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

Wendy A. Kennedy; Claudine Laurier; Jean-Luc Malo; Heberto Ghezzo; Jocelyne L'archevêque; André-Pierre Contandriopoulos

doi:10.1017/S0266462303000023

Abstract

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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.

Crossref Citations

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Argimon Pallás, Josep M.a. and Jiménez Villa, Josep 2004. Métodos de investigación clínica y epidemiológica. p. 132.

Reardon, Tim 2005. Research Findings and Strategies for Assessing Telemedicine Costs. Telemedicine and e-Health, Vol. 11, Issue. 3, p. 348.

Mason, James M and Mason, Anne R 2006. The Generalisability of Pharmacoeconomic Studies. PharmacoEconomics, Vol. 24, Issue. 10, p. 937.

Guller, Ulrich 2006. Surgical Outcomes Research Based on Administrative Data: Inferior or Complementary to Prospective Randomized Clinical Trials?. World Journal of Surgery, Vol. 30, Issue. 3, p. 255.

Shavit, Oren Leshno, Moshe Goldberger, Assaf Shmueli, Amir and Hoffman, Amnon 2007. Itʼs Time to Choose the Study Design!. PharmacoEconomics, Vol. 25, Issue. 11, p. 903.

Zeiger, Robert S. Hay, Joel W. Contreras, Richard Chen, Wansu Quinn, Virginia P. Seal, Brian and Schatz, Michael 2008. Asthma costs and utilization in a managed care organization. Journal of Allergy and Clinical Immunology, Vol. 121, Issue. 4, p. 885.

Riechelmann, Rachel P. Chin, Soo Wang, Lisa Tannock, Ian F. Berthold, Domink R. Moore, Malcolm J. and Knox, Jennifer J. 2008. Sorafenib for Metastatic Renal Cancer. American Journal of Clinical Oncology, Vol. 31, Issue. 2, p. 182.

Janson, Martin Edlund, Gunnar Kressner, Ulf Lindholm, Elisabet Påhlman, Lars Skullman, Stefan Anderberg, Bo and Haglind, Eva 2009. Analysis of patient selection and external validity in the Swedish contribution to the COLOR trial. Surgical Endoscopy, Vol. 23, Issue. 8, p. 1764.

Golomb, Beatrice A Chan, Virginia T Evans, Marcella A Koperski, Sabrina White, Halbert L and Criqui, Michael H 2012. The older the better: are elderly study participants more non-representative? A cross-sectional analysis of clinical trial and observational study samples. BMJ Open, Vol. 2, Issue. 6, p. e000833.

Zhu, Carolyn W. Sano, Mary Ferris, Steven H. Whitehouse, Peter J. Patterson, Marian B. and Aisen, Paul S. 2013. Health‐Related Resource Use and Costs in Elderly Adults with and without Mild Cognitive Impairment. Journal of the American Geriatrics Society, Vol. 61, Issue. 3, p. 396.

Chi, Benjamin H Musonda, Patrick Lembalemba, Mwila K Chintu, Namwinga T Gartland, Matthew G Mulenga, Saziso N Bweupe, Maximillian Turnbull, Eleanor Stringer, Elizabeth M and Stringer, Jeffrey SA 2014. Universal combination antiretroviral regimens to prevent mother-to-child transmission of HIV in rural Zambia: a two-round cross-sectional study. Bulletin of the World Health Organization, Vol. 92, Issue. 8, p. 582.

Twilley, Heidi and Jones, Sarahjane 2016. Heel ulcers – Pressure ulcers or symptoms of peripheral arterial disease? An exploratory matched case control study. Journal of Tissue Viability, Vol. 25, Issue. 2, p. 150.

Jones, Sarahjane 2016. Alternative perspectives of safety in home delivered health care: a sequential exploratory mixed method study. Journal of Advanced Nursing, Vol. 72, Issue. 10, p. 2536.

Rao, Anirudh MacNeill, Stephanie J van de Luijtgaarden, Moniek W M Chesnaye, Nicholas C Drechsler, Christiane Wanner, Chistoph Torino, Claudia Postorino, Maurizio Szymczak, Maciej Evans, Marie Dekker, Friedo W Jager, Kitty J Ben-Shlomo, Yoav and Caskey, Fergus J 2022. Using datasets to ascertain the generalizability of clinical cohorts: the example of the European QUALity study on the treatment of advanced chronic kidney disease. Nephrology Dialysis Transplantation, Vol. 37, Issue. 3, p. 540.

Article contents

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

Abstract

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This article has been cited by the following publications. This list is generated based on data provided by Crossref.

Article contents

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

Abstract

Keywords

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