ot: randomized controlled trials: Evaluating treatments in health care: The instability of a one-legged stool

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Evaluating treatments in health care: The instability of a one-legged

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Bonnie J Kaplan et al

/BMC Medical Research Methodology/ 2011, *11**:*65

http://www.biomedcentral.com/1471-2288/11/65

Background

Both scientists and the public routinely refer to randomized controlled

trials (RCTs) as being the 'gold standard' of scientific evidence.

Although there is no question that placebo-controlled RCTs play a

significant role in the evaluation of new pharmaceutical treatments,

especially when it is important to rule out placebo effects, they have

many inherent limitations which constrain their ability to inform

medical decision making. The purpose of this paper is to raise questions

about over-reliance on RCTs and to point out an additional perspective

for evaluating healthcare evidence, as embodied in the Hill criteria.

The arguments presented here are generally relevant to all areas of

health care, though mental health applications provide the primary

context for this essay.

Discussion

This article first traces the history of RCTs, and then evaluates five

of their major limitations: they often lack external validity, they have

the potential for increasing health risk in the general population, they

are no less likely to overestimate treatment effects than many other

methods, they make a relatively weak contribution to clinical practice,

and they are excessively expensive (leading to several additional

vulnerabilities in the quality of evidence produced). Next, the nine

Hill criteria are presented and discussed as a richer approach to the

evaluation of health care treatments. Reliance on these multi-faceted

criteria requires more analytical thinking than simply examining RCT

data, but will also enhance confidence in the evaluation of novel

treatments.

Summary

Excessive reliance on RCTs tends to stifle funding of other types of

research, and publication of other forms of evidence. We call upon our

research and clinical colleagues to consider additional methods of

evaluating data, such as the Hill criteria. Over-reliance on RCTs is

similar to resting all of health care evidence on a one-legged stool.

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