we aim to investigate in this study.Methods:We analysed data from 391 advanced non-small-cell lung cancer (NSCLC) patients enrolled in the EORTC 08975 study, which compared palliative chemotherapy regimens. HRQoL was assessed at baseline and after each chemotherapy cycle using the EORTC QLQ-C30 and QLQ-LC13. The prognostic significance of HRQoL scores at baseline and their changes over time was assessed with Cox regression, after adjusting for clinical and socio-demographic variables.Results:After controlling for covariates, every 10-point increase in baseline pain and dysphagia was associated with 11% and 12% increased risk of death with hazard ratios (HRs) of 1.11 and 1.12, respectively. Every 10-point improvement of physical function at baseline (HR=0.93) was associated with 7% lower risk of death. Every 10-point increase in pain (HR=1.08) was associated with 8% increased risk of death at cycle 1. Every 10-point increase in social function (HR=0.91) at cycle 2 was associated with 9% lower risk of death.Conclusions:Our findings suggest that changes in HRQoL scores from baseline during treatment, as measured on subscales of the EORTC QLQ-C30 and QLQ-LC13, are significant prognostic factors for survival.

Health-related quality of life in small-cell lung cancer: a systematic review on reporting of methods and clinical issues in randomised controlled trials

Small-cell lung cancer represents about 15% of all lung cancers; increasingly, randomised controlled trials of this disease measure the health-related quality of life of patients. In this Systematic Review we assess the adequacy of reporting of health-related quality-of-life methods in randomised controlled trials of small-cell lung cancer, and the potential effect of this reporting on clinical decision making. Although overall reporting of health-related quality of life was acceptable, improvements are needed to optimise the use of health-related quality of life in randomised controlled trials.

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

Introduction As 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 analysis Data 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 dissemination All 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.

Quality of life as a prognostic indicator of survival: A pooled analysis of individual patient data from canadian cancer trials group clinical trials: Quality of Life as a Prognostic Indicator

The aims of this study were to externally validate an established association between baseline health‐related quality of life (HRQOL) scores and survival and to assess the added prognostic value of HRQOL with respect to demographic and clinical indicators.

Measuring the Quality of Life of Patients with Cancer

© Touch MEdical MEdia 2013 Abstract What is quality of life? clinical trials have long been dominated by clinically based endpoints, but research has proved that health-related quality of life (hRQol) can only be captured accurately by patients themselves using patient reported outcomes (PRos). The united States Food and drug administration defines PRos as the measurement of any aspect of a patient’s health status that comes directly from the patient, that is, a measurement taken without interpretation of the patient’s responses by a physician or anyone else. The EoRTc QlQ-c30 is the most widely cancer specific hRQol questionnaire used for PRos in the world. developed in 1991 by the EoRTc Quality of life Group, it has been translated into more than 60 languages and has over 40 developed or under development cancer specific modules. one of the key challenges faced is pooling data and performing meta-analyses of the results of closed trials. The EoRTc Patient Reported outcomes and Behavioural Evidence (PRoBE) team is dedicated to the meta-analysis of EoRTc randomised clinical trial quality of life results. during the last five years, pooled data have revealed important results, such as prognostic indicators of survival, which have informed clinical practice. This research shows how the patient perspective in palliative and curative EoRTc trials has been considered of major importance. The inclusion of patient perspective in drug development shows that a more comprehensive hRQol assessment has taken place over time as better instruments have become available. as clinicians, regulatory bodies and industry acknowledge the value of the patient perspective, we expect that EoRTc will continue including hRQol endpoints where appropriate.