It is important to identify unknown and unquantified benefits and risk
s of therapeutic intervention that are reflected in the quality of lif
e. This is especially important when the benefit : risk analysis is no
t clearly in favour of treatment. Quality of Life is defined and targe
t areas identified. The steps in the measurements of quality of life a
re discussed, including the validity, repeatability and sensitivity to
change of existing methods; their acceptability, analytical problems;
the presentation of the results; and the use of the results in econom
ic evaluations. The Sickness Impact Profile, the Nottingham Health Pro
file and the Quality of Well-Being scale are compared for the assessme
nt of patients with angina. The advantages and disadvantages of each i
s discussed together with the results from a double-blind trial of tre
atment in angina where the Sickness Impact Profile was employed. Gener
ic and disease-specific instruments are compared. The advantages and d
isadvantages of economic evaluations employing quality-of-life outcome
s are discussed. Methods should be employed that withstand rigorous sc
ientific evaluation. Both a health profile and a summary statistic suc
h as a Health Status Index should be measured. If different treatments
are to be compared, a randomised controlled trial should be employed.
If the more expensive treatment is likely to be superior then costs s
hould be collected and a cost-utility analysis performed.