Efstathios Zikos

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.

Health-related quality of life in locally advanced and metastatic breast cancer: methodological and clinical issues in randomised controlled trials

Breast cancer is the leading cause of cancer death among women worldwide, and increasingly, randomised controlled trials of this disease are measuring the health-related quality of life of these patients. In this systematic Review, we assess the adequacy of methods used to report health-related quality of life (HRQOL) from 49 eligible randomised controlled trials of advanced breast cancer. We compare our findings with those from the literature to investigate whether the standard of HRQOL reporting in this field has changed. We conclude that the overall reporting of HRQOL has improved, but some crucial aspects remain problematic, such as the absence of HRQOL research hypotheses and the overemphasis on statistical rather than clinical significance. Additionally, new challenges are arising with the emergence of novel treatments and the advent of personalised medicine, and improved HRQOL tools are required to cover the range of side-effects of newer therapies.

A systematic review of the quality of statistical methods employed for analysing quality of life data in cancer randomised controlled trials

AIMS Over the last decades, Health-related Quality of Life (HRQoL) end-points have become an important outcome of the randomised controlled trials (RCTs). HRQoL methodology in RCTs has improved following international consensus recommendations. However, no international recommendations exist concerning the statistical analysis of such data. The aim of our study was to identify and characterise the quality of the statistical methods commonly used for analysing HRQoL data in cancer RCTs. METHODS Building on our recently published systematic review, we analysed a total of 33 published RCTs studying the HRQoL methods reported in RCTs since 1991. We focussed on the ability of the methods to deal with the three major problems commonly encountered when analysing HRQoL data: their multidimensional and longitudinal structure and the commonly high rate of missing data. RESULTS All studies reported HRQoL being assessed repeatedly over time for a period ranging from 2 to 36 months. Missing data were common, with compliance rates ranging from 45% to 90%. From the 33 studies considered, 12 different statistical methods were identified. Twenty-nine studies analysed each of the questionnaire sub-dimensions without type I error adjustment. Thirteen studies repeated the HRQoL analysis at each assessment time again without type I error adjustment. Only 8 studies used methods suitable for repeated measurements. CONCLUSION Our findings show a lack of consistency in statistical methods for analysing HRQoL data. Problems related to multiple comparisons were rarely considered leading to a high risk of false positive results. It is therefore critical that international recommendations for improving such statistical practices are developed.

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.