How should we analyse hospitalizations in clinical trials

See doi:10.1016/S1095-668X(02)00384-6for the article to which this editorial refers. Heart failure is the fourth leading cause of hospitalization in the United States and the most frequent cause in the population over 65 years of age.1 Due to the rising prevalence of heart failure in the aging population, morbidity and mortality from this disease is increasing in epidemic proportions.2 While it is impossible to measure perfectly the burden of heart failure on patients, their families and society, both the acute and chronic symptoms of heart failure eventually translate into increased hospitalization time.3 Admission to hospital due to heart failure is a clinically important event and is associated with a striking increase in the risk of death.4 However, assessment of the overall impact of hospitalization is not straightforward, and one of the challenges involved in designing and performing clinical trials in these patients is to determine the mostappropriate method. Hospitalization data does not represent reporting of surrogate endpoints. Surrogate endpoints relate to biologic mechanisms involved in the disease process. In patients with heart failure these include haemodynamic measurements, arrhythmias, exercise capacity, neurohumoral profile, ejection fraction and autonomic nervous system markers.5 …