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

  • Wendy A. Kennedy (a1), Claudine Laurier (a1), Jean-Luc Malo (a2), Heberto Ghezzo (a3), Jocelyne L'archevêque (a2) and André-Pierre Contandriopoulos (a1)...
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.

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International Journal of Technology Assessment in Health Care
  • ISSN: 0266-4623
  • EISSN: 1471-6348
  • URL: /core/journals/international-journal-of-technology-assessment-in-health-care
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