Does clinical trial subject selection restrict the ability to generalize use and cost of health services to "real life" subjects?

Authors :: Kennedy WA
Laurier C
Malo JL
Ghezzo H
L'Archevêque J
Contandriopoulos AP
Source :: International journal of technology assessment in health care [Int J Technol Assess Health Care] 2003 Winter; Vol. 19 (1), pp. 8-16.
Publication Year :: 2003
Abstract: Objectives: To explore one aspect of the external validity of the randomized controlled trial (RCT), specifically how being selected for inclusion in a trial and having participated has influenced the use and cost of asthma-related health services.<br />Methods: Services used by asthmatic users of inhaled corticosteroids (iCSTs) having previously participated in an RCT (TS, n = 46) were compared with individuals who had never participated (NS, n = 51).<br />Results: TS were more likely to use higher (> or = 400 microg) daily doses of iCSTs than NS (OR, 3.3; 95% Cl, 1.1-8.3) but less likely to visit emergency departments (OR, 0.3; 95% Cl, 0.1-0.7). Total asthma-related costs did not differ significantly.<br />Conclusions: Subject differences may impede generalizing from RCTs to real life.

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