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"Pragmatic" clinical trials: from whose perspective?
1 University of Western Ontario; London, Ontario, Canada
2 Mayo Clinic; Rochester, Minnesota, USA
3 McMaster University, Hamilton, Ontario, Canada
| The first 150 words of the full text of this article appear below. |
Over the past 40 years, methodologists have become increasingly enthusiastic about conducting "pragmatic" clinical trials, which aim to simulate real-world settings as much as possible.1 In contrast to explanatory trials that are conducted under idealised circumstances, successful pragmatic trials will have the intended benefit of directly informing healthcare decision making. We wholeheartedly support the notion that, to the extent possible, trials should inform real-world decisions. In this editorial, we will, however, argue that the current conceptualisation of pragmatic trials sometimes serves the needs of only a small proportion of healthcare decision makers. Furthermore, a truly pragmatic or practical trial requires that clinical trialists carefully define the real-world context to which they hope their results apply, and design their trials accordingly.2
Authors’ descriptions of pragmatic trials have varied slightly, but most agree that such trials should enrol all patients to whom healthcare providers might offer the intervention, allow clinicians
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