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DOES CLINICAL TRIAL SUBJECT SELECTION RESTRICT THE ABILITY TO GENERALIZE USE AND COST OF HEALTH SERVICES TO “REAL LIFE” SUBJECTS?

Published online by Cambridge University Press:  22 January 2003

Wendy A. Kennedy ,
Claudine Laurier ,
Jean-Luc Malo ,
Heberto Ghezzo ,
Jocelyne L'archevêque  and
André-Pierre Contandriopoulos
Wendy A. Kennedy
Affiliation:
University of Montreal
Claudine Laurier
Affiliation:
University of Montreal
Jean-Luc Malo
Affiliation:
Hôpital du Sacré Coeur de Montréal
Heberto Ghezzo
Affiliation:
Meakins Christie Laboratories
Jocelyne L'archevêque
Affiliation:
Hôpital du Sacré Coeur de Montréal
André-Pierre Contandriopoulos
Affiliation:
University of Montreal
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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.

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).

Results: TS were more likely to use higher (≥400 μg) daily doses of iCSTs than NS (OR, 3.3; 95% CI, 1.1–8.3) but less likely to visit emergency departments (OR, 0.3; 95% CI, 0.1–0.7). Total asthma-related costs did not differ significantly.

Conclusions: Subject differences may impede generalizing from RCTs to real life.

Keywords

Clinical trialEconomic evaluationAsthmaCost-effectiveness
Type
GENERAL ESSAYS
Information
International Journal of Technology Assessment in Health Care , Volume 19 , Issue 1 , January 2003 , pp. 8 - 16
Copyright
© 2003 Cambridge University Press

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