Integrated reporting of quality and length of life--a statistician's perspective

The reporting of trials has been dominated by a concentration on single measures of response, such as survival or extent of side-effects, perhaps selected as giving an impressive P value for treatment comparisons. Relevant questions about trade-offs are seldom answered or even envisaged in the trial design. Cardiovascular trials should provide evidence on quality of life after myocardial infarction or during antihypertensive therapy. Examples from oncology are used to illustrate how the robustness of treatment recommendation can be explored through a grid of quality adjustments, ranging from complete intolerance of side-effects to absolute acceptance of them. Treatment recommendations may need to be specific to patients unless they are independent of the system of quality adjustment used.