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.