TY - JOUR
T1 - Complementing the randomized controlled trial evidence base
T2 - Evolution not revolution
AU - Price, David
AU - Bateman, Eric D.
AU - Chisholm, Alison
AU - Papadopoulos, Nikolaos G.
AU - Bosnic-Anticevich, Sinthia
AU - Pizzichini, Emilio
AU - Hillyer, Elizabeth V.
AU - Buist, A. Sonia
N1 - Copyright:
Copyright 2014 Elsevier B.V., All rights reserved.
PY - 2014/2
Y1 - 2014/2
N2 - 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.
AB - 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.
KW - Complementary
KW - Integrated evidence base
KW - Observational study
KW - Pragmatic trial
KW - Randomized controlled trial
UR - http://www.scopus.com/inward/record.url?scp=84898748102&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84898748102&partnerID=8YFLogxK
U2 - 10.1513/AnnalsATS.201308-276RM
DO - 10.1513/AnnalsATS.201308-276RM
M3 - Article
C2 - 24559027
AN - SCOPUS:84898748102
SN - 2325-6621
VL - 11
SP - S92-S98
JO - Annals of the American Thoracic Society
JF - Annals of the American Thoracic Society
IS - SUPPL. 2
ER -