Literature DB >> 12701935

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

Wendy A Kennedy1, Claudine Laurier, Jean-Luc Malo, Heberto Ghezzo, Jocelyne L'Archevêque, André-Pierre Contandriopoulos.   

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 (> 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.
CONCLUSIONS: Subject differences may impede generalizing from RCTs to real life.

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Year:  2003        PMID: 12701935     DOI: 10.1017/s0266462303000023

Source DB:  PubMed          Journal:  Int J Technol Assess Health Care        ISSN: 0266-4623            Impact factor:   2.188


  7 in total

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Review 4.  The generalisability of pharmacoeconomic studies: issues and challenges ahead.

Authors:  James M Mason; Anne R Mason
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7.  The older the better: are elderly study participants more non-representative? A cross-sectional analysis of clinical trial and observational study samples.

Authors:  Beatrice A Golomb; Virginia T Chan; Marcella A Evans; Sabrina Koperski; Halbert L White; Michael H Criqui
Journal:  BMJ Open       Date:  2012-12-14       Impact factor: 2.692

  7 in total

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