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Health-Related Quality of Life in Non–Small-Cell Lung Cancer: Methodologic Issues in Randomized Controlled Trials

Andrew Bottomley, Fabio Efficace, Ronald Thomas, Veerle Vanvoorden, Sam H. Ahmedzai

From the Quality of Life Unit, European Organization for Research and Treatment of Cancer Data Center, Brussels, Belgium; Clinical Consultant, Palmerston North, New Zealand; Academic Palliative Medicine Unit, and University of Sheffield, Royal Hallamshire Hospital, Sheffield, United Kingdom.

Address reprint requests to Andrew Bottomley, PhD, Coordinator, Quality of Life Unit, European Organization for Research and Treatment of Cancer Data Center, Avenue E. Mounier 83/11, 1200 Brussels, Belgium; email: abo{at}eortc.be.

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.

F. Efficace supported by the Camilla Samuel Fellowship in Memory of Lady Grierson.

The contents of this article are solely the views of the authors and do not necessarily represent the official views of the respective organizations.

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