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

2014 ◽  
Vol 15 (2) ◽  
pp. e78-e89 ◽  
Author(s):  
Efstathios Zikos ◽  
Irina Ghislain ◽  
Corneel Coens ◽  
Divine E Ediebah ◽  
Elizabeth Sloan ◽  
...  
2003 ◽  
Vol 21 (15) ◽  
pp. 2982-2992 ◽  
Author(s):  
Andrew Bottomley ◽  
Fabio Efficace ◽  
Ronald Thomas ◽  
Veerle Vanvoorden ◽  
Sam H. Ahmedzai

Purpose: Non–small-cell lung cancer (NSCLC), a leading cause of cancer-related deaths in both developed and developing countries, heavily impacts patient health-related quality of life (HRQOL). Although recent research has found many positive and significant steps in randomized controlled trials (RCTs) in which HRQOL has been used as an outcome, questions remain regarding methodologic quality and impact value of HRQOL outcome assessments in some RCTs. To date, no detailed systematic review exists of HRQOL methodology in NSCLC RCTs. Methods: A systematic review using Cochrane methodology evaluated HRQOL components in RCTs. Identified studies were evaluated independently by three reviewers on a broad set of predetermined criteria. Results: Twenty-nine published RCTs (NSCLC patient samples total, N = 8,445) with an HRQOL component were identified. Although most trials exhibited good-quality research and useful HRQOL and clinical data, the weaknesses identified in some trials include such common limitations as no clear hypothesis, lack of a clear approach to missing data and data analysis, and limited presentation of results. Conclusion: Although it is clear that HRQOL is an important end point in NSCLC RCTs because the information helps to influence treatment recommendations, the identified weaknesses in conducting HRQOL measurement in NSCLC RCTs and the reporting of results need to be addressed.


2011 ◽  
Vol 29 (15) ◽  
pp. 2104-2120 ◽  
Author(s):  
Lily Claassens ◽  
Jan van Meerbeeck ◽  
Corneel Coens ◽  
Chantal Quinten ◽  
Irina Ghislain ◽  
...  

Purpose This study is an update of a systematic review of health-related quality-of-life (HRQOL) methodology reporting in non–small-cell lung cancer (NSCLC) randomized controlled trials (RCTs). The objective was to evaluate HRQOL methodology reporting over the last decade and its benefit for clinical decision making. Methods A MEDLINE systematic literature review was performed. Eligible RCTs implemented patient-reported HRQOL assessments and regular oncology treatments for newly diagnosed adult patients with NSCLC. Included studies were published in English from August 2002 to July 2010. Two independent reviewers evaluated all included RCTs. Results Fifty-three RCTs were assessed. Of the 53 RCTs, 81% reported that there was no significant difference in overall survival (OS). However, 50% of RCTs that were unable to find OS differences reported a significant difference in HRQOL scores. The quality of HRQOL reporting has improved; both reporting of clinically significant differences and statistical testing of HRQOL have improved. A European Organisation for Research and Treatment of Cancer HRQOL questionnaire was used in 57% of the studies. However, reporting of HRQOL hypotheses and rationales for choosing HRQOL instruments were significantly less than before 2002 (P < .05). Conclusion The number of NSCLC RCTs incorporating HRQOL assessments has considerably increased. HRQOL continues to demonstrate its importance in RCTs, especially in those studies in which no OS difference is found. Despite the improved quality of HRQOL methodology reporting, certain aspects remain underrepresented. Our findings suggest need for an international standardization of HRQOL reporting similar to the CONSORT guidelines for clinical findings.


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