Complementing the randomized controlled trial evidence base: Evolution not revolution

David Price, Eric D. Bateman, Alison Chisholm, Nikolaos G. Papadopoulos, Sinthia Bosnic-Anticevich, Emilio Pizzichini, Elizabeth V. Hillyer, A. Sonia Buist

Research output: Contribution to journalArticle

35 Scopus citations

Abstract

Observational studies and pragmatic trials can complement classical randomized controlled trials (RCTs) by providing data more relevant to the circumstances under which medicine is routinely practiced, thereby providing practical guidance for clinicians. The bearing of RCT findings on day-to-day practice can be weighted and the data more meaningfully interpreted by practicing clinicians if evidence is integrated from a variety of different study designs and methodologies. The advent of observational studies and pragmatic trials, often referred to as "real-life studies," has met with a degree of cynicism, but their role and value is gaining widespread recognition and support among clinicians. This article discusses where observational studies and pragmatic trials have utility, namely: in addressing clinical questions that are unanswered and/or unanswerable by RCTs; in testing new hypotheses and possible license extensions; and in helping to differentiate between available therapies for a given indication. Moreover, it seeks to highlight how the different approaches fit within a conceptual framework of evidence relevant to clinical practice, a step-change in the traditional view of medical evidence.

Original languageEnglish (US)
Pages (from-to)S92-S98
JournalAnnals of the American Thoracic Society
Volume11
Issue numberSUPPL. 2
DOIs
StatePublished - Feb 2014

Keywords

  • Complementary
  • Integrated evidence base
  • Observational study
  • Pragmatic trial
  • Randomized controlled trial

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

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  • Cite this

    Price, D., Bateman, E. D., Chisholm, A., Papadopoulos, N. G., Bosnic-Anticevich, S., Pizzichini, E., Hillyer, E. V., & Buist, A. S. (2014). Complementing the randomized controlled trial evidence base: Evolution not revolution. Annals of the American Thoracic Society, 11(SUPPL. 2), S92-S98. https://doi.org/10.1513/AnnalsATS.201308-276RM